Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
Stirnimann, Guido (University of Bern)
Berg, Thomas (Leipzig University Medical Center)
Spahr, Laurent. (Geneva University Hospitals (Ginebra, Suïssa))
Zeuzem, Stefan (University Hospital of Frankfurt (Alemanya))
McPherson, Stuart (Newcastle University)
Lammert, Frank (Hannover Medical School)
Storni, Federico (University of Bern)
Banz, Vanessa (University of Bern)
Babatz, Jana (Universitätsklinikum Carl Gustav Carus)
Vargas Blasco, Víctor (Hospital Universitari Vall d'Hebron)
Geier, Andreas (University Hospital Würzburg)
Engelmann, Cornelius (Charité-Universitätsmedizin Berlin)
Herber, Adam (Leipzig University Medical Center)
Trepte, Claudia (Sequana Medical NV)
Capel, Jeroen (Sequana Medical NV)
De Gottardi, Andrea (Università della Svizzera Italiana)
Universitat Autònoma de Barcelona

Data:	2022
Resum:	Background and aims: 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. Methods: 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. Results: Approximately half of the patients died on-study, about a quarter was withdrawn because of serious adverse events leading to explant, a sixth were withdrawn because of liver transplant or recovery, and nine completed follow-up.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. Conclusions: The device reduced paracentesis frequency in a real-world setting. Technical complications were successfully decreased by optimization of management and device modification (NCT01532427).
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Alfapump ; Ascites ; Cirrhosis ; Large-volume paracentesis ; TIPSS
Publicat a:	Liver international, Vol. 42 Núm. 10 (october 2022) , p. 2247-2259, ISSN 1478-3231

DOI: 10.1111/liv.15337
PMID: 35686702

13 p, 1.8 MB

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