Technical Parameters Inł1uencingOutcome and Relapsesin Varicocele Scleroembolization: Considerations on3300 pts.M. Morucci, San Camillo Hosp., Rome, !taty. G. La Pera •P Agresti • S. Pieri. G. Fiocca • L. de Medici

PURPOSE: Varieocele is a frequent benign eondition,seriously affeeting fertility. Traditional open surgiealtreatments have a high relapse rate, with higher financialand biologie costs, than endovascular percutaneousscleroembolization (PSE). Purpose of this study is to evaluatehow some technical aspects of PSE procedure can affecttechnical sueeess, clinical outcome and relapses.

MATERIALS AND METHODS: Between Sept 1987 andSept 2002 more than 3300 pts underwent internal spermaticveins retrograde phlebography with superseleetivescleroembolization, mostly by transbraehial pereutaneous

Coil Embolotherapy or Pulmonary ArteriovenousMalCormations: Efficacy oC Platinum Versus StainlessSteel.V. Prasad, University o/Toronto, Toronto, ON, Canada •R.P Chan. M.E. Faughnan

PURPOSE: To eompare the results of transeatheterembolotherapy (TCE) of pulmonary arteriovenousmalformations (PAVMs) using platinum versus stainless steelcoils. Both embolie agents are used in the treatment of PAVMs,however, to the best of our knowledge, there has been nocomparison of their effieaey.

MATERIALS AND METHODS: From a.database of 78eonsecutive patients with PAVMs treated by TCE betweenMay 1992 and September200l, 54 patients with 306 PAVMswere se1ected for retrospective evaluation. Exclusion eriteriawere PAVMs with no or less than 12 month follow-upcomputed tomography (CT) sean of the thorax (15 patients),TCE with a mixture of embolic materials (8 patients), andrepeat TCE for prior treatment failures (1 patient with 2PAVMs and 22 other PAVMs). Data sources included thefilms and medical reeords ofthe patients. Suecessful treatmentwas defined as complete resolution of the aneurysm sac anddraining vein on foJlow-up CT (all patients) and/or absence ofcontrast flow through the PAVM on pulmonary angiography(27 patients). Fisher's exaet test was used to eompare theproportion of suecess between the groups.

RESULTS: Of 48 patients with 267 PAVMs embolized withstainless steel coils, 249 PAVMs (93.3%; 95% confideneeinterval: 89.6,95.7%) were successfully occluded (meanfollow-up 3.1 years). Of 17 patients with 39 PAVMsembolized with płatinum eoils, 35 PAVMs (89.7%; 95%eonfidence interval: 76.4,95.9%) were suceessfulIy occluded(mean follow-up 2.1 years). The rate of suceessful occlusionwith platinum eoils was not signifieantly different from thatfor stainless steel (p=0.5). Potentially serious complicationsincluded coil reflux (3), PAVM perforation (2), transientischemic attack (2) and systemic embolization of a coił (1) inthe stainless steel group, and PAVM perforation (2) and coilreflux (1) in the platinum group. There were no long-termsequelae.

CONCLUSlON: Both stainless steel and platinum coilsdemonstrate a high rate of sueeessful occlusion. Our resultsindicate no statistically significant difference in proportion ofocclusion between the materials. A limitation is the relativelysmall number of PAVMs in the platinum group.

Scientific Session 4Gllnterventions

Sll

Abstract No. 31

Friday, March 28, 200310:00 AM - 12:00 PMModerator(s): Aravind Arepally, MD

F1~A·IUmI>ABSTRACT

COlJllJlclltalor: "Iichacl C. 8nlllllu. MI>

10:00AM

access (97%) under local anesthesia. Standard DSA andangiographic eatheters were used. 305213300 (93%) underwentspermatie veins sclerosing therapy alone (athossisclerol 2%or tetra-deeyl-sulphate 2 %); 250/3300 (7.5%) had alsoembolization by coils. 938/3300 (28.4%) pts had bilateraItreatrnent, either for bilateral varicocele or bilateral incontinence.AlI pts had previously underwent testieular eeography witheco (eolor) doppler (ECD) evaluation. ECD follow-up hasbeen performed at I, 6 , 12 an 24 mo (respectively on 97%,84%,61 % and 43% of the initiał pts population).

RESULTS: An overall96% immediate teehnieal suceess wasobtained, with 11 % relapses at 12 mo. (6% in last 3 yrs). Astrong semen quality improvement was also obtained.Significant differences in results have been eneountered takinginto consideration different technical options introduced during15 yrs. Major differences in outcome, relapse rate and fertilityparameters were found to be mostJy related to: l) the leveI ofsclerosis; 2) the sclerosing agent used; 3) bilateraI PSEtreatment. Moreover other technical parameters seem to betaken into eonsideration for influeneing the immediate andlong-term outcome.

CONCLUSlON: PSE plays an important and inereasing rolein the treatrnent of varieocele. In our opinic::m, it eould beconsidered the treatment of choice, aecording to its very highinunediate teehnical suceess, the low relapse rate and its veryłow financial and bioIogical costs. Different technieaI optionseoułd be taken into eonsideration to improve results.

Specialty Trends in Gastrointestinal Access Services:An Analysis oC Medicare UtiJization Data.R. Duszak, Jr., The Reading Hospital & Medical Center;Reading, PA, USA. M.R. Mcibry

PURPOSE: To evaIuate n-ational trends in enteral aeeessservices with respect to provider speeialty.

MATERIALS AND METHODS: The most recent 4-yearperiod ofavailable Medicare data (1997-2000) was.reviewed,summarized, and analyzed for trends in gastrointestina1 aeeessserviees. CPT codes for gastrostomy lUbe placement (43246,43653, 43750, 43830, 43831, 43832) and fueding tubemaintenance services (43760, 43761) were selected as markersof aU enteral aceess services. Their frequeney of utiłization

was analyzed with respect lo physician provider speeialty.

RESULTS: For aU sampled enterał aceess procedures, thetotaI annuaI number of serviees to Medieare benefieiariesincreased from 279,509 to 283,353 (+1.4%) during the4-year period. These were most oflen performed bygastroenterologists (48.6%), surgeons (25.1 %), radiologists(7:3%), and others (18.9%). Over this period, total proeeduralvolumes by gastroenterologists, surgeons and other non­radiologists ehanged by +6.9%, -4.9% and -10.2%,respectively. In contrast, total proeedures by radiologistsincreased 29.6% (15,989 to 20,722). For new gastrostomy

Abstract No. 29

Abstract No. 30

8:58AM

9:09AM

CONCLUSION: The course of the inferior epigasł.lic arterywas 0.5 to 1.5 vertebraI body widths from midline in over95% of cases. Choosing an access site guided by theselandmarks may minimize the potential for vessel injury duringpercutaneous gastric procedures.

RESULTS: 50 epigasuic arteries in 25 patients were examined.The mean distance of the IEAs from the midline was 4.15 cm,with a range of2.25-6.23cm (SD=1.09cm). The mean widthof the LI vertebral body was 4.l5cm, with a range of 3.45­5.00cm (SD=.44cm). The mean distance of the IEAs from themidline normalized the vertebral body width (VBW) was.99VBW, with a range of .57-1.61VBW (SD=.25VBW). In48/50 (96%) cases, the course of the IEA was between 0.5and 1.5 VBW from the midline.

access, radiologists sawa 46.9% increase in volume (4,940 to7,259). Gastrostomy service volume by gastroenterologists,surgeons, and all others changed by +7.9%, -5.0%, and -21.5%,respectively. For feeding tube maintenance services, radiologistsalso saw the largest increase in volume (+21.8%, from 11,049to 13,463). Maintenance services by gastroenterologists,surgeons and all others (notably emergency physicians andphysician extenders) changed by +3.1 %, -4.7%, and +7.9%,respectively.

CONCLUSION: Although the volume of gastrointestinalaccess services provided to Medicare beneficiaries nationallyhas remained relatively fiat, radiologists have experienced amarked increase in proceduraI volume, particularly with respectto new gastrostomy procedures (+47%). This increase islargely at the expense of surgeons and other non­gastroenterologists. Radiologists, however, still provide onlya relatively smali portion (7%) of all gastrointestinal accessservices nationwide. The potential for enteral access servicegrowth by radiologists is thus very high.

Avoiding Injury to the Inferior Epigastric Artery duringPercutaneous Gastrostomy Via F1uoroscopic Landmarks.A V. Rao, Brigham and Women sHospital, Boston, MA, USA• R. G. 5hieman

PURPOSE: Injury to the inferior epigastric artery (IEA) is aknown complication of percutaneous gastric procedures. Thepurpose of this study is to provide simple fluoroscopiclandmarks to predict the course of the IEA and minimize thepotential for vessel injury during percutaneous gastricprocedures.

MATERIALS AND METHODS: Abdominal CT angiogramswhich clearly depicted the course ofthe IEAs were studied ona GE PACS workstation. The width of the LI vertebrai bodywas measured to standardize measurements for patients ofvarying sizes. The distance of each IEA was measured frommidline. The mid1ine was determined using a line drawnanteriorly from the posterior aspect of the LI spinous processwhich bisected the vertebral body. The range, mean average,and standard deviation of absolute distances were recorded,as well as the values normalized for the with of the LI vertebra.

Abstract No. 34

Abstract No. 33

Long-Term Follow Up of Life-Threatening ColonicHaemorrhage Treated with Embolisation.G.J. Robinson, Hull Royal Infirmary, Hull, East Yorkshire,UK • D.F. Ettles • AA Nicholson

PURPOSE: Very good results have been published widely forimmediate outcomes of embolisation for Iife-threateningcolonic haemorrhage. It is recognised that interventionalradiologists can substantially reduce or stop haemorrhageacute1y, rendering surgery unnecessary or allowing tirne forresuscitation and optimisation of patients prior to surgery.

MATERIALS AND METHODS: Retrospective case notereview of patients embolised for colonic haemorrhage over a6-year period in a teaching hospital.

RESULTS: 20 patients (11 males, median age 73 years, range43-91) were embolised with coils and/or Gelfoam.Haemorrhage was thought to be due to diverticular disease or

10:38AM

Superse1ective Catheterization for Acute LowerGastrointestinal Tract B1eeding.F.A. Otitoju, VA Texas Healthcare System, Dallas, TX, USA• R.J. Gray • L. e. Brown. M.R. Antani • D.R. Buck •H.M. Richard, III, et al.

PURPOSE: We reviewed our experience to determine theimmediate efficacy and safety of superselective transcathetertreatment for lower gastrointestinal (LGI) tract bleeding.

MATERIALS AND METHODS: The medical records of 180patients referred between January l, 1993 and September 30,2001 for angiography to detect acute LGI bleeding distal tothe ligament of Treitz were retrospectively reviewed withIRB approval. The hospital course of patients undergoingsuperselective catheterization was folIowed until in-hospitaldeath or discharge.

RESULTS: Of 45 patients with positive angiograms, 12 weretreated by transcatheter vasopressin (8) or inunediate surgicalresection (4) at the physician's discretion. The other 33patients underwent attempted superselective transcatheterembolization and constitute the study group; 3 were bleedingin the jejunum, 4 in the ileum, 5 in the cecum, 8 in the ascendingcolon, 3 in the transverse colon, 5 in the lefL colon and 5 in therectum. 31/33 (94%) were controlled immediately aftersuperselective catheterization: 22/33 (67%) were embolizedusing micro fibularcollagen (12), gel foam pledgets (4), microfibular collagen with coils (2), polyvinyl alcohol particles (2),or coils alone (2); 9/33 (27%) had catheter-induced spasmwith angiographic cessation ofbleeding and embolization wasnot performed; and 2/33 (6%) had failure to select the bleedingvessel. 29/33 (88%) of the superselective catheterizationpatients had no further bleeding: 22/33 (67%) were discharged;3/33 (9%) underwent definitive surgical resection; and 4/33(12%) died from unrelated causes. 9/33 (27%) went to surgery:2 for b1eeding after failure to catheterize, 4 for rebleeds afterembolization (2) or catheter-induced spasm (2), and 3 fordefinitive resection. 1/33 (3%) patients developed transientsigns and symptoms of intestinal ischemia after embolization.

CONCLUSION: Superselective embolization is efficaciousfor immediate control of acute LGI bleeding; catheter-inducedspasm can obscure the bleeding site but will usually controlthe bleed. Some patients will require surgery for ongoingbleeding, rebleeding or defmitive resection. Superselectiveembolization is also safe although transient intestinal ischemiacanoccur.

10:27 AM

Abstract No. 3210:16AM

S12

Embolization: An Effective and Durable Technique ofTreating Visceral Artery Aneurysms andPseudoaneurysms.V. Kapoor, Northwestern Memorial Hospital, Chicago, lL,USA. RL Vogelzang

PURPOSE: Visceral artery aneurysms and pseudoaneurysmsare clinically important vascular lesions with a high risk ofrupture. We prospectively eva1uated the teehnieal successand clinical outcome of patients undergoing spleniclhepaticartery aneurysm and pseudoaneurysm embolization.

angiodysplasia in the majority, with 1 bleeding reetal tumourand 1 post haemorrhoideetomy. Haemorrhage was eontrolledatthe end of the embolisation procedure in all patients, although2 (l 0%) eontinued bleeding and required emergeneyhemieoleetomy. 9 (45%) had no further bleeding, 8 (40%) hadfurther bleeding managed eonservatively and 1 (5%) requireda further embolisation at the same site 15 months later. 3(15%) patients developed minor isehaemie eomplieationswhieh were managed eonservatively, and there were noeomplieations requiring further intervention or surgery. 30day mortality was 5%. Median follow up was 37.6 months(range 0-69).

CONCLUSION: Seleetive embolisation is an effeetivetreatment for eolonie haemorrhage in both the short and longterm.

S13

Abstract No. 37ll:llAM

PTA/Stenting for Chronic Mesenteric Ischemia: Mid andLongterm Results.S.R. Parikh, Swedish Providence Campus, Seattle, WA, USA• K.R. Johansen • T.A. Eglin

PURPOSE: To prospectively evaluate efficacy, safety, midand longterm durability ofPTAlstenting for chronic mesentericischemia.

MATERlALS AND METHODS: 34 patients(pts.) withc1inieal, ultrasound and angiographic confumation of superiormesenteric(SMA) and celiac artery(CA) stenosis/occlusionunderwent preferential PTAlstenting. 23 females and 11 malesmanaged between 1996-2001 at a university affiliatedeomrnunity teaching hospita1 were prospectively surveyed.Age ranged from 46-92 yrs (mean 68.7).All pts. had a historyof smoking, 77% were smoking atthe time of intervention.32pts underwent transbrachial (L=29;R=3) PTAlstenting and 3of 5 pts. attempted via a femora1 approach fai led. Outcomesof aJl pts. reviewed for mortality, morbidity, relief of symptomsand need for reintervention.

MATERlALS AND METHODS: 25 patients (15 mate, 10female) with a mean age of 58.3 years (range: 32-80yr) wereadmitted for arteriography and eoil embolization of splenie(12125) and hepatie (13125) artery lesions. The lesions wereintentionaJly oeeluded or trapped in all patients using aconventional eoaxialtechnique (16125) or "triaxiaJ" teehnique(9/25). The triaxial technique added the use of a microcatheterthrough a coaxiaJ (guiding eatheter plus angiographic catheter)setup. Imaging follow-up was prospectively obtained in 22125 patients. Post-procedural clinical follow-up, within 2months, was obtained in aJl patients. Long term clinicaJ follow­up (range: >2months-8 years) was obtained in 16/25 patients.

RESULTS: TechnicaJ success was achieved in 23125 patients,who had complete aneurysm/pseudoaneurysm thrombosis atthe time of initial embolization; 2 patients required repeatsuccessful embolization for persistent flow through the lesion.There were no deaths related to the procedure. Imaging follow­up, obtained within 3 months, confirmed aneurysm/pseudoaneurysm occlusion in 22125 patients. ProceduraIcomplieations included asymptomatic splenic/hepaticinfaretions on post-embolization CT in 11/22 patients. Onepatient had a post-embolization splenic abscess treated withspleneetomy. Long-term c1inical follow-up in 16 patientsshows all to be free of signs and symptoms related to theseviseeral artery lesions.

CONCLUSION: Embolization is an effective and durablemethod of treating splenic/hepatic artery aneurysms andpseudoaneurysms.

RESULTS: PTAlstenting of the SMA, CA or both was carriedout in 34 pts (47 arteries:14 CA: 33 SMA).All pts had postprandial abdominal pain and al! but l pl. had weight loss (avg221bs). 24 SMA lesions were treated with PTA folIowed bystenting, 4 primarily stented, 5 PTA al one. These included 3SMA occlusions. 10 CA lesions were treated with PTA andstents, 4 primarily stented. 100% technical success wasaecomplished in crossing the lesion folIowed by PTA, 97%for stenting. There was no angiographic or clinical evidencefor thrombosis. dissection or reperfusion phenomenon.Sixeomplications occured in 5 pts(15%).5 were related to brachiaJpunture site, 4 requiring surgery. Initial resolution ofsymptoms occured in 33 pts (97%). During mean follow-upof 25 months (range 1-68),5 pts died, none from intestillalischemia. 5 required 6 repeat interventions, 4 of them beingPTA alone as primary intervention and 2 post bypass distalanastomoses stenosis. Actuarial 5 yr patency was 80%:assisted primary and secondary patency were 90%.

Abstract No. 35

Abstract No. 36

lO:49AM

RESULTS: Immediate hemostasis was achieved in all 22patients. Rebleeding occurred in 3 patients (14%) who eachunderwent colonoscopic intervention with success. Colonieresection (one partial and one totał) was performed in twopatients. One patient-a 16 month-old girl-underwent afollow-up exploratory laparotomy showing viable jejunumstatus post embolization of a proximal jejunaJ branch of theSMA. Among 64% (14/22) of patients undergoing objectivefollow-up evaluation, a postembolization ischemic ulcer inthe colon was documented in one patient (7%) viacolonoscopy. Four patients expired, for reasons unrelated tohemorrhage or embolization, before routine follow-up cou1dbe performed. Four additionaJ patients were followed clinicallyand experienced no symptoms of intestinal ischemia.

CONCLUSlON: Superselective coi1 embolization is a relativelysafe and effective treatment for lower gastrointestinalhemorrhage.

Superselective Arterial Coił EmboHzation for theTreatment of Lower Gastrointestinal Hemorrhage.D.E. Lee, University ojRochester Medical Center,Rochester, NY, USA. w.T. Kuo • W.E.A. Saad • N. Palel.L. Sahler • DL Waldman

PURPOSE: To evaluate the safety and effeetiveness of eoilembolization for the treatment of lower gastrointestinalhemorrhage.

MATERlALS AND METHODS: Superseleetive eoilembolization was performed in 22 patients with angiographicevidence of lower Gl bleeding. Hemorrhage was treated withinthe colon (n=19) and jejunum (n=3). Both microcoils andgelfoam were used in two patients, and coils with Ivalonparticles were injected in two additional patients.Postembolization ischemia was evaJuated objectively in 14patients by colonoscopy (n=10), surgical specimen (n=3),and barium enema (n=I). Four patients were followed forclinicaJ evidenee ofbowel ischemia.

ll:00AM

PURPOSE: To report our experienee with the use ofendoluminal metal stent plaeement for relief of eolorectalobstruetion.

PURPOSE: To identify faetors predieting development ofbiliary strietures in reeipients of Living-Donor LiverTransplams (LDLT).

CONCLUSION: Stenting for symptomatie CMI is safe,effeetive and durable. Catheter direeted therapy is the initialtreatment of ehoiee in symptomatie ehronie mesenterieisehemia.

High Rate of Perforation CompIicating Large DiameterEndoluminal Stent Placement for ColorectalObstruction.N.P. Plaskas, University ofToranta, Toronto, ON, Canada• M. Asch • C.HL Law • J.R. Kachura • C.S. Ho • M.Simons, et al.

Abstract No. 40

Efficacy ofPercutaneous Diłationof Anastomotic BiliaryStrictures in Living-Donor Liver Transplant Recipients.J. Susman, New York Presbyterian Hospital/Columbia, NewYork, NY, USA. Z.J. Haskal • I.H. Foley • JL Weintrr;ub •J.H. Rundback. J. Guarrera, et al.

PURPOSE: To assess the effieaey of pereutaneous biliarystrieture dilation in living-donor liver transplant reeipients(LDLT).

MATERlALS AND METHODS: 85 eonseeutive patientsunderwent LDLT between January 1998 and July 2002. Ofthese, 23 (27%) patients developed anastomotie biliarystrietures at a mean 202.3 days ± 280 (r, 15-1150, median122). Mean age was 27.2 yr (r, 0.3-67.4); 13 adult (24.4% ofLDLT adults)110 pediatrie «18 yr) (37% of pediatrie LDLTpatients); 14 female 19male. Donor grafts included 10 rightlobes, 4 left, and 9 left lateral segments. Etiologies of liverdisease were biliary atresia (n=lO), hepatitis C eirrhosis(5), hepatoma (2), autoimmune hepatitis (2), other (4).Presenting symptoms included: elevated LFTs (56.5%),hyperbilirubinemia (26.1 %), fever (21.7%), liver biopsyindicating biliary obstruetion (21.7%), jaundiee (8.7%), andpruritis (8.7%). 15 patients sueeessfully eompleted the eourseof pereutaneous dilation; 4 were primarily revised surgieally;4 were referred for surgery after 1-2 dilations. Sueeessfultreatrnent (and eatheter remova!) was deteITnined by cliniealtrial &1 or biliary stress manometry.

CONCLUSlON: Biliary atresia and a 2:1 donor duet toanastomosis ratio were most predietive of development ofbiliary strietures following LDLT. Duet intubation eorrelatedwith shorter times to strieture formation.

MATERlALS AND METHODS: Retrospeetive analysis of 85eonseeutive patients who underwent LDLT between January1998 and July 2002. Mean age was 34.8y (r 0.3-67.4); 58adult and 27 pediatrie «18y); 43 FI 42 Male. Donor graftswere 50 right lobes, 13 left , and 22 left lateral segments. 24reeipients (28.2%) developed biliary strietures followingLDLT. 23 strietures were anastomotie, l was intrahepatie.Multivariate, t-test, Chi-square, and contingeney table analysiswere used to evaluate 8 parameters: gender, age, preexistingliver disease, donor liver lobe, anastomosis type, donor duetto anastomosis ratio, stent plaeement during transplant, andhepatie artery thrombosis or stenosis.

RESULTS: Signifieant risk faetors predieting strietureformation were: biliary atresia (56% vs. other etiologies ofliver disease (25% hepatitis C, 14.3% hepatomas, 33.3%autoimmune hepatitis), p=0.05), and 2: 1 donor duet toanastomosis ratio (53.3% vs. 17.6% of patients with a 2:2ratio, p=0.03). Biliary atresia predieted strieture developmentindependent of age or transplant type (odds ratio 5.0). Non­signifieant faetors (p>0.05) included: gender, type ofanastomosis, stent plaeement, and hepatie artery thrombosislstenosis (HAT). No eases of RAT were found in the strieturepatients (vs. 3 eases in the non-strieture eohort). Trends towardsignifieanee included age group eomparisons (41 % < 6y vs.24% ~ 6y ,p=0.125) and donor graft type (37% allleft lobesvs. 22% right lobes, p=O.13). Mean time for strieturedevelopment was 213d ± 279 (r, 15-1150). Stent plaeementeorrelated with shorter time to strieture development (89.7dvs. 301d for non-intubated, p=0.038). Non-significant faetorsfor time to strieture (p>0.05) included age, donor graft, rouxvs. duet-duet anastomoses, and donor duet to anastomosisratio.

11:44AM

AbstraetNo. 39

Abstract No. 38

11:33AM

Multivariate Analysis of Factors Predicting BiliaryStricture Formation in Living-Donor Liver TransplantRecipients.1.H. Foley, New York Presbyterian Hospital/ Columbia, NewYork, NY, USA • Z.J. Haskal • J. Susman • JL Weintraub• J. Guarrera • R. Brown, et al.

MATERlALS AND METHODS: Patients referred by surgeryfor either pre-operative or palliative stent insertions wereprospeetively entered into a trial of a new design of a self­expandable metallie enteral stent (Bard Memotherm™). Aliproeedures were performed under fluoroseopie guidaneewithout endoseopie assistanee. The primary endpoints wereradiologieal and symptomatie relief of obstruetion, clinieallysignifieant perforation, and death.

RESULTS: Between April2000 and August 2002,15 eligiblepatients were identified and 11 underwent stent insertion.Indieations included ineurable disease (n=7), preoperativebowel preparation (n=3), and poor surgieal eanclidate (n=I). 8had malignaney and 3 had benign lesions. 7 patients reeeived1 stent, while 4 patients required 2 stents. Four 25 mmdiameter stents were plaeed in three patients, eleven 30 mmstents were plaeed in eight patients. Immediate post-insertionimaging demonstrated anatomie result in 72.7%. On the post­stent imaging, one patient had an obstruetion at the clistal endof the stent and was sueeessfully restented. Two patientsdemonstrated a perforation at the stent but only one hadc1inieal symptoms. Subsequent clinieally signifieant bowelperforation oeeurred in 5 of the remaining 9 patients. In total,7 out of 11 (63.6%) patients had a perforation in a mediantime of7.5 days (range: l - 21 days). 6 out of 7 patients withperforations underwent laparotomy and eolostomy; onepatient died 1 week post-operatively. Follow-up at a mean of2.48 months post stent insertion (range 0.4 to 5.7 months)shows that 45.5% of stents are patent, 9.1 % have reeurrentobstruetive symptoms and 9.1 % of patients have died oftheir underlying disease.

CONCLUSlON: This study demonstrated that 25 and 30mm diameter stents are sueeessful in aehieving early relief ofeolorectal obstruetion. However, approximately 60% ofpatients developed subsequent perforation neeessitatinglaparotomy and eolostomy. We have diseontinued the use ofthe Bard Memotherm Nitinol stents for this indication.

11:22AM

S14

Scientific Session 5Thrombolysis/MechanicalThrombectomy

RESULTS: Patients receiving biliary dilation undeIWent a meanof2.3 biJiary stricture dilations (r. 1-4) over an average periodof61 days (r, 20-106), with a mean 21 days (r, 6-55) betweensessions. The mean diameteroflargest balloon used was 5.5mm(r, 4-7) for pediatric patients and 6.3mm (r, 5-8) for adults.During the course of treatment, 27.5% (n=ll) of catheterexchanges were triggered by catheter malfunction (withdrawal,obstruction, or fracture): 45.5%of exchanges for malfunctionoccurred in patients ages < 6 yr, 21 % in ages 2: 6 yr. Meanfollow-up time for those completing dilations was 12.9 m ±10.9 (r, 0.4-35.7), with 93% remaining obstruction free. UsingKaplan-Meier analysis, obstruction-free survival for thesepatients was 93%, at 6, 12, and 24 months.

CONCLUSION: Anastomotic strictures in LDLT patientscan be effectively managed in a percutaneous fashion. Cathetermalfunction is a more prevalent problem in transplant patientsless than 6 years of age.

The VSI Acolysis™ Ultrasound Thrombo1ysis System:Endovascular Recanalization of Femoral Arteri-alOcciusioDS.G. Rudofsky, University Hospital Essen, Essen, Germany,Europe • G. Strubel • E. Michler • C. Kugler. U.Rosenschein • M.D. Olson, et al.

PURPOSE: Petipheral occlusive arterial disease (POAD)management presents a therapeutic challenge. Cavitationproduced by low frequency, high energy ultrasound (US)selectively lyses thrombi without vessel wall damage. Wereport experience with anovel method of transcatheter USthrombolysi·s using the VSI Acolysis™ UltrasoundThrombolysis System.

MATERlALS AND METHODS: This was a prospective singlecenter study occuring over 34 months (7/98-5/01). POADpatients (150) included ll4males/36 females(mean age 63.3± 10.4 yrs) with intermittent claudication (107 [71.4%]) orcritical limb ischemia (43 [28:6%]). Treatment includedAcolysis™, rt-PA + Acolysis™ or long-term (3 day)thrombolysis therapy + Acolysis™; adjunct balloonangioplasty folIowed (128 [94%]). A 0.018" guide wire and7F sheath were used. The US catheter was extended intothrombi (",l cm), moved slowly ("'I cm/lO sec), and activatedup to 900 sec with angiography every 5 min. ECGs, bloodpressure and heart rate were monitored. Blood cells,haptoglobin, myoglobin, LDH, creatinine, c-reactive protein,fibrinogen and d-dimers were monitored in 20 patients. Ankle­brachial index (ABI) Was noted before and after intervention.

RESULTS: Recanalization was successful in 136 (90.7%)patients, primarily with femoral arterial occlusions > I yr(acute-IO yrs) in duration. Occlusion length (mean 13.6 ± 8.8cm [4-70 cm]) influenced succeSs rates. Recanalization wasachieved in 65170 (92.9%) patients treated with Acolysis™,

S15

Abstract No. 4210:llAM

25129 (86.2%) with rt-PA + Acolysis™, and 46/51 (90.2%)with 3-day thrombolysis + Acolysis™. Mean lumen dia.increased to 3.2 ±0.9 mm after Acolysis™ and 4.5 ± 1.1 mmafter Acolysis™+ balloon angioplasty. Adjunct stenting wasused in 9 (6.7%) patients. Intervention failed in 14 (9.3%)patients primarily due to technical problems. The ABIincreased from 0.64 to 0.83 (p<O.OOl). Laboratory parametersnormalized within 24hrs and no significant side effects/complications occurred.

CONCLUSION: The VSI Acolysis™ UltrasoundThrombolysis System is a feasible, rapid and safe techniquefor clot dissolution and debulking organized thrombotic mateńal

achieving recanalization ofpeńpheralarteńalocclusions withina wide range of age and length.

Dialysis Graft Thrombolysis Using the ResolutionEndovascular System: Interim Results from a Phase IStudy.G.P. Siskin, Albany Medical Center, Albany, Nr, USA. J.Ross • A. Powell • S. Quarfordt

PURPOSE: To evaluate the safety and efficacy of theResolution Endovascular System for the treatment ofthrombosed arteńovenousdialysis access grafts

MATERIALS AND METHODS: A single-arm prospectivemulti-center feasibility study was performed and inteńm resultswere analyzed. The Resolution Endovascular System(OmniSonics, Wilmington MA) consists of a probe, a handpiece, and a generator. The generator creates an electrical signalthat is transmitted to the hand piece, where it is converted tomechanical energy and transmitted to the probe. Probe motionresults in cavitation, creating acoustic energy that destroysthrombus. Patients were eligible for inclusion in this study ifthey exhibited signs and/or symptoms consistent with graftthrombosis within 2 weeks of presentation. Major procedurerelated adverse events (e.g. death, pulmonary embolus, dialysissite injury, etc.) through 30 day follow-up was the primarystudy endpoint. Secondary endpoints were efficacy basedand included the ability to insert and activate the device, toablate thrombus, to restore flow through the graft, and toallow patients to be dialyzed at leasl once after thrombolysis.

RESULTS: Nine patients (7 female, 2 maie) with a mean ageof 67 years, were treated in this study. The mean age of thetreated grafts was 21.6 months. The mean graft length was21.5 cm wilh configurations including a forearm loop (n=3),upper-arm loop (n=2), and upper-arm straight (n=4). Graftflow was restored in all patients and all patients weresuccessfully dialyzed at least once through the treated graft.In 8/9 patients, at least 80% of the estimated thrombus burdenwas removed with this device. Ali patients required adjunctivetreatrnent to dilate a stenosis at the venous anastomosis andto remove an arterial plug. The 30-day pńmary patency ratewas 77.8%. No primary endpoint adverse events wereattributed to the device or procedure based on independentadjudication.

CONCLUSION: Results of this interim analysis from a phaseI study indicate the Resolution Endovascular System can beused to treat thrombosed dialysis access grafts safely andeffectively.

Abstract No. 41

Friday, March 28, 200310:00 AM - 12:00 PMModeracor(s): Jacob Cynamon, MD

Hans-Joachim Wagner, MD

FEATCRED ABSTRACT

10:00AM