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A prospective, multicenter, single-arm study of performance of the micra transcatheter pacemaker in chinese patients: A comparison to the global experience
Keping Chen1, Shu Zhang1, Liqun Wu2, Xingbin Liu3, Yangang Su4, Yujie Zhou5, Jiangang Zou6, Jian-An Wang7, Meixiang Xiang7, Chengjun Guo5, Xuejun Ren5, Xiaofeng Hou6, Shufeng Liu8, Ming Zhang9, Dedra H Fagan8, Kejiang Cao6
1 Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
2 Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
3 Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
4 Department of Cardiology, Shanghai Zhongshan Hospital, Shanghai, China
5 Beijing Anzhen Hospital, Capital Medical University, Beijing, China
6 Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China
7 Department of Cardiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
8 Medtronic, Inc., Minneapolis, MN, USA
9 Medtronic (Shanghai) Management Co., Ltd., Shanghai, China
Correspondence Address:
Dr. Shu Zhang
Fuwai Hospital CAMS and PUMC, No. 167, Belishi Road, Xicheng District, Beijing
China
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijhr.ijhr_4_21
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Background: We have compared the patient characteristics and safety and efficacy results of the Micra transcatheter pacemaker from the China Micra Transcatheter Pacing Study with those from the global trials. Subjects and Methods: In this prospective, multicenter, single-arm study, patients with a class I or II guideline recommendation for single-chamber pacemaker therapy were enrolled from seven centers in China between July 30, 2018, and December 12, 2018. The primary outcome measure of this study was freedom from system- or procedure-related major complications through 6 months postimplantation (prespecified performance goal 83%). Patient baseline characteristics and major complications were compared with data from the global trials. Performance after medically indicated magnetic resonance imaging (MRI) scans was characterized. The study was approved by the ethics committee at each participating center and registered with ClinicalTrials.gov (Identifier: NCT03624504). Results: Implantation was successful in 81 of 82 (98.8%) patients with a mean follow-up of 8.7 ± 1.5 months. Chinese patients who had lower body mass index were more often female, and less frequently had a pacing indication associated with atrial fibrillation (AF) compared with global patients. Through 6 months postimplantation, two major complications occurred, with a major complication-free rate of 97.6% (95% confidence interval: 90.6–99.4%), exceeding the primary endpoint performance goal (P = 0.002). The major complication rate was in line with rates from the Micra investigational trial and Post-Approval Registry (2.4% vs. 3.7% and 2.9%, respectively, P = 0.50). Among 14 patients who underwent 3T MRI scans, electrical performance was stable with mean pre- and post-MRI pacing thresholds of <0.5 V. No MRI-related device performance issues were observed. Conclusion: In the hands of new operators in China, the Micra pacemaker was implanted successfully with a very low complication rate. Although Chinese Micra patients were on average of smaller stature and the majority had a pacing indication not associated with AF, Micra performance was excellent and in line with the global trial experience.
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