The role of a novel self-expanding metal stent in variceal bleeding: a multicenter Australian and New Zealand experience

Abstract

Background and study aims Refractory variceal bleeding is associated with high mortality in patients with chronic liver disease. A fully-covered self-expanding metal stent (SEMS) has been reported to have excellent rates of technical success and initial bleeding control; however, studies to date are small and limited to Europe and Asia. Our aim was to evaluate the efficacy and safety of this SEMS for control of refractory variceal bleeding (VB).

Patients and methods A retrospective analysis was undertaken of all patients who received the SX-ELLA Danis SEMS for management of VB at 9 tertiary centers across Australia and New Zealand. A total of 32 SEMS had been deployed in 30 patients (median age 53.3).

Results Technical success of SEMS placement was achieved in 100 % of cases, resulting in immediate control of bleeding across 31 of 32 cases (96.9 %). Re-bleeding with SEMS in situ occurred in three of 32 cases (9.4 %). Mean SEMS in-dwelling time was 6.4 days. Delayed SEMS migration occurred in 6.3 % of cases. Interventional radiological therapy for management of varices within 6 weeks was performed in 12 of 30 patients (40 %). Death with SEMS in situ occurred in seven of 30 patients (23.3 %). Seven-day bleeding-related mortality was 16.7 %, 14-day mortality 23.3 %, and 6-week mortality 33.3 %. Three of 30 patients (10 %) received orthotopic liver transplantation following SEMS insertion, including two patients within 6 weeks.

Conclusions SX-Danis Ella SEMS is highly effective for immediate control of refractory VB and bridging to definitive therapy because it has excellent technical success rates, appears to be relatively easy to use, and has low rates of serious adverse events.

Publication History

Received: 15 February 2021

Accepted after revision: 19 October 2021

Article published online:
14 March 2022

• References

• 1 de Franchis R, Faculty BV. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol 2015; 63: 743-752
• 2 García-Pagán JC, Reverter E, Abraldes JG. et al. Acute variceal bleeding. Semin Respir Crit Care Med 2012; 33: 46-54
• 3 Jairath V, Rehal S, Logan R. et al. Acute variceal haemorrhage in the United Kingdom: patient characteristics, management and outcomes in a nationwide audit. Dig Liver Dis 2014; 46: 419-426
• 4 Hogan BJ, OʼBeirne JP. Role of self-expanding metal stents in the management of variceal haemorrhage: Hype or hope?. World J Gastrointest Endosc 2016; 8: 23-29
• 5 Sarin SK, Kumar A, Angus PW. et al. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int 2011; 5: 607-624
• 6 DʼAmico M, Berzigotti A, Garcia-Pagan JC. Refractory acute variceal bleeding: what to do next?. Clin Liver Dis 2010; 14: 297-305
• 7 Puente A, Hernández-Gea V, Graupera I. et al. Drugs plus ligation to prevent rebleeding in cirrhosis: an updated systematic review. Liver Int 2014; 34: 823-833
• 8 D'amico G, Criscuoli V, Fili D. et al. Meta-analysis of trials for variceal bleeding. Hepatology 2002; 36: 1023-1024 ; author reply 4–5
• 9 Panés J, Terés J, Bosch J. et al. Efficacy of balloon tamponade in treatment of bleeding gastric and esophageal varices. Results in 151 consecutive episodes. Dig Dis Sci 1988; 33: 454-459
• 10 García-Pagán JC, Caca K, Bureau C. et al. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med 2010; 362: 2370-2379
• 11 Monescillo A, Martínez-Lagares F, Ruiz-del-Arbol L. et al. Influence of portal hypertension and its early decompression by TIPS placement on the outcome of variceal bleeding. Hepatology 2004; 40: 793-801
• 12 García-Pagán JC, Di Pascoli M, Caca K. et al. Use of early-TIPS for high-risk variceal bleeding: results of a post-RCT surveillance study. J Hepatol 2013; 58: 45-50
• 13 Riggio O, Ridola L, Lucidi C. et al. Emerging issues in the use of transjugular intrahepatic portosystemic shunt (TIPS) for management of portal hypertension: time to update the guidelines?. Dig Liver Dis 2010; 42: 462-467
• 14 Escorsell A, Bosch J. Self-expandable metal stents in the treatment of acute esophageal variceal bleeding. Gastroenterol Res Pract 2011; 2011: 910986
• 15 Holster IL, Kuipers EJ, van Buuren HR. et al. Self-expandable metal stents as definitive treatment for esophageal variceal bleeding. Endoscopy 2013; 45: 485-488
• 16 Hubmann R, Bodlaj G, Czompo M. et al. The use of self-expanding metal stents to treat acute esophageal variceal bleeding. Endoscopy 2006; 38: 896-901
• 17 Zehetner J, Shamiyeh A, Wayand W. et al. Results of a new method to stop acute bleeding from esophageal varices: implantation of a self-expanding stent. Surg Endosc 2008; 22: 2149
• 18 Wright G, Lewis H, Hogan B. et al. A self-expanding metal stent for complicated variceal hemorrhage: experience at a single center. Gastrointest Endosc 2010; 71: 71-78
• 19 Dechêne A, El Fouly A, Bechmann L. et al. Acute management of refractory variceal bleeding in liver cirrhosis by self-expanding metal stents. Digestion 2012; 85: 185-191
• 20 Pfisterer N, Riedl F, Pachofszky T. et al. Outcomes after placement of a SX-ELLA oesophageal stent for refractory variceal bleeding-A national multicentre study. Liver Int 2019; 39: 290-298
• 21 Escorsell À, Pavel O, Cárdenas A. et al. Esophageal balloon tamponade versus esophageal stent in controlling acute refractory variceal bleeding: A multicenter randomized, controlled trial. Hepatology 2016; 63: 1957-1967
• 22 Shao XD, Qi XS, Guo XZ. Esophageal stent for refractory variceal bleeding: a systemic review and meta-analysis. Biomed Res Int 2016; 2016: 4054513
• 23 de Franchis R, Faculty BV. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol 2010; 53: 762-768
• 24 Jain M, Balkrishanan M, Snk C. et al. SX-Ella Danis stent in massive upper gastrointestinal bleeding in cirrhosis – a case series. Clin Exp Hepatol 2018; 4: 97-99
• 25 Fierz FC, Kistler W, Stenz V. et al. Treatment of esophageal variceal hemorrhage with self-expanding metal stents as a rescue maneuver in a swiss multicentric cohort. Case Rep Gastroenterol 2013; 7: 97-105
• 26 Zakaria MS, Hamza IM, Mohey MA. et al. The first Egyptian experience using new self-expandable metal stents in acute esophageal variceal bleeding: pilot study. Saudi J Gastroenterol 2013; 19: 177
• 27 Avgerinos A, Klonis C, Rekoumis G. et al. A prospective randomized trial comparing somatostatin, balloon tamponade and the combination of both methods in the management of acute variceal haemorrhage. J Hepatol 1991; 13: 78-83
• 28 Haddock G, Garden OJ, McKee RF. et al. Esophageal tamponade in the management of acute variceal hemorrhage. Dig Dis Sci 1989; 34: 913-918
• 29 Chojkier M, Conn HO. Esophageal tamponade in the treatment of bleeding varices. A decadel progress report. Dig Dis Sci 1980; 25: 267-272