Why the study?
Do System I and System II leads for an automatic implantable defibrillator provide satisfactory defibrillation thresholds in animal models?
Do System I and System II leads for an automatic implantable defibrillator provide satisfactory defibrillation thresholds in animal models?
The tested lead systems for an automatic implantable defibrillator demonstrated stable and satisfactory defibrillation thresholds in animal models, supporting their feasibility.
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Supports preclinical lead feasibility; human trials required before clinical adoption.
We examined the feasibility of using a standby automatic implantable defibrillator and established thresholds for internal defibrillation. The implantable defibrillator senses ventricular fibrillation and delivers an electrical impulse for defibrillation. Two lead systems for the device have been investigated. System I consists of two 12-cm2 silicone-covered titanium mesh patches attached to the atrial and diaphragmatic pericardial surfaces. System II has an identical diaphragmatic patch and a titanium spring catheter, with a 12-cm2 surface area of conductivity, placed transvenously in the right atrium. Both systems were implanted by thoracotomy in 12 dogs (mean weight 20 kg) and by a subxiphoid approach in 10 pigs (mean weight 20 kg). The defibrillation threshold (lowest energy required for 80% success) was determined periodically for 54 weeks in the dogs (615 trials) and at 6 weeks for the pigs (100 trials). In dogs, the mean defibrillation threshold with system I leads at 4 weeks was 10.5 J and did not change significantly over a 54-week period (p greater than 0.05). Similar results were obtained in the pig at 4 weeks. The defibrillation thresholds for both lead systems in dogs and pigs using a transpleural thoracotomy or a subxiphoid approach are satisfactory for an implantable defibrillator that produces 20-35 J.
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Deeb et al. (1981) studied this question.
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