Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
Author: Larry H Bernstein, MD, FCAP And Curator: Justin D Pearlman, MD, PhD, FACC
Article ID #67: Treatment Options for Left Ventricular Failure – Temporary Circulatory Support: Intra-aortic balloon pump (IABP) – Impella Recover LD/LP 5.0 and 2.5, Pump Catheters (Non-surgical) vs Bridge Therapy: Percutaneous Left Ventricular Assist Devices (pLVADs) and LVADs (Surgical). Published on 7/17/2013
Doctors at the Cleveland Clinic began to suspect in 2012 that something might be wrong with a high-tech implant used to treat patients with advanced heart failure like former Vice President Dick Cheney.
Thoratec Corportation
The HeartMate II is a left ventricular assist device, which contains a pump that continuously pushes blood through the heart.
The number of patients developing potentially fatal blood clots soon after getting the implant seemed to be rising. Then early this year, researchers completed a check of hospital records and their concern turned to alarm.
The data showed that the incidence of blood clots among patients who got the device, called the HeartMate II, after March 2011 was nearly four times that of patients who had gotten the same device in previous years. Patients who developed pump-related clots died or needed emergency steps like heart transplants or device replacements to save them.
“When we got the data, we said, ‘Wow,’ ” said Dr. Randall C. Starling, a cardiologist at Cleveland Clinic.
On Wednesday, The New England Journal of Medicineposted a study on its website detailing the findings from the Cleveland Clinic and two other hospitals about the device. The HeartMate II belongs to a category of products known as a left ventricular assist device and it contains a pump that continuously pushes blood through the heart.
The abrupt increase in pump-related blood clots reported in the study is likely to raise questions about whether its manufacturer, Thoratec Corporation, modified the device, either intentionally or accidentally. By March, the Cleveland Clinic had informed both Thoratec and the Food and Drug Administration about the problems seen there, Dr. Starling said.
Officials at Thoratec declined to be interviewed. But in a statement, the company, which is based in Pleasanton, Calif., said that the HeartMate II had been intensively studied and used in more 16,000 patients worldwide with excellent results. It added that the six-month survival rate of patients who received the device had remained consistently high.
“Individual center experience with thrombosis varies significantly, and Thoratec actively partners with clinicians at all centers to minimize this risk,” the company said in a statement.
Thoratec and other cardiologists also pointed to a federally funded registry that shows a smaller rise in the rate of blood clots, or thrombosis, among patients getting a HeartMate II than the one reported Wednesday by the three hospitals. In the registry, which is known as Intermacs, the rate of pump-related blood clot associated with the HeartMate II rose to about 5 percent in devices implanted after May 2011 compared with about 2 percent in previous years.
The data reported on Wednesday in The New England Journal of Medicine found rates of clot formation two months after a device’s implant had risen to 8.4 percent after March 2011 from 2.2 percent in earlier years. Researchers also suggested in the study that the Intermacs registry might not capture all cases of pump-related blood clots, such as when patients gets emergency heart transplants after a clot forms.
Not only did the rate of blood clots increase, but the clots also occurred much sooner than in the past, according to the study. After March 2011, the median time before a clot was 2.7 months, compared with 18.6 months in previous years. In addition to the Cleveland Clinic, the report on Wednesday included data from Duke University and Washington University in St. Louis.
All mechanical heart implants are prone to producing blood clots that can form on a device’s surface. And experts say that the rate of blood clot formation can be affected by a variety of factors like changes in the use of blood-thinning drugs or the health of a patient.
In a telephone interview, Dr. Starling described the Thoratec officials as cooperative, adding that they have been looking into the problem since March to understand its cause. He said that he could only speculate about the reason for the rapid rise in early blood clots but believed it was probably device-related.
“My belief is that it is something as subtle as a change in software that affects pump flow or heat dissipation near a bearing,” said Dr. Starling, who is a consultant to Thoratec.
Asked about his comments, Thoratec responded that it had yet to determine the reason for even the smaller rise in blood clots seen in the federally funded database. “We have performed extensive analysis on HeartMate II and have not identified any change that would cause the increase observed in the Intermacs registry,” the company said.
In a statement, the F.D.A. said that it was reviewing the findings of the study. “The agency shares the authors concerns about the possibility of increased pump thrombosis,” the F.D.A. said in a statement.
The fortunes of Thoratec, which has been a favorite of Wall Street investors, may depend on its ability to find an answer to the apparent jump in pump-related blood clots. Over the last two years, the company’s stock has climbed from about $30 a share to over $43 a share. In trading Wednesday, Thoratec stock closed at $42.12 a share, up 61 cents. (The New England Journal of Medicine article was released after the stock market closed.)
The HeartMate II has been a lifesaver for many patients like Mr. Cheney in the final stages of heart failure, who got his device in 2010, sustaining them until they get a heart transplant or permanently assisting their heart. Dr. Starling said that he planned to keep using the HeartMate II in appropriate patients at the Cleveland Clinic because those facing death from heart failure had few options.
But the company has also been pushing to expand the device’s use beyond patients who face imminent death from heart failure. For example, the F.D.A. approved a clinical trial for patients with significant, but less severe, heart failure to receive a HeartMate II to compare their outcomes with patients who take drugs for the same condition. Researchers at the University of Michigan Medical Center who are leading the trial said on Wednesday that, based on the lower rates of blood clots seen in the Intermacs registry, they are planning to move forward with the trial.
Dr. Starling and researchers at the Cleveland Clinic tried this spring to get The New England Journal of Medicine to publish a report about the findings at that hospital, but the publication declined, saying the data might simply represent the experience of one facility. As a result, Dr. Starling contacted Duke University and Washington University for their data. When analyzed, it mirrored events at the Cleveland Clinic, he said.
The problems seen with the HeartMate II at the three hospitals were continuing as recently as this summer, when researchers paused the collection of data to prepare Wednesday’s study. The study also noted that a preliminary analysis of data provided by a fourth hospital, the University of Pennsylvania, showed the same pattern of blood clot formation, but that the data had been submitted too late for full analysis.
This account is a vital piece of recognition of very rapid advances in cardiothoracic interventions to support cardiac function mechanically by pump in the situation of loss of contractile function and circulatory output sufficient to sustain life, as can occur with the development of cardiogenic shock. This has been mentioned and its use has been documented in other portions of this series. On the one hand, PCI has a long and steady history in the development of interventional cardiology. This necessitated the availability of thoracic-surgical operative support. The situation is changed, and is more properly, conditional.
I. Impella LD – ABIOMED, Inc.
This micro-axial blood pump can be inserted into the left ventricle via open chest procedures. The Impella LD device has a 9 Fr catheter-based platform and a 21 Fr micro-axial pump and is inserted through the ascending aorta, across the aortic and mitralvalves and into the left ventricle. It requires minimal bedside support and a 9 Fr single-access point requires no priming outside the body.
Impella Recover LD/LP 5.0
The Impella Recover miniaturized impeller pump located within a catheter. The Impella Recover LD/LP 5.0 Support System has been developed to address the need for ventricular support in patients who develop heart failure after heart surgery (called cardiogenic shock) and who have not responded to standard medical therapy. The system is designed to provide immediate support and restore hemodynamic stability for a period of up to 7 days. Used as a bridge to therapy, it allows time for developing a definitive treatment strategy.
The Impella Recover LD 5.0 showing implantation via direct placement into the left ventricle.
Insert B – location in LV
The Impella Recover system is a miniaturized impeller pump located within a catheter. The device can provide support for the left side of the heart using either the
Recover LD 5.0 (implanted via direct placement into the left ventricle) or the
Recover LP 5.0 LV (placed percutaneously through the groin and positioned in the left ventricle).
The microaxial pump of the Recover LP/LD 5.0 can pump up to 4.5 liters per minute at a speed of 33,000 rpm. The pump is located at the distal end of a 9 Fr catheter.
II. IABP VS. Percutaneous LVADS
An intra-aortic balloon pump (IABP) remains the method of choice for mechanical assistance1 in patients experiencing LV failure because of its
proven hemodynamic capabilities,
prompt time to therapy, and
low complication rates.
Percutaneous left ventricular assist devices (pLVADs), such as described above, represent an emerging option for partial or total circulatory support2 and several studies have compared the and efficacy of these devices with intra-aortic balloon pump (IABP) (IABP.)
Despite some randomized controlled trials demonstrating better hemodynamic profiles for pLVADs compared with IABP, there is no difference in 30-day survival or trend toward a reduced 30-day mortality rate associated with pLVADs. Patients treated with pLVADs tended to have a
higher incidence of leg ischemia and
device related bleeding.3
Further, no differences have been detected in the overall use of
positive inotropic drugs or
vasopressors in patients with pLVADs.4,5
However, pLVADs may increase their use for patients not responding to
PCI,
fluids,
inotropes, and
IABP
Therefore, the decision making process on how to treat requires an integrated stepwise approach. A pLVAD might be considered on the basis of
anticipated individual risk,
success rates, and for
postprocedural events.6
Potential Algorithm for Device Selection during High-Risk PCI
Until an alternative modality, characterized by improved efficacy and safety features compared with IABP, is developed, IABP remains the cornerstone of temporary circulatory support.2
Device Comparison for Treatment of Cardiogenic Shock: traditional intra-aortic balloon therapy with Impella 2.5 percutaneous ventricular assist device
1. Percutaneous LVADs in AMI complicated by cardiogenic shock. H Thiele, et al. EHJ 2007;28:2057-2063
2. Cardiogenic shock current concepts and improving outcomes. H R Reynolds et al. Circulation 2008 ;117 :686-697
3. Percutaneous left ventricular assist devices vs. IABP counterpulsation for treatment of cardiogenic shock. J M Cheng, et al. EHJ doi:10.1093/eurheart/ehp292
4. A randomized clinical trial to evaluate the safety and efficacy of a pLVAD vs. IABP for treatment of cardiogenic shock caused by MI. M Seyfarth, et al. JACC 2008;52:1584-8
5. A randomized multicenter clinical study to evaluate the safety and efficacy of the tandem heart pLVAD vs. conventional therapy with IABP for treatment of cardiogenic shock.
6. Percutaneous LVADs in AMI complicated by cardiogenic shock. H Thiele, et al. EHJ 2007;28:2057-2063
The Impella 2.5 is a percutaneously placed partial circulatory assist device that is increasingly being used in high-risk coronary interventional procedures to provide hemodynamic support. The Impella 2.5 is able to unload the left ventricle rapidly and effectively and increase cardiac output more than an intra-aortic balloon catheter can. Potential complications include bleeding, limb ischemia, hemolysis, and infection. One community hospital’s approach to establishing a multidisciplinary program for use of the Impella 2.5 is described.
Patients who undergo high-risk percutaneous coronary intervention (PCI), such as procedures on friable saphenous vein grafts or the left main coronary artery, may have an intra-aortic balloon catheter placed if they require hemodynamic support during the procedure. Currently, the intra-aortic balloon pump (IABP) is the most commonly used device for circulatory support. A newer option that is now available for select patients is the Impella 2.5, a short-term partial circulatory support device or percutaneous ventricular assist device (VAD).
In this article, I discuss the Impella 2.5, review indications and contraindications for its use, delineate potential complications of the Impella 2.5, and discuss implications for nursing care for patients receiving extended support from an Impella 2.5. Additionally, I share our experiences as we developed our Impella program at our community hospital. Routine management of patients after PCI is not addressed.
IABP Therapy: Background
decreases after-load,
decreases myocardial oxygen consumption,
increases coronary artery perfusion, and
modestly enhances cardiac output.1,2
The IABP cannot provide total circulatory support. Patients must have some level of left ventricular function for an IABP to be effective.
Optimal hemodynamic effect from the IABP is dependent on:
the balloon’s position in the aorta,
the blood displacement volume,
the balloon diameter in relation to aortic diameter,
the timing of balloon inflation in diastole and deflation in systole, and
the patient’s own blood pressure and vascular resistance.3,4
Impella 2.5 Catheter – ABIOMED, Inc.
Effect
reduces myocardial oxygen consumption,
improves mean arterial pressure, and
reduces pulmonary capillary wedge pressure.2
The Impella 2.5 has been used for
hemodynamic support during high-risk PCI and for
hemodynamic support of patients with
myocardial infarction complicated by cardiogenic shock or ventricular septal defect,
cardiomyopathy with acute decompensation,
postcardiotomy shock,
off-pump coronary artery bypass grafting surgery, or
heart transplant rejection and
as a bridge to the next decision.9
The Impella provides a greater increase in cardiac output than the other IABP provides. In one trial5 in which an IABP was compared with an Impella in cardiogenic shock patients, after 30 minutes of therapy, the cardiac index (calculated as cardiac output in liters per minute divided by body surface area in square meters) increased by 0.5 in the patients with the Impella compared with 0.1 in the patients with an IABP.
Unlike the IABP, the Impella does not require timing, nor is a trigger from an electrocardiographic rhythm or arterial pressure needed (Table 1). The device received 510(k) clearance from the Food and Drug Administration in June 2008 for providing up to 6 hours of partial circulatory support. In Europe, the Impella 2.5 is approved for use up to 5 days. Reports of longer duration of therapy in both the United States and Europe have been published.8,9
Clinical Research and Registry Findings
Abiomed has sponsored several trials, including PROTECT I, PROTECT II, RECOVER I, RECOVER II, and ISAR-SHOCK.
The PROTECT I study was done to assess the safety and efficacy of device placement in patients undergoing high-risk PCI.10
Twenty patients who had
poor ventricular function (ejection fraction =35%) and had
PCI on an unprotected left main coronary artery or the
last remaining patent coronary artery or graft.
The device was successfully placed in all patients, and the duration of support ranged from 0.4 to 2.5 hours. Following this trial, the Impella 2.5 device received its 510(k) approval from the Food and Drug Administration.
The ISAR-SHOCK trial was done to evaluate the safety and efficacy of the Impella 2.5 versus the IAPB in patients with cardiogenic shock due to acute myocardial infarction.5 Patients were randomized to support from an IABP (n=13) or an Impella (n=12).
The trial’s primary end point of hemodynamic improvement was defined as improved cardiac index at 30 minutes after implantation.
Improvements in cardiac index were greater with the Impella (P=.02).
The diastolic pressure increased more with Impella (P=.002).
There was a nonsignificant difference in the MAP (P=.09), as was the use of inotropic agents and vasopressors similar in both groups of patients.
Device Design: Impella 2.5 Catheter
The Impella 2.5 catheter contains a nonpulsatile microaxial continuous flow blood pump that pulls blood from the left ventricle to the ascending aorta, creating increased forward flow and increased cardiac output. An axial pump is one that is made up of impellar blades, or rotors, that spin around a central shaft; the spinning of these blades is what moves blood through the device.13
The Impella 2.5 catheter has 2 lumens. A tubing system called the Quick Set-Up has been developed for use in the catheterization laboratory. It is a single tubing system that bifurcates and connects to each port of the catheter. This arrangement allows rapid initial setup of the console so that support can be initiated quickly. When the Quick Set-Up is used, the 10% to 20% dextrose solution used to purge the motor is not heparinized. One lumen carries fluid to the impellar blades and continuously purges the motor to prevent the formation of thrombus. The proximal port of this lumen is yellow. The second lumen ends near the motor above the level of the aortic valve and is used to monitor aortic pressure.
The components required to run the device are assembled on a rolling cart and include the power source, the Braun Vista infusion pump, and the Impella console. The Impella console powers the microaxial blood pump and monitors the functioning of the device, including the purge pressure and several other parameters. The console can run on a fully charged battery for up to 1 hour.
Placement of the Device
The Impella 2.5 catheter is placed percutaneously through the common femoral artery and advanced retrograde to the left ventricle over a guidewire. Fluoroscopic guidance in the catheterization laboratory or operating room is required. After the device is properly positioned, it is activated and blood is rapidly withdrawn by the microaxial blood pump from the inlet valve in the left ventricle and moved to the aorta via the outlet area, which sits above the aortic valve in the aorta.
If the patient tolerates the PCI procedure and hemodynamic instability does not develop, the Impella 2.5 may be removed at the end of the case, or it can be withdrawn, leaving the arterial sheath in place, which can be removed when the patient’s activated clotting time or partial thromboplastin time has returned to near normal levels. For patients who become hemodynamically unstable or who have complications during the PCI (eg, no reflow, hypotension, or lethal arrhythmias), the device can remain in place for continued partial circulatory support, and the patient is transported to the critical care setting.
Potential Complications of Impella Therapy
The most commonly reported complications of Impella 2.5 placement and support include
limb ischemia,
vascular injury, and
bleeding requiring blood transfusion.6,9
Hemolysis is an inherent risk of the axial construction, and results in transfusions.5,10
Hemolysis can be mechanically induced when red blood cells are damaged as they pass through the microaxial pump. Other potential complications include
aortic valve damage,
displacement of the distal tip of the device into the aorta,
infection, and
sepsis.
Device failure, although not often reported, can occur.
Patients on Impella 2.5 support who may require
interrogation of a permanent pacemaker or
implantable cardioverter defibrillator
present an interesting situation. In order for the interrogator to connect with the permanent pacemaker or implantable cardioverter defibrillator, the Impella console must be turned off for a few seconds while the signal is established. As soon as the signal has been established, Impella support is immediately restarted.
Impella 2.5 Console Management
The recommended maximum performance level for continuous use is P8. At P8, the flow rate is 1.9 to 2.6 L/min and the motor is turning at 50000 revolutions per minute. When activated, the console is silent. No sound other than alarms is audible during Impella support, unlike the sound heard with an IABP. Ten different performance levels ranging from P0 to P9 are available. As the performance level increases, the flow rate and number of revolutions per minute increase. At maximum performance (P9), the pump rotates at 50000 revolutions per minute and delivers a flow rate of 2.1 to 2.6 L/min. P9 can be activated only for 5-minute intervals when the Impella 2.5 is in use.
IV. PROTECT II Study – Experts Discussion
the use of the Impella support device and the intraortic balloon pump for high-risk percutaneous coronary intervention
DR. SMALLING: Well, the idea about the PROTECT trial is that it would show that using the Impella device to support high-risk angioplasty was not inferior to utilizing the balloon pump for the same patient subset. Ejection fraction’s were in the 30%–35% range. Supposedly last remaining vessel or left main disease or left-main plus three-vessel disease and low EF; so I think that was the screening for entry into the trial.
major adverse cardiac event endpoints
Acute myocardial infarction,
mortality,
bleeding,
mortality was the same. Their endpoints really didn’t show that much difference. In subgroup analysis, they felt that they Impella may have had a little advantage over balloon pump.
DR. KERN: So do you think this study would tip the interventionalist to move in one direction or the other for high-risk angioplasty?
DR. SMALLING: That’s an interesting concept, you know? One has to get to: What is really a high-risk angioplasty. I think you and I are both old enough to remember that back in the mid-’80s, we determined that high-risk angioplasty was a patient with an ejection fraction of 25% or less, with a jeopardy score over 6. The EFs were a little higher. And, I guess, based on our prior experience with other support devices — like, for instance, CPS and then, later on, the Tandem Heart — there really was not an advantage of so-called more vigorous support systems. And so, the balloon pump served as well.
DR. SMALLING:
Those of us that have looked carefully at what it can really do, I think it may get one liter a minute at most, maybe more.1-6 But I think, for all intents and purposes, it doesn’t support at a very vigorous level. So I think personally, if I had someone I was really worried about, I would opt for something more substantial like, for instance, a Tandem Heart device.
DR. KERN: I think this is a really good summary of the study and the. Are there any final thoughts for those of us who want to read the PROTECT II study when it comes out?
DR. SMALLING: We have to consider a $20,000, $25,000 device. Is that really necessary to do something that we could often do without any support at all, or perhaps with a less costly device like a balloon pump.
DR. KERN: We’re going to talk for a few minutes about the PROTECT II study results that were presented here in their form. And Ron, I know you’ve been involved with following the work of the PROTECT II investigators. Were you a trial site for this study?
DR. WAKSMAN: No, actually, we were not, but we have a lot of interest in high-risk PCI and using devices to make this safe — mainly safe — and also effective. We were not investigators, but we did try to look, based on the inclusion/exclusion criteria, on our own accord with the balloon pump. If you recall, this study actually was comparing balloon time to the Impella device for patients who are high-risk PCI.
The composite endpoint was very complicated. They added like probably nine variables there, which is unusual for a study design. … They basically estimated that the event rate on the balloon pump would be higher than what we thought it should be. So we looked at our own data, and we found out that the actual — if you go by the inclusion/exclusion criteria and their endpoints — the overall event rate in the balloon pump would be much lower than they predicted and built in their sample size.
DR. KERN: And, so, the presentation of the PROTECT II trial, was it presented as a positive study or a negative study.
DR. WAKSMAN: Overall the study did not meet the endpoint. So the bottom line, you can call it the neutral study, which is a nice way to say it.
if you go and do all those analyses, you may find some areas that you can tease a P value, but I don’t think that this has any scientific value, and people should be very careful. We’re not playing now with numbers or with statistics, this is about patient care. You’re doing a study — the study, I think, has some flaws in the design to begin with — and we actually pointed that out when we were asked to participate in the study. But if the study did not meet the endpoint, then I think all those subanalyses, subgroups, you extract from here, you add to there, and you get a P value, that means nothing. So we have to be careful when we interpret this, other than as a neutral study that you basically cannot adopt any of the … it did not meet the hypothesis, that’s the bottom line.
A first-in-man study of the Reitan catheter pump for circulatory support in patients undergoing high-risk percutaneous coronary intervention.
Smith EJ, Reitan O, Keeble T, Dixon K, Rothman MT.
Department of Cardiology, London Chest Hospital, United Kingdom.
Catheter Cardiovasc Interv. 2009 Jun 1;73(7):859-65. http://dx.doi.org/10.1002/ccd.21865.
To investigate the safety of a novel percutaneous circulatory support device during high-risk percutaneous coronary intervention (PCI).
BACKGROUND:
The Reitan catheter pump (RCP) consists of a catheter-mounted pump-head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion.
METHODS:
Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 +/- 9; LVEF 34% +/- 11%; jeopardy score 8 +/- 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose sutures. PCI was performed via the radial artery. Outcomes included in-hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal.
RESULTS:
The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 +/- 1,424 rpm maintained an aortic gradient of 9.8 +/- 2 mm Hg. Although fHb increased,
there was no significant hemolysis (4.7 +/- 2.4 mg/dl pre vs. 11.9 +/- 10.5 post, P = 0.04, reference 20 mg/dl).
Platelets were unchanged (pre 257 +/- 74 x 10(9) vs. 245 +/- 63, P = NS).
Renal function improved (cre pre 110 +/- 27 micromol/l vs. 99 +/- 28, P = 0.004).
All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal.
CONCLUSIONS:
The RCP can be used safely in high-risk PCI patients.
A coronary angiogram that shows the LMCA, LAD and LCX. (Photo credit: Wikipedia)
English: Simulation of a wave pump human ventricular assist device (Photo credit: Wikipedia)
English: Figure A shows the structure and blood flow in the interior of a normal heart. Figure B shows two common locations for a ventricular septal defect. The defect allows oxygen-rich blood from the left ventricle to mix with oxygen-poor blood in the right ventricle. (Photo credit: Wikipedia)
Vascular Surgery: International, Multispecialty Position Statement on Carotid Stenting, 2013 and Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD
Author and Curator: Aviva Lev-Ari, PhD, RN
Article ID #66: Vascular Surgery: International, Multispecialty Position Statement on Carotid Stenting, 2013 and Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD. Published on 7/14/2013
WordCloud Image Produced by Adam Tubman
Part One:
Vascular Surgery International, Multispecialty Position Statement on Carotid Stenting, 2013
Part Two:
Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD, Chief, Division of Vascular and Endovascular Surgery Co-Director, Thoracic Aortic Center @ MGH
I. Recollection of a visit at Dr. Cambria’s Office, 2004
II. Shadowing Dr. Cambria in OR @MGH
III. Dr. Cambria: Selection of Contributions to Scientific Research on Vascular Surgery
IV. Cardiovascular Clinical Observational Experience – Aviva Lev-Ari, PhD, RN
V. Cases with Complications: CEA and CAS
Part Three:
On 8/1/2013, Cleveland Clinic Reports Equivalence between carotid endarterectomy (CEA) and open-heart surgery (OHS) and carotid artery stenting (CAS) followed by coronary artery bypass graft (CABG) surgery or non-CABG cardiac surgery
Part One:
Vascular Surgery International, Multispecialty Position Statement on Carotid Stenting, 2013 Part
No other invasive intervention procedure in the history of Vascular Surgery has stormed the profession more than the two treatment options for carotid artery partial to complete blockage than Carotid endarterectomy (CEA) and Carotid angioplasty and stenting (CAS).
The debate required evidence based resolution for the two treatment options in terms of patient outcomes and adverse events. As the title of the Position statement explained below, the verdict is non equivocal: Routine Carotid Stenting is inferior to Carotid endarterectomy (CEA) from a patient safety and outcomes.
In conclusion, current global evidence shows that, even in the best academic centers, CAS is less effective (causing more strokes) and more expensive than CEA. It is premature that some guidelines have recently added support for routine practice CAS as an alternative to CEA for
asymptomatic43,44 and
low/ average surgical risk symptomatic patients43–45
because CAS may easily be misinterpreted by readers as being equivalent for
stroke prevention46 and
historical procedural standards were cited.
CAS, for these patients, should still only be performed and paid for within well‐designed, adequately powered trials. The US Center for Medicare and Medicaid Services is doing its job and setting an excellent global example. It is protecting Medicare beneficiaries from routine practice procedures, which are currently more likely to harm them and waste finite resources47 that could be used for their advantage. Meanwhile, we need to reassess the current routine practice role of CEA and deliver optimal current medical treatment to all who need it.
Clinical Trials Results
To avoid misguidance from calls for more routine practice (nontrial) carotid angioplasty/stenting (CAS), we need to distinguish relevant facts and patients’ best interests from all else (distractions). A recent editorial by White and Jaff1 is one publication which illustrates this need particularly well. First, these authors are correct in reminding us that the responsibility of physicians is to provide best patient care, putting aside personal interest. This is inherent in any profession.2 However, misconception, bias, and conflict of interest exist. Therefore, healthcare payment organizations, such as the US Center for Medicare and Medicaid Services are important gatekeepers to facilitate patient access to interventions that are likely to help them, as opposed to all others.
It is also true that CAS and carotid endarterectomy (CEA) result in better outcomes when patients are carefully selected and skilled operators perform the procedures in experienced centers.1 We would add that key indicators (such as 30‐day periprocedural stroke/death rates) must be accurately measured in routine (real‐world) practice, particularly as stroke and death rates here may be unacceptably higher than in trials. 3–5 Therefore, it is most appropriate, as suggested by White and Jaff,1 that coverage for carotid procedures be dependent on facility accreditation and audited measurement of key standards indicators in all practices performing these procedures.
This is a priority issue. White and Jaff1 also correctly state “a major change in evidence based stroke prevention strategies will require clinical trial data.,7,8 meta‐analyses, and routine practice.9–14 Most of these data relate to low/average risk symptomatic patients and demonstrate that, for these patients, even in the best academic centers, CAS is consistently associated with significantly higher rates of stroke or death (during or after the periprocedural period) compared with CEA.
It is incorrect that CREST “failed to show a difference in overall stroke rate between CAS and CEA” as stated by White and Jaff.1 In CREST, for average surgical risk symptomatic patients, the periprocedural stroke and death rates were 6.0% for CAS versus 3.2% for CEA (hazard ratio, 1.89; 95% confidence interval, 1.11–3.21; P=0.02).8
The higher periprocedural risk of stroke or death with CAS is particularly evident in the most senior patients (>68–70 years),13,15,16 those undergoing the procedure <7 days of incident cerebral or retinal ischemic symptoms17 (when CEA has the highest stroke prevention potential),18 those undergoing CAS outside clinical trials,19 and those with certain anatomic features.20 No study has shown that CAS is more effective than CEA in preventing stroke. Further, most analyses show that CAS costs considerably more,21–24 despite calculations derived from CREST results.25 No randomized trial has been adequately powered to compare the procedural and longer term risk of CAS on stroke or death in low/average risk asymptomatic patients. However, in CREST, the direction of effect was toward nearly twice the risk (periprocedural stroke/death rate was 2.5% for CAS versus 1.4% for CEA; hazard ratio, 1.88; 95% confidence interval, 0.79–4.42; P=0.15).8 This was consistent with the significantly higher periprocedural stroke rates seen in CREST CAS‐treated symptomatic patients8 and nontrial CAS‐treated asymptomatic patients.9,26
Meanwhile, medical treatment for asymptomatic carotid disease has improved significantly since past randomized trials of medical treatment alone versus additional CEA.27–32 Medical treatment consists of identification of risk factors for heart and vascular disease and risk reduction using healthy lifestyles and appropriate drugs. Improvement in medical treatment is clear from robust analyses of all published comparable, quality stroke rate calculations (including from, and within, randomized surgical trials) of patients with 50% to 99% asymptomatic carotid stenosis. This knowledge is not, as claimed by White and Jaff,1 derived from short‐cut extrapolation from coronary artery trials. Using the same standardized rate calculations, we are now seeing an average annual rate of ipsilateral stroke of ≈0.5% with medical treatment alone.30,33,34 This is about 3X— lower than that of asymptomatic CREST CAS‐treated patients and about half the rate of asymptomatic CREST CEA‐treated patients.7,9 This low rate with medical treatment is likely to fall further with improvements in efficacy, definition, and implementation.
However, recently published rate calculations indicate that, at most, only ≈2.5% of low/average CEA risk patients with 50% to 99% asymptomatic carotid stenosis will receive a stroke prevention benefit from CEA or CAS during their remaining average 10‐year lifetime if they receive good, current medical treatment (assuming the procedural risk of stroke/death is always zero).35 This indicates that a one‐size‐fits‐all procedural approach for these asymptomatic patients is now unlikely to be beneficial overall. We need to be much more selective. Research is required to determine which asymptomatic subgroups now benefit from carotid procedures in addition to current optimal medical treatment.
We have found no direct information about the influence of current medical treatment in patients with low/average CEA risk symptomatic carotid stenosis. However, improving results for medically treated asymptomatic patients27–32 and procedural trial asymptomatic and symptomatic patients8 indicate that a 6% periprocedural risk of
stroke or
death (the current standard) is now too high.
New randomized and risk stratification studies are required using current optimal medical treatment and procedural methods.36 For example,
improved plaque37 and
thrombus identification38 or
embolic signal detection39 above and below the stenosis
may help better identify carotid plaques responsible for carotid territory ischemic symptoms. Further, the best approach for patients with high surgical risk carotid stenosis remains uncertain because risk of stroke or death has not been measured with any standard of medical treatment or adequate procedural trials. However, some registries show significantly higher risks of stroke/death with CAS compared with CEA in asymptomatic and symptomatic high surgical risk patients.40
Incidence of MI
Calls from other authors for more routine CAS on the grounds of lower periprocedural myocardial infarction (MI) rates compared with CEA are distracting.41 MI is not a measure of stroke prevention efficacy, even though it is an important procedural complication. The inclusion of periprocedural MI with stroke and death in the primary outcome measure in CREST resulted in primary outcome equivalence between CAS and CEA. However, it did not result in efficacy equivalence. In CREST, 1.1% (14/1262) of CAS patients had periprocedural clinical MI (biomarkers plus chest pain/ECG evidence) compared with 2.3% (28/1240) of CEA patients7 (P=0.03). However, periprocedural stroke was nearly twice as common (81/2502; 3.2%)7 as periprocedural clinical MI (42/2502; 1.7%) and, as mentioned above, CAS caused almost twice as many of these strokes as CEA.Further, in CREST, the mortality rate up to 4 years was equally poor for CREST patients with periprocedural stroke (20%),42 periprocedural clinical MI (19%),41 or periprocedural biomarker‐positive only MI (25%).41 Finally, nonfatal stroke was associated with a poorer quality of life at 1 year than nonfatal MI.7 Therefore, MI is a measure of carotid procedural risk (not benefit) and must be considered separately from stroke risk. Moreover, in CREST, CAS‐associated stroke was more troublesome for patients than CEA‐associated MI.
Conclusion
Calls for More Routine Carotid Stenting Are Currently Inappropriate, 3/2013
Carotid artery disease, also called carotid artery stenosis, occurs when the carotid arteries, the main blood vessels that carry oxygenated blood to the brain, become narrowed. The narrowing of the carotid arteries is most commonly related to atherosclerosis (a buildup of plaque, which is a deposit of fatty substances, cholesterol, cellular waste products, calcium, and fibrin in the inner lining of an artery). Atherosclerosis, or “hardening of the arteries,” is a vascular disease (disease of the arteries and veins). Carotid artery disease is similar to coronary artery disease, in which blockages occur in the arteries of the heart, and may cause a heart attack.
Click Image to Enlarge
To better understand how carotid artery disease affects the brain, a basic review of the anatomy of the circulation system of the brain follows.
What are the carotid arteries?
The main supply of blood to the brain is carried by the carotid arteries. The carotid arteries branch off from the aorta (the largest artery in the body) a short distance from the heart, and extend upward through the neck carrying oxygen-rich blood to the brain.
There are four carotid arteries: the right and left internal carotid arteries and the right and left external carotid arteries. One pair (external and internal) is located on each side of the neck. Just as a pulse can be felt in the wrists, a pulse can also be felt on either side of the neck over the carotid arteries.
Click to Enlarge
Why are the carotid arteries important?
Because the carotid arteries deliver blood to the brain, carotid artery disease can have serious implications by reducing the flow of oxygen to the brain. The brain needs a constant supply of oxygen in order to function. Even a brief interruption in blood supply can cause problems. Brain cells begin to die after just a few minutes without blood or oxygen. If the narrowing of the carotid arteries becomes severe enough to block blood flow, or a piece of atherosclerotic plaque breaks off and obstructs blood flow to the brain, a stroke may occur.
What causes carotid artery disease?
Atherosclerosis is the most common cause of carotid artery disease. It is unknown exactly how atherosclerosis begins or what causes it. Atherosclerosis is a slow, progressive, vascular disease that starts as early as childhood. However, the disease has the potential to progress rapidly. It is generally characterized by the accumulation of fatty deposits along the innermost layer of the arteries. If the disease process progresses, plaque formation may take place. Plaque is made up of deposits of smooth muscle cells, fatty substances, cholesterol, calcium, and cellular waste products. This thickening narrows the arteries and can decrease blood flow or completely block the flow of blood to the brain.
Risk factors associated with atherosclerosis include:
Older age
Male
Family history
Race or ethnicity
Genetic factors
Hyperlipidemia (elevated fats in the blood)
Hypertension (high blood pressure)
Smoking
Diabetes
Obesity
Diet high in saturated fat
Lack of exercise
A risk factor is anything that may directly increase or be associated with a person’s chance of developing a disease. It may be an activity, such as smoking, diet, family history, or many other things. Different diseases have different risk factors.
Although these risk factors increase a person’s risk, they do not necessarily cause the disease. Some people with one or more risk factors never develop the disease, while others develop disease and have no known risk factors. Knowing your risk factors to any disease can help to guide you into the appropriate actions, including changing behaviors and being clinically monitored for the disease.
What are the symptoms of carotid artery disease?
Carotid artery disease may be asymptomatic (without symptoms) or symptomatic (with symptoms). Asymptomatic carotid disease is the presence of a significant amount of atherosclerotic buildup without obstructing enough blood flow to cause symptoms. However, a sufficiently tight stenosis will not always cause symptoms. Symptomatic carotid artery disease may result in either a transient ischemic attack (TIA) and/or a stroke (brain attack).
A transient ischemic attack (TIA) is a sudden or temporary loss of blood flow to an area of the brain, usually lasting a few minutes to one hour. Symptoms go away entirely within 24 hours, with complete recovery. Symptoms of a TIA may include, but are not limited to, the following:
Sudden weakness or clumsiness of an arm and/or leg on one side of the body
Sudden paralysis (inability to move) of an arm and/or leg on one side of the body
Loss of coordination or movement
Confusion, decreased ability to concentrate, dizziness, fainting, and/or headache
Numbness or loss of sensation (feeling) in the face
Numbness or loss of sensation in an arm and/or leg
Temporary loss of vision or blurred vision
Inability to speak clearly or slurred speech
TIA may be related to severe narrowing or blockage or from small pieces of an atherosclerotic plaque breaking off, traveling through the bloodstream, and lodging in small blood vessels in the brain. With TIA, there is rarely permanent brain damage.
Call for medical help immediately if you suspect a person is having a TIA, as it may be a warning sign that a stroke is about to occur. Not all strokes, however, are preceded by TIAs.
Stroke is another indicator of carotid artery disease. The symptoms of a stroke are the same as for a TIA. A stroke is loss of blood flow (ischemia) to the brain that continues long enough to cause permanent brain damage. Brain cells begin to die after just a few minutes without oxygen. The area of dead cells in tissues is called an infarct.
The area of the brain that suffered the loss of blood flow will determine what the physical or mental disability may be. This may include impaired ability with movement, speech, thinking and memory, bowel and bladder function, eating, emotional control, and other vital body functions. Recovery from the specific ability affected depends on the size and location of the stroke. A stroke may result in problems, such as weakness in an arm or leg or may cause paralysis, loss of speech, or even death.
The symptoms of carotid artery disease may resemble other medical conditions or problems. Always consult your doctor for a diagnosis.
How is carotid artery disease diagnosed?
In addition to a complete medical history and physical examination, diagnostic procedures for carotid artery disease may include any, or a combination, of the following:
Auscultation (listening to) of carotid arteries. Placement of a stethoscope over the carotid artery to listen for a particular sound called a bruit (pronounced brew-ee). A bruit is an abnormal sound that is produced by blood passing through a narrowed artery. A bruit is generally considered a sign of an atherosclerotic artery; however, an artery may be diseased without producing this sound.
Carotid artery duplex scan. A type of vascular ultrasound study performed to assess the blood flow of the carotid arteries. A carotid artery duplex scan is a noninvasive (the skin is not pierced) procedure. A probe called a transducer sends out ultrasonic sound waves at a frequency too high to be heard. When the transducer (like a microphone) is placed on the carotid arteries at certain locations and angles, the ultrasonic sound waves move through the skin and other body tissues to the blood vessels, where the waves echo off of the blood cells. The transducer picks up the reflected waves and sends them to an amplifier, which makes the ultrasonic sound waves audible. Absence or faintness of these sounds may indicate an obstruction to the blood flow.
Magnetic resonance imaging (MRI). A diagnostic procedure that uses a combination of large magnets, radiofrequencies, and a computer to produce detailed images of organs and structures within the body. To have this test done, you lie inside a big tube while magnets pass around your body. It is very loud. Sometimes it is done with IV contrast injected into your veins and sometimes not.
Magnetic resonance angiography (MRA). A noninvasive diagnostic procedure that uses a combination of magnetic resonance technology (MRI) and intravenous (IV) contrast dye to visualize blood vessels. Contrast dye causes blood vessels to appear opaque on the MRI image, allowing the doctor to visualize the blood vessels being evaluated.
Computed tomography scan (also called a CT or CAT scan). A diagnostic imaging procedure that uses a combination of X-rays and computer technology to produce horizontal, or axial, images (often called slices) of the body. A CT scan shows detailed images of any part of the body, including the bones, muscles, fat, and organs. CT scans are more detailed than general X-rays. Like an MRI, it is sometimes done with IV contrast injected into your veins and sometimes not.
Angiography. An invasive procedure used to assess the degree of blockage or narrowing of the carotid arteries by taking X-ray images while a contrast dye in injected. The contrast dye helps to visualize the shape and flow of blood through the arteries as X-ray images are made.
Treatment for carotid artery disease
Specific treatment for carotid artery disease will be determined by your doctor based on:
Your age, overall health, and medical history
Extent of the disease
Your signs and symptoms
Your tolerance of specific medications, procedures, or therapies
Expectations for the course of the disease
Your opinion or preference
Carotid artery disease (asymptomatic or symptomatic) in which the narrowing of the carotid artery is less than 50 percent is most often treated medically. Asymptomatic disease with less than 70 percent narrowing may also be treated medically, depending on the individual situation.
Medical treatment for carotid artery disease may include:
Modification of risk factors. Risk factors that may be modified include smoking, elevated cholesterol levels, elevated blood glucose levels, lack of exercise, poor dietary habits, and elevated blood pressure.
Medications. Medications that may be used to treat carotid artery disease include:
Antiplatelet medications. Medications used to decrease the ability of platelets in the blood to stick together and cause clots. Aspirin, clopidogrel, and dipyridamole are examples of antiplatelet medications.
Antihyperlipidemics. Medications used to lower lipids (fats) in the blood, particularly cholesterol. Statins are a group of antihyperlipidemic medications, and include simvastatin, atorvastatin, and pravastatin, among others. Studies have shown that certain statins can decrease the thickness of the carotid artery wall and increase the size of the lumen (opening) of the artery.
Antihypertensives. Medications used to lower blood pressure. There are several different groups of medications which act in different ways to lower blood pressure.
In people with narrowing of the carotid artery greater than 50 to 69 percent, a more aggressive treatment may be recommended, particularly in people with symptoms. Surgical treatment decreases the risk for stroke after symptoms such as TIA or minor stroke, especially in people with an occlusion (blockage) of more than 70 percent who are good candidates for surgery.
Surgical treatment of carotid artery disease includes:
Carotid endarterectomy (CEA). Carotid endarterectomy is a procedure used to remove plaque and clots from the carotid arteries, located in the neck. Endarterectomy may help prevent a stroke from occurring in people with symptoms with a carotid artery narrowing of 70 percent of more.
Illustration of Carotid Endarterectomy (Click to Enlarge)
Carotid artery angioplasty with stenting (CAS). Carotid angioplasty with stenting is an option for patients who are high risk for carotid endarterectomy. This is a minimally invasive procedure in which a very small hollow tube, or catheter, is advanced from a blood vessel in the groin to the carotid arteries. Once the catheter is in place, a balloon may be inflated to open the artery and a stent is placed. A stent is a cylinder-like tube made of thin metal-mesh framework used to hold the artery open. Because there is a risk of stroke from bits of plaque breaking off during the procedure, an apparatus, called an embolic protection device, may be used. An embolic protection device is a filter (like a small basket) that is attached on a guidewire to catch any debris that may break off during the procedure.
Carotid Artery Angioplasty with Stenting (CAS) Click to Enlarge
Carotid Artery Disease and Stroke: Prevention and Treatment – John Hopkins
VIEW VIDEO –
Carotid Endarterectomy with Temporary Bypass – A Fifty year old procedure
Docteur Jean VALLA
Chirurgien Cardiovasculaire et Thoracique
AIHR/ACCA – Ancien Chirurgien des Hôpitaux Universitaires.
Membre de la Société de Chirurgie Thoracique et Cardiovasculaire de Langue Française Conventionné
Carotid artery stenosis is the narrowing of the carotid arteries. These are the main arteries in the neck that supply blood to the brain. Carotid artery stenosis, also called carotid artery disease, is a major risk factor for ischemic stroke.The narrowing is usually caused by plaque in a blood vessel. Plaque forms when cholesterol, fat and other substances build up in the inner lining of an artery.Depending on the degree of stenosis and the patient’s overall condition, carotid artery stenosis can usually be treated with surgery. The procedure is called carotid endarterectomy. It removes the plaque that caused the carotid artery to narrow. Carotid endarterectomy has proven to benefit patients with arteries stenosed (narrowed) by 70 percent or more. For people with arteries narrowed less than 50 percent, anti-clotting medicine is usually prescribed to reduce the risk of ischemic stroke.
VIEW VIDEO –
Carotid angioplasty and stenting (CAS) – Mayo Clinic
In carotid angioplasty and stenting, a long hollow tube called a catheter is inserted in the femoral artery in the groin area. The catheter is then maneuvered through the arteries until it reaches the narrowing in the carotid artery in the neck. An umbrella-shaped filter is inserted beyond the narrowing to catch any plaque or debris that may break off during the procedure. Then, a tiny balloon at the end of the catheter is inflated to push the plaque to the side and widen the vessel. A small metal coil called a stent is inserted into the vessel. The stent serves as a scaffold to help prevent the artery from narrowing again.
Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD, Chief, Division of Vascular and Endovascular Surgery Co-Director, Thoracic Aortic Center @ MGH
I. Recollection of a visit at Dr. Cambria’s Office @MGH, 2004
The author arrived for a 4PM appointment @ MGH with a referral from NWH for a Carotid artery duplex scan that in 2004 was not performed at NWH. The consultation appointment with Dr. Kwolek CJ, a vascular surgeon trained under Dr. RP Cambria, took place in Dr. Cambria’s Office. Few minutes into the patient Medical History interview, Dr. Kwolek was called for an emergency in the OR and asked me to wait for him till he comes back. I looked around and found myself in a 14’x22′ Room, the Office of Dr. Richard Cambria @ MGH, Chief Vascular Surgery and among the Top ten in the World. Except for the glass entrance door and the wide window to the right of the entrance – 3 1/2 walls from the ceiling to one yard above the floor where completely covered with framed Awards, licenses, renewed licenses, Pictures with graduating Medical Students, Pictures with Faculty, with Patients and in the OR. I waited for Dr. Kwolek’s return for the completion of my Medical History Interview about 30 minutes. I used that time to walk along the walls in Dr. Cambria’s Office and read the framed Exhibits. It was clear to me that this Office will need, one day, in the future, to become a Museum @MGH, for most significant milestones in Vascular Surgery, a branch of Cardiothoracic Surgery. Dr. Kwolek returned and completed the interview, scheduled my Lab appointment and the next appointment to discuss the duplex scan results.
II. Shadowing Dr. Cambria in OR @MGH
Per section IV, below which described the author’s Cardiovascular Clinical Observational Experience, I recorded my Shadowing experience at the OR @MGH, including Dr. Cambria performing a CEA on a 84 year old women under going aorta valve replacement (performed by Dr. Walker) priot to a CEA performed by Dr. Cambria. It was all captivating to watch his double gloved hands performing sutures on a >95% blocked carotid artery prior to incision.
The dexterity and the speed of Dr. Cambria’s fingers’ movement, could only have reminded me of World #1 Harp Player: Nicanor Zabaleta, which I met in person, in the presence of my prominent Harp teacher, on his US Tour in 11/1989. He was awarded the Premio Nacional de Música of Spain in 1982 and six years later, in 1988, he was elected to the Real Academia de Bellas Artes de San Fernando. Dr. Cambria’s and Mr. Zabaleta’s fingers dexterity and eye hand coordination, both are of the rarest endowments in fine motor precision and perfection with Worldly finest outcomes in art, Surgery is Art, the mastering of the Harp is Art, too.
The Author in the OR — Mass General Hospital, Boston
Cardiac Surgery – Operating Room
Supervisor: Dr. J. Walker, Cardiac Surgeon
Experience: Shadowing Open Heart Surgery at MGH
1/24/2005: Carotid Artery endarterectomy operation by Dr. Richard Cambria
1/24/2005: Mitral Valve Replacement by Dr. Jennifer Walker
1/26/2005: Aorta Valve Replacement and Coronary Artery Bypass Grafting by Dr. Jennifer Walker
[Saphenous vein harvested from the leg and Radial vein harvested from the right arm]
III. Dr. Cambria: Selection of Contributions to Scientific Research on Vascular Surgery
The Author covered In Part One, Dr. Cambria’s participation in and contribution to the International, Multispecialty Position Statement on Carotid Stenting, 2013.
In Part Two Section II, I share with the e-Reader watching Dr. Cambria in the Surgical Theater performing CEA
In Part Two Section III, I am carrying with me the heavy weight of my Recollections from a Visit to his Office in 2004, my experience shadowing Dr. Cambria in the OR @MGH on 1/24/2005. Now I am giving back.
I became aware that both events have impacted favorably my 7/2013, Editorial decision, for a forthcoming book on Cardiovascular Disease in 2013. The Editorial decision is two fold:
the selection and representation of a prominent Vascular Surgery Center in the US, @MGH, and
my personal decision to select a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD @MGH.
The decision to focus on Peripheral Vascular Surgery @MGH as described in Dr. Richard P Cambria’s research had yielded one Sub-Chapter (5.5) in Chapter 5
Chapter 5
Invasive Procedures by Surgery versus Catheterization
in Volume Three in a forthcoming three volume Series of e-Books on Cardiovascular Diseases
This very Sub-Chapter, 5.5, represents milestones in Dr. Cambria as a Vascular Surgeon. His eminent profile as a Vascular Surgery Researcher, is now in:
IV. Cardiovascular Clinical Observational Experience – Aviva Lev-Ari, PhD, RN
Brigham and Women’s Hospital, Boston. MA
Cardiac ICU, Coronary Care Unit, Medical Rounds [100 hours] June 2006-November 2006
Brigham and Women’s Hospital, Boston. MA
CDIC – Cardiovascular Diagnostic and Interventional Center
Angiography & Interventional Radiology [100 hours] March 2006-August 2006
Experience shadowing the daily activities of three Physician Assistants
1. attended consultation appointments with patient candidate for procedures: fibroid embolization
2. patient candidate for intra-vertebral cement injection in fractured vertebrae in spinal column, L-9 – Kyphoplasty vertebral augmentation
3. drainage of bile leakage – biliary duct obstruction
4. attended invasive procedures in the Angiography Lab
5. attended 7:30AM department meeting on all cases scheduled for procedures in the Lab for the day
6. discussed procedure outcomes and patient follow ups with PAs
7. Shadowing PAs and Interventional Radiologists performing angiography.
– VENOUS ACCESS PROCEDURES – TUNNELED CATHETER AND PORT PLACEMENT
– DIALYSIS ACCESS MANAGEMENT – ARTERIOVENOUS FISTULA/GRAFT.
ANGIOGRAMS/ANGIOPLASTIES
Mass General Hospital, Boston
Cardiac Catheterization Lab
Supervisor: Dr. Igor Palacios, Director, Cath Lab
Experience Shadowing in the Cath Lab at MGH
1/19/2005: stenting – MI case, mitral valve opening with balloon
The cerebral hyperperfusion syndrome is a very rare complication after revascularization of the carotid artery and accompanied by postoperative or postinterventional hypertension in almost all patients. We report a case of a 77-year-old man who developed a complete aphasia and increased right-sided weakness following endovascular treatment of severe occlusive disease of the left internal carotid artery. We discuss the risk and management of cerebral hyperperfusion syndrome after carotid artery stenting.
Introduction
Neurological complications following carotid artery stenting (CAS) are usually ischemic in nature, due to embolization or occlusion of the carotid artery. However, in a small subset of patients, cerebral hyperperfusion causes postinterventional neurological dysfunction, characterized by ipsilateral headache, focal seizure activity, focal neurological deficit, and ipsilateral intracerebral edema or hemorrhage. A high clinical suspicion and early diagnosis will allow early initiation of therapy and preventing fatal brain swelling or bleeding in patients with peri- and postinterventional cerebral hyperperfusion syndrome (CHS).
Discussion
In 1981, Sundt et al. [1] described a triad of complications that included atypical migrainous phenomena, transient focal seizure activity, and intracerebral hemorrhage after CEA and used the term cerebral hyperperfusion syndrome (CHS). The first report on CHS after CAS was published by Schoser et al. [2]. They described a 59-year-old woman with ipsilateral putaminal hemorrhage that was diagnosed on the 3rd day after CAS of a high-grade stenosis of the left ICA. Outcome in this case was not fatal. The patient recovered with a mild upper limb paresis. McCabe et al. [3] were the first to report the occurrence of fatal ICH soon after CAS. Only a few hours after the procedure, neurological symptoms occurred without any prodromata (severe headache, nausea, and seizures) postulated by Sundt et al. [1] to be an obligate component of CHS. CT of the brain revealed extensive ICH and the patient died 18 days later. Abou-Chebl et al. [4] reported a retrospective single-center study on 450 patients who had been treated with CAS. Three patients (0.67%) developed ICH after the intervention. Further reports on results and complications after CAS have been published [5]. Nearly all reports on CHS after carotid revascularizations in general and CAS in particular have in common patients who had high-grade stenoses in the treated vessel.
CHS following surgical or endovascular treatment of severe carotid occlusive disease is thought to be the result of impaired cerebral autoregulation, hypertension, ischemia-reperfusion injury, oxygen-derived free radicals, baroreceptor-dysfunction, and intraprocedural ischemia [6]. Chronic cerebral hypoperfusion due to critical stenosis leads to production of vasodilatory substances. Autoregulatory failure results in the cerebral arterioles being maximally dilated over a long period of time, with subsequent loss of their ability to constrict when normal perfusion pressure is restored. The degree of microvascular dysautoregulation is proportional to the duration and severity of ischemia determined by the severity of ipsilateral stenosis and poor collateral flow.
Hypertension plays an important role in the development of CHS. In the absence of cerebral autoregulation, cerebral blood flow is directly dependent on the systemic blood pressure. The restoration of normal blood flow to chronically underperfused brain can result in edema, capillary breakthrough, and perivascular and macroscopic hemorrhages aggravated by peri- and postinterventional hypertension [6, 7]. The risk factors for CHS after CAS are summarized in Table 1.
The classic clinical presentation includes ipsilateral headache, seizures or focal neurological deficit, and ipsilateral intracerebral edema or hemorrhage. The diagnosis can be made readily with color Doppler ultrasound of the carotid artery and especially with transcranial Doppler (TCD) of the middle cerebral artery [9]. An increase in peak blood flow velocity of >100% is predictive of postinterventional hyperperfusion. Diffusion weighted MRI or single photon emission computed tomography (SPECT) could also be performed for diagnosis [10]. Angiography normally shows normal findings.
The prognosis of CHS depends on timely recognition of hyperperfusion and adequate treatment of hypertension before cerebral edema or hemorrhage develops. The prognosis following intracerebral bleeding is very poor, with mortality over 50% and significant morbidity of 80% in the survivors [4, 6]. The prognosis of CHS in patients without cerebral edema or hemorrhage is clearly better especially when they are identified and treated early. The most important aspects in preventing and treating this syndrome are early identification, careful monitoring, and control of blood pressure ideally in a high-dependency unit setting. In our special case, early diagnosis of CHS and immediate intensive medical treatment of blood pressure could prevent devastating cerebral edema or hemorrhage following CAS.
Conclusion
CHS, which is characterized by ipsilateral headache, hypertension, seizures, and focal neurological deficits, is a rare but devastating complication following carotid artery stenting. Hypertension is the most important risk factor. The diagnosis can be confirmed quickly by TCD, DWI, or SPECT. Especially peri- or postinterventional TCD monitoring should be available to identify patients with hyperperfusion who may benefit from intensive blood pressure management ideally in a specialized intensive care unit.
Abbreviations
CAS:
Carotid artery stenting
CCA:
Common carotid artery
CEA:
Carotid endarterectomy
CHS:
Cerebral hyperperfusion syndrome
CT:
Computed tomography
CVR:
Cerebrovascular reactivity
DWI:
Diffusion-weighted imaging
ICA:
Internal carotid artery
ICH:
Intracerebral haemorrhage
MRI:
Magnetic resonance imaging
SPECT:
Single photon emission computed tomography
TCD:
Transcranial Doppler.
REFERENCES
T. M. Sundt Jr., F. W. Sharbrough, and D. G. Piepgras, “Correlation of cerebral blood flow and electroencephalographic changes during carotid endarterectomy. With results of surgery and hemodynamics of cerebral ischemia,” Mayo Clinic Proceedings, vol. 56, no. 9, pp. 533–543, 1981.View at Scopus
B. G. H. Schoser, C. Heesen, B. Eckert, and A. Thie, “Cerebral hyperperfusion injury after percutaneous transluminal angioplasty of extracranial arteries,” Journal of Neurology, vol. 244, no. 2, pp. 101–104, 1997. View at Publisher · View at Google Scholar · View at Scopus
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R. Gupta, A. Abou-Chebl, C. T. Bajzer, H. C. Schumacher, and J. S. Yadav, “Rate, predictors, and consequences of hemodynamic depression after carotid artery stenting,” Journal of the American College of Cardiology, vol. 47, no. 8, pp. 1538–1543, 2006. View at Publisher · View at Google Scholar · View at Scopus
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Y. Kaku, S. I. Yoshimura, and J. Kokuzawa, “Factors predictive of cerebral hyperperfusion after carotid angioplasty and stent placement,” American Journal of Neuroradiology, vol. 25, pp. 1403–1408, 2004.
Patient came to her appointment as part of a standard pre-operative evaluation for removal of a uterine myoma. She had a history of stroke with residual slurred speech, making it difficult to understand her. Accordingly, I assumed I would see some carotid stenosis, but her ultrasound showed a stunning 70-99% stenosis in her right internal carotid artery and full occlusion of her left internal carotid artery.
Flow in the common carotid arteries looked fine. The plaque itself in the internal carotid arteries was relatively hypoechoic and not easily visualized in brightness mode, so bidirectional color flow at the proximal internal carotid arteries was surprising. Adding power Doppler allowed me to conclude that there was presence of flow on the right, though minimal, and absolutely no flow in the left internal carotid artery.
Upon completion of the exam, I called the ER and spoke with the doctor, who asked me to bring Rose to the ER. Unfortunately, due to the location of the right internal carotid artery stenosis in the bony canal and total occlusion of the left internal carotid artery, surgery was not an option for clearing out the carotid plaque, but doctors believed she could continue functioning well with collateral vasculature carrying blood to her brain.
Thankfully, the patient passed her other pre-operative tests, consented to her surgery, and underwent general anesthesia with no complications. An 8-cm malignant mass was removed from her uterus and her prognosis is good.
opinion/26redberg.html. Last accessed Jan 8, 2013.
Part Three:
Cleveland Clinic Reports Equivalence between carotid endarterectomy (CEA) and open-heart surgery (OHS) and carotid artery stenting (CAS) followed by coronary artery bypass graft (CABG) surgery or non-CABG cardiac surgery
Stent first, then heart surgery, for patients with severe carotid/coronary disease
Cleveland, OH – With the absence of randomized, controlled clinical trials to address the optimal management of patients with severe carotid and coronary artery disease, a new retrospective study suggests the best tactic is a staged approach that sees the patient undergo carotid artery stenting (CAS) followed by coronary artery bypass graft (CABG) surgery or non-CABG cardiac surgery [1].
Investigators report that a combined approach that includes carotid endarterectomy (CEA) and open-heart surgery (OHS) is equivalent in terms of short-term outcomes with the staged CAS-OHS procedure. Beyond one year, however, the staged CAS-OHS approach resulted in the lowest risk of all-cause mortality, stroke, and MI when compared with a combined CEA-OHS procedure and staged CEA-OHS.
“The surgeons get very worried about doing operations on these patients because they don’t want to do a beautiful job on the bypass only to have the patient have a stroke,” lead investigator Dr Mehdi Shishehbor(Cleveland Clinic, OH) told heartwire.
Shishehbor said that when patients are undergoing open-heart surgery, whether it’s CABG or valve surgery, they are screened for carotid artery disease, given the heightened risk of stroke when undergoing heart surgery. As a result, various teams from neurology, vascular surgery, and interventional cardiology are called to address the safety of the surgery in the setting of severe carotid disease, said Shishehbor.
“These patients are the sickest of the sick in the sense that they have two conditions that are occurring concomitantly,” he said. “These are not patients who just have carotid disease. There are many patients who have moderate or mild carotid disease who undergo open-heart surgery with no problem. These are people with severe disease, those with more than 80% stenosis in one of their carotid arteries or maybe both. They also have severe coronary artery disease. These are people with left-main or three-vessel disease who are destined to undergo bypass.”
The whole point is to prevent stroke
In the study, published this week in the Journal of the American College Cardiology, the investigators reported data on 350 patients who underwent carotid revascularization and cardiac surgery. These included 45 patients who were treated with a staged CEA-OHS approach (OHS performed a median of 14 days after CEA), 110 who were treated with a staged CAS-OHS procedure (OHS performed a median of 47 days after CEA), and 195 patients treated with a combined CEA-OHS procedure. OHS is defined as CABG, CABG plus other cardiac procedures, or non-CABG cardiac surgery (isolated valve or aortic-repair surgery). In total, just 8% of procedures were non-CABG surgeries.
In a propensity-adjusted analysis analyzed by intention-to-treat, the 30-day risk of death, stroke, and MI was similar between the staged CAS-OHS and combined CEA-OHS procedures. The highest risk of the composite end point was observed in patients who underwent staged CEA-OHS.
At one year and beyond (median follow-up was 3.7 years), the staged CAS-OHS patients had the lowest risk of death, stroke, and MI. Compared with staged CEA-OHS, those treated with CAS-OHS had a 67% lower risk of death, stroke, and MI and a 65% lower risk compared with combined CEA-OHS.
Unadjusted comparison of primary/secondary end points
Event
Staged CEA-OHS,n=45 (%)
Combined CEA-OHS,n=195 (%)
Staged CAS-OHS,n=110 (%)
p
Overall 30-d risk post-OHS
31
10
10
0.003
Death
7
5
6
0.75
Stroke
2
7
2
0.11
MI
24
0.5
3
<0.001
Overall composite risk 1 y and beyond
27
39
12
<0.001
Death
38
39
11
<0.001
Stroke
2.2
1.5
0
0.37
MI
0
3.1
2.7
0.5
“In the long term, stenting [followed by OHS] definitely did better than the combined approach,” said Shishehbor. “What’s also important is that with the combined approach, the reason they didn’t do very well is because they had a higher rate of stroke in the perioperative period. . . . Remember the whole point of doing this is to prevent stroke. This is why we feel the combined approach is a little bit inferior to the staged CAS/open-heart-surgery approach. If you have a 7% risk of stroke in the 30-day perioperative period, that doesn’t appear to be the best option for the majority of patients.”
To heartwire, Shishehbor said that while the patients were well matched, the patients undergoing stenting tended to be sicker. For example, they were more likely to have symptomatic carotid stenosis and were more likely to have undergone a previous carotid revascularization. Shishehbor also said that clinical events occurring between the initial carotid artery revascularization procedure and OHS were included in the analysis. These deaths, strokes, and MIs were identified and accounted for in the data.
In an editorial accompanying the study [2], Drs Ehtisham Mahmud and Ryan Reeves (University of California, San Diego) say the work by the Cleveland Clinic group is strengthened by the propensity-adjusted analysis and long follow-up beyond the perioperative period. Most important, they say the study provides clarity for the management of patients with carotid and coronary disease.
“For patients presenting with an acute coronary syndrome requiring urgent coronary revascularization in whom waiting three to four weeks is not safe, combined CEA-OHS is the optimum revascularization strategy, though associated with higher neurological ischemic events,” write Mahmud and Reeves.
“However, for patients with a stable or an accelerating anginal syndrome who can wait three to four weeks to complete dual antiplatelet therapy [DAPT] after carotid stenting, staged CAS followed by OHS leads to superior early and long-term outcomes.”
Since completing the analysis, Shishehbor said there have been discussions with colleagues in vascular surgery, vascular medicine, cardiac surgery, and cardiology to establish the optimum way to treat patients with severe carotid and coronary disease. “The bottom line is that there will never be a randomized, clinical trial in this setting,” he told heartwire. “I hope there would be, but I doubt it. So I think papers like this are critical because we’re doing these procedures to prevent stroke. It’s important that we pick the right procedure for the right patient.”
Confounded by registry requirements
Shishehbor is also concerned about the scrutiny carotid stenting is under from the Centers for Medicare&Medicaid Services(CMS). Currently, the CMS reimburses procedures for asymptomatic patients only if they are included in one of the industry-funded and -maintained registries. He believes the scrutiny has led to a dwindling number of clinicians with the expertise capable of doing the procedure, and this is concerning, since the present analysis shows there are cohorts of asymptomatic patients who would benefit from the treatment.In addition, to be included in a registry, an asymptomatic patient must receive DAPT with aspirin andclopidogrel for four weeks. If the patient does not meet the DAPT requirements, they can’t be included in the registry. However, Shishehbor said, many of these patients have significant coronary disease and can’t wait four weeks. As a result, they are treated with a combined CEA-OHS approach, an approach that is associated with a higher risk of stroke.
Shishehbor reports serving as a speaker and consultant for Abbot Vascular, Medtronic, and Gore but waives all compensation for his work. Mahmud reports trial support from Boston Scientific and Abbott Vascular. In addition,he consults for Cordis andthe Medicines Companyand serves on the speaker‘s bureau for Medtronic. Disclosures for the coauthors are listed in the paper.
Sources
Shishehbor MH, Venkatachalam S, Sun Z, et al. A direct comparison of early and late outcomes with three approaches to carotid revascularization and open heart surgery. J Am Coll Cardiol 2013; available at: http://content.onlinejacc.org.
Mahmud E, Reeves R. Carotid revascularization prior to open heart surgery: The data driven treatment strategy. J Am Coll Cardiol 2013; available at: http://content.onlinejacc.org.
2013 ACCF/AHA Guideline for the Management of Heart FailureA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
Clyde W. Yancy, MD, MSc, FACC, FAHA; Mariell Jessup, MD, FACC, FAHA; Biykem Bozkurt, MD, PhD, FACC, FAHA; Javed Butler, MBBS, FACC, FAHA; Donald E. Casey, MD, MPH, MBA, FACP, FAHA; Mark H. Drazner, MD, MSc, FACC, FAHA; Gregg C. Fonarow, MD, FACC, FAHA; Stephen A. Geraci, MD, FACC, FAHA, FCCP; Tamara Horwich, MD, FACC; James L. Januzzi, MD, FACC; Maryl R. Johnson, MD, FACC, FAHA; Edward K. Kasper, MD, FACC, FAHA; Wayne C. Levy, MD, FACC; Frederick A. Masoudi, MD, MSPH, FACC, FAHA; Patrick E. McBride, MD, MPH, FACC; John J.V. McMurray, MD, FACC; Judith E. Mitchell, MD, FACC, FAHA; Pamela N. Peterson, MD, MSPH, FACC, FAHA; Barbara Riegel, DNSc, RN, FAHA; Flora Sam, MD, FACC, FAHA; Lynne W. Stevenson, MD, FACC; W.H. Wilson Tang, MD, FACC; Emily J. Tsai, MD, FACC; Bruce L. Wilkoff, MD, FACC, FHRS
We present below four National institutions with pubic mandate to promote all Healthcare aspects of Cardiovascular Diseases.
A. 2020 Vision of the Heart Failure Society of America (HFSA)
Special Communication: The Heart Failure Society of America in 2020: A Vision for the Future
Journal of Cardiac Failure Vol. 18 No. 2 2012 written by BARRY H. GREENBERG, MD,1,3 INDER S. ANAND, MD, PhD,2 JOHN C. BURNETT JR, MD,2,3 JOHN CHIN, MD,2,3 KATHLEEN A. DRACUP, RN, DNSc,3 ARTHUR M. FELDMAN, MD, PhD,3 THOMAS FORCE, MD,2,3 GARY S. FRANCIS, MD,3 STEVEN R. HOUSER, PhD,2 SHARON A. HUNT, MD,2 MARVIN A. KONSTAM, MD,3 JOANN LINDENFELD, MD,2,3 DOUGLAS L. MANN, MD,2,3 MANDEEP R. MEHRA, MD,2,3 SARA C. PAUL, RN, DNP, FNP,2,3 MARIANN R. PIANO, RN, PhD,2 HEATHER J. ROSS, MD,2 HANI N. SABBAH, PhD,2 RANDALL C. STARLING, MD, MPH,2 JAMES E. UDELSON, MD,2 CLYDE W. YANCY, MD, MSc,3 MICHAEL R. ZILE, MD,2 AND BARRY M. MASSIE, MD2,3
From the 1Chair, ad hoc Committee for Strategic Development, Heart Failure Society of America; 2Member of Executive Council, Heart Failure Society of America and 3Member, ad hoc Committee for Strategic Development, Heart Failure Society of America.
They write:
The preceding 2 decades had been marked by unprecedented insights into the underlying pathophysiology of cardiac dysfunction that were paralleled by therapeutic advances that, for the first time, were shown to clearly improve outcomes in heart failure patients. At the same time, heart failure prevalence was rapidly increasing throughout the world because of the aging of the population, improved survival of patients with myocardial infarction and other cardiac conditions, and inadequate treatment of common risk factors such as hypertension.
More recently the Heart Failure Society successfully promoted establishment of Advanced Heart Failure and Transplant Cardiology as an American Board of Internal Medicine recognized secondary subspecialty of cardiology developed a board review course to help physicians prepare for the certification examination for the new subspecialty and created a national heart failure review course.
The Society has Advocacy goals, membership goals – to increase by 10% per year for 3 years from all disciplines of Heart Failure.
Education Goals:
The Heart Failure Society of America will be recognized for its innovative approaches to educating and content dissemination on heart failure targeting
healthcare professionals and patients
Grow and enhance the annual meeting through innovative approaches
Continue board review course
Increase web-based programs for patients and health care providers
Enhance the website as a portal for information dissemination for health care professionals and patients
Grow and enhance the relevance and value of the Journal of Cardiac Failure
Conceptual analysis of projection done by the AHA regarding the increase in the Cost of Care for the the American Patient in Heart Failure were developed in the following two articles:
National Heart, Lung, And Blood Institute Working Group identified the most urgent knowledge gaps in Heart Transplantation Research. These gaps require to address the following 4 specific research directions:
enhanced phenotypic characterization of the pre-transplant population
donor-recipient optimization strategies
individualized immunosuppression therapy, and
investigations of immune and non-immune factors affecting late cardiac allograft outcomes.
D. Donor-Recipient Optimization Strategies – 33,640 Cases in the United Network for Organ Sharing database – Organ Donor’s Age is BEST predictor for survival after Heart Transplant
IF the donor age is in the 0- to 19-year-old group the median survival of 11.4 years follows the Heart Transplant.
The effect of ischemic time on survival after heart transplantation varies by donor age: An analysis of the United Network for Organ Sharing database
The Journal of Thoracic and Cardiovascular Surgery ● February 2007
Mark J. Russo, MD, MS,a,b Jonathan M. Chen, MD,a Robert A. Sorabella, BA,a Timothy P. Martens, MD,a
Mauricio Garrido, MD,a Ryan R. Davies, MD,a Isaac George, MD,a Faisal H. Cheema, MD,a Ralph S. Mosca, MD,a Seema Mital, MD,c Deborah D. Ascheim, MD,b,d Michael Argenziano, MD,a Allan S. Stewart, MD,a Mehmet C. Oz, MD,a and Yoshifumi Naka, MD, PhDa
Objectives:
(1) To examine the interaction of donor age with ischemic time and their effect on survival and
(2) to define ranges of ischemic time associated with differences in survival.
Methods: The United Network for Organ Sharing provided de-identified patientlevel data. The study population included 33,640 recipients undergoing heart transplantation between October 1, 1987, and December 31, 2004. Recipients were divided by donor age into terciles: 0 to 19 years (n 10,814; 32.1%), 20 to 33 years (11,410, 33.9%), and 34 years or more (11,416, 33.9%). Kaplan-Meier survival functions and Cox regression were used for time-to-event analysis. Receiver operating characteristic curves and stratum-specific likelihood ratios were generated to compare 5-year survival at various thresholds for ischemic time.
Results: In univariate Cox proportional hazards regression, the effect of ischemic time on survival varied by donor age tercile: 0 to 19 years (P .141), 20 to 33 years (P .001), and 34 years or more (P .001). These relationships persisted in multivariable regression. Threshold analysis generated a single stratum (0.37-12.00 hours) in the 0- to 19-year-old group with a median survival of 11.4 years. However, in the 20- to 33-year-old-group, 3 strata were generated: 0.00 to 3.49 hours (limited), 3.50 to 6.24 hours (prolonged), and 6.25 hours or more (extended), with median survivals of 10.6, 9.9, and 7.3 years, respectively. Likewise, 3 strata were generated in the group aged 34 years or more: 0.00 to 3.49 (limited), 3.50 to 5.49 (prolonged), and 5.50 or more (extended), with median survivals of 9.1, 8.5, and 6.3 years, respectively.
Conclusions: The effect of ischemic time on survival after heart transplantation is dependent on donor age, with greater tolerance for prolonged ischemic times among grafts from younger donors. Both donor age and anticipated ischemic time must be considered when assessing a potential donor.
Procedures Outcomes of Heart Transplant (HT) Indication for Heart Failure (HF)
Center for Heart Failure @Cleveland Clinic, and
Transplant Center @Mayo Clinic
Center for Heart Failure @Cleveland Clinic: Institution Profile
Heart failure (sometimes called congestive heart failure or ventricular dysfunction) means your heart muscle is not functioning as well as it should. Either the left ventricle (lower chamber of the heart) is not contracting with enough force (systolic heart failure), or the ventricles are stiff and do not relax and fill properly (diastolic heart failure). The treatment of heart failure requires a specialized multidisciplinary approach to manage the overall patient care plan.
The George M and Linda H Kaufman Center for Heart Failure is one of the premier facilities in the United States for the care of people with heart failure.
The Kaufman Center Heart Failure Intensive Care was the recipient of the Beacon Award of Excellence for continuing improvements in providing the highest quality of care for patients. With over 6,000 ICUs in the Unites States, the Center joins a distinguished group of just 300 to receive this honor that recognizes the highest level of standards in patient safety and quality in acute and critical care.
In 2011, Cleveland Clinic received the American Heart Association’s Get With The Guidelines Heart Failure GOLD Plus Certification for improving the quality of care for heart failure patients. Gold Plus distinction recognizes hospitals for their success in using Get With The Guidelines treatment interventions. This quality improvement program provides tools that follow proven, evidence-based guidelines and procedures in caring for heart failure patients to prevent future hospitalizations.
The Kaufman Center for Heart Failure Team brings together clinicians that specialize in cardiomyopathies and ischemic heart failure. The team includes physicians and nurses from Cardiovascular Medicine, Cardiothoracic Surgery, Radiology, Infectious Disease, Immunology, Pathology, Pharmacy, Biothetics and Social Work with expertise in diagnostic testing, medical and lifestyle management, surgical procedures, and psychosocial support for patients with:
Patients at Cleveland Clinic Kaufman Center for Heart Failure have available to them the full array of diagnostic testing, treatments and specialized programs.
Outcomes of Heart Failure and Heart Transplant @Cleveland Clinic
1,570 Number of heart transplants performed at Cleveland Clinic since inception of the Cardiac Transplant Program in 1984.
The survival rates among patients who have heart transplants at Cleveland Clinic exceeds the expected rates. Of the 150 transplant centers in the United States, Cleveland Clinic is one of only three that had better-than-expected one-year survival rates in 2011.
Ventricular Assist Device Volume 2007 – 2011
2007 – N = 23
2008 – N = 48
2009 – N = 76
2010 – N = 51
2011 – N = 56
Mechanical circulatory support (MCS) devices are used in patients with heart failure to preserve heart function until transplantation (bridge-to-transplant) or as a final treatment option (destination therapy). Cleveland Clinic has more than 20 years of experience with MCS devices for both types of therapy.
LVAD In-Hospital Mortality 2007 – 2011
Cleveland Clinic continues to make improvements to reduce mortality rates among patients who are placed on mechanical circulatory support. The mortality rate among patients who have a left ventricular assist device (LVAD) has been drastically reduced over the past five years.5% in 2011
VAD Mortality 2011
The mortality rate among Cleveland Clinic patients placed on ventricular assist devices (VADs) was much lower than expected in 2011. Observed 10%, Expected 17.5%
Heart Failure – National Hospital Quality Measures
This composite metric, based on four heart failure hospital quality process measures developed by the Centers for Medicare and Medicaid Services (CMS), shows the percentage of patients who received all the recommended care for which they were eligible. Cleveland Clinic has set a target of UHC’s 90th percentile.
Cleveland Clinic, 2010 (N = 1,194) 93.9%
Cleveland Clinic, 2011 (N = 1,163) 96.9%
UHC Top Decile, 2011 99.2%
SOURCE
University HealthSystem Consortium (UHC) Comparative Database, January through November 2011 discharges.
The Centers for Medicare and Medicaid Services (CMS) calculates two heart failure outcome measures: all-cause mortality and all-cause readmission rates, each based on Medicare claims and enrollment information. Cleveland Clinic’s performance appears below.
Heart Failure All-Cause 30-Day Mortality (N = 762) July 2008 – June 2011
Cleveland Clinic 9.2%
National Average 11.6%
Heart Failure All-Cause 30-Day Readmission (N = 1,029) July 2008 – June 2011
Cleveland Clinic 27.3%
National Average 24.7%
SOURCE:
hospitalcompare.hhs.gov
Cleveland Clinic’s heart failure risk-adjusted 30-day mortality rate is below the national average; the difference is statistically significant. Our heart failure risk-adjusted readmission rate is higher than the national average; that difference is also statistically significant. To further reduce this rate, a multidisciplinary team was tasked with improving transitions from hospital to home or post-acute care facility. Specific initiatives have been implemented in each of these focus areas: communication, education and follow-up.
In 2011, 51% of lung transplant patients were from outside the state of Ohio.
Cleveland Clinic surgeons transplanted 111 lungs in 2011. Our Lung and Heart-Lung Transplant
Program is the leader in Ohio and among the best programs in the country.
July 2010 – June 2011
160 Performed in 2009
Liver-Lung
Heart-Lung
Double Lung
Single Lung
53.5% Idiopathic
Primary Disease of Lung Transplant Recipients (N = 101)
Source: Scientific Registry of Transplant Recipients. March 2011. Ohio, Lung Centers, Cleveland Clinic. Table 7
Cleveland Clinic surgeons transplanted 111 lungs in 2011. Our Lung and Heart-Lung Transplant Program is the leader in Ohio and among the best programs in the country.
Transplant Center @Mayo Clinic: Heart Transplant Procedures Outcomes
Mayo Clinic History
Dr. W.W. Mayo
Drs. William (left) and Charles Mayo
Mayo Clinic developed gradually from the medical practice of a pioneer doctor, Dr. William Worrall Mayo, who settled in Rochester, Minn., in 1863. His dedication to medicine became a family tradition when his sons, Drs. William James Mayo and Charles Horace Mayo, joined his practice in 1883 and 1888, respectively.
From the beginning, innovation was their standard and they shared a pioneering zeal for medicine. As the demand for their services increased, they asked other doctors and basic science researchers to join them in the world’s first private integrated group practice.
Although the Mayo doctors were initially viewed as unconventional for practicing medicine through this teamwork approach, the benefits of a private group practice were undeniable.
As the success of their method of practice became evident, so did its acceptance. Patients discovered the advantages to a “pooled resource” of knowledge and skills among doctors. In fact, the group practice concept that the Mayo family originated has influenced the structure and function of medical practice throughout the world.
Along with its recognition as a model for integrated group practice, “the Mayos’ Clinic” developed a reputation for excellence in individual patient care. Doctors and students came from around the world to learn new techniques from the Mayo doctors, and patients came from around the world for diagnosis and treatment. What attracted them was not only technologically advanced medicine, but also the caring attitude of the doctors.
Through the years, Mayo Clinic has nurtured and developed its founders’ style of working together as a team. Shared responsibility and consensus still provide the framework for decision making at Mayo.
That teamwork in medicine is carried out today by more than 55,000 doctors, nurses, scientists, students and allied health staff at Mayo Clinic locations in the Midwest, Arizona and Florida.
Alternative Solutions to Treatment of Heart Failure
Mayo Clinic, with transplant services in Arizona, Florida and Minnesota, performs more transplants than any other medical center in the world. Mayo Clinic has pre-eminent adult and pediatric transplant programs, offering cardiac, liver, kidney, pancreas and bone marrow transplant services. Since performing the first clinical transplant in 1963, Mayo’s efforts to continually improve and expand organ transplantation have placed Mayo at the leading edge of clinical and basic transplant research worldwide. Research activities in the Transplant Center at Mayo Clinic have contributed significantly to the current successful outcomes of organ transplantation.
People who survive a heart attack face the greatest risk of dying from sudden cardiac death (SCD) during the first month after leaving the hospital, according to a long-term community study by Mayo Clinic researchers of nearly 3,000 heart attack survivors.
Sudden cardiac death can happen when the hearts electrical system malfunctions; if treatment — cardiopulmonary resuscitation and defibrillation — does not happen fast, a person dies.
After that first month, the risk of sudden cardiac death drops significantly — but rises again if a person experiences signs of heart failure. The research results appear in the Nov. 5 edition of Journal of the American Medical Association.
Veronique Roger, M.D., a Mayo Clinic cardiologist provides an overview of the study and it’s findings.
For more information on heart attacks, click on the following link:http://www.mayoclinic.org/heart-attack/
VIEW VIDEOon Mayo Clinic Regenerative Medicine Consult Service – Stem Cell Transplantation post MI
In a proof-of-concept study, Mayo Clinic investigators have demonstrated that induced pluripotent stem (iPS) cells can be used to treat heart disease. iPS cells are stem cells converted from adult cells. In this study, the researchers reprogrammed ordinary fibroblasts, cells that contribute to scars such as those resulting from a heart attack, converting them into stem cells that fix heart damage caused by infarction. The findings appear in the current online issue of the journal Circulation.
Timothy Nelson, M.D., Ph.D., first author on the Mayo Clinic study, talks about the study and it’s findings.
Heart Transplant: Volumes and success measures Transplant Center@ Mayo Clinic
Mayo Clinic doctors’ experience and integrated team approach results in transplant outcomes that compare favorably with national averages. Teams work with transplant recipients before, during and after surgery to ensure the greatest likelihood of superior results.
Volumes and statistics are maintained separately for the three Mayo Clinic locations. Taken together or separately, transplant recipients at Mayo Clinic enjoy excellent results.
Volumes
Arizona
More than 100 heart transplants have been completed since the program began in 2005.
Florida
Surgeons at Mayo Clinic in Florida have performed more than 167 heart transplants and eight heart-lung transplants since the program began in 2001. Mayo surgeons have performed combined transplants, such as heart-kidney and heart-lung-liver transplants.
Minnesota
Mayo Clinic’s outcomes for heart transplantation compare favorably with national norms. Doctors at Mayo Clinic in Minnesota have transplanted more than 450 adult and pediatric patients, including both isolated heart transplants and combined transplants such as heart-liver, heart-kidney and others.
The Center for Heart Failure @Cleveland Clinic’s, and the Transplant Center @Mayo Clinic’s Institutions Profiles, Procedures Outcomes and Selection of their Research are now in:
Article ID #65: Becoming a Cardiothoracic Surgeon: An Emerging Profile in the Surgery Theater and through Scientific Publications. Published on 7/8/2013
WordCloud Image Produced by Adam Tubman
Two components of an Emerging Profile of a Young Cardiothoracic Surgeon were researched by the Author for the case of Dr. Isaac George, Assistant Professor of Surgery, Division of Cardiothoracic Surgery, Department of Surgery, New York Presbyterian Hospital/Columbia University Medical Center , New York, NY.
The two components being:
1. the Cardiothoracic Surgery Theater
2. the Scientific Publications
I noted with interest Dr. George’s second publication, to be about a very well known surgeon in the US and Europe, John Benjamin Murphy. written by Dr. George and two other colleagues, George I, Hardy MA, Widmann WD. published in Curr Surg. 2004 Sep-Oct;61(5):439-41.
I assume that Dr. Murphy’s contributions to Thoracic surgery were of interest to Dr. George to inspire him to write on the subject and elect that Specialty in Surgery.
Murphy was first in the U.S. to induce (1898) artificial immobilization and collapse of the lung in treatment of pulmonary tuberculosis. He was a pioneer in the use of bone grafting and made contributions to the understanding and management of ankylosis as well as independently proposing artificial pneumothorax to manage unilateral lung disease in tuberculosis.
«It is the purpose of every man’s life to do something worthy of the recognition and appreciation of his fellow men. . . . By their superior intellectual qualifications, their fidelity to purpose and above all their indefatigable labour the few become leaders.»
SOURCEWhonamedit? A dictionary of medical eponyms, John Benjamin Murphy
I came across Dr. Isaac George’s name while researching clinical indications for Inhaled Nitric Oxide in June 2013, upon the recent publication of Leaders in Pharmaceutical Business Intelligence FIRST e-Book on Amazon (Biomed e-Books) [Kindle Edition]
Being myself in Analytics and quantitative model design, 1976-2004, I found of particular interest the range of quantitative methodologies used in the following article by Isaac George, assuming that his days at MIT, came very handy in 2006:
George, Isaac, Xydas, Steve, Topkara, Veli K., Ferdinando, Corrina, Barnwell, Eileen C., Gableman, Larissa, Sladen, Robert N., Naka, Yoshifumi, Oz, Mehmet C. Clinical Indication for Use and Outcomes After Inhaled Nitric Oxide Therapy Ann Thorac Surg 2006 82: 2161-2169
As a result of studying this article, I became aware that it has impacted favorably my 6/2013, Editorial decision, for a forthcoming book on Cardiovascular Disease in 2013. The Editorial decision regarding the selection and representation of prominent Cardiothoracic Surgery Theater in the US, and my personal decision to select a Young Cardiothoracic Surgeon
Dr. Isaac George, Assistant Professor of Surgery, Division of Cardiothoracic Surgery, Department of Surgery, New York Presbyterian Hospital/Columbia University Medical Center, New York, NY
Education Profile and Medical Training of a Cardiac Surgeon
NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY
2012-present
Assistant Professor of Surgery
Division of Cardiothoracic Surgery, Department of Surgery, New York Presbyterian Hospital/Columbia University Medical Center , New York, NY
Clinical Specialties
Adult aortic and mitral valve surgery
Transcatheter aortic and mitral valve implantation
Hybrid coronary artery bypass surgery
Complex aortic surgery
Complex valvular surgery
Heart failure and transplant surgery
Reoperative cardiac surgery
Thoracic aortic endograft implantation
1. Regulation of myostatin signaling in human cardiomyopathy
2. TGFB regulation in non-syndromic aortic aneurysm formation
3. Valve interstitial cell activation mechanisms after surgical and transcatheter valve replacement
4. Clinical outcomes after valve and hybrid surgery
Education and Training
2011-2012
Interventional Cardiology/Hybrid Cardiac Surgery Fellowship
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
2011
Ventricular Assist Device/Cardiac Transplant Fellowship, Minimally Invasive, Cardiac Surgery
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
2009-2011
Fellow, Cardiothoracic Surgery
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
2008-2009
Post-Doctoral Clinical Fellow, Cardiothoracic Surgery
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
2006-2008
Resident, General Surgery
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
2004-2006
Research Fellow, Cardiothoracic Surgery
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
2002-2004
Resident, General Surgery
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
2001-2002
Internship, General Surgery
New York Presbyterian Hospital – Columbia University Medical Center, New York, NY
1997-2001
MD, Medicine
Duke University School of Medicine, Durham, NC
1993-1997
BS, Mechanical Engineering
Massachusetts Institute of Technology, Cambridge, MA
Board Certifications
American Board of Thoracic Surgery, 2012-
American Board of Surgery, 2008-
Certification, Pediatric Advanced Life Support, 2008-
Certification, Advanced Trauma Life Support, 2006-
MD, State of New York, 2005-
Certification, Advanced Cardiac Life Support/Basic Life Support, 2001-
United States Medical Licensing Examination Step 3, 2004
United States Medical Licensing Examination Step 2, 2001
United States Medical Licensing Examination Step 1, 2000
Professional Honors
2008 Blakemore Prize – Best Resident Research Award, Columbia University College of Physicians and Surgeons
2007 Blakemore Award – Best Resident Research Award, Columbia University College of Physicians and Surgeons
2006 Blakemore Award – Best Resident Research Award, Columbia University College of Physicians and Surgeons
2004 New Era Cardiac Surgery Conference Scholarship
1995 Pi Tau Sigma, Mechanical Engineering Honor Society
1993 Duke University Comprehensive Cancer Center Fellowship
The decision to focus on Cardiothoracic Surgery @Presbeterian as described in Dr. Isaac George’s research had yielded one Sub-Chapter (4.1) in Chapter 4
Cardiac Surgery, Cardiothoracic Surgical Procedures and Percutaneous Coronary Intervention (PCI)/Coronary Angioplasty – Heart and Cardiovascular Medical Devices in Use in Operating Rooms and in Catheterization Labs in the US
in Volume Three in a forthcoming three volume Series of e-Books on Cardiovascular Diseases
This very Sub-Chapter represents milestones in Dr. Isaac George – Becoming a Cardiothoracic Surgeon: An Emerging Profile through Scientific Publications, This profile is now in:
VIEW VIDEOon Mitral Valve Repair and Replacement – Dr. Karl H. Krieger
Dr. Karl H. Krieger, the Vice Chairman of the Department of Cardiothoracic Surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City, discusses treatment for Mitral Valve Disease. Specifically, Dr. Krieger compares the options of Mitral Valve Repair with Mitral Valve Replacement.
This video with Dr. Krieger is from a web cast at the Ronald O. Perelman Heart Institute at NewYork-Presbyterian.
VIEW VIDEOon Left Ventricular Assist Devices (LVADs) – Dr. Jonathan Chen
Dr. Jonathan Chen, the Site Chief for Pediatric Cardiac Surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City, explains how Left Ventricular Assist Devices (LVADs) work and how they can benefit patients with heart failure.
LVADs are implantable devices that help the heart pump blood. They can be used as a temporary therapy, allowing patients’ hearts to rest while they recover from cardiac events such as heart attacks, or while they wait for hearts to become available for transplants. For some patients whose hearts are unlikely to recover and are not candidates for heart transplants, the devices may be used as a permanent therapy. Heart failure, especially in severe forms, can force patients to lead restricted lives because often even very limited physical activity, such as walking from one room to another, will leave them breathless.
Dr. Chen is a pediatric cardiothoracic surgeon, yet the information in the video is applicable to adult patients as well.
Organ transplantation that prolongs and dramatically improves quality of life is nearly a daily occurrence at Columbia University Medical Center.
The success of solid organ transplantation – with improved surgical techniques, replacement organ procurement, and medical management – is advancing each year. Many of these advances have resulted from scientific and clinical research conducted at Columbia University Medical Center.
A Brief History of Transplantation at Columbia
Transplantation: Where we’ve been, where we’re going
Eric A. Rose, MD, former chairman of the department of surgery, left center, performing the first successful pediatric heart transplant in 1984. Transplant pioneer Keith Reemtsma, MD, who is overseeing the operating field (top of photo).
When he transplanted a chimpanzee kidney into a human patient in the late 1960’s, the late Keith Reemtsma, MD, then Department of Surgery Chairman at Tulane University, revolutionized treatment of end-stage organ failure and initiated an era of unprecedented exploration into organ transplantation that would affect the lives of patients around the world.
Transferring to Columbia-Presbyterian Medical Center in 1971, Dr. Reemtsma recruited Mark A. Hardy, MD, who laid another cornerstone of organ transplant medicine by founding the program for dialysis and kidney transplantation. Dr. Hardy based the new program on the principle of collaborative clinical care between surgeons and nephrologists. During a time when renal transplant programs were managed by one or the other discipline but never by both simultaneously, the medical community regarded the concept as folly. Yet the program grew steadily, as did the program’s immune tolerance research initiatives to induce the transplant recipient’s body to accept a donor organ. This multidisciplinary cooperation also led to major contributions in immunogenetics, immunosuppression, and treatment of autoimmune diseases and lymphoma — and it ultimately became the overarching principle for all the NewYork-Presbyterian Hospital transplant services.
Colleagues universally give credit to Eric A. Rose, MD, who co-founded the heart transplantation program with Dr. Reemtsma, for his successful transformation of the program into the outstanding center it is today. A parade of achievements marks the history of the heart transplant program, including the first mechanical bridge-totransplantation using intra-aortic balloon pumps in the 1970’s, and the first successful pediatric heart transplant, performed by Dr. Rose in 1984. Under the guidance of Dr. Rose and his successors, the program has pioneered research in immunosuppressant medications, mechanical assist devices, and minimally invasive surgical procedures. It currently performs over 100 heart transplants yearly, with among the highest success rates in the nation.
Also in 2004, Lloyd E. Ratner, MD, succeeded Dr. Hardy as director of the renal and pancreas transplant program. One of the first to perform laparoscopic donor operations, Dr. Ratner has found creative solutions to overcome immune barriers to kidney transplantation. The program now routinely uses extended-criteria donor organs, performs transplants among incompatible donors, and is a leader in coordinating “donor swaps” to maximize availability of compatible donor organs. Since Dr. Ratner’s arrival, Columbia has been designated one of ten regional islet resource centers in the U.S. that isolate and transplant pancreatic cells to treat type 1 diabetes as part of a limited protocol controlled by the FDA. Recent progress in visualization of pancreatic islets using PET technology, under the guidance of Paul Harris, PhD, has been recognized by the scientific community as a milestone in this developing field.
NYPH/Columbia received UNOS approval for pancreatic transplantation in January 2008. Our premier kidney transplant program is facilitating rapid growth of the new pancreatic transplantation program, which overlaps both in its patient population and its surgical and medical expertise. The northeast region of the U.S. has been consistently underserved as far as access to pancreatic transplantation, with relatively few centers serving a disproportionately large metropolitan population. The expanding program at NewYork-Presbyterian now provides much-needed access to patients with end-stage pancreatic disease in New York state, particularly those with the most complex medical and surgical challenges.
Transplantation of cells, rather than organs, is emerging as a therapy with enormous potential. Transplantation of either a patient’s own or a foreign donor’s bone marrow cells, for example, offers hope of regenerating the heart so that patients with heart failure may be able to avoid heart transplantation.
In introducing the transplantation programs, it would be remiss to neglect mention of the yet another dimension in which they excel — education. Physician training is a top priority, and NYPH/Columbia has trained many of the greatest transplant surgeons over the last 20 years, including many of the leaders of transplant programs throughout the U.S.
At NewYork-Presbyterian Hospital/Columbia University Medical Center, the Transplant Initiative (TI) has been launched to drive the growth of both clinical and research aspects of transplantation. This multi-year undertaking will involve Departments of Medicine, Pathology, Pediatrics, and Surgery and all of the solid organ transplantation programs, both adult and pediatrics. It is led by its Executive Director, Jean C. Emond, MD.
Although NYP/Columbia is already a national leader in clinical transplantation with respect to volume and patient outcomes, this initiative will further leverage the diverse expertise of its transplant scientists and clinicians.
Approximately 2,200 heart transplants are now performed each year in more than 150 heart transplant centers in the United States. The surgeons and cardiologists of Columbia University Medical Center of NYPH have a long and distinguished history of advancing “standards of care” and the survival rates of our patients by using innovative surgical techniques, by applying our basic scientific research in immunosuppression to the clinical setting, and by inventing and perfecting life-sustaining cardiac assist devices that prolong life while waiting for organ availability.
Columbia University Medical Center’s lung and heart-lung transplantation program, which began in 1985, is fast approaching its 200th transplant. Performing more than 30 transplants each year, the lung and heart-lung transplant teams have earned a national reputation for excellence. Our world-renowned transplantation researchers have helped lead the way to improvements in care that, nationwide, have increased the long-term survival rate for lung transplantation by 50% over the past seven years. Among those improvements are new immunosuppressive agents, new antibiotics, refined surgical techniques, and a more comprehensive understanding of follow-up care.
It is the combination of basic research at the molecular cardiology level, biomaterial, surgical procedures and PUBLICATION of Cases and research results that found me in Dr. George’s territory as a renewed inspiration.
For Author’s training & experience @ MGH – Cardiac Floor – Ellison 11, BWH – CCU, Tower 3 – 12Fl, BIDMC – Acute Surgery, Farr 9, and Texas Heart Institute, Perfusion, Faulkner Hospital – ICU
Russo MJ, Chen JM, Sorabella RA, Martens TP, Garrido M, Davies RR, George I, Cheema FH, Mosca RS, Mital S, Ascheim DD, Argenziano M, Stewart AS, Oz MC, Naka Y.
Heart Failure and Dietary Sodium: Do we know as much as we think?
Samar Sheth,1 Alan B. Weder2 and Scott L. Hummel2,3; 1. Department of Internal Medicine, University of Michigan; 2. Division of Cardiovascular Medicine, Department of Medicine, University of Michigan Medical School; 3. Staff Cardiologist, Department of Veterans Affairs Medical Center, Ann Arbor, Michigan
Depolarisation Reserve: A New Identification Concept of Responders to Biventricular Stimulation.
Philippe Chevalier and Alina Scridon; Centre de Référence des Troubles du Rythme Cardiaque Héréditaires, Hôpital Cardiologique Louis Pradel, Bron Cedex
Treatment Strategies – Cardiology is a print (on request) and online eBook publication that provides its readership with a collection of comprehensive and thought-provoking articles from the most respected key opinion leaders, leading doctors and authorities in the cardiology field. The series informs and educates clinicians on the latest therapeutic and technological advances. Published in line with the foremost cardiology congresses, the editorial content includes an unbiased, independent inbound supplement reviewing either the ESC or ACC congress. The review is dedicated to bringing readers the latest cardiology breaking news, exhibition highlights, awards and prizes and research developments from the key-note presentations at the congress.
Treatment Strategies – Cardiology (European and US edition) is available online as a free-to-view eBook providing its readers with an exciting interactive experience. Easily accessible, user friendly and free-to-print, the eBook can provide you with a wide range of dynamic features, including links to external websites, newsletters and email addresses to direct readers to your specialist products and services forming strong links with media partnerships. Importantly, an eBook can be sent out to clients worldwide in an organised and professional layout that allows a far-reaching distribution of your products. The eBook also offers you the opportunity to include, on any page, videos and podcasts of current events such as symposium proceedings that you may wish to highlight for the readership. The latest eBook also permits the advertiser to track statistical data for each page and publication; including the number of unique visits, click though pages, geographical location of the visitor and average time spent viewing.
Advisory Panel
Treatment Strategies – Cardiology is shaped by an advisory panel of world-renowned specialists from the leading associations and societies, including experts from:
Nicholas Antony Boon, Consultant Cardiologist, Royal Infirmary of Edinburgh, Honorary Reader, University of Edinburgh and former President of the British Cardiovascular Society (BCS)
Carl J. Pepine, Professor of Medicine, Division of Cardiovascular Medicine, University of Florida; Past-President, American College of Cardiology (ACC)
Bertram Pitt, University of Michigan Medical Center, William Beaumont Hospital, Ann Arbor, Michigan; President of the Michigan Chapter of American College of Cardiology, Chairman, Young Investigator’s Award Committee of the American College of Cardiology, Chairman of the Reveal Committee of the ACC
Treatment Strategies – CardiologyVolume 5 Issue 1 will include an unbiased, independent inbound supplement reviewing the ACC Congress, taking place in San Francisco in March. The inbound supplement will present the readers with the latest news, exhibition highlights, awards and prizes and research developments from the key-note presentations from the ACC. The publication will be published in April 2013.
European Edition
Treatment Strategies – Cardiology Volume 5 Issue 2will include an independently written review of the ESC congress taking place in Amsterdam in August. The review is dedicated to bringing readers the latest cardiology news, exhibition highlights, awards and prizes and research developments from the key-note presentations at the congress. Please click on the image (below) to view the media pack as an eBook. Volume 5 Issue 2 will be published in September 2013.
“When heart failure (HF) progresses to an advanced stage, difficult decisions must be made,” the AHA says on its website. “Do I want to receive aggressive treatment? Is quality of life more important than living as long as possible? How do I feel about resuscitation?”
LVADs can take over the pumping function of a failing heart, but they also present some of the most expensive implantable-device surgeries. An article in the peer-reviewed journal JACC: Heart Failure reported last year that the average total cost to implant an LVAD in Medicare beneficiaries was $175,000, more than double the cost of a heart transplant.
Amador said between 5,000 and 5,500 Americans will have LVAD implants this year. That compares with 2,200 adult heart transplants that happen annually in the U.S., according to the JACC article.
For patients with advanced heart failure, outcomes are good after heart transplantation, but not enough donor hearts are available. Fortunately, mechanical circulatory assist devices have become an excellent option and should be considered either as a bridge to transplantation or as “destination therapy.” Current mechanical circulatory assist devices improve quality of life in patients who are candidates.
For some patients, conventional treatments are inadequate to relieve the effects of heart failure. Under these circumstances, mechanical circulatory support is considered. There are now a variety of devices capable of pumping blood to restore circulation of vital organs, even temporarily replacing the function of the native heart.
The ABIOMED AB5000™ Circulatory Support System is a short-term mechanical system that can provide left, right, or biventricular support for patients whose hearts have failed but have the potential for recovery. The AB5000™ can be used to support the heart, giving it time to rest – and potentially recover native heart function. The device can also be used as a bridge to definitive therapy.
What is Acute Heart Failure? (Photo credit: Novartis AG)
English: The CardioWest™ temporary Total Artificial Heart (Photo credit: Wikipedia)
English: Graph showing the correlation between BNP serum level and mortality. Source: Inder S. Anand, Lloyd D. Fisher, Yann-Tong Chiang, Roberto Latini, Serge Masson,Aldo P. Maggioni, Robert D. Glazer, Gianni Tognoni, Jay N. Cohn (24th Feb 2003). Changes in Brain Natriuretic Peptide and Norepinephrine Over Time and Mortality and Morbidity in the Valsartan Heart Failure Trial (Val-HeFT). Circulation 107: 1278-83. DOI: 10.1161/01.CIR.0000054164.99881.00 (Photo credit: Wikipedia)
BACKGROUND: We retrospectively analyzed the potential of sirolimus as a primary immunosuppressant
in the long-term attenuation of cardiac allograft vasculopathy progression and
the effects on cardiac-related morbidity and mortality.
METHODS: Forty-five cardiac transplant recipients were converted to sirolimus 1.2 years (0.2, 4.0) after transplantation with complete calcineurin inhibitor withdrawal. Fifty-eight control subjects 2.0 years (0.2, 6.5 years) from transplantation were maintained on calcineurin inhibitors.
Age,
sex,
ejection fraction, and
time from transplantation to baseline intravascular ultrasound study were not different (P>0.2 for all) between the groups;
neither were secondary immunosuppressants and
use of steroids.
Three-dimensional intravascular ultrasound studies were performed at baseline and 3.1 years (1.3, 4.6 years) later.
RESULTS: Plaque index progression (plaque volume/vessel volume) was attenuated in the sirolimus group (0.7±10.5% versus 9.3±10.8%; P=0.0003) owing to
reduced plaque volume in patients converted to sirolimus early (<2 years) after transplantation (P=0.05) and
improved positive vascular remodeling (P=0.01) in patients analyzed late (>2 years) after transplantation.
Outcome analysis in 160 consecutive patients maintained on 1 therapy was performed regardless of performance of intravascular ultrasound examinations.
Five-year survival was improved with sirolimus (97.4±1.8% versus 81.8±4.9%; P=0.006),
There was freedom from cardiac-related events (93.6±3.2% versus 76.9±5.5%; P=0.002).
CONCLUSIONS: Substituting calcineurin inhibitor with sirolimus as primary immunosuppressant
attenuates long-term cardiac allograft vasculopathy progression and
may improve long-term allograft survival owing to favorable coronary remodeling.
Because of the lack of randomization and retrospective nature of our analysis, the differences in outcome should be interpreted cautiously, and prospective clinical trials are required.
Other related articles published on this Open Access Online Scientific Journal include the following:
Svelte Drug-Eluting Stent Utilizing New Class of Bioabsorbable Drug Coating Attains 0% Clinically-Driven Events Through 12-Months in First-In-Man Study
The medulla, located in the brainstem above the spinal cord, is the primary site in the brain for regulating sympathetic and parasympathetic (vagal) outflow to the heart and blood vessels. The nucleus tractus solitarius (NTS) of the medulla receives sensory input from different systemic and central receptors (e.g., baroreceptors and chemoreceptors).
The heart is innervated by vagal and sympathetic fibers. The right vagus nerve primarily innervates the SA node, whereas the left vagus innervates the AV node; however, there can be significant overlap in the anatomical distribution. Atrial muscle is also innervated by vagal efferents, whereas the ventricular myocardium is only sparsely innervated by vagal efferents. Sympathetic efferent nerves are present throughout the atria (especially in the SA node) and ventricles, including the conduction system of the heart.
Cardiac function is altered by neural activation. Sympathetic stimulation increases heart rate (positive chronotropy), inotropy and conduction velocity (positive dromotropy), whereas parasympathetic stimulation of the heart has opposite effects. Sympathetic and parasympathetic effects on heart function are mediated by beta-adrenoceptors and muscarinic receptors, respectively.
The overall effect of sympathetic activation is to increase cardiac output, systemic vascular resistance (both arteries and veins), and arterial blood pressure. Enhanced sympathetic activity is particularly important during exercise, emotional stress, and during hemorrhagic shock.
The actions of autonomic nerves are mediated by the release of neurotransmitters that bind to specific cardiac receptors and vascular receptors. These receptors are coupled to signal transduction pathways that evoke changes in cellular function.
By Richard N. Fogoros, M.D., About.com Guide Updated November 18, 2011
The most common form of ablation is done during a specialized form of cardiac catheterization, performed by a type of doctor known as a cardiac electrophysiologist (heart rhythm specialist). These procedures are sometimes called “trans-catheter ablations.”
During trans-catheter ablation procedures, specialized electrode catheters are positioned inside the heart, and the cardiac electrical system is mapped, showing the abnormal electrical pathways that are often responsible for producing the rapid heart rate. If these abnormal pathways are identified, the tip of the catheter (a tube) is placed on the abnormal pathway and the pathway is ablated (eliminated). The ablation itself is accomplished by transmitting some form of energy through the catheter (heat energy, freezing energy, or microwave energy), in order to damage the tissue at the tip of the catheter.
Decreased postoperative atrial fibrillation following cardiac transplantation: the significance of autonomic denervation.
BACKGROUND: Endocardial ablation approaches have been proposed to targeting the retroatrial cardiac ganglia to treat atrial fibrillation (AF) . The potential value using this approach is unknown. Disruption of the autonomic inputs with orthotropic heart transplant (OHT) provides a unique opportunity to study the effects of autonomic innervation on AF genesis and maintenance.
The investigators hypothesized that due to denervation, the risk of postoperative AF would be lower following OHT compared to surgical maze even though both groups get isolation of the pulmonary veins.
METHODS: We reviewed 155 OHTs (mean age 52 ± 11 years, 72% males) and used 1:1 age-, sex-, and date-of-surgery-matched two control groups from patients undergoing surgical maze or only coronary artery bypass grafting (CABG). Using conditional logistic regression we compared the odds of AF within 2 weeks following OHT versus controls.
RESULTS: Postoperative AF occurred in 10/155 (6.5%) OHT patients.
The conditional odds of postoperative AF were lower for OHT as compared to controls (vs maze: odds ratio [OR] 0.27 [95% confidence interval (CI) 0.13-0.57], vs CABG: OR 0.38 [0.17-0.81], P = 0.003; and
on additional adjustment for left atrial enlargement, vs maze: OR 0.28 [0.13-0.60], vs CABG: OR 0.14 [0.04-0.47], P = 0.0009).
CONCLUSIONS:
Risk of postoperative AF is significantly lower with OHT as in comparison to surgical maze. As both surgeries entail isolation of the pulmonary veins but
only OHT causes disruption of autonomic innervation,
this observation supports a mechanistic role of autonomic nervous system in AF. The benefit of targeting the cardiac autonomic system to treat AF needs further investigation.
Xarelto (Rivaroxaban): Anticoagulant Therapy gains FDA New Indications and Risk Reduction for: (DVT) and (PE), while in use for Atrial fibrillation increase in Gastrointestinal (GI) Bleeding Reported
Sympathetic (red) and parasympathetic (blue) nervous system Русский: Аанатомия иннервации вегетативной нервной системы. Системы: симпатическая (красным) и парасимпатическая (синим) Українська: Аанатомія іннервації вегетативної нервової системи. Симпатична (червоним) та парасимпатична (синім) гілки Polski: Układ autonomiczny: czerwony – sympatyczny, niebieski – parasympatyczny. (Photo credit: Wikipedia)
Scheme of atrial fibrillation (top) and sinus rhythm (bottom). The purple arrow indicates a P wave, which is lost in atrial fibrillation. (Photo credit: Wikipedia)
English: A graphical representation of the Electrical conduction system of the heart showing the Sinoatrial node, Atrioventricular node, Bundle of His, Purkinje fibers, and Bachmann’s bundle (Photo credit: Wikipedia)
Coronary artery bypass surgery (CABG) , is performed to relieve angina and reduce the risk of death from coronary artery disease. Arteries or veins from elsewhere in the patient’s body are grafted to the coronary arteries to bypass atherosclerotic narrowings and improve the blood supply to the coronary circulation supplying the myocardium. This surgery is usually performed with the heart stopped, necessitating the usage of cardiopulmonary bypass; techniques are available to perform CABG on a beating heart, so-called “off-pump” surgery.
Russian cardiac surgeon, Dr. Vasilii Kolesov, performed the first successful internal mammary artery–coronary artery anastomosis in 1964. Using a standard suture technique in 1964, and over the next five years he performed 33 sutured and mechanically stapled anastomoses in St. Petersburg, Russia.
Dr. René Favaloro, an Argentine surgeon, achieved a physiologic approach in the surgical management of coronary artery disease—the bypass grafting procedure—at the Cleveland Clinic in May 1967. His new technique used a saphenous vein autograft to replace a stenotic segment of the right coronary artery, and he later successfully used the saphenous vein as a bypassing channel, which has become the typical bypass graft technique we know today; in the U.S., this vessel is typically harvested endoscopically, using a technique known as endoscopic vessel harvesting (EVH). Soon Dr. Dudley Johnson extended the bypass to include left coronary arterial systems. In 1968, Doctors Charles Bailey, Teruo Hirose and George Green used the internal mammary artery instead of the saphenous vein for the grafting.
A person with a large amount of coronary artery disease (CAD) may receive fewer bypass grafts owing to the lack of suitable “target” vessels. A coronary artery may be unsuitable for bypass grafting if
it is small (< 1 mm or < 1.5 mm depending on surgeon preference),
heavily calcified (meaning the artery does not have a section free of CAD) or
intramyocardial (the coronary artery is located within the heart muscle rather than on the surface of the heart).
Similarly, a person with a single stenosis (“narrowing”) of the left main coronary artery requires only two bypasses (to the LAD and the LCX). However, a left main lesion places a person at the highest risk for death from a cardiac cause.
Both PCI and CABG are more effective than medical management at relieving symptoms, (e.g. angina, dyspnea, fatigue).
CABG is superior to PCI for some patients with multivessel CAD.
The Surgery or Stent (SoS) trial was a randomized controlled trial that compared CABG to PCI with bare-metal stents. The SoS trial demonstrated CABG is superior to PCI in multivessel coronary disease.
The SYNTAX trial was a randomized controlled trial of 1800 patients with multivessel coronary disease, comparing CABG versus PCI using drug-eluting stents (DES). The study found that
rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the DES group (17.8% versus 12.4% for CABG; P=0.002).
This was primarily driven by
higher need for repeat revascularization procedures in the PCI group with no difference in repeat infarctions or survival.
Higher rates of strokes were seen in the CABG group.
S Karthik and BM Fabri
Ann R Coll Surg Engl 2008; 85(4):367-69.
Over the last two decades, many studies have shown better long-term patency rates and survival in patients undergoing coronary artery bypass grafting (CABG) with left internal mammary artery (LIMA) to the left anterior descending artery (LAD).
Although the current focus in the UK is on mortality rates, we believe that it will not be long before this will also include the incidence of major morbidity after CABG such as stroke, myocardial infarction (MI), renal failure and sternal wound problems. We also believe that we should now consider LIMA usage as a marker of quality control in CABG. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1964611/
This study very clearly demonstrated that:
Approximately 4% of all patients undergoing first-time CABG do not need a graft to the LAD.
Of the rest, about 92% receive LIMA to LAD.
Six sub-groups of patients in whom LIMA usage was significantly less were:
(i) the elderly (> 70 years of age);
(ii) females;
(iii) diabetics;
(iv) patients having emergency CABG;
(v) poor left ventricular (LV) function (ejection fraction [EF] < 30%); and
(vi) respiratory disease.
LIMA usage was also reduced in patients undergoing combined CABG and valve procedures.
Multiple arterial grafts improve late survival of patients undergoing CABG
BACKGROUND: Use of the left internal mammary artery (LIMA) in multivessel coronary artery disease improves survival after coronary artery bypass graft surgery; however, the survival benefit of multiple arterial (MultArt) grafts is debated. (Perhaps not without reason. One problem is the small size of the left circumflex artery, and where does the right coronary artery have a place?)
METHODS : We reviewed 8622 Mayo Clinic patients who had isolated primary coronary artery bypass graft surgery for multivessel coronary artery disease from 1993 to 2009. Patients were stratified by number of arterial grafts into the LIMA plus saphenous veins (LIMA/SV) group (n=7435) or the MultArt group (n=1187). Propensity score analysis matched 1153 patients.
RESULTS: Operative mortality was 0.8% (n=10) in the MultArt and 2.1% (n=154) in the LIMA/SV (P=0.005) group.This result was not statistically different (P=0.996) in multivariate analysis or the propensity-matched analysis (P=0.818). Late survival was greater for MultArt versus LIMA/SV (10- and 15-year survival rates were 84% and 71% versus 61% and 36%, respectively [P<0.001], in unmatched groups and 83% and 70% versus 80% and 60%, respectively [P=0.0025], in matched groups). The large difference between the MultiArt versus the LIMA/SV appears to be the 61% and 36% in unmatched and 80% and 60% in matched, evident at 15-years, favorable for the MultiArt group.
MultArt subgroups with bilateral internal mammary artery/SV (n=589) and
bilateral internal mammary artery only (n=271) had improved 15-year survival (86% and 76%; 82% and 75% at 10 and 15 years [P<0.001]), and
bilateral internal mammary artery/radial artery (n=147) and LIMA/radial artery (n=169) had greater 10-year survival (84% and 78%; P<0.001) versus LIMA/SV.
In multivariate analysis, MultArt grafts remained a strong independent predictor of survival (hazard ratio, 0.79; 95% confidence interval, 0.66-0.94; P=0.007).
CONCLUSIONS:
In patients undergoing isolated coronary artery bypass graft surgery with LIMA to left anterior descending artery,
arterial grafting of the non-left anterior descending vessels conferred a survival advantage at 15 years compared with Saphenous Venous (SV) grafting.
It is still unproven whether these results apply to higher-risk subgroups of patients.
The internal mammary artery and its branches. (Photo credit: Wikipedia)
Coronary artery bypass surgery, the usage of cardiopulmonary bypass Русский: Коронарное шунтирование (Photo credit: Wikipedia)
A coronary angiogram that shows the LMCA, LAD and LCX. (Photo credit: Wikipedia)
Micrograph of an artery that supplies the heart with significant atherosclerosis and marked luminal narrowing. Tissue has been stained using Masson’s trichrome. (Photo credit: Wikipedia)
Coronary Reperfusion Therapies: CABG vs PCI – Mayo Clinic preprocedure Risk Score (MCRS) for Prediction of in-Hospital Mortality after CABG or PCI
Author and Curator: Larry H. Bernstein, MD, FCAP
and
Curator: Aviva Lev-Ari, PhD, RN
Published on Mar 27, 2012
Mayo Clinic cardiologist Charanjit Rihal, M.D. discusses a recent study conducted by Mayo Clinic that focuses on predicting operator outcomes in coronary angioplasty procedures.
“We’ve been interested in prediction of outcomes after coronary angioplasty and stent procedures for some time,” says Dr. Rihal. “Almost ten years ago, we published a paper called ‘The Mayo Clinic Risk Score for Prediction of Adverse Events following Coronary Angioplasty and Stent Procedures’. We’ve since refined into the ‘New Mayo Clinic Risk Score’, which includes seven key variables that predict bad outcomes following PCI procedures.”
The study, which was presented at the 2012 ACC Annual Scientific Session & Expo, presents a novel application of the Mayo Clinic Risk Score to predict operator specific outcomes in coronary angioplasty procedures.
“We looked at the outcomes of over 8000 procedures performed by 21 Mayo Clinic interventional cardiologists as predicted by the Mayo Clinic Risk Score,” says Dr. Rihal. “On an individual basis, we were able to calculate the expected mortality and adverse event rate and compare that to the actual observed mortality and adverse event rate. We were able to show that in our clinical practice of PCI, this risk score was very useful as a performance measure.
In a pleasant surprise, the study also discovered an outlier whose outcomes for instances of adverse event rates were much better than expected. “We don’t know exactly why this operator has such good results,” remarks Dr. Rihal, “But that will be the next phase of this analysis. We can compare procedural, pre-procedural, and post procedural practices of this operator and see if there are things that are translatable to the rest of us.”
VIEW VIDEO
Singh M, Gersh BJ, Li S, Rumsfeld JS, Spertus JA, O’Brien SM, Suri RM, Peterson ED.
BACKGROUND: Current risk models predict in-hospital mortality after either coronary artery bypass graft surgery or percutaneous coronary interventions. The overlap of models suggests that the same variables can define the risks of alternative coronary reperfusion therapies. We sought a preprocedure risk model that can predict in-hospital mortality after either percutaneous coronary intervention or coronary artery bypass graft surgery.
METHODS AND RESULTS: We tested the ability of the recently validated, integer-based Mayo Clinic Risk Score (MCRS) for percutaneous coronary intervention, which is based solely on preprocedure variables:
age,
creatinine,
ejection fraction,
myocardial infarction < or = 24 hours,
shock,
congestive heart failure
peripheral vascular disease
to predict in-hospital mortality among 370,793 patients in the Society of Thoracic Surgeons (STS) database undergoing isolated coronary artery bypass graft surgery from 2004 to 2006. The median age of the STS database patients was 66 years (quartiles 1 to 3, 57 to 74 years), with 37.2% of patients > or = 70 years old. The high prevalence of comorbid conditions included
diabetes mellitus (37.1%)
hypertension (80.5%)
peripheral vascular disease (15.3%)
renal disease (creatinine > or = 1.4 mg/dL; 11.8%).
A strong association existed between the MCRS and the observed mortality in the STS database. The in-hospital mortality ranged between 0.3% (95% confidence interval 0.3% to 0.4%) with a score of 0 on the MCRS and 33.8% (95% confidence interval 27.3% to 40.3%) with an MCRS score of 20 to 24. The discriminatory ability of the MCRS was moderate, as measured by the area under the receiver operating characteristic curve(C-statistic = 0.715 to 0.784 among various subgroups); performance was inferior to the STS model for most categories tested.
CONCLUSIONS: This model is based on the 7 preprocedure risk variables listed above. However, it may be useful for providing patients with individualized, evidence-based estimates of procedural risk as part of the informed consent process before percutaneous or surgical revascularization.
It appears to this reviewer that the model might provide a better AUC if it were reconstructed as follows:
age
estimated creatinine clearance (which has been improved substantially by the Mayo Clinic)
There is another question that This reviewer has about the approach to prediction of post-procedural survival from pre-procedural information.
Age falls into interval classes that would suffice for use as classification variables.
Creatinine is a measurement that is a continuous variable, but I call attention to the fact that eGFR would be preferred, as physicians tend to look at the creatinine roughly in relationship to age, gender, and body size or BMI.
The laboratory contribution as powerful information is underutilized.
On the one hand, CHF is important, but how is the distinction made between
stable CHF and
decompensated CHF, or degrees in between?
This is where the amino-terminal pro b-type natriuretic perptide, or the BNP has been used in isolation, but not in a multivariate model such as described. There is a difference between them, but whether the difference makes a difference is unproved.
The BNP, derived from the propeptide is made by the myocardium as a hormonal mediator of sodium retention. The BNP is degraded by the vascular endothelium, so it’s half time of disappearance would not reflect renal dysfunction, which is not the case for the NT proBNP. This observation has nothing to do with the medical use of BNP.
Three coronary artery bypass grafts, a LIMA to LAD and two saphenous vein grafts – one to the right coronary artery (RCA) system and one to the obtuse marginal (OM) system. (Photo credit: Wikipedia)
Forrester-classification for classification of Congestive heart failure ; Forrester-Klassifikation zur Einteilung einer akuten Herzinsuffizienz (Photo credit: Wikipedia)