对印度人群中与心脏支架相关的不良事件的回顾性研究。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-22 DOI:10.1080/17434440.2025.2456526
Sandeep Mewada, Shatrunajay Shukla, Maneesh Soni, Meenakshi Dahiya, Vivekanandan Kalaiselvan, Pooja Reddy, Avinash Singh Mandloi, Vipin Dhote
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引用次数: 0

摘要

背景:心脏支架用于治疗冠状动脉疾病,冠状动脉疾病是包括印度在内的世界范围内死亡的主要原因。我们调查了印度人群中与心脏支架相关的不良事件(ae)的频率和性质。方法:源数据由印度国家协调中心-物质警戒规划(NCC-MvPI)系统收集,匿名收集时间为2020 - 2022年。该数据库包含10,542例医疗器械不良事件报告,其中心脏支架占2,075例。这些报告经过精心收集、清理、分离和分析。结果:我们观察到93%与心脏支架相关的ae是严重的,最常见的是夹层,其次是胸痛、血栓形成和呼吸困难。然而,只有5%的报告导致死亡。此外,男性患者的不良反应发生率高于女性,老年患者在支架置入后的不良反应发生率更高。结论:该研究强调了在该领域继续研究的必要性,以确定与心脏支架相关的ae的根本原因,并制定有效的措施来减少这些发生率。未来的研究还可以关注于评估心脏支架患者的长期预后,以衡量不同类型支架的安全性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A retrospective study of reported adverse events associated with cardiac stents in Indian population.

Background: Cardiac stents are utilized to treat coronary artery diseases, a leading cause of death worldwide including in India. We investigated frequency and nature of adverse events (AEs) associated with cardiac stents in the Indian population.

Methods: The source data was systematically collected by National Coordination Centre-Materiovigilance programme of India (NCC-MvPI), anonymized from 2020 to 2022. The database contained 10,542 reports of medical devices adverse events, with cardiac stents accounting for 2,075 of these events. These reports were meticulously collected, cleaned, segregated, and analyzed.

Results: We observed that 93% AEs associated with cardiac stents were serious, with the most common being dissection followed by chest pain, thrombosis, and breathing difficulties. However, only 5% of reports resulted in death. Additionally, male patients experienced more AEs than female and elderly patients had a higher incidence of AEs after stent placement.

Conclusion: The study highlights the need for continued research in this area to identify the root cause of AEs associated with cardiac stents and develop effective measures to reduce these incidences. Future studies can also focus on evaluating the long-term outcomes of patients with cardiac stents to gauge safety and effectiveness of different stent types.

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