CI-525-01 EARLY EXPERIENCE WITH A LEADLESS VENTRICULAR PACEMAKER PROVIDING ATRIOVENTRICULAR SYNCHRONOUS PACING IN THE REAL-WORLD SETTING: RESULTS FROM THE MICRA AV POST-APPROVAL REGISTRY

Abstract

Advances in leadless pacemaker technology have enabled accelerometer based atrioventricular synchronous (AVS) pacing by sensing atrial mechanical contraction. However, performance of these devices in real-world clinical practice has not been assessed. To report the acute performance of the Micra AV leadless pacemaker from the global Micra AV post-approval registry (PAR). The Micra AV PAR is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of Micra AV in the real-world setting. The registry will enroll approximately 750 patients and follow them for 3-years. For this analysis, baseline characteristics, device performance, and pericardial effusion events were summarized. The device was successfully implanted in 400 of 402 patients (99.5%) at 77 centers (mean age 75.4±14.1 years, 43.8% female). The most common pacing indication was AV block (49.0%), followed by sinus node dysfunction (17.9%), and bradyarrhythmia with AF (16.2%). Co-morbidities included diabetes (33.6%), heart failure (14.7%), and COPD (9.0%) with 33.3% precluded from transvenous devices. Pericardial effusion occurred in 5 patients (1.24%). Of the 153 patients programmed to VDD mode with ≥30 days of device follow-up, median pacing percentage was 70.7% with 43.1% of patients having >90% pacing. The median percentage of ventricular paces preceded by atrial mechanical detection was 75% in the 66 patients with >90% ventricular pacing (Figure). The Micra AV leadless pacemaker was implanted with a high rate of success among patients with a high co-morbidity burden. Longer-term performance of the device will continue to be assessed in this ongoing trial.