Temporal trends with the Evolut family of self‐expanding transcatheter heart valves: A single‐center experience

Abstract

BackgroundThe Evolut self‐expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time.Aims:This study aimed to examine whether these changes impacted clinical outcomes.MethodsEPROMPT is a prospective, investigator‐initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+ SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared.ResultsValve Academic Research Consortium (VARC)−2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC‐3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43).ConclusionDuring a 3‐year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri‐procedural pacemaker rates for SEV.

And the beat goes on

“…overlap technique to allow higher implantation-appear to have modestly reduced the pacemaker implantation rate in most studies, 1,3 this reduction was not observed in the study by Merdler et al 2 The Merdler study tells us that that TAVR outcomes certainly can improve as technical advances and implantation techniques change, but the continued high rate of pacemaker implantation remains an issue with self-expanding valve systems. Even with the newest generation Evolut FX (Medtronic) system, the in-hospital pacemaker implantation rate was 11.9%, 4 significantly higher compared to the newest generation balloon-expandable valve system (5.6%), 5 attributed to the continuous radial force exerted on the conduction system.…”

“…In this issue of Catheterization and Cardiovascular Interventions, Merdler et al2 analyzed their single-center experience of TAVR using a self-expanding valve system. A total of 300 patients who underwent TAVR from January, 2018 through November, 2021 were divided into three equal groups (January 2018 to October 2018: 100 patients, November 2018 to July 2020: 100 patients, August 2020 to November 2021: 100 patients).…”