Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.
Department of Cardiology, Georgetown University School of Medicine, Washington, District of Columbia.
Catheter Cardiovasc Interv. 2021 Sep;98(3):572-577. doi: 10.1002/ccd.29501. Epub 2021 Feb 4.
We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott).
Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited.
Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports.
Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group.
Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.
我们分析了美国食品和药物管理局（FDA）制造商和用户设施设备体验（MAUDE）数据库的上市后监测数据，该数据库用于缝线式血管闭合装置（VCD）- Perclose ProGlide（雅培，芝加哥，伊利诺伊州）和 Prostar XL（雅培）。
缝线式 VCD 主要用于大口径股动脉入路部位的闭合。与这些设备相关的最常见并发症和故障模式的实际、当代经验有限。
我们分析了 FDA MAUDE 数据库中的上市后监测数据，涉及 ProGlide 系统和 Prostar XL 系统，得出 827 份 Perclose ProGlide 报告和 175 份 Prostar XL 报告。
在涉及 Perclose ProGlide 装置的 827 份重大并发症报告中，有 404 份报告涉及与装置相关的损伤，1 份报告涉及与装置相关的死亡。在 Prostar XL 分析中，有 94 份报告涉及损伤，1 份报告涉及死亡。血管损伤引起的出血是两种装置最常见的不良后果，其次是血肿和血栓形成。手术修复是最常用的治疗策略。就装置故障而言，缝线相关故障（212 份报告）在 Perclose ProGlide 组中最常见，而在 Prostar XL 组中最常见的是装置部署失败。
我们对 MAUDE 数据库的分析表明，在实际实践中，缝线式 VCD 与并发症相关，包括血管损伤、装置本身的困难，甚至死亡。持续的用户教育和术前患者选择对于最大限度地降低缝线式血管闭合装置相关风险非常重要。
