Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at ≥ Intermediate Risk

Background: The incidence and clinical importance of bioprosthetic valve dysfunction (BVD) in patients undergoing supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) or surgery is not well understood. Objectives: The purpose of this study was to evaluate the 5-year incidence and clinical outcomes of BVD in patients undergoing CoreValve/Evolut TAVR or surgery. Methods: This post hoc analysis pooled data from the U.S. High Risk Pivotal (n = 726) and SURTAVI (n = 1,618) randomized controlled trials (RCTs), the Extreme Risk Pivotal trial (n = 608), and CoreValve Continued Access Study (n = 2,654). The primary endpoint was the incidence of BVD through 5 years from the RCTs. The association of BVD with 5-year clinical outcomes was evaluated in the pooled RCT and non-RCT populations. Results: Of 5,606 patients evaluated, 3,070 (54.8%) were men, and the mean age was 82.2 ± 7.4 years. A total of 2,344 RCT patients, including 1,227 who received TAVR and 1,117 who received surgery, and 3,262 non-RCT TAVR patients were included. The rate of BVD was lower in RCT patients undergoing CoreValve/Evolut TAVR compared with surgery (9.7% vs 15.3%; subdistribution HR: 0.57; 95% CI: 0.45-0.73; P < 0.001). In the pooled RCT and non-RCT cohort, BVD was associated with increased 5-year all-cause mortality (HR: 1.49; 95% CI: 1.32-1.68; P < 0.001), cardiovascular mortality (HR: 1.76; 95% CI: 1.52-2.03; P < 0.001), and hospitalization for valve disease or worsening heart failure (HR: 1.48; 95% CI: 1.23-1.78; P < 0.001). Conclusions: Five-year valve performance was significantly better after CoreValve/Evolut TAVR compared with surgery. Development of BVD in TAVR and surgery patients was associated with worsened 5-year clinical outcomes.