title: A multicenter, randomized trial comparing an active can implantable defibrillator with a passive can system. Jewel Active Can Investigators.
abstract: Replacing one defibrillation electrode lead by the defibrillator can may simplify implantation of the ICD. In this multicenter study, 304 patients were randomized to receive either the biphasic active can (AC) (model 7219C system, Medtronic, Inc.) or the passive can (PC) (model 7219D system). The AC and PC systems were compared with respect to their ability to meet the implant defibrillation criterion and to defibrillate VF, and to DFTs, implant time, patient adverse events, and survival rates. A higher percentage fulfilled the implant defibrillation criterion on the first configuration with the AC (86.3% vs 75.9% for PC; P = 0.023), and the first shock success for terminating induced VF was 94% for AC compared to 89% for PC (P = 0.026). DFTs were significantly lower (10.9 vs 12.7 J; P = 0.031), and implant time was significantly shorter for the AC patients (99.2 vs 112.0 min; P = 0.002). The two groups showed no significant differences in 3-month adverse event rates, 3-month survival, and hospital stay.
authors.affiliation: St. Elizabeth's Medical Center, Boston, Massachusetts 02135, USA.
authors.forename: C
authors.initials: C
authors.lastname: Haffajee
authors.forename: D
authors.initials: D
authors.lastname: Martin
authors.forename: A
authors.initials: A
authors.lastname: Bhandari
authors.forename: G H
authors.initials: GH
authors.lastname: Bardy
authors.forename: C
authors.initials: C
authors.lastname: DeSouza
authors.forename: V
authors.initials: V
authors.lastname: Kuehlkamp
authors.forename: T
authors.initials: T
authors.lastname: Church
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000145:classification*; D004553:Electric Conductivity; D004567:Electrodes, Implanted; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006323:Heart Arrest / Q000628:therapy; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D017180:Tachycardia, Ventricular / Q000628:therapy; D013997:Time Factors; D014693:Ventricular Fibrillation / Q000628:therapy