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

• References

• 1 Albasini JL, Aledo VS, Dexter SP. et al. Bile leakage following laparoscopic cholecystectomy. Surgical endoscopy 1995; 9: 1274-1278
• 2 Shaikh IA, Thomas H, Joga K. et al. Post-cholecystectomy cystic duct stump leak: a preventable morbidity. Journal of digestive diseases 2009; 10: 207-212 . doi:10.1111/j.1751-2980.2009.00387.x
• 3 Hollands MJ, Little JM. The role of hepatic resection in the management of blunt liver trauma. World J Surg 1990; 14: 478-482
• 4 Schirmer WJ, Rossi RL, Hughes KS. et al. Common operative problems in hepatobiliary surgery. The Surgical clinics of North America 1991; 71: 1363-1389
• 5 Steiner Z, Brown RA, Jamieson DH. et al. Management of hemobilia and persistent biliary fistula after blunt liver trauma. Journal of pediatric surgery 1994; 29: 1575-1577
• 6 Ryan ME, Geenen JE, Lehman GA. et al. Endoscopic intervention for biliary leaks after laparoscopic cholecystectomy: a multicenter review. Gastrointestinal endoscopy 1998; 47: 261-266
• 7 Vu DN, Strub WM, Nguyen PM. Biliary duct ablation with N-butyl cyanoacrylate. J Vasc Interv Radiol 2006; 17: 63-69 . doi:10.1097/01.RVI.0000195399.68445.DD
• 8 Venbrux AC, Rudakov L, Plass A. et al. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol 2014; 37: 85-93 . doi:10.1007/s00270-013-0626-y
• 9 Corvino F, Silvestre M, Cervo A. et al. Endovascular occlusion of pulmonary arteriovenous malformations with the ArtVentive Endoluminal Occlusion System. Diagnostic and interventional radiology 2016; 22: 463-465 . doi:10.5152/dir.2016.15620
• 10 Pyra K, Wozniak S, Drelich-Zbroja A. et al. Evaluation of Effectiveness of Embolization in Pelvic Congestion Syndrome with the New Vascular Occlusion Device (ArtVentive EOS): Preliminary Results. Cardiovasc Intervent Radiol 2016; 39: 1122-1127 . doi:10.1007/s00270-016-1380-8
• 11 Tamrazi A, Wadhwa V, Duarte A. et al. Successful Occlusion of the Splenic Artery Using the Endoluminal Occlusion System. J Vasc Interv Radiol 2015; 26: 1412-1414 . doi:10.1016/j.jvir.2015.05.020
• 12 Kuetting D, Meyer C, Schild HH. et al. In Vitro Evaluation of the Occlusive Properties of the ArtVentive EOS occlusion device for Transrenal Ureteral Occlusion. Journal of endourology 2017; DOI: 10.1089/end.2017.0493.
• 13 Ferrucci Jr JT, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage: technique, results, and applications. Radiology 1980; 135: 1-13 . doi:10.1148/radiology.135.1.7360943
• 14 McMahon AJ, Fullarton G, Baxter JN. et al. Bile duct injury and bile leakage in laparoscopic cholecystectomy. The British journal of surgery 1995; 82: 307-313
• 15 Koch M, Garden OJ, Padbury R. et al. Bile leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the International Study Group of Liver Surgery. Surgery 2011; 149: 680-688 . doi:10.1016/j.surg.2010.12.002
• 16 Schaible A, Schemmer P, Hackert T. et al. Location of a biliary leak after liver resection determines success of endoscopic treatment. Surgical endoscopy 2017; 31: 1814-1820 . doi:10.1007/s00464-016-5178-1
• 17 Nagano Y, Togo S, Tanaka K. et al. Risk factors and management of bile leakage after hepatic resection. World J Surg 2003; 27: 695-698 . doi:10.1007/s00268-003-6907-x
• 18 de Castro SM, Kuhlmann KF, Busch OR. et al. Incidence and management of biliary leakage after hepaticojejunostomy. Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract 2005; 9: 1163-1171 discussion 1171-1163. doi:10.1016/j.gassur.2005.08.010
• 19 Stampfl U, Hackert T, Radeleff B. et al. Percutaneous management of postoperative bile leaks after upper gastrointestinal surgery. Cardiovasc Intervent Radiol 2011; 34: 808-815 . doi:10.1007/s00270-011-0104-3
• 20 Sugiyama M, Atomi Y, Matsuoka T. et al. Endoscopic biliary stenting for treatment of persistent biliary fistula after blunt hepatic injury. Gastrointestinal endoscopy 2000; 51: 42-44
• 21 Brady AP, Malone DE, Deignan RW. et al. Fibrin sealant in interventional radiology: a preliminary evaluation. Radiology 1995; 196: 573-578 . doi:10.1148/radiology.196.2.7617880
• 22 Matsumoto T, Iwaki K, Hagino Y. et al. Ethanol injection therapy of an isolated bile duct associated with a biliary-cutaneous fistula. Journal of gastroenterology and hepatology 2002; 17: 807-810
• 23 Uller W, Muller-Wille R, Loss M. et al. Percutaneous management of postoperative bile leaks with an ethylene vinyl alcohol copolymer (Onyx). Rofo 2013; 185: 1182-1187 . doi:10.1055/s-0033-1350153
• 24 Thompson PM, Hare CM, Lees WR. Bile duct disruption following radiofrequency ablation: successful repair using a covered stent. Cardiovasc Intervent Radiol 2004; 27: 383-385 . doi:10.1007/s00270-003-0220-9
• 25 Grasso RF, Luppi G, Giurazza F. et al. Bile leak refilling an intrahepatic biloma managed with AMPLATZER vascular plug. J Vasc Interv Radiol 2011; 22: 1637-1638 . doi:10.1016/j.jvir.2011.07.016
• 26 Doshi T, Mojtahedi A, Goswami GK. et al. Persistent cystic duct stump leak managed with hydrocoil embolization. Cardiovasc Intervent Radiol 2009; 32: 394-396 . doi:10.1007/s00270-008-9431-4
• 27 Kusano T, Kida H, Nishiwaki Y. et al. Percutaneous sclerotherapy for intractable external biliary fistula after hepatectomy. International surgery 2003; 88: 72-75
• 28 Kyokane T, Nagino M, Sano T. et al. Ethanol ablation for segmental bile duct leakage after hepatobiliary resection. Surgery 2002; 131: 111-113
• 29 Isayama H, Komatsu Y, Tsujino T. et al. A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53: 729-734
• 30 Vaidya S, Tozer KR, Chen J. An overview of embolic agents. Semin Intervent Radiol 2008; 25: 204-215 . doi:10.1055/s-0028-1085930