The European clinical experience of 400 patients with a multi-zone automatic impiantatile cardioverter defibrillator, Ventak PRx

The CPI Ventak PRx AICD is designed to detect and terminate ventricular tachycardias and ventricular fibrillation with a wide variety of either antitachycardia pacing schemes or shocks programmable from 0.1 to 34 Joules, as well as to provide VVI pacing for bradycardia, In patients with serious or potentially serious ventricular tachyarrhythmias. A clinical study commenced in Europe in October 1990 and to date 400 patients have been implanted with the Ventak PRx with either thoracotomy based systems, comprising an endocardial lead or sutureless myocardlal leads for rate sensing and epicardial patches for shocking, or transvenous systems consisting of the Endotak lead for both rate sensing and shocking, the latter sometimes in combination with a subcutaneous or sub muscular patch. The PRx has been shown to be both safe and efficacious In combination with the thoracotomy and transvenous systems. There have been no device related deaths. The single transvenous lead, Endotak, with or without the subcutaneous or sub muscular patch, with a lower perioperative mortality risk compared with the thoracotomy based systems, and a less than one percent incidence of dislocation, is the lead system of choice.