Conduction Disturbances and Permanent Pacemaker Implantation After TAVR With Self-Expanding Devices: The CONNAVIPRO Study.

Abstract

Background: The Evolut and the Navitor transcatheter heart valves (THVs) represent the most widely used self-expanding implanted valves. Despite a similar implant concept, they markedly differ in design and hemodynamic performance. In both THVs, conduction disturbances following transcatheter aortic valve replacement (TAVR) are reported higher than in balloon-expandable devices. Nevertheless, to date, no direct comparative studies have analyzed their real difference rates.

Aim: Aim of the present study was to directly compare the self-expanding Evolut PRO+ and Navitor THVs, with specific focus on the incidence of new permanent pacemaker implantation (PPI) and post-procedural hemodynamic performance.

Methods: The CONNAVIPRO registry is an international, multicenter, retrospective study including 880 consecutive patients with severe aortic stenosis treated with Evolut PRO+ (n = 451) or Navitor (n = 429) between May 2022 and December 2024. The primary endpoint was new PPI within 30 days among pacemaker-naïve patients. Secondary endpoints included technical and device success, transprosthetic gradients, and paravalvular leak (PVL). Inverse probability weighting (IPW) was applied to adjust for baseline differences.

Results: Procedural success was high with both valves (97.6%), and early safety outcomes were comparable. At 30 days, the Navitor group showed a higher PPI rate than Evolut (23.2% vs. 17.6%), reaching statistical significance after IPW adjustment (OR 1.53, 95% CI 1.08-2.17; p = 0.018). Mean transprosthetic gradients were slightly higher with Navitor (8 vs. 7 mmHg; p = 0.002), whereas moderate or greater PVL was less frequent (2.8% vs. 7.7%; p < 0.001). Variables independently associated with PPI were hypertension, and pre-existing right bundle branch block.

Conclusions: Both Evolut PRO+ and Navitor THVs provided excellent safety and hemodynamic outcomes. Navitor may be associated with a higher 30-day PPI rate, a lower incidence of moderate or greater PVL, and clinically non-significant higher gradients. These associations should be interpreted as hypothesis-generating and warrant confirmation in prospective studies.