A leadless pacemaker in the real-world setting : The Micra Transcatheter Pacing System Post-Approval Registry
Roberts, Paul R. (Southampton General Hospital-University Hospital Southampton NHS Foundation Trust)
Clementy, Nicolas (Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau)
Al Samadi, Faisal (King Salman Heart Center-King Fahad Medical City)
Garweg, Christophe (Universitaire ziekenhuizen Leuven-Campus Gasthuisberg)
Martinez-Sande, Jose Luis (Hospital Clínico Universitario (Santiago de Compostela, Galícia))
Iacopino, Saverio (Maria Cecilia Hospital)
Johansen, Jens Brock (Odense University Hospital (Dinamarca))
Viñolas, Xavier (Institut d'Investigació Biomèdica Sant Pau)
Kowal, Robert C. (Medtronic)
Klug, Didier (Centre Hospitalier Régional Universitaire de Lille)
Mont, Lluis (Hospital Clínic i Provincial de Barcelona)
Steffel, Jan (Universitats Spital Zürich)
Shelby, Li (Medtronic)
Van Osch, Dirk (Medtronic Bakken Research Center)
El-Chami, Mikhael F. (Emory University)
Universitat Autònoma de Barcelona

Date:	2017
Abstract:	First-in-man studies of leadless pacemakers have demonstrated high rates of implant success, and safety and efficacy objectives were achieved. Outside of the investigational setting, there are concerns, particularly over cardiac effusion and perforation, device dislodgement, infection, telemetry, and battery issues. The acute performance of the Micra transcatheter pacemaker from a worldwide Post-Approval Registry is reported. The registry is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of Micra in the post-approval setting. The safety end point was system- or procedure-related major complications at 30 days post implant. We compared the major complication rate with that of the 726 patients from the investigational study. Electrical performance was also characterized. The device was successfully implanted in 792 of 795 registry patients (99. 6%) by 149 implanters at 96 centers in 20 countries. Through 30 days post implant, a total of 13 major complications occurred in 12 patients, for a major complication rate of 1. 51% (95% confidence interval, 0. 78%-2. 62%). Major complications included cardiac effusion/perforation (1, 0. 13%), device dislodgement (1, 0. 13%), and sepsis (1, 0. 13%). After adjusting for baseline differences, the rate of major complications in the registry trended lower than the investigational trial (odds ratio, 0. 58, 95% confidence interval, 0. 27-1. 25; P =. 16). Early pacing capture thresholds were low and stable. Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high rate (99. 6%) of implant success and low rate (1. 51%) of major complications through 30 days post implant. In particular, the rates of pericardial effusion, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Acute performance ; Leadless pacemaker ; Real-world performance
Published in:	Heart Rhythm, Vol. 14 Núm. 9 (september 2017) , p. 1375-1379, ISSN 1556-3871

DOI: 10.1016/j.hrthm.2017.05.017
PMID: 28502871

5 p, 202.6 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
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