University Clinic for Visceral Surgery and Medicine, Inselspital University Hospital, University of Bern, Bern, Switzerland.
Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.
Liver Int. 2022 Oct;42(10):2247-2259. doi: 10.1111/liv.15337. Epub 2022 Jul 25.
Patients with cirrhotic refractory ascites ineligible for transjugular intrahepatic shunt (TIPSS) have limited treatment options apart from repeated large volume paracentesis. The alfapump® is an implantable device mobilizing ascites from the peritoneal cavity to the bladder, from where it can be excreted. The aim of this observational cohort study was to prospectively investigate safety and efficacy of the device in a real-world cohort with cirrhotic refractory ascites and contraindications for TIPSS.
A total of 106 patients received an implant at 12 European centres and were followed up for up to 24 months. Complications, device deficiencies, frequency of paracentesis, clinical status and survival were recorded prospectively.
Approximately half of the patients died on-study, about a quarter was withdrawn because of serious adverse events leading to explant, a sixth were withdrawn because of liver transplant or recovery, and nine completed follow-up. The most frequent causes of on-study death and complication-related explant were progression of liver disease and infection. The device reduced the requirement for large-volume paracentesis significantly, with more than half of patients not having required any post-implant. Survival benefits were not observed. Device-related reinterventions were predominantly caused by device deficiencies. A post-hoc comparison of the first 50 versus the last 50 patients enrolled revealed a decreased reintervention rate in the latter, mainly related to peritoneal catheter modifications.
The device reduced paracentesis frequency in a real-world setting. Technical complications were successfully decreased by optimization of management and device modification (NCT01532427).
对于不符合经颈静脉肝内分流术（TIPSS）条件的肝硬化难治性腹水患者，除了反复进行大量腹腔穿刺术外，治疗选择有限。 Alfapump®是一种可植入装置，可将腹水从腹腔转移到膀胱，然后从膀胱排出。本观察性队列研究的目的是前瞻性研究该设备在患有肝硬化难治性腹水且存在 TIPSS 禁忌证的真实世界队列中的安全性和疗效。
共有 106 名患者在 12 个欧洲中心接受了植入手术，并进行了长达 24 个月的随访。前瞻性记录并发症、器械缺陷、腹腔穿刺频率、临床状况和生存率。
大约一半的患者在研究期间死亡，约四分之一的患者因严重不良事件导致器械取出而退出，六分之一的患者因肝移植或恢复而退出，九人完成了随访。研究期间死亡和与器械相关的取出的最常见原因是肝病进展和感染。该设备显著减少了大容量腹腔穿刺术的需求，超过一半的患者在植入后无需进行任何治疗。未观察到生存获益。器械相关再干预主要由器械缺陷引起。对纳入的前 50 名和后 50 名患者的事后比较显示，后者的再干预率降低，主要与腹膜导管的修改有关。
该设备减少了真实环境中的腹腔穿刺频率。通过优化管理和器械修改，成功降低了技术并发症的发生率（NCT01532427）。
