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The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.

Complications Associated With Implantable Cardioverter-Defibrillator Replacement in Response to Device Advisories

Gould, Paul A.·2006·JAMA

Abstract

CONTEXT: Recent implantable cardioverter-defibrillator (ICD) advisories and recalls have caused management dilemmas for physicians, particularly because there are no specific guidelines or data on outcomes from current management strategies. The risk of ICD generator replacement has not been assessed in this population. OBJECTIVE: To determine the complication rate associated with ICD generator replacement for the current ICD advisories. DESIGN AND SETTING: Seventeen ICD implanting centers in Canada were surveyed to assess complication rates as a result of generator replacements because of ICD advisories from October 2004 to October 2005. MAIN OUTCOME MEASURE: Complications associated with elective ICD generator replacement for current device advisories. RESULTS: At the 17 surveyed centers, 2915 patients had recall devices, including 533 (18.3%) who had advisory ICDs replaced a mean (SD) of 26.5 (11.5) months after their initial implant. Of these patients, 66% had a secondary prevention ICD, and 45% had received a previous appropriate shock. During a mean (SD) of 2.7 (2.8) months' follow-up after ICD generator replacement, complications occurred in 43 patients (8.1%). Major complications attributable to advisory device replacement requiring reoperation occurred in 31 patients (5.8%), with death in 2 patients after extraction for pocket infection. Minor complications occurred in 12 patients (2.3%). There were 3 (0.1%) advisory-related device malfunctions reported, without clinical consequences. CONCLUSIONS: ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death. These complications need to be considered in the development of guidelines determining the appropriate treatment of patients with advisory devices.

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Metadata

Authors
Gould, P. A.
Venue
JAMA
Published
2006-04-26
Volume
295
Issue
16
Pages
1907
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W2028662312
Cited by
288
References
21
FWCI
21.43
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Complications Associated With Implantable Cardioverter-Defibrillator Replacement in Response to Device Advisories. https://app.cochat.ai/papers/10.1001/jama.295.16.1907
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Gould, P. A. (2006). Complications Associated With Implantable Cardioverter-Defibrillator Replacement in Response to Device Advisories. JAMA. https://doi.org/10.1001/jama.295.16.1907

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