A RETRIEVABLE NITINOL VENA-CAVA FILTER - EXPERIMENTAL AND INITIAL CLINICAL-RESULTS

PURPOSE: The authors describe the properties of a new retrievable nitinol vena cava filter and report experimental and initial clinical results. MATERIALS AND METHODS: The filters, made of nitinol monofilament wire that forms a spiral cone and retrieval wire, were introduced through an indwelling 5.5-F transfemoral sheath into the infrarenal portion of the inferior vena cava in 10 sheep. In seven animals, four 4 x 30-mm radiopaque clots were injected below the filter to test its thrombus-trapping efficacy. Aspiration thrombectomy was then attempted, and the filter was removed. Follow-up venography was performed 1 week after placement in three other animals. After successful preclinical testing, the filter was implanted and retrieved in two patients. RESULTS: All 10 filters were successfully and easily placed in sheep. All filters were thrombus-free at follow-up venography. All clots injected in the iliac veins were trapped by the filter and successfully removed by means of aspiration thrombectomy. All 10 filters were retrieved without difficulty. Temporary filter implantation and retrieval were accomplished in two patients for 5 and 7 days. In one patient, infrafilter thrombus was aspirated. Perisheath thrombosis occurred in both patients. One patient subsequently underwent permanent filter placement. CONCLUSION: Temporary vena cava filtration is feasible. Potential advantages include easy placement, surveillance, and retrieval. One current limitation is pericatheter thrombosis, which may be eliminated by a less thrombogenic sheath.