Gabor Z Duray1, Philippe Ritter2, Mikhael El-Chami3, Calambur Narasimhan4, Razali Omar5, Jose M Tolosana6, Shu Zhang7, Kyoko Soejima8, Clemens Steinwender9, Leonardo Rapallini10, Aida Cicic10, Dedra H Fagan10, Shufeng Liu10, Dwight Reynolds11. 1. Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. Electronic address: gduray@yahoo.com. 2. Department of Cardiac Pacing and Electrophysiology, CHU/Université de Bordeaux, Pessac, France. 3. Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, Georgia. 4. CARE Hospitals, CARE Foundation, Hyderabad, India. 5. Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia. 6. Hospital Clinic, Universitat de Barcelona, Barcelona, Spain. 7. Fuwai Hospital, Beijing, China. 8. Department of Cardiology, Kyorin University Hospital, Tokyo, Japan. 9. Department of Cardiology, Kepler University Hospital, Linz, Austria; Paracelsus Medical University Salzburg, Salzburg, Austria. 10. Medtronic, plc, Mounds View, Minnesota. 11. Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, Oklahoma.
Abstract
BACKGROUND: Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months. OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months. METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates. RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years. CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
BACKGROUND: Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months. OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months. METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates. RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years. CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
Authors: Jonathan S Gordon; Elizabeth J Maynes; Thomas J O'Malley; Behzad B Pavri; Vakhtang Tchantchaleishvili Journal: J Interv Card Electrophysiol Date: 2021-01-12 Impact factor: 1.900
Authors: Clemens Steinwender; Hermann Blessberger; Daniel Kiblböck; Karim Saleh; Jürgen Kammler Journal: Herzschrittmacherther Elektrophysiol Date: 2018-11-19
Authors: Roshini S Asirvatham; Vaibhav R Vaidya; Trena M Thome; Paul A Friedman; Yong-Mei Cha Journal: J Interv Card Electrophysiol Date: 2019-11-14 Impact factor: 1.900