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Comparative Study
Comparative Matched Outcome of Evolut-R vs CoreValve Transcatheter Aortic Valve Implantation.
- Uri Landes, Tamir Bental, Alon Barsheshet, Abid Assali, Hana Vaknin Assa, Amos Levi, Katia Orvin, and Ran Kornowski.
- Department of Cardiology, Beilinson Hospital-Rabin Medical Center, Jabotinski St. 39, Petah-Tikva, 39100, Israel. ran.kornowski@gmail.com.
- J Invasive Cardiol. 2017 Feb 1; 29 (2): 69-74.
ObjectivesThe Evolut-R (Medtronic, Inc) is a transcatheter aortic valve implantation (TAVI) system that was built on the well-established foundation of Medtronic's CoreValve device platform. Although already in extensive clinical utilization, it is unknown if the Evolut-R improves TAVI outcomes. Herein, we compared TAVI outcomes of the Evolut-R and CoreValve devices.MethodsA propensity score 1:1 matching was conducted on 358 Evolut-R patients (n = 75) and CoreValve patients (n = 283). Thirty-day outcomes were compared using Valve Academic Research Consortium (VARC)-2 criteria. A combined 30-day endpoint including all-cause death, stroke, major vascular complication, major bleeding, implantation failure, paravalvular leak (PVL) ≥ moderate, and new pacemaker implantation was also tested.ResultsThe final study group included 146 patients (73 Evolut-R; 73 CoreValve). Post matching, baseline characteristics were similar between the two groups. Mean patient age was 82 ± 6 years, mean STS score was 5.2 ± 3.8, 72% were female, and 17% were deemed frail. Implantation success reached 99% with Evolut-R and 94% with CoreValve (P=.10). Both groups had low periprocedural stroke/myocardial infarction/mortality rates and there was also no difference in 30-day vascular complications (P=.18), bleeding (P=.37), PVL (P=.24), and new pacemaker (P=.14). The combined outcome rate was 24% with Evolut-R and 37% with CoreValve (P=.10).ConclusionThis study indicates that the efficacy and safety of the self-expandable second-generation Evolut-R transcatheter valve is at least comparable with the first-generation CoreValve. The observed improved performance in correct positioning of a single valve and the numerically lower chance to suffer a combined TAVI endpoint needs further investigation.
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