Outcomes after placement of a SX‐ELLA oesophageal stent for refractory variceal bleeding—A national multicentre study

Abstract

Background Current guidelines favour the use of bleeding stents over balloon tamponade (BT) for refractory variceal bleeding (VB) from oesophageal varices. However, data on the efficacy and safety of self‐expandable metal SX‐ELLA Danis stents (SEMS) are limited. Methods Cirrhotic patients receiving SEMS for VB at four tertiary care centres were included in this retrospective multicentre study. Rates of failure‐to‐control bleeding (within 5 days) and bleeding‐related mortality (6 weeks) were assessed. Results SEMS controlled VB in 79.4% (27/34) of patients. In the rest of patients, other rescue treatments including endoscopic band ligation (EBL, n = 3), SEMS renewed (n = 2) or Linton (n = 2) were applied; however, VB was only controlled in one patient. Early rebleeding within six weeks occurred in 17.6% (6/34) patients. Median SEMS dwell time was three (IQR:6) days. Overall n = 13/34 (38.2%) patients died with SEMS in situ. After SEMS removal, rebleeding and bleeding‐related death occurred in n = 7 (35%) and n = 5 (14.7%) patients respectively. Only 32.4% (10/34) patients did not experience any rebleeding within six weeks after SEMS removal. Bleeding‐related mortality was 47.1% (n = 16/34) and the median survival after SEMS placement was 2.1 months. Notably, no patient received an early transjugular intrahepatic portosystemic shunt (TIPS). The most common adverse events were stent dislocations (n = 13; 38.2%), while ulcers/necrosis of the oesophageal mucosa was seen in only four (11.8%) patients. Conclusion SEMS controlled refractory VB in most patients. However, bleeding‐related mortality remained high. While SEMS dislocations were frequent, ulcers/necrosis of the oesophagus was rare. Further studies should investigate whether the wider use of early TIPS reduces bleeding‐related mortality after SEMS placement.

Self-expanding metal stents versus TIPS in treatment of refractory bleeding esophageal varices: a systematic review and meta-analysis

“…Our study demonstrates that use of SEMS is associated with a pooled all-cause mortality rate of 44 %, immediate bleeding control rate of 85 % and a rebleeding rate of 19 %. A recent multicenter study by Pfiesterer et al reported a mortality rate of 47 % with the use of SEMS in refractory EV bleeding and our results are on par with this study [9]. We report a pooled allcause mortality rate of 28 % with TIPS.…”

“…One SEMS study was prospective, whereas rest were retrospective [8]. Three were from multicenter data [9,28,29]. No studies were population-based.…”

“…No studies were population-based. Overall, four studies were considered high quality and the rest were medium quality [9,28,29,34]. There were no low-quality studies.…”

“…Use of TIPS is limited by technical difficulties and availability [6]. Studies published thus far report the use of SEMS as a 'bridge' therapy with majority of the patients eventually being treated with EV banding and/ or TIPS [3,[7][8][9]. Although the current Baveno consensus workshop recommends the use of SEMS, an evidence-based approach to guide the use of SEMS in potentially life-threatening refractory EV bleeding is not established.…”

Where does TIPS fit in the management of patients with cirrhosis?

“… 8 , 46 Current clinical practice guidelines recommend self-expandable metallic stent (SEMS), or if not available, balloon tamponade as a bridge to definite treatment. SEMS seem to be more effective and safe 50 and have a longer dwell time, however, we would like to emphasise that they should not be removed before placement of a functional rescue/salvage TIPS due to the high risk of rebleeding. 50 Of note, the studies which established the value of TIPS as a rescue/salvage therapy were uncontrolled (due to the lack of an adequate comparator), still used sclerotherapy/uncovered stents, and indicated considerable short- and long-term mortality despite high rates of bleeding control.…”