Arnold Miller1, Nir Lilach2, Raanan Miller3, Lowell Kabnick4. 1. Amsel Medical Corporation, Cambridge, Mass. Electronic address: arnold@amseltech.com. 2. Eliachar Technologies Development, Haifa, Israel. 3. Amsel Medical Corporation, Cambridge, Mass. 4. Langone Vein Center, New York University, New York, NY.
Abstract
BACKGROUND: Secure, permanent occlusion of the great and small saphenous veins, their tributaries, and perforators is critical for the successful treatment of varicose veins. Current minimally invasive methods replacing surgery are all endoluminal and involve heat (radiofrequency or laser), chemicals (sclerosants and glues), or a combination of mechanical and chemical interventions. This study evaluated in a porcine model the performance of a percutaneous delivery of the Amsel Vessel Occluder (AVO; Amsel Medical Corp, Cambridge, Mass) using ultrasound guidance. The AVO has received United States Food and Drug Administration premarket 510(k) clearance for use in open surgical procedures for tubular structures with diameters of 2 to 7 mm. METHODS: The AVO, a novel mechanical occlusion clip similar to a transfixion suture, is delivered through an 18-gauge hypodermic needle. The AVO is subsequently expanded on either side of the vessel wall, collapsed, and locked together to effect secure vascular occlusion, thus transfixing the targeted vessel. The targeted vessels in five swine (weight >60 kg) under general anesthesia were identified, and the vessel size was measured. Patency of the targeted vessels was confirmed on duplex ultrasound imaging. Each animal provided multiple vessels for percutaneous AVO occlusion. Occlusion was confirmed by duplex ultrasound imaging and by direct examination of the occluded vessel after open surgical exploration. RESULTS: Thirty vessel occlusions were performed percutaneously, including the common and superficial femoral arteries and veins (n = 24), the carotid artery (n = 4), and the external jugular vein (n = 1) and external jugular vein tributary (n = 1). Measured vessel sizes ranged from 1.8 to 12.7 mm. After vessel transfixion, occlusion was achieved in <30 seconds. A second AVO, if necessary, was delivered to completely occlude the targeted vessel where the vessel was >7 mm diameter (n = 2; external jugular vein, 12.7 mm; carotid artery, 7 mm), or where the initial AVO did not occlude the vessel because of nontransfixion (n = 1). Surgical exposure after occlusion confirmed that all targeted vessels were successfully occluded and demonstrated no evidence of injury to any of the adjacent structures. CONCLUSIONS: This study confirms that the AVO can be effectively delivered percutaneously under ultrasound guidance to occlude blood vessels in the porcine model and may be a useful, time-saving, and cost-effective adjunct to current primary methods of treating reflux in the saphenous veins, their tributaries, or perforators for the treatment of symptomatic varicose veins.
BACKGROUND: Secure, permanent occlusion of the great and small saphenous veins, their tributaries, and perforators is critical for the successful treatment of varicose veins. Current minimally invasive methods replacing surgery are all endoluminal and involve heat (radiofrequency or laser), chemicals (sclerosants and glues), or a combination of mechanical and chemical interventions. This study evaluated in a porcine model the performance of a percutaneous delivery of the Amsel Vessel Occluder (AVO; Amsel Medical Corp, Cambridge, Mass) using ultrasound guidance. The AVO has received United States Food and Drug Administration premarket 510(k) clearance for use in open surgical procedures for tubular structures with diameters of 2 to 7 mm. METHODS: The AVO, a novel mechanical occlusion clip similar to a transfixion suture, is delivered through an 18-gauge hypodermic needle. The AVO is subsequently expanded on either side of the vessel wall, collapsed, and locked together to effect secure vascular occlusion, thus transfixing the targeted vessel. The targeted vessels in five swine (weight >60 kg) under general anesthesia were identified, and the vessel size was measured. Patency of the targeted vessels was confirmed on duplex ultrasound imaging. Each animal provided multiple vessels for percutaneous AVO occlusion. Occlusion was confirmed by duplex ultrasound imaging and by direct examination of the occluded vessel after open surgical exploration. RESULTS: Thirty vessel occlusions were performed percutaneously, including the common and superficial femoral arteries and veins (n = 24), the carotid artery (n = 4), and the external jugular vein (n = 1) and external jugular vein tributary (n = 1). Measured vessel sizes ranged from 1.8 to 12.7 mm. After vessel transfixion, occlusion was achieved in <30 seconds. A second AVO, if necessary, was delivered to completely occlude the targeted vessel where the vessel was >7 mm diameter (n = 2; external jugular vein, 12.7 mm; carotid artery, 7 mm), or where the initial AVO did not occlude the vessel because of nontransfixion (n = 1). Surgical exposure after occlusion confirmed that all targeted vessels were successfully occluded and demonstrated no evidence of injury to any of the adjacent structures. CONCLUSIONS: This study confirms that the AVO can be effectively delivered percutaneously under ultrasound guidance to occlude blood vessels in the porcine model and may be a useful, time-saving, and cost-effective adjunct to current primary methods of treating reflux in the saphenous veins, their tributaries, or perforators for the treatment of symptomatic varicose veins.