ICD implant improves survival in patients with a higher risk for sudden cardiac death. During ICD implant, the functions of the ICD are tested in several ways, amongst other by defibrillation testing (DFT). During a DFT, a cardiac arrhythmia is induced. If the S-ICD is working properly, it will give a shock and the normal heart rhythm will be restored. During a DFT, the patient is fully sedated. Research has shown that in most cases a defibrillation test during S-ICD implantation is successful. However, performing a defibrillation test involves a (very small) risk of complications and poses a logistical burden. Comparative research has shown for the transvenous ICD, in which the guidewires run through the blood vessels, that performing a DFT during implant does not improve outcome. Therefore, the DFT is no longer routinely performed after TV-ICD implant. PRAETORIAN DFT investigates whether the DFT after S-ICD implant can be replaced by an alternative check. In this check, the correct position of the S-ICD is confirmed on chest X-rays that are routinely taken after S-ICD implantation. This position of the S-ICD is determined by calculating the PRAETORIAN Score
The primary objective is to determine whether the S-ICD implant without DFT (with PRAETORIAN Score) is non-inferior to the S-ICD implant with DFT.
The secondary objectives are to evaluate the PRAETORIAN score and to evaluate anesthesia protocols for implantation.