[Local lysis with alteplase for the treatment of acute embolic leg ischemia following the use of the duett closure device: preliminary results]. / Lokale Alteplase-Lyse zur Therapie der akuten embolischen Beinischämie nach Einsatz des Duett-Verschluss-Systems: vorläufige Ergebnisse.

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.