Defibrillators, Implantable, Sudden Cardiac Death Due to Cardiac Arrhythmia
Conditions
Keywords
Implantable cardioverter defibrillator, sudden cardiac death, Extravascular Implantable Cardioverter-Defibrillator
Brief summary
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.
Interventions
DEVICEExtra-Vascular Implantable Cardioverter Defibrillator
The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.
Sponsors
European Georges Pompidou Hospital
University Hospital, Grenoble
University Hospital, Clermont-Ferrand
University Hospital, Rouen
Centre Hospitalier Universitaire de Besancon
Clinique du Millenaire
Institut Mutualiste Montsouris
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Lille
University Hospital, Caen
Hospices Civils de Lyon
CHU de la Timone, Marseille, France
Centre Cardio-Thoracique de Monaco
Hospital of Lens
Institute Arnault Tzanck, France
University Hospital, Strasbourg, France
University Hospital, Limoges
University Hospital, Montpellier
Clinique Pasteur Toulouse
University Hospital, Bordeaux
University Hospital, Toulouse
Institut Jacques Cartier - Massy
Clinique Saint Augustin - Bordeaux
Rennes University Hospital
Clinique de la Sauvegarde
University Hospital of Saint-Etienne
Centre Hospitalier Universitaire, Amiens
Poitiers University Hospital
Clinique Saint-Gatien - Tours
CHU de Reims
Centre Hospitalier Universitaire Dijon
Hospital St. Joseph, Marseille, France
Centre Hospitalier Annecy Genevois
Clinique St Pierre, Perpignan, France
Bichat Hospital
Universite de La Reunion
University Hospital Center of Martinique
Henri Mondor University Hospital
University Hospital, Angers
Central Hospital, Nancy, France
Hôpital privé Clairval - Marseille
Médipôle Lyon-Villeurbanne
Hôpital Privé Les Franciscaines
Hospital Ambroise Paré Paris
Central Hospital, Metz Thionville, France
Hopital Prive Saint Martin - Bordeaux
Hôpital Privé de Parly II - Le Chesnay
Paris Sudden Death Expertise Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients undergoing EV-ICD implantation
Exclusion criteria
* Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Appropriate Therapies | Through the study completion, an average of 5 years | The incidence of ICD shocks or ICD ATPs. |
| EV-ICD-related Early Complications (Prior to Hospital Discharge) | Through the study completion, an average of 5 years | 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. |
| EV-ICD related Late Complications (After Hospital Discharge) | Through the study completion, an average of 5 years | 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 |
| Overall and Specific Mortalities | Through the study completion, an average of 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Transplantation | Through the study completion, an average of 5 years | The incidence of heart transplant during follow-up |
| Interventions During Follow-up | Through the study completion, an average of 5 years | Incidence and type of all EV-ICD related intervention. Raison of reintervention: complication, type of complication, generator change and pacing need. |
Countries
France
Contacts
Primary ContactEloi MARIJON, MD, PhD
Backup ContactFawzi KERKOURI, MD, MPH
Outcome results
None listed