One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker
Reinoud E. Knops, James E. Ip, Rahul N. Doshi, Derek V. Exner, Pascal Defaye, Robert C. Canby, Maria Grazia Bongiorni, Morio Shoda, Gerhard Hindricks, Petr Neužil, Mayer Rashtian, Karel Breeman, Jordan R. Nevo, Leonard I. Ganz, Chris Hubbard, Anu Bulusu, Vivek Y. Reddy
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.