Societies Recommend TAVR Program Requirements

With transcatheter aortic valve replacement (TAVR) in its infancy in the United States, 4 major cardiology societies have released initial recommendations for creating and maintaining TAVR programs. Chief among the proposed criteria, published online March 1, 2012, ahead of print in the Journal of the American College of Cardiology, is commitment to a ‘heart team’ concept.

“The most important thing is for a center to establish a multidisciplinary team,” said Carl L. Tommaso, MD, of Skokie Hospital (Skokie, IL), chair of the document writing committee, in a telephone interview with TCTMD. “[TAVR] really needs the input of interventional cardiologists, surgeons, echocardiographers, cardiac anesthesiologists, and perhaps even vascular surgeons and interventional radiologists. There are a lot more people involved [in TAVR] that what we have experienced with PCI.”

Since there are few randomized data other than those from the PARTNER (Placement of AoRticTraNscathetER valves) trial upon which to base recommendations for TAVR, the Society for Cardiovascular Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American College of Cardiology Foundation (ACCF), and the Society of Thoracic Surgeons (STS) joined together to create the document based largely on expert consensus.

A Good Starting Point

Following on the heels of US Food and Drug Administration (FDA) approval in November 2011 of the Sapien Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) for use in inoperable patients with severe aortic stenosis, the participating societies believe that their recommendations can serve as an appropriate starting point.

Operating requirements for centers that intend to develop a TAVR program include credentialing requirements for cardiothoracic surgeons and interventional cardiologists, and guidance for maintaining approval to perform TAVR.

Just last month, the Centers for Medicare and Medicaid Services (CMS), in a memo outlining its decision for potential coverage of TAVR, listed 5 conditions for coverage:

• TAVR should be performed for an FDA-approved indication, with a complete valve and implantation system that has received premarket approval for this indication
• Two cardiac surgeons should evaluate the patient’s suitability for open surgery
• TAVR should take place in a facility using a ‘heart team’ approach with adequate experience in both interventional and surgical procedures, varying according to whether the center has previously participated in a premarket approval clinical trial
• The procedure should be carried out by physicians who have specific qualifications and experience levels, which differ for surgeons and interventionalists
• Patient and treating physician team should be enrolled in a prospective national registry through 5-year follow-up

According to Dr. Tommaso, the expert consensus document is meant to help in this ongoing effort to let clinicians and institutions know what they can expect once a national coverage decision is handed down. He added that the 4 societies had “indirect contact with CMS regarding what our document was going to show.”

“Part of our problem is that we’re flying by the seat of our pants,” he said. “All we really have in this country is the PARTNER study, so it’s very difficult to put criteria on what credentialing would be for TAVR.”

The new consensus statement also discusses criteria for establishing a transcatheter valve program and maintenance of competence. Among the societies’ recommendations for minimum competence for new TAVR programs are:

• Institutions—1,000 catheterizations/400 PCIs per year
• TAVR interventionalists—100 structural procedures lifetime, or 30 left-sided structural procedures per year, of which 60% should be balloon aortic valvuloplasty; suitable training on the devices to be used
• Surgical centers—50 aortic valve replacements per year, of which at least 10 should be high-risk (STS score ≥ 6)
• TAVR surgeons—100 valve replacements over their career, of which at least 10 should be high riskInstitutional—All cases submitted to a single national database

Different Criteria for Veteran, New Programs

The recommendations differentiate between centers that have and have not participated in previous TAVR trials. At experienced trial centers, the minimum volume requirement annually is 30 procedures. The institution also must have ongoing continuing medical education (or nursing/technologist equivalent) of 10 hours per year of relevant material, and all cases must be submitted to a national database.

The consensus document further recommends that components of a national database include:

• Preoperative risk factors and valve assessment
• Intraoperative details
• Early postoperative morbidity
• Late follow-up including survival, need for re-intervention, functional class, device-related complications, and late assessment of valve performance

Nontrial centers wanting to start a new TAVR program should perform a minimum volume of 20 TAVR procedures per year, or 40 over 2 years, with a 30-day all-cause mortality rate of less than 15%, 30-day all-cause neurologic event rate (including TIA) of less than 15%, major vascular complication rate of less than 15%, have greater than 90% institutional follow-up, and have a 60% 1-year survival rate for inoperable patients within 2 years of the program’s start. The specialist board certification, CME, and national database submission criteria also apply.

“New start-up sites are going to have a learning curve,” Dr. Tommaso said, “[because] this is complex technology.”

For now, he observed, the societies have no plans to oversee or assist in the training or credentialing process for operators and institutions. “However, I think that’s going to be up to the vendors and whatever CMS requires,” he added.

Source:

Tommaso CL, Bolman III RM, Feldman T, et al. SCAI/AATS/ACCF/STS multisociety expert consensus statement: Operator and institutional requirements for transcatheter valve repair and replacement: Part 1 TAVR. J Am Coll Cardiol. 2012:Epub ahead of print.

Related Stories:

• CMS Publishes Proposed TAVR Coverage Conditions
• FDA Approves Sapien Transcatheter Valve for Inoperable Aortic Stenosis
• Medical Societies Issue Position Paper in Anticipation of Transcatheter Valve Availability