Khalid Nauman, Javed Hasan, Ahmad Sarah Aftab, Edelman J James, Shlofmitz Evan, Chen Yuefeng, Musallam Anees, Rogers Toby, Hashim Hayder, Bernardo Nelson L, Waksman Ron
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.
Department of Cardiovascular Surgery, Saint Francis Medical Center, Monroe, LA, United States of America.
Cardiovasc Revasc Med. 2020 Feb;21(2):230-234. doi: 10.1016/j.carrev.2019.11.011. Epub 2019 Nov 20.
BACKGROUND/PURPOSE: We assessed commonly reported patient- and circuit-related adverse events involving extracorporeal membrane oxygenation (ECMO) devices by analyzing post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. ECMO is a rescue therapy for critically ill patients requiring oxygenation and cardiopulmonary support. Key configurations include veno-venous (VV) ECMO for respiratory support and veno-arterial (VA) ECMO for cardio-respiratory support. Robust data on the most commonly reported complications associated with ECMO therapy are limited.
METHODS/MATERIALS: The MAUDE database was queried from January 1, 2009, through March 31, 2019, yielding 93 reports. After excluding duplicate reports, 82 reports were included in the final analysis.
Percentages represent the proportion of total submitted MAUDE reports on ECMO. Of the reported cases, 24 were VV-ECMO, 8 were VA-ECMO, and the remainder were unspecified. The most commonly reported patient-related adverse events included hemodynamic decompensation of patients (12.2%), death (12.2%), atrial perforation (7.3%), and bleeding (7.3%). The most commonly reported failure modes were in the following circuit components: mechanical pump (19.5%, mostly due to technical failure or clots), membrane oxygenator (19.5%, mostly due to tear in the membrane or temperature probe), and access cannulae (18.3%, mostly due to structural damage).
Analysis of the MAUDE database demonstrates that in real-world practice, ECMO devices are associated with important complications. With broadened global utilization of ECMO devices, standard complication and failure reporting policies may improve patient selection, operator proficiency, and existing device technology.
An analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience database demonstrates that in real-world practice, extracorporeal membrane oxygenation devices are associated with serious complications. The most commonly reported patient-related adverse events were hemodynamic decompensation of patients and death, and the most commonly reported failure modes were in the device's mechanical pump and membrane oxygenator.
背景/目的：我们通过分析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）数据库的上市后监测数据，评估了体外膜肺氧合（ECMO）设备常见的与患者及回路相关的不良事件。ECMO是一种用于需要氧合和心肺支持的重症患者的挽救性治疗方法。关键配置包括用于呼吸支持的静脉-静脉（VV）ECMO和用于心肺支持的静脉-动脉（VA）ECMO。关于ECMO治疗最常见并发症的可靠数据有限。
方法/材料：查询了MAUDE数据库2009年1月1日至2019年3月31日期间的数据，得到93份报告。排除重复报告后，最终分析纳入82份报告。
百分比表示提交的关于ECMO的MAUDE报告总数的比例。在报告的病例中，24例为VV-ECMO，8例为VA-ECMO，其余未明确说明。最常报告的与患者相关的不良事件包括患者血流动力学失代偿（12.2%）、死亡（12.2%）、心房穿孔（7.3%）和出血（7.3%）。最常报告的故障模式发生在以下回路组件中：机械泵（19.5%，主要由于技术故障或血栓）、膜式氧合器（19.5%，主要由于膜撕裂或温度探头问题）和接入插管（18.3%，主要由于结构损坏）。
对MAUDE数据库的分析表明，在实际应用中，ECMO设备与重要并发症相关。随着ECMO设备在全球的广泛使用，标准的并发症和故障报告政策可能会改善患者选择、操作人员的熟练程度以及现有的设备技术。
对美国食品药品监督管理局制造商和用户设施设备经验数据库的分析表明，在实际应用中，体外膜肺氧合设备与严重并发症相关。最常报告的与患者相关的不良事件是患者血流动力学失代偿和死亡，最常报告的故障模式发生在设备的机械泵和膜式氧合器中。
