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Alfapump^® implantable device in management of refractory ascites: An update.

ABSTRACT: Refractory ascites (RA) is a frequent and life-threatening complication of cirrhosis. In selected patients with RA, transjugular intrahepatic portosystemic shunt (TIPS) placement and liver transplantation (LT) are currently considered the best therapeutic alternatives to repeated large volume paracentesis. In patients with a contraindication to TIPS or LT, the alfapump^® system (Sequana Medical, Ghent, Belgium) has been developed to reduce the need for iterative paracentesis, and consequently to improve the quality of life and nutritional status. We report here recent data on technical progress made since the first implantation, the efficacy and tolerance of the device, the position of the pump in the therapeutic arsenal for refractory ascites, and the grey areas that remain to be clarified regarding the optimal selection of patients who are potential candidates for this treatment.

SUBMITTER: Weil-Verhoeven D

PROVIDER: S-EPMC9376776 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Alfapump<sup>®</sup> implantable device in management of refractory ascites: An update.

Weil-Verhoeven Delphine D Di Martino Vincent V Stirnimann Guido G Cervoni Jean Paul JP Nguyen-Khac Eric E Thévenot Thierry T

World journal of hepatology 20220701 7

Refractory ascites (RA) is a frequent and life-threatening complication of cirrhosis. In selected patients with RA, transjugular intrahepatic portosystemic shunt (TIPS) placement and liver transplantation (LT) are currently considered the best therapeutic alternatives to repeated large volume paracentesis. In patients with a contraindication to TIPS or LT, the alfapump<sup>®</sup> system (Sequana Medical, Ghent, Belgium) has been developed to reduce the need for iterative paracentesis, and conse ...[more]

PMID: 36158913

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Project description:BackgroundTreatment of refractory ascites in liver cirrhosis is challenging. Transjugular intrahepatic portosystemic shunt and alfapump® have been proposed for the management, but few data comparing both exist.AimsThe aim of this study was to evaluate the characteristics and outcomes of patients treated with transjugular intrahepatic portosystemic shunt and alfapump® for refractory ascites at our centre.MethodsAll consecutive patients were retrospectively reviewed for baseline characteristics, efficacy of treatment, complications and survival.ResultsIn total, 19 patients with transjugular intrahepatic portosystemic shunt and 40 patients with alfapump® were included. Patients with transjugular intrahepatic portosystemic shunt had better liver function and less hepatic encephalopathy at baseline. Fifty-eight per cent of patients developed hepatic encephalopathy in the first six months after transjugular intrahepatic portosystemic shunt. In patients with alfapump®, renal function decreased and 58% developed prerenal impairment and 43% hepatorenal syndrome in the first six months. Alfapump® patients with new catheters required less reinterventions (26% versus 57% with old catheters, p = 0.049). Transplant-free survival at 1 year was 25% in alfapump® and 65% in transjugular intrahepatic portosystemic shunt. Hepatic encephalopathy predicted transplant-free survival in patients with alfapump® (hazard ratio 2.00, 95% confidence interval 0.99-4.02, p = 0.05). In a sensitivity analysis comparing patients with similar liver function, the rate of hepatorenal syndrome and prerenal impairment was higher in patients with alfapump® and these patients were hospitalised more frequently, whereas the rate of hepatic encephalopathy was similar in both treatment groups.ConclusionsBoth transjugular intrahepatic portosystemic shunt and alfapump® were effective treatments for refractory ascites in cirrhosis. Patients treated with transjugular intrahepatic portosystemic shunt had a better one-year transplant-free survival but had less negative prognostic factors at baseline. Selecting patients without hepatic encephalopathy prior to implantation of an alfapump® might improve transplant-free survival.

Project description:IntroductionThe SmartClic®/ClicWise® autoinjector is a new reusable, multi-use, single-patient device for the administration of subcutaneously administered biologics in the treatment of chronic conditions, including rheumatoid arthritis. The device will be used in conjunction with a mobile application (app). The aim of this study was to collect feedback on the usability, functionality, and applicability of the device and the companion app from health care professionals (HCPs) who perform injections as part of their role and care for patients with rheumatic conditions.MethodsThe study was conducted from September to October 2020 in Germany. HCPs participated in a training session for the device and gained experience by performing simulated injections with water. Following the simulations, HCPs answered questions on the ease of use, feature design, effectiveness, and injection speed of the SmartClic/ClicWise device and estimate the patient training time required. They also answered questions on the functionality of the proposed app after attending a storyboard presentation. Responses were recorded as multiple-choice answers, Likert scale ratings (seven-point scale), or open-ended comments. The mean, median, and mode scores were recorded.ResultsTwenty-five HCPs (mean age, 38.2 years; females, n = 22 [88%]; registered nurses, n = 19 [76%]) participated in the study. HCP feedback on questions related to the SmartClic/ClicWise device was positive overall, with mean scores > 4.50 across questions; mean scores < 5.00 were reported on 2/40 questions. Twenty-four of 25 participants (96%) estimated that a training time of ≤ 20 min would suffice for patients learning to use the device. Positive feedback was also reported on questions related to the companion app, with mean scores > 5.70.ConclusionsInitial feedback from HCPs on the SmartClic/ClicWise device and proposed app was generally favorable, suggesting they will provide an acceptable alternative for self-administration of biologics for patients with rheumatoid arthritis and other chronic conditions.

Dataset Information

Alfapump^® implantable device in management of refractory ascites: An update.

Publications

Alfapump<sup>®</sup> implantable device in management of refractory ascites: An update.

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Dataset Information

Alfapump® implantable device in management of refractory ascites: An update.

Publications

Alfapump<sup>®</sup> implantable device in management of refractory ascites: An update.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Alfapump^® implantable device in management of refractory ascites: An update.