Evaluation of balloon catheter-guided intra-arterial thrombolysis for acute peripheral arterial occlusion.

BACKGROUND: The objective of this study was to evaluate the effectiveness of a new method of in situ thrombolysis using a porous balloon with low pressure compared with traditional in situ infusion of a fibrinolytic agent in the treatment of acute limb ischemia.

METHODS: Between January 2010 and December 2011, 14 patients (mean age, 67.2 years; range, 40-89 years) treated for grade II acute lower limb ischemia for fewer than 14 days were included in the study. Thromboaspiration was tried initially in all the cases. All patients benefitted from a novel method of intra-arterial thrombolysis guided with a balloon catheter (ClearWay; Atrium Medical, Hudson, NH) and using the same agent thrombolytic (Actosolv). The total amount injected, the rate of morbidity associated with the thrombolytic treatment, and the duration of hospitalization in the continuous monitoring unit were analyzed.

RESULTS: Recanalization was obtained in 92% of cases (13 of 14). The rate of morbidity related to the procedure was 7%. The amount of fibrinolytic agent necessary was relatively low (82,000 units/cm of occluded artery). The rate of limb salvage 6 months after recanalization was of 92%. The mean duration of stay in the continuous monitoring unit was 1.1 day.

CONCLUSIONS: Intra-arterial thrombolysis using the ClearWay balloon catheter is an effective method in the treatment of acute peripheral arterial occlusion. In the event of embolic occlusion, mainly among very old patients, it could decrease the hemorrhagic risk. A randomized study in these high-risk patients could confirm these first results.