Long-term intravascular defibrillator placement is feasible and maintains vascular patency and device stability in a canine model.
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Supports preclinical feasibility in canines; leaves open translation to human safety and efficacy trials.
INTRODUCTION: A percutaneously placed implantable intravascular defibrillator (PICD) has been developed with a right ventricular (RV) single-coil lead and titanium electrodes in the superior vena cava (SVC) and the inferior vena cava (IVC). This study evaluated implant techniques, device stability, and anchor histology of the PICD over 9 months in a canine model. METHODS: Twenty-four hounds (wt = 30-55 kg) were anesthetized and a custom sheath introduced into the right femoral vein. The PICD was advanced over a wire and positioned with the titanium electrodes (cathodes) in the SVC and the IVC. A nitinol anchor secured the device in the jugular. The RV lead was positioned in the RV apex and screwed into place. The catheters, wires, and sheath were removed with an average implant time of 14 minutes. In one group of animals (n = 13), serial venograms were performed at 7 days, 14 days, and 28 days. In a second group (n = 6) and third group (n = 5), venograms were also performed at 90 days and 270 days, respectively. Six canines were sacrificed and anchor histologic examination done at 90 days. RESULTS: All implants were successful with no surgical complications observed. Devices (N = 24) remained appropriately positioned with no anchor migration. Histology at 90 days showed 98% endothelialization of the anchor. Venograms revealed patent IVC and jugular veins in all animals at every time point examined. CONCLUSIONS: The PICD can be rapidly and chronically implanted in animals. Long-term intravascular defibrillator placement is feasible in a canine model.
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Merkely et al. (2013) studied this question. Percutaneously placed implantable intravascular defibrillator (PICD) was evaluated on Implant success, device stability, and anchor histology.
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