Transcatheter Mitral Valve Programs: No Volume Data

June 4th, 2014

Transcatheter Mitral Valve Programs: No Volume Data

Richard A. Lange, MD, MBA and L. David Hillis, MD

The Society for Cardiac Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS) recently joined together to provide recommendations for institutions that are considering starting and/or maintaining a transcatheter mitral valve (MV) program.

Unlike PCI, for which abundant data show a relationship between the volume of procedures and outcomes, the writing group acknowledged that little or no data exist regarding a volume-outcome relationship for transcatheter valve therapy.

Nevertheless, they recommend the following institutional and operator requirements:

INSTITUTION

1000 cath/400 PCI per year (with acceptable outcomes compared with NCDR benchmarks)
At least 25 total MV surgeries per year for treatment of regurgitation (at least 10 with MV repairs)

OPERATOR

50 structural procedures per year (including ASD/PFO and transseptal punctures)

EXISTING PROGRAMS

15 transcatheter mitral procedures each year (total experience)

NEW PROGRAMS

Because the indications are not defined, no volume criteria are proposed

What do you think of the requirements?

What is the minimum number of transcatheter MV procedures the operator should perform to (a) establish a program and then (b) maintain the program?

With each center performing a small number of procedures (~15/ year), are the outcomes data meaningful?

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June 4th, 2014