Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement: Insights From the NCDR STS/ACC TVT Registry.

ABSTRACT:

Importance

Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for severe aortic stenosis in patients who cannot undergo surgery and for patients at high operative risk. Use of TAVR for off-label indications has not been previously reported.

Objective

To evaluate patterns and adverse outcomes of off-label use of TAVR in US clinical practice.

Design, setting and participants

Patients receiving commercially funded TAVR in the United States are included in the Transcatheter Valve Therapy Registry. A total of 23 847 patients from 328 sites performing TAVR between November 9, 2011, and September 30, 2014, were assessed for this study. Off-label TAVR was defined as TAVR in patients with known bicuspid valve, moderate aortic sten

SUBMITTER: Hira RS 

PROVIDER: S-EPMC5710589 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature