Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut. (15th June 2022)

• Record Type: Journal Article
• Authors: Rheude, Tobias; Pellegrini, Costanza; Allali, Abdelhakim; Bleiziffer, Sabine; Kim, Won-Keun; Neuser, Jonas; Landt, Martin; Rudolph, Tanja; Renker, Matthias; Widder, Julian D.; Qu, Lailai; Alvarez-Covarrubias, Hector A.; Mayr, N. Patrick; Richardt, Gert; Xhepa, Erion; Joner, Michael
• Is Part Of: International journal of cardiology. Volume 357(2022)
• Page Start: 115
• Page End: 120
• Publication Date: 2022-06-15
• Subjects: Transcatheter aortic valve replacement -- Transcatheter heart valves -- Balloon-expandable valves -- Self-expanding valves -- SAPIEN -- Evolut; CHF Congestive Heart Failure -- EuroSCORE logistic European System for Cardiac Operative Risk Evaluation SCORE -- NYHA New York Heart Association -- PPI Permanent pacemaker implantation -- PSM Propensity Score Matching -- PVL Paravalvular leakage -- TAVR Transcatheter Aortic Valve Replacement -- THV Transcatheter Heart Valves -- VARC Valve Academic Research Consortium; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2022.03.043
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: Direct comparisons of latest-generation balloon-expandable versus self-expanding transcatheter heart valves (THV) are scarce. To compare outcomes after transcatheter aortic valve replacement (TAVR) with SAPIEN 3 Ultra (Ultra) versus Evolut R or Pro (Evolut) THVs. Methods: 1612 consecutive patients undergoing TAVR with either Ultra ( n = 616) or Evolut ( n = 996) were included. After propensity score matching (PSM), 467 and 205 matched pairs were identified in the entire cohort and with latest-generation THVs, respectively. Outcomes were investigated up to 30 days after TAVR. Results: After PSM, baseline characteristics were comparable in the entire cohort ( n = 934). Device success (92.7% vs. 87.6%; p = 0.011) and need for permanent pacemaker implantation (PPI) (15.2% vs. 8.4%; p = 0.002) were higher for Evolut compared with Ultra. Elevated gradients (≥20 mm Hg) were less frequent (1.6% vs. 10.4%; p < 0.001), whereas rates of ≥ moderate paravalvular leakage (PVL II+) were more frequent for Evolut compared with Ultra (3.7% vs. 1.3%; p = 0.019). With latest-generation THVs ( n = 410), device success was comparable (93.2% vs. 89.8%; p = 0.216), whereas the need for PPI was higher for Evolut Pro compared with Ultra (15.6% vs. 9.8%; p = 0.075). Elevated gradients were less frequent (0% vs. 8%; p < 0.001), whereas rates of PVL II+ were more frequent for Evolut compared with Ultra (5.4% vs. 1.5%; p = 0.028). Conclusions: Device success rates were high with both THV platforms with low rates of adverse events up to 30 days after TAVR. Compared with Ultra, Evolut was associated with higher pacemaker rates as well as PVL II+, but with less elevated gradients. Highlights: Large, multicenter, propensity-matched comparison of latest-generation SAPIEN 3 Ultra versus Evolut THVs High device success rates with both THV platforms with low rates of adverse events up to 30 days after TAVR Use of Evolut was associated with higher permanent pacemaker rates as well as moderate or severe paravalvular leakage, but with less elevated transprosthetic gradients compared with Ultra