DTIC ADA614805: A Clinical Series of Resuscitative Endovascular Balloon Occlusion of the Aorta for Hemorrhage Control and Resuscitation

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ORIGINAL ARTICLE
A clinical series of resuscitative endovascular balloon occlusion
of the aorta for hemorrhage control and resuscitation
Megan L. Brenner, MD, Laura J. Moore, MD, Joseph J. DuBose, MD, George H. Tyson, MD,
Michelle K. McNutt, MD, Rondel P. Albarado, MD, John B. Holcomb, MD, Thomas M. Scalea, MD,
and Todd E. Rasmussen, MD
BACKGROUND: Arequirementforimprovedmethodsofhemorrhagecontrolandresuscitationalongwiththetranslationofendovascular
specialtyskillshasresultedinreappraisalofresuscitativeendovascularballoonocclusionoftheaorta(REBOA)forend-stage
shock.TheobjectiveofthisreportwastodescribeimplementationofREBOAinciviliantraumacenters.
METHODS: DescriptivecaseseriesofREBOA(December2012toMarch2013)usedinscenariosofend-stagehemorrhagicshockatthe
UniversityofMaryland,R.AdamsCowleyShockTraumaCenter,Baltimore,Maryland,andHermanMemorialHospital,The
TexasTraumaInstitute,Houston,Texas.
RESULTS: REBOAwasperformedbytraumaandacutecaresurgeonsforblunt(n 4)andpenetrating(n 2)mechanisms.Threecases
wereREBOAinthedescendingthoracicaorta(ZoneI)andthreeintheinfrarenalaorta(ZoneIII).Mean(SD)systolicblood
pressureatthetimeofREBOAwas59(27)mmHg,andmean(SD)basedeficitwas13(5).Arterialaccesswasaccomplished
usingbothdirectcutdown(n 3)andpercutaneous(n 3)accesstothecommonfemoralartery.REBOAresultedinamean
(SD)increaseinbloodpressureof55(20)mmHg,andthemean(SD)aorticocclusiontimewas18(34)minutes.Therewereno
REBOA-relatedcomplications,andtherewasnohemorrhage-relatedmortality.
CONCLUSION: REBOAisafeasibleandeffectivemeansofproactiveaorticcontrolforpatientsinend-stageshockfrombluntandpenetrating
mechanisms.Withavailabletechnology,thismethodofresuscitationcanbeperformedbytraumaandacutecaresurgeonswho
havebenefitedfrominstructiononalimitedendovascularskillset.Futureworkshouldbeaimedatdevicesthatalloweasy,
fluoroscopy-freeaccessandstudiestodefinepatientsmostlikelytobenefitfromthisprocedure.(JTraumaAcuteCareSurg.
2013;75:506 511.Copyright*2013byLippincottWilliams&Wilkins)
LEVELOFEVIDENCE: Therapeuticstudy,levelV.
KEYWORDS: Trauma;hemorrhagicshock;endovascularsurgery;resuscitation;balloonaorticocclusion.
The use of endovascular technology in the management of combatcasualtycareinAfghanistanandIraq.Reportsfromthe
trauma has increased over two decades.1Y5 Improved out- war have shown that the leading cause of death in casualties
comesusingthesetechniquesisnotsurprising,asafavorable with otherwise survivable injuries has been hemorrhage.15Y18
trend has occurred with endovascular approaches to vascular ArecentstudyfromEastridgeetal.18suggeststhataquarterof
disease.6Y8 Outcomesfollowing ruptured abdominal aortic an- otherwise survivabledeaths inthebattlefieldcould havebeen
eurysmhaveimproved,inpart,becauseoftheuseofresuscita- prevented with improved methods of resuscitation and hem-
tiveendovascularballoonocclusionoftheaorta(REBOA).9Y11In orrhage control. This burden of morbidity and mortality has
the setting of ruptured aneurysm, this technique may be initi- laidbareanimperativetodevelopbettermethodsanddevices
atedintheemergencydepartmentoroperatingroomproviding tomanagevasculardisruption and hemorrhagic shock.19
proactive aortic control. Similar to thoracotomy with aortic These proceedings have spurred a series of initiatives
clampingfortraumaticarrest,REBOAsupportsproximalaortic aimedattranslatingendovasculartechniquesandskillsfromthe
pressureandminimizeshemorrhageuntilanesthesiacanbein- realm of age-related disease to trauma including hemorrhagic
ducedandhemostasisobtained.12Y14 shock. Translational studies have demonstrated the efficacy of
Concurrent with the expansion of endovascular tech- REBOAinmodelsofshock,andanewfluoroscopy-freedevice
niquestomanagevasculartraumahavebeenobservationsfrom has been proposed.20Y23 A technical description for REBOA
nowexists, and the Endovascular Skills for Trauma and Resus-
citative Surgery(ESTARS)curriculumhasbeendeveloped.24,25
Submitted:May6,2013,Revised:May29,2013,Accepted:May30,2013.
FromtheRAdamsCowleyShockTraumaCenter(M.L.B.,J.J.D.,T.M.S.),Uni- Despite momentum in these areas, modern descriptions of the
versityofMaryland;TheUniformedServiceUniversityoftheHealthSciences useofREBOAintheclinicalsettingarelacking.Theobjectiveof
(T.E.R.,J.J.D.),Baltimore,Maryland;TexasTraumaInstitute(L.J.M.,J.B.H., thisreportwastodemonstratepreliminaryclinicalapplicationof
M.K.M.,R.P.A.,G.H.T.),UniversityofTexasatHouston,Houston;andUS
ArmyInstituteofSurgicalResearch(T.E.R.),JointBaseFortSamHouston,San REBOAintwoUSciviliantraumacenters.
Antonio,Texas.
Theviewsexpressedinthisarticlearethoseoftheauthorsanddonotreflectofficial
positionsorpolicyoftheUSGovernment,theDepartmentofDefense,ortheUS
AirForce. PATIENTS AND METHODS
Addressforreprints:ToddE.Rasmussen,MD,USArmyInstituteofSurgicalResearch,
JointBaseFortSamHouston,Texas;email:[email protected].
A clinical series of REBOA for trauma performed at
DOI:10.1097/TA.0b013e31829e5416 theUniversityofMaryland,R.AdamsCowleyShockTrauma
JTraumaAcuteCareSurg
506 Volume75,Number3
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1. REPORT DATE 2. REPORT TYPE 3. DATES COVERED
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4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER
A clinical series of resuscitative endovascular balloon occlusion of the
5b. GRANT NUMBER
aorta for hemorrhage control and resuscitation.
5c. PROGRAM ELEMENT NUMBER
6. AUTHOR(S) 5d. PROJECT NUMBER
Brenner M. L., Moore L. J., DuBose J. J., Tyson G. H., McNutt M. K.,
5e. TASK NUMBER
Albarado R. P., Holcomb J. B., Scalea T. M., Rasmussen T. E.,
5f. WORK UNIT NUMBER
7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION
United States Army Institute of Surgical Research, JBSA Fort Sam REPORT NUMBER
Houston, TX
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Approved for public release, distribution unlimited
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JTraumaAcuteCareSurg
Volume75,Number3 Brenneretal.
Center,Baltimore,Maryland,andHermanMemorialHospital, and the patient required no additional vasopressor or blood
TheTexasTraumaInstitute,Houston, Texas(December2012 transfusions.Arteriographyintheoperatingroomdemonstrated
to March 2013). The cases described in this series were con- extravasationfromadivisionoftherightinternaliliacanddeep
ducted as a matter of routine clinical care, and observations circumflexiliacarteries.Coilembolizationwasperformed,and
related to reporting of the case series were made in a retro- thepatientrequiredminimaladditionalresuscitation.Thesheath
spectivemanner. wasremovedwithoperativeexposureandclosureofthefemoral
artery,andthepatienthadanuneventfulhospitalcourse.
RESULTS
Case 2
Case 1
A 24-year-old male presented with a gunshot wound to
A 63-year-old male presented after a fall with an ex-
the right posterior axillary line at the level of the eighth rib
aminationrevealingonlytendernessoftherighthip(Table1).
(Table1).Onarrival,hispulsewas119beatsperminute(bpm)
A plain film of the pelvis showed a right acetabulum fracture
andhisbloodpressure70/42mmHg.Asubclavianveinsheath
withhemitransversefractures, aninferior pubicramifracture,
wasplaced,andthetransfusionprotocolwasinitiated.Percuta-
and a medially displaced wall of the acetabulum. Computed
neous5Frsheathaccesswasgainedtotherightfemoralartery
tomography (CT) showed this fracture and several pelvic he-
forpressuremonitoring.Arighttubethoracostomywasplaced
matomas. The patient was taken to the operating room for
for hemothorax with return of 700 mL of blood, and an ab-
acetabular repair when he became hypotensive, requiring
dominal x-ray demonstrated a missile overlying the mid-
pressurizedresuscitationwithbloodproductsandvasopressor
epigastrium.FASTfindingwaspositiveintheabdominalbutnot
therapy. These interventions were ineffective, and his blood
cardiacviews.Rapidinfusionofbloodproductsfailedtocorrect
pressure was 50 mm Hg. Repeat focused assessment with
hypotension, and the femoral monitoring line was upsized to
sonography for trauma (FAST) and chest x-ray revealed no
a 14 Fr sheath using a plain x-ray to confirm position. Zone I
abnormalities,andpercutaneousaccesswasgainedtotheleft
REBOAwas performed using a Cook Coda balloon, and the
femoral artery. A 12 Fr sheath was placed over awire using
patient’sbloodpressureincreasedto122mmHg.Thepatientwas
fluoroscopic guidance, and Zone 3 REBOA was performed
intubated and taken for laparotomy, whichrevealed a complex
using the Cook Coda balloon (Cook Medical, Indianapolis,
injury to the hilum of the right kidney. Vascular control was
IN).WithREBOA,thebloodpressureincreasedto135mmHg,
obtained, REBOA was deflated, and a nephrectomy was per-
formed. Additional hemorrhage was noted from the lumbar
vertebralbodywherethemissilehadlodged.Thiswaspacked,
TABLE1. DemographicsandSummaryofREBOAUsein
and the patient taken to radiology for coil embolization. The
SixPatients
patient was returned to the operating room for the removal of
Patient 1 2 3 4 5 6 the femoral sheath with repair of the artery. The rest of the
patient’scoursewasuneventful.
Age,y 62 24 59 25 40 27
Sex Male Male Male Male Male Female
Mechanism of MVC GSW GSW MVC MCC ATVcollision Case 3
injury
A 59-year-old male presented to the emergency depart-
InjurySeverity 28 50 9 25 48 43
ment following a through-and-through gunshot wound to the
Score(ISS)
pelvis (Table 1). On arrival, the pulse was 130 bpm, and the
SBPbefore 70 70 0 60 70 85
REBOA,mmHg systolicbloodpressure(SBP)was60mmHg.Theabdominal
Cardiacarrest No No Yes No No No portionoftheFASTfindingwaspositive,andthepatientsoon
beforeREBOA manifestpulselesselectricalactivity.Thepatientwasintubated,
SBPafter 135 122 100 110 130 125 cardiopulmonaryresuscitationwasinitiated,andasheathwas
REBOA,mmHg placedinthesubclavianveinfortransfusionofbloodproducts.
Admissionbase 12 4 NA 16 14 19 Openexposureoftherightfemoralarterywasperformedanda
deficit
14 Fr sheath placed over a 0.035-inch wire using x-ray to
Timetoocclusion, 5 4 4 6 6 6
confirmposition.ZoneIREBOAwasperformedusingaCook
min
Codaballoonagainusingx-rayforpositioning.WithREBOA
Timeofocclusion, 12 16 70 60 65 36
min andtransfusionofproducts,therewasreturnofapulse,andthe
Surgeryafter No Yes Yes Yes Yes Yes systolic pressure improved to 100 mm Hg. The patient was
REBOA taken to the operating room for laparotomy, whichrevealed a
Pelvicembolization Yes Yes No No Yes Yes hemoperitoneumandbleedingfromtherightiliacvein.Control
afterREBOA wasobtainedatthevenacavaandfemoralvein,andtheinjury
Complicationof No No No No No No was ligated. REBOA was deflated, and the patient was main-
REBOA
tained a pressure of greater than 100 mm Hg. Bowel injuries
Outcome Alive Alive Alive Alive Brain Death(care
were resected, and a temporary abdominal closurewas applied.
death withdrawn)
The aortic balloon and sheath were removed with repair of
ATV,all-terrainvehicle;GSW,gunshotwound;MCC,motorcyclecollision;MVC, thefemoralarteryaccesssite.Thepatientisneurologicallyintact
motorvehiclecollision;NA,notapplicable.
andrecovering.
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JTraumaAcuteCareSurg
Volume75,Number3 Brenneretal.
Figure3. AorticzonesrelatedtoREBOA.ZoneIextendsfromtheoriginoftheleftsubclavianarterytotheceliacartery.ZoneII
extendsfromtheceliacarterytothelowestrenalarteryandisano-occlusionzone.ZoneIIIextendsfromthelowestrenalarterytothe
aorticbifurcation.ReproducedwithpermissionfromStannardA,EliasonJE,RasmussenTE.Resuscitativeendovascularballoon
occlusionoftheaorta(REBOA)asanadjunctforhemorrhagicshock.JTrauma.2011;71(6):1869 1872.
andZoneIIIwasREBOAinitiatedusingfluoroscopicguidance ESTARS training preceded performance of REBOA for three
ofthe0.035-inchwireandCookCodaballoon.REBOAresulted surgeons,whilethreehadbasicendovascularskillsobtainedas
inanincreaseinbloodpressurefrom85mmHgto125mmHg partofresidencyaugmentedwithcadaver-basedendovascular
with a decrease in heart ratefrom 143 bpm to 120 bpm. With laboratories.Despiteseverityofinjuryandadversephysiology,
improvedhemodynamics,anexternalfixatorwasappliedtothe all patients survived hemorrhagic shock without REBOA-
pelvistofurtherreducepelvicvolumewhileawaitingtransport related complications. Two patients progressed to brain death
tointerventionalradiology. caused bynonsurvivable neurologic injuries.
In the interventional radiology, arteriography demon- REBOA as an adjunct for shock was reported by
strated contrast extravasation and vasospasm in areas of both Hughes26duringtheKoreanWar.Althoughnotnew,REBOA
internal iliac arteries and an abrupt cutoff of a right internal hasreceivedareappraisalbecauseofthemilitary’simperative
iliac artery branch suggesting thrombosis. Gelfoamemboliza- todevelopbetterwaystomanagehemorrhagicshock.Todate,
tionwasperformedtotheareasofextravasation,andtheanterior these efforts in damage-control resuscitation have focused on
branchwas treated withcoilembolization. Following arteriog- training, hemostatic dressings, extremity and junctional tour-
raphy,thepatientwasreturnedtotheoperatingroomforremoval niquet devices, and balanced resuscitation using all blood
of the balloon, wire, and sheath with local thrombectomy and components and tranexamic acid.27Y29 The impetus behind
closure of the femoral access site. CTimaging of the head re- REBOA stems from a need to develop mechanical or proce-
vealedtraumaticcerebralcontusions,leftinternalcarotidartery duraladjunctstoimprovesurvivalfromshock.Thereappraisal
injurywithischemicstroke,andmultipleacutepulmonaryem- of this technique also takes place in an endovascular era in
boli. The patient never regained neurologic function, and care which devices and skills are advanced and shown to benefit
waswithdrawnonhospitalDay6. patientswithruptured aortic aneurysm.9Y11
Stannard et al.24 published a description of REBOA in
which occlusion zones were defined (Fig. 3) to facilitate un-
DISCUSSION
derstandingofthetechniqueandtoprovideaframeworkwith
This clinical series represents the largest contemporary whichtorefineitsuse.ZoneIisthedescendingthoracicaorta
report of REBOA for hemorrhage control and resuscitation between the origins of the left subclavian and celiac arteries.
following trauma. This report represents the preliminary ap- ZoneIREBOAisakintoaorticclampingotherwiseperformed
plication of this technique extending a considerable amount during resuscitative thoracotomy. Zone II is the paravisceral
translational research work, which has been accomplished on segment and was proposed as a potential no-occlusion zone,
thistopicduringthepastnumberofyears.Observationsfrom while Zone III represents the infrarenal aorta extending from
thisseriesdemonstratethefeasibilityofREBOAusingexisting the lowest renal artery to the bifurcation. Despite the plausi-
endovascular and imaging technology in patients with shock. bility of description of Stannard et al., it was not a clinical
The procedure in each case was performed emergently as a report,anduntilthecurrentseries,thefeasibilityandutilityof
resuscitative adjunct by the trauma surgeon. Completion of this nomenclatureremained inquestion.
*2013Lippincott Williams& Wilkins 509
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JTraumaAcuteCareSurg
Brenneretal. Volume75,Number3
The rationale behind REBOA is that aortic occlusion initiating programs to develop basic skills among trauma and
supportsmyocardialandcerebralperfusionuntilresuscitation acute caresurgeons. Novel programs involving simulatorsand
can be initiated and hemostasis obtained. These are the same cadaveric laboratories have been initiated at the University of
goalsofopenaorticcrossclamping,butREBOAisperformed MarylandShockTraumaCenterandtheUniversityofTexasat
in a less invasive manner, sparing a compromised patient ad- Houston,TexasTraumaInstitute.Observationsfromthecurrent
ditional morbidity.20,30,31 In the current series, REBOA was casesdemonstratethevalueofbasicendovascularskillstaughtto
accomplished quickly and resulted in an average increase in boardedsurgeonsatESTARSandtheseothervenuesandtheir
blood pressure of 55 mm Hg. The average aortic occlusion applicationinclinicalscenarios.
timewas 18 minutes, which allowed hemorrhage control ma-
Limitations
neuverstobeaccomplished.Bydefiningzones,Stannardetal.
acknowledged that some cases of shock may be amenable to Observations from this series should be interpreted cau-
distalocclusion,allowingperfusiontotheproximalaortaand tiouslybecausethesesuccessesmaynottranslatetofuturesce-
its intercostal, visceral, and lumbar branches during REBOA. narios.Blindplacementofwires,sheaths,andcatheterswithin
In this series, three cases comprised Zone III REBOA, while thearterialcirculationisnotwithoutriskandisnotrecommended
theremainingcasesrequiredproximalZoneIaorticocclusion. under elective circumstances. These maneuvers and inflation
The decision whether to perform a resuscitative thora- ofaballoonwithintheaortamayresultindamagetotheaorta
cotomywithaorticclamping,REBOA,orrushtotheoperating anditsbranchvesselsorendorganssuchasthevisceraorbrain
roomforlaparotomyrequiresjudgment.Ineachofthecurrent from embolization or dissection. However, it is worth noting
cases,thesurgeonfeltthatthepatienthadalreadyarrestedorthat thateachofthetoolsordevicesusedinthesecasesisdesigned
cardiac arrest was imminent and that aortic occlusion was re- forendovascularplacementincludingacompliantaorticocclu-
quired. Familiarity with the recent literature and a current un- sionballoon.Assuch,itisreasonabletoconsiderthattheiruseby
derstandingoftheneededendovascularskillsledtoREBOAin board-certifiedsurgeonsduringREBOAprovidesanalternative
thesecases.TheeffectivenessofREBOAandarecognitionthat to thoracotomy with aortic clamping. Finally, performance of
endovasculartechnologieswillimprovehavecausedthefaculty REBOA doesnot portendanability for traumaand acute care
atthesecenterstoundergoanevolutioninthought.Mostagree surgeons to perform more complex endovascular procedures.
thatREBOAwillreplace resuscitative thoracotomy withaortic On the contrary, the ability to accomplish REBOA represents
clamping as a means for proactive aortic control in cases of a limited skill set, which should be performed when other
exsanguinatinghemorrhage. alternatives are limited.24 More complex endovascular proce-
It is worth noting that arterial access was accomplished dures would require more comprehensive endovascular train-
quickly in all cases. Through a variety of methods including ing, possibly within the skill set of a new generation of acute
blindandultrasound-guidedpercutaneousaccessaswellasrapid caresurgeons.
cutdown,theproviderineachcasewasabletoplacea12Frto
14 Fr sheath in the femoral artery. The variety of approaches CONCLUSION
speakstothe appropriatenessofthistechniqueinthe handsof
REBOA is a feasible and effective means of proactive
surgeons with a range of operative skills and a willingness to
aortic control for patients in end-stage shock from blunt and
applythemintheemergentsetting.Itisalsoworthnotingthat
penetratingmechanisms. With theuseofexistingtechnology,
basicimagingwasusedincludingbasicspotfilmsoftheabdo-
this method of resuscitation can be performed by acute care
menandorchest.Thisimprovisedbutsmartuseofportablex-ray
surgeonswhohavebenefitedfrombriefinstructiononalimited
demonstrates that REBOA does not require extensive fluoro-
endovascular skill set. Future work should be aimed at the
scopic imaging but instead select images to confirm wire and
development of devices that minimize complications and fa-
balloonposition.
cilitateaccessaswellasstudiestodefinepopulationsinwhich
All cases in this series were performed by trauma and
this adjunct isbeneficial.
acute care surgeons without certification in interventional or
vascularspecialties.EachproviderwhoperformedREBOAdid
AUTHORSHIP
havethe required training and experience invascular disease,
M.L.B.contributedintheliteraturesearch,studydesign,datacollection,
anatomy,andsurgerytobecertifiedasageneralsurgeonbythe
data analysis, and writing. L.J.M. contributed in the literature search,
AmericanBoardofSurgery.Inthiscontext,traumaandacute studydesign,datacollection,dataanalysis,andwriting.J.J.D.contrib
care surgeons are not starting from scratch as they apply this utedintheliteraturesearch,studydesign,datacollection,dataanalysis,
skillset.Inadditiontoboardcertification,threeoftheproviders and writing. G.H.T. contributed in the study design, data collection,
data analysis, and writing. M.K.M. contributed in the data collec
had undergone training in the ESTARS course. The surgeons
tion,dataanalysis,andwriting.R.P.A.contributedinthedatacollection,
who had not attended the ESTARS course had basic skills
dataanalysis,andwriting.J.B.H.contributedinthestudydesign,data
obtainedaspartofsurgicalresidencyaugmentedwithcadaver- collection,datainterpretation,writing,criticalrevision,andobtaining
based endovascularlaboratories. study funding. T.M.S. contributed in the study design, data collec
TheESTARScourseisanovel2-daycurriculuminvolving tion,datainterpretation,writing,criticalrevision,andobtainingstudy
funding. T.E.R. contributed in the study design, data collection, data
astructuredsyllabusconsistingofdidacticteaching,livetissue,
interpretation,writing,criticalrevision,andobtainingstudyfunding.
and simulator components. As part of ESTARS, participants
arerequiredtodemonstrateproficiencythroughcompletionofa
pretestandposttestincludingexaminationofhand-onskillswith DISCLOSURE
bothanimalandsimulatormodules.Themilitaryisnotalonein Theauthorsdeclarenoconflictsofinterest.
510 *2013Lippincott Williams &Wilkins
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JTraumaAcuteCareSurg
Volume75,Number3 Brenneretal.
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