Document Detail


European results with a continuous-flow ventricular assist device for advanced heart-failure patients.
MedLine Citation:
PMID:  19616963     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The HeartMate II (HM II) LVAD is a small, quiet, continuous-flow, left ventricular assist device (LVAD) for circulatory support in advanced heart-failure patients, with over 2000 implants worldwide. This article reports on the European experience with this device.
METHODS: The HM II was implanted in 571 patients at 64 European institutions. In 72% of cases (411 patients), implantation has taken place at least 6 months before the closing date of the study (1 August 2008). Patients (19% female, 70% ischaemic aetiology) were on maximum medical therapy, including inotropic support. Body surface area ranged from 1.30 to 2.50 m(2) and age from 14 to 75 years (mean: 51+/-14 years; n=115, 28% over age 60 years). The intention of support was to provide a bridge to transplantation (73%), destination therapy (21%) and a bridge to recovery (6%). Adverse events were documented in the first 53 patients - for obtaining the Conformité Européenne (CE) Mark (group A) - from a European multicentric study (Strüber et al. [Strüber M, Sander K, Lahpor J, Ahn H, Litzler P-Y, Drakos SG, Musumeci F, Schlensak C, Friedrich I, Gustafsson R, Oertel F, Leprince P. HeartMate II left ventricular assist device; early European experience. Eur J Cardiovasc Surg 2008;34(2):289-94.]: 101 patients) and from a single-centre study (UMCU, The Netherlands: 30 patients).
RESULTS: The mean support duration ranged from 0 to 1019 days with a mean of 236+/-214 days (249 patients: >6 months, 119: 1 year, 12: >2 years; total support time: 293 years). The overall survival to transplantation, recovery or ongoing device support at the end of the study was 69% (284) with an early mortality of 17.5% and late mortality of 13.5%. Of the surviving patients, 23% have been transplanted, 4% had their device removed after recovery of the left ventricle and 42% are still ongoing. Adverse events included bleeding (ranging from 42% in group C to 59% in group A), percutaneous lead infections (A: 0.19, B: 0.61 and C: 0.18 events per patient year), pocket infections (A: 0.08, B: 0.07 and C: 0.09 events per patient year), ischaemic stroke (A: 0.06, B: 0.09 and C: 0.04 events per patient year), haemorrhagic stroke (B: 0.07, C: 0.04 events per patient year) and transient ischaemic attacks (TIAs; A: 0.08, B: 0.02 and C: 0.13 events per patient year).
CONCLUSIONS: These results support the use of the HM II continuous-flow LVAD for long-term support as a bridge to transplantation and possibly for destination therapy. Future emphasis should focus on minimising adverse events such as infections, bleeding and neurological events.
Authors:
Jaap Lahpor; Asghar Khaghani; Roland Hetzer; Alain Pavie; Ivar Friedrich; Kaare Sander; Martin Strüber
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Multicenter Study     Date:  2009-07-18
Journal Detail:
Title:  European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery     Volume:  37     ISSN:  1873-734X     ISO Abbreviation:  Eur J Cardiothorac Surg     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-03     Completed Date:  2011-01-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8804069     Medline TA:  Eur J Cardiothorac Surg     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  357-61     Citation Subset:  IM    
Copyright Information:
Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.
Affiliation:
Department of Heart and Lung, University Medical Center, Utrecht, The Netherlands. j.r.lahpor@umcutrecht.nl
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Cerebrovascular Disorders / etiology
Female
Follow-Up Studies
Heart Failure / therapy*
Heart Transplantation
Heart-Assist Devices* / adverse effects
Hemorrhage / etiology
Humans
Male
Middle Aged
Prosthesis-Related Infections / etiology
Survival Analysis
Treatment Outcome
Young Adult

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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