Objective—To evaluate manufacturing variability, diffusion of filling solutions, and maintenance of occlusion over time in 3 sizes of silicone hydraulic occluders (HOs).
Sample Population—2-, 5-, and 20-mm HOs (HO2, HO5, and HO20, respectively).
Procedures—Manufacturing variability was analyzed by comparing variation in internal luminal areas and filling volumes within each size group. Occluders were filled to 100% occlusion with air (n = 4), saline (0.9% NaCl) solution (4), or sodium hyaluronate (4) and submerged in simulated body fluid. Changes in luminal area and weight were recorded for 133 days to evaluate maintenance of occlusion.
Results—Considerable variability in uninflated luminal area and fill volumes was observed among the 3 sizes of HOs. Loss of occlusion developed in the first 12 hours in all air-filled HOs. Fluid-filled occluders were reliable in maintenance of occlusion after 133 days (99.99% for HO20, 99.59% for HO5, and 90.40% for HO2), although diffusion of saline solution and hyaluronate from all HOs was confirmed by detection of significant decreases in weight over time. There was no significant difference in weight loss between HOs filled with saline solution and HOs filled with sodium hyaluronate.
Conclusions and Clinical Relevance—Saline solution or sodium hyaluronate may be used as a filling solution in the HOs tested. Maintenance of occlusion was best in the larger sizes. Saline solution or sodium hyaluronate should be used in future clinical investigations of HOs. Retrograde filling to remove air should be used when filling HOs with fluid.
OBJECTIVE To evaluate the closure rate and completeness of closure for a silicone–polyacrylic acid gradual venous occlusion device placed around an intra-abdominal vein to simulate gradual occlusion of an extrahepatic portosystemic shunt.
ANIMALS 3 purpose-bred cats and 2 purpose-bred dogs.
PROCEDURES The device was surgically placed around an external (cats) or internal (dogs) iliac vein. Computed tomographic angiography was performed at the time of surgery and 2, 4, and 6 weeks after surgery. Ultrasonographic examinations of blood flow through the vein within the device were performed at the time of surgery and at weekly intervals thereafter. Dogs were euthanized 6 weeks after surgery, and the external iliac veins were harvested for histologic examination.
RESULTS The prototype gradual venous occlusion device was successfully placed in all animals, and all animals recovered without complications following the placement procedure. The vessel was completely occluded in 2 cats by 6 weeks after surgery, as determined on the basis of results of CT and ultrasonography; there was incomplete occlusion with a luminal diameter of 1.5 mm in the other cat by 6 weeks after surgery. The vessel was completely occluded in both dogs by 6 weeks after surgery. Histologic examination of the external iliac veins obtained from the dogs revealed minimal inflammation of the vessel wall and no thrombus formation.
CONCLUSIONS AND CLINICAL RELEVANCE The prototype device induced gradual attenuation of an intra-abdominal vessel over a 6-week period. This device may provide another option for gradual occlusion of extrahepatic portosystemic shunts.