Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study

Larry A. Chinitz, Mikhael F. El-Chami, Venkata Sagi, Hector Garcia, F. Kevin Hackett, Miguel Leal, Patrick Whalen, Charles A. Henrikson, Arnold J. Greenspon, Todd Sheldon, Kurt Stromberg, Nicole Wood, Dedra H. Fagan, Joseph Yat Sun Chan

    Research output: Contribution to journalArticlepeer-review

    1 Scopus citations

    Abstract

    Background: Previous studies demonstrated that accelerometer-based, mechanically timed atrioventricular synchrony (AVS) is feasible using a leadless ventricular pacemaker. Objective: The purpose of this study was to determine the performance of a leadless ventricular pacemaker with accelerometer-based algorithms that provide AVS pacing. Methods: AccelAV was a prospective, single-arm study to characterize AVS in patients implanted with a Micra AV, which uses the device accelerometer to mechanically detect atrial contractions and promote VDD pacing. The primary objective was to characterize resting AVS at 1 month in patients with complete atrioventricular block (AVB) and normal sinus function. Results: A total of 152 patients (age 77 ± 11 years; 48% female) from 20 centers were enrolled and implanted with a leadless pacemaker. Among patients with normal sinus function and complete AVB (n = 54), mean resting AVS was 85.4% at 1 month, and ambulatory AVS was 74.8%. In the subset of patients (n = 20) with programming optimization, mean ambulatory AVS was 82.6%, representing a 10.5% improvement (P <.001). Quality of life as measured by the EQ-5D-3L (EuroQol Five-Dimensions Three-Level questionnaire) improved significantly from preimplant to 3 months (P = .031). In 37 patients with AVB at both 1 and 3 months, mean AVS during rest did not differ (86.1% vs 84.1%; P = .43). There were no upgrades to dual-chamber devices or cardiac resynchronization therapy through 3 months. Conclusion: Accelerometer-based mechanical atrial sensing provided by a leadless pacemaker implanted in the right ventricle significantly improves quality of life in a select cohort of patients with AV block and normal sinus function. AVS remained stable through 3 months, and there were no system upgrades to dual-chamber pacemakers.

    Original languageEnglish (US)
    Pages (from-to)46-54
    Number of pages9
    JournalHeart Rhythm
    Volume20
    Issue number1
    DOIs
    StatePublished - Jan 2023

    Keywords

    • Accelerometer
    • Atrial contraction
    • Atrioventricular block
    • Atrioventricular synchrony
    • Clinical trials
    • Leadless pacing

    ASJC Scopus subject areas

    • Cardiology and Cardiovascular Medicine
    • Physiology (medical)

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