This post was authored by William J Oetgen, MD, MBA, FACC, ACC's senior vice president of Science and Quality.

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Results from the ASCERT study released today during the final Late-Breaking Clinical Trial session found that patients who underwent PCI had a higher death rate in the first four years after treatment than those who had opted for coronary artery bypass graft (CABG) surgery. The study, which used combined patient data from the ACC’s CathPCI Registry, the Society of Thoracic Surgeons CABG database and the Medicare claims database, suggests better survival in patients undergoing CABG compared to PCI.

While past studies have suggested that the two treatments have similar long-term outcomes, others have shown better outcomes with CABG. Patents and doctors tend to choose the less-invasive PCI when both treatments are an option. Recently updated ACCF/AHA Guidelines for CABG and PCI state that PCI to improve patient survival is a reasonable alternative to CABG in stable patients with left main CAD who have a low risk of PCI complications and an increased risk of adverse surgical outcomes. The guidelines also confirm the superiority of CABG compared to medical therapy and to PCI for most patients with 3-vessel disease.

Should physicians start recommending CABG over PCI as a result of this study? The answer is no. A major limitation of observational studies, such as this one, is that the groups may not have the same level of risk, and so it is possible that the worse outcomes in the PCI patients were related to these patients being sicker overall. These results do, however, underscore the importance of the Guideline-recommended “heart team” approach to determine which procedure should be used. This approach means that the interventional cardiologist and the cardiac surgeon review the patient’s condition, determine the pros and cons of each treatment option, and then present this information to the patient, allowing him or her to make a more informed decision. Results from studies like ASCERT should be shared with patients as part of the decision-making process.

Read more on the study here.

There is no denying that change is in the air when it comes to large medical meetings like the ACC’s Annual Scientific Session and Expo. Not only has the rapid growth and use of mobile technologies made it easier to stay up-to-date on scientific research and guidelines, tough economic times and increasing regulations governing relationships with industry have limited travel sponsorships and overall meeting funding.

However, while these changes are very real and require a shift in focus from decades past, they don’t overshadow or negate the importance of these meetings in providing a one-stop-shop for the hottest clinical breakthroughs, increasingly important maintenance of certification opportunities, and forums for professionals across the spectrum of care delivery to network and share ideas.

At ACC.12 in Chicago, the College under the guidance of ACC President David Holmes, Jr., MD, FACC, has taken a renewed look at the meeting format and offerings and developed a well-rounded agenda that accommodates both the changing landscape of cardiology and the changing needs of the professional world.

In particular, the meeting format has been changed to feature new science in the mornings, followed by afternoon sessions focused on actual application of the science. Many of these sessions take advantage of innovative new technology to allow for the “piping in” of live cases from around the globe, as well as online debate and conversation with panel presenters while the session is occurring.

In addition, the College recognizing the importance of working closely with partner cardiovascular societies both in the U.S. and around the globe, is featuring numerous co-sponsored sessions each day with societies like the Society of Vascular Surgery, The Society of Thoracic Surgeons, the International Society for Cardiovascular Translational Research, the Heart Rhythm Society, the Heart Failure Society of America, the American Society of Echocardiography, the American Heart Association, and others. On a global scale, the record 18 International Lunch Symposia, which are jointly sponsored by ACC and international cardiology societies, will cover topics ranging from using registries for quality improvement; best practices for treating adult congenital cardiology; improving outcomes for patients with acute coronary syndromes; and more.

All of these education sessions are vital for professionals to earn Maintenance of Certification (MOC) credits, an increased point of emphasis at ACC.12. For example, entire afternoons will be dedicated to a review the fundamentals, such as MOC and clinical interpretations, with an increased number of MOC sessions from past meetings so attendees can complete much of their required elements and core content. This is something not offered to attendees at European meetings, but is vital for professional development.

Of course, networking is something else that can’t be done behind a desk and in front of a computer. ACC.12 provides many unique opportunities for cardiologists, nurses, nurse practitioners, practice administrators, pharmacists, training directors, fellows in training and others to come together in a forum not seen anywhere else. Only at ACC.12 will there be opportunities to meet and ask questions of cardiovascular legends credited for making the delivery of cardiovascular care what it is today. whenever 20,000 people who love cardiovascular science, clinical research, and health policy get together to describe the future, it has to both a very special and unique experience.

As the needs of cardiovascular professionals are changing, the ACC’s meeting is changing with them. The need for cutting edge cardiology science, education and innovation to better benefit patients and save lives will never diminish. ACC.12 shows just how far we’ve come in ensuring the meeting remains relevant and continues to benefit all cardiovascular professionals in terms of their learning and scientific needs.

Whenever 20,000 people who love cardiovascular science, clinical research, and health policy get together to describe the future, it has to be a very special and unique experience.

A study published earlier this week in The Lancet shows that treating heart attack patients with an infusion of their own heart-derived cells helps damaged hearts re-grow healthy muscle. The study results are from the Cedars-Sinai Heart Institute clinical trial CADECEUS and is the first-of-its-kind stem cell procedure.

As it has shown that cardiosphere-derived cells (CDCs) reduce scarring after myocardial infarction, increase viable myocardium, and boost cardiac function in preclinical models, the authors aimed to assess safety of such an approach in patients with left ventricular dysfunction after myocardial infarction.

The study involved 25 patients who had suffered a myocardial infarction that left them with damaged heart muscle. Eight patients received standard care, and the remaining 17 received the stem cell treatment. The results showed that one year later, scar size was reduced from 24 percent to 12 percent of the heart in patients with cells. Patients also experienced sizable increase in healthy heart muscle following the experimental stem cell treatments. Patients in the control group who did not receive stem cells did not experience a reduction in their heart scars.

Eduardo Marban, MD, PhD, director of the Cedars-Sinai Heart Institute who invented the procedures and technology involved in the study noted, “While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and regrow lost heart muscle... this has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks.”

While the grim concerns about the alarming contributions of health care costs to the national deficit seem to dominate the conversation, who could deny that this is an unprecedented and exciting time for the cv community! Science is moving fast. The ACC wants more medical research and NIH funding to pursue innovative, life-saving therapies. Although funding of stem cell research is often a topic of controversy, we need to publicly educate how life-saving therapies like these are exactly what innovators in medicine and science strive to achieve.

Let’s not forget that this type of innovation requires funding and support, and it’s not looking good for those of us in the U.S. folks. President Obama’s Fiscal Year 2013 Budget Proposal freezes funding for NIH, and many in Congress advocate for significantly slashing funding for innovation and research.  Nonetheless, innovators like Marban are paving the wave of the future. Let’s have at it!

This post is written by Manesh Patel, MD, FACC, lead author of the updated appropriate use criteria for coronary revascularization and the John Bush Simpson Assistant Professor of Cardiology at Duke University, assistant director of the Duke Cardiac Catheterization Laboratory and director of Duke Catheterization Lab Research.

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Yesterday the ACC along with the Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, Heart Failure Society of America, and Society of Cardiovascular Computed Tomography released updated appropriate use criteria (AUC) for coronary revascularization.

Coronary Artery Disease (CAD) occurs when the arteries supplying the heart with oxygen and nutrients narrow and become blocked. According to the National Heart, Lung, and Blood Institute, CAD is the most common type of heart disease, and is the #1 cause of death for both men and women in the U.S.

As a result of the increasing prevalence of CAD, continued advances in surgical and percutaneous techniques for revascularization and concomitant medical therapy for CAD, and the cost of revascularization, there has been heightened interest regarding the appropriate use of coronary revascularization.

The updated appropriate use criteria replace a previous set published in 2009, and help patients, physicians, and payers determine when it’s reasonable to do a procedure that is intended to improve the patient’s quality of life, health status, and long-term survival. The updated criteria can also assist patients and physicians with health-related discussions and shared decision-making, so that patients are confident they are getting the right procedures for them.
In particular, the updated criteria address the following two areas:

1. Re-evaluation of the indications for the treatment of multivessel CAD with symptoms by PCI and CABG as a result of data from the SYNTAX trial, which came out after the original AUC were published; and
2. Specific indications that represent gaps identified when mapping the 2009 AUC to the CathPCI Registry^®.

Like previous appropriate use criteria, the scope of indications is purposely broad and intended to represent the most common patient scenarios for which, in this case, coronary revascularization is considered. As a result, the clinical scenarios presented and scored were developed to represent common situations encountered in everyday practice and include information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing and coronary anatomy. They are not inclusive of every possible clinical situation.

The new appropriate use criteria will certainly stimulate discussion regarding appropriate use of revascularization. A rating of uncertain does not mean that it’s not reasonable or should not be done. These are areas where we don’t have definitive evidence and think more research is needed. That’s where physicians apply their clinical experience and knowledge to patient care and patients express their wishes. The authors and I hope physicians, surgeons, caregivers and patients have a conversation in each individual case about the best way to improve patient outcomes.

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To learn more, visit CardioSource.org. Be sure to check out the Jan/Feb issue of Cardiology magazine for the complete cover story. Also view the Heart Minute video with commentary from Peter Block, MD, FACC below. Do you agree? Leave your thoughts in the comments section.

Atrial fibrillation (AFib) is the most common sustained cardiac rhythm disturbance, increasing in prevalence with age. It is often associated with structural heart disease, although a substantial proportion of patients with AFib have no detectable heart disease. Hemodynamic impairment and thromboembolic events related to AFib result in significant morbidity, mortality, and cost.

Several of the Late-Breaking Clinical Trials coming out of the American Heart Association’s (AHA’s) 2011 Annual Meeting focused on new treatments for this common condition, particularly in high-risk patients.

Among the results:

• Video-assisted epicardial surgical ablation was found superior to catheter ablation in high-risk patients with enlarged atrial and hypertension, or unsuccessful prior catheter ablations. However, the adverse event rate for surgical ablations was higher. Read more about the FAST trial here.

• Radiofrequency catheter ablation (RFA) worked as well as or better than antiarrhythmic drug therapy as first-line therapy in patients with paroxysmal AFib. The study found that at 24 months AFib burden, occurrence of AFib and symptomatic AFib were significantly lower with RFA. Read more about the MANTRA-PAF trial here.

• Dronedarone was found to be unexpectedly dangerous in some patients with permanent AFib in the PALLAS trial. Researchers stopped enrollment in the trial in July when the Data and Safety Monitoring Board detected excessive serious vascular events and deaths. The drug has been shown to reduce unplanned hospital admissions and death in patients with non-permanent AFib. This was the first trial to investigate interventions in morbidity and mortality in high-risk patients. Read more about the PALLAS trial here.

As the health care world continues to focus on improving care and reducing costs, new trials, like those above, are crucial to the continued evolvement of how to best prevent and treat this condition. New drugs and therapies, if used appropriately, can offer some real solutions. The ACC continues to work with partners like AHA, the European Society of Cardiology and the Heart Rhythm Society (HRS) to follow these and other trial results, and provide cardiovascular providers with the best, evidence-based guidance on how to manage AFib patients. Updated AFib guidelines were released earlier this year. The ACC and HRS are also partners in the “Atrial Fibrillation Community” on CardioSource.org, which provides latest news and updates, discussions on hot topics and more. In addition, ACC.12 in Chicago this next March will offer additional opportunities to explore the latest scientific advances when it comes to AFib.

This week, I am joined by David Holmes, Bill Zoghbi, Ralph Brindis and interventional cardiologists, radiologists, clinical cardiologists, scientists, vascular medicine specialists, surgeons, nurses and others interested in interventional and vascular medicine in San Francisco for CRF’s Transcatheter Cardiovascular Therapeutics Conference—also known as TCT. This year marks the first time ACC is co-sponsoring the symposium and we have been working closely with CRF throughout the year to share content and distribute educational materials. Last year, a “Collaboration Council” of senior physician leaders was formed to set the strategic direction of the partnership in order to accomplish the joint goal of expanding educational opportunities for interventional cardiovascular professionals.

During this year’s conference, over 20 late-breaking clinical trials will be presented, with several that have the potential to significantly impact clinical practice. Results from RAPID GENE, one of the most ground-breaking trials at TCT, were presented this afternoon.  One of the limitations of pharmacogenetic strategies has been the inability to perform rapid genetic testing at the patient’s bedside in the hospital. Currently, costs, a lack of local genetic testing expertise and the inability to provide timely information have been impediments to the application of genetics. As a result, a prospective evaluation of the personalized approach to anti-platelet therapy after PCI based on genetic data has not been possible. This late-breaker evaluated the first point-of-care genetic test in medicine for its accuracy and potential clinical utility by looking at Prasugrel vs. Clopidogrel in CYP2C19*2 carriers.

CYP2C19*2, a common genetic variant, is associated with an increased occurrence of major cardiovascular events following percutaneous coronary intervention (PCI). The innovative point-of-care genetic test, Spartan RX-CYP2C19, used in the study enabled carriers of the genetic variant to be identified within 60 minutes after a buccal swab.

CYP2C19*2 carriers in the rapid genotyping group who were  administered prasugrel saw a significant reduction in the primary endpoint (0%) relative to the standard therapy group (clopidogrel) (30.4%) (p=0.009). The study also found a significant reduction in the percentage of platelet inhibition in carriers from the rapid genotyping group compared to the standard therapy group (73.3% vs. 27.0%, p<0.001).

The authors of the study found that the point-of-care genetic testing device proved feasible in a clinical setting and that it facilitates rapid personalization of anti-platelet therapy. Given these outcomes, we are sure to see larger scale studies that will evaluate the role of pharmacogenomics after PCI in the future.

Keep on the look-out for coverage of other noteworthy trials, including TRIGGER-PCI, BRIDGE, RIFLE STEACS, STACCATO and TWENTE throughout the week.  If you’re in San Francisco for TCT this week, make sure to stop by the ACC’s table in the CRF Collaboration Pavilion on the Lower Level Concourse of Moscone North Hall. I hope to see you there!

For complete coverage:

• Visit the TCT meeting page on CardioSource.org
• Follow ACC on Twitter and Facebook 
• Join the Interventional CardioSource Community
• View the video on RAPID GENE and BRIDGE Trials

AFib is catching a lot of buzz lately. Two weeks ago, the PINNACLE Registry announced the expansion of its outpatient registry with a new platform focusing on atrial fibrillation that will include the next generation of anticoagulants and will be free for all cardiology practices. The new registry will help providers evaluate and improve adherence to established guidelines and performance measures and will strengthen future research and innovation. PINNACLE, part of NCDR, is the largest cardiovascular outpatient database in the country and currently has 2.1 million patient records representing valid patient encounters from hundreds of outpatient practices nationwide. Of the 2.1 million patients, more than 100,000 have AFib. Stay tuned for more developments as the registry becomes operational in 2012 and delves into collecting data that will improve patient care.

How do you use anticoagulants in your practice when dealing with AFib? Weigh in on the poll and see how others are thinking about new agents as well.

Results from the AFFIRM Trial (Atrial Fibrillation Follow-Up Investigation of Rhythm Management) were released last week. This trial explored how individual rhythm-control agents affect cardiovascular outcomes in patients with atrial fibrillation, looking at individual antiarrhythmic drug therapies compared with rate control with propensity score-matched analyses.  It turns out that rhythm-control agents had no effect on all-cause mortality, but were associated with an increased risk of cardiovascular hospitalizations.

This month’s featured article in the Atrial Fibrillation Community covers the clinical significance of silent stroke. According to the article, “[Recent] studies raise strong evidence that ‘ablation technology and energy source matters’ since non-irrigated multielectrode ablation resulted is a significantly higher silent stroke rate as compared to other ablation techniques. Thus, regarding the mechanism(s) leading to silent stroke it is very likely that most thromboembolic events are due to energy application, i.e. charring at the ablation catheter, rather than due to mobilization of pre-existing left atrial thrombi or air embolization.” So, should we be worried? Even though there is no current evidence that silent stroke impacts cognitive function, future studies are needed that explore the factors leading to their occurrence.

I invite you to visit the AFib Community which is a great resource to stay up-to-date on AFib developments and features articles, hot topics, news, case challenges and much more.

Although a significant amount of data exists in relation to early clinical outcomes after transcatheter aortic valve replacement (TAVR), there are few data on outcomes beyond one year. As such, a new study released today in the Journal of the American College of Cardiology (JACC) provides a much-needed look at the long-term outcomes after TAVR in high-risk patients with severe aortic stenosis.  

In 2007, the UK established a national registry – the United Kingdom Transcatheter Aortic Valve Implantation Registry – to coordinate and monitor the practice and dissemination of all TAVR procedures, regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term. The new study, based on data from this registry from January 2007 through December 2009, found that, overall, midterm to long-term survival after TAVR was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year.   

Specifically, survival at 30 days was 92.9 percent, followed by 78.6 percent at one year and 73.7 percent at two years. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction _30 percent), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model. 

A corresponding editorial commentary, suggests that “all our efforts to pursue the development of this technique should aim at improving patient selection both by a dedicated medicosurgical team and by improving procedural performance through careful training and improvement in technology, and also by adequately evaluating randomized studies as well as good-quality registries that represent real life and are a necessary complement to the former.”  

As TAVR moves forward in the U.S., we need to look closely at these results from abroad and learn from them. You can be sure that as the American College of Cardiology and the Society for Thoracic Surgeons move forward with their joint TVT Registry, the lessons learned from the UK experience will be critical as we attempt to harmonize data elements from around the world. In a recent JACC President’s Page I marveled out how the process and the need for measuring things has occupied a central role in human history, and how nowhere in the medical field is measurement more important than when new therapeutic strategies are developed. Data from registries like the one in the UK and the one being developed by us and STS in the U.S. are essential to the appropriate use of transformational technologies like TAVR.

By Thom Rooke, MD, FACC, Krehbiel Professor of Vascular Medicine at the Mayo Clinic and Alan T. Hirsch, MD, FACC, Professor of Medicine, Epidemiology and Community Health, at the University of Minnesota Medical School. Rooke is the chair of the PAD Guidelines Writing Committee. Hirsch is its vice chair.

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The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) today released updated guidelines for the diagnosis and management of peripheral artery disease (PAD), as part of PAD Awareness Month. The updated document provides agreed-upon approaches and treatments for PAD that clinicians can apply to help improve patient care.

PAD is a major American health problem. It affects one out of every 20 Americans over the age of 50, making it one of the most common cardiovascular diseases. In addition, its effects can be devastating: heart attack, stroke, leg amputations and death all can result from PAD. Despite this, scientific advances have made it possible to inexpensively and accurately diagnosis the disease, as well as effectively treat it.

However, reducing its prevalence will require more active detection. The focused update details the specific population who would benefit from an active approach to PAD diagnosis through ankle-brachial index (ABI) diagnostic testing. Specifically, the document recommends that ABI diagnostic testing is performed beginning at age 65, rather than age 70. This decision was based on mounting evidence demonstrating that people 65 and older have a one in five chance of having either symptomatic or asymptomatic PAD. 

Other recommendations set forth in the guidelines include:

• Strengthening efforts to help individuals with PAD quit smoking and, in turn, lower rates of heart attack, stroke and lower limb amputations. This includes consistently asking current and former smokers about tobacco use at each visit, as well as proactively offering support through counseling, pharmacologic therapies and/or formal smoking cessation programs
• Considering leg artery angioplasty as a first line treatment for certain individuals with severe PAD who may face amputation. Because angioplasty does not provide an ideal treatment for all patients with PAD, in particular for those in whom a lifespan greater than two years is anticipated, traditional vascular surgery may be more durable and most effective
• Understanding new data showing that aortic aneurysms can be safely treated by both traditional open surgical and less invasive endovascular treatments with nearly equal efficacy and safety

The guidelines provide a road map to greater prevention opportunities, which will be necessary if we are to reduce the number of people needlessly affected by PAD. Full text of the new guidelines -- which update the original 2005 recommendations and are collaboration with representatives from the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine and Society for Vascular Surgery -- are online, as is a summary on CardioSource.

The ESC Congress for the first time is having two sessions dedicated to clinical registries in order to highlight the growing number of innovative registries, the data they collect and the conclusions that can be drawn from this data. The sessions focus on “Risk and Treatment Reality” and “Interventions and Devices” and showcase registries from France, Italy and more.

The prominent treatment of the registry data trials at ESC Congress 2011 is a testament to their growing importance. Registry research is unique because it uses real-world data. The patients included in the registry are not chosen because they have limited comorbidities or fit a certain profile, like in clinical trials, but are included simply because they are a patient at a participating hospital. What this means is that we can see what the effects of certain treatments are on patients who may never qualify for a clinical trial. The results are a better understanding of adverse outcomes and better treatment protocols. The ACC frequently requests for FDA to require new drug and device manufacturers to conduct post-market approval studies through registries to ensure that the new drug/device doesn’t have any adverse events not caught in the clinical trials.

Of course, that’s not to say that registries aren’t without limitations. Currently, it’s challenging to connect care between the outpatient and inpatient settings because the U.S. will not implement a unique patient identifier system that could connect a patient’s progress in the hospital to the ambulatory setting and, in some cases, back to the hospital. We’ll need to find a way to work around this. With the growing emphasis on reducing readmissions, hospitals will need to have a better understanding of why and which types of patients are most frequently readmitted. Registries should be able to help fill this gap.

ACC’s registries suite, NCDR (National Cardiovascular Data Registry), has experienced a landmark year in terms of the science researchers have produced. The following studies have been some of the most interesting:

1. Non–Evidence-Based ICD Implantations in the United States (JAMA, 305;1). Researchers found that ICD implantations were not in accordance with practice guidelines in 20+% of patients, most commonly because of newly diagnosed heart failure or an MI within 40 days.
   
   
2. Patterns and Intensity of Medical Therapy in Patients Undergoing PCI (JAMA, 305;18). The authors conclude that optimal medical therapy is underutilized in patients with stable CAD.
   
   
3. Association of Door-In to Door-Out Time with Reperfusion Delays and Outcomes Among Patients for Primary PCI (JAMA, 305;24). Study showing improvement is needed in the treatment of heart attack patients who require transfer to another hospital for primary PCI).
   
   
4. Appropriateness of Percutaneous Coronary Intervention (JAMA, 306;1): This study concluded that although the majority of patients are appropriately selected for PCI procedures, there are opportunities for improvement, especially in the non-emergency setting.
   
   
5. Hospital Variability in the Rate of Finding Obstructive Coronary Artery Disease at Elective, Diagnostic Coronary Angiography (JACC, 58;8). Former ACC Prez Pam Douglas, MACC, et al., find that hospitals vary greatly when it comes to the rate at which obstructive CAD is found in patients without known heart disease undergoing elective diagnostic coronary angiography or catheterization.

These are just five of the hundreds of studies using NCDR data that have been published over the registries’ 14-year history. We may not always like what the studies find, but it’s the measurement that pushes cardiology as a profession to move forward and to find ways to more consistently implement best practices and guidelines. By measuring patient care in an appropriate and actionable way, registries bring to light the invaluable improvements being made by physicians and care teams.

I commend ESC for bringing registry data to the forefront of their meeting. I think we’ll see more and more about registry data in the future, as it addresses some of the gaps left by clinical trial data.