Reliable post-approval surveillance of implantable cardioverter-defibrillator (ICD) lead performance remains a challenge. In the past, two ICD leads were recalled due to a high frequency of failures. In this meta-analysis, we sought to provide a combined estimate of failure-free rate for ICD leads by reconstructing individual patient data from published Kaplan-Meier (KM) curves and to investigate whether estimates could be influenced by the characteristics of the study.
Implantable cardioverter defibrillator lead performance: A systematic review and individual patient data Meta-analysis
Comoretto, Rosanna Irene;Gregori, Dario
2022-01-01
Abstract
Reliable post-approval surveillance of implantable cardioverter-defibrillator (ICD) lead performance remains a challenge. In the past, two ICD leads were recalled due to a high frequency of failures. In this meta-analysis, we sought to provide a combined estimate of failure-free rate for ICD leads by reconstructing individual patient data from published Kaplan-Meier (KM) curves and to investigate whether estimates could be influenced by the characteristics of the study.
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