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 (nâ¯= 116), Evolut R (nâ¯= 160) or Evolut PRO (nâ¯= 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%, pâ¯= 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, pâ¯= 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%, pâ¯= 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (Râ¯+ PRO) (OR 2.46, 95% CI 0.98-6.16, pâ¯= 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, pâ¯= 0.10), stroke (6% vs 3% vs 2%, pâ¯= 0.21) or major vascular complications (10% vs 12% vs 4%, pâ¯= 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.
