Rapid thrombectomy with a hydrodynamic catheter: results from a prospective, multicenter trial.

PURPOSE: To evaluate efficacy and safety of a hydrodynamic rheolytic thrombectomy device for rapid percutaneous treatment of acute thromboembolic occlusions of native lower-extremity arteries and bypass grafts. MATERIALS AND METHODS: In 50 patients, thrombectomy was performed with the rheolytic catheter at four centers. Patients had acute occlusions of native lower-extremity arteries (n = 39) or acute thrombosis of lower-limb bypass grafts (n = 11). Estimated occlusion age was 5 days +/- 5. Mean thrombus length was 15 cm +/- 11. Clinical success was measured on a scale of -3 (deterioration) to +3 (improvement) with established criteria. RESULTS: With the thrombectomy catheter, the majority of thrombus material was removed and antegrade blood flow was reestablished in 45 (90%) patients. Technical success (residual luminal narrowing < 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 improvement) in nine (18%). Clinically unimportant complications related to use of the device were one (2%) distal embolization and two (4%) dissections. Laboratory analysis revealed hemolysis without clinical sequelae. Primary patency rates were 76% after 30 days, 74% after 3 months, and 69% after 1 year. CONCLUSION: The hydrodynamic catheter appears to be safe and effective for rapid thrombectomy.