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1.
5 p, 202.6 KB 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
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. [...]
2017 - 10.1016/j.hrthm.2017.05.017
Heart Rhythm, Vol. 14 Núm. 9 (september 2017) , p. 1375-1379  
2.
8 p, 562.2 KB 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
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. [...]
2018 - 10.1016/j.hrthm.2018.08.005
Heart Rhythm, Vol. 15 Núm. 12 (december 2018) , p. 1800-1807  

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