Zeitschrift für Kardiologie
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Randomized Controlled Trial Multicenter Study Clinical Trial
[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). ⋯ 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.