ABSTRACT
OBJECTIVES: Endovascular occlusion of blood vessels represents a key component of interventional therapy. While coils are most commonly used, vessel occlusion is generally not achieved immediately and may necessitate a large number of devices. It has been suggested that endovascular plugs may overcome these limitations; however, immediate and durable occlusion remains a challenge with plugs as well. This study evaluates a newly designed endovascular occlusion system (EOS) METHODS: The EOS combines a nitinol coil with an impermeable membranous cap made of expanded polytetrafluoroethylene. The coil offers sufficient radial force to expand the membrane and minimize post-deployment migration. Fifteen test devices were deployed in the iliac (external and internal) and femoral arteries of five miniature swine, while two commercially available devices (platinum coils and a vascular plug) were used as controls in one miniswine. Angiography was performed 1, 5, and 10 minutes after device implantation. Follow-up angiography was obtained either on day 29 or day 61, prior to devices harvesting for histological evaluation and biocompatibility assessment. RESULTS: No clinical complications were observed in the animals throughout the study course. All test devices were deployed as intended, and produced complete and immediate vessel-occlusion. No recanalization or acute migration was observed within 10 minutes of deployment, whereas five test devices had migrated between 5 and 15 mm at follow-up angiography. Complete and durable vessel-occlusion without any sign of recanalization was observed in all EOS devices during the follow-up period. CONCLUSION: The EOS is a safe and reliable device resulting in immediate and durable vessel occlusion in the peripheral arterial circulation. While no device migration was observed in the pelvic area, it was observed with five test and one control devices in the vicinity of highly mobile articulations, leading to the conclusion that occlusion devices should not be placed within hypermobile areas such as the hip joint.
Subject(s)
Blood Vessel Prosthesis , Embolization, Therapeutic/instrumentation , Endovascular Procedures/instrumentation , Animals , Disease Models, Animal , Embolization, Therapeutic/methods , Endovascular Procedures/methods , Female , Femoral Artery/diagnostic imaging , Follow-Up Studies , Iliac Artery/diagnostic imaging , Intraoperative Care/methods , Prosthesis Design , Radiography , Random Allocation , Swine , Swine, Miniature , Time Factors , Treatment OutcomeABSTRACT
PURPOSE: The purpose of this study was to determine the safety and efficacy of a new endoluminal occlusion device, ArtVentive endoluminal occlusion system (EOS), to occlude the spermatic vein in symptomatic males with varicoceles. METHODS: The ArtVentive EOS device has been developed for percutaneous, peripheral occlusion of the peripheral arterial and venous vasculature. The system is comprised of an implantable occlusion device and a delivery catheter. At present, there are two device sizes: (a) size 1 for target vessels ranging between 3.5 and 5.5 mm in diameter, and (b) size 2 for target vessels 5.5-8.5 mm in diameter. The treatment group included six adult males, ages 22-34 years. Nine target vessels were occluded. A total of 20 devices were implanted in six subjects. RESULTS: The acute occlusion rate at the end of the procedure was 100 % occurring in nine of nine vessels. The spermatic veins of all patients remained occluded on venography at 30 days follow-up. Pain scores related to varicoceles decreased in five of six patients. CONCLUSIONS: Although we recognize this study is limited, initial experience indicates that the ArtVentive EOS is a safe and effective new device for occlusion of vessels (varicoceles). The device has potential applications in other clinical conditions requiring occlusion of veins or arteries.
Subject(s)
Embolization, Therapeutic/instrumentation , Prostheses and Implants , Spermatic Cord/blood supply , Varicocele/therapy , Adult , Contrast Media/administration & dosage , Humans , Male , Pain Measurement , Phlebography , Prosthesis Design , Radiography, Interventional , Treatment Outcome , VeinsABSTRACT
Endovascular occlusion of blood vessels is an important part of interventional therapy concepts. Here, we evaluate the feasibility, procedural safety and efficacy of the novel endovascular occlusion system (EOS) in the arterial system in a porcine model. Thirteen devices were deployed in the iliac and femoral arteries (diameter: 4-5 mm) of five adult swine. Post-deployment angiography was performed at 1, 5 and 10 min and 6 h. All devices (n = 13) could be successfully delivered without any complications, such as dissection, perforation or rupture. The devices could be easily advanced to the target vessel segment, deployed at the intended target location and produced immediate and complete vessel occlusion which was confirmed to be maintained after 6 h. No leaks, recanalization or device migration was observed. In this pilot study, we demonstrate the feasibility, safety and efficacy of immediate vessel occlusion with the EOS device in the peripheral arterial system in a porcine animal model. Our data indicate that this novel device allows precise delivery without the occurrence of cardiovascular complications. Owing to its long-term safety and efficacy the EOS may represent a promising and effective alternative to currently available devices for vessel occlusion during vascular interventions.
