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Leadless vs. Transvenous Pacemakers After TAVR
Quick Takes
- Adoption of leadless pacemakers following TAVR has slowly increased and was associated with a lower rate of in-hospital overall complications compared with the transvenous pacemaker.
- Furthermore, mid-term all-cause death, heart failure hospitalization, and infective endocarditis were similar between leadless and transvenous pacemakers, while device-related complications were lower with leadless pacemakers.
- These data suggest that the leadless pacemaker is a safe and effective alternative to the transvenous pacemaker among the elderly patients undergoing TAVR.
Study Questions:
What are the national trends in utilization of leadless pacemaker implantation following transcatheter aortic valve replacement (TAVR) and its performance compared with transvenous pacemakers?
Methods:
The investigators conducted a retrospective cohort study and included Medicare fee-for-service beneficiaries aged ≥65 years who underwent leadless or transvenous pacemakers following TAVR between 2017 and 2020. Outcomes included in-hospital overall complications, as well as mid-term (up to 2 years) all-cause death, heart failure hospitalization, infective endocarditis, and device-related complications. Propensity-score overlap weighting analysis was used. In-hospital complications were compared using a logistic regression model, while length of stay and total health care spending were compared using a linear regression model, both before and after weighted adjustment.
Results:
A total of 10,338 patients (leadless 730 vs. transvenous 9,608) 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 mid-term, the authors found no significant differences in all-cause death (adjusted hazard ratio [HR], 1.13; 95% confidence interval [CI], 0.96-1.32; p = 0.15), heart failure hospitalization (subdistribution HR, 0.89; 95% CI, 0.74-1.08; p = 0.24), and infective endocarditis (subdistribution HR, 0.98; 95% CI, 0.44-2.17; p = 0.95) between the two 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:
The authors report that leadless pacemakers were associated with a lower rate of in-hospital complications and mid-term device-related complications compared to transvenous pacemakers without a difference in mid-term mortality.
Perspective:
This study reports that the adoption of leadless pacemakers following TAVR has slowly increased and was associated with a lower rate of in-hospital overall complications compared with the transvenous pacemaker. Furthermore, mid-term all-cause death, heart failure hospitalization, and infective endocarditis were similar between leadless and transvenous pacemakers, while device-related complications were lower with leadless pacemakers. These data suggest that the leadless pacemaker is a safe and effective alternative to the transvenous pacemaker among the elderly patients undergoing TAVR. Additional prospective studies are indicated to validate these findings and identify factors to guide selection of leadless pacemakers over transvenous pacemakers in individual patients.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Arrhythmias and Clinical EP
Keywords: Pacemaker, Artificial, Transcatheter Aortic Valve Replacement
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