Abstract 14992: Outcomes of Off-Label Use of Transcatheter Aortic Valve Replacement (TAVR) in the U.S.: Insights From the STS/ACC TVT Registry

Abstract

Background: TAVR was approved by the US FDA for treatment of severe aortic stenosis (AS) in symptomatic inoperable and high-risk patients. Off-label use of TAVR in the US has not been previously studied. Methods: Patients receiving commercially funded TAVR in the US are included in the Transcatheter Valve Therapy (TVT) Registry. Within this registry, we assessed 23,841 patients from 328 sites receiving TAVR between 11/201-9/2014. We evaluated the frequency and outcomes of off-label TAVR use, defined as TAVR in patients with known bicuspid or unicuspid valve, failing bioprosthetic aortic valve, moderate AS, severe mitral or aortic regurgitation or subaortic stenosis. Data were linked with CMS for 15,394 patients to evaluate 30-day and 1-year outcomes. Results: Off-label TAVR was used in 2682/23841 patients (11.2%); indications noted in the Table 1. Compared to on-label use, off-label use patients were more likely to be younger, male, receive care in urban, teaching hospitals with higher TAVR volume, have higher STS score (median 7.2 vs 6.8, p <0.0001) and less likely to have elective procedures. In CMS-linked data, patients undergoing off-label TAVR had higher 30-day mortality but similar 1 -year mortality compared to on-label TAVR (Table 2). Conclusion: About 1 in 10 patients in the US have received TAVR for an off-label indication. One-year outcomes were similar to on-label indication patients. These results reinforce the urgent need for additional research on the efficacy of TAVR in specific patient cohorts for whom TAVR is being considered in clinical practice.