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.

Esophageal Stent in Acute Refractory Variceal Bleeding: A Systematic Review and a Meta-Analysis

“…The stent can be left in place for up to two weeks and can be easily removed by endoscopy. Most of the studies included in our meta-analysis (11 out of 12) used the SEMS SX-Ella Danis stent (Ella-CS, Hradec Kralove, Czech Republic), which is 135 mm in length, has a 25 mm mid-diameter, and has a 30 mm end-diameter designed to tamponade bleeding varices in the distal esophagus [11,23]. The stent can be left in situ for up to 7 days.…”

“…This meta-analysis updates a prior meta-analysis published in 2020 [9] and includes three additional studies published in 2021 and 2022 [10][11][12] to evaluate the effectiveness and safety profiles of SEMSs in managing acute refractory variceal bleeding, including immediate bleeding control rate, rates of rebleeding, stent ulceration, stent migration, and overall mortality rate as a bridge to more definitive therapy.…”

Purastat as an Adjunct Treatment Option in Acute Esophageal Varices Bleeding: A Case Report

“…Danis stent placement is usually reserved for refractory cases with variceal bleeding when first-line endoscopic treatment fails. Danis stent was a valid option in our case [ 7 ].…”

Best Practices in Esophageal, Gastroduodenal, and Colonic Stenting

“…This strategy is often used as a bridge to transjugular intrahepatic portosystemic shunt or liver transplantation in a significant proportion of patients [ 89 ], and 6-week survival is mostly related to the severity of the underlying liver disease. Dedicated FC-SEMSs (SX-Ella Danis) for esophageal variceal bleeding are available; when used, retrieval should be performed using a specifically designed system [ 92 , 93 ]. There is only one RCT comparing FC-SEMS (SX-Ella Danis stent) with balloon tamponade [ 94 ], with successful therapy more frequent in the stent group (66% vs. 20%), with a significantly higher rate for control of bleeding (85% vs. 47%), lower transfusion requirements, and a lower incidence of serious AEs (15% vs. 47%), mainly due to differences in aspiration pneumonia (0 vs. 5) and esophageal tear (1 patient in the balloon tamponade group); no significant difference in 6-week survival was observed (54% vs. 40%).…”