This post is authored by John S. Rumsfeld, MD, PhD, FACC, chief science officer of the NCDR.

The NCDR’s annual conference (NCDR.13) started today and is already off to a great start. Over 950 registry professionals, cardiovascular physicians and administrators are in attendance, and the meeting opened with a great keynote presentation about excellence in cardiovascular care and the role of the NCDR given by Martha Radford, MD, FACC, director of clinical quality and safety at NYU Hospital Center.

In response to physician and health care administrator’s growing interest in the NCDR, we've added a MD/Administrator track to NCDR.13, which includes a series of workshops specifically designed for their needs. Health care in the U.S. is changing dramatically and cardiovascular professionals face a future that will include more public reporting of quality measures, increased needs to demonstrate performance improvement, and an increased focus on outcomes. The NCDR can directly help physicians and administrators with these, so this is a major focus for the NCDR programs going forward, starting with the NCDR.13 meeting.

Meanwhile, NCDR research will be featured throughout ACC.13. Twenty-two abstracts, including oral and poster presentations will feature NCDR research. Several of the topics discussed at the NCDR.13 will be further fleshed out in educational sessions as well, including sessions focused on the use of registry data for MOC purposes, international registry lessons learned, TAVR research and more.

Congratulation to Jonathan Hsu, MD author of the poster “Inappropriate Oral Anticoagulant Use in Atrial Fibrillation Patients with a Low Risk of Thromboembolism: Insights from the NCDR® PINNACLE Program,” which is being recognized as a Best of Poster and Best FIT Poster at ACC.13. The poster will be on display Monday, March 11th from 9:45-10:30 a.m. in Poster Sessions, Expo North.

For the complete guide to NCDR abstracts at ACC.13, visit NCDR.com/ACC13 or stop by ACC Central during Expo hours.

This post was authored by James Fasules, MD, FACC, senior vice president of Advocacy for the ACC.

Just when you thought you’d learned enough healthcare acronyms to understand what we should care about as cardiologists, they add another one. This time, it’s the UFAs – the User Fee Acts, the quick way insiders refer to the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and the new generic drug and biologic user fee programs. Collectively, these programs help to fund the congressionally-mandated mission of the Food and Drug Administration, which is necessary given the dichotomy between what is expected of the FDA and what Congress appropriates for the FDA to achieve those expectations. The first of the programs, PDUFA, came out of the HIV-AIDS crisis when it became clear that the FDA did not have the necessary resources to review new drug applications quickly enough. Industry pays certain fees to have their applications reviewed. In exchange, the FDA commits to reviewing and coming to decisions (approval or otherwise) within certain timeframes.

The programs, created by Congress, sunset every five years, and it is up to Congress to decide whether to reauthorize the program. Thus, without Congressional action, PDUFA and MDUFA are set to expire on Sept. 30. To put it in perspective, funding from the PDUFA program is so important to the Agency today that approximately 2,000 staff reviewers will lose their jobs in the event that PDUFA is not reauthorized and the application review process will come to a grinding halt. Because of differences between the two programs and the two industries, the expiration of MDUFA would lead to the loss of between 200 and 300 jobs for device reviewers.

So why should cardiologists care? After all, if it’s just about approvals for devices and drugs, shouldn’t that be industry’s problem?  Well, if you think the FDA is slow at reviewing applications now, imagine how slowing things would move without all of those individuals reviewing the applications. New devices and pharmaceuticals would take even longer to get to market and even fewer patients would have access to them. Just think about how much further behind Europe we would be. It’s not just about TAVR; it’s about all of the new interventions that have been developed in recent years and have helped to reduce mortality resulting from cardiovascular disease.

Over the last two years, ACC’s Advocacy team has been meeting with members of Congress and their staff on these issues, as well as agency officials, industry representatives, consumer groups and public health advocates. Additionally, the ACC is working with a number of physician organizations to promote the passage of the UFAs, as well as legislation pertaining to related issues.

Recently, both the House and Senate overwhelmingly passed their respective versions of bills reauthorizing the UFAs.  Over the next month, Committee staff from both chambers will work together to iron out differences between both House and Senate bills before voting on final legislation and sending to the president for his signature.  It’s an exciting time to be an UFA!

Yesterday was a big day for Transcatheter Aortic Valve Replacement (TAVR) therapy in the U.S. The Centers for Medicare and Medicaid Services (CMS) announced approval of a National Coverage Determination (NCD) of TAVR. The announcement follows an analysis based on an NCD request from the ACC and The Society of Thoracic Surgeons (STS) in late 2011.

The NCD covers TAVR when performed with a FDA-approved device consistent with labeled indications and any other FDA requirements. In addition, it permits Medicare coverage only in facilities meeting certain requirements. The NCD also requires all patients to be included in a national TAVR registry. Medicare coverage will be available for non-FDA-approved indications when performed in a CMS-approved clinical study.

In a statement, the ACC commended CMS on its decision and its comprehensive approach to the introduction of TAVR. This means that this transformative technology will be available to Medicare patients who do not have other options for treating severe, debilitating aortic stenosis. We also agree with CMS’s decision to structure the NCD in a manner that supports access to TAVR while ensuring that services are performed by the best qualified team of physicians and hospitals. We hope this NCD proves to be a successful model for providing rapid access to promising new technologies for Medicare beneficiaries while focusing on patient safety, quality care and outcome.

Earlier in the day, I also participated in an STS/ACC joint Town Hall meeting to discuss the ASCERT study which was presented at ACC.12 (read a previous blog post on the study here and listen to a recording of the town hall meeting here). Although the study has caused some controversy, all of the panelists, which included Dr. Jeff Rich, president of STS, Drs. William Weintraub and Fred Edwards (principal investigators) and others,  underscored the importance of the heart team approach to shared decision making with patients and transparent discussions to determine which revascularization procedure is best suited for a particular patient with multivessel coronary artery disease.

This same “heart team” approach has been apparent throughout the introduction of TAVR into the U.S. Over the past year, the ACC has worked with STS, SCAI and other professional societies on several clinical documents and recommendations in order to effectively and appropriately introduce this new therapy. In addition, the STS/ACC TVT Registry was developed as a collaboration between STS and ACC, also working with CMS, the Food and Drug Administration, Edwards Lifesciences and others.

It is gratifying to see this “heart team” approach starting to take hold. Congratulations to all involved in making this a reality; a victory for our patients.

For more TAVR news and updates and links to additional clinical documents, visit CardioSource.org/TVT.

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?

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.

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.

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee on Wednesday voted to recommend approval of the Edwards SAPIEN Transcatheter Heart Valve. The Edwards valve was tested in the PARTNER trial, which examined its effectiveness in inoperable patients with severe aortic stenosis. PARTNER found that transcatheter aortic replacement (TAVR) significantly reduced symptomatic mortality and composite endpoints at one year compared to medical therapy for specific patient populations (particularly the elderly with multiple comorbidities). FDA is not required to follow the recommendations of its panels, but typically does.

I spoke at the meeting, as did Michael Mack, MD, president of the Society of Thoracic Surgeons (STS), Gus Picard, MD, from the Society for Cardiovascular Angiography and Interventions and others prominent in this field. On the panel was Rick Page (chair), chair of ACC’s EP Committee and immediate past president of ACC Ralph Brindis, MD, MACC. There were many other ACC members in attendance as well.

During my comments, I outlined ACC’s recommendations for rational dispersion and post-market surveillance of the Edwards device. The ACC believes that dispersion will rely of three key players: Edwards, in educating physicians on how to properly use this specific device; the ACC, STS and other applicable specialty societies, in educating physicians about the particular disease state and therapeutic options; and the government, which must facilitate interactions and collaboration among all involved. In these modern times, novel implantable devices, such as the Edwards valve, require that relations between federal agencies and professional societies be revisited with a creative and visionary eye.

My comments stressed practical elements that will be required to ensure that implementation of TAVR improves quality. First and foremost, the procedure must be completed by a multi-disciplinary team; no one subspecialty should perform TAVR alone. Additionally, because patient selection is so important, there must be further development of the criteria used for patient selection. In terms of facilities, the ACC supports the development of centers with specialized expertise in TAVR.  This is based upon the literature that has indicated that structural heart disease outcomes have a direct relationship to center procedure volume. Finally, the ACC recommends tracking patient outcomes and safety through a registry for valvular heart disease, created by linking clinical and administrative databases.

There was also detailed discussion of the risk-benefit ratio in terms of periprocedural stroke.  This in-depth discussion extended the information available in the published trial.  The panel included experts in the field of stroke, and there was much discussion on the etiology of the stroke and development of preventive strategies.

In addition, there was detailed discussion of the issue of patients who might be too grail or who have such extensive comorbidities that they would not benefit from the procedure.  Better patient selection criteria are needed to identify patients who are too frail, in whom intervention may be futile.

Following the hearing, the Advisory Committee voted on three main questions:

1. In a vote of 7-3, the committee agreed there was "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is safe for use in patients with severe aortic stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis."
2. In a vote of 9-1, the committee said there is "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is effective for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication." 
3.  In a vote of 9-0-1, the committee said the "benefits of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication outweigh the risks of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication."

The ACC submitted written comments in advance of the panel meeting as well. The ACC and STS in June released an overview document of transcatheter valve therapy, and it is the first of a series of documents that will address the issues critical to successful integration of TAVR into medical practice. Look here and to CardioSource for more as these documents are released. For more on the initial overview document and PARTNER results, see my previous blog.

Here’s the video again:

The ACC and the Society of Thoracic Surgeons (STS) earlier today released a societal overview of transcatheter valve therapy (TVT). The overview highlights the issues that will be faced as cardiology and surgical societies try to guide the process of rational dispersion of this very new and important technology. Transcatheter aortic valve replacement (TAVR), one form of TVT, has been documented by the PARTNER trial to improve outcomes in patients with severe aortic stenosis who are inoperable. It has been found to significantly reduce mortality and composite endpoints at one year compared to medical therapy for specific patient populations, including balloon aortic valvuloplasty.

The overview makes several key points:

1. Use of team-based care will be critical to TVT success. The therapy cannot revolve around just surgery and cardiology, but must involve interventionalists, echocardiographers, hospitalists and others who deal with structural heart disease and heart failure.
2. Providers performing TVT must be very skilled and well-educated in the field. The devices can substantially improve outcomes, but there are potential side effects that may be very significant and clinically important.
3. Randomized trials have included only patients with severe aortic stenosis who are at very high risk for conventional aortic valve replacement, or patients who are not surgical candidates because of a variety of comorbidities.  Accordingly, we do not have randomized trials on other patient groups. For this reason, patient selection is critically important.
4. Efforts need to be focused on evaluation of data on the outcomes of patients both in the hospital and for longer-term follow up. Understanding outcomes will be important in identifying areas that need to be modified or improved. The use of registries will be exceedingly important to complete this task.

The document provides a 20,000-foot view of TVT, and is the first of a series of documents that will address the topic in a more detailed fashion. More specific documents on pre- and post-procedural issues and training and credentialing will be developed jointly by the ACCF, cardiovascular specialty societies, and thoracic surgery societies and released in the future. It’s also important to note that many key milestones for the technology must be met – including FDA approval. TAVR is scheduled to be considered by an FDA panel on July 20, with the agency to make a decision following the results of that hearing.

TVT technology has the potential to be transformational for the field of cardiology and thoracic surgery. However, this transformation will not happen overnight. It’s going to be a long road with many hurdles.

Additional Resources:

• 10 Points to Remember on the ACC, STS Position Statement on TVT
  
• PARTNER Cohort A: TAVI vs. Surgical AVR
• PARTNER Cohort B: Transfemoral TAVI vs. Medical Management

UPDATED: 6/28/11