Updated performance of the Micra transcatheter pacemaker in the real-world setting : A comparison to the investigational study and a transvenous historical control
El-Chami, Mikhael F. (Emory University)
Al-Samadi, Faisal (King Salman Heart Center - King Fahad Medical City)
Clementy, Nicolas (Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau)
Garweg, Christophe (Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg)
Martinez-Sande, Jose Luis (Hospital Clínico Universitario (Santiago de Compostela, Galícia))
Piccini, Jonathan P. (Duke University Medical Center)
Iacopino, Saverio (Maria Cecelia Hospital)
Lloyd, Michael (Emory University)
Viñolas, Xavier (Institut d'Investigació Biomèdica Sant Pau)
Jacobsen, Michael Dilou (University of Copenhagen)
Ritter, Philippe (Université Bordeaux)
Johansen, Jens Brock (Odense University Hospital (Dinamarca))
Tondo, Claudio (University of Milan)
Liu, Fang (Medtronic. plc)
Fagan, Dedra H. (Medtronic. plc)
Eakley, Alyssa K. (Medtronic. plc)
Roberts, Paul R. (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Universitat Autònoma de Barcelona

Date:	2018
Abstract:	Early results of the Micra Investigational Device Exemption (IDE) study and Micra Post-Approval Registry (PAR) demonstrated excellent safety and efficacy performance; however, intermediate-term results across a large patient population in the real-world setting have not been evaluated. We report updated performance of the Micra transcatheter pacemaker from a worldwide PAR and compare it with the IDE study as well as a transvenous historical control. The safety objective of the analysis was system- or procedure-related major complications through 12 months postimplantation. We compared the major complication rate with that of the 726 patients from the IDE and with a reference data set of 2667 patients with transvenous pacemakers by using a Fine-Gray competing risk model. The Micra device was successfully implanted in 1801 of 1817 patients (99. 1%). The mean follow-up period was 6. 8 ± 6. 9 months. Through 12 months, the major complication rate was 2. 7% (95% confidence interval [CI] 2. 0%-3. 7%). The risk of major complications for Micra PAR patients was 63% lower than that for patients with transvenous pacemakers through 12 months postimplantation (hazard ratio 0. 37; 95% CI 0. 27-0. 52; P <. 001). The major complication rate trended lower in the PAR than in the IDE study (hazard ratio 0. 71; 95% CI 0. 44-1. 1; P =. 160), driven by the lower pericardial effusion rate in the PAR. There were 3 cases of infection associated with the procedure, but none required device removal and there were no battery or telemetry issues. Pacing thresholds were low and stable through 12 months postimplantation. Performance of the Micra transcatheter pacemaker in international clinical practice remains consistent with previously reported data. Major complications were infrequent and occurred 63% less often compared to transvenous systems. Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials. gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials. gov identifier: NCT02004873.
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:	Leadless pacing ; Real-world performance ; Transcatheter pacemaker ; Transvenous pacemaker ; Updated results
Published in:	Heart Rhythm, Vol. 15 Núm. 12 (december 2018) , p. 1800-1807, ISSN 1556-3871

DOI: 10.1016/j.hrthm.2018.08.005
PMID: 30103071

8 p, 562.2 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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