Percutaneous Venous Thrombectomy with the Use of a Balloon Sheath

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Abstract
To test mechanical thrombectomy of extensive iliofemoral and iliocaval thrombi in an in vitro flow model with the use of 12F and 18F balloon sheaths. Newly developed 12F and 18F sheaths were evaluated in four vessel models (simulation of femoral, iliofemoral, iliocaval, and caval thrombi by clotted bovine blood in a flow model). After retrograde insertion of the sheath and blocking of the vessel proximal to the thrombus by inflating the balloon, mechanical fragmentation was performed coaxially through the sheath lumen by using a 7F pigtail rotation device. With an occlusion balloon catheter, residual thrombi were withdrawn to the orifice of the sheath and aspirated. Twelve silicone tubes occluded by thrombi were recanalized in each setting. In the latex model, seven recanalizations were performed. Al l clots were removed completely within a treatment duration of 2 to 14 minutes. Fluid loss during the procedure was 29.6 to 129.3 mL for the femoral flow model, 61.9 to 137.2 mL for the iliofemoral model, 74.5 to 163.4 mL for the iliocaval model, and 102.7 to 236.7 mL for the caval model. No fragments were washed downstream. In four settings, small residual thrombi were attached to the balloon after deflation of the sheath. Clot amounts up to 171 g were removed quickly and completely by using these large-caliber balloon sheaths. Fluid loss from aspiration was negligible. Balloon occlusion prevented embolization of thrombus fragments proximal to the sheath. Further studies are needed to prove the efficacy of this technique in vivo.