PURPOSE: To evaluate safety and cost benefits of the percutaneous technique for treatment of aortic aneurysm, a prospective randomized study was performed that compared the endovascular suture technique with conventional cutdown access and repair. MATERIALS AND METHODS:From January 2002 through July 2002, 30 endografts, including 14 Talent stent-grafts (Medtronic, Sunrise, Fla) and 16 Zenith endografts (Cook, Bloomington, Ind) were implanted in 30 patients for endovascular aneurysm treatment. The patients were randomized to either percutaneous technique (group A) or conventional cutdown (group B). Fifty-five femoral arteries were cannulated with large-bore (14F-25F) introducers and were included in the study. Safety and efficiency of both techniques were assessed by recording the complication rates, operation time, discharge, and time to ambulation. Comparison of selected estimated costs included both variable and fixed costs for femoral access and expenses for treatment of complications. RESULTS: No operative deaths occurred. The complication rates were similar and included 1 arterial thrombosis in each group, 3 lymphoceles in group B, and 1 conversion to cutdown because of bleeding in group A. Mean surgery time (86.7 +/- 27 minutes vs 107.8 +/- 38.5 minutes; P <.05) and time to ambulation (20.1 +/- 4.3 hours vs 33.1 +/- 18.4 hours; P <.001) were significantly shorter in the group treated percutaneously. Because of the cost of the closure device, total cost of the percutaneous technique averaged 99.2 euro; more than cutdown. CONCLUSIONS: The percutaneous technique decreases the invasiveness of endovascular therapy of aortic aneurysm and reduces operative time and time to ambulation. Complications were roughly equivalent in severity. The additional cost for the device appears to justify its use for this form of aneurysm treatment.
RCT Entities:
PURPOSE: To evaluate safety and cost benefits of the percutaneous technique for treatment of aortic aneurysm, a prospective randomized study was performed that compared the endovascular suture technique with conventional cutdown access and repair. MATERIALS AND METHODS: From January 2002 through July 2002, 30 endografts, including 14 Talent stent-grafts (Medtronic, Sunrise, Fla) and 16 Zenith endografts (Cook, Bloomington, Ind) were implanted in 30 patients for endovascular aneurysm treatment. The patients were randomized to either percutaneous technique (group A) or conventional cutdown (group B). Fifty-five femoral arteries were cannulated with large-bore (14F-25F) introducers and were included in the study. Safety and efficiency of both techniques were assessed by recording the complication rates, operation time, discharge, and time to ambulation. Comparison of selected estimated costs included both variable and fixed costs for femoral access and expenses for treatment of complications. RESULTS: No operative deaths occurred. The complication rates were similar and included 1 arterial thrombosis in each group, 3 lymphoceles in group B, and 1 conversion to cutdown because of bleeding in group A. Mean surgery time (86.7 +/- 27 minutes vs 107.8 +/- 38.5 minutes; P <.05) and time to ambulation (20.1 +/- 4.3 hours vs 33.1 +/- 18.4 hours; P <.001) were significantly shorter in the group treated percutaneously. Because of the cost of the closure device, total cost of the percutaneous technique averaged 99.2 euro; more than cutdown. CONCLUSIONS: The percutaneous technique decreases the invasiveness of endovascular therapy of aortic aneurysm and reduces operative time and time to ambulation. Complications were roughly equivalent in severity. The additional cost for the device appears to justify its use for this form of aneurysm treatment.
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