Aim: This study evaluates the short-term outcome of ultrasound-accelerated thrombolysis in patients with lower extremity ischemia caused by thromboembolic occlusions.
Methods: A retrospective cohort study was conducted from December 2008 to May 2011 of 57 patients (42 men; median age, 66 ± 11 years) undergoing 62 episodes of ultrasound-accelerated thrombolysis for thromboembolic arterial occlusions of the lower extremities. The EKOS EndoWave System (EKOS Corporation, Bothell, WA, USA) was combined with urokinase (100000 IU/hour). Thirty-day and 6-month follow-up consisted of clinical evaluation, and Duplex scan or magnetic resonance angiography of the treated extremity.
Results: Initial technical success was 97%, radiologic success was 82%, and overall clinical success was 77%. Median thrombolysis time was 21 hours (IQR, 15-24). In 38 of 51 procedures with successful lysis (75%) complete lysis was achieved within 24 hours. Major hemorrhage occurred in 2 procedures (3%), and distal embolization in 2 procedures (3%). During the initial hospitalization, the major amputation rate was 8% (N.=5) and the mortality rate was 2% (N.=1). The 30-day patency rate was 81%, without additional mortality. During a median 6-month (range, 2-14) follow-up, 9 reinterventions were performed. Two patients underwent major amputation and 3 patients died; because of malignancy (N.=2) and stroke (N.=1).
Conclusion: Initial success rates of ultrasound-accelerated thrombolysis are high and complication rate is low. However, reintervention rate during short-term follow-up for recurrent ischemia is substantial. Results from a randomized controlled trial comparing ultrasound-accelerated thrombolysis with standard thrombolysis for lower extremity ischemia (DUET, Current Controlled Trials, ISRCTN72676102) are eagerly awaited.