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A Multicenter, Randomized Trial Comparing an Active Can Implantable Defibrillator with a Passive Can System
Author(s) -
HAFFAJEE CHARLES,
MARTIN DAVID,
BHANDARI ANIL,
BARDY GUST H.,
DeSOUZA CYNTHIA,
KUEHLKAMP VICTOR,
CHURCH TIMOTHY
Publication year - 1997
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/j.1540-8159.1997.tb04846.x
Subject(s) - medicine , defibrillation , implant , multicenter study , randomized controlled trial , defibrillation threshold , implantable cardioverter defibrillator , multicenter trial , adverse effect , cardiology , surgery
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.