Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker

Mikhael F El-Chami, Timothy Shinn, Sundeep Bansal, Jose L Martinez-Sande, Nicolas Clementy, Ralph Augostini, Bipin Ravindran, Venkata Sagi, Hemanth Ramanna, Christophe Garweg, Paul R Roberts, Kyoko Soejima, Kurt Stromberg, Dedra H Fagan, Nicky Zuniga, Jonathan P Piccini, Mikhael F El-Chami, Timothy Shinn, Sundeep Bansal, Jose L Martinez-Sande, Nicolas Clementy, Ralph Augostini, Bipin Ravindran, Venkata Sagi, Hemanth Ramanna, Christophe Garweg, Paul R Roberts, Kyoko Soejima, Kurt Stromberg, Dedra H Fagan, Nicky Zuniga, Jonathan P Piccini

Abstract

Background: The feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA.

Methods: Patients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA. Baseline characteristics, acute and follow-up outcomes, and electrical performance were compared between patients with and without AVNA during the follow-up period.

Results: A total of 192 patients (mean age 77.4 ± 8.9 years, 72% female) underwent AVNA at the time of Micra implant and were followed for 20.4 ± 15.6 months. AVNA patients were older, more frequently female, and tended to have more co-morbid conditions compared with non-AVNA patients (N = 2616). Implant was successful in 191 of 192 patients (99.5%). The mean pacing threshold at implant was 0.58 ± 0.35 V and remained stable during follow-up. Major complications within 30 days occurred more frequently in AVNA patients than non-AVNA patients (7.3% vs. 2.0%, p < .001). The risk of major complications through 36-months was higher in AVNA patients (hazard ratio: 3.81, 95% confidence interval: 2.33-6.23, p < .001). Intermittent loss of capture occurred in three AVNA patients (1.6%), all were within 30 days of implant and required system revision. There were no device macrodislodgements or unexpected device malfunctions.

Conclusion: Concomitant AVN ablation and leadless pacemaker implant is feasible. Pacing thresholds are stable over time. However, patient comorbidities and the risk of major complications are higher in patients undergoing AVNA.

Trial registration: ClinicalTrials.gov NCT02536118 NCT02488681 NCT02004873.

Keywords: AV node ablation; Micra; leadless pacemaker.

© 2021 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals LLC.

Figures

Figure 1
Figure 1
Maximum weekly pacing capture thresholds in patients with concomitant atrioventricular nodal ablation following implant procedure. Mean pacing capture thresholds standardized to a pulse duration of 0.24 ms. Gray shaded area represents 10th–90th percentile intervals. N values represent the number of patients with data available at each timepoint
Figure 2
Figure 2
Electrical performance over time by concomitant atrioventricular nodal ablation status. (A) Pacing capture thresholds standardized to a pulse duration of 0.24 ms. (B) Impedance. Error bars represent the standard deviation. n values represent the number of patients with data available at each timepoint
Figure 3
Figure 3
Major complication rates through 36‐months postimplant for patients with and without concomitant atrioventricular nodal ablation. (A) Unadjusted (univariate) comparison. (B) Comparison adjusted for differences in baseline characteristics using overlap weights. HR = hazard ratio from Cox model. CI = confidence interval
Figure 4
Figure 4
System revision rates for any reason through 36‐months postimplant for patients with and without concomitant atrioventricular nodal ablation. (A) Unadjusted (univariate) comparison. (B) Comparison adjusted for differences in baseline characteristics using overlap weights. HR = hazard ratio from Cox model. CI = confidence interval

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