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Purpose <p>To assess the impact of enhancements to the Atrioventricular Synchrony (AVS) algorithms of a next generation Micra leadless pacemaker (Micra AV2).</p> Methods <p>Accelerometer data were extracted from the AccelAV clinical study and were used to create virtual patients. A series of Monte Carlo simulations were run for each virtual patient to compare an enhanced Atrial Sensing Setup algorithm and Auto + A3 Threshold algorithm vs. original algorithms. A real-world survey was also conducted to observe clinical time savings from AVS programming burden reduction.</p> Results <p>The enhanced Atrial Sensing Setup in Micra AV2 devices demonstrated &gt; 70% AVS in 27 of 30 (90%) patients while 13 of 30 (43%) Micra AV patients had &gt; 70% AVS (<i>p</i> &lt; 0.001) with no manual programming. The Micra AV2 Auto + A3 Threshold without additional manual programming demonstrated improved overall ambulatory AVS in the 80–100&#xa0;bpm range (84.1%). Based upon survey results, the enhanced Atrial Sensing Setup algorithm accounted for an estimated reduction in median device check time of 13 min per patient.</p> Conclusions <p>Simulation-based analyses of the Micra AV2 leadless pacemaker projected significant improvements in automatic AVS at high sinus rates and an increase in the number of patients with &gt; 70% AVS without clinician programming. Real-world survey results reported a reduction in device check time with the improvements. <i>Significance:</i> Improvements in the AVS algorithms in Micra AV2 allow for better automatic AVS at higher heart rates and reduced clinic utilization&#xa0;burden.</p>

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Atrioventricular Synchrony Algorithm Modeling of a Leadless Pacemaker Family: A Virtual Patient Analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月27日

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  • Miguel A. Leal,
  • Todd Sheldon,
  • Keelia Escalante,
  • Mikayle Holm,
  • Michelle Galarneau,
  • Kurt Stromberg,
  • Jonathan P. Piccini

摘要

Purpose

To assess the impact of enhancements to the Atrioventricular Synchrony (AVS) algorithms of a next generation Micra leadless pacemaker (Micra AV2).

Methods

Accelerometer data were extracted from the AccelAV clinical study and were used to create virtual patients. A series of Monte Carlo simulations were run for each virtual patient to compare an enhanced Atrial Sensing Setup algorithm and Auto + A3 Threshold algorithm vs. original algorithms. A real-world survey was also conducted to observe clinical time savings from AVS programming burden reduction.

Results

The enhanced Atrial Sensing Setup in Micra AV2 devices demonstrated > 70% AVS in 27 of 30 (90%) patients while 13 of 30 (43%) Micra AV patients had > 70% AVS (p < 0.001) with no manual programming. The Micra AV2 Auto + A3 Threshold without additional manual programming demonstrated improved overall ambulatory AVS in the 80–100 bpm range (84.1%). Based upon survey results, the enhanced Atrial Sensing Setup algorithm accounted for an estimated reduction in median device check time of 13 min per patient.

Conclusions

Simulation-based analyses of the Micra AV2 leadless pacemaker projected significant improvements in automatic AVS at high sinus rates and an increase in the number of patients with > 70% AVS without clinician programming. Real-world survey results reported a reduction in device check time with the improvements. Significance: Improvements in the AVS algorithms in Micra AV2 allow for better automatic AVS at higher heart rates and reduced clinic utilization burden.