Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry.

Autor:	El-Chami MF; Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, Georgia., Garweg C; Department of Cardiovascular Sciences, Universitaire Ziekenhuizen Leuven, Leuven, Belgium., Clementy N; Department of Cardiologic Medicine, Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau, Tours, France., Al-Samadi F; Department of Medicine, King Salman Heart Center-King Fahad Medical City, Riyadh, Saudi Arabia., Iacopino S; Department of Clinical Electrophysiology & Cardiac Pacing, Centro Cardiologico Monzino, IRCCS, Department of Biomedical, Surgical, and Dental Sciences, University of Milan, Milan, Italy., Martinez-Sande JL; Arrhythmia Unit, Cardiology Service, University Clinical Hospital of Santiago de Compostela, CIBER-CV, IDIS, Santiago de Compostela, Spain., Roberts PR; Department of Medicine, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom., Tondo C; Monzino Cardiac Center, IRCCS, Department of Clinical Sciences and Community, University of Milan, Milan, Italy., Johansen JB; Department of Cardiology, Odense University Hospital, Odense, Denmark., Vinolas-Prat X; Arrhythmia Unit, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain., Cha YM; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA., Grubman E; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT, USA., Bordachar P; Cardio-Thoracic Unit, Bordeaux University Hospital, Pessac-Bordeaux, France., Stromberg K; Medtronic, Inc., Mounds View, MN, USA., Fagan DH; Medtronic, Inc., Mounds View, MN, USA., Piccini JP; Electrophysiology Section, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Jazyk:	angličtina
Zdroj:	European heart journal [Eur Heart J] 2024 Apr 07; Vol. 45 (14), pp. 1241-1251.
DOI:	10.1093/eurheartj/ehae101
Abstrakt:	Background and Aims: Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. Methods: All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine-Gray competing risk models. Results: 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR: 21.6-64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI): 3.6%-5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR: .47, 95% CI: .36-.61; P < .001). The all-cause system revision rate at 60 months was 4.9% (95% CI: 3.9%-6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P < .001). Conclusions: Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection. (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
Databáze:	MEDLINE
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