Acute peripheral arterial occlusion: prospective study evaluating intra-arterial thrombolysis with a micro-porous balloon catheter.

PURPOSE: To assess the efficacy of a new in situ thrombolysis method using a low-pressure micro-porous balloon catheter (MPBC) compared to a traditional in situ infusion (ISI) of a fibrinolytic agent in the treatment of acute limb ischemia.

METHODS: Between January 2010 and December 2011, 21 patients (14 men; mean age 64.6 years, range 40-92) treated for acute lower limb ischemia were prospectively enrolled in the study. Seven patients underwent in situ thrombolysis using the ISI method and 14 patients the MPBC method to deliver urokinase. The total urokinase dose injected and the length of stay in an intermediate care unit were compared between the groups.

RESULTS: Recanalization was successful in 90% of cases (6/7 patients in the ISI group; 13/14 patients in the MPBC group). The morbidity was 7% (1 pseudoaneurysm). The dose of urokinase needed was significantly lower (p<0.001) in the MPBC group (0.7±0.44 IU, range 0.15-1.6) vs. the ISI group (1.66±0.71 IU, range 0.2-2). The average length of stay in the intermediate care unit was significantly shorter in the MPBC group (1.2 vs. 3.9 days, p<0.002). The overall 6-month limb salvage rate after recanalization was 90% (83% for the ISI patients vs. 93% for the MPBC group).

CONCLUSIONS: Intra-arterial thrombolysis using a balloon catheter is an effective method in the treatment of acute peripheral arterial occlusions. In the case of occlusion caused by embolism, primarily in very elderly patients, it may reduce the risk of hemorrhage. A randomized study on high-risk patients is needed to confirm these initial results.