136-41: Initial Real World Performance of Micra™ Leadless Transcatheter Pacemaker Anticipates Outstanding Battery Longevity

Abstract

Introduction: Battery longevity is especially important for leadless pacemakers designed to be endocardially abandoned at end-of-life. The Micra™ transcatheter pacemaker incorporates multiple features to prolong battery life. These include low power electronics driven by a high density battery (120 mA hr) and a Capture Management (CM) algorithm that measures the capture threshold daily, confirms it hourly, and adjusts the pacing safety margin to +0.5 V. Methods: Factors relevant to battery longevity were evaluated in the first 300 patients to complete 6-month follow-up in the Micra™ clinical study. Battery longevity for each patient was projected based on real world use conditions. Results: Alow (≤2 V) and stable (≤1.5 V rise from implant) capture threshold was observed in 292 of 297 (98.3%) patients with baseline and follow-up data. The CM threshold was accurate to within 0.5 V of the manual threshold in 279 of 280 (99.6%) patients with paired test data. The pacing output was set using CM and the pulse width was held at 0.24 ms in 298 of 300 (99.3%) patients for whom programming was reported. Loss of capture was never observed in 27 patients who completed Holter monitoring, even for hourly confirmation test paces at the daily CM threshold +0.125 V. Mean pacing parameters included amplitude = 1.1 V, impedance = 594 Ω CI, rate 73 bpm, and pacing percentage = 50%. Mean projected longevity was 12.5 years (Figure). Conclusions: Real world performance of the Micra™ transcatheter pacemaker through 6-month follow-up anticipates mean battery longevity of 12.5 years. Longevity is achieved with a high density battery and algorithms that reduce pacing current without risking reliable capture. (Figure Presented).