Document Detail

Decision-making, emotional distress, and quality of life in patients affected by the recall of their implantable cardioverter defibrillator.
MedLine Citation:
PMID:  18442964     Owner:  NLM     Status:  MEDLINE    
AIMS: We sought to investigate whether patients with implantable cardioverter defibrillators (ICDs) were suffering from emotional distress related to the recent United States Food and Drug Administration (FDA) recalls, to better understand their decision process related to device replacement, and to assess any impact of recall on quality of life (QOL). METHODS AND RESULTS: Thirty-one patients experiencing device recalls answered questions regarding their knowledge about the recall and their decision whether to replace the device. Fifty patients whose devices were not recalled reported demographic data. In both groups, psychological factors were assessed. No significant differences were found for psychological factors. Most patients reported being informed of their recall by their physician. Most estimated the risk of device failure to be low or very low, but they overestimated the fail rate. Thirty-six per cent of patients reported feeling anxious about the recall. CONCLUSION: No significant differences existed in psychological factors and QOL between patients whose ICDs were recalled compared with those whose devices were not. The majority of patients whose ICDs are the subject of an FDA advisory/recall have a realistic understanding of the risks of device failure. Prompt information, support, and reassurance provided by healthcare professionals may allay patient distress.
Douglas P Gibson; Kristin K Kuntz; James L Levenson; Kenneth A Ellenbogen
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology     Volume:  10     ISSN:  1532-2092     ISO Abbreviation:  Europace     Publication Date:  2008 May 
Date Detail:
Created Date:  2008-04-29     Completed Date:  2008-05-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883649     Medline TA:  Europace     Country:  England    
Other Details:
Languages:  eng     Pagination:  540-4     Citation Subset:  IM    
Virginia Commonwealth University School of Medicine, 1200 East Broad Street, PO Box 980268, Richmond, VA 23298-0268, USA.
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MeSH Terms
Aged, 80 and over
Attitude to Health*
Decision Making*
Defibrillators, Implantable / psychology*
Middle Aged
Patient Acceptance of Health Care / psychology*
Product Surveillance, Postmarketing*
Quality of Life*
Stress, Psychological / psychology*

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

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