Meet the Author Session I

Friday, March 26, 2004 7:30 AM - 8:30 AM

Poster No. 210

Percutaneous Closure of Interatrial Defects in 1l(i5 Patients: Midterm Results and Complications. M Reschke, CVC, Franlifurt, Germany-s. Ostermayer' F Buescheck'Y Bayard·H. Sievert

PURPOSE: Interatrial defects have to be closed either for hemodynamic reasons or for prevention of recurrent paradoxical embolism . We report on complications that occurred during the procedure or follow up.

MATERIALS AND METHODS: Between August 1994 and October 2003 transcatheter closure of interatrial defects was attempted in 1166 patients, aged 13 to 90 years {mean 48 ± 15). The persistant foramen ovale was suspected to have caused 1- 9 embolic events per patient (594 strokes, 437 TIA, 39 peripheral embolisms). The annual recurrence rate before PFO closure was 26.8%. Balloon sizing of the defects revealed a diameter between 2 and 36.6mm.

RESULTS: Closure of the defect was successful in 1153 of 1165 patients. Eight different devices (232 STARFlex, 52 SIDERIS, I Rashkind, 232 HELEX, 1 ASD Star, 27 CardioSEAL, 42 ASDOS, 30 Angelwings, 548 Amplatzer) have been used. Ten patients died during follow up, only two of these deaths were related to the procedure. A thrombus formation was found in 18 patients, 15 of them remained asymptomatic. In two of these patients the occluder was removed surgically. Another 19 patients. underwent surgery due to pericardial effusion (8), malposition of the devicel implantation impossible (5), embolism (2), residual shunting (2) sepsis (I). 53 patients developed transient atrial fibrillation. 12 patients underwent surgery before transcatheter closure. In 22 patients the metallic frame of the occluder was broken without sequelae. Annual recurrence rate after defect closure was 1.5%.

CONCLUSION: Transcatheter closure of interatrial defects is a safe and feasible procedure. Severe complications are rare. With newer devices the complication rate. is lower than with older devices.

Poster No. 211

Uterine Artery Embolization for Pedunculated Subserosal Fibroids. T. Katsumori, Saiseikai Shiga Hospital, Rillo, Shiga, Japan-T. Mihara·K. Akazawa

PURPOSE: To assess the outcomes of uterine artery embolization (UAE) for pedunculated subserosal fibroids.

MATERIALS AND METHODS: Over 69 months, 190 consecutive women underwent UAE using gelatin sponge particles 0.5 to 1.0 mm in diameter alone for symptomatic uterine fibroids , which were confirmed with baseline sagittal and axial MRI in all women . We defined pedunculated subserosal fibroids when the diameter of the stalk was narrower than 50% of the diameter ofthe fibroid. Of these 190 women, 12 had one or more pedunculated subserosal fibroids . Mean age of the women was 42.3 years old (range, 34 to 48 years old). The follow-up period ranged from 2 to 48 months (mean 16.1 months). Change in bulk-related symptoms and tumor

and uterus reduction rates were assessed using questionnaire and serial MR! .

RESULTS: Fifteen pedunculated subserosal fibroids were identified in 12 women with baseline MR!. Tumor diameter ranged from 4 to 15.5 cm (mean 8.3 cm). The stalk diameter ranged from 2 to 4.8 cm (mean 2.9 cm). There have been no serious complications including separation of the tumors from the uterus, torsion of the tumors or infection after UAE. Enhanced MRI obtained one week afte r UAE showed complete devascularization of the tumors was achieved in 73% (11 11 5) of the tumors. The mean tumor reduction rates were 39% (range, 12 to 70%) at 4 months after UAE and 53.% (range, 31 to 85%) at I year. The mean uterus reduction rates were 35% (range, 15 to 47%) at 4 months after UAE and 47% (range, 35 to 60%) at I year. Marked or moderate improvement of bulk-related symptoms were achieved in 100 % (llll!) of women at 4 months after UAE and in 100 % (SIS) at I year, and 100 % (2/2) at 2 years. One hundred % (11/11) of women were satisfied with the outcomes at 4 months after UAE, 100% (SIS) at I year, and 100 % (2/2) at 2 years.

CONCLUSION: We found no serious complications after UAE for pedunculated subserosal fibroids with a stalk diameter 2 cm or larger. Successful outcomes can be obtained for such tumors.

Poster No. 212

Endoprosthetic Bicuspid Venous Valve: Long Term Results. D. Pavcnik, DOller Institute, Portland, OR, USA' L. Machan·J. Kaufman-B. Uchida ·FS. Keller ·J. Rosch

PURPOSE: To report long term results of initial clinical experience with endoprosthetic bicuspid venous valve (BVV).

lvfATERIALS AND METHODS: Three patients with severe deep chronic venous insufficiency (DC VI) were treated with a BVV as part of a safety trial. The valves were implanted percutaneously by right internal jugular approach using an over the wire 9F delivery system. Descending venograms of the involved limb were done in the upright position. The proximal and distal femoral vein (FV) diameters were measured in two projections in the area of the intended vein implantation. The valves selected were 1-2 mm larger than vein diameter. The BVVs were studied for function and stability in the up­right position by injecting contrast medium above the BVY. Follow up descending venograms were done at two-months and duplex ultrasound at 1, 3, 6 and 12 months.

RESULTS: Patient #1: 15 mm BVV was deployed in the proximal FV in 38 year old male with an active ulcer (CEAP C-6). Follow up descending venograms at 2 month and duplex ultrasound at I , 3, 6 and 12 months demonstrated no spontaneous reflux through the valve into FY. Patient's active ulcer was found healed at one month after BVV implantation and did not recur at one-year follow-up (CEAP C-5). Patient #2 : There was no change in his symptoms. Patient # 3. The I I mm BVV placed into the distal left FV resulted in about 30% valve tilting. Immediate follow up venogram showed good valve function with minimal leak. Patient showed immediate and I year clinical improvement, mainly decrease ofleg pain and edema. The BVVs remained patent without thrombosis or other complications. Proper sizing and proper placement of the valves was critical to their function.

CONCL USION: A manufactured, percutaneously implantable, nonimunogenic and nonthrombogenic bioprosthetic venous valve that remains patent and competent over time is an attractive alternative to direct venous valvular

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reconstruction or transplantation. Although a great deal of work remains to be done, these very promising early results indicate that the development of a BVV for transcatheter placement is more than just feasible. Currently we are testing a second generation BVV to eliminate the occasional valve tilting.

Poster No. 213

Acetic Acid Ablation of Hepatic Tumors: Mid Term Results. J.H. Rundback. Columbia-Presbyterian Medica{Center, New York. NY, USA ·G.N. Rozenblit·S. Gyftopoulos·J. Susman"z. Haskal·J. Weintraub. et al.

PURPOSE: To evaluate the mid term clinical outcomes after percutaneous acetic acid ablation (AcA) of primary and metastatic hepatic tumors.

MATERlALS AND METHODS: Since 2/2000, 33 patients (22 male, mean age 63, r 43-78) with 40 histologically proven hepatic tumors (28 HCC, 12 mets) have received 69 AcA treatments under CT guidance using 21 gauge endhole needles. Maximal mean tumor diameter was 43 mm for BCC (r 20-98) and 36 mm for mets (r 20-65); 18 tumors measured < 4 cm. AcA was perfonned in sequential treatment sessions until the treated lesion was either entirely ablated or viable despite treatment. Follow-up imaging was obtained at 1-, 3-, 6-, and q 12-months after treatment completion.

RESULTS: Patients received an average of 1.8 treatment sessions (r 1-4) with 21 /40 (53%) lesions having single treatment. Mean injected volume was 7.6 ccllesion and 9.2 ccl patient. On follow-up (mean 5.4 mths, r 1-36), local recurrence occurred in 54%, and 13 patients received adjunctive treatments (4 OLT, II chemoembolization, I RFA). Recurrence was noted in 4/10 tumors < 4cm and 13/23 24cm (p=0.03). By Kaplan-Meier method, overall cumulative survival was 83%,68% and 68% at 3 months, 1- and 2-years, respectively. Major complications occurred in 4/58 (6.9%) procedures (one each - hemothorax, peritoneal bleed, aspiration, transient ARF, death).

CONCLUSION: AcA is safe and well tolerated. Larger lesions often require additionaL adjunctive therapies for complete tumor response. Unifonn intratumoral diffusion remains a challenge. 0£mEE1

Meet the Author Session II

Friday, March 26, 2004 8:30 AM - 9:30 AM

Poster No. 214

Femoropopliteal Outcomes with Cryoplasty: Final Results of the CryoVascular Safety Registry. J.R. Laird, Washington Hospital Center, Washington, DC, USA ·G. Biamino ·MR. JajJ

PURPOSE: A novel form of angioplasty, called cryoplasty, combines traditional balloon dilation with short-tenn vessel cooling in a system that uses nitrous oxide as the inflation medium. The cryoplasty balloon has a target surface temperature of -I OCC and simultaneously dilates to 8atm for -30 seconds per inflation. In vitro and in vivo preclinical studies, as well as flfst-in-man clinical cases have demonstrated this device to be safe and effective for femoropopliteallesions . This study was designed to validate our initial experience in a

large, controlled, FDA-approved registry of patients with femoropopliteal arterial disease.

MATERIALS AND METHODS: This study was a non­randomized, multi-center registry of I 00 patients with stenotic or occluded superficial femoral and popliteal arteries. Inclusion criteria required the length of the lesion to be :::;1 Ocm and for the limb to have at least single vessel run-off. The treatment strategy called for lesions to be treated with stand-alone cryoplasty, with stenting reserved for bailout indications only. Cryoplasty was performed with the PolarCath system in all patients (CryoVascular Systems, Los Gatos, CA). The primary endpoints ofthe study were acute procedural success and 9-month target lesion revascularization (TLR). The secondary endpoints included 3-month and 9-month binary restenosis as assessed by arterial duplex scans. All scans were analyzed by a central core lab.

RESULTS: A total of 102 patients were enrolled at 16 sites. The acute procedural success rate (defined as <30% residual angiographic stenosis and <50% residual stenosis by Duplex) was 94% (96/102). Only 9% (9/102) of the patients required stenting. Three months after cryoplasty, the clinical patency rate was 100%. Nine-month TLR and duplex-driven restenosis rates in the complete data set will be presented at the annual meeting.

CONCLUSION: Cryoplasty safely dilated stenotic and occluded lesions in femoropopliteal arteries with optimal acute results and minimal need for stenting. Clinical outcomes at 3 months were excellent. Nine-month data are necessary to support the favorable outcomes previously reported with first-in-man cryoplasty cases.

Poster No. 215

Mechanisms of Healing and Endoleak Formatio'n Following Endovascular Treatment of Abdominal Aortic Aneurysms. G. Soulez, CHUM-Notre Dame, Montreal. QC, Canada·S. Lerouge·l. Salaskine ·J. Raymond·R. Guidoin"Vr. Oliva, et al.

PURPOSE: To analyze mechanisms of healing and endoleak formation following stem-grafting in animal models of endoleak type I and II.

MATERlALS AND METHODS: Three different aneurysmal models using venous patch were created in dogs: I, A model of endoleak type II in the abdominal aorta by creating a fusiform aneurysm and preserving the patency of collateral arteries and implanting a Talent extension (n=3). 2. A bilateral model in iliac arteries (n=3) of endoleak type I on one side and type II on the contralateral side by creating a fusiform aneurysm on both corrtrnon iliac artery followed by reimplantation of the caudal arteries in the aneurysmal sac. Leak type I was obtained by inducing a partial defonnation on the proximal end of a Jostent graft whereas endoleak type II was obtained after full expansion of the Jostent. 3. Control iliac aneurysms without endoleak (n=3). Follow-up Doppler ultrasound and angiographic examinations were performed, Animals were sacrificed at 3 months and the aorta or iliac arteries were harvested. Tissue-implant interface and surrounding thrombus were analyzed macroscopically and by light microscopy on histologic sections prepared using the Exakt cutting-grinding.

RESULTS: Doppler and angiographic examinations confmned the reproducibility of endoleak type I or II models, On histologic examination, incorporation was observed on proximal and distal necks in leak type II model, whereas in leak type I,