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

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.