A prospective randomized cross-over comparison of mono- and biphasic defibrillation using nonthoracotomy lead configurations in humans.

Biphasic Defibrillation with Nonthoracotomy Leads. Introduction: For current implantable defibrillators, the nonthoracotomy approach to implantation fails in a substantial number of patients. In a prospective randomized cross-over study the defibrillation efficacy of a standard monophasic and a new biphasic waveform was compared for different lead configurations. Methods and Results: Intraoperatively, in 79 patients receiving nonthoracotomy defibrillation leads, the defibrillation threshold was determined in the initial lead configuration for the mono-and biphasic waveform. In each patient, both waveforms were used alternately with declining energies (20, 15,10, 5 J) until failure of defibrillation occurred. Three different initial lead configurations were tested in different, consecutive, nonrandomized patients using a bipolar endocardial defibrillation lead alone (A; n = 36) or in combination with a subcutaneous defibrillation patch (B; n = 24) or array (C; n = 19) lead. The lowest successful defibrillation energy with the biphasic waveform was less than, equal to, or higher than with the monophasic waveform in 64%, 28%, and 8% of patients, respectively, and on average significantly lower with the biphasic waveform for all three lead configurations (A: 11.3 ± 4.4 J vs 14.5 ± 4.5.); B: 9.7 ± 4.7 J vs 15.1 ± 4.5 J; C: 7.9 ± 4.5 J vs 12.4 ± 4.9 J). Defibrillation efficacy at 20 J was significantly improved by the biphasic waveform (91% vs 76%). Conclusion: In combination with nonthoracotomy defibrillation leads, the biphasic waveform of a new implantable cardioverter defibrillator showed superior defibrillation efficacy in comparison to the standard monophasic waveform. Defibrillation thresholds were improved for lead systems with and without a subcutaneous patch or array lead.