Khalid Nauman, Rogers Toby, Shlofmitz Evan, Chen Yuefeng, Musallam Anees, Khan Jaffar M, Iantorno Micaela, Gajanana Deepakraj, Hashim Hayder, Torguson Rebecca, Bernardo Nelson, Waksman Ron
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute National Institutes of Health, Bethesda, MD, United States of America.
Cardiovasc Revasc Med. 2019 Jun;20(6):503-506. doi: 10.1016/j.carrev.2019.03.010. Epub 2019 Mar 16.
BACKGROUND/PURPOSE: Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints.
MATERIALS/METHODS: The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis.
In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%).
Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF.
背景/目的：右心室（RV）机械循环支持仍然是药物治疗难治性RV衰竭的重要辅助治疗方法。Impella RP（美国马萨诸塞州丹弗斯市的Abiomed公司生产）已获批准用于为急性右心衰竭患者或在植入左心室辅助装置、心肌梗死、心脏移植或心脏直视手术后出现失代偿的患者提供临时RV支持。目前缺乏关于Impella RP最常见报告并发症和故障模式的有力数据。我们分析了美国食品药品监督管理局（FDA）制造商和用户设施设备经验（MAUDE）数据库中的上市后监测数据，以评估这些终点。
材料/方法：通过搜索以下事件类型，查询MAUDE数据库在2009年1月1日至2018年12月31日期间的Impella设备：“损伤”、“故障”、“死亡”和“其他”。搜索产生了436份设备报告。对Impella RP医疗器械报告进行筛选，最终纳入35份报告进行分析。
在报告的并发症病例中，Impella RP最常用于心脏切开术后发生右心室衰竭（RVF）的患者（20%）。最常报告的并发症包括出血（42.9%）和血管并发症（22.8%）。故障模式包括设备元件损坏或断裂（34.2%）；系统中的血栓或凝块（17.1%）；以及设备脱离（8.6%）。
MAUDE数据库的研究结果突出了Impella RP设备的故障模式，为改善设备性能并在用于RVF时获得更好的临床结果，应解决这些故障模式。
