of 4 /4
Scientific Session 5 Thrombolysis/Mechanical Thrombectomy RESULTS: Patients receiving biliary dilation undeIWent a mean of2.3 biJiary stricture dilations (r. 1-4) over an average period of61 days (r, 20-106), with a mean 21 days (r, 6-55) between sessions. 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 catheter exchanges were triggered by catheter malfunction (withdrawal, obstruction, or fracture): 45.5%of exchanges for malfunction occurred in patients ages < 6 yr, 21 % in ages 2: 6 yr. Mean follow-up time for those completing dilations was 12.9 m ± 10.9 (r, 0.4-35.7), with 93% remaining obstruction free. Using Kaplan-Meier analysis, obstruction-free survival for these patients was 93%, at 6, 12, and 24 months. CONCLUSION: Anastomotic strictures in LDLT patients can be effectively managed in a percutaneous fashion. Catheter malfunction is a more prevalent problem in transplant patients less than 6 years of age. The VSI Acolysis™ Ultrasound Thrombo1ysis System: Endovascular Recanalization of Femoral Arteri-al OcciusioDS. 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. Cavitation produced by low frequency, high energy ultrasound (US) selectively lyses thrombi without vessel wall damage. We report experience with anovel method of transcatheter US thrombolysi·s using the VSI Acolysis™ Ultrasound Thrombolysis System. MATERlALS AND METHODS: This was a prospective single center study occuring over 34 months (7/98-5/01). POAD patients (150) included ll4males/36 females(mean age 63.3 ± 10.4 yrs) with intermittent claudication (107 [71.4%]) or critical limb ischemia (43 [28:6%]). Treatment included Acolysis™, rt-PA + Acolysis™ or long-term (3 day) thrombolysis therapy + Acolysis™; adjunct balloon angioplasty folIowed (128 [94%]). A 0.018" guide wire and 7F sheath were used. The US catheter was extended into thrombi (",l cm), moved slowly ("'I cm/lO sec), and activated up to 900 sec with angiography every 5 min. ECGs, blood pressure and heart rate were monitored. Blood cells, haptoglobin, myoglobin, LDH, creatinine, c-reactive protein, fibrinogen and d-dimers were monitored in 20 patients. Ankle- brachial 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 ± 8.8 cm [4-70 cm]) influenced succeSs rates. Recanalization was achieved in 65170 (92.9%) patients treated with Acolysis™, S15 Abstract No. 42 10: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 mm after Acolysis™+ balloon angioplasty. Adjunct stenting was used in 9 (6.7%) patients. Intervention failed in 14 (9.3%) patients primarily due to technical problems. The ABI increased from 0.64 to 0.83 (p<O.OOl). Laboratory parameters normalized within 24hrs and no significant side effects/ complications occurred. CONCLUSION: The VSI Acolysis™ Ultrasound Thrombolysis System is a feasible, rapid and safe technique for clot dissolution and debulking organized thrombotic achieving recanalization of occlusions within a wide range of age and length. Dialysis Graft Thrombolysis Using the Resolution Endovascular System: Interim Results from a Phase I Study. G.P. Siskin, Albany Medical Center, Albany, Nr, USA. J. Ross A. Powell S. Quarfordt PURPOSE: To evaluate the safety and efficacy of the Resolution Endovascular System for the treatment of thrombosed dialysis access grafts MATERIALS AND METHODS: A single-arm prospective multi-center feasibility study was performed and results we re analyzed. The Resolution Endovascular System (OmniSonics, Wilmington MA) consists of a probe, a hand piece, and a generator. The generator creates an electrical signal that is transmitted to the hand piece, where it is converted to mechanical energy and transmitted to the probe. Probe motion results in cavitation, creating acoustic energy that destroys thrombus. Patients were eligible for inclusion in this study if they exhibited signs and/or symptoms consistent with graft thrombosis within 2 weeks of presentation. Major procedure related adverse events (e.g. death, pulmonary embolus, dialysis site injury, etc.) through 30 day follow-up was the primary study endpoint. Secondary endpoints were efficacy based and included the ability to insert and activate the device, to ablate thrombus, to restore flow through the graft, and to allow patients to be dialyzed at leasl once after thrombolysis. RESULTS: Nine patients (7 female, 2 maie) with a mean age of 67 years, were treated in this study. The mean age of the treated grafts was 21.6 months. The mean graft length was 21.5 cm wilh configurations including a forearm loop (n=3), upper-arm loop (n=2), and upper-arm straight (n=4). Graft flow was restored in all patients and all patients were successfully dialyzed at least once through the treated graft. In 8/9 patients, at least 80% of the estimated thrombus burden was removed with this device. Ali patients required adjunctive treatrnent to dilate a stenosis at the venous anastomosis and to remove an arterial plug. The 30-day patency rate was 77.8%. No primary endpoint adverse events were attributed to the device or procedure based on independent adjudication. CONCLUSION: Results of this interim analysis from a phase I study indicate the Resolution Endovascular System can be used to treat thrombosed dialysis access grafts safely and effectively. Abstract No. 41 Friday, March 28, 2003 10:00 AM - 12:00 PM Moderacor(s): Jacob Cynamon, MD Hans-Joachim Wagner, MD FEATCREDABSTRACT 10:00AM

Scientific Session 5 Thrombolysis/Mechanical Thrombectomy

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Page 1: Scientific Session 5 Thrombolysis/Mechanical Thrombectomy

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

Page 2: Scientific Session 5 Thrombolysis/Mechanical Thrombectomy

EłTect of Ultrasonic Wire on Arterial Wall: Relation toPower and Not to Deposited Energy.J.F Polak, Brigham and Women sHospital, Boston, MA,USA. F Chen • B. Hare • R. Rabiner

PURPOSE: To study the possible effects on the artery wallof an ultrasonic wire operating above the cavitation thresholdneeded to induce thrombolysis in dog arteries.

MATERIALS AND METHODS: A prototype ultrasonic wire(0.5 mm diameter) operating at 20 KHz was introduced intothe common femoraI artery of mongrel dogs (n = 8) through asix french sheath and activated in the ilio-femoral arteries. Alipower levels were selected to be sufficient to induce cavitation(at least 2 Watts). In addition, higher power levels were usedto study their effects on the artery wall (2.2 Watts, 3.3 Wattsand 3.5 Watts). Exposure times were varied between 4 and 8minutes. After 30 days, the animals were sacrificed and thearteries harvested. Prepared H&E sampies were subjected toquatitative morphometric analyses with determination of theareas defined by the mediaI (Extemal Elastic lamina; EEL),intimal (Intimal Elastic Lamina; IBL) and lumen boundaries.The extent of fibrointimal proliferation was quantified fromthe measured IEL and lumen areas.

Francisco, CA) immediately prior to AJ treatrnent. Adjunctivethrombolysis following AJ treatment was used in 18 (42.9%)patients (14 with rt-PA, mean dose = 21.0 ± 11.9 mg, meanduration = 27.0 ± 22.6 hours.) The mean AJ run time was 191± 111 seconds. Significant thrombus removal (>50%) wasachieved in 34 patients (81 %), with complete thrombusresolution in 23 patients. Patients with symptom onset < 24hours were more likely to achieve treatmeIit success (oddsratio 9.8, 95% CI [confidence interval] 1.2-83; P=0.016). Anunderlying stenosis was treated with PTA and stenting in 19patients. There were 4 major non-device related complicationsin-hospital. No symptomatic pulmonary embolism wasobserved, and recurrent thrombosis occurred in 8 patientsduring follow-up evaluation ranging from 1 to 9 months. At 5months, the estimated recurrence-free survival rate was 63.8%(95% CI 45-83)'. There were 3 deaths, all cancer related.

CONCLUSlON: Rheolytic thrombectomy is a rapid andrelatively low-risk therapeutic option in patients with venousthrombosis. The definitive role of rheolytic thrombectomyand long-term durability awaits the results of larger prospectivetriais.

lO:22AM Abstract No. 43

lO:44AM Abstract No. 45

PURPOSE: To evaluate the safety and efficacy of rheolyticthrombectomy for treatrnent of symptomatic deep venousthrombosis.

Rheolytic Thrombectomy for Management of VenousThrombosis: Results of a Multicenter Venous Registry.K. Kasirajan, University ojNew Mexico School ojMedicine,Albuquerque, NM, USA. J. Matsuura • M. Arata. J.Swischuk • D. Hunter. C. Cazenave

CONCLUSlON: The thrombolytic effect of this prototypeultrasonic wire is known to occur near cavitation. At powerlevels sufficient to induce cavitation, there is minimai effecton the artery wall (intima). It is only with excess applicationof power above the ideal operating range that changes are seenin the artery wall, presumably due to thermal effects.

RESULTS: Known etiology for thrombosis includedmalignancy in 12, May-Thurner syndrome in 6 andimmobilization in 4 patients. Thrombolysis was used pre-AJtreatment in 22 (52.4%) patients: 13 of whom were treatedwith AJ following suboptimal thrombolysis, and another 9received a bolus of rt-PA (Alteplase, Genentech, South San

Use of Rheolytic Thrombectomy in Treatment of AcuteMassive Pulmonary Embolism.P.T. Zeni, Baptist Memorial Hospital-Memphis, Memphis,TN, USA. B. Blank

PURPOSE: The 6Fr Xpeedior rheolytic thrombectomycatheter (RTC) uses high velocity saline jets for thrombusaspiration, maceration and evacuation, via the Bernoulliprinciple. The purpose of this study was to evaluate theefficacy of thrombus removal using the RTC in patients withacute massive pulmonary embolism (PE).

MATERIALS AND METHODS: Seventeen patients (meanage 51.7 + 16.6 years, range 30-86; 9 male/8 female) withmassive PE initially diagnosed by CT or VQ scan and confirmedby pulmonary angiography ~ere treated with the RTC. Allpatients had acute onset of PE symptoms and all presentedwith hemodynamic compromise and dyspnea. Six patientshad contraindications to thrombolytic therapy. One patientpresented with renal cell carcinoma and tumor embolus assuspected cause of PE. Angiographic and clinical outcomesthroughout the hospital stay were evaluated.

RESULTS: The RTC was successfully delivered and operatedover a .035 inch guide wire in all attempted cases. Treatmentresulted in immediate angiographic improvement and initialrelief of PEsymptoms (improvement in dyspnea and oxygensaturation) in 16/17 patients. One patient developed heartblock during the procedure, and further treatment with theRTC was discontinued. Bradycardia occurred in one patient(managed with lidocaine.) Following thrombectomy, 10patients received adjunctive retevase thrombolysis fortreatrnent of residual thrombus, and 12 received IVC filters.In the patient with renal celi carcinoma, histopathologic analysisof the evacuated material confirmed tumor origin of theembolism. There were 2 deaths, both within 24 hours oftreatment and secondary to PE. One death occurred in a patientthat had only minimal thrombus removal following treatmentwith the RTC and thrombolysis. The remaining 15 patientsshowed continued improvement in PE symptoms and wereeventual1y discharged from the hospital with mean length ofstay 10.3 + 6.5 days (range 5-30).

CONCLUSlON: Rheolytic thrombectomy can be performedsafely and effectively in patients with massive PE. Furtherevaluation in a larger cohort of patients is warranted to assesswhether this treatment may offer an alternative or complementto thrombolysis or surgical thrombectomy.

Abstract No. 44lO:33AM

RESULTS: Power was directly associated with the extent ofintimal proliferation (p < 0.0001 by analysis of variance.Intimal area increased from 0.03 mm2 (n = 35) for controls, to0.05 mm2 (n = 27) at 2.0 Watts (typical operating powerlevel) to 0.25 mm2 (n=32) at 3.3 Watts. There was no apparentassociation between energy deposited and extent of intimalproliferation: average intimal proliferation of 0.08 mm2 (±0.33 mm2 sdev; n = 18) at a power level of 2 Watts for 8minutes but much greater at 0.28 mm2 (± 0.42 mm2 sdev; n =11) for less energy being deposited by exposure to a powerlevel of 3.3 watts for 4 minutes.

MATERIALS AND METHODS: Data from 42 patients (meanage 48.7 ±16.8 years, 23% male), contributed from 7 centers,were available for analysis. Ali patients were treated with the6Fr AngioJet (AJ) rheolytic catheter (Possis Medical,Minneapolis, MN), with lower extremity involvement in 33patients and upper extremity in 9 patients. Logistic regressionanalysis was used to assess the association between baselinefactors and >50% thrombus extraction.

516

Page 3: Scientific Session 5 Thrombolysis/Mechanical Thrombectomy

Antibodies of Platelet Receptors and Reteplase forThrombolysis in PeripheraI Arteries(APART)-Phase n·Tria!.G. Tepe. Dep. Diag. Radiol. - University ofTuebingen.Tuebingen, BW, Germany • J. Schmehl • J. Wiskirchen. T.Dietrich • M. Bitzer • SB. Duda

S17

Abstract No. 4811:17 AM

agent was given in a pulsed spray fashion. Study end pointswere amputation-free survival and survival without opensurgery Ol' major amputation after 90 days, and the rate ofmajor complications at 30 days.

RESULTS: Currently 68170 patients are enrolled in the tria!.The success rate did not differ between both groups. Theduration of thrombolysis was 216 ± 124 min in the reteplaseand 181 ± 61 min the urokinase group. The total amount Ol'

fibrinolytic agent for the interventional treatment was 3.42 ±1.14 U reteplase and 644,164 ± 159,671 U urokinase. Patientswho received the combination therapy with reteplase showeda slightly higher tendency of minor and major bleedingcomplications.

CONCLUSION: Our preliminary conclusion from the intel1manalysis is that a strategy using abciximab as an adjunct tourokinase and reteplase in patients with subacute peripheralartery occlusions are both safe and according efficacy do notdiffer significantly. The 3 months data will be available at the2003 meeting of the SIR. This will be the first presentation ofthe APART tria!.

PURPOSE: To evaluate continuous infusion peripheralchernical thombolysis (PCT) with Tenecteplase (TNK) witha potential to decrease infusion times and improve outcomesin PCT. Sparse data exist reporting TNK use in PCT.

MATERIALS AND METHODS: Between November 1999and July 2002, 48 patients presented with criticallimb ischemia(CLI) and iliofemoral thrombosis, requiring continuous PCTusing TNK. 40 variabIes were retrospectively analyzedincluding total infusion time (TIT), total TNK dose (TTD),25% fibrinogen drop (FD), outcomes, and complications inGroup I: TNK 0.50 mg/hr (22 patients) and Group II: TNK0.25 mglhr (26 patients). AlI patients received peri-proceduralheparin (500 u/hr) and peri and post procedural Aggrastat(tirofiban) 6-12 hours. Follow-up included baseline, l and 6­month ankle brachial index (ABI) and duplex ultrasound (DU).

RESULTS: No deaths, intracranial bleed.ing (lCB), Ol' embolicevents occurred in either group. There were 3/48 (6.2%) overallmajor complications including one femoral repair (Group I)and two 0.50cm nonsurgical hematomas (Table); 5/48 overallminor complications including 3 minor hematomas and 2 <2uGl bleeding (1 in each group); 30-day limb salvage (LS) rate =46/48 (95.5%). Mean 14-month limb salvage (LS) rate = 43/48 (89.5%).

Tenecteplase in Peripheral Thrombolysis: Initial Safetyand Feasibility Experience.D.E. Allie, CIS Lafayette, Lafayette, LA, USA • M.H. Khan.M.A. Khan. G. Chaisson • CJ. Hebert • CM. Walker, etal.

CONCLUSION: Continuous TNK infusion (0.25-0.50 mg/hr) is a safe and feasible treatment for PeT potentially offeringdecreased infusion times, bleeding complications, andimproved outcomes. A larger randomized prospectivemulticenter trial is warranted.

Group I (0.50mgihr) Group II (0.25mg1hr)N=22 N=26

Age(years) 68.8±11.4 68.1±10.5nD (mg) 1.5-10tmean=5.2) 1.~.5(mean=3.8)

TIT (hrs) 4-18 (mean =7.3) 3-20 (mean = 7.8)25% FD O(O) O(O)Procedural success 21 (95:5) 25 (96)Failure 1 (4.5) 1 (3.9)3O-day LS 21 (95) 25 (96)3O-dayamputation rale 2 (9) 2 (7.5)Major1 complications 2 (9) 1 (3.8)Minor2 complicalions 3 (11 :5)' 2 (7.6)1 = "Major" = Any surgery. >5cm hematoma, ar >2u lransfusion2 = "Minor" = <5cm hematoma, or any non ICB or retroperitoneal hematoma• = L 2u Gl bleeding

ComposijeEndpdnt72%

5Il"k

Abstract No. 46

Abstract No. 47

63%66%20%

Outcome in lhe Iwo Ireatment groupsMajor Patency Ciot LysisBleeding (20 hr) (20 hr)15% 49% 39%

10:55AM

Treatment Group

r-PA monotherapy(n=36)r-PA + Abciximab(n=38)

CONCLUSION: The combination of rPA+abx had acceptablesafety as assessed by major bleeding and prevention of distalembolization compared with rPA monotherapy. roPA dosesof 0.2UIh and above are clinically effective at ciot Iysis andrestoring patency.

11:06AM

Safety and Efficacy of Catheter·Directed Thrombolysisfor Peńpheral Arterial Occlusion· The RELAX Trial.K. Ouriel. The Cleveland Clinic Foundation. Cleveland,OH, USA • S. H. Duda • T. O. McNamara • K.M. Sterling •J. Smith • F Castaneda, et al.

PURPOSE: The efficacy of catheter-directed fibrinolysis maybe improved by co-administration of the platelet inhibitorabciximab (abx, ReoPro). The RELAX trial was a multicenter,dose-escalating, phase II trial of patients with symptoms oflower limb ischemia for 4 weeks to assess the safety ofreteplase (r-PA, Retavase) monotherapy and rPA + abxcombination therapy.

MATERIALS AND METHODS: Patients (6/group) wereassigned to intra-arterial roPA 0.1, 0.2, 0.5 Ol' 1.0 UIh with Ol'

without intravenous abx infusion. A dose confirmation phaseenrolled in selected dosing paneIs. (total N=74 patients).Aspirin and heparin (30Ulkg bolus) were administered to allpatients. Angiography was repeated at 6±2 and 20± 4 hrs Ol'

for clinical concem. Infusion was terminated for restorationof patency, worsening ischemia, serious bleeding, Ol'

completion of the protoco!. The primary endpoint was theincidence of major bleeding (>5 gm drop in hemoglobin Ol'

intracranial hemorrhage [ICH]) by dischargelday 7. Efficacywas assessed by the restoration of antegrade flow (Patency),>95% cIot Iysis and a chnical composite (death, majoramputation, Ol' need for target vessel revascularization forongoing Ol' recurrent ischemia at 30 days).

RESULTS: There were no ICH events in this study. Therewere 2 deaths and II patients required major amputationthrough 30 days. rPA at 0.1 UIh was less effective than dosesof 0.2U1h Ol' higher at removing thrombus and re-establishingdistal blood flow. Distal embolization requiring interventionwas reduced by the addition of abciximab (31 % vs. 5%, p =0.0139).

PURPOSE: Glycoprotein (GP) IIbIIITa receptor inhibitorsenhance thrombolysis in patients with acute peripheral arteryocclusions. In a recent trial (PROMPT) a combination therapyof abciximab, a GP IIbillla inhibitor, and urokinase couldshown to be safe and more efficacious than urokinase alone.This prospective randomised APART-trial evaluates thesafety and efficacy of the combination of the newerthrombolytic agent reteplase versus urokinase.

MATERJALS AND METHODS: Seventy patients with lowerextremity thrombi were randomised (2:5 ratio) to reteplaseplus abciximab Ol' to urokinase plus abciximab. The fibrinolytic

Page 4: Scientific Session 5 Thrombolysis/Mechanical Thrombectomy

Impact oC lA Reteplase on Fibrinogen Levels in theTreatment oC Peripheral Arterial Occlusive Disease(RELAX-llial).G. Tepe, Dep. Diagn. Radiology, Tuebingen, BW, Germany• F. Casteneda • K. Sterling. 1. Clark .1. Smith. onBehalfofthe RELAX lnvestigators

PURPOSE: The RELAX study was a multi-center pilot studyto evaluate the safety and efficacy of escalating doses ofreteplase with or without abcixirnab in patients with acule orsubacute peripheral arterial occlusive disease. We examinedfibrinogen (Fb) levels by dose, over time, frorn the RELAXtria!.

MATERIALS AND METHODS: Patients (6/group) wereassigned to intra-arterial reteplase (r-PA) 0.1, 0.2, 0.5 or 1.0U/h with or without intravenous abciximab (abx) infusion. Adose confirmation phase added patients in selected dosingpaneis to atotaJ enrollment of74 patients. Fb levels measuredat basehne and at prespecified angiography (6 ± 2, 20 ± 4hours).

RESULTS: Across all doses, Fb levels show only minorreductions from basehne (see table). The addition of abciximabto reteplase monotherapy at each r-PA had no signiflcanleffect on Fb depletion. Observed differences were notstatisticaUy significant by Anova. Values expressed as mean± SD (N). 6 patients had any Fb level <100 mg/dl across alldosing groups.

CONCLUSION: The infusion of intra-arterial reteplase aloneor in combination with intravenous abciximab in aculeperipheral arterial occlusive disease appears to minimaUy effectsystemic levels of Fb in this dose finding safety tria!.

Scientific Session 6Biopsy and Drainage

CI·, and Ca++ before and 3, 7, and 14 days after perfusion.The wound infection, edema, and mobile function wereobserved one month after perfusion.

RESULTS: According to the flow coefficient offered byultrasound, one could establish an ILP rabbit model with a100ml/min oxygen-exchange rate and compensating withglucose. No rabbit was dead within one month after perfusion.AST, AKP, Cr and electrolytes did not differ significantlybefore and after perfusion in both DDP and controi groups(P>0.05), while LDH and CK were significantly different inthe two groups. There were also significant differences inUrea, WBC between DDP-perfusion and pre-perfusiongroups. The degree of regional toxic reaction in DDP groupwas higher than that in controi group (P<0.05). Acute regionaland systemic toxic reaction was obviously observed in therabbits perfused with a dose of 4mg/kg.

CONCLUSION: The selection of lOOml/min oxygen-exchangerate and compensation with glucose could set up an ILP rabbitmodel as in the physiological state. Therapeutic cisplatinperfusion with a dose of 2mglkg in ILP model is a safe therapywith little acute regional toxic reaction and no serious systemicto::<ic reaction.

Abstract No. 51

Friday, March, 28, 200310:00 AM - 12:00 PMModerator(s): Albert A. Nemcek, lI:, MD

Eric Van Sonnenberg, MD

10:00AM

Abstract No. 4911:28AM

ResultsDose r-PA (n) Basel!ne (mg/dl) 6hr(mg/dl) D Baselln. 20hr(mg/dl) D Baseline Fb<100

range(n) range (n) to6hr range (n) to20hr mg/dl(N)

0.1 UAlr (6) 441 ± 154 (6) 381 ±164 6O± 73 359 ± 217 82 ± 169 1(6) (6) (6) (6)

0.2 UAlr (12) 349 ± 37 (11) 302 ± 102 50±64 235 ± 85 120±80 2(12) (11) (12) (11)

0.5 UAlr(6) 394 ±90(4) 324 ± 60 88± 102 242±75 149± 124 O(4) (4) (6) (6)

1.0UAlr(12) 394±151 (11) 350 ± 136 35±70 262 ± 101 154± 126 1(12) (11) (10) (9)

0.1 UJhr+ 421 ±88(6) 383± 141 38±71 273 ± 158 148 ± 107 OAbx(6) (6) (6) (6) (6)0.2 UAlr+ 382 ± 76 (10) 334±113 33±65 305±112 64± 131Abx(12) (11) (10) (11) (10)0.5 U/hr+ 380±100(11) 303 ± 87 56±88 281 ± 126 67 ± 121Abx(14) (13) (12) (11) (10)1.0Ulhr+ 389± 102 (4) 297 ± 107 67± 54 281± 126 185±71Abx(6) (6) (4) (11) (3)

Experimental Studyon the Isolated Limb PerCusion oCRabbit Model.1. Wang, 1st Affiliated Hospital Nanjing Medical University,Nanjing, China. Y Wang • W Wang • L. Wu • L. Li

PURPOSE: To set up an isolated limb perfusion (LIP) modelof rabbit and to investigate the acute local and systemie toxicreaction after isolated perfusion of cisplatin (DDP).

MATERIALS AND METHODS: Twelve rabbits wererandomly divided into two groups, DDP group and controlgroup. The rabbit's femoral artery and vein were cannulatedfor establishing an UP system wilh a mini-membrane­oxygenator and a micro-pump, and the separated circulatoryrate was measured and monitored with Doppler ultrasound.DDP group consisted of 5 rabbits perfused with 2 mg/kgDDP and one rabbi t with 4mg/kg. We infused with normalsaline in the controi group. Blood specimens were collected totest ALT, AST, AKP, Urea, Cr, LDH, CK, WBC, K+, Na+,SI8

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Percutaneous Liver Biopsy: Our Experience in 145Patients.A.M.K. Agha, UCSD, San Diego, CA, USA • G. Rivera­Sanfeliz • T.B. Kinney • A. C. Roberts • K. Valji • S.c. Rose,et al.

PURPOSE: To describe our experience with US-guidedpercutaneous liver biopsies using the INRAD® l8G coreneedle biopsy system.

MATERlALS AND METHODS: We reviewed 145 consecutivepercutaneous core liver biopsy procedures performed in asingle institution over a period of 32 months (January 2000 ­October 2002). The chnical charts. pathology and radiologyfiles were reviewed. The number ofbiopsy passes, the changein hematocrit level and the adequacy of specimens forhistologic analysis were evaluated.

RESULTS: AU patients were male, with ages ranging between30-83 (mean,52). AU our biopsies were performed for chronicliver diseases, with the majority of our patients havingHepatitis C as the indication for the procedure. Ali biopsypatients were discharged to home after completing four hoursof observation. The majority of our patients (99/145, 68%)underwent a single pass liver biopsy. The mean hematocritdecrease was 2.9 (45.1 to 42.2). Pain was the most frequentcomplication and was treated wilh analgesics. No majorcomplications occured and there were no biopsy-relateddeaths. The technical success rate was 98.6%. There weretwo technical failures with severely fragmented sarnples thatrequired an intraprocedural switch to a different commercialIyavailable core biopsy system. AU final biopsy sampIes weredeemed appropriate and no patients had to be rebiopsied.

CONCLUSION: Percutaneous US-guided liver biopsy withthe INRAD® l8G core needle biopsy system is a safe