The Center for Medicare and Medicaid Services (CMS) has announced approval of a National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR). The May 1 announcement follows an analysis based on an NCD request from the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS) in late 2011. (The CMS press release and link to the decision can be found here: http://go.cms.gov/IPxlly )

According to the decision memo, CMS will cover TAVR under Coverage with Evidence Development with the following conditions:

• TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA approved indication and when all of the following conditions are met.
• The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA approved indication
• Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient’s suitability for open aortic valve replacement (AVR) surgery; and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.
• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals.

Team Care

The heart team concept, required by CMS, embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.

What does that mean specifically? CMS outlines that in two ways: for centers wanting to develop a TAVR team and the other for centers with TAVR experience.

Qualifications to begin a TAVR program for heart teams without TAVR experience:

The heart team must include:

• Cardiovascular surgeon with:
─ ≥ 100 career AVRs including 10 high-risk patients; or
─ ≥ 25 AVRs in one year; or
─ ≥ 50 AVRs in 2 years; and which include at least 20 AVRs in the last year prior to TAVR initiation; and

• Interventional cardiologist with:
─ Professional experience with 100 structural heart disease procedures lifetime; or;
─ 30 left-sided structural procedures per year of which 60% should be balloon aortic valvuloplasty (BAV). Atrial septal defect and patent foramen ovale closure are not considered left-sided procedures.

• Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers; and
• Device-specific training as required by the manufacturer.

Qualifications for hospital programs with TAVR experience:

The hospital program must maintain the following:
─ ≥ 20 AVRs per year or ≥ 40 AVRs every 2 years; and
─ ≥ 2 physicians with cardiac surgery privileges; and
─ ≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.

Qualifications for heart teams with TAVR experience:

The heart team must include:

• A cardiovascular surgeon and an interventional cardiologist whose combined experience maintains the following:
─ ≥ 20 TAVR procedures in the prior year, or;
─ ≥ 40 TAVR procedures in the prior 2 years; and

• Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers.
• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

As explained by William Zoghbi, MD, ACC President, this same “heart team” approach has been apparent throughout the introduction of TAVR into the U.S. He said, “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.

Wider Use of Teams

In early May, during the American Association for Thoracic Surgeons meeting in San Francisco, a number of experts gathered for an STS/ACC joint Town Hall meeting to discuss the ASCERT study which was presented at ACC.12.¹ The analysis of health outcomes for 190,000 patients across the U.S. between 2004 and 2008 used data from the ACC’s CathPCI Registry®, The STS CABG database, and the Medicare claims database. The study indicated that coronary artery bypass graft (CABG) surgery appears to carry a higher long-term survival rate than percutaneous coronary intervention (PCI).

One of the ASCERT study’s principal investigators, Fred H. Edwards, MD, underscored the importance of the heart team approach. “One of the best practices to arise from ASCERT is embracing this concept of the heart team approach,” he said. “Taking this from something we might be doing someday to something we are really doing in day-to-day practice is a key element and one of the key lessons I hope will come from the ASCERT trial.”

The study’s other PI, William S. Weintraub, MD, added, The heart team approach is really critical and we have to rethink our entire decision makingprocess for our patients. There has been a shift in recent years in more percutaneous intervention and less coronary surgery and ASCERT will help change that balance and I think using the heart team approach is one way to accomplish this. With so much data at our fingerprints to help guide our decision, patients can largely rest assured that when their surgeon and cardiologist come together to make a decision, for a patient to have coronary bypass surgery, that the decision is a good one.

Added David R. Holmes, Jr., MD, immediate past-president of the ACC, whether with TAVR.PCI, or CABG, he said, “As we become more patient-centric, as practicing physicians and societies, our role will be to make sure patients and their families have the right information the most complete dataset of information that we can give to them in an understandable way so that they can make it clear what they want to receive – not what we are going to give to them, but what they want to receive.” And at the heart of cardiovascular care, he said, is the heart team.

References:

1. Weintraub WS, Grau-Sepulveda MV, Weiss JM, et al. Comparative effectiveness of revascularization strategies. N Engl J Med 2012;366:1467-76.

Keywords: Survival Rate, Heart Septal Defects, Atrial, Catheterization, Foramen Ovale, Patent, Coronary Artery Bypass, Cardiac Surgical Procedures, Percutaneous Coronary Intervention, Patient-Centered Care

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