First European experience with a leadless atrial pacemaker

Background: Leadless pacemakers (LPs) can reduce long-term complications compared with conventional devices. However, previous studies have primarily focused on single chamber right ventricular LPs. Objective: This study aimed to evaluate the implantation, safety, and device performance characterist...

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Main Authors: Elia von Felten, MD, Alexander Breitenstein, MD, Andreas Müller, MD, Caroline Wiederkehr, Theresa Brix, MD, Raban Jeger, MD, Daniel Hofer, MD
Format: Article
Language:English
Published: Elsevier 2025-08-01
Series:Heart Rhythm O2
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Online Access:http://www.sciencedirect.com/science/article/pii/S2666501825001618
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author Elia von Felten, MD
Alexander Breitenstein, MD
Andreas Müller, MD
Caroline Wiederkehr
Theresa Brix, MD
Raban Jeger, MD
Daniel Hofer, MD
author_facet Elia von Felten, MD
Alexander Breitenstein, MD
Andreas Müller, MD
Caroline Wiederkehr
Theresa Brix, MD
Raban Jeger, MD
Daniel Hofer, MD
author_sort Elia von Felten, MD
collection DOAJ
description Background: Leadless pacemakers (LPs) can reduce long-term complications compared with conventional devices. However, previous studies have primarily focused on single chamber right ventricular LPs. Objective: This study aimed to evaluate the implantation, safety, and device performance characteristics in a first real-world European use of an active fixation atrial LP for either dual chamber or single chamber pacing. Methods: For this prospective, single-center, single-operator analysis, we included consecutive patients undergoing implantation of an active fixation atrial LP either as a standalone therapy or as part of a dual chamber LP system. Results: Of the 45 included patients, 22 (48.9%) underwent de novo dual chamber, 9 (20%) an upgrade from ventricular single chamber to dual chamber, and 14 (31.1%) an atrial single chamber LP implantation. All implantations were successful and without the need for device repositioning. The median procedure time was 35 minutes (interquartile range 30–40), and complications occurred in 2 patients (4.4%) who developed pericardial effusions. Sensing, impedance, and stimulation thresholds of the atrial and ventricular device remained stable or improved over a median follow-up of 21 days. Median implant-to-implant throughput was 88% for atrial-to-ventricular and 87% for ventricular-to-atrial. The estimated median battery life of the atrial device was significantly higher in single chamber vs dual chamber settings (11.9 years vs 5.8 years, P < .001). Conclusion: Our first real-world European experience demonstrates that leadless atrial pacemaker implantation can be performed efficiently and safely, with satisfactory device measurements during the early follow-up period.
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spelling doaj-art-5447b89466c04a749ed49cd98ba2a70a2025-08-24T05:14:43ZengElsevierHeart Rhythm O22666-50182025-08-01681062106910.1016/j.hroo.2025.05.011First European experience with a leadless atrial pacemakerElia von Felten, MD0Alexander Breitenstein, MD1Andreas Müller, MD2Caroline Wiederkehr3Theresa Brix, MD4Raban Jeger, MD5Daniel Hofer, MD6Department of Cardiology, Triemli Hospital Zürich, Zürich, SwitzerlandDepartment of Cardiology, University Heart Center, University Hospital Zürich, Zürich, SwitzerlandDepartment of Cardiology, Triemli Hospital Zürich, Zürich, SwitzerlandDepartment of Cardiology, Triemli Hospital Zürich, Zürich, SwitzerlandDepartment of Cardiology, Triemli Hospital Zürich, Zürich, SwitzerlandDepartment of Cardiology, Triemli Hospital Zürich, Zürich, Switzerland; University of Basel, Basel, SwitzerlandDepartment of Cardiology, Triemli Hospital Zürich, Zürich, Switzerland; Department of Cardiology, University Heart Center, University Hospital Zürich, Zürich, Switzerland; Address reprint requests and correspondence: Dr Daniel Hofer, Department of Cardiology, Triemli Hospital Zürich, Birmensdorferstrasse 497, 8055 Zürich.Background: Leadless pacemakers (LPs) can reduce long-term complications compared with conventional devices. However, previous studies have primarily focused on single chamber right ventricular LPs. Objective: This study aimed to evaluate the implantation, safety, and device performance characteristics in a first real-world European use of an active fixation atrial LP for either dual chamber or single chamber pacing. Methods: For this prospective, single-center, single-operator analysis, we included consecutive patients undergoing implantation of an active fixation atrial LP either as a standalone therapy or as part of a dual chamber LP system. Results: Of the 45 included patients, 22 (48.9%) underwent de novo dual chamber, 9 (20%) an upgrade from ventricular single chamber to dual chamber, and 14 (31.1%) an atrial single chamber LP implantation. All implantations were successful and without the need for device repositioning. The median procedure time was 35 minutes (interquartile range 30–40), and complications occurred in 2 patients (4.4%) who developed pericardial effusions. Sensing, impedance, and stimulation thresholds of the atrial and ventricular device remained stable or improved over a median follow-up of 21 days. Median implant-to-implant throughput was 88% for atrial-to-ventricular and 87% for ventricular-to-atrial. The estimated median battery life of the atrial device was significantly higher in single chamber vs dual chamber settings (11.9 years vs 5.8 years, P < .001). Conclusion: Our first real-world European experience demonstrates that leadless atrial pacemaker implantation can be performed efficiently and safely, with satisfactory device measurements during the early follow-up period.http://www.sciencedirect.com/science/article/pii/S2666501825001618Leadless pacemakerAtrialHelix fixationDual chamber pacemakerImplant procedurePacemaker complications
spellingShingle Elia von Felten, MD
Alexander Breitenstein, MD
Andreas Müller, MD
Caroline Wiederkehr
Theresa Brix, MD
Raban Jeger, MD
Daniel Hofer, MD
First European experience with a leadless atrial pacemaker
Heart Rhythm O2
Leadless pacemaker
Atrial
Helix fixation
Dual chamber pacemaker
Implant procedure
Pacemaker complications
title First European experience with a leadless atrial pacemaker
title_full First European experience with a leadless atrial pacemaker
title_fullStr First European experience with a leadless atrial pacemaker
title_full_unstemmed First European experience with a leadless atrial pacemaker
title_short First European experience with a leadless atrial pacemaker
title_sort first european experience with a leadless atrial pacemaker
topic Leadless pacemaker
Atrial
Helix fixation
Dual chamber pacemaker
Implant procedure
Pacemaker complications
url http://www.sciencedirect.com/science/article/pii/S2666501825001618
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