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, G. Duray, Nicolas Clementy, Todd Sheldon, Vincent Splett, Kurt Stromberg, Nicole Wood, Clemens Steinwender

Research output: Article

21 Citations (Scopus)

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.

Original languageEnglish
JournalHeart Rhythm
DOIs
Publication statusAccepted/In press - jan. 1 2018

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Feasibility Studies
Atrioventricular Block
Heart Ventricles
Multicenter Studies
Electrocardiography
Software
Prospective Studies
Confidence Intervals
Equipment and Supplies

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker : Results from the Micra atrioventricular feasibility studies. / Chinitz, Larry; Ritter, Philippe; Khelae, Surinder Kaur; Iacopino, Saverio; Garweg, Christophe; Grazia-Bongiorni, Maria; Neuzil, Petr; Johansen, Jens Brock; Mont, Lluis; Gonzalez, Efrain; Sagi, Venkata; Duray, G.; Clementy, Nicolas; Sheldon, Todd; Splett, Vincent; Stromberg, Kurt; Wood, Nicole; Steinwender, Clemens.

In: Heart Rhythm, 01.01.2018.

Research output: Article

Chinitz, L, Ritter, P, Khelae, SK, Iacopino, S, Garweg, C, Grazia-Bongiorni, M, Neuzil, P, Johansen, JB, Mont, L, Gonzalez, E, Sagi, V, Duray, G, Clementy, N, Sheldon, T, Splett, V, Stromberg, K, Wood, N & Steinwender, C 2018, 'Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies', Heart Rhythm. https://doi.org/10.1016/j.hrthm.2018.05.004
Chinitz, Larry ; Ritter, Philippe ; Khelae, Surinder Kaur ; Iacopino, Saverio ; Garweg, Christophe ; Grazia-Bongiorni, Maria ; Neuzil, Petr ; Johansen, Jens Brock ; Mont, Lluis ; Gonzalez, Efrain ; Sagi, Venkata ; Duray, G. ; Clementy, Nicolas ; Sheldon, Todd ; Splett, Vincent ; Stromberg, Kurt ; Wood, Nicole ; Steinwender, Clemens. / Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker : Results from the Micra atrioventricular feasibility studies. In: Heart Rhythm. 2018.
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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.",
keywords = "Accelerometer, Atrial contraction, Atrioventricular block, Atrioventricular synchronous pacing, Leadless pacemaker",
author = "Larry Chinitz and Philippe Ritter and Khelae, {Surinder Kaur} and Saverio Iacopino and Christophe Garweg and Maria Grazia-Bongiorni and Petr Neuzil and Johansen, {Jens Brock} and Lluis Mont and Efrain Gonzalez and Venkata Sagi and G. Duray and Nicolas Clementy and Todd Sheldon and Vincent Splett and Kurt Stromberg and Nicole Wood and Clemens Steinwender",
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T1 - Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker

T2 - Results from the Micra atrioventricular feasibility studies

AU - Chinitz, Larry

AU - Ritter, Philippe

AU - Khelae, Surinder Kaur

AU - Iacopino, Saverio

AU - Garweg, Christophe

AU - Grazia-Bongiorni, Maria

AU - Neuzil, Petr

AU - Johansen, Jens Brock

AU - Mont, Lluis

AU - Gonzalez, Efrain

AU - Sagi, Venkata

AU - Duray, G.

AU - Clementy, Nicolas

AU - Sheldon, Todd

AU - Splett, Vincent

AU - Stromberg, Kurt

AU - Wood, Nicole

AU - Steinwender, Clemens

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - Accelerometer

KW - Atrial contraction

KW - Atrioventricular block

KW - Atrioventricular synchronous pacing

KW - Leadless pacemaker

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