Redo-Transcatheter Aortic Valve Replacement With Self-Expanding Valves: A U.S. Registry Analysis.
Abstract
Background
Redo-transcatheter aortic valve replacement (TAVR) for failed transcatheter heart valves is expected to increase, but data on outcomes with self-expanding valves remain limited.
Objectives
The aims of this study were to evaluate procedural, clinical, and quality-of-life outcomes following redo-TAVR using self-expanding Evolut valves and to compare these outcomes with those among a contemporary native TAVR cohort.
Methods
Outcomes after redo-TAVR with Evolut R, Evolut PRO, and Evolut PRO+ valves in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were analyzed and compared with outcomes after native-valve TAVR using the same valve platform during the same study period. The primary endpoints were all-cause mortality, stroke, and readmission at 30 days and 1 year.
Results
Among 439 redo-TAVR patients (mean age 78.9 ± 9.8 years, 63.1% women), procedural complication rates were low. Redo-TAVR reduced transvalvular gradients at 1 year, although gradients remained modestly higher than after native TAVR (11.3 ± 6.1 mm Hg vs 8.2 ± 4.6 mm Hg; P < 0.001). After adjustment, clinical outcomes were similar between redo-TAVR and native TAVR at 30 days (mortality adjusted HR: 0.66 [95% CI: 0.39-1.13; P = 0.129]; stroke adjusted HR: 0.95 [95% CI: 0.54-1.68; P = 0.853]; readmission adjusted HR: 0.88 [95% CI: 0.65-1.20; P = 0.422]) and 1-year (mortality adjusted HR: 0.91 [95% CI: 0.72-1.15; P = 0.441]; stroke adjusted HR: 0.91 [95% CI: 0.63-1.34; P = 0.644]; readmission adjusted HR: 0.92 [95% CI: 0.76-1.13; P = 0.439]). Improvements in functional status and quality of life were observed early after redo-TAVR and were sustained through 1 year. Findings were consistent across prespecified subgroups.
Conclusions
In a national registry, redo-TAVR with the Evolut platform was associated with low procedural complication rates and clinical outcomes comparable with those observed with native TAVR. These findings support redo-TAVR with Evolut as a feasible and effective treatment strategy in appropriately selected patients.