Six-month electrical performance of the first dual-chamber leadless pacemaker
Language English Country United States Media print-electronic
Document type Journal Article
PubMed
38697271
DOI
10.1016/j.hrthm.2024.04.091
PII: S1547-5271(24)02525-6
Knihovny.cz E-resources
- Keywords
- Aveir DR, Chronic pacing, Dual chamber, Helix fixation, Leadless pacemaker, Pacing capture threshold, Sensed amplitude,
- MeSH
- Atrioventricular Block therapy physiopathology MeSH
- Time Factors MeSH
- Equipment Design * MeSH
- Cardiac Pacing, Artificial * methods MeSH
- Pacemaker, Artificial * MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Aged MeSH
- Heart Ventricles physiopathology MeSH
- Sick Sinus Syndrome therapy physiopathology MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: The first dual-chamber leadless pacemaker (DC-LP) system consists of 2 separate atrial and ventricular devices that communicate to maintain synchronous atrioventricular pacing and sensing. The initial safety and efficacy were previously reported. OBJECTIVE: The purpose of this study was to evaluate the chronic electrical performance of the DC-LP system. METHODS: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with the DC-LP system (Aveir DR, Abbott), including right atrial and ventricular helix-fixation LPs (atrial leadless pacemaker [ALP], ventricular leadless pacemaker [VLP]). Pacing capture threshold, sensed amplitude, and pacing impedance were collected using the device programmer at prespecified timepoints from 0-6 months postimplant. RESULTS: De novo devices were successfully implanted in 381 patients with complete 6-month data (62% male; age 69 ± 14 years; weight 82 ± 20 kg; 65% sinus nodal dysfunction, 30% atrioventricular block). ALPs were implanted predominantly in the right atrial appendage anterior base and VLPs primarily at the mid-to-apical right ventricular septum. From implant to 1 month, pacing capture thresholds (0.4-ms pulse width) improved in both ALPs (2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.001) and VLPs (0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.001). Sensed amplitudes improved in both ALPs (1.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001) and VLPs (8.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001). Impedances were stable in ALPs (334 ± 68 Ω to 329 ± 52 Ω; P = .17) and reduced in VLPs (789 ± 351 Ω to 646 ± 190 Ω; P <.001). Electrical measurements remained relatively stable from 1-6 months postimplant. No differences in electrical metrics were observed among ALP or VLP implant locations. CONCLUSION: This first in-human evaluation of the new dual-chamber leadless pacemaker system demonstrated reliable electrical performance throughout the initial 6-month evaluation period.
Amsterdam UMC Amsterdam The Netherlands
Centre Hospitalier Universitaire Grenoble Alpes Grenoble France
Cleveland Clinic Foundation Cleveland Ohio
Deutsches Herzzentrum der Charite Berlin Germany
Foothills Medical Centre Calgary Canada
HonorHealth Cardiac Arrhythmia Group Scottsdale Arizona
Mount Sinai Fuster Heart Hospital New York New York
Na Homolce Hospital Prague Czech Republic
San Rossore Private Hospital and Medical Center Pisa Italy
South Denver Cardiology Littleton Colorado
Texas Cardiac Arrhythmia Institute Austin Texas
Tokyo Women's Medical University Tokyo Japan
Weill Cornell Medicine New York Presbyterian Hospital New York New York
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