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  • Title: [Local lysis with alteplase for the treatment of acute embolic leg ischemia following the use of the duett closure device: preliminary results].
    Author: Schürmann K, Janssens U, Bücker A, Wingen M, Tacke J, Wein B, Günther RW.
    Journal: Rofo; 2004 Apr; 176(4):574-9. PubMed ID: 15088184.
    Abstract:
    PURPOSE: To analyze retrospectively the result of the alteplase lysis therapy of embolic complications following the use of the Duett closure device. METHODS AND MATERIALS: For 3.5 years, the Duett closure device was used in 1,398 angiographies to close the femoral puncture site. The Duett device consists of a balloon and a liquid procoagulant containing collagen and thrombin, which is injected into the puncture tract under endovascular balloon protection of the arterial puncture site. In 9 patients (0.64 %), the procoagulant was incidentally injected into the femoral artery causing acute leg ischemia. Eight patients received local lysis therapy with alteplase via a contralateral femoral access. One patient underwent surgery. On average, 21 mg alteplase (4 - 35 mg) were administered within 14 h (4 - 21 h). The course of the lysis was followed angiographically and clinically. All patients were interviewed by telephone 23 months (4 - 35 months) later. RESULTS: In 3 patients, lysis was complete. In 5 patients, only little thrombotic material remained. In all patients, symptoms of ischemia resolved completely within the first hours after initiation of lysis. In 5 cases, bleeding occurred at the puncture site closed with the Duett device during lysis, including development of a false aneurysm in 2 cases. Complications led to premature termination (n = 2) or interruption of the lysis (n = 3). All complications were treated conservatively. Clinically, long-term sequelae were paresthesia and hypoesthesia in the lower leg and foot in 2 patients treated with lysis, and in the patient who underwent surgery. CONCLUSION: Very rarely occurring embolic complications after use of the Duett closure device can be effectively treated with alteplase lysis. A high rate of complications is to be expected at the puncture site closed with the Duett device.
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