Clinical consequences of consecutive self-expanding transcatheter heart valve iterations

H. G. Kroon, L. van Gils, F. Ziviello, M. P.H. van Wiechen, J. F.W. Ooms, Z. Rahhab, N. El Faquir, A. M. Maugenest, J. A. Goudzwaard, P. Cummins, M. Lenzen, I. Kardys, J. Daemen, F. Mattace-Raso, P. P.T. de Jaegere, N. M. Van Mieghem*

*Corresponding author for this work

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Abstract

Objective: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs). Methods: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database. Results: TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31–5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98–6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed. Conclusions: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.

Original languageEnglish
Pages (from-to)140-148
Number of pages9
JournalNetherlands Heart Journal
Volume30
Issue number3
DOIs
Publication statusPublished - Mar 2022

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