AIMS: The aim of the study was to compare the defibrillation energy requirements and the probability of successful defibrillation at multiples of the minimum defibrillation energy requirements in active pectoral implantable defibrillators with single- and dual-coil lead systems. METHODS AND RESULTS:Eighty-three consecutive patients undergoing implantation of an active pectoral cardioverter-defibrillator were randomized to receive a dual- or single-coil lead system. Defibrillators of two manufacturers with a fixed tilt biphasic defibrillation waveform were used. Defibrillation energy requirements were determined using a step-down defibrillation testing protocol. According to the randomization protocol, the patients were assigned to three additional consecutive defibrillation attempts during device implantation and during pre-discharge testing of either 1.0, 1.5 or 2.0 times the determined defibrillation energy requirement. Patients presenting defibrillation energy requirements > 15 J were excluded from analysis. Eighty of 83 patients (96%) completed the study protocol. Three patients were excluded due to elevated defibrillation energy requirements. The defibrillation energy requirements in the dual- and single-coil patient groups were 8.0 +/- 3.6 J and 8.4 +/- 3.7 J (ns), respectively. A comparable percentage of study patients showed defibrillation energy requirements <10 J (dual-coil: 88% vs single-coil: 83%). Defibrillation impedance was significantly different (dual-coil: 50 +/- 5.8 Ohm; single-coil: 39.8 +/- 4.2 Ohm). Regarding the probabilities of successful defibrillation, there were no significant differences between the two patient groups. The probabilities of defibrillation at the three multiples of the defibrillation energy requirement using a dual- and single-coil lead system were 82, 89.7 and 93.6 and 77.8, 94.1 and 95.8%, respectively (P=0.88, P=0.42, P=0.62, respectively). CONCLUSIONS: Dual- and single-coil active pectoral defibrillator systems show no difference in defibrillation energy requirements and no difference in the probability of successful defibrillation at multiples of the minimum defibrillation energy requirement. The use of more simplified defibrillator lead systems may contribute to a future lead design focusing on improvement in lead durability.
RCT Entities:
AIMS: The aim of the study was to compare the defibrillation energy requirements and the probability of successful defibrillation at multiples of the minimum defibrillation energy requirements in active pectoral implantable defibrillators with single- and dual-coil lead systems. METHODS AND RESULTS: Eighty-three consecutive patients undergoing implantation of an active pectoral cardioverter-defibrillator were randomized to receive a dual- or single-coil lead system. Defibrillators of two manufacturers with a fixed tilt biphasic defibrillation waveform were used. Defibrillation energy requirements were determined using a step-down defibrillation testing protocol. According to the randomization protocol, the patients were assigned to three additional consecutive defibrillation attempts during device implantation and during pre-discharge testing of either 1.0, 1.5 or 2.0 times the determined defibrillation energy requirement. Patients presenting defibrillation energy requirements > 15 J were excluded from analysis. Eighty of 83 patients (96%) completed the study protocol. Three patients were excluded due to elevated defibrillation energy requirements. The defibrillation energy requirements in the dual- and single-coil patient groups were 8.0 +/- 3.6 J and 8.4 +/- 3.7 J (ns), respectively. A comparable percentage of study patients showed defibrillation energy requirements <10 J (dual-coil: 88% vs single-coil: 83%). Defibrillation impedance was significantly different (dual-coil: 50 +/- 5.8 Ohm; single-coil: 39.8 +/- 4.2 Ohm). Regarding the probabilities of successful defibrillation, there were no significant differences between the two patient groups. The probabilities of defibrillation at the three multiples of the defibrillation energy requirement using a dual- and single-coil lead system were 82, 89.7 and 93.6 and 77.8, 94.1 and 95.8%, respectively (P=0.88, P=0.42, P=0.62, respectively). CONCLUSIONS: Dual- and single-coil active pectoral defibrillator systems show no difference in defibrillation energy requirements and no difference in the probability of successful defibrillation at multiples of the minimum defibrillation energy requirement. The use of more simplified defibrillator lead systems may contribute to a future lead design focusing on improvement in lead durability.