Hydrodynamic thrombectomy system versus pulse-spray thrombolysis for thrombosed hemodialysis grafts: A multicenter prospective randomized comparison

PURPOSE: To evaluate the safety and efficacy of a hydrodynamic thrombectomy system in a prospective, multicenter randomized comparison with pulse-spra y thrombolysis in hemodialysis grafts. MATERIALS AND METHODS: Nine centers enrolled 120 adult patients with recent ly (less than or equal to 14 days) thrombosed hemodialysis grafts. Craft ve nography was used to confirm occlusion in 62 patients randomly assigned to thrombectomy and 58 to thrombolysis. For thrombolysis, a mixture of 5,000 U of heparin and 250,000 U of urokinase was distributed throughout the throm bus, first to the venous then to the arterial graft end. For thrombectomy, the catheter was passed in the same sequence. Technical success was removal of 80% or more of thrombus. Clinical success was technical success plus th e ability to dialyze. Also assessed were total procedure time, thrombus tre atment time, procedure-related blood loss, other complications, and 30- and 90-day outcomes. RESULTS: Patient demographics were comparable. Technical success rates were 95% (59 of 62) for thrombectomy and 90% (52 of 58) for thrombolysis (P = . 31). Clinical success rates were 89% (55 of 62) and 81% (47 of 58), respect ively (P = .24). At 30 days, 69% (43 of 62) and 66% (38 of 58), respectivel y, could be dialyzed through the graft (P = .70); at 90 days, the rates wer e 40% (25 of 62) and 41% (24 of 58), respectively (P = .91). None of these differences or those for procedure-related blood loss and early and late co mplications were statistically significant. Thrombus treatment times of 16. 8 minutes for thrombectomy and 23.4 minutes for thrombolysis were significa ntly different (P < .01). CONCLUSION: The hydrodynamic thrombectomy system is at least as efficacious and safe as pulse-spray thrombolysis but shortens thrombus treatment time.