Why the study?
What is the rate and clinical/financial impact of ICD generator and lead advisories in ICD recipients?
Population
1,051 patients with implanted cardioverter-defibrillators (ICDs) in a single cardiology department
Design
Cohort
Follow-up
8 years (2000-2008)
Authors
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Device recalls add substantial outpatient burden and costs; leaves open optimal surveillance strategies in real-world ICD cohorts.
What is the rate and clinical/financial impact of ICD generator and lead advisories in ICD recipients?
ICD recalls and safety alerts affect over a quarter of devices, leading to significant financial costs and extra outpatient visits, though major clinical complications are rare.
Schwartz et al. (2010) studied this question.
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