Comparative Matched Outcome of Evolut-R vs. CoreValve Transcatheter Aortic Valve Implantation

Background: The Evolut-R transcatheter valve is fortified with smaller caliber delivery system and a fully re-capturable platform. This new generation valve could theoretically improve Transcatheter Aortic Implantation (TAVI) outcome compare to older devices.

Methods: Based on a comprehensive set of clinical characteristics, we performed a propensity score 1:1 matching on 335 patients who underwent TAVI using the Evolut-R (study group) and CoreValve (matched control group) devices. 30 days outcomes were compared and reported according to Valve Academic Research Consortium 2 definitions. A combined endpoint of major events (1 month: death, stroke, major vascular complication, major bleeding, implantation success, paravalvular leak (PVL) ≥ moderate and new pacemaker implantation [PPM]) was also tested.

Results: The study included 100 (50 Evolut-R; 50 CoreValve) patients. Mean age was 81±6.7 years, 70% women, STS-score 5.6±3.8, 18% patients in each group adjudged frail. Implantation success reached 100% (Evolut-R) and 94% (CoreValve), using an additional valve (within valve) was required in 3 and 2 cases; respectively. Most safety endpoints had low event rate: there were no periprocedural stroke/MI/mortality and no differences in vascular-complications (p=0.581) and major-bleeding (p=0.484). At 30-days, mean transaortic gradient [mmHg] was 7.8±6.6 and 8.8±5.5, p=0.231, ≥moderate PVL was seen in 2.5% and 12%, p=0.172, and survival reached 100% in the Evolut-R and CoreValve groups; respectively. Evolut-R patients were less likely to experience the combined endpoint compared to CoreValve patients (odds-ratio [OR] = 0.12, 95% confidence interval [CI] 0.04-0.40, p<0.001). The OR (95% CI) was 0.14 (0.03-0.68) for a new PPM, p=0.015, and 0.29 (0.07-1.14) for the combined endpoint without including a new PPM, p=0.077.

Conclusion: Compared with the CoreValve, the new generation Evolut-R transcatheter valve offers a better efficacy-safety profile, mostly derived from higher implantation success, less PVL and a decrease in the need for a new PPM after TAVI.