Device Failure in Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Implantation

Abstract

Recent studies showed the favorable outcomes of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BAV) stenosis. However, data on the relation between BAV morphology and optimal transcatheter heart valve (THV) selection are limited. This study sought to evaluate the determinants of device performance in patients with BAV who underwent TAVI. Consecutive patients with BAV who underwent TAVI with the SAPIEN 3 from multicenters were evaluated. Outcomes were the incidence and predictors of device failure. Device failure was defined as peak aortic velocity >3.0 m/s, mean pressure gradient >20 mm Hg, moderate or severe paravalvular leakage and/or procedure mortality. A total of 187 patients with BAV were identified, aged 77 years, and 38.0% were women. A total of 37 patients (19.8%) were treated with 23-mm valve, 58 (31.0%) with 26-mm valve, and 92 (49.2%) with 29-mm valve. Predischarge echocardiogram demonstrated 37 patients (19.8%) with device failure. BAV with excessive leaflet calcification plus calcified raphe (EC-BAV) (OR 16.7, 95% CI 1.99 to 39.6) and smaller THV (OR 4.41, 95% CI 1.43 to 13.6) were independently associated with increased risk of device failure. In addition, 4.0%, 5.1%, and 11.1% of device failures were observed in patients without EC-BAV who underwent TAVI with 23-, 26- and 29-mm THV (p = 0.47), respectively, and 91.7%, 31.6% and 23.2% in those with EC-BAV, respectively (p <0.001). In conclusion, EC-BAV morphology was the major determinant of a device failure after TAVI. Moreover, TAVI in patients with EC-BAV requiring small SAPIEN 3 could be challenging. Further data on device and treatment selection in patients with BAV are still warranted.