Clinical experience with downsized lower energy output implantable cardioverter defibrillators. Ventak Mini II Clinical Investigators.

BACKGROUND AND STUDY OBJECTIVE

Technical improvements in cardioverter defibrillators technology has resulted in decrease in can size coupled with improved electrodes technology. A decrease in maximum energy output allows further decrease in device size. The aim of this study was to evaluate the feasibility of a single lead transvenous implant employing a downsized cardioverter-defibrillator (volume 59 cm3), with a related decrease in maximum energy output (29-31 joules as stored energy and 25-27 joules as delivered energy).

METHODS AND RESULTS

Fifty-five patients with ventricular tachyarrhythmias were enrolled in 17 European institutions for implantation. At implantation step-down defibrillation threshold (DFT) was determined and the device was implanted only if a safety margin > or =10 joules was maintained between DFT and maximum programmable output. Implantation was performed in 54 of the 55 referred patients (98%) in a single electrode-device configuration. Step-down DFT testing was performed in 44 patients (43 finally implanted) and DFT was 7.77+/-4.41 joules (range 3-20). In 20 of the tested patients (45%) DFT was < or =5 joules, in 26 patients (59%) was < or =8 joules and in 34 patients (77%) it was < or =10 joules. No differences were found in DFT comparing patients with left ventricular ejection fraction < or = or >40% or patients treated or not with antiarrhythmic drugs or beta-blockers. Mean implant duration was 85+/-34 min.

CONCLUSIONS

Employing a downsized cardioverter defibrillator, successful transvenous implantation can be achieved in 98% of the patients, with maintenance of adequate defibrillation safety margins despite a reduction in stored energy to 29 joules.