A Predictive Model for the Long-Term Electrical Performance of a Leadless Transcatheter Pacemaker.

OBJECTIVES

This study sought to formulate a predictive model for describing the long-term electrical performance of Micra (Medtronic, Mounds View, Minnesota).

BACKGROUND

The Micra leadless pacemaker is an alternative ventricular pacing option that avoids the pitfalls of transvenous leads. However, well-defined metrics to predict the long-term electrical performance of the device are lacking.

METHODS

We identified all patients who underwent successful Micra implantation enrolled in the investigational device exemption study, continued access study, or post-approval registry with complete 1-year post-implantation data or system revision due to elevated thresholds (N = 1,843). The analysis endpoint was an elevated pacing capture threshold (PCT) at ≥12 months post-implantation, defined as ≥2.0 V at 0.24 ms or an increase of ≥1.5 V from implantation or need for system revision due to elevated thresholds at ≤12 months post-implantation. We evaluated for univariate and multivariate associations between patient and device characteristics at implantation and for elevated thresholds at 12 months.

RESULTS

Among the total cohort, 75 patients (4.1%) had elevated thresholds at 12 months; of these, 13 required system revisions. Predictors associated with elevated thresholds in univariate analysis included the total number of deployments (excluded from the multivariable model), impedance and PCT at implantation, male sex, history of diabetes, and ischemic cardiomyopathy. Multivariable regression modeling found that male sex, history of diabetes, implantation PCT of ≥2 V, and impedance of <800 Ω were independent predictors of elevated PCT at 12 months (all p < 0.05).

CONCLUSION

A history of diabetes, male sex, elevated PCT, and low impedance at implantation were independent predictors of elevated thresholds at 12 months. These metrics represent the foundation of a simple tool to aid in procedural decision making.

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Ms. Wallace is an employee and shareholder of Medtronic. Mr. Stromberg is an employee and shareholder of Medtronic. Dr. Piccini is supported by R01HL128595 from the National Heart, Lung, and Blood Institute; receives grants for clinical research from Abbott, the American Heart Association, Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips; and serves as a consultant to Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, Myokardia, Sanofi, Philips, and UpToDate. Dr. Roberts has received honoraria from Medtronic. Dr. El-Chami has served as a consultant for Medtronic and Boston Scientific. Dr. Soejima has received honoraria for lecturing with Medtronic, Japan and Abbott, Japan. Dr. Garweg has received research funding from Biotronik, Boston Scientific, and Medtronic; and has received speaker fees and consultancy fees from Medtronic; Boston Scientific, and Biotronik. Dr. Fagan is an employee and shareholder of Medtronic. Dr. Lloyd has provided consulting and research support to Medtronic; and has provided research support to Boston Scientific. Dr. Kiani has reported that he has no relationships relevant to the contents of this paper to disclose.