j endovasc ther 2010

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¤CLINICAL INVESTIGATION ¤ Aneurysm Sac ‘‘Thrombization’’ and Stabilization in EVAR: A Technique to Reduce the Risk of Type II Endoleak Salvatore Ronsivalle, MD 1 ; Francesca Faresin, MD 1 ; Francesca Franz, MD 1 ; Carlo Rettore, MD 2 ; Mario Zanchetta, MD 3 ; and Armando Olivieri, MD 4 1 Department of Cardiovascular Disease–Vascular and Endovascular Surgery and Angiology, 2 Department of Radiology, 3 Division of Cardiology, and 4 Department of Prevention–Epidemiology Unit, Cittadella Hospital, Cittadella, Italy. ¤ ¤ Purpose: To evaluate the reduction in type II endoleak risk after introducing a new prevention method, ‘‘thrombization’’ or clotting of the aneurysm sac, during endovascular aneurysm repair (EVAR) versus the standard EVAR technique. Methods: From September 1999 to December 2008, 469 consecutive patients underwent EVAR for AAA at our institution. In 2003, the injection of fibrin glue with or without microcoils into the aneurysm sac was added to the EVAR treatment plan (‘‘thrombization’’ technique). Patients who did not meet the inclusion criterion (at least 1-year follow-up imaging) were censored at the end of 2007, leaving 404 patients eligible for the study: 224 patients (210 men; mean age 71.968.5 years, range 25–88) undergoing EVAR alone from September 1999 to May 2003 (group 1) compared to 180 patients (161 men; mean age 72.668 years, range 46–89) who underwent EVAR + thrombization from June 2003 to December 2006 (group 2). Results: The 2 treatment groups were similar with regard to aneurysm morphology. No allergic or anaphylactic reactions were encountered related to the fibrin glue. Over median follow-up times of 72 months in group 1 and 26 months in group 2, there were 34 (15.2%) endoleaks in group 1 versus 4 (2.2%) in group 2 (p,0.0001). The incidence of type II endoleak was 0.25/100 person-months for group 1 versus 0.07/100 person-months for group 2. The preventive sac thrombization technique was significantly associated with a reduced risk of type II endoleak (HR 0.13, 95% CI 0.05 to 0.36; p,0.0001) regardless of the type of stent-graft fixation (infrarenal versus suprarenal). Conclusion: The preventive method of intrasac ‘‘thrombization‘‘ using fibrin glue injection with or without the insertion of coils proves to be a simple, low cost, safe, and effective technique to significantly reduce the risk of type II endoleaks irrespective of the endograft used. J Endovasc Ther. 2010;17:517–524 Key words: abdominal aortic aneurysm, endovascular aneurysm repair, type II endoleak, microcoils, fibrin glue, sac thrombosis ¤ ¤ Endovascular aneurysm repair (EVAR) is used increasingly to treat abdominal aortic aneu- rysm (AAA) in patients with suitable anatomy. See commentary page 525 This less invasive technique has been estab- lished as a safe and effective method of short- term aneurysm exclusion, but the surveil- lance program is still debated. Nevertheless, unique mid- and long-term graft-specific The authors have no commercial, proprietary, or financial interest in any products or companies described in this article. Address for correspondence and reprints: Salvatore Ronsivalle, MD, Department of Cardiovascular Disease, Vascular Surgery and Angiology, Cittadella Hospital, Via Riva dell’Ospedale, 35013 Cittadella, Padua, Italy. E-mail: vascolare_cit@ ulss15.pd.it J ENDOVASC THER 2010;17:517–524 517 ß 2010 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at www.jevt.org

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Page 1: J ENDOVASC THER 2010

¤CLINICAL INVESTIGATION ¤

Aneurysm Sac ‘‘Thrombization’’ and Stabilizationin EVAR: A Technique to Reduce the Risk ofType II Endoleak

Salvatore Ronsivalle, MD1; Francesca Faresin, MD1; Francesca Franz, MD1;Carlo Rettore, MD2; Mario Zanchetta, MD3; and Armando Olivieri, MD4

1Department of Cardiovascular Disease–Vascular and Endovascular Surgery andAngiology,2Department of Radiology,3Division of Cardiology, and4Department ofPrevention–Epidemiology Unit, Cittadella Hospital, Cittadella, Italy.

¤ ¤Purpose: To evaluate the reduction in type II endoleak risk after introducing a newprevention method, ‘‘thrombization’’ or clotting of the aneurysm sac, during endovascularaneurysm repair (EVAR) versus the standard EVAR technique.Methods: From September 1999 to December 2008, 469 consecutive patients underwentEVAR for AAA at our institution. In 2003, the injection of fibrin glue with or without microcoilsinto the aneurysm sac was added to the EVAR treatment plan (‘‘thrombization’’ technique).Patients who did not meet the inclusion criterion (at least 1-year follow-up imaging) werecensored at the end of 2007, leaving 404 patients eligible for the study: 224 patients (210 men;mean age 71.968.5 years, range 25–88) undergoing EVAR alone from September 1999 to May2003 (group 1) compared to 180 patients (161 men; mean age 72.668 years, range 46–89) whounderwent EVAR + thrombization from June 2003 to December 2006 (group 2).Results: The 2 treatment groups were similar with regard to aneurysm morphology. Noallergic or anaphylactic reactions were encountered related to the fibrin glue. Over medianfollow-up times of 72 months in group 1 and 26 months in group 2, there were 34 (15.2%)endoleaks in group 1 versus 4 (2.2%) in group 2 (p,0.0001). The incidence of type IIendoleak was 0.25/100 person-months for group 1 versus 0.07/100 person-months forgroup 2. The preventive sac thrombization technique was significantly associated with areduced risk of type II endoleak (HR 0.13, 95% CI 0.05 to 0.36; p,0.0001) regardless of thetype of stent-graft fixation (infrarenal versus suprarenal).Conclusion: The preventive method of intrasac ‘‘thrombization‘‘ using fibrin glue injectionwith or without the insertion of coils proves to be a simple, low cost, safe, and effectivetechnique to significantly reduce the risk of type II endoleaks irrespective of the endograft used.

J Endovasc Ther. 2010;17:517–524

Key words: abdominal aortic aneurysm, endovascular aneurysm repair, type II endoleak,microcoils, fibrin glue, sac thrombosis

¤ ¤

Endovascular aneurysm repair (EVAR) is usedincreasingly to treat abdominal aortic aneu-rysm (AAA) in patients with suitable anatomy.

See commentary page 525

This less invasive technique has been estab-lished as a safe and effective method of short-term aneurysm exclusion, but the surveil-lance program is still debated. Nevertheless,unique mid- and long-term graft-specific

The authors have no commercial, proprietary, or financial interest in any products or companies described in this article.

Address for correspondence and reprints: Salvatore Ronsivalle, MD, Department of Cardiovascular Disease, VascularSurgery and Angiology, Cittadella Hospital, Via Riva dell’Ospedale, 35013 Cittadella, Padua, Italy. E-mail: [email protected]

J ENDOVASC THER2010;17:517–524 517

� 2010 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at www.jevt.org

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complications related to EVAR continue topresent management dilemmas for clinicians.Principal among these adverse events is thepresence of a type II endoleak, which occursat some interval after EVAR in 20% to 30% ofpatients.1,2

Type II endoleak, the most common se-quelae of the EVAR procedure, is due topartial or incomplete thrombosis of theaneurysm sac after successful aneurysmexclusion in conjunction with retrogradeperfusion from aortic collateral branches(lumbar, inferior mesenteric, sacral, and renalaccessory arteries). The treatment approach-es to types I and III endoleak are wellestablished, while the management of typeII is still a matter of debate. A conservativeapproach is usually used when there isgradual sac shrinkage, although its impact onlong-term outcome after EVAR is still un-known.3–5 On the other hand, aneurysm sacenlargement within 6 to 12 months calls formore aggressive techniques, such as percuta-neous transarterial or direct translumbar em-bolization with microcoils or liquid embolicagents, laparoscopic retroperitoneal branchligation, or endoscopic aneurysm sac fenes-tration.6–16 These procedures seldom resolvethe problem, and the best results are achievedwith open surgery, which is therefore the mostappropriate choice in most cases.

The natural history of a type II endoleak ledus to believe that prevention is the beststrategy in managing this complication. In2003, we began stimulating and acceleratingcomplete aneurysm sac thrombosis by intro-ducing biocompatible materials during EVAR,primarily fibrin glue.14,15 Several years later,we introduced microcoils along with thefibrin glue to stabilize the sac in a processwe now call ‘‘thrombization.’’ The aim of thisstudy was to evaluate the effect that thrombi-zation of the aneurysm sac has on the risk oftype II endoleak compared to the standardEVAR technique alone.

METHODS

Study Design

This observational retrospective study wasdesigned to encompass all consecutive pa-

tients who underwent EVAR for AAA at ourinstitution from September 1999 to December2008 and had at least 1-year follow-upimaging. A contrast-enhanced helical com-puted tomography scan with 2.5-mm cutswas used preoperatively to determine if apatient met the radiological criteria for stent-graft repair based on the manufacturer’sInstructions for Use. Five different stent-graftdesigns were used in the study period: Talent,AneuRx, and Endurant (Medtronic CardioVas-cular, Santa Rosa, CA, USA); Excluder (W.L.Gore & Associates, Inc. Flagstaff, AZ, USA);and Anaconda (Vascutek, a Terumo Compa-ny, Inchinnan, Scotland, UK). The follow-upprotocol included a color duplex ultrasound(CDU) scan at discharge; at 3, 6, and12 months; and at 6-month intervals thereaf-ter. Abdominal radiography was also per-formed at discharge and a year later. A CTscan was scheduled at 6 months.

At the end of the observation period, allimaging tests were collected and separatelyviewed in a double-blinded manner by 2EVAR experts (a vascular surgeon and aninterventional cardiologist). The size of theaneurysm sac and the presence and type ofendoleak were evaluated. In accordance withcurrent standard reports for EVAR,17 primaryclinical success was defined as absence ofaneurysm-related death, aneurysm rupture,conversion to open surgery, and secondaryendovascular or surgical procedures. Assist-ed primary and secondary clinical successwere applicable when success was achievedwith additional endovascular or surgical pro-cedures, respectively.

Fibrin Sealant

Fibrin glue (Tisseel/Tissucol; Baxter-HylandImmuno AG, Vienna, Austria) is a fullyabsorbable biological adhesive matrix with-out cytotoxic effects made from a fibrinogensolution containing plasma proteins andfactor XIII and a thrombin solution containingcalcium chloride and aprotinin. These com-ponents are commercially prepared fromhuman plasma, except for aprotinin, whichis extracted from bovine lung. When mixedtogether, the 2 solutions recreate the finalphase of the natural coagulation cascade

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forming a structured fibrin clot similar to thephysiological clot, susceptible to fibrinolyticdegradation by proteolytic enzymes such asplasmin.18 Over the last 3 decades, fibrin gluehas been used extensively by surgeons.19,20

Fibrin glue does not interfere with magneticresonance imaging (MRI), CT, or CDU. Therequired dose of sealant to cover 40 cm2 or3.5 cm3 is about 5 mL; however, its use inaneurysm sac embolization is an off-labelindication. In Italy, 5 mL of Tissucol costs 435euros (,US$565).

Coils

MReye embolization coils (IMWCE 35-20-20; Cook Medical, Bloomington, IN, USA) aremade of a radiopaque nickel and cobalt alloy(inconel) that allows the use of MRI withoutaltering CT or CDU imaging. Most commonlyutilized in arterial and venous embolization,these coils exert a greater radial strength thanplatinum coils; they are introduced through0.035- or 0.038-inch catheters. In Italy, one coilcosts 48 euros (,US$62).

Thrombization Technique

After deployment of the main stent-graftcomponent with its contralateral iliac exten-sion, the angiographic pigtail catheter iswithdrawn, leaving a 180-cm-long 0.035-inchstandard J guidewire between the endograftand the native aorta. A 23- to 35-cm-long 5-FBrite Tip introducer (Cordis, a Johnson &Johnson company, Miami Lakes, FL, USA) isthen fed through the standard guidewireunder fluoroscopic monitoring and releasedinto the desired position inside the aneurysmsac. After the guidewire and 5-F cannula havebeen removed, an aneurysmogram is per-formed by manually injecting 10 mL ofcontrast into the sac to identify the numberand site of lumbar and inferior mesentericarteries. One or more MReye embolizationcoils are then advanced into the sac throughthe 5-F dilator and released by advancing the0.035-inch J guidewire inside the dilatortoward the end of the introducer sheath. A25- to 35-cm-long Duplocath catheter (BaxterInternational) inserted on a Duploject syringeclip (Baxter International) is fed into the

introducer until it reaches the aneurysm sac.Then a latex balloon is inflated into the distalend of the iliac graft extension so as toprevent distal embolization of the fibrin glue.With the balloon inflated, 2.5 mL of eachfibrin glue solution are simultaneously inject-ed into the sac through a 2-way catheter; asecond injection with the same amount canbe done if necessary. After the Duplocathcatheter is removed, an aneurysmogram isperformed to verify sac thrombization withroot occlusion of the lumbar and inferiormesenteric arteries. The Brite Tip introduceris then removed, and the completion angio-gram is performed (Fig. 1).

Patient Sample

During the study period, 469 patientsunderwent temporally sequential EVARtechniques. From September 1999 to May2003, 224 patients (210 men; mean age71.968.5 years, range 25–88) had standardEVAR. From June 2003 to December 2006, 124patients (114 men; mean age 73.268 years,range 51–89) underwent EVAR with preven-tive fibrin glue intrasac thrombization. Finally,from January 2007 to December 2008, 121patients (110 men; mean age 71.767 years,range 46–88) underwent EVAR with enhancedpreventive intrasac thrombization featuringinsertion of $1 microcoils followed by a fibrin

Figure 1¤ (A) Control CT with visible inconel(radiopaque nickel and cobalt alloy) coils and (B)final aneurysmogram performed to verify sacthrombization, with occlusion of lumbar andinferior mesenteric arteries.

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glue injection to achieve better aneurysm sacstabilization.

Patients who did not meet the criteria forstudy inclusion were censored at the end of2007, along with those who died or were lostto follow-up. Thus, 65 patients were excludedowing to lack of 1-year follow-up due to deathor loss to follow-up, leaving 404 patientseligible for the study. For purposes of analy-sis, the 224 patients undergoing EVAR alone(Table 1) were compared to the 180-patientcohort (161 men; mean age 72.668 years,range 46–89) who had either form of throm-bization.

Statistical Analysis

Continuous data are presented as the mean6 standard deviation or the median fornonparametric data; categorical data aregiven as counts (percentages). Time to iden-tification of a type II endoleak was the primaryoutcome in the study: freedom from endoleakwas estimated with Kaplan-Meier analysisfrom the date of surgery/intervention to thedate at which type II endoleak was diagnosed.

The log-rank test was used to compare theoutcomes in patients with and without sacthrombization. Cox proportional hazard mod-eling was used to examine the risk of type IIendoleak between the 2 groups after adjust-ing for potential confounders [age, gender,smoking habit, family history of AAA, chronicrenal failure, carotid artery disease, peripheralartery disease, obesity (body mass index.30 kg/m2), hypertension, cardiac disease,hyperlipidemia, stent-graft type, aneurysmdiameter, aneurysm length, neck diameter,neck length, and number/size of patent lum-bar and inferior mesenteric arteries]. Out-comes of the model are given as the hazardratio (HR) and the 95% confidence intervals(CI). Statistical analysis was performed withStata software (version 8.2; Stata Corpora-tion, College Station, TX, USA).

RESULTS

Both groups were homogeneous for allanatomical parameters assessed (Table 2;sac and neck size, diameter of the iliacarteries, and number of sacral and/or renalaccessory arteries). Mean AAA diameter was58.1613.1 mm in the EVAR-only patients(group 1) and 58.2614.1 mm in the EVAR +thrombization patients (group 2). The patientswith suprarenal fixation of the main stent-graft (Talent, Endurant) were homogeneousfor all anatomical parameters with patientsreceiving infrarenally fixed stent-grafts (An-euRx, Excluder, Anaconda; Table 3). Patientshad an average of 3 to 4 patent lumbararteries.

Endoleak Analysis

Over median follow-up times of 72 monthsin group 1 and 26 months in group 2(composite 19,065 months of follow-up aftersurgery), there were 38 episodes of type IIendoleak: 34 (15.2%) in group 1 and 4 (2.2%)in group 2. Half of the type II endoleaks ingroup 1 arose within the first month of follow-up. Among the 34 type II endoleaks detected,16 (47%) resolved spontaneously, 3 (9%) weretreated with open surgery (complete conver-sion) after failed transarterial embolization, 1(3%) underwent surgical ligation of a lumbar

¤ ¤TABLE 1

Baseline Characteristics of the Study Cohort

EVAR Alone(n5224)

EVAR + Thrombi-zation (n5180) p

Men 210 (93.7%) 161 (89.4%) 0.116Age, y 71.968.5 72.668 0.385Smoking 51 (22.7%) 19 (10.5%) 0.001Family history of

AAA 2 (0.8%) 1 (0.5%) 0.695Chronic renal

failure 54 (24.1%) 38 (21.1%) 0.475Carotid artery

disease 88 (39.2%) 103 (57.2%) ,0.001Peripheral artery

disease 80 (35.7%) 24 (13.3%) ,0.001BMI .30 kg/m2 47 (20.9%) 41 (22.7%) 0.664Hypertension 190 (84.8%) 172 (95.5%) ,0.001Cardiac disease 125 (55.8%) 130 (72.2%) 0.001Diabetes

mellitus 40 (17.8%) 26 (14.4%) 0.356Hyperlipidemia 150 (66.9%) 158 (87.7%) ,0.001¤ ¤

Continuous data are presented as means 6

standard deviation; categorical data are given ascounts (percentages).EVAR: endovascular aneurysm repair, AAA: ab-dominal aortic aneurysm, BMI: body mass index.

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artery (semi-conversion), 4 (12%) were un-available for follow-up, and 10 (29%) werestable at follow-up. All patients having beentreated with transarterial embolization of thecollateral aortic arteries with a negativeoutcome underwent open surgery. Of the 4type II endoleaks in the EVAR + thrombizationgroup (all occurring after 1 month), 1 resolvedspontaneously, 1 was unavailable for follow-up, and 2 were stable. The reduction in sacdiameters averaged 5 mm in both groups(p5NS).

The incidence of type II endoleak was 0.25/100 person-months for the EVAR-alone groupand 0.07/100 person-months for the EVAR +thrombization group. The Kaplan-Meier anal-ysis (Fig. 2) showed significantly better(p,0.0001) freedom from type II endoleak inthe EVAR + thrombization group. In thehazard model, preventive sac thrombizationwas shown to significantly reduce the risk oftype II endoleak (HR 0.13, 95% CI 0.05 to 0.36;p,0.0001). Among the other factors analyzed,only female gender (HR 0.32, 95% CI 0.14 to0.74; p50.007) and obesity (HR 0.10, 95% CI

¤ ¤TABLE 2

Anatomical Parameters for the EVAR Alone VersusEVAR + Thrombization Groups

EVARAlone

EVAR +Thrombization p

AAA

Diameter, mm 58.1613.1 58.2614.1 0.949Length, mm 70.9625.1 69.0622.3 0.432

Neck

Diameter, mm 23.162.7 23.462.9 0.299Length, mm 27.3610.9 27.7612.8 0.734

Right CIA 15.566.8 17.1610.6 0.089Left CIA 17.1610.2 15.766.1 0.079¤ ¤

Data are presented as means 6 standard devia-tion.EVAR: endovascular aneurysm repair, AAA: ab-dominal aortic aneurysm, CIA: common iliacartery.

¤ ¤TABLE 3

Anatomical Parameters for the EVAR Alone Versus EVAR + Thrombization GroupsAccording to the Level of Stent-Graft Fixation

Suprarenal Fixation Infrarenal Fixation

EVAR AloneEVAR +

Thrombization EVAR AloneEVAR +

Thrombization

AAA

Diameter, mm 60.7612.6 59.1614.0 52.9612.5 55.4614.4Length, mm 71.1626.4 69.6622.7 70.4622.5 67.2621.1

Neck

Diameter, mm 23.562.7 23.762.9 22.462.6 22.462.6Length, mm 27.069.8 26.5612.4 28.0612.9 31.7613.3

Right CIA 15.466.4 17.3611.7 15.867.5 16.466.2Left CIA 17.6610.9 15.665.8 16.268.6 15.867.0¤ ¤

Data are presented as means 6 standard deviation.EVAR: endovascular aneurysm repair, AAA: abdominal aortic aneurysm, CIA: common iliac artery.

Figure 2¤The Kaplan-Meier analysis comparingthe freedom from type II endoleak for the 2treatment groups. Numbers under the curvesrepresent the patients at risk at each time interval.Standard error #10% up to 113 months.

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0.01 to 0.73; p50.023) were independentlyassociated with type II endoleak.

Late Complications

In group 1, 6 (2.6%) patients presented withlate type Ia endoleak. Five were treated withsurgical conversion and 1 had additional cuffimplantation. Six (2.6%) patients in thissubgroup developed type Ib endoleak andreceived an iliac extension. One (0.4%) patienthad a type III endoleak that was treated withadditional cuff implantation. Three (1.3%)patients developed a partial graft limb throm-bosis that was treated with angioplastyaccompanied by stenting in 2 and by addi-tional iliac cuff implantation in the third. Nine(4%) patients had graft limb occlusion; 4underwent femorofemoral bypass, 4 werestable at regular follow-up, and the lastpatient was not available for follow-up. One(0.4%) patient developed acute renal failuredue to partial renal artery occlusion, whichwas treated by stenting.

In group 2 patients, 2 (1.1%) type Iaendoleaks were detected; 1 was treated withopen surgery and the other with an additionalcuff implantation. Four (2%) type Ib endoleakswere resolved by iliac extension. There were 3(1.6%) partial graft limb thromboses treatedwith stent insertion in 2 and iliac cuffimplantation in the other. Three (1.6%) graftlimb occlusions required femorofemoral by-pass crossover in 2 (the other is stable). Two(1.1%) cases of acute renal failure due topartial renal artery occlusion were identified;1 was treated with stenting and the otherunderwent surgical conversion. There wasalso 1 (0.5%) case of colon ischemia that wastreated with partial colon resection.

There were no signs of allergic, anaphylac-tic, or tissue reaction to the microcoils orfibrin glue in any patient during the follow-upperiod.

Survival Analysis

In group 1, 21 (9%) patients died of multiplecauses at a median follow-up of 24 months,whereas 20 (9%) patients were lost to follow-up at a median 12 months. In group 2, 20(11%) patients died of multiple causes at a

median follow-up of 12 months and 14 (8%)patients were lost at a mean follow-up of11 months. There were no statistically signif-icant differences (p.0.05) in the all-causemortality rates between group 1 (10.7%) andgroup 2 (11.1%).

DISCUSSION

Type II endoleak represents the most frequentform of endoleak after EVAR. Several treat-ment options are available for the manage-ment of type II endoleak. A few of these, forexample, transarterial chemical or coil embo-lization, as well as translumbar sac emboliza-tion, have been well described in the litera-ture.6–11 Laparoscopic or open ligation offeeding vessels has also been advocated as apotential option.12 However, the success ofthese techniques varies widely. Baum et al.10

compared transarterial coil embolization withtranslumbar embolization: transarterial treat-ment had an 80% failure rate, while 92% ofcases were treated successfully with translum-bar embolization. Timaran et al.21 had similarresults in catheter-based treatment of persis-tent endoleaks: a transfemoral approachachieved only a 38% success rate, although a71% success rate was noted with a translumbarapproach. Muthu et al.22 tried a branch vesselmanagement strategy consisting of routineintraoperative embolization of all patent mes-enteric arteries, but there were no significantdifferences in the incidence of type II endoleakrate between the pre-protocol group comparedwith the post-protocol group. Evidently, inferi-or mesenteric artery (IMA) embolization doesnot avoid type II endoleak, which can developin the setting of chronic IMA occlusion.

Most of the treatment techniques that areavailable for type II endoleak seldom solvethis problem once present; hence, we believethat the best strategy is prevention. Ourexperience indicates a 13% lower risk of typeII endoleak in patients who received intrasacthrombization during EVAR either with fibringlue alone or with combined inconel coils andfibrin glue compared to patients havingundergone standard EVAR alone.

In the thrombization technique, biomateri-als used for intrasac embolization are insertedbetween the main stent-graft and aneurysm

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wall as a means of forming a scaffold. Theaddition of a fibrin sealant accelerates andconsolidates clot formation into a concretion,resulting in a durable, long-lasting, sturdystabilization of the entire complex en bloc.Centripetal backflow inside aortic collateralbranches reduces the risk of peripheral micro-embolization during the procedure. In ourcohort, fibrin glue injections did not causeany allergic or anaphylactic reactions norwere there any intra- or perisac tissue reac-tions when using fibrin glue. The addition ofpreventive sac thrombization adds ,US$630to the total cost of the EVAR procedure, whichis far less that the time and resources neededto follow type II endoleaks and treat those thatpersist.

In addition to documenting the type IIendoleak risk reduction potential of ourpreventive strategy, Cox proportional hazardmodeling identified only gender and obesityas factors associated with type II endoleak.Indeed, more than a third (36%) of the womenin group 1 developed a type II endoleak and11% in group 2. However, identification ofpositive predictive factors for type II endoleakwas not an endpoint of this study. Theprognostic role of gender and obesity (aswell as other variables) might be consideredin future studies.

Limitations

This study was limited because it wasobservational and nonrandomized; nonethe-less, the results were positive. The EVARprocedures without thrombization were allperformed before 2004, and although somestudies23,24 have indicated that the moreexperienced the operator or center the betterthe patient outcome, Shackley et al.23 docu-mented an unchanged endoleak rate basedon patient volume in their review. Further, allinterventions in the study period (1999–2008)were performed by the same primary surgeontogether with the same interventional cardi-ologist; both had passed the EVAR learningcurve before the 1999 start date.

The EVAR procedures with thrombizationactually consisted of 2 groups of patients:those who received only fibrin glue and thosewho received fibrin glue and coils. Therefore,

it is unclear which technique resulted inendoleak reduction.

Conclusion

The natural history of a type II endoleakleads us to consider that prevention is thebest strategy to manage this complication.Intrasac thrombization performed duringEVAR, with coil insertion followed by fibringlue injection, seems to be a quick, money-saving, and safe technique, regardless of thestent-graft used. It is effective in demonstrat-ing a significant reduction of type II endoleakincidence without complications, thereby in-creasing EVAR success and reducing the needof a close follow-up.

REFERENCES

1. Jones JE, Atkins MD, Brewster DC, et al.Persistent type 2 endoleak after endovascularrepair of abdominal aortic aneurysm is associ-ated with adverse late outcomes. J Vasc Surg.2007;46:1–8.

2. Gelfand DV, White GD, Wilson SE. Clinicalsignificance of type II endoleak after endovas-cular repair of abdominal aortic aneurysm. AnnVasc Surg. 2006;20:69–74.

3. Veith FJ, Baum RA, Ohki T, et al. Nature andsignificance of endoleaks and endotension: sum-mary of opinions expressed at an internationalconference. J Vasc Surg. 2002;35:1029–1038.

4. van Marrewijk C, Buth J, Harris PL, et al.Significance of endoleaks after endovascularrepair of abdominal aortic aneurysm: theEUROSTAR experience. J Vasc Surg. 2002;35:461–473.

5. Faries PL, Briggs VL, Bernheim J, et al. In-creased recognition of type II endoleaks usinga modified intraoperative angiographic proto-col: implications for intermittent endoleak andaneurysm expansion. Ann Vasc Surg. 2003;17:608–614.

6. Laheij RJ, Buth J, Harris PL, et al. Need forsecondary interventions after endovascularrepair of abdominal aortic aneurysms. Inter-mediate-term follow-up results of a Europeancollaborative registry (EUROSTAR). Br J Surg.2000;87:1666–1673.

7. Gould DA, McWilliams R, Edwards RD, et al.Aortic side branch embolization before endo-vascular aneurysm repair: incidence of type IIendoleak. J Vasc Interv Radiol. 2001;12:337–341.

J ENDOVASC THER2010;17:517–524

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8. Kasirajan K, Matteson B, Marek JM, et al.Technique and results of transfemoral super-selective coil embolization of type II lumbarendoleak. J Vasc Surg. 2003;38:61–66.

9. Baum RA, Cope C, Fairman RM, et al. Trans-lumbar embolization of type 2 endoleaks afterendovascular repair of abdominal aortic aneu-rysms. J Vasc Interv Radiol. 2001;12:111–116.

10. Baum RA, Carpenter JP, Golden MA, et al.Treatment of type 2 endoleaks after endovas-cular repair of abdominal aortic aneurysms:comparison of transarterial and translumbartechniques. J Vasc Surg. 2002;35:23–29.

11. Mansueto G, Cenzi D, Scuro A, et al. Treatmentof type II endoleak with a transcatheter trans-caval approach: results at 1-year follow-up.J Vasc Surg. 2007;45:1120–1127.

12. Ho P, Law WL, Tung PH, et al. Laparoscopictransperitoneal clipping of the inferior mesen-teric artery for the management of type IIendoleak after endovascular repair of ananeurysm. Surg Endosc. 2004;18:870.

13. van Nes JG, Hendriks JM, Tseng LN, et al.Endoscopic aneurysm sac fenestration as atreatment option for growing aneurysms dueto type II endoleak or endotension. J EndovascTher. 2005;12:430–434.

14. Zanchetta M, Faresin F, Pedon L, et al. Fibrin glueaneurysm sac embolization at the time ofendografting. J Endovasc Ther. 2005;12:579–582.

15. Zanchetta M, Faresin F, Pedon L, et al. Intra-operative intrasac thrombin injection to pre-vent type II endoleak after endovascular ab-dominal aortic aneurysm repair. J EndovascTher. 2007;14:176–83.

16. Bush RL, Lin PH, Ronson RS. Colonic necrosissubsequent to catheter directed thrombinembolization of the inferior mesenteric artery

via the superior mesenteric artery: a complica-tion in the management of a type II endoleak.J Vasc Surg. 2001;34:1119–1122.

17. Chaikof EL, Blankensteijn JD, Harris PL, et al.Reporting standards for endovascular aorticaneurysm repair. J Vasc Surg. 2002;35:1048–1060.

18. Sierra DH. Fibrin sealant adhesive systems: areview of their chemistry, material propertiesand clinical application. J Biomaterial Appl.1993;7:309–352.

19. Clark RA. Fibrin glue for wound repair: factsand fancy. Thromb Haemost. 2003;90:1003–1006.

20. Radosevich M, Goubran HI, Burnouf T. Fibrinsealant: scientific rationale, production meth-ods, properties, and current clinical use. VoxSang. 1997;72:133–143.

21. Timaran CH, Ohki T, Rhee SJ, et al. predictinganeurysm enlargement in patients with persis-tent type II endoleaks. J Vasc Surg. 2004;39:1157–1162.

22. Muthu C, Maani J, Plank LD, et al. Strategies toreduce the rate of type II endoleaks: routineintraoperative embolization of the inferiormesenteric artery and thrombin injection intothe aneurysm sac. J Endovasc Ther. 2007;14:661–668.

23. Shackley P, Slack R, Booth A, et al. Is there apositive volume-outcome relationship in pe-ripheral vascular surgery? Results of a system-atic review. Eur J Vasc Endovasc Surg. 2000;20:326–335.

24. Killeen SD, Andrews EJ, Redmond HP, et al.Provider volume and outcomes for abdominalaortic aneurysm repair, carotid endarterecto-my, and lower extremity revascularizationprocedures. J Vasc Surg. 2007;45:615–626.

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