Initial Results of Catheter-Directed Ultrasound-Accelerated Thrombolysis for Thromboembolic Obstructions of the Aortofemoral Arteries: A Feasibility Study
Department of Vascular Surgery, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands. CardioVascular and Interventional Radiology
(Impact Factor: 2.07).
05/2011; 35(2):279-85. DOI: 10.1007/s00270-011-0164-4
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.
Available from: Bram Fioole
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ABSTRACT: The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US) has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease) is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis.
Sixty adult patients with recently (between 1 and 7 weeks) thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A) or US-accelerated thrombolysis (group B). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery.
The DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications.
Current Controlled Trials ISRCTN72676102.
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To compare the safety and efficacy of ultrasound-accelerated thrombolysis (UAT) and standard catheter-directed thrombolysis (CDT) in patients with acute and subacute limb ischemia.
Materials and methods:
Medical records of all patients treated with thrombolysis for acute and subacute limb ischemia between August 2005 and January 2012 were reviewed. Coprimary (increase in ankle-brachial index, degree of lysis) and secondary endpoints (technical success, distal embolization, bleeding complications, need for additional interventions) were assessed. UAT was performed in 75 patients, and CDT was performed in 27 patients. Patients' baseline demographic and clinical parameters and procedure details, including lytic drug infusion rate (P = .704 and P = .987), total infusion time (P = .787 and P = .377), and use of adjunctive procedures (P = .457), did not differ significantly between the two groups.
Complete lysis was achieved in 72.0% (UAT) and 63.0% (CDT) of patients (P = .542); hemodynamic success was achieved in 91.8% (UAT) and 92.3% (CDT) (P = .956). Overall major and minor bleeding complications were observed in 6.9% (UAT) and 3.9% (CDT) of patients. Major (P = .075) and minor (P = .276) bleeding independently did not differ between UAT and CDT. Major and minor bleeding combined was lower: 6.7% (UAT) versus 22.2% (CDT) (P = .025). Overall target vessel patency after 8.0 months (range, 1.5-20.5 mo) was 73.5%; target vessel patency for UAT was 75.9% versus 64.3% for CDT (P = .379). Median long-term survival was not significantly different between UAT and CDT: 3.6 years (range, 2.42-5.33 y) versus 1.8 years (range, 1.33-4.92 y) (P = .061).
Both UAT and CDT are safe and efficient treatment modalities for patients with acute and subacute limb ischemia. The observed lower risk of total bleeding for UAT versus CDT may warrant prospective comparative trials.
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ABSTRACT: Acute limb ischemia is a vascular event presenting with sudden decrease in limb perfusion (of <14days' duration) that threatens limb viability. Acute thrombosis of the native artery or graft makes up the bulk of etiopathogenesis. Prompt revascularization is the cornerstone of management of acute limb ischemia in limbs that have not undergone irreversible tissue and nerve damage. Amputation is performed in patients with irreversible tissue and nerve damage.
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