Treatment of thrombosed dialysis access grafts: randomized trial of surgical thrombectomy versus mechanical thrombectomy with the Amplatz device.

PURPOSE: To report the preliminary results in a trial comparing the Amplatz mechanical thrombectomy (MT) device with surgical thrombectomy (ST) to declot occluded dialysis access grafts. PATIENTS AND METHODS: Thirty-seven patients were randomly assigned by computer to either ST (n = 18) or MT (n = 19). Diagnostic fistulograms were obtained at the end of the procedure, and Doppler ultrasound was performed at 1-month follow-up. Plasma free hemoglobin levels were measured before, immediately after, and 24 hours after the procedure in the MT group. Success was defined as initial success with restoration of flow through the graft, primary patency at 30 days, and secondary patency at 30 days.
RESULTS: Technical success with MT was 89%. Primary patency in the MT series was 47% and secondary 30-day patency was 68%. Technical success with ST was 83%. Primary patency in the ST series was 77% and secondary patency at 30 days was 77%. Angioplasty (n = 18) and stent placement (n = 6) were performed in the MT cases. Angioplasty was impossible in one patient. Immediately after MT, plasma free hemoglobin levels above normal were noted in 63% of the cases, but these levels were within normal levels after 24 hours in 88% of the cases.
CONCLUSION: Initial success of MT in patients with occluded dialysis access grafts is comparable to that of ST. No statistically significant differences in primary or secondary patencies were seen.

RCT Entities:   Population Interventions Outcomes