Sambommatsu Yuzuru, Imai Daisuke, Savsani Kush, Datta Mallika, Tarashi Junpei, Hallesy Jacob, Wolfe Samuel, Khan Aamir A, Lee Seung Duk, Sharma Amit, Saeed Muhammad, Kumaran Vinay, Cotterell Adrian H, Levy Marlon F, Bruno David A
Department of Surgery, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.
Department of Surgery, Division of Transplant Surgery, Hume- Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.
Clin Transplant. 2025 May;39(5):e70170. doi: 10.1111/ctr.70170.
Normothermic machine perfusion (NMP) has emerged as a promising technology in liver transplantation, but limited data exist regarding real-world implementation in the United States following FDA approval. We report our experience establishing an NMP program and share insights from our first 100 cases.
We retrospectively analyzed 100 consecutive liver NMP cases performed between July 2023 and May 2024 using the OrganOx Metra device. Program establishment required assembling a dedicated team, comprehensive training, establishing a dedicated perfusion facility, coordinating with multiple departments including laboratory, blood bank, electronic medical record vendors, and billing services, and developing institutional viability criteria.
Of 100 NMP cases, 92 proceeded to transplantation while eight were declined. Early allograft dysfunction occurred in 19 cases (20.7%) with no instances of primary non-function, and 90-day graft survival was 94.6%. No graft losses were directly attributable to NMP. Six grafts showed delayed lactate clearance but achieved successful outcomes with extended perfusion time. We systematically refined our protocols and developed standardized troubleshooting approaches to address various technical challenges including graft bleeding, arterial flow monitoring issues, persistent acidosis, and bile duct drainage issues.
Successful implementation of an NMP program requires careful preparation, dedicated staffing, and interdepartmental coordination. Although various challenges are expected in the initial phase of the program, these can be successfully managed with a systematic approach. Our experience provides practical guidance for centers planning to establish NMP programs.
常温机器灌注(NMP)已成为肝移植领域一项有前景的技术,但在美国食品药品监督管理局(FDA)批准后,关于其在现实世界中的应用数据有限。我们报告了我们建立NMP项目的经验,并分享了我们前100例病例的见解。
我们回顾性分析了2023年7月至2024年5月期间使用OrganOx Metra设备进行的100例连续肝脏NMP病例。项目建立需要组建一个专门的团队、进行全面培训、建立一个专门的灌注设施、与包括实验室、血库、电子病历供应商和计费服务在内的多个部门进行协调,并制定机构可行性标准。
在100例NMP病例中,92例进行了移植,8例被拒绝。19例(20.7%)发生早期移植物功能障碍,无原发性无功能病例,90天移植物存活率为94.6%。没有移植物丢失直接归因于NMP。6例移植物乳酸清除延迟,但通过延长灌注时间取得了成功结果。我们系统地完善了我们的方案,并开发了标准化的故障排除方法,以解决各种技术挑战,包括移植物出血、动脉血流监测问题、持续性酸中毒和胆管引流问题。
成功实施NMP项目需要精心准备、专门的人员配备和部门间的协调。尽管在项目的初始阶段会遇到各种挑战,但通过系统的方法可以成功应对。我们的经验为计划建立NMP项目的中心提供了实际指导。