Grand Round Summaries

REBOA: Resuscitative Endovascular Balloon Occlusion of the Aorta

 

The use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) has become a topic of considerable interest as of late, primarily to treat non-compressible truncal hemorrhage (NCTH). However, it is beginning to expand into other causes of non-compressible bleeding. 

Why do we care?

Bleeding is the 2nd leading cause of traumatic death behind only traumatic brain injury (TBI). Additionally, it is the number one cause of preventable death in trauma, causing 85% of all preventable trauma deaths.  Furthermore, 35% of all pre-hospital deaths and over 40% of deaths within the first 24 hours following trauma are attributed to bleeding (Kauvar, Lefering, & Wade, 2006).  One article states that there are around 60 000 civilian deaths per year in the US secondary to traumatic bleeding (Sauaia et al., 1995).

Is this REBOA thing new?!

Nope. 
 
The concept and use of REBOA has been around since at least 1954, when Lieutenant Colonel Carl Hughes of the US military published an article describing one injury in which REBOA was used to treat NCTH and two other battlefield injuries in which REBOA could potentially have been used to stem the bleeding (Hughes, 1954).
 
The next published data following this initial report was in 1986 and 1989 (Gupta et al., 1989Low, Longmore, Rubinstein,Flores, & Wolvek, 1986) showing the use intra-aortic balloon occlusion in traumatic injuries actually leading to some individuals surviving. However, with no randomization obviously it was not possible to determine if this was due to use of REBOA, extent of injuries or something else entirely.  Interestingly, following these publications the study and use of REBOA for trauma seemed to fall off the map entirely….until recently.

How do I put in a REBOA?

REBOA consists of non-rigid catheter with a balloon on the end inflated with a radiopaque substance such as saline. One example includes the CODA balloon catheter pictured here:  

 

REBOA
CODA Balloon Catheter
 
In order to place this catheter, a minimum 12 F introducer sheath (but more commonly a 14 or 16F sheath) is placed in the common femoral artery, followed by insertion of a long, stiff wire (eg. 150 cm Amplatz extra stiff wire) with the balloon catheter inserted over the wire to the desired location within the aorta, estimated by external landmarks and measurements.
 
The two main landing zones for REBOA placement are in zone I (intra-thoracic) for intra-abdominal bleeding, or zone III (intra-abdominal distal to renal arteries) for pelvic bleeding.  
REBOA
REBOA in Zone I
 
Classically, placement was confirmed via x-ray/fluoroscopy, however more recent data shows either ultrasound confirmation or simply clinical assessment may be accurate.
 
Advances in equipment have seen intuitive and important improvements on the intra-aortic balloon design.  One example of this (NB: I receive no funding/support from any company) is the Pryor Medical “Prytime”ER-REBOA catheter (seen here; images from product brochure). 
 
REBOA
PRYOR MEDICAL Prytyme ER-REBOA Catheter

Changes to the new design include, but are not limited to: 
  • More rigidity and thus guidewire-free
  • Requires only a 7F introducer sheath eliminating the need for arterial repair on removal
  • A protective “p-tip” to avoid vascular injury on insertion
  • External landmarks for more accurate placement without additional equipment and a proximal arterial line port in order to accurately measure blood pressure following balloon inflation.

One would expect these design improvements to not only improve provider placement and use of the balloon, but potentially improve patient outcomes, however this has yet to be proven in the literature.

Does REBOA work?

In theory it should however there are currently no RCTs to prove this. One must also consider the alternatives when deciding to implement new technologies despite the lack of research-based evidence.  In this instance, that alternative would be a resuscitative thoracotomy (RT) followed by cross-clamping of the descending thoracic aorta.  What we do have in the literature, is evidence that using this technique is quite poor for patient outcomes in the bleeding patient.  Mattox et al (1979) showed a 0% survival rate in 51 patients with intra-abdominal bleeding who received a RT & aortic cross-clamping, regardless of a penetrating or blunt mechanism.  More recently, multiple lines of evidence – mainly from Baltimore, Houston, LA and Denver in the US – have demonstrated (albeit non-prospectively) that REBOA may in fact improve outcomes in traumatic bleeding.
 
Dr. Megan Brenner and colleagues (Brenner et al., 2013) published a case-series of 6 patients receiving REBOA in either Shock Trauma in Baltimore or Herman Memorial in Houston, in which 4 patients survived to discharge (see below; image from publication).  
REBOA
Subsequently, Moore et al. published a study based on trauma registry data of REBOA (n=24) vs RT (n=72) in which 62.5% of REBOA patients died vs 90.3% of RT (see table below from published manuscript)
REBOA
 
REBOA

Additionally, as presented by Dr. Gareth Grier at the scientific meeting of AGN in Graz, Austria in April 2016, the prehospital HEMS service in London has placed 5 prehospital REBOA catheters and an additional 4 on arrival to hospital, and have had no deaths due to bleeding, further demonstrating the efficacy of REBOA.

Who gets REBOA?

As with many invasive procedures in critically ill patients (eg. ECMO), the million dollar question really is who gets REBOA.  Trauma centres in both Denver (from manuscript; below) and Baltimore (below; widely available on internet) have proposed various algorithms in order to determine who gets REBOA in the trauma bay, and where REBOA should be placed (ie. Zone I vs Zone III)

 
REBOA
REBOA

It’s not all roses…

Of vital importance is to recognize that REBOA is not a cure for everything! Like ECMO, it is simply a bridge in an effort to keep patients alive in order to get them to definitive treatment for their primary problem – OR vs angio in the case of traumatic bleeding.  
Using a swine model, Morrison and his colleagues (2014) demonstrated significant physiologic derangements that worsened with duration of REBOA balloon inflation at 30, 60 and 90 minutes, including; 
  • increased IL-6 levels
  • increased norepinephrine requirements for hemodynamic instability
  • increased incidence of ARDS.
 Additionally, use of REBOA has been reported to cause significant arterial injury and/or dissection, complete bowel ischemia and necrosis, distal limb necrotic ulcers and lower body ischemia. 
 
One Japanese study reported a 21.4% amputation rate (3/14 survivors out of 24 total cases; Saito et al., 2015), demonstrating the potential for quite significant adverse events from REBOA.  Contradicting this however, is data reported by Moore et al. at the Military Health Research Symposium in 2016, where they show no amputations in 21 survivors out of 33 cases, however 62% required a primary common femoral artery repair, and additional 8 patients required a thrombectomy, dissection flap repair or angioplasty due to REBOA usage.
 
Of additional consideration is the maintenance of competency in terms of insertion of a REBOA catheter, nursing care following insertion and most importantly a system in place to get patients to definitive care in a timely manner following REBOA insertion.

The future of REBOA

Although the utility of REBOA in traumatic bleeding is promising, more research is indeed required to demonstrate the efficacy and safety of this modality.  The American Association for the Surgery of Trauma (AAST) has created a registry in order to collect as much data from as many different sources as possible once a REBOA catheter is utilized for traumatic bleeding (DuBose et al., 2016).  
 
As well, promising research is demonstrating the use of partial (p-REBOA) and intermittent (i-REBOA) as modalities to extend the safety profile of aortic occlusion if prolonged resuscitation or transfer is required (Davidson et al. 2016Johnson, Neff, Williams, &DuBose, 2016Williams et al., 2016).
 
Case reports have also begun popping up regarding the use in non-traumatic bleeding requiring urgent resuscitation, including; post-partum hemorrhage (Yamashita et al., 2016), non-variceal upper GI bleeding (Sano et al., 2016), ectopic pregnancy rupture (Okumura, Tsurukiri, Oomura, Tanaka, & Oomura,2016) among others.
 

Conclusions

REBOA has proven itself to likely be a true player in the management of NCTH in trauma with the potential for use in other pathologies requiring urgent hemorrhage control.  It has shown itself to seemingly be at least as effective as resuscitative thoracotomy (perhaps better?) and certainly creates much less of a secondary iatrogenic injury.  Burgeoning advances in catheter technology, increasing utilization in major international trauma centres and considerations of altering balloon inflation characteristics all lend themselves to an exciting time in the treatment of one of the most lethal problems we face as physicians, with the real potential to vastly improve patient outcomes.
Dr. Noam Katz is a 5th year Emergency Medicine Resident in the FRCPC program. He has a special interest in acute care medicine and resuscitation.
Edited by Dr. Robert Suttie, PGY2, Emergency Medicine

References

1. Brenner, M. L., Moore, L. J., DuBose, J. J., Tyson, G. H., McNutt, M. K., Albarado, R. P., Rasmussen, T. E. (2013). A clinical series of resuscitative endovascular balloon occlusion of the aorta for hemorrhage control and resuscitation. The Journal of Trauma and Acute Care Surgery, 75(3), 506–11. http://doi.org/10.1097/TA.0b013e31829e5416
2. Davidson, A. J., Russo, R. M., DuBose, J. J., Roberts, J., Jurkovich, G. J., & Galante, J. M. (2016). Potential benefit of early operative utilization of low profile, partial resuscitative endovascular balloon occlusion of the aorta (P-REBOA) in major traumatic hemorrhage. Trauma Surgery & Acute Care Open, 1(1), e000028. http://doi.org/10.1136/tsaco-2016-000028
3. DuBose, J. J., Scalea, T. M., Brenner, M., Skiada, D., Inaba, K., Cannon, J., … Poulin, N. (2016). The AAST prospective Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry. Journal of Trauma and Acute Care Surgery, 81(3), 409–419. http://doi.org/10.1097/TA.0000000000001079
4. GUPTA, B. K., KHANEJA, S. C., FLORES, L., EASTLICK, L., LONGMORE, W., & SHAFTAN, G. W. (1989). The Role of Intra-aortic Balloon Occlusion in Penetrating Abdominal Trauma. The Journal of Trauma: Injury, Infection, and Critical Care. http://doi.org/10.1097/00005373-198906000-00026
5. Hughes, C. (1954). Use of an Intra-Aortic Balloon Catheter Tamponade for Controlling Intra-Abdominal Hemorrhage in Man. Surgery, 36(1), 65–8. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/13178946
6. Johnson, M. A., Neff, L. P., Williams, T. K., & DuBose, J. J. (2016). Partial Resuscitative Balloon Occlusion of the AORTA (P-REBOA). Journal of Trauma and Acute Care Surgery, 1. http://doi.org/10.1097/TA.0000000000001146
7. Kauvar, D. S., Lefering, R., & Wade, C. E. (2006). Impact of hemorrhage on trauma outcome: an overview of epidemiology, clinical presentations, and therapeutic considerations. The Journal of Trauma, 60(6 Suppl), S3-11. http://doi.org/10.1097/01.ta.0000199961.02677.19
8. Low, R. B., Longmore, W., Rubinstein, R., Flores, L., & Wolvek, S. (1986). Preliminary report on the use of the percluder® occluding aortic balloon in human beings. Annals of Emergency Medicine, 15(12), 1466–1469. http://doi.org/10.1016/S0196-0644(86)80945-3
9. Moore, L. J., Brenner, M., Kozar, R. A., Pasley, J., Wade, C. E., Baraniuk, M. S., … Houston, T. (2014). Implementation of resuscitative endovascular balloon occlusion of the aorta as an alternative to resuscitative thoracotomy for noncompressible truncal hemorrhage. J Trauma Acute Care Surg, 79(4), 523–532. http://doi.org/10.1097/TA.0000000000000809
10. Morrison, J. J., Ross, J. D., Markov, N. P., Scott, D. J., Spencer, J. R., & Rasmussen, T. E. (2014). The inflammatory sequelae of aortic balloon occlusion in hemorrhagic shock. Journal of Surgical Research, 191(2), 423–431. http://doi.org/10.1016/j.jss.2014.04.012
11. Okumura, E., Tsurukiri, J., Oomura, T., Tanaka, Y., & Oomura, R. (2016). Partial resuscitative endovascular balloon occlusion of the aorta as a hemorrhagic shock adjunct for ectopic pregnancy. The American Journal of Emergency Medicine, 34(9), 1917.e1-1917.e2. http://doi.org/10.1016/j.ajem.2016.02.026
12. Saito, N., Matsumoto, H., Yagi, T., Hara, Y., Hayashida, K., Motomura, T., … Wagatsuma, Y. (2015). Evaluation of the safety and feasibility of resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg, 78(5), 897–904. http://doi.org/10.1097/TA.0000000000000614
13. Sano, H., Tsurukiri, J., Hoshiai, A., Oomura, T., Tanaka, Y., & Ohta, S. (2016). Resuscitative endovascular balloon occlusion of the aorta for uncontrollable nonvariceal upper gastrointestinal bleeding. World Journal of Emergency Surgery. http://doi.org/10.1186/s13017-016-0076-3
14. Sauaia, A., Moore, F. A., Moore, E. E., Moser, K. S., Brennan, R., Read, R. A., & Pons, P. T. (1995). Epidemiology of Trauma Deaths. The Journal of Trauma: Injury, Infection, and Critical Care, 38(2), 185–193. http://doi.org/10.1097/00005373-199502000-00006
15. Williams, T. K., Neff, L. P., Johnson, M. A., Ferencz, S.-A., Davidson, A. J., Russo, R. M., & Rasmussen, T. E. (2016). Extending resuscitative endovascular balloon occlusion of the aorta. Journal of Trauma and Acute Care Surgery, 81(2), 294–301. http://doi.org/10.1097/TA.0000000000001075
16. Yamashita, Y., Kawashima, A., Hasegawa, J., Oba, T., Nakamura, M., Yamashita, T., … Sekizawa, A. (2016). Intra-aortic balloon occlusion without fluoroscopy for life-threating post-partum hemorrhage. Case Reports in Perinatal Medicine, 5(1), 19–22. http://doi.org/10.1515/crpm-2015-0050

EMottawa

EMottawa

Leave a Reply

Your email address will not be published. Required fields are marked *