Leadless Versus Transvenous Dual-Chamber Pacemakers: Real-World Evidence From AVEIR DR Coverage With Evidence...

AVEIR DR, an industry-first dual-chamber leadless pacemaker (LP), provides continuous atrioventricular synchrony through implant-to-implant (i2i) communication between atrial and ventricular LP devices. It is important to evaluate the early real-world comparative safety of AVEIR DR LP.

To compare complications and mortality between AVEIR DR LP and dual-chamber transvenous pacemakers (TP).

De novo LP and TP patients were identified in Medicare Fee-for-Service claims (October 2023 and December 2024). Outcomes were 30-day and 6-month complications, reinterventions, heart failure hospitalizations, and all-cause mortality. Comparisons were adjusted for demographics, comorbidities, and hospital encounter characteristics.

Compared to TP (N = 77 422, age = 79.6 ± 7.5), LP patients (N = 759, age = 78.5 ± 7.8) had a higher comorbidity index, more dialysis dependence, end-stage renal disease, and atrial fibrillation. Adjusted 30-day overall complications (7.9% vs. 9.2%; odds ratio [OR] 0.85, p = 0.36) and mortality (1.8% vs. 1.5%; hazard ratio [HR] 1.21, p = 0.47) were comparable, while device-related complications (2.0% vs. 3.9%; OR 0.50, p < 0.01) were lower with LP. Adjusted 6-month overall complications (4.1% vs. 6.9%; HR 0.59, p < 0.01), device-related complications (2.8% vs. 5.9%; HR 0.48, p < 0.01), and device reinterventions (2.1% vs. 4.3%; HR 0.49, p < 0.01) were reduced with LP, with no difference in mortality (6.6% vs. 5.6%; HR 1.18, p = 0.43) and heart failure hospitalizations (3.8% vs. 4.1%; HR 0.91, p = 0.65).

Despite a higher comorbidity burden, AVEIR DR LP had significantly fewer device-related complications, overall 6-month complications, and device reinterventions compared to TP, with similar overall 30-day complications, mortality, and heart failure hospitalizations.