PURPOSE: To evaluate the safety and efficacy of a hydrodynamic thrombectomy system in a prospective, multicenter randomized comparison with pulse-spray thrombolysis in hemodialysis grafts. MATERIALS AND METHODS:Nine centers enrolled 120 adult patients with recently (</=14 days) thrombosed hemodialysis grafts. Graft venography 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 thrombus, 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 the ability to dialyze. Also assessed were total procedure time, thrombus treatment 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), respectively (P: =.24). At 30 days, 69% (43 of 62) and 66% (38 of 58), respectively, could be dialyzed through the graft (P: =.70); at 90 days, the rates were 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 complications were statistically significant. Thrombus treatment times of 16.8 minutes for thrombectomy and 23.4 minutes for thrombolysis were significantly different (P: <.01). CONCLUSION: The hydrodynamic thrombectomy system is at least as efficacious and safe as pulse-spray thrombolysis but shortens thrombus treatment time.
RCT Entities:
PURPOSE: To evaluate the safety and efficacy of a hydrodynamic thrombectomy system in a prospective, multicenter randomized comparison with pulse-spray thrombolysis in hemodialysis grafts. MATERIALS AND METHODS: Nine centers enrolled 120 adult patients with recently (</=14 days) thrombosed hemodialysis grafts. Graft venography 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 thrombus, 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 the ability to dialyze. Also assessed were total procedure time, thrombus treatment 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), respectively (P: =.24). At 30 days, 69% (43 of 62) and 66% (38 of 58), respectively, could be dialyzed through the graft (P: =.70); at 90 days, the rates were 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 complications were statistically significant. Thrombus treatment times of 16.8 minutes for thrombectomy and 23.4 minutes for thrombolysis were significantly different (P: <.01). CONCLUSION: The hydrodynamic thrombectomy system is at least as efficacious and safe as pulse-spray thrombolysis but shortens thrombus treatment time.
Authors: Peter H Lin; Tamuru Okada; James L Steinberg; Wei Zhou; Hosam F El Sayed; Anish Rawat; Panos Kougias; Qizhi Yao; Changyi Chen Journal: World J Surg Date: 2007-04 Impact factor: 3.352