Yesterday the ACC in partnership with the American Association for Thoracic Surgery (AATS), Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS), released an Expert Consensus Document (ECD) on Transcatheter Aortic Valve Replacement (TAVR), a new technology for patients with severe aortic valvular stenosis who are either high-risk candidates or inoperable for surgical aortic valve replacement.

The document elaborates on the previously published joint ACCF/STS societal overview of transcatheter valve therapy (read my previous blog post here) and assesses the current state of evidence available for TAVR. It is also intended to inform practitioners, payers, and other interested parties of how TAVR should be introduced into the practice community.

The consensus document outlines key recommendations for the successful roll out of this new therapy and provides detailed criteria on:

• Careful patient selection
• Team-based approach given the complexity of procedure coupled with the high-risk profile of suitable patients, many of whom have extensive comorbid conditions that require ongoing management
• Specialized heart centers and physician expertise in treating valve disorders; this includes use of proctors as needed to serve on the heart care team during the first few cases, as well as proper facilities (hybrid operating rooms or modified cath labs)
• TAVR screening tests to inform treatment decisions
• Enhanced patient and family education in the risk and benefits of this procedure
• Ongoing evaluation and participation in national TAVR registry to assess real world outcomes

An estimated 45,000 patients have received TAVR worldwide. Clinical use of TAVR, its continued evolution, and outcomes will be evaluated in the recently launched STS/ACC TVT Registry^TM which will further inform future recommendations on application of this transformational technology. The ACC is currently awaiting the Centers for Medicare and Medicaid Services’ (CMS) decision regarding a request for a National Coverage Determination.

The consensus document was also developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Society of Cardiovascular Anesthesiologists, Society of Cardiac Computed Tomography, and Society of Cardiac Magnetic Resonance. The writing committee also comprised of a consumer perspective from Mended Hearts due to the sensitive issues related to this procedure.  Since these are very sick patients facing dire consequences, the College acknowledges the importance of valuing the patient not just in the day-to-day doctor-patient relationship, but also in development of policy statements that affect those daily situations.

The ACC is continuing to work closely with the other stakeholders on the development of future clinical documents and educational programming. Overall, the College welcomes opportunities to provide clinical guidance to the Food and Drug Administration, CMS, payers, and others to roll out new devices and therapies and help provide a balanced clinical viewpoint.  This is a new, transformational technology for our patients, and by working together we can effectively and appropriately introduce new therapies with clear recommendations and guidance for its use.

Don’t miss the TAVR sessions at ACC.12 in Chicago. Advance registration closes soon!

UPDATE (2/3): CMS Releases Proposed NCD for TAVR

As 2011 comes to a close we can look back with pride on all of the accomplishments in the field of cardiovascular medicine over the year. Whether it was all of the great science presented at ACC’s scientific session in New Orleans; development of new and/or updated guidelines reflecting how to best use new treatments or drugs; participating in the United Nations Summit on Non-Communicable Diseases; or partnering with public and private entities on the Million Hearts Initiative – we have made great strides. Our field can be a challenging one at times, but the end results are well worth the battle.

One of the accomplishments I am most proud of, however, is our work related to transcatheter valve therapy (TVT). Early 2011 brought us the PARTNER Cohort A trial, which looked at this transformational procedure that had been used in 40 other countries outside the U.S. until this year. Soon after, The Society of Thoracic Surgeons (STS) and ACC together developed a high-level societal overview on TVT to ensure safe introduction of the therapy into the U.S.  Michael Mack, MD, president of STS, and I testified at a Food and Drug Administration (FDA) committee hearing about the importance of a team-based approach when implementing this procedure.

In the past few months, not only has the FDA approved this new technology, which has the promise and potential to significantly affect the management of patients with severe aortic stenosis, but the Centers for Medicare and Medicaid Services (CMS) has opened up a National Coverage Determination analysis at our request. We are ending this year with the official launch of the STS/ACC TVT Registry^TM, which will track patient safety and real-world outcomes related to the newly introduced transcatheter aortic valve replacement (TAVR) procedure. The Registry is a great example of teamwork between professional societies as we worked closely with STS, the FDA and CMS, with input from The Society for Cardiovascular Angiography and Intervention (SCAI) and The American Association for Thoracic Surgery (AATS). We are continuing to work closely with these stakeholders on the development of future clinical documents and educational programming to ensure appropriate use of this new therapy. It is our hope that our efforts now will serve as the model when new devices or therapies are developed in the future.

We’ve had quite an exciting year, and as we head into 2012, I am excited for what this next year will bring!

What do you think were some of the great innovations of 2011?

The ACC has joined the ABIM Foundation’s Choosing Wisely^TM campaign along with eight other leading medical specialty societies and Consumer Reports to help physicians, patients and other health care stakeholders think and talk about overuse or misuse of health care resources in the U.S.

According to the Organization for Economic Co-operation and Development, decade after decade the U.S. spends more money per capita on health care than any other developed country with little progress in quality or value to show for it. The Congressional Budget Office estimates that up to 30 percent of care delivered in the U.S. goes toward unnecessary tests, procedures, medical appointments, hospital stays and other services that may not improve health. Coupled with the fact that the Centers for Medicare & Medicaid Services estimates U.S. health care spending will reach $4.3 trillion by 2019, it is clear that our current health care system is unsustainable and in need of an intervention.

As part of our longstanding effort to play an active role in addressing the quality of care, the College is joining the campaign to encourage open communication about the risks, costs and benefits of tests and treatments so that our patients can be informed partners when making important decisions about their care. We believe that partnerships between patients and health care providers are crucial to achieving better outcomes and lowering health care costs. From our CardioSmart^TM National Care Initiative, aimed at helping patients better understand and/or prevent heart disease, to our state-of-art educational programing and decision-support tools that place evidence-based guidelines at a clinician’s fingertips, we have been and will continue to be committed to ensuring the most appropriate, cost-effective care.

Over the course of the multi-year campaign, we will be working with the ABIM Foundation to identify and reduce waste in the health care system. With the medications, devices and imaging technology available to cardiologists today, we can save and improve the lives of patients who would not have had a chance just 15 years ago, but we also have a responsibility to use these powerful tools effectively and make sure we are choosing wisely.

To learn more about the Choosing Wisely campaign visit, www.ChoosingWisely.org.

Today the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS) officially launched the STS/ACC TVT Registry^TM, a new benchmarking tool developed to track patient safety and real-world outcomes related to new and emerging transcatheter valve therapy (TVT) procedures.

Backed by the registry expertise of the ACC’s National Cardiovascular Data Registry (NCDR^®) and the STS National Database, the TVT Registry will serve as the main repository for all clinical data related to TVT and is positioned to capture outcomes data for expanded indications, as well as additional devices and procedures that will likely emerge in the future. It will be an ideal mechanism for monitoring the use of TVT since it can provide relatively rapid feedback to individual sites and help identify trends in its usage. It will also provide a rich source of data for long-term research.

The launch of this registry is testament to what can be accomplished when medical professional societies, industry and regulatory agencies come together. The College and STS worked closely with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), with input from The Society for Cardiovascular Angiography and Intervention (SCAI) and The American Association for Thoracic Surgery (AATS), to make this registry a reality. We also continue to work with these same stakeholders on educational programs and several clinical documents that will guide appropriate use moving forward.

TVT is truly a transformational procedure and this is an exciting time for our profession. While we still have a ways to go, the launch of the TVT Registry, coupled with last month’s approval by the FDA of the Edwards Lifesciences SAPIEN Transcatheter Heart Valve and the announcement of a National Coverage Determination Analysis by CMS, puts us one more giant step forward on the TVT path. I encourage everyone to take advantage of the current clinical documents addressing TVT, as well as take part in education programs like next week’s ACCF/STS Transcatheter Heart Valve (THV) Symposium and ACC.12 in Chicago next March.

To learn more about the registry and for additional TVT resources, visit TVTregistry.org. Stay tuned for upcoming educational opportunities and events.

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.

Today was a big day for late-breaking clinical trials related to transcatheter aortic valve replacement (TAVR) at TCT 2011. Three separate trials addressed the following: PARTNER Cohort B Two-Year, PARTNER Cohort A Quality of Life, and PARTNER Cohort A Cost-Effectiveness.

In addition, results from the STACCATO trial were also released. This trial focused on implantation of the Edwards Sapien transcatheter aortic valve, which was recently given the green light by the Food and Drug Administration (FDA). The STACCATO trial was designed to include 200 relatively low-risk patients, but was halted after enrollment of 70 patients by the Data Safety and Monitoring Board. However, the trial results suggest that transapical TAVR in its current stage of development should be restricted to high-risk patients, and that use in patients who are otherwise good operative candidates may not be in the patient’s best interest. It must be remembered that we have not seen the final data, it has not been subjected to peer review, and the results must be considered in light of other data available. There are multiple issues to be considered including patient selection, operator experience as well as experience of the whole team.  This data provides the rationale of continuing to optimize strategies of care for these patients, with optimal selection and optimal procedural performance.

The results of these trials continue to underscore the necessity for specialty societies like the ACC and the Society of Thoracic Surgeons (STS), the FDA, the Centers for Medicare and Medicaid Services and industry to work together as we move forward with TAVR. Patient selection and provider training will be key. It also underscores the necessity of the new ACC/STS TVT Registry™ scheduled for release later this year. Backed by the registry expertise of the ACC’s NCDR^® and the STS National Database, the TVT Registry will serve as the main repository for clinical data related to TAVR and is positioned to capture outcomes data for expanded indications, additional devices and procedures that will likely emerge in the future. The goal of the registry is to link clinical and administrative claims data to assess early and longer term outcomes. The registry also forms the basis of a new platform that can be used for FDA post approval studies in future generations of transcatheter valve devices.

This is an exciting time for interventional medicine and as president of the ACC, I’m proud of the collaborative work we are doing to make sure that this transformational new therapy is appropriately used. Hopefully the lessons learned from TAVR will serve as a new paradigm for other devices and drugs developed in the future.

Keep up with all of the TCT 2011 coverage on CardioSource.org.

The past few weeks have been quite busy in the world of guidelines with the release of the revised American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and the Society for Cardiovascular Angiography and Interventions (SCAI) guideline for percutaneous coronary intervention (PCI); the ACCF/AHA guideline for coronary artery bypass graft surgery (CABG); and a new ACCF/AHA guideline on the diagnosis and treatment of Hypertrophic Cardiomyopathy. Lastly, an update to the AHA/ACCF guideline for Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease was also published.

Under the direction of Alice Jacobs, MD, FACC, chair of the ACCF/AHA Task Force on Practice Guidelines, a Process Improvement Group was initiated two years ago to review guidelines and implement changes in response to comments that the scientific guidelines should be more user-friendly at the point of care. According to Jacobs, the overarching goal of our guideline effort is to maintain relevance and ease of use at the point of care while guiding evidence-based clinical practice. The PCI guideline piloted several new initiatives including a focus on replacing and limiting text with evidence/summary tables and highlighting recommendations with their level of evidence and supporting references in color tables.

In addition, for the first time, a combined a section on revascularization was crafted together by the PCI and CABG writing committees for ease of use by the clinician.  Members from the ST-segment elevation myocardial infarction (STEMI), PCI and CABG Writing Committees worked together to draft recommendations that overlap multiple guidelines during a Consensus Conference in an effort to shorten the development time and maintain concordance.

There were also several important updates in the guidelines, including a new concept of a “heart team” approach in the combined PCI and CABG section on revascularization to determine which procedure should be used. This approach involves an interventional cardiologist and a cardiac surgeon reviewing a patient’s condition, determining the pros and cons of each treatment option, and then presenting this information to the patient, allowing him or her to make a more informed decision.

I welcome your feedback about these new guidelines below or join the discussions on the CardioSource Communities pages.

To learn more about the guidelines, read the CABG guideline “10 Points to Remember” and the PCI guideline “10 Points to Remember” CardioSource journal scans. Full text of the guidelines for PCI, CABG, Hypertrophic Cardiomyopathy, and Secondary Prevention and Risk Reduction Therapy are available online and will be published in JACC.

Last night the Million Hearts initiative hosted a fantastic reception in Washington, DC, that was sponsored by the ACC, along with the American Heart Association and the Association of Black Cardiologists. The event not only provided us with an opportunity to highlight our commitment to help prevent 1 million heart attacks and strokes over the next five years, but also network with other public and private stakeholders around this shared goal.

The Million Hearts initiative was launched in September to directly address heart disease and stroke – two of the leading causes of death in the U.S. – by bringing “together communities, health systems, nonprofit organizations, federal agencies, and private-sector partners from across the country” (read a previous blog post about the initiative here). The program is jointly managed by the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), with former ACC Senior Vice President for Science and Quality Janet Wright, MD, FACC, leading the charge.

During the reception, ACC CEO Jack Lewin, MD, committed the College to educating both consumers and the entire cardiac care team about the best, evidence-based strategies for reducing cardiovascular disease. In particular, we are excited about the opportunity to help monitor progress toward the goals of the campaign and provide important feedback to providers through the ACC’s PINNACLE Registry^TM.  On the consumer front, the ACC’s CardioSmart^TM National Care Initiative will play an important role in educating consumers about the “ABCS” (Aspirin for high-risk patients, Blood-pressure control, Cholesterol management, and Smoking cessation) and everyday strategies for healthy living.

These and other strategies are also highlighted in a recent letter to Health and Human Services Secretary Kathleen Sebelius. I personally am very excited about the opportunity to partner with Million Hearts on this important venture that takes an important step towards dethroning heart disease as America’s #1 killer.

For more information on the Million Hearts initiative, including partner commitments, visit the Million Hearts website. Be on the lookout for an article about Million Hearts in the Nov./Dec. issue of Cardiology Magazine. For additional CardioSmart patient fact sheets or to view the fact sheets in Spanish, visit CardioSmart.org.

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.

On Monday I had the opportunity to speak on CBS Radio to respond to a Consumer Reports article on “The Business of Healing Hearts.” The article provides a critical look at how heart disease is treated across the country. The basic points of the article are as follows:

• People often get the wrong tests
• Angioplasty is overused
• Consumers don’t have enough information on cardiologists
• Heart disease is often misunderstood

The article discusses how financial incentives, such as direct-to-consumer advertising or fee-or-service payments, drive patients to seek care that is not necessary and drive physicians to subject patients to “fancy tests” and aggressive treatment that aren’t necessarily the best care. The report notes that PCI procedures are often overused in the nonemergency setting and that patients cannot find useful information about interventional cardiologists.

In general, the report underscores why reform of our current payment system is so needed. The current focus on volume and episodic care without regard to improved quality, better patient outcomes or patient satisfaction limits communication and creates hurdles to achieving the triple aim of better health care quality, better health and lower costs. It’s why the ACC is proactively advocating for a new payment system (or systems) that rewards improved coordination of care, team-based care delivery, appropriate use of tests and procedures and improved medication adherence to treatment therapies.

In my interview with CBS radio, I also noted the growing importance of “appropriate use criteria” (AUC) in helping allay some of the fears noted in the report. AUC are developed in partnership with key specialty societies to help define “when to do” and “how often to do” a given procedure in the context of scientific evidence, the health care environment, the patient’s profile and a physician’s judgment. Appropriate Use Criteria for Coronary Revascularization were developed in 2009 by the ACC using a combination of clinical science, knowledge and expert opinion to help understand when PCI is appropriate, not appropriate or uncertain. However, it can be challenging to implement AUC into practice. The ACC is looking at new ways to harness technology that can place the documents and other clinical documents like guidelines at the point of care.

Registries are also a key component of high-quality, cardiovascular care. The ACC strongly believes in the power of registries to improve the patient care experience. The Consumer Reports article notes that patients should ask their hospital if it participates in the NCDR because participation in the registry can help the hospital to monitor their performance and adopt quality improvement initiatives to optimize the care they deliver. Fred Masoudi, MD, FACC, is quoted in the article and says that NCDR is working to make NCDR metrics more accessible.

The majority of CV professionals are doing the right thing, but the ACC recognizes as with any industry, there are outliers and that there is always room for improvement. The ACC is proactively working to identify innovative ways – along with all the tools we already use, like NCDR registries, clinical documents and quality programs – to ensure high quality, cost-effective care for every patient.

I look forward to hearing your thoughts in the comments section below.