concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de <i>novo</i> defibrillator implantation
AIMS: Although defibrillation (DF) testing is still considered a standard procedure during implantable cardioverter-defibrillator (ICD) insertion and has been an essential element of all trials that demonstrated the survival benefit of ICD therapy, there are no large randomized clinical trials demonstrating that DF testing improves clinical outcome and if the outcome would remain the same by omitting DF testing. METHODS AND RESULTS: Between February 2011 and July 2013, we randomly assigned 1077 patients to ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres. After inducing a fast ventricular tachycardia (VT) with a heart rate ≥240 b.p.m. or ventricular fibrillation (VF) with a low-energy T-wave shock, DF was attempted with an initial 15 J shock. If the shock reversed the VT or VF, DF testing was considered successful and terminated. If unsuccessful, two effective 24 J shocks were administered. If DF was unsuccessful, the system was reconfigured and another DF testing was performed. An ICD shock energy of 40 J had to be programmed in all patients for treatment of spontaneous VT/VF episodes. The primary endpoint was the average efficacy of the first ICD shock for all true VT/VF episodes in each patient during follow-up. The secondary endpoints included the frequency of system revisions, total fluoroscopy, implantation time, procedural serious adverse events, and all-cause, cardiac, and arrhythmic mortality during follow-up. Home Monitoring was used in all patients to continuously monitor the system integrity, device programming and performance. CONCLUSION: The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial is one of two large prospective randomized trials assessing the effect of DF testing omission during ICD implantation. CLINICALTRIALSGOV IDENTIFIER: NCT01282918.
Europace, 2015, Vol 17, Issue 1, p. 142-7
Adolescent; Adult; Aged; Aged, 80 and over; Defibrillators, Implantable; Equipment Failure Analysis; Europe; Female; Heart Failure; Humans; Male; Middle Aged; Monitoring, Intraoperative; Research Design; Treatment Outcome; Young Adult; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't