This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
Implantable cardioverter defibrillators (ICD) are strongly recommended in patients with left ventricular systolic function ≤35% or selected patients with channelopathies and cardiomyopathies. Defibrillation threshold testing (DFT) defines the minimal energy required to successfully terminate a ventricular arrhythmia by an ICD. It remains the gold standard to evaluate the electrical integrity of the device. However inherent complications of this procedure have been registered, such as refractory ventricular fibrillation, and the need for this practice during implant and/or replacement of ICD has recently been questioned. If several studies have led to abandonment of the DFT during initial ICD implant, its interest during replacement is still controversial. Indeed, the leads essential for the device electrical integrity are older, more fragile, and the ICD replacement may damage it. Device replacement is indicated when battery reaches the point of Elective Replacement Interval (ERI). Patients over 18 years old with indication for replacement of defibrillator will be included. Patient's informations (comorbidities, medical history and events during hospitalization or follow-up) and device characteristics will be collected. Procedure will be realized under local or general anesthesia and prophylactic antibiotic will be administrated. Leads will be tested before and after the implantation of the new device. After connexion of the new implanted device to the leads a DFT will be performed. Protocol of DFT will be decided by the physician who will chose between induction of ventricular fibrillation or R-wave synchronized shock. Patients will be followed for 6 and 12 months from the date of defibrillator replacement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
143
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock
Hôpital Trousseau
Chambray-lès-Tours, Centre-Val de Loire, France
Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Grand Est, France
CHU de Caen
Caen, Normandy, France
CHU de Toulouse-Hôpital Rangueil
Toulouse, Occitanie, France
Rate of defibrillator electrical integrity dysfunction during generator replacement.
Abnormal shock impedance value.
Time frame: 4 hours
Rate of lead malfunction
abnormal impedance value
Time frame: 12 months
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Hôpital Privé du Confluent
Nantes, Pays de la Loire Region, France
Centre Hospitalier Henri Duffaut
Avignon, Provence-Alpes-Côte d'Azur Region, France
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, France