Clinical and economic evaluation of the trellis thrombectomy device for arterial occlusions: preliminary analysis.

OBJECTIVES This preliminary study examined the technical efficacy, safety, and cost of treating arterial occlusions with a single device that combines pharmacologic and mechanical thrombolysis. METHODS The technical success, bleeding complications, and costs for the first 26 consecutive patients in whom lower extremity ischemia was treated with the Trellis infusion catheter (TIC) were analyzed. Procedure time, thrombolytic infusion time, technical success, bleeding complications (major and intracranial hemorrhage), interventional suite time, and 30-day amputation-free survival were evaluated. RESULTS 15 of 26 patients (58%) who received treatment with the TIC had acute arterial occlusions, and 11 of 26 patients (42%) had nonacute arterial occlusions. Nineteen of 26 patients (73.1%) received treatment of an infrainguinal occlusion, and 7 of 26 patients (26.9%) received treatment of a suprainguinal occlusion. Lower extremity native arteries were treated in 18 of 26 patients (69%), and lower extremity bypass grafts in 8 of 26 patients (31%). The technical success rate with TIC treatment was 92%, and the 30-day amputation-free survival rate was 96%. There was no difference in technical success or amputation-free survival rate between acute versus nonacute arterial occlusions, native artery versus bypass grafts, and suprainguinal versus infrainguinal arterial occlusions. Procedure time was 2.1 +/- 0.9 hours, and infusion time was 0.3 +/- 0.2 hours. There were no bleeding complications; however, 3 of 26 patients (11.5%) required further intervention to treat distal embolization. The overall mean cost for patients with TIC treatment was $3216 +/- $1740. CONCLUSIONS Early results of TIC treatment in patients with arterial occlusions suggest that it is as effective as traditional catheter-directed thrombolysis. Furthermore, there were no bleeding complications, likely the result of TIC requiring shorter procedure and infusion times.