Observational studyLiver international : official journal of the International Association for the Study of the Liver2022
Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump.
Observational study in Liver international : official journal of the International Association for the Study of the Liver, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01532427 (ALFApump System Post Marketing Surveillance Registry, In Support of the Following Indication), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
ALFApump System Post Marketing Surveillance Registry, In Support of the Following Indication: Automated Removal of Excess Peritoneal Fluid Into the Urinary Bladder in Patients With Cirrhosis or Malignancy, With Persistent or Refractory Ascites
Who cites it
7 citing papers in PubMed, 12 citations in OpenAlex.
- Drainage of ascites in cirrhosis.World journal of hepatology · 2024Review
- Acute kidney injury in patients with cirrhosis: Acute Disease Quality Initiative (ADQI) and International Club of Ascites (ICA) joint multidisciplinary consensus meeting.Journal of hepatology · 2024Review
- Innovative Management of a Difficult Case of Hepatic Hydrothorax.ACG case reports journal · 2024Article
- Recent developments in the management of ascites in cirrhosis.United European gastroenterology journal · 2024Review
- Innovative approaches to the management of ascites in cirrhosis.JHEP reports : innovation in hepatology · 2023Review
- Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump.Liver international : official journal of the International Association for the Study of the Liver · 2022Observational
- Managing a Prospective Liver Transplant Recipient on the Waiting List.Journal of clinical and experimental hepatologyReview
Corrections and comments
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Authors and funding
16 authors at 11 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsPatients 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.
methodsA 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.
resultsApproximately 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.
conclusionsThe device reduced paracentesis frequency in a real-world setting. Technical complications were successfully decreased by optimization of management and device modification (NCT01532427).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.