Comparison of Patient Outcomes Between Leadless vs Transvenous Pacemakers Following Transcatheter Aortic Valve Replacement.

ABSTRACT

BACKGROUND: Evidence is limited regarding the effectiveness of leadless pacemaker implantation for conduction disturbance following transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to examine the national trends in the use of leadless pacemaker implantation following TAVR and compare its performance with transvenous pacemakers. METHODS: Medicare fee-for-service beneficiaries aged ≥65 years who underwent leadless or transvenous pacemakers following TAVR between 2017 and 2020 were included. Outcomes included in-hospital overall complications as well as midterm (up to 2 years) all-cause death, heart failure hospitalization, infective endocarditis, and device-related complications. Propensity score overlap weighting analysis was used. RESULTS: A total of 10,338 patients (730 leadless vs 9,608 transvenous) were included. Between 2017 and 2020, there was a 3.5-fold increase in the proportion of leadless pacemakers implanted following TAVR. Leadless pacemaker recipients had more comorbidities, including atrial fibrillation and end-stage renal disease. After adjusting for potential confounders, patients with leadless pacemakers experienced a lower rate of in-hospital overall complications compared with patients who received transvenous pacemakers (7.2% vs 10.1%; P = 0.014). In the midterm, we found no significant differences in all-cause death (adjusted HR 1.13; 95% CI 0.96-1.32; P = 0.15), heart failure hospitalization (subdistribution HR 0.89; 95% CI 0.74-1.08; P = 0.24), or infective endocarditis (subdistribution HR 0.98; 95% CI 0.44-2.17; P = 0.95) between the 2 groups, but leadless pacemakers were associated with a lower risk of device-related complications (subdistribution HR 0.37; 95% CI 0.21-0.64; P < 0.001). CONCLUSIONS: Leadless pacemakers are increasingly being used for conduction disturbance following TAVR and were associated with a lower rate of in-hospital complications and midterm device-related complications compared to transvenous pacemakers without a difference in midterm mortality.