Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut
T. Rheude1, C. Pellegrini1, A. Allali2, S. Bleiziffer3, W.-K. Kim4, J. G. Neuser5, M. Landt2, T. K. Rudolph6, M. Renker4, J. Widder5, H. Alvarez-Covarrubias1, P. Mayr7, G. Richardt8, E. Xhepa1, M. Joner9
1Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München; 2Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg; 3Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 4Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim; 5Kardiologie und Angiologie, Medizinische Hochschule Hannover, Hannover; 6Klinik für Kardiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 7Institut für Anästhesiologie, Technische Universität München, München; 8Herz- Gefäßzentrum, Segeberger Kliniken GmbH, Bad Segeberg; 9Deutsches Herzzentrum München, München;

Background: Direct comparisons of latest-generation balloon-expandable versus self-expanding transcatheter heart valves (THV) are scarce.

Aims: To compare outcomes after transcatheter aortic valve implantation (TAVI) with SAPIEN 3 Ultra (Ultra) versus Evolut R or Pro (Evolut) THVs.

Methods: 1,612 consecutive patients undergoing TAVI with either Ultra (n=616) or Evolut (n=996) at 5 German high-volume centers were included. After propensity score matching (PSM), 499 and 205 matched pairs were identified in the entire cohort and with latest-generation THVs, respectively. Outcomes were investigated up to 30 days after TAVI.

Results: After PSM, baseline characteristics were comparable in the entire cohort (n=998). Device success (94.2% vs. 88.0%; p=0.001), need for permanent pacemaker implantation (PPI) (16.4% vs. 8.6%; p<0.001) as well as all-stroke (5.2% vs. 2.6%; p=0.034) were higher for Evolut compared with Ultra. Elevated transprosthetic gradients (>20mmHg) were less frequent (1.3% vs. 10.5%; p<0.001), whereas rates of ≥ moderate paravalvular leakage (PVL II+) were more frequent for Evolut compared with Ultra (3.7% vs. 1.0%; p=0.006). With latest-generation THVs (n=410), device success was comparable (93.2% vs. 89.8%; p=0.216), whereas need for PPI was higher for Evolut Pro compared with Ultra (15.6% vs. 9.8%; p=0.075). Elevated transprosthetic 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 TAVI. Compared with Ultra, Evolut was associated with higher pacemaker rates as well as PVL II+, but less elevated gradients.


https://dgk.org/kongress_programme/jt2022/aP1602.html