The Low Energy Safety Study (LESS): rationale, design, patient characteristics, and device utilization.

BACKGROUND: A 10-J energy safety margin has traditionally been used in programming implantable cardioverter defibrillators (ICDs). The Low Energy Safety Study (LESS) tests the hypothesis that programming shocks to lower energy margins is safe and effective. METHODS: Patients with standard ICD indications undergo defibrillation threshold testing (DFT) at the time of ICD implant, with reconfirmation of lowest successful energy twice (DFT++). Patients are randomized to 2 groups: the first has the initial 2 shocks for ventricular fibrillation conversion programmed at 2 energy steps above DFT++ (typically 4-6 J, maximum 10 J) with subsequent shocks at maximum energy, and the second has all shocks programmed at maximum energy. Patients are followed up every 3 months for 2 years to assess shock conversion efficacy of spontaneous arrhythmias. In a subgroup of patients, there is a second randomization to energy levels of 0, 1, 2, 3, or 4 steps above implant DFT++ for conversion testing of 3 induced ventricular fibrillation episodes at prehospital discharge, 3 months, and 12 months after implant. RESULTS: Enrollment is complete (702 patients), but follow-up results are pending. There were no significant variations in implant indications and baseline antiarrhythmic drug use over the 3-year enrollment period, although an increase in the percentage of dual-chamber ICDs implanted occurred, with the majority (65%) of implanted ICDs being dual-chamber devices by the end of the enrollment period. CONCLUSION: The results of LESS should facilitate the development of algorithms for programming ICD energy safety margins.