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Archive for the ‘Peripheral Arterial Disease & Peripheral Vascular Surgery’ Category

Genetics of Aortic and Carotid Calcification: The Role of Serum Lipids

Reporter: Aviva Lev-Ari, PhD, RN

Genetic Loci for Coronary Calcification and Serum Lipids Relate to Aortic and Carotid Calcification

Daniel Bos, MD, M. Arfan Ikram, MD, PhD, Aaron Isaacs, PhD, Benjamin F.J. Verhaaren, MD, Albert Hofman, MD, PhD, Cornelia M. van Duijn, PhD, Jacqueline C.M. Witteman, PhD, Aad van der Lugt, MD, PhD and Meike W. Vernooij, MD, PhD

Author Affiliations

From the Departments of Radiology (D.B., M.A.I., B.F.J.V., A.v.d.L., M.W.V), Epidemiology (D.B., M.A.I., A.I., B.F.J.V., A.H., C.M.v.D., J.C.M.W., M.W.V.), and Genetic Epidemiology Unit (A.I., C.M.v.D.), Erasmus MC, Rotterdam, the Netherlands.

Correspondence to Meike W. Vernooij, MD, PhD, Department of Radiology, Erasmus MC, Gravendijkwal 230, PO Box 2040, 3000CA Rotterdam, the Netherlands. E-mailm.vernooij@erasmusmc.nl

Abstract

Background—Atherosclerosis in different vessel beds shares lifestyle and environmental risk factors. It is unclear whether this holds for genetic risk factors. Hence, for the current study genetic loci for coronary artery calcification and serum lipid levels, one of the strongest risk factors for atherosclerosis, were used to assess their relation with atherosclerosis in different vessel beds.

Methods and Results—From 1987 persons of the population-based Rotterdam Study, 3 single-nucleotide polymorphisms (SNPs) for coronary artery calcification and 132 SNPs for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol or triglycerides were used. To quantify atherosclerotic calcification as a marker of atherosclerosis, all participants underwent nonenhanced computed tomography of the aortic arch and carotid arteries. Associations between genetic risk scores of the joint effect of the SNPs and of all calcification were investigated. The joint effect of coronary artery calcification–SNPs was associated with larger calcification volumes in all vessel beds (difference in calcification volume per SD increase in genetic risk score: 0.15 [95% confidence interval, 0.11–0.20] in aorta, 0.14 [95% confidence interval, 0.10–0.18] in extracranial carotids, and 0.11 [95% confidence interval, 0.07–0.16] in intracranial carotids). The joint effect of total cholesterol SNPs, low-density lipoprotein SNPs, and of all lipid SNPs together was associated with larger calcification volumes in both the aortic arch and the carotid arteries but attenuated after adjusting for the lipid fraction and lipid-lowering medication.

Conclusions—The genetic basis for aortic arch and carotid artery calcification overlaps with the most important loci of coronary artery calcification. Furthermore, serum lipids share a genetic predisposition with both calcification in the aortic arch and the carotid arteries, providing novel insights into the cause of atherosclerosis.

 SOURCE:

Circulation: Cardiovascular Genetics.2013; 6: 47-53

Published online before print December 16, 2012,

doi: 10.1161/ CIRCGENETICS.112.963934

 

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St. Jude’s CEO is still betting on EnligHTN IV Study Renal Denervation System, despite Medtronic’s setback related to SYMPLICITY Phase IV

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #92: St. Jude’s CEO is still betting on EnligHTN IV Study Renal Denervation System, despite Medtronic’s setback related to SYMPLICITY Phase IV. Published on 12/10/2013

WordCloud Image Produced by Adam Tubman

UPDATED on 1/14/2014

This is in continuation to our 1/9/2014 article:

Market Impact on Global Suppliers of Renal Denervation Systems by Pivotal US Trial: Metronics’ Symplicity Renal Denervation System FAILURE at Efficacy Endpoint

http://pharmaceuticalintelligence.com/2014/01/09/market-impact-on-global-suppliers-of-renal-denervation-systems-by-pivotal-us-trial-metronics-symplicity-renal-denervation-system-failure-at-efficacy-endpoint/

In the short term, the company, St. Jude suspended enrollment in three other related trials and announced plans to gather an independent panel of experts to plot a future course. 

St. Jude Medical won a CE mark for its next-gen EnligHTN IV renal denervation system over the summer, but halted its own U.S. trial in December. Minnesota-based St. Jude said it had struggled to recruit viable candidates for the 590-patient trial, and was concerned that Medtronic’s Symplicity might siphon off viable patients needed for its own study. At the time, St. Jude said it would work to develop a new protocol to address trial enrollment challenges.

According to Mark Hollmer:

Symplicity’s setbacks may make that job much easier for St. Jude. They also create new opportunities for other rivals focused on developing similar technology, such as Boston Scientific ($BSX) and Covidien ($COV).

Curator of this article has expressed a different view in 

http://pharmaceuticalintelligence.com/2014/01/09/market-impact-on-global-suppliers-of-renal-denervation-systems-by-pivotal-us-trial-metronics-symplicity-renal-denervation-system-failure-at-efficacy-endpoint/

St. Jude’s CEO is still betting on renal denervation, despite Medtronic’s setback

By Mark Hollmer

Medtronic’s Symplicity renal denervation device

If Medtronic’s ($MDT) recent U.S. clinical trial failure for its Symplicity renal denervation device throws the door wide open for its competitors, St. Jude Medical ($STJ) will likely waste no time walking through.

As MassDevice reported, St. Jude CEO Daniel Starks told an audience at the JPMorgan Healthcare conference in San Francisco that the company plans to keep plowing ahead with the development of its own technology.

“The fact that we had and that there have been favorable early clinical results in numerous other experiences is still valid,” MassDevice quoted Starks as saying. “There is open surgical data dating back several decades that was favorable to the impact of surgical renal denervation to treat hypertension.

That said, he also expressed genuine surprise about Medtronic’s trial setback.

“This was unexpected for us, to have a negative result from Medtronic’s trial, and it’s too soon for us to know what to make of that,” Starks said in the story.

Medtronic’s Symplicity device, which has a CE mark and is a market leader, had done well in previous trials in patients with different forms of hypertension and was on track to win FDA approval in 2015–potentially the first renal denervation device to reach that point.

The Minnesota device giant announced a few days ago that Symplicity proved safe in a 535-patient trial but failed to significantly lower blood pressure for drug-resistant hypertension.

This was a trial that mattered, designed to help fuel FDA approval.

Related Articles:

Medtronic’s flunked trial throws its hypertension program into doubt

St. Jude Medical will try again another day for a U.S. renal denervation study

St. Jude bags EU approval for next-gen renal denervation

 SOURCE

From: FierceMedicalDevices <editors@fiercemedicaldevices.com>
Date: Tue, 14 Jan 2014 18:14:06 +0000 (GMT)
To: <avivalev-ari@alum.berkeley.edu>

Renal Denervation: EnligHTN IV Study Called Off and Potential Novel Indications – Diastolic Heart Failure

Reporter: Aviva Lev-Ari, PhD, RN

This Open Access Scientific Journal has covered all the major developments reported on Renal Denervation since its inception

The Archive for Renal denervation

http://pharmaceuticalintelligence.com/category/cardiac-and-cardiovascular-surgical-procedures/renal-denervation/

Search Results for Renal Denervation

http://pharmaceuticalintelligence.com/?s=Renal+denervation

Heartwire Reported on December 09, 2013

EnligHTN IV Renal Denervation Study Called Off

ST PAUL, MN – The EnligHTN IV study (St Jude Medical, St Paul, MN), testing the multielectrode renal-denervation system in patients with resistant hypertension, has been stopped almost before it even began. The trial, which was announced in June and began enrolling a small number of patients this fall, was canceled because of concerns about slow enrollment.

To heartwire ,

Denise Perkins-Landry, a spokesperson for St Jude Medical, said the decision to discontinue the study was based on “anticipated recruitment challenges” and is not the result of any safety or efficacy issues with the device. “A US clinical trial for EnligHTN remains a very high priority for St Jude Medical, and we will be working with the FDA to develop a new protocol that will address anticipated enrollment challenges,” she stated in an email.

The full results of the SYMPLICITY HTN-3 trial, a study similar to the EnligHTN IV study, which is sponsored by Medtronic (Minneapolis, MN), are expected in early 2014. While neither device is approved for clinical use in the US, it is expected that the Medtronic renal-denervation system will be first. As a result, it might be difficult to enroll patients to a sham procedure if there is another commercially available system for treating resistant hypertension, according to St Jude.

EnligHTN IV was to be a randomized, single-blind, controlled study with patients randomized from as many as 80 clinical centers in the US and Canada. It was intended to show the safety and effectiveness of the renal-denervation system in the reduction of systolic blood pressure in 590 patients with an office blood pressure >160 mm Hg despite taking three or more antihypertensive medications, including a diuretic.

Abrupt Decision to Stop the Study

Dr William White (University of Connecticut Medical Center, Farmington), one of the cochairs of the EnligHTN IV steering committee, told heartwire the decision to cancel the study was made just last week. In fact, there were clinical centers already up and running in terms of enrollment, although these were pilot centers where any “bugs could be worked out.” The meeting for training investigators participating in the trial was scheduled for Saturday in Chicago, IL, although that is now off.

“In the grander scheme of things, I can tell you that the decision was not made because of any problem with the catheter or any safety issues,” said White. “Outside the US, the development is continuing as planned, but the biggest concern is that it might be very difficult, if not impossible, to continue doing a sham-controlled study a year from now if there were a commercially available renal-denervation catheter in the US, which there very well could be with Medtronic.”

Still, White said that it’s not even known if the SYMPLICITY HTN-3 study is positive or if the FDA will be satisfied with the trial and its outcomes. He said a lot of assumptions are being made by St Jude Medical in stopping the trial, and it could turn out to be a bad decision. In addition, reimbursement remains an open question.

“Commercially available doesn’t mean there’s going to be a payer,” White told heartwire . “If that happens, it will be doubly unfortunate for the patients that are out there because they might be willing and able to go into a clinical trial but they won’t have that opportunity.”

As a scientist, White said that he would have preferred the trial be pursued, regardless of what happens with Medtronic. He believes the EnligHTN catheter is “outstanding,” as it has multiple electrodes to enable physicians to thoroughly ablate the renal arteries within a couple of minutes. “The clinical scientist in me would have preferred that we go ahead as planned,” he said. “I think we would have gained a great deal of knowledge. And just because one study shows a p value of 0.05 doesn’t mean a second study will.”

The Medtronic SYMPLICITY renal-denervation system was launched in 2010 and is available in parts of Europe, Asia, Africa, and South America. The first-generation EnligHTN device has had CE Mark approval in Europe since 2012 while the updated second-generation system with multiple electrodes received European approval this past summer.

News of the halting of EnligHTN IV was first reported by Wells Fargo analyst Larry Biegelsen.

SOURCE

http://www.medscape.com/viewarticle/817482?nlid=41903_2105&src=wnl_edit_medp_card&uac=93761AJ&spon=2

On December 06, 2013 Marlene Busko reported to Heartwire on

Renal Denervation’s Structural, Functional Heart Benefits May Be Independent of BP

HAMBURG, GERMANY — In a small study of patients undergoing renal denervation for resistant hypertension, left-ventricular hypertrophy and diastolic function improved independently of changes in blood pressure and heart rate [1].

“The novelty of our findings is the independence of morphologic improvements [regression of LV hypertrophy] from hemodynamic changes (reduction of blood pressure and heart rate),” Dr Stephan H Schirmer (University of Saarland, Hamburg, Germany) told heartwire in an email. “If this is confirmed in larger trials, it might open up novel indications for the use of renal denervation, for example, in [diastolic] heart-failure patients, independent of blood pressure.”

Dr Deepak L Bhatt (Harvard Medical School, Boston, MA) told heartwire that the study observations are “provocative” and “exciting” but stressed that they need to be confirmed in a blinded, larger, multicenter study before they could be accepted into clinical practice. Bhatt and Dr George Bakris (University of Chicago, IL) are co–principal investigators for the ongoing SYMPLICITY HTN-3 trial of bilateral renal denervation in patients with uncontrolled hypertension.

The study was published online December 4, 2013 in the Journal of the American College of Cardiology.

Are Renal Denervation Effects Always Tied to BP Change?

Renal denervation reduces heart rate and blood pressure in patients with resistant hypertension, and as reported by heartwire , a recent small study suggested that the procedure also reduces left-ventricular mass and improves diastolic function in such patients, Schirmer and colleagues write.

They hypothesized that renal denervation might affect cardiac structure and function, independent of the effect on blood pressure.

They enrolled 66 consecutive patients who underwent renal denervation using the Flex catheter system (Medtronic) at their center during 2010 and 2011 for treatment of resistant hypertension (office systolic blood pressure >140 mm Hg). Patients had a mean age of 64 years, and 55% were men. They were on a mean of 4.3 antihypertensive drugs. All were taking a diuretic, 89% were taking a beta-blocker, and 55% were taking an angiotensin-receptor blocker.

Six months after renal denervation,

  • Mean blood pressure decreased from 172.9/92.5 to 151.3/85.5 mm Hg, confirmed by 24-hour ambulatory monitoring, if available (n=50).
  • Mean heart rate decreased from 67.7 to 60.5 bpm.
  • Mean left-ventricular mass index decreased from 61.5 to 53.4 g/m2.
  • Measures of diastolic function also improved.

The changes in cardiac function and ventricular size were not tied to the magnitude of the blood-pressure reduction, which “suggest[s] a direct effect of the sympathetic nervous system on myocardial morphology and function,” Schirmer and colleagues write. They call for further research to investigate functional cardiovascular benefits of renal denervation beyond blood-pressure reduction.

Promising Early Benefit, Needs Confirmation

In an accompanying editorial [2], Bakris and Dr Sandeep Nathan (University of Chicago) commend Schirmer and colleagues “for providing promising early benefit of catheter-based renal denervation and for highlighting a possible blood-pressure–independent facet of this technique.” However, they caution that although the findings are “intriguing,” the study’s limitations include that it was

  • relatively small,
  • conducted at a single center,
  • lacked a sham control, and
  • relied on echocardiography rather than magnetic resonance imaging.

Therefore, “these observations need confirmation before acceptance in clinical practice . . . and can only be applied to those with inclusion criteria used in their study,” the editorialists conclude.

“It’s an exciting, provocative result, and there’s a good chance that it will stand the test of time, but I still think in general, it’s best to be cautious about new technologies and relatively small studies, because time typically shows that they provide an overestimate of what the true effects will be,” Bhatt commented when interviewed.

“Whether the reduction in left-ventricular mass is beyond what would be anticipated with blood-pressure and heart-rate reduction—certainly this analysis suggests that is a possibility—needs to be confirmed in larger studies,” he added, echoing the authors and editorialists.

Potentially referring physicians, in the United States where the procedure is investigational, and even in Europe where it’s approved, appear to be waiting for the results of SYMPLICITY HTN-3, Bhatt said. This blinded, randomized, multicenter trial will provide a clearer picture of what sort of blood-pressure reductions are achievable in patients with resistant hypertension who undergo renal denervation. Results are expected by mid-2014.

References

  1. Schirmer SH, Sayed M, Reil J-C, et al. Improvements of left-ventricular hypertrophy and diastolic function following renal denervation – Effects beyond blood pressure and heart rate reduction. J Am Coll Cardiol 2013; DOI:10.1016/j.jacc.2013.10.073. Abstract
  2. Bakris G, Nathan S. Renal denervation and left ventricular mass regression: A benefit beyond blood pressure reduction? J Am Coll Cardiol 2013; DOI:10.1016/j.jacc.2013.11.015. Editorial

SOURCE

This Open Access Scientific Journal has covered all the major developments reported on Renal Denervation since its inception

The Archive for Renal denervation

http://pharmaceuticalintelligence.com/category/cardiac-and-cardiovascular-surgical-procedures/renal-denervation/

Search Results for Renal Denervation

http://pharmaceuticalintelligence.com/?s=Renal+denervation

For the ORIGINAL work on 

Renal Sympathetic Denervation: Updates on the State of Medicine

the Readers is called to go to the ORIGINAL SOURCES listed below:

Intravascular Stimulation of Autonomics: A Letter from Dr. Michael Scherlag

http://pharmaceuticalintelligence.com/2012/09/02/intravascular-stimulation-of-autonomics-a-letter-from-dr-michael-scherlag/

Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

http://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

Interaction of Nitric Oxide and Prostacyclin in Vascular Endothelium

http://pharmaceuticalintelligence.com/2012/09/14/interaction-of-nitric-oxide-and-prostacyclin-in-vascular-endothelium/

Absorb™ Bioresorbable Vascular Scaffold: An International Launch by Abbott Laboratories

http://pharmaceuticalintelligence.com/2012/09/29/absorb-bioresorbable-vascular-scaffold-an-international-launch-by-abbott-laboratories/

The Molecular Biology of Renal Disorders: Nitric Oxide – Part III

http://pharmaceuticalintelligence.com/2012/11/26/the-molecular-biology-of-renal-disorders/

Treatment of Refractory Hypertension via Percutaneous Renal Denervation

http://pharmaceuticalintelligence.com/2012/06/13/treatment-of-refractory-hypertension-via-percutaneous-renal-denervation/

Renal Denervation Technology of Vessix Vascular, Inc. been acquired by Boston Scientific Corporation (BSX) to pay up to $425 Million

http://pharmaceuticalintelligence.com/2012/11/08/renal-denervation-technology-of-vessix-vascular-inc-been-acquired-by-boston-scientific-corporation-bsx-to-pay-up-to-425-million/

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Resistance Hypertension: Renal Artery Intervention using Stenting

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED 2/4/2014

Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis

Christopher J. Cooper, M.D., Timothy P. Murphy, M.D., Donald E. Cutlip, M.D., Kenneth Jamerson, M.D., William Henrich, M.D., Diane M. Reid, M.D., David J. Cohen, M.D., Alan H. Matsumoto, M.D., Michael Steffes, M.D., Michael R. Jaff, D.O., Martin R. Prince, M.D., Ph.D., Eldrin F. Lewis, M.D., Katherine R. Tuttle, M.D., Joseph I. Shapiro, M.D., M.P.H., John H. Rundback, M.D., Joseph M. Massaro, Ph.D., Ralph B. D’Agostino, Sr., Ph.D., and Lance D. Dworkin, M.D. for the CORAL Investigators

N Engl J Med 2014; 370:13-22 January 2, 2014DOI: 10.1056/NEJMoa1310753

BACKGROUND

Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain.

METHODS

We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy).

RESULTS

Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (−2.3 mm Hg; 95% CI, −4.4 to −0.2; P=0.03).

CONCLUSIONS

Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.)

SOURCE

http://www.nejm.org/doi/full/10.1056/NEJMoa1310753

based on

What Do CORAL and ERASE Mean for Peripheral Intervention?

Seth Bilazarian, MD, Mark A. Creager, MD

November 27, 2013

Seth Bilazarian, MD: Hi. I’m Seth Bilazarian from the heart.org on Medscape. I’m here at the American Heart Association Scientific Sessions in Dallas with Dr. Mark Creager, Director of Vascular Medicine at Brigham and Women’s Hospital in Boston. Dr. Creager was the moderator of a session enriched with peripheral vascular disease topics yesterday. And I’m fortunate to be with him to unpack 2 of those studies: the ERASE study,[1] a study of peripheral artery disease in the lower extremities and exercise; and the CORAL study,[2] a study of renal artery intervention using stenting.

As a practicing endovascular medicine physician, I’m excited to get Dr. Creager’s take on this. The CORAL study, to start with, was a study that was sponsored by the NHLBI (National Heart, Lung, and Blood Institute), -looking at patients who had greater than 60% stenosis who had resistant hypertension or renal insufficiency and were optimally treated with medical therapy. The patients were given free antihypertensive therapies and statin therapy. And that alone was compared with medical therapy plus renal artery intervention with stenting.

Dr. Creager, can you summarize the take-home message and the results for our audience?

Mark A. Creager, MD: Thank you, Seth. This was an important study. The CORAL study compared these 2 groups, and the primary endpoints were cardiovascular and renal death, hospitalization for congestive heart failure, stroke, myocardial infarction, progressive renal insufficiency, and renal replacement therapy. The trial found that there was no significant difference in this primary composite endpoint between the 2 groups.

That’s an important message: that if we treat our patients with hypertension and renal insufficiency who have concomitant renal artery stenosis with appropriate medical therapy, they will do as well — in terms of cardiovascular and renal endpoints — as those who undergo renal artery stenting.

Dr. Bilazarian: A very strong message that stenting adds nothing, if we take home the short answer that renal stenting adds nothing on top of optimal medical therapy. Previously, enthusiasts for renal stenting criticized studies such as ASTRAL[3] and STAR[4] that the patients may not have been optimally chosen and may not have had significant enough renal artery stenosis.

In the CORAL study, we saw yesterday that in a subgroup analysis looking at patients who had greater or less than 80% stenosis, the average was 72% in the whole trial. But those at greater than 80% did not seem to fare any better from this study. They were the same as those at less than 80%. So does this largely close the door to renal stenting for atherosclerotic disease?

Dr. Creager: As implied by your question, one might have anticipated that those individuals with the most severe renal artery stenosis would have been those most likely to benefit. But as you stated, there was no difference between the patients who had a greater than 80% stenosis and those who did not. That really continues to raise questions about the efficacy of renal artery stenting in this population in general.

But it doesn’t entirely close the door. I think it still is very important for all physicians to deal with their patients individually and inform their decisions by the evidence that’s available. But there will be patients who have hypertension and remain refractory despite aggressive and appropriate medical therapy. And in those individuals, one might consider looking for the presence of renal artery stenosis, and if found, treat them.

But keep in mind that in this trial, the group randomized to medical therapy did demonstrate benefit. In fact, they demonstrated a 15-mm Hg (on average) decrease in systolic blood pressure, indicating that before enrollment in the trial they probably were being treated as aggressively as they should be.

My take-home message is: If you have a patient with significant hypertension, make sure you’re implementing guideline-based therapies to bring their blood pressure into appropriate control. And if one is not successful in that case, then consider other options.

Dr. Bilazarian: One of the findings in the study was that at the end of the trial, there was a 2.5-mm Hg blood pressure difference between those with renal stenting and those without renal stenting (both on optimal medical therapy). Did that result surprise you?

Dr. Creager: It did surprise me for the very reason I just alluded to. I think that prior to enrollment in the trial, many of these patients who were treated with 2 or more antihypertensive drugs still might not have been treated aggressively enough with the right doses of these drugs or the right number of drugs to bring their blood pressure down.

In fact, I was pleased to see that an intensive medical regimen could be effective in these patients. And it sends another important message to our medical community that we can do more for these patients.

Dr. Bilazarian: You mentioned in this last answer that there may still be a role for identifying patients with renal artery stenosis. Can you help clarify that for me as a director of the vascular lab at Brigham and Women’s Hospital? As a teacher of postgraduate physicians, help me understand in what situation patients should be evaluated.

Currently, patients who may not have frank resistant hypertension get referrals to duplex ultrasound for assessment. Should that bar be moved up? Or is it only the most refractory patients who should be investigated? Or is it still valuable to know whether a patient has renal artery stenosis with noninvasive testing?

Dr. Creager: The bar does need to be moved without question. But there are several situations. I’ll give you 2 examples. One I mentioned: The patient who continues to have resistant hypertension despite aggressive medical therapy will be one such patient where I’ll be looking for secondary causes. And one of those secondary causes could be renal artery stenosis. So in that individual, duplex ultrasound would be appropriate, and if renal artery stenosis is found, continue the evaluation and treat that patient as the renal artery stenosis is confirmed.

Another example might be an individual who has recurrent acute pulmonary edema that cannot be explained by coronary artery disease or severe left ventricular dysfunction. That’s a patient I would consider working up for bilateral renal artery stenosis. And if found, I would treat. That patient population was really not the type that was included in the CORAL trial. So those are 2 examples.

Dr. Bilazarian: Our current guidelines say that there is a role for renal artery intervention for resistant hypertension, acute pulmonary edema, and declining renal function. It seems like the first of those has been taken off the table. Is there a role in the patient with declining renal function?

Dr. Creager: Well, that’s an important subset of patients, indeed. And I would be evaluating them for the potential causes of declining renal function. If they have renal artery stenosis, I would then initiate aggressive risk factor modification, antiplatelet therapy, and if they’re hypertensive, treat that as well.

But if in spite of that there still is evidence of declining renal function, then there’s a situation of someone who has failed medical therapy, and I would consider evaluating them for a renal artery stenosis. If one were to find, for example, bilateral renal artery stenosis in that patient or a severe stenosis to a single functioning kidney, then, yes, I would consider renal artery stenting in that individual.

Dr. Bilazarian: Great. Thank you for that summary on the trial called CORAL. Let’s move on to the second trial that you moderated. That trial is called ERASE, a study looking at supervised exercise therapy — an abbreviation I wasn’t familiar with: SET — supervised exercise therapy alone or supervised exercise therapy plus intervention of lower-extremity peripheral arterial disease. And that study was called ERASE. It built on an earlier study called CLEVER.[5] Please summarize the take-home message for the audience in that trial.

Dr. Creager: These were patients with peripheral artery disease and intermittent claudication, and the peripheral artery disease could have affected the aortoiliac system or the femoropopliteal system. The bottom line is that those patients who were randomized to both endovascular intervention and supervised exercise training had a much greater improvement in their walking time as assessed by treadmill testing, and also in quality of life as assessed by a number of instruments, compared with those patients who were just treated with supervised exercise training.

It adds incrementally to what we’ve previously understood. We know that supervised exercise training is extremely effective in improving walking time in patients with intermittent claudication. And as was shown with CLEVER, compared with medical therapy, endovascular intervention — at least in the aortoiliac area — is also associated with improvement in walking time.

So perhaps it’s no surprise that if you put the two together, they’re going to do better. And that’s what the ERASE trial showed.

Dr. Bilazarian: I agree with you. Many times, studies compare one or the other. And, of course, both is better than one or the other. I was happy to see that this trial looked at both.

There is one part of the trial that I had difficulty getting a take-home message from, and I’d love your input. As endovascular medicine physicians, we think in terms of the 3 zones of lower-extremity vascular disease: above the inguinal ligament, the fem-pop system, and then below the knee. Each becomes increasingly difficult, both for acute result as well as for durability. In this trial, half the patients had aortoiliac disease and half had fem-pop disease. Am I right to say that that might make it somewhat difficult to interpret whether the effects of supervised exercise therapy might be different for fem-pop disease or, say, aortoiliac disease, and that the bar for intervention might be lower for aortoiliac disease?

Dr. Creager: That’s a very important question. We don’t know yet what the subset analysis will be between those patients who had aortoiliac disease and underwent randomization and those who had femoropopliteal artery disease. And I’m sure we all await that analysis when it’s available.

Having said that, however, the studies show several things. It underscores the fact that no matter where the lesion is, patients still do better when exercise training is included in their therapeutic interventions. I think those of us who practice vascular medicine recognize the fact that endovascular intervention in the iliac arteries has been extremely successful and durable. And those patients really do benefit. d Our practice pattern and standard of care is to do endovascular intervention in patients with disabling claudication who have aortoiliac disease.

Superficial femoral artery disease, as you implied, is a little bit of a different situation. Those lesions are sometimes more difficult to treat and the durability is not as great. Within the context of this study, durability was pretty good in terms of restenosis. But I still think we need to see the subset analysis to make sure that those patients benefited as much as the entire group.

Dr. Bilazarian: Help us with a take-home message for US-based physicians. This was supervised exercise therapy in-home. We don’t have that available in the United States. Other than adding to our knowledge base, which is, of course, valuable, and being able to impart this knowledge to our patients and show them that this is of value, what other things can we do as a change in our practice to integrate this?

Dr. Creager: Currently we do need changes in healthcare policy, at least as it applies to supervised exercise training. We need reimbursement from CMS (Centers for Medicare & Medicaid Services). We need reimbursement from other third-party payers to provide additional incentive for physicians to recommend supervised exercise training for their patients. Unfortunately, that’s not available. And that’s one reason why patients in this country are not being referred for supervised exercise training. It’s an extremely effective intervention in patients with intermittent claudication.

Dr. Bilazarian: Great. Mark, thanks for joining me and for helping unpack these 2 trials for our audience: the ERASE trial of lower-extremity exercise in PAD patients, and the CORAL trial of renal artery stenting. I think they will add to our knowledge base and hopefully make practice changes in both areas. Thank you again for joining. And thank you for joining us for this program.

SOURCE

http://www.medscape.com/viewarticle/815029?src=emailthis#1

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Investigational Bioengineered Blood Vessel: Humacyte Presents Interim First-in-Human Data at the American Heart Association (AHA) Scientific Sessions 2013

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #86: Investigational Bioengineered Blood Vessel: Humacyte Presents Interim First-in-Human Data at the American Heart Association (AHA) Scientific Sessions 2013. Published on 11/20/2013

WordCloud Image Produced by Adam Tubman

The investigational bioengineered blood vessels represent a research and development milestone in vascular tissue engineering, as this technology could have the potential to help reduce or avoid surgical interventions and hospitalizations for patients with end-stage renal disease.

The Humacyte investigational bioengineered blood vessels are manufactured in a novel bioreactor system. The investigational bioengineered vessels go through a process of decellularization, which is designed to render them potentially non-immunogenic and implantable into any patient. These investigational bioengineered vessels are designed to be stored off-the-shelf for up to 12 months under standard refrigerated conditions, including, if successfully developedand approved,  on-site in hospitals.

 

Gail Thornton
Media Relations, Humacyte
1 908 392 3420 MOBILE
gail@westmillconsulting.com

Jim Modica

West Mill Consulting

908-872-4919

Jim@westmillconsulting.com

Humacyte Presents Interim First-in-Human Data

For Investigational Bioengineered Blood Vessel at the American Heart Association (AHA) Scientific Sessions 2013

  • The Humacyte investigational bioengineered blood vessel technology represents a research and development milestone in vascular tissue engineering.
  • Interim data from 28 patients in a three-center, first-in-human study in Poland indicate that all of the investigational blood vessels to date remain open to blood flow (patent), with no indication of an immune response in recipients, no aneurysms, and flow rates and durability suitable for dialysis.
  • The interim data suggest that the Humacyte investigational technology may have the potential to have high patency rates.
  • Longer follow-up and additional clinical studies will be required to confirm these preliminary observations.

 

RESEARCH TRIANGLE PARK, N.C., November 20, 2013 –Humacyte, Inc., a pioneer in regenerative medicine, today announced the presentation of interim, first-in-human data from an ongoing, multi-center study in Poland, evaluating the company’s investigational bioengineered blood vessel in hemodialysis patients with End-Stage Renal Disease (ESRD). The data were presented by Dr. Jeffrey H. Lawson, M.D., Ph.D., at the American Heart Association Scientific Sessions 2013 in Dallas, Texas (abstract). Dr. Lawson is Professor of Surgery and Pathology with tenure at Duke University Medical Center (Durham, North Carolina, USA), and Director of the Vascular Research Laboratory and Director of Clinical Trials for the Department of Surgery. He is also Clinical Consultant to Humacyte.

This is the first time surgical data from patients have been reported for the Humacyte investigational bioengineered vessel; the interim data come from a cohort of 28 study participants out of a total of 30 that will ultimately be enrolled in the three-site study in Poland (http://clinicaltrials.gov/show/NCT01744418%20CLN-PRO-V001%20NCT01744418). The first patients were implanted with the investigational vessels in December, 2012, and the vessels were first used for hemodialysis in February, 2013. The primary endpoints of the study in Poland are safety, tolerability, and patency to be examined at each visit within the first six months after graft implantation. Patients will be followed for an additional six months.

The interim patient data suggest that the Humacyte investigational bioengineered vessel may potentially be associated with low rates of vessel clotting, low infection rates, and low rates of surgical interventions. Low rates of clotting and intervention are consistent with preclinical data from animal testing that indicated little intimal hyperplasia. Preclinical data also indicated that, in animals, investigational vessels were remodeled to become living and more similar to native tissue. To date in the Polish study, the investigational vessel has remained open to blood flow (patent), with no indication of an immune response in recipients, no aneurysms (abnormal widening or ballooning of part of an artery due to weakness in the blood vessel wall), and flow rates and durability suitable for dialysis. Longer follow-up and additional clinical studies will be required to confirm these preliminary observations.

Co-authors on the presentation were: Drs. Marek Iłżecki, Tomasz Jakimowicz, Alison Pilgrim, Stanisław Przywara, Jacek Szmidt, Jakub Turek, Wojciech Witkiewicz, Norbert Zapotoczny, Tomasz Zubilewicz, and Laura Niklason.

Described by Investigator as “Breakthrough Investigational Technology”

“Based on our experience to date, this is breakthrough investigational technology,” said Principal Investigator Prof. Tomasz Zubilewicz, M.D., Ph.D., head, Department of Vascular Surgery and Angiology, Medical University of Lublin, Poland. “The investigational bioengineered vessel seems like it could have the potential to be shown to be superior to synthetic grafts in vascular access for hemodialysis in all aspects. This technology also has potential for other areas of vascular surgery, including replacement of infected synthetic grafts.”

“We are very encouraged by the Humacyte investigational bioengineered vessel’s performance in end-stage renal disease patients,” said Dr. Lawson. “Tremendous medical need exists for vascular access grafts in patients with ESRD who require dialysis. Based on this interim data and other ongoing research, we believe that the investigational bioengineered vessel has potential to meet this significant need.”

Need to Overcome Limitations of PTFE Grafts

Currently available synthetic vessels made from polytetrafluoroethylene (PTFE) are subject to many complications and about half fail within a year, requiring replacement surgery. PTFE vessels tend to become blocked (have low patency rates), have high rates of stenosis (an abnormal narrowing in a blood vessel that can be associated with hemodialysis), and high intervention rates.

“We continue to make significant progress in our research and development program with the Humacyte investigational bioengineered blood vessel,” said Laura E. Niklason, M.D., Ph.D., professor and vice chair of Anesthesia, professor of Biomedical Engineering, Yale University, and founder, Humacyte. “With our current interim study data, all of the Humacyte vessels have remained open to blood flow, with 20 out of the 28 implants requiring no intervention to date. We are grateful to patients, investigators, regulators and the broader vascular community for their ongoing collaboration and support in advancing this science.”

Unmet Medical Need in Chronic Kidney Disease

The Humacyte investigational technology is being developed with the goal of pursuing approval for use in patients with chronic kidney disease, a major global health problem affecting 26 million Americans[i] and around 40 million people in the European Union (EU).[ii] Individuals who progress to end-stage renal disease (ESRD) require renal replacement therapy (hemodialysis or kidney transplant); more than 380,000 patients currently require hemodialysis in the U.S.[iii] and some 250,000 patients require hemodialysis or have had kidney transplants in the EU.[iv] The investigational bioengineered vessels, if successfully developed and approved for use in ESRD by regulatory authorities, could offer the potential for significant cost savings to the healthcare system. These investigational bioengineered vessels represent a research and development milestone in vascular tissue engineering, as this technology could have the potential to help reduce or avoid surgical interventions and hospitalizations for patients with ESRD.

Investigators Highlight Preliminary Experiences In Patients

The investigators involved with the study in Poland cited their clinical observations in connection with the release of the preliminary patient data obtained for the Humacyte investigational technology.

“It was an exciting experience to be involved with this study, and to participate in this potential breakthrough in vascular surgery. This investigational bioengineered vein is a promising development for vascular surgeons,” said Principal Investigator Prof. Jacek Szmidt, head of the Department of General, Vascular and Transplant Surgery, Medical University of Warsaw, Poland.

“The Humacyte investigational bioengineered vessel was very easy to handle during implantation in this study. The graft maintained excellent mechanical properties, and based on our team’s experience, the complication rate to date has been very low compared with synthetic grafts,” said Investigator Stanisław Przywara, M.D., Ph.D., senior assistant, Department of Vascular Surgery and Angiology, Medical University of Lublin, Poland.

“During implantation in this study, the Humacyte investigational vessel behaved very much like a native vein.  Anastomotic hemostasis was achieved almost immediately. Insertion of needles to perform hemodialysis was easy and as reported by our nephrologists, provides very good adequacy of hemodialysis,” said Investigator Marek Iłżecki, M.D., Ph.D., senior resident, Department of Vascular Surgery and Angiology, Medical University of Lublin, Poland.

U.S. Clinical Trial Started in May, 2013

A multi-center U.S. clinical trial began in May, 2013 under a U.S. Investigational New Drug (IND) application. The U.S. trial will involve up to 20 patients across three sites to assess safety and performance of the innovative, investigational bioengineered blood vessels to provide vascular access for hemodialysis in ESRD patients.

About the Investigational Bioengineered Blood Vessels

The Humacyte investigational bioengineered blood vessels are manufactured in a novel bioreactor system. The investigational bioengineered vessels go through a process of decellularization, which is designed to render them potentially non-immunogenic and implantable into any patient. These investigational bioengineered vessels are designed to be stored off-the-shelf for up to 12 months under standard refrigerated conditions, including, if successfully developed and approved,  on-site in hospitals. Subject to receipt of regulatory approval, these properties could make the investigational bioengineered vessels readily available to surgeons and patients, and could eliminate the wait for vessel production or shipping. Data from studies of the investigational bioengineered vessels in large animal models reflect resistance to thickening for up to one year, and the early human studies that are now underway will provide safety and performance data in patients to support a future application for regulatory approval.

About Humacyte

Humacyte, Inc., a privately held company founded in 2005, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that are designed be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for a variety of patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to result in off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.

Forward-Looking Statement

Information in this news release contains “forward-looking statements” about Humacyte. These statements, including statements regarding management’s projections relating to future results and operations, are based on, among other things, management’s views, assumptions and estimates, developed in good faith, all of which are subject to known and unknown factors that may cause actual results, performance or achievements, or industry results, to differ materially from those expressed or implied by such forward-looking statements.

 

References


[iv]http://www.ekha.eu/usr_img/info/factsheet.pdf

SOURCE

From: Gail Thornton <gail@westmillconsulting.com>
Reply-To: Gail Thornton <gail@westmillconsulting.com>
Date: Wed, 20 Nov 2013 09:24:32 -0800 (PST)
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: Re: American Heart Association: Humacyte Investigational Bioengineered Blood Vessels

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Heart Metabolism or Metabolic Cardiology: The Role of Ribose (D-ribose) for the Ischemic Heart -The Work of John St. Cyr, M.D., Ph.D.

Reporter: Aviva Lev-Ari, PhD, RN

REVIEW

An interview with John St. Cyr, M.D., Ph.D. on Ribose : A Key to Heart Health and Energy

By Richard A. Passwater, Ph.D.

 

© Whole Foods Magazine

January 2005

Ribose : A Key to Heart Health and Energy

An interview with John St. Cyr, M.D., Ph.D.

By Richard A. Passwater, Ph.D.

SOURCE

http://www.drpasswater.com/nutrition_library/John_St_Cyr.html

 

John St. Cyr, M.D., Ph.D. — PATENTS:

Issued:

Suture removal device, USP5250052

Double layer prophylactic incorporating pharmacological fluid and spiral barrier layer, USP5623945

Compositions for increasing energy in vivo, USP6159942

Method for determining viability of a myocardial segment, USP6339716

Method for raising the hypoxic threshold, USP6218366

Use of ribose to prevent cramping and soreness in muscles, USP6159943

Compositions for increasing athletic performance in mammals, USP6429198

Dual lumen adjustable length cannulae for liquid perfusion or lavage, USP6692473

Method for treating acute mountain sickness, USP6511964

Compositions for increasing energy in vivo, USP6534480

Compositions for the storage of platelets, USP6790603

Compositions for enhancing the immune response, USP6663859

Composition methods for improving cardiovascular function, USP7553817

Rejuvenation of stored blood, USP7687468

 

John St. Cyr, M.D., Ph.D. — Pending applications:

Method for improving ventilatory efficiency, SN20050277598

Storage of blood SN20070111191

Ventilatory benefits of ribose in COPD, smoking, SN

Use of ribose in recovery from anesthesia, SN20070105787

Use of ribose to alleviate rhabdomyolysis and the side effects of statin drugs, SN20060135440

Use of ribose in first response to acute myocardial infarction, SN20100055206

Compositions and methods for improving cardiovascular function, SN20100009924

Use of ribose in lessening the clinical symptoms of aberrant firing of neurons, SN20090286750

Compositions for indoor tanning, SN20090232750

Compositions for improving and repairing skin, SN20090197819

Use of ribose for recovery from anesthesia, SN20090197818

Cosmetic use of D-ribose, SN20080312169

Method for improving ventilator efficiency SN20100099630

Method and compositions for improving pulmonary hypertension, SN20080146514

Storage of blood, SN20070111191

Compositions and methods for feeding poultry, SN201100221446

Use of D-ribose for fatigued subjects, SN20100189785

Fibrin sealants and platelet concentrates applied to effect hemostasis in the interface of an implantable medical device with body tissue, SN20060190017

Compositions for reducing the deleterious effects of stress and aging, SN20120045426

 

John St. Cyr, M.D., Ph.D. — Provisional patents:

Use of ribose in pre-slaughtering of animals

Rescue therapy for acute decompensated heart failure

Combination of D-ribose plus caffeine

Role of ribose in reducing joint swelling in mammals

Role of D-ribose in cardiac remodeling

Role of D-ribose in cachexia

Use of ribose in stem cells

Use of ribose in cardioplegia

Use of ribose for doping blood for cardioplegia

Surgical adhesive for bleeding situations

Metabolic approach with EECP

Role of ribose in mitral regurgitation

Compositions for the preservation of morphology in stored blood

Methods and nutritional supplements for improving the quality of meat

 

John St. Cyr, M.D., Ph.D. — Publications 2011 to 2013

This list does not include Publication #1 to #219

220. Shecterle LM, Wagner S, St.Cyr JA.  A sugar for congestive heart failure patients.  Ther Adv Cardiovasc Dis 5(2):95-97, 2011.

221. Perkowski D, Wagner S, Schneider JR, St.Cyr JA.  A targeted metabolic protocol with D-ribose for off pump coronary artery bypass procedures: A retrospective analysis.  Ther Adv Cardiovasc Dis 5(4):185-192, 2011.

222. Foker J, Berry J, Harvey B, Befera N, Tveter K, St.Cyr J, Bianco R.  Heart failure is initiated by and progresses because of normal responses of energy metabolism to stress.  Circ Res   , 2011.

223. Rakow N, Barka N, Gerhart R, Rothstein P, Green M, Schu C, Grassl E, St.Cyr JA, Kopcak MW, Jr.  Chronic aortic root pressure-loading assessment model.  J Invest Surg 25(2):137, 2012.

224. Shecterle LM, St.Cyr JA.  Chapter 11; Myocardial Ischemia: Alterations in myocardial cellular energy and diastolic function, a potential role for D-ribose. In: Novel Strategies in Ischemia Heart Disease. Lakshmanadoss U(Ed). InTech, Croatia.  219-228, 2012.

225. Addis P, Shecterle LM, St.Cyr JA.  Cellular protection during oxidative stress: a potential role for D-ribose and antioxidants.  Journal of Dietary Supplements 9(3):178-182, 2012.

226. Holsworth R, Shecterle L, St.Cyr J, Sloop G.  Letter to the Editor.  Importance of monitoring blood viscosity during cardiopulmonary bypass.  Perfusion 28(1):91-2, 2013.

227. Seifert JG, Frost J, ST.Cyr JA.  Recovery benefits of a heat and moisture exchange mask when performing sprint exercise in cold temperature environments.  Aviation, Space and Environmental Medicine.    , 2013.

228. Seifert JG, McNair M, DeClercq P, St.Cyr JA.  A heat and moisture mask attenuates cardiovascular stress during cold air exposure.  Ther Adv Cardiovasc Dis 7(3):123-129, 2013.

229. Holsworth R, Cho Y, Weldman J, Sloop G, St.Cyr, J.  Cardiovascular benefits of phlebotomy: Relationship to changes in hemorheological variables.  Perfusion,   2013.

 

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Risks for Patients’ and Physician’s Health in the Cath Lab

Reporter and Curator: Aviva Lev-Ari, PhD, RN

On Thursday, June 27th, 2013, Bayer HealthCare, Nuance® Healthcare, and The Mount Sinai Hospital held a live webinar outlining how one of America’s leading Radiology Departments is pioneering the next generation of imaging informatics. If you were unable to watch it live, or would like to view it again, it is now available online here.
The Mount Sinai Hospital in New York has taken Contrast Dose Management and IT interoperability to a new level with two industry-leading forces – Bayer’s Certegra® Informatics Platform and Nuance’s PowerScribe® 360 | Reporting.
The FREE 60-minute webinar includes:
• New Trends in Imaging Informatics & Dose Management
• Emerging Contrast Dose Management Best Practices as a Standard of Care at The Mount Sinai Hospital
• Experiences with Informatics including Point of Care Documentation, Injection Protocol Management for Patient-Based Dosing, Interfacing with IT Systems, and Analytics
• Live Q&A panel: The Mount Sinai Hospital, Bayer and Nuance

Interfacing with the Future of Imaging:
THE MOUNT SINAI HOSPITAL’S EXPERIENCE
with Contrast Dose Management™
WEBINAR PLAYBACK

 

VIEW VIDEO

http://www.insite24.com/downstream/bayer%2Dcdm%2Dwebinar/

 

Risks for Physician’s Health in the Cath Lab

EuroIntervention. 2012 Jan;7(9):1081-6. doi: 10.4244/EIJV7I9A172.

Brain tumours among interventional cardiologists: a cause for alarm? Report of four new cases from two cities and a review of the literature.

Source

Interventional Cardiology, Rambam Medical Center, Bruce Rappaport Faculty of Medicine, the Technion, Israel Institute of Technology, Haifa, Israel. aroguin@technion.ac.il

Abstract

AIMS:

Interventional cardiologists who work in cardiac catheterisation laboratories are exposed to low doses of ionising radiation that could pose a health hazard. DNA damage is considered to be the main initiating event by which radiation damage to cells results in development of cancer.

METHODS AND RESULTS:

We report on four interventional cardiologists, all with brain malignancies in the left hemisphere. In a literature search, we found five additional cases and thus present data on six interventional cardiologist and three interventional radiologists who were diagnosed with brain tumours. All worked for prolonged periods with exposure to ionising radiation in the catheterisation laboratory.

CONCLUSIONS:

In interventional cardiologists and radiologists, the left side of the head is known to be more exposed to radiation than the right. A connection to occupational radiation exposure is biologically plausible, but risk assessment is difficult due to the small population of interventional cardiologists and the low incidence of these tumours. This may be a chance occurrence, but the cause may also be radiation exposure. Scientific study further delineating occupational risks is essential. Since interventional cardiologists have the highest radiation exposure among health professionals, major awareness of radiation safety and training in radiological protection are essential and imperative, and should be used in every procedure.

Risks for Patients’ Health in the Cath Lab

Contrast-Induced Nephropathy

  • Author: Renu Bansal, MD; Chief Editor: Vecihi Batuman, MD, FACP, FASN

SOURCE

http://emedicine.medscape.com/article/246751-medication#showall

Contrast-induced nephropathy (CIN) is defined as the impairment of renal function and is measured as either a 25% increase in serum creatinine (SCr) from baseline or 0.5 mg/dL (44 µmol/L) increase in absolute value, within 48-72 hours of intravenous contrast administration. (See Etiology.)

For renal insufficiency (RI) to be attributable to contrast administration, it should be acute, usually within 2-3 days, although it has been suggested that RI up to 7 days post–contrast administration be considered CIN; it should also not be attributable to any other identifiable cause of renal failure. A temporal link is thus implied.[1] Following contrast exposure, SCr levels peak between 2 and 5 days and usually return to normal in 14 days. (See Clinical and Workup.)

Complications

CIN is one of the leading causes of hospital-acquired acute renal failure. It is associated with a significantly higher risk of in-hospital and 1-year mortality, even in patients who do not need dialysis.

Nonrenal complications include procedural cardiac complications (eg, Q-wave MI, coronary artery bypass graft [CABG], hypotension, shock), vascular complications (eg, femoral bleeding, hematoma, pseudoaneurysm, stroke), and systemic complications (eg, acute respiratory distress syndrome [ARDS], pulmonary embolism).

There is a complicated relationship between CIN, comorbidity, and mortality. Most patients who develop CIN do not die from renal failure. Death, if it does occur, is more commonly from either a preexisting nonrenal complication or a procedural complication.

Concerns

Many physicians who refer patients for contrast procedures and some who perform the procedure themselves are not fully informed about the risk of CIN. A survey found that less than half of referring physicians were aware of potential risk factors, including diabetes mellitus. (See Differentials.)

CIN suffers from a lack of consensus regarding its definition and treatment. Studies differ in regard to the marker used for renal function (SCr vs eGFR), the day of initial measurement and remeasurement of the marker, and the percentage increase used to define CIN. This makes it difficult to compare studies, especially in terms of the efficacy of various treatment modalities. (See Treatment and Medication.)[2]

The reported incidence of CIN might be an underestimation. SCr levels normally rise by day 3 of contrast administration. Most patients do not remain hospitalized for so long and there is no specific protocol to order outpatient SCr levels 3-5 days after the procedure.

Other renal function markers

The use of SCr as a marker of renal function has its limitations. Indicators such as the estimated glomerular filtration rate (eGFR) and cystatin C are increasingly considered to be more reliable and accurate reflectors of existing renal function.[3, 4]

The eGFR can be calculated using the Modification of Diet in Renal Disease (MDRD) formula or the Cockroft-Gault formula. The Cockroft-Gault formula calculates eGFR using age, sex, and body weight, which are factors that, independent of GFR, influence SCr. The MDRD equation also includes blood urea nitrogen (BUN) and serum albumin.

The eGFR works best at low creatinine values. SCr and GFR share a curvilinear relationship. At lower SCr values, doubling SCr is associated with a corresponding 50% decrease in GFR. However, in elderly patients with chronic kidney disease(CKD) who have high SCr values at baseline, a 25% rise in SCr is actually indicative of a relatively modest reduction in GFR. Nonetheless, even a 25% increase in SCr in this situation has been shown to have great impact, especially in terms of inhospital and 1-year mortality.[5]

Serum cystatin C is a serum protein that is secreted by nucleated cells. It is freely filtered by the glomerulus and has been found to be an accurate marker of GFR. Compared with SCr, cystatin C changes much earlier after contrast administration and is not subject to confounding factors, such age, sex, and muscle mass, that influence SCr values independent of the underlying GFR. Cystatin C is increasingly being used as a marker of renal function in cardiac surgical patients.

Patient education

Patients with risk factors for CIN should be educated about the necessity of follow-up care with their physicians with a postprocedure SCr estimation, especially if the initial procedure was done on an outpatient basis.

Etiology

Contrast media (CM) act on distinct anatomic sites within the kidney and exert adverse effects via multiple mechanisms. They cause a direct cytotoxic effect on the renal proximal tubular cells, enhance cellular damage by reactive oxygen species, and increase resistance to renal blood flow. They also exacerbate renal vasoconstriction, particularly in the deeper portions of the outer medulla. This is especially important in patients with CKD, because their preexisting abnormal vascular pathobiology is made worse by the effects of CM.[6, 7]

Renal (particularly medullary) microcirculation depends on a complex interplay of neural, hormonal, paracrine and autocrine influences. Of note are the vasodilator nitric oxide (NO) and the vasoconstrictors vasopressin, adenosine (when it acts via the high affinity A1 receptors), angiotensin II, and endothelins. Prostaglandins cause a redistribution of blood flow to the juxtamedullary cortex and, therefore, are protective.

NO, in particular, seems to be very important, with antiplatelet, vasodilatory, insulin sensitizing, anti-inflammatory, and antioxidant properties. It has been suggested that plasma levels of asymmetrical dimethylarginine (ADMA), which is an endogenous inhibitor of all NO synthase isoforms, can be used as a marker of CIN, especially in patients with unfavorable outcomes.

CM-mediated vasoconstriction is the result of a direct action of CM on vascular smooth muscle and from metabolites such as adenosine and endothelin. Additionally, the osmotic property of CM, especially in the tubular lumen, decreases water reabsorption, leading to a buildup of interstitial pressure. This, along with the increased salt and water load to the distal tubules, reduces GFR and causes local compression of the vasa recta. All of this contributes to worsening medullary hypoxemia and renal vasoconstriction in patients who are already volume depleted.

Finally, CM also increase resistance to blood flow by increasing blood viscosity and by decreasing red cell deformability. This intravascular sludging generates local ischemia and causes activation of reactive oxygen species that result in tubular damage at a cellular level.

Comparison of contrast-agent nephropathy potential

The ability of different classes of CM to cause CIN is influenced by their osmolality, ionicity (the ability of the contrast media to dissociate in water), and molecular structure. Each of these characteristics, in turn, influences their behavior in body fluid and their potential to cause adverse effects. (See Table 1, below.)[8]

Agents are classified as high, low, or iso-osmolar, depending on their osmolality in relation to blood. Low-osmolarity contrast media (LOCM) is actually a misnomer, since these agents have osmolalities of 600-900 mOsm/kg and so are 2-3 times more hyperosmolar than blood. High-osmolarity contrast media (HOCM) are 5-7 times more hyperosmolar than blood, with osmolalities greater than 1500 mOsm/kg.

Molecular structure of CM refers to the number of benzene rings. Most CM that were developed in the 1990s are dimers with 2 benzene rings. Dimeric CM, while nonionic and with low osmolarity, have high viscosity, which may influence renal tubular blood flow.

The ratio of iodine to dissolved particles describes an important relationship between opacification and osmotoxicity of the contrast agent. The higher ratios are more desirable. High-osmolar agents have a ratio of 1.5, low-osmolar agents have a ratio of 3, and iso-osmolar agents have the highest ratio, 6.

While the safety of LOCM over HOCM in terms of CIN seems intuitive, clinical evidence of it came from a meta-analysis by Barrett and Carlisle.[9] They showed the benefit of using LOCM over HOCM mostly in high-risk patients. The Iohexol Cooperative Study was a large, prospective, randomized, double-blinded, multicenter trial that compared the risk of developing CIN in patients receiving the low-osmolarity agent iohexol versus the high-osmolarity agent diatrizoate. While the HOCM group was 3.3 times more likely to develop CIN compared with the LOCM group, this was seen only in patients with preexisting CKD (baseline SCr greater than or equal to 1.5 mg/dL). In addition to CKD; diabetes mellitus, male sex, and contrast volume were found to be independent risk factors.

Even within the LOCM category, the risk is not the same for all agents. High-risk patients receiving iohexol have a higher likelihood of developing CIN than do patients receiving another agent (ie, iopamidol) in the same class.

When LOCM were compared with iso-osmolar contrast media (IOCM), the Nephrotoxicity in High-Risk Patients Study of Iso-Osmolar and Low-Osmolar Non-Ionic Contrast Media (NEPHRIC study), arguably the most definitive study in this category to date, found that the odds of developing CIN in high-risk patients were almost 9 times greater for the study’s iohexol group than for the investigation’s iodixanol group (iso-osmolar contrast agent). The incidence of CIN was 3% in the iodixanol group versus 26% in the iohexol group.[10] These results, though promising, were not duplicated in some subsequent studies.

When iodixanol was used, the Rapid Protocol for the Prevention of Contrast-Induced Renal Dysfunction (RAPPID) trial found a 21% incidence of CIN,[11] and the Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty (CONTRAST) trial found a 33% incidence of CIN.[12] Finally, the Renal Toxicity Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Patients With Renal Insufficiency Undergoing Coronary Angiography (RECOVER) trial compared the iso-osmolar contrast medium iodixanol to the low-osmolarity agent ioxaglate and found a significantly lower incidence of CIN with iodixanol than with ioxaglate (7.9% vs 17%, respectively).[13]

Thus, although the data are by no means uniform, they seem to suggest that the iso-osmolar contrast agent iodixanol may be associated with smaller increases in SCr and lower rates of CIN when compared with low-osmolar agents, especially in patients with CKD and in those with CKD and diabetes mellitus.[14]

Risk factors

Risk factors for CIN can be divided into patient-related, procedure-related, and contrast-related factors (although the risk factors for CIN are still being identified and remain poorly understood). Patient-related risk factors are as follows:

  • Age
  • CKD
  • Diabetes mellitus
  • Hypertension
  • Metabolic syndrome
  • Anemia
  • Multiple myeloma
  • Hypoalbuminemia
  • Renal transplant
  • Hypovolemia and decreased effective circulating volumes – As evidenced by congestive heart failure (CHF), an ejection fraction (EF) of less than 40%, hypotension, and intra-aortic balloon counterpulsation (IABP) use

Procedure-related risk factors are as follows:

  • Urgent versus elective
  • Arterial versus venous
  • Diagnostic versus therapeutic

Contrast-related risk factors are as follows:

  • Volume of contrast
  • Contrast characteristics, including osmolarity, ionicity, molecular structure, and viscosity

The single most important patient-related risk factor is preexisting CKD, even more so than diabetes mellitus.[15] Patients with CKD in the setting of diabetes mellitus have a 4-fold increase in the risk of CIN compared with patients without diabetes mellitus or preexisting CKD.

Table: Physiochemical Properties of Contrast Media

Although the data is by no means uniform, they seem to suggest that the iso-osmolar contrast agent iodixanol may be associated with smaller increases in SCr and lower rates of CIN when compared with low-osmolar agents, especially in patients with CKD and in those with CKD and diabetes mellitus.[14] Guidelines from the American Heart Association (AHA)/American College of Cardiology (ACC) for the management of acute coronary syndromes patients with CKD recommend the use of IOCM (Class I, level of Evidence).

Table 1. Physiochemical Properties of Contrast Media[16] (Open Table in a new window)

Class of Contrast Agent Type of Contrast Agent Iodine Dose(mg/mL) Iodine/Particle Ratio Viscosity(cPs at 37°C) Osmolality(mOsm/kg H2 O) Molecular Weight (Da)
High-osmolar monomers(ionic) Diatrizoate (Renografin)Ioxithalamate (Telebrix) 370350 1.51.5 2.32.5 18702130 636643
Low-osmolar dimers(ionic) Ioxaglate (Hexabrix) 320 3 7.5 600 1270
Low-osmolar monomers(nonionic) Iohexol (Omnipaque)Iopamidol (Isovue)Iomeprol (Iomeron)

Ioversol (Optiray)

Iopromide (Ultravist)

Iopentol (Imagopaque)

350370400

350

370

350

333

3

3

3

10.49.412.6

9

10

12

780790620

790

770

810

821777778

807

791

835

Iso-osmolar dimers(nonionic) Iodixanol (Visipaque)Iotrolan (Isovist) 320320 66 11.88.5 290290 15501620

Epidemiology

Occurrence in the United States

CIN is the third leading cause of hospital-acquired renal failure. Decreased renal perfusion and surgery (or in some studies, nephrotoxic medications) are the number one and number two causes, respectively.

An analysis of 15 prospective and retrospective studies from 1976-1996 report an incidence of CIN of 3.1-31%. The number varies depending on the definition used for CIN; the contrast agent characteristics, including the type, amount, duration, and route of administration; preexisting risk factors; and length of follow-up (including the day of measurement of postcontrast serum creatinine).

In patients without risk factors, the incidence may be as low as 2%. With the introduction of risk factors, like diabetes, the number rises to 9%, with incidences being as high as 90% in diabetics with CKD. Therefore, the number and the type of preexisting risk factors directly influence the incidence of renal insufficiency. It is also procedure dependant, with 14.5% overall in patients undergoing coronary interventions compared to 1.6-2.3% for diagnostic intervention, as reported in literature.[17]

Race- and age-related demographics

While African Americans with diabetic nephropathy have a faster acceleration of end-stage renal disease (ESRD), independent of other variables, race has not been found to be a risk factor for CIN.

The incidence of CIN in patients older than age 60 years has been variously reported as 8-16%. It has also been shown that in patients with acute MI who have undergone coronary intervention, an age of 75 years or older is an independent risk factor for CIN.

Prognosis

CIN is normally a transient process, with renal functions reverting to normal within 7-14 days of contrast administration. Less than one-third patients develop some degree of residual renal impairment.

Dialysis is required in less than 1% of patients, with a slightly higher incidence in patients with underlying renal impairment (3.1%) and in those undergoing primary PCI for myocardial infarction (MI) (3%). However, in patients with diabetes and severe renal failure, the rate of dialysis can be as high as 12%.

Of the patients who need dialysis, 18% end up on permanent dialysis therapy. However, many of these patients will have had advanced renal insufficiency and concomitant diabetic nephropathy and will have been destined for dialysis regardless of the episode of CIN.

A growing body of knowledge indicates that acute kidney injury after contrast medium can be a harbinger of CKD or ESRD. In one observational study, the population studied appeared representative of the general population undergoing angiography and the rate of acute kidney ingury was consonant with other studies. The finding that persistent kidney damage can occur after contrast-induced acute kidney injury highlights the potential for acceleration of the progression of kidney injury in individuals with pre-existing CKD.[18]

Mortality

Patients who require dialysis have a considerably worse mortality rate, with reported rates of 35.7% inhospital mortality (compared with 7.1% in the nondialysis group) and a 2-year survival rate of only 19%.

CIN by itself may be an independent mortality risk factor. Following invasive cardiology procedures, patients with normal baseline renal function who develop CIN have reduced survival compared with patients with baseline chronic CKD who do not develop CIN.

Gadolinium-based agents

Gadolinium-based CM (used for magnetic resonance imaging [MRI]), when compared with iodine-based CM, have a similar, if not worse, adverse effect profile in patients with moderate CKD and eGFR of less than 30 mL/min. Their use has been implicated in the development of nephrogenic systemic fibrosis, a chronic debilitating condition with no cure.

A review of 3 series and 4 case reports suggested that the risk of renal insufficiency with gadolinium is similar to that of iodinated radiocontrast dye. The reported incidence varies from 4% in stage 3 CKD to 20% in stage 4 CKD. It may even be worse, as suggested by some investigators. A prospective study of 57 patients found that acute renal failure was seen in 28% of patients in the gadolinium group, compared with 6.5% of patients in the iodine group, despite prophylactic saline and N-acetylcysteine (NAC).

The risk factor profile is similar to that for iodinated CM; increased incidence of acute renal failure is seen in older patients and in those with lower baseline creatinine clearance, diabetic nephropathy, anemia, and hypoalbuminemia.

Risk stratification scoring systems

CIN is the result of a complex interplay of many of the above risk factors. The presence of 2 or more risk factors is additive, and the likelihood of CIN rises sharply as the number of risk factors increases. Researchers have tried to objectively quantify and predict the contribution of each risk factor to the ultimate outcome of CIN.

Risk stratification scoring systems have been devised to calculate an individual patient’s risk of developing CIN. This has mostly been done in patients undergoing percutaneous coronary intervention (PCI), especially those with preexisting risk factors. Mehran et al developed the following scoring system based on points awarded to each of 7 multivariate predictors[19] :

  • Hypotension = 5 points
  • IABP use = 5 points
  • CHF = 5 points
  • SCr of greater than 1.5 mg/dL = 4 points
  • Age greater than 75 years = 4 points
  • Anemia = 3 points
  • Diabetes mellitus = 3 points
  • Contrast volume = 1 point for each 100 cc used

Based on the total calculated score, patients were divided into low-risk (score of less than or equal to 5), moderate-risk (score of 6-10), high-risk (score of 11-15), and very–high-risk (score of greater than or equal to 16) categories. The rate of CIN and the requirement for dialysis were 7.5 and 0.04%, 14 and 0.12%, 26.1 and 1.09%, and 57.3 and 12.6%, respectively, for each of the 4 groups.

Bartholomew et al worked to create another scoring system and took into consideration 8 variables, including creatinine clearance of less than 60 mL/min, IABP use, urgent coronary procedure, diabetes mellitus, CHF, hypertension, peripheral vascular disease (PVD), and volume of contrast used.[20]

History and Physical Examination

History

Patients usually present with a history of contrast administration 24-48 hours prior to presentation, having undergone a diagnostic or therapeutic procedure (eg, PCI). The renal failure is usually nonoliguric.

Physical examination

A physical examination is useful for ruling out other causes of acute nephropathy, such as cholesterol emboli (eg, blue toe, livedo reticularis) or drug-induced interstitial nephritis (eg, rash). Patients may have evidence of volume depletion or may be in decompensated CHF.

Diagnostic Considerations

Conditions to consider in the differential diagnosis of CIN include the following:

  • Atheroembolic renal failure – More than 1 week after contrast, blue toes, livedo reticularis, transient eosinophilia, prolonged course, and lower recovery
  • Acute renal failure (includes prerenal and postrenal azotemia) – There may also be associated dehydration from aggressive diuresis, exacerbated by preexisting fluid depletion; the acute renal failure is usually oliguric, and recovery is anticipated in 2-3 weeks
  • Acute interstitial nephritis (triad of fever, skin rash, and eosinophilia) – Also eosinophiluria; the nephritis is usually from drugs such as penicillin, cephalosporins, and nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Acute tubular necrosis – Ischemia from prerenal causes; endogenous toxins, such as hemoglobin, myoglobin, and light chains; exogenous toxins, such as antibiotics, chemotherapeutic agents, organic solvents, and heavy metals

Approach Considerations

SCr concentration usually begins to increase within 24 hours after contrast agent administration, peaks between days 3 and 5, and returns to baseline in 7-10 days. Serum cystatin C (which has been suggested as a surrogate marker of renal function in lieu of SCr) is increased in patients with CIN.

Nonspecific formed elements can appear in the urine, including renal tubular epithelial cells, pigmented granular casts, urate crystals, and debris. However, these urine findings do not correlate with severity.

Urine osmolality tends to be less than 350 mOsm/kg. The fractional excretion of sodium (FENa) may vary widely. In the minority of patients with oliguric CIN, the FENa is low in the early stages, despite no clinical evidence of volume depletion.

Histology

CM cause direct toxic effects on renal tubular epithelial cells, characterized by cell vacuolization, interstitial inflammation, and cellular necrosis. In a study, these characteristic changes, called osmotic nephrosis, were observed in 22.3% of patients undergoing renal biopsy, within 10 days of contrast exposure.[21]

Approach Considerations

Hydration therapy is the cornerstone of CIN prevention. Renal perfusion is decreased for up to 20 hours following contrast administration. Intravascular volume expansion maintains renal blood flow, preserves nitric oxide production, prevents medullary hypoxemia, and enhances contrast elimination.

However, a number of other CIN therapies have been investigated, including the use of statins, bicarbonate, N-acetylcysteine (NAC), ascorbic acid, the adenosine antagonists theophylline and aminophylline, vasodilators, forced diuresis, and renal replacement therapy. Patients with CIN should be managed in consultation with a nephrologist.

Hydration Therapy

The first study revealing the benefit of hydration in CIN prevention came from Solomon et al.[22] They also found forced diuresis to be inferior to hydration with 0.45% saline. Fluids with different compositions and tonicity have since been studied, including bicarbonate and mannitol.

Normal saline has been found to be superior to half-normal saline in terms of its enhanced ability in intravascular volume expansion. It also causes increased delivery of sodium to the distal nephron, prevents rennin-angiotensin activation, and thus maintains increased renal blood flow. In terms of route of administration, oral fluids, while beneficial, are not as effective as intravenous hydration.[23, 24]

The CIN Consensus Working Panel found that adequate intravenous volume expansion with isotonic crystalloids (1-1.5 mL/kg/h), 3-12 hours before the procedure and continued for 6-24 hours afterward, decreases the incidence of CIN in patients at risk. The panel studied 6 clinical trials with different protocols for volume expansion. The studies differed in the type of fluid used for hydration (isotonic vs half-normal saline), route, duration, timing, and amount of fluid used.[25]

For hospitalized patients, volume expansion should begin 6 hours prior to the procedure and be continued for 6-24 hours postprocedure. For outpatients, administration of fluids can be initiated 3 hours before and continued for 12 hours after the procedure. Postprocedure volume expansion is more important than preprocedure hydration. It has been suggested that a urine output of 150 mL/h should guide the rate of intravenous fluid replacement, although the CIN Consensus Working Panel did not find it useful to recommend a target urine output.

CHF poses a particular challenge. Patients with compensated CHF should still be given volume, albeit at lower rates. Uncompensated CHF patients should undergo hemodynamic monitoring, if possible, and diuretics should be continued. In emergency situations, one’s clinical judgment should be used, and, in the absence of any baseline renal function, adequate postprocedure hydration should be carried out.

What is interesting, however, is that, while hydration remains the cornerstone for CIN prevention, a randomized, controlled trial comparing a strategy of volume expansion with no volume expansion has not been performed to date.

Statins

Statins are widely used in coronary artery disease (CAD) for their pleiotropic effects (favorable effects on endothelin and thrombus formation, plaque stabilization, and anti-inflammatory properties), and it was believed that, given the vascular nature of CIN, they might have similar renoprotective effects. The data for statin use, however, are retrospective and anecdotal; they are taken mostly from patients already on statins who underwent PCI.[26]

A significantly lower incidence of CIN was found in patients treated with statins preoperatively (CIN incidence of 4.37% in the statin group vs 5.93% in the nonstatin group). However, prospective trials looking at statin use in patients undergoing noncardiac procedures are needed to better qualify this initial promise.

Bicarbonate Therapy

Bicarbonate therapy alkalinizes the renal tubular fluid and, thus, prevents free radical injury. Hydrogen peroxide and an oxygen ion (from superoxide) react to form a hydroxide ion, all agents of free radical injury. This reaction, called the Harber-Weiss reaction, is activated in an acidic environment. Bicarbonate, by alkalinizing the environment, slows down the reaction. It also scavenges reactive oxygen species (ROS) from NO, such as peroxynitrite.

Bicarbonate protocols most often include infusion of sodium bicarbonate at the rate of 3 mL/kg/hour an hour before the procedure, continued at 1 mL/kg/hour for 6 hours after. Some investigators have used 1 mL/kg/hour for 24 hours, starting 12 hours before the procedure. The exact duration, however, remains a matter of debate. Hydration with sodium bicarbonate has been found by some researchers to be more protective than normal saline alone.

Treatment controversy

A 2008 retrospective cohort study at the Mayo Clinic assessed the risk of CIN associated with the use of sodium bicarbonate, NAC, and the combination of sodium bicarbonate with NAC and found that, compared with no treatment, sodium bicarbonate used alone was associated with an increased risk of CIN. NAC alone or in combination with sodium bicarbonate did not significantly affect the incidence of CIN. The results were obtained after adjusting for confounding factors, including total volume of hydration, medications, baseline creatinine, and contrast iodine load.[27] Given the above new information, it is recommended that the use of sodium bicarbonate to prevent CIN should be further evaluated.

N-acetylcysteine

NAC is acetylated L-cysteine, an amino acid. Its sulfhydryl groups make it an excellent antioxidant and scavenger of free oxygen radicals. It also enhances the vasodilatory properties of nitric oxide. Twelve meta-analyses covering 29 randomized, controlled trials have been published on the effect of NAC therapy in CIN. They all suffer from significant heterogeneity. The standard oral NAC regimen consists of 600 mg twice daily for 24 hours before and on the day of the procedure. Higher doses of 1 g, 1200 mg, and 1500 mg twice daily have also been studied, with no significant dose-related or route-related (oral vs intravenous) difference. NAC has very low oral bioavailability; substantial interpatient variability and inconsistency between the available oral products obscure the picture further.[3, 24, 28]

Treatment controversy

The latest controversy relating to NAC therapy questioned the parameter on which its effectiveness was based. It was suggested that the beneficial effect of NAC in CIN is related to its SCr-lowering ability rather than to improved GFR. It was believed that NAC directly reduces SCr by increasing SCr’s excretion (tubular secretion), decreasing its production (augments activity of creatine kinase), or interfering with its laboratory measurement, enzymatic or nonenzymatic (Jaffe method).

This was supported by a study that demonstrated a significant decrease in SCr after 4 doses of 600 mg of oral NAC in healthy volunteers with normal kidney function and no exposure to radiocontrast media.[29] This would bring doubt into the results of at least 13 randomized, controlled trials that showed NAC to be protective in CIN, with SCr used as the endpoint. However, Haase et al compared the effect of NAC on SCr by simultaneously studying its effect on cystatin C and found that NAC did not artifactually lower SCr when measured by the Jaffe method.[30]

The CIN Working Panel concluded that the existing data on NAC therapy in CIN is sufficiently varied to preclude a definite recommendation.[25] In the practice of medicine, though, it remains part of the standard of care and is routinely administered because of its low cost, lack of adverse effects, and potential beneficial effect, as demonstrated by the relative risk reduction of CIN, ranging from 0.37-0.73, as reported in several meta-analyses.

Renal Replacement Therapy

Less than 1% of patients with CIN ultimately go on to require dialysis, the number being slightly higher in patients with underlying renal impairment (3.1%) and in those undergoing primary PCI for MI (3%). However, in patients with diabetes and severe renal failure, the rate of dialysis can be as high as 12%. Patients who get dialyzed do considerably worse, with inhospital mortality rates of 35.7% (compared with 7.1% in the nondialysis group) and a 2-year survival rate of only 19%.

CM have molecular weights that range between 650 and 1600 mOsm/kg. They have low lipophilicity, low plasma protein binding, and minimal biotransformation. They quickly equilibrate across capillary membranes and have volumes of distribution equivalent to that of the extracellular fluid volume. In patients with normal renal function, CM are excreted with the first glomerular passage and the decrease in their plasma concentration follows a 2-part exponential function, a distribution phase and an elimination phase. However, in patients with renal impairment, the renal clearance values are reduced. For example, 50% of the low-osmolarity contrast agent iomeprol is eliminated within 2 hours in healthy subjects, compared with 16-84 hours in patients with severe renal impairment.

In patients already on dialysis, the commonly sited issues with contrast administration include volume load and direct toxicity of contrast to the remaining nonfunctional nephrons and nonrenal tissues. Thus, the perceived need for emergent dialysis and contrast removal.

Rodby attempted to address these concerns, calculating that the administration of 100 mL of hyperosmolar contrast would move 265 mL of water from the intracellular to the extracellular compartment, resulting in an increase in extracellular volume by 365 mL. The increase in intravascular space would therefore be only a third, or 120 mL. Fluid shifts with LOCM are even less. He also found that extrarenal toxicity of CM was cited in mostly single case reports, and no objective evidence could be identified in 3 prospective studies.[31]

The risk of acute damage from contrast is therefore greatest in patients with CKD. This can be explained by the increase in single nephron GFR and, thus, the filtered load of contrast per nephron. This is akin to a double hit to the remaining nephrons; increased contrast load and prolonged tubular exposure. While this may not seem to be a concern in patients with ESRD who are already on dialysis, residual renal function, in fact, plays a big role in their outcome, more so in patients on peritoneal dialysis. Its preservation is therefore important.[31]

CM can be effectively and efficiently removed by hemodialysis (HD). Factors that influence CM removal include blood flow, membrane surface area, molecular size, transmembrane pressure, and dialysis time. High-flux dialysis membranes with blood flows of between 120-200 mL/min can remove almost 50% of iodinated CM within an hour and 80% in 4 hours. Even in patients with CKD, in whom contrast excretion is delayed, it was found that 70-80% of contrast can be removed by a 4-hour HD treatment. In view of the limited benefit of therapies such as hydration, bicarbonate and NAC, dialysis may seem like the definitive answer.

However, an excellent meta-analysis by Cruz et al—8 trials (6 randomized and 2 nonrandomized, controlled studies) were included in the analysis, with a pooled sample size of 412 patients—indicated that periprocedural extracorporeal blood purification (ECBP) does not significantly reduce the incidence of CIN in comparison with standard medical therapy. ECBP in the study consisted of HD (6 trials), continuous venovenous hemofiltration (1 trial), and continuous venovenous hemodiafiltration (1 trial).[32]

Cruz et al found that the incidence of CIN in the standard medical therapy group was 35.2%, compared with 27.8% in the ECBP group. Renal death (combined endpoint of death or dialysis dependence) was 12.5% in the standard medical therapy group, compared with 7.9% in the ECBP group.

An important consideration is the role of ECBP therapy in patients with severe renal impairment (ie, stage 5 CKD) not yet on maintenance dialysis. A study by Lee et al indicated that in patients with chronic renal failure who are undergoing coronary angiography, prophylactic HD can improve renal outcome. The study included 82 patients with stage 5 CKD who were not on dialysis and who were referred for coronary angiography.[33] The patients were randomly assigned to either undergo prophylactic HD (initiated within 81 ± 32 min) or to receive intravenous normal saline (control group).

The baseline creatinine of the dialysis group was 13.2 mL/min/1.73 m2, comparable to that of the control group (12.6 mL/min/1.73 m2). The investigators’ primary endpoint was change in creatinine clearance in the 2 groups on day 4, which was found to be statistically significant (0.4 ± 0.9 mL/min/1.73 m2 in the dialysis group vs 2.2 ± 2.8 mL/min/1.73 m2 in the control group).

Lee et al found that 35% of the control group required temporary renal replacement therapy, compared with 2% of the dialysis group. In addition, long-term, postdischarge dialysis was required in 13% of the control patients but in none of the dialysis patients. Among those patients who did not require chronic dialysis, an increase in SCr at discharge of over 1 mg/dL from baseline was found in 13 patients in the control group and in 2 patients in the dialysis group.

The study, though hopeful, does raise some concerns. While the change in creatinine clearance on day 4 from baseline was statistically significant, the day 4 creatinine clearance itself was not significantly different between the 2 groups. Also, the results were not expressed as CIN incidence. This patient population is very fragile and is already on the verge of dialysis. How much time off dialysis a single HD session was able to buy these patients was not discussed. The duration of follow-up was also not clear.

Marenzi et al found better outcomes in patients who received venovenous hemofiltration both pre- and post-CM administration than in patients who received post-CM hemofiltration or no hemofiltration at all. These outcomes included a lower likelihood of CIN, no need for HD, and no 1-year mortality, in the pre-/post-CM group.[34]

The biggest confounder in studies of continuous renal replacement therapy (CRRT) is that the outcome measure (SCr) is affected by the treatment itself. While the advantage of CRRT is the lack of delay in its institution, contrast clearance rates would be 1 L/h (16.6 mL/min provided a maximal sieving coefficient for contrast across the hemofiltration membrane of 1), substantially less than standard HD.

Furthermore, continuous venovenous hemofiltration is expensive, highly invasive, and requires trained personnel; the procedure itself needs to be performed in the intensive care unit (ICU). In the face of equivocal benefit of a highly invasive and expensive procedure, the role of continuous venovenous hemofiltration has yet to be accepted as a prophylactic treatment for avoiding CIN.

Dialysis immediately after contrast administration has been suggested for patients already on long-term HD and for those at very high risk of CIN. Three studies looked at its necessity and found that LOCM can be given safely to patients with ESRD who are being maintained on HD without the added expense or inconvenience of emergent postprocedural HD.

The only condition in which HD might be argued to have a beneficial role is in patients on peritoneal dialysis who rely on their residual renal function. In this setting, HD performed soon after CM administration may provide enhanced removal and therefore protect residual renal function. It should be noted, however, that these patients on peritoneal dialysis would therefore need an additional HD procedure with concomitant vascular access, as the clearance with peritoneal dialysis would be far too slow to offer any protection.

In a study to determine if renal replacement therapy in concert with contrast administration helps, Frank et al found that although the overall clearance of contrast was significantly increased by dialysis, the peak plasma concentration of iomeprol 15 minutes after contrast administration was not significantly changed by simultaneous dialysis. In their report, the investigators prospectively studied 17 patients with chronic renal insufficiency (SCr >3 mg/dL), dialysis independent, who were then randomized to receive high-flux HD over 6 hours simultaneously with contrast administration, and[35]

In the study, Frank et al also found that to be clinically effective, simultaneous dialysis should reduce the risk of developing ESRD by 50%. If type 1 and type 2 errors are set at 0.01, the result could be accepted only if none of the 48 sequential patients with simultaneous dialysis required dialysis during the 8 weeks after contrast exposure. To reject the hypothesis, 239 sequential patients with simultaneous dialysis would have to be included. Therefore, most CIN studies, are seriously underpowered.

Studies of HD for CIN vary with respect to the definition of CIN used, the patient population, the type and volume of CM, how long after CM administration HD is started, and, finally, the dialysis treatment modality itself. While existing studies do not show HD to be superior to hydration alone for CIN prevention, if HD is used in conjunction with hydration and CIN protective therapy, such as NAC and bicarbonate, it might prove to be efficacious in some high-risk patients. However, most studies have had only an 8-week follow-up period. While the initiation of long-term dialysis was 5-15%, the progression to uremia over a long-term follow-up period is still unanswered.[16]

Other Therapies

Ascorbic acid, which has antioxidant properties, was studied for its ability to counter the effect of free radicals and reactive oxygen species. One study found that oral ascorbic acid administered in a 3-g dose preprocedure and two 2-g doses postprocedure was associated with a 62% risk reduction in CIN incidence.[36]

Theophylline and aminophylline are adenosine antagonists that counteract the intrarenal vasoconstrictor and tubuloglomerular feedback effects of adenosine. They have been found to have a statistically significant effect in preventing CIN in high-risk patients. However, their use is limited by their narrow therapeutic window and adverse effects profile.

Vasodilators, such as calcium channel blockers, dopamine/fenoldopam, atrial natriuretic peptide, and L-arginine, all with different mechanisms of action, have a favorable effect on renal hemodynamics. However, their use for CIN prevention has not been borne out by most controlled trials, and they are not routinely recommended at this point.

Forced diuresis with furosemide and mannitol was studied in the hope that this procedure would dilute CM within the tubular lumen and enhance their excretion. Furosemide and mannitol in fact worsen CIN by causing dehydration in patients who may already have intravascular volume depletion. Their use at this time is discouraged.

Deterrence and Prevention

The best therapy for CIN is prevention. Physicians need to be increasingly aware that CIN is a common and potentially serious complication. Patients at risk should be identified early, especially those with CKD (ie, eGFR < 60 mL/min/1.73 m2). A detailed history inquiring for risk factors, especially diabetes mellitus, should be ascertained.

In patients with risk factors for CIN, the possibility of alternative imaging studies that do not need contrast should be explored. MRI with gadolinium is no longer considered a safe alternative to contrast because of the risk of nephrogenic systemic fibrosis, an irreversible, debilitating condition seen mostly in patients with an eGFR of less than 30 mL/min/1.73 m2.

In patients with a moderate to severe risk of CIN, creatinine clearance rates or eGFR should be estimated by either the MDRD formula or the Cockroft-Gault formula and then measured again 24-48 hours after contrast administration.

In the emergency setting, where the benefit of very early imaging studies outweighs that of waiting, the imaging procedure can be carried out without an initial estimation of SCr or eGFR.

Intra-arterial administration of iodinated CM poses a greater risk for CIN than does the intravenous approach. For patients at an increased risk for CIN receiving intra-arterial contrast, nonionic iso-osmolar agents (iodixanol) are associated with the lowest risk of CIN.

The amount of contrast used during the procedure should be limited to as little as possible and kept under 100 mL. Most investigators have found this to be the cut-off value below which no patient needed dialysis. The risk of CIN increases by 12% for each 100 mL of contrast used beyond the first 100 mL. Most angiographic diagnostic studies usually require 100 mL of contrast, compared with 200-250 mL for angioplasty. The maximum amount of contrast that can be used safely should be individualized, taking into account the preexisting renal function.

Various formulas for calculating the maximal safe CM dose have been suggested. Two most often cited are those suggested by Cigarroa et al and the European Society of Urogenital Radiology (ESUR).[37, 38] Cigarroa et al, in a retrospective study of 115 patients undergoing cardiac catheterization and angiography, using the HOCM diatrizoate, suggested that the dose of CM should not exceed 5 mL/kg of body weight (maximum 300 mL divided by SCr [mg/dL]). The ESUR, in turn, has published maximal LOCM volumes for various SCr cut-off values.

While the formulas from Cigarroa and the ESUR take into account the SCr, it has been suggested that the eGFR (a more accurate predictor of renal function) and the iodine dose of CM should be reflected in any estimates or predictions of safe CM dosages. There exists, however, no unimpeachably safe CM dose algorithm for CIN prevention.

The length of time between 2 contrast procedures should be at least 48-72 hours. Rapid repetition of contrast administration has been found to be a univariate risk factor for CIN.

Potentially nephrotoxic drugs (eg, NSAIDs, aminoglycosides, amphotericin B, cyclosporin, tacrolimus) should be withdrawn at least 24 hours prior, in patients at risk (eGFR < 60 mL/min).

Metformin, though not nephrotoxic, should be used prudently, because if renal failure does occur, there is risk of concomitant lactic acidosis. Therefore, metformin should be stopped at the time of the procedure and resumed 48 hours later if renal function remains normal.

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) cause a 10-15% rise in SCr by reducing intraglomerular pressure. While they should not be started at this time, whether they should be discontinued remains a matter of debate. Much of the literature in this area is unclear and controversial.

Minimizing contrast administration

The amount of contrast used during the procedure should be limited to as little as possible and kept under 100 mL. Most investigators have found this to be the cut-off value below which no patient needed dialysis. The risk of CIN increases by 12% for each 100 mL of contrast used beyond the first 100 mL. Most angiographic diagnostic studies usually require 100 mL of contrast, compared with 200-250 mL for angioplasty. The maximum amount of contrast that can be used safely should be individualized, taking into account the preexisting renal function.

Various formulas for calculating the maximal safe CM dose have been suggested. Two most often cited are those suggested by Cigarroa et al and the European Society of Urogenital Radiology (ESUR).[37, 38] Cigarroa et al, in a retrospective study of 115 patients undergoing cardiac catheterization and angiography, using the HOCM diatrizoate, suggested that the dose of CM should not exceed 5 mL/kg of body weight (maximum 300 mL divided by SCr [mg/dL]). The ESUR, in turn, has published maximal LOCM volumes for various SCr cut-off values.

While the formulas from Cigarroa and the ESUR take into account the SCr, it has been suggested that the eGFR (a more accurate predictor of renal function) and the iodine dose of CM should be reflected in any estimates or predictions of safe CM dosages. There exists, however, no unimpeachably safe CM dose algorithm for CIN prevention.

RAAS blockade

A prospective, 50-month Mayo study found renin-angiotensin-aldosterone system (RAAS) blockade, particularly in older patients with CHD, exacerbates CIN (43% incidence of dialysis and 29% progression to ESRD).[39] The marker used for renal function was eGFR, as calculated by the MDRD formula. The study recommended that RAAS blockade be withheld 48 hours prior to contrast exposure.

RAAS blockage, however, can improve renal perfusion and decrease proximal tubular reabsorption, including CM absorption by the tubular cells. This effect can be documented with the increase in the fractional excretion of urea seen with low-dose RAAS therapy in patients with CHF and moderate CKD (the majority of the CIN-susceptible population).[40] In this group, reduction in intraglomerular pressure and filtration fraction from RAAS therapy might decrease tubular CM concentration and therefore lessen its adverse effects.

Medication Summary

NAC is acetylated L-cysteine, an amino acid. As previously mentioned, its sulfhydryl groups make it an excellent antioxidant and scavenger of free oxygen radicals. It also enhances the vasodilatory properties of nitric oxide. Twelve meta-analyses covering 29 randomized, controlled trials have been published on the effect of NAC therapy in CIN. They all suffer from significant heterogeneity. The standard oral NAC regimen consists of 600 mg twice daily for 24 hours before and on the day of the procedure. Higher doses of 1 g, 1200 mg, and 1500 mg twice daily have also been studied, with no significant dose-related or route-related (oral vs intravenous) difference. NAC has very low oral bioavailability; substantial interpatient variability and inconsistency between the available oral products obscure the picture further.[24, 28]

Antidote, Acetaminophen

Class Summary

Used for prevention of contrast toxicity.

N-acetylcysteine (Acetadote)

Used for prevention of contrast toxicity in susceptible individuals such as those with diabetes mellitus. May provide substrate for conjugation with toxic metabolites.

Antilipemic Agents

Class Summary

These agents are used for their favorable effects on endothelin and thrombus formation, plaque stabilization and anti-inflammatory properties by improving lipid profile.

Simvastatin (Zocor)

Indicated for hyperlipoproteinemia (Type III). Inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA reductase), which in turn inhibit cholesterol synthesis, and increases cholesterol metabolism. Increase HDL cholesterol and decrease LDL-C, total-C, apolipoprotein B, VLDL cholesterol, and plasma triglycerides.

Atorvastatin (Lipitor)

The most efficacious of the statins at high doses. Inhibits 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA reductase), which in turn inhibits cholesterol synthesis and increases cholesterol metabolism. Reports have shown as much as a 60% reduction in LDL-C. The Atorvastatin versus Revascularization Treatment study (AVERT) compared 80 mg atorvastatin daily to standard therapy and angioplasty in patients with CHD. While events at 18 mo were the same between both groups, the length of time until the first CHD event occurred was longer with aggressive LDL-C lowering. The half-life of atorvastatin and its active metabolites is longer than that of all the other statins (ie, approximately 48 h compared to 3-4 h).

May modestly elevate HDL-C levels. Clinically, reduced levels of circulating total cholesterol, LDL-C, and serum TGs are observed.

Before initiating therapy, patients should be placed on a cholesterol-lowering diet for 3-6 mo; the diet should be continued indefinitely.

Lovastatin (Mevacor, Altoprev)

Adjunct to dietary therapy in reducing serum cholesterol. Immediate-release (Mevacor) and extended-release (Altocor) are available.

Fluvastatin (Lescol, Lescol XL)

Synthetically prepared HMG-CoA reductase inhibitor with some similarities to lovastatin, simvastatin, and pravastatin. However, structurally distinct and has different biopharmaceutical profile (eg, no active metabolites, extensive protein binding, minimal CSF penetration).

Used as an adjunct to dietary therapy in decreasing cholesterol levels.

Pravastatin (Pravachol)

Effective in reducing circulating lipid levels and improving the clinical and anatomic course of atherosclerosis.

Rosuvastatin (Crestor)

HMG-CoA reductase inhibitor that in turn decreases cholesterol synthesis and increases cholesterol metabolism. Reduces total-C, LDL-C, and TG levels and increases HDL-C level. Used adjunctively with diet and exercise to treat hypercholesterolemia.

SOURCE

Managing Your Risks: Patient and Physician Health in the Cath Lab

flouro image

In this post we’ll explore the issue of radiation exposure, occupational risks in the catheterization lab, and how that can impact your care.

I. Patient Risks in the Cath Lab

Fluoroscopy is a type of medical imaging used during percutaneous coronary interventions that displays a continuous x-ray image. Blood flow and artery blockages are not able to be seen using x-ray only imaging. Physicians inject a contrast solution into the arteries so that when an x-ray beam is passed through the tissue, the physician can get a real-time image of the coronary arteries. On average, angioplasty procedures will last about an hour, this means the patient is exposed to ionizing radiation from the fluoroscopy for a significant amount of time. Lengthy procedures lead to greater exposure to the radiation of fluoroscopy.

Radiation has a cumulative effect and leads to increased risk for many conditions, most notably, cancer.  In healthcare where radiation is required for treatment, there is a prevailing philosophy called ALARA, which stands for as low as (is) reasonably achievable.   Wherever possible, physicians should be looking for ways to limit exposure to radiation to limit the cumulative effects of radiation on patients. Along with the risks posed by radiation, patients in the cath lab also face potentially high doses of the contrast medium which can cause a condition known as contrast induced nephropathy. The contrast solution that is so valuable to imaging can be toxic to the kidneys, and when the body is unable to process the contrast, it leads to CIN in which the kidneys shut down.  While most patients who develop CIN typically recover within 1- 2 weeks, it can cause serious renal (kidney) complications in patients with certain risk factors including diabetes, prior kidney transplant, chronic kidney disease, and hypertensive disorders. Therefore, physicians need to keep a constant watch on the contrast volume used during procedures to minimize the risk of CIN.

II. Occupational Hazards in the Cath Lab

It is well documented that Interventional Cardiologists face serious dangers of long-term radiation exposure in the cath lab. Risks to clinicians include: skin damage to hands and exposed tissue, injury to the lens of the eye/ cataracts, and in some cases the development of brain tumors and other cancers. In a 2012 study, researchers found an increased incidence of left hemisphere brain tumors in a study group of interventional cardiologists that may be attributed to the prolonged exposure to ionizing radiation to the left side of the head during interventional procedures.

Via LifeScience PLUS

Physicians in the Cardiac Cath Lab (Via LifeScience PLUS)

Lead aprons are the standard convention used in Cath labs across the US to reduce radiation exposure to physicians and staff; however these protective barriers can weigh between 15-20 pounds and place up to 300 pounds per square inch of pressure on vertebral disks. In one study more than 400 interventionalists were surveyed and 71% of the study population reported some type of orthopedic disease. According to Dr. Tom Ports, Director of Interventional Cardiology at University of San Francisco, the leading cause of early retirement for interventional cardiologists is spinal injury!

Attention to the danger of radiation exposure and other risks in the cath lab for both patients and staff is on the rise. As more focus is being brought upon safety practices in the cath lab, improved procedural measures are being put in place to protect physicians and staff, and improve the quality of care for patients.

http://blog.corindus.com/?p=124

REFERENCES

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  30. Haase M, Haase-Fielitz A, Ratnaike S, et al. N-Acetylcysteine does not artifactually lower plasma creatinine concentration. Nephrol Dial Transplant. May 2008;23(5):1581-7. [Medline].
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  32. [Best Evidence] Cruz DN, Perazella MA, Bellomo R, et al. Extracorporeal blood purification therapies for prevention of radiocontrast-induced nephropathy: a systematic review. Am J Kidney Dis. Sep 2006;48(3):361-71. [Medline].
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Myocardial Infarction: The New Definition After Revascularization

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/31/2014

Myocardial Ischemia Symptoms

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2014/07/29/myocardial-ischemia-symptoms/

 

VIEW VIDEO

Gregg Stone, MD

Co-DIrector, Medical Research & Education Division Cardiovascular Research Foundation

http://www.medpagetoday.com/Cardiology/MyocardialInfarction/42256?xid=nl_mpt_DHE_2013-10-15&goback=%2Egmr_4346921%2Egde_4346921_member_5795830612724035588#%21

Primary source: Journal of the American College of Cardiology
Source reference: Moussa I, et al “Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI)” J Am Coll Cardiol2013; 62: 1563-1570.

Additional source: Journal of the American College of Cardiology
Source reference:White H “Avatar of the universal definition of periprocedural myocardial infarction” J Am Coll Cardiol 2013; 62: 1571-1574.

Moussa reported that he had no conflicts of interest.

Stone is a consultant for Boston Scientific, Eli Lilly, Daiichi Sankyo, and AstraZeneca. The other authors reported relationships with Guerbet, The Medicines Company, Bristol-Myers Squibb/Sanofi, Merck, Maya Medical, AstraZeneca, Abbott Vascular, Regado Biosciences, Janssen Pharma, Lilly/Daiichi Sankyo, St. Jude Medical, Medtronic, Terumo, Bridgepoint/Boston Scientific, Gilead, Boston Scientific, Eli Lilly, and Daiichi Sankyo.

White is co-chairman for the Task Force for the Universal Definiton of Myocardial Infarction; has received research grants from sanofi-aventis, Eli Lilly, The Medicines Company, the NIH, Pfizer, Roche, Johnson & Johnson, Schering-Plough, Merck Sharpe & Dohme, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo Pharma Development, and Bristol-Myers Squibb; and has served on advisory boards for AstraZeneca, Merck Sharpe & Dohme, Roche, and Regado Biosciences.

WASHINGTON, DC — A “clinically meaningful” definition of MI following PCI or CABG is urgently needed to replace the arbitrarily chosen “universal definition” proposed in recent years that has no relevance to patients and may be muddying clinical-trial results. Those are the conclusions of a new expert consensus document released Monday by the Society of Cardiovascular Angiography and Interventions (SCAI)[1].

The notion of a “universal definition of MI” was first proposed in 2000 and updated in 2007 and 2012. The 2012 document defines a PCI-related MI as an increase in cardiac troponin (cTn) of more than five times the upper limit of normal (ULN) during the first 48 hours postprocedure plus specific clinical or ECG features. Post-CABG, the definition is a cTn increase of >10 times the ULN, plus different clinical or ECG features.

The problem, lead author Dr Issam Moussa (Mayo Clinic, Jacksonville, FL) told heartwire , is that these cutoffs were arbitrarily chosen and not based on any hard evidence that these biomarker levels spelled a poor prognosis. Moreover, “overnight, the rate of MI went from 5% following these procedures to 20% to 30%!” he said.

The SCAI committee, in its new document, focuses on post-PCI procedures and highlights the importance of acquiring baseline cardiac biomarkers and differentiating between patients with elevated baseline CK-MB (or cTn) in whom biomarker levels are stable or falling, as well as those in whom it hasn’t been established whether biomarkers are changing.

SCAI’s Proposed Clinically Meaningful MI Definitions

Group Definition
Normal baseline CK-MB CK-MB rise of >10x ULN or >5x ULN with new pathologic Q-waves in at least 2 contiguous leads or new persistent left bundle branch block
OR
In the absence of baseline CK-MB, a cTn rise of >70x ULN or a rise of>35 ULN plus new pathologic Q-waves in at least 2 contiguous leads or new persistent left bundle branch block
Elevated baseline biomarkers that are stable or falling A CK-MB or cTn rise that is equal (by an absolute increment) to the definitions described for patients with normal CK-MB at baseline.
Elevated baseline biomarkers that have not been shown to be stable or falling A CK-MB or cTn rise that is equal (by an absolute increment) to the definitions described for patients with normal CK-MB at baseline
Plus
New ST-segment elevation or depression
Plus
New-onset or worsening heart failure or sustained hypotension or other signs of a clinically relevant MI.

Moussa is quick to emphasize that these new clinically meaningful definitions have limited evidence to support them—and most of what exists supports CK-MB definitions, not cTn—but that the new document is based on the best scientific evidence available.

“We don’t want to come out with a definitive statement” saying this is the final word on MI definitions,” he stressed. “There is more science that needs to be done and there remains more uncertainty. We framed this to be inclusive and also to open the field for discussion.”

His hope is that this will lead to important changes in how patients are managed and money is spent. Currently, patients with clinically meaningless biomarker elevations may become unnecessarily panicked over news that they’ve had a “heart attack,” while hospital stays may be extended and further tests ordered on the basis of these results.

Moussa et al’s proposal also has important implications for clinical trials, he continued. Currently, for studies that include periprocedural MIs as an individual end point or as part of a composite end point, the very high number of biomarker-defined “MIs” collected in the trial could potentially overwhelm the true impact of any given therapy. “You are really using an end point that is truly not relevant to patients. . . . This could really affect the whole hypothesis.”

He’s expecting some push-back from cardiologists and academics, particularly those who championed the need for the universal definition in the first place, but believes most people will welcome a clinically meaningful definition.

“I think many in the medical community will accept this because they have not really been using the universal definition in their day-to-day practice anyhow.” What’s more, the National Cardiovascular Data Registry (NCDR) does not include the reporting of MI postangiography, in part because of concerns that the universal definition of MI overestimates the true incidence of this problem. “I think many in the community will look at this definition as more reflective of the true incidence of MI after angioplasty, and if it’s accepted, they are more likely to report it to databases like NCDR and use it to reflect quality-of-care processes.”

http://www.medscape.com/viewarticle/812533?nlid=35983_2105&src=wnl_edit_medp_card&uac=93761AJ&spon=2

  • ESC/ACCF/AHA/WHF Expert Consensus Document

Circulation.2012; 126: 2020-2035  Published online before print August 24, 2012,doi: 10.1161/​CIR.0b013e31826e1058

Third Universal Definition of Myocardial Infarction

  1. Kristian Thygesen;
  2. Joseph S. Alpert;
  3. Allan S. Jaffe;
  4. Maarten L. Simoons;
  5. Bernard R. Chaitman;
  6. Harvey D. White
  7. the Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction
  1. *Corresponding authors/co-chairpersons: Professor Kristian Thygesen, Department of Cardiology, Aarhus University Hospital, Tage-Hansens Gade 2, DK-8000 Aarhus C, Denmark. Tel: +45 7846-7614; fax: +45 7846-7619: E-mail: kristhyg@rm.dk. Professor Joseph S. Alpert, Department of Medicine, Univ. of Arizona College of Medicine, 1501 N. Campbell Ave., P.O. Box 245037, Tucson AZ 85724, USA, Tel: +1 520 626 2763, Fax: +1 520 626 0967, E-mail: jalpert@email.arizona.edu. Professor Harvey D. White, Green Lane Cardiovascular Service, Auckland City Hospital, Private Bag 92024, 1030 Auckland, New Zealand. Tel: +64 9 630 9992, Fax: +64 9 630 9915, E-mail: harveyw@adhb.govt.nz.

Table of Contents

  • Abbreviations and Acronyms. . . . . . . . . . . . . . . . . . . .2021

  • Definition of Myocardial Infarction. . . . . . . . . . . . . . .2022

  • Criteria for Acute Myocardial Infarction. . . . . . . . . . . .2022

  • Criteria for Prior Myocardial Infarction. . . . . . . . . . . .2022

  • Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2022

  • Pathological Characteristics of Myocardial Ischaemia and Infarction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2023

  • Biomarker Detection of Myocardial Injury With Necrosis. . .2023

  • Clinical Features of Myocardial Ischaemia and Infarction. . .2024

  • Clinical Classification of Myocardial Infarction. . . .2024
    • Spontaneous Myocardial Infarction (MI Type 1). . . .2024

    • Myocardial Infarction Secondary to an Ischaemic Imbalance (MI Type 2). . . . . . . . . . . . . . . . . . . . . . . .2024

    • Cardiac Death Due to Myocardial Infarction (MI Type 3). .2025

    • Myocardial Infarction Associated With Revascularization Procedures (MI Types 4 and 5). . . . . . . . . . . . . . . . . . …

New Definition for MI After Revascularization

Published: Oct 14, 2013 | Updated: Oct 15, 2013

By Todd Neale, Senior Staff Writer, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

The Society for Cardiovascular Angiography and Interventions (SCAI) has released a new definition for myocardial infarction (MI) following coronary revascularization aimed at identifying only those events likely to be related to poorer patient outcomes.

In the new criteria — published as an expert consensus document inCatheterization and Cardiovascular Interventions and the Journal of the American College of Cardiology — creatine kinase-myocardial band (CK-MB) is the preferred cardiac biomarker over troponin, and much greater elevations are required to define a clinically relevant MI compared with the universal definition of MI proposed in 2007 and revised in 2012.

Also, the new definition uses the same biomarker elevation thresholds to identify MIs following both percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), whereas the universal definition has different thresholds for events following the two procedures.

“What we’ve really tried to emphasize in this classification scheme is the primary link between biomarker elevations and prognosis,” according to Gregg Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation in New York City, one of the authors of the document.

“In the universal definition of MI, they even acknowledged that their criteria were arbitrary,” Stone said in an interview. “We’ve tried to reduce the arbitrariness of the cutoff values that we selected so that the researcher, academician, clinician, hospital administrator, etc., can be confident that these levels that we’re recommending are the ones that are associated with a worse prognosis for patients suffering periprocedural complications.”

The Change

The existing universal definition for MI defines events following PCI according to an increase in cardiac troponin to greater than five times the 99th percentile upper reference limit (URL) within 48 hours when baseline levels are normal, with confirmation by electrocardiogram (ECG), imaging, or symptoms.

For CABG-related MI, the increase must be more than 10 times the 99th percentile URL within 48 hours when baseline levels are normal, with confirmation by ECG, angiography, or imaging.

But, Stone and colleagues wrote, the relationship between that degree of troponin elevation after a revascularization procedure and prognosis is not as strong as the association between a CK-MB elevation and patient outcomes.

Using a small elevation in troponin to define a post-procedure MI could find myocardial necrosis that is unlikely to be associated with poor clinical outcomes, which could have far-reaching implications, they wrote.

“Widespread adoption of an MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence,” they wrote.

To address that issue, the expert panel convened by SCAI sought to define clinically relevant MI after PCI or CABG.

A clinically relevant MI is defined in the new document based on an increase of at least 10 times the upper limit of normal in the level of CK-MB within 48 hours after a revascularization procedure when baseline levels are normal.

When the CK-MB level is not available, then an increase in troponin I or T of at least 70 times the upper limit of normal can be used to define a clinically relevant MI, according to the authors.

However, if an ECG shows new pathologic Q-waves in at least two contiguous leads or a new persistent left bundle branch block, then the thresholds can be lowered to at least five times and at least 35 times the upper limit of normal for CK-MB and troponin, respectively.

Further guidance is provided for identifying clinically relevant post-procedure MIs when the cardiac biomarker levels are elevated at baseline.

Dueling Definitions

Co-chairman of the Task Force for the Universal Definition of Myocardial Infarction, Harvey White, DSc, of Auckland City Hospital in Auckland, New Zealand, noted some limitations of the new definition, including the lack of a requirement for ischemic symptoms.

“Ischemic symptoms have always been a basic tenet of the diagnosis of MI, and it should be no different for a [PCI-related] MI,” he wrote in an accompanying editorial.

In addition, with the use of such large elevations in biomarker levels in the new definition, “there will be very few PCI-related events identified, and an opportunity to improve patient outcomes may be lost,” he wrote.

Troponin should remain the preferred biomarker over CK-MB, White argued, pointing to variability in and analytical issues with CK-MB assays, the need for sex-specific cutoffs for CK-MB levels, the need for higher thresholds of CK-MB to determine abnormalities because all individuals have circulating levels of the biomarker, and the reduced sensitivity and specificity of CK-MB.

Also, he said, CK-MB is becoming increasingly unavailable at medical centers.

“With CK-MB becoming obsolete, troponin will become the gold standard, and CK-MB will no longer have a role in defining PCI injury and infarction in clinical practice,” White wrote.

Stone admitted that troponin ultimately might be preferable to CK-MB because of its greater specificity, although the evidence does not yet support it.

“I think there’s a general desirability to move to troponins, although when you look at the data that’s out there it’s much stronger correlating CK-MB elevations to subsequent prognosis,” he said. “I think a lot of the troponin elevations are just noise or troponins are just too sensitive.”

Room for Both?

White noted in his editorial that “the rationale for the SCAI definition has been well articulated by its authors and may be appropriate in an individual trial, but it should not supplant the universal definition of MI,” he wrote.

When asked whether the new definition would replace the universal definition, Stone said there is a place for both sets of criteria.

“We would propose the clinically relevant definition be the one that is used to make most substantial decisions right now, [such as] trade-offs between efficacy and safety for new drugs and devices, in judging hospital systems and physicians, etc.,” he said. “But I do think there’s value in both, and they will both continue to evolve over time as new data becomes evident.”

http://www.medpagetoday.com/Cardiology/MyocardialInfarction/42256?xid=nl_mpt_DHE_2013-10-15&goback=%2Egmr_4346921%2Egde_4346921_member_5795830612724035588#%21 

Articles citing 

Third Universal Definition of Myocardial Infarction

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  • Factors Influencing the 99th Percentile of Cardiac Troponin I Evaluated in Community-Dwelling Individuals at 70 and 75 Years of AgeClin. Chem.. 2013;59:1068-1073,
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  • Prevalence, Incidence, and Implications of Silent Myocardial Infarctions in Patients With Diabetes MellitusCirculation. 2013;127:965-967,
  • 2013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Acute Coronary Syndromes and Coronary Artery Disease Clinical Data Standards)Circulation. 2013;127:1052-1089,
  • Clin. Chem.. 2013;59:574-576,
  • Percutaneous Coronary Intervention Versus Optimal Medical Therapy for Prevention of Spontaneous Myocardial Infarction in Subjects With Stable Ischemic Heart DiseaseCirculation. 2013;127:769-781,
  • Frequency of Myocardial Infarction and Its Relationship to Angiographic Collateral Flow in Territories Supplied by Chronically Occluded Coronary ArteriesCirculation. 2013;127:703-709,
  • The Power of More Than OneCirculation. 2013;127:665-667,
  • The curious life of the biomarkerJournal of the American Dental Association. 2013;144:126-128,
  • Persistent Increases in Cardiac Troponin Concentrations As Measured with High-Sensitivity Assays after Acute Myocardial InfarctionClin. Chem.. 2013;59:443-445,
  • 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice GuidelinesCirculation. 2013;127:e362-e425,

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Carotid Ultrasound more sensitive for Detecting Subclinical Atherosclerosis in patients with rheumatoid arthritis (RA) than CT with calculation of Coronary Artery Calcification Scores

Reporter: Aviva Lev-Ari, PhD, RN

Ultrasound Predicts CVD Risk in Arthritis

Published: Oct 8, 2013 | Updated: Oct 8, 2013

By Nancy Walsh, Staff Writer, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

 

Carotid ultrasound was more sensitive for detecting subclinical atherosclerosis in patients with rheumatoid arthritis (RA) than CT with calculation of coronary artery calcification scores, Spanish researchers found.

Among a group of 60 patients classified as being at moderate cardiovascular risk on a conventional scoring system, the presence of severe abnormalities on ultrasound reclassified 51 as being at high or very high risk, according to Miguel A. Gonzalez-Gay, MD, of Universitario Marques de Valdecilla in Santander, and colleagues.

And of those 51 reclassified patients, only 12 would have been reclassified as being at high or very high cardiovascular risk using a coronary artery calcification score,the researchers reported in the NovemberAnnals of the Rheumatic Diseases.

Patients with RA are at markedly increased risk for cardiovascular disease (CVD), both from conventional risk factors and the ongoing systemic inflammation associated with RA.

Comprehensive management of these patients therefore should include risk assessment and appropriate interventions, but “adequate stratification of the CV risk in patients with RA is still far from being completely established,” Gonzalez-Gay and colleagues noted.

The insensitivity of conventional risk assessments such as the Systematic Coronary Risk Evaluation (SCORE), even when modified by the European League Against Rheumatism(mSCORE) to account for the increased background risk in RA, has been confirmed byreports of ischemic heart disease among patients not considered to be at elevated risk on these measures.

These researchers previously suggested that carotid ultrasonography be added to the overall risk assessment of RA patients, particularly those with moderate SCORE risk, but whether other noninvasive approaches such as coronary artery calcification also could be useful has been uncertain.

Therefore, they enrolled 95 rheumatoid arthritis patients with no history of cardiovascular events and no diabetes or chronic renal disease.

Most were women, mean age was 59, and mean disease duration was 11 years.

Rheumatoid factor and/or anticyclic citrullinated peptide was present in 72%, and extra-articular manifestations in 16%.

All patients had carotid ultrasonography to assess for plaque and multi-detector CT scanning to detect coronary artery calcification.

Carotid intima-media thickness of 0.90 or the presence of plaque was considered predictive of CVD on ultrasound.

A coronary artery calcification score of zero was considered normal, and a score over 100 indicated a high likelihood of coronary artery disease.

Patients also were given conventional SCORE ratings, based on factors such as age, sex, smoking, blood pressure, and atherogenic index, as well as mSCORE ratings, to estimate the 10-year risk for a fatal cardiovascular event.

The mean SCORE was 2.30, and the mean mSCORE was 2.78.

Cardiovascular risk according to mSCORE was low in 21, moderate in 60, and high or very high in 14.

Most patients with low mSCOREs also had scores of zero for coronary artery calcification, and none of the low mSCORE patients had calcification scores above 100.

But 57% of patients with calcification scores of zero had carotid plaques identified on ultrasound, as did 76.3% of patients with calcification scores between 1 and 100.

While calcification scores above 100 weren’t much more sensitive than mSCOREs for detection of high risk (23.6% versus 19.4%), almost all (70 of 72) patients with high or very high risk were identified with carotid ultrasound, for a sensitivity of 97.2% (95% CI 90.3-99.7).

And when the ultrasound model of intima-media thickness above 0.9 mm and/or carotid plaque also included mSCOREs above 5%, all 72 were correctly identified, for a sensitivity of 100% (95% CI 95-100).

This lack of sensitivity for calcification scores likely reflects the finding that arterial calcification is a later vascular development, and its absence doesn’t rule out the presence of the more vulnerable noncalcified plaques, the researchers explained.

“These results support the use of carotid ultrasonography as the imaging technique of choice for detection of high/very high CV risk in RA patients with moderate mSCORE,” they said.

In an editorial accompanying the study, Patrick H. Dessein, MD, of the University of Witwatersrand in Johannesburg, South Africa, and Anne G. Semb, MD, of Diakonhjemmet Hospital in Oslo, Norway, noted that the use of ultrasound more than tripled the number of patients considered to be at high risk.

If only mSCORE was used for risk stratification, they pointed out, many patients “in routine clinical settings” would be unlikely to receive preventive treatments, “with the serious consequences this has.”

Dessein and Semb also noted that there were certain limitations to this study, including its cross-sectional design and inclusion of patients with long disease duration.

“It remains to be clarified whether carotid ultrasound is as helpful among patients with early disease versus those with longstanding disease in enhancing CVD risk stratification,” the editorialists wrote.

The authors reported no conflicting interests.

From the American Heart Association:

http://www.medpagetoday.com/Rheumatology/Arthritis/42138?xid=nl_mpt_DHE_2013-10-09&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g99985d0r&userid=99985&email=avivalev-ari@alum.berkeley.edu&mu_id=5099207

 

 

 

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Coronary Circulation Combined Assessment: Optical Coherence Tomography (OCT), Near-Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) – Detection of Lipid-Rich Plaque and Prevention of Acute Coronary Syndrome (ACS)

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC

and

Article Curator: Aviva Lev-Ari, PhD, RN

The clinical motivations for coronary artery imaging include identifying and characterizing obstructive lesions, analyzing suitability for various feasible interventions, and assessing comparative risk with and without interventions. With improvements in non-invasive detection of fixed obstructions in the coronary arteries, it should not be surprising that half of the lesions that cause heart attacks (myocardial infarction) among those who had recent imaging consisted of unstable plaques that were less than 50% obstructive. Therefore there is growing interest not only in more reliable detection of lesions that exceed 50% obstruction, but also improved characterization of lesions that are not obstructive but may be unstable.

By way of analogy, think of impaired blood supply to the heart as a traffic jam in a roadway. The best time to check for a traffic jam is during rush hour. The corresponding clinical scenario is stress testing. There are three major roadways in the heart: left anterior, left circumflex, and right, each with branches (forks). The two left major vessels stem from a short but treacherous left main (“widow maker”). A temporary traffic jam results in symptoms of impaired delivery (angina, from hunger due to late delivery of food). Alternatively, a prolonged traffic disruption can result in suicidal tissue destruction (starvation). A fixed obstruction consists of potholes and landslides resulting in a persisting shutdown of half or more of the lanes in the highway. An unstable plaque consists of a less severe abnormality that can cause accidents (plaque rupture, local hemorrhage, sudden occlusion). A road may shutdown not only from progressive road damage, but also a truck can flip over and shutdown a relatively clean roadway.

Among patients who had recent coronary imaging prior to the onset of a heart attack, half do not have occlusive lesions. Instead of slow progressive reduction in vessel diameter leading to a critically severe flow reduction, the mechanism in the cases of no severe narrowing is attributed to unstable plaque, meaning plaque with thin fibrous caps that rupture, causing sudden thrombosis. Stress tests focus on detection of fixed obstructions and do not warn who has unstable plaque. Thus the next great frontier for coronary imaging is not just to identify flow reducing lesions, but also to identify unstable plaque even if it is not currently flow limiting. This article presents candidate imaging methods and their current capabilities.

Coronary imaging methods include:

  • intra-coronary ultrasound (IVUS)
  • optical coherence imaging (fiberoptic)
  • computed tomographic xray angiography (CTA)
  • magnetic resonance angiography (MRA)
  • near infra-red spectroscopic imaging (NIRS)

    NIRS-IVUS Imaging To Characterize the Composition and Structure of Coronary Plaques 

    David Rizik, MD1 and James, A. Goldstein, MD2

    1. Scottsdale Healthcare Hospital, Scottsdale, AZ

    2. Department Cardiovascular Medicine, William Beaumont Hospital, Royal Oak, MI

    This supplement,

    http://www.invasivecardiology.com/files/Infraredx_FINALPDF.pdf

    authored by highly experienced interventional cardiologists expert in the field of coronary plaque characterization, contains a detailed description of the new NIRS-IVUS combination catheter, and the clinical information obtained during its use in over 90 hospitals in over 10 countries. Case vignettes, cohort outcomes, reviews, and plans for future studies are also presented. It is our hope that this information will be useful in the near term to those seeking to improve PCI. For the longer term, we believe that the NIRS-IVUS system is an excellent candidate for evaluation as a detector of vulnerable plaque. Success in the prospective studies that are planned will make it possible to detect vulnerable plaques and thereby enhance efforts to prevent coronary events.

    Imaging Methods for Detection of Intravascular Plaque – Direct, Robust and/or Validated

    Cap Thickness – OCT

    Expansive Remodeling – IVUS & NIRS-IVUS [Combination TVC System & TVC Insight Catheter]

    Plaque Volume – IVUS & NIRS-IVUS

    Calcification – Angiography, IVUS & NIRS-IVUS

    Thrombus – Angioscopy & OCT

    Inflammation Macrophages – Indirect by OCT

    Lipid Core – IVUS & NIRS-IVUS

    Requires Blood-Free FOV – Angioscopy & OCT

    based on Table 1 p.5

    http://www.invasivecardiology.com/files/Infraredx_FINALPDF.pdf

    Comparative Intravascular Imaging for Lipid Core Plaque: VH-IVUS vs OCT vs NIRS

    Eric Fuh, MD and Emmanouil S. Brilakis, MD, PhD

    VA North Texas Healthcare System, Dallas, TX and Division of Cardiology, Dept of Medicine, UT Southwestern Medical Center, Dallas, TX

    Conclusions

    VH-IVUS, OCT, and NIRS can assist in the detection and evaluation of lipid core plaque. Comparative studies have shown important differences between modalities, but are all limited from lack of comparison with the gold standard of histology. Given the different strengths and weaknesses of each modality, combination imaging will likely provide the best results.41 Further refinement of the clinical implications of LCP detection and its impact on optimizing treatment strategy selection will stimulate advances in LCP detection imaging.

    OCT and NIRS can image through calcified lesions, whereas IVUS cannot. LCPs are often accompanied by neovascularization, which can only be visualized by OCT. VH-IVUS may classify stents, which usually appear white (misclassified as “calcium”) surrounded by red (misclassified as “necrotic core”), although this does not appear to be a limitation for NIRS and OCT.54

    Reference 41:

    Bourantas CV, Gracia-Gracia HM, Naka KK, et al. Hybrid intravascular imaging: current applications and prospective potential in the study of coronary atherosclerosis, JACC 2013;61:1369-1378

    Abstract

    The miniaturization of medical devices and the progress in image processing have allowed the development of a multitude of intravascular imaging modalities that permit more meticulous examination of coronary pathology. However, these techniques have significant inherent limitations that do not allow a complete and thorough assessment of coronary anatomy. To overcome these drawbacks, fusion of different invasive and noninvasive imaging modalities has been proposed. This integration has provided models that give a more detailed understanding of coronary artery pathology and have proved useful in the study of the atherosclerotic process. In this review, the authors describe the currently available hybrid imaging approaches, discuss the technological innovations and efficient algorithms that have been developed to integrate information provided by different invasive techniques, and stress the advantages of the obtained models and their potential in the study of coronary atherosclerosis.

    http://content.onlinejacc.org/article.aspx?articleid=1671094

    Reference 54

    Kim SW, Mintz GS, Hong YJ, et al. The virtual histology intravascular ultrasound appearance of newly placed drug-eluting stents. Am J Cardiol. 2008;102:1182-1186.

    American Journal of Cardiology
    Volume 102, Issue 9 , Pages 1182-1186, 1 November 2008

    The Virtual Histology Intravascular Ultrasound Appearance of Newly Placed Drug-Eluting Stents

    Received 17 January 2008; received in revised form 17 March 2008; accepted 17 March 2008. published online 13 June 2008.

    Intravascular ultrasound (IVUS) is used before and after intervention and at follow-up to assess the quality of the acute result as well as the long-term effects of stent implantation. Virtual histology (VH) IVUS classifies tissue into fibrous and fibrofatty plaque, dense calcium, and necrotic core. Although most interventional procedures include stent implantation, VH IVUS classification of stent metal has not been validated. In this study, the VH IVUS appearance of acutely implanted stents was assessed in 27 patients (30 lesions). Most stent struts (80%) appeared white (misclassified as “calcium”) surrounded by red (misclassified as “necrotic core”); 2% appeared just white, and 17% were not detectable (compared with grayscale IVUS because of the software-imposed gray medial stripe). The rate of “white surrounded by red” was similar over the lengths of the stents; however, undetectable struts were mostly at the distal edges (31%). Quantitatively, including the struts within the regions of interest increased the amount of “calcium” from 0.23 ± 0.35 to 1.07 ± 0.66 mm2 (p <0.0001) and the amount of “necrotic core” from 0.59 ± 0.65 to 1.31 ± 0.87 mm2 (p <0.0001). Most important, because this appearance occurs acutely, it is an artifact, and the red appearance should not be interpreted as peristrut inflammation or necrotic core when it is seen at follow-up. In conclusion, acutely implanted stents have an appearance that can be misclassified by VH IVUS as “calcium with or without necrotic core.” It is important not to overinterpret VH IVUS studies of chronically implanted stents when this appearance is observed at follow-up. A separate classification for stent struts is necessary to avoid these misconceptions and misclassifications.

    Table 2. Comparison of three intravascular imaging modalities for the detection of coronary lipid core plaque.

    Intravascular Imaging Modalities for Detecting LCP

    Vol. 25, Supplement A, 2013

    13A

     VH-IVUS (20 MHz)                        OCT                          NIRS-IVUS (40 MHz)

    Hybrid intravascular imaging  No No Yes

    Axial resolution, μm 200 10 100

    Imaging through blood ++ – ++

    Need for blood column clearance during image acquisition No Yes No

    Imaging through stents No Yes Yes

    Imaging through calcium No Yes Yes for NIRS – No for IVUS

    Imaging neovascularization No Yes No

    Detection of non-superficial LCPs Yes No No

    Evaluation of LCP cap thickness + ++ *

    Detection of thrombus – + *

    Expansive remodeling ++ – ++

    Need for manual image processing for LCP detection Yes Yes No

    ++ = excellent; + = good; ± = possible; – = impossible; * = potential under investigation

    VH-IVUS = virtual histology intravascular ultrasound; OCT = optical coherence tomogra-phy; NIRS = near-infrared spectroscopy; LCP = lipid core plaque 

    The Search for Vulnerable Plaque — The Pace Quickens

     

    Ryan D. Madder, MD1, Gregg W. Stone, MD2, David Erlinge, MD3, James E. Muller, MD4

    Affiliations

    1Frederik Meijer Heart & Vascular Institute, Spectrum Health, Grand Rapids, Michigan;

    2New York Presbyterian Hospital, Columbia University and Car-diovascular Research Foundation, New York, New York;

    3Department of Cardiology, Lund University, Lund, Sweden;

    4Infraredx, Inc., Burlington, Massachusetts

    Disclosure: Drs. Madder and Erlinge report no financial relationships or conflicts of interest regarding the content herein.

    Dr. Stone is a consultant for Infraredx, Inc., Volcano Corp., Medtronic, and Boston Scientific, and is a member of the scientific advisory boards for Boston Scientific and Abbott Vascular.

    Dr. Muller is a full-time employee of Infraredx, Inc from which he receives salary and equity.

    Address for Correspondence: Email: ryan.madder@spectrumhealth.org

    The search for the vulnerable plaque has been a lengthy endeavor requiring the work of multiple individuals and institutions over many years. It is disappointing that in more than 2 decades since the “vulnerable plaque” concept was formulated, over 40 million coronary events have occurred. However, it is encouraging that positive answers are now available for most of the questions related to a vulnerable plaque detection and treatment strategy. As shown in Table 1, most of the essential preconditions of a successful vulnerable plaque strategy are present. This positive information has accelerated the pace of work in this area. The pathophysiology of coronary events is well-understood; powerful imaging methods are available; and therapies, both existing and novel, may well be effective (although appropriately powered randomized trials are required to demonstrate their safety and effectiveness). The time is approaching for the conduct of prospective outcome trials to determine the value of a vulnerable plaque strategy for more effective prevention of coronary events.

    Table 1. Essential Components of a Strategy to Prevent Coronary Events by the Detection and Treatment of Vulnerable Plaques

     
    Essential Components Evidencefrom  Published Research
    Pathophysiology of Coronary Events
    • Are the causes of coronary events known? Yes Constantinides and others have shown that most coronary events are caused by rupture of a thin-capped LRP with subsequent formation of an occlusive thrombus.1-5
    • Are LRPs focal? Yes Cheruvu et al demonstrated that ruptures and TCFA occupy less than 4% of the length of arteries studied at autopsy.8
    • Are LRPs stable over time? Yes Kubo et al demonstrated that most fibroatheromas by radiofrequency IVUS remain fibroatheromas over time.39
    Detection of Suspected Vulnerable Plaque by Invasive Imaging (For Secondary Prevention)
    • Can invasive imaging safely detect LRP? Yes Waxman et al, Ino et al, and many others have demonstrated the safety of detecting LRP in patients.40
    • Do cross-sectional studies show increased LRP concentrated at culprit sites? Yes Madder et al, Erlinge et al, Ino et al have shown LRP concentrated at the culprit site across the spectrum of ACS.14,16,41
    • Do prospective studies show that suspected vulnerable plaque can be detected in advance? Yes PROSPECT, VIVA, PREDICTION established the principle by proving that increased plaque burden predicted events but prediction lacked specificity.23-25
    • Is more specific detection of vulnerable plaque possible? ? NIRS-IVUS and OCT may provide more specific detection of VP, but have not yet been tested in a prospective study.
    Can Vulnerable Plaques be Treated?
    • Is systemic treatment of LRPs possible with current agents? Yes YELLOW study showed a reduction in LRP with rosuvastatin.33
    • Is focal treatment of LRPs possible with current methods? Yes Ruptured LRPs are routinely stented in ACS in clinical practice with good outcomes.
    • Can systemic treatment be enhanced with new agents? ? PCSK9 inhibitors, Apo A1 Milano, other agents in development may be more effective than statins, but more costly.35,36
    • Can focal treatments be enhanced with new methods? ? Bioresorbable vascular scaffolds and/or drug-coated balloons may be useful for VP.
    Primary Prevention
    • Can demographic and serum biomarkers be used as a first step in a screening strategy? Yes Framingham Risk Score, improved serum biomarkers, and genetic markers can identify individuals at increased risk.
    • Can non-invasive imaging with CTA detect LRP and increased risk? Yes Motoyama et al have identified CTA markers associated with future events.26
    Cost-Effectiveness
    • Will a strategy of detection and treatment of vulnerable plaque, if proven to be successful, be cost-effective for secondary prevention? Probably Bosch et al demonstrated that for patients already undergoing invasive imaging, the added costs of detection and treatment of VP are likely to be less than the cost of second events, leading to a cost-saving approach that also improves health.38
    • Will a strategy of detection and treatment of vulnerable plaque, if proven to be successful, be cost-effective for primary prevention? ? Bosch et al: For primary prevention the cost of screening would be greater than for secondary prevention. Cost-effectiveness would depend upon cost, the accuracy of detection, and effectiveness of therapy.38
    ACS = acute coronary syndrome; CTA = coronary computed tomographic angiography; LRP = lipid-rich plaque; TCFA = thin-capped fibroatheroma; 

    References

    1. Constantinides P. Plaque fissures in human coronary thrombosis. J Atheroscler Res. 1966;6:1-17.

    2. Friedman M, Van den Bovenkamp GJ. The pathogenesis of a coronary thrombus. Am J Pathol. 1966;48:19-44.

    3. Burke AP, Farb A, Malcom GT, et al. Coronary risk factors and plaque morphology in men with coronary disease who died suddenly. N Engl J Med. 1997;336:1276-1282.

    4. Farb A, Tang AL, Burke AP, et al. Sudden coronary death. Frequency of active coronary lesions, inactive coronary lesions, and myocardial infarction. Circulation. 1995;92:1701-1709.

    5. Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol. 2000;20:1262-1275.

    6. Waksman R, Serruys PW. Handbook of the Vulnerable Plaque. Martin Dunitz: London, England, 2004.

    7. Libby P, Ridker PM, Hansson GK. Progress and challenges in translating the biology of atherosclerosis. Nature. 2011;473:317-325.

    8. Cheruvu P, Finn A, Gardner C, et al. Frequency and distribution of thin-cap fibroatheroma and ruptured plaques in human coronary arteries – a pathologic study. J Am Coll Cardiol. 2007;50:940-949.

    9. Hong M, Mintz GS, Lee CW, et al. Comparison of coronary plaque rupture between stable angina and acute myocardial infarction: a three-vessel intravascular ultrasound study in 235 patients. Circulation. 2004;110:928-933.

    10. Fujii K, Kobayashi Y, Mintz GS, et al. Intravascular ultrasound assessment of ulcerated ruptured plaques. A comparison of culprit and non-culprit lesions of patients with acute coronary syndromes and lesions in patients without acute coronary syndromes. Circulation. 2003;108:2473-2478.

    11. Ehara S, Kobayashi Y, Yoshiyama M, et al. Spotty calcification typifies the culprit plaque in patients with acute myocardial infarction. An intravascular ultrasound study. Circulation. 2004;110:3424-3429.

    12. Lee SY, Mintz GS, Kim SY, et al. Attenuated plaque detected by intravascular ultrasound: clinical, angiographic, and morphologic features and post-percutaneous coronary intervention complications in patients with acute coronary syndromes. J Am Coll Cardiol Intv. 2009;2:65-72.

    13. Asakura M, Ueda Y, Yamaguchi O, et al. Extensive development of vulnerable plaques as a pan-coronary process in patients with myocardial infarction: an angioscopic study. J Am Coll Cardiol. 2001;37:1284-1288.

    14. Ino Y, Kubo T, Tanaka A, et al. Difference of culprit lesion morphologies between ST-segment elevation myocardial infarction and non-ST-segment elevation acute coronary syndrome. J Am Coll Cardiol Intv. 2011;4:76-82.

    15. Madder RD, Smith JL, Dixon SR, Goldstein JA. Composition of target lesions by near-infrared spectroscopy in patients with acute coronary syndrome versus stable angina. Circ Cardiovasc Interv. 2012;5:55-61.

    16. Madder RD, Goldstein JA, Madden SP, et al. Detection by near-infrared spectroscopy of large lipid core plaques at culprit sites in patients with acute ST-segment elevation myocardial infarction. J Am Coll Cardiol Intv. In press, 2013.

    17. Hoffmann U, Moselewski F, Nieman K, et al. Noninvasive assessment of plaque morphology and composition in culprit and stable lesions in acute coronary syndrome and stable lesions in stable angina by mulitdetector computed tomography. J Am Coll Cardiol. 2006;47:1655-1662.

    18. Motoyama S, Kondo T, Sarai M, et al. Multislice computed tomographic characteristics of coronary lesions in acute coronary syndromes. J Am Coll Cardiol. 2007;50:319-326.

    19. Madder RD, Chinnaiyan KM, Marandici AM, Goldstein JA. Features of disrupted plaques by coronary computed tomographic angiography: correlates with invasively proven complex lesions. Circ Cardiovasc Imaging. 2011;4:105-113.

    20. Muller JE, Tofler GH, Stone PH. Circadian variation and triggers of onset of acute cardiovascular disease. Circulation. 1989;79;733-743.

    21. Kolodgie FD, Burke AP, Farb A, et al. The thin-cap fibroatheroma: a type of vulnerable plaque: the major precursor lesion to acute coronary syndromes. Curr Opin Cardiol. 2001;16:285-292.

    22. Yamagishi M, Terashima M, Awano K, et al. Morphology of vulnerable coronary plaque: insights from follow-up of patients examined by intravascular ultrasound before an acute coronary syndrome. J Am Coll Cardiol. 2000;35:106-111.

    23. Stone GW, Maehara A, Lansky A, et al. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011;364:226-235.

    24. Calvert PA, Obaid DR, O’Sullivan M, et al. Association between IVUS findings and adverse outcomes in patients with coronary artery disease: the VIVA (VH-IVUS in Vulnerable Atherosclerosis) study. J Am Coll Cardiol Imaging. 2011;4:894-901.

    25. Stone PH, Saito S, Takahashi S, et al. Prediction of progression of coronary artery disease and clinical outcomes using vascular profiling of endothelial shear stress and arterial plaque characteristics: the PREDICTION study. Circulation. 2012;126:172-181.

    26. Motoyama S, Sarai M, Harigaya H, et al. Computed tomographic angiography characteristics of atherosclerotic plaques subsequently resulting in acute coronary syndrome. J Am Coll Cardiol. 2009;54:49-57.

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    28. Madder RD, Steinberg DH, Anderson RD. Multimodality direct coronary imaging with combined near-infrared spectroscopy and intravascular ultrasound: Initial US experience. Catheter Cardiovasc Interv. 2013;81:551-7.

    29. Kume T, Akasaka T, Kawamoto T, et al. Measurement of the thickness of the fibrous cap by optical coherence tomography. Am Heart J. 2006;152:755.e1-4.

    30. Nissen SE, Tuzcu EM, Schoenhagen P, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA. 2004;291:1071-1080.

    31. Nissen SE, Nicholls SJ, Sipahi I, et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006;295:1556-1565.

    32. Nicholls SJ, Ballantyne CM, Barter PJ, et al. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011;365:2078-2087.

    33. Kini AS, Baber U, Kovacic JC, et al. Changes in plaque lipid content after short-term, intensive versus standard statin therapy: the YELLOW trial. J Am Coll Cardiol. 2013 (In press).

    34. Takarada S, Imanishi T, Kubo T, et al. Effect of statin therapy on coronary fibrous-cap thickness in patients with acute coronary syndrome: assessment by optical coherence tomography study. Atherosclerosis. 2009;202:491-497.

    35. Stein EA, Gipe D, Bergeron J, et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet. 2012;380:29-36.

    36. Nissen SE, Tsunoda T, Tuzcu EM, et al. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003;290:2292-2300.

    37. Braunwald, E. Epilogue: What do clinicians expect from imagers? J Am Coll Cardiol. 2006;47:C101-C103.

    38. Bosch JL, Beinfeld MT, Muller JE, Brady T, Gazelle GS. A cost-effectiveness analysis of a hypothetical catheter-based strategy for the detection and treatment of vulnerable coronary plaques with drug-eluting stents. J Interv Cardiol. 2005;18:339-349.

    39. Kubo T, Maehara A, Mintz GS, et al. The dynamic nature of coronary artery lesion morphology assessed by serial virtual histology intravascular ultrasound tissue characterization. J Am Coll Cardiol. 2010;55:1590-1597.

    40. Waxman S, Dixon SR, L’Allier P, et al. In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results and exploratory analysis of the SPECTroscopic Assessment of Coronary Lipid (SPECTACL) multicenter study. J Am Coll Cardiol Imaging. 2009;2:858-868.

    41. Erlinge D, Muller JE, Puri R, et al. Validation of a near-infrared spectroscopic signature of lipid located at culprit lesions in ST-segment elevation myocardial infarction. European Atherosclerosis Society. June 2013 (abstract).

    http://www.invasivecardiology.com/files/Infraredx_FINALPDF.pdf

    Proposed Algorithm for Vulnerable Plaque Screening and Treatment 

    SOURCE

    Page 31A in

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    Long-term Consequences of a Lipid Core Plaque

    Christos V. Bourantas, MD, PhD1, Hector M. Garcia, MD, PhD1, Roberto Diletti, MD1, Carlos A.M. Campos, MD1, Yaojun Zhang, MD, PhD1, Scot Garg, MRCP, PhD2, Patrick W. Serruys, MD, PhD1

    1Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands and 2Department of Cardiology, East Lancashire NHS Trust, Haslingden Road, Blackburn, Lancashire, United Kingdom.

    Disclosures: The authors report no financial relationships or conflicts of interest regarding the content herein.

    Address for correspondence:  Email: p.w.j.c.serruys@erasmusmc.nl

    The advent of intravascular imaging in the 1980s allowed us to study in vivo plaque morphology and its prognostic implications.

    • Angioscopy and intravascular ultrasound (IVUS) were the first imaging techniques that provided information about the composition of plaque and allowed detection of its lipid component.7,8

    However, the first applications of these modalities in the clinical setting not only underscored their potential value in the study of atherosclerosis but also highlighted their limitations in characterizing atheroma.9-11 Therefore an effort was made over the last few years to develop advanced techniques that would allow more reliable assessment of a plaque’s composition. Today several modalities are available for this purpose including:

    • the radiofrequency analysis of the IVUS backscatter signal (RF-IVUS),
    • near-infrared spectroscopy (NIRS),
    • optical coherence tomography (OCT),
    • magnetic resonance spectroscopy,
    • intravascular magnetic resonance imaging,
    • Raman spectroscopy,
    • photoacoustic imaging, and
    • time resolved spectroscopic imaging (Figure 1).

    Some of these modalities are still in their infancy, while others have already been used in the clinical setting providing robust evidence about the prognostic implications of the differing compositions of the plaque. The aim of this review article is to present the most recent evidence about the long-term consequences of the atheroma’s phenotype. 

    Current Evidence from NIRS-based Clinical Studies

    NIRS relies on the principle that different organic molecules absorb and scatter NIRS light to different degrees and wavelengths. Recent advances in device technology enabled the development of a catheter suitable for assessing the plaque in human coronaries that is able to emit NIR light and acquire the scattered signal. Spectral analysis of the obtained signal provides a color-coded display, called a chemogram (Figure 1C), which provides the probability that lipid core is present in the superficial plaque (studied depth approximately: 1 mm). Several studies have examined the reliability of this technique using histology as the gold standard and demonstrated a high overall accuracy in detecting lipid-rich plaques while others demonstrated its feasibility in the clinical setting.19-20

    The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis (NCT01789411) – NIRS sub-study was the first prospective trial designed to evaluate the prognostic implications of an increased lipid component, as detected by NIRS, in coronary plaques. Two hundred three patients that underwent X-ray angiography, and PCI if it was indicated, had NIRS in a non-culprit coronary segment and were followed-up for 1 year. Twenty-eight patients sustained a MACE during the follow-up period; 21 of these events were non-culprit lesion related. Lipid plaque burden index appeared to be an independent predictor of MACE (hazard ratio: 4.04, 95% confidence interval: 1.33-12.29; P=0.01). 

    Currently, the Chemometric Observation of Lipid Rich Plaque of Interest in Native Coronary Arteries (COLOR, NCT00831116) registry is recruiting patients. This study is planning to recruit 2000 patients that will be investigated with NIRS imaging, and aims to examine the association between the presence of a necrotic core in the atheroma and subsequent coronary events. Preliminary results indicate that the absence of lipid-rich plaques is related with better outcomes (www.infraredx.com/the-color-registry). 

    Current Evidence From OCT-based Clinical Studies

    OCT imaging with its high resolution appears able to provide detailed assessment of the superficial plaque and visualize structures that are unseen by other techniques such as the presence of micro calculations of thin-capped fibroatheroma (TCFA). However, a significant limitation of this technique is its poor penetration (1-2 mm), which does not permit through visualization of plaque burden, as well as its low capacity in differentiating lipid from calcific tissue when these are deeply embedded in the vessel wall.21

    In this analysis, 53 patients who underwent PCI had OCT imaging in non-obstructive lesion sat baseline and repeat angiography at 7 months follow-up. They found that plaques with a TCFA phenotype, exhibiting vessel walldiscontinuities, macrophages, neo-vessels, and thrombi were morelikely to progress and cause significant angiographic obstructions.22

    Future Perspective in Plaque Imaging – Conclusions

    Cumulative data derived from intravascular imaging studies have provided robust evidence about the prognostic implications of plaque’s composition and burden, and demonstrated a strong association between the presence of lipid-rich plaques and future cardiovascular events. Plaque pathology and quantification of lipid components is done by hybrid catheters able to acquire different intravascular imaging data.23

    References on page 26A in

     http://www.invasivecardiology.com/files/Infraredx_FINALPDF.pdf

    1.Kragel AH, Reddy SG, Wittes JT, Roberts WC. Morphometric analysis of the composition ofatherosclerotic plaques in the four major epicardial coronary arteries in acute myocardial infarctionand in sudden coronary death. Circulation. 1989;80:1747-1756.

    2.ᆳacteristics of coronary atherosclerotic plaques underlying fatal occlusive thrombi. Br Heart J.1983;50:127-134.

    3.Clark E, Graef I, Chasis H. Thrombosis of the aorta and coronary arteries. Archives of Pathology.1936;22:183-212.

    4.Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death:a comprehensive morphological classification scheme for atherosclerotic lesions. ArteriosclerThromb Vasc Biol. 2000;20:1262-1275.

    5.Stary HC, Chandler AB, Glagov S, et al. A definition of initial, fatty streak, and intermediatelesions of atherosclerosis. A report from the Committee on Vascular Lesions of the Council onArteriosclerosis, American Heart Association. Circulation. 1994;89:2462-2478.

    6.ᆳrotic lesions and a histological classification of atherosclerosis. A report from the Committee onVascular Lesions of the Council on Arteriosclerosis, American Heart Association. Circulation.1995;92:1355-1374.

    7.Di Mario C, The SH, Madretsma S, et al. Detection and characterization of vascular lesionsby intravascular ultrasound: an in vitro study correlated with histology. J Am Soc Echocardiogr. 1992;5:135-146.

    8.ᆳdation by histomorphologic analysis and association with stable and unstable coronary syndromes.J Am Coll Cardiol. 1996;28:1-6.

    9.Hiro T, Leung CY, Russo RJ, et al. Variability in tissue characterization of atherosclerotic plaqueby intravascular ultrasound: a comparison of four intravascular ultrasound systems. Am J CardImaging. 1996;10:209-218.

    10.ᆳdial infarction: ability of optical coherence tomography compared with intravascular ultrasoundand coronary angioscopy. J Am Coll Cardiol. 2007;50:933-939.

    11.ᆳated with future risk of acute coronary syndrome: detection of vulnerable patients by angioscopy.J Am Coll Cardiol. 2006;47:2194-2200.

    12.ᆳnary syndrome using integrated backscatter intravascular ultrasound. J Am Coll Cardiol.2006;47:734-741.

    13.Amano T, Matsubara T, Uetani T, et al. Lipid-rich plaques predict non-target-lesion ischemicevents in patients undergoing percutaneous coronary intervention. Circ J. 2011;75:157-166.

    14.ᆳsclerosis. N Engl J Med. 2011;364:226-235.

    15.Calvert PA, Obaid DR, O’Sullivan M, et al. Association between IVUS findings and adverseᆳsclerosis) Study. JACC Cardiovasc Imaging. 2011;4:894-901.

    16.Granada JF, Wallace-Bradley D, Win HK, et al. In vivo plaque characterization using intravascularultrasound-virtual histology in a porcine model of complex coronary lesions. Arterioscler ThrombVasc Biol. 2007;27:387-393.

    17.Sales FJ, Falcao BA, Falcao JL, et al. Evaluation of plaque composition by intravascular ultrasound“virtual histology”: the impact of dense calcium on the measurement of necrotic tissue. ᆳvention. 2010;6:394-399.

    18.ᆳtual histology intravascular ultrasound in porcine coronary artery disease. Circ Cardiovasc Imaging. 2010;3:384-391.

    19.ᆳmens with a novel catheter-based near-infrared spectroscopy system. JACC Cardiovasc Imaging. 2008;1:638-648.

    20.Waxman S, Dixon SR, L’Allier P, et al. In vivo validation of a catheter-based near-infrared spectrosᆳcopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study.JACC Cardiovasc Imaging. 2009;2:858-868.

    21.Manfrini O, Mont E, Leone O, et al. Sources of error and interpretation of plaque morphology byoptical coherence tomography. Am J Cardiol. 2006;98:156-159.

    22.Uemura S, Ishigami K, Soeda T, et al. Thin-cap fibroatheroma and microchannel findings inoptical coherence tomography correlate with subsequent progression of coronary atheromatousplaques. Eur Heart J. 2012;33:78-85.

    23.ᆳplications and prospective potential in the study of coronary atherosclerosis. J Am Coll Cardiol.2013;61:1369-378.

    24.ᆳtroscopy and intra-vascular ultrasound catheter to identify composition and structure of coronaryplaque. EuroIntervention. 2010;5:755-756.

    25.ᆳᆳgrated Biomarker and Imaging Study-3 (IBIS-3). EuroIntervention. 2012;8:235-241.

     http://www.invasivecardiology.com/files/Infraredx_FINALPDF.pdf

    NIRS-IVUS Imaging Identifies Lesions at High Risk of Peri-Procedural Myocardial Infarction

    James A. Goldstein, MD, Simon R. Dixon, MBChB*, Gregg W. Stone, MD

    From the Department of Cardiovascular Medicine, William Beaumont Hospital, Royal Oak, MI.

    Address for correspondence: James A. Goldstein, MD, FACC, Department of Cardiovascular Medicine, William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, Michigan 48073. Email: jgoldstein@beaumont.edu

    Disclosures: Dr. Goldstein is a consultant for and owns equity in Infraredx, Inc. Dr. Stone is a consultant for Infraredx, Inc., Volcano Corp., Medtronic, and Boston Scientific, and is a member of the scientific advisory boards for Boston Scientific and Abbott Vascular. Dr. Dixon reports no financial relationships or conflicts

    Abstract:

    Percutaneous coronary intervention (PCI) is associated with distal embolization complications, including peri-procedural myocardial infarction (PPMI), including no-reflow, in 3%-15% of cases. These complications are predominantly related to distal embolization of lipid core plaque (LCP) components. Catheter-based near-infrared spectroscopy (NIRS) provides rapid, automated detection of LCPs, the magnitude of which appears associated with a high-risk of PPMI. Employing this technique may facilitate development of preventive measures such as embolic protection devices (EPDs).

    J INVASIVE CARDIOL 2013;25 (Suppl A):14A-16A

    Key words: Distal embolization, lipid core plaque, near-infrared spectroscopy, peri-procedural myocardial infarction

    Figures 1. A 62-year-old man with stable angina underwent coronary angiography, which demonstrated a complex hazy ulcerated culprit lesion in the mid-right coronary artery (Figure 1A, solid arrow). Neither the angiogram nor an intravascular ultrasound image indicated the presence of thrombus. NIRS demonstrated a large yellow signal spanning the circumference of the culprit site (Figure 1B, white rectangle), indicating the presence of a napkin-ring LCP; a smaller LCP was evident distally (Figure 1, open arrow).

    Figure 2. Balloon angioplasty was performed (Figure 2A, arrow), which led to prompt no-reflow (Figure 2B, arrow) associated with severe bradyarrhythmia and profound hypotension (Figure 2C). After brief cardiopulmonary resuscitation and pharmacological support with atropine and dopamine, physiologic rhythm and blood pressure were restored and stenting resulted in excellent angiographic outcome. However, the patient developed a peri-stenting non-transmural infarction (peak creatine kinase of 512 ng/mL) and required an additional day of hospital care in an intensive care unit. (Goldstein JA, et al. JACC Cardiovasc Imaging. 2009;2(12):1420-1424. Reproduced with permission.)

    On Page 14A in

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    Pharmacological Therapy of Lipid Core Plaque

    Jason C. Kovacic, MD, PhD, Annpoorna Kini, MD, MRCP

    From The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai School of Medicine, New York, New York.

    Address for correspondence: Dr. Annapoorna Kini, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1030, New York, NY, 10029. Email: annapoorna.kini@mountsinai.org

    Disclosures: Dr. Kovacic is supported by National Institutes of Health Grant K08HL111330 and has received research support from AstraZeneca. Dr. Kini acknowledges honoraria from Medscape and has received research grant support from InfraReDx.

    A new group of terms is slowly creeping in to the atherosclerotic disease lexicon: “Lipid Arc,” “Lipid Core Plaque,” “Lipid-Rich Plaque,” “Lipid Core Burden Index” and other similar phrases. While clinicians and researchers have long been aware of the central importance of lipid in the biology of atherosclerosis, the growing use of these terms is driven by the recent widespread use of novel imaging modalities that provide accurate detection, and even quantification, of the extent of lipid that is contained within the core of an atherosclerotic plaque. Our ability to detect and quantify lipid in plaques is opening up new therapeutic opportunities for modifying the atherosclerotic disease process, which may ultimately be of benefit to patients.

    At the present time there are 3 methods that are commonly used to measure the extent of lipid in atherosclerotic plaques. Perhaps most familiar of these is coronary computer tomographic (CT) scanning. While more commonly used to quantitate calcification or luminal stenosis, CT scanning is readily able to quantitate the extent of lipid associated with an atherosclerotic lesion. However, while several studies have reported various Hounsfield Unit (HU)-based criteria to distinguish lipid-rich from fibrous plaques, the HU cut-off points have so far been inconsistent. The use of CT for detecting lipid-rich plaque is further limited by its relatively low spatial resolution and the fact that the HU values for distinguishing between fibrous and lipid-rich plaques are overlapping.1 In contrast, optical coherence tomography (OCT) offers perhaps the greatest spatial resolution of all clinically available coronary imaging devices. OCT can offer exquisite detail of abluminal coronary artery anatomy, including detection of lipid core plaque. However, while automated systems are being developed, at the present time the quantitation of lipid by OCT is a somewhat specialized process that typically involves detailed off-line analysis.

    A specific intra-coronary imaging catheter for the quantitation of coronary artery lipid content is now available and FDA approved: diffuse reflectance near-infrared spectroscopy (NIRS). The application of NIRS to identify lipid deposition within coronary arteries has been validated ex vivo2-5 and in vivo.6,7 Although NIRS itself is essentially only able to detect and quantitate lipid, design changes and technological advances to this catheter have now made it possible to combine intravascular ultrasound (IVUS) and NIRS technology on a single instrument. In one of the few clinical studies published to date using this device, NIRS has already shown that a high lipid burden in a target lesion undergoing percutaneous coronary intervention (PCI) is associated with an increased likelihood of peri-procedural myocardial infarction.7

    It is well known that the reduction of cholesterol levels by statin therapy is associated with significant decreases in plaque burden. REVERSAL,8 ASTEROID,9 and more recently the SATURN II10 trial showed that in patients with coronary artery disease (CAD), lipid lowering with high-dose statin therapy reduced progression of plaque atheroma burden, even causing plaque regression of some lesions. However, while reduction in atheroma burden and plaque size are important anatomical endpoints, a major unresolved question had been the mechanism of action of statins and the unanswered question of whether they reduce plaque lipid content. Indeed, a high burden of plaque lipid is one of the cardinal features of a rupture-prone vulnerable lesion.11 Therefore, the ability to reduce plaque lipid content may have important effects on lesion stability and therefore, might impact clinical endpoints.

    The advent of sensitive imaging tools for the evaluation of plaque lipid content has paved the way for the investigation of potential pharmacological therapies for lipid core plaque. In particular, the ability of NIRS to provide an automated quantitation of plaque lipid provides a ready-made platform for this task. We recently completed the YELLOW study of high-dose statin therapy for the potential reduction of coronary artery lipid content as assessed by NIRS. We randomized 87 patients with multivessel CAD undergoing elective PCI to rosuvastatin 40 mg daily vs conventional statin therapy. Following PCI of the culprit lesion, non-culprit lesions with a fractional flow reserve (FFR) <0.8 were interrogated using IVUS and NIRS. Changes in plaque composition were assessed after 6-12 weeks during follow-up angiography. The core finding of this study was that high-dose statin therapy was associated with significant reductions in the lipid content of coronary atherosclerotic plaques. Interestingly, despite reduced plaque lipid content, in this relatively short time period concordant changes in gross lesion characteristics such as total atheroma volume or % plaque burden were not observed.12 In short, the YELLOW study identified that even before gross atheroma regression occurs, lipid removal from plaques is an early event upon initiation of high-dose statin therapy. Furthermore, the results of the YELLOW study are concordant with the known acute benefits of statin therapy in patients presenting with acute coronary syndromes, where the early introduction of these agents is known to be of clinical benefit.13 While the YELLOW study was the first of this nature and the results remain to be replicated in a larger trial, these findings have revived interest in the concept of the “vulnerable plaque” because it appears possible that by causing lipid core reduction over a just few weeks, high-dose statin therapy may have rapid plaque stabilizing effects. We are now embarking on the YELLOW II study, where we will further explore the utility of high-dose rosuvastatin for the early reduction of plaque lipid content and potential mechanistic pathways.

    What other agents might have therapeutic efficacy for lipid core reduction? This question is perhaps more complex than it might first appear, because at the present time we do not know the specific mechanism whereby high-dose rosuvastatin causes lipid reduction in plaques. Theoretically it may be due to reduced LDL, increased HDL, other mechanisms or a combination of these effects. Potentially, other agents that are already available such as bile acid sequestrants, ezetimibe, and fibrates may have a weak lipid core reducing effect. However, we would underscore the fact that at the present time the utility of these agents is speculative, and no other agent (apart from high-dose rosuvastatin in the YELLOW study) has been shown to reduce lipid content in vivo in human plaques. Furthermore, given the fact that these other agents are far less potent in their overall effect than rosuvastatin 40 mg/day, it may be clinically challenging to determine if they have efficacy for lipid core reduction beyond that of statins.

    In addition to pharmacotherapy, it must be remembered that we have several non-pharmacological treatments in our armamentarium that may impact lipid core reduction. For example, exercise is known to be associated with reduced plaque lipid content,14 and proper adherence to current guidelines with respect to lifestyle and diet are of paramount importance in any patient in whom it is considered desirable to reduce plaque lipid content.

    Looking ahead, there are several emerging and investigational agents that may hold promise for lipid core reduction. Microsomal triglyceride transfer protein (MTP) is expressed in the liver, intestine, and the heart and is required for the proper assembly of VLDL and chylomicrons. In animals, treatment with an MTP inhibitor leads to a rapid reduction in plasma lipid levels, with a significant decrease in lipid content and monocyte-derived (CD68+) cells in atherosclerotic plaques.15 On December 21, 2012, the first of the MTP inhibitors was approved for clinical use. Lomitapide (marketed as Juxtapid) was approved by the FDA as an adjunct to a low fat diet and other lipid-lowering treatments for patients with homozygous familial hypercholesterolemia. However, concerns have been raised due to hepatic side effects and liver toxicity. As a result, lomitapide will carry a boxed warning and will only be available through a restricted program.16 Another new drug that was recently given restricted approval in the US for homozygous familial hypercholesterolemia is mipomersen. This agent is an antisense therapeutic that targets messenger RNA for apolipoprotein B, leading to reduced apoB protein and LDL levels. While showing efficacy for lowering LDL,17 safety concerns have thus far prohibited this agent from gaining approval for use in Europe. PCSK9 inhibitors are yet another novel class of agents that may hold promise for reducing lipid core plaque. PCSK9 is involved in the degradation of the LDL receptor (LDLR), and by inhibiting PCSK9 it is believed that this permits more LDL receptors to remain active and participate in LDL removal from the blood, thereby reducing plasma LDL and cholesterol levels. Denis et al18 recently demonstrated that gene inactivation of PCSK9 in mice reduced aortic cholesterol accumulation and atherosclerotic lesion development in atherosclerosis-prone mice. Based on their powerful LDL lowering effect, intense efforts are currently underway to develop clinically efficacious PCSK9 inhibitors with several agents already moving to phase II/III human studies.19 While all of these new and emerging therapies are cause for optimism, the recent experience with CETP-inhibitors and the overall failure of this class so far to stand up to rigorous testing as HDL raising agents in phase III studies20,21 serves to remind us that not all “promising future therapies” survive through the arduous clinical testing pipeline.

    In conclusion, there is renewed interest in the concept of “plaque regression” and pharmacological therapy for “lipid core reduction.” This has been driven by our increasing ability to image and quantify these phenomena, and more recently by the provocative findings that high-dose statin therapy may achieve both of these clinical endpoints. Further studies are now required to evaluate novel agents, define mechanisms of action and, most importantly, to confirm that atherosclerotic lipid core reduction is associated with plaque stabilization and fewer clinical endpoints.

    References, pp. 27A-28A in the Supplement

    1. Kristanto W, van Ooijen PM, Greuter MJ, et al. Non-calcified coronary atherosclerotic plaque visualization on CT: effects of contrast-enhancement and lipid-content fractions. Int J Cardiovasc Imaging. 2013; online ahead of print.

    2. Cassis LA, Lodder RA. Near-IR imaging of atheromas in living arterial tissue. Anal Chem. 1993;65:1247-1256.

    3. Jaross W, Neumeister V, Lattke P, et al. Determination of cholesterol in atherosclerotic plaques using near infrared diffuse reflection spectroscopy. Atherosclerosis. 1999;147:327-337.

    4. Moreno PR, Lodder RA, Purushothaman KR, et al. Detection of lipid pool, thin fibrous cap, and inflammatory cells in human aortic atherosclerotic plaques by near-infrared spectroscopy. Circulation. 2002;105:923-927.

    5. Wang J, Geng YJ, Guo B, et al. Near-infrared spectroscopic characterization of human advanced atherosclerotic plaques. J Am Coll Cardiol. 2002;39:1305-1313.

    6. Waxman S, Dixon SR, L’Allier P, et al. In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study. JACC Cardiovasc Imaging. 2009;2:858-868.

    7. Goldstein JA, Maini B, Dixon SR, et al. Detection of lipid-core plaques by intracoronary near-infrared spectroscopy identifies high risk of periprocedural myocardial infarction. Circ Cardiovasc Interv. 2011;4:429-437.

    8. Nissen SE, Tuzcu EM, Schoenhagen P, et al. Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N Engl J Med. 2005;352:29-38.

    9. Nissen SE, Nicholls SJ, Sipahi I, et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006;295:1556-1565.

    10. Nicholls SJ, Ballantyne CM, Barter PJ, et al. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011;365:2078-2087.

    11. Varnava AM, Mills PG, Davies MJ. Relationship between coronary artery remodeling and plaque vulnerability. Circulation. 2002;105:939-943.

    12. Kini AS, Baber U, Kovacic JC, et al. Changes in plaque lipid content after short-term, intensive versus standard statin therapy: The YELLOW Trial. J Am Coll Cardiol. 2013;62:21-29.

    13. Hulten E, Jackson JL, Douglas K, et al. The effect of early, intensive statin therapy on acute coronary syndrome: a meta-analysis of randomized controlled trials. Arch Intern Med. 2006;166:1814-1821.

    14. Yoshikawa D, Ishii H, Kurebayashi N, et al. Association of cardiorespiratory fitness with characteristics of coronary plaque: assessment using integrated backscatter intravascular ultrasound and optical coherence tomography. Int J Cardiol. 2013;162:123-128.

    15. Hewing B, Parathath S, Mai CK, et al. Rapid regression of atherosclerosis with MTP inhibitor treatment. Atherosclerosis. 2013;227:125-129.

    16. Cuchel M, Bloedon LT, Szapary PO, et al. Inhibition of microsomal triglyceride transfer protein in familial hypercholesterolemia. N Engl J Med. 2007;356:148-156.

    17. Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375:998-1006.

    18. Denis M, Marcinkiewicz J, Zaid A, et al. Gene inactivation of proprotein convertase subtilisin/kexin type 9 reduces atherosclerosis in mice. Circulation. 2012;125:894-901.

    19. Roth EM, McKenney JM, Hanotin C, et al. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med. 2012;367:1891-1900.

    20. Schwartz GG, Olsson AG, Abt M, et al. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012;367:2089-2099.

    21. Kovacic JC, Fuster V. From Treating Complex Coronary Artery Disease to Promoting Cardiovascular Health: Therapeutic Transitions and Challenges, 2010-2020. Clin Pharmacol Ther. 2011;90:509-518.

    KOVACIC and KINI

    28A

    The Journal of Invasive Cardiology®

    KEY SOURCE for this Article

    Journal of Invasive Cardiology, August 2013, Vol 25/Supplement A

    Print ISSN 1042-3931 / Electronic ISSN 1557-2501

    Introduction 

    NIRS-IVUS Imaging To Characterize the Composition and Structure of Coronary Plaques

    D. RIZIK AND J.A. GOLDSTEIN……………………………………..2A

    Background 

    Imaging of Plaque Composition and Structure with the TVC Imaging System™ and TVC Insight™ Catheter

    B. SHYDO, ET AL…………………………………………………………5A

    Comparative Intravascular Imaging for Lipid Core Plaque: NIRS vs VH-IVUS vs OCT

    E. FUH AND E.S. BRILAKIS……………………………………………9A

    Plaque Characterization and PCI Procedural Outcomes

    NIRS-IVUS Imaging Identifies Lesions at High Risk of

    Peri-Procedural Myocardial Infarction

    J.A. GOLDSTEIN, ET AL……………………………………………..14A

    Case Vignettes:

    Multiple Plaque Ruptures in a Patient with ST-Segment Elevation Myocardial Infarction: Does Infrared Spectroscopy Evidence Explain a Significant Change in the Angiogram?

    M.J. LIM AND J.M. STOLKER……………………………………….16A

    Missing the Culprit Yellow Plaque

    D. ERLINGE…………………………………………………………….18A

    The Use of Near-Infrared Spectroscopy to Optimize Stent Length

    G.A. STOUFFER ………………………………………………………19A

    Employing NIRS-IVUS to Guide Optimal Lesion Coverage—Avoidance of Geographic Miss

    I. HANSON, ET AL……………………………………………………..20A

    Peri-Procedural Myocardial Injury Unraveled: Combined

    Assessment by Optical Coherence Tomography, Near-Infrared

    Spectroscopy, and IVUS

    A. KARANASOS, ET AL………………………………………………..22A

    Plaque Characterization and Long-Term 

    Clinical Outcomes

    Long-term Consequences of a Lipid Core Plaque

    C.V. BOURANTAS, ET AL…………………………………………….24A

    Pharmacological Therapy of Lipid Core Plaque

    J.C. KOVACIC AND A. KINI………………………………………….27A

    The Search for Vulnerable Plaque — The Pace Quickens

    R.D. MADDER, ET AL…………………………………………………29A

    Case Vignettes:

    Observations from Intracoronary Near-Infrared Spectroscopy in Patients with ST-Segment Elevation Myocardial Infarction

    R.D. MADDER…………………………………………………………34A

    NIRS Imaging of Cardiac Allograft Vasculopathy

    G. WEISZ ……………………………………………………………….35A

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Advanced Topics in Sepsis and the Cardiovascular System at its End Stage

Author: Larry H Bernstein, MD, FCAP

http://pharmaceuticalintelligence.com/2013/08/18/advanced-topics-in-Sepsis-and-the-Cardiovascular-System-at-its-End-Stage/

This article was written in continuation to and it is addressing additional scientific matters to the content presented on this subject in the third Section titled

III. Incidence of Sepsis (circulation infection with serious consequences)

of the 7/23/2013 article on:

Cardiovascular Complications: Death from Reoperative Sternotomy after prior CABG, MVR, AVR, or Radiation; Complications of PCI; Sepsis from Cardiovascular Interventions

Justin D Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

Cardiovascular Complications: Death from Reoperative Sternotomy after prior CABG, MVR, AVR, or Radiation; Complications of PCI; Sepsis from Cardiovascular Interventions

The Cardiac Dysfunction Attributable to Sepsis, Hemodynamic Collapse, and the Search for Therapeutic Options

Sepsis and the Heart – Cardiovascular Involvement in General Medical Conditions
M.W. Merx, MD; C. Weber, MD
University Hospital (C.W.), RWTH Aachen University, Aachen, Germany.
Circulation.2007; 116: 793-802doi: 10.1161/​CIRCULATIONAHA.106.678359
http://circ.ahajournals.org/content/116/7/793.full

Sepsis is generally viewed as a disease aggravated by an inappropriate immune response encountered in the afflicted individual. As an important organ system frequently compromised by sepsis and always affected by septic shock, the cardiovascular system and its dysfunction during sepsis have been studied in clinical and basic research for more than 5 decades. Although a number of mediators and pathways have been shown to be associated with myocardial depression in sepsis, the precise cause remains unclear to date. There is currently no evidence supporting global ischemia as an underlying cause of myocardial dysfunction in sepsis.  A circulating myocardial depressant factor in septic shock has long been proposed, and potential candidates for a myocardial depressant factor include cytokines, prostanoids, and nitric oxide, among others.  Endothelial activation and induction of the coagulatory system also contribute to the pathophysiology in sepsis.

Prompt and adequate antibiotic therapy accompanied by surgical removal of the infectious focus, if indicated and feasible, is the mainstay and also the only strictly causal line of therapy. In the presence of severe sepsis and septic shock, supportive treatment in addition to causal therapy is mandatory.  We delineate some characteristics of septic myocardial dysfunction, to assess the most commonly cited and reported underlying mechanisms of cardiac dysfunction in sepsis, and to briefly outline current therapeutic strategies and possible future approaches.

Sepsis, defined by consensus conference as “the systemic inflammatory response syndrome (SIRS) that occurs during infection,” is generally viewed as a disease aggravated by the inappropriate immune response encountered in the affected individual.  Morbidity and mortality are high, resulting in sepsis and septic shock being the 10th most common cause of death in the United States.  The total national hospital cost invoked by severe sepsis in the United States was estimated at approximately $16.7 billion with 215 000 associated deaths annually. A study from Britain documented a 46% in-hospital mortality rate for patients presenting with severe sepsis on admission to the intensive care unit.

Current Criteria for Establishment of the Diagnosis of SIRS, Sepsis, and Septic Shock

The cardiovascular system is an important organ system frequently affected by sepsis and always affected by septic shock.  Waisbren was the first to describe cardiovascular .dysfunction due to sepsis in 1951.  He recognized a hyperdynamic state with full bounding pulses, flushing, fever, oliguria, and hypotension.  He also described a second, smaller patient group who presented clammy, pale, and hypotensive with low volume pulses and who appeared more severely ill. The latter group might well have been volume underresuscitated, and indeed, timely and adequate volume therapy has been demonstrated to be one of the most effective supportive measures in sepsis therapy.

Under conditions of adequate volume resuscitation, the profoundly reduced systemic vascular resistance typically encountered in sepsis leads to a concomitant elevation in cardiac index that obscures the myocardial dysfunction that also occurs. As early as the mid-1980s, significant reductions in both stroke volume and ejection fraction in septic patients were observed with normal total cardiac output. The presence of cardiovascular dysfunction in sepsis is associated with a significantly increased mortality rate of 70% to 90% compared with 20% in septic patients without cardiovascular impairment.

Characteristics of Myocardial Dysfunction in Sepsis

Using portable radionuclide cineangiography, Calvin et al. were the first to demonstrate myocardial dysfunction in adequately volume-resuscitated septic patients who had decreased ejection fraction and increased end-diastolic volume index. Adding pulmonary artery catheters to serial radionuclide cineangiography, Parker and colleagues extended these observations with the 2 major findings that

(1) survivors of septic shock were characterized by increased end-diastolic volume index and decreased ejection fraction, whereas nonsurvivors typically maintained normal cardiac volumes, and

(2) these acute changes in end-diastolic volume index and ejection fraction, although sustained for several days, were reversible.

More recently, echocardiographic studies have demonstrated impaired left ventricular systolic and diastolic function in septic patients. These human studies, in conjunction with experimental studies have clearly established decreased contractility and impaired myocardial compliance as major factors that cause myocardial dysfunction in sepsis. Similar functional alterations, as discussed above, have been observed for the right ventricle.

Myocardial dysfunction in sepsis has also been analyzed with respect to its prognostic value. Parker et al. reviewing septic patients on initial presentation and at 24 hours to determine prognostic indicators, found a heart rate of <106 bpm to be the only cardiac parameter on presentation that predicted a favorable outcome.  At 24 hours after presentation, a systemic vascular resistance index > 1529 dyne · s−1 · cm−5 · m−2, a heart rate < 95 bpm or a reduction in heart rate >18 bpm, and a cardiac index > 0.5 L · min−1 · m−2 suggested survival.  In a prospective study, Rhodes et al. demonstrated the feasibility of a dobutamine stress test for outcome stratification, with nonsurvivors being characterized by an attenuated inotropic response.

The well-established biomarkers in myocardial ischemia and heart failure, cardiac troponin I and T, as well as B-type natriuretic peptide, have also been evaluated with regard to sepsis-associated myocardial dysfunction. B-type natriuretic peptide studies have delivered conflicting results in septic patients, confounded by pre-existing heart failure early in the course. Several small studies have reported a relationship between elevated cardiac troponin T and I and left ventricular dysfunction in sepsis, as assessed by echocardiographic ejection fraction or pulmonary artery catheter–derived left ventricular stroke work index.  Cardiac troponin levels also correlated with the duration of hypotension and the intensity of vasopressor therapy. In addition, increased sepsis severity, measured by global scores such as the Simplified Acute Physiology Score II (SAPS II) or the Acute Physiology And Chronic Health Evaluation II score (APACHE II), was associated with increased cardiac troponin levels, as was poor short-term prognosis.

Despite the heterogeneity of study populations and type of troponin studied, the mentioned studies were unequivocal in concluding that elevated troponin levels in septic patients reflect higher disease severity, myocardial dysfunction, and worse prognosis. In a recent meta-analysis of 23 observational studies, Lim et al. found cardiac troponin levels to be increased in a large percentage of critically ill patients. Furthermore, in a subset of studies that permitted adjusted analysis and comprised 1706 patients, this troponin elevation was associated with an increased risk of death (odds ratio, 2.5; 95% CI, 1.9 to 3.4, P<0.001). Thus, it appears reasonable to recommend inclusion of cardiac troponins in the monitoring of patients with severe sepsis and septic shock to facilitate prognostic stratification and to increase alertness to the presence of cardiac dysfunction in individual patients.

Mechanisms Underlying Myocardial Dysfunction in Sepsis

Cardiac depression during sepsis is probably multifactorial. Nevertheless, it is important to identify individual contributing factors and mechanisms to generate worthwhile therapeutic targets. As a consequence, a vast array of mechanisms, pathways, and disruptions in cellular homeostasis have been examined in septic myocardium.

An early theory of myocardial depression in sepsis based on the hypothesis of global myocardial ischemia has no support. Septic patients have been shown to have high coronary blood flow and diminished coronary artery–coronary sinus oxygen difference.  Coronary sinus blood studies in patients with septic shock have demonstrated complex metabolic alterations in septic myocardium, including increased lactate extraction, decreased free fatty acid extraction, and decreased glucose uptake.  Several magnetic resonance studies in animal models of sepsis have demonstrated the presence of normal high-energy phosphate levels in the myocardium.  CAD-aggravating factors encountered in sepsis encompass generalized inflammation and the activated coagulatory system. The endothelium plays a prominent role in sepsis, but little is known of the impact of preexisting, CAD-associated endothelial dysfunction in this context. In a postmortem study of 21 fatal cases of septic shock, previously undiagnosed myocardial ischemia at least contributed to death in 7 of the 21 cases (all 21 patients were males, with a mean age of 60.4 years

Myocardial Depressant Substance

Parrillo et al. first proposed  a circulating myocardial depressant factor in septic shock  more than 50 years ago. They quantitatively linked the clinical degree of septic myocardial dysfunction with the effect that serum, taken from respective patients, had on rat cardiac myocytes, with clinical severity correlating well with the decrease in extent and velocity of myocyte shortening. These effects were not seen when serum from convalescent patients whose cardiac function had returned to normal was applied or when serum was obtained from other critically ill, nonseptic patients. These findings were extended when ultrafiltrates from patients with severe sepsis and simultaneously reduced left ventricular stroke work index (< 30 g · m−1 · m−2) displayed cardiotoxic effects and contained significantly increased concentrations of interleukin (IL)-1, IL-8, and C3a. Recently, Mink et al. demonstrated that lysozyme c, a bacteriolytic agent believed to originate mainly from disintegrating neutrophilic granulocytes and monocytes, mediates cardiodepressive effects during Escherichia coli sepsis and, importantly, that competitive inhibition of lysozyme c can prevent myocardial depression in the respective experimental sepsis model. Additional potential candidates for myocardial depressant substance include other cytokines, prostanoids, and nitric oxide (NO).

Cytokines

Infusion of lipopolysaccharide (LPS, an obligatory component of Gram-negative bacterial cell walls) into both animals and humans partially mimics the hemodynamic effects of septic shock. Only a minority of patients with septic shock have detectable LPS levels, and the prolonged time course of septic myocardial dysfunction make the role of LPS inconsistent with LPS representing the sole myocardial depressant substance. Tumor necrosis factor-α (TNF-α) is an important early mediator of endotoxin-induced shock. TNF-α is mainly derived from activated macrophages. Studies using monoclonal antibodies directed against TNF-α or soluble TNF-α receptors failed to improve survival in septic patients. IL-1 is synthesized by monocytes, macrophages, and neutrophils in response to TNF-α and plays a crucial role in the systemic immune response. IL-1 depresses cardiac contractility by stimulating NO synthase (NOS). Transcription of IL-1 is followed by delayed transcription of IL-1 receptor antagonist (IL-1-ra), which functions as an endogenous inhibitor of IL-1. Recombinant IL-1-ra was evaluated in phase III clinical trials, which showed a tendency toward improved survival and increased survival time in a retrospective analysis of the patient subgroup with the most severe sepsis; but this initially promising therapy failed to deliver a survival benefit. IL-6, another proinflammatory cytokine, has also been implicated in the pathogenesis of sepsis and is considered a more consistent predictor of sepsis than TNF-α because of its prolonged elevation in the circulation. Although cytokines may very well play a key role in the early decrease in contractility, they cannot explain the prolonged duration of myocardial dysfunction in sepsis, unless they result in the induction or release of additional factors that in turn alter myocardial function, such as prostanoids or NO.

Prostanoids

Prostanoids are produced by the cyclooxygenase enzyme from arachidonic acid (an omega-6 derivative). The expression of cyclooxygenase enzyme-2 is induced, among other stimuli, by LPS and cytokines (cyclooxygenase enzyme-1 is expressed constitutively). Elevated levels of prostanoids such as thromboxane and prostacyclin that alter coronary autoregulation, coronary endothelial function, and intracoronary leukocyte activation, have been demonstrated in septic patients. Early animal studies with cyclooxygenase inhibitors such as indomethacin yielded very promising results. Along with other positive results, these led to an important clinical study involving 455 septic patients who were randomized to receive intravenous ibuprofen or placebo, but that study did not demonstrate improved survival for the treatment arm. Similarly, a smaller study on the effects of lornoxicam failed to provide evidence for a survival benefit through cyclooxygenase inhibition in sepsis.

Endothelin-1

Endothelin-1 upregulation has been demonstrated within 6 hours of LPS-induced septic shock. Cardiac overexpression of ET-1 triggers an increase in inflammatory cytokines (among others, TNF-α, IL-1, and IL-6), interstitial inflammatory infiltration, and an inflammatory cardiomyopathy that results in heart failure and death. The involvement of ET-1 in septic myocardial dysfunction is supported by the observation that tezosentan, a dual endothelin-A and endothelin-B receptor antagonist, improved cardiac index, stroke volume index, and left ventricular stroke work index in endotoxemic shock. However, higher doses of tezosentan exhibited cardiotoxic effects and led to increased mortality. Although ET-1 has been demonstrated to be of pathophysiological importance in a wide array of cardiac diseases through autocrine, endocrine, or paracrine effects, its biosynthesis, receptor-mediated signaling, and functional consequences in septic myocardial dysfunction warrant further investigation to assess the therapeutic potential of ET-1 receptor antagonists.

Free Radicals and Antioxidants: an Overview

The presence of free radicals in biological materials was discovered about 50 years ago. Today, there is a large body of evidence indicating that patients in hospital intensive care units (ICUs) are exposed to excessive free radicals from drugs and other substances that alter cellular reduction -oxidation (redox) balance, and disrupt normal biological functions. However, low levels of free radicals are also vital for many cell signaling events and are essential for proper cell function.

Normal cellular metabolism involves the production of ROS, and in humans, superoxide (O2 -) is the most commonly produced free radical. Phagocytic cells such as macrophages and neutrophils are prominent sources of O2 -. During an inflammatory response, these cells generate free radicals that attack invading pathogens such as bacteria and, because of this, the production of O2- by activated phagocytic cells in response to inflammation is one of the most studied free radical producing systems.

Excess free radicals can result from a variety of conditions such as tissue damage and hypoxia (limiting oxygen levels), overexposure to environmental factors (tobacco smoke, ultraviolet radiation, and pollutants), a lack of antioxidants, or destruction of free radical scavengers. When the production of damaging free radicals exceeds the capacity of the body’s antioxidant defenses to detoxify them, a condition known as oxidative stress occurs.

The hydroxyl radical (.OH) is the most reactive of the free radical molecules. OH- damages cell membranes and lipoproteins by a process termed lipid peroxidation. In fact, lipid peroxidation can be defined as the process whereby free radicals “steal” electrons from the lipids in our cell membranes, resulting in cell damage and increased production of ROS.

Catalase and glutathione peroxidase both work to detoxify O2-reactive radicals by catalyzing the formation of H2O2 derived from O2 -. The liver, kidney, and red blood cells possess high levels of catalase, which helps to detoxify chemicals in the body. The water-soluble tripeptide-thiol glutathione also plays an important role in a variety of detoxification processes. Glutathione is found in millimolar concentrations in the cell cytosol and other aqueous phases, and readily interacts with free radicals, especially the hydroxyl radical, by donating a hydrogen atom.

Adhesion Molecules

Surface-expression upregulation of intercellular adhesion molecule-1 and vascular cell adhesion molecule-1 has been demonstrated in murine coronary endothelium and cardiomyocytes after LPS and TNF-α stimulation. After cecal ligation and double puncture, myocardial intercellular adhesion molecule-1 expression increases in rats. Vascular cell adhesion molecule-1 blockade with antibodies has been shown to prevent myocardial dysfunction and decrease myocardial neutrophil accumulation, whereas both knockout and antibody blockade of intercellular adhesion molecule-1 ameliorate myocardial dysfunction in endotoxemia without affecting neutrophil accumulation. But neutrophil depletion does not protect against septic cardiomyopathy, which suggests that the cardiotoxic potential of neutrophils infiltrating the myocardium is of lesser importance in this context.

Cells and signaling pathways

It is believed that sepsis and therefore septic shock are due to the inappropriate increase in the innate immune response via circulating and tissue inflammatory cells, such as monocytes/macrophages and neutrophils. These cells normally exist in a nonactivated state but are rapidly activated in response to bacteria. Sepsis induces a dysfunction in immune cells that contributes to the development of injuries by producing mediators such as cytokines and ROS.

LPS of Gram-negative organisms induces macrophages to secrete cytokines, which in turn activate T, and B cells to upregulate the adaptive immune responses. Toll-like receptor 4 (TLR4) is the LPS receptor and its stimulation induces nuclear factor kB (NF-kB) activation. The activation of NF-kB involves phosphorylation and degradation of IkB, an inhibitor of NF-kB. The NF-kB/IkB system exerts transcriptional regulation on proinflammatory genes encoded for various adhesion molecules and cytokines. Activation of NF-kB leads to the induction of NF-kB binding elements in their promoter regions and also leads to the induction of NF-kB dependent effector genes, which produce modifications in blood flow, and aggregation of neutrophils, and platelets. This results in damaged endothelium and also coagulation abnormalities often seen in patients with sepsis and septic shock. Therefore, NF-kB is reported to be an O2 sensor in LPS-induced endotoxemia.

The sources of ROS during sepsis are:

  • the mitochondrial respiratory chain.
  • the metabolic cascade of arachidonic acid.
  • the protease-mediated enzyme xanthine oxidase.
  • granulocytes and other phagocytes activated by complement, bacteria, endotoxin, lysosomal enzymes, etc.
  • Other oxidases mainly NADPH oxidase.

Activated immune cells produce O2 – as a cytotoxic agent as part of the respiratory burst via the action of membrane-bound NADPH oxidase on O2.

The increase of ROS after LPS challenge has been demonstrated in different models of septic shock in peritoneal macrophages and lymphocytes. This disturbance in the balance between pro-oxidants (ROS) and antioxidants in favor of the former is characteristic of oxidative stress in immune cells in response to endotoxin. In this context,

a typical behavior of these cells under an oxidative stress situation implies changes in different immune functions such as an increase in adherence and phagocytosis and a decrease in chemotaxis.  Neutrophils play a crucial role in the primary immune defense against infectious agents,which includes phagocytosis and the production of ROS. In addition, endogenous antioxidant defenses exist in a number of locations, namely intracellularly, on the cell membrane and extracellularly. The immune system is highly reliant on accurate cell-cell communication for optimal function, and any damage to the signaling systems involved will result in an impaired immune responsiveness.

Oxidative stress and modulation on GSH/GSSG (GSSG=oxidized GSH) levels also up-regulate gene expression of several other antioxidant proteins, such as manganese SOD, glutathione peroxidase, thioredoxin (Trx) and metallothionein.

Nitric Oxide

The current understanding of sepsis is a cascade of events that involves the microcirculation unevenly because of a differential effect on the large and contiguous intestinal epithelium, secondary effects on cardiopulmonary blood flows and cardiac output. This leads to a substantial body of work on therapeutic targets, either aimed at total inhibition or selective inhibition of NO synthase, and the special role of iNOS.

NO is synthesized from L-arginine by different isoenzymes of (NOS), and is implicated in a wide range of disease processes, exerting both detrimental and beneficial effects at the cellular and vascular levels. To date, three main isoforms of NOS are known:

  • neuronal NOS (NOS-1 or nNOS),
  • inducible NOS (NOS-2 or iNOS), and
  • endothelial NOS (NOS-3 or eNOS).

NO has been shown to play a key role in the pathogenesis of septic shock

Hyperproduction of NO induces

  • excessive vasodilation,
  • changes in vascular permeability, and
  • inhibition of noradrenergic nerve transmission,
  • all characteristics of human septic shock.

The recogniton of NO production by activated macrophages as part of the inflammatory process was an important milestone for assesing both the biological production of NO and the phenomenon of induction of NOS activity. The observation has been extended to neutrophils, lymphocytes, and other cell types. The role of NO in the pathophysiology of endotoxic shock was advanced by Thiemermann and Vane, who observed that administration of the specific NOS inhibitor N-methyl-L-arginine (L-NMMA) decreased the severe hypotension produced by administration of LPS. Other groups simultaneously reported similar results indicating that endotoxin increases NO production and prompted the idea that pharmacological inhibition of NOS may be useful in the treatment of inflammation and septic shock. However, clinical trials using L-NMMA failed to show a beneficial effect in septic shock patient. The major limitation for the use of NOS inhibitors in clinical studies is the development of pulmonary hypertension as a side effect of NOS blockade, which can be alleviated by the use of inhaled NO.

However, several compounds which modulate NO synthesis have been patented in recent years, such as various inflammatory mediators that have been implicated in the induction and activation of iNOS, particularly IFNg, TNFa, IL-1b, and platelet-activating factor (PAF) alone or synergistically. In addition to the activation of iNOS, cytokines and endotoxin may increase NO release by increasing arginine availability through the opening of the specific y+ channels and the expression of the cationic amino acid transporter (CAT), or by increasing tetrahydrobiopterin levels, a key cofactor in NO synthesis. Several experimental studies have demonstrated a decrease in NOS activity resulting in an impairment in endothelial-dependent relaxation during endotoxemia and experimental sepsis, possibly as the result of a cytokine-or hypoxia-induced shortened half-life of NOS mRNA, or of altered calcium mobilization.

Advanced Topics in Sepsis and the Cardiovascular System –  Augmentation for the third Section titled:

III. Incidence of Sepsis (circulation infection with serious consequences)

of the 7/23/2013 article on: Cardiovascular Complications: Death from Reoperative Sternotomy after prior CABG, MVR, AVR, or Radiation; Complications of PCI; Sepsis from Cardiovascular Interventions

NO exerts in vitro toxic effects including nuclear damage, protein and membrane phospholipid alterations, and the inhibition of mitochondrial respiration in several cell types. Mitochondrial impairment could also be considered as an adaptive phenomenon, decreasing cellular metabolism when the energy supply is limited. The toxicity of NO itself may be enhanced by the formation of ONOO- from the reaction of NO with O-2. Therefore, the multiple organ failure syndrome (MOFS) that often accompanies severe sepsis may be related to the cellular effects of excess NO or ONOO-.

Involvement of Nitrogen Species

NO reacts rapidly with ferrous iron, and at physiological concentrations, NO also binds to soluble guanylate cyclase and to another hemoprotein, cytochrome c oxidase (Complex IV), the terminal enzyme of the mitochondrial respiratory chain. NO can therefore control cellular functions via the reversible inhibition of respiration. There are a number of reactive NO species, such as

N2O3 and
ONOO-
that can also alter critical cellular components.

During the first hours after injury, iNOS-mediated NO production is upregulated, producing a burst of NO that far exceeds basal levels. This overabundance of NO produces significant cellular injury via several mechanisms.

NO may directly promote overwhelming peripheral vasodilation, resulting in vascular decomposition;

NO may upregulate the transcription NF-kB initiating an inflammatory signaling pathway that, in turn, triggers numerous inflammatory cytokines.

NO also interacts with the O-2 to yield ONOO-, a highly reactive compound that exacerbates the injury produced by either O-2 alone or NO alone.

The ONOO- generation which occurs during fluid resuscitation in the injured subject produces cellular death by enhancing DNA single strand breakage, activates the nuclear enzyme polyADP ribose synthetase (PARS), leading to cellular energy depletion and cellular necrosis. The detrimental effects of ONOO- in shock and resuscitation have been attributed to oxidation of sulfhydryl groups, the nitration of tyrosine, tryptophane, and guanine, as well as inhibition of the membrane sodium-potassium adenosine triphosphatase. PARS activation depletes NAD and thus alters electron transport, ATP synthesis, and glycolysis; and leads to DNA fragmentation and cellular apoptosis.

The activation of monocytes, macrophages and endothelial cells by LPS results in the expression of iNOS, and consequently increases the transformation of L-arginine to NO, which can combine with O2- to form ONOO-, causing tissue injury during shock, inflammation and ischemia reperfusion. NO stimulates H2O2 and O-2 production by mitochondria, increasing leakage of electrons from the respiratory chain. H2O2, in turn, participates in the upregulation of iNOS expression via NFkB activation. ONOO- has been shown to stimulate H2O2 production by isolated mitochondria. On the other hand, NO can decrease ROS-produced damage that occurs at physiological levels of NO. The high reactivity of NO with radicals might be beneficial in vivo by scavenging peroxyl radicals and inhibiting peroxidation. ONOO- may also be a signal transmitter and can mediate vasorelaxation, similarly to NO.

In sepsis, NO may exert direct and indirect effects on cardiac function. Sustained generation of NO occurs in systemic inflammatory reactions, such as septic shock with involvement in circulatory failure. In fact, myocardial iNOS activity has been reported in response to endotoxin and cytokines and inversely correlated with myocardial performance. Low-to-moderate doses of iNOS inhibitors restore myocardial contractility in hearts exposed to proinflammatory cytokines, whereas at higher doses, the effects are reversed. This finding may indicate that small amounts of NO produced by iNOS may be necessary to maintain contractility and can be cardio-protective in experimental sepsis.

A list of effects of NO in sepsis is as follows:

  • Inhibition of nitric oxide synthesis causes myocardial ischemia in endotoxemic rats
  • Nitric oxide causes dysfunction of coronary autoregulation in endotoxemic rats
  • Prolonged inhibition of nitric oxide synthesis in severe septic shock

Effect of L-NAME, an inhibitor of nitric oxide synthesis, on cardiopulmonary function in human septic shock:  Pulmonary hypertension and reduced cardiac output during inhibition of nitric oxide synthesis in human septic shock

Effect of L-NAME, an inhibitor of nitric oxide synthesis, on plasma levels of IL-6, IL-8, TNF-a and nitrite/nitrate in human septic shock

Endothelin-1 and blood pressure after inhibition of nitric oxide synthesis in human septic shock

Distribution and metabolism of NO-nitro-L-arginine methyl ester in patients with septic shock

Pulmonary hypertension and reduced cardiac output can be major side effects of continuous NO synthase inhibition. Pulmonary vasoconstriction is undesirable because it may compromise pulmonary gas exchange and because it increases the workload on the right ventricle.

Blood pressure and systemic vascular resistance increased during infusion of the NO synthase inhibitor L-NAME, and the dosage of catecholamines was reduced. The vasoconstrictive response to L-NAME most likely was the result of blocking the NO system . In addition to the systemic effects of L-NAME, severe pulmonary vasoconstriction was observed with L-NAME.

S-Methylisothiourea sulfate (SMT) is at least 10- to 30-fold more potent as an inhibitor of inducible NOS (iNOS) in immuno-stimulated cultured macrophages (EC50, 6 ,AM) and vascular smooth muscle cells (EC50, 2 ,uM) than NG-methyl-L-arginine (MeArg) or any other NOS inhibitor yet known. The effect of SMT on iNOS activity can be reversed by excess L-arginine in a concentration-dependent manner.  SMT, a potent and selective inhibitor of iNOS, may have considerable value in the therapy of circulatory shock of various etiologies and other pathophysiological conditions associated with induction of iNOS. SMT, or other iNOS-selective inhibitors, are likely to have fewer side effects which are related to the inhibition of eNOS, such as excessive vasoconstriction and organ ischemia), increased platelet and neutrophil adhesion and accumulation, and microvascular leakage.

Administration of the iron (III) complex of diethylenetriamine pentaacetic acid (DTPA iron (III), prevented death in Corynebacterium parvum 1 LPS-treated mice. Using electrochemistry, the binding of NO to DTPA iron (II) is confirmed.  Treatment with DTPA iron (III) resulted in a significant decrease in mortality compared to the untreated controls. The efficacy of DTPA iron (III) increased when given to mice 2 h or more after infection. The best results were observed when DTPA iron (III) was given 5 h after infection.  The iron (III) complex of diethylenetriamine pentaacetic acid (DTPA iron [III]) protected mice and baboons from the lethal effects of an infusion with live LD 100 Escherichia coli. In mice, optimal results were obtained when DTPA iron (III) was administered two or more hours after infection.

PJ34, a novel, potent PARP-1 inhibitor was found to protect against LPS induced tissue damage. PARP inhibitors protected Langendorff-perfused hearts against ischemia-reperfusion induced damages by activating the PI3-kinase–Akt pathway. The importance of the PI3-kinase–Akt pathway in LPS induced inflammatory mechanisms has gained support, raising the question whether this pathway was involved in the effect of PJ34 on LPS-induced septic shock.
Activation of the PI3-kinase–Akt/protein kinase B cytoprotective pathway is likely to contribute to the protective effects of PARP inhibitors in shock and inflammation.

Asymmetrical dimethyl arginine (ADMA) is an endogenous non-selective inhibitor of nitric oxide synthase that may influence the severity of organ failure and the occurrence of shock secondary to an infectious insult. Levels may be genetically determined by a promoter polymorphism in a regulatory gene encoding dimethylarginine dimethylaminohydrolase II (DDAH II).

ADMA levels and Sequential Organ Failure Assessment scores were directly associated on day one (p = 0.0001) and day seven (p = 0.002). The degree of acidaemia and lactaemia was directly correlated with ADMA levels at both time points (p < 0.01). On day seven, IL-6 was directly correlated with ADMA levels (p = 0.006). The variant allele with G at position -449 in the DDAH II gene was associated with increased ADMA concentrations at both time points (p < 0.05).
http://pharmaceuticalintelligence.com/2012/10/20/nitric-oxide-and-sepsis-hemodynamic-collapse-and-the-search-for-therapeutic-options/  larryhbern

Sepsis, Multi-organ Dysfunction Syndrome, and Septic Shock: A Conundrum of Signaling Pathways Cascading Out of Control   larryhbern
http://pharmaceuticalintelligence.com/2012/10/13/sepsis-multi-organ-dysfunction-syndrome-and-septic-shock-a-conundrum-of-signaling-pathways-cascading-out-of-control/

During sepsis, the inflammation triggers widespread coagulation in the bloodstream. A severe form of acute lung injury features pulmonary inflammation and increased capillary leak, is associated with a high mortality rate, and accounts for 100,000 deaths annually in the United States, especially associated with  sepsis. Neutrophils are major effector cells at the frontier of innate immune responses, and they play a critical role in host defense against invading .microorganisms. The tissue injury appears to be related to proteases and toxic reactive oxygen radicals released from activated neutrophils. Excessive procoagulant activity is of pathophysiological significance in these disease settings. This is consistent with a pneumonia or lung injury preceding sepsis. Indeed, it is not surprising that abdominal, cardiac bypass, and post cardiac revascularization may also lead to events resembling sepsis and/or cardiovascular collapse.

The activation of the coagulation cascade is one of the earliest events initiated following tissue injury. The prime function of this complex and highly regulated proteolytic system is to generate insoluble, crosslinked fibrin strands, which bind and stabilize weak platelet hemostatic plugs, formed at sites of tissue injury. The tissue factor-dependent extrinsic pathway is the predominant mechanism by which the coagulation cascade is locally activated. The cellular effects mediated via activation of proteinase-activated receptors (PARs) may be of particular importance. In this regard, studies in PAR1 knockout mice have shown that this receptor plays a major role in orchestrating the interplay between coagulation, inflammation and lung fibrosis.  The systemic inflammatory response syndrome (SIRS) is the massive inflammatory reaction resulting from systemic mediator release that may lead to multiple organ dysfunction.

For signal transduction, 01TREM-1 couples to the ITAM-containing adapter DNAX activation protein of 12 kDa (23DAP12 ). MARV and EBOV activate TREM-1 on human neutrophils, resulting in 12DAP12 phosphorylation, TREM-1 shedding, mobilization of intracellular calcium, secretion of proinflammatory cytokines, and phenotypic changes. TREM-1 is the best-characterized member of a growing family of 12DAP12-associated receptors that regulate the function of myeloid cells in innate and adaptive responses. TREM-1 (triggering receptor expressed on myeloid cells), a recently discovered receptor of the immunoglobulin superfamily, activates neutrophils and monocytes/macrophages by signaling through the adapter protein 12DAP12.

Circulating and organ-specific cell populations are activated to produce proinflammatory mediators during sepsis. Neutrophils and PBMCs bear TLR2 and TLR4, as well as other receptors, such as protein —coupled receptor, that induce increased generation of cytokines and other immunoregulatory proteins, as well as enhance release of proinflammatory mediators, including reactive oxygen species.

The expression of cytokines such as TNF-α and IL-1β is increased in sepsis, and engagement of TNF-α with type I(p55) and type II(p75) TNF receptors or IL-1β with IL-1 receptors belonging to the TLR/IL-1 receptor family produces activation of kinases (including Src, p38, extracellular signal—regulated kinase, and phosphoinositide 3–kinase) and transcriptional factors (such as nuclear factor [NF]–κB) important for further up-regulation of inflammatory proteins.

Identification of patients with cellular phenotypes characterized by increased activation of NF-κB, Akt, and protein 38, as well as discrete patterns of gene activation, may permit identification of patients with sepsis who are likely to have a worse clinical outcome In support of the hypothesis, greater nuclear accumulation of NF-κB is accompanied by higher mortality and worse clinical course in patients with sepsis. Persistent activation of NF-κB was found in nonsurvivors, with surviving patients having lower nuclear concentrations of NF-κB at early time points in their septic course than did nonsurvivors as well as more rapid return of nuclear accumulation of NF-κB. A study of surgical patients without sepsis supports the hypothesis that neutrophil phenotypes defined by NF-κB activation patterns predict clinical outcome. In that clinical series of patients undergoing repair of aortic aneurysms, higher preoperative levels of NF-κB in peripheral neutrophils were associated with death and with the development of postoperative organ dysfunction.

Insulin alleviates degradation of skeletal muscle protein by inhibiting the ubiquitin-proteasome system in septic rats

Qiyi Chen, Ning Li, Weiming Zhu, Weiqin Li, Shaoqiu Tang, et al. Chen et al. Journal of Inflammation 2011, 8:13

http://www.journal-inflammation.com/content/8/1/13

Hypercatabolism is common under septic conditions. Skeletal muscle is the main target organ for hypercatabolism, and this phenomenon is a vital factor in the deterioration of recovery in septic patients. In skeletal muscle, activation of the ubiquitin-proteasome system plays an important role in hypercatabolism under septic status. Insulin is a vital anticatabolic hormone and previous evidence suggests that insulin administration inhibits various steps in the ubiquitin-proteasome system. However, whether insulin can alleviate the degradation of skeletal muscle protein by inhibiting the ubiquitin-proteasome system under septic condition is unclear. This paper confirmed that mRNA and protein levels of the ubiquitin-proteasome system were upregulated and molecular markers of skeletal muscle proteolysis (tyrosine and 3-methylhistidine) simultaneously increased in the skeletal muscle of septic rats. We concluded that the ubiquitin-proteasome system is important skeletal muscle hypercatabolism in septic rats. Infusion of insulin can reverse the detrimental metabolism of skeletal muscle by inhibiting the ubiquitin-proteasome system, and the effect is proportional to the insulin infusion dose.

The International Sepsis Forum’s frontiers in sepsis: high cardiac output should be maintained in severe sepsis

Jean-Louis Vincent
Erasme Hospital, University of Brussels, Brussels, Belgium
Critical Care 2003; 7:276-278 (DOI 10.1186/cc2349)

Despite a usually normal or high cardiac output, severe sepsis is associated with inadequate tissue oxygenation, leading to organ failure and death. Some authors have suggested that raising cardiac output and oxygen delivery to predetermined supranormal values may be associated with improved

survival. While this may be of benefit in certain patients, bringing all patients to similar, supranormal values, is simplistic. It is much preferable to titrate therapy according to the needs of each individual patient. A combination of variables should be used for this purpose, in addition to a careful clinical evaluation, including not only cardiac  output but also the mixed venous oxygen saturation and the blood lactate concentrations. The concept is to assess the adequacy of the cardiac output in patients with severe sepsis, enabling management strategies aimed at optimizing cardiac output to be tailored to the individual patient.

The State of US Health, 1990-2010:  Burden of Diseases, Injuries, and Risk Factors

JAMA Aug 14, 2013, Vol 310, No. 6
US Burden of Disease Collaborators

We used the systematic analysis of descriptive epidemiology of 291 diseases and injuries, 1160 sequelae of these diseases and injuries, and 67 risk factors or clusters of risk factors from 1990 to 2010 for 187 countries developed for the Global Burden of Disease 2010. Disability-adjusted life-years (DALYs) were estimated as the sum of YLDs and YLLs. Deaths and DALYs related to risk factors were based on systematic reviews and meta-analyses of exposure data and relative risks for risk-outcome pairs. Healthy life expectancy (HALE) was used to summarize overall population health, accounting for both length of life and levels of ill health experienced at different ages.  From 1990 to 2010, US life expectancy at birth and HALE increased, all-cause death rates at all ages decreased, and age-specific rates of years lived with disability remained stable. However, morbidity and chronic disability now account for nearly half of the US health burden, and improvements in population health in the United States have not kept pace with advances in population health in other wealthy nations. http://jama.jamanetwork.com/article.aspx?articleid=1710486HYPERLINK “http://jama.jamanetwork.com/article.aspx?articleid=1710486&goback=.gde_3267353_member_265629812#%21″&HYPERLINK “http://jama.jamanetwork.com/article.aspx?articleid=1710486&goback=.gde_3267353_member_265629812#%21″goback=%2Egde_3267353_member_265629812#%21

The Evolution of an Inflammatory Response.

Stephen F Lowry
Surgical Infections 09/2009; 10(5):419-25. · 1.80 Impact Factor

An understanding of patient-specific variation and adaptability could direct individualized biologic and management interventions for severe injury and infection. Despite more detailed appreciation of the molecular mechanisms of danger and pathogen recognition and response biology, we have much to learn about the complexity of severe injury and infection. There is a great need to extend our investigation of these mechanisms to experimental and stress-modified clinical scenarios.

Frailty and Heart Disease.

Stephan von Haehling, Stefan D Anker, Wolfram Doehner, John E Morley, Bruno Vellas
Department of Cardiology, Campus Virchow-Klinikum, Berlin, Germany.
Int j cardiol (impact factor: 7.08). 08/2013; DOI:10.1016/j.ijcard.2013.07.068

Frailty is emerging as a syndrome of pre-disability that can identify persons at risk for negative outcomes. Its presence places the individual at risk for rapid deterioration when a major event such as myocardial infarction or hospitalization occurs. In patients with cardiovascular disease, frailty is about three times more prevalent than among elderly persons without.

Pro-atrial natriuretic peptide is a prognostic marker in sepsis, similar to the APACHE II score: an observational study

Nils G Morgenthaler1, Joachim Struck1, Mirjam Christ-Crain2, Andreas Bergmann1 and Beat Müller2

1Research Department, BRAHMS AG, Biotechnology Center, Hennigsdorf/Berlin, Germany

2Department of Internal Medicine, University Hospital, Basel, Switzerland
Critical Care 2005, 9:R37-R45 (DOI 10.1186/cc3015)

This article is online at: http://ccforum.com/content/9/1/R37

Additional biomarkers in sepsis are needed to tackle the challenges of determining prognosis and optimizing selection of high-risk patients for application of therapy. In the present study, conducted in a cohort of medical intensive care unit patients, our aim was to compare the prognostic

value of mid-regional pro-atrial natriuretic peptide (ANP) levels with those of other biomarkers and physiological scores.  Blood samples obtained in a prospective observational study conducted in 101 consecutive critically ill patients admitted to the intensive care unit were analyzed. The prognostic value of pro-ANP levels was compared with that of the Acute Physiology and Chronic Health Evaluation (APACHE) II score and with those of various biomarkers (i.e. C-reactive protein, IL-6 and procalcitonin). Mid-regional pro-ANP was detected in EDTA plasma from all patients using a new sandwich immunoassay.  The median pro-ANP value in the survivors was 194 pmol/l (range 20–2000 pmol/l), which was significantly lower than in the nonsurvivors (median 853.0 pmol/l, range 100–2000 pmol/l; P < 0.001). On the day of admission, pro-ANP levels, but not levels of other biomarkers, were significantly higher in surviving than in nonsurviving sepsis patients (P = 0.001). In a receiver operating characteristic curve analysis for the survival of patients with sepsis, the area under the curve (AUC) for pro-ANP was 0.88, which was significantly greater than the AUCs for procalcitonin and C-reactive protein, and similar to the AUC for the APACHE II score.

Bench-to-Bedside Review: Significance and Interpretation of Elevated Troponin in Septic Patients

Raphael Favory1,2 and Remi Neviere1
1Physiology Department, School of Medicine, EA2689 University of Lille, France

2Medical Intensive Care Unit, Universitary Hospital of Lille, France

Critical Care 2006, 10:224 (doi:10.1186/cc4991)  http://ccforum.com/content/10/4/224

Because no bedside method is currently available to evaluate myocardial contractility independent of loading conditions, a biological marker that could detect myocardial dysfunction in the early stage of severe sepsis would be a helpful tool in the management of septic patients. Clinical and experimental studies have reported that plasma cardiac troponin levels are increased in

sepsis and could indicate myocardial dysfunction and poor outcome. The high prevalence of elevated levels of cardiac troponins in sepsis raises the question of what mechanism results in their release into the circulation.
(Note: This study is prior to the hs-troponins)
The presence of microvascular failure and regional wall motion abnormalities, which are frequently observed in positive-troponin patients, also suggest ventricular wall strain and cardiac cell necrosis. Altogether, the available studies

support the contention that cardiac troponin release is a valuable marker of myocardial injury in patients with septic shock.

Myocardial Protection in Sepsis

Simon Shakar and Brian D Lowes
University of Colorado Denver, Aurora, CO 80045, USA
Critical Care 2008, 12:177 (doi:10.1186/cc6978)  http://ccforum.com/content/12/5/177

Sepsis with myocardial dysfunction is seen commonly. Beta-blockers have been used successfully to treat chronic heart failure based on the premise that chronically elevated adrenergic drive is detrimental to the myocardium. However, recent reports on the acute use of beta-blockers in situations with potential hemodynamic compromise have shown the risks associated with this approach.

Myocardial injury and depression are common during sepsis and are likely multi-factorial in etiology. The adrenergic nervous system is activated in sepsis and pharmacological doses of agonists are commonly utilized during goal directed therapy to support oxygen delivery and maintain perfusion pressure. There is a large body of evidence suggesting that excessive adrenergic levels can cause myocardial damage.

Recent large prospective trials would mandate caution when using beta-blockers in acute settings of hemodynamic compromise. The COMMIT trial in acute myocardial infarction showed that metoprolol’s benefit in reducing reinfarction and arrhythmia (10 per 1,000) was offset by an increase in cardiogenic shock (11 per 1,000). This was most prominent in the first day of therapy in elderly patients with tachycardia and low blood pressure, a population reminiscent

of the one discussed in the current series. The POISE trial showed that metoprolol, started 2 to 4 hours before surgery in high risk cardiac patients, led to increased rates of death and stroke. The rates of myocardial infarction were

reduced. Hypotension was very instrumental in causing the adverse events. Interestingly, sepsis and infection were also clearly more common on metoprolol.

Myocardial depression with beta-blockers could explain the need to escalate therapy with vasoactive drugs in the current series. Gore and colleagues showed that esmolol acutely reduced cardiac output by 20% in septic patients. There was also a reduction in blood pressure and oxygen delivery. Kukin

and colleagues studied low dose beta-blockers in chronic heart failure patients. They found that even 6.25 mg of metoprolol, given orally, acutely decreased cardiac output, stroke volume and stroke work index. After 3 months and uptitration to 50 mg bid, the administration of the drug continued to cause a decrease in cardiac output and stroke work index.

Bench-to-Bedside Review: Beta-Adrenergic Modulation in Sepsis

Etienne de Montmollin, Jerome Aboab, Arnaud Mansart and Djillali Annane
Service de Réanimation Polyvalente de l’hôpital Raymond Poincaré,  Garches, France
Critical Care 2009, 13:230 (doi:10.1186/cc8026  http://ccforum.com/content/13/5/230
Sepsis, despite recent therapeutic progress, still carries unacceptably high mortality rates. The adrenergic system, a key modulator of organ function and cardiovascular homeostasis, could be an interesting new therapeutic target for septic shock. beta-adrenergic regulation of the immune function in sepsis is complex and is time dependent. However, beta-2 activation as well as beta-1 blockade seems to downregulate proinflammatory response by modulating the

cytokine production profile. beta-1 blockade improves cardiovascular homeostasis in septic animals, by lowering myocardial oxygen consumption without altering organ perfusion, and perhaps by restoring normal cardiovascular variability. Beta-Blockers could also be of interest in the systemic catabolic response to sepsis, as they oppose epinephrine which is known to promote hyperglycemia, lipid and protein catabolism. Beta-1 blockade may reduce platelet aggregation and normalize the depressed fibrinolytic status induced by adrenergic stimulation. Therefore, beta-2 blockade as well as beta-2 activation improves sepsis-induced immune, cardiovascular and coagulation

dysfunctions. Beta-2 blocking, however, seems beneficial in the metabolic field. Enough evidence has been accumulated in the literature to propose beta-2 adrenergic modulation, beta-1 blockade and beta-2 activation in particular, as new promising therapeutic targets for septic dyshomeostasis, modulating favorably immune, cardiovascular, metabolic and coagulation systems.

Brain Natriuretic Peptide for Prediction of Mortality in Patients with Sepsis: a Systematic Review and Meta-Analysis

Fei Wang1†, Youping Wu1†, Lu Tang2,3†, Weimin Zhu1, Feng Chen1, et al.
Critical Care 2012, 16:R74    http://ccforum.com/content/16/3/R74

The prognostic role of brain natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) in septic patients remains controversial. The purpose of this systematic review and meta-analysis was to investigate the value of elevated BNP or NT-proBNP in predicting mortality in septic patients.
PubMed, Embase and the Cochrane Central Register of Controlled Trials were searched (up to February 18, 2011). Studies were included if they had prospectively collected data on all-cause mortality in adult septic patients with either plasma BNP or NT-proBNP measurement. 12 studies with a total of 1,865 patients were included.
Elevated natriuretic peptides were significantly associated with increased risk of mortality (odds ratio (OR) 8.65, 95% confidence interval (CI) 4.94 to 15.13, P < 0.00001). The association was consistent for BNP (OR 10.44, 95% CI 4.99 to 21.58, P < 0.00001) and NT-proBNP (OR 6.62, 95% CI 2.68 to 16.34, P < 0.0001). The pooled sensitivity, specificity, positive likelihood ratio, and negative

likelihood ratio were 79% (95% CI 75 to 83), 60% (95% CI 57 to 62), 2.27 (95% CI 1.83 to 2.81) and 0.32 (95% CI 0.22 to 0.46), respectively.

Genetic Variation in Vitamin D Biosynthesis is associated with Increased Risk of Heart Failure

Genetic variation in CYP27B1 is associated with congestive heart failure in patients with hypertension.
RA Wilke, RU Simpson, BN Mukesh, SV Bhupathi, et al.
Pharmacogenomics 2009; 10(11): 1789-1797. http://dx.doi.org/10.2217/pgs.09.101

Genetic variation in vitamin D-dependent signaling is associated with congestive heart failure in human subjects with hypertension. Functional polymorphisms were selected from five candidate genes:

CYP27B1, CYP24A1, VDR, REN and ACE.

Using the Marshfield Clinic Personalized Medicine Research Project,
205 subjects with hypertension and congestive heart failure,
206 subjects with hypertension alone and
206 controls (frequency matched by age and gender) were genotyped.

In the context of hypertension, a SNP in CYP27B1 was associated with congestive heart failure (odds ratio: 2.14 for subjects homozygous for the C allele; 95% CI: 1.05–4.39).

Novel Mechanism for Disease Etiology for the Cardiac Phenotype: Modulation of Nuclear and Cytoskeletal Actin Polymerization.
Lamin A/C and emerin regulate MKL1–SRF activity by modulating actin dynamics

Chin Yee Ho, Diana E. Jaalouk, Maria K. Vartiainen & Jan Lammerding
Nature (2013) doi:10.1038/nature12105  http://www.nature.com/nature/journal/vaop/ncurrent/full/nature121

Laminopathies, caused by mutations in the LMNA gene encoding the nuclear envelope proteins lamins A and C, represent a diverse group of diseases that include Emery–Dreifuss muscular dystrophy (EDMD), dilated cardiomyopathy (DCM), limb-girdle muscular dystrophy, and Hutchison–Gilford progeria syndrome1. Most LMNA mutations affect skeletal and cardiac muscle by mechanisms that remain incompletely understood. Loss of structural function and altered interaction of mutant lamins with (tissue-specific) transcription factors have been proposed to explain the tissue-specific phenotypes.

Altered nucleo-cytoplasmic shuttling of MKL1 was caused by altered actin dynamics in Lmna−/− and Lmna N195K/N195K mutant cells. Ectopic expression of the nuclear envelope protein emerin, which is mislocalized in Lmna mutant cells and also linked to EDMD and DCM, restored MKL1 nuclear translocation and rescued actin dynamics in mutant cells.

These findings present a novel mechanism that could provide insight into the disease aetiology for the cardiac phenotype in many laminopathies, whereby lamin A/C and emerin regulate gene expression through modulation of nuclear and cytoskeletal actin polymerization.

Heart Disease and Stroke Statistics—2011 Update

A Report From the American Heart Association
American Heart Association Statistics Committee and Stroke Statistics Subcommittee
Circulation. 2011;123:e18-e209.  DOI: 10.1161/CIR.0b013e3182009701


● On the basis of 2007 mortality rate data, more than 2200 Americans die of CVD each day, an average of 1 death every 39 seconds. More than 150 000 Americans killed by CVD (I00 –I99) in 2007 were  65 years of age. In 2007,

nearly 33% of deaths due to CVD occurred before the age of 75 years, which is well before the average life expectancy of 77.9 years.

● Coronary heart disease caused  1 of every 6 deaths in the United States in 2007. Coronary heart disease mortality in 2007 was 406 351. Each year, an estimated 785 000 Americans will have a new coronary attack, and  470 000 will have a recurrent attack. It is estimated that an additional 195 000 silent first myocardial infarctions occur each year. Approximately every 25 seconds, an American will have a coronary event, and approximately every minute, someone will die of one.

Prevalence and Control of Traditional Risk Factors Remains an Issue for Many Americans

● Data from the National Health and Nutrition Examination Survey (NHANES) 2005–2008 indicate that 33.5% of US adults 20 years of age have hypertension (Table 7-1). This amounts to an estimated 76 400 000 US adults with hypertension. The prevalence of hypertension is nearly equal between men and women. African American adults have among the highest rates of hypertension in the world, at 44%. Among hypertensive adults, ~ 80% are aware of their condition, 71% are using antihypertensive medication, and only 48% of those aware that they have hypertension have their condition controlled.

● Despite 4 decades of progress, in 2008, among Americans ­­>18 years of age, 23.1% of men and 18.3% of women continued to be cigarette smokers. In 2009, 19.5% of students in grades 9 through 12 reported current tobacco use. The percentage of the nonsmoking population with detectable serum cotinine (indicating exposure to secondhand smoke) was 46.4% in 1999 to 2004, with declines occurring, and was highest for those 4 to 11 years of age (60.5%) and those 12 to 19 years of age (55.4%).

● An estimated 33 600 000 adults > 20 years of age have total serum cholesterol levels > 240 mg/dL, with a prevalence of 15.0% (Table 13-1).

● In 2008, an estimated 18 300 000 Americans had diagnosed diabetes mellitus, representing 8.0% of the adult population. An additional 7 100 000 had undiagnosed diabetes mellitus, and 36.8% had prediabetes, with abnormal

fasting glucose levels. African Americans, Mexican Americans, Hispanic/Latino individuals, and other ethnic minorities bear a strikingly disproportionate burden of diabetes mellitus in the United States (Table 16-1).

Commentary on Other Related Articles on this topic published on this Open Access Online Scientific Journal:

Automated Inferential Diagnosis of SIRS, sepsis, septic shock
http://pharmaceuticalintelligence.com/2012/08/01/automated-inferential-diagnosis-of-sirs-sepsis-septic-shock/  larryhbern

The role of biomarkers in the diagnosis of sepsis and patient management
http://pharmaceuticalintelligence.com/2012/07/28/the-role-of-biomarkers-in-the-diagnosis-of-sepsis-and-patient-management/   larryhbern

The SIRS reaction involves hormonally driven changes in liver glycogen reserves, triggering of  lipolysis, lean body proteolysis, and reprioritization of hepatic protein synthesis. The SIRS reaction unabated leads to a recurring cycle with hemodynamic collapse from septic shock, indistinguishable from cardiogenic shock, and death.
Alternative Designs for the Human Artificial Heart: Patients in Heart Failure –  Outcomes of Transplant (donor)/Implantation (artificial) and Monitoring Technologies for the Transplant/Implant Patient in the Community
http://pharmaceuticalintelligence.com/2013/08/05/alternative-designs-for-the-human-artificial-heart-the-patients-in-heart-failure-outcomes-of-transplant-donorimplantation-artificial-and-monitoring-technologies-for-the-transplantimplant-pat/

LH Bernstein, J Pearlman, A Lev-Ari

Postoperative Results

No injury (2324) Injury (231) P
PRCs 4.5 7.2 6.5 8.9 0.046
ICU stay (h) 102.3 228.6 146.3 346.9 < 0.001
Reoperation 127 5.5% 21 9.1% 0.024
sepsis 86 3.7% 16 6.9% 0.017
stroke 56 2.4% 11 4.8% 0.033
Prolonged
ventilation
505 21.7% 97 42.0% <0.001
Pneumonia 123 5.3% 25 10.8% <0.001
ARDS 32 1.4% 8 3.5% 0.015
Postop RenalFailure 237 10.2% 51 22.1% <0.001
MODS 45 1.9% 13 5.6% <0.001
Hosp Death 151 6.5% 43 18.6 <0.001

Confined Indolamine 2, 3 dioxygenase (IDO) Controls the Hemostasis of Immune Responses for Good and Bad
http://pharmaceuticalintelligence.com/2013/07/31/confined-indolamine-2-3-dehydrogenase-controls-the-hemostasis-of-immune-responses-for-good-and-bad/ Demet Sag

The immune response mechanism is the holy grail of the human defense system for health.   IDO, indolamine 2, 3-dioxygenase, is a key gene for homeostasis of immune responses and producing an enzyme catabolizing the first rate-limiting step in tryptophan degradation metabolism. The hemostasis of immune system is complicated.  IDO belongs to globin gene family to carry oxygen and heme.

The main function and genesis of IDO comes from the immune responses during host-microbial invasion and choice between tolerance and immunogenicity. In addition IDO has a role in vascular tone as well.  In human there are three kinds of IDOs, which are IDO1, IDO2, and TDO, with distinguished mechanisms and expression profiles. , IDO mechanism includes three distinguished pathways: enzymatic acts through IFNgamma, non-enzymatic acts through TGFbeta-IFNalpha/IFNbeta and moonlighting acts through AhR/Kyn.

IDO is a key homeostatic regulator and confined in immune system mechanism for the balance between tolerance and immunity.  This gene encodes indoleamine 2, 3-dioxygenase (IDO) – a heme enzyme (EC=1.13.11.52) that catalyzes the first rate-limiting step in tryptophan catabolism to N-formyl-kynurenine and acts on multiple tryptophan substrates including D-tryptophan, L-tryptophan, 5-hydroxy-tryptophan, tryptamine, and serotonin (1; 2; 3; 4).

Expression of IDO is common in antigen presenting cells (APCs), monocytes (MO), macrophages (MQs), DCs, T-cells, and some B-cells. IDO presentation in APCs is related to its role in the hierarchy and level of DC expression, but includes MOs in three DC cell subsets, CD14+CD25+, CD14++CD25+ and CD14+CD25++.

There are three types of IDO, pro-IDO like, IDO1, and IDO2.  In addition, another enzyme called TDO, tryptophan 2, 3, dehydrogenase solely degrades L-Trp by a rate-limiting mechanism in liver and brain.

The IDO1 mechanism is the target for immunotherapy applications. The initial discovery of IDO in human physiology is protection of pregnancy since lack of IDO results in premature recurrent abortion.   The initial rate-limiting step of tryptophan metabolism is catalyzed by either IDO or tryptophan 2, 3-dioxygenase (TDO), but the two are regulated with different mechanisms due to a His55 in TDO and a Ser167b in IDO.

IDO binds to only immune response cells, and TDO relates to NAD biosynthesis and is expressed solely in liver and brain.  It has been shown that knowledge on NADH/NAD, Kyn/Trp or Trp/Kyn ratios as well as Th1/Th2, CD4/CD8 or Th17/Th_reg are equally important for assessing the metabolic state.

DCs are the orchestrator of the immune response  with list of functions in uptake, processing, and presentation of antigens; activation of effector cells, such as T-cells and NK-cells; and secretion of cytokines and other immune-modulating molecules to direct the immune response.

Systemic inflammation (pneumonia, sepsis, malaria) creates hypotension and IDO expression has the effect of decreased vascular tone.  Moreover, inflammation activates the endothelial coagulation activation system causing coagulopathies on patients.  This reaction is namely endothelial cell activation of IDO by IFNgamma inducing Trp to Kyn conversion. Inflammation induces IDO expression in endothelial cells producing Kyn causing decrease of trp, arterial relaxation, and hypotension.

IDO for Commitment of a Life Time: The Origins and Mechanisms of IDO, indolamine 2, 3-dioxygenase
http://pharmaceuticalintelligence.com/2013/08/04/ido-for-commitment-of-a-life-time-the-origins-and-mechanisms-of-ido-indolamine-2-3-dioxygenase/

IDO, indolamine 2, 3-dioxygenase, is a key gene for homeostasis of immune responses and producing an enzyme catabolizing the first rate-limiting step in tryptophan degradation metabolism.

The mechanism of microbial response and origination of IDO is based on duplication of microbial IDO .  During microbial responses, Toll-like receptors (TLRs) play a role to differentiate and determine the microbial structures as a ligand to initiate production of cytokines and pro-inflammatory agents to activate specific T helper cells. Uniqueness of TLR comes from four major characteristics of each individual TLR by ligand specificity, signal transduction pathways, expression profiles and cellular localization . Thus, TLRs are important part of the immune response signaling mechanism to initiate and design adoptive responses from innate (naïve) immune system to defend the host.

The modification of IDO+ monocytes manage towards a specific subset of T cell activation with specific TLRs are significantly important.  The type of cell with correct TLR and stimuli improves or decreases the effectiveness of stimuli. .

3D Cardiovascular Theater – Hybrid Cath Lab/OR Suite, Hybrid Surgery, Complications Post PCI and Repeat Sternotomy/  A Lev-Ari
http://pharmaceuticalintelligence.com/2013/07/19/3d-cardiovascular-theater-hybrid-cath-labor-suite-hybrid-surgery-complications-post-pci-and-repeat-sternotomy/

Treatment options for LV failure, temporary circulatory support, IABP, impella recover.
http://pharmaceuticalintelligence.com/2013/07/17/treatment-options-for-left-ventricular-failure-temporary-circulatory-support-intra-aortic-balloon-pump-iabp-impella-recover-ldlp-5-0-and-2-5-pump-catheters-non-surgical-vs-bridge-therapy/  larryhbern

Clinical Indications for Use of Inhaled Nitric Oxide (iNO) in the Adult Patient Market: Clinical Outcomes after Use, Therapy Demand and Cost of Care/ A Lev-Ari
http://pharmaceuticalintelligence.com/2013/06/03/clinical-indications-for-use-of-inhaled-nitric-oxide-ino-in-the-adult-patient-market-clinical-outcomes-after-use-therapy-demand-and-cost-of-care/

Inhaled nitric oxide is a selective pulmonary vasodilator that improves ventilation–perfusion matching at low doses in patients with acute respiratory failure, potentially improving oxygenation and lowering pulmonary vascular resistance.

Treatment Goals for Inhaled Nitric Oxide

  • Improved oxygenation
  • Decreased pulmonary vascular resistance
  • Decreased pulmonary edema
  • Reduction or prevention of inflammation
  • Protection against infection

Dose-Response for Respiratory Failure in the Adult Patient – a response is defined as a 20 percent increase in oxygenation.
Dose-Response for Pulmonary Hypertension in the Adult Patient – a 30 percent decrease in pulmonary vascular resistance during the inhalation of nitric oxide (10 ppm for 10 minutes) has been used to identify an association with vascular responsiveness to agents that can be helpful in the long term.

Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems
http://pharmaceuticalintelligence.com/2013/05/15/diagnosis-of-cardiovascular-disease-treatment-and-prevention-current-predicted-cost-of-care-and-the-promise-of-individualized-medicine-using-clinical-decision-support-systems-2/  JPearlman, LH Bernstein, A lev-Ari

among older Americans, more are hospitalized for HF than for any other medical condition.

Prevalence estimates for HF were determined from 1999–2008 National Health and Nutrition Examination Survey (NHANES) and US Census Bureau projected population counts for years 2012 to 2030. HF is a clinical syndrome that results from a variety of cardiac disorders.

In the Western world the top 3 causes of HF are:

  • coronary artery disease
  • valvular disease
  • hypertension

Stages C and D represent the symptomatic phases of HF, with stage C manageable and stage D failing medical management, resulting in marked symptoms at rest or with minimal activity despite optimal medical therapy.

Classic demographic risk factors for the development of HF include:

  • older age,
  • male gender,
  • ethnicity, and
  • low socioeconomic status.
  • comorbid disease states contribute to the development of HF
  • Ischemic heart disease
  • Hypertension

Diabetes mellitus, insulin resistance, and obesity are also linked to HF development,
with diabetes mellitus increasing the risk of HF by +2-fold in men and up to 5-fold in women.
Smoking remains the single largest preventable cause of disease and premature death in the United States.

Hypertension caused by Arterial Stiffening is Ineffectively Treated by Diuretics and Vasodilatation Antihypertensives
Dr Reuven Zimlichman (Tel Aviv University, Israel)
http://www.theheart.org/article/1502067.do
the definitions of hypertension, as well as the risk-factor tables used to guide treatment, are no longer appropriate for a growing number of patients. New ambulatory blood-pressure-monitoring devices also measure arterial elasticity. “Unquestionably, these will improve our ability to diagnose both the status of the arteries and the changes of the arteries with time as a result of our treatment. So if we treat the patient and we see no improvement in arterial elasticity, something is not working—either the patient is not taking the medication, or our choice of medication is not appropriate, or the dose is insufficient, etc.”

Hypertension and Vascular Compliance: 2013 Thought Frontier – An Arterial Elasticity Focus
http://pharmaceuticalintelligence.com/2013/05/11/arterial-elasticity-in-quest-for-a-drug-stabilizer-isolated-systolic-hypertension-caused-by-arterial-stiffening-ineffectively-treated-by-vasodilatation-antihypertensives/   J Pearlman & A Lev-Ari

Conceptual development of the subject is presented in the following nine parts:
1.            Physiology of Circulation and Role of Arterial Elasticity
2.            Isolated Systolic Hypertension caused by Arterial Stiffening may be inadequately treated by Diuretics or Vasodilatation Antihypertensive Medications
3.            Physiology of Circulation and Compensatory Mechanism of Arterial Elasticity
4.            Vascular Compliance – The Potential for Novel Therapies Novel Mechanism for Disease Etiology: Modulation of Nuclear and Cytoskeletal Actin Polymerization. Genetic Therapy targeting Vascular Conductivity, Regenerative Medicine for Vasculature Protection
5.            In addition to curtailing high pressures, stabilizing BP variability is a potential target for management of hypertension
6.            Mathematical Modeling: Arterial stiffening explains much of primary hypertension
7.            Classification of Blood Pressure and Hypertensive Treatment Best Practice of Care in US
8.            Genetic Risk for High Blood Pressure
9.            Is it Hypertension or Physical Inactivity: Cardiovascular Risk and Mortality – New results in 3/2013.

Elastance in a cyclic pressure system of systole-diastole (contraction-dilation) presents impedance as a pulsatile load on the heart. Chronic exposure to elevated vascular impedance leads to impairment of lusiotropy (diastolic failure, stiff heart) and inotropy (systolic failure, weak heart).

Stiff or “lead pipe” blood vessels drop pressure precipitously to dangerously low levels in response to diuretics.
Stiff walls due to fibrosis or scar tissue have limited ability to dilate

Physiology of Circulation and Compensatory Mechanism of Arterial Elasticity

Arguably, HMG-CoA reductase inhibitors,  statin therapy is a second example of a medication that helps protect vascular elasticity, both by its lipid effects and its anti-inflammatory effects.

http://pharmaceuticalintelligence.com/2012/11/28/special-considerations-in-blood-lipoproteins-viscosity-assessment-and-treatment/

http://pharmaceuticalintelligence.com/2012/11/28/what-is-the-role-of-plasma-viscosity-in-hemostasis-and-vascular-disease-risk/

While among other reasons for Hypertension increasing prevalence with aging, arterial stiffening is one.

Yet, stiffer vessels are more efficient at transmitting pressure to distal targets. With aging, muscle mass diminishes markedly and the contribution to circulation from skeletal muscle tissue compressions combined with competent venous valves fades.

http://pharmaceuticalintelligence.com/2012/08/27/endothelial-dysfunction-diminished-availability-of-cepcs-increasing-cvd-risk-for-macrovascular-disease-therapeutic-potential-of-cepcs/

http://pharmaceuticalintelligence.com/2012/10/19/clinical-trials-results-for-endothelin-system-pathophysiological-role-in-chronic-heart-failure-acute-coronary-syndromes-and-mi-marker-of-disease-severity-or-genetic-determination/

http://pharmaceuticalintelligence.com/2012/11/13/peroxisome-proliferator-activated-receptor-ppar-gamma-receptors-activation-pparγ-transrepression-for-angiogenesis-in-cardiovascular-disease-and-pparγ-transactivation-for-treatment-of-dia/

With aging heart contractility diminishes. These issues can cause under perfusion of tissues, inadequate nutrient blood delivery (ischemia), lactic acidosis, tissue dysfunction and multi-organ failure. Hardened arteries may compensate. Thus, pharmacotherapy to increase Arterial Elasticity may be counter-indicated for patients with mild to progressive CHF.

http://pharmaceuticalintelligence.com/2013/05/05/bioengineering-of-vascular-and-tissue-models/

http://pharmaceuticalintelligence.com/2012/10/20/nitric-oxide-and-sepsis-hemodynamic-collapse-and-the-search-for-therapeutic-options/

http://pharmaceuticalintelligence.com/2012/10/17/chronic-heart-failure-personalized-medicine-two-gene-test-predicts-response-to-beta-blocker-bucindolol/

http://pharmaceuticalintelligence.com/2013/04/28/genetics-of-conduction-disease-atrioventricular-av-conduction-disease-block-gene-mutations-transcription-excitability-and-energy-homeostasis/

http://pharmaceuticalintelligence.com/2013/04/14/mitochondrial-metabolism-and-cardiac-function/

http://pharmaceuticalintelligence.com/2012/10/28/mitochondrial-damage-and-repair-under-oxidative-stress/

The hypothesis that we should focus on cellular therapies to increase vascular compliance may decrease the circulation efficiency and result in worsening of cardiac right ventricular morphology and development of Dilated cardiomyopathy and hypertrophic cardiomyopathy (muscle thickening and diastolic failure), an undesirable outcome resulting from an attempt to treat the hypertension.

http://pharmaceuticalintelligence.com/2012/10/01/ngs-cardiovascular-diagnostics-long-qt-genes-sequenced-a-potential-replacement-for-molecular-pathology/

http://pharmaceuticalintelligence.com/2012/08/29/positioning-a-therapeutic-concept-for-endogenous-augmentation-of-cepcs-therapeutic-indications-for-macrovascular-disease-coronary-cerebrovascular-and-peripheral/

http://pharmaceuticalintelligence.com/2012/08/28/cardiovascular-outcomes-function-of-circulating-endothelial-progenitor-cells-cepcs-exploring-pharmaco-therapy-targeted-at-endogenous-augmentation-of-cepcs/

http://pharmaceuticalintelligence.com/2013/02/28/the-heart-vasculature-protection-a-concept-based-pharmacological-therapy-including-thymosin/

Mitochondrial Dysfunction and Cardiac Disorders   larryhbern
http://pharmaceuticalintelligence.com/2013/04/14/mitochondrial-dysfunction-and-cardiac-disorders/

Mitochondria and Cardiovascular Disease: A Tribute to Richard Bing, Larry H Bernstein, MD, FACP http://pharmaceuticalintelligence.com/2013/04/14/chapter-5-mitochondria-and-cardiovascular-disease/

Mitochondrial Metabolism and Cardiac Function, Larry H Bernstein, MD, FACP http://pharmaceuticalintelligence.com/2013/04/14/mitochondrial-metabolism-and-cardiac-function/

Reversal of Cardiac mitochondrial dysfunction, Larry H Bernstein, MD, FACP http://pharmaceuticalintelligence.com/2013/04/14/reversal-of-cardiac-mitochondrial-dysfunction/

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