Transcatheter aortic valve replacement using the new Evolut-Pro system: a prospective comparison with the Evolut-R device

Abstract

Background: Evolut Pro (EVP) is a novel self-expandable aortic valve. This prosthesis consists of an external porcine pericardial wrap designed to reduce paravalvular leak (PVL), maintaining the benefits of its predecessor, the Evolut R (EVR). The aim was to compare the functional and clinical results in the short and medium term of the new EVP with the EVR system.Methods: Consecutive patients receiving either the EVR (n=50) or the EVP (n=33) from June 2015 to October 2018 were compared. Baseline characteristics, cardiovascular imaging, procedural outcomes, short and mid-term follow-up outcomes were prospectively collected and assessed.Results: Residual mild PVL was common and comparable in the two groups (EVR 79% vs. EVP 70%; P=0.4). In the EVR group, the presence of PVL was directly related to prosthesis size, but this correlation was not observed in the EVP group. Conduction abnormalities were more prevalent with the EVP, but these did not translate into a higher need of permanent pacemaker implantation. Vascular and bleeding complications were infrequent in both groups. At mid-term clinical follow-up (median survival time: EVR 11±0.3 months, EVP 12±0.2 months), the 1-year rate of adverse events was similar (EVR: 24%, EVP: 33%; P=0.3).Conclusions: Both protheses are effective for the treatment of severe aortic stenosis with excellent results at mid-term clinical follow up. The EVP remains associated with a significant rate of residual mild PVL that appears to be similar to that observed with EVR.

Outcomes of Transcatheter Aortic Valve Implantation Comparing Medtronic’s Evolut PRO and Evolut R: A Systematic Review and Meta-Analysis of Observational Studies

“…Of these, 751 were excluded because they were not pertinent to the design of the meta-analysis or did not meet the explicit inclusion criteria. Eleven observational studies [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ] (among them seven multi-center registries), including N = 12,363 patients, were eventually included in the analysis. Potential sources of study bias were analyzed with the use of the components recommended by the ROBINS-I tool, and the results are shown in Supplementary Table S2 .…”

“… Risk Ratios (RRs) and corresponding 95% Confidence Intervals (CIs) for the comparison of Evolut PRO and Evolut R devices [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ]; ( A ) moderate-to-severe paravalvular leak; ( B ) mild paravalvular leak. Each square represents study point estimate; diamonds reflect the overall effect.…”

“… Risk Ratios (RRs) and corresponding 95% Confidence Intervals (CIs) for the comparison of Evolut PRO and Evolut R devices [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 27 , 28 ]; ( A ) serious bleeding; ( B ) major vascular complications. Each square represents study point estimate; diamonds reflect the overall effect.…”

Gender Disparities after Transcatheter Aortic Valve Replacement with Newer Generation Transcatheter Heart Valves: A Systematic Review and Meta-Analysis

“…Secondly, the newer generation THVs, including Edwards SAPIEN-3 and Evolut Pro valves, have the development of an outer skirt that can deliver a better seal, resulting in a lower PVL risk, which is a common risk factor for long-term mortality in patients undergoing TAVR. Even in patients who develop at least moderate PVL after TAVR, the study showed that this population had a regression of PVL at the one-year follow-up [ 34 , 35 ]. Additionally, the pacemaker placement rates decreased with SAPIEN-3 and Evolut R, which deployed the valves at higher implantation heights.…”