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. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement, NCT01240902; Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI], NCT01586910; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement, NCT01531374).