scientific session 9 abdominal aortic aneurysm: endoprosthesis

4
CONCLUSION: ApproKimately 60% of all patients presenting with rupture have infrarenal aneurysms. Based on aortic/iliacl femoral diameter and lengths, 80% of all infrarenal ruptured AAA could be candidates for stent grafts. Potential Application for Stent Grafts in Ruptured Abdominal Aortic Aneurysms. S. Padia, Johns Hopkins Hospital, Baltimore, MD, USA. A. Arepally L. Hofmann G. Roseborough M. Williams B. Perler Scientific Session 9 Abdominal Aneurysm: Endoprosthesis Saturday, March, 29, 2003 12:30 PM - 2:30 PM Moderator(s): Jeffrey Hull, MD Mahmood K. Razavi, MD 529 Abstract No. 82 Abstract No. 83 12:41PM Learning Curve EtTect and Procedure-Related & Late Outcomes ofEndovascular AAA Repair (EVAR). G.J. Becker, Miami Cardiac & Vascular Institute, Miami, FL, USA. M. F. Kovacs B. T. Katzen J.F. Benenati G. Zemel A. Powell, et al. PURPOSE: I) Identify factors influencing outcome of endovascular AAA repair (EVAR) by applying the SVS reporting standards (J Vasc Surg 2002;35(5): 1048-60 & 1061- 66) to a series analysis, 2) Exarnine "Iearning-curve" effect on EVAR procedure and outcomes. MATERIALS AND METHODS: Study group: 437 consecutive EVARs (mean AAA diameter of 5.75±1.lcm)from 3/94 to 81 02 in a not-for-profit tertiary CV center. Reports of office visits, procedures, imaging studies, lab values, computerized medical records, telephone followup, online Social Security Death Index were analyzed. Measures: Implant success, adverse events, procedure-related mortality, procedural efficiencies, LOS, and late survival. EVARs pre-FDA-approval of 2 devices (10/99, n=157, Gpl) were compared to those since (n=280, GplI). Statistical analysis was done with StatsDirect v.I.9.5; significance was set at p<.05. RESULTS: GpII v. Gpl EVARs were proportionately more female (11.4% v. 4.4%, p=.OI), similar in mean risk (1.45 v. 1.48, p=.08), renal, cardiac, and pulmonary risk, but older (75.9yrs v. 73.5, p=.007), had less aR time (171 v. 145 min, p<.OOO I), tluoro time (32 v. 27 min, p=.OOOI), and contrast dose (223 v. I62cc, p<.OOOl). Deployment success was 4201 437 (96.1 %); surgical conversions occurred in 7/437 (1.6%); 10/437 (2.3%) were aborted. Deployment-related complications (DRCs) increased with risk stratification (p=.026), as did all procedure-related complications (p=.OO 19). Gp II had fewer DRCs, severe systemic complications, and all procedure-related complications (p=.017, p=.02, and p=.0005 respectively), and fewer days in lCU (.62 v.. 28, p=.0006). Mean LOS was 2.35 for lowest and 5.11 d for highest-risk patients. Procedure-related mortality was 7/437 (1.6%), lower than predicted (2.3%- 7.2%). Actuarial survival was 67% (5yr) and 65% (7yr). Most of 70 late deaths were due to CV causes (n=26, including 3 post-EVAR AAA ruptures) or cancer (n=19). CONCLUSION: In this study, EVAR safety surpassed that in published reports of open repair. Institutional learning- curve effect was demonstrated for aR time, fluoro time, contrast dose, DRCs, severe systemic complications, all procedure-related complications, and LOS in the ICU. Late mortality was equivalent to that of open repair. 12:52PM CTA as the Sole Angiographic Modality Prior to AAA Endografting. BL Dolmatch, UT-Southwestem Medical Center, Dallas, TX, USA S. Josephs F. Rivera M. Jackson PURPOSE: To assess whether computerized tomographic angiography (CTA) without digital subtraction angiography (DSA) was sufficient for pre-op abdominal aortic aneurysm (AAA) and iliac aneurysm characterization and endoprosthesis sizing prior to endografting (EG). MATERIALS AND METHODS: We reviewed all patients with AAAs who had CTA with or without DSA over a 17 month period. CTA was performed on a Toshiba Aquillion 4 channel CT scanner with 3mm collimation and 1.5mm spacing, using a Vital Irnages Vitrea-2 workstation for multiplanar reformation and 3-D volume renderings. Patients who did not undergo EG were excluded as noted below. The EG group was divided into Abstract No. 81 Juxtarenal 74.5 6.8 33.3"10 83.3"/0 Infrarenal 68.4 ::fi 41.4% 93.1% 12:30PM PURPOSE: To find potential stent graft candidates based on CT criteria in the setting of a ruptured AAA. MATERIALS AND METHODS: A retrospective analysis was performed on a database in patients with the diagnosis of ruptures AAA over a 9 year period. Electronic medical records were reviewed for demographic data, type of aneurysms operative findings, length of stay, complications, and survival. Ali available CT scans for infrarenal andjuxtarenal aneursyms were reviewed. Standard stent graft measurements, including proximal neck diameters, length of proximal neck, diameters of common iliac arteries, length from renal artery to common iliac artery, diameter of femoral arteries and angulations of aortic neck were performed with an electronic caliper. Median diameters, lengths and percentile quantification of the measurements were performed. RESULTS: 49 patients (38 males, II females) presented with rupturep AAA. Distribution of aneurysms were 29 (59%) infrarenal, 12 (24%) juxtarenal and 8 (16%) suprarenal. Seventeen CT scans were evaluated for stent graft measurements. In patients with IR AAA, the proximal median diameter was 23.2mm (15mm-36.9mm) with 75% of aU diameters less than 25.3 mm. The right and left median iliac artery diameter was 12.5 mm (6.6-19.7) and 12.8mm (9.8- 17.2) respective1y with 75% of alJ iliac diameters below 14.2mm. Median 1ength of proximal infra renallength was 29. l (15-48 mm) with all patients having greater than 15mm length. Median diameter of right and left femora1 arteries were 11.4 (8-15.7mm) and 11.0 (6.5-14.7 mm) with 75% offemora1 arteries greater than 9.9mm. No significant angulation of the proximal or distallanding sites were noted. PTA median patency 105 days, p=0.008). Thrill at PE diSlal was predictive of outcome (p=0.039) and even more so when T and TSP combined were compared to PST and P combined (p=0.026). Similar but less pronounced effects were seen at PEnUd and PEplIl';m'J" CONCLUSION: The presence of a thrill or slightly pulsatile thrill at the distal (venous) end of a dialysis graft is the best predictor of outcome following percutaneous intervention. Physical findings should supplant pressures as an endpoint of dialysis access interventions, and serve as an essential component of quality assurance in such interventions. age Lenglh ol stay (days) SurvivaJ Complications

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CONCLUSION: ApproKimately 60% of all patients presentingwith rupture have infrarenal aneurysms. Based on aortic/iliaclfemoral diameter and lengths, 80% of all infrarenal rupturedAAA could be candidates for stent grafts.

Potential Application for Stent Grafts in RupturedAbdominal Aortic Aneurysms.S. Padia, Johns Hopkins Hospital, Baltimore, MD, USA.A. Arepally • L. Hofmann • G. Roseborough • M. Williams• B. Perler

Scientific Session 9Abdominal Aorłic Aneurysm:Endoprosthesis

Saturday, March, 29, 200312:30 PM - 2:30 PMModerator(s): Jeffrey Hull, MD

Mahmood K. Razavi, MD

529

Abstract No. 82

Abstract No. 83

12:41PM

Learning Curve EtTect and Procedure-Related & LateOutcomes ofEndovascular AAA Repair (EVAR).G.J. Becker, Miami Cardiac & Vascular Institute, Miami,FL, USA. M. F. Kovacs • B. T. Katzen • J.F. Benenati • G.Zemel • A. Powell, et al.

PURPOSE: I) Identify factors influencing outcome ofendovascular AAA repair (EVAR) by applying the SVSreporting standards (J Vasc Surg 2002;35(5): 1048-60 & 1061­66) to a series analysis, 2) Exarnine "Iearning-curve" effect onEVAR procedure and outcomes.

MATERIALS AND METHODS: Study group: 437 consecutiveEVARs (mean AAA diameter of 5.75±1.lcm) from 3/94 to 8102 in a not-for-profit tertiary CV center. Reports of officevisits, procedures, imaging studies, lab values, computerizedmedical records, telephone followup, online Social SecurityDeath Index were analyzed. Measures: Implant success,adverse events, procedure-related mortality, proceduralefficiencies, LOS, and late survival. EVARs pre-FDA-approvalof 2 devices (10/99, n=157, Gpl) were compared to thosesince (n=280, GplI). Statistical analysis was done withStatsDirect v.I.9.5; significance was set at p<.05.

RESULTS: GpII v. Gpl EVARs were proportionately morefemale (11.4% v. 4.4%, p=.OI), similar in mean risk (1.45 v.1.48, p=.08), renal, cardiac, and pulmonary risk, but older(75.9yrs v. 73.5, p=.007), had less aR time (171 v. 145 min,p<.OOO I), tluoro time (32 v. 27 min, p=.OOOI), and contrastdose (223 v. I62cc, p<.OOOl). Deployment success was 4201437 (96.1 %); surgical conversions occurred in 7/437 (1.6%);10/437 (2.3%) were aborted. Deployment-relatedcomplications (DRCs) increased with risk stratification(p=.026), as did all procedure-related complications(p=.OO 19). Gp II had fewer DRCs, severe systemiccomplications, and all procedure-related complications(p=.017, p=.02, and p=.0005 respectively), and fewer daysin lCU (.62 v..28, p=.0006). Mean LOS was 2.35 for lowestand 5.11 d for highest-risk patients. Procedure-relatedmortality was 7/437 (1.6%), lower than predicted (2.3%­7.2%). Actuarial survival was 67% (5yr) and 65% (7yr). Mostof 70 late deaths were due to CV causes (n=26, including 3post-EVAR AAA ruptures) or cancer (n=19).

CONCLUSION: In this study, EVAR safety surpassed thatin published reports of open repair. Institutional learning­curve effect was demonstrated for aR time, fluoro time,contrast dose, DRCs, severe systemic complications, allprocedure-related complications, and LOS in the ICU. Latemortality was equivalent to that of open repair.

12:52PM

CTA as the Sole Angiographic Modality Prior to AAAEndografting.BL Dolmatch, UT-Southwestem Medical Center, Dallas,TX, USA • S. Josephs • F. Rivera • M. Jackson

PURPOSE: To assess whether computerized tomographicangiography (CTA) without digital subtraction angiography(DSA) was sufficient for pre-op abdominal aortic aneurysm(AAA) and iliac aneurysm characterization and endoprosthesissizing prior to endografting (EG).

MATERIALS AND METHODS: We reviewed all patients withAAAs who had CTA with or without DSA over a 17 monthperiod. CTA was performed on a Toshiba Aquillion 4 channelCT scanner with 3mm collimation and 1.5mm spacing, usinga Vital Irnages Vitrea-2 workstation for multiplanar reformationand 3-D volume renderings. Patients who did not undergo EGwere excluded as noted below. The EG group was divided into

Abstract No. 81

Juxtarenal74.56.833.3"1083.3"/0

Infrarenal68.4::fi41.4%93.1%

12:30PM

PURPOSE: To find potential stent graft candidates based onCT criteria in the setting of a ruptured AAA.

MATERIALS AND METHODS: A retrospective analysis wasperformed on a database in patients with the diagnosis ofruptures AAA over a 9 year period. Electronic medical recordswere reviewed for demographic data, type of aneurysmsoperative findings, length of stay, complications, and survival.Ali available CT scans for infrarenal andjuxtarenal aneursymswere reviewed. Standard stent graft measurements, includingproximal neck diameters, length of proximal neck, diametersof common iliac arteries, length from renal artery to commoniliac artery, diameter of femoral arteries and angulations ofaortic neck were performed with an electronic caliper. Mediandiameters, lengths and percentile quantification of themeasurements were performed.

RESULTS: 49 patients (38 males, II females) presented withrupturep AAA. Distribution of aneurysms were 29 (59%)infrarenal, 12 (24%) juxtarenal and 8 (16%) suprarenal.Seventeen CT scans were evaluated for stent graftmeasurements. In patients with IR AAA, the proximal mediandiameter was 23.2mm (15mm-36.9mm) with 75% of aUdiameters less than 25.3 mm. The right and left median iliacartery diameter was 12.5 mm (6.6-19.7) and 12.8mm (9.8­17.2) respective1y with 75% of alJ iliac diameters below14.2mm. Median 1ength of proximal infra renallength was29. l (15-48 mm) with all patients having greater than 15mmlength. Median diameter of right and left femora1 arteries were11.4 (8-15.7mm) and 11.0 (6.5-14.7 mm) with 75% offemora1arteries greater than 9.9mm. No significant angulation of theproximal or distallanding sites were noted.

PTA median patency 105 days, p=0.008). Thrill at PEdiSlal

waspredictive of outcome (p=0.039) and even more so when Tand TSP combined were compared to PST and P combined(p=0.026). Similar but less pronounced effects were seen at

PEnUd and PEplIl';m'J"

CONCLUSION: The presence of a thrill or slightly pulsatilethrill at the dis tal (venous) end of a dialysis graft is the bestpredictor of outcome following percutaneous intervention.Physical findings should supplant pressures as an endpointof dialysis access interventions, and serve as an essentialcomponent of quality assurance in such interventions.

ageLenglh ol stay (days)SurvivaJComplications

patients with pre-op CTA vs those with CTA + DSA. Bothgroups were reviewed for operative and post-op outcomesincluding early and late endoleaks, unanticipated intra-opfindings, and adjunctive procedures in the OR.

RESULTS: Of 55 patients, 21 underwent EG, 29 wereexcluded, and 5 patients were awaiting endografting. Reasonsfor exclusion included AAAs that were too smali (4), AAAswith proximal neck too dilated (17), too short (3), or tooangulated (3), juxtarenal or higher AAA (5), and iliac arteryclisqualifiers (3). Of the 21 EG patients, 12 had CTA as thesole pre-op angiogram while 9 had pre-op CTA + DSA. Nointra-op difficulties were encountered, there were noconversions to open surgery, and no unanticpated proceduresin either group. l early endoleak in the CTA-only group and Ilate endoleak in the CTA + DSA group were seen. CTApredicted the need for l renal stent, 1 IMA emboJization, Iiliac angioplasty, and embolization of 2 arteries; l accessoryrenal and one hypogastric.

CONCLUSION: CTA, alone, can be used to select patientssuitable for EG, accurately determine the type and size ofendoprosthesis, and detect arterial findings that may needpre-op DSA and/or intervention.

MATERIALS AND METHODS: Sample size calculation for aretrospective case-control study yielded 35 cases with analpha of 0.5, power of 0.8 and a 95% DCT vs. 70% CTAendoleak detection rate. 42 cases and 51 contemporaneouscontrols were read by two radiologists blinded to the clinicalread. Presence ofendoleak on CTA and/or DCT was recordedfor each case and contro!. Time to DCT was recorded.McNemar's test was used to evaluate differences in proportionof endoleak between CTA and DCT for each reader. Kappastatistic was used to evaluate interóbserver variability.

Endoleak Detection: CT Angiography Versus DelayedCT.M.e. Famer, University ojPennsylvania Medieal Center,Philadelphia, PA, USA. E. Jnsko • A. lati • R. Fainnan • l.Carpenter • S. W Stavropoulos

PURPOSE: Surveillance for endoleak after endovascular repairof AAA is usually performed by a combination of CTangiography (CTA) and delayed CT (DCT) imaging. It hasbeen proposed that DCT is more sensitive than CTA for thedetection of endoleaks. The purpose of this study is toevaluate the clifference in endoleak detection by CTA versusDCT.

1:14PM Abstract No. 84

1:25PM Abstract No. 85

RESULTS: The proportion of endoleaks detected by CTAwas 88% and 81 % agreement respectively for each radiologist.The proportion of endoleaks detected by DCT was 91 % and93% agreement respectiveły. These proportions are notsignificantly different between CTA and DCT or betweenreaders (p=NS). Four cases were only detected on the CTA,while 3 cases were only seen on the DCT. The interobserveragreement for both CTA (92%, kappa 0.83) and DCT (89%,kappa 0.76) was good. Median DCT scan time was 2 rninutes(range 1-8 minutes) after CTA acquisition.

CONCLUSION: There was no difference in endoleak detectionrates by DCT when compared to CTA by two blinded readers.Because some endoleaks were seen on onły one of the series,both DCT and CTA should be performed. The best protocolfor endoleak detection by CT remains to be determined byprospective studies evaluating different delay times.

Embolization of Type-ll Endoleaks: Follow-Up Imagingand lnitial ResuJts.Ws. Rilling, Medieal College oJWiseonsin, Milwaukee, WI,USA. R.A. Hieb • M.R. Crain • l.B. Towne • R.A. Cambria• G.R. Seabrook, et al.

PURPOSE: To review the imaging finclings and initial resultsof various embolization techniques for treatment of type-IIendoleaks following endovascular repair of abdomlnal aorticaneurysm (AAA).

MATERlALS AND METHODS: Over a three-year period, atotal of 97 endovascular AAA procedures were performed.Eleven secondary interventions for type-1I endoleaks wereperformed on nine patients in this series. Indications forembolization of type-II endoleak were either aneurysmexpansion on follow-up CT or enlarging type-II endoleak. Alipatients except one were folIowed with helical CT scanningto assess for recurrent or residual endoleak and to folio waneurysm size. One patient was folIowed with color Dopplerultrasound due to chronic renal insufficiency.

RESULTS: Ten of 11 procedures were initially technicallysuccessful with access obtained to the endoleak andembolization performed. The endoleak was approached via

530

Migration ofEndovascular Devices: Improved DefinitionTo Aid with Device Complication Evaluation.A.M. Ture, Cleveland Clinie Foundation, Cleveland, OH,USA • R.K. Greenberg • S. Haulon • S.P Lyden • S.Srivastava • T.P Sarae, et al.

PURPOSE: Endograft migration, as defined by the SVS/AAVSstandards is a conglomerate of clinical and radiographicobservations. The intention of this paper is to further delineateclinically identified migrations to better understand problemswith device fixation.

MATERlALS AND METHODS: Consecutive patients treatedwith endovascular prostheses were reviewed. Patients thatunderwent secondary interventions for presumed migrationwere identified. Radiographic studies and clinical reports werereviewed. Endograft rnigration with respect to the arterial treewas assessed by CT analysis, wbile component migrationwas determined by review of the KUBs. Proximal migrationwas defined as movement of the prosthesis >=lOmrn withrespect to the origin of the superior mesenteric artery andlowest renal artery. Distal rnigration was present if the devicemoved proximally or distally >=lOmrn with respect to theaortic bifurcation or hypogastric artery origin. Componentseparation was determined by assessing marker movementnoted on the fiat plated radiographs.

RESULTS: Ofthe 703 patients treated over a six-year period,24 patients underwent secondary procedures for presumedinigration. Mean follow-up was 12.1 months. Detectedmigrations were noted in the four devices Iisted in the tablehelowo Two devices, the Excluder (n=25) and the Endologix(n=2) had no detectable migration. Four patients wereidentified as having rnigrations based on clinical procedureshad no racliographic evidence of migration.

AneuRx Aneure Talent ZenithNumber ol Implanls 270 63 33 333Proximal Migration 7(2.6%) 1 (1.5%) 1 (2.6%) 1(0.3%)Distal Migration 3(1.1%) 1 (1.5%) O 2(0.6%)Oisunion and Componenl Separation 3 (1.1%) O O 3(0.9%)

CONCLUSJON: The conglomerate definition of rnigrationhas the potential to confuse issues with endograft fixation andother variables. Migration should be defmed as movement ofthe prosthesis with respect to the arterial tree at a specificfixation point, or relative movement between de vicecomponents.

1:36PM Abstract No. 86

Transcaval Approach for Translumbar EndoleakEmbolization.S. W Stavropoulos, University ojPennsylvania,Philadelphia, PA, USA • R.A. Baum • l.P Carpenter • R.M.Fairman

translumbar access in five procedures, perigraft access in threecases and access via collateraJ arterial pathways in three cases.Embolization materials used inc1uded microcoils alone in fourcases, nBCA in five cases and a combination of microcoils andthrombin in two cases. Despite substantial artifact from boththe microcoils and the ethiodollnBCA mixture, it was possibleto assess for recurrent ar residual endoleak in aJI cases. At amean of 11.3 months follow-up (ranges two weeks to 41months) there was recurrent endoleak identified in one patientfollowing the latest embolization procedure. One patient hada recurrent endoleak at one month requiring a seondembolization procedure with no endoleak subsequentlyidentified on 8 month follow-up. Overall aneurysm sizedecreased in five patients and was stable in four patients.

CONCLUSION: Recurrent or residual type-II endoleaks aredetectable following microcoil or nBCA embolization.Aneurysm size remained stable or decreased followingembolization in all patients.

PURPOSE: When embolization ofa collateral (type 2) endoleakfollowing stent graft repair of AAA is indicated, directendoleak sac embolization through a translumbar approach isoften the procedure of choice. Because of the position of theendoleak, interposed bowel ar othel' structures, it is sometimesnecessary to use a right-sided approach and traverse theinferior vena cava (IVC) when accessing the endoleak sac. Thepurpose of this study was to evaluate the safety and feasibilityof a transcaval approach when treating type 2 endoleaks.

MATERIALS AND METHODS: Twelve type 2 endoleaks innine patients were treated with transcaval translumbarembolization during a 34 month period. Technical successwas defined as ability to access the sac and place coils using atranscaval approach. lnitial embolization failure was definedas a persistent endoleak on the 30 day follow up computedtomography angiography (CTA). Delayed failure was definedas recurrent endoleak seen on any subsequent CTA after anendoleak free CTA. An institutional review board (IRB)exemption was granted for this retrospective study.

RESULTS: Access to the endoleak and subsequentembolization using a transcaval approach was technicallysuccessful in all twelve procedures. Onecomplication occurredwhen a coil became lodged between the aneurysm sac and theIVC, with the majority of the coil resting in the IVC. This coilwas removed from the IVC using a snare via the same accessthat was used for the embolization procedure. The endoleakwas then re-accessed and additional coils were successfullyplaced. No clinically significant hemorrhage occurred in anyof these patients. 30 day CTA revealed persistent endoleakafter 22.2% (2/9) of initial procedures, requiring repeatembolization. Repeat translumbar embolization, also using atranscaval approach was successful for these two initialfailures. The delayed endoleak rate was 11.1 % (1/9), with amean follow up of 14.1 months (range 3-34 months).

CONCLUSION: Embolizing type 2 endoleaks using a righttranslumbar approach through the rvc is feasible and safe.Long-term follow up with more patients is necessary to fullyevaluate the durability of this procedure.

S31

Abstract No. 89

Abstract No. 88

2:09PM

AnimaI Evaluation of a Newly Developed Low ProfileDevice for Aortic Exc1usion.V. Crisostomo, Centro de Cirugia de Minima lnvasion,Caceres, Caceres, Spain • E.P Strecker • F Sun • C. Calles• J. Us6n • M. Maynar

PURPOSE: To develop a new low profile device for AAAexc1usion and to evaluate its deployment characteristics andthe protection it confers from rupture in an animaI model.

MATERIALS AND METHODS: Device: The test deviceconsists of three parts that are introduced sequentially. First,a self expanding double coil stent, made of three circularframes, two of which are filled with a Dacron mesh, isintroduced through a 9 F sheath and placed at the AAA neckoThen two iliac selfexpanding stent-grafts are introduced fromeach femora! artery through the Dacron mesh to exc1ude theaneurysm. Deployment tests: Deployment and handling'characteristics were assessed in 5 dogs that had an AAAcreated by overexpansion of a Palmaz stent. Effectivenesstests: AAAs were surgically created in ten pigs by suturing aperitoneal patch to the anterior aortic wall. Group A (n=5)did not receive therapy and were used as controls. Group B(n=5) received the test device through a percutaneous approach

Aneurysm Creation with Pressure AugmentedFractionated Elastase Infusion in Swine.A. Konya, University ojTexas M.D. Anderson CancerCenter, Houston, TX, USA .D.C. Mado!!. K.C. Wright

PURPOSE: In a former study, continuous aortic elastaseinfusion under moderate pressure resulted in inconsistent muraJelastin degradation and subsequent aneurysm formation innormal pigs. Therefore, the aim of the present study was toincrease the consistency of aneurysm formation byfractionating the infusion of elastase.

MATERIALS AND METHODS: Four 16-mm/4-cm and three14-mm/4-cm balloons with 1 or 2 smali side-holes were usedto infuse elastase (porcine type 1) in normal swine infrarenalaortas (10.5-12.0 mm in diameters, median 11.5 mm). Infusionswere performed in 5-min intervals at 2-4 atm until atotal of100 mg of protein was administered. Four additional aortaswere treated with saline administered the same way (one witha 16-mm and three with 14-mm balloons). The animals werefolIowed for up to 3 weeks.

RESULTS: Fractionated administration doubled the infusiontime when compared to continuous infusion. Three aneurysmswith 100-110% increase in maximum aortic diameter wereobserved at 3 weeks; alllumbar arteries covered by the balloonremained patent. Three aneurysms with 60-120% aorticdilatation post-procedure ruptured within 24 hours; two werecreated using 16-mm balloons. One aneurysm with a 65%increase in maximum aortic diameter at 1 week almostcompletely disappeared by 3 weeks. Saline infusion resultedin moderate diffuse narrowing (n=3; 14-mm baJloons) andacute aortic perforation (n=l; 16-mm balIoon).

CONCLUSION: The use of fractionated elastase infusionincreased the efficacy of aneurysm creation. However, theinfusate (elastase and saline) ex.ited the balloon as a high velocityjet resulting in aortic wall perforation in some cases. Whenthis jet-phenomenon was coupled with significant over­dilatation (16-mm balIoon), it proved overly detrimental. Thismodel with use of 14-mm balioons seems suitable for testingendovascular aneurysm treatment modalities immediatelyfollowing aneurysm creation.

1:58PM

Abstract No. 871:47PM

CONCLUSION: TEPS is teehnically feasible after IVUS­guided portal vein access.

Transvenous Extrahepatic Portacaval Shunt (TEPS) ­Feasibility Study in a Swine Model.M.J. Wallace, M.D. Anderson CallCer Center, Houston, TX,USA. K. Ahrar • C. Stephens • K.c. Wright

PURPOSE: The purpose of this investigation was to evaluate,in the swine model, the feasibility of IVUS guided access oflhe extrahepatic segment of the main portal vein to create atransvenous extrahepatic portacaval shunt (TEPS) as an easierand more durable altemative to TIPS.

remain living. Thirteen patients have died, and three patentshave received liver transplants. The DlPS remained patentwith slabie PSG by venography in 31 of the 35 (89%) patients,either currently, or until death or liver transplantation. Therehas been one early occluison at 10 monthsand 3 patients withelevated gradients on follow-up at 11, 11, and 17 monthsrespectively. Th~se four patients were treated by placementof stent-grafts extending further into the portal vein (n=3) orIVC (n=2) for 100% secondary patency. Additionally, 2patients have developed IVC narrowings cephalad to the DlPS,attributed to focal nodular hyperplasia, requiring IVC stentplacement.

CONCLUSION: The rvus guided DlPS procedure allowssafe placement of a stent-graft directly between the IVC andportal vein and exhibits increased primary patency over theconventional TIPS procedure.

MATERlALS AND METHODS: Portal vein (PV) access fromthe inferior vena cava (IVC) to the main portal vein (MPV)was performed in 8 pigs under IVUS guidance, and either aprototype stent graft or Wallgraft was used to create theshunt. IVUS demonstrated the MPV to be in direct contactwith the IVC in all animals. A mean of 1.75 needle passeswere required to enter the PV. lmmediate postproeedureeomputed tomography (CT) of the abdomen was obtained toidentify and quantify the presence ofhemoperitoneum. Shuntvenography was perforrned at two weeks and folIowed bynecropsy.

RESULTS: PV access and TEPS creation were successful inall 8 animals. Contrast extravasation, due to inadequatecoverage of the portacaval tract, was identified during 4procedures and addressed by the placement of additionaldevices in 3 cases and prolonged balloon inflation in the fourthcase. The shunt was created with a prototype stent in sixanimals and Wallgrafts in two. er exarnination of the abdomendemonstrated smali amounts of hemoperitoneum in 5 animalsand moderate to large amounts in three. Two animals did notreach the 2 week follow-up study. One animal was sacrificedon the day of the procedure due to intraperitoneal hemorrhageand the second animaI died 10 days after TEPS from bowelnecrosis relating to intussuception. Shunts were occluded orseverely stenotie by venography and necropsy in the remainingsix anirnals.

Abstract No. 913:16PM

3:00 PM Abstract No. 90

lVUS Guided DIPS Procedure: Midtenn Followup.B.D. Petersen, Dotter lnterven.tionallnstitute. Portland, OR,USA

Scienti"ric Session 10Percutaneous Portosystemic Shunt:New Devicesrrechniques

FEATURED ABSTRACT

Commcntator: Timothy P. MIII'phy, MD

Saturday, March, 29, 20033:00 PM - 4:30 PMModerator(s): Ernest 1. Ring, MD

to both femoral arteries. Animals were foJlowed up usingultrasonography and angiography at one month afterdeployment.

RESULTS: Deployment tests: Ali aneurysms wereimmediately excluded from the circulation, without any minoror major complications related to the technique. Pathologicstudy showed the interspace between the membranes to befiJled with thrombotic material that ensured aneurysmalexclusion. Effectiveness tests: Ali the animals in group A diedof aneurysmaI rupture within 2-8 days of AAA creation.Deployment was successful in aJl group B anjmals, and lheaneurysms were excluded at completion angiography. Onemonth foJlow-up showed graft occlusion in one pig, evidencedboth by Doppler sonography and angiography. DSAdemonstrated a type l endoleak in one pig, but ultrasonographyfailed to detect it. The remaining pigs showed grafts to bepatent and functional by both diagnostic tests, with no evidenceof graft thrombosis or leakage at one month foJlow up. NoAAA rupture occurred during follow up.

CONCLUSION: This new low profile device can be used toexclude AAA in the experimental setting. The device can bedeployed percutaneously and is effective in protecting fromAAA rupture in a model of spontaneously rupturing aorticaneurysm.

PURPOSE: To evaluate the safety and patency of directportacaval shunts (DlPS)created by placement of stent-graftsfrom the inferior vena cava (IVC) to the portal vein usingintravascular u1trasound (IVUS) guidance.

MATERIALS AND METHODS: The DlPS procedure wasperforrned in 35 male patients, ages 43 t075, mean 54 years,for the indication of asci tes(n=34)and/of bleeding (n=8) duelo hepatic cirrhosis. Childs-Pugh score was from 6 to 13,mean 9.3. IVUS transducers were positioned in the IVC froma transfemoral route to guide the puncture from the IVC to theportal vein which was perforrned from a transjugular approachwith a modified Rosch Uchida liver access set. Two types ofIVUS transducers were used. The shunts were completedwith the use of single (n= 13) ar overlapping (n=22) PTFEcovered Palmaz stent-grafts, deployed at 8 mm diameter.Patienls were folIowed c1inically and with ultrasound andvenography, to establish patency rates.

RESULTS: Ali DlPS were created successfully. Portosystemicgrailients (PSG) werereduced from 16 to 38 mmHg (mean=24)pre DIPS, to 7 to 14 mm Hg, (mean=lO) post DIPS. Twoextrahepatic portal vein punctures occurred, with one patientrequiring a blood transusion post procedure. No othersignificant complications occurred. Follow-up has been from

S32 2 days to 28 months, mean 11 months. Nineteen patients