Scientific Session 8 Stent-Grafts for AAA: Clinical Trials

in decreases in uterine volwne, focal adenomyoma volume, and junctional zone thickness in this patient population. 1:47 pm

Abstract No. 56

FEATURED ABSTRACT Commentator: James B. Spies, MD Uterine Arterial Embolization for the Treatment ofSymptomadc Adenomyosis 'of the Utems C. Ahn, Sungnam, South Korea • WH. Lee • T W Sunwoo • Y.s. Kho PURPOSE: To evaluate the potential usefulness of transcatheter uterine artery embolization as a treatment for symptomatic adenomyosis oCthe uterus. Jl.1ATERJALS & METHODS: Uterine arterial embolization using polyvinyl alcohol particles sized 250-710 micrometers was performed in 65 pa'tients (mean; 40.6 years, range; 25-53 years) with dysmenorrhea, menorrhagia, or bulk-related symptoms (heaviness, urinary frequency) due to adenomyosis. All patieats were evaluated with contrast enhanced dynamic magnetic resonance imaging (MRI) before the procedure and 3.5 months (range; 31-238 days) after. Clinical symptoms were also assessed at the time of MRI before and after embolization. RESULTS: At 3.5 months follow-up, 61 of 65 patients(93.8%) reported improvement of the symptoms. Contrast enhanced dynamic MRI revealed non-enhancing ,areas at the previously noted ade-· nomyosis suggesting coagulation necrosis in 44 patients (67,7%), decreased size of adenomyosis in 17 patients (26.1%), and no change of adenomyosis in 4 patients (6,2%), 6 patients (mean age; 45.2 years, age range; 40-53 years) b~came amenorrheic. CONCLUSION Particulate transcatheter uterine arterial embo.lization is an effective therapy for me treatment of symptomatic adenomyosis and may be a valuable alternative to hysterectomy, or other surgical procedures. Further investigation is warranted.

Scientific Session 8 Stent-Grafts for AAA: Clinical Trials Moderator: James F Benenati, MD

Mondav, March 27, 2000 12:30 pm-2:00 pm 12:30 pm

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Abstract No. 57

First Five and One-Half Years Experience With Transluminal Endografting for Abdominal Aortic Aneurysm Gj. Becker, Miami, PL • M. Kovacs • B.T Katzen • IF Benenati • G. Zemel • A. Powell, et at

PURPOSE:· To report our single-center results of abdominal aortic aneurysm (AAA) repair by transluminal endografting (TE). METHODS: 180 TE were attempted from 3/94-10/99 in average to extremely high risk AAA patients, age 53 to 94 yrs, 1J=73±8.2. In each case the TE physician team comprised a senior JR, 1 IR fellow, vascular surgeon, surgical asst., anesthesiologist. Epidural anesthesia and bifemoral access were used in almost all cases. Followup included Hx, PE, spiral CT. Data sources were charts, case report forms, and since 1/96, computerized medical records. Fifteen TE procedures were performed from 3/94 to 12/95. Office consults from 1/96-10/99 included 392 AAA patients: 360 (91.8%)M; 32 (8.2%)F. Overall 158/360 (43.9%) men, but only 7/32 (21.9%) women underwent TE. Most exclusions in women were due to small iliacs. The other 227/392 had open surgery or are under observation for smaller AAAs. TE devices were home-made, n=9; EVT (Guidant), n=62; Talent (Medtronic-World Medica!), n=55; Vanguard (Boston Scientific), n=29, Excluder (W.L. Gore & Associates), n=25. Configurations were: bifurcated 88%, tube 6%, and unilateral aortoiliac+cross-femoral graft 6%. RESULTS: Implantation success was 173/180 (96,1%) overall, and 99/101 (98%) after Jan 1, '98; 2/7 failures reqUired immediate conversion to open repair 0.1 %); 5/7 were simply aborted. Though 3/392 AAAs ruptured during the preliminary workup and planning (2 died, 1 survived emergency operation elsewhere), no patienl (0%) has experienced AAA rupture after TE. Operative mortality (30d) was 7/180 (3,9%). Major non-fatal perioperative complications occurred in 29/18006.1%), Averages for LOS were: median=3d, mode=2d, mean=4.0±3,ld, There were 9 late deaths unrelated to TE. Of 32 07.8%) patients with endoleaks, 3 self-resolved, 5 died of unrelated causes, 5 underwent second

reparative TE, 5 open surgical repair, 3 embolization, 11 are still under observation. CONCLUSION TE is a safe, effective treatment for AAA, even in high-risk patients. LOS is short. Endoleak prevention and management are among the greatest challenges we face today. 12:41 pm

Abstract No. 58

Early Clinical Experience in the Treatment of Infrarenal Aortic Aneursyms Utilizing the AneuRx Bifurcated Stent-Graft System R.A, White, Torrance, CA • C.E. Donayre • 1. Walot • G. Kopchok PURPOSE: To evaluate the safety, efficacy and ease of use of the AneuRx Stent-Graft System in the endoluminal treatment of infrarenal abdominal aortic aneurysms (AAAs). METHODS: Endovascular treatment of infrarenal AAA was attempted in 171 patients 055 male/16 female) ranging in age from 46-90 years (mean 73.4 years).

Mean Mean AAA AAA diameter diameter was 5.6 em. cm. General anesthesia was was utilized util ized in in 149 149 patients, pat ients, epidural epidura l in 4 patients, and local local anesthesia anesthesia in in 18 patients. Most procedures were done done in in aa dedicated dedicated endovascular suite sui te (160) by a team consisting consisting of of vascular vascular surgeons su rgeons and interventional intervent iona l radirad iologists, and 11 11 patients were treated in an operating ologists, and rOom rOom with w ith portable portable imaging equipment. Associated iliac aneuJYsms in 19 patients (4 bilateral). aneurysms were were treated in RESULTS: RESULTS: Successful Successful device deployment dep loyment was achieved

in in 98% 98% (168 (168 patients), patients), and 99% of patients were we re successfully cessfully treated. treated. No No patients reqUired required open conversion during device device placement, however one patient sion during experienced experienced early ea rly aneuJYsm aneurysm rupture (16 hours post procedure) procedure) and and was converted. Procedure related mortality mortality was was 1.8%. 1.8%. 12 month mon th (54 patients) pa tients) and 24 month month (19 (19 patients) foJJow~up follow-up show a low endoleak endo leak rate rate with with almost almost all all patients patients having either stable sta ble or regressing gressing aneuJYsm aneurysm size. A Single patient, anticoagulated lated for for atrial atr ial fibrillation, fibrillation , has had increasing increas ing aneurysm aneurysm size size secondal)' secondary to persistenl collateral coll ateral vessel vesse l backflow embolizatio n). Several Several patients backflow (treated (treated with embolization). have have required required aa second second procedure to place additional additiona l graft graft components. components.

of 89%. 89%. giving a "primary" aneurysm aneuJYsm exclusion rate rate of One large early proximal endoleak req required aortic uired aortic banding embolisation the ban ding and one other needed embol isario n but the majority sealed spontaneously in uunder monrhs. nder 3 months. appeared at at Three addit additional (secondal)') endoleaks appeared iona l (secondary) with addi~ 18-24 months and these were all treated w ith additional percutaneous endoluminal grafts. There There were were three ea early related to to rl y lilimb mb occlusions, procedural or related native disease,, and two of these led led to to ve vascular disease nati femoro-femora cross crass over grafts. Seven late limb limb ococfemoro-femoro 12-36 of more more clusions cl usions occurred at 1236 months and were of concern 5/7 were du duee to distortion or disp displacement conce rn as 517 lacement of stent gra graft surgift limbs, and the majority resulted in surgimigration was was cal cross-over grafts. One late device migration treated,, prior to endoleak, endoleak, identified ide ntified at 30 months and treated (1.8%) ococwith a prox proximal imal cuff. One AAA rupture 0.8%) curred at 15 months. CONCLUSION Further design modifications of the the VanVanincidence of guard device are required to reduce the incide nce of distortions. system apaplate graft limb di stortions. But the current system reasonably durable,wlth endovascularr or or pears to be reaso nably durable, with endovascula surgical suppOrt sUppOrl where required,in rcquired,in the medi medium um term.

1,03 pm CONCLUSiON: CONCLUSION The The AneuR.'C. AneuR."I{ Stem-Graft Stent-Graft System has

shown shown excellent excellent early results in the treatment treatmen t of infrarenal AAA. The The system's flexible flex ib le modular approach frarena l AM. the interventionalist interventionalist to treat most carefully carefull y seenables the enables lected patients patients with with low mortality and morbidity. Long lected term follow-up fo ll ow-up isis necessalY necessary to see if endovascular e ndovascular reterm pair isis as as durable d urable as open surgical repair. pair 12,52 pm pm 12,52

Abstract No. 59

The Vanguard Vanguard EndovascuJar EndovascuJar Stent Graft: Medium The Term Reliability? Reliability? Term ID. Rose, Rose, Newcastle Newcastle upon upon Tyne, Tyne, United Kingdom. Kingdom . ID. R. jackson •. S. S. Dugdill Dugdill •• T.A. T.A. Lees. Lees . M.G. M .G. \Vyatt R.jackson PURPOSE: Endovascular Endovascular technology techno logy is currently adPURPOSE:

vancing more more rapidly rapid ly than than clinical experience and there vancing no good good evidence evidence as to the durabiliLY durabiliLy of the "second isis no generation " devices devices for abdominal aortic aneul)'sm aneurysm generation" (AAA) repair. repair. The The aim of this paper was to to examine the (AAA) outcome of cases treated with the Vanmedium term term outcome medium guard modular modular bifurcate bifurcate stem stent graft. guard MATERIALS & & METHODS· METHODS' Between December 1995 MATERIALS

anel January January 1999, 1999, 55 patients underwent u nderwent endovascular and AAA repair repair with with the Vanguard system. Follow up imAAA aging with with C1' C1' and and plain plai n films was scheduled at aging 1,3,6,12,18 and 24 months, then at yearly intervals. If 1,3,6,12,18 and 24 months,then endo leak or iliac limb occlusion was suspected then endoleak or iliac angiog raphy was performed and where possible enangiography was dovasc ular treatme nt utilised. dovascular treatment RESULTS: Graft Graft deployment dep loyment was successful in all paRESULTS:

ti ents, with with no no open open conversions. convers io ns. Median Med ian follow up up tients, has reached reached 24 24 months months (range (range 9-46). 9-46). There There were were 33 has deaths(peri-operative mortality mortality 5.6%). 5.6%). Six Six ene nearly deaths(peri-operative early doleaks were were present prese n t on on the the post-operative post-ope rat ive scans, sca ns, doleaks

No. 60 60 Abstract No.

Current Status of the Vanguard Aortic Aortic Endograft Endograft United States Trlal Trial Katzen, Miami, FL B.T Katzen, FL·. H.G. H.C. Beebe. Vanguard Vanguard Tnaiists Tnalists PURPOSE: This multicente multicenterr trial ooff a new endograft endograft for for

infrarena l abdomi nal aortic aneurysm (AAA) was was dedeinfrarenal abdominal -cause mortality signed to test safety by comparing all all-cause mortality ity between eendograftndograftand majo majorr and ancl minor morbid morbidity treated patients (EAG) and those receiving conventional open surgery surgeJY (COS) and efficacy as measured by by EAG EAG aneurysm rim analysis aneul)'sm exclusion. We report an inte interim analysis of of curren t results current results.. METHODS: Concurrent, nonrandomizecl assignment assignment to to

ters was determined treatment group at 17 cen centers determined by by rs. All patients were of average sl.l!"gistlrgianatomical facto factors. ca l risk and all COS had infra renal clamping clamping and and graft graft cal radianastomosis. Joint participation particjparion of interventional radiow up vascularr surgery was required. Foll Follow up ology and vascula cl inical exami nation and serial CT scan or n rad iclinical examination or plai plain radiograph at 1, 3, 6 and 12 months included independent independent core imaging laboratory assessment. Independent Core Independent adadngoing. REjudication of morbidity end points is oongoing. SULTS.' 243 bifurcation EAG and 98 COS parients SULTS.. patients had had mean AAA diameter of 5.5 cm and and 6.0 cm em respectively. respectively. The 30 d mortality rate ooff EAG 4/ 243 0.6%) 4/243 (1.6%) and and COS COS 3/ 98 0 .1%) was s imi lar (p 0.68). Primary endoleak 3/98 0.1%) similar endoleak was observed in 12.1% of EAG at 30 d regard less of regardless of il e persistent endoleak rate declined to type, wh while to 3.8% 3.8% at 12 12 mos. No patient ost EAG at mos. No patient had had ppost EAG ruptured ruptured AAA. AAA. At At 1% and seconda lY 12 mos EAG primary patency was 991% secondalY ignificantly less patency 94.6%, ssignificantly less than than COS, COS, 100%. 100%. Mean EAG fluoroscopy fluoroscopy lime time was was 34 34 min min and and contrast contrast Mean EAG load 217 mL Median Median length length ooff stay stay days days was was 33 for for EAG EAG load 217 mi. and 8 for COS. EAG convers io n to COS was requ ired and 8 for COS. EAG conversion to COS was reqUired

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primarily in 5 cases (4 due to case selection issues and 1 operator error) and late in 1 patient for device failure due to fabric hole and 2 for endograft occlusion. All conversions had satisfactory clinical outcome. Significant morphology change in successfully excluded aneurysms was common. CONCLUSION: The US Vanguard trial interim analysis shows EAG early safety and protection from aneurysm rupture results comparable to COS. Further early follow up demonstrates the need for close and continuing evaluation of patency and endoleak. Final comparative morbidity assessment awaits further analysis.

1:14 pm

Abstract No. 61

The Results of EndovascuJar Aortic Aneurysm Repair With the AneuRx Stent Graft Systelll; The United Kingdom AneuRx Study Group Experience D.O. Kessel, Leeds, United Kingdom • 1. Robertson PURPOSE: To report the UK experience with the AneuRx stent graft system since October 1997. MATERIALS AND MElliODS: A prospective study of all patients treated with a modular stent graft (AneuRx, Medtronic) in the UK. Procedural details were recorded contemporaneously. Follow up data were collected by questionnaire.

RESULTS: 224 patients with infrarenal abdominal aOltic aneurysms have been treated up to July 1999 complete follow up is available in 171. 93% were male and the mean age was 73 years, aneurysm size ranged from 5-11cm (mean 6.1). 14% of patients were ASA category III and IV. Median procedure time was 135 minutes (range 60-410) and median blood loss was 300ml (15-3000). Length of hospital stay ranged from 2-42 clays (median 5). Proximal neck diameters ranged from 20-26mm the minimum neck length was 10mm. Bifurcated devices were used in 97% of patients with straight tube grafts deployed in 5 patients. 2 bifurcated graft lengths were available: 16.5cm devices were used in 84% patients with 13.5cm grafts used in the remainder. Additional graft cuffs and extensions were used in 44%, the majority were distal extensions and permitted treatment of iliac arteries up to 20mm diameter. There were 2 surgical conversions. 'There were 4 (1.8%) deaths within 30 clays, 5 patients had aCLlte graft limb occlusion and there was a single iliac artery rupture. lbere have been no stump dislocations and no graft migrations. There has been a single surgical conversion, 1 proximal cuff and 3 embolization procedures for late leaks. There have been 15 late deaths none rdated to aneurysm llJpture of graft failure. Contemporary results will be presented.

194

CONCLUSION: Selected aortic aneurysms can be safely and successfully treated with the AneuRx system. Modular systems make more aneurysms treatable and increase the likelihood of success. lbe mid-term results at 2 years are promising.

1:25 pm

Abstract No. 62

Treatment of Abdominal Aortic Aneurysm With the EVf-EGS Endograft: Mid-Term Results A.S. Gomes, Los Angeles, CA • WS. Moore • W J. QuinoneS-Baldrich • c.L. Vescera PURPOSE To describe the results of abdominal aortic aneurysm repair with the EVT-EGS endograft in 102 patients with a minimum of one year follow-up. MATERIAL AND METHODS: 39 patients received the EVT-EGS tube graft; 47 the bifurcated graft; and 16 the aortoiliac graft.

RESULTS: Follow-up ranges from 1 to 6.4 years. Tube Graft: Thirty-six of 39 (92%) grafts were successfully placed. Three patients required early conversion and one undelwent late conversion for graft slippage. Attachment hook breaks occurred in five patients, and a concomitant frame break occurred in one patient whose aneurysm has enlarged. Seven patients had a persistent pengraft leak, one which was repaired surgically and one which required late conversion. Bifurcated Graft: Forty-one of 47 (87%) grafts were successfully placed. Six patients required immediate conversion. Five developed a persistent perigraft leak. One patient thrombosed a graft limb and was treated with lysis and angioplasty. Aortoiliac Graft: Fifteen grafts (94%) were placed successfully. Five patients required Wallstent placement in the iliac limb for obstruction detected intraoperatively during endograft placement. One patient requiring immediate operative conversion expired 4 clays post-operation. One patient requiring inunediate perioperative percutaneous stenting for graft thrombosis developed lower extremity paresis. Three patients had a persistent pengraft leak. For the total group, persistent perigraft leaks occurred in 15/102 (15%), Four leaks thrombosed spontaneously, four were treated with interventional techniques, and one converted to open repair resulting in a chronic pengraf( leak rate of 6/102 (6%), 30 clay mortality at our site is 2/102 (2%). CONCLUSION Current results indicate abdominal aortic aneurysms can be effectively treated with the EVT-EGS endograft.

1:36 pm

Abstract No. 63

Treatment of AAA With the Talent Stent-Graft Device. Phase n High-risk USA Trial. Six Month Interim Report R Uflacker, Charleston, SC • j. Robison • j.B. Selby PURPOSE: To present the first 6 months results of phase n high-risk trial for the treatment of AAA using the Talent stent-graft device. MATERIALS AND lJ.1ElliODS: From March to December, 1998, 45 patients were enrolled in the trial. All patients were at high risk for conventional surgical aneurysm repair. 89 % were males and 11% females with a mean age of 71 yrs. A bifurcated Talent stent-graft was used in all patients, under epidural anesthesia and sedation,

and bilateral femoral cutdown was performed.The device was place under fluoroscopy and the patients were followed with CT scan at time of discharge, at 3 months, and 6 months. Technical success (TS) and clinical success (CS) were evaluated and recorded, as well as adverse events and complications. RESULTS: At implantation TS was 40/45 (88.9%), CS

was 39/45 (86.7%), 2 endoleaks, 2 convertions, 1 device kinking, 1 >500mL blood loss. At discharge TS was 41/43 (95.3%), CS was 41/43 (95.3%), 2 endoleaks (l new, 1 resolved). At 1 month TS was 27/31 (87.1 %), CS was 24/31 (77.4%), 4 endoleaks (2 new), 3 deaths. At 6 months TS was 14/15 (93.3%), CS was 12/15 (80%), 1 endoleak, 1 death, 1 renal impairment. CONCLUSIONS: The Talent endovascular stent-graft

proved to be a reliable device to treat patients at high risk for conventional surgical repair of AAA. The procedure related morbidity was minimal and the mortality related to the procedure was very small. Four patients died within the 6 months follow-up, consistent with the mortality encountered in that group of patients with multiple clinical problems. 1:47 pm

Abstract No. 64

Does Suprarenal Fixation of Aortic Stent-Grafts Affect Renal Function? R. W Jackson, Newcastle upon Tyne, United Kingdom • l.A. Ahmed • P Keavey • TA. Lees • M.G. Wyatt. J.D. Rase PURPOSE: Endovascular aneurysm repair (EVAR) may

involve placement of the bare metal stent across the renal arteries (RAs) in order to protect against late migration. This study aimed to evaluate the effect of suprarenal stents on renal function. MEWODS: 68 patients (64 males; median age 73 years)

underwent EVAR between December 1995 and December 1998. Pre-, post-operative and follow-up (>3 months) serum creatinine levels were recorded (micromol/L). Operative angiograms were reviewed and the relation of the stent-graft to the RAs was noted. Patients were grouped according to the number of RAs covered by metal stent: group 0, neither RA covered; group 1, one RA covered; group 2, both RAs covered. 19 patients (7 group 1 and 12 group 2) also underwent pre-and post-operative DTPA renography. RESULTS: Median follow-up was 11 (3--39) months for

the creatinine estimation and 13 (7-26) months for the renograms. The creatinine data, presented as medians with ranges (Table), showed no Significant change on follow-up (Mann Whitney U test). One patient with pre-existing chronic renal impairment progressed to renal failure requiring dialysis. Renography showed a reduction in relative function in the covered kidney from 420/0 to less than 10%. Significant renographic changes (>5%) in relative function were seen in a further 4 patients (2 group 1, 2 group 2) affecting kidneys whose renal arteries had

been covered. Only one of these had a significant increase in serum creatinine. CONCLUSION The placement of bare metal stent across

the renal artery orifices during EVAR does not affect gross renal function during the immediate post-operative period or at medium term foHow-up. Both clinical and subclinical changes in relative function are seen in a small number of kidneys. Further studies are required to assess the significance of these renographic changes and the long-term influence on renal function. Creatinine Pre-op Post-op Follow-u

Scientific Session 9 Venous Thromboembolic Disease Moderators: Herve P Rousseau,MD Robert L. Vogelzang, MD

Monday, March 27, 2000 12:30 pm-2:00 pm 12:30 pm

Abstract No. 65

New Retrievable Inferior Vena Cava Filter: Results in an Animal Model j.A. Kaufman, Boston, MA • A.C. Venbru.x • PRo Brown PURPOSE: To evaluate the immediate and extended re-

trievability of a new inferior vena cava (lVC) filter in an animal model. Materials and Methods. This was a pivotal pre-elinical animal study of a new filter. The fUter, made from nitinol wire, has 6 centering arms and 6 legs with elastic anchoring hooks. In vitro the filter withstands a 70 mm Hg pressure gradient in a 21 mm diameter tube without migraLion, and traps emboli equivalent to current permanent filters. Retrieval is from the jugular venous approach using a new grasping-cone device. A total of 24 filters were deployed in 18 adult female Dorset or Suffolk sheep (mean weight 99 +/- 11 Ibs). Cavography and pathological evaluation of the NC and adjacent structures were obtained in all animals. Four groups of animals were studied: A) 3 animals, sacrifice after deployment with immediate intraprocedural retrieval; B) 3 animals, sacrifice 3 weeks after deployment with immediate intraprocedural retrieval; C) 6 animals, sacrifice after removal at 12 weeks implant time; and D) 6 animals, sacrifice 8 weeks after removal at 12 weeks implant time. FINDINGS Filter deployment in the infrarenal NC was successful in all animals. Two filters were deployed in each animal in groups A & B. 24/24 filter retrievals were successful, including 12 removed after 12 weeks implant time (groups C & D). The NC was patent in 24/24 animals

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