Authors' objectives: To assess the efficacy / effectiveness, safety, economic and organisational implications of REBOA as adjunctive measure in management of non-compressible haemorrhages.

Authors' results and conclusions: Based on retrievable evidence, REBOA had shown to improve SBP by an estimation of 50mmHg in major haemorrhage from both traumatic and non-traumatic sources. Survival benefit beyond 28 days was evident among non-compressible torso haemorrhage patients who experience delays in surgical intervention more than one hour and compared to those who underwent RT. REBOA was significantly associated with improved survival to discharge in patients with isolated abdominal injury or pelvis/lower extremity injury. REBOA did not confer any long-term survival advantage when used in traumatic cardiac arrest compared with standard of care. Based on limited evidence, the utilisation of prophylactic REBOA among obstetric patients with morbidly adherent placenta had shown to lower the amount of intraoperative haemorrhage and lower the requirement of blood products transfusion. There was a good level of retrievable evidence that showed the risk of complications with the use of REBOA was 5%. The most common complications included arterial disruption, dissection, pseudoaneurysms, haematoma, thromboembolic problems, and extremity ischaemia. These complications had resulted in limb loss and/or the need for patch angioplasty, complex arterial reconstructions or bypass. The emergent placement carried higher risk of complications compared to prophylactic placement. Other main risk factors were high body mass index, thrombocytopaenia, emergency procedures, big size of the introducer, and use of anti-platelet drugs. Complications seemed to reduce significantly with 7-Fr catheter. Based on a cost utility analysis from the perspective of NHS UK, the use of REBOA was not cost-effective (ICER £44,617.44 per QALY) exceeding WTP threshold of £30,000. A formal REBOA curriculum improves knowledge and comfort with critical aspects of this procedure. Simulation-based training of REBOA had shown to be effective in improving the knowledge and competency of REBOA placement. This knowledge persisted at six months, though subjective comfort deteriorated among those without REBOA placement in the interim. REBOA refresher training should be considered at six-month intervals in the absence of clinical REBOA cases.

Authors' recommendations: REBOA may be used as lifesaving adjunct in a highly selective population of patients with non-compressible haemorrhages. The procedure should be performed by a credentialed operator. There should be a national consensus on indications, contra-indications and physiological parameters for patient selection for the procedure. There is also a need for a system-wide inter-displinary approach to the implementation of REBOA, in order to reduce, recognize, and address potentially life and limb-threatening problems quickly and effectively. Further research is needed on the use of REBOA in obstetric population taking into account the risk of aorta–fetal circulation compromise.

Authors' methods: Electronic databases were searched through the Ovid interface: Ovid MEDLINE® In-process and other Non-indexed citations and Ovid MEDLINE® 1946 to present, EBM Reviews - Cochrane Central Register of Controlled Trials – October 2020, EBM Reviews - Cochrane Database of Systematic Reviews - 2005 to October 2020, EBM Reviews - Health Technology Assessment – 4th Quarter 2016, EBM Reviews – NHS Economic Evaluation Database 1st Quarter 2016. Searches were also run in PubMed. Google was used to search for additional web-based materials and information. No limits were applied. Additional articles were identified from reviewing the references of retrieved articles. Last search was conducted on 31 October 2020.

Authors' identified further research: Further research is needed to evaluate risk benefit of prophylactic use of REBOA in obstetric population with morbidly adherent placenta.

Project Status: Completed

Year Published: 2020

URL for published report: https://www.moh.gov.my/index.php/database_stores/store_view_page/30/364

Requestor: Ministry of Health

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)