RESULTS: All pts. had rapid cessation of bleeding. Next day catheter site follow up was assessed for all pts. None had soaking of their bandage requiring dressing change or reinforcement. 2 pts. (7.7%) had removal of catheter for suspected infection (I cellulitis, I with FUO). Catheter placement related infection was defined as within 2 weeks from initial placement. No difference between thrombin and polymer was identified.

CONCLUSION: Utilization of a thrombin/blood patch subcutaneous sealant is a safe and effective method to treat and/or prevent bleeding complications in the placement of TCVA in coagulopathic pts. Infectious complications are similar to those for pts. with nonnal coagulation profiles. Given the results found in this study, traditional algorithm parameters for placement of temporary versus TCVA come into question. Randomized studies evaluating safety, cost savings potential and pI. satisfaction should be perfonned to confum the findings of this study.

4:56PM Abstract No. 124

Analysis of Tip Malposition and Correction in PICCs Placed at Bedside by a Dedicated Nursing Team. S.O. Trerotola, Hospital of the University of Pennsylvania, Philadelphia, PA, USA·S. Thompson·K. Vieregger

PURPOSE: To analyze the patterns of immediate post­placement tip malposition in PICCs placed by a dedicated nursing team without imaging guidance, and to describe results of bedside and imaging guided correction of tip malposition.

MATERIALS AND /vIETHODS: Bedside placement ofPICC is the initial procedure of choice at our hospital, with IR backup for failed placement and correction of malposition. Using a quality assurance database, all episodes of tip malposition in PICCs placed at bedside were reviewed since the inception of the service. Catheter tip location, success or failure of bedside repositioning (in a subset of patients, using flushing and over-the-wire techniques), findings in the IR suite, and method of IR tip correction (repositioning versus replacement) were determined by review of paper and electronic medical records. IRB exemption was granted.

RESULTS: During the 18 month study period, 2367 bedside attempts at PICC placement were made, and 1654 were initially successful (70%). Of these, 163 tips were malpositioned (10%). Complete records could not be obtained for 31 of these, leaving 132 tip malpositions. Tip position was as follows: ipsilateral intemaljugular n=45 (36%), axillary n=36 (27%), ipsilateral subclavian n=25 (I9%), ipsilateral innominate n= 15 (II %), contralateral subclavian n=4 (3%), coiled in superior vena cava n=3 (2%), contralateral innominate n=2 (2%), contralateral IJ n=1 (I %), subclavian tributary n= I (l %). Malposition was corrected by catheter exchange n=76 (58%), repositioning n=48 (36%), or removal (n=l, 1%).7 (5%) tips spontaneously repositioned and needed no further manipulation. 109 (83%) of mal positions were corrected by [R using imaging guidance and 16 (12%) were repositioned successfully at bedside. In the subset of patients in whom bedside repositioning was attempted (n=25), 16 attempts (64%) were successful.

CONCLUSION: Tip malposition occurs relatively frequently with bedside placement ofPICC lines. Preliminary data in a subset of patients suggest that the majority of malpositions can be corrected using bedside techniques . Spontaneous correction may occur but is relatively uncommon.

5:07PM Abstract No. 125

Percutaneous Declotting of Native Hemodialysis Access Fistulae Using Rheolytic Thrombectomy. S.D. Altman, Open Access Vascular Access Center, Inc., N. Miami, FL, USA

PURPOSE: To retrospectively review the success and patency of percutaneous declotting of arteriovenous fistu lae using the 6F Xpeedior rheolytic thrombectomy system.

MA TERIALS AND METHODS: From March 2, 200 I through January 17, 2003, 53 patients (72% male, mean age 58 ± 16 years) underwent fistula declotting using the Xpeedior device as a stand-alone technique (42%) or in combination with manual thromboaspirationlthrombolysis (58%). Fistula type was radiocephalic (45%), brachiocephalic (38%), and brachiobasilic (17%), with mean age of32 months. In 49 (93%) patients, 93 hemodynamically significant stenoses were identified and treated with percutaneous angioplasty. In 3 patients (6%), elastic stenoses were treated with stenting. Two patients had competing collateral veins treated with percutaneous embolization using Gianturco coils.

RESULTS: Technical success (successful declotting and restored flow) was achieved in 91 %. Clinical success (ability to receive dialysis through the fistula at the next scheduled session) was achieved in 89%. In 2 patients with fistulae infiltration, catheters were placed to allow the fistula to rest while the infiltration resolved. In 9%, fistula could not be declotted due to lack of adequate arterial inflow, venous outflow, or aneurysm size. Primary patency rates of 91 %, 72%,61 %, 48%,40%, and 30% were achieved at 1,3,6,9,12, and 18 months respectively. Secondary patency rates of98%, 91%,84%, 77%,74%, and 64% were achieved at 1,3,6,9,12 and 18 months respectively. There were 5 minor complications : I vein perforation, 3 episodes of intra­procedure bleeding through old dialysis puncture sites, and I episode of transient nausea during treatment, all successfully managed. One patient required overnight hospitalization for acute dialysis.

CONCLUSION: Percutaneous declotting of native fistulae using the Xpeedior thrombectomy device either as a stand­alone treatment or in conjunction with other de clotting techniques is a safe, effective treatment option. Although percutaneous intervention in fistulae is technically challenging, patency rates exceeding the K-DOQI recommendations for graft declotting can be achieved .

Scientific Session 25 Arterial Recanalization

Saturday, March 27, 2004 4:30 PM - 6:00 PM Moderalor(s): Joseph Bonn, MD

David J. Spinosa, MD

4:30PM

FEATl ' I~EI> ASS I R\cT

Cummentatur: Bal't L J)nlmatch, ~10

Abstract No. 126

Endovascular Placement of Extraluminal Bypass Graft in the Superficial Femoral Artery: A New Concept. Z. Qian, LSU Health Sciences Cenlel; New Orleans, LA, USA ·J. Lopera ·R. U ·H. FerrahW. Maynar ·w. Castaneda

PURPOSE: A new concept oftbc cndovascular placement of an extraluminal bypass graft (EPEG) wa tested in the SFA of canine models , in an attemp t to e 'pant! the cope of eridovascular therapy in the treatment of peripheral vascular

SI87

S188

lesions. Thi tudywas to evaluate the technical rea ibility o~ EPEG in a canine model.

'MATERJALSAND lvlETllODS: Thc EPEG was performed in S dogs. An 8-F introducer sheath was placed into the external il iac artery th rough the carotid artery. Dital ipsilateral SFA! access was percutaneou Iy established with a 5 F sheath Embolization ofthe mid-segment of the FA was achievedb~ placing c iL. Through the 5 F sheadl, a Chiba needle was directed to intentionally perforate the medial wall ofthe di ta~ SFA to create a track adjacent to the SFA within the oft! tissues. A coaxial needle with a catheter heath wa, advanced through the carotid sheath and used to perforate the proximal SFA medial wall. The need le wa exchanged for a snare used to grasp the wire placed from the distal femoral acces . The snared wire was puUed into the carotid sheath in a through­f\nd-lirrough fa hion. The wire \Va then exchanged for a supen stiffwirc. After the track between the two ascular puncture ~ites wa dilated with an angioplasty balloon, a 5 mm xl 0 crn Viabahn wa deployed between the conti guous arterial egments to e tablish the "extraluminsl bypa ". The animals

were followed angiographically at I , eek, I 1110nth and 3 months after the procedure and ultrasonographically monthly.

RESULTS: Technical uccess was achieved in all three animals. Angiogram perfoTIned immediately after bypas grafting showed tbat the grafts were patent. Although a hematoma developed arollnd thc popliteal puncture siles, all three animals were able to walk within 20 hour after the procedure. Angiography and ultrasound Doppler howed that all bypass graft were palent during the 3 months follow-up period. Follow, lip of these animals continues as the Uldy progre e.

CONCLUSION: EPEG i technicaJly rea ible. Follow up results demonstrate high , hort-term patency rates. This cone pt can expand the scope of endovascular therapy and Illay also be appli ed to the endovascular creation of A-V 'fistula for hemodialysis.

4:45PM Abstract No. 127

Technique and Long-Term Results of Iliac Artery Stenting for Chronic Total Occlusion. K. Kichikawa, Nara Medical University, Kashihara, Nara, Japan" W. Higashiura os. Sakaguchi -r. Nagata-K. Nishimine-H. Nishiofilku, et al.

PURPOSE: To evaluate the technique and results of iliac artery stenting for chronic total occlusion in a patient cohort with a > 4-year median follow-up.

MATERIALS AND METHODS: One hundred fifteen consecutive patients with 120 iliac artery complete occlusions (mean length; 9.9cm) underwent recanalization with stent. For the occlusion in common or common and external iliac artery, recanalization was first attempted from the ipsilateral side. If the occlusion could not be crossed, it was traversed from the contralateral side. If the wires from both directions ended subintimally in the lesion, the wire from the contralateral side was caught with snare wire from the ipsilateral groin. For external iliac artery occlusion, recanalization was attempted from the contralateral side. In 38 lesions, UK infusion and balloon angioplasty followed by stenting was performed. In 82 lesions primary stenting was performed. Patients were followed with ABI measurement, US Doppler and DSA. The period of follow-up was 2-173 months (median 49). Initial outcome, complications and cumulative patency rate and reintervention were analyzed.

RESULTS: Recanalization was possible in 119 of 120 (99%) lesions. Complications occurred in 5 (4.3%) patients. Distal emboli occurred in 3 patients, which were successfully treated by fibrinolysis and balloon angioplasty. RupUlre of EIA occurred in 1 patient, which was repaired using covered stent. In I patient, the wire was destructed during manipulation, which was fixed to the arterial wall by implanting a stent. There were II late recurrent lesions at a median 7 months (range I - 72). The recurrent lesions were treated with intervention in 9 limbs and surgery in I limb, and I patient refrained from further intervention. Primary and secondary patency rate were 91.2% and 99.1 % at3 year and 88.7% and 97.6% at 5 year. There was no significant statistical relationship noted between the probability of recurrence and the lesion length.

CONCLUSION: The present sUldy suggests that percutaneous recanalization of chronic total occlusion of iliac artery with stent placement provides high technical success rate and acceptable long-term results even in long-segmental occlusions.

4:56PM Abstract No_ 128

Chronic Mesenteric Ischemia: Role of PTA/Stenting in Celiac and SMA Disease, D.£. A !lie, Cardiovascular Institute of the South, Lafayette, LA. USA-c.;. Hebert-MH. Khan"MA. Khan"A.A. Allie ·C.M Walker

PURPOSE: Surgical revascularization for chronic mesenteric ischemia (CMl) is effective but carries high mortality (3-14.7%) and morbidity (8-44.7%). Percutaneous balloon angioplasty (PTA) alone carries a high recurrence rate (12-60%; mean = 26%). Sparse data exist regarding PTAlstenting in CMI therefore we report our immediate and mid-term experience. i MATERIALS AND METHODS: Between January 1998 and' March 2003, 74 visceral artery stenosis [45 superior mesenteric (SMA) and 29 celiac trunk (CT)] in 50 patients underwent PTA/stenting. Abdominal pain and weight loss were present in 46/50 (92%) and 43/50 (86%) respectively. A transfemoral approach was successful in 39/45 (87%) SMA and 24/29 (83%) CTwith 11174 (15%) requiring transbrachial vascular access. 45174 (61%) vessels had 6-month duplex ultrasound (DU) and 32174 (43%) angiography at a mean follow-up (FU) of22 months (range 7-57).

RESULTS: Immediate procedural success was achieved in 71 / 74 (96%) with > 90% clinical success; pain relief42/46 (91 %) and weight gain 39/43 (91 %). There were no 30-day periprocedural deaths or major complications with 4174 (5.4%) minor « 2 em) vascular access hematomas. 15177 (19%) vessels available for objective FU developed > 50% restenosis [DU 10/45 (22%) and angiography 5/32 (16%)] . 12/13 (92%) underwent successful repeat percutaneous revascularization (3115 UJ1treated); 8112 (67%) were treated with excimer laser (Spectranetics, Colorado Springs, CO) assisted PTA. The J, 2, and 3-year symptom free survival rates were 41 /45 (9 J %), 37/42 (88%), and 28/34 (82%) respectively.

CONCLUSION: SMA and CT PTA/stenting is a safe and effective treatment for CMI offering excellent procedural success and acceptable mid-term clinical success. However, it is associated with moderate restenosis oftentimes requiring a secondary reintervention.

5:07PM Abstract No. 129

Temporary ZA-Stent - Clinical Study. ZA. Kavleladze, CELT, Moscow, Russian Federation-D.? Dundua·S.A. Drozdov·D.S. Kartashov·K. V. Bylov·A.M Babunashvili

PURPOSE: To evaluate the feasibility and safety of new temporary vascular ZA-stent.

MATERIALS AND METHODS: 20 temporary ZA-stents were implanted in 20 patients with symptomatic iliac artery stenosis. Stents were retrieved percutaneously 7 days later. S and 10 mm diameter modified ZA-stents (W. Cook Europe NS, Denmark) with lengths from 40 to SO mm were implanted in 9 common and II superficial iliac arteries. Stents were deployed and retrieved via SF delivery system. Clinical examination included: serial ABI measurements, duplex sonography before, after implantation of the stent, immediately after retrieval and I, 3 and 6 months later. Quantitative angiography in all patients was performed before and immediately after stent implantation, before and after retrieval of the stent 7 days later. 6 month control angiography was performed for 14 patients.

RESULTS: All 20 stents were implanted and retrieved without stent thrombosis, late migration, damage of distal arterial embolization. There were no cases oflate thrombosis or need for TVR. The mean MLD of the target artery reached 7.S ± 0.4 mm after stent implantation and did not change significantly after stent retrieval. ABI increased from 0.5 ± 0.04 up to 0.9 ± 0.05 after implantation of the stent, and did not change significantly 6 months later. Calculated transstenotic pressure gradient by Doppler decreased from 40 ± 13 mm Hg to 5 ± 2 mm Hg after stent implantation and did not increase during the follow up. 6 months angiography did not reveal restenosis or significant reduction of MLD.

CONCLUSION: Temporary ZA-stent implantation and retrieval in patients with peripheral vascular disease is technically feasible and safe. 6 month follow up revealed sustained clinical benefit.

5:18PM Abstract No. 130

Initial Experience with an IVUS-Guided Transmembrane Puncture Device to Facilitate Recanalization of SFA­Occlusions. D. Scheinert, University of Leipzig - Hearl Center, Leipzig, GermanY's. Scheinert ·A. Schmidt·S. Braunlich ·G. Biamino

PURPOSE: Failure to recanalize chronic superficial femoral al1ery occlusions is caused in the majority of the cases by subintimal passage of the occlusion with inability to re-enter the true lumen with the guide-wire. The present study details our initial experience with the CrossPoint TransAccess crossing device (Transvascular Inc.) to facilitate recanalization of total femoral artery occlusions.

A1ATERIALS AND METHODS: 14 consecutive patients (1 I male, mean age 63 years) who failed recanalization attempts of chronic superficial femoral artery occlusions (mean occlusion length 12.7 cm) with standard techniques were re-scheduled for a secondary recanalization procedure. The CrossPoint device is a 6.2F rapid exchange catheter, which tracks over an 0.014" -wire. A 20MHz phased array IVUS transducer is integrated into the tip of the catheter allowing visualization of the vessel morphology. Using the guidance of the IVUS crossectional image supported by color-flow imaging, the true lumen is punctured with an integrated 24G needle allowing delivery ofa second 0.014"-wire.

RESULTS: Re-entry into the true lumen was successfully accomplished in all cases without complications. In 4 cases with severe calcification, predilatation of the false channel was necessary to allow advancement of the CrossPoint device. Furthermore, in patients with severe calcification multiple puncture attempts were necessary to penetrate the dissection membrane. A procedural success «25% residual stenosis) could be achieved in all cases after predilatation and stenting of the occlusion with self-expanding nitinol stents. There were peri procedural complications related to the device.

CONCLUSION: The CrossPoint device is an effective and safe tool to facilitate true lumen re-entry during recanalization of total superficial femoral artery occlusions.

5:29PM Abstract No. 131

Complement Inhibitory Stent Coating Reduces Inflammation and Neointima Formation in New Zealand White Rabbits. G. Tepe, Department of Diagnostic Radiology, Tuebingen, BW, Germany-T Dietrich·W. Schober·CD. Claussen-S.H. Duda

PURPOSE: Inflammation has been described as a major component of restenosis occurring after stent implantation. The purpose of this study was to investigate the role of inflammation during stent placement and the value of complement inhibition by stent coating with C IIC3 esterase inhibitor.

MATERiALS AND METHODS: Animals were randomly assigned to one of 5 treatment groups and sacrificed after 4 days or 6 weeks, respectively. After 4 days uncoated bare metal control stents [C] (n=S) were compared with polyvinylpyrrolidone coated stents [P] (n=7), and after 6 weeks C stents (n=7) were compared with P stents (n=7) and P C I IC3 esterase inhibitor coated stents [PI] (n=7) . All morphometJic measurements were performed on Elastica-van­Gieson stained segments, and the inflammation index (adapted from Komowski et al.) was assessed using hematoxylin-eosin staining.

RESULTS: No acute or subacute thrombosis was observed. After 6 weeks neointima fonnation was I.S ± 0.6 mm2 (bare stent) . and 2.6 ± 1.3 mm2 (P) in the control groups. In the treatment group (PI) neointima reduction was detectable (1.5 ± 0.6 mm2). Inflammation was increased by P coating. In the PI stents the inflammation was significantly reduced compared to the P stents. Inflammation was noted 4 days after stent implantation with granulocytes whereas mononuclear infiltrates (lymphocytes, plasma cells) were predominant after 6 weeks.

CONCLUSION: Inflammation is a key component of restenosis following stent administration. Inflammation can be reduced by C I/C3 esterase inhibitor coated stents. Because the hydrogel coating itself induced inflammation, this coating seems not to be the ideal for intravascular use.

5:40PM Abstract No. 132

Reduction of Tissue Hyperplasia after Stent Placement with Radioactive Balloon Dilation in Canine Urethral Model. 1. Shin, Asan Medical Center, Seoul, Korea·H. Song ·D. Moon'S. Oh' W. Choi'K Sung

PURPOSE: To evaluate the feasibility and efficacy of beta­radiation therapy with a rhenium-ISS­mercaptoacetyltriglycine C88Re-MAG3)-fi lied balloon to reduce tissue hyperplasia secondary to stent placement in 14 canine urethras. S189

MATERIALS AND METHODS: The four dogs with radioactive balloon dilation immediately after stent placement were sacrificed four weeks (group I, n=2) or eight weeks (group II, n=2) later. Five dogs with radioactive balloon dilation two weeks after stent placement were sacrificed four weeks following stent placement (group III). The remaining five dogs witb conventional balloon dilation immediately after stent placement were sacrificed four weeks later; control group (group IV). We obtained retrograde urethrography (RGU) during follow-up and histologic findings (number of epithelial layers, tbickness of granulation tissue and papillary projection, and degree of submucosal inflammatory cell infiltration) at botb the in-stent and out-stent areas for each stent after sacrificing each dog. The Mann-Whitney U test was performed to test the significant difference of the RGU or pathologic findings between radioactive balloon dilation (group J to III) and conventional balloon dilation (group TV). When all four groups were compared, the Kruskal-Wallis test was used to test for a difference among the means.

RESUL TS: There were no complications such as stent migration or blockage of the stent. RGU and the histologic findings showed less tissue hyperplasia in the radioactive balloon group than in the conventional balloon group in all comparisons with statistical significance in six of eight pathologic comparisons. There were significant differences in five of eight pathologic comparisons wben the mean values of each pathologic item were compared among the four groups. Group II showed the least tissue byperplasia in the histologic fmdings.

CONCLUSION: Beta-irradiation using 188Re-MAG3-filled balloon dilation was feasible and effective in reducing tissue hyperplasia secondary to stent placement in a canine urethral model.

Scientific Session 26 Oncology

Sunday, March 28, 2004 12:30 PM ·2:00 PM Moderator(s): Andreas Adam, ME, BS, FRCR

Marshall Hicks, MD

12:30 PM Abstract No, 133

Relative Thermosensitivity of Cytotoxic Drugs Commonly Used in Transarterial Chemoembolization of Liver Tumors. K. Ahrar, M D. Anderson Cancer Center, Houston, TX, USA 'R.A. Newman-MJ. Wallace'S. Gupta'F.A. Morello K C Wright

PURPOSE: There is a trend towards multimodality treatment ofiarge hepatocellular carcinoma tumors with combination of transarterial chemoembolization (TACE) and radiofrequency ablation (RFA). Cytotoxic activity of anticancer drugs used in TACE may be adversely affected by high temperatures attained during RFA. Our goal is to report the relative thermosensitivity of anticancer agents commonly used in TACE.

MATERiALS AND METHODS: We examined the relative cytotoxicity of cisplatin, doxorubicin HCL, and mitomycin on human colon (HT 29) and human lung (A 549) adenocarcinoma cells before and after heating each chemotherapeutic agent. The drugs were exposed to 120°C for a period of2 hours. Drugs were then cooled and added to cells. To assess the effect of absolute temperature on the relative cytotoxioity of doxorubicin HCL and mitomycin, each drug was exposed to various temperatures (60, 80, 100, and 120°C) for 2 hours. Drugs were then cooled and added to cells. Finally, to evaluate the effect of exposure duration on

S 190 relative cytotoxicity of doxorubicin HCL and mitomycin, each

• drug was heated to 120°C for a variable period of time (15,30, 60,90, and 120 minutes). Drugs were then cooled and added to cells. After 72 hours of incubation, cell growth inhibition was assessed by MTT assay and IC 50 was calculated for each cytotoxic agent in each experiment.

RESULTS: After heating the drugs to 120°C for a period of 2 hours, the relative cytotoxic activity of cisplain, doxorubicin HCL, and mitomycin decreased by a factor of 1.35 (range, I to 1.75),9.5 (range, 8.5 to 10.5), and 7.05 (range, 3.5 to 12), respectively. With incremental increases in temperature, the cytotoxic activity of doxorubicin HCL and mitomycin decreased. Similarly, with incremental increases in duration mf exposure to heat, the cytotxic activity of the two drugs decreased.

CONCLUSION: Cytotoxic activity of cisplatin is not affected by exposure to heal. In contrast, cytotoxicity of doxorubicin HCL and mitomycin was adversely affected by temperature and duration of exposure to heat.

12:41 PM Abstract No, 1~4

Combined Chemoembolization and Radiofrequency Ablation of Liver Tumors: One-Year Follow-Up, R. Agarwal, University of Pennsylvania, Philadelphia, PA, USA-MC Soulen-T.W Clark'CM Tuite'S.W Stavropoulos 'J.I. Mondschein

PURPOSE: Radiofrequency ablation (RFA) has a high local failure rate for liver tumors >2.5 cm. We evaluated the one­year outcome after chemoembolization and RFA ofliver tumors up to 6 cm in diameter.

MATERiALS AND METHODS: 32 tumors (18 HCC, 14 metastases) in 26 patients were chemoembolized with CAM} EthiodoVPYA, followed by RFA the next day. Patients with bilobar disease had the other lobe treated one month later. 21 patients had one tumor, 4 had two, and one had three tumors ablated. 14/32 tumors were treated using a 3.5 cm radial array and a 90W generator (Radiotherapeutics), 18/32 were treated with a second-generation 4 cm array and a 200W generator. 5 tumors were treated with one burn, 27 with mUltiple overlapping burns. Follow-up laboratory studies, tumor markers, clinical assessment, and imaging were performed at one month, then every 3 montbs. All patients have been followed until transplant, death, or a minimum of 12 months.

RESULTS: Technical success was 100%, with rolloff achieved in all cases. Complications requiring rehospitalization included 2 cases of bacteremia, one patient developed a bilocutaneous fistula, and one left lobe infarction . One patient developed a large groin hematoma that did not require intervention. Tumor markers were evaluable in 18 patients; there were 3 CR 's, 11 PRlMR's, 2 remained stable, and 2 progressed. Lesion size was 4.3 ± 1.1 cm initially, 5.8 ±1.4 cm one month after RFA (p<0.05 , paired t-test), 5.0 ± 1.2 cm at4 months, and 5.5± 0.9 cm at 7 months. 4/32 tumors had residual viable tissue on post-treatment imaging, and 2 developed local failure at 10 and 11 months. Four patients underwent transplantation within 6 months. 64% of the remaining 22 patients progressed elsewhere within 12 months; 9 had intrahepatic progression at new sites, 3 had extrahepatic progression, and 2 had both intra-and extrahepatic progression. One non-transplanted patient had liver recurrence after 37 months. With a mean follow-up of 13 months, overall and disease-free survival at one year are 50% and 18%.

CONCLUSION: Chemoembolization and RFA provided durable local control of26/32 liver tumors up to 6 cm (81 %). In the absence of a transplant, progression at other sites remains a therapeutic challenge.