Implantable cardioverter-defibrillators (ICDs) are widely recognized for their efficacy in reducing the risk of sudden cardiac death in high-risk patients. Nonetheless, there remains significant scope for improving outcomes through advancements in device technology and design. The extravascular cardioverter-defibrillator (EV-ICD) represents such an innovation, offering key advantages over other ICD systems. It incorporates a lead positioned in the substernal space, enabling the delivery of pause-prevention security pacing, antitachycardia pacing, and defibrillation energy similar to that provided by conventional transvenous ICDs. Previous studies have demonstrated that EV-ICDs can be implanted safely and are capable of terminating majority of induced ventricular arrhythmias during implantation; however, follow-up data are limited to highly experienced selected centers and over a relatively small follow-up period (6-month follow-up). The FOREVER cohort study, initiated by the French Institute of Health and Medical Research, aims to evaluate the EV-ICD use in France. This nationwide evaluation will provide an exhaustive collection of all EV-ICD implantations in France, offering valuable real-world evidence on the long-term safety and efficacy of the device.
Study Type
OBSERVATIONAL
Enrollment
1,000
The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.
European Georges Pompidou Hospital
Paris, France
RECRUITINGIncidence of Appropriate Therapies
The incidence of ICD shocks or ICD ATPs.
Time frame: Through the study completion, an average of 5 years
EV-ICD-related Early Complications (Prior to Hospital Discharge)
The incidence of each complication related to the procedure or the device: pocket hematoma, infection, poor wound healing, inappropriate shocks, lead issues, pneumothorax, pericardial injury, other complications with details.
Time frame: Through the study completion, an average of 5 years
EV-ICD related Late Complications (After Hospital Discharge)
The incidence of each complication related to the device or genetaor change procedure: infection, pocket hematoma, poor wound healing, inappropriate shocks, lead issues, premature battery depletion, chronic pain, painful pacing, EV-ICD related death
Time frame: Through the study completion, an average of 5 years
Overall and Specific Mortalities
Incidence of deaths. Causes of Deaths: cardiovascular cause with the main raison leading to death, non-cardiovascular cause with the main raison leading to death, EV-ICD related death with details, and unknown cause.
Time frame: Through the study completion, an average of 5 years
Interventions During Follow-up
Incidence and type of all EV-ICD related intervention. Raison of reintervention: complication, type of complication, generator change and pacing need.
Time frame: Through the study completion, an average of 5 years
Heart Transplantation
The incidence of heart transplant during follow-up
Time frame: Through the study completion, an average of 5 years
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