Resuscitative Endovascular Balloon Occlusion of the Aorta in trauma: a systematic review of the literature
Gamberini et al. World Journal of Emergency Surgery
Resuscitative Endovascular Balloon Occlusion of the Aorta in trauma: a systematic review of the literature
Emiliano Gamberini 0
Federico Coccolini 2
Beatrice Tamagnini 1
Costanza Martino 0
Vittorio Albarello 0
Marco Benni 0
Marcello Bisulli 6
Nicola Fabbri 5
Tal Martin Hörer 4
Luca Ansaloni 2
Carlo Coniglio 3
Marco Barozzi 7
Vanni Agnoletti 0
0 Anesthesia and Intensive Care Department, AUSL Romagna Trauma Center “Maurizio Bufalini” Hospital , Viale Ghirotti 286, 47521 Cesena , Italy
1 Emergency Medicine, University of Modena and Reggio Emilia , via Università 4, 41121 Modena , Italy
2 General and Emergency Surgery Department, ASST Trauma Center “Papa Giovanni XXIII” Hospital , Piazza OMS 1, 24127 Bergamo , Italy
3 Anesthesia, Intensive Care and 118 Emergency System Department, AUSL Bologna Trauma Center “Maggiore” Hospital , Largo Nigrisoli 2, 40133 Bologna , Italy
4 Cardiothoracic and Vascular Surgery Department, Örebro University Hospital , Södra Grev Rosengatan, 701 85 Örebro , Sweden
5 General and Emergency Surgery Department, AUSL Romagna Trauma Center “Maurizio Bufalini” Hospital , Viale Ghirotti 286, 47521 Cesena , Italy
6 Interventional Radiology Department, AUSL Romagna Trauma Center “Maurizio Bufalini” Hospital , Viale Ghirotti 286, 47521 Cesena , Italy
7 Emergency Medicine Department, AUSL Modena Trauma Center “Sant'Agostino” Hospital , Via Pietro Giardini 1355, 41126 Modena , Italy
Aims: Resuscitative endovascular balloon occlusion of the aorta has been a hot topic in trauma resuscitation during these last years. The aims of this systematic review are to analyze when, how, and where this technique is performed and to evaluate preliminary results. Methods: The literature search was performed on online databases in December 2016, without time limits. Studies citing endovascular balloon occlusion of the aorta in trauma were retrieved for evaluation. Results: Sixty-one articles met the inclusion criteria and were selected for the systematic review. Overall, they included 1355 treated with aortic endovascular balloon occlusion, and 883 (65%) patients died after the procedure. In most of the included cases, a shock state seemed to be present before the procedure. Time of death and inflation site was not described in the majority of included studies. Procedure-related and shock-related complications are described. Introducer sheath size and comorbidity seems to play the role of risk factors. Conclusions: Resuscitative endovascular balloon occlusion of the aorta is increasingly used in trauma victim resuscitation all over the world, to elevate blood pressure and limit fluid infusion, while other procedures aimed to stop the bleeding are performed. High mortality rate is probably due to the severity of the injuries. Time and place of balloon insertion, zone of balloon inflation, and inflation cutoff time are very heterogeneous.
REBOA; Aortic balloon occlusion; Hemorrhagic shock; Severe trauma; Trauma system; Trauma center; Bleeding; Systematic review
Hemorrhagic shock is a major cause of death [
Although the main aims of resuscitation are to stop the
hemorrhage and restore circulating blood volume,
persistent hemorrhage can be rapidly fatal. In major trauma,
uncontrolled bleeding is the first cause of potentially
preventable death [
]. Resuscitative endovascular
balloon occlusion of the aorta (REBOA) has been used in a
variety of clinical settings (postpartum hemorrhage,
upper gastrointestinal hemorrhage, pelvic hemorrhage
during pelvic/sacral tumor surgery, traumatic
abdominopelvic hemorrhage, ruptured aneurysm abdominal aorta
]) to successfully elevate central blood pressure in
the setting of shock, even if the evidence base is weak
and devoid of clear indications. The effectiveness in this
clinical target seems to have been confirmed by recent
pooled analyses [
] that demonstrated an increase in
mean systolic pressure following REBOA use; however,
benefits in terms of overall reduction of trauma patient
mortality are controversial [
] (Table 1). Prospective
data collection is underway in the form of an American
Association for the Surgery of Trauma-sponsored
observation study  and a European registry [
should permit the consistent recording of
REBOAspecific data, including indications and outcome. The
aortic level of balloon inflation is usually reported
35 REBOA + other treatments
according to the three zone classifications: zone I thoracic
aorta from left subclavian and celiac artery, zone II
between celiac and renal artery, and zone III infra-renal
]. For bleeding in the abdominal cavity,
the REBOA balloon is placed in zone I. For pelvic
bleeding, generally from iliac artery branches, the balloon is
placed in the distal aorta (zone III). Zone II is not
currently in use. Prophylactic balloon placement in
hemodynamically stable patients at risk of significant
hemorrhage  has also been described. Positioning
could lead to device-related morbidity (3.7%) and
mortality (0.8%) due to arterial perforation or dissection,
insertion site bleeding, and balloon-related thromboembolic
This aims to provide a systematic analysis of currently
available literature regarding the use of REBOA in
Materials and methods
The methodological approach includes the development
of selection criteria, definition of search strategies, and
abstraction of relevant data. The PRISMA statement
checklist for reporting a systematic review was followed.
Types of study included and criteria selection
All studies concerning REBOA use in trauma were
retrieved and analyzed.
Review articles, systematic reviews, interventional
trials, case series, and reports were considered eligible for
inclusion in this systematic review. Conference abstracts,
letters, experimental papers with animals, and
commentaries were not considered.
Types of participants and intervention
Trauma victims who underwent REBOA during
emergency department (ED) and operating room (OR)
resuscitation phase were considered.
Types of outcome measures
The primary outcome was hospital mortality. All
secondary parameters reported in the selected studies were
Literature search and selection
Literature search was performed online on MEDLINE
(through PubMed) and Cochrane Oral Health Group
Specialized Register, with the addition of five articles
identified from references of other works.
In order to facilitate the identification of relevant
articles, the research equation was based on the following
text words and criteria: “REBOA” or “resuscitative
endovascular balloon occlusion of the aorta” or “ABO” or
“aortic balloon” and “trauma” as title/abstract.
The literature search was performed in December
2016, with no time limit.
Out of the 144 initially identified articles, 61 met the
inclusion criteria and were selected for the systematic
review, 28 of which were actually analyzed for outcome
measures and included in this review. The flow chart of
study identification and the inclusion/exclusion process
is shown in Fig. 1.
It was not possible to recover the full text of some
articles; however, these have been included in the table
(but not commented), when the data necessary for our
analysis could be extrapolated from the abstracts.
One thousand three hundred fifty-five patients treated
with REBOA were included in this systematic review.
Most of them were in a state of shock when REBOA
was positioned; mortality was 65% (883 patients) and
time of death was not always reported.
One hundred forty-nine patients were treated with
REBOA in zone I, 5 in zone II, and 38 in zone III. In the
majority of cases, REBOA zone was not described.
Criteria of inclusion/exclusion of patients
The studies were carried out mostly on an adult
population (namely patients aged over 15 [
] or 16 [
18 years old, according to the explicit indications).
The studies are retrospective and used registries, so they
refer to the time period in which the cases were selected
(e.g., 2014 or from January 2007 to December 2013).
Inclusion criteria are heterogeneous. Patients included
in the studies were analyzed for uncompressible trunk
hemorrhage, intra-abdominal bleeding (e.g., liver or
splenic injury), retroperitoneal hemorrhage (e.g., renal
injury or pelvic fracture), and non-traumatic hemorrhage
(e.g., obstetric or gastrointestinal that have been excluded
from this review).
Patients’ selection criteria vary depending on the
studies, and they are usually indicated for example
hemoperitoneum or pelvic ring fractures with potential imminent
cardiac arrest or fluid resuscitation unresponsiveness
state with a sustained SBP of less than 90 mmHg [
Some studies excluded patients who went into cardiac
arrest during admission, were diagnosed with any
terminal disease during the study period [
], or sustained
what were defined as un-survivable injuries [
Lastly, some research excluded patients where REBOA
was positioned to prevent shock (still hemodynamically
stable); in the queue of their article, Irahara et al. [
described an interesting case report regarding the
prophylactic use of REBOA in potentially evolutionary cases.
While this practice is of great interest, other authors have
confessed fears that they may become too invasive [
Many studies include patients undergoing treatment
with REBOA for reasons other than trauma (e.g.,
bleeding of the gastrointestinal tract, post-partum bleeding);
those only dealing with REBOA in non-traumatic cases
were eliminated in the initial selection of this systematic
review (Fig. 1), whereas articles including trauma
patients were analyzed to extract data of interest.
Definition of shock
Some studies provided an explicit definition of shock
(e.g., SBP < 90 mmHg or SI ≥ 1 [
]; SBP < 90 mmHg or
HR > 120 bpm or base deficit < − 5 [
]; SBP < 80 mmHg
and no response to fluid treatment [
]) while others
did not; however, it was possible to deduce patient’s vital
parameters from the tables (mean patient SBP was often
indicated in the tables, and for the purposes of this
review, < 90 mmHg was defined as shock).
Almost all REBOA was introduced from the femoral
artery (which is considered as the ideal access point).
Other access points are described in a limited number of
cases described (e.g., left brachial artery or left common
carotid artery [
Access can be achieved using different techniques:
percutaneous (with the Seldinger method), open exposure
by surgical cutdown of the vessel, or exchange over a
guidewire from an existing arterial line [
Imaging techniques can be used (e.g., eco guide for
access and RX to confirm the balloon position), or it is
also possible to work blindly, using only external
landmarks; MacTaggart et al. describe the use of
“morphometric roadmaps” to improve accurate device delivery
for fluoroscopy-free REBOA, according to the patient
REBOA insertion time in the simulation laboratory
was under 5 min (Brenner et al.) [
were often videotaped in the trauma center, with a few
performances under 3 min and some lasting up to
15 min when femoral access was difficult to obtain [
Operator and training
Operators who insert REBOA vary depending on the
context; in a multidisciplinary team, the practice may be
performed by an interventional radiologist, a vascular
surgeon, a trauma surgeon, an intensive care unit expert,
or an emergency department physician who is familiar
with the endovascular approach.
The skill can be quickly acquired; for physicians with
limited previous endovascular skills, attendance at procedural
courses provides an opportunity to gain competence and it
seems that the insertion of no. 3–5 REBOA under expert
], or a training period of some months, can
be enough [
There is no universal certification for REBOA
positioning. For example, in order to become an emergency
physician, the Japanese Association for Acute Medicine
requires a minimum experience of no. 3 cases of REBOA
insertion during residency training. It does not differ
from the US “BEST” (Basic Endovascular Skills for
Trauma) courses which include didactic lectures, virtual
reality simulation, and cadaveric instruction, whereas
“ESTARS” (Endovascular Skills for Trauma and
Resuscitative Surgery) courses use simulations and live animal
models to establish procedural competence [
There are also some courses in Europe, especially in
London (Royal Medical Hospital and London’s Air
Ambulance) and in Örebro, Sweden (“EVTM” EndoVascular
and hybrid Trauma and bleeding Management).
Type of device
In most of the studies, a 10 to 12 Fr introducer is used
(Okada et al. considered the large size as a contributory
cause of ischemic complications that led to lower limb
amputation patients with a smaller build [
Seven-French catheters are currently available (since
2014) and in use in Japan; Tsurukiri et al. have noted
that this has enabled a reduction in complications
coupled with 100% technical success [
Time and method of inflation
An ideal time of occlusion has not been established,
although it is clear that it must be as short as it possible.
There are several studies on animals (especially pigs and
dogs) which identify 60–90 min as a cutoff time;
however, it is difficult to adapt these data for human
patients. Saito et al. define the golden time as 20 min of
hemostasis as a goal for the future [
Some of the analyzed retrospective studies do not
report occlusion time as it had not been recorded.
However, it was found that occlusion time was shorter in
survivors than in patients who died [
]. Mean occlusion
time in the various articles ranged from 20 to 65 min.
During the CT scan, the balloon is partially deflated to
let the contrast pass. It is interesting to note that when
occlusion must necessarily exceed 20 min, Ogura et al.
practiced a partial deflation for a few minutes and completed a
rapid transfusion of blood products in order to take
advantage of the ischemic preconditioning effect as a
strategy to increase tissue tolerance. During this interval, if
SBP was not maintained above 70 mmHg, the balloon was
inflated again for a further 20 min. In this study, the total
mean occlusion time is 80 min (although one patient did
not tolerate deflation) and there were no complications
related to the use of REBOA [
]. However, this approach
does not seem to bring other advantages.
A significant correlation between total occlusion time,
serum lactate concentration, and the shock index was
The sheath can be left in place until it has been
established with certainty that it is no longer required (although
this could cause ischemic complications, especially
patients with a smaller build [
The development of new devices that do not require
an oversized sheath or long guidewires is likely to reduce
not only complications but also time to occlusion [
REBOA is mostly positioned in emergency departments,
in some cases in the operating room or, where available,
in a hybrid room. There is also REBOA experience in
prehospital settings (e.g., London’s Air Ambulance, although
limited to blind positioning in zone III only [
Mortality (when, where, why)
As for mortality, several aspects must be considered:
when, where (emergency department, operating room,
intensive care unit), and why.
Some studies report mortality percentages with precise
temporal references (e.g., mortality at 24 h, 30 days,
60 days, etc.), while others do not.
Saito et al. claim that mortality within 24 h is more
relatable to REBOA because after this time, patients die
from other causes [
Many studies compare the mortality of patients treated
with REBOA versus resuscitative thoracotomy, matching
patients with similar characteristics; most of them do
not report favorable data for REBOA. However, Moore
et al. [
] noted that the deaths of REBOA patients
appear to be delayed and typically occur when the patient
is already out of the emergency department and due to
complications other than bleeding (especially
multiorgan failure and brain injury). Post-REBOA deaths
more commonly occurred in emergency or operatory
room while a significantly larger portion of post-open
aortic occlusion occurred in the intensive care unit [
In several series of patients, no complications have been
related to the use of REBOA.
Eventually, complications may be related to the
insertion, to the REBOA mechanism (pressure increases
upstream from the occlusion), or to the failure of the
Described complications are:
0.66% distal ischemia/thromboembolic events [
21, 26, 29
] (with eventual need for amputation) 
0.07% intracranial massive hemorrhage [
0.22% pseudo-aneurysm in the access site [
injury caused by puncture [
0.89% kidney failure [
Spinal cord ischemia (no REBOA cases) [
0.15% balloon migration (e.g., in zone II) [
0.30% infections [
0.07% retroperitoneal hematoma following the blind
insertion (the vessel was repaired a few days later
without further complications); this is more common
in obese patients in whom multiple attempts are
performed; ultrasound-guided procedure, thanks
to the widespread of portable devices, is useful as
long as this does not cause an excessive elongation of
the time [
0.66% introducer insertion failure: especially in elderly
patients (over 75 years, above all females) who had
subsequently undergone resuscitative thoracotomy or
REBOA in the angiography room and where the
angiography revealed severe tortuosity or twisting
of the femoral artery. 
0.07% rupture of the balloon (immediately replaced)
The main risk factors are high body mass index,
thrombocytopenia, emergency procedures, big size of the
introducer, and use of anti-platelet drugs [
Complications seem to reduce significantly with 7-Fr catheter [
REBOA in combination with other techniques
REBOA is not considered as a permanent solution,
rather it constitutes a bridge for patient stabilization until
definitive hemostasis (angioembolization, surgery, or
hybrid technique), eventually achieved during the
diagnostic completion techniques (TC) and transfers.
However, in some circumstances, it was not enough by
itself and it has been used in conjunction with other
techniques to control bleeding, e.g., external fixator and pelvic
packing. Sometimes, it was necessary to convert to an
aortic open occlusion (e.g., 4 of 46 patients described by
DuBose et al. [
]); other times, REBOA has been used in
patients who have already undergone resuscitative
thoracotomy; however, such cases have been excluded from the
study (Saito et al. [
]) and from this review.
Table 1 shows the list of papers included, in
chronological order, except for the last three to whom full text
was recovered from other sources.
Resuscitative endovascular balloon occlusion of the aorta
has been used increasingly during the last 10 years to
elevate central arterial blood pressure in severely injured
trauma victims with abdominal and/or pelvic bleeding,
limiting infused fluid volume. Studies included in this
review showed huge heterogeneity in patient selection,
procedure performing time and environment, and
balloon deflation cutoff time. However, there is
homogeneity in using REBOA in severely injured patients using
femoral artery access, with the aim to transiently stop or
reduce distal aortic blood flow, while various procedures
to finally control the bleeding are performed. Direct
REBOA-related complications seem to have a minor role
on mortality and are limited to local vascular injuries.
High mortality rate is a feature of severely multiple
injured patients, and REBOA role as a bridge to final
bleeding control clearly emerges, even though not always
effective. Pre-hospital REBOA role in trauma victim
resuscitation, partial or intermittent balloon inflation,
“prophylactic” REBOA insertion in selected cases,
REBOA in combination with resuscitative thoracotomy
for witnessed traumatic cardiac arrest, and resuscitative
endovascular balloon occlusion of inferior vena cava to
treat injuries in this site, should be interesting issues for
the next future. Taking into account worldwide huge
heterogeneity in trauma team composition and setting,
considering also available literature concerning REBOA
flow charts [
], an updated Trauma System should
equip oneself of specific REBOA algorithm, included in
severe trauma resuscitation protocol, accordingly with
his own features. Different Trauma System benchmark
will be the way to better understand and perform in
severe hemorrhagic trauma resuscitation.
ED: Emergency department; REBOA: Resuscitative endovascular balloon
occlusion of the aorta
The authors would like to thank Dr. Magda Djellab for her help in revising
the final version of the manuscript.
Availability of data and materials
The authors are responsible of the data described in the manuscript and
assure full availability of the study material upon request to the corresponding
EG and FC contributed to the concept of the study design, literature search,
data analysis, data interpretation, and article drafting. BT contributed to the
literature search, data collection, data analysis, and manuscript drafting. CM,
VA, MBe, MBi, NF, LA, GG, and MB contributed to the literature search, data
collection, data analysis, and manuscript revision. TMH and VA contributed to
the concept of the study design, data analysis, data interpretation, and manuscript
critical revision. All authors read and approve the final version of the manuscript.
Ethics approval and consent to participate
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