One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker. Academic Article uri icon

Overview

abstract

  • BACKGROUND: A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals. METHODS: Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing. Enrolled patients were implanted with an Aveir DR dual-chamber leadless pacemaker system, which comprised 2 communicating leadless pacemakers (1 in the right atrium and 1 in the right ventricle). The primary safety outcome evaluated whether freedom from serious device- or procedure-related events through 365 days exceeded the predetermined performance goal of 76.5%. The primary performance outcome determined whether the composite of atrial capture threshold (≤3.0 V at 0.4 ms) and sensing amplitude (P-wave ≥1.0 mV) at the 12-month visit exceeded the predetermined performance goal of 80.0%. RESULTS: Sites attempted implantation in 300 subjects, where 63.3% had sinus-node dysfunction and 33.3% had atrioventricular block as their primary pacing indication. The primary safety end point was achieved, with a Kaplan-Meier 12-month complication-free rate of 88.6% (95% CI, 84.5-91.8; P<0.001). The primary performance end point was achieved in 92.8% of patients (95% CI, 89.7-95.8; P<0.001). CONCLUSIONS: Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual-chamber leadless pacemaker. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05252702.

authors

  • Knops, Reinoud E
  • Ip, James E.
  • Doshi, Rahul
  • Exner, Derek V
  • Defaye, Pascal
  • Canby, Robert
  • Bongiorni, Maria Grazia
  • Shoda, Morio
  • Hindricks, Gerhard
  • Neužil, Petr
  • Rashtian, Mayer
  • Breeman, Karel T N
  • Nevo, Jordan R
  • Ganz, Leonard
  • Hubbard, Chris
  • Bulusu, Anu
  • Reddy, Vivek Y

publication date

  • March 27, 2025

Research

keywords

  • Atrioventricular Block
  • Bradycardia
  • Cardiac Pacing, Artificial
  • Heart Rate
  • Pacemaker, Artificial
  • Sick Sinus Syndrome

Identity

Scopus Document Identifier

  • 105002406187

Digital Object Identifier (DOI)

  • 10.1161/CIRCEP.124.013619

PubMed ID

  • 40143804

Additional Document Info

volume

  • 18

issue

  • 4