PURPOSE: To evaluate a percutaneous thrombolytic device (PTD) designed for treating thrombosed hemodialysis access grafts. MATERIALS AND METHODS: To compare the PTD with pulse-spray pharmacomechanical thrombolysis (PSPMT) by using urokinase, 122 randomly chosen patients with synthetic, thrombosed hemodialysis access grafts from multiple centers prospectively underwentthrombolysis with the PTD (5-F, low-speed rotational mechanical device) or PSPMT. Major outcome variables included the procedure time, the immediate technical patency rate, the complication rate, and the 3-month patency rate. RESULTS: Sixty-four PTD and 58 PSPMT procedures were performed with intent to treat. The immediate technical patency rate was 95% (61 of 64 [PTD] and 55 of 58 [PSPMT]) in both procedures. Median procedure times were 75 minutes in the PTD group (range, 25-209 minutes) and 85 minutes in the PSPMT group (range, 50-273 minutes; P < .04). Major complications occurred in 8% (five of 64) of PTD procedures (none related to the PTD) and 9% (five of 58) PSPMT procedures (not significant). Two devices broke (one during training) with no clinical sequela. The 3-month primary patency rate was 39% (25 of 64) in the PTD group and 40% (23 of 58) in the PSPMT group (not significant). CONCLUSION: The PTD is safe and effective for treating thrombosed hemodialysis access grafts. The technical and long-term success rates are similar to those of PSPMT; procedure times are shorter.
RCT Entities:
PURPOSE: To evaluate a percutaneous thrombolytic device (PTD) designed for treating thrombosed hemodialysis access grafts. MATERIALS AND METHODS: To compare the PTD with pulse-spray pharmacomechanical thrombolysis (PSPMT) by using urokinase, 122 randomly chosen patients with synthetic, thrombosed hemodialysis access grafts from multiple centers prospectively underwent thrombolysis with the PTD (5-F, low-speed rotational mechanical device) or PSPMT. Major outcome variables included the procedure time, the immediate technical patency rate, the complication rate, and the 3-month patency rate. RESULTS: Sixty-four PTD and 58 PSPMT procedures were performed with intent to treat. The immediate technical patency rate was 95% (61 of 64 [PTD] and 55 of 58 [PSPMT]) in both procedures. Median procedure times were 75 minutes in the PTD group (range, 25-209 minutes) and 85 minutes in the PSPMT group (range, 50-273 minutes; P < .04). Major complications occurred in 8% (five of 64) of PTD procedures (none related to the PTD) and 9% (five of 58) PSPMT procedures (not significant). Two devices broke (one during training) with no clinical sequela. The 3-month primary patency rate was 39% (25 of 64) in the PTD group and 40% (23 of 58) in the PSPMT group (not significant). CONCLUSION: The PTD is safe and effective for treating thrombosed hemodialysis access grafts. The technical and long-term success rates are similar to those of PSPMT; procedure times are shorter.