In Vitro Evaluation of the Occlusive Properties of the ArtVentive Endoluminal Occlusion System Occlusion Device for Transrenal Ureteral Occlusion

Abstract

Purpose:

Current techniques for percutaneous ureteral occlusion are either technically difficult or not satisfactory because of frequent ureteral recanalization. The purpose of this in vitro study was to evaluate the occlusive properties of an “off the shelf” solution (Endoluminal Occlusion System [EOS™]; ArtVentive Medical Group, Inc., Carlsbad, CA) for transrenal ureteral occlusion.

Materials and Methods:

Both 8 and 11 mm expanded polytetrafluoroethylene-covered ArtVentive EOS devices were used in 10 porcine models. Experiments were performed in explanted porcine ureters to simulate physiologic conditions. EOS devices were deployed in a midureteral position using a transrenal approach. Contrast agent (Iopamidol 300) diluted in saline solution was infused into the renal pelvis under continuous fluoroscopic guidance. Intrapelvic pressure measurements were performed until leakage, plug dislocation, or until pelvic blow out occurred.

Results:

All EOS devices were deployed effectively and achieved prompt total ureteral occlusion. Ureteral leakage occurred with intraureteral pressures between 60 to 109 cm H₂O (8 mm EOS) and between 65 and 125 cm H₂O (11 mm EOS). Before leakage, tubular reflux was seen in all cases, pelvic blowout occurred in half of the cases.

Conclusions:

The ArtVentive EOS occlusive device is an effective tool for “off the shelf” ureteral occlusion. Both the 8 mm and the 11 mm devices fully occluded ureters at pressure levels that are to be expected in vivo.