Scientific Session 15Lower Extremity Arterial Disease

treatment). Plasma and tissue concentration of doxorubicinand doxombicinol were measured at the time of sacrifice.Histology was performed to evaluate tumor necrosis.

RESULTS: In the animals treated with doxorubicin-elutingbBads, the concentration of doxorubicin within the tumor wasgreatest in the 3-day grou'p (413.52 nMol/g) followed by theI-day group (200.09 nMol/g), and remained high in the 7-daygroup (46.30 nMol/g), suggesting continuous elution ofdoxorubicin from the beads. In contrast, the plasmaconcentration ofdoxorubicin was low at all time points (0.01to 0.05 uM) and declined sharply from 20 to 180 minutesafter administration, indicating high retention of doxorubicinwithin the tumor tissue. Plasma concentration of doxorubicinand doxorubicihol was also significantly lower (7 to 10 times)than when injected intraarterially without the beads. Histologicanalysis revealed that tumor necrosis was greatest in the 14­day group.

CONCLUSION: Intraarterial injection of doxorubicin elutingbeads results in prolonged delivery to the tumor resulting insignificantly greater, sustained concehtration of the drug withinthe tumor tissue when compared to intraarterial injection ofdoxorubicin-alone. These results suggest a prolonged durationof action of doxorubicin, which could lead to greater anti­tumor efficacy.

Long-Term Results of Stent Placement for Iliac ArteryOcclusion: Is the TASC D Patient a Candidate for StentPlacement?K. Kichikawa, Nara Medical University, Kashihara, Nara,lapanW HigashiuraS Sakaguchi·T. NakagtaK NishimineA.Takahashi

PURPOSE: To evaluate long-term outcomes afterrecanalization of chronic iliac artery occlusion with stents andto determine whether stent placement can be applied to iliacartery occlusion in TASC D patients.

MATERIALS AND METHODS: One hundred thirty-fourconsecutive patients (TASC B; 42, C; 31, D; 61) with 139iliac artery occlusions (mean length; 9.9 cm) underwentrecanalization with stents. For the occlusion in common orcommon and external iliac artery, recanalization was firstattempted from the ipsilateral femoral artery. If the occlusioncould not be crossed, it was traversed from the contralateralfemoral artery. If the wires from both directions endedsubintimally in the lesion, the wire from the contralateral sidewas caught with a snare wire from the ipsilateral groin. Forexternal iliac artery occlusion, recanalization was attemptedfrom the contralateral femoral artery. Patients were followedwith ABI measurement, clinical follow-up, US Doppler andIA-DSA. The period of follow-up was 6-168 months (median54). Initial outcome, complications and long-term outcomewere analyzed.

RESULTS: Recanalization was successful in 133 of 134 (99%)patients. In a patient with severe calcified plaque we couldnot pass through the lesion with a guide wire. Complicationsoccurred in 5 patients (3.7%), including distal emboli in 3,

Bivalirudin in Percutaneous Peripheral Interventions:Results of the Approve Trial.DE Allie, Cardiovascular Institute of the South, Lafayette,LA, USA 'p' Hall

PURPOSE: The risks and nature of percutaneous peripheralinterventions (PPI) require predictable and reliableanticoagulation. Preliminary studies with bivalirudin, athrombin-specific anticoagulant, demonstrate consistentanticoagulation in patients undergoing PPI versus heparin.The Angiomax Eeripheral Erocedure Registry Qf Yascular

Abstract No. 87

Abstract No. 86

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RESULTS: 79 (38 female, 41 male) patients with CCLI werecandidates for SIR. Successful SIR resulting in creation ofstraight-line flow to the foot was accomplished in 92 (100%)limbs. 71 limbs (77%) had tissue loss and 21 limbs (23%) hadrest pain alone. Medical comorbidities included diabetesmellitus (67%), coronary artery disease (77%), and chronicrenal insufficiency (46%). 65 consecutive limbs comprisedGroup I and 27 consecutive limbs comprised Group 2. The6-month limb salvage rates in Group I and Group 2 were 86%(95% CI; 73,93%) and 90% (56,98%), respectively (p=0.71).

CONCLUSION: Subintimal recanalization is a useful techniqueto treat chronic critical limb ischemia for limb salvage inpatients who are poor candidates for infrainguinal arterialbypass surgery. Long segment stenting (>200 mm) of SIRchannels did not appear to improve limb salvage compared toPTA with selective stenting «200 mm).

Long Segment SFA Stenting with SubintimalRecanalization to Improve Limb Salvage to Treat LimbThreatening Ischemia.D.l. Spinosa, University of Virginia Health Systems,Charlottesville, VA, USA 'N.D. Harthun'DL Cage 'E.A.Bissonette 'CD. Hartwell'A.H. Matsumoto, et al.

PURPOSE: To evaluate the role of long segment SFA stenting(> 200 mm) in subintimal recanalization (SIR) to treat limbsin patients with chronic critical limb ischemia (CCLI).

MATERIALS AND METHODS: Patients with CCLI (rest painor tissue loss) who were considered poor candidates forinfrainguinal arterial bypass surgery (lABS) because ofsignificant medical comorbidities and/or lack of suitable veinconduit underwent SIR of the SFAJpopliteal segment with orwithout tibial SIR to create straight-line flow to the involvedfoot for limb salvage. SFAJpopliteal SIR segments were treatedwith either PTA ± selective stenting of <200 mm (Group I)or >200 mm of stenting (Group 2). Limb salvage for Group Iand Group 2 was determined using survival analysis accountingfor correlated data.

8:12AM

rupture ofEIA in I, and destruction of wire during manipulationin I. There were II late recurrent lesions at a median 7 months(range I - 72), which were treated with endovascular techniquein 9 limbs and surgery in I limb, and I patient refrained fromfurther intervention. Recurrence rates in TASC B, C and Dwere 2/42(4.8%), 2/31(6.5%) and 7/61(11%) respectively,which were not significantly difference between the threegroups. Primary and secondary patency rate were 91.2% and99.1 % at 3 year and 88.7% and 97.6% at 5 year.

CONCLUSION: Stenting for iliac artery occlusion provides ahigh technical success rate and acceptable long-tenn results,and TASC D also can be treated with stent placement safelyand effectively.

Abstract No. 85

Sunday, April 3, 20058:00 AM - 9:30 AMModerator(s): Daniel Sze, MD

Tony Krajina, MD

8:00AM

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Oulcomes at 30-Days

Events (APPROVE) trial assesses ischemic and bleedingoutcomes with bivalirudin in PPI of the renal, iliac, or femoralarteries.

CONCLUSION: Bivalirudin provided similar outcomes in allvessel-types treated, with low ischemic and hemorrhagiccomplications. The results of this trial verify that bivalirudinprovides reliable and consistent anticoagu lation regardless ofthe vessel being treated and represents an attractiveanticoagulant for use during PPI.

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Abstract No. 89

Abstract No. 90

8:48AM

FK778 starting as late as 7 days after balloon angioplasty(group 3) did not lead to reduction of neointimal hyperplasiain either dosage group.

CONCLUSION: In this double-injury rat model, balloon­mediated neointima formation was inhibited by short-telmperunterventional systemic application ofFK778. Significantreduction of intimal hyperplasia seems to depend onsuppression of early cell migration- and proliferation. Theresults may be a rationale for adjunctive short-termimmunosuppression after balloon angioplasty. [GBYIA]

MATERIALS AND METHODS: Between December 1, 2002and January 31, 2004, 39 patients with symptomatic SFAdisease underwent 8-F percutaneous revascularization. Eachreceived bivalirudin (Angiomax, The Medicines Company,Cambridge, MA) and a lIblIlIa bolus and 8-12 infusion.Periprocedural hemostasis and clinical outcomes werecompared with a contemporary matched manual compression(MC) group ( N= 39).

Staple ven in Peripheral Interventions with IIbllIIa andDirect Thrombin Inhibition: Safety and Feasibility.D.E. Allie, Cardiovascular Institute of the South, Lafayette.LA, USA 'CJ. Hebert·CM. Walker

PURPOSE: Larger sheaths, interventions, anticoagulation, IIb/lIla inhibition and peripheral vascular disease (PVD) arepredictors of femoral access complications andcontraindications for use with existing VCDs. VCD use in 8­F peripheral interventions with lIb/lIlas has been rarelydescribed. The current (3 mm) Angiolink EVS (AngiolinkCorp., Taunton, MA) extravascular staple expands toaccommodate a size 15-French arteriotomy pursingextraluminal tissue (femoral sheath, adventitia, and media) toachieve immediate, secure, mechanical arteriotomy site closure.

RESULTS: The variables analyzed included major surgicalcompljcations (MSC), minor complications, retroperitonealhematoma (RH), time to hemostasis (TTH), sheath removaltime (SRT) < 60 minutes, time to ambulation (TA) < 6 hours,length of stay (LOS) < 36 hours, and ACT level at sheathremoval (Table).

CONCLUSION: The Angiolink staple-mediated VCD is asafe and feasible option for vascular closure in 8-F sheathbased SFA interventions using IIbIIIIa and direct thrombininhibition.

FEATlJREDABSTRACT

Commentator: TnD

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Variables MC N=39 Angiolink N=39 p-valueTTH (min) 31.1±17.2 2.8±2.4 <0.001MSC 1 (2.5%) 0 0243Hemaloma > SCm 3(7.6%) 1(2.5%) 0.181RH 1(2.5%) 1(2.5%) 0.500Pseudoaneurysm 1 (2.5%) 0 0.243Blood transfusion 3(7.6%) 1(2.5%) 0.181SRT<60min 0 39(100%) <0.001TA< 6 hrs 7(18%) 31 (79.4%) <0.001LOS<36hrs 1 (25.5%) 30(77%) <0.001ACT at SR (sec) 169.4 ± 27.4 219.6±69.7 <0.001

Hypoxia-Inducible Factor lex Promotes TherapeuticArteriogenesis in an Endovascular Model of RabbitHindlimb Ischemia.TH. Patel, Johns Hopkins Medical Institutions, Baltimore,MD, USA -K. Hideo 'WR. Cliff·S. Gregg·H. V. Lawrence

PURPOSE: Therapeutic arteriogenesis is the deljvery ofexogenous agents to promote development of stable vascular

Abstract No. 888:36AM

Renal. Iliac. Femorai. EPP'"N=173 n (%) N=140 n (%) N=184 n (%) =505n (%)

Procedural Success' 168 (97.1) 130 (93.5) 173 (94.0) 471' (95.0)Death 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)MI 0 (0.0) 0 (0.0) 1 (0.5) 1(0.2)Revascularizalion 0 (0.0) 0 (0.0) 4 (2.2) 4 (0.8)Ar\1)ulalion 0 (0.0) 0 (0.0) 2 (1.1) 2 (0.4)Major hemorrhage" 4 (2.3) 4 (2.9) 3 (1.6) 11 (2.2)Minor hemorrhage" 10(5.8) 14(10.0) 19(10.3) 43(8.5)'=evaluated in 496 patients. "=by discharge. "'=evaluable patient population

Limited Peri-Interventional Immunosuppression withFK778 Inhibits Neointima Formation in a Rat Model ofRestenosis.T. Jahnke, University Clinics SH, Campus Kiel, Kiel, SH,Germany-J. Brossmann·.K.W. Schafer·H. Bolte·P.l.Schafer'S. Miiller-Hiilsbeck

PURPOSE: To test the hypothesis tbat there is a "window ofopportunity" for periinterventional short-termimmunosuppression to inhibit neointima formation in a double­injury rat model of restenosis.

MATERIALS AND METHODS: For induction of stenoses,silicon cuffs (inner lumen diameter Imm) were placedoperatively around the infrarenal aorta of Lewis rats. After 21days the aortic cuffs were removed and the lesions were dilatedusing a 2-F Fogarty catheter inserted via the left commoncarotid artery. The novel immunsuppressantMalononitrilamide (FK778), a lef]unomid-analogon, wasapplied systemically in daily dosages of 5 or 15 mglkg/bw ina total of 36 animals. For each dosage the application waslimited to three periinterventional time periods with 6 rats ineach group: (i) group 1: days -2 - +2, (ii) group 2: days I - 5und (iii) group 3: days 7 - 11. After 3 weeks histomorphometricanalysis was performed.

RESULTS: In group 1 (day -2 bis +2) both dosages showedinhibition of neointima formation at 21 days when comparedto untreated control rats. In group 2 (day 1-5) the effect wassignificant in the higher dose group (p< 0,05). Application of

MATERIALS AND METHODS: An open-label, multicenter,single arm study in patients undergoing PPI that assessedbivalirudin as the sole procedural anticoagulant (0.75 mglkgbolus/1.75 mglkg/hr infusion). The primary endpoint wasprocedural success (residual stenosis:;:; 20%). Ischemic andhemorrhagic endpoints were also assessed.

RESULTS: Twenty-six sites enrolled 505 patients. Baselinedemographics were comparable. Patients were pretreated withc1opidogrel (95%) and aspirin (96.8%). Glycoprotein (GP)IIblllIa inhibitors were used in 4.4% (investigators' discretion).Mean ACTs were similar between groups renal, 353.8 seconds;iliac, 335.9 s; femoral, 343.5 s. Procedural success was achievedin 95% of patients. Event rates were low and similar betweenvessel types.

Scientific Session 16Oncologic Interventions: Embolization

MATERIALS AND METHODS: The medical records of allpatients with gastrointestinal stromal tumors metastatic tothe liver who underwent HACE at our institution betweenJanuary 1999 and April 2004 were reviewed. We comparedthe follOW-Up cross-sectional imaging with the baseline imagingto determine the objective tumor response, graded accordingto World Health Organization criteria. Survival durations werecalculated from the day of initial embolization session usingthe Kaplan-Meier method.

networks to ischemic tissues. Most modern approachesconcentrate on the delivery ofa single arteriogenic molecule topremote neovascularizatiol1. We have developed an adenoviralvector encoding a constitutively active form of HIF-Ialpha(AdHIF), a transcriptional activator that induces cell- typespecific upregulation of multiple arteriogenic factors (ANG­I, ANG-2, PIGF, PDGF-B and VEGF). We sought todetermine the atteriogenic response of the intramuscular (1M)delivery of AdHIF in our endovascular model of hindlimbischemia.

Gastrointestinal Stromal Thmors Metastatic to Liver:Response and Survival after Hepatic ArteryChemoembolization.K. Kobayashi, University of Texas M. D. Anderson CancerCenter, Houston, TX, USA-So Gupta'LD. Broemeling'D.C.Madoff'K. Ahrar'M.E. Hicks, et al.

PURPOSE: To evaluate response and survival after hepaticartery chemoembolization (RACE) with cisplatin and gelfoamlpolyvinyl alcohol for patients with gastrointestinal stromaltumors metastatic to the liver.

Abstract No. 928:12AM

RESULTS: During the study period, 39 patients (21 men and18 women; mean age 57.4 years) were treated with 91 sessions(range, 1-7 sessions per patient) of HACE using gelfoam orpolyvinyl alcohol particles and cisplatin (150 mg). 22 patients(56.4%) had extrahepatic metastatic disease at the time oftreatment. 21 patients had failed prior systemic chemotherapyincluding imatinib (STI 571) in 3. Of 30 patients in whomradiologic response could be evaluated, partial response (PR)was observed in 7 (23.3%), stable disease (SD) in 22 (73.4%),and progressive disease in 1 (3.3%). Among the 29 patientswith PR or SD. 14 developed intrahepatic progression at amean time on.8 months (range, 3.3-13.2 months). Cumulativesurvival from initial chemoembolization was 51.7% at 1 year,28.5% at 2 years, and 25.3% at 3 years, with a median survivaltime of 12.9 months. One patient died of ARDS 31 days afterchemoembolization. Cholecystitis and bacteremia controlledwith antibiotics were seen in I and 2 patients, respectively.

CONCLUSION: Hepatic arterial chemoembolization canresult in durable response or disease stabilization in patientswith gastrointestinal stromal tumors metastatic to the liver.

Treatment of Metastatic Sarcoma to the Liver withParticle Embolization.A.M. Covey, Memorial Sloan Kettering Cancer Center, NewYork. NY, USA 'M. Maluccio 'J. Schubert 'c.T. Sofocleous ·LA.Brody'CI. Getrajdman. et al.

PURPOSE: Resection of liver metastases in patients withsarcoma has been shown to impact a survival benefit. Inunresectable patients, improved survival has been reportedfollowing chemoembolization, despite the fact that thesetumors are typically resistant to chemotherapy. The purposeof this study is to investigate the effect of bland particleembolization on survival in patients with metastatic sarcomato the liver.

MATERIALS AND METHODS: A retrospective review ofour single center embolization database identified over 500patients who underwent embolization between 1996 and 2002,of which 24 were treated for metastatic sarcoma to the liver.Overall survival was calculated using the Kaplan Meiermethod. Patient, tumor and embolization variables wereanalyzed to elucidate factors which might be useful inprognosticating overall survival.

RESULTS: Between 1996 and 2002, 24 patients with a meanage of 51 years with sarcoma were treated with bland hepaticarterial embolization for liver metastases. The histologicdiagnosis was gastrointestinal stromal tumor in 16 (67%),leiomyosarcoma in 7 (29%) and liposarcoma in one (4%.)Mean and median time to the development of metastasesfollowing the initial diagnosis was 31 and 18 months,respectively (range 0-156.) Following embolization, the 1,2,and 3 year actuarial survival was 62%, 41 % and 29%,respectively with median survival of20.S months. Radiologicresponse was defined as >50% necrosis or decrease in size oftarget lesion following embolization. In the subgroup ofpatients in whom both pre and post embolization imagingwas available, the mean survival in patients who had aradiographic response to embolization was 81 months andthe median has not yet been reached. A mean and mediansurvival of 34 and 21 months, respectively, was achieved inradiographic non-responders. There was no difference insurvival based on tumor type or number of liver metastases.

CONCLUSION: Bland arterial embolization for local controlof Iiver metastases in patients with metastatic sarcoma shows

Abstract No. 91

Sunday, April 3, 20058:00 AM - 9:30 AMModerator(s): Karen T. Brown, MD

Jae-Hyung Park, MD

8:00AM

MATERIALS AND METHODS: The left superficial femoralartery of New Zealand White rabbits was occluded usingthrombogenic coils. Then, a total dose of 1.2 x lOS plaqueforming units of AdHlF (n=6) or AdLacZ (n=6,control) wasadministered into the left medial thigh via six 1M injections.

RESULTS: At day 14, the AdHlF transfected hindlimbsshowed significantly greater calf blood pressure ratios thanthose receiving AdLacZ (0.89 ± 0.29 vs 0.51 ± 0.10, p= 0.009).The angiographic perfusion score, a variation of the TIMIframe count, demonstrated -better perfusion in the AdHIFtreated group (3.5 ± 1.4 frames vs 8.3 ± 3.2 frames, P= 0.007).There was no statistical difference detected in the number ofnewly formed vessels determined by either angiographic orimmunohistochemical analysis between the two groups onday 14. However, the vessel in the region of vectoradministration, the distal profunda femoris artery, had anangiographically larger vessel diameter ratio, in the AdHIFgroup (1.39 ± 0.08 vs 1.14 ± 0.12, p= 0.012). Moreover, thearteriolar luminal area, as determined by immunohistochemicalanalysis was greater in the treatment group (316762 ±45879.811m vs 211575.8 ± 25563.7 11m, p=O.04).

CONCLUSION: Intramuscular administration of AdHIFinduces an arteriogenic response by stimulating the enlargementofpre-existing arteries and arterioles in our endovascular model.These results demonstrate a possible strategy for combatingperipheral vascular ischemic disease by which arteriogenesisis achieved via a transcriptional regulatory strategy. [RIF]

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