Objectives: This study analyzed the advantage of combining a biphasic device with a transvenous system and compared the results with those obtained with a standard monophasic device.
Background: Available lead systems use monophasic pulses and may require lengthy intraoperative testing to achieve adequate defibrillation threshold in a conspicuous number of patients. The option of biphasic waveform may provide further benefits. However, clinical experience with a permanent implant is lacking.
Methods: Fifty-five patients underwent testing and received a permanent implant using the Endotak lead system associated with a CPI monophasic device. The remaining 36 patients received a permanent implant with the Endotak lead system connected to a biphasic device. In both groups a subcutaneous patch was combined when needed to obtain acceptable defibrillation thresholds.
Results: Biphasic pulses resulted in lower mean (+/- SD) defibrillation thresholds (monophasic 15 +/- 4.7 J vs. biphasic 12 +/- 5 J, p = 0.03) and a better implantation rate (100% biphasic vs. 89% monophasic, p = 0.07). Biphasic pulses allowed implantation with less ventricular fibrillation induction (7.4 +/- 3.2 vs. 3.5 +/- 1.8, p < 0.01) and a mean shorter procedure time (168 +/- 39 vs. 111 +/- 30 min, p < 0.01). With the biphasic waveform a greater proportion of patients met the implantation criteria with the lead system alone (83% vs. 45%, p < 0.01). When needed, the left prepectoral location of the patch electrode was always sufficient in left subscapular position was required in 15 patients in the monophasic group. Implantation of the biphasic device was associated with a shorter mean hospital stay (3.8 +/- 0.8 vs. 5.4 +/- 2.2 days, p < 0.01).
Conclusions: Incorporation of a biphasic device in a transvenous implantable cardioverter-defibrillator uniformly increases the efficacy of the system and the ease of implantation.