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HeartMate II left ventricular assist device; early European experience

Strueber, Martin; Sander, Kare; Lahpor, Jaap; Ahn, Henrik; Litzler, Pierre-Yves; Drakos, Stavros G.; Musumeci, Francesco; Schtensak, Christian; Friedrich, Ivar and Gustafsson, Ronny LU , et al. (2008) In European Journal of Cardio-thoracic Surgery 34(2). p.289-294
Abstract
Objective: The novel axial flow left ventricular assist device HeartMate II was introduced into clinical practice in Europe as part of the pilot study and after CE approval in November 2005. In order to get an overview of the use and performance of the device in Europe a group of investigators was founded to compare the initial results. Methods: In a retrospective analysis of the first 101 consecutive cases in Europe, data were collected with regard to postoperative outcome and severe adverse events and anticoagulation protocols. Results were stratified by intention to treat as a bridge to transplant or as chronic support therapy in heart failure (destination therapy). Results: In 70% of patients, the HeartMate II was intended as a bridge... (More)
Objective: The novel axial flow left ventricular assist device HeartMate II was introduced into clinical practice in Europe as part of the pilot study and after CE approval in November 2005. In order to get an overview of the use and performance of the device in Europe a group of investigators was founded to compare the initial results. Methods: In a retrospective analysis of the first 101 consecutive cases in Europe, data were collected with regard to postoperative outcome and severe adverse events and anticoagulation protocols. Results were stratified by intention to treat as a bridge to transplant or as chronic support therapy in heart failure (destination therapy). Results: In 70% of patients, the HeartMate II was intended as a bridge to transplant therapy, in 30%, it was used as a destination therapy device. The perioperative mortality post implant was 20% in the bridge to transplant patients and 7% in the destination therapy arm. However, after 1 year a comparable survival was observed in both groups (69% destination therapy, 63% bridge to transplant). Main causes of death were multiple organ failure (n = 12) and cerebrovascular accidents (n = 5). All, but one cerebrovascular accident occurred in the first 9 days after surgery. Only one other death was reported thereafter and there was no mechanical failure of the device. Conclusions: Even in the early experience the HeartMate II was used as a chronic support device in a substantial number of patients in Europe. Although the total experience is still limited, the incidence of cerebrovascular accidents is very tow and the survival beyond the perioperative period is excellent. (C) 2008 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. Alt rights reserved. (Less)
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Contribution to journal
publication status
published
subject
keywords
adverse events, LVAD, HeartMate II
in
European Journal of Cardio-thoracic Surgery
volume
34
issue
2
pages
289 - 294
publisher
Elsevier
external identifiers
  • wos:000258518400011
  • scopus:46949087096
ISSN
1010-7940
DOI
10.1016/j.ejcts.2008.05.011
language
English
LU publication?
yes
id
261dad40-2d87-4873-80c3-add69dd6f9ca (old id 1251947)
date added to LUP
2008-11-04 12:25:18
date last changed
2017-08-06 03:38:54
@article{261dad40-2d87-4873-80c3-add69dd6f9ca,
  abstract     = {Objective: The novel axial flow left ventricular assist device HeartMate II was introduced into clinical practice in Europe as part of the pilot study and after CE approval in November 2005. In order to get an overview of the use and performance of the device in Europe a group of investigators was founded to compare the initial results. Methods: In a retrospective analysis of the first 101 consecutive cases in Europe, data were collected with regard to postoperative outcome and severe adverse events and anticoagulation protocols. Results were stratified by intention to treat as a bridge to transplant or as chronic support therapy in heart failure (destination therapy). Results: In 70% of patients, the HeartMate II was intended as a bridge to transplant therapy, in 30%, it was used as a destination therapy device. The perioperative mortality post implant was 20% in the bridge to transplant patients and 7% in the destination therapy arm. However, after 1 year a comparable survival was observed in both groups (69% destination therapy, 63% bridge to transplant). Main causes of death were multiple organ failure (n = 12) and cerebrovascular accidents (n = 5). All, but one cerebrovascular accident occurred in the first 9 days after surgery. Only one other death was reported thereafter and there was no mechanical failure of the device. Conclusions: Even in the early experience the HeartMate II was used as a chronic support device in a substantial number of patients in Europe. Although the total experience is still limited, the incidence of cerebrovascular accidents is very tow and the survival beyond the perioperative period is excellent. (C) 2008 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. Alt rights reserved.},
  author       = {Strueber, Martin and Sander, Kare and Lahpor, Jaap and Ahn, Henrik and Litzler, Pierre-Yves and Drakos, Stavros G. and Musumeci, Francesco and Schtensak, Christian and Friedrich, Ivar and Gustafsson, Ronny and Oertel, Frank and Leprince, Pascal},
  issn         = {1010-7940},
  keyword      = {adverse events,LVAD,HeartMate II},
  language     = {eng},
  number       = {2},
  pages        = {289--294},
  publisher    = {Elsevier},
  series       = {European Journal of Cardio-thoracic Surgery},
  title        = {HeartMate II left ventricular assist device; early European experience},
  url          = {http://dx.doi.org/10.1016/j.ejcts.2008.05.011},
  volume       = {34},
  year         = {2008},
}