Off-Label TAVI Associates With Higher Risk for Poor Outcomes

Transcatheter aortic valve implantation for off-label indications increases risk for poor outcomes.

Transcatheter aortic valve implantation (TAVI) for off-label indications is associated with increased risk for mortality, stroke, and bleeding compared with guideline-directed (GD)-TAVI. These findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium 2022 held from September 17th through 19th, in Boston, Massachusetts.

Investigators from Thomas Jefferson University Hospital and John H Stroger Jr Hospital of Cook County in the United States sourced data for this study from the National Readmission Database. Patients (N=223,238) who received off-label-TAVI or GD-TAVI between 2015 and 2019 were evaluated for outcomes using a propensity-matching approach.

The study population comprised 55% men and 18.5% received off-label-TAVI.

In general, both off-label-TAVI and GD-TAVI use increased between 2015 and 2019 (P =.026).

Among the propensity-matched cohort, off-label-TAVI was associated with increased risk for mortality (adjusted odds ratio [aOR], 2.94; 95% CI, 2.66-3.24), net adverse cardiac events (aOR, 1.83; 95% CI, 1.73-1.95), major bleeding (aOR, 1.49; 95% CI, 1.36-1.63), and stroke (aOR, 1.20; 95% CI, 1.07-1.34) during index hospitalization compared with GD-TAVI. At 30 days (aOR, 1.54; 95% CI, 1.23-1.92) and 180 days (aOR, 1.30; 95% CI, 1.03-1.65) off-label-TAVI associated with increased major bleeding risk compared with GD-TAVI.

The use of transcatheter aortic valve implantation (TAVI) in patients with off-label (OL) indications has increased with no large-scale data on safety.

Stratified by TAVI indication, off-label-TAVI was associated with increased readmission rates among patients with end-stage renal disease, bioprosthetic aortic valves, and coagulopathy compared with GD-TAVI. Patients with a bicuspid aortic valve, leukopenia, and peptic ulcer disease had similar outcomes following off-label- or GD-TAVI.

The trends observed in this study should be confirmed in a large safety study.

“OL [Off-label]-TAVI utilization has increased significantly over the 4-year study period,” the study authors wrote. “Patients undergoing OL-TAVI have a higher likelihood of mortality, stroke, and bleeding compared with those undergoing GD-TAVI during the index hospitalization.”


Ullah W, DiMeglio M, Sana MK, et al. Outcomes of off-label uses of transcatheter aortic valve implantation: insights from the nationwide readmission database. Presented at: The Transcatheter Cardiovascular Therapeutics Scientific Symposium; September 17-19, 2022; Boston, MA. Abstract #438.