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CABG Survival in Multivessel Disease Patients: Comparison of Arterial Bypass Grafts vs Saphenous Venous Grafts

Posted in Biomedical Measurement Science, CABG, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Medical Devices R&D and Inventions, Medical Devices R&D Investment, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery, Pharmaceutical Industry Competitive Intelligence, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Statistical Methods for Research Evaluation, Stents & Tools, tagged CABG, Coronary artery bypass surgery, Coronary artery disease, Heart disease, Internal thoracic artery, Mayo Clinic, Percutaneous coronary intervention, surgery on June 30, 2013| 2 Comments »

CABG Survival in Multivessel Disease Patients: Comparison of Arterial Bypass Grafts vs Saphenous Venous Grafts

Writer and Curator: Larry H. Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

This article examines 10-year to 15-year survivals from arterial bypass grafts using arterial vs saphenous venous grafts.

Locker C, Schaff HV, Dearani JA, Joyce LD, Park SJ, et al.

Division of Cardiovascular Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. lekerlocker.chaim@mayo.edu

Circulation. 2012 Aug 28;126(9):1023-30. PMID: 22811577 http://dx.doi.org/10.1161/CIRCULATIONAHA.111.084624. Epub 2012 Jul 18. Review.

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.

http://upload.wikimedia.org/wikipedia/commons/thumb/c/c3/Coronary_artery_bypass_surgery_Image_657C-PH.jpg/230px-Coronary_artery_bypass_surgery_Image_657C-PH.jpg

http://upload.wikimedia.org/wikipedia/commons/thumb/3/30/Heart_saphenous_coronary_grafts.jpg/220px-Heart_saphenous_coronary_grafts.jpg

Left Internal Mammary Artery Usage in Coronary Artery Bypass Grafting: A Measure of Quality Control

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.

Brachytherapy Cardiac and Coronary Artery Disease (heartdisease.answers.com)
Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty (emberbranch.wordpress.com)
Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. (zedie.wordpress.com)
Risks of Coronary Artery Bypass Surgery (everydayhealth.com)
The CARP trial: Preoperative revascularization prior to elective vascular surgery [Classics Series] (2minutemedicine.com)
Orsiro From BIOTRONIK, Industry’s First Hybrid Drug-Eluting Stent, Performs as Best in Class (newsmaker.com.au)
Functional Flow Reserve in Diagnostic Coronary Angiography Changes Decisions in 25 Percent of Cases (medindia.net)
Heart Bypass Versus Stent (heartdisease.answers.com)

Coronary Reperfusion Therapies: CABG vs PCI – Mayo Clinic preprocedure Risk Score (MCRS) for Prediction of in-Hospital Mortality after CABG or PCI

Posted in Biomarkers & Medical Diagnostics, Biomedical Measurement Science, CABG, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Chemical Biology and its relations to Metabolic Disease, Computational Biology/Systems and Bioinformatics, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, International Global Work in Pharmaceutical, Medical Devices R&D and Inventions, Pharmaceutical Industry Competitive Intelligence, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Statistical Methods for Research Evaluation, Systemic Inflammatory Response Related Disorders, Technology Transfer: Biotech and Pharmaceutical, tagged Aviva Lev-Ari, Cardiovascular disease, Conditions and Diseases, Coronary artery bypass surgery, Drug-eluting stent, Heart disease, Mayo Clinic, Percutaneous coronary intervention, Society of Thoracic Surgeons on June 30, 2013| 9 Comments »

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.

SOURCE: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN

Circulation. 2008 Jan 22;117(3):356-62. http://dx.doi.org/10.1161/CIRCULATIONAHA.107.711523 Epub 2008 Jan 2. PMID: 18172033

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)
EF
AMI < 24 hrs
Decompensated CHF or shock
PVD, or carotid artery disease, or PAD
MAP

Mean arterial pressure (MAP) Calculator: Systolic BP: mm Hg: Diastolic BP: mm Hg Background: Equation: MAP = [(2 x diastolic)+systolic] / 3 http://www.globalrph.com/map.htm

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.

Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty (emberbranch.wordpress.com)
Risks of Coronary Artery Bypass Surgery (everydayhealth.com)
Heart Attack Treatment Options (everydayhealth.com)
Cabbage Surgery Overview (surgery.answers.com)
Comparison of cardiothoracic bypass and percutaneous interventional catheterization survivals (pharmaceuticalintelligence.com)
Functional Flow Reserve in Diagnostic Coronary Angiography Changes Decisions in 25 Percent of Cases (medindia.net)
High incidence of acute coronary occlusion in patients without protocol positive ST segment elevation referred to an open access primary angioplasty programme. (zedie.wordpress.com)
Bioresorbable Drug-Eluting Scaffolds Emerging As The Dominant Device Of The Future For Percutaneous Coronary Interventions (medicalnewstoday.com)

CVD Core

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CVD Core

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #62: CVD Core. Published on 6/26/2013

WordCloud Image Produced by Adam Tubman

When this post will be ready it needs be place

under below link

http://pharmaceuticalintelligence.com/biomed-e-books/cardiovascular-diseases-causes-risks-and-management/introduction-to-the-three-volume-series-core-research-on-cardiovascular-diseases/

See in red my comments, below

Cardiovascular Diseases: Causes, Risks and Management

Justin D. Pearlman MD PhD MA FACC, Editor

Cardiovascular diseases comprise problems of the heart and blood vessels, including rhythm, blood supply, blood pressure, birth defects, or damage from cholesterol, tobacco, street drugs, radiation, viruses, bacteria, or fungi.

Thus the category includes heart failure (inadequate pump function), heart or vessel infection (endocarditis, vasculitis), birth defects (congenital heart disease)

Cardiovascular Diseases: Causes, Risks and Management

Justin D. Pearlman MD ME PhD MA FACC, Editor

Leaders in Pharmaceutical Business Intelligence

^{Aviva Lev-Ari, PhD, RN}

Director and Founder

Editor-in-Chief

Other e-Books in the BioMedicine Series

Perspectives on Nitric Oxide in Disease Mechanisms

Human Immune System in Health and in Disease

Metabolic Genomics & Pharmaceutics

Infectious Disease & New Antibiotic Targets

Cancer Biology and Genomics for Disease Diagnosis

Nanotechnology in Drug Delivery

Genomics Orientations for Personalized Medicine

This book is a comprehensive review of Innovations in Cardiovascular Medicine, including the latest discoveries in

Cardiac Medical Imaging,

Regenerative Medicine,

Pharmacotherapy,

Medical Devices for Cardiac Repair,

Genomics, and opportunities for Targeted Therapy.

It is written by experts in their respective subspecialties. The e-Book’s articles have been published on the Open Access Online Scientific Journal, since April 2012. All new articles on this subject will continue to be incorporated with periodical updates.

http://www.pharmaceuticalIntelligence.com

The Journal is a scientific, medical and business, multi-expert authoring environment for information syndication in domains of Life Sciences, Medicine, Pharmaceutical and Healthcare Industries, BioMedicine, Medical Technologies & Devices. Scientific critical interpretations and original articles are written by PhDs, MDs, MD/PhDs, PharmDs, Technical MBAs as Experts, Authors, Writers (EAWs) on an Equity Sharing basis.

The Editor, Justin D. Pearlman MD ME PhD MA FACC, has many different perspectives developed during the years, including:

Chief of Cardiology,

non-invasive imaging,

molecular biology,

mathematics,

imaging research

contributed a number of firsts:

non-endemic Chagas diagnosis,

intensity projection angiography,

magnetization tagging,

myocardial injury mapping by magnetic resonance contrast retention,

myocardial viability by MRI,

atheroma lipid liquid crystal characterization,

outpatient inotropic infusion therapy,

angiogenesis imaging,

multimodal in vivo stem cell imaging,

real-time velocity beam MRI,

in vivo microscopic MRI,

dobutamine stress echocardiography for low gradient valve disease,

alternative stress tests,

diagnostic electrocardiography in magnetic environments,

statistical methods to solve error propagation of large array genomics,

discovery of monocyte role in native coronary collateral development,

image tracked stem cell treatment of heart attacks,

singularity editing in differential topology.

Preface to the Three Volume Series

Cardiovascular disease has been a leading cause of death and disability and so it has also been a major focus for intense research, development, and progress. Knowledge of the causes, risks, and best practices for management continually change. That is why a dynamic electronic living textbook presents an exciting opportunity to help you keep current with the ephemeral leading edge. This book is an outgrowth of the commitment of Leaders in Pharmaceutical Business Intelligence to present the most exciting timely and pertinent advances of our day, in a continual medium to stay fresh and up to date. We hope diverse multispecialty perspectives will help you in your quest to understand, adapt and advance the leading edge of cardiovascular disease causes, risks and best practices management.

On the Diagnosis of Cardiovascular Disease: causes, manifestations, consequences and priorities

Doctors aim to spend their time on prevention, diagnosis, and disease management. More and more the time is diverted to expanding demands for documentation and bureaucratic navigation. This article focuses on the art of diagnosis, with examples based on cardiovascular diseases. Diagnosis cannot be achieved without a knowledge of the causes (etiology) of ailments, a necessary but not sufficient component of diagnosis. The causes broadly relate to nature and nurture, how our biological system develops and functions (nature), and its interactions with the outside world driven in part by behavior, diet, exposures, and activities (nurture). The nature of our individuality has been traced to the human genome, a map of code for protein products that build our structures and mediate our body part functions. Numerous blood tests have been devised to check the expression and activity level of such genomic products to identify disease and characterize its stage. The role of diet, behavior, exposures, activities or lack thereof is well established as a complicit factor in disease development and progression.

The art of diagnosis is designed to find out what is wrong. Literally, it is a flow of knowing, based on knowledge of causes of ailments, probabilities (prevalence), consequences, manifestations, priorities (which would be most urgent) and tests: CPCMPT. Review of those elements generates a list of concerns, often expressed as a “differential diagnosis” which is a prioritized list of plausible explanations for the observations, patient’s report of symptoms and findings from patient examination. The second stage of diagnosis, called the “work-up,” selects and applies tests to stratify the list of possibilities further as well as to characterize the manifestations and stage of disease. Technically, analysis of biological samples, imaging studies and intervention trials each represent tests; however, they are often viewed as distinct tools with just the former labeled as tests (biological samples include blood tests, urine tests, sputum or saliva samples, and biopsies). The primary goal of the work-up is to establish one or more specific diagnoses as the cause of ailment. The secondary goal of the work-up is to characterize the manifestations and stage of disease to define expectations and clarify options for the disease management. The third goal is to develop a management a plan to slow or stop the ailment, decrease risks of complications, slow or stop progression of disease manifestations or otherwise minimize functional impairment.

The manifestations of disease are categorized as signs and symptoms.

Signs are observable evidence of consequences,
Symptoms are subjective complaints.

A major component of diagnostic skill is the ability to identify and characterize correctly signs and symptoms of all relevant disease conditions. A second major component of diagnostic skill is the ability to select appropriate tests and interpret their significance in context, in keeping with the patient’s presentation.

When someone sees a doctor about chest pain, coronary artery disease is a prominent consideration. The most common causes of chest pain are mechanical (muscle and bone, e.g., muscle spasms, muscle and bone inflammation), but those conditions are not generally life-threatening. The consequences of blocked arteries – arrhythmia, permanent weakness of the heart, blood clots, pulmonary emboli, stroke, cardiogenic shock, death – raise the stakes and push coronary disease high in priority even when the probabilities are low. The prioritization of the differential diagnosis list has multiple considerations: urgency (how quickly it can worsen), severity of consequences, and the probabilities of a macrovascualar event (prevalence, risk factors). A ten percent risk of coronary disease typically takes precedence over a 70% likelihood of muscle spasm in terms of diagnostic testing.

The road map for the construction of our individuality as humans has been fully mapped: the human genome. Genetic variation means we are not fully determined by the mix of genes inherited from our parents. In addition to the genetic material on our 48 chromosomes, and the genetic material in mitochondria inherited from the mother, there are spontaneous changes in the genetic code, and there are modifications that affect gene expression (which codes produce gene products, quantities, rates, and post-production modifications).

The causes of cardiovascular disease are defined by Murphy’s law: what can go wrong will. However, on the nature side, most malfunctions are too severe to reach the light of day, so there is a limited list of disease mechanisms associated with sufficient viability to reach medical attention. Those mechanisms can be summarized by a mnemonic: diseases can develop new metals in-flame, a-fact externs generated (disease mechanisms: congenital, developmental, neoplastic, metabolic, inflammatory, infectious, extrinsic (e.g. stab wound), and degenerative). A taxonomy of cardiovascular diseases can be constructed in various ways: (1) itemize the major cardiovascular functions and subclassify the dysfunctions, (2) itemize by principle anatomic involvement and subclassify by pathology, (3) classify by mechanism of disease, etiology. Compendiums of cardiovascular disease may be found in: (1) French’s Differential Diagnosis, (2) Robbins and Angel Pathology, (3) Guyton’s Textbook of Physiology, as well as cardiovascular disease textbooks such as Hurst, Braunwald, Mayo Clinic, Cleveland Clinic…

Diagnosis takes many forms. The paranoid inclusive approach, manifested as “medical student syndrome”, considers any semblance of a sign or symptom vaguely similar to a disease manifestation as a frightening prospect worthy of detailed pursuit. The minimalist pragmatic approach commonly attributed to general practitioners focuses on reassurance, and pursuit of persisting complaints that match a common ailment. That approach has been summarized by the advice: when you hear hoof beats think of horses, not zebras. Specialists, on the other hand, are taught to consider all possibilities, with due consideration to urgency and treatability, so that zebras are not punished.

The healthcare system promotes the idea of generalists serving as the front line, identifying who can be managed simply, with specialists serving as finishers for more complex cases or cases requiring special skills. A flaw in that model is the need for detailed knowledge of zebras and subtle findings that may represent an urgent issue at the front line for triage. If the generalist does not know that mild symptoms from mitral valve disease or aortic valve disease may require urgent detailed assessment, patients may be referred to a specialist too late to prevent consequences that requires an earlier intervention.

Parsimony in diagnosis refers to identifying the fewest number of diagnoses that explain all the findings. The concept has been attributed to Osler, and it builds on a guiding procedure voiced in the middle ages by Occum, known as Occum’s razor: when deciding between two explanations, favor the one that requires the fewest assumptions. Parsimony is a useful guide for diagnosis of a previously healthy patient who develops a number of findings that are temporally coherent. After age 65 (official geriatrics age), physicians are taught to abandon parsimony and expect more diagnoses than findings.

A study of difficult diagnoses lead to the concept of a pivotal finding as one that has a narrow differential list. The diagnostic process is prone to errors, including cognitive biases, which may benefit from computer assistance. Intuition and analytics can be applied to reduce cognitive bias. The author developed a just-in-time social networking system within a software package called Missive(c) that enables rapid access to such tools, combining efficiency in documentation with improved quality of analysis and reports (faster and better).

Among older Americans, more are hospitalized for heart failure than for any other medical condition (diastolic failure=stiff heart, systolic failure= inadequate pumping).

Genomics – the study of the genetic basis for disease – is rapidly expanding knowledge about etiology (cause of disease), and it helps identify opportunities for accurate diagnosis and treatment. The American Heart Association journal CIRCULATION has published 348 relevant articles related to cardiovascular genomics from 2010-2013. For example, just on the subtopic of atherosclerosis (hardening of arteries), genomics offers major progress. The genetic factors that affect arterial stiffness are strongly related to a very common underlying health concern, hypertension (high blood pressure). The counterpart to genetics is environment (nature versus nurture), but genetics carries the trump cards because it determines the sensitivities to environment.

anatomy

physiology

laboratory tests

interventional trials

Boundaries of the Domain: Cardiovascular Diseases: Causes, Risks and Management – Volume 1,2,3

The scope of cardiovascular disease scholarly contributions will grow to include: anatomy, surgery, molecular biology, ethics, imaging (echo, nuclear, PET, MRI, OCT, CT), congenital, stress tests, ECG, electrophysiology/rhythm/channelopathies, pacing, resynchronizing, AICD, cardiomyopathies, syncope, valve disease, aorta, renal artery, thrombosis, venous diseases, vasculitis, endothelium, metabolic syndrome, dyslipidemia, risk factors, biomarkers, hypertension, embolism, pulmonary hypertension, cardiac tumors, women’s health, CAD, Angina, Stem cells, complications of MI, thrombolysis, rehabilitation, reflexes, hormones, diastology, pharmaceuticals, myocarditis, hypertrophy, failure, shock, hemodynamics, interventions, contrast nephropathy, and contrast systemic fibrosis, as well as other relevant topics you may suggest.

An overview of the Core Research on Cardiovascular Diseases is based on the following NINE articles:

Have only the article title as a live link of the following 9 [originally were on CVD Zero, title and links, now only links]

The main points are

[bring here ONLY the INTRODUCTION and the Summary of each, THEN The EDITOR will provide perspective on the Research and the current STate of Cardiology in the US in 2013/2014]

A. Now you provide ONLY links to

Volume #

Contributors to Volume #

eTOCS in Volume #

REPEAT A. for each Volume

Volume One: Causes of Cardiovascular Diseases

Contributors

Chapter 1.1: The hardening of arteries

Hardening of the arteries is described as atherosclerosis, or porridge-like wall changes with scarring, which leads to heart attacks, high blood pressure, stroke, and organ injury mediated by ischemia (insufficient nutrient blood supply). The causes are both nature (genetic) and nurture (behavior, diet). Specifics of the causes guide diagnosis and management.

Chapter 1.2: Genomics

The completion of the human genome map was a major accomplishment, as gene products make signals, receptors and building blocks that establish health and disease. However, it is just a stepping stone, not explaining why, where, or how the gene products are regulated and interact.

Chapter 1.3: Cardiovascular Imaging

Imaging applies a principle of physics (light transmission, sound transmission, xray transmission, magnetic resonance, radioactivity) to provide a map of interior structures and/or activities. Image processing (computing) derives further information than simple display of an observed tissue-sensitive parameter. In the case of computed tomography (CT), magnetic resonance (MRI), positron-emission tomography (PET), and single-photon emission tomography (SPECT), computer reformatting of image data is essential.

Introduction

Volume Two: Risk Assessment of Cardiovascular Diseases

Contributors

Chapter 2.1: Cardiovascular Risks

Cardiovascular disease is the leading cause of death and disability, affecting more than four times as many people as all forms of cancer combined.

Chapter 2.2: Testing for cardiovascular risk

The volunteer population of Framingham Massachusetts provided decades of data clarifying determinants of risk for cardiovascular diseases. That data helped establish the usefulness of cholesterol screening, and lead to the search for additional tests to identify risk and guide management.

Chapter 2.3: Biomarkers

Biomarkers are chemistry levels (concentrations in the blood) that identify injury or risk for injury.

Introduction

Volume Three: Management of Cardiovascular Diseases

Contributors

Chapter 3.1: Therapeutic Genomics

As the mysteries of the human genome products are unraveled, we get closer to identifying key components. One of them is Thymosin beta 4 (Tβ4) , which plays an essential role in cardiac and blood vessel development and regeneration. It may lead to breakthroughs in angiogenesis and vasculogenesis, or new vessel development, mimicking the behavior of the lucky few who develop new vessels, or collaterals, as a natural bypass system, without requiring a surgeon to provide a blood supply to avoid or limit heart attacks.

Chapter 3.2: Image guidance of Therapy

The US government is helping to sponsor new imaging methods, while they also inhibit it by adding new taxes.

Chapter 3.3: Drug therapy

Emerging new therapies are presented, along with the biological basis.

Chapter 3.4: Cardiovascular Interventions

Technological advances enable minimally invasive solutions to problems previously addressed by surgery or autopsy.

Introduction

Contributors above, need a LINK to the appropriate contributors in each volume. Table of Contents of each volume above need a LINK to the eTOCS of each volume.

Please UPDATE all links ABOVE to the appropriate locations in the respective volumes, after implementing the carry over, remove links below EXCEPT CVD1,2,3 and remove this comment of mine in RED, here

REFERENCES for CVD CORE

A. Diagnosis of Cardiovascular Disease and Cost of Care

Bernstein, HL and A. Lev-Ari 5/15/2013 Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems

http://pharmaceuticalintelligence.com/2013/05/15/diagnosis-of-cardiovascular-disease-treatment-and-prevention-current-predicted-cost-of-care-and-the-promise-of-individualized-medicine-using-clinical-decision-support-systems-2/

B. Cardiovascular Diseases: Disease Management Decision Making – use of CDSS

Pearlman, JD and A. Lev-Ari 5/4/2013 Cardiovascular Diseases: Decision Support Systems for Disease Management Decision Making

http://pharmaceuticalintelligence.com/2013/05/04/cardiovascular-diseases-decision-support-systems-for-disease-management-decision-making/

C. Genomics & Genetics of Cardiovascular Disease Diagnoses

Lev-Ari, A. and L H Bernstein 3/7/2013 Genomics & Genetics of Cardiovascular Disease Diagnoses: A Literature Survey of AHA’s Circulation Cardiovascular Genetics, 3/2010 – 3/2013

http://pharmaceuticalintelligence.com/2013/03/07/genomics-genetics-of-cardiovascular-disease-diagnoses-a-literature-survey-of-ahas-circulation-cardiovascular-genetics-32010-32013/

D. Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging

Lev-Ari, A. 5/17/2013 Synthetic Biology: On Advanced Genome Interpretation for Gene Variants and Pathways: What is the Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging

http://pharmaceuticalintelligence.com/2013/05/17/synthetic-biology-on-advanced-genome-interpretation-for-gene-variants-and-pathways-what-is-the-genetic-base-of-atherosclerosis-and-loss-of-arterial-elasticity-with-aging/

E. Hypertension and Vascular Compliance: 2013 Thought Frontier – An Arterial Elasticity Focus

Pearlman, JD and A. Lev-Ari 5/11/2013 Hypertension and Vascular Compliance: 2013 Thought Frontier – An Arterial Elasticity Focus

http://pharmaceuticalintelligence.com/2013/05/11/arterial-elasticity-in-quest-for-a-drug-stabilizer-isolated-systolic-hypertension-caused-by-arterial-stiffening-ineffectively-treated-by-vasodilatation-antihypertensives/

F. Arterial Stiffness: Pharmacotherapy for Hypertension and Hypercholesterolemia Management

Pearlman, JD and A. Lev-Ari 5/24/2013 Imaging Biomarker for Arterial Stiffness: Pathways in Pharmacotherapy for Hypertension and Hypercholesterolemia Management

http://pharmaceuticalintelligence.com/2013/05/24/imaging-biomarker-for-arterial-stiffness-pathways-in-pharmacotherapy-for-hypertension-and-hypercholesterolemia-management/

G. Genetics of Conduction Disease

Lev-Ari, A. 4/28/2013 Genetics of Conduction Disease: Atrioventricular (AV) Conduction Disease (block): Gene Mutations – Transcription, Excitability, and Energy Homeostasis

http://pharmaceuticalintelligence.com/2013/04/28/genetics-of-conduction-disease-atrioventricular-av-conduction-disease-block-gene-mutations-transcription-excitability-and-energy-homeostasis/

H. Arrhythmia after Cardiac Surgery Prediction and ECG Prediction of Paroxysmal Atrial Fibrillation Onset

Pearlman, JD and A. Lev-Ari 5/7/2013 On Devices and On Algorithms: Arrhythmia after Cardiac Surgery Prediction and ECG Prediction of Paroxysmal Atrial Fibrillation Onset

http://pharmaceuticalintelligence.com/2013/05/07/on-devices-and-on-algorithms-arrhythmia-after-cardiac-surgery-prediction-and-ecg-prediction-of-paroxysmal-atrial-fibrillation-onset/

I. Myocardial Infarction: Quantification of Myocardial Perfusion Viability

Pearlman, JD and A. Lev-Ari 5/22/2013 Acute and Chronic Myocardial Infarction: Quantification of Myocardial Perfusion Viability – FDG-PET/MRI vs. MRI or PET alone

http://pharmaceuticalintelligence.com/2013/05/22/acute-and-chronic-myocardial-infarction-quantification-of-myocardial-viability-fdg-petmri-vs-mri-or-pet-alone/

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Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, CABG, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Mitral Valve: Repair and Replacement, PCI, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Stents & Tools, Valves & Tools, tagged CABG, Coronary artery bypass surgery, Drug-eluting stent, Heart disease, Houston, Percutaneous coronary intervention, Stanford University School of Medicine, Stent, Texas Heart Institute, University of Michigan on June 23, 2013| 15 Comments »

Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

Larry H. Bernstein, MD, Writer
And
Aviva Lev-Ari, PhD, RN, Curator

This is a summary of several studies, mostly reviewing one decade of work at Texas Heart Institute, Houston, TX.

Seminal treatments of the evolving methods, leading to a recent review of options for

Survival comparison of CABD vs PCI
Mitral valve repair or mitral valve replacement for the treatment of ischemic mitral regurgitation. This might further consolidate a series of articles in these chapters.

SOURCES

1. Bypass, Angioplasty Similar in Survival 10 Years After Heart Procedures, Survival Rates Differ Little. K Doheny. WebMD Health News Oct. 15, 2007

http://www.webmd.com/heart-disease/news/20071015/bypass-angioplasty-similar-survival

2. Will Drug-Eluting Stents Replace Coronary Artery Bypass Surgery?

RM Reul, Tex Heart Inst J. 2005; 32(3): 323–330

3. Will Stent Revascularization Replace Coronary Artery Bypass Grafting? JM Wilson Tex Heart Inst J. 2012; 39(6): 856–859

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528239/

4. Coronary Artery Bypass Surgery versus Coronary Stenting. Risk-Adjusted Survival Rates in 5,619 Patients. RP Villlareal,V-V Lee, MA Elayda, JM Wilson. Tex Heart Inst J. 2002; 29(1): 3–9.

http://www.ncbi.nlm.nih.gov/pubmed/11995845

5. Should all ischemic mitral regurgitation be repaired? When should we replace? DJ LaPar, IL Kron. Curr Opin Cardiol. 2011 March; 26(2): 113–117

6. Hybrid Cath Lab Combines Nonsurgical, Surgical Treatments

http://www.dicardiology.com/article/hybrid-cath-lab-combines-nonsurgical-surgical-treatments

Bypass, Angioplasty Similar in Survival 10 Years After Heart Procedures

The survival rates 10 years after coronary artery bypass surgery and angioplasty are similar, according to a new analysis of nearly 10,000 heart patients. Five years after the procedures, 90.7% of the bypass patients and 89.7% of the angioplasty patients were still alive, says Mark A. Hlatky, MD, senior author of the analysis and a professor of health research and policy and professor of medicine at Stanford University School of Medicine in Palo Alto.

Hlatky and colleagues stress that their analysis only applies to a select group of heart patients: those for whom either procedure would be considered a reasonable choice. For patients who are eligible for either heart intervention, “either is feasible,” Hlatky tells WebMD. The report is released early online and will be published in the Nov. 20 issue of the Annals of Internal Medicine.

CABG vs. Angioplasty

The researchers evaluated the results of 23 clinical trials in which 5,019 patients (average age 61 years; 73% men) were randomly assigned to get angioplasty with or without stents (PCI), and 4,944 were assigned to get coronary artery bypass graft surgery (CABG) In angioplasty, interventional cardiologists push a balloon-like device into the coronary arteries and inflate the balloon to widen the vessel. An expandable wire mesh tube called a stent may be inserted to keep the vessel open. Some stents are coated with drugs meant to help prevent the artery from clogging up. In 2005, about 645,000 angioplasty procedures were done in the U.S. In bypass surgery, cardiac surgeons harvest a segment of a healthy blood vessel from another part of the body and use it to bypass the clogged artery or arteries, rerouting the blood to improve blood flow to the heart. About 261,000 bypass procedures were done in the U.S. in 2005.

Findings

Besides similar survival rates overall, the researchers found no significant survival differences between the two procedures for patients with diabetes, although earlier research had seemed to favor bypass surgery. Similar numbers of patients suffered heart attacks within five years of the procedures. While 11.9 of those who got angioplasty had a heart attack within five years, 10.9% of those who got bypass did. Repeat procedures were more common in angioplasty patients. While 46.1% of angioplasty patients who didn’t get a stent needed repeat procedures, 40.1% of those who got a stent did. But just 9.8% of surgery patients needed another procedure. The study didn’t include information on drug-coated stents.

Second Opinions

The new analysis is “very complete,” says Kim A. Eagle, MD, director of the Cardiovascular Center and Albion Walter Hewlett Professor of Internal Medicine at the University of Michigan, Ann Arbor. The study shows, he says, that if either procedure is considered appropriate for an individual patient, the decision can rest on patient attitudes and preferences. Patients preferences might be based on lower need to repeat in favor of surgery, or on avoidance of surgery in favor of angioplasty. But it is important to note, acoording to Curtis Hunter at Santa-Monica-UCLA, that the studies cover the least sick with heart disease, so the two procedures are shown to be equal in a very small subset of the patients.

Coronary Artery Bypass Surgery versus Coronary Stenting – Risk-Adjusted Survival Rates in 5,619 Patients THIJ. 2002

We used the Texas Heart Institute Cardiovascular Research Database to retrospectively identify patients who had undergone their 1st revascularization procedure with coronary artery bypass surgery (CABG; n=2,826) or coronary stenting (n=2,793) between January 1995 and December 1999. Patients were classified into 8 anatomic groups according to the number of diseased vessels and presence or absence of proximal left anterior descending coronary artery disease. Mortality rates were adjusted with proportional hazards methods to correct for baseline differences in severity of disease and comorbidity.

We found that in-hospital mortality was significantly greater in patients undergoing CABG than in those undergoing stenting (3.6% vs 0.75%; adjusted OR 8.4; P <0.0001). At a mean 2.5-year follow-up, risk-adjusted survival was equivalent (CABG 91%, stenting 95%; adjusted OR 1.26; P = 0.06). When subgroups matched for severity of disease were compared, no differences in risk-adjusted survival were seen. A survival advantage of stenting was noted in 3 categories of patients: those >65 years of age (OR 1.33, P = 0.049), those with non-insulin-requiring diabetes (OR 2.06, P = 0.002), and those with any noncoronary vascular disease (OR 1.59, P = 0.009).

In this nonrandomized observational study, CABG had a higher periprocedural mortality rate than did percutaneous stenting. At 2.5 years, however, the survival advantage of stenting was no longer evident. These data suggest that there is no intermediate-term survival advantage of CABG over stenting in patients who have multivessel disease with lesions that can be treated percutaneously. (Tex Heart Inst J 2002;29:3–9)

Fig. 1 Adjusted and unadjusted survival rates in all patients treated with CABG or PCI-stenting
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC101260/table/t3-2/?report=previmg

TABLE III. Multivariate Correlates of Intermediate-Term (2.5-Year) Mortality
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC101260/table/t3-2/?report=previmg

Fig. 2 Adjusted odds ratios comparing the results of CABG and PCI-stenting in the 8 anatomic subgroups.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC101260/bin/2FF2.jpg

TABLE IV. Intermediate-Term (2.5-Year) Survival According to Treatment in Each of the 8 Anatomic Groups
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC101260/bin/2TT4.jpg

Fig. 3 Adjusted odds ratios comparing the results of CABG and PCI-stenting in the various prespecified subsets.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC101260/bin/2FF3.gif

Will Drug-Eluting Stents Replace Coronary Artery Bypass Surgery?

Abstract

Introduction

The growth of the PCI industry and the consequent decline in the number of patients referred for CABG has produced much speculation about the future role of each type of intervention. Because the new drug-eluting stents allow PCI to be performed with lower rates of early restenosis than do bare-metal stents or percutaneous transluminal coronary angioplasty (PTCA) alone, 2–8 some have predicted that surgical revascularization will soon be obsolete.

CABG vs Pharmaco-Therapy

Randomized clinical trials performed during the 1970s and early 1980s clearly established the advantages of CABG over medical therapy in patients with triple-vessel CAD, left main coronary artery stenosis, double-vessel CAD with proximal left anterior descending (LAD) coronary artery stenosis, or left ventricular dysfunction. Problems arose subsequently because of the limitations built into the trial so that the results were biased in favor of medical therapy. These were:

stringent exclusion criteria that eliminated a large percentage of potential participants
left main CAD and an ejection fraction of less than 0.40, eliminated patients for whom CABG would have been beneficial
the high rate of crossover from the medical to the surgical groups

The numerous technical and technological advances made since these trials were completed limit the degree to which their results resemble those of the CAD treatments used today. The maximal medical therapy used during the trials did not routinely include lipid-lowering agents, β-blockers, angiotensin-converting enzyme (ACE) inhibitors, clopidogrel, or some of the other drugs currently used for CAD. Nor did the CABG groups benefit from advances that were subsequently made in preoperative imaging, perfusion and myocardial protection, anesthesia, and perioperative and intensive care practices. CABG did not then include the use of left internal mammary artery (LIMA) grafts, much less other arterial conduits. Finally, PCIs, including balloon angioplasty and stenting, were not included in these trials.

CABG vs PTCA

Randomized trials comparing PTCA with CABG revealed dramatically higher re-intervention rates in the PTCA groups and better angina relief in the CABG groups, although there were no significant differences in death or myocardial infarction rates. The Duke database study. 9 showed better survival rates with PTCA than with CABG in patients with single-vessel CAD, whereas CABG produced better survival than did PTCA in patients with severe, triple-vessel CAD.

These results are not necessarily representative of the results obtainable today with PTCA and CABG, for several reasons.

1. stents were not used in the PTCA patients in these trials

2. operative mortality rates for the CABG groups were higher than the rates currently found in the Society of Thoracic Surgeons (STS) database

3. the inclusion/exclusion criteria of these studies eliminated a high percentage of those patients who might have benefited more from CABG than from PTCA

CABG vs Stents

The introduction of coronary artery stenting resulted in better outcomes than those produced by balloon angioplasty or by other adjuncts, including rotational atherectomy, brachytherapy, and laser angioplasty. Since then, stent designs and delivery techniques have advanced considerably. The use of coronary stents has greatly decreased the necessity of emergent CABG for technical failure of PCI and for dissection or rupture of coronary arteries during PCI. Another major advance in the application of PCI is the use of the antiplatelet agent clopidogrel in addition to aspirin after PCI, as well as the use of glycoprotein (GP) IIb/IIIa receptor inhibitors during the procedure. These adjuncts have significantly reduced the incidence of acute and subacute thrombosis after PTCA with stenting.

Randomized trials comparing PTCA plus stenting with PTCA alone have shown that stenting significantly reduces rates of restenosis and re-intervention, as well as the frequency of emergent CABG. On the other hand, randomized trials of stenting versus surgery have produced less conclusive results regarding the mid-term survival and freedom from adverse events. For example, the Stent or Surgery (SOS) trial reported a greater need for repeat revascularization in the stent group (21%) than in the CABG group (6%) and a survival advantage in the CABG group (hazard ratio, 2.91; 95% CI, 1.29–6.53; P = 0.01) during the 3-year follow-up period. Additionally, angina and the use of anti-angina medications were less common in the CABG group at 1-year follow-up.

The ARTS and ERACI trials also reported an increased need for revascularization in the stent groups but did not show a survival advantage in the CABG groups. This was due in part to a higher operative mortality rate in the CABG group than reported in the STS database. Like the PCI versus CABG trials mentioned previously, these randomized trials involved a select group of patients with relatively low expected mortality rates and relatively high expected technical success with PCI.

Observational data in retrospective analyses of large patient databases comparing CABG with PCI plus stenting does indicate that, because of the greater invasiveness of surgical revascularization, CABG produces greater operative mortality than does PCI. However, in patients with multivessel CAD, the risk-adjusted survival rates at 2.5 years of follow-up are no better for PCI than for CABG, and 3 recent risk-adjusted observational studies showed that the CABG patients had a significant survival advantage at 3- to 8-year follow-up. The CABG patients had significantly more preoperative risk factors than did the PCI patients in each study, so that unadjusted, the CABG groups in each study included significantly more patients with triple-vessel disease and fewer patients with double-vessel disease than did the PCI groups. Again, we have a moving target with recent advances in both surgery and PCI technology.

Disadvantages of Stenting

The Achilles’ heel of PCI is restenosis and the need for repeat revascularization. Stents have decreased the rate of acute and subacute periprocedural thrombosis. The newer, drug-eluting stents (DESs) have improved in-stent restenosis rates, especially in the carefully selected patient populations studied in the early DES trials. In the RAVEL trial, the early reports of zero in-stent restenosis compared favorably with the 27% in-stent restenosis rates in the bare-metal stent control group at 6-month follow-up. However, the RAVEL trial excluded patients with lesions longer than 18 mm, ostial targets, calcified or thrombosed targets, or target arteries less than 2.5 mm in diameter.

The media frenzy that followed the release of these findings created a public demand for these new “miracle” stents that apparently did not re-occlude. Stories of CAD patients refusing conventional PCI and CABG —instead, adding their names to the list of patients waiting for U.S. Food and Drug Administration (FDA) approval of DESs—appeared to change the practice patterns of cardiologists and cardiac surgeons overnight. And then there were the calls for class-action lawsuits and recall of various DES models. After the FDA approved the Cordis Cypher™ DES (Cordis Corporation, a Johnson & Johnson company; Miami Lakes, Fla), a few reports of subacute thrombosis and hypersensitivity reactions prompted the FDA to release a public health notification on 29 October 2003.

The SIRIUS trial had slightly less strict exclusion criteria than did the RAVEL trial, admitting patients with target lesions 2.5 to 3.5 mm in diameter and 15 to 30 mm long, as well as patients with diabetes mellitus (who constituted 26% of the total group). The SIRIUS trial also differed from the RAVEL trial in that the reported end-point was in-segment restenosis, rather than in-stent restenosis. The results showed a significant advantage of DESs over bare-metal stents for preventing in-segment restenosis (9.2% vs 32.3%) and target failures (10.5% vs 19.5%), but major adverse cardiac events were more frequent in the DES group than in the bare-metal stent group (3.7% vs 1.0%). Interestingly, the 6-month restenosis rates of the bare-metal stents in the RAVEL and SIRIUS control groups were much higher than the 19% 12-month restenosis rate associated with bare-metal stents in an earlier study comparing bare-metal stents with PTCA. In fact, the restenosis rates in the RAVEL and SIRIUS control groups more closely resembled the 40% restenosis rate reported for the PTCA control group in the earlier study.

The practical advantages of DESs over bare-metal stents are evident; nonetheless, we still do not have sufficient mid-term or long-term clinical data to argue that PTCA with DESs is preferable to CABG in “real-world” patients who require revascularization. Although DESs will likely provide better outcomes than bare-metal stents for many patients for whom stenting is indicated, a general extrapolation of existing data to justify the use of DESs in patients for whom CABG is currently indicated is unknown, perhaps undeterminable because the lesion and patient characteristics that lead to the failure of PCI are multifactorial, and the size of the population with lesions having unfavorable characteristics , such as,

longer
total occlusion
branch
small-diameter
calcified
multiple
left main
ostial, and
diffuse lesions

are being treated with PCI more often, as well as diabetics, multiple lesions, and patients with multiple comorbidities.

Advantages of CABG

Over the last 4 decades, surgical coronary artery revascularization techniques and technology have advanced significantly. As a result, despite an increasingly older and sicker patient population, CABG outcomes continue to improve. Observed operative mortality rates have decreased because advances in preoperative evaluation, including more precise coronary artery and myocardial imaging and diagnostic techniques, have allowed more appropriate patient selection and surgical planning. In addition, preoperative, intraoperative, and postoperative monitoring and therapeutic interventions have made CABG safer, even for critically ill and high-risk patients. Improvements in cardiopulmonary perfusion and careful myocardial protection, as well as the use of off-pump and on-pump beating- heart techniques in selected patients, have also decreased perioperative morbidity and mortality rates.

LIMA-to-LAD Long-Term Patency

The long-term benefits of CABG with regard to survival and quality of life are dependent on prolonged graft patency. The LIMA-to-LAD bypass, which is now performed in more than 90% of CABG procedures, shows excellent patency in 10- to 20-year angiographic follow-up studies, setting the gold standard with which other revascularization strategies should be compared. Tatoulis et al. reported that LIMA-to-LAD grafts had a 97.1% patency rate in patients who underwent angiography for cardiac symptoms. Those authors also found high patency rates at 5-year (98%), 10-year (95%), and 15-year (88%) follow-up. However, there are not yet long-term data on bare-metal stents or DESs, and by the time 10- or 20-year data are available, DESs probably will have been replaced by a newer, more advanced technology.

Because of the reported success of the LIMA-to-LAD bypass, other types of arterial conduits are also being used much more frequently. Conduit selection has become an area of great interest to cardiac surgeons, and conduit studies are expanding our understanding of the mechanisms of graft failure and ways to improve bypass graft patency. For example, studies have shown that patients who undergo CABG with both LIMA and right internal mammary artery (RIMA) conduits have better results than those who undergo CABG with one IMA and one or more saphenous vein grafts.

Techniques to Improve Conduit Patency

To maximize the odds of long-term graft patency, surgeons carefully harvest the graft as a pedicled or skeletonized conduit using “no touch” techniques. Using careful anastomotic technique to avoid excessive turbulence at the anastomosis site will prolong graft patency, and the quality of the conduit is crucial. Long-term graft patency depends not only on the conduit chosen but also on the target artery and the degree of stenosis proximal to the anastomosis. Maintaining flow patterns in the native artery, including residual flow (that is, competitive flow) and outflow, is important to avoid stasis in the graft, turbulence at the anastomosis, and vasospasm, especially in arterial conduits. Studies have shown an inverse relationship between the degree of proximal stenosis and graft patency. Targeting the LAD produces the highest patency rates. The characteristics of the target artery also determine graft patency, including –

1. the diameter of the target artery,

2. the presence or absence of diffuse disease within the artery,

3. whether or not the artery requires endarterectomy

Surgeons can avoid atheroembolic events by handling the aorta carefully or not at all. They can also improve safety by

1. using aggressive myocardial protection techniques;

2. avoiding the induction of inflammatory mediators; and

3. carefully controlling

blood pressure,
body temperature, and
electrolyte and glucose levels.

Although there have been major innovations that have enabled surgeons to perform cardiac surgery (including CABG) less invasively, minimally invasive surgical procedures are useful only if they are at least as efficacious as conventional surgery. New technology is being developed to enhance the evolving field of minimally invasive coronary bypass surgery.

Hybrid Coronary Revascularization

As PCI technology improves and techniques of LIMA-to-LAD grafting become less invasive, hybrid coronary revascularization is becoming a distinct possibility. For example, a minimally invasive, off-pump, direct LIMA-to-LAD anastomosis can be combined with DES placement in a focal mid-right-coronary-artery lesion in a patient with complex proximal LAD lesions. Hybrid coronary revascularization procedures are currently being performed, with promising early results. A few centers now have hybrid operating rooms with cardiac surgical and coronary angiographic capabilities that make it possible to perform simultaneous hybrid coronary revascularizations.

Although coronary artery bypass grafting (CABG) remains the treatment of choice for certain types of coronary artery disease (CAD), percutaneous coronary intervention (PCI)—particularly coronary angioplasty with stenting—has become the most popular nonmedical treatment approach to CAD. Some have speculated that, with the advent of drug-eluting stents (DESs), PCI will replace CABG entirely. However, the complete disappearance of CABG is both unlikely and unwarranted, for several reasons. Published randomized trials of CABG, PCI, and medical approaches to CAD compared only highly selected subgroups of patients because of strict exclusion criteria that often favored the PCI cohorts. Therefore, their results do not constitute sufficient evidence for the superiority of PCI over CABG in all CAD patients requiring revascularization. As PCI indications broaden to include more complex lesions and more high-risk patients, outcomes will not remain as favorable. In addition, although PCI is less invasive than surgery, CABG offers more complete revascularization and better freedom from repeat revascularization. Furthermore, no long-term patency data on DESs yet exist, whereas excellent 10- and 20-year patency rates have been reported for the left internal mammary artery-to-left anterior descending artery graft used in most CABG procedures. While PCI has been changing, CABG has not been stagnant; recently, advances in many aspects of the CABG procedure have improved short- and long-term outcomes in CABG patients. Both CABG and PCI technologies will continue to advance, not necessarily exclusive of one another, but no data yet exist to suggest that DESs will render CABG obsolete any time soon.

Will Stent Revascularization Replace Coronary Artery Bypass Grafting?

When we discuss revascularization outcomes, we are talking about 3 major endpoints: death, myocardial infarction, and symptom control. With respect to death, we know that revascularization benefits patients who have severe multivessel disease and left ventricular dysfunction or other physiologic indicators of high risk. 2-vessel disease with proximal left anterior descending coronary artery (LAD) stenosis has been accepted as an indication for revascularization, even though the supporting data come from a small subgroup in a single trial. There has been no success in proving that endovascular treatment has a positive impact on stable CAD, but it is relevant because we leave the native arteries relatively intact. Attempts to improve graft performance beyond the relatively spectacular performance of the pedicled internal mammary artery (IMA) graft to the LAD have been disappointing.

Fig. 1 Graph of graft patency shows deterioration rates over 10 years and the comparative superiority of using the internal mammary artery (IMA) instead of the saphenous vein (SVG).http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528239/bin/25FF1.gif

Percutaneous Transluminal Coronary Angioplasty

When angioplasty was introduced, the hope was for a method of revascularization that would rival coronary artery bypass grafting. However, the results were mixed. Angioplasty worked well in patients with no major risk factors, such as diabetes mellitus, but failed miserably in diabetic patients. In fact, the Bypass Angioplasty Revascularization Investigation (BARI) taught us this: if revascularization is needed, regardless of physiologic markers of high risk, the use of percutaneous coronary intervention (PCI) is potentially harmful in comparison with an IMA bypass for the LAD.

Stents and Short-Term Outcomes

The use of stents drastically reduced the probability of emergent surgery after attempted; however, the probability of new lesion formation or restenosis after intervention did not decrease.

Fig. 2 Diagrams show the calculated success (after percutaneous revascularization) of A) percutaneous transluminal coronary angioplasty (PTCA), and B) bare-metal and C) drug-eluting stenting in patients with 3-vessel coronary artery disease (CAD).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528239/bin/25FF2.gif

At the same time, surgeons got better. Myocardial preservation techniques improved, and the use of the pedicled IMA graft changed the game. As a result, successful revascularization, meaning long-term success, became the domain of the surgeon. We at the Texas Heart Institute/St. Luke’s Episcopal Hospital (THI/SLEH) examined our long-term outcomes after stenting or surgery, and we initially reported that stenting was just as beneficial as surgery. This was in accord with the results of several trials: whenever placing a stent was feasible, stent therapy and surgery had the same outcome.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528239/bin/25TT1.jpg

success after PTCA vs bare-metal and drug-eluting stents

Stents and Long-Term Outcomes

Later, when we looked at longer-term follow-up data and the effects of multiple procedures, this picture began to change. Stented patients underwent more procedures. When the risk of one surgical procedure was compared with that of multiple endovascular procedures, the outcomes became more similar, especially in patients with bifurcation lesions or lesions with severe calcification. Drug-eluting stents, with their promise of no restenosis, substantially increased interventional cardiologists’ reach, but not their grasp. In patients with multivessel disease and high-risk lesions, DES placement was almost as risky as surgery and did not yield the same long-term benefit.

Nevertheless, we found locally that the introduction of the DES, with its lower risk of restenosis, was treated as a blessing to proceed with stenting (Table I). This did not follow the data, but cardiologists continued anyway, given the promise of less restenosis. Early risk was discounted, glycoprotein IIb/IIIa inhibitor use declined overnight, and the rate of endovascular procedural complications rose to meet that of surgery without the promise of an IMA graft in our future.

Table I. Independent Predictors of 30-Day Major Adverse Cardiac Events and 3-Year Survival after Drug-Eluting Stent Placement
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528239/bin/25TT1.jpg

Comparing Stenting and Surgery

For decades, methods have been sought to quantify lesion complexity in order to compare the early and late risks associated with stenting versus surgery. Although no perfect system has been devised, the SYNTAX was an important step forward. The SYNTAX score is a simple, computer-based tool for evaluating the risk of complications or failure after PCI. And there are other tools for estimating the same complications after surgery. These estimates enable cardiologists to give patients objective advice regarding the revascularization method that has the best short- and long-term probability of success.

In the patient with non-life-threatening disease (that is, not left main or severe multivessel CAD with left ventricular dysfunction or severely impaired function), stent revascularization has become a reasonable, although not ideal, alternative to surgical revascularization. However, this is true only if stenting is confined to patients whose anatomy and physiology are suited to it—considerations that are well quantified in the SYNTAX score. Whenever questions arise as to the most appropriate therapy, the SYNTAX score should be weighed against clinical characteristics that affect surgical risk. This will guide discussions between the cardiologist, cardiovascular surgeon, patient, and treating physician.

I think that our THI risk is more useful than the other available scores. It uses simple clinical data and can be easily calibrated to the geographic location of its use. Other scores require data that might not be available at the time of clinical decision-making or at all—making such predictions hazardous, at best.

Conclusion

With regard to the chosen mode of revascularization, it is perhaps safe to say that the decision goes beyond the individual physician and must become collective. When a patient has multivessel disease, a reasoned approach must be taken, using these predictive tools and considering the patient’s wishes. Treatment decisions should include all interested parties: the patient, cardiologist, cardiovascular surgeon, and anesthesiologist. The time of ad hoc angioplasty for the patient with multivessel CAD has passed.

Should all ischemic mitral regurgitation be repaired? When should we replace? Curr Opin Cardiol. 2011

Abstract

Purpose of review

Ischemic mitral regurgitation (IMR) is a major source of morbidity and mortality. Although mitral valve repair has become recently popularized for the treatment of IMR, select patients may derive benefits from replacement. The purpose of this review is to describe current surgical options for IMR and to discuss when mitral valve replacement (MVR) may be favored over mitral valve repair.

Recent findings

Current surgical options for the treatment of IMR include surgical revascularization alone, mitral valve repair, or MVR. Although surgical revascularization alone may benefit patients with mild–moderate IMR, most surgeons advocate the performance of revascularization in combination with either mitral valve repair or replacement. In the current era, mitral valve repair has proven to offer improved short-term and long-term survival, decreased valve-related morbidity, and improved left ventricular function compared with MVR. However, MVR should be considered for high-risk patients and those with specific underlying mechanisms of IMR.

Summary

In the absence of level one evidence, mitral valve repair offers an effective and durable surgical approach to the treatment of mitral insufficiency and remains the operation of choice for IMR. MVR, however, is preferred for select patients. Future randomized, prospective clinical trials are needed to directly compare these surgical techniques.

Introduction

Ischemic mitral regurgitation (IMR) describes insufficiency of the mitral valve in the setting of myocardial ischemia, resulting from coronary artery disease. Although IMR may present in the acute setting, usually as a papillary rupture (Carpentier type II), it is usually a consequence of chronic myocardial ischemia that typically presents weeks following a complete infarction. IMR describes mitral insufficiency in the absence of degenerative (structural) mitral valve disease. The underlying pathophysiologic mechanisms of IMR are often complex, resulting from several different structural changes involving left ventricular geometry, the mitral annulus, and the valvular/subvalvular apparatus. Although changes to any one component may result in detectable mitral valve insufficiency, moderate-to-severe IMR requiring surgical correction often involves the complex interplay of several co-existent anatomic changes. These underlying mechanisms result in clinically significant valve incompetence due to the combined effects of decreased ventricular function and restricted motion of the valve itself due to tethering.

IMR is a major source of patient morbidity and mortality. Although the frequency of IMR differs based upon imaging modality, estimates have suggested that nearly 20–30% of patients experience mitral insufficiency following myocardial infarction. Furthermore, its intimate association with heart failure and poor outcomes for suboptimal medical management further complicates the management of clinically significant IMR. Recent evidence suggests that moderate or severe mitral regurgitation may be associated with a three-fold increase in the adjusted risk of heart failure and a 1.6-fold increase in risk-adjusted mortality at 5-year follow-up. In addition, unfavorable patient profiles and co-existing comorbid disease, including renal failure, chronic obstructive pulmonary disease, diabetes, and impaired left ventricular function, further complicate the clinical picture for those with IMR. Consequently, surgical correction of this condition is often required.

The purpose of this review is to analyze published results for the surgical correction of IMR and to provide current opinion regarding the selection of mitral valve procedure in the setting of myocardial ischemia. Herein, we review current surgical options for IMR and discuss when MVR may be favored over mitral valve repair.

Surgical options for ischemic mitral regurgitation: surgical revascularization alone

Surgical revascularization alone with CABG may be beneficial for some patients. Although CABG alone may be performed in cases of mild-to-moderate IMR, for the treatment of severe IMR, evidence supports performance of CABG with a mitral valve. In fact, a lack of evidence exists to support the performance of CABG alone for severe IMR. In one retrospective review of propensity-matched cohorts, Diodato et al. suggested that addition of a mitral valve procedure to patients undergoing CABG for moderately severe to severe IMR did not increase mortality or improve survival over the performance of CABG alone. This study, however, was limited by small sample sizes (51 CABG + mitral valve repair vs. 51 CABG alone) and 3-year follow-up. To the contrary, substantial evidence exists to support the performance of surgical revascularization alone in cases of mild-to-moderate IMR.

A study by Aklog et al. investigated the role of CABG alone in the correction of moderate IMR. In their series of 136 patients with moderate IMR, they demonstrated that performance of revascularization alone conferred improvement of mitral regurgitation in 51% of patients with complete resolution in an additional 9%. Despite these results, 40% of patients remained with 3–4+ mitral regurgitation, leading the authors to conclude that CABG alone may not be the optimal therapy for most patients and suggest that concomitant mitral annuloplasty may improve results. Other series similarly suggest that complete resolution of functional IMR is uncommon following revascularization alone. Despite the presence of residual mitral regurgitation following revascularization, the impact of performance of CABG without a valve procedure on long-term survival remains ill defined. Currently, on-going prospective evaluation may help to define the potential role of revascularization alone for patients with moderate IMR. Until the completion of these trials, however, evidence supports the performance of surgical revascularization combined with a mitral valve procedure for moderate-to-severe mitral regurgitation.

Surgical revascularization with a mitral valve procedure

The majority of patients with moderate-to-severe IMR require surgical revascularization with a concomitant mitral valve procedure (MVR or mitral valve repair). Historically, these procedures have been associated with high morbidity and mortality as well as poor long-term. However, improved surgical techniques and postoperative management have improved contemporary outcomes. Those favoring mitral valve repair promote its beneficial effects on survival, preserved ventricular function, and the avoidance of long-term anticoagulation, whereas those favoring MVR argue that it ensures long-term freedom from recurrent mitral insufficiency.

Mitral valve replacement vs. mitral valve repair

The use of MVR for IMR eliminates the possibility of recurrent IMR. In addition, previous literature suggests improvements in surgical technique for MVR 29–32. For patients with IMR, MVR with preservation of the subvalvular apparatus using a chordal sparing technique has been shown to be beneficial 33. David and Ho 33 demonstrated a significant survival benefit for patients undergoing MVR with preservation of chordae tendineae (89%) compared with complete excision of the mitral valves (59%) in a cohort of 51 patients with IMR. In addition, Cohn et al. suggested disproportionate survival benefits favoring MVR in a cohort of 150 patients with both functional and structural IMR, concluding that survival following performance of mitral valve procedures for IMR was more dependent on underlying pathophysiology rather than surgical technique. More recently, series have suggested equivalent results for the MVR and mitral valve repair. Mantovani et al. report that prosthetic MVR and mitral valve repair offer very similar results for chronic IMR, demonstrating similar operative mortality and 5-year actuarial survival for both techniques. In a similar report, Magne et al.•• compared short-term and long-term outcomes for 370 patients undergoing mitral valve repair (n = 186) and MVR (n = 184) for IMR. Although operative mortality was lower for mitral valve repair compared with MVR (9.7 vs. 17.4%, P = 0.03), 6-year survival was similar for both operations (73 ± 4 vs. 67 ± 4%, P = 0.17). Type of procedure was also not an independent predictor of mortality following risk adjustment. As a result, the authors suggest that mitral valve repair is not superior to MVR for patients with IMR.

In contrast, other series favor the performance of mitral valve repair for functional IMR. Although several repair techniques exist, restrictive annuloplasty remains the most commonly performed operation 37• and has been shown to be beneficial in both functional and chronic IMR 38•. The purported benefits of improved survival, decreased valve-related morbidity, and improved left ventricular function have been previously established, and several series have reported lower hospital mortality with mitral valve repair compared with MVR.

The Cleveland Clinic published a landmark review of 482 patients undergoing mitral valve procedures for IMR to study the influence of mitral valve procedure type on survival 1. In this series, propensity-matched cohorts were compared: mitral valve repair (n = 397) vs. MVR (n = 85). Concomitant CABG was performed in 95% of operations, and annuloplasty for repair occurred in 98% of cases. After matching, patients were risk stratified into five quintiles. Group 1 represented the highest-risk patients with higher degrees of heart failure and emergent operations, and group 5 represented the lowest-risk patients. Subsequent survival analysis revealed that overall 5-year survival was poor for patients with IMR (58% mitral valve repair vs. 36% MVR, P = 0.08). Moreover, within matched quintiles, the highest-risk patients (quintile 1) had the worst survival, but survival was similar (P = 0.4) despite mitral valve procedure type. In contrast, survival favored mitral valve repair over replacement for quintiles III–V (P = 0.003).

In the absence of published randomized trials, two recently published meta-analyses provide more robust comparisons of the influence of surgical mitral valve repair or replacement. Shuhaiber and Anderson compared outcomes of 29 studies, including over 10 000 patients. Study groups were stratified based upon mitral valve etiology into ischemic, degenerative/myxomatous, rheumatic, and mixed groups. Summary analyses indicated worse overall survival for MVR (early mortality odds ratio = 2.24 and total survival hazard ratio = 1.58) compared with repair. Mitral valve repair was also associated with lower rates of thromboembolism. Moreover, a nonsignificant trend toward lower 30-day mortality favored mitral valve repair for those with IMR. The most recent meta-analysis to date compared short-term and long-term survival of mitral valve repair vs. replacement specifically for IMR ••. In this analysis, nine studies were included based upon stringent exclusion criteria to ensure direct comparisons of survival for mitral valve procedures exclusively performed for IMR. Interestingly, in this series, although patients undergoing MVR were older, those undergoing repair often had higher rates of hypertension and diabetes with lower ejection fractions. Further, the proportion of patients with severe ventricular dysfunction was similar between procedure groups. These findings conflict with a common assumption that an inherent selection bias exists within published studies for the performance of mitral valve repair in healthier patients. Nevertheless, MVR was associated with worse short-term mortality (odds ratio = 2.667) and long-term mortality (hazard ratio = 1.35) compared with mitral valve repair, and the authors advocate that choice in mitral procedure should be based upon individual patient profile.

When not to repair ischemic mitral regurgitation?

Within the context of published literature and current dogma among practicing surgeons, the fundamental question of when not to repair an ischemic mitral valve remains. For several years, accumulated evidence supports the performance of mitral valve repair over replacement for the surgical treatment of functional IMR. The aforementioned benefits of repair include improved long-term survival, durability and efficacy, improved ventricular function, and avoidance of chronic anticoagulation therapy. Nevertheless, MVR still plays a select role in the treatment of IMR.

With respect to the performance of MVR, the use of bioprosthetic valves and the avoidance of mechanical valve replacement are preferred. This choice is largely driven by the avoidance of complications due to long-term anticoagulation use as well as by the belief that it is unlikely that the majority of patients requiring MVR are likely to encounter bioprosthetic deterioration in their lifetime. In addition, MVR with techniques to preserve the subvalvular apparatus should be performed when possible.

Summary

Undoubtedly, the debate regarding when to perform repair or replacement for IMR remains unsettled. In the recent era, mitral valve repair has proven efficacious and remains the preferred surgical strategy for most cases of IMR. MVR should be considered for severe tethering, complex or uncertain mechanisms of mitral insufficiency, regurgitation due to papillary muscle rupture, and perhaps for the sickest and highest-risk patients.

The present review was supported by Award Number 2T32HL007849-11A1 (D.J.L.) from the National Heart, Lung, and Blood Institute. The content is solely the responsibility of the authors.

Hybrid Cath Lab Combines Nonsurgical, Surgical Treatments 2008

A new cardiac treatment facility that couples the benefits of interventional cardiology with cardiothoracic surgery for critically ill newborns, children and adults has opened at Rush University Medical Center, Chicago. Toshiba’s new biplane hybrid cardiac suite, which is one of only three facilities of its kind in the U.S., is equipped with the latest in continuous, real-time imaging technology and radio frequency identification (RFID) technology which allows “all-in-one-room” care. The suite allows collaboration between the surgeon and interventional cardiologist on complex heart problems. For example, fixing a very large hole in the heart can be done by inserting a catheter through a small incision in the chest rather than relying on major surgery to open the chest to reach the heart. “Now, interventional cardiologists and cardiothoracic surgeons working together in this suite will reduce the amount of time required to correct complex heart problems and reduce the emotional and physical stress placed on a patient and their family – which translates into less pain, less scarring and a faster recovery time,” Ziyad Hijazi, M.D., director of the new Rush Center for Congenital and Structural Heart Disease. The hybrid suite is equipped with the latest technology for minimally invasive interventional cardiology that involves the use of a catheter and an image-guidance system to thread tiny instruments through blood vessels to repair the heart. Through these special catheters, physicians at Rush can implant stents, artificial heart valves and insert patches for holes in the heart. In many complex cardiac cases, patients who would otherwise have no other option but to undergo open-heart bypass surgery can now have minimally invasive procedures that would otherwise not be available to them. “We can now communicate with colleagues and obtain their expertise in real time for very complex situations,” said Dr. Hijazi. “If physicians decide another procedure is needed, even surgery, the suite can be converted into an operating room and the surgical team can be assembled in the new suite ”Patients at Rush will stay in one place in the new hybrid cardiac suite where all the imaging technology and implantable devices that might be needed are stored and located. The additional ability it gives us to provide surgical treatments allows us to provide the most comprehensive care in the most sensitive manner for patients with often extremely fragile conditions.” The new hybrid cardiac catheterization suite has the most advanced imaging technologies and can still get a precise, optimal image of any region of the heart regardless of the size or complexity of congenital heart disease. The imaging system also features eight-inch cardiac flat panel detectors designed to deliver distortion-free images. The suite also includes intravascular ultrasound machines, which takes real-time images to allow physicians to see the progress of the procedure taking place inside the patient’s body. A high-tech, automated clinical resource management system located in the suite stores and tracks the medication, surgical tools, medical devices, and implantable devices and supplies using the latest RFID enabled technology.

Hybrid Cath Lab/ORs Are the Way of the Future

Recent developments in cardiac surgery and interventional cardiology with new percutaneous alternatives for aneurysm repair, valve replacements, shunt closure devices and aortic arch reconstruction have led to the creation of integrated, hybrid cath lab/operating rooms (OR) that allow both surgical and intravascular procedures. These rooms offer both surgical equipment and high-end angiographic equipment. Creating such rooms requires special planning and design from both surgical and interventional cardiologists working closely together. Cath labs have high-quality fluoroscopy equipment, but generally are smaller rooms and lack the sterile requirements and equipment needed for surgical procedures. ORs tend to use lower quality mobile C-arms, which are not ideal for interventional procedures. The hybrids aim to provide the best of both worlds. The trend toward hybrid labs has been reinforced by digital angiography manufacturers partnering with surgical equipment companies to create easy-to-integrate hybrid room solutions with coordinated installation. Philips partners with both Skytron and Steris. Toshiba partners with MAQUET. GE Healthcare, Siemens and Toshiba also offer hybrid installations. Philips said while some hospitals want to combine interventional procedures with minimally invasive surgeries, they also want a properly equipped room in case emergency surgery is needed.

Philips said hybrids also allow hospitals with lower PCI numbers to get a bigger bang for their buck by allowing the same room to serve the needs of surgeons. Penn Presbyterian Medical Center in Philadelphia, PA, created a hybrid lab with help from Siemens, which opened in November. Wilson Szeto, M.D., cardio-thoracic surgeon, and William Matthai, M.D., interventionalist, both from Penn Presbyterian said hybrid labs are ideally suited for procedures that require both percutaneous and surgical interventions, percutaneous valve replacements, deploying percutaneous septal occluders or installing aortic stent grafts. Interventionalists can also be called in after cardiac surgery to perform a completion angiography.

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54. Lam BK, Gillinov AM, Blackstone EH, et al. Importance of moderate ischemic mitral regurgitation. Ann Thorac Surg. 2005;79:462–470. discussion 462–470. [PubMed]

55. Ryden T, Bech-Hanssen O, Brandrup-Wognsen G, et al. The importance of grade 2 ischemic mitral regurgitation in coronary artery bypass grafting. Eur J Cardiothorac Surg. 2001;20:276–281. [PubMed]

56•. Goland S, Czer LS, Siegel RJ, et al. Coronary revascularization alone or with mitral valve repair: outcomes in patients with moderate ischemic mitral regurgitation. Tex Heart Inst J. 2009;36:416–424. This series documents current outcomes for the performance of CABG alone with/without concomitant mitral valve repair for ischemic mitral regurgitation. The authors report similar 5-year survival rates for both techniques; however, revascularization with repair resulted in significantly reduced mitral regurgitation grade, improved left ventricular function, and functional class compared with revascularization alone. This study provides an important comparison of these two techniques in the current surgical era. [PMC free article] [PubMed]

57••. Magne J, Girerd N, Senechal M, et al. Mitral repair versus replacement for ischemic mitral regurgitation: comparison of short-term and long-term survival. Circulation. 2009;120(11 Suppl):S104–S111. In this study, the authors compare postoperative outcomes for mitral valve repair and replacement for ischemic mitral regurgitation. Despite lower operative mortality following mitral valve repair, long-term survival was equivalent between surgical groups. This study adds important long-term comparisons of mitral valve procedures to accumulating data examining surgical treatments for ischemic mitral regurgitation. [PubMed]

58. Silberman S, Klutstein MW, Sabag T, et al. Repair of ischemic mitral regurgitation: comparison between flexible and rigid annuloplasty rings. Ann Thorac Surg. 2009;87:1721–1726. discussion 1726–1727. This study provides a contemporary comparison between the use of flexible and rigid annuloplasty rings for the surgical treatment of IMR. The authors report significantly improved clinical and hemodynamic results for rigid mitral annuloplasty rings compared with flexible rings. [PubMed]

59•. Tekumit H, Cenal AR, Uzun K, et al. Ring annuloplasty in chronic ischemic mitral regurgitation: encouraging early and midterm results. Tex Heart Inst J. 2009;36:287–292. This study reports early and midterm results for the use of flexible annuloplasty rings for the surgical treatment of chronic IMR. The authors demonstrate that use of flexible mitral valve annuloplasty conferred a reduction in left ventricular diameter with improved New York Heart Association functional class. This study reports current, encouraging results and provides a context for future investigations comparing flexible and rigid annuloplasty rings for chronic IMR. [PMC free article] [PubMed]

60. Shuhaiber J, Anderson RJ. Meta-analysis of clinical outcomes following surgical mitral valve repair or replacement. Eur J Cardiothorac Surg. 2007;31:267–275. [PubMed]

61••. Vassileva CM, Boley T, Markwell S, Hazelrigg S. Meta-analysis of short-term and long-term survival following repair versus replacement for ischemic mitral regurgitation. Eur J Cardiothorac Surg. 2010 [Epub ahead of print] This meta-analysis provides a comparison of nine published series specifically addressing the performance of mitral valve repair vs. replacement for IMR. The authors demonstrate worse short-term and long-term mortality for MVR. Their analysis offers an up-to-date and robust comparison of these two surgical techniques. [PubMed]

Texas Heart Institute: 50 Years of Accomplishments

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, CABG, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Mitral Valve: Repair and Replacement, PCI, Renal Denervation, Stents & Tools, Valves & Tools, tagged Cardiovascular disease, Texas Heart Institute, Texas Medical Center, University of Texas MD Anderson Cancer Center on May 4, 2013| Leave a Comment »

Texas Heart Institute: 50 Years of Accomplishments

Reporter: Aviva Lev-Ari, PhD, RN

Texas Heart Institute’s Overachieving President and Medical Director Dr. James T Willerson Profiles THI’s 50 Years Of Accomplishments

Posted Thursday , April 25,2013

The Texas Heart Institute is a not-for-profit cardiology and heart surgery center located at the Texas Medical Center in Houston. Founded in 1962 by Dr. Denton A. Cooley, the mission of the Texas Heart Institute has been to reduce the devastating toll of cardiovascular disease through innovative programs in research, education and improved patient care. Over the past 51 years the Institute has been involved in training cardiologists, heart surgeons, imaging specialists in cardiovascular medicine and cardiac electrophysiology, and pathologists, and educated hundreds of cardiovascular specialists.

A nonprofit organization in the truest sense, and unlike most institutions that have a source of operating revenue, the Texas Heart Institute relies solely on government grants, research contracts and, above all, philanthropy, with donations from grateful patients, foundations, corporations, physicians, and the general public account for more than half of the Institute’s annual operating budget. The Institute’s location in and affiliations with St. Luke’s Episcopal Hospital and Texas Children’s Hospital have assured that all age groups will be treated, and has freed the Institute of the burden of financing a health care facility.

The Texas Heart Institute (THI) and its clinical partner, St. Luke’s Episcopal Hospital, have become one of America’s largest cardiovascular centers, whose 160-member professional staff have reportedly performed more than 100,000 open heart operations, 200,000 cardiac catheterizations, and 1,000 heart transplants.

In its 2010 annual survey of “America’s Best Hospitals,” U.S. News & World Report ranked the Texas Heart Institute at St. Luke’s Episcopal Hospital number four in the United States for heart care, marking this its 20th consecutive year of inclusion as one of the top 10 heart centers in the country.

In an interview with the European science news journal Research Media, THI President and Medical Director, Dr. James T Willerson, says that when he originally came to the Institute in 2004, then still President Dr Cooley wanted him to be Medical Director of Cardiovascular Research, and upon Dr. Cooley’s resignation in 2008, he asked Dr. Willerston to succeed him in that position.

In the interview, Dr. Willerston, a native Texan, profiles the THI’s achievements and shares his thoughts on reducing the heavy burdens of Cardiovascular disease, which is estimated to cost the economy $449 billion annually.

Accounting for over a quarter of all deaths in the U.S. each year, cardiovascular disease is obviously a major health concern, but mortality from coronary heart disease (CHD) has substantially decreased in recent decades. Dr. Willerston attributes the decrease to research discoveries that have provided insights into mechanisms responsible for thrombosis in injured coronary and cerebral arteries, and led to improved treatment.

He cites as an example that increased understanding of ‘bad’ low-density lipoprotein (LDL) cholesterol in patients to values well below 100 mg/dl has been a very important contribution, as has the development of statins to lower LDL has also been crucial, the use of low-dose aspirin and other medications to control blood pressure, avoidance of smoking and use of recreational drugs, control of blood sugar in patients who are diabetic, emphasis on diet and exercise, and improved imaging techniques for blood vessels and the cardiovascular system, as factors that have played a role in protecting CHD patients and decreasing mortality risk.

However, he notes that the greatest GHD risk factor is a genetic one, and a remaining priority must be to identify genes that contribute to this risk; ultimately silencing the most dangerous ones using microRNA methodology. Dr. Willerston says numerous clinical studies in patients with cardiovascular disease using a variety of stem cell types, including mesenchymal stem cells taken from the bone marrow or adipose tissue have been conducted, and that through the pioneering work of Dr Doris Taylor, scientists are now able to deplete human hearts of their cellular structure and then restore that same heart to normal function by the infusion of stem cells. With continued success, these efforts could fill a great unmet need and pave the way to a new area of transplant medicine.

Dr. Willerston maintains that prevention would be the single most effective means of reducing healthcare costs, and should be the main concern initiated at very young ages and continue throughout adulthood.

Dr. James T. Willerson, born in Lampasas, Texas, is President of The University of Texas Health Science Center at Houston where he is the Alkek-Williams Distinguished Professor and holds the Edward Randall III Chair in Internal Medicine. In October 2004, Dr. Willerson was named President-Elect of the Texas Heart Institute in Houston, Texas. He holds the Dunn Chair in Cardiology Research and the John O’Quinn Chair named the “James T. Willerson Distinguished Chair in Cardiovascular Research,” both at the Texas Heart Institute, Houston, Texas. From 1989 through 2000, he was the Chairman of the Department of Internal Medicine at The University of Texas Medical School at Houston where an Annual Lectureship has been established in his name. During this same period, he served as the Chief of Medical Services at Memorial Hermann Hospital. He is also the Medical Director, Director of Cardiovascular Research, and Co-Director of the Cullen Cardiovascular Research Laboratories at the Texas Heart Institute. He is an Adjunct Professor of Medicine at Baylor College of Medicine and at The University of Texas M.D. Anderson Cancer Center in Houston.

Dr. Willerson also founded TexGen Research, a collaboration which brings together all of the institutions in the Texas Medical Center to collect blood samples necessary for the discovery of those genes and proteins that play a key role in causing major diseases. With TexGen, each Texas Medical Center institution obtains blood samples from patients who have a personal or family history of cardiovascular disease, stroke, dementia, or selected cancers and who are admitted to their hospitals. Great progress is being made by this collaborative biomedical research effort.

A graduate of the Texas Military Institute in San Antonio, Texas, where he was the Battalion Commander, President of the Senior Class, Editor of the school newspaper, and a state swimming champion, Dr. Willerston attended The University of Texas at Austin, graduating as a Phi Beta Kappa, member of the Texas Cowboys, and where he lettered for three years in varsity swimming. Upon graduating as a member of Alpha Omega Alpha from Baylor College of Medicine in Houston, Texas, he completed his medical and cardiology training as an intern, resident, and research and clinical fellow at the Massachusetts General Hospital in Boston, Massachusetts, and as a Clinical Associate at the National Institutes of Health in Bethesda, Maryland.

He is the former Chairman of the National American Heart Association Research Committee and of the Cardiovascular and Renal Study Section of the National Institutes of Health. He has received the Award of Merit from the American Heart Association and has served as a member of the Board of Directors and Steering Committee of the National American Heart Association. Before coming to The University of Texas Medical School at Houston, Dr. Willerson was Professor of Medicine and Director of the Cardiology Division at The University of Texas Southwestern Medical School in Dallas, Texas, and Director and Principal Investigator of the National Heart, Lung, and Blood Institute’s Specialized Center of Research under a major grant from the NIH. Upon his departure, the “James T. Willerson, M.D. Distinguished Chair in Cardiovascular Diseases” was established at The University of Texas Southwestern Medical School.

Dr. Willerson has served as visiting professor and invited lecturer at more than 220 institutions worldwide, and has received numerous national and international awards, as well as having served on editorial boards for many professional publications including: The New England Journal of Medicine, Journal of Clinical Investigation, Circulation, Circulation Research, Arteriosclerosis and Thrombosis, American Journal of Medicine, Journal of the American College of Cardiology, American Journal of Cardiology, American Heart Journal, and Cardiovascular Medicine. From 1993 to 2004, he was the longest-serving Editor of Circulation, the major publication of the American Heart Association. In 1998, the monthly journal was converted to a weekly publication and attained the highest Impact Factor of any cardiology journal in the world. He has edited or co-edited twenty-four textbooks, including the Third Edition of Cardiovascular Medicine which was released in February of 2007. Additionally, he has published more than 850 scientific articles.

Dr. Willerson has been elected to membership in numerous professional societies, including the American Society of Clinical Investigation, the Association of American Physicians, the Association of Professors of Medicine, and the Institute of Medicine of the National Academy of Sciences. He was named a Distinguished Alumnus by the Baylor College of Medicine in 1998 and a Distinguished Alumnus of The University of Texas at Austin in 1999.

SOURCE:

http://bionews-tx.com/news/2013/04/25/texas-heart-institutes-overachieving-president-and-medical-director-dr-james-t-willerson-profiles-this-50-years-of-accomplishments/

Comment of Note

Dr. Lev-Ari, was a visitor at Texas Heart Institute, Perfusion Program, and shadowed Open Heart Surgery in 8/2005.

The museum on the First floor of the building represents a Historical exhibit of Images of Cardiac Procedures. On display is a complete array of surgical tools used in Cardiac Repair during the last 50 years of unprecedented development in Cardiac Medical Devices and Procedures. A duplicate of the exhibit is available at the Smithsonian Museum at WashDC.

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Revascularization: PCI, Prior History of PCI vs CABG

Posted in Atherogenic Processes & Pathology, CABG, Frontiers in Cardiology and Cardiovascular Disorders, Origins of Cardiovascular Disease, PCI, Stents & Tools, Uncategorized, tagged Acute coronary syndrome, Angina pectoris, CABG, Coronary artery bypass surgery, Coronary circulation, Electrocardiography in myocardial infarction, Fractional Flow Reserve, myocardial infarction, Percutaneous coronary intervention, ST elevation on April 25, 2013| 13 Comments »

Revascularization: PCI, Prior History of PCI vs CABG

Curator: Aviva Lev-Ari, PhD, RN

UPDATED 9/25/2013

Table. Comparison of Surgical Therapy and Coronary Angioplasty (Open Table in a new window)

Endpoint	Pocock et al*		Pocock et al^†		BARI Study^‡
Endpoint	CABG(N=358)	PTCA(N=374)	CABG(N=1303)	PTCA(N=1336)	CABG(N=914)	PTCA(N=915)
Death (%)	0.3	1.9	2.8	3.1	10.7	13.7
Death or MI	4.5	7.2	8.5	8.1	11.7	10.9
Repeat CABG	1.4	16.0^§	0.8	18.3^§	0.7	20.5^§
Repeat CABG or PTCA	3.6	30.5^§	3.2	34.5^§	8.0	54.0^§
More than mild angina	6.5	14.6^§	12.1	17.8^§	…	…
Meta-analysis of results of 3 trials at 1 year. Patients with single-vessel disease were studied.^[22]†Meta-analysis of results of 3 trials at 1 year. Patients with multivessel disease were studied.^[22] ‡Reported results are for 5-year follow-up. Patients with multivessel disease were studied.^[21] § P < .05. BARI = Bypass Angioplasty Revascularization Investigation; CABG = coronary artery bypass grafting; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty. SOURCE* http://emedicine.medscape.com/article/161446-overview#aw2aab6b2b5

Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical technique for treating multiple conditions, including unstable angina, acute myocardial infarction (MI), and multivessel coronary artery disease (CAD).

Essential update: Cangrelor decreases periprocedural complications of PCI

According to a pooled analysis of 3 CHAMPION trials—CHAMPION-PCI , CHAMPION-PLATFORM , and CHAMPION-PHOENIX—cangrelor can reduce the risk of periprocedural thrombotic complications of PCI.^{[1, 2, 3]}The 3 trials included patients with ST-elevation MI (STEMI), non-STEMI, and stable CAD who were randomly assigned to receive either cangrelor or control therapy consisting of either clopidogrel or placebo.

The primary outcome in this analysis was a composite of death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours.^[2]The frequency of this outcome was significantly lower in cangrelor-treated patients than in control subjects (absolute difference, 1.9%; relative risk reduction [RRR], 19%). Stent thrombosis was also reduced in the cangrelor-treated group (absolute difference, 0.3%; RRR, 41%). Primary safety outcomes were comparable in the 2 groups, but cangrelor-treated patients had a higher rate of mild bleeding.

Indications and contraindications

Clinical indications for PCI include the following:

Acute STEMI
Non–ST-elevation acute coronary syndrome (NSTE-ACS)
Stable angina
Anginal equivalent (eg, dyspnea, arrhythmia, or dizziness or syncope)

In an asymptomatic or mildly symptomatic patient, objective evidence of a moderate-sized to large area of viable myocardium or moderate to severe ischemia on noninvasive testing is an indication for PCI. Angiographic indications include hemodynamically significant lesions in vessels serving viable myocardium (vessel diameter >1.5 mm).

Clinical contraindications for PCI include the presence of any significant comorbid conditions (this is a relative contraindication). Angiographic contraindications include the following:

Left main stenosis in a patient who is a surgical candidate (except in carefully selected patients^[4])
Diffusely diseased small-caliber artery or vein graft
Other coronary anatomy not amenable to PCI

In patients with stable angina, medical therapy is recommended as first-line therapy unless one or more of the following indications for cardiac catheterization and PCI or CABG are present:

A change in symptom severity
Failed medical therapy
High-risk coronary anatomy
Worsening left ventricular (LV) dysfunction

American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines on the management of unstable angina/non-STEMI recommend that an early invasive approach (angiography and revascularization within 24 hours) should be used to treat patients presenting with the following high-risk features^[5]:

Recurrent angina at rest or low level of activity
Elevated cardiac biomarkers
PCI in the past 6 months or prior CABG
New ST-segment depression
Elevated cardiac biomarkers
High-risk findings on noninvasive testing
Signs or symptoms of heart failure or new or worsening mitral regurgitation
Hemodynamic instability
Sustained ventricular tachycardia
LV systolic function < 40%
High risk score (eg, Thrombolysis in Myocardial Infarction [TIMI] score >2) (see the TIMI Score for Unstable Angina Non ST Elevation Myocardial Infarction calculator)

See Overview for more detail.

Equipment

Balloon catheters for PCI have the following features:

A steerable guide wire precedes the balloon into the artery and permits navigation through the coronary tree
Inflation of the balloon compresses and axially redistributes atheromatous plaque and stretches the vessel wall
The balloon catheter also serves as an adjunctive device for many other interventional therapies

Atherectomy devices have the following features:

These devices are designed to physically remove coronary atheroma, calcium, and excess cellular material
Rotational atherectomy, which relies on plaque abrasion and pulverization, is used mostly for fibrotic or heavily calcified lesions that can be wired but not crossed or dilated by a balloon catheter
Atherectomy devices may be used to facilitate stent delivery in complex lesions
Directional coronary atherectomy (DCA) has been used to debulk coronary plaques
Laser atherectomy is not widely used at present
Atherectomy is typically followed by balloon dilation and stenting

Intracoronary stents have the following features:

Stents differ with respect to composition (eg, stainless steel, cobalt chromium, or nickel chromium), architectural design, and delivery system
Drug-eluting stents have demonstrated significant reductions in restenosis and target-lesion revascularization rates
In the United States, stents are available that elute the following drugs: sirolimus (Cypher), paclitaxel (Taxus), zotarolimus (Endeavor), and everolimus (Xience V)
Stents are conventionally placed after balloon predilation, but in selected coronary lesions, direct stenting may lead to better outcomes

Other devices used for PCI include the following:

Thrombus aspiration limits the adverse effects that prolonged time to treatment has on myocardial reperfusion^[6]
Distal embolic protection during saphenous vein graft intervention has become the standard of care

See Periprocedural Care and Devices for more detail.

Technique

Intravascular ultrasonography (IVUS) is used in PCI as follows:

Provide information about the plaque, the vessel wall, and the degree of luminal narrowing
Assessment of indeterminate lesions
Evaluation of adequate stent deployment

Intracoronary Doppler pressure wires are used in PCI as follows:

To characterize coronary lesion physiology and estimate lesion severity
Comparison of pressure distal to a lesion with aortic pressure enables determination of fractional flow reserve (FFR)
An FFR measurement below 0.75-0.80 during maximal hyperemia (induced via administration of adenosine) is consistent with a hemodynamically significant lesion

Antithrombotic therapy

Aspirin and heparin have been the traditional adjunctive medical therapies
Direct thrombin inhibitors (ie, hirudin, bivalirudin) are slightly better than heparin in preventing ischemic complications during balloon angioplasty but do not affect restenosis rates
Low-molecular-weight heparins (LMWHs) are substituted for standard heparin at some centers

Antiplatelet therapy

Patients receiving stents are treated with a combination of aspirin and clopidogrel. Duration of therapy is as follows:

Bare-metal stents: A minimum of 4 weeks
Drug-eluting stents: A minimum of 12 months

Use of proton pump inhibitors is appropriate in patients with multiple risk factors for GI bleeding who require antiplatelet therapy.

Glycoprotein inhibitor therapy

Abciximab, tirofiban, and eptifibatide have all been shown to reduce ischemic complications in patients undergoing balloon angioplasty and coronary stenting
In primary PCI, GPIIb/IIIa receptor inhibitors have also been shown to improve flow and perfusion and to reduce adverse events
Abciximab may improve outcomes in patients when given before arrival in the catheterization lab for primary PCI^[7]

See Technique and Medication for more detail.

SOURCE & References for the UPDATE, in

http://emedicine.medscape.com/article/161446-overview#aw2aab6b2b5

Outcomes comparison between PCI and CABG was explored in the past by authors on this Open Access Online Scientific Journal, in the following articles:

CABG or PCI: Patients with Diabetes – CABG Rein Supreme

http://pharmaceuticalintelligence.com/2012/11/05/cabg-or-pci-patients-with-diabetes-cabg-rein-supreme/

To Stent or Not? A Critical Decision

http://pharmaceuticalintelligence.com/2012/10/23/to-stent-or-not-a-critical-decision/

PCI Outcomes, Increased Ischemic Risk associated with Elevated Plasma Fibrinogen not Platelet Reactivity

http://pharmaceuticalintelligence.com/2013/01/10/pci-outcomes-increased-ischemic-risk-associated-with-elevated-plasma-fibrinogen-not-platelet-reactivity/

New Definition of MI Unveiled, Fractional Flow Reserve (FFR)CT for Tagging Ischemia

http://pharmaceuticalintelligence.com/2012/08/27/new-definition-of-mi-unveiled-fractional-flow-reserve-ffrct-for-tagging-ischemia/

Age-Dependent Depression in Circulating Endothelial Progenitor Cells in Coronary Artery Bypass Grafting Patients

http://pharmaceuticalintelligence.com/2012/08/17/age-dependent-depression-in-circulating-endothelial-progenitor-cells-in-coronary-artery-bypass-grafting-patients/

Now we are reporting an Original Contribution on this subject which includes also Prior History of PCI, a factor NOT included in the other studies. The major conclusions are the following three:

In a contemporary cohort of STEMI patients undergoing primary PCI, a history of prior CABG was found to be an independent predictor of in-hospital mortality.
In contrast, despite more comorbidities at the time of STEMI, patients with prior PCI had no significant difference in the rates of death, stroke, or periprocedural MI when compared to a STEMI population without prior coronary revascularization.
Thus, only prior surgical — and not percutaneous — revascularization should be considered a significant risk factor in the setting of primary PCI.

Number 1, above is related to patient medical history of cardiovascular disease SEVERITY prior to CABG

Number 2, above indicates that patients can tolerate and benefit several cycles of PCI and stent implantation rather than PCI being a determinant predictor of future prognosis

Number 3, above is as well related to patient medical history of cardiovascular disease SEVERITY prior to CABG

The Original Contribution on this subject is present, below.

The Impact of Previous Revascularization on Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention

Travis J. Bench, MD1, Puja B. Parikh, MD1, Allen Jeremias, MD1, Sorin J. Brener, MD2, Srihari S. Naidu, MD3,

Richard A. Shlofmitz, MD4, Thomas Pappas, MD4, Kevin P. Marzo, MD3, Luis Gruberg, MD1

Authors Affiliations:

1Division of Cardiovascular Medicine, Stony Brook University Medical Center, Stony Brook, New York,

2Department of Cardiology, Methodist Hospital, Brooklyn, New York,

3Division of Cardiology, Winthrop University Hospital, Mineola,

New York, and

4The Heart Center, St Francis Hospital, Roslyn, New York.

The authors report no conflicts of interest regarding the content herein.

Manuscript submitted October 10, 2012, provisional acceptance given October 20, 2012, final version accepted November 28, 2012.

Address for correspondence:

Luis Gruberg, MD, FACC, Department of Medicine, Division of Cardiology, Health Sciences Center, T16-080, Stony Brook, NY 11794- 8160. Email: luis.gruberg@stonybrook.edu

Abstract : While the impact of prior coronary artery bypass graft surgery (CABG) on in-hospital outcomes in patients with STelevation myocardial infarction (STEMI) has been described, data are limited on patients with prior percutaneous coronary intervention (PCI) undergoing primary PCI in the setting of an STEMI. The aim of the present study was to assess the effect of previous revascularization on in-hospital outcomes in STEMI patients undergoing primary PCI. Between January 2004 and December 2007, a total of 1649 patients underwent primary PCI for STEMI at four New York State hospitals. Baseline clinical and angiographic characteristics and in-hospital outcomes were prospectively collected as part of the New York State PCI Reporting System (PCIRS). Patients with prior surgical or percutaneous coronary revascularization were compared to those without prior coronary revascularization. Of the 1649 patients presenting with STEMI, a total of 93 (5.6%) had prior CABG, 258 (15.7%) had prior PCI, and 1298 (78.7%) had no history of prior coronary revascularization. Patients with prior CABG were significantly older and had higher rates of peripheral vascular disease, diabetes mellitus, congestive heart failure, and prior stroke. Additionally, compared with those patients with a history of prior PCI as well as those without prior coronary revascularization, patients with previous CABG had more left main interventions (24% vs 2% and 2%; P<.001), but were less often treated with drug-eluting stents (47% vs 61% and 72%; P<.001).

Despite a low incidence of adverse in-hospital events, prior CABG was associated with higher all-cause in-hospital mortality (6.5% vs 2.2%; P=.012), and as a result, higher overall MACE (6.5% vs 2.7%; P=.039). By multivariate analysis, prior CABG (odds ratio, 3.40; 95% confidence interval, 1.15-10.00) was independently associated with in-hospital mortality. In contrast, patients with prior PCI had similar rates of MACE (4.3% vs 2.7%; P=.18) and inhospital mortality (3.1% vs 2.2%; P=.4) when compared to the de novo population. Patients with a prior history of CABG, but not prior PCI, undergoing primary PCI in the setting of STEMI have significantly worse in-hospital outcomes when compared with patients who had no prior history of coronary artery revascularization. Thus, only prior surgical — and not percutaneous — revascularization should be considered a significant risk factor in the setting of primary PCI.

J INVASIVE CARDIOL 2013;25(4):166-169

Key words: PCI risk factor, CABG

Demographics and Angiographic Characteristics

Between 2004 and 2007, a total of 25,025 patients underwent PCI at these medical institutions, and their data were prospectively collected and submitted as required by the New York State Department of Health. Of these patients, a total of 1649 underwent primary PCI in the setting of an STEMI and constituted our study population. In this group, a total

No Prior Revascularization (n = 1298)

Prior PCI (n = 258)

Prior CABG (n = 93)

Demographics

Age (years) 61 ± 13 62 ± 12 67 ± 12 <.001

Male gender 956 (73.6%) 194 (75.2%) 76 (81.7%) .21

White 1165 (89.8%) 231 (89.5%) 87 (93.5%) .51

African-American 78 (6%) 18 (7%) 1 (1.1%) .51

Hispanic 91 (7%) 11 (4.3%) 4 (4.3%) .51

Medical history

Ejection fraction (%) 43 ± 12 44 ± 13 45 ± 11 .079

Diabetes mellitus 196 (15.1%) 69 (26.7%) 27 (29%) <.001

Peripheral vascular disease 53 (4.1%) 25 (9.7%) 12 (12.9%) <.001

Chronic lung disease 47 (3.6%) 17 (6.6%) 4 (4.3%) .09

Congestive heart failure 74 (5.7%) 25 (9.7%) 10 (10.8%) .02

Prior myocardial infarction 3 (0.2%) 1 (0.4%) 1 (1.1%) .35

Prior cerebrovascular event 56 (4.3%) 9 (3.5%) 10 (11%) .01

Chronic dialysis 6 (0.5%) 6 (2.3%) 0 (0%) .004

Creatinine (mg/dL) 1.1 ± 0.8 1.3 ± 1.4 1.3 ± 1.1 .002

Glomerular filtration rate (mL/min/1.73 m2) 79 ± 26 75 ± 28 71 ± 27 .002

Angiographic characteristics

Left main 19 (1.5%) 5 (1.9%) 22 (23.7%) <.001

Left anterior descending 942 (72.6%) 178 (69%) 69 (74.2%) .45

Left circumflex 579 (44.6%) 122 (47.3%) 70 (75.3%) <.001

Right coronary 806 (62.1%) 187 (72.5%) 67 (72%) .002

Graft (arterial or venous) n/a n/a 20 (21.5%)

Stent type

Bare-metal stent 241 (18.6%) 52 (20.2%) 23 (24.7%) .31

Drug-eluting stent 928 (71.5%) 158 (61.2%) 44 (47.3%) <.001

of 1298 patients (78.7%) had no prior history of revascularization,

while 93 patients (5.6%) had a history of previous

CABG and 258 (15.7%) had a history of previous PCI. Considerable

differences in baseline clinical and procedural characteristics were noted among these groups (Table 1).

Discussion

While STEMI patients with prior CABG are well known to have worse clinical outcomes than those without prior revascularization, a direct comparison between patients who underwent primary PCI in the setting of prior CABG or prior PCI has not yet been reported. The principal findings from the present analysis suggest that in a contemporary, unrestricted patient population presenting with STEMI and undergoing primary PCI, patients with a prior history of CABG are:

(1) usually older and have multiple comorbidities, including peripheral vascular disease, diabetes, and chronic obstructive lung disease;

(2) are more likely to undergo intervention on a native vessel and not a bypass graft;

(3) are more likely to be treated with bare-metal stents; and (4) have higher rates of in-hospital mortality without a significant increase in stroke or MI rates, when compared with patients with a prior history of PCI or patients with no previous history of coronary artery revascularization. Interestingly, these outcomes did not apply to patients with a history of prior PCI in this analysis. Instead, this cohort of patients had no significant difference in the rate of death, stroke, or periprocedural infarction when compared to a STEMI population without prior coronary revascularization, despite a significantly higher burden of comorbidities than those with no prior revascularization.

Our findings concur with previous studies that have shown higher mortality rates among patients with prior surgical bypass presenting with acute MI.7,9,14 Despite changes in revascularization strategies over the past 30 years, invasive therapies to treat acute coronary syndromes in patients with prior bypass surgery appear to have yielded less robust results than in other populations. In fact, Stone and colleagues already described in the Primary Angioplasty in Myocardial Infarction (PAMI-2) study that patients with a previous CABG undergoing primary PCI in the setting of an acute MI had significantly greater in-hospital mortality than patients without previous CABG, especially if the infarct-related vessel was a bypass conduit. However, by logistic regression analysis, only advanced age (P=.004), triple-vessel disease (P=.004), and Killip class ≥2 (P=.02) were independent predictors of in-hospital mortality in that study.13 In a more contemporary study of 128 STEMI patients with prior CABG, who were enrolled in the Assessment of PEXelizumab in Acute

Figure 1. In-hospital major adverse cardiac and cerebrovascular events (MACCE), mortality, and stroke rates for patients without prior history of coronary revascularization (light grey bars), prior percutaneous coronary revascularization (PCI) (dark grey bars), and prior coronary artery bypass graft (CABG) (black bars). Vol. 25, No. 4, April 2013 169

STEMI and Prior Revascularization Myocardial Infarction (APEX-AMI) trial, Welsh and colleagues reported that post-CABG patients are less likely to undergo acute reperfusion (only 79% underwent primary PCI), have worse angiographic outcomes following primary PCI, and have higher 90-day mortality rates (19.0% vs 5.7%; P=.05). This difference was even more apparent when the infarct-related artery was a bypass graft that was not successfully reperfused (23.1% vs 8.5%; P=.03).3 These results are similar to our current analysis, where in-hospital mortality rates for patients who underwent primary PCI of a graft were numerically roughly 4 times as high as those undergoing PCI of a native vessel. Likewise, Gurfinkel et al reported a significant reduction in hard endpoints, such as all-cause death and MI at 6 months in patients treated with an invasive approach in the Global Registry of Acute Coronary Events (GRACE).15 In this large, multinational, observational study of 3853 patients with prior bypass surgery presenting with an acute coronary syndrome, only 497 (12.9%) were managed invasively and the rest were treated medically.

Despite significant differences in baseline characteristics, including a higher rate of STEMI in patients treated invasively (14% vs 27%; P<.001), in-hospital mortality was similar in both groups (3.4% vs 3.2%; P=.86). However, at 6-month follow-up, mortality was significantly higher in those patients treated medically (6.5% vs 3.4%; P<.02) as was the combined endpoint of death or MI (11% vs 5.8%; P<.01).

Whether these results apply to patients with a prior history of PCI has not been well defined. By the nature of vascular disease, patients with prior PCI are more likely to have more comorbidities than those without prior revascularization, a finding confirmed in our study. Despite considerable differences in baseline characteristics, however, these differences did not translate into a differential risk after STEMI. In fact, the cohort of patients presenting with STEMI who had a history of prior PCI had no statistically significant difference in in-hospital mortality or overall MACCE when compared to a population of patients presenting with STEMI in the absence of any prior revascularization.

Study limitations. The database utilized was derived from four New York State teaching hospitals and was designed to track quality of care and clinical outcomes. As all studies involving multicenter databases and registries, there is potential error in data entry and availability. Potential confounding comorbidities, including smoking status and family history of coronary artery disease, were not collected in this database, and information regarding long-term follow-up is not available, all of which are important limitations of this analysis. As such, deficiencies such as these limit the conclusions that can be drawn from our multivariate analysis. Additionally, there is no audit of data quality, and the low overall event rates limit effective statistical comparison.

Conclusions

In a contemporary cohort of STEMI patients undergoing primary PCI, a history of prior CABG was found to be an independent predictor of in-hospital mortality. In contrast, despite more comorbidities at the time of STEMI, patients with prior PCI had no significant difference in the rates of death, stroke, or periprocedural MI when compared to a STEMI population without prior coronary revascularization. Thus, only prior surgical — and not percutaneous — revascularization should be considered a significant risk factor in the setting of primary PCI.

REFERENCES

1. Kushner FG, Hand M, Smith SC Jr, et al. 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Catheter Cardiovasc Interv. 2009;74(7):E25-E68.

2. Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003;361(9351):13-20.

3. Welsh RC, Granger CB, Westerhout CM, et al. Prior coronary artery bypass graft patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. JACC Cardiovasc Interv. 2010;3(3):343-351.

4. Mathew V, Gersh B, Barron H, et al. In-hospital outcome of acute myocardial infarction in patients with prior coronary artery bypass surgery. Am Heart J. 2002;144(3):463-469.

5. Lee KL, Woodlief LH, Topol EJ, et al. Predictors of 30-day mortality in the era of reperfusion for acute myocardial infarction. Results from an international trial of 41,021 patients. GUSTO-I Investigators. Circulation. 1995;91(6):1659-1668.

6. Dittrich HC, Gilpin E, Nicod P, et al. Outcome after acute myocardial infarction in patients with prior coronary artery bypass surgery. Am J Cardiol. 1993;72(7):507-513.

7. Berry C, Pieper KS, White HD, et al. Patients with prior coronary artery bypass grafting have a poor outcome after myocardial infarction: an analysis of the VALsartan in acute myocardial iNfarcTion trial (VALIANT). Eur Heart J. 2009;30(12):1450-1456.

8. Grines CL, Booth DC, Nissen SE, et al. Mechanism of acute myocardial infarction in patients with prior coronary artery bypass grafting and therapeutic implications. Am J Cardiol. 1990;65(20):1292-1296.

9. Labinaz M, Sketch MH Jr, Ellis SG, et al. Outcome of acute ST-segment elevation myocardial infarction in patients with prior coronary artery bypass surgery receiving thrombolytic therapy. Am Heart J. 2001;141(3):469-477.

10. Peterson LR, Chandra NC, French WJ, Rogers WJ, Weaver WD, Tiefenbrunn AJ. Reperfusion therapy in patients with acute myocardial infarction and prior coronary artery bypass graft surgery (National Registry of Myocardial Infarction-2). Am J Cardiol. 1999;84(11):1287-1291.

11. Nguyen TT, O’Neill WW, Grines CL, et al. One-year survival in patients with acute myocardial infarction and a saphenous vein graft culprit treated with primary angioplasty. Am J Cardiol. 2003;91(10):1250-1254.

12. Al Suwaidi J, Velianou JL, Berger PB, et al. Primary percutaneous coronary interventions in patients with acute myocardial infarction and prior coronary artery bypass grafting, Am Heart J. 2001;142(3):452-459.

13. Stone GW, Brodie BR, Griffin JJ, et al. Clinical and angiographic outcomes in patients with previous coronary artery bypass graft surgery treated with primary balloon angioplasty for acute myocardial infarction. Second Primary Angioplasty in Myocardial Infarction Trial (PAMI-2) Investigators. J Am Coll Cardiol. 2000;35(3):605-611.

14. Labinaz M, Kilaru R, Pieper K, et al. Outcomes of patients with acute coronary syndromes and prior coronary artery bypass grafting: results from the platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial. Circulation. 2002;105(3):322-327.

15. Gurfinkel EP, Perez de la Hoz R, Brito VM, et al. Invasive vs non-invasive treatment in acute coronary syndromes and prior bypass surgery. Int J Cardiol. 2007;119(1):65-72.

Other related studies on this subject published on this Open Access Online Scientific Journal include the following:

Lev-Ari, A. 2/12/2013 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

http://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

Lev-Ari, A. 12/31/2012 Renal Sympathetic Denervation: Updates on the State of Medicine

http://pharmaceuticalintelligence.com/2012/12/31/renal-sympathetic-denervation-updates-on-the-state-of-medicine/

Lev-Ari, A. 9/2/2012 Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

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

Lev-Ari, A. 8/13/2012 Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents http://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

Lev-Ari, A. 7/18/2012 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

http://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

Lev-Ari, A. 6/13/2012 Treatment of Refractory Hypertension via Percutaneous Renal Denervation

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

Lev-Ari, A. 6/22/2012 Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

http://pharmaceuticalintelligence.com/2012/06/22/competition-in-the-ecosystem-of-medical-devices-in-cardiac-and-vascular-repair-heart-valves-stents-catheterization-tools-and-kits-for-open-heart-and-minimally-invasive-surgery-mis/

Lev-Ari, A. 6/19/2012 Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

http://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

Lev-Ari, A. 6/22/2012 Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

http://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

Lev-Ari, A. 7/23/2012 Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

http://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

Lev-Ari, A. (2006b). First-In-Man Stent Implantation Clinical Trials & Medical Ethical Dilemmas. Bouve College of Health Sciences, Northeastern University, Boston, MA 02115

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Minimally Invasive Structural CVD Repairs: FDA grants 510(k) Clearance to Philips’ EchoNavigator – X-ray and 3-D Ultrasound Image Fused.

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, CABG, Cardiac & Vascular Repair Tools Subsegment, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Mitral Valve: Repair and Replacement, PCI, Valves & Tools, tagged EchoNavigator, Food and Drug Administration, Philips, Philips Healthcare, University Hospital Zurich, University of Colorado Hospital on March 21, 2013| 3 Comments »

Minimally Invasive Structural CVD Repairs: FDA grants 510(k) Clearance to Philips’ EchoNavigator – X-ray and 3-D Ultrasound Image Fused.

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 7/15/2018

The growing role of echocardiography in interventional cardiology: The present and the future

https://doi.org/10.1016/j.hjc.2017.01.008 Get rights and content

Open Access funded by Hellenic Cardiological Society

Under a Creative Commons license

Abstract

As structural heart disease interventions continue to evolve to a sophisticated level, accurate and reliable imaging is required for pre-procedural selection of cases, intra-procedural guidance, post-procedural evaluation, and long-term follow-up of patients.

Traditionally, cardiovascular procedures in the catheterization laboratory are guided by fluoroscopy and angiography. Advances in echocardiography can overcome most limitations of conventional imaging modalities and provide successful completion of each step of any catheter–based treatment. Echocardiography’s unique characteristics rendered it the ideal technique for percutaneous catheter-based procedures.

The purpose of this review is to demonstrate the use of the most common and up-to-date echocardiographic techniques in recent non-coronary percutaneous interventional procedures, underlining its inevitable and growing role, as well as illustrating areas of weakness and limitations, and to provide future perspectives.

SOURCE

https://www.sciencedirect.com/science/article/pii/S1109966617300258

On January 28, we reported on several FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

http://pharmaceuticalintelligence.com/2013/01/28/fda-pending-510k-for-the-latest-cardiovascular-imaging-technology/

On March 7, 2013 a very significant, pending clearance event, in favor of Philips Healthcare, was announced:

U.S. FDA Clears Philips’ EchoNavigator for Fused TEE-Angiography Image Guidance

March 7, 2013

March 7, 2013 — Philips Healthcare announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EchoNavigator live image-guidance tool. The technology helps interventional cardiologists and cardiac surgeons perform minimally invasive structural heart disease repairs by providing an intelligently integrated view of live X-ray and 3-D ultrasound images.

Following the CE marking of EchoNavigator in Europe, Philips will now be able to introduce the system globally, with systems already installed in Europe and the United States.

EchoNavigator was developed in response to an upward trend in the use of both X-ray imaging and 3-D cardiac ultrasound imaging (echocardiography) during structural heart disease procedures — an area of interventional cardiology that is growing at around 40 percent per year. During such procedures, ultrasound imaging provides critical insights into the heart’s soft tissue anatomy, while X-ray imaging has particular strengths in visualizing the catheters and heart implants. EchoNavigator was designed to address the unique challenges associated with working with live X-ray and 3-D ultrasound images simultaneously.

“Together with Philips, we set out to bring two separate medical imaging techniques together in a way that provides clear visual guidance,” said John Carroll, M.D., interventional cardiologist, University of Colorado Hospital, Denver. “EchoNavigator is enabling us to use X-ray images combined with real-time 3-D ultrasound images to navigate catheters and deploy implants in the right position in the heart, making such treatments more straightforward.”

EchoNavigator will enable clinicians to perform procedures more efficiently by providing intelligently integrated X-ray and 3-D ultrasound images into one intuitive and interactive view, as well as providing easy-to-use system navigation and better communication between the multidisciplinary team carrying out the procedure.

“We have learned that ideally two live imaging technologies are needed to guide catheter-based repairs to the heart, and a multidisciplinary team is needed to perform it,” said Roberto Corti, M.D., interventional cardiologist, University Hospital Zurich, Switzerland. “This adds to the complexity of such procedures. The development of a more sophisticated imaging technology such as EchoNavigator will definitely provide us with a better understanding of the complex structures of the heart and their repair.”

“As the global market leader in interventional cardiology, we have worked with our partners to lead the way with pioneering solutions such as our real-time 3-D ultrasound technology and more recently our HeartNavigator navigation tool,” said Gene Saragnese, CEO for Imaging Systems at Philips Healthcare. “EchoNavigator is further evidence of our commitment to transforming healthcare through the introduction of innovations that enable best in class minimally invasive procedures.”

“In the emerging field of complex structural heart disease interventions, the information obtained by merging imaging technologies, as now possible with HeartNavigator and EchoNavigator, will be of tremendous value to the interventionalist, and in turn to the patient,” said Carlos Ruiz, M.D., director of the structural and congenital heart disease program, department of interventional cardiology, Lenox Hill Hospital, New York.

For more information: http://www.healthcare.philips.com

SOURCE:

http://www.dicardiology.com/article/us-fda-clears-philips’-echonavigator-fused-tee-angiography-image-guidance?goback=%2Egde_3693995_member_223204362

3-D, 4-D Enhancements May Be the Future of Ultrasound

Written By:

Dave Fornell

May 15, 2012

A single-beat, short-axis 4-D echo imaged by GE’s Vivid E9. The system also offers software to reduce the number of clicks needed for exams. Photo courtesy of GE Healthcare

Hardware and software advances are enabling echocardiography to greatly expand its capability with increased quantification accuracy, ease-of-use, increased workflow efficiencies and wider use outside of echo labs. Today, cardiovascular ultrasound systems are being integrated into point-of-care for triage, and in operating rooms and cath labs for procedural guidance to cut the use of contrast and ionizing radiation. Advances in 4-D echo are making it an enhanced tool for structural heart evaluation and visualization during procedures.

3-D, 4-D Echo Advances

3-D echo images a volume of data (similar to a computed tomography [CT] dataset) rather than the traditional 2-D image rendering. These volumes can be manipulated with advanced visualization software just like a CT, slicing images on any plane and enabling the creation of 3-D images that can be rotated.

The proliferation of 3-D echo was previously handicapped by the large amount of labor involved in creating images from a volume dataset, explained Stephen Little, M.D., FRCPC, FACC, FASE, cardiovascular imaging section, department of cardiology, Methodist DeBakey. He said earlier generation systems required 30 or 40 mouse clicks to create an image.

“3-D required a lot of manual processing to slice and dice the images. It just took too long to do anything,” Little explained.

However, he said the newer 3-D systems are making the technology more viable with automation. He said echo is following the same path previously followed by CT advanced visualization software, where automation made a big difference in its wider market adoption for daily use.

Two big technology innovations have recently made 3-D and 4-D systems more commercially viable for everyday use. First, there has been a rapid increase in computing power in less expensive, smaller packages. Second, the automation of many advanced visualization functions drastically simplifies use and reduces the staff time required to manipulate volumes.

The introduction of 4-D echo (the fourth dimension is the addition of time) has opened new possibilities in ultrasound imaging. The analogy of 4-D is the difference between video and a still photograph. The technology allows 3-D images to be continuously updated for a live video view. The platforms with this feature require very fast processors to reconstruct large volumes of data into 3-D images over and over in milliseconds.

4-D ultrasound offers several advantages. It offers real-time color flow to assess hemodynamic information in the same heart cycle. It offers very accurate qualification of the left ventricle, free of geometric and shape assumptions used in 2-D echo. By using a 3-D volume of data, left ventricular wall motion tracking analysis can be done using the raw data volumes acquired. Vendors say this increases the accuracy of quantification.

It also offers multi-dimensional imaging, where operators can simultaneously acquire bi-plane and tri-plane images from the same heartbeat without moving the probe’s position. This offers two or three different axis views concurrently or as a composite view of the heart in real-time, offering a new field-of-view that previously could not be obtained. This helps acquire more information in fewer steps.

Real-time 4-D can produce images that are incredibly lifelike. This makes them easier to interpret and offers more meaningful information, including better procedural guidance. As technology continues to advance, 4-D echo will offer images comparable to CT 3-D reconstructions. Surgeons are now using 3-D echo reconstructions to aid procedural planning.

Use of 4-D greatly aids assessment of congenital heart diseases. Siemens recently introduced an updated version of its SC2000 cardiac ultrasound that quantifies volumetric color blood flow when evaluating holes in the heart (ASDs, VSDs, PFOs). The system uses a 3-D representation to show the true surface area and helps estimate the size of the holes for procedural planning.

Innovations in 4-D make possible real-time, comprehensive analysis of the beating heart during the entire cardiac cycle and allows even more detailed surgical-like views of the anatomy.

Toshiba’s new Aplio 500 shows the future of 4-D, where it can reconstruct volumes into color, fly-through video of vessel lumens. It works with peripheral vessels, but the heart is still too fast for the new technology to capture coronary vessels or ventricles. Image quality is similar to CT virtual colonoscopy.

Practical Application of 3-D

Methodist DeBakey Heart and Vascular Center has its own imaging center, which uses 3-D echo extensively. The center also images patients with both magnetic resonance imaging (MRI) and 3-D echo for comparative effectiveness research.

In the echo lab, 3-D echo is very good at estimating left ventricular ejection fractions (LVEF). However, there is a need for standardization between vendors before this technology will be used mainstream, Little said. Each 3-D echo machine is slightly different, so the workflow is not the same from vendor to vendor, and each requires use of proprietary workstations.

He explained 3-D offers a more accurate picture of cardiac function, but the basic concepts of 2-D echo still apply.

“3-D is not magic. It starts with a good 2-D image and you face all the same physics challenges as you do with 2-D technology,” Little said.

At DeBakey, echo contrast is often used to improve 2-D image quality when imaging obese patients, but they found 3-D has some limitations with contrast, said Miguel A. Quiñones, M.D., MACC, chairman, department of cardiology. The software uses automated 3-D tracking of the borders of the ventricle, he explained, but the automated tracking system is confused by the contrast and has issues. However, an operator can overcome this by switching to a manual mode.

Little said hospitals need to assess whether there is a need for 3-D. “It depends on what they plan to do with the system. If you plan to use it for surgical procedures, then it might be worth investing in a 3-D system. If you are involved in activities with more emphasis on structural heart, then 3-D has a lot of application.”

Expanding TEE Use

Little said DeBakey makes extensive use of 3-D echo transesophogeal echo (TEE) to better guide mitral valve prolapse and regurgitation repairs, atrial septal defects (ASDs) and trans-aortic valve repair (TAVR). In TAVR, he said TEE helps accurately place the angiographic pigtail catheter in the non-coronary cusp of the aortic root. It also offers Doppler flow imaging to evaluate the hemodynamics of the valves and check for paravalvular leaks.

Little explained 3-D TEE offers a definite imaging advantage during complex interventions. The use of an X-plane (also referred to as bi-plane) TEE probe allows visualization from two different angles. He said these views are displayed on the main screen in a cath lab or hybrid OR to better visualize where a catheter or device is located in the anatomy more clearly than 2-D angiography. This helps with procedural navigation and in cutting the radiation dose from fluoroscopy.

“You can get two views simultaneously from two different perspectives, which helps speed things up,” Little said. “It adds a level of confidence to show you where wires and devices are inside the heart.”

DeBakey uses 3-D echo from various vendors, including Philips, GE and Siemens, but only the Philips system had offered 3-D TEE, Little said.

Siemens recently introduced syngo FourSight 3-D TEE. It can scan the whole heart in one volume instead of stitching two or three images to create a whole-heart image.

GE Healthcare also has a new 4-D TEE system pending FDA review, which it previewed as a work-in-progress in March at American College of Cardiology (ACC) 2012 .

Comparison Chart

This article served as an introduction to the cardiovascular ultrasound systems comparison chart in the May-June 2012 issue of DAIC. Participants included:

Esaote North America –http://www.esaoteusa.com

GE Healthcare – http://www.gehealthcare.com

Mindray – http://www.mindray.com

Philips – http://www.philips.com

Siemens – http://www.medical.siemens.com

Toshiba – http://www.medical.toshiba.com

SOURCE:

http://www.dicardiology.com/article/3-d-4-d-enhancements-may-be-future-ultrasound

New Software to aid Interventional Cardiologists and Cardiac Surgeons in TAVI Procedures.

We covered the procedure and the technologies in the following curated article:

Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

TAVI Planning Software Introduced

Software enables selection of patients and access routes; aids procedure navigation, annulus sizing

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Written By:

Dave Fornell

February 1, 2012

Philips received FDA clearance in December 2011 for its Heart Navigator TAVI planning and image guidance tool.

With the approval of the Sapien valve in November 2011, transcatheter aortic valve implantation (TAVI) technology is expected to revolutionize heart valve replacement with a minimally invasive procedure to replace open-heart surgery. However, it requires a good deal of planning, sizing and anatomical assessment of access routes using computed tomography (CT) scans with manipulation by advanced visualization software.

The success of this new procedure depends on correct patient selection and reliable pre-operative planning. In the conventional procedure, the necessary measurements are made during the actual surgery under direct visualization, but with TAVI, this can only be done pre-operatively with the aid of image data. A clear appreciation of the involved anatomy is crucial, and due to the fact that aortic anatomy is complex, 3-D visualization and measurement tools may enable more accurate and efficient pre- and post-intervention planning, which can be further enhanced with stereoscopic 3-D.At the 2011 Radiological Society of North America (RSNA) annual meeting, TeraRecon and Qi Imaging (formerly Ziosoft) both unveiled TAVI planning and tool set software packages. The software helps automate manipulation of a CT dataset to quickly extract only the anatomy of interest and measurements, such as sizing of the aortic valve annulus and evaluation of clearance between the new valve and the right and left main coronary arteries. The software helps evaluate the aortic anatomy of patients to see if the route is clear for the larger delivery catheters required for the procedure. A heavily calcified aorta may disqualify a patient from the femoral access route.
Qi Imaging applied its super-computing, deformable registration software to its TAVI package, allowing lifelike motion of the cardiac cycle. This may offer a more accurate assessment of the motion of annulus for better valve sizing.
Philips Healthcare received FDA clearance in December for its HeartNavigator procedure planning and image guidance tool to help perform minimally invasive heart valve replacements. The technology merges pre-operatively acquired 3-D CT scans of the patient’s heart with the live interventional X-ray views. Using this technology, physicians can now simultaneously see the detailed 3-D anatomy of the patient’s heart together with the positioning of the catheter and the placement and deployment of the artificial valve.
TAVI has been available in Europe since March 2010. In August 2010, Siemens introduced its syngo Aortic ValveGuide in Europe to aid in TAVI procedures. It uses rotational angiography dataset images in the hybrid OR to help surgeons and interventional cardiologists navigate during transcatheter valve implantations. The software processes CT-like images of the heart from images acquired with the angiography system and creates 3-D overlay images on the live fluoroscopy. The software also finds the correct optimal C-arm angulation with a perpendicular view on the aortic root.

Siemens’ syngo Aortic ValveGuide aids TAVI navigation with rotational angiography image overlays.

SOURCE:

http://www.dicardiology.com/article/tavi-planning-software-introduced

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Introducing Western Medical Devices in China

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Atherogenic Processes & Pathology, Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, CABG, Cardiac & Vascular Repair Tools Subsegment, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Drug Delivery Platform Technology, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Health Law & Patient Safety, International Global Work in Pharmaceutical, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Mitral Valve: Repair and Replacement, PCI, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Population Health Management, Genetics & Pharmaceutical, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Scientist: Career considerations, Stents & Tools, Technology Transfer: Biotech and Pharmaceutical, Valves & Tools, tagged Chinese Traditional Medicine, Edwards, Food and Drug Administration, Medical device, Mitral valve, State Food and Drug Administration on February 13, 2013| 1 Comment »

Author: Michael, Ward, DVM

I recently found a report, written by Mark Hollmer and published 28 November, 2012 by Fierce Medical Devices

http://www.fiercemedicaldevices.com/signup?sourceform=Viral-Tynt-

entitled, “Edwards’ mitral heart valve wins Chinese SFDA nod”.

Though I wonder why Edwards would be taking a more than 30 year-old medical device to China – only Edwards’ business leaders could answer that – I was stuck by one small paragraph that led to this writing.

“Edwards, like many device companies, has turned to China for new growth opportunities and the country factors into its long-term growth plans. Known for heart valves and hemodynamic monitoring devices, Edwards has also propelled U.S. growth with its Sapien transcatheter aortic heart valve, which won FDA approval earlier this fall to treat a larger class of patients.”

This discussion will address the current trend of Western companies attempting to penetrate China’s medical device market. As one who is often asked to speak at public meetings on this topic, I have given frequent and serious reflection on my experiences with and knowledge of this topic.

The uninitiated Western medical device companies may not realize that China is very much different from other major countries, in the areas of

marketing/sales,
regulatory affairs,
clinical research, and
hospital practices.

Historically, SFDA has been active since the 1990’s; however, their initial focus was limited to understanding and approving pharmaceuticals. Thus, SFDA’s

regulations,
extent of product and therapeutic knowledge, and
GCP certification programs

have been primarily focused on drugs. With the exception of the counterfeit medicine epidemic, global pharmaceutical companies have become well entrenched and enjoy a strong presence in China’s hospitals. That does not mean they are making great profits.

Counterfeit drug enterprises in China have steadily grown into a lucrative opportunity since the 1990s. Often supported by local government and Chinese Military investment, counterfeit drug manufacturing plants can be rapidly set up and also re-established, if subjected to raids by SFDA officials. These fake medications have found their way into China’s pharmacies and hospitals, and now are a threat to the United States. The loss of bona fide sales as well as the money required to fight this criminal element significantly erodes the profits of major pharmaceutical companies.

In and above the aforementioned challenge to global pharmaceutical companies, all biomedical companies must share a considerable portion of any given patient population with Chinese Traditional Medicine (CTM). CTM has enjoyed centuries of development and use and it is an integral part of China’s society. Medical schools and hospitals teach and offer CTM therapies. Given the paucity of health insurance among the majority of China’s population and limited disposable income to pay for expensive medical treatments, CTM offers an attractive alternative – one that is deeply entrenched within the culture and also easily affordable. For reasons to which I will allude later, CTM lends itself to a culture that readily accepts anecdotal evidence and rarely scrutinizes medical therapies for compelling clinical evidence.

Medical devices have their own unique challenges to address. Initially, many of them are not readily apparent to any neophyte company that expects ‘business as usual’ when introducing products to China. Unlike Japan, where one of the biggest barriers to market entry rests in dealing with a well-organized, challenging, and complex regulatory authority, SFDA is a ‘work in progress’. China is the only country, of which I am aware, where the regulatory authority (SFDA) has asked experts in global companies for helpful guidance on the approval and oversight of medical devices. Couple that with the national governments focus on making it easier for Chinese medical device companies to access the market, and it’s easy to understand why several large home-born enterprises, such as Microport Medical, enjoy large shares of the domestic market for most indications.

For many years, and even today, many companies refuse to go to China for fear of having their technology reverse engineered and copied. This fear is fueled by China’s lack of effective laws on intellectual property (IP). Even where laws do exist, they are rarely enforced. This fear on the part of Western companies is irrational, which is why the major global medical device companies and many smaller organizations, including Edwards LifeSciences, have concluded that threats to their IP are no more an issue in China than in any other region of the world.

That is not to say copycat devices don’t exist in China. Many observers are curious as to how these large domestic medical device companies in China could have product portfolios that closely replicate those of the major global companies. To illustrate this point – during the 1990s, I knew a Chinese woman in Southern California who worked in QA and, therefore, had access to drawings, test results, and manufacturing processes for any of her current company’s product portfolios. Her open confession to me was that, after another year or so, she planned to go back to China to establish her own catheter company, using all the knowledge and information she had gathered in her job. Western media have uncovered a lot of copying of company proprietary information by Chinese citizens who find jobs in the USA or Europe. Many ‘industrial spies’ are highly qualified engineers and scientists who make valuable contributions to all aspects of product development. In spite of their devotion to product development, one can understand their culturally-inbred insensitivity toward issues of confidentiality and intellectual property.

Some readers might be thinking right now, “Damned if you do!” (going to China) and “Damned if you don’t!” (opting to stay in a protective mode outside China). Some might conclude that, if Western countries open up their doors to foreign engineers and scientists, no IP is safe. However, one only has to look at WL Gore (Flagstaff AZ), which experienced an American-bred and educated manufacturing ‘associate’ relocating down the mountain to Phoenix to establish a company that was alleged to have incorporated biomaterials, knowhow, and manufacturing processes inherent to Gore. Though the latter is uncommon, it does underscore the point that industrial espionage is not just a China-based challenge; however, in most Western countries, rigorous enforcement of strict IP laws is quite effective in keeping ‘copycat’ medical devices, including those that originate in China, off the market. Given this perspective, avoiding China only for fear of IP threats is irrational.

In September 2012, in Northern California, I met with a VP of International Business for one of the largest of China’s domestic medical device companies. I was curious about his company having no presence in the U.S. market and their international focus on African and South American countries – both regions being weak in enforcing laws on IP. Given his company’s limited global focus and his admission that the company leadership in Shanghai only understood China’s processes and had no appreciation of or interest in appropriate development and expensive testing of medical devices sufficient to achieve CE Mark or 510(k) clearance, Western medical device business leaders can breathe easy about the prospect of a company in China threatening market share in Europe, USA and many other Western countries with copycat devices.

This is just one of several instances where China’s culture and laws are deeply entrenched in the medical device community, resulting in unique perspectives and practices. Some of these differences and limitations make it very difficult for China’s physicians to compete with their Western counterparts in such areas as publishing in Western peer-reviewed medical journals and in carrying out quality research with medical devices. A significant challenge for Western medical device companies is to assure that their China-trained customers have sufficient skills to use their devices. Two-day training programs for physicians have proven to be quite ineffective.

There are many endemic factors, which contribute to the lack of sufficient technical skill and therapeutic proficiency on the part of China’s medical device users. Some of these are

(a) strong tendency to be dogmatic and carry on with older therapeutic approaches (justification is based on having treated large numbers of patients with long-established methods);

(b) hospital hierarchical management style, with older physicians at the top who direct all staff members to propagate older methods;

(d) Western medical devices are often sold at Western prices, leaving so many uninsured patients unable to pay for these therapies (limited use of Western devices); and,

(e) the role of CTM further erodes opportunities to get valuable experience.

Edwards LifeSciences may enjoy early market penetration with a 30-year-old heart valve. Most companies initially focus on

Beijing,
Shanghai,
Guangzhou and
a few other major cities,

where more patients have health insurance and/or sufficient cash to pay for expensive treatments. But, to gain major market share, prices would have to come down dramatically, something many multi-national medical device companies are reluctant to consider.

The above comments are only a cursory reflection of some of the key challenges facing a company interested in the medical device market in China. I have not mentioned the unique challenges for

marketing and
distribution or the rather unique approach one must adopt to
sponsor and manage clinical trials in China.

A STORY OF LAGGING BEHIND:

For more than a decade, medical device applications, modernization, and market expansion in China have lagged well behind a more mature pharmaceutical domain. Compounding this is another gap created between a hierarchical, dogmatic, and historically/culturally-entrenched medical community and those components of China’s society (examples are, IT, capitalism, banking, fashion) that have dramaticall expanded, modernized, and brought economic prosperity. I believe that the aforementioned gaps have narrowed in recent years and can be increasingly narrowed such that many Western medical devices will find a formidable market presence in China.

FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Atherogenic Processes & Pathology, CABG, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Mitral Valve: Repair and Replacement, PCI, Personalized and Precision Medicine & Genomic Research, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Renal Denervation, Statistical Methods for Research Evaluation, Technology Transfer: Biotech and Pharmaceutical, tagged Center for Devices and Radiological Health, Critical Path Institute, FDA, Food and Drug Administration, MDIC, Medical device, Public–private partnership, Regulatory science on January 28, 2013| 16 Comments »

FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 11/22/2018

Device Approvals, Denials and Clearances

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

FDA clears AI technology that evaluates echocardiograms – Ultrasound Images

https://www.healthdatamanagement.com/news/fda-clears-ai-technology-that-evaluates-echocardiograms

Heart Murmur Detection done by AI Algorithm (Eko Core and Eko Duo) Devices Outperform most Auscultatory Skills of Cardiologists

https://pharmaceuticalintelligence.com/2018/11/21/heart-murmur-detection-done-by-ai-algorithm-eko-core-and-eko-duo-devices-outperform-most-auscultatory-skills-of-cardiologists/

FDA Clears Remote Multichannel ECG Compared to Holter

https://www.cardiovascularbusiness.com/topics/electrophysiology-arrhythmia/fda-clears-remote-multichannel-ecg-compared-holter

Arterys Cardio AI – MR Images

Arterys CEO Fabien Beckers, along with Michael Poon, MD, Northwell Health cardiologist, will present “The Potential of a Web Platform to Transform Medical Imaging with AI and Cloud Computation” in the 2018 RSNA Machine Learning Showcase, Tuesday November 27 at 11:30am CST. Arterys will provide demonstrations of its AI-powered, web-based solutions, including:

Arterys Cardio AIMR combines the power of deep learning and cloud computing to automate analysis of cardiac MR images. By eliminating many tedious, manual tasks, Arterys Cardio AI enables clinicians to quickly and easily identify, determine treatment for and track heart problems. It is the first and only commercial solution to offer deep learning-based semi-quantitative perfusion and quantitative delayed enhancement analysis*.

https://www.marketwatch.com/press-release/arterys-to-demonstrate-suite-of-ai-powered-cloud-based-medical-image-analysis-solutions-at-rsna-2018-2018-11-21/print

AI software for detecting brain bleeds receives FDA approval – CT Images

November 08, 2018 | Melissa Rohman | Artificial Intelligence

The FDA recently administered 510(k) clearance to software developed by MaxQ AI that uses AI to detect brain bleeds on CT images, according to a report published Nov. 8 by AI in Healthcare.

“The Accipio Ix Intracranial Hemorrhage platform uses AI technology to automatically analyze non-contrast head CT images, and can do so without impacting a physician’s workflow, altering the original series or storing protected health information,” according to the article.

The clinical diagnostics intelligence platform company hopes that the software can help physicians prioritizes patients who show symptoms of brain bleeds.

With FDA approval, the AI software can be sold for commercial use within the U.S. and will be on display during this year’s Radiological Society of North America (RSNA) Annual Meeting in Chicago.

https://www.healthimaging.com/topics/artificial-intelligence/ai-detection-software-brain-bleeds-fda-approved

More in Artificial Intelligence

Chest x-ray AI similar, but quicker than radiologists at detecting diseases

AI may help radiologists interpret screening mammography without added reading time

Predictive model may reduce overtreatment of ground glass nodules

Philips launches IntelliSpace Discovery* Research platform at RSNA to support the development and deployment of Artificial Intelligence assets in radiology

Machine learning method helps radiologists diagnose uterine cancer

Radiomics, AI fall short of radiologists in breast lesion classification on MRI

New trial may allow CMAs to perform echocardiograms with AI-guided ultrasound

CDS tool improves reader diagnosis of bladder cancer response to treatment

AI estimates full-dose PET images from low-dose scans

Australian university hopes digital pathology method can address pathologist shortage

SOURCE

https://www.healthimaging.com/topics/artificial-intelligence/ai-detection-software-brain-bleeds-fda-approv

Cardiovascular Medical Devices in the News

3D printing can identify device size for LAA occlusion

March 13, 2018 — Determining the best occluder device size necessary to properly seal the left atrial appendage (LAA) before implanting the device may be feasible with the assistance of 3D printing, according to two separate presentations at ECR 2018 in Vienna.

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=2

Machine learning can help assess atherosclerosis
February 7, 2018 — Machine-learning techniques analyze imaging measurements to automatically stratify patients by the level of atherosclerotic burden, offering the potential of personalized prediction of disease progression and more effective treatment for individual patients, according to researchers from Italy. Discuss

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=3

CCTA biomarker may predict mortality from heart disease
August 28, 2018 — The use of coronary CT angiography (CCTA) to measure fatty tissue around arteries could help predict the risk of mortality from heart disease, according to research published online on 28 August in the Lancet and being presented at the European Society of Cardiology congress in Munich. Discuss

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=1

SCOT-HEART: CCTA cuts risk of heart attack, death by 41%
August 25, 2018 — Patients with chest pain who underwent coronary CT angiography (CCTA) with standard care had a markedly lower rate of myocardial infarction or death from coronary artery disease than those who only received standard care in a new study, published on August 25 in theNew England Journal of Medicine. Discuss

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=1

Indiana University Health adds CT scans to 911 calls for stroke

Emergency response service aims to pinpoint cause of brain injury and speed correct treatment to patients.

RadiologyDiana Manos April 26
Brain MRI images can predict cognitive function after heart attack

Assessment finds which patients may respond best to treatment and fully recover from post-attack comas.

RadiologyMarla Durben HirschApril 23
Device able to quickly and accurately detect stroke

Neurologic assessment sends radio waves through the brain in a scanning process that takes just 30 seconds.

RadiologyGreg Slabodkin April 2
Geisinger taps EHR, genomics to identify high-risk patients

The provider may make the MyCode Community Health Initiative and its DNA sequencing a part of routine care.

Genome sequencingGreg Slabodkin March 23
Smartwatch app accurately detects atrial fibrillation

Cleveland Clinic study shows ECG algorithm reliably differentiates between AFib and normal heart rhythm.

Wearable technologyGreg Slabodkin March 2
Algorithm uses EHR data to identify undiagnosed hypertension patients

Leveraging clinical data increases accuracy, efficiency of identifying and diagnosing high blood pressure.

EHR analysisGreg SlabodkinFebruary 27
VA leverages EHR data to assess care quality for mini-stroke patients

Agency uses electronic process measures to evaluate patients after transient ischemic attacks instead of manual chart review.

SOURCE

https://www.healthdatamanagement.com/tag/cardiovascular-disease

FDA’s Medical Devices Frontier in 2013

Michelle McMurry-Heath

Office of the Center Director, Center for Devices and

Radiological Health, U.S. Food and Drug Administration (FDA)

and

Margaret A. Hamburg

Office of the Commissioner, FDA

In their article Creating a Space for Innovative Device Development stated that the FDA announces a partnership with a new nonprofit organization—the Medical Device Innovation Consortium (MDIC) —to advance regulatory science in the medical technology arena.

The promise of MDIC is to eliminate the currently existing shortfalls in applied research in areas such as health-related engineering and regulatory science, which comprises the development of new tools, standards, and approaches to assess a product’s safety, efficacy, quality, and performance.

MDIC will foster regulatory science breakthroughs in the medical technology space with the ultimate goal of improving human health.

FDA and LifeScience Alley (LSA; https://www.lifesciencealley.org)—a biomedical science trade association—have worked together to develop the first medical device public-private partnership (PPP) whose sole objective is to advance the entire spectrum of regulatory science in this sector. MDIC will facilitate this groundbreaking collaboration among federal agencies, nonprofit organizations, industry, academic institutions, and other trade associations such as MassMedic (www.massmedic.com) and the California Healthcare Institute (www.chi.org). Key goals:

(1) encourage members to leverage their resources by focusing jointly on precompetitive

(2) early-stage technology development ef orts that otherwise would not take place because of the organizational structure of the device sector.

About 75% of the more than 5,000 device manufacturers in the United States are small companies with fewer than 20 employees (3).

Start-up device companies have limited capital, and a startup’s future of en depends on the success of one complex device. Advances in regulatory science would speed the translation of these next-generation technologies.

Medical Devices sector lacks the resources to support regulatory science research, as well as mechanisms for working together to pool their resources to solve scientific issues.

MDIC members will make it a priority to develop regulatory methods and tools that can be adopted by the medical device community and will provide a forum for medical device stakeholders to securely share proprietary precompetitive data. Each advance achieved by medical device stakeholders through the sharing and leveraging of resources will assist industry in developing new REGULATORY SCIENCE Creating a Space for Innovative Device Development.

GOALS OF PARTNERING WITH MDIC

MDIC was designed with f exibility in mind, so that it can adapt to address the most pressing needs of patients and of the device industry as they evolve over time.

In keeping with the goal of stakeholder engagement, MDIC is currently recruiting founding members who will work jointly with FDA to determine research priorities for the endeavor.

Much like other successful PPPs in the pharmaceutical space, such as the Foundation for NIH or Critical Path Institute, the founding members will be asked to represent their stakeholder communities in

(i) suggesting the most promising areas for research collaboration,

(ii) raising funds to support these areas of investigation, and then

(iii) issuing requests for grant proposals.

Researchers and engineers from all sectors—industry, government, academia, or nonprofit organizations—will be encouraged to apply, and preference will be given to research consortia that cross sectors and take interdisciplinary approaches to problems.

MDIC strives to support science conducted by research teams that have innovative ideas for the development of tools and methods for medical device design, testing, and regulatory approval.

MDIC’s potential to improve patient care is computational modeling and simulation of human pathophysiology, which can be used to augment in vitro and animal disease models in the preclinical stages of device development.

FDA’s Center for Devices and Radiological Health (CDRH) expects computational modeling to accelerate and streamline the regulatory review process but first needs to develop a strategy for assessing the technology’s credibility—its usefulness, quality, and reproducibility. CDRH has begun to develop a technological framework called the Virtual Physiological Patient (4), which, once completed, will provide a model for the human body as a single complex system.

However, cross-sector research teams are required to develop the normal and diseased reference models that will serve as benchmarks for device performance and safety. Using computational modeling and simulation, device designs can potentially be ref ned even before they enter clinical trials, improving safety for patients and reducing the cost of device development for companies, computational modeling and simulation, device designs can potentially be ref ned even before they enter clinical trials, improving safety for patients and reducing the cost of device development for companies.

Another emerging research area is medical device interoperability—the development of devices that seamlessly operate with other medical devices and information systems (5). MDIC could establish a framework to identify gaps in the interoperability field, prioritize the gaps, and then fund research accordingly.

MDIC also could help prioritize the development of standards for innovative interoperable medical devices and build test beds for these technologies. is research will help to ensure that interoperability issues do not pose a hazard to patients.

With the emergence of new materials in medical devices, FDA must develop updated biocompatibility standards based on the most recent scientific advances.

MDIC could support the development of new preclinical biocompatibility assays that predict potential adverse health responses in people exposed to biomaterials or nanoparticles (6).

INNOVATION INFRASTRUCTURE With today’s fiscal realities, FDA cannot rely on government-funded “Manhattan projects” to bridge the funding gap for regulatory science. Partnerships bring together private-sector expertise, academic science ingenuity, and federal regulatory knowledge, and new structures are needed to promote these multifaceted collaborations.

It would be convenient if such partnerships formed organically, but all too of en, bureaucratic red tape gets in the way of sensible scientif c collaboration. MDIC will serve as a collaborative freeway to biomedical discovery and development by forming a foundation that makes it easy for industry, academia, and government to come together to set research priorities; to pool their distinct intellectual capital; and then to work together to advance knowledge that modernizes regulatory science and improves patient access to high-quality medical technology.

Sci. Transl. Med. 4, 163fs43 (2012).

[ScienceTranslationalMedicine.org 5 December 2012 Vol 4 Issue 163 163fs43]

Statistics on Device use — Number of procedures in the United States (2009)

Number of domestic inpatient procedures (N = 48 million per year)

Insertion of coronary artery stent: 528,000
Diagnostic ultrasound: 902,000
CT scan: 497,000
Arteriography and angiocardiography: 1.9 million
Cardiac catheterization: 1.1 million
Total hip replacement: 327,000
Total knee replacement: 676,000

Source:

U.S. Centers of Disease Control www.cdc.gov/nchs/fastats/insurg.htm

This sector is best known for

surgical instruments,
cardiology devices, and
orthopedic implants, it also includes all of the
diagnostic tests and
imaging equipment currently used to pinpoint disease
companion diagnostics, which are needed to fulfill the promise of personalized medicine (1).

FDA 510 (k) Pending for the Latest Cardiovascular Imaging Technology

Editor’s choice of the most innovative technology at RSNA 2012

By:

Dave Fornell

December 11, 2012

Toshiba is developing a radiation dose alert to show interventionalists how much dose they have delivered to their patient from X-ray angiography.

The latest advances in cardiovascular imaging are usually shown first at the Radiological Society of North America (RSNA) annual meeting, the largest radiology show in the world, held the last week of November in Chicago. After spending five days walking three expo halls filled with more than 600 product vendors, the following is my editor’s choice for the most innovative new cardiovascular imaging technology.

New Angiography Systems

Siemens unveiled two new 510(k)-pending angiography systems, the Artis Q and Artis Q.zen, which incorporate new X-ray tube, detector and imaging software technology that can help reduce dose significantly, while offering improved image quality.

The new X-ray tube is intended to help physicians identify small vessels up to 70 percent better than conventional X-ray tube technology. The Artis Q.zen combines this innovative X-ray source with a new detector technology designed to support interventional imaging in ultra low-dose ranges to patients, doctors and medical staff, particularly during more complex, longer interventions.

The second generation of Siemens’ flat emitter technology replaced the coiled filaments used in conventional X-ray tubes to emit electrons. Flat emitters are designed to enable smaller quadratic focal spots that lead to improved visibility of small vessels.

The Artis Q.zen combines the X-ray tube with a detector technology that allows detection at ultra-low radiation levels. It can image with doses as low as half the standard levels applied in angiography. Instead of detectors based on amorphous silicon, a new crystalline silicon structure of the Artis Q.zen detector is designed to be more homogenous, allowing for more effective amplification of the signal, greatly reducing the electronic noise.

Siemens also introduced new software applications for interventional imaging. Clear Stent Live freezes an enhanced image of a stent during deployment with the balloon radio-opaque markers and uses it as an overlay on live fluoroscopy. Siemens says the main application will be for better visualization when implanting overlapping stents or stenting bifurcation lesions. It also helps suppress and stabilize heart motion on the image.

Other new 3-D applications are designed to image the smallest structures inside the head. Their high spatial resolution is crucial for imaging intracranial stents or other miniscule structures such as the cochlea in the inner ear. Moving organs such as the lungs can be imaged in 3-D in less than three seconds, reducing motion artifacts and the required amount of contrast agent.

GE Healthcare showcased its IGS (Image Guided System) 750 hybrid OR angiography system. It was displayed at RSNA 2011, but did not receive FDA clearance until earlier this year. It offers the mobility of a mobile C-arm, but the image quality and software features of a ceiling or floor mounted fixed system. It uses laser guidance for very accurate positioning. It can rove around the room on a powered caster system to enable different positioning around the table, or be parked out of the way during open surgical procedures.

Hands-Free Physician Control of Images

GestSure displayed a new, FDA-cleared system that allows interventionalists in the cath lab, or surgeons in the operating room, to pick reference images to display on the overhead screens in the room and manipulate the images all hands-free. It allows physicians to pick and enlarge the images they need for better procedural navigation, while maintaining the sterile field.

A video sensor detects all the people in the work area and displays their outlines on a separate screen, with each person assigned a specific color. When one of those people raises their arms in the “hands up” pose, the system detects this and allows the person control of the system. Using the right arm/hand, they can scroll through images and use the left arm/hand as a mouse click by a pushing motion forward. The system detects the motions and translates them in real time to mouse actions on the overhead screen.

The software works as a vendor-neutral layer on top of existing PACS or advanced visualization software.

Outpatient, Office-Based Catheter Interventions

Outpatient, office-based peripheral vascular procedures are an increasing trend, according to GE healthcare, which showcased a new “mobile hybrid OR” solution. The trend includes setting up an outpatient cath lab in an office setting to reduce the costs of using hospital ORs or cath labs. The room system GE highlighted centers around its OEC 9900 Elite mobile C-arm and Venue 40, which is combined with a ultrasound system in an all-in-one unit. The GE Venue 40 tablet ultrasound system is mounted within the OEC 9900 Elite C-arm’s workstation to reduce the floor space required.

Wireless Ultrasound Transducer

Siemens introduced the world’s first wireless transducer ultrasound system, the Acuson Freestyle. It eliminates the impediment of cables in ultrasound imaging by using a battery-powered transducer, about the size of a large TV controller. The transducer can be submerged for cleaning. It is capable of 90 minutes of continuous scanning before the battery needs to be recharged.

The Freestyle is a point-of-care system that will expand ultrasound’s use in interventional and therapeutic applications. The transducer can be used to image up to 10 feet from the console. Siemens said it hopes to refine and expand the wireless transducer technology to its other systems in the coming years.

Engineers had to overcome several issues to create a wireless transducer. For example, a cardiac echo requires about 40 frames per second and each frame is equal to about 1 megabyte of data. To accommodate the amount of data and speed the computer processing involved, some of the electronics are placed in the transducer rather than processing the data in the machine console. The wireless system transmits the data over an 8 GHz ultrawideband radio frequency to the console. The amount of data and the bandwidth transmitted by the transducer is equal to about 10 4G smart phones working continuously.

Noiseless MRI

GE Healthcare introduced its 510(k)-pending noiseless MRI Silent Scan technology that it hopes to introduce in 2013 for its MR450W 1.5T system. The technology addresses one of the most significant impediments to patient comfort — excessive noise generated during the exam that can be in excess of 110 decibels. A combination of software and a pulse sequence lowers the noise level to that of a chirping bird outside a window.

Historically, acoustic noise mitigation techniques have focused on insulating components and muffling sound as opposed to treating the noise at the source. With Silent Scan, acoustic noise is essentially eliminated by employing a new advanced 3-D acquisition and reconstruction technique called Silenz, in combination with GE Healthcare’s proprietary design of the high-fidelity MR gradient and RF system electronics. Silent Scan is designed to eliminate the noise at its source.

640-Slice CT Scanner

Toshiba unveiled its 640-slice Aquilion One Vision edition CT scanner. The vendor already offers the highest-slice system on the market, the 320-slice Aquilion One. The new system is equipped with a gantry rotation of 0.275 seconds, a 100 kw generator and 320 detector rows (640 unique slices) covering 16 cm in a single rotation, with the industry’s thinnest slices at 500 microns (0.5 mm). The system can accommodate larger patients with its 78 cm bore and fast rotation, including bariatric and patients with high heart rates.

FFR-Like CT Culprit Vessel Analysis

TeraRecon released new research software in response to fractional flow reserve (FFR)-CT analysis being developed by HeartFlow. The HeartFlow software uses a supercomputing algorithm to look at the fluid dynamics of the iodine contrast flow in coronary vessels to calculate a virtual a FFR number, similar to invasive pressure wire based FFR in the cath lab. TeraRecon’s Lesion Specific Analysis software cannot calculate FFR, but uses the same principle of tracking contrast flow in the myocardium. It uses lobular decomposition to look at each vessel segment to determine the tissue it feeds to show areas of ischemia and the expected culprit vessel segment. It shows a color contrast level maps on a 3-D model of the heart and in a coronal view of the left ventricle. Automated detection boxes highlight suspected ischemic areas of interest and identifies the vessel responsible for supplying blood to the region.

Radiation Dose Monitoring

Radiation dose monitoring solutions have been shown at previous RSNAs, but were highlighted by several companies this year as several states began implementing requirements for radiology departments to record patient dose. Dose records will have the most application with CT systems, especially for longer duration, higher dose cardiac exams, and catheter based angiography. Angiography is becoming an increasing issue due to the longer duration of more complex transcatheter interventions.

Toshiba demonstrated a work-in-progress dose tracking software for its Infinix-i angiography system. It can be displayed on a screen in the cath lab to show the approximate radiation dose that has been delivered cumulatively to specific areas of a patient. It takes into consideration the amount of time, power setting used and orientation of the C-arm to show a color-coded map of radiation delivery projected on a human figure. The colors change in real time as X-ray imaging continues. It is designed to be a visual reminder to physicians about the dose the patient has received and that they may want to change the location of the C-arm.

Sectra demonstrated 510(k)-pending Dose Track software, which radiology or cardiology departments can use to track radiation dose by patient, machine, physician, technologist, procedure type and room. The system can be set up to create alerts if a reasonable amount of dose if exceeded for a particular exam, or if certain physicians or technologists are using higher than average doses.

OLED Displays

Flat panel display technology migrated from CRT screens to LCDs over the past decade. The next major innovation in display technology is OLED, which offers even smaller components, faster response time than LCD, and the ability to display quick motion with virtually no blur. Sony showed the new PVM-2551MD OLED medical-grade monitor, which incorporates technology to achieve pure black, faithful to the source signal. By providing superb color reproduction, especially for dark images, surgeons can observe very subtle details such as the faint color difference between various tissues and blood vessels.

Aesthetically Pleasing Cath Labs

Philips Healthcare displayed video of its recent install of the Ambient Experience in a cath lab. The system uses colored lighting, subtle room design details and projected image visual effects to calm patients and make procedure rooms look less clinical. The installation highlighted allowed doctors or patients to choose a theme, such as a tropical rainforest, where diffused, indirect lighting would take a green hue and a photo projection on the ceiling of a tropical scene. Philips said at facilities that have installed these type of labs, patient satisfaction rose, as did staff morale. They say doctors and staff compete to use these rooms at some facilities.

Single Detector Spectral CT Imaging

Philips introduced an innovative work-in-progress CT system that uses new detector technology to simplify spectral imaging, offering soft tissue image quality similar to MRI. Currently, CT special imaging can be performed using systems with two X-ray tubes and two detectors. The new system in development uses a single X-ray source and a single detector that has two layers of detectors, one on top of the other, for high and low energy.

Better Transcatheter Mitral Valve Repair Guidance

Philips’ showed its new Echo Navigator system, designed to synchronize views from TEE ultrasound with the orientation on live angiography. The primary application is to aid navigation during transcatheter mitral valve procedures, which require very accurate 3-D echo navigation to deploy devices like the Abbott MitraClip.

3-D Sculptures From 3-D Datasets

Taking 3-D images shown on 2-D display screens to a true physical 3-D form, Vidar Systems/3D Systems displayed the new Z Printer 450. It takes any 3-D advanced visualization dataset and can print the image in true 3-D using gypsum powder (the same material used to make drywall), standard color ink jet printer cartridges and a binding agent. The image is saved as an STL file and sent to the printer, which prints 1/10^th of a millimeter each pass, up to 2 cm per hour.

The 3-D sculptures it created can be printed in color, eliminating the need to paint the models.

The printer offers a new way to create 3-D anatomical models for medical education, complex surgical planning and cosmetic reconstruction. Another application suggested at RSNA was to print sculptures for sale to the patients, such as fetal faces taken from 3-D obstetrics ultrasound exams.

The company printed a full-sized, 3-D, color heart during the show using a cardiac CT dataset on a thumb drive provided by one of the advanced visualization vendors in the same hall.

Siemens unveiled the world’s first wireless ultrasound transducer at RSNA 2012.

http://www.dicardiology.com/article/latest-cardiovascular-imaging-technology

REFERENCES

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PET/CT: Challenge for Nuclear Cardiology

THE JOURNAL OF NUCLEAR MEDICINE • Vol. 46 • No. 10 • October 2005

PCI Outcomes, Increased Ischemic Risk associated with Elevated Plasma Fibrinogen not Platelet Reactivity

Posted in Bio Instrumentation in Experimental Life Sciences Research, CABG, Cardiac & Vascular Repair Tools Subsegment, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Coagulation Therapy and Internal Bleeding, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, HTN, Interviews with Scientific Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, PCI, Pharmacotherapy of Cardiovascular Disease, Population Health Management, Genetics & Pharmaceutical, Stents & Tools, Systemic Inflammatory Response Related Disorders, tagged Conventional PCI, Dade-Behring, fibrinogen, MICHAEL WARD, myocardial infarction, University of California San Francisco on January 10, 2013| 12 Comments »

PCI Outcomes, Increased Ischemic Risk associated with Elevated Plasma Fibrinogen not Platelet Reactivity

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #13: PCI Outcomes, Increased Ischemic Risk associated with Elevated Plasma Fibrinogen not Platelet Reactivity. Published on 1/10/2013

WordCloud Image Produced by Adam Tubman

Q&A Session between Dr. Michael Ward and Dr. Larry Bernstein presented for in our Research Category on

Interviews with Scientific Leaders

Primary research:

Ang L, et al “Elevated plasma fibrinogen rather than residual platelet reactivity after clopidogrel pre-treatment is associated with an increased ischemic risk during elective percutaneous coronary intervention” J Am Coll Cardiol2013; 61: 23-34.

Question by DR. MICHAEL WARD

How ironic that an old diagnostic parameter should
reappear in the limelight of diagnostic predictors.

Of course, decades ago, doctors asked for “sed rates”, seeking to know if red cells, thought to be bound to fibrinogen, settled faster in a patient compared to a control subject’s blood. Fibrinogen has always been a diagnostic number in evaluating inflammatory results.

However, the diagnostic world, like the worlds of pharmaceuticals, medical devices, biologics, and other industries, always seek the ‘new kid on the block’ to differentiate themselves from the rest of the pack in the
marketplace.

So there was a binge (and still is) to seek new and exotic blood proteins that are surrogate markers for specific diagnoses or prognoses.

That is the irony, that in this case at least, fibrinogen has come full circle. Biology works in mysterious ways.

Answer by Dr. Larry Bernstein, MD, FCAP

Dear Dr. M. Ward:

Doctors asked for “sed rates”, seeking to know if red cells, thought to be bound to fibrinogen, settled faster in a patient compared to a control
subject’s blood. Fibrinogen has always been a diagnostic number in evaluating inflammatory results.

You are quite right that physicians used “sed rates” as a measure of inflammation, and more in Lupus Erythematosis, Rheumatoid Arthritis, Nephritides, Systemic Sclerosis, and so forth. The “sed rate” was not a part of the thinking about CVD, and PCI didn’t exist. Recently, MI post-PCI has been defined as a type (NSTEMI?).

Yes. In principle, the sed rate is related to fibrinogen and red-cell aggregation. I am not prepared to accept that a platelet count over 400,000 would make no contribution, even if many of the PCI related infarcts are within a range of 150-300,000. I don’t know how much power there is in the discussion. The role of tissue factor (plaque), and of platelets in hemostasis is undeniable.

The industry does look for every opportunity to seize on promising biomarkers. The coagulation assays developed at Dade-Behring (Dade, Dupont Division; then Dade) were far better and more explanatory that the “sed rate”. The sed rate measurement requires that you set up graduated tubes to watch the rate of sedimentation. It is not a walkaway procedure. Industry has been so good at introducing automation that led to high volume efficiency, that this led to the only part of hospital operations that had good accounting measures. The long trip to reducing personnel, but of course the profiles were a piece of cake. I continually reorganized to carve out services for immunology and toxicology, which took longer to get automated.

The only use for sed rate now is for Temporal Thrombosis (?).

In the early days Yale NH Hospital had some 5 Perkin Elmer HPLCs to measure calcium. Electrophoretic separation of isoenzymes was not helpful for managing patients. The procedure was run batchwise once a day. I was the first in CT to be running the immunoassay three times a day on the Roche COBAS Bio CFA., and Dupont put it on the ‘aca’. A med tech could run it at 3 am at Detroit Receiving, Bellevue, or Cook County, when the phone didn’t stop ringing for STAT results.

Physicians had expectations too. So we had the progression from AST, LDH, and CK to isoenzyme MBCK, and then there were the cancer biomarkers – CEA, CA-125, PSA, with much to be discussed.

Q&A is derived from the following Article in

MedPage Today

Published: January 07, 2013

Fibrinogen Level Tied to Poorer PCI Outcomes

By Todd Neale, Senior Staff Writer, MedPage Today

Published: January 07, 2013

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

An elevated serum fibrinogen level predicted worse short-term ischemic outcomes among patients undergoing elective percutaneous coronary intervention after pretreatment with clopidogrel, researchers found.

Significantly higher levels of fibrinogen were seen in patients with periprocedural myocardial infarction (MI) defined by either creatine kinase-myocardial band (CK-MB) or troponin (P<0.02 for both), according to Ehtisham Mahmud, MD, of the University of California, San Diego, and colleagues.

Those relationships remained consistent after adjustment for several factors, including platelet function, which was not itself associated with periprocedural MI, the researchers reported in the Jan. 8 issue of the Journal of the American College of Cardiology.

“The results of the current study suggest that an elevated fibrinogen level…is related to significant platelet cross-linking and thrombus formation independent of residual P2Y12 receptor-mediated platelet activity during clopidogrel therapy,” they wrote.

Higher risk of ischemic cardiovascular events has been observed with both high platelet reactivity after thienopyridine treatment and elevated serum fibrinogen.

“As an acute phase reactant involved in the final common pathway of the coagulation cascade and essential component of platelet cross-linking in thrombus formation, fibrinogen possesses a clear biological mechanism for its adverse cardiovascular effects,” Mahmud and colleagues wrote.

In fact, high levels of serum fibrinogen have been shown to contribute to high platelet reactivity during clopidogrel treatment, resulting in uncertainty about whether insufficient platelet inhibition and elevated fibrinogen levels are independent or interactive risk factors for ischemic events.

To explore the issue, the researchers looked at data from 189 patients undergoing elective PCI who were pretreated with clopidogrel, defined as 75 mg daily for at least 7 days or a 600-mg bolus at least 12 hours before study enrollment. The mean age of the patients was 63.8 and most (74.1%) were male.

Nearly two-thirds (63%) had undergone a previous PCI, and 18% had undergone revascularization with coronary artery bypass grafting (CABG).

Baseline platelet function was measured using the VerifyNow P2Y12 assay. Markers of ischemic myocardial injury, including troponin and CK-MB, were measured every 8 hours after PCI until hospital discharge.

Periprocedural MI defined by troponin I or T occurred in 13.9% of patients. Those who had an MI had significantly higher levels of fibrinogen (363.1 versus 309.1 mg/dL, P=0.017).

The rate of CK-MB-defined periprocedural MI was 5.8%. Patients with that outcome also had elevated levels of fibrinogen (403.4 versus 313.5 mg/dL, P=0.007).

Both differences remained significant after multivariate adjustment that accounted for platelet function and other inflammatory markers.

The researchers found that a fibrinogen level of 345 mg/dL or higher — a cutoff identified as having optimal combined sensitivity and specificity for CK-MB-defined periprocedural MI — was associated with periprocedural MI defined by either troponin or CK-MB (P<0.04 for both).

Those relationships were stronger when systemic inflammation was low (C-reactive protein ≤0.5 mg/dL).

The platelet reactivity measurements were not associated with either definition of periprocedural MI, which is inconsistent with the findings from several smaller studies. The authors noted, however, that “the significance of these negative findings may be limited due to inadequate study power.”

In discussing the limitations of the study, the researchers pointed out that “the findings … do not provide insight into whether the relationship between high platelet reactivity and ischemic cardiovascular events demonstrated in previous studies is a direct one or mediated through the effect of serum fibrinogen.”

To get to the bottom of that, they wrote, “future studies relating platelet reactivity and adverse cardiac events should measure baseline fibrinogen.”

Mahmud has received clinical trial support from Accumetrics, Eli Lilly, and sanofi-aventis, and is on the speakers bureau for Medtronic. One of his co-authors is a consultant for Abbott Vascular, Boston Scientific, St. Jude Medical, Medtronic, and sanofi-aventis.

From the American Heart Association:

ACCF/AHA/SCAI Guidelines for Percutaneous Coronary Intervention

Primary source: Journal of the American College of Cardiology
Source reference:
Ang L, et al “Elevated plasma fibrinogen rather than residual platelet reactivity after clopidogrel pre-treatment is associated with an increased ischemic risk during elective percutaneous coronary intervention” J Am Coll Cardiol2013; 61: 23-34.

Add Your Knowledge ™

Todd Neale

Senior Staff Writer

Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University.

SOURCE:

http://www.medpagetoday.com/Cardiology/PCI/36734?goback=%2Egde_2184987_membe

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC101260/bin/2FF3.gif

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