Hospital PCI Volume Unrelated to Outcomes of Transcatheter Valve Replacement, Repair

The U.S. Centers for Medicare and Medicaid Services (CMS) requires at least 300 percutaneous coronary interventions (PCIs) annually for a hospital to initiate and maintain a transcatheter aortic valve replacement (TAVR) program and 400 or more PCIs annually to initiate and maintain a transcatheter mitral valve repair (TMVr) program. Yet the associations between PCI volume and the outcomes of TAVR and TMVr have never been studied.

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In JAMA Cardiology, Neel M. Butala, MD, MBA, research fellow, and Sammy Elmariah, MD, MPH, director of Interventional Cardiology Research in the Corrigan Minehan Heart Center at Massachusetts General Hospital, and colleagues report that according to cross-sectional data, hospital inpatient PCI volume is not associated with objective outcomes of TAVR or TMVr.

Study Methods

The researchers made use of the Healthcare Cost and Utilization Project 2016 Nationwide Readmission Database, which contains information on 49% of U.S. hospitalizations.

For the period between January 1, 2016, and November 30, 2016, they identified:

• 283 hospitals that performed at least five TAVR procedures (median inpatient PCI volume, 386 procedures)
• 125 hospitals that performed at least five TMVr procedures (median inpatient PCI volume, 451 procedures)

Co-Primary Outcomes

TAVR

There was no association between inpatient PCI volume and:

• Median risk-standardized in-hospital mortality rates (bottom quartile of annual inpatient PCI volumes, 1.82%; top quartile, 1.82%)
• Median 30-day readmission rates (bottom quartile, 13.6%; top quartile, 13.8%)

TMVr

Similarly, there was no association between inpatient PCI volume and:

• In-hospital mortality rates (bottom quartile of annual inpatient PCI volumes, 1.84%; top quartile, 1.76%)
• 30-day readmission rates (bottom quartile, 13.4%; top quartile, 13.3%)

A Need for Reconsideration

PCI volume thresholds are said to ensure that hospitals have the infrastructure and skills required to deal with complications of structural heart procedures. TAVR-associated coronary issues may require such expertise, but there is a very low risk of coronary complications with current TMVr systems.

What's worse, volume requirements actually incentivize hospitals to perform unnecessary procedures.

Because of the lack of evidence for an association with outcomes, policymakers should consider eliminating the PCI thresholds for structural heart disease interventions. It may be possible to identify other requirements that are directly linked to quality of care and clinical outcomes.

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