Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump

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, fr...

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Autores: Stirnimann, Guido|||0000-0003-3447-264X, Berg, Thomas|||0000-0003-0003-6241, Spahr, Laurent.|||0000-0001-8407-2463, Zeuzem, Stefan|||0000-0002-0845-6833, McPherson, Stuart|||0000-0002-5638-2453, Lammert, Frank, Storni, Federico|||0000-0001-5570-4281, Banz, Vanessa|||0000-0002-4887-5776, Babatz, Jana, Vargas Blasco, Víctor|||0000-0002-7190-6948, Geier, Andreas, Engelmann, Cornelius, Herber, Adam, Trepte, Claudia|||0000-0003-1995-5539, Capel, Jeroen|||0000-0002-6047-9880, De Gottardi, Andrea|||0000-0002-4401-2340
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:292163
Acceso en línea:https://ddd.uab.cat/record/292163
https://dx.doi.org/urn:doi:10.1111/liv.15337
Access Level:acceso abierto
Palabra clave:Alfapump
Ascites
Cirrhosis
Large-volume paracentesis
TIPSS
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spelling Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pumpStirnimann, Guido|||0000-0003-3447-264XBerg, Thomas|||0000-0003-0003-6241Spahr, Laurent.|||0000-0001-8407-2463Zeuzem, Stefan|||0000-0002-0845-6833McPherson, Stuart|||0000-0002-5638-2453Lammert, FrankStorni, Federico|||0000-0001-5570-4281Banz, Vanessa|||0000-0002-4887-5776Babatz, JanaVargas Blasco, Víctor|||0000-0002-7190-6948Geier, AndreasEngelmann, CorneliusHerber, AdamTrepte, Claudia|||0000-0003-1995-5539Capel, Jeroen|||0000-0002-6047-9880De Gottardi, Andrea|||0000-0002-4401-2340AlfapumpAscitesCirrhosisLarge-volume paracentesisTIPSSBackground 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).Universitat Autònoma de Barcelona 22022-01-0120222022-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/292163https://dx.doi.org/urn:doi:10.1111/liv.15337reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest 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.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2921632026-06-06T12:50:31Z
dc.title.none.fl_str_mv Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
title Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
spellingShingle Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
Stirnimann, Guido|||0000-0003-3447-264X
Alfapump
Ascites
Cirrhosis
Large-volume paracentesis
TIPSS
title_short Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
title_full Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
title_fullStr Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
title_full_unstemmed Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
title_sort Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump
dc.creator.none.fl_str_mv Stirnimann, Guido|||0000-0003-3447-264X
Berg, Thomas|||0000-0003-0003-6241
Spahr, Laurent.|||0000-0001-8407-2463
Zeuzem, Stefan|||0000-0002-0845-6833
McPherson, Stuart|||0000-0002-5638-2453
Lammert, Frank
Storni, Federico|||0000-0001-5570-4281
Banz, Vanessa|||0000-0002-4887-5776
Babatz, Jana
Vargas Blasco, Víctor|||0000-0002-7190-6948
Geier, Andreas
Engelmann, Cornelius
Herber, Adam
Trepte, Claudia|||0000-0003-1995-5539
Capel, Jeroen|||0000-0002-6047-9880
De Gottardi, Andrea|||0000-0002-4401-2340
author Stirnimann, Guido|||0000-0003-3447-264X
author_facet Stirnimann, Guido|||0000-0003-3447-264X
Berg, Thomas|||0000-0003-0003-6241
Spahr, Laurent.|||0000-0001-8407-2463
Zeuzem, Stefan|||0000-0002-0845-6833
McPherson, Stuart|||0000-0002-5638-2453
Lammert, Frank
Storni, Federico|||0000-0001-5570-4281
Banz, Vanessa|||0000-0002-4887-5776
Babatz, Jana
Vargas Blasco, Víctor|||0000-0002-7190-6948
Geier, Andreas
Engelmann, Cornelius
Herber, Adam
Trepte, Claudia|||0000-0003-1995-5539
Capel, Jeroen|||0000-0002-6047-9880
De Gottardi, Andrea|||0000-0002-4401-2340
author_role author
author2 Berg, Thomas|||0000-0003-0003-6241
Spahr, Laurent.|||0000-0001-8407-2463
Zeuzem, Stefan|||0000-0002-0845-6833
McPherson, Stuart|||0000-0002-5638-2453
Lammert, Frank
Storni, Federico|||0000-0001-5570-4281
Banz, Vanessa|||0000-0002-4887-5776
Babatz, Jana
Vargas Blasco, Víctor|||0000-0002-7190-6948
Geier, Andreas
Engelmann, Cornelius
Herber, Adam
Trepte, Claudia|||0000-0003-1995-5539
Capel, Jeroen|||0000-0002-6047-9880
De Gottardi, Andrea|||0000-0002-4401-2340
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Alfapump
Ascites
Cirrhosis
Large-volume paracentesis
TIPSS
topic Alfapump
Ascites
Cirrhosis
Large-volume paracentesis
TIPSS
description 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).
publishDate 2022
dc.date.none.fl_str_mv 2
2022-01-01
2022
2022-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/292163
https://dx.doi.org/urn:doi:10.1111/liv.15337
url https://ddd.uab.cat/record/292163
https://dx.doi.org/urn:doi:10.1111/liv.15337
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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