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

## TL;DR

This study compares the safety of a new leadless pacemaker with traditional pacemakers and finds fewer device-related complications with the new model.

## Contribution

The study provides real-world evidence on the comparative safety of the AVEIR DR leadless pacemaker versus transvenous pacemakers.

## Key findings

- Leadless pacemakers had fewer device-related complications and reinterventions compared to transvenous pacemakers.
- There was no significant difference in mortality or heart failure hospitalizations between the two types of pacemakers.
- Patients with leadless pacemakers had a higher comorbidity burden but similar 30-day complication rates.

## Abstract

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.