Title: A simplified, single-lead unipolar transvenous cardioversion-defibrillation system.
Abstract: BACKGROUND Transvenous implantable cardioverter-defibrillators provide significant advantages in the treatment of patients with life-threatening ventricular arrhythmias. However, present technology requires considerable electrophysiology expertise, multiple incisions, and long operative times for successful implementation. METHODS AND RESULTS In this study, we present a prototype of a new, easy-to-insert unipolar transvenous defibrillation system that has the reliability of epicardial defibrillation but the ease of pacemaker insertion. This system incorporates a single anodal right ventricular defibrillation electrode using a 65% tilt biphasic pulse delivered to a 108-cm2 surface area pulse generator titanium alloy shell as an active cathode placed in a left infraclavicular pocket. Testing of this system was performed before implantation of a standard nonthoracotomy-transvenous defibrillation system in 40 consecutive patients with a history of ventricular tachycardia or fibrillation. The simplified unipolar single-lead system resulted in a defibrillation threshold of 9.3 +/- 6.0 J with 37 of 40 patients (93%) having a defibrillation threshold of less than 20 J. Moreover, the unipolar defibrillation system was efficiently used requiring only 3.4 +/- 0.8 ventricular fibrillation inductions to measure the defibrillation threshold and 100 +/- 28 minutes to implement. CONCLUSIONS This new unipolar transvenous defibrillation system is as simple to insert as a pacemaker, requires few ventricular fibrillation inductions, demands less technical expertise, and provides defibrillation at energy levels comparable to that reported with epicardial lead systems. It should substantially reduce the morbidity, time, and cost of defibrillator implantation.