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April 25, 2006JAMA

ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death.

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Why the study?

What are the complication rates associated with ICD generator replacement in patients with advisory devices?

Population

Patients with implantable cardioverter-defibrillator (ICD) advisory devices

Authors

PGPaul A. Gould

Discussion

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Overview

Supports careful risk-benefit evaluation before advisory ICD replacement; leaves open need for prospective trials.

Key Points

  • Assess the clinical risks and complication rates associated with replacing implantable cardioverter-defibrillator (ICD) generators in response to manufacturer device advisories.
  • Analyzed complication profiles and clinical outcomes in patients undergoing ICD generator replacement specifically prompted by device safety advisories.
  • ICD generator replacement in response to device advisories was associated with a substantial rate of complications, including death.
  • The clinical risks of replacement surgery warrant structured consideration in the development of treatment guidelines for managing advisory-affected devices.

Structured PICO

What are the complication rates associated with ICD generator replacement in patients with advisory devices?

P
Population
Patients with implantable cardioverter-defibrillator (ICD) advisory devices
I
Intervention
ICD generator replacement
O
Outcome
Complications, including deathsafety

ICD generator replacement in response to device advisories carries a substantial risk of complications, including death, highlighting the need for careful risk-benefit assessment.

Cite This Study

Paul A. Gould (2006) studied this question.

synapsesocial.com/papers/69d56c3c75589c71d767cd0bhttps://doi.org/10.1001/jama.295.16.1907
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