Treatment of critical limb ischemia using ultrasound-enhanced thrombolysis (PARES Trial): final results.

Abstract

PURPOSE:

To evaluate the safety and performance of ultrasound-enhanced thrombolysis in the treatment of acute thrombotic or embolic occlusion of the lower limb arteries.

METHODS:

From April 2005 to July 2006, 25 patients (15 men; mean age 64.1 years, range 37-82) presenting with acute (<14 days old) occlusions of the lower limb arteries were treated with local thrombolysis [recombinant tissue plasminogen activator (rtPA)] in a dosage of 1.0 mg/h using the EKOS Lysus Peripheral Catheter System with an ultrasound core. No bolus injection of rtPA was given. The mean occlusion length was 25.1 cm (range 2-70).

RESULTS:

The technical success rate was 100%. Total clot removal was achieved in 22 (88%) patients after 16.9 hours (range 5-24) using a mean 17 mg (range 5-25) of rtPA. In 8 cases, total clot removal of the main lesion was achieved after 6 hours (6 mg of rtPA). In 1 patient, lysis was stopped after 2.5 hours because of bleeding due a dislocation of the introducer sheath. In 2 cases, total clot removal could not be achieved; these patients were successfully treated with thromboaspiration. At the 1-month follow-up, the treated vessel was still patent in 20 patients. Two reocclusions occurred; 1 was treated with a bypass graft and the other with conservative therapy. There were no cases of amputation or death during follow-up. There were no side effects related to rtPA or the catheter system.

CONCLUSION:

This study demonstrates that local lysis of acute arterial occlusions using the Lysus Peripheral Catheter System is safe and effective. Blood flow is restored quickly.

• Authors: Christian Wissgott, André Richter, Peter Kamusella, Hermann J Steinkamp
• Journal: Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists (J Endovasc Ther) Vol. 14 Issue 4 Pg. 438-43 (Aug 2007) ISSN: 1526-6028 [Print] United States
• PMID: 17696616 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Fibrinolytic Agents
• Recombinant Proteins
• Tissue Plasminogen Activator

Topics

• Adult
• Aged
• Aged, 80 and over
• Combined Modality Therapy
• Critical Illness
• Embolism (complications, diagnostic imaging, drug therapy, physiopathology, therapy)
• Equipment Design
• Female
• Fibrinolytic Agents (adverse effects, therapeutic use)
• Humans
• Ischemia (diagnostic imaging, drug therapy, etiology, physiopathology, therapy)
• Lower Extremity (blood supply)
• Male
• Middle Aged
• Radiography
• Recombinant Proteins (therapeutic use)
• Recurrence
• Severity of Illness Index
• Thrombolytic Therapy (adverse effects)
• Thrombosis (complications, diagnostic imaging, drug therapy, physiopathology, therapy)
• Time Factors
• Tissue Plasminogen Activator (adverse effects, therapeutic use)
• Treatment Outcome
• Ultrasonic Therapy (adverse effects, instrumentation)
• Vascular Patency