STS News, Winter 2021 — The first public reporting results are expected to be available in October for transcatheter aortic valve replacement (TAVR) procedures in the United States. More than 300,000 TAVRs have been performed since the Food and Drug Administration’s first TAVR device approval in 2011 and the subsequent Medicare reimbursement requirement that all TAVR procedures be reported to the STS/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry.
“When we first considered public reporting for TAVR, we started off by asking the question, ‘Do we need to do this?’,” explained Nimesh D. Desai, MD, PhD, chair of the STS TVT Registry Risk Model Work Group. “We found that the answer was ‘Yes’ because early data show a variation in mortality outcomes between hospitals. We don’t know if it relates to volume or something else, but there certainly is site-level variation in outcomes after TAVR.”
Public reporting through the STS National Database and other registries has shown that the activity encourages transparency of outcomes, attention to quality metrics by hospitals and physicians, contributions to national registries, and increased choice by consumers—more shared-decision making between caregivers and patients.
The new TVT Registry public reporting website will include information on a participant’s first TAVR procedure, the number of cumulative procedures performed, and average annual volume over a 3-year rolling period. It also will show a distribution of the participating hospital’s annual volume compared to that of other hospitals in the TVT Registry. Outcomes will be a 30-day composite reflecting 30-day death, stroke, life-threatening major bleed, acute kidney injury, moderate to moderately severe paravalvular leak, or none of the above.
Each site will be categorized as having results that are better than expected, as expected, or worse than expected.
“TAVR technology is changing rapidly, but more importantly the patients that we are operating on are changing rapidly,” said Dr. Desai. “We are performing TAVR on younger and healthier patients, so we needed to develop a risk model that not only would be predictive of outcomes in 2020, but also would adapt and evolve to what things might look like in 2025 and beyond.”
The methodology for the risk model is expected to be published this spring.
For more information on the state of TAVR, see page 14.