Key result
Newer Evolut valves linked to ~62% lower PPI risk versus CoreValve.
Why the study?
The study aimed to compare conduction dynamics and the need for permanent pacemaker implantation across three consecutive generations of self-expanding TAVR valves.
Do newer generation self-expanding transcatheter heart valves (Evolut R and PRO) reduce the need for permanent pacemaker implantation at 30 days compared to CoreValve in patients undergoing TAVR?
Observational (n=362)
No
Do newer generation self-expanding transcatheter heart valves (Evolut R and PRO) reduce the need for permanent pacemaker implantation at 30 days compared to CoreValve in patients undergoing TAVR?
Effect estimate: OR 0.38 (95% CI 0.19-0.78)
Absolute Event Rate: 17% vs 27%
p-value: p=0.008
Newer generation self-expanding transcatheter heart valves (Evolut R and PRO) are associated with a significantly lower need for permanent pacemaker implantation at 30 days compared to the older CoreValve.
Newer Evolut valves were associated with lower PPI risk after TAVR; leaves open whether this extends to randomized device selection.
INTRODUCTION: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR)). METHODS: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days. RESULTS: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19-0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19-0.91, P-value = 0.028) were independently associated with less need for PPI. CONCLUSION: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR.
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Kroon et al. (2021) conducted an observational in Severe aortic valve stenosis (n=362). Evolut R vs. CoreValve was evaluated on Need for permanent pacemaker implantation (PPI) at 30 days (OR 0.38, 95% CI 0.19-0.78, p=0.008). The newer generation Evolut R and Evolut PRO transcatheter heart valves reduced the need for permanent pacemaker implantation compared to CoreValve (OR 0.38 and 0.41, respectively).
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