Scientific Session 1 Venous Insufficiency

Scientific Session 1 Venous Insufficiency Friday, March 26, 2004 12:30 PM - 2:00 PM Moderator(s): Janice Newsome, MD A/ex Powell, MD

12:30 PM

Abstract No.1

FEATCRE[) AHSTRACT

Commentator: Rohet·t .J. ;\lin, ;\11> ~ndovenousLaser

Treahnent: A MuItkenter Long-~erm Study. 'K. Todd, Southeast Vein and Lase/' Center, Dothan, AL, SA ·E. Mackay·H. Fronek·M. Isaaes ~onow-up

PURPOSE: Approximately 15% of men and.25% of women uffer from lower extremity superficial vi.mou insufficiency, commonly caused by an incompetent saphenofemora l j unclion (SFJ) and great saphcnou vein (GSY) refllLx. Surgica l venous ligation and stripping, the llsual treatment, has significant peri operative morbid ity, cost of hospita lization, extended recovery, and high failurelrecurrence rates. Endovenous laser treatment (EVLT®, Diomed), a'minimally invasive allemative, a been explored to reduce risk, morbidity, and co t. This was a retrospective, non-random ized, multicenter long-tean fo llow-up study to evaluate the etficacy ofEVLT® treatment ofGSV ret\ux. MATERiA LS AND METHODS: EVLT® was used to treat 270 incompetent GS\! . Patients ranged in age from 19-84 (mean, 57). Patienl inclusion criteria were: > 18 years of age, d iagnosis .via duplex ultrasound, and varicosities due to incompetent SFJ with OSV reflux. A 5F introducer sheath was inserted in to the GSV, then a 600pm laser fiber was advanced 2 -3cm below the SFJ, and perivenous anesthesia (0.05% lidocaine) was administered, followed by pulseo (~J2W) or conti.nuous (14W) laser energy (81 Onm; I cl)1!2~ec pullback rale). Follow-up occurred at 1, 3,6, and 1.2 months. !RESULTS: uccess rates ofGS V closure (no-flow) at varying follow -up periods included : 100% (2701270) at 1 month, 8.9% (2671270) at 3 months, 97.8% (264/270) at 6 months and 96.7% (2 61 /270) at 12 months; The 12 month recurrence rate of3.34% included 2.6% Wilh pulsed laser energy compared to 0.74% with con ti nuous laser energy. All recurrences were r oted prior to 9 month . Patients reported satisfaction wi th the procedure with improved appearance and quality of li fe. 'CONCL USION: The 12 month recurrence rate of 3.34% was superior to those reported for venous stripping and ligatio (30%) and high ligation alone (71 %). The overall 96.7-1 00% success rate compared favorably with those reported for·other minimally invasive techniques. Recurrence rates of 0-4.0% are comparable lo those reported for other EVLT® studies, as well as comparable or superior to other GSV treatment options; EVLT® proved to be a safe, effi cacious and cost effective means of eliminating GSV reflux.

12:45PM

Abstract No.2

Second Generation Bioprosthetic Venous Valve. D. Pavcnik, Dotter Institute, Portland, OR, USA'J Kaufman-B. Uchida'T Hiraki·L. Correa·J Rosch, et at.

PURPOSE: To evaluate deployment, stability and short-tenn function of the second generation BVVs in an animal model.

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MATERIALS AND METHODS: The small intestinal submucosa (SIS) square stent bicuspid venous valve (BVV) has shown the most promising results of all of the artificial venous valves developed. In long- term experimental studies in sheep, 25 valves were placed into the external jugular veins (EJV) and 88% exhibited good function, while 12% had decreased function due to valve tilting. Only 4% had partial thrombosis in the tilted valve. Valves were also placed in three patients. The BVVs remained patent without thrombosis or other complications. Proper sizing and proper placement of the valves was critical to their function. The valve construction needs to be improved to prevent occasional tilting during their deployment. Forty-eight BvVs made of modified square stents with barbs and lyophilized SIS coverings were implanted percutaneously by femoral vein approach into the ElV of24 female sheep using over the wire 10 F delivery system . All BVVs were placed across the natural valve (NV) of the proximal EN. Deployment, stability and function ofBVVs were studied by immediate venograms with contrast medium injections distal and central to BVVs. Animals had follow-up venograms and were sacrificed at 5-6 weeks (n=24). Gross pathologic examinations were performed. RESULTS: The EN diameters ranged from 9.8 mm to 14.4 mm (mean 12. 1 ± 1.2 mm) in 24 sheep. Placement of 48 BVVs, which included twenty- six 10-1 I mm valves in diameter and twenty-two 12-13 mm valves, was successful. There was no tilting or migration of the BVVs. These valves exhibited 100 % patency at the time of animals sacrifice. Immediate follow up venogram showed good valve function with no or minimal leak in48 of 48 BVVs and in 44 of 48 (91 .6%) BVVs at six weeks. CONCLUSION: Placement without tilting appears essential for proper BVV function. Second generation BVVs provided a good anatomical support for the venous blood return during the follow up period.

12:56 PM

Abstract No.3

Endovenous Laser Ablation ofInternal Jugular Vein and Its Effects on Common Carotid Arteries in Swine Models. H.s. Kim. The Johns Hopkins Medical Institutions, Baltimore, MD, USA .£. Liapi ·A. Arepa//y .s.£. Mitchell 'JF Geschwind PURPOSE: To assess the effects of endovenous laser ablation of internal jugular veins on live swine models. This is a feasibility study for testicular and ovarian endovenous laser ablation. MATERIALS AND METHODS: Five internal jugular veins (IN) in three swine models were ablated using 980nm continuous pulse duration laser at five different power outputs (8W, 9W, lOW, II Wand 12W) percutaneously via 5F guide catheter from right common femoral venous approacb . One internal jugular vein was untreated as a control. Real time temperatures were measured using fiber optic temperature probes percutaneously placed within common carotid arteries (CCA) via right common femoral artery (CFA) and aorta via left CFA as a basal temperature. Fiber optic probes were placed between IN and CCA, and outside as a control. Internal jugular venograms and carotid angiograms were performed pre and post laser ablation. Histologic examination performed in six IN and CCA. RESULTS: Diameter of PV range from 4.2 mm to 7.lmm. Collapsed veins after ablation resulted with lOW, II Wand 12W. Vein perforation observed after ablation with 12W. The peak temperature with 8W in CCA was 36.58°C and between IN and CCA was 41.04°C when basal temperature was 37.08°C. The peak temperature with 9W in CCA was 36.02°C and between IJV and CCA was 45.56 °C when basal

temperature was 36.58°C. The peak temperature with lOW in CCA was 37.38°C and between IN and CCA was 37°C when basal temperature was 35.98°C. The peak temperature with II W in CCA was 35.22°C and between IN and CCA was 43.18°C when basal temperature was 35A°C. The peak temperature with 12W in CCA was 35.82°C and between IJV and CCA was 36A2°C when basal temperature was 36A°C. No reduction in diameter of CCA observed after IJV laser ablation. CCA was intact histologically after laser ablation.

CONCLUSION: Percutaneous endovenous ablation ofIJV in our swine model appears safe to adjacent CCA and effective with 980nm continuous pulse duration laser using lOW and IIW. Long term study is required to establish long-term effectiveness and safety.

1:07PM

Abstract No.4

Endovenous Radiofrequency Ablation of Large Greater Saphenous Veins. MJ Sichlau, Decatur Memorial Hospital, Decatur, IL, USA ·R.K. Ryu PURPOSE: Endovenous radiofrequency ablation (RFA) of the greater saphenous vein (GSV) for symptomatic venous insufficiency is recommended for incompetent GSVs of diameters up to 12 mm. With aggressive tumescent technique, most GSVs with larger diameters can be reduced to a size appropriate for RFA. We aimed to test the hypothesis that GSVs with diameters greater than 12mm treated with RFA and aggressive tumescent technique respond with equivalent technical success and long-term closure compared to GSVs of 12mm and under treated with RFA. MATERIALS AND METHODS: Data were collected from a prospectively acquired database of patients who underwent endovenous RFA over a period of 14 months. All patients received tumescent anesthesia of dilute lidocaine with epinephrine into the perivenous space, with circumferential distribution of tumescent solution around the GSv. Technical success and sustained GSV closure out to 14 months were compared between patients who had GSV diameters greater than 12mm and those who had GSV diameters of 12mm or less. Data were subjected to Chi Square analysis. RESULTS: A total of33 patients underwent GSV RFA for 37 symptomatic legs, with GSV diameters ranging from 5mm to 22mm. Of the 37 GSVs treated, 9 had a diameter greater than 12mm (group A), and 28 had GSV diameters of 12mm or less (group B). Technical success was 100% for both groups. Follow up was available for a range of 1-14 months (mean = 6 months). All treated GSVs remained closed in both groups (p>.05). CONCLUSION: With effective delivery of tumescent anesthesia, we found no significant difference in technical success and long term closure for large GSVs treated with RFA.

1:18 PM

Abstract No.5

Saphenous Vein Ablation with Hot Contrast in a Canine Model. D. Kirsch, LSU Health Sciences Cente!; New Orleans, LA, USA'z. Qian-M Eissa'J Lopare·J Hamide'W Castaneda PURPOSE: Endovascular ablation is an increasingly accepted alternative to surgery in the treatment of saphenous venous insufficiency. Although laser and radiofrequency (RF) ablation appear to be safe and effective, they require a capital investment on the required generators, plus the additional cost of

disposable probes. The purpose of this study is to determine the feasibility, efficacy and safety of thermal ablation of the vein (SV) with hot contrast media (HCM) as an alternative to laser or RF ablation.

MA TERIALS AND METHODS: Under general anesthesia and surgically sterile conditions, the SV of 4 dogs were percutaneously ablated with HCM. An occlusion balloon catheter was placed in the infragenicular segment of the SV via a jugular access to prevent unwanted thermal effects on the non-target segment ofthe Sv. After inflation of the balloon, 5mL ofHCM was injected under fluoroscopic control through a sheath placed in the SV immediately above the ankle. A seco'nd injection was made after 5 min in each vessel. Venographic follow-up ofthe ablated veins was performed at I month (n=4) and 2 months (n=4) after which the animals were euthanized. Histological examination of the resected saphenous veins was performed. RESULTS: All animals tolerated the procedures well and became ambulatory the next day. The follow-up venograms at one and two months showed complete occlusion ofthe ablated venous segment in all of the animals. During necropsy, the ablated segment of the SV appeared whitish, hard and adherent to the surrounding tissues. The SV above the ablated segment remained patent and presented a normal appearance. Histologic examination is underway in order to determine the microscopic changes and will be discussed. CONCLUSION: HCM thermal ablation of the SV is feasible and appears to be safe and effective in the canine model. A comparison study of HCM ablation with laser and RF is warranted to compare this method to the other therapeutic modalities. If this technique proves to be equal or better than the laser and RF techniques, it has the potential to reduce procedural cost and could benefit a larger patient population, especially in circumstances where the laser or RF technology is not available.

1:29PM

Abstract No.6

Percutaneous External Jugular Vein Ablation with Small Intestinal Submucosa: Pilot Study in an Animal Model. D. Pavcnik, Dotter Institute, Portland, OR, USA'J Kaufman-L. Correa·B. Uchida'H Timmermans'J Rosch PURPOSE: To report short and mid-term follow-up results of experimental external jugular vein (EN) ablation with small intestinal submucosa (SIS) modified closure device (MCD) by percutaneous exit catheterization. MATERIALS AND AfETHODS: The EN in sheep (n=4) and swine (n=5) was chosen for study because of its similar size' to human enlarged GSv. MCD was constructed of a 30-cm long sheet of lyophilized SIS. After EJV puncture a modified Rosch-Uchida transjugular access set was used to exit the EN lumen centrally through the skin. MCD was delivered with pull in technique through a 10 F sheath. Eighteen ENs in 9 animals were occluded with MCDs. Animals were evaluated clinically and with ear vein venograms at 2 week, and at the time of sacrifice at I month or 3 months to assess treatment efficacy and possible adverse reactions. Gross examinations focused on the EN and surrounding structures and lungs. Specimens were preserved in formalin and histologic studies were performed. RESULTS: The EN diameters ranged from lOA nun to 12. I mm (mean 11.3 ± 0.6mm) in 4 sheep and from 7.0 mm to 8.8 mm (mean 8.1 ± 0.7 mm) in 5 swine. The length of isolated EN segment was 21.8 ± 1.3 cm in sheep and 12.1 ± 2.7 cm in swine. Successful closure of the EJV, defined as absence of blood flow on venogram inside excluded EN, was noted in 18

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of 18 EN s (100%) after initial treatment. Sixteen of 18 treated ENs followed for I and 3 month remained closed, with the treated portions of the ENs not seen on follow-up venograms. Two ENs in a growing pig that doubled his size and weight were partially recanalized at I month. There has been one skin inflammatory reaction. No progression of thrombosis in the deep vein system was found. Necropsies revealed completely excluded collapsed EJV segments with partial incorporation of the SIS into vein wall. Histologic evaluation demonstrated early SIS remodeling with variable fibrocytes, fibroblasts, endothelial cells and some inflammatory cells. CONCLUSION: EJV ablation with SIS by percutaneous exit catheterization is a fast, safe and effective treatment. It might be promising methods for GSV ablation ill humans. Longterm follow-up studies are in progress.

Scientific Session 2 Late Breaking Abstracts

Scientific Session 3 Carotid Interventions Friday, March 26, 2004 12:30 PM - 2:00 PM Moderator(s): Barry r Katzen, MD Klaus D. Mathias, MD Abstract No.7

FF:ATlJREIl ARSTRAcr Commentator: Mahmood K. Raz;"i. :\ID

SAPPHI.RE: Results in Diabetic Patients Randomized to Carotid E ndarte rectom y or Stcnting with Emboli rotection. '-'1.1 I. Wholey Jor fhe SAPP /lIRE Invesligafors and (he APPH1RE Executive Commit f!!!!. Pill burgh Va cular 'insti/llte, P illsburgh, PA. USA 'PURPOSE: ndarterectomy ( EA) and stenting with emboli protection ( EP) were eva luated in patien ts pre enting a high risk for CEA. The SAPPHIRE trial is the frrst prospective, mul ti-center randomi zed contro lled trial comparing carotid stentingwilh distal proteclion versus carotid endarterectomy

IMATERlALS AND METHODS: Asymptomat ic pati ents with ~ ~

80% stenosi by ultrasound and s ymptomatic patient witH 50% stenosis and a high risk criteria (CHF, severe COPD, previolls CEA, severe CAD, rad ical neck urgery, radiatio . thej'ap y) were enrolled at 29 US centers. The pri mary endpoints were the incidence of M aj or Ad verse Events (MAE). i.e., death, any stroke and/or MI at 30 days postproced lLre, a nd a co mp o ite of MA E plus death aud/oli psil ateral stroke between 31 days and 360 days posh rocedure.

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12:45 PM

Abstract No.8

Biochemical Markers of Neurological Injury for Unprotected & Protected Carotid Stenting: A Randomized Trial. S. Macdonald, Sheffield Vascular Institute, Sheffield, Yorkshire, England·IJ. Cleveland·PA. Gaines ·D. Thompson'P Griffiths'F McKevitt, et af. PURPOSE: To utilize biochemical markers of neuronal (Neurone Specific Enolase; NSE) and glial (S I OOB) injury as surrogates of adverse neurological events to compare unprotected and protected carotid stenting (EmboShield™).

Friday, March 26, 2004 12:30 PM - 2:00 PM

12:30 PM

DNCLVSTO : In the SAPPHIRE pro ' peclive, multi-center randomized, controlled trial of carotid stenting with emboli protection versus EA carotid stenting with emboli prorectio was assoc iated witb a lo wer ri k of MAE without nonneurologic deatb, Ml and Major Bleeding when compared tu carotid endarterectom y in diabetic patients.

fRESULT. : A total of334 pat.ients were randomized and treated by either E.P or CEA in the randomized ln tent-to-Treat population. The diabetic subset was composed of86 patients. he MAE rate fo r th e diabetic pati ent subset at one-yea l:ollow-up , howed a numerica l trend favoring carotid stentin at 16.7% (7/42) versus 3 1.8% ( 14/44) for CEA (p=0.i 3). Significant di fferences were observed respectively for SE,B ver CEA for MI (2.4%, J142 vs J 8.2%. 8/44, p=O.03), ajor Bleeding (4.8%, 2/42 vs. 20. 5%. 9/44. p=O.05) and MA E without non-neurologic death (4. %. 2/42 vs. 25.0, .11 /44, p=O.OI-). .

MATERIALS AND METHODS: 30 patients with symptomatic atherosclerotic carotid artery stenosis (~ 70%, NASCET) were randomised between protected and unprotected treatment limbs. Cystatin C, a sensitive marker of glomerular function was assayed as measurement of S I OOB is sensitive to renal impairment. Samples were taken from the ipsilateral jugular vein for NSE, S I OOB and cystatin C at baseline, 2, 6 and 24 hours post-stenting. Samples were analyzed off-site using an immunoluminetric assay based on monoclonal antibodies for NSE and S I OOB and an immunonephelometric assay for cystatin C. The laboratory were blinded with respect to treatment group. Groups were compared using a summary statistic for serial measurements (area under the curve). Data were rendered normal (logarithmic and square-root transformations) and rise-to-peak values compared using independent-samples t-tests. The influence of cystatin C on the rise in S I OOB was addressed using ANCOVA. RESULTS: There were no significant differences between groups. There was a significant rise in S I OOB and cystatin C (reflecting subclinical contrast nephrotoxicity) in both groups. There was no significant rise in NSE. The rise in S I OOB cannot be explained by the rise in cystatin C alone (p=0.067, eta squa.red=0.18, correlation= -0.42). CONCLUSION: Carotid stenting causes a release of SIOOB implying transient glial injury which is neurologically silent, regardless of whether cerebral protection (EmboShield™) is utilised. If these results are correlated with other aspects of this randomised trial, the mechanism of injury may be hemodynamic rather than atheroembolic.

12:56 PM

Abstract No.9

MAVERIC International Carotid Stenting Trial. G. Soulez, CHUM-Notre Dame, Montreal, QC, Canada·MD. Hill·G. Maleux·E.K. Hauptmanll'J. Schofer- V. Oliva, et al. PURPOSE: The objective of this study was to evaluate the safety and feasibility of using the Medtronic AVE SelfExpanding Carotid Stent (ExponentTM) in combination with the Medtronic Interceptor™ Carotid Filter System in patients at high risk for carotid endarterectomy. MATERlALS AND METHODS: Fifty-one high risk patients for carotid endarterectomy with a carotid artery stenosis of the internal or distal common carotid artery ( 50% for