Clinical application of the coil-sack vascular occlusion device in infants and children

Transcatheter interventional procedures for the treatment of congenital heart defects have become increasingly important. A few devices are available for use in the United States. Each device is effective for a limited number of cardiovascular defects. Thus, there remains a need for additional safe and effective transcatheter occlusion devices. We developed a new transcatheter device, the Gianturco-Grifka Vascular Occlusion Device, which consists of a nylon sack attached to an end-hole catheter. A wire is advanced through the catheter into the sack. The wire coils, filling the sack, occluding the vessel, and providing transmural pressure to maintain the sack position. Prior to release, the device may be repositioned, removed, or exchanged for a different size device. The device is available in four sizes (3, 5, 7, and 9 mm). We evaluated this device in a canine model, occluding subclavian and carotid arteries, and surgically created aorto-pulmonary shunts. All vessels were occluded completely without complication. The device received FDA approval, and we have used the device to occlude patent ductus arteriosus, aorto-pulmonary collateral vessels, intrapulmonary arteriovenous malformation, and other defects. In every patient, the vessel was occluded completely without complication. This device can occlude a tubular PDA, aorto-pulmonary collateral, arteriovenous fistula, aneurysm, synthetic graft, vessel supplying a tumor, or other vascular structure. There are only two limitations; an & French sheath is needed to deliver the device, and the vessel must be long enough for the sack to contact firmly against the vessel wall. When compared to other occlusion devices, this device has several advantages: the ability to reposition the device or remove it prior to release, several different sizes, and the device conforms to many vascular shapes. The GGVOD is another important tool in the transcatheter armamentarium. Copyright (C) 1996 Elsevier Science Ireland Ltd.