Multiple successful conversions of ventricular fibrillation (VF) at 10 J below the maximum output of implantable cardioverter defibrillator (ICD) have been recommended as a minimum device implantation criterion. This recommendation is based on the probabilistic properties of defibrillation that necessitates multiple shocks to establish an adequate safety margin for the conversion of subsequent spontaneous arrhythmias. We hypothesized that a single successful shock at a 14 J may suffice.
Methods and results: The Low Energy Safety Study (LESS) enrolled 720 patients undergoing initial ICD implantation with a dual-coil transvenous lead and active pulse generator. At implant, an enhanced defibrillation threshold (DFT++) was determined by a rigorous protocol beginning at 14 J, and requiring at least 4 shocks. Fifty percent of all patients were then randomized to full output shock energy and the conversion rates for spontaneous ventricular tachyarrhythmias at rates > 200 beats/min were measured. There were 318 patients randomized to 31 J, of whom 254 were successfully defibrillated by an initial 14 J shock. During a mean follow-up of 24 +/- 12 months, 112 spontaneous VF episodes occurred in 31 patients. The combined conversion success of the first and second shock (when needed) did not differ between the subgroup of patients who were successfully defibrillated by an initial 14 J shock, regardless of the results of additional testing, and the whole cohort who underwent more systematic testing (97% vs 97%). All spontaneous episodes of VF were successfully treated during long-term follow-up.
Conclusions: A first successful shock of 14 J may be a sufficient endpoint to allow the implantation of ICDs with the Triad lead configuration, when programming all shocks to 31 J.