Retrospective Cohort Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Aug 27, 2022; 14(8): 1584-1597
Published online Aug 27, 2022. doi: 10.4254/wjh.v14.i8.1584
Survival outcomes and predictors of mortality, re-bleeding and complications for acute severe variceal bleeding requiring balloon tamponade
Charlotte Y Keung, Aparna Morgan, Suong T Le, Marcus Robertson, Paul Urquhart, Michael P Swan
Charlotte Y Keung, Aparna Morgan, Suong T Le, Marcus Robertson, Michael P Swan, Department of Gastroenterology, Monash Health, Melbourne 3168, Victoria, Australia
Charlotte Y Keung, Paul Urquhart, Department of Gastroenterology, Eastern Health, Melbourne 3128, Victoria, Australia
Charlotte Y Keung, Suong T Le, Marcus Robertson, Department of Medicine, Monash University, Melbourne 3168, Victoria, Australia
Suong T Le, Monash Digital Therapeutics and Innovation Laboratory, Monash University, Melbourne 3168, Victoria, Australia
Author contributions: Keung C designed the study, collected and analysed data and wrote the manuscript; Morgan A collected data and wrote the manuscript; Le ST reviewed the statistical analysis and performed critical revisions of the manuscript; Robertson M performed critical revisions of the manuscript; Urquhart P performed critical revisions of the manuscript; Swan M designed and supervised the study and performed critical revisions of the manuscript.
Institutional review board statement: This study was reviewed and approved by the Monash Health Human Research Ethics Committee (RES-21-0000-218Q-70254).
Informed consent statement: Patients were not required to give informed consent to this study and the analysis used anonymous clinical data.
Conflict-of-interest statement: All authors declare no conflicts-of-interest related to this article.
Data sharing statement: No additional data are available.
STROBE statement: All authors have read the STROBE Statement checklist of items and the manuscript was prepared and revised according to the STROBE Statement checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Charlotte Y Keung, FRACP, MBBS, Academic Fellow, Doctor, Department of Gastroenterology, Monash Health, 246 Clayton Road, Clayton, Melbourne 3168, Victoria, Australia. charlotte.keung@monashhealth.org
Received: March 30, 2022
Peer-review started: March 30, 2022
First decision: June 8, 2022
Revised: June 22, 2022
Accepted: July 26, 2022
Article in press: July 26, 2022
Published online: August 27, 2022
Processing time: 148 Days and 21.9 Hours
ARTICLE HIGHLIGHTS
Research background

Salvage treatment using balloon tamponade techniques such as Sengstaken-Blakemore tubes (SBT) represents the most severe end of the spectrum of acute variceal bleeding (AVB), where failure to achieve primary haemostasis inevitably results in death. However, few studies report on the clinical practice and outcomes of this procedure in the current era, and only include small study populations where balloon tamponade is often performed by non-specialists in the emergency department setting. This retrospective multi-centre cohort study is the largest study including 80 patients over a decade who have undergone SBT for salvage therapy performed by gastroenterologists during endoscopy in tertiary hospitals. This study provides detailed technical aspects of the SBT insertion procedure and provides insight into the success rate, clinical outcomes of patients who undergo SBT insertion for refractory AVB and predictors of mortality, re-bleeding and complications from SBT.

Research motivation

The main topics of this study include detailed descriptions regarding the real-world practice of SBT performed by gastroenterologists in tertiary hospitals, and the clinical outcomes and predictors of short- and long-term mortality after SBT for AVB, the success rate of balloon tamponade in achieving primary haemostasis and the rate of re-bleeding and complications arising from SBT insertion. Information regarding these topics are not currently available for the current era which significantly differs from historical cohorts from the 1970-1980s due to a very different patient population where balloon tamponade was often first-line therapy. Currently, there are clear expert opinion-based consensus guidelines using a range of medical and endoscopic therapies and definitive treatment with radiologic procedures or liver transplantation for AVB. Furthermore, performing salvage technique with SBT is highly resource-intense and thus appropriate risk stratification to optimise outcomes for patients is required.

Research objectives

To assess the primary outcome which was all-cause mortality of AVB requiring SBT in the short-term (6 wk) as well as long-term (52 wk) and the secondary outcomes of re-bleeding and complications after SBT insertion. The predictors of these outcomes were also analysed. These objectives were all achieved apart from the predictors of complications from SBT as serious complications were infrequent.

Research methods

Due to the infrequent need to perform SBT for AVB, an appropriate method to undertake this study resulted in a multi-centre retrospective cohort study including 80 adult patients with SBT for refractory AVB from 2008 to 2019. The study population was identified using International Classification of Diseases-10 codes and clinical data was collected from medical records. Descriptive statistics, univariate and multivariate binomial regression and survival analyses were used to analyse the data collected.

Research results

SBT salvage for refractory AVB is a life-threatening condition with high mortality rates of 48.8% at 6 wk and 53.8% at 52 wk. The SBT procedure was highly successful in achieving primary haemostasis in 91.3% of patients but re-bleeding was common at 34.2% and associated with very high mortality of 76.0%. The predictors of mortality after SBT insertion included increased severity of liver disease, severe metabolic disturbance, presence of hepatocellular carcinoma (HCC) and re-bleeding. Serious complications from SBT insertion were uncommon at 6.3% and the main complications were superficial mucosal trauma without perforation which was managed conservatively. Despite this procedure being performed by specialist gastroenterologists in this study, there was still significant variation amongst technical aspects of the SBT procedure particularly amongst gastric and oesophageal balloon inflation volumes.

Research conclusions

In the current era, SBT as a salvage therapy for refractory AVB continues to be associated with high short and long-term mortality rates. The utilisation of this temporising procedure remains relevant and is associated with high rates of primary haemostasis over 90%. As the mortality rate exceeds 75% after re-bleeding, this highlights the importance of prompt treatment with definitive therapies such as transjugular intrahepatic portosystemic shunts to optimise clinical outcomes. Furthermore, as SBT is associated with intense use of resources with even greater mortality in the presence of advanced HCC, this study suggests early palliation may be more appropriate in this futile setting.

Research perspectives

Future directions of this research should focus on strategies to optimise the clinical outcomes for this cohort of severe refractory AVB including prevention, the use of covered self-expandable oesophageal stents and prompt transition to definitive treatments before re-bleeding occurs. Further studies into risk stratification for optimal outcomes is required as well to assist clinicians in decision making regarding whether or not salvage therapy should be performed at all.