RAPID THROMBECTOMY WITH A HYDRODYNAMIC CATHETER - RESULTS FROM A PROSPECTIVE, MULTICENTER TRIAL

PURPOSE: To evaluate efficacy and safety of a hydrodynamic rheolytic t hrombectomy device for rapid percutaneous treatment of acute thromboem bolic occlusions of native lower-extremity arteries and bypass grafts. MATERIALS AND METHODS: In 50 patients, thrombectomy was performed wit h the rheolytic catheter at four centers. Patients had acute occlusion s of native lower-extremity arteries (n = 39) or acute thrombosis of l ower-limb bypass grafts (n = 11). Estimated occlusion age was 5 days /- 5. Mean thrombus length was 15 cm +/- 11. Clinical success was meas ured on a scale of -3 (deterioration) to +3 (improvement) with establi shed criteria. RESULTS: With the thrombectomy catheter, the majority o f thrombus material was removed and antegrade blood flow was reestabli shed in 45 (90%) patients. Technical success (residual luminal narrowi ng <50%) was 52% with use of the device alone. Adjunctive therapy was performed in 45 patients. Clinical improvement after intervention was +3 in 25 (50%) patients, +2 in 10 (20%), +1 in six (12%), and 0 (no im provement) in nine (18%). Clinically unimportant complications related to use of the device were one (2%) distal embolization and two (4%) d issections. Laboratory analysis revealed hemolysis without clinical se quelae. Primary patency rates were 76% after 30 days, 74% after 3 mont hs, and 69% after 1 year. CONCLUSION: The hydrodynamic catheter appear s to be safe and effective for rapid thrombectomy.