[Is ICD-programming for double intraoperative defibrillation threshold energy safe and effective during long-time follow-up? Results of a prospective randomized multicenter study (Low-Energy Endotak Trial--LEET)].

The aim of this prospective and randomized study was to evaluate the safety and efficacy of a reduced shock strength in transvenous implantable defibrillator therapy. So far clinical data concerning the safety margin of the shock energy in ICD therapy do not exist. The shock energy tested during long-term follow-up in this study was twice the intraoperatively measured defibrillation threshold (DFT). A total number of 176 consecutive patients representing a typical cohort of ICD patients were evaluated. All patients received a non-thoracotomy lead system (CPI, Endotak 0070, 0090) and a biphasic cardioverter-defibrillator with the ability to store episodes (Cardiac Pacemakers Inc., Ventac TM PRx II, PRx III). The intraoperative defibrillation threshold (DFT) was evaluated in a step-down protocol (15, 10, 8, 5 J) and had to be < or = 15 J for inclusion into the study. The lowest effective energy terminating induced ventricular fibrillation had to be confirmed and was defined as DFT+ augmented defibrillation threshold. The DFT+ value was tested immediately after successful implantation, at discharge, and after a follow-up period of one year. Prior to implantation the patients were randomized into two groups. The energy of the first shock in the study group was programmed at twice DFT+ and in the control group at the maximum energy output (34 J). The efficacy of the first shock and its reproducibility in DFT testings and in spontaneous episodes during long-term follow-up of the study group were compared to those in the control group. A DFT+ value was found to be < or = 15 J in 166 of 176 patients (94%). The DFT+ in the study group was 9.6 +/- 3.2; in control group 10.1 +/- 3.5 J. The prohability of successful defibrillation at DFT+ level after one year was 84%. The success rate of the first shock meant to terminate induced ventricular fibrillation (VF) was 99.5% in the study group (217 of 218 episodes) and 99% in the control group (201 of 203 episodes). During follow-up of 24 +/- 9 months spontaneous episodes in the study group, 83/86 (96.5%) monomorphic ventricular tachycardias (MVT) and 38/40 (95%) VF-episodes were converted successfully by the 2x DFT+ shock. In the control group the first shock was successful in 151/156 (96.8%) spontaneous MVTs and in 30/33 (91%) VF episodes. The efficacy of the first shock was not influenced by clinical data such as the underlying cardiac disease, left ventricular function, ongoing antiarrhythmic therapy with amiodarone, or the number of spontaneous episodes per day or by the DFT itself. At a mean follow-up of two years there was no significant difference between the two groups concerning the incidence of sudden cardiac death (2.4% in the study group vs. 3.8% in the control group). In conclusion programming the first shock with the ICD lead system used in this study at 2x DFT+ is as efficient as a shock energy of 34 J in order to terminate induced and spontaneous episodes of VT/VF. Thus, the safety of ICD-therapy is not impaired when programming the shock energy at the 2x DFT+ value.