RATIONALE AND OBJECTIVES: To evaluate the efficacy of a rheolytic thrombectomy catheter (RTC) for treatment of acutely occluded infra-aortic native arteries and bypass grafts and to determine midterm primary patency, death, and amputation-free survival rates. METHODS: From March 1995 to September 1997, 112 patients with occluded arteries or bypass grafts were primarily treated with RTC at two centers. Thrombus removal was evaluated by two angiographers. RESULTS: More than 75% of the thromboembolic material could be removed with RTC alone. Mean activation time of RTC was 280 +/- 163 seconds. Residual mural or organized thrombi (29%) required adjunctive fibrinolytic therapy or aspiration thrombectomy. Remaining stenoses were treated with percutaneous transluminal angioplasty and additional stent implantation. For acute reocclusions, surgical intervention was required. Technical success after the entire procedure was 88.4%. RTC-associated complications included distal embolization, dissection, vessel perforation, and technical failure of RTC. Mean follow-up time was 14.8 months +/- 11.5, rates of primary patency, secondary patency, death, and amputation-free survival were 60%, 84%, 16%, and 75% after 2 years, respectively. CONCLUSIONS: RTC is a rapid and efficient technique for mechanical thrombectomy of acutely thrombosed native leg arteries and bypass grafts. Midterm results are comparable to the results of alternative treatment modalities such as Fogarty balloon thromboembolectomy or local fibrinolysis.
RATIONALE AND OBJECTIVES: To evaluate the efficacy of a rheolytic thrombectomy catheter (RTC) for treatment of acutely occluded infra-aortic native arteries and bypass grafts and to determine midterm primary patency, death, and amputation-free survival rates. METHODS: From March 1995 to September 1997, 112 patients with occluded arteries or bypass grafts were primarily treated with RTC at two centers. Thrombus removal was evaluated by two angiographers. RESULTS: More than 75% of the thromboembolic material could be removed with RTC alone. Mean activation time of RTC was 280 +/- 163 seconds. Residual mural or organized thrombi (29%) required adjunctive fibrinolytic therapy or aspiration thrombectomy. Remaining stenoses were treated with percutaneous transluminal angioplasty and additional stent implantation. For acute reocclusions, surgical intervention was required. Technical success after the entire procedure was 88.4%. RTC-associated complications included distal embolization, dissection, vessel perforation, and technical failure of RTC. Mean follow-up time was 14.8 months +/- 11.5, rates of primary patency, secondary patency, death, and amputation-free survival were 60%, 84%, 16%, and 75% after 2 years, respectively. CONCLUSIONS: RTC is a rapid and efficient technique for mechanical thrombectomy of acutely thrombosed native leg arteries and bypass grafts. Midterm results are comparable to the results of alternative treatment modalities such as Fogarty balloon thromboembolectomy or local fibrinolysis.