Resuscitative Endovascular Balloon Occlusion of the Aorta

Original Date: 04/2003 | Supersedes: 07/2017 | Last Review Date: 10/2021
Purpose: To outline use of REBOA

Recommendations:

  • REBOA may be considered as an adjunct to temporary hemorrhage control in patients with life-threatening non-compressible torso hemorrhage arising below the diaphragm
  • REBOA should not be used in:
    • Patients where source(s) of bleeding arises cephalad to the diaphragm
    • Penetrating thoracic trauma with:
      • Clinically significant hemothorax
      • Possible or confirmed cardiac injury
      • Possible or confirmed thoracic vascular injury
    • REBOA may be considered in non-trauma patients at the discretion of EM and Trauma Surgery staff
    • When the need for REBOA is anticipated, an 18-gauge common femoral arterial line should be placed immediately
    • Once the patient has been stabilized and REBOA is no longer necessary:
      • Remove the REBOA catheter completely and flush the femoral artery introducer sheath with normal saline (may be used temporarily for arterial blood pressure monitoring)
      • Confirm pedal blood flow by palpation or Doppler
      • Remove the femoral artery introducer sheath as soon as possible after obtaining a normal rapid TEG, then:
        • Apply manual compression for 30 minutes or repair the femoral artery primarily
        • The patient should remain supine (no hip/knee flexion) for 6 hours
        • A duplex arterial ultrasound of the access site should be obtained 48 hours after sheath removal to assess for pseudoaneurysm or thrombus formation

Summary:

  • No randomized controlled trials of REBOA vs open aortic occlusion have been published, though enrollment in the UK REBOA study is ongoing
  • The current literature base is heavily confounded by indication bias. Accordingly, the current literature cannot offer a meaningful comparison between:
    • REBOA vs. No REBOA for hemorrhagic shock
    • REBOA vs. Open Aortic Occlusion for hemorrhagic shock
  • REBOA has not been shown to be superior to pre-peritoneal pelvic packing in hemodynamically significant pelvic fractures
  • From large, prospective database studies:
    • Time for successful REBOA placement is short and is likely similar to open aortic occlusion
    • Placement of REBOA in zone 1 or zone 3 increases systolic blood pressure

Background:

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a novel endovascular adjunct that is used to temporarily control non-compressible torso hemorrhage (NCTH) arising below the diaphragm. A catheter-based balloon is advanced retrograde from the common femoral artery into the aorta. The balloon is then inflated in order to occlude the aorta and stop blood flow. The intent is similar to that of cross-clamping the aorta during a resuscitative thoracotomy (RT). Although balloon occlusion of the aorta was described in the literature as early as 1954, its use has become increasingly popular since 2015. Increase in utilization is driven mainly by the introduction of a low-profile REBOA device (ER-REBOA, Prytime Medical). Unlike the first generation REBOA catheter (CODA, Cook Medical), which requires open femoral access for placement of a 12 French introducer sheath, the ER-REBOA catheter can be deployed through a 7 French sheath that may be placed percutaneously and does not require open femoral artery repair at the time of device removal. The technique is most commonly described in the trauma population, though REBOA use in non-trauma applications (e.g., obstetric emergencies, spontaneous intraabdominal hemorrhage, retroperitoneal sarcoma resection) has been described.

REBOA occlusion balloons may be placed in either the descending thoracic aorta between the left subclavian and celiac trunk or the infrarenal aorta. Placement in the descending thoracic aorta (zone 1) is intended for management of bleeding arising from the abdominal viscera or pelvic vessels. Placement in the infrarenal aorta (zone 3) is intended only for management of bleeding from the pelvic vessels. The balloon should never be positioned between the celiac trunk and renal arteries (zone 2), as this may selectively increase the risk of visceral ischemic complications without decreasing bleeding.

Despite its renewed interest, there are currently no published randomized control trials of endovascular balloon occlusion of the aorta, though the UK REBOA randomized control trial continues to enroll subjects (enrollment end date: December 2022).1 The United States Department of Defense (DoD) sponsored a prospective cohort study that collected data on patients with NCTH undergoing either REBOA or RT.2  However, study enrollment was completed in 2017, and the primary report does not offer a meaningful comparison to RT. Two prospective databases of REBOA procedures have been established that continue to enroll patients: the AAST AORTA registry in the United States and the ABO registry in Europe and Asia.3,4 Use of REBOA is not randomized, and case submission to the database is done voluntarily by participating institutions. Of the two, only the AAST AORTA registry offers a comparison to RT. The ABO registry does not compare REBOA to any other intervention.

PROSPECTIVE DATA

Data from the DoD NCTH study and the ABO registry show that REBOA can be placed rapidly and result in substantial improvement in hemodynamics.  Median time from decision for AO to REBOA balloon inflation was 7 (IQR 5-11) minutes.2  Median increase in SBP was 41 mmHg in the DoD NCTH study and 40 mmHg in a 2018 review of the ABO registry.2,4

The initial report from the AAST AORTA registry, AORTA1, was conducted in 2016 and captured the first 114 aortic occlusion (AO) patients (REBOA 46, open AO 68).3  This study compared open AO to REBOA deployment in any zone and found no difference in time to AO (REBOA 6.6 ±5.6 minutes vs. open AO 7.2 ±15.1 min; p = 0.842) or mortality (REBOA 28.2% vs. open AO 16.1%; p = 0.120).  Both techniques for AO were successful at improving hemodynamics and reached equivalent levels of hemodynamic stability following AO.  However, the groups were not similar at baseline.  The open AO group presented with greater physiologic derangement (i.e., higher heart rate, lower SBP) and was more likely to require CPR prior to AO.  The second report from the AAST AORTA database, AORTA2, was conducted in 2018 and captured 285 AO patients (REBOA 83, open AO 202).5  However, this study compared only zone 1 REBOA to open AO (excluding the more stable zone 3 REBOA group with a primarily pelvic source of hemorrhage).  Again, the groups were dissimilar at baseline, with the open AO group being younger, more likely to have a penetrating mechanism, and more hypotensive prior to AO.  Overall, survival to discharge was greater in the REBOA group (9.6% vs 2.5%, p = 0.023), however this difference is driven primarily by the minority of patients who did not require CPR prior to AO (n = 56; REBOA 22.2% vs. open AO 3.4%; p = 0.048).  The study showed no difference in survival to discharge in patients who received prehospital CPR (n = 172; REBOA 4.7% vs. open AO 2.3%; p = 0.60) or those who received CPR in the ED prior to AO (n = 57; REBOA 0% vs. open AO 2.3%; p = 1.000).  The authors conclude that REBOA can confer a survival benefit over open AO in patients not requiring CPR, however because open AO was preferentially performed in patients presenting in cardiac arrest, this is likely the result of residual confounding from indication bias.

RETROSPECTIVE DATA

Of the retrospective studies published (excluding case reports and case series), no definitive conclusions about REBOA can be drawn.

REBOA vs. No REBOA (any indication)

Six retrospective studies evaluated outcomes in trauma patients managed with REBOA compared to those managed without REBOA.  2015 and 2016 propensity-matched analyses of the Japan Trauma Data Bank (data years 2004-2011 and 2004-2014) and a 2019 propensity-matched analysis of the Trauma Quality Improvement Project (TQIP) database (data years 2015-2016) showed increased mortality in REBOA patients compared to no REBOA.6,7,8 Conversely, a 2018 Japanese single-center retrospective cohort study, a 2019 propensity-matched analysis of the Japan Trauma Data Bank, and a 2020 Colombian single-center retrospective cohort study show decreased mortality in the REBOA groups compared to no REBOA.9, 10, 11

REBOA vs Open Aortic Occlusion (AO)

Three retrospective studies have compared REBOA to open AO.  A 2015 propensity-matched study of the Japan Trauma Data Bank showed lower mortality in the REBOA group.12 However, a 2017 propensity-matched database study of Japanese hospital diagnosis and procedure data showed no difference in mortality between REBOA and open AO.13 A 2020 single-center retrospective study of REBOA and open AO in Cali, Colombia also showed no difference in mortality.14

REBOA vs Pre-peritoneal Packing (PPP)

Two retrospective studies have compared REBOA to PPP. A 2020 propensity-matched study of TQIP data (data years 2015-2017) showed lower mortality in the PPP group and no differences in blood product transfusion.15 However, a 2021 propensity-matched study of 2017 TQIP data showed lower mortality and less blood product transfusion in patients treated with REBOA.16

META-ANALYTIC DATA

Three systematic reviews with meta-analyses of the pooled data have been published.  A 2017 systematic review includes three studies (AORTA13 and two retrospective Japanese Trauma Data Bank studies12,13).17  Meta-analysis of pooled data comparing REBOA to RT showed decreased mortality in the REBOA group.  A 2018 systematic review included 89 studies, though the overwhelming majority of these were case reports, case series, or retrospective cohort studies of fewer than 20 patients.  Its meta-analysis of the pooled data from three large retrospective studies (the DoD NCTH study,2 AORTA1,3 and a Japanese study comparing REBOA to RT+REBOA) showed decreased mortality in the REBOA group.18  The final systematic review was published in 2021, and included studies are limited to the large prospective and retrospective studies outlined above.19  Meta-analysis of the pooled data showed decreased mortality when REBOA was compared to RT but increased mortality when REBOA was compared to No REBOA (i.e., REBOA was worse than doing nothing but better than doing open AO).  Unfortunately, each of these systematic reviews is limited by study heterogeneity (I2 as high as 87%), and the included studies are limited by indication bias.

Search Strategy

Search Database Search Term Limits # of Articles # Excluded # Included
1 PubMed (((REBOA[Title/Abstract]) OR (balloon occlusion[Title/Abstract])) AND (aorta[Title/Abstract])) AND (trauma[Title/Abstract]) Human, Randomized control trial 2 2
(1 not human; 1 not RCT)		 0
2 PubMed (((REBOA[Title/Abstract]) OR (balloon occlusion[Title/Abstract])) AND (aorta[Title/Abstract])) AND (trauma[Title/Abstract]) Human, Systematic review 9 6
(1 not REBOA; 1 not trauma; 1 complications only; 3 no comparator group)		 3
3 PubMed (((REBOA[Title/Abstract]) OR (balloon occlusion[Title/Abstract])) AND (aorta[Title/Abstract])) AND (trauma[Title/Abstract]) Human 189 171 (129 review, case report, or case series; 26 no comparator; 9 not trauma; 7 not human) 18
Duplicates 3
Included Articles: 18 (3 systematic review, 15 prospective and retrospective cohort studies)

References

  1. Study News. The UK-REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) Trial. UK REBOA Trial. Published 2017. Accessed October 6, 2021. https://w3.abdn.ac.uk/hsru/reboa/public/public/index.cshtml
  2. Moore LJ, Fox EE, Meyer DE, Wade CE, Podbielski JM, Xu X, Morrison JJ, Scalea T, Fox CJ, Moore EE, Morse BC, Inaba K, Bulger EM, Holcomb JB. Prospective Observational Evaluation of the ER-REBOA Catheter at 6 U.S. Trauma Centers. Ann Surg. 2020 Jun 23. doi: 10.1097/SLA.0000000000004055. Epub ahead of print. PMID: 33064384.
  3. DuBose JJ, Scalea TM, Brenner M, Skiada D, Inaba K, Cannon J, Moore L, Holcomb J, Turay D, Arbabi CN, Kirkpatrick A, Xiao J, Skarupa D, Poulin N; AAST AORTA Study Group. The AAST prospective Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry: Data on contemporary utilization and outcomes of aortic occlusion and resuscitative balloon occlusion of the aorta (REBOA). J Trauma Acute Care Surg. 2016 Sep;81(3):409-19. doi: 10.1097/TA.0000000000001079. PMID: 27050883.
  4. Sadeghi M, Nilsson KF, Larzon T, Pirouzram A, Toivola A, Skoog P, Idoguchi K, Kon Y, Ishida T, Matsumara Y, Matsumoto J, Reva V, Maszkowski M, Bersztel A, Caragounis E, Falkenberg M, Handolin L, Kessel B, Hebron D, Coccolini F, Ansaloni L, Madurska MJ, Morrison JJ, Hörer TM. The use of aortic balloon occlusion in traumatic shock: first report from the ABO trauma registry. Eur J Trauma Emerg Surg. 2018 Aug;44(4):491-501. doi: 10.1007/s00068-017-0813-7. Epub 2017 Aug 11. PMID: 28801841; PMCID: PMC6096626.
  5. Brenner M, Inaba K, Aiolfi A, DuBose J, Fabian T, Bee T, Holcomb JB, Moore L, Skarupa D, Scalea TM; AAST AORTA Study Group. Resuscitative Endovascular Balloon Occlusion of the Aorta and Resuscitative Thoracotomy in Select Patients with Hemorrhagic Shock: Early Results from the American Association for the Surgery of Trauma’s Aortic Occlusion in Resuscitation for Trauma and Acute Care Surgery Registry. J Am Coll Surg. 2018 May;226(5):730-740. doi: 10.1016/j.jamcollsurg.2018.01.044. Epub 2018 Feb 6. Erratum in: J Am Coll Surg. 2018 Oct;227(4):484. PMID: 29421694.
  6. Norii T, Crandall C, Terasaka Y. Survival of severe blunt trauma patients treated with resuscitative endovascular balloon occlusion of the aorta compared with propensity score-adjusted untreated patients. J Trauma Acute Care Surg. 2015 Apr;78(4):721-8. doi: 10.1097/TA.0000000000000578. PMID: 25742248.
  7. Inoue J, Shiraishi A, Yoshiyuki A, Haruta K, Matsui H, Otomo Y. Resuscitative endovascular balloon occlusion of the aorta might be dangerous in patients with severe torso trauma: A propensity score analysis. J Trauma Acute Care Surg. 2016 Apr;80(4):559-66; discussion 566-7. doi: 10.1097/TA.0000000000000968. PMID: 26808039.
  8. Joseph B, Zeeshan M, Sakran JV, Hamidi M, Kulvatunyou N, Khan M, O’Keeffe T, Rhee P. Nationwide Analysis of Resuscitative Endovascular Balloon Occlusion of the Aorta in Civilian Trauma. JAMA Surg. 2019 Jun 1;154(6):500-508. doi: 10.1001/jamasurg.2019.0096. PMID: 30892574; PMCID: PMC6584250.
  9. Otsuka H, Sato T, Sakurai K, Aoki H, Yamagiwa T, Iizuka S, Inokuchi S. Effect of resuscitative endovascular balloon occlusion of the aorta in hemodynamically unstable patients with multiple severe torso trauma: a retrospective study. World J Emerg Surg. 2018 Oct 25;13:49. doi: 10.1186/s13017-018-0210-5. PMID: 30386415; PMCID: PMC6202823.
  10. Yamamoto R, Cestero RF, Suzuki M, Funabiki T, Sasaki J. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is associated with improved survival in severely injured patients: A propensity score matching analysis. Am J Surg. 2019 Dec;218(6):1162-1168. doi: 10.1016/j.amjsurg.2019.09.007. Epub 2019 Sep 13. PMID: 31540683.
  11. García AF, Manzano-Nunez R, Orlas CP, Ruiz-Yucuma J, Londoño A, Salazar C, Melendez J, Sánchez ÁI, Puyana JC, Ordoñez CA. Association of resuscitative endovascular balloon occlusion of the aorta (REBOA) and mortality in penetrating trauma patients. Eur J Trauma Emerg Surg. 2020 Apr 16. doi: 10.1007/s00068-020-01370-9. Epub ahead of print. PMID: 32300850.
  12. Abe T, Uchida M, Nagata I, Saitoh D, Tamiya N. Resuscitative endovascular balloon occlusion of the aorta versus aortic cross clamping among patients with critical trauma: a nationwide cohort study in Japan. Crit Care. 2016 Dec 15;20(1):400. doi: 10.1186/s13054-016-1577-x. Erratum in: Crit Care. 2017 Feb 22;21(1):41. PMID: 27978846; PMCID: PMC5159991.
  13. Aso S, Matsui H, Fushimi K, Yasunaga H. Resuscitative endovascular balloon occlusion of the aorta or resuscitative thoracotomy with aortic clamping for noncompressible torso hemorrhage: A retrospective nationwide study. J Trauma Acute Care Surg. 2017 May;82(5):910-914. doi: 10.1097/TA.0000000000001345. PMID: 28430760.
  14. Ordoñez CA, Rodríguez F, Orlas CP, Parra MW, Caicedo Y, Guzmán M, Serna JJ, Salcedo A, Zogg CK, Herrera-Escobar JP, Meléndez JJ, Angamarca E, Serna CA, Martínez D, García AF, Brenner M. The critical threshold value of systolic blood pressure for aortic occlusion in trauma patients in profound hemorrhagic shock. J Trauma Acute Care Surg. 2020 Dec;89(6):1107-1113. doi: 10.1097/TA.0000000000002935. PMID: 32925582.
  15. Mikdad S, van Erp IAM, Moheb ME, Fawley J, Saillant N, King DR, Kaafarani HMA, Velmahos G, Mendoza AE. Pre-peritoneal pelvic packing for early hemorrhage control reduces mortality compared to resuscitative endovascular balloon occlusion of the aorta in severe blunt pelvic trauma patients: A nationwide analysis. Injury. 2020 Aug;51(8):1834-1839. doi: 10.1016/j.injury.2020.06.003. Epub 2020 Jun 6. PMID: 32564964.
  16. Asmar S, Bible L, Chehab M, Tang A, Khurrum M, Douglas M, Castanon L, Kulvatunyou N, Joseph B. Resuscitative Endovascular Balloon Occlusion of the Aorta vs Pre-Peritoneal Packing in Patients with Pelvic Fracture. J Am Coll Surg. 2021 Jan;232(1):17-26.e2. doi: 10.1016/j.jamcollsurg.2020.08.763. Epub 2020 Oct 3. PMID: 33022396.
  17. Manzano Nunez R, Naranjo MP, Foianini E, Ferrada P, Rincon E, García-Perdomo HA, Burbano P, Herrera JP, García AF, Ordoñez CA. A meta-analysis of resuscitative endovascular balloon occlusion of the aorta (REBOA) or open aortic cross-clamping by resuscitative thoracotomy in non-compressible torso hemorrhage patients. World J Emerg Surg. 2017 Jul 14;12:30. doi: 10.1186/s13017-017-0142-5. PMID: 28725258; PMCID: PMC5512749.
  18. Borger van der Burg BLS, van Dongen TTCF, Morrison JJ, Hedeman Joosten PPA, DuBose JJ, Hörer TM, Hoencamp R. A systematic review and meta-analysis of the use of resuscitative endovascular balloon occlusion of the aorta in the management of major exsanguination. Eur J Trauma Emerg Surg. 2018 Aug;44(4):535-550. doi: 10.1007/s00068-018-0959-y. Epub 2018 May 21. PMID: 29785654; PMCID: PMC6096615.
  19. Castellini G, Gianola S, Biffi A, Porcu G, Fabbri A, Ruggieri MP, Coniglio C, Napoletano A, Coclite D, D’Angelo D, Fauci AJ, Iacorossi L, Latina R, Salomone K, Gupta S, Iannone P, Chiara O; Italian National Institute of Health guideline working group on Major Trauma. Resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with major trauma and uncontrolled hemorrhagic shock: a systematic review with meta-analysis. World J Emerg Surg. 2021 Aug 12;16(1):41. doi: 10.1186/s13017-021-00386-9. PMID: 34384452; PMCID: PMC8358549.