Conduction Disturbances and Permanent Pacemaker Implantation After TAVR With Self‐Expanding Devices: The CONNAVIPRO Study
Enrico Poletti, Omar Alessandro Oliva, Ahmad Hassan, Giuseppe Esposito, Mauro Massussi, Valentina Ardizzone, Baydaroglu Nurcan, Antonella Millin, Vittorio Zuccarelli, Andrea Raffaele Munafò, Jacopo Oreglia, Federico De Marco, Marianna Adamo, Didier Tchetché, Andrea ZuffiABSTRACT
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.