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DOI: 10.1055/s-2003-45342
A New Concept for Covered stent Protected Carotid Angioplasty: An ex vivo Study
Ein neuartiges Konzept der stentgeschützten Karotisangioplastie: Eine KadaverstudiePublikationsverlauf
Publikationsdatum:
08. Dezember 2003 (online)
![](https://www.thieme-connect.de/media/roefo/200312/lookinside/thumbnails/10.1055-s-2003-45342-1.jpg)
Zusammenhang
Ziel: Bestimmung der Effektivität eines zur Karotisangioplastie beschichteten Stent-Prototypen zur Reduktion zerebraler Embolien. Material und Methode: Der getestete Stent ist aus Nitinol gefertigt und mit einer Polyurethan Membran ausgekleidet (MembraX™; Porosität 80 µm). In einem Flussmodell (Flussrate 650 ml/min, pulsatil [dikrot] 123 Pulse/min, Druck 100/ 60 mmHg [mittlerer Druck 80 mmHg]) wurden humane, präparierte Karotiden von Leichen eingespannt (n = 6) und Stents implantiert (8/32 mm). Embolisierte Partikel (mg) wurden in einem 100 µm Filter im Ausflusstrakt der A. carotis interna vor, nach Stentimplantation sowie nach zusätzlicher Dilatation (5 mm) bestimmt. Ergebnisse: Wenn humane Leichenkarotiden gestentet werden, so ist die gemessene Embolierate während der Prozedur der Stenteinlage und Entfaltung (6,8 mg; für alle p < 0,05) am höchsten, Embolien nach zusätzlicher Ballondilatation sowie die in der abströmenden Flüssigkeit gemessenen Partikel vor Stenteinlage waren signifikant niedriger (3,8 mg; p < 0,05). Äste der A. carotis externa blieben nach Stenteinlage offen. Schlussfolgerungen: Das vorgestellte Konzept der stentgeschützten Karotisangioplastie mit dem MembraX™ Prototypen hat vielversprechende Ergebnisse einer niedrigen zerebralen ex vivo Embolierate belegt. Weitere Untersuchungen im Tiermodell und eine Größenreduktion des Freisetzungskatheters sind vor Einsatz im Menschen notwendig.
Abstract
Objective: To determine the efficacy of a covered stent prototype designed for protected carotid angioplasty to reduce cerebral embolization. Material and Method: The covered stent tested is made of nitinol, coated with a polyurethane membrane (MembraX™; porous size 80 µm). In a bench-top model (flow-rate 650 ml/min, pulsatile flow [dicrote] 123 Pulses/min, pressure 100/60 mm Hg [mean pressure 80 mmHg]) with inserted human carotid (n = 6) stent implantation was performed (8/32 mm). Passed particles (mg) were determined in the effluent of a 100 µm filter prior to intervention, after stent deployment and after final dilation (5 mm). Results: When stenting carotid arteries obtained from human cadavers, the highest rate of particle embolization was measured while crossing the lesion with the delivery device (6,8 mg; for all p < 0,05), embolization after additional balloon angioplasty and particle rates measured in the effluent filter prior covered stent placement were significantly lower (3,8 mg; p < 0,05). Branches of the external carotid artery remained patent in all cases. Conclusions: The introduced concept of covered stent protected carotid angioplasty with the MembraX™ prototype has proven promising results for low cerebral embolization rates ex vivo. Further evaluations using an animal model and a miniaturization of the delivery device are warranted prior to human use.
Key words
Carotid arteries, interventional procedures - interventional procedures, experimental - interventional procedures, complications - embolism, experimental
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Stefan Müller-Hülsbeck, M.D.
Dept. of Radiology, University Hospital Schleswig-Holstein - Campus Kiel
Arnold-Heller-Straße 9
24105 Kiel, Germany
Telefon: +49-431-5973154
Fax: +49-431-5973151
eMail: muehue@rad.uni-kiel.de