1. Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut.
- Author
-
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, and Joner, Michael
- Subjects
- *
HEART valve prosthesis implantation , *HEART valves , *PROPENSITY score matching - 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. • 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 [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF