Abstract

The purpose of this in vitro study was to evaluate the occlusive properties of the ArtVentive EOS for transrenal ureteral occlusion and percutaneous occlusion of biliary leaks. A total of 20 ArtVentive EOS devices were used. Examinations were performed under fluoroscopic guidance. Transrenal ureteral embolization was performed in 10 explanted porcine ureters/kidneys using 8 mm and 11 mm devices (5 devices each). EOS devices were deployed in a mid-ureteral position using a transrenal approach. Intra-pelvic pressure measurements were performed while diluted contrast agent was infused into the renal pelvis until leakage, device dislocation, or pelvic blow out occurred. Biliary leak embolization was performed in 5 explanted porcine livers and in 3 explanted bovine livers. After gaining access to the biliary system via a standard percutaneous transhepatic biliary drainage access artificially created biliary leaks were occluded using either 5 mm or 8 mm EOS devices. Using the 5 mm device peripheral (n = 3), central (n = 1) and cystic duct leaks (n = 1) were occluded. Using the 8 mm device peripheral (n = 1), central (n = 1), main (n = 1) and cystic duct leaks (n = 2) were occluded. Intraureteral device deployment was successful enabling total ureteral occlusion in all cases. Leakage occurred with intraureteral pressures between 60-109 cmH2O (8 mm EOS) and 65-125 cm H20 (11 mm EOS). Prior to leakage tubular reflux was seen in all cases, pelvic blowout occurred in half of the studies. Selective deployment and occlusion of central biliary leaks (3/3) and cystic stump leaks (3/3) was successful in all cases. Peripheral leaks could not be selectively catheterized in 3/4 cases making device deployment several millimeters proximal of the leaks necessary. The ArtVentive EOS occlusive device offers an “off the shelf” solution for percutaneous ureteral occlusion. In the biliary system the device allows for single setting occlusion of larger peripheral, central and cystic duct leaks; a disadvantage is that smaller peripheral leaks cannot be treated selectively.

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