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Ultrasound Thrombolysis Effective for Peripheral Occlusive Artery Disease: Presented at SIR

By Peggy Peck

SALT LAKE CITY, UT -- April 3, 2003 -- Ultrasound thrombolysis appears to be equally effective as a single intervention or in combination with tissue plasminogen activator (tPA) for recanalization in patients with peripheral occlusive artery disease (POAD).

In a prospective, single-center series of 150 patients, "91.9% were successfully recanalized using this technique," said Gottfried Rudofksy, MD, of University Hospital, Essen, Germany. Dr. Rudofksy presented the results here March 28^th at the 28^th Annual Scientific Meeting of the Society of Interventional Radiology.

Interventional approaches to POAD management are difficult and often unsuccessful, said Dr. Rudofsky, who noted that there is a significant risk for vessel wall damage when attempting lysis. The investigational system used in this study, Acolysis (Vascular Solutions, Minneapolis, MN, USA), uses low-frequency, high-energy ultrasound to produce cavitation that allows for selective thrombus lysis without risk to the vessel wall, he said.

A total of 150 patients (114 men, mean age 63) were recruited between July 1998 and May 2001. One hundred seventeen patients had intermittent claudication, and 43 presented with critical limb ischemia.

The ultrasound catheter was slowly (1 cm/10 sec) extended into thrombi using a 0.018" guide wire and 7F sheath. The catheter was activated for up to 900 seconds, and angiography was performed every 5 minutes to monitor progress. Seventy patients received ultrasound thrombolysis alone, 29 received tPA plus ultrasound thrombolysis, and 51 were treated with 3-day thrombolysis therapy plus ultrasound thrombolysis; 128 received adjunct balloon angioplasty.

Treatment with ultrasound thrombolysis alone was the most successful recanalization strategy, said Rudofsky. "It was successful in 65 of the 70 patients treated," or 92.9%, he said. Ultrasound thrombolysis plus tPA had a recanalization rate of 86.2%, while extended thrombolysis plus ultrasound was successful in 90.2% of patients. As might be expected, occlusion length correlated with success, with shorter lesions associated with better recanalization rates.

Mean lumen diameter increased to 3.2 ± 0.9 mm after ultrasound thrombolysis alone and 4.5 ± 1.1 mm after ultrasound thrombolysis plus balloon angioplasty. In 20 patients who had the ankle-brachial index measured at baseline and post procedure, it increased from 0.64 to 0.83 (p <.001). Treatment failed in 14 patients (9.3%), mostly because of technical problems, and 9 patients (6.7%) required adjunct stenting.

The Acolysis system is available in Europe, but has not yet been approved by the US Food and Drug Administration.

The study was funded by Vascular Solutions.


[Study title: The VSI Acolysis Ultrasound Thrombolysis System: Endovascular Recanalization of Femoral Arterial Occlusions. G Rudofsky et al. Abstract: 41]

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