Kroon H G, van Gils L, Ziviello F, van Wiechen M P H, Ooms J F W, Rahhab Z, El Faquir N, Maugenest A-M, Goudzwaard J A, Cummins P, Lenzen M, Kardys I, Daemen J, Mattace-Raso F, de Jaegere P P T, Van Mieghem N M
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Neth Heart J. 2022 Mar;30(3):140-148. doi: 10.1007/s12471-021-01568-5. Epub 2021 Apr 29.
To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs).
Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database.
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.
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.
比较经导管主动脉瓣植入术（TAVI）使用三代连续的自膨胀瓣膜（SEV）后的早期临床结果。
将接受CoreValve、Evolut R或Evolut PRO进行TAVI的连续患者的临床终点纳入前瞻性数据库。
使用CoreValve（n = 116）、Evolut R（n = 160）或Evolut PRO（n = 92）进行TAVI。与CoreValve相比，Evolut R和Evolut PRO显示出永久起搏器植入（PPI）率较低的趋势（CoreValve为27%，Evolut R为16%，Evolut PRO为18%，p = 0.091）。通过多变量回归分析，与Evolut R相比，CoreValve发生PPI的风险显著更高（优势比（OR）为2.79，95%置信区间（CI）为1.31 - 5.94，p = 0.008），而Evolut R和PRO相似。仅CoreValve出现严重瓣周漏（PVL），但中度PVL未观察到显著差异（10%对8%对6%，p = 0.49）。与Evolut平台（R + PRO）相比，CoreValve发生超过轻度PVL的风险有升高趋势（OR为2.46，95% CI为0.98 - 6.16，p = 0.
