Consensus Paper Spells Out Transcatheter MV Program Criteria

Marlene Busko

May 15, 2014

WASHINGTON, DC, BEVERLY, MA, and CHICAGO, IL — A newly published consensus paper from four professional medical associations provides guidance for US institutions that are setting up or already have programs for performing transcatheter mitral-valve procedures[1].

The recommendations for minimum operator and institution requirements come just days before an expected decision on May 18 from the Centers for Medicare & Medicaid Services (CMS) about whether or not it will fund these procedures[2], the chair of the writing committee, Dr Carl L Tommaso (NorthShore University HealthSystem Skokie Hospital, Evanston, IL) told heartwire .

"We can only write guidelines on things that have been approved. This [consensus paper] is basically [about] the MitraClip" (Abbott Vascular) device, he noted.

As reported by heartwire , in October 2013 the FDA approved the use of a MitraClip for high-risk patients with symptomatic mitral-valve degeneration, such as frail or elderly patients for whom open surgery might be too risky. The minimally invasive procedure uses a catheter to place a clip on a leaking mitral valve to reduce regurgitation. FDA approval was based on results from the Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) and other registry data.

The current recommendations were developed by a committee of cardiac surgeons and interventional cardiologists, and the paper emphasizes the need for a multidisciplinary "heart-team" approach.

"I think in most institutions now the heart team is used for assessing patients who may be candidates for [transcatheter aortic-valve replacement] TAVR or [surgical aortic-valve replacement] SAVR; or MitraClip or mitral-valve surgery or repair or in complex coronary disease; and certainly in other structural heart areas," Tommaso said.

All physicians performing these procedures, regardless of their specialties, should have certain core competences, according to the consensus statement. They should have a solid understanding of valvular heart disease, know how to use 3D echocardiography, and be experts in interpreting CT scans related to valve disease to be able to determine patient eligibility and procedure type. They also need to understand basic radiation safety principles and how to use X-ray contrast agents.

Institutions should have an active valvular heart disease surgical program with at least two institutionally based cardiac surgeons experienced in valvular surgery. They also need a full range of diagnostic imaging and therapeutic facilities, including a cardiac cath lab and noninvasive imaging labs.

Based on the STS national database, the authors estimate that approximately 256 sites in 46 states would meet the minimum requirements.

By far the greatest experience to date has been with the MitraClip. There are currently 37 sites in the EVEREST REALISM Registry and 57 sites in COAPT , coauthor Dr Ted Feldman (Evanston Hospital, IL) told heartwire .

The statement stresses that centers performing this procedure must participate in a national registry. "We're insisting . . . that all cases be reported to a central national database—the STS/ACC [ TVT-NCDR ] database for structural disease, which is really important, because we won't know longitudinally what the outcome is, what the success is, and what complications may occur, unless we are able to follow these patients," Tommaso said.

The document was jointly issued May 15, 2014 by the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS) and is being simultaneously published online in these societies' journals—Catheterization and Cardiovascular Interventions, the Journal of Thoracic and Cardiovascular Surgery, the Journal of the American College of Cardiology, and the Annals of Thoracic Surgery.

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