INITIAL CLINICAL-EXPERIENCE WITH A NEW SMALL-SIZED 3RD-GENERATION IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR - RESULTS OF A MULTICENTER STUDY

This study reports the acute clinical experience with the new CPI VENT AK MINI: a small sized (68 cc), implantable cardioverter defibrillator (ICD) with 33 J stored energy. Implantation of the device was attempt ed in 113 patients (90 men, mean age 57 +/- 16 years, 64 with coronary artery disease, mean left ventricular ejection fraction 41%) with ven tricular tachycardia or ventricular fibrillation (VF). All 113 patient s (100%) were ultimately implanted, 12% of them for ICD replacement. T ransvenous 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 dem onstrated in all but 7 patients (6%). In 6 of these, safety criteria w ere not fully assessed while in the last patient defibrillation effica cy was not determined. Of the 104 patients with new leads, 90% underwe nt pectoral implantation. Of the 9 patients (9%) abdominally implanted , only 4 (4%) (3 children) were judged small sized for pectoral implan t. At predischarge testing, reliable VF detection and conversion were noted in 96 of 97 patients tested. There was no perioperative mortalit y. At a 3.6 +/- 1.3 months follow-up, 34% of the patients had a sponta neous arrhythmic event, and 24% of the patients received shocks. Clini cally inappropriate therapies occurred in 8% of the episodes in which any kind of therapy was delivered. This study demonstrates the short-t erm clinical efficacy and safety of the new device, and that pectoral implantation can be performed in the large majority of patients.