Abstract No. 207: Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: Long-term results from a prospective single-center randomized trial

cases respectively. All procedures were carried out via femoral artery route with Seldinger’s technique. Chemoembolizations was performed while adrenal neovascularity was confirmed and a microcatheter was superselectively used if necessary. All patients were followed-up with CT or Ultrasonics. Results: 38 sessions of adrenal arterial chemoembolizations was successful in 31 (96.9%) of 32 patients and failed in one case because the tumor feeding artery was not found. 1⬃2 weeks later, the backache was alleviated or disappeared in all 18 symptomatic cases. PR and NC were in 5(15.6%) and 17(53%) respectively. 22 patients survived from 6 to 41 months and median survival was 11 months. There was no severe complications in this series. Conclusion: Adrenal arterial chemoembolizations is a good conservative therapy for adrenal tumors. It could effectively control the mass growth, alleviate pain, and prolong the patient survival. 5:24 PM

Abstract No. 205

Results of varicocele embolization using sotradecol foam and fibered coils M.H. Arici, E. Reiner, J. Kirsch, H.R. Mojibian, J. Pollak, K. Henderson, R. Weiss, R.I. White; Yale University School of Medicine, New Haven, CT. Purpose: To describe the results of an improved method for the treatment of varicocele, using sotradecol (STS) foam and pushable fibered coils.

Conclusion: We believe our improved results, compared to earlier reports, are due to greater STS foam penetration of ISV collaterals after placement of coils in the inguinal portion of the ISV. Using this technique, there is no need for left groin compression and future access to the ISV is preserved if recurrences occur.

In vivo deformation and arterial distribution of Embozene vs Embosphere microspheres in sheep kidney and uterus V. Verret1, J. Pelage2, M. Wassef3, S. Ghegediban3, J. Golzarian4, A. Laurent1,5; 1APHP Lariboisie`re Hospital, University Paris 7 Denis Diderot, Faculty of Medicine, Paris, France; 2APHP Ambroise Pare´ Hospital, Boulogne sur Seine, France; 3APHP Lariboisie`re Hospital, Paris, France; 4University of Minnesota, Minneapolis, MN; 5 APHP/INRA, Jouy en Josas, France. Purpose: To compare the in-vivo localization and deformation of Embosphere (ES) and Embozene (EZ) in sheep renal and uterus arteries. Materials and Methods: Twelve sheep were selectively embolized in one renal artery and bilateral uterine arteries using ES 500-700um ,700-900um and EZ 700um and 900um microspheres. All animals were sacrificed at 72 hours and pathologic examination was conducted. The renal vasculature was partitioned into 5 zones (renal artery and first branches, interlobar, junction, interlobular artery, interlobular superficial) and the uterine vasculature into 4 zones (proximal, perimyometrium, myometrium, endometrium). In-vivo localization and deformation was measured for both embolic agents. Results: 491 vessels were analysed. EZ occluded more distally than ES in the renal vasculature (p⬍0.0001), and in the uterine vasculature (p⬍0.0001). In kidney, 44% of ES 500-700 and 76% of ES 700-900 were located in the interlobar artery while 55% of EZ 700 and 44% of EZ 900 were located in interlobular superficial arterioles. In the uterus, 75% of ES 500-700 and 100% of ES 700-900 were located in the perimyometrium whereas 92% of EZ 700 were located in perimyometrium, 23% of EZ 900 were located in endometrium. EZ deformation was significantly higher vs ES in the renal (p⬍0.0001) and in the uterine vasculature (p⫽0.0473). EZ deformation increased from proximal to distal in location for both kidney or uterus (p ⬍0.0001, each), and correlated negatively with vessel diameter (Rho ⫽ -0.623 p⬍0.0001). Conclusion: Embozene microspheres had a higher in vivo deformation which resulted in more distal occlusion and localization within the vascular network compared to reference Embosphere microspheres. The difference in in-vivo deformation and location between Embosphere and Embozene may influence devascularization and therefore should be considered when selecting microspheres for clinical practice.

Scientific Session 23 Peripheral Vascular Disease and Aneurysms Wednesday, March 17, 2010 4:00 PM - 6:00 PM Room: 7/8 4:00 PM

Abstract No. 207

Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: Long-term results from a prospective single-center randomized trial S. Spiliopoulos, K. Katsanos, A. Diamantopoulos, D. Karnabatidis, D. Siablis; University Hospital of Patras, Patras, Greece. S79

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Results: 55 consecutive patients (mean age 21 years) were treated successfully during 58 procedures. The primary technical success rate was 57/58 (98%). There were no procedure related complications but 10/55 (18%) had mild self limited pampiniform phlebitis. Follow-up by ultrasound and/or physical exam is complete in 47 patients and 8 patients did not return for follow-up. There were 3 recurrences and 2 of 3 have been successfully retreated.

Abstract No. 206

Scientific Sessions

Materials and Methods: Between September 2004 and August 2008, 55 patients with varicoceles associated with pain, testicular atrophy or infertility were treated as outpatients by transcatheter embolization of the internal spermatic vein (ISV) using pushable fibered coils and STS. Follow up at 6 months was performed by ultrasound and/or physical exam. Outcomes were tabulated with human investigation committee approval. Our improved technique included right femoral vein access with a 7 French guiding catheter and distal catheterization of the ISV with 5 French glide catheter or microcatheter. Pushable fibered coils were packed into the proximal ISV at the level of the inguinal canal. Undiluted contrast material was injected during a valsalva maneuver, distally into the ISV beyond the inguinal set of coils and into parallel collateral veins which were not apparent on the initial venogram. 2% STS foam was injected in 2-3 ml aliquots to displace the static contrast material, until parallel collaterals were no longer apparent. After the deployment of a second set of coils at the level of the upper 1/3 of the sacroiliac joint, additional foam was injected.

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Purpose: To report the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Materials and Methods: The study was approved by the Hospital’s Scientific Committee and all patients signed an informed consent. 50 diabetic patients (41 males, mean age 68 years) were randomized to undergo either PolarCath Cryoplasty (Group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (Group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as ⬍30% residual stenosis without any adjunctive stenting. Regular clinical and angiographic follow-up was scheduled at 6 months, 1 year and annually thereafter. Primary clinical endpoints were patient survival, limb salvage and repeat intervention events of the treated artery. Primary angiographic endpoints included primary patency and angiographic binary restenosis (⬎50%) of the treated lesion. Multivariable Cox model analysis (stepwise backwards logistic regression) was performed to adjust for confounding factors of heterogeneity. Results: Angioplasty technical success rate was 58% in group CRYO vs. 64% in group COBA (p⫽ns). Overall follow-up period was similar in both groups (32⫾9 and 32⫾2 months, respectively). After 3 years, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA) and limb salvage (95.8% vs. 92.1% in groups CRYO and COBA, respectively). Angiographic binary restenosis was similar between the 2 groups (HR: 1.31, 95%CI: 0.66-2.61, p⫽0.45). Primary patency was significantly lower in group CRYO versus group COBA (HR: 2.20, 95%CI: 1.12-4.31, p⫽0.02). Significantly more repeat intervention events because of recurrent symptoms were observed in group CRYO (HR: 2.49, 95%CI: 1.16-5.31, p⫽0.02). Conclusion: Compared to conventional balloon angioplasty, cryoplasty of the femoropopliteal artery in diabetic patients was associated lower primary patency and more clinically driven repeat procedures after long-term followup. 4:12 PM

Abstract No. 208

Single center experience with drug eluting stents for infrapopliteal occlusive disease in patients with critical limb ischemia A.M. Fischman, S.S. Shah, E. Kim, P. Stangl, F. Nowakowski, J.L. Weintraub, R. Lookstein; Mount Sinai Medical Center, New York, NY. Purpose: Drug-eluting stents (DES) have been shown to be effective in the treatment of coronary artery disease. This study reports a single center experience in the use of this technology in the treatment of infrapopliteal occlusive disease in the setting of critical limb ischemia. Materials and Methods: From October 2005 to September 2009, 53 patients (32 male, 21 female)(mean age 82, range 43-93) underwent implantation of drug eluting stents to treat a suboptimal angioplasty result in an infrapopliteal artery. All patients had symptoms of critical limb ischemia with Rutherford grade 4 (n⫽15), 5 (n⫽29) or 6 (n⫽9) disease at presentation prior to treatment. Angiographic, clinical and noninvasive vascular examination results were collected prospectively at regular intervals. Primary endpoints included technical success of the revascularization procedure, primary patency, freedom from major amputation and survival at follow up. S80

Results: 94 infrapopliteal drug eluting stents (80 sirolimus, 12 evirolimus, 2 paclitaxel) were placed in 53 patients (32 men, 21 women, mean age 82, range 43-93) to treat 60 angiographic lesions. Initial technical success rate was 100% with all treated lesions having less than 10% residual angiographic stenosis at completion of the procedure. The mean number of stents placed per patient was 1.62 (range 1-5). Stent diameter ranged from 2.5mm to 4mm. 35/53 (66%) underwent simultaneous femoralpopliteal intervention. 21/60 (35%) lesions treated were total occlusions. Mean follow up was 17 months (142months). Primary patency at 12 months was 45/55 (80%). Freedom from major amputation at followup was 90.6% (48/53) for the entire cohort, 100% (44/44) for patients with Rutherford category 4 and 5 disease. 30 day mortality rate was 1.9% (1/53). Overall mortality rate was 22.6% (12/53). Complete follow up data will be presented at the meeting. Conclusion: Placement of infrapopliteal drug eluting stents is safe and effective therapy following suboptimal angioplasty in patients with critical limb ischemia. This procedure has excellent technical success and demonstrates high primary patency and limb salvage rates. 4:24 PM

Abstract No. 209

Single center outcomes of selective percutaneous endografting L. Garcia1, B. Arslan2,3, U.C. Turba2, S. Sabri2, E.A. Ahmad2, J.F. Angle2, J.D. Adams2, K. Hagspiel2; 1 Surgery, University of Virginia, Charlottesville, VA; 2Radiology, University of Virginia, Charlottesville, VA; 3Moffitt Cancer Center and Research Institute, Tampa, FL. Purpose: To evaluate the safety and efficacy of selective percutaneous percutaneous endografting in a large single university institution. Materials and Methods: A retrospective review of all percutaneous TEVAR and EVAR cases from July 2006 until October 2008 was performed. There were 72 patients that underwent endografting with percutaneous closure of their arteriotomies using the Proglide arterial closure device during this time period. A previously described “pre-closure” technique utilizing two closure devices was used in all of these cases. Although this was not a prospective study, in all cases pre-procedure CTA findings of the common femoral arteries were reviewed as a practice pattern in our institution. Severe anterior wall calcifications, small femoral artery diameter, and severe surgical scarring were considered as contraindications for percutaneous closure. Only patients who had available CT Angiogram studies prior to and after endografting were included in the study. Patients were evaluated for hematoma, pseudoaneurysm formation, and degree of stenosis at the access site in comparison to pre-procedure imaging. Degree of stenosis was grouped into four catergories: 1) less than 10% 2) ⬎10% but ⬍50% 3) ⬎50% 4) occluded. All CTAs were reviewed by a board certified radiologist at our institution to eliminate bias. Results: A total of 50 patients had adequate follow up imaging to be included in this study. There were 77 common femoral arteriotomies that were closed with the proglide devices. Sheath sizes ranged from 18 French to 25 French. The average follow up time was 6 months. We achieved hemostasis in all femoral arteries that were closed percutaneously. There were no early or late bleeding com-