Implantable cardioverter-defibrillators have been proven to be effective in the prevention of sudden cardiac death in high-risk patients. However, it is well acknowledged that such a strategy could be optimised, especially through new technologies/devices. Data on the entirely sub-cutaneous implantable cardioverter defibrillator (S-ICD) published so far come from high-volume centers and/or selected populations. The HONEST Cohort -taking the opportunity of a unique scenario with a single manufacturer and remote monitoring system available- aims to collect retrospectively baseline information as well as follow-up of all patients implanted with an S-ICD in France since the first implant in October 13, 2012 until December 31, 2019. An extended prospective yearly follow-up will be carried out since January 1, 2020 until December 31, 2024.
Study Type
OBSERVATIONAL
Enrollment
5,000
Implantation of an S-ICD
Paris Cardiovascular Research Center (HONEST Investigators)
Paris, France
RECRUITINGVentricular Arrhythmias
Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation
Time frame: Through study completion, an average of 5 years
Device-Related Complications
Rate of complications related to ICD including inappropriate therapies, infection, lead or generator dysfunction
Time frame: Through study completion, an average of 5 years
Overall and Specific Mortalities
Overall mortality and causes of death
Time frame: Through study completion, an average of 5 years
Early Device-Related Complications
Complications occurring within the 3 months following implantation
Time frame: 3 months
Late Device-Related Complications
Complications occurring after 3 months following implantation
Time frame: Through study completion, an average of 5 year
Stratified Analyses by Sex, Underlying Heart Disease
Primary and secondary outcomes studied by sex and types of heart diseases
Time frame: Through study completion, an average of 5 year
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