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


CONCLUSIONS
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.
Wissgott
Christian
C
Department of Radiology, DRK Kliniken Mark Brandenburg, Berlin, Germany. cwissgott@gmx.de
Richter
André
A
Kamusella
Peter
P
Steinkamp
Hermann J
HJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D016638:Critical Illness; D004617:Embolism / Q000150:complications* / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy; D004867:Equipment Design; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011859:Radiography; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012720:Severity of Illness Index; D015912:Thrombolytic Therapy / Q000009:adverse effects; D013927:Thrombosis / Q000150:complications* / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000009:adverse effects / Q000295:instrumentation; D014654:Vascular Patency
D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator