(CCSP032) FIVE-YEAR BIOPROSTHETIC VALVE DYSFUNCTION AFTER SURGERY OR SELF-EXPANDING TRANSCATHETER AORTIC VALVE IMPLANTATION

Background: Bioprosthetic valve dysfunction (BVD) after aortic valve replacement includes structural valve deterioration (SVD), non-structural valve dysfunction (NSVD) (prosthesis-patient mismatch [PPM], paravalvular regurgitation [PVR]), clinical valve thrombosis, and infectious endocarditis. Our prior work from the CoreValve US High Risk and SURTAVI randomized clinical trials (RCTs) demonstrated a significantly lower 5-year incidence of SVD in TAVI vs surgery.1 Here, we evaluate 5-year valve performance and durability by incidence of overall BVD.

METHODS AND RESULTS: Five-year BVD data from the CoreValve Pivotal and SURTAVI trials were recently presented at CRT 2023 as a late breaker.

A total of 1128 TAVI and 971 surgery patients from the CoreValve US High Risk and SURTAVI RCTs were retrospectively analyzed. BVD was defined as: 1) SVD; mean gradient increase ≥10 mmHg from discharge/30-day to last echo AND ≥20 mmHg at last echo, OR new onset/increase of ≥ moderate intraprosthetic aortic regurgitation, 2) NSVD; severe PPM (VARC-3) at 30-day/discharge, OR severe PVR through 5 years, 3) clinical valve thrombosis, OR 4) infectious endocarditis. The cumulative incidence rates of BVD, SVD, NSVD and severe PVR were estimated using interval censoring analysis and treating death as a competing risk. The cumulative incidence rates of thrombosis and endocarditis were estimated using proportional sub-distribution hazard regression for right-censored data. Severe PPM rate was estimated as a proportion.

BVD was found in 80 TAVI and 130 surgery randomized patients through 5 years. The cumulative incidence rate of BVD was significantly lower following TAVI than surgery (7.8% vs 14.2%; hazard ratio [HR], 0.50; 95% confidence interval [CI], 0.38-0.66; p< 0.001). SVD and NSVD were significantly lower after TAVI vs surgery, whereas no significant differences were found in the incidence of valve thrombosis or endocarditis (Table).

Conclusion: Five-year valve performance assessed by BVD was significantly better after self-expanding, supra-annular TAVI vs surgery, with three times lower severe PPM. These findings may have implications for shared decision-making in lower risk patients with severe aortic stenosis, where durability should be a key consideration for initial valve selection.

1. O’Hair D, Yakubov SJ, Grubb KJ, et al. (2022). Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol, doi:10.1001/jamacardio.2022.4627.
2. Yakubov SJ, Van Mieghem NM, Oh JK, et al (2023). Five-Year Incidence of Bioprosthetic Valve Dysfunction in Patients Randomized to Surgery or TAVR: Insights From the CoreValve US Pivotal and SURTAVI Trials. Late breaker presentation, CRT 2023, February 25-28, 2023. Washington, USA.