Abstract
Duett™, a novel vascular sealing device, was first clinically used in July 1997. A European multi-center registry was established to evaluate the safety and procedural success of the Duett™ sealing device in a broad range of patients undergoing diagnostic or interventional endovascular procedures.
At 25 European sites 1587 patients were enrolled. All patients (≥ 18 years) must have given informed consent for the use of the sealing device after a diagnostic and/or interventional endovascular procedure performed via a femoral arterial approach. Standard length (<-10 cm) 5 to 9 F introducer sheaths had to be used. An ACT of ≤400 s, and any approved GP IIb/IIIa platelet receptor antagonist was permitted.
Successful deployment could be achieved in 96.2% (1526/1587 patients) with complete hemostasis within 2 to 5 minutes in over 95% of the patients. The complication-free rate was 96.4%. Arterial occlusions were rare (4 patients) and successfully treated with surgical repair in 1 and with thrombolysis in 3 patients. Pseudoaneurysms occurred in 34 patients, the majority (30/34) were successfully treated with ultrasound-guided compression or resolved spontaneously. The total rate of major complications was 2.6% (41/1587).
The final results of the European registry demonstrate that the Duett™ sealing device can be used with a high procedural success following diagnostic and interventional endovascular procedures. The incidence of major complications is low and comparable to all other approved vascular closure devices and manual compression. CE-mark certification was approved at the end of 1998.
Zusammenfassung
Duett™, ein neues arterielles Verschlußsystem, wurde zum ersten Mal im Juli 1997 klinisch eingesetzt. Um die Sicherheit und Wirksamkeit bei einem breiten Spektrum von Patienten nach diagnostischem bzw. interventionellem Katheter zu beurteilen, wurde ein Europäisches Multicenterregister eingerichtet.
An 25 europäischen Zentren wurden 1587 Patienten in das Register aufgenommen. Alle Patienten (≥18 Jahre) mußten sich mit der Anwendung des Verschlußsystems (femoraler Zugang) einverstanden erklären. Bei der Katheteruntersuchung sollte ein Schleusendurchmesser von 5 bis 9 F bei einer Standardlänge bis zu 10 cm verwendet werden. Die ACT sollte nicht über 400 s betragen, die zusätzliche Gabe eines zugelassenen GP-IIb/IIIa-Rezeptorantagonisten war gestattet.
Das Verschlußsystem konnte in 96,2% (1526/1587 Patienten) erfolgreich eingesetzt werden, eine vollständige Hämostase trat innerhalb von zwei bis fünf Minuten bei über 95% der Patienten ein. Bei 96,4% der Patienten wurden keine Komplikationen beobachtet. Ein intraluminaler Verschluß der Femoralarterie war selten und wurde erfolgreich operativ bei cinem und mittels Thrombolyse bei drei Patienten behandelt. Beidrei Patienten war eine Bluttransfusion erforderlich. 30 der 34 beobachteten Pseudoaneurysmen konnten ultraschallgestützt erfolgreich komprimiert werden oder bildeten sich spontan zurück. Da entsprechend der FDA-Definition auch diese Pseudoaneurysmen als größere Komplikation klassifiziert werden müssen, errechnete sich eine Gesamtrate an größeren Komplikationen von 2,6% (41/1587).
Die endgültigen Ergebnisse des Europäischen Multicenter-registers zeigen, daß das Deutt™-Verschlußsystem sicher urfolgreich nach diagnostischer und interventioneller Katheteruntersuchung eingesetzt werden kann. Die Rate an größeren Komplikationen ist mit der aller anderen zugelassenen arteriellen Verschlußsysteme sowie der manuellen Kompression vergleichbar. Die CE-Zertifizierung wurde Ende 1998 erteilt.
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Silber, S., Tofte, A.J., Kjellevand, T.O. et al. Final report of the European multi-center registry using the Deutt™ vascular sealing device. Herz 24, 620–623 (1999). https://doi.org/10.1007/BF03044486
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DOI: https://doi.org/10.1007/BF03044486