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Resuscitative Endovascular Balloon Occlusion of the Aorta for Control of Non-Compressible Truncal Hemorrhage: A Review of Clinical Effectiveness and Guidelines

CADTH Rapid Response Report: Summary with Critical Appraisal

and .

Context and Policy Issues

Truncal hemorrhage is one of the leading causes of death following traumatic injury in Canada among both military1 and civilian populations.2 A study of all Canadian Forces members who died in Afghanistan over a two year period found that torso hemorrhage accounted for 33% of deaths,1 and a study of all deaths occurring over a five year period at a level one trauma center in Toronto, Canada found that 15% of all deaths were due to hemorrhage, primarily from the torso.2

Hemorrhage is broadly classified as compressible and non-compressible. Compressible hemorrhages are due to injuries to the extremities and can be managed with direct pressure or tourniquets, whereas non-compressible hemorrhage cannot be controlled by direct pressure and involves vascular disruption in the thoracic cavity, solid abdominal organs, named axial torso vessel, or pelvic fracture with ring disruption.3 Mortality rates among patients with non-compressible truncal hemorrhaging (NCTH) are very high, with estimates ranging from 18% to 86%,4,5 and among military populations approximately 75% of NCTH deaths occur before hospital admission.5 Death can occur quickly due to severe blood loss, and quickly addressing blood loss has the potential to greatly improve survival rates; studies from wars in Iraq and Afghanistan indicate that among potentially survivable injuries, 50% to 80% of deaths were due to severe blood loss.6,7

One strategy to quickly address blood loss due to NCTH is to administer pre-hospital treatment.8 However, standard pre-hospital treatment options are extremely limited, and include rapid transport to a care facility and administration of blood products.1 Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a promising new treatment for addressing NCTH blood loss in the pre-hospital setting.8 REBOA is achieved with a balloon catheter that occludes large vessels to reduce blood loss, and the balloon can be inflated in different locations within the thoracic cavity depending on the location of the injury.8,9 However, the efficacy and safety of this device compared to usual treatment is not well known.9

The purpose of this report is to examine the comparative clinical effectiveness and safety of REBOA versus usual treatment (e.g., rapid evacuation, administration of blood product) in pre-hospital settings, and to examine clinical guidelines regarding the use of REBOA in pre-hospital settings.

Research Questions

  1. What is the clinical effectiveness of resuscitative endovascular balloon occlusion of the aorta for control of non-compressible truncal hemorrhage in the pre-hospital environment?
  2. What are the evidence-based guidelines regarding the use of resuscitative endovascular balloon occlusion of the aorta for the management of non-compressible truncal hemorrhage in the pre-hospital environment?

Key Findings

No relevant clinical effectiveness evidence or evidence-based guidelines regarding the use of resuscitative endovascular balloon occlusion of the aorta for the management of non-compressible truncal hemorrhage in the pre-hospital environment were identified.

Methods

Literature Search Methods

A limited literature search was conducted on key resources including Ovid Medline, PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases and a focused Internet search. No methodological filters were applied to limit retrieval by publication type. The search was limited to English language documents published between January 1, 2013 and February 6, 2018.

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.

Table 1. Selection Criteria.

Table 1

Selection Criteria.

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or were published prior to 2013. Additionally, clinical practice guidelines with unclear methodology were excluded.

Summary of Evidence

Quantity of Research Available

A total of 295 citations were identified in the literature search. Following screening of titles and abstracts, 269 citations were excluded and 26 potentially relevant reports from the electronic search were retrieved for full-text review. Sixteen potentially relevant publications were retrieved from the grey literature search. Of these potentially relevant articles, 42 publications were excluded for various reasons, while no publications met the criteria for inclusion in this report. Appendix 1 describes the PRISMA flowchart of the study selection. References of potential interest are provided in Appendix 2.

Summary of Findings

No relevant clinical effectiveness or guidelines were identified; therefore, a summary of findings cannot be provided.

Conclusions and Implications for Decision or Policy Making

This review did not identify any studies evaluating the comparative effectiveness of REBOA versus usual care in the pre-hospital setting, or any evidence-based clinical guidelines. Given the lack of identified evidence, the effectiveness of REBOA versus usual care and guidelines for the use of REBOA in pre-hospital settings remains unclear.

A few case studies of REBOA in the pre-hospital setting indicate it may be a promising treatment. A case series of four patients injured during wartime found that pre-hospital use of REBOA resulted in immediate normalization of blood pressure, and all four patients survived transfer to the next level of care.10 Two other case reports indicate favorable outcomes (i.e., survival) for civilians in the pre-hospital setting,11,12 although long-term complications due to use of REBOA included leg amputation.12 Although these case reports provide some preliminary evidence of the clinical effectiveness of REBOA, a much stronger research base is needed to make any conclusion about the effectiveness of REBOA and guidelines for its use. Future research comparing REBOA with usual treatment in pre-hospital settings may help reduce uncertainty.

References

1.
Pannell D, Brisebois R, Talbot M, Trottier V, Clement J, Garraway N, et al. Causes of death in Canadian Forces members deployed to Afghanistan and implications on tactical combat casualty care provision. J Trauma. 2011 Nov;71(5 Suppl 1):S401–S407. [PubMed: 22071995]
2.
Tien HC, Spencer F, Tremblay LN, Rizoli SB, Brenneman FD. Preventable deaths from hemorrhage at a level I Canadian trauma center. J Trauma. 2007 Jan;62(1):142–6. [PubMed: 17215745]
3.
Moore LJ, Martin CD, Harvin JA, Wade CE, Holcomb JB. Resuscitative endovascular balloon occlusion of the aorta for control of noncompressible truncal hemorrhage in the abdomen and pelvis. Am J Surg. 2016 Dec;212(6):1222–30. [PubMed: 28340927]
4.
Kisat M, Morrison JJ, Hashmi ZG, Efron DT, Rasmussen TE, Haider AH. Epidemiology and outcomes of non-compressible torso hemorrhage. J Surg Res. 2013 Sep;184(1):414–21. [PubMed: 23831230]
5.
Morrison JJ, Stannard A, Rasmussen TE, Jansen JO, Tai NR, Midwinter MJ. Injury pattern and mortality of noncompressible torso hemorrhage in UK combat casualties. J Trauma Acute Care Surg. 2013 Aug;75(2 Suppl 2):S263–S268. [PubMed: 23883918]
6.
Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, et al. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 Jul;71:(1 Suppl):S4–S8. [PubMed: 21795876]
7.
Kelly JF, Ritenour AE, McLaughlin DF, Bagg KA, Apodaca AN, Mallak CT, et al. Injury severity and causes of death from Operation Iraqi Freedom and Operation Enduring Freedom: 2003-2004 versus 2006. J Trauma. 2008 Feb;64:(2 Suppl):S21–S26. [PubMed: 18376168]
8.
van Oostendorp SE, Tan EC, Geeraedts LM, Jr. Prehospital control of life-threatening truncal and junctional haemorrhage is the ultimate challenge in optimizing trauma care; a review of treatment options and their applicability in the civilian trauma setting. Scand J Trauma Resusc Emerg Med [Internet]. 2016 Sep 13 [cited 2018 Mar 6];24(1):110. Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC5022193 [PMC free article: PMC5022193] [PubMed: 27623805]
9.
Qasim Z, Brenner M, Menaker J, Scalea T. Resuscitative endovascular balloon occlusion of the aorta. Resuscitation. 2015 Nov;96:275–9. [PubMed: 26386370]
10.
Manley JD, Mitchell BJ, DuBose JJ, Rasmussen TE. A modern case series of resuscitative endovascular balloon occlusion of the aorta (REBOA) in an out-of-hospital, combat casualty care setting. J Spec Oper Med. 2017; Spring;17(1):1–8. [PubMed: 28285473]
11.
Sadek S, Lockey DJ, Lendrum RA, Perkins Z, Price J, Davies GE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) in the pre-hospital setting: An additional resuscitation option for uncontrolled catastrophic haemorrhage. Resuscitation. 2016 Oct;107:135–8. [PubMed: 27377669]
12.
Rich JA, Coleman J, Devaux C, Hoffman K. Acute rehabilitation after resuscitative endovascular balloon occlusion of the aorta (REBOA) in major trauma. BMJ Case Rep. 2017 Jul 17;2017, 2017 Jul 17. [PMC free article: PMC5535212] [PubMed: 28716775]

Appendix 1. Selection of Included Studies

Image app1f1

Appendix 2. References of Potential Interest

Clinical Practice Guidelines – no systematic methodology

Feasibility of teaching REBOA to nonsurgical medical specialists in pre-hospital setting – simulated (non-human) study

  • Teeter W, Romagnoli A, Glaser J, Fisher AD, Pasley J, Scheele B, et al. Resuscitative endovascular balloon occlusion of the aorta: pushing care forward. J Spec Oper Med. 2017;17(1):17–21. [PubMed: 28285476]

Review Article – complications and mitigating strategies for REBOA

  • Davidson AJ, Russo RM, Reva VA, Brenner ML, Moore LJ, Ball C, et al. The pitfalls of REBOA: risk factors and mitigation strategies. J Trauma Acute Care Surg. Oct 4;2017 [PubMed: 29266052]

Review Articles – feasibility in pre-hospital military settings

  • Knight RM. A perspective on the potential for battlefield resuscitative endovascular balloon occlusion of the aorta. J Spec Oper Med. 2017;17(1):72–5. [PubMed: 28285483]
  • Rees P, Waller B, Buckley AM, Doran C, Bland S, Scott T, et al. REBOA at Role 2 Afloat: resuscitative endovascular balloon occlusion of the aorta as a bridge to damage control surgery in the military maritime setting. J R Army Med Corps. 2017 Dec 20;2017 Dec 20. [PubMed: 29269480]
  • Smith SA, Hilsden R, Beckett A, McAlister VC. The future of resuscitative endovascular balloon occlusion in combat operations. J R Army Med Corps. 2017 Aug 9;2017 Aug 09. [PubMed: 28794007]

About the Series

CADTH Rapid Response Report: Summary with Critical Appraisal
ISSN: 1922-8147

Version: 1.0

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Suggested citation:

Resuscitative endovascular balloon occlusion of the aorta for control of non-compressible truncal hemorrhage: a review of clinical effectiveness and guidelines: Ottawa: CADTH; 2018 Mar. (CADTH rapid response report: summary with critical appraisal).

Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.

While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.

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Bookshelf ID: NBK531932PMID: 30325621

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