Damien Brunet

Background: Conduction disturbances and the subsequent need for permanent pacemaker implantation (PPMI) remain a major limitation of transcatheter aortic valve replacement (TAVR) with self-expanding transcatheter heart valves (SE-THVs). The cusp-overlap technique (COT) has been proposed to optimize implantation depth and reduce PPMI rates compared to the standard three-cusp technique (3CT). Methods: This retrospective, single-center study included 113 consecutive patients with symptomatic severe aortic stenosis who underwent TAVR with the Medtronic CoreValve Evolut™ SE-THV(Medtronic, Minneapolis, MN, USA) between September 2020 and March 2023. Patients were treated using either COT (n = 49) or 3CT (n = 62). Baseline characteristics, procedural outcomes, and 30-day clinical events were compared before and after one-to-one propensity score matching. The primary endpoint was the incidence of PPMI at hospital discharge; the secondary endpoint was a composite of death, stroke, life-threatening or disabling bleeding, major vascular complications, and moderate/severe paravalvular regurgitation at 30 days. A post hoc power calculation was performed given the low observed event rate. Results: Procedural success was achieved in 98.2% of patients. In the unmatched cohort, PPMI occurred in 6.1% (COT) vs. 9.7% (3CT) (p = 0.48). In the matched cohort (49 pairs), PPMI rates were 6.1% (COT) vs. 12.2% (3CT) (p = 0.48). With only 3 vs. 6 PPMI events in the matched cohort, the study had an estimated post hoc power of approximately 19% (two-sided α = 0.05) to detect the observed difference, so the negative primary result should be regarded as inconclusive rather than as evidence of equivalence between techniques. The secondary composite endpoint occurred less frequently in the COT group both before matching (14.3% vs. 32.3%; p = 0.049) and after matching (14.3% vs. 30.6%, p = 0.049). This composite difference was driven predominantly by the moderate/severe paravalvular regurgitation (PVL) component (12.2% vs. 24.2% unmatched; 12.2% vs. 22.4% matched) rather than by death, stroke, or major vascular complications. Evolut device generation differed markedly by arm (COT patients received later-generation devices far more often than 3CT; p < 0.001), and is presented in the Methods/Results Sections as a key temporal confounder. COT was associated with a lower incidence of moderate/severe paravalvular regurgitation, without prolonging procedural time. Conclusions: In this real-world single-center cohort, the cusp-overlap technique was not associated with a statistically significant reduction in PPMI after TAVR with the CoreValve Evolut™ SE-THV. COT was, however, associated with fewer paravalvular leaks and a lower rate of the secondary composite of adverse clinical events at 30 days.

Background: Conduction disturbances and the subsequent need for permanent pacemaker implantation (PPMI) remain a major limitation of transcatheter aortic valve replacement (TAVR) with self-expanding transcatheter heart valves (SE-THVs). The cusp overlap technique (COT) has been proposed to optimize implantation depth and reduce PPMI rates compared to the standard three-cusp technique (3CT). Methods: This retrospective, single-center study included 113 consecutive patients with symptomatic severe aortic stenosis who underwent TAVR with the Medtronic CoreValve Evolut™ SE-THV between September 2020 and March 2023. Patients were treated using either COT (n = 49) or 3CT (n = 62). Baseline characteristics, procedural outcomes, and 30-day clinical events were compared before and after one-to-one propensity score matching. The primary endpoint was the incidence of PPMI at hospital discharge; the secondary endpoint was a composite of death, stroke, life-threatening or disabling bleeding, major vascular complications, and moderate/severe paravalvular regurgitation at 30 days. Results: Procedural success was achieved in 98.2% of patients. In the unmatched cohort, PPMI occurred in 6.1% (COT) vs. 9.7% (3CT) (p = 0.48). In the matched cohort (49 pairs), PPMI rates were 6.1% (COT) vs. 12.2% (3CT) (p = 0.48). The secondary composite endpoint occurred less frequently in the COT group both before matching (14.3% vs. 32.3%; p = 0.049) and after matching. COT was associated with a lower incidence of moderate/severe paravalvular regurgitation, without prolonging procedural or fluoroscopy times. Conclusion: In this real-world single-center cohort, the cusp overlap technique did not significantly reduce PPMI rates after TAVR with the CoreValve Evolut™ SE-THV, but was associated with fewer paravalvular leaks and a lower rate of adverse clinical events at 30 days.