Leadless Versus Transvenous Dual‐Chamber Pacemakers: Real‐World Evidence From AVEIR DR Coverage With Evidence Development Study

Background 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. Objective To compare complications and mortality between AVEIR DR LP and dual‐chamber transvenous pacemakers (TP). Methods 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. Results 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). Conclusion 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.