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Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut

Authors :
Tobias Rheude
Costanza Pellegrini
Abdelhakim Allali
Sabine Bleiziffer
Won-Keun Kim
Jonas Neuser
Martin Landt
Tanja Rudolph
Matthias Renker
Julian D. Widder
Lailai Qu
Hector A. Alvarez-Covarrubias
N. Patrick Mayr
Gert Richardt
Erion Xhepa
Michael Joner
Source :
International Journal of Cardiology. 357:115-120
Publication Year :
2022
Publisher :
Elsevier BV, 2022.

Abstract

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.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.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).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.

Details

ISSN :
01675273
Volume :
357
Database :
OpenAIRE
Journal :
International Journal of Cardiology
Accession number :
edsair.doi.dedup.....53b50085430000f5f0277dba2576236d
Full Text :
https://doi.org/10.1016/j.ijcard.2022.03.043