Long-term Performance of a Transcatheter Pacing System: 12 month results from the Micra Transcatheter Pacing Study

• Published in: Heart rhythm Vol. 14; no. 5; pp. 702 - 709
• Main Authors: Duray, Gabor Z., MD, PhD, Ritter, Philippe, MD, El-Chami, Mikhael, MD, FHRS, Narasimhan, Calambur, MD, Omar, Razali, MD, FHRS, Tolosana, Jose M., MD, PhD, Zhang, Shu, MD, FHRS, Soejima, Kyoko, MD, Steinwender, Clemens, MD, Rapallini, Leonardo, MScEng, Cicic, Aida, MD, Fagan, Dedra H., PhD, Liu, Shufeng, MS, Reynolds, Dwight, MD, FHRS
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2017
• Subjects: Aged; Arrhythmias, Cardiac - therapy; Cardiac Catheters; Cardiac Pacing, Artificial - adverse effects; Cardiovascular; Equipment Design; Equipment Failure Analysis; Female; Follow-Up Studies; Humans; Leadless transcatheter pacing; Long-term performance; Male; Pacemaker, Artificial - adverse effects; Patient Safety; Prospective Studies; Prosthesis Failure; Transcatheter pacemaker; Treatment Outcome; long-term results; Transcatheter pacemaker; leadless pacing; Leadless transcatheter pacing; Long-term performance
• ISSN: 1547-5271; 1556-3871
• DOI: 10.1016/j.hrthm.2017.01.035

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 pre-specified long-term safety objective of Micra at 12 months and electrical performance through 24 months are reported. 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 indications for de novo ventricular pacing. The long-term safety objective was freedom from a system or procedure related major complication at 12 months. A pre-defined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates. Results The long-term safety objective was met with a freedom from major complication rate of 96.0% at 12 months (95% CI: 94.2%-97.2%, P<0.0001 versus performance goal). The risk of major complications for Micra patients (N=726) was 48% lower than for transvenous patients through 12-months post-implant (HR: 0.52, 95% CI: 0.35-0.77, P=0.001). 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 projected battery longevity of 12.1 years. Conclusions Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months follow-up, and all patient subgroups benefited as compared to a transvenous pacemaker historical control group.