The first-generation CoreValve was associated with a significantly higher risk for permanent pacemaker implantation compared to the newer generation Evolut R valve (27% vs 16%, OR 2.79).
Observational (n=368)
No
Does transcatheter aortic valve implantation with newer generation self-expanding valves (Evolut R or Evolut PRO) reduce the need for permanent pacemaker implantation and paravalvular leakage compared to the first-generation CoreValve in patients with severe aortic stenosis?
Effect estimate: OR 2.79 (95% CI 1.31-5.94)
Absolute Event Rate: 16% vs 27%
p-value: p=0.008
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.
Kroon et al. (Thu,) conducted a observational in Severe aortic stenosis (n=368). Evolut R vs. CoreValve was evaluated on Permanent pacemaker implantation at 30 days (OR 2.79, 95% CI 1.31-5.94, p=0.008). The first-generation CoreValve was associated with a significantly higher risk for permanent pacemaker implantation compared to the newer generation Evolut R valve (27% vs 16%, OR 2.79).