Long-Term Outcomes of Patients Requiring Pacemaker Implantation After Transcatheter Aortic Valve Replacement: The SwissTAVI Registry.

Abstract

Background The impact of pacemaker (PM) implantation on outcomes following transcatheter aortic valve replacement (TAVR) remains controversial, especially as TAVR indications expand to low-risk patients.Objectives This study sought to evaluate the all-cause and cardiovascular mortality of patients undergoing PM implantation after TAVR.Methods In this prospective, observational, nationwide TAVR cohort study, the outcomes of patients undergoing permanent PM implantation were investigated. Patients were enrolled from 19 centers across Switzerland between February 2011 and June 2022.Results Among 13,360 patients enrolled (mean age 82 ± 7 years, 47% female, self-expanding valves 48%, median follow-up 889 days [Q1-Q3: 365-1,765 days]), 2,028 (15%) required PM implantation within 30 days post-TAVR. Patients requiring post-TAVR PM implantation were older (82 ± 6 years of age vs 81 ± 7 years of age), were predominantly male (58% vs 50%), and more often had atrial fibrillation (34% vs 29%). At 1-year follow-up, these patients had higher overall mortality (aHR: 1.15; 95% CI: 1.05-1.26; P = 0.002) and cardiovascular mortality (aHR: 1.25; 95% CI: 1.06-1.46; P = 0.006). These trends persisted at 5- and 10-year follow-up. After multivariable adjustments, significantly higher rates of cardiovascular mortality, LVEF decline ≥10%, and NYHA functional class III or IV at 1-year follow-up were observed (aHR: 1.44,; 95% CI: 1.35-1.54; P < 0.001), along with higher all-cause and cardiovascular mortality rates at 5- and 10-year follow-up in patients requiring PM implantation following TAVR compared with those not needing a PM.Conclusions In this large nationwide registry, patients receiving PM implantation within 30 days after TAVR had significantly higher rates of overall and cardiovascular mortality up to 10 years. (SwissTAVI Registry; NCT01368250).