Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study
| Autor: | Razali Omar, Mikhael F. El-Chami, José María Tolosana, Philippe Ritter, Shu Zhang, Shufeng Liu, Dedra H. Fagan, Leonardo Rapallini, Clemens Steinwender, Kyoko Soejima, Aida Cicic, Calambur Narasimhan, Dwight Reynolds, Gabor Z. Duray |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Pacemaker Artificial 030204 cardiovascular system & hematology Cardiac Catheters 03 medical and health sciences 0302 clinical medicine Physiology (medical) medicine Electrical performance Humans 030212 general & internal medicine Major complication Prospective Studies Aged business.industry Cardiac Pacing Artificial Arrhythmias Cardiac Guideline Equipment Design Confidence interval Surgery Transvenous pacemakers Prosthesis Failure Clinical trial Equipment Failure Analysis Treatment Outcome Intracardiac pacemaker Female Implant Patient Safety Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Heart rhythm. 14(5) |
| ISSN: | 1556-3871 |
| Popis: | 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.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.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.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.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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|