Ex Vivo Evaluation of the ArtVentive EOS Occlusion Device for the Management of Biliary Leaks

Abstract

Purpose Percutaneous treatment of biliary leaks is frequently required, yet technically challenging and limited to smaller fistulas. This study sought to evaluate the off-the-shelf use of the ArtVentive EOS device for the occlusion of biliary or cystic stump leaks.

Materials and Methods ePTFE-covered ArtVentive EOS devices were used to perform biliary leak embolization in 5 explanted porcine livers and in 3 explanted bovine livers. After establishing standard percutaneous transhepatic biliary drainage access, artificially created biliary leaks were occluded using 5 & 8 mm EOS devices. Using the 5 mm device, peripheral (n = 3), central (n = 1) and cystic duct leaks (n = 1) were occluded. Using the 8 mm device, peripheral (n = 1), central (n = 1), main (n = 1) and cystic duct leaks (n = 2) were occluded. Total leak occlusion was controlled by cholangiography.

Results Selective deployment and occlusion of central biliary leaks (3/3) and cystic stump leaks (3/3) was successful in all cases. Peripheral leaks could not be selectively catheterized in 3 out of 4 cases, making device deployment several millimeters proximal to the leaks necessary.

Conclusion Selective occlusion of the cystic stump, central biliary, and larger peripheral biliary leaks using the EOS device is technically feasible ex-vivo in a single setting.

Key points 

• Due to the impermeable ePTFE membrane, one EOS suffices to completely occlude biliary leaks.

• The EOS enables selective occlusion of central and larger peripheral biliary leaks.

• Smaller biliary leaks cannot be treated selectively with the EOS.

Citation Format

• Kuetting D, Schild HH, Pieper CC. Ex Vivo Evaluation of the ArtVentive EOS Occlusion Device for the Management of Biliary Leaks. Fortschr Röntgenstr 2019; 191: 553 – 559

Zusammenfassung

Ziel Die perkutane Behandlung von postoperativen Gallenleckagen ist eine zunehmend geforderte Intervention, die jedoch technisch anspruchsvoll und meist auf kleinere Leckagen beschränkt ist. Das Ziel dieser Ex-vivo-Studie war es, die okklusiven Eigenschaften des ArtVentive EOS für den Verschluss von Gallengangleckagen und Ductus-cysticus-Insuffizienzen zu untersuchen.

Materialen und Methoden Das verwendete Okklusions-Device – EOS – besteht aus einer ablösbaren, mit ePTFE überzogenen Nitinolspirale. Mittels EOS-Device wurden in insgesamt 5 explantierten Schweinelebern und 3 explantierten Rinderlebern künstlich geschaffene Gallenleckagen okkludiert. Nach Schaffung eines transhepatischen Gallengangzugangs in üblicher PTCD-Technik und Einwechslung einer 6F-Schleuse wurden über einen 6F-Führungskatheter die Gallenleckagen mit 5-mm- und 8-mm-EOS-Devices verschlossen. Mit dem 5-mm-Device wurden periphere (n = 3), zentrale (n = 1) und Ductus-cysticus-Leckagen (n = 1) verschlossen, während mit dem 8-mm-Device periphere (n = 1), zentrale (n = 1), Hauptgang- (n = 1) und Ductus-Leckagen (n = 2) verschlossen wurden. Ergebnisse: Selektives Freisetzen unmittelbar vor und sofortige Okklusion von zentralen Gallenleckagen (3/3) und Ductus-cysticus-Leckagen (3/3) war in allen Fällen mit dem EOS-Device erfolgreich. Periphere Gallenleckagen konnten in 3 von 4 Fällen nicht selektiv katheterisiert werden, sodass eine Platzierung des Device einige Millimeter proximal der Leckage notwendig war.

Schlussfolgerung Die selektive und sofortige Okklusion von Ductus-cysticus-, zentralen und größeren peripheren Gallenleckagen mit dem EOS ist ex vivo technisch in einer Sitzung machbar.

Kernaussagen 

• Aufgrund des flüssigkeitsundurchlässigen ePTFE-Überzugs genügt ein EOS-Device zum Leckageverschluss.

• Mittels EOS-Device können zentrale und größere periphere Gallengangleckagen selektiv verschlossen werden.

• Ein selektiver Verschluss kleinerer Gallengangleckagen ist mit dem EOS-Device nicht möglich.

Key words

biliary leaks - percutaneous embolization - occlusive device - EOS

Schlüsselwörter

Gallengangleckagen - perkutane Embolisation - Verschlusssystem

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