Initial results of catheter-directed ultrasound-accelerated thrombolysis for thromboembolic obstructions of the aortofemoral arteries: a feasibility study.
ABSTRACT This article reports the 30-day technical and clinical outcome of ultrasound (US)-accelerated thrombolysis in patients with aortofemoral arterial thromboembolic obstructions.
A prospective cohort study was conducted from December 2008 to December 2009 of patients who were treated with US-accelerated thrombolysis for thromboembolic obstructions of aortofemoral arteries or bypasses. Urokinase was infused in a dosage of 100,000 IU per hour. Twice daily, a control angiography was performed. Thirty-day follow-up consisted of duplex scanning, combined with magnetic resonance angiography.
The study included 21 consecutive patients (20 men; median age, 66 (range, 52-80) years) with 24% artery versus 76% bypass occlusions. Median duration of symptoms was 11 (range, 7-140) days. Median occlusion length was 32 (range, 6-80) cm. In 20 patients (95%), an US-accelerated thrombolysis catheter could be successfully placed. In one patient, placement of an US-accelerated thrombolysis catheter was technically not feasible, and therefore a standard catheter was placed. Median thrombolysis time was 26.5 (range, 8.5-72) hours. Complete thrombolysis (>95% lysis of thrombus) was achieved in 20 patients; in 9 patients within 24 hours. Median ankle-brachial index (ABI) increased from 0.28 (range, 0-0.85) to 0.91 (range, 0.58-1.35). One patient had a thromboembolic complication and needed surgical intervention. No hemorrhagic complications, and no deaths occurred. At 30-day follow-up, 17 of 21 patients (81%) had a patent artery or bypass.
This feasibility study showed a high technical success rate of US-accelerated thrombolysis for aortofemoral arterial obstructions. US-accelerated thrombolysis led to complete lysis within 24 hours in almost half of patients, with a low 30-day major complication rate.
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ABSTRACT: Ultrasound reversibly alters the structure of polymerized fibrin, an effect that could influence tissue-plasminogen activator (t-PA) binding. We have, therefore, characterized the effects of ultrasound on binding of t-PA to fibrin using a novel system in which radiolabeled, active-site blocked, single chain tissue-plasminogen activator flowed through a fibrin gel at constant rate, and specific binding was determined by monitoring incorporation of radiolabel. Results using polymerized fibrin were compared with those using a surface of fibrin immobilized on Sepharose beads in a similar system. Interaction of t-PA with surface-immobilized fibrin involved two classes of binding sites (Kd = 31 nmol/L and 244 nmol/L) and a maximum binding ratio of 3.8 mol t-PA/mol fibrin. Ultrasound increased Kd for the high affinity site to 46 nmol/L (P < .0001), but it had no significant effects on the Kd 244 nmol/L site nor on Bmax. Tissue-plasminogen activator binding to noncrosslinked fibrin involved two sites with Kds of 267 nmol/L and 952 nmol/L, while a single Kd 405 nmol/L site was identified for crosslinked fibrin. Ultrasound had no significant effect on the binding affinity for noncrosslinked fibrin, but Bmax was increased in the presence of ultrasound, from 31 mumol/L to 43 mumol/L (P < .0001). Ultrasound decreased the Kd for crosslinked fibrin to 343 nmol/L (P = .026) and also increased Bmax from 22 mumol/L to 25 mumol/L (P = .015). Ultrasound also affected the kinetics of t-PA binding to fibrin, significantly accelerating the rate of dissociation by 77% +/- 5% for noncrosslinked fibrin and by 69% +/- 3% for crosslinked fibrin (P < .001 for each). These results indicate that ultrasound exposure accelerates t-PA binding, alters binding affinity, and increases maximum binding to polymerized fibrin, effects that may result from ultrasound-induced changes in fibrin structure.Blood 03/1998; 91(6):2019-25. · 9.78 Impact Factor
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ABSTRACT: Twenty-two patients were selected from a group of 33 patients who underwent recombinant human tissue-type plasminogen activator (rt-PA) thrombolysis for thrombosed infrainguinal bypass grafts of the lower extremity and were compared with 38 matched patients who had undergone surgical thrombectomy during the same period. The proportion of persons with diabetes mellitus, smokers, and types of bypass grafts was similar in both groups. More patients in the rt-PA-treated group had hypertension (p = 0.01). To evaluate the different lengths of follow-up, Kaplan-Meier survival analysis was used with a log-rank test to compare the proportion of persons with patent grafts in the two treatment groups. At 30 days, 86% of the rt-PA-treated grafts were still patent compared with 42% of the surgically treated grafts (p = 0.001). When risk factors on the Kaplan-Meier curves were compared, there was no statistical difference with regard to graft patency among the groups. According to simultaneous Cox regression analysis, no risk factor was significantly associated with graft patency. When amputation was evaluated between treatment groups simultaneously with other risk factors in a logistic regression analysis, smoking and age of the graft were marginally significant (p = 0.07), whereas all other factors were clearly not significant. In 91% of the rt-PA-treated patients, a secondary surgical procedure was required to maintain patency of the graft segment. Eighty-nine percent of the surgically treated patients required similar graft revisions. Two patients in the surgical group and one patient in the rt-PA-treated group had major complications.(ABSTRACT TRUNCATED AT 250 WORDS)Journal of Vascular Surgery 03/1988; 7(2):347-55. · 2.88 Impact Factor
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ABSTRACT: To evaluate the safety and performance of ultrasound-enhanced thrombolysis in the treatment of acute thrombotic or embolic occlusion of the lower limb arteries. 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). 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. 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.Journal of Endovascular Therapy 08/2007; 14(4):438-43. · 2.70 Impact Factor