Mikhael F El-Chami1, Faisal Al-Samadi2, Nicolas Clementy3, Christophe Garweg4, Jose Luis Martinez-Sande5, Jonathan P Piccini6, Saverio Iacopino7, Michael Lloyd8, Xavier Viñolas Prat9, Michael Dilou Jacobsen10, Philippe Ritter11, Jens Brock Johansen12, Claudio Tondo13, Fang Liu14, Dedra H Fagan14, Alyssa K Eakley14, Paul R Roberts15. 1. Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, Georgia. Electronic address: melcham@emory.edu. 2. King Salman Heart Center - King Fahad Medical City, Riyadh, Saudi Arabia. 3. Department of Cardiologic Medicine, Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau, Tours, France. 4. Department of Cardiovascular Sciences, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium. 5. Unidad de Arritmias, Servicio de Cardiología, University Clinical Hospital of Santiago de Compostela, Santiago de Compostela, Spain. 6. Duke Center for Atrial Fibrillation, Duke University Medical Center, Durham, North Carolina. 7. Electrophysiology Unit, Arrhythmology Department, Maria Cecelia Hospital, Cotignola, Italy. 8. Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, Georgia. 9. Arrhythmia Unit, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain. 10. Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. 11. Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, Bordeaux, France. 12. Department of Cardiology, Odense University Hospital, Odense, Denmark. 13. Monzino Cardiac Center, IRCCS, Department of Clinical Sciences and Community, University of Milan, Milan, Italy. 14. Medtronic, plc, Mounds View, Minnesota. 15. University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
Abstract
BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.
BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.
Authors: Mohamed ElRefai; Mohamed Abouelasaad; Christina Menexi; John Morgan; Paul R Roberts Journal: J Interv Card Electrophysiol Date: 2022-04-23 Impact factor: 1.900
Authors: Soroosh Kiani; George B Black; Birju Rao; Nancy Thakkar; Christopher Massad; Akshar V Patel; Marvin Louis Roy Lu; Faisal M Merchant; Michael H Hoskins; David B De Lurgio; Anshul M Patel; Anand D Shah; Angel R Leon; Stacy B Westerman; Michael S Lloyd; Mikhael F El-Chami Journal: J Atr Fibrillation Date: 2019-06-30
Authors: Moghniuddin Mohammed; Juwairiya Arshi; Brian M Ramza; Alan P Wimmer; Daniel A Steinhaus; Michael J Giocondo; Sanjaya K Gupta; Omair K Yousuf Journal: Indian Pacing Electrophysiol J Date: 2020-03-04