A Prospective, Randomized, Comparison in Patients Between a Pectoral Unipolar Defibrillation System and That Using an Additional Inferior Vena Cava Electrode

The decrease of defibrillation energy requirement would render the currently available transvenous defibrillator more effective and favor the device miniaturization process and the increase of longevity. The unipolar defibrillation systems using a single RV electrode and the pectoral pulse generator titanium shell (CAN) proved to be very efficient. The addition of a third defibrillating electrode in the coronary sinus did not prove to offer advantages and in the superior vena cava showed only a slight reduction of the defibrillation threshold (DFT). The purpose of this study was to determine whether the defibrillation efficacy of the single lead unipolar transvenous system could be improved by adding an electrode in the inferior vena cava (IVC). In 17 patients, we prospectively and randomly compared the DFT obtained with a single lead unipolar system with the DFT obtained using an additional of an IVC lead. The RV electrode, Medtronic 6936, was used as anode (first phase of biphasic) in both configurations. A 108 cm2 surface CAN, Medtronic 7219/7220 C, was inserted in a left submuscular infraclavicular pocket and used as cathode, alone or in combination with IVC, Medtronic 6933. The superior edge of the IVC coil was positioned 2-3 cm below the right atrium-IVC junction. Thus, using biphasic 65% tilt pulses generated by a 120 microF external defibrillator, Medtronic D.I.S.D. 5358 CL, the RV-CAN DFT was compared with that obtained with the RV-CAN plus IVC configuration. Mean energy DFTs were 7.8 +/- 3.6 and 4.8 +/- 1.7 J (P < 0.0001) and mean impedance 65.8 +/- 13 O and 43.1 +/- 5.5 O (P < 0.0001) with the RV-CAN and the IVC configuration, respectively. The addition of IVC significantly reduces the DFT of a single lead active CAN pectoral pulse generator. The clinical use of this biphasic and dual pathway configuration may be considered in patients not meeting implant criteria with the single lead or the dual lead RV-superior vena cava systems. This configuration may also prove helpful in the use of very small, low output ICDs, where the clinical impact of ICD generator size, longevity, and related cost may offset the problems of dual lead systems.