Sun Xinghe, Zhao Yifei, Li Yan
Department of Cardiology, Peking University International Hospital, Life Park Road No.1, Life Science Park of Zhongguancun, Chang Ping District, Beijing, 102206, China.
Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing, 100022, China.
BMC Cardiovasc Disord. 2025 Jan 10;25(1):11. doi: 10.1186/s12872-025-04471-8.
The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes.
A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related to MitraClip implantation from October 2013 to September 2023. Duplicate reports and records from unrelated sources were excluded. The Cochran-Armitage test was performed to evaluate trends in the proportion of fatal events over time.
During the 10-year period following FDA approval, the MAUDE database recorded a total of 927 death reports and 9,211 injury reports associated with MitraClip. After excluding duplicates and irrelevant reports, 592 death cases were analyzed. The most commonly reported complications were MR (26.69%), tissue damage (24.16%), and hypotension (22.13%). The most frequent device-related issues were incomplete coaptation (14.70%), difficulty removing the divice (6.42%), and failure to adhere or bond/positioning failure(4.90%). Notably, 76.94% of deaths occurred within one year of implantation. The proportion of fatal events demonstrated a gradual decline, from 15.9% in 2014-2015 to 3.5% in 2020-2021 (p < 0.0001).
This analysis of the MAUDE database indicates a gradual decline in the proportion of fatal events associated with MitraClip implantation, which may be attributed to growing operator experience and advancements in device design. Nonetheless, persistent focus is required on managing complications and addressing potential risks to further enhance device performance and optimize its clinical utility.
经导管缘对缘修复（TEER）技术，由MitraClip装置辅助，是一种为二尖瓣反流（MR）高危患者设计的微创干预措施。本研究利用美国食品药品监督管理局（FDA）的制造商和用户设施设备经验（MAUDE）数据库的数据，对十年间与MitraClip植入相关的死亡事件进行回顾性分析，以评估安全结果的趋势。
对公开可用的MAUDE数据库进行全面搜索，以检索2013年10月至2023年9月期间与MitraClip植入相关的死亡和伤害报告。排除重复报告和来自无关来源的记录。进行 Cochr an - Armitage检验以评估致命事件比例随时间的趋势。
在FDA批准后的10年期间，MAUDE数据库记录了总共927份与MitraClip相关的死亡报告和9211份伤害报告。排除重复和无关报告后，分析了592例死亡病例。最常报告的并发症是二尖瓣反流（26.69%）、组织损伤（24.16%）和低血压（22.13%）。最常见的与设备相关的问题是不完全贴合（14.70%）、取出装置困难（6.42%）以及未能粘附或粘结/定位失败（4.90%）。值得注意的是，76.94%的死亡发生在植入后一年内。致命事件的比例呈逐渐下降趋势，从2014 - 2015年的15.9%降至2020 - 2021年的3.5%（p < 0.0001）。
对MAUDE数据库的这项分析表明，与MitraClip植入相关的致命事件比例逐渐下降，这可能归因于操作人员经验的增加和设备设计的进步。尽管如此，仍需要持续关注并发症的管理和潜在风险的解决，以进一步提高设备性能并优化其临床效用。
