Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study

JOURNAL OF HEPATOLOGY

卷:67

Article

Bureau, Christophe¹  Adebayo, Danielle²  de Rieu, Mael Chalret¹  Elkrief, Laure^3,4,5  Valla, Dominique^3,4,5  Peck-Radosavljevic, Markus⁶  McCune, Anne⁷  Vargas, Victor⁸  Simon-Talero, Macarena⁸  Cordoba, Juan⁸  Angeli, Paolo⁹  Rosi, Silvia⁹  MacDonald, Stewart²  Malago, Massimo¹⁰  Stepanova, Maria¹¹  Younossi, Zobair M.¹²  Trepte, Claudia¹³  Watson, Randall¹⁴  Borisenko, Oleg¹⁵  Sun, Sun^15,16,17  Inhaber, Neil¹³  Jalan, Rajiv² 

[1] CHU Toulouse, Serv Hepatogastroenterol, Toulouse, France

[2] UCL, Royal Free Hosp, UCL Inst Hepatol, London, England

[3] Hop Beaujon, DHU UNITY, Clichy, France

[4] Univ Paris Diderot, Paris, France

[5] INSERM, U1149, Paris, France

[6] Klinikum Klagenfurt Worthersee, Dept Gastroenterol Hepatol Endocrinol & Nephrol, Klagenfurt, Austria

[7] Bristol Royal Infirm & Gen Hosp, Dept Hepatol, Bristol, Avon, England

[8] Univ Autonoma Barcelona, VHIR, Hosp Univ Vall dHebron, Dept Internal Med,Liver Unit,CIBERehd, Barcelona, Spain

[9] Univ Padua, Fac Med & Chirurg, Padua, Italy

[10] UCL, Royal Free Hosp, Hepatopancreat Biliary & Liver Transplantat Surg, London, England

[11] Ctr Outcomes Res Liver Dis, Washington, DC USA

[12] Inova Fairfax Hosp, Dept Med, Falls Church, VA USA

[13] Sequana Med AG, Zurich, Switzerland

[14] Medicalwriters Com, Zurich, Switzerland

[15] Synergus AB, Danderyd, Sweden

[16] Karolinska Inst, Dept Learning Informat Management & Eth, Hlth Outcomes & Econ Evaluat Res Grp, Stockholm, Sweden

[17] Umea Univ, Dept Publ Hlth & Clin Med, Div Epidemiol & Global Hlth, Umea, Sweden

关键词: Refractory ascites;    Liver cirrhosis;    Paracentesis;   

DOI  :  10.1016/j.jhep.2017.06.010

来源: Elsevier

【 摘 要 】

Background and Aims: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with a poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump (R) [AP]) compared with LVP standard of care [SoC]. Methods: A randomized controlled trial, in seven centers, with six month patient observation was conducted. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival. Nutrition, hemodynamics, and renal injury biomarkers were assessed in a sub-study at three months. Results: Sixty patients were randomized and 58 were analyzed (27 AP, 31 SoC, mean age 61.9 years, mean MELD 11.7). Eighteen patients were included in the sub-study. Compared with SoC, median time to first LVP was not reached after six months in the AP group, meaning a significant reduction in LVP requirement for the AP patients (AP, median not reached; SoC, 15.0 days (HR 0.13; 95% CI 13.0-22.0; p<0.001), and AP patients also showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores compared with SoC patients (p<0.05 between treatment arms). Improvements in nutritional parameters were observed for hand-grip strength (p = 0.044) and body mass index (p<0.001) in the sub-study. Compared with SoC, more AP patients reported adverse events (AEs; 96.3% vs. 77.4%, p = 0.057) and serious AEs (85.2 vs. 45.2%, p = 0.002). AEs consisted predominantly of acute kidney injury in the immediate postoperative period, and re-intervention for pump related issues, and were treatable in most cases. Survival was similar in AP and SoC. Conclusions: The AP system is effective for reducing the need for paracentesis and improving quality of life in cirrhotic patients with RA. Although the frequency of SAEs (and by inference hospitalizations) was significantly higher in the AP group, they were generally limited and did not impact survival. Lay summary: The alfapump (R) moves abdominal fluid into the bladder from where it is then removed by urination. Compared with standard treatment, the alfapump reduces the need for large volume paracentesis (manual fluid removal by needle) in patients with medically untreatable ascites. This can improve life quality for these patients. (C) 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

【 授权许可】

Free