early and mid-term results of ruptured abdominal aortic aneurysms in the endovascular era in a...

From the Society for Clinical Vascular Surgery

Early and mid-term results of ruptured abdominalaortic aneurysms in the endovascular era in a

community hospitalPaul M. Anain, MD,' foseph M. Anain, Sr, MD," Michael Tiso, BS,b Nad€r D. Nader, MD, PhD,' andHasar H. Dosluogln Mi)d Blffalo, NT; aul South Bend, btd

ObJ|ctitc: Bndovasc\rlar rcpair (EVAR) has been increasingly used for rl.pnrred abdominal aortic aneurysms (rAAAs),csp€dally in major academic centers. The goal ofthis article is to rcport our results with an EVAR-first approach for rAAAwhich we adoptcd in 2001 in our community hospital.-l{rt olj.'All consecutive patients who underwcnt aftempted rqrair for iAAA betlv€en F€bruat'y 2001 and tuly 2006 w€reanallzed. Or y paticnts with computcd tomographic or visual vcrification of cxtrduminal blood were includcd.Rar*la A total of40 paticnts (30 men; mean

^8g76.4 ! 7.2 y.ars; range, 57'89 ycars) pres€nted with iAAA, Thirty

paticnts undcrwcnt attqryrted EVAR for rAAA, coDstituting 4,I% of all EVAR cases (n = 738), and I0 patients hadattempted opcn rcpair. Twcnty one (53%) wcrc tra$f€rr€d from another instinttion. Computed tomognphy waspcrfomled in 97.5%. On arrival to thc emergelcy dq)artrnent, 43%% werc hypotensive (systolic blood pressure <80 mmHg). Transfcmoral balloon o€clusion was uscd in 12 cases (30%; l0 in thc EVAR group and 2 in thc ol>en group). Thclength ofoperatron was 128 = 35 minutes (range, 77-210 minutqs) in EVARca.ses. EVAR was codrplct€d in 93.3% (ilircanatorny and proximal endoleak caused open conversion in tf,'o raics). Out of tne lO open trcatcd cescs, I was convertedto BVAR and suivived. Thc grafts used for EVAR were AneuRx (n = 2I), Z.nith (n = 5), and Ancure (n = 4), and 97%were bifrrcatcd. Fivc paticnts (16.6%) in the BVAR group dicd within 30 days (four requircd balloon occlusion). Thcmcan length ofstay was 9.1 t 6.2 days (raogc' 4-30 days) itr survivors ofEVAX- In th€ EvAR-tr'eated group, two patientjdied (7 and 9 months; unrclatcd), alld six of thc surviving patients (23%) requircd sccondary procedures (fivefemorofemonl bypasses for limb occlusions and one proximal clfl for a t)'pe I endoleak that caused rq)eat rupture)during a mean follow-up of 13.8 ! 10.4 months (range, 3 39 morths). The mortalit! rate w^s 40% (4/10) in patientswho ulders'cnt open ptocedure.s during this period, with an overall moftality rate of 22,5% for all ruptures rr€ated. Thediffcrencc in 30-day mortality in the BVAR and open groups did not rcach statistical significanc! ( t 7yo vs 40%; P = .19).In the entrre cohort, hypotcnsion (systolic blood pressure <8O mrn Hg) on arrival and loss of consciousncss wcrearsociatcd with 30-day mortality. Balloon ocrlusion was correlated with mortality in the EvAR-trcated group (,{4% vs4%; P = .019). The multivariate ana\sis using logistic rcgre.ssion show.d that hlTrotcnsion (odds ratio [OR], 7.4; 95%confidenc€ interval ICll,l.3-42.Oi P= -O25),loss ofconsciousness (O& 37.5;95% CI,3.4-40.E; P = .003), and the occdfor ba.lloon occlu$ion (O& 5.2; 95% CL I.8-25.5; P = .042) were correlatcd vrith highe p€rioperative mortality, whcreasagc grcatcr tlran 76 years, coronary artcry discase, chronic obstructive pulmonary disease' h)?ertension, drabetes, renalinsufficicnry, and typ€ ofprocedurc did not.Anclesions: Our results show that EVAR is feasible with favorable outcomcs in patieots pres€nting with rAAA in a busycommunity hospitel. There is a high secondrry intcrvcntioD rate, which can potcntialy be dccreascd by edsuring goodiliac limb anatomy at the cnd of the proceduie and by a closer follow up. ( f Vasc Surg 2007;.{6:89E-905. )

Despite advances made in critical care, prehospital care,anesrhcsia carc, and postopcntivc tcchniques in reccntdecades, the mortality afteropen repair ofruptured abdom-inal aonic ancurysms (rAAAs) remains 35% to 80%.r'2 Thishas resulted in the use of the less invasive endovascularaneurysm repair (EVAR)3 4 in an cflort to improve survival

F.om rhc Sisurs ofCbanN Hospiral,' Dcpafi cnr ofAncsrhcsiolo!ry,. indDcpMmcnr ofSo.gcry, Diosion ofVascular Surgeryd, Srarc UnivcrsiwofNes York it B!ffalo, ard Notic D!mc Universiry, Sourh B€nd.b

Competition of nrtcrcsr: mDe.Presenrcd ar rhc Thirr.v 6fth Annual Mee rg of rhe Society of Clinical

vascular SD.sery, Orlaod(r,Fl^, Mt 2L 24,2OO7.Rcprirr rcquest5: Hasan H. Dosluo8lu, MD, Doplr ncnr ofSugelv, Srlrc

l-lnivcrsity of Ncw Yo.k ar Bufialo, VA wcsrcrn Nes Yo.k HcalrhcarcSysrem, 3495 Bailcy Ave. Butralo, NY 14215 (e mail: dcluoglu@

o74t 5214/532 00CoDrieJlr O 2007 try Thc Slxic!.' for Vrrcular Surgcrv.doi:l0.l016lj.jvs.2007.06.037

898

in these patients. Although some authors have reportedsignificantly dccreascd mortality (9%-45%) when comparcdwith historical controls,s u others have not shown anysignificant differcnces between rhesc wo modalities-to l I

However, thcre is a wide variation bctween studies in thedisrribution of unstablc parients, inclusion of symptomaticpatiens without rupture, exclusion criteria, and percentageofpatients treatcd by EVA\ thus making it extremely hardto determine thc true effect of EVAR on morraliry after

In addition, most of the sludrcs were reponed liomeither large acadcmic centers4's 12 or large referral centcrswhere regionalizcd medicine is practiccd,e rr and the cffectof EVAR on r,{.M morrality in the community at larg€ is

still largely unknown. We scaned using EVAR in electivcrcpair of AAAs in 1999 in our community hospital afterapproval of the dcvices by the US Food and Drug Admin-isuation and devclopcd a very high volume EVARpractice.

,OURNAL OF VASCUI-\R SURCERYVolume 46, Numbcr s

Wc adopted an EVAR'lirst approach fbr all comers witbrAAAs since our first EVAR ofan rAAA in 2001. The goalofthis anide is to rcport our management protocol, techniques, and results with the EVAR'first approach in pa'tients presenting with rAAA to our communiry hospital.

MATERIALS AND METHODS

All consecutive patients who presented with rAAA tothe Sisters ofCharity Hospital berween February 2001 andOctober 2006 were inch.rdcd. Rupture was dclined as visualization ofextraluminal blood by computed tomography(CT), operative findings, or both. Patients with symptomaric AAA without CT evid€nc€ ofextraluminal blood werenot included. Demographic characteristics, comorbidities,clinical presencrtion, hemodynamic stability on arrival, preopcrativc scrum creatinine, hcmoglobin level, cleclrocar-diographic findings of myocardial ischemia, t.ansfer fromanorhcr institution, maximum aneurysm diamcter (milli-mcters), opcrative timc, qpc ofstent gnft used, intraoperadvc events (including adjunctive use of intra-aortic bal-loon placcment), and 30'day postoperative outcomcs aodfollow-up (CTand clinical) wcrc allobtained iiom paticnts'hospital and omce charts. Institutional review board approval was obtained for this retrospective srudy involvingchart rcvicw.

Thc diagnosis of IAAA in a stablc patient was usuallymade by thc CT scan ordercd by the emergency depart-ment (ED) physician and read by an on-call radiolog.ist.The operadng room team was activatcd by the ED physi-cian, who wolrld notifo the vascular surgeon on call. Wehave 24-hour coveragc by a radiologisr in our hospital. Thesame would occur when a paticnt rvith a diagnosis ofrAAAwas !o bc ransfcrred to our ED. lvh€n an unstable patientarrived in thc ED witi a suspected rAAA, the pauent was

immediatcly transferred to the CT scanner as the operatingroom was prcpared for both EVAR and open repair. Whcnthe vascular surgeons were in the hospital, they accompanied the patient to the CT scanncr and/or the operatingroom. When they were not in lhe hospital, they would bcnotified of thc paticnt's transfcr to CT scamer or thcoperahng roomr and the surgeon would see the patienteither in thc CT scanner. en route to the opera!rng room, orin the operadng roorn. The vascular surgcons would decidethe type ofapproach to use (open vs EVAR), as well as thegraft gpe to be used, with no f'urthcr contact rvith theradiologist. Two vascular surgeons were involvcd whencvcrfeasible; however, both vascu-lar surgcons are equally capa

blc and comfortablc with both qpes of rcpair and operatedalone in t2 ofthe 40 cascs in this cohon. Onc vcry unstableparient wirh a known AAA who developed hypotensionwhile in the hospital was taken straight to the operatingroom flom rhe floor. Thiswas the only patientwho did nothave a preoperativc CT scan. His rupturc was verified withthe postprocedure Cf scan, as was routinely obtained in allpaticns aftcr EVAR Thc time ofarrival to our ED and thetimc of stan of thc opcration werc recorded, and theintcrvals were calculatcd.

Anain et al 899

Hcmodynamic insmbility was defined as systolic bloodpressurc less than 80 mm Hg and/or loss ofconsciousncss.Blood pressure less than 80 mm Hg on arrival to the EDwas noted. If rhc prtient became unstablc at any timebeforc the operation, this was also noted. Pcrmissivc hypo'tension was practiccd and fluid resuscitation kept to a

minimum as long as the patient did not lose consciousness.CT with intravenous contrast using 3'mm sliccs was performed. Increased creatininc did not change thc protocolused, and all patients received intravenous contrast. Rupture was defined when cxuavasated blood was seen outsidcofthc aneurysm sac either in the CT scan or in thc operat-ing room. The eligibility of EVAR vs open rcpair and thcty?e of graft to be used was dcterrnined b1, the surgeons,both of whom havc been reading CTs and pcrformingEVAR sincc 1999, using very similar criteria. The anatornicinclusion critcria for EVAR included a neck length of atleast 5 mm, a neck diameter lcss than 28 mm ((26 mmbefbre thc 2003 approval of thc Zenith [Cook Inc, BIoo-mington, Ind] graft), and accessibiliry of the iliac ancrics(heary calcilication, tomrosity, and size <7 mm). Paticntswith circumfcrcntial heary calcification in the ncck wercexcludcd, but tortuous necks wete evaluated by intraopcr-ative angiogram for the feasibility ofEVAR- Because ofourhigh volume of EVAR practice, we havc always maintainedthe most commonly used sizes of the commercially avail-able endograf'ts (Ancure IGuidant, St Paul, Minn],AncuRxfMedtronic, Minncapolis, Minn], Excludcr lGore Inc,Flagstaff, Arizl, and Zenith [Cook lnc, Bloomington,Ind]) in our stock fi)r Eeatment of rAAA with EVARAncuRx grafts w€re used prefercntially unless the neckdiameter was grcatcr than 26 mm, at which time the Zenithgraft was used. Bifurcated grafts wcre prel'erentially uscd.

Conversion ro a uni iliac grafi was not necessary in anypatient. Beforc July 2003, one paticnt was treated with anaonouni iliac graft (Ancurc) with contralatcral commoniliac artery ligation and a femorofemoral bypass using aringed 8 mm pol''tctrafluoroeth.vlenc graft. If the patient'sanatomv was not clear by the CT scan (patiena who hadCT scans in an ourside hospiu with S-mm cuts), if thiscould not be performed, or ifthe patient was unstable, thepatient was takcn straight to the operating room, and a

single f'emoral cutdown was performed with the patientunder local anesthcsia. An aortogram was pcrformed a-fter

acccss to thc aorta to evaluate the proximal ncck for ade_

quacy of EVAR In scvcn paticnE who did not scem to be

candidates for EVA\ EVAR was attempted. One ofthesepaticnts had persistent cndolcak rhat led to immediatcconversion to open repair, and the second patient had a late

migration and rupture at I I months and undcrwent suc

ccssful rcpair by using a culf extension. Ifpaticnt was notdeemed a candidate for EVA\ the fcmoral access was

maintaincd for possiblc usc of balloon occlusion.Dedicated vascular operatrng room personncl consist

ing ofa circularing nursc, scrub technician, and radiologytechnician, in addition to th€ vascular surgeon (one or two)cxpcricnccd in both opcn rcpair and EVA\ were always

available. The room was prepared for open repair ifneeded.

9OO Anain et al

Unlike the clective EVAR patients in our practicc, whoundergo regional anesthesia, all cases with rAAA werepcrformcd undcr general anesthesia; however, local anesthesia was used in unstable patients for initial access,latcr tobc convcrted to general anesthcsia when proximal controlwas obtained. Similar to Mchta et al,r2 we prefer gcneralanesthesia in tiese cascs to expcdite the process and to lcaveopcn the possibility for open conversion. All procedureswere pcrfbrmed by vascular surgeons in thc opcrating roomusing rhc OEC 9800 systcm (GE Mcdical Sysrcms, SaltL;*e Ciry, Utah).

Alier the initial cutdown, usuallv performed simulta-ncously by rwo surgeons, a guidewire was advanccd to thcdescending thoracic aorta and was then changed !o a supcrst fguidewirc, over which a l6F shcarh was placed intothe aorta. The balloon occludcr (Relianr [Medtronic] orCoda [Cookj) was madc available and was placed throughthis sheath ar any rime during the procedure ifthe paricntbccame morc unstable with a worscning ofh;potension orlost consciousness. The contralarcral femoral artery wasused to access the suprarcnal aorta, and a markcr flushpigtail cathctcrwas used to perforrn an angiogram. Hcparinwas not uscd during dtese proccdures, as is our roudne inIAAA cascs, ro decrease coagulopathyin a blceding patient.The stent graft deployment was completcd as dictated byeach device in a routine fashion. Wc favored femoral accessin all patients who rcquircd balloon occlusion. Wc did notfind it necessary to use brachial acccss for balloon inserrionin any casc in dris scrics and prefer to suppon the balloonvia thc shcath insertcd via rhe femoral artery. After thcinfladon ofthe balloon above rhe ccliac artery, we dcliveredthc main body delivery dcvice through thc contralateralsheath, and after wc marked the rcnal artcries by usingretrograde injcctions through the shcath where rhe balloonwas insened, the balloon was deflated, and the graft wasdeployed. The balloon had to be rcinsened and inflated inthe main body ofrhc graft, bclow tie rcnal arteries, in 8 ofthe l0 cases in whom balloon occlusion was used. Thecontralateral limb was cannulated, and iliac limb extcnsionswere deploycd to complere the proccdure. After completion of the graft deployment, the complerion angiogramswere performcd for qpc I or r)?e III endoleaks, and nopatient left rhe operating room with these gpes of en-doleaks. A CT scan wirh conrtast was repeated bcforedischargc on all paricnrs to exdude any cndoleaks. Wewould plan ro treat rype II endoleaks only if the patienrremained unstable. One stablc parient wirh a rype II endolcak was observed in our series.

Open repair was performed with the patient undergeneral anesthcsia via rhe transabdominal approach in astandard fashion with a Dacron graft (DuPont, Wilmington, Del) in all cases, and supraceliac or inliarenal clampingwas uscd as deemed nccessary. Cell saving dcvices wereuserl only in parients who untierwent open repair.

Thc measured or.rtcomes includcd technical succcsswith complete sealing of rhe aneurysm, conversion, inrcnsive care unit (ICU) lcngth of stay (LOS), total hospitalI-OS, 30-day in-hospital mortality, complications, early and

JOURNAL OI VASCUIAR SURCF,RYNovcmbc.2007

Table I. Demographic characteristics ofall patienspresenting wi*r ruprured abdominal aortic rncurysms(age,76.4 L 7.2 yearc', run5.,57-89 ycars)

MaleCoronary artery diseascHypenensionDiabetes mellitusCerebrovascular disea5eHyperlipid€miaChronic pulmonary occlusive diseaseRenal insufficiency (crcatinine >t.5 m&/dl-)CirrhosisSmoken (ective)

latc reinterventions, aneurysm-related cvents, and condition on last follow-up. The patients who underwent EVARwere followed up with our follow-up prorocol fbr electivcEVA\ which consisted ofclinic visits and CT scans at 3, 6,and 12 months and then yearly thereaftcr. Thc patiennwho survivcd opcn repair werc followed up yearly afterbcing seen within I month after dischargc. These parientsdid not have the vigorous posr,EVAR surveillence withrepeated CT scans.

Data analysis was performed with SPSS 14.0 software(SPSS Inc, Chicago. tll;. The descripdve statistics are givenas mean a SD, with median and range numbers indicatedin parentleses whcn data were skewed. Cross tabulation ofprcdictive covariatcs was performcd berwcen two groups(survivors vs nonsurvivors) by using the Fisher exact test fornonparametric variables. Muhivariatc analysis was pcr,fbrmcd with stepwise (fbrward: likelihood rario) binarylogistic regression analysis for prcdicring pcrioperativemortality (dearh within 30 days). IGplan-Mcier lifc tableswere used fbr statistical analysis of overall, r€intervention-liee, and endoleak-liee survival ratcs. All P valucs wereconsidered significant if <.05.

RESIILTS

A roral of40 paricnrs (30 men; me,in age,76.4 t 2.2years; rangc, 57 89 ycars) presentcd with rAAAs. Thirtypatients underwent attempted EVAR for rAAA, constiruting 4.2% (t = 738) ofall EVAR cases and 75% (n = 40) ofall patienrs who prescnted wirh rAAA during this pcriod.The patients' demographic charactcrisrics are shown inTablc I. Thc peripror:cdural characreristics are shown inTable IL Twenty one (53%) were transferred from anotherinstitution- CT uas performed in 39 (97.5oA). The mcantime to rhe start ofrhe operation fiom arrival to the ED was57 :! l8 minurcs (rangc, 19 98 minutcs), and rhere was asignificant diffcrence betwcen stable and unstable padenrs(65 :r l7 minuresvs49 I l5 minutes; P: .02). The mcansize ofthe AAAwas 6.7 a 1.3 cm (rang€,4-2-12.0 cm). Onarrival to che ED, 17 (43%) paticna were hypotensive. Lossofconsciousness was seen in 6 ( l5%), and 2I (53%) becameunstable at some point before the opcration. Transfemoralballoon occlusion was used in l0 patients in the EVAR

秘鍋協秘協螺釧獅既魏

IOURNAL OFヽりSCULAR SURCERYVdunc 46,Nu nber 5 И″″′″′′″′ 901

Table II. Periprocedural charactcristics ofpaticnts who had endovascular aneurysm repair (EVAR) for rupturedabdominal aortic aneurysms

Op"" P palue

CT pcrformedTransfcrUnstablelnirial systolic bloo.l prrssurr <80 mm HgLss of consciousnesslschcmic changes on ECGNeed for aonic occlusion balloonBifurcated devicc/graftOperation timc (min)

Mean I SDRange

Mean PRBCS tmnsfused (units)

郷

秘

訊

銘

％

眺

協

ＮＲ

ＮＲ

蝋砺鍋弼瑯畑郷叫

％％幌秘幌郷幌為

126± 3277‐ 21024± 27

192=27150-23550■ 19

9947372199153089696NR

く 001

008

Cl Compued tomoe;nphy; ECG, clccrcddioBlaq PRaC,, packcd r.d blood cclls; lvlt, oor rclev:nt

group and 2 patients in thc open group. Bifurcated devices

were used in all paticnts but one. One paticnt who pre

scnted with a stablc rupturc and a marginal ncck length (8

mm) was ficund to have a rupturcd inflammatory aonicancurysm on exploration, and as a rcsult ofcxcessivc dim-culry with cxposurc, he was succcssf'ully converted toEVAR and survived. He temains problcm liee 24 monthsalier the procedure. AneuRx (n : 22;7l%), Zenith (n = 5;

16%), and Ancurc (n : 4; l3%) grafu wcrc used (97%;

bifurcated ).The mean operation time was 126 a 32 minutes

(range,77-2IO minutes) in the EVAR grotp ^nd

I92 ! 27minutcs (range, 150-235 minutes) in opcn cases, all ofwhom had bifurcated grafts placed. EVAR was complctedin 29 cas€s: 28 (93%) of EVAR-anemptcd cases and Iconversion from the opcn goup. Inability to deliver thcdcvice because of iliac art€ry tonuosity and calcifcation(one patient) and a proximal endolcak in another Patientwith an 8-mm,90'angled rcnuous neckcauscd conversion

to open procedures in two patients (AfleuRx was attcmpted

in both). Mean blood transfusion requiremcnts wcre 2.6 :1:

2.7 units (rangc,0'13 units; median,2 units) in the EVARgroup and 5.0 :l 1.9 units (range, 3 8 units; median,4units) in opcn cases (P = .008). Thc reasons for choosingopen rcpair wcrc unFavorable neck analomy in scven cascs

and iliac anatomy in thc remaining threc cases. Thc clamp

could be placed infrarenally in three and suprarenally in six

cases, and thc remaining patient with marginal ncck anat'

omy was successfully converted to EVARA total of 12 paticnts had common iliac ancurysms

larger than 2 cm in diamcrcr. Two simply had extension ofthe iliac limbs to external iliac aneries, and three had

additional coil cmbolizations of their intcrnal iliac aneries

befbre placcmcnt of cxtcrnal iliac artcry extcnsions. The

rcmaining common iliac aneurysms werc sealed by using an

aoroc extension cuff(24'28 mm). At least one internal iliacartcry was prcscrved in all patients

Fivc patiens (17%) in rhc EVAR group and four Pa-

ticnts (40%) in the open group died within 30 days (P =.19). The 30-day mortality ratc for thc cntirc cohon was

22.5%. ln the EVAR group, onc patient with oxygen

dependcnt chronic obstructive pulmonary disease and cirrhosis with portal ht?crtension died 7 hours after thcprocedurc. Another paticnt who had a cardioPulmonaryarrest bcfbrc rhe procedurc had a persistcnt qpc I cndoleakliom his severcly angulatcd neck, which was recognizcd inthe opcrating room; additional placement ofan aortic cuffwas not succcssf'ul, and the procedurc was immcdiately

convcrted to an open approach. Balloon occlusion was kept

until a suprarenal damp could be placed and the repair

complctcd. Unfbnunatcly, the Patient dicd 8 hours latcr inthe ICU. The rcmaining three patients died of multiplcsystem organ failure within 48 hours after successful exclu-

sion of their aneurysms. They wcre all anuric and acidotic,had increased liver function tests, and had acute rcspiratory

diso:ess syndrome. In the open-tr€rted group, four patients

died on postoperativc da)'s I (two Paticnts), 5, and 8 frommultiple organ systcm llilure Three of rhesc four Patrentshad suprarenal clamps placed, and all were unstable; twolost consciousness bcfbrc surgery'

The mortaliry ratcs in Padcnts with various preopcra-

tive and preoperative chancteristics are shown in Table IIIfor a.ll paticnts and for those trcated with EVAR Mortalityin patients who required balloon occlusion was 44% rs 4%

in those who did not (P = .019) in thc EVAR grouP and

was 45% and l4%, rcspectivcly, io thc cntire cohon (P =.083). The mortality rate was 5% in those who prescntcd

and remained stablc, whercas it was 38% in thosc who wcrc

not stable (P = .021 ). Therc was no differencc in morralityin those uansferrcd from another institulion ( l4%) as com-pared with those pr€senting primarily to our ED (31%; P = .

.265). The stabiliry ratc was the samc betwccn transferred

patients (43%) and nontransferred Patients (53%; P =.752). Monality was higher in those who expcrienced loss

of consciousness (83% vs l2%; P = 00f) and ischcmic

changes on the elecuocardiogram (50% vs l6%; P: .059).

Thc multivariatc analysis using logistic regrcssion showed

thar hypotension on admission (systolic blood pressure

(80 mm Hg; odds ratio [OR], 7 4;95% confidencc intcr'val [CI], 1.3-42.0; P: .025), loss ofconsciousn€ss (OR'

9O2 Anain ct al

Table III. Thc effect ofdiffcrent factors on morraliw

Pフ″“′

MaleAge >76'!Coronary artery diseaseHlpenensi()nDiabetes mcllitusCer€brova$ular diseascHypcrlipidemiaChronic pulmonary

occlusi!'c diseaseRenal insu-ffciency

(creatinine > 1.5nE/dL)

CirrhosisSmokers (activr )TransfarHyF)tension on arrival

(<80 mm Hg)Unstable belbre surgeryl,oss ofconsciousn€ssIschcmia on ECGHardman score >lBalloon ()cclusionPRBCS >2 unitsType of repair (EVAR)

30%100%14%14%

6654571171623489999

456

665225453265

023*021*001059*127083*001*190

.EC1G, Elecrrocardiogralni PRB(! pack€d rcd blood .clls; €y,{& cndovascular dcurysm repair.

37.5;95oA CI, 3.4-40.8; P = .003), and the need t'brballoon occlusion (O& 5.2; 95% CI, 1.8,25.5; P = _O42)werc correlated with higher perioperative monality,whercas agc older tban 76 ycars, coronary anery disease,chronic obstructive pulmonary disease, hl.pertension, dia-betes, renal insufficiency, and rype of proccdure did not.The pcrioperative mortJiry of unsrable patients was 67%(4/6\ in rhe opcn group and 270A (4/I5) in thc EVAR,treated group (P = .146).

The numbcr of blood rransfusions inversely corclaredwith survival. All patients who requircd two unitl or less ofpacked red blood cells in the EVAR goup (n = 2l)survived, whercas five (56%) dicd if more than rwo unirswere uscd (P = .001). In addition, patients who requiredthree or fbur units of packed red blood cclls but did notrequire balloon ocdusion survivcd, whercas those whorequired balloon occlusion died. All three patients whorcquired more than four units of packcd red blood cclls

. died.The mcan length ofstay in the ICU was 3.2 1 1.4 days,

and rhe rotal hospiral LOS was 9.4 1 6.4 days (range,4-30days) in surviving EVAR-neated patients. The major 30-day morbidities in survivors included one (4%) mvocardialinfarction, one (4%) dcep vein thrombosis *ith pulmonaryembolism, and one (4%) limb ischemia sccondary to graftlimb occlusion necessitating femorofemoral blpass. We didnot diagnose any abdominal comparlmcnt syndrome orbowel ischemia necessiatingre exploration in this group of

'OURNAL OI VASCI] I,\ R SU R(] I]RY

Nolcmbcr 2007

patients. In dre open group, two surviving patients hadpostoperative pneumonia and renal insufficiency, and onehad limb ischcmia necessitating thrombecromy. The meanICU and total hospital LOS wcre 4.7 t 2.0 days and I0 :t3.7 days, respectively, in thc open ricatcd patients whosurvivcd (P : .046 for ICU stay; P: .149 for total LOSwhen compared wirh EVAR cases).

Thc mean fbllow up lbr thc EVAR group was 13.8 1I0.4 months (range,3-48 months; median, 12 months116.0 a I1.2 montis in survivors]). An additional lburpatients presented with limb ischcmia and undcrwen!l'emorofbmoral bypass 4, 5, 7, and 7 months after theEVA& giving a total of 6ve parienrs who underwcnt rhisprocedure (16%; 19% in rhose surviving >30 days). Onlyone ofrhese had an Ancurc graft, and the resr had AneuR\grafts placed. The overall late endolcak rate was 8%. The 6-and 12 month endoleak free survival iares wcre 96% a 4%(89% t 8%) in survivors. Onc paricnt prcsented with arcpcat rupture I I months after the first one, and the t,vpe Iendoleak caused by graft migration was successli ly re-paired with a proximal cufextension; this paticnt remainsalivc 5 months after the second repair. There was one rypeII cndoleak, which was managcd conservatively and disap,peared at the 6-month fiollow,up. Sac shrinkage of5 mm ormore was obscrved in 62%, as measurcd by the surgcon inthe last CT, wirh only one sac increase notcd in rh€ parienton CT when he prescnrcd with repeat rupturc due toproximal migration. This paticnt's sac remained stable atthe last follow up. The mcan sac size on the last follow-upCT was 5.6 :! l 0 cm, with a mean decrease of I.0 a 0.9cm. The ovcrall ancurysm-related secondary reinterventionrate was 23% (6/26) in survivors. The 6- and 12 monthreintervention-free survival rarcswere 83% ! 8o/^^nd 670/^ )I l%, respectively, in survivors.

The l2-month survival of the cndre EvAR-trearedgroup was 77oA ! 8% (91% t 6% in those surviving theinitial operation). Iatc mortalities included rwo patients:Onc paricnt with chronic steroid use and multiple medicalcomorbidities dicd as a result of sepsis 7 monrhs after ap€rfo.ared appcndix, which fistulized into the aneurysmsac. The secondpatient died 9 monrhs larcr liom pancreariccancer.

DISCUSSION

Thcre has bccn a significaor incrcase in recent years ofreports involving EVAR in rhe treatment of rAAA.s'ra Thisis likely thc result ofdissatisfaction on rhe surgcons' paft onthe lack of improvement on ovcrall mortaliry with thetraditional open surgical rcpair. This increase in EVAR usein rAAA also parallele,i the dramatic increase in expcrtiseand availability of ncwer graf's in rcccnt ycars. Althoughearlier reports includcd only high-risk patients,.3 4 more andmore cenrcrs are adopting an EVAR-first approach when-ever feasible and are rcponing improved outcomes withd€creased morbidiry, monaliry, blood rransfusions, andLOS.7 e'r2 14 Howevcr, there is a wide variability bctwccnstudies, making comparisons and conclusions nearly impos-sible regarding EVAR's value in rAAAs. Thesc variabilities

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'OURNAL OF VASCUI-{R SURGERY

Volume 46, Numbcr 5

include the pcrccntage of patients with hemodynamic in-stability, the minimum neck length criteria used for indu'sion for EVAR (5 l5 mm ), the rillingness to procecd withEVAR widrout prcopcrativc CT scan in unstable patients,

the willingncss to acccpt lower blood prcssurcs bcfbrerushing the patient to the O\ the availability of experi'cnced vascular surgcons, and fic availability of grafu ac-

commodating more qpes ofanatomy 3 t"

Wc adoptcd thc EVAR-fint approach for rAAA aftcracquiring a significanr experiencc with eleclive EVAR after

is Food and Drug Administradon approval in thc UnitedStates in 1999. Aftcr our 6rst EVAR ofrAAA, wc adoptcdthis fbr all comers relatively easily because of thc level offamiliarity our ED, O\ and radiology staff developed inmanaging thcse patients as a result ofour large volumc ofEVARs in elecrive and urgcnt nonruptured aneurysms. We

cmphasized (l) fluid rcstriction unless the patient lost

consciousncss and (2 ) instant and simultaneous notilicationof thc vascular surgcon, O\ and CT scanner by thc EDseffin the eventofan rAAA diagnosis or transfer. Althoughwc did not devclop a protocol and pcrfbrmed test runs

before we started our EVAR expcricnce in rAAA Padents,we do recommend this approach to centers that contemplarc starting their own rAAA/EVAR program, especially iftheir AAA volumc is not high.

Bccausc ofits rninimally invasive nature, EVAR shouldintuitively have a bigger cffect on patients with hemody-

namic instability; however, this is used as an exclusion

criterion in some sludiesr I or uscd as a criterion for skip-

ping the CT scanncr, thus resuldng in many fcwer patients

ieciiving EVAR in this subgroup. Mchta et alr2 rcported

that only 3 ofthc 45 surgically tleated paticnts who were

u:eated after they launched their EVAR for rAAA protocolhad absolutely prohibitivc anatomy tbr EVAR Reporting

on a mostly (65%) unstlble grouP ofpatients, Moore et ale

rcported a mortality rate of 5% after EVAR vs 28% in

surgically treatcd patients, with corresponding figures ofl4% and 56% in hemodynamically unstable patients; this is

not too dissimilar to ov 27% and 66% ratcs in unstablc

patients. ln contrast, CopPi et al6 rcponed 53% mortaliryafter EVA\ compared wilh 6l% in thc open group inunstable rAAA patients. It is of notc, however, that al-

though 52% of all paticns were eligrble, only 270/o wete

treatcd by EVARin this scrics. Overall, 53% ofour patients

were unstable before surgery (50% in the EVAR group and

60% io thc opcn goup). Hlpotension on arrival to the ED,loss ofconsciousness, and need for balloon occlusion, all ofwhich were rclated to instability, were conelrted withpoorer outcomcs, and the rype oftreatment did notseem toaffect periopcratrve survival, likely because of the small

numbcr of patients treated. Although our mortality was

significandy higher in unstable than in stablc padcnts (38%

vs 5%; P: -02I), it is still reasonably low, especially when

one considcrs that the study indudcd all comcrs and thathemodynamic instability was not an exclusion criterion.

Successfi:l exclusion ofrAAA with EVAR was accomplishcd

in 72.5% of all paticnts with rAAA, including the twoconversions: one fo( iliac anatorny and the other for persis

Anain et sl 9O3

tcnt proximal endoleak. Incidcntally, this sccms to bc very

high whcn compared with other studres that include all

comers (18% 49%).6'7 ro 12 Our number is also almostdouble the previously quoted 40% of EVAR suitabiliry fora.llcomcrswith rAAA.r6 Howcver, the criteria used in thosc

studies for anatomic suitabiliry, including neck length and

quality, were very stringent, and our willingness to com-plcte thc proccdure even in those with unclcar ncck anat-

omy by CT scan may have contributed to this high percent-

agc- We ttrink that scaling the rAAA even whcn theanatomic features are not ideal and converting a lifc-thrcat'ening situation into a more manageable and stablc condi-

tion is an acccptable short'tcrm goal, cspecially in this

high-risk patient population.Thc CT scan is usually skipped in those with blood

prcssures less than 80 mm Hg in most protocols, with the

ftar oflosing the paticnt en route; however, this is rarely the

causc ofpatient death as long as fluid rcstriction is fbllowedand unnecessary delays are avoidcd between thc ED, CTscanncr, and O\ cspccially uhen the spccd ofthc modern

CT scanners and mandatory times for ORsetuP arc consid

ered. Lloyd et alrT rcported lhe time to dcath fiom admis

sion to be more than 2 hours in nonoPerated rAAA pa

tients, with the median time being 10 5 hours liomadmission to thc ED, which should give amplc timc for

both CT scan and OR prcparation for most padents. OurCT scan acquisition rate of97.5% is on€ ofthc highcst in

the literaturc reporting on all comcrs with rAAA, and the

mean Eme liom arnval to the ED and start of the operation(49 minutes) in unstablc patients is accePtable.

There is no 24_7 in house coverage by vascular sur-

gcons in our hospital, and therc arc no surgery residents orvascular surgery fellows taking thc fust call{iom the ED' as

is rcponcd liom thc large academic centers.e't0 12 wc have

nol found this to be a problcm bccause ofthe simultancous

activation ofall vascular surgeoos, CT scanner, and ORstaffby the ED physicians, mostly even bcfore the patient with a

high likclihood of rAAA reachcs the hospital Those trans-

firring from othcr institutions would be accompanied by

their CT results, thus making it cven casier to make plans

ahead of timc, but rhere was never a time that surgery was

dclayed bccause ofsurgeon's late arrival. It is important to

note that tlle surgeons live widin 20 to 25 minutcs ofdriving distance lrom the hospital, and t}re entire surgical

tcam would havc becn mobilizcd b€fore thc surgeons'

arrival.Although balloon occlusion was initially described via

the transbrachial approach with a cutdown, the uansfemo-

ral approach has been our prefbrred approach, as is the casc

for most surgeons.rs This mancuvcrwas nccessary in a thirdofour paticnts bu!was nccessary in up to 73% ofpatients in

somc series.r4 Because of its inhercnt potential complica'

tions, such as mesenteric ot renal aftery ischcmia, withadditional risks of embolization or thrombosis, it is very

impoftant not to use balloon occlusion unless it is abso-

lutely necessary. we did not encounter any complications

rclated directly to balloon occlusion in this series involving12 padents, and thc 45% mortality in this group was a

9O4 Anait et al

reflccrion of the patient's condition rather than being a

result ofit.Uni-iliac gafu have been suggested as a means of

expediting exclusion of AAA by some authors6 ro; how'ever, we havc not found placcment of bifurcatcd grafis tobe an issuc during surgery. Still, we would not hesirare roconv€rt to an aortouni iliac configuration, followed bycontralatcral occlusion and fcmorofemoral blpass, if con-tinued exccssive bleeding coupled with dillicult contralar'eral cannulation were encountered. We havc cncounteredadditional limb occlusions (19% in survivors) in our patients, all ofwhom were trcatcd witlr femorofemoral bypassgrafu. This coosotuted thc most common rcason foraneurysm-rclatcd secondary intcrvcntion in our series. Wethink that this was the result ofnot performing the obliqueviews ofthe iliac arteries atthe cnd oftheproccdurc in theseemergency cascs, as is our routine in elective cases- Avoidance of contrast load and the tendency to end the emergency opcration as soon as possible may have becn thereasons for this practice, but wc have since been payingmore attenuon to the quality oithc iliac arteries and graftlimbs at the completion of the EVAR in these paticnn. Ourlimb occlusion rate in the clectivc EVAR popularion is2.7%, and we thinl< that the highcr rate in rAAA parientsresulted liom failing to recognize the anatomic defects inthe final repair.

The secondary intervention rate following emergencyEVAR has been reported to be vcry similar to that fbllowingelective EVAR by Oranen etal,r3 with a 2 yearintcrvenrionratc of16%, whcrcas Hechelhammer ct alr'3 reponed this tobc much highcr, at 35%- Endoleaks with or wirhout migration were the most common causes fbr reintervention inthcse series, whercas we had only one late t!?e I endoleakdue to migration with rupture in our series, Onc parientwith qpe II endolcak was treated conservarively; wpc IIendoleak have not been reponed to cause problems afterrAAA treatment with EVAR-re

We have not diagnosed any abdominal comparrmentsyndrome, which has been reported in up to l8% ofpatienrsaftcr EVAR for rAAA,r2 in our scric!. However, we havenot routinely performcd bladder prcssure measurcments.Wc rcly on other criteria (tense distended abdomen, in-creascd airwav prcssures, h)?otension, and oligoanuria).We have recendy adoptcd routine bladder pressure mea-surcmcn$. Mehra er alr2 suggested that thcy started sceingless abdominal compartment syndrome after they stoppedusing heparin in their patients. We havc nor used heparin inrAAA patients liom thc bcginning ofour erperience, and itis possible that this mav havc affected our favorable cxperi-encc widr this particular complication.

Thcrc are somc wcaknesses ofour study. It is retrospec,tive, and data were not prospectively collected. We have notanalyzed the ourcome ofparienrs rreared beforc the EVAR-6rst approach was sraned, thus making it hard to prove thatwe improvcd the mortality in patients with rAAA in ourhospital, although comparing rcsults with historical con,trols has its own drawbacks. Because the duration encom,passes ncarly 4 years, there has been a signilicant variation in

JOI]R}iAL OF VASCT]IrTR STIRGERYNovcrnbcr 2007

the availabiliry of the types of stent grafts; therefbrc, ourcurrent experience is likely not rcprcsented uniformly bythe study group. Finally, thc lack ofa written protocol mayhave caused somc variations in rhc way some patients weretrcated, espccially befbre reaching thc OR However, we donot believc chat such small variations werc significantenough to havc any eli'ect on the frnal oLrtcome of anypatient in this scrics.

CONCLUSIONS

Our results, along wirh thc rcsulrs of orher studies,show that EVAR is feasible, with favorable outcomes inpatients presenting with rAAA in a busy community hospiul, as long as therc arc trained personncl who are capable ofperforming opcn or EVAR procedures in rAAA. Thisshould be performed in the OR so the patient can undcrgoemcrgcnry convcrsion ifnecessary. The perioperative mor.taliry is still largely determined by thc parient's hemody-namic status at prescntation. The relarively high reintervention rate can be potentially decreased by cnsuring good iliacanatomy at the end ofthe procedure, and close follow up isnecessary to ensure early diagnosis oflatc-onset endolcaksto prcvcnt secondary ruptures-

AUTIIOR CONTRIBUTIONS

Conception and design: PMA, JMA, HHDAnalysis and interpreradon: PMA, NDN, HHDData collcction: PMA, MTWriting thc article: PMA, HHDCritica.l revision of the article: PMA, HHDFinal approval of the ardcle : PMA, JMA, MT, NDN, HHDStatistical analysis: NDN, HHDOverall responsi biliry: PMA

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