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Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience

BACKGROUND: The use of left ventricular assist devices (LVADs) has increased in the last decade. Major complications have been well described, but there is no data on device alarms and actual or threatening malfunction which impair quality of life and may impair outcomes. This study describes the te...

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Autores principales: Najjar, Emil, Hallberg Kristensen, Ann, Thorvaldsen, Tonje, Hubbert, Laila, Svenarud, Peter, Dalén, Magnus, Månsson Broberg, Agneta, Lund, Lars H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6008928/
https://www.ncbi.nlm.nih.gov/pubmed/29921307
http://dx.doi.org/10.1186/s13019-018-0759-9
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author Najjar, Emil
Hallberg Kristensen, Ann
Thorvaldsen, Tonje
Hubbert, Laila
Svenarud, Peter
Dalén, Magnus
Månsson Broberg, Agneta
Lund, Lars H.
author_facet Najjar, Emil
Hallberg Kristensen, Ann
Thorvaldsen, Tonje
Hubbert, Laila
Svenarud, Peter
Dalén, Magnus
Månsson Broberg, Agneta
Lund, Lars H.
author_sort Najjar, Emil
collection PubMed
description BACKGROUND: The use of left ventricular assist devices (LVADs) has increased in the last decade. Major complications have been well described, but there is no data on device alarms and actual or threatening malfunction which impair quality of life and may impair outcomes. This study describes the technical problems related to the use of the HVAD® left ventricular assist device in a single center. METHODS: We retrospectively reviewed device malfunctions and outcomes in 22 patients with HVAD® left ventricular assist device followed at Karolinska University Hospital between 2011 and 2016. Device malfunction was defined by INTERMACS as a failure of one or more of the components of the LVAD system. The primary outcome was defined as death or hospitalization or unplanned urgent clinic visit due to device alarm of unknown significance or actual or threatening malfunction. Separate secondary outcomes were malfunction resulting in controller exchange and malfunction resulting in battery change. Exploratory outcomes were death, transplantation, or explantation because of recovery. RESULTS: Median age was 59 years and 19% were women. Over a mean follow-up time of 1.7 years (37 patient-years), the primary outcome occurred 30 times (0.8 events per patient-year; 0 deaths, 2 hospitalizations and 28 un-planned clinic visits). Secondary outcomes were 41 device malfunctions for 14 patients requiring 45 controller exchanges in 12 patients (1.1 events per patient-year) and 128 battery changes in 12 patients (3.5 events per patient-year). Exploratory outcomes were 8 deaths (36.4%), 7 transplantations (31.8%) and 2 explants due to recovery (9.1%). CONCLUSION: The use of HVAD® was associated with technical problems requiring frequent un-planned clinic visits and changes of controller and/or batteries. There were no deaths due to device malfunction. Further studies are warranted to evaluate the risk of device malfunction and associated reductions in quality of life and cost.
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spelling pubmed-60089282018-06-26 Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience Najjar, Emil Hallberg Kristensen, Ann Thorvaldsen, Tonje Hubbert, Laila Svenarud, Peter Dalén, Magnus Månsson Broberg, Agneta Lund, Lars H. J Cardiothorac Surg Research Article BACKGROUND: The use of left ventricular assist devices (LVADs) has increased in the last decade. Major complications have been well described, but there is no data on device alarms and actual or threatening malfunction which impair quality of life and may impair outcomes. This study describes the technical problems related to the use of the HVAD® left ventricular assist device in a single center. METHODS: We retrospectively reviewed device malfunctions and outcomes in 22 patients with HVAD® left ventricular assist device followed at Karolinska University Hospital between 2011 and 2016. Device malfunction was defined by INTERMACS as a failure of one or more of the components of the LVAD system. The primary outcome was defined as death or hospitalization or unplanned urgent clinic visit due to device alarm of unknown significance or actual or threatening malfunction. Separate secondary outcomes were malfunction resulting in controller exchange and malfunction resulting in battery change. Exploratory outcomes were death, transplantation, or explantation because of recovery. RESULTS: Median age was 59 years and 19% were women. Over a mean follow-up time of 1.7 years (37 patient-years), the primary outcome occurred 30 times (0.8 events per patient-year; 0 deaths, 2 hospitalizations and 28 un-planned clinic visits). Secondary outcomes were 41 device malfunctions for 14 patients requiring 45 controller exchanges in 12 patients (1.1 events per patient-year) and 128 battery changes in 12 patients (3.5 events per patient-year). Exploratory outcomes were 8 deaths (36.4%), 7 transplantations (31.8%) and 2 explants due to recovery (9.1%). CONCLUSION: The use of HVAD® was associated with technical problems requiring frequent un-planned clinic visits and changes of controller and/or batteries. There were no deaths due to device malfunction. Further studies are warranted to evaluate the risk of device malfunction and associated reductions in quality of life and cost. BioMed Central 2018-06-19 /pmc/articles/PMC6008928/ /pubmed/29921307 http://dx.doi.org/10.1186/s13019-018-0759-9 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Najjar, Emil
Hallberg Kristensen, Ann
Thorvaldsen, Tonje
Hubbert, Laila
Svenarud, Peter
Dalén, Magnus
Månsson Broberg, Agneta
Lund, Lars H.
Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience
title Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience
title_full Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience
title_fullStr Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience
title_full_unstemmed Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience
title_short Controller and battery changes due to technical problems related to the HVAD® left ventricular assist device - a single center experience
title_sort controller and battery changes due to technical problems related to the hvad® left ventricular assist device - a single center experience
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6008928/
https://www.ncbi.nlm.nih.gov/pubmed/29921307
http://dx.doi.org/10.1186/s13019-018-0759-9
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