Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies
Larry Chinitz, Philippe Ritter, Surinder Kaur Khelae, Saverio Iacopino, Christophe Garweg, Maria Grazia-Bongiorni, Petr Neuzil, Jens Brock Johansen, Lluis Mont, Efrain Gonzalez, Venkata Sagi, Gabor Z Duray, Nicolas Clementy, Todd Sheldon, Vincent Splett, Kurt Stromberg, Nicole Wood, Clemens Steinwender, Larry Chinitz, Philippe Ritter, Surinder Kaur Khelae, Saverio Iacopino, Christophe Garweg, Maria Grazia-Bongiorni, Petr Neuzil, Jens Brock Johansen, Lluis Mont, Efrain Gonzalez, Venkata Sagi, Gabor Z Duray, Nicolas Clementy, Todd Sheldon, Vincent Splett, Kurt Stromberg, Nicole Wood, Clemens Steinwender
Abstract
Background: Micra is a leadless pacemaker that is implanted in the right ventricle and provides rate response via a 3-axis accelerometer (ACC). Custom software was developed to detect atrial contraction using the ACC enabling atrioventricular (AV) synchronous pacing.
Objective: The purpose of this study was to sense atrial contractions from the Micra ACC signal and provide AV synchronous pacing.
Methods: The Micra Accelerometer Sensor Sub-Study (MASS) and MASS2 early feasibility studies showed intracardiac accelerations related to atrial contraction can be measured via ACC in the Micra leadless pacemaker. The Micra Atrial TRacking Using A Ventricular AccELerometer (MARVEL) study was a prospective multicenter study designed to characterize the closed-loop performance of an AV synchronous algorithm downloaded into previously implanted Micra devices. Atrioventricular synchrony (AVS) was measured during 30 minutes of rest and during VVI pacing. AVS was defined as a P wave visible on surface ECG followed by a ventricular event <300 ms.
Results: A total of 64 patients completed the MARVEL study procedure at 12 centers in 9 countries. Patients were implanted with a Micra for a median of 6.0 months (range 0-41.4). High-degree AV block was present in 33 patients, whereas 31 had predominantly intrinsic conduction during the study. Average AVS during AV algorithm pacing was 87.0% (95% confidence interval 81.8%-90.9%), 80.0% in high-degree block patients and 94.4% in patients with intrinsic conduction. AVS was significantly greater (P <.001) during AV algorithm pacing compared to VVI in high-degree block patients, whereas AVS was maintained in patients with intrinsic conduction.
Conclusion: Accelerometer-based atrial sensing is feasible and significantly improves AVS in patients with AV block and a single-chamber leadless pacemaker implanted in the right ventricle.
Trial registration: ClinicalTrials.gov NCT02930980 NCT03157297.
Keywords: Accelerometer; Atrial contraction; Atrioventricular block; Atrioventricular synchronous pacing; Leadless pacemaker.
Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed