Initial clinical experience with a new small sized third-generation implantable cardioverter defibrillator: results of a multicenter study. European Ventak Mini Investigator Group.

This study reports the acute clinical experience with the new CPI VENTAK MINI: a small sized (68 cc), implantable cardioverter defibrillator (ICD) with 33 J stored energy. Implantation of the device was attempted in 113 patients (90 men, mean age 57 +/- 16 years, 64 with coronary artery disease, mean left ventricular ejection fraction 41%) with ventricular tachycardia or ventricular fibrillation (VF). All 113 patients (100%) were ultimately implanted, 12% of them for ICD replacement. Transvenous lead implantation was accomplished in all 104 patients (100%) receiving new leads, 95% of them with a single lead configuration. The safety criteria for implantation (2 consecutive VF conversions at 15 J or 3 at 20 J, in both cases without failures to convert) were demonstrated in all but 7 patients (6%). In 6 of these, safety criteria were not fully assessed while in the last patient defibrillation efficacy was not determined. Of the 104 patients with new leads, 90% underwent pectoral implantation. Of the 9 patients (9%) abdominally implanted, only 4 (4%) (3 children) were judged small sized for pectoral implant. At predischarge testing, reliable VF detection and conversion were noted in 96 of 97 patients tested. There was no perioperative mortality. At a 3.6 +/- 1.3 months follow-up, 34% of the patients had a spontaneous arrhythmic event, and 24% of the patients received shocks. Clinically inappropriate therapies occurred in 8% of the episodes in which any kind of therapy was delivered. This study demonstrates the short-term clinical efficacy and safety of the new device, and that pectoral implantation can be performed in the large majority of patients.