Scientific Session 7 UFE: Technical Developments

Scientific Session 7 UFE: Technical Developments

12:41 pm

Uterine Artery Embolization in the Sheep Model Using a New Embolic Agent, Embolyx JI. SWischuk, Peoria, I1 • F Castaneda • R. Ii • K. Young

Moderator: Lindsay Machan, MD

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

Abstract No. 50

Abst....d ct No. 49

The Feasibility of Perfonning Uterine Fibroid Embolization as an Outpatient Procedure: Experience in 73 Patients GoP Siskin, Albany, NY • B.F Siainken • K. Dowling • P Mea • j. AIm • E.G. Dolen PURPOSE: To assess the feasibility of performing uterine fibroid embolization as an outpatient procedure. MATERIALS AND MElliODS: 73 consecutive patients (mean age 44.3 years) underwent uterine artery embolization during a 12-month period. Embolizaton was performed with 350-500u polyvinyl alcohol particles (67173) or gelfoam pledgets (6173). At discharge, patients were given instructions regarding the expected symptoms after embolization and were prescribed Prochlorperazine, Ketorolac, Meperidine, and Hydrocodone for symptomatic relief. All patients were telephoned within 24 hours of discharge. During follow-up, a questionnaire was administered to evaluate the periprocedural experience. 3-month clinical follow-up is available in 42 patients and imaging was performed at 6 months in 22 patients. RESULTS: Presenting symptoms included menorrhagia (n=25), bulk-related symptoms including distension, incontinence, or pain (n=l1), or both (n=37). 71173 patients were discharged 6-8 hours after embolization; 2 patients required overnight observation 0 due to post-procedure hypertension and 1 due to a late procedure completion time). At the first follow-up phonecall, symptoms included pelvic pain in 82.2% (60173), fatigue in 75.3% (55173), nausea/vomiting in 43.8% (32/73) and a vaginal discharge in 17.8% (3173). 5 patients called our staff to obtain additional medication instfllctions(n=3) or to request additional medication for pain control (n=2). Symptoms were controlled with discharge medications in 71/73 patients. 1 patient visited the emergency room and required admission for additional pain control during the first 48 hours after discharge. 69/73 patients were satisfied with the decision for home discharge. The mean uterine volume reduction in 22 patients imaged at 6 months was 49.2%. 88.1% of patients with 3month clinical follow-up reported improvement or elimination of symptoms. CONCLUSION: With defined telephone follow-up, staff availability, and a protocol designed to alleviate the post-procedure constitutional symptoms, uterine artery embolization can be safely performed as an outpatient procedure without sacrificing patient comfort.

PURPOSE To determine the depth of penetration and the effects of transcatheter uterine artery embolization with EMBOLYX in sheep. MATERIAL AND MElliODS: Uterine arteries of 10 sheep were embolized with EMBOLYX , Polyvinyl alcohol par· ticles (PYA) or both. Three sheep were embolized with PYA (350-500 microns), four sheep were embolized with EMBOLYX (two each with 6.5% andl0% solutions) and three sheep had one uterine artery embolized with PYA and the other with EMBOLYX (6.5%). Successful embolization was achieved in 18 uterine alteries. All animals were sacrificed at 3-4 weeks. The uteri and ovaries were explanted and examined macroscopically and microscopically. Microscopic sections were taken through the main uterine artery, ovaries and the body, and horns (proximal, mid, and distal) of the uteri to determine the distribution of embolic agents. RESULTS: All specimens treated with EMBOLYX showed no angiographic evidence of recanalization. At sacrifice all uteri grossly appeared normal. The only instance of endometrial necrosis occurred in a single sheep embolized with PYA bilaterally. Both agents were seen to penetrate to similar size vessels (400-500 microns). The microscopic changes seen with both agents was identical and consisted of intimal hyperplasia and foreign body reaction with the presence of giant cells. PYA panicles were seen microscopically in 94% of uterine segments when bilateral embolization was successful whereas, EMBOLYX panicles were seen in only 46%. No evidence of ovarian infarction was seen with either agent. Permanent main uterine artery occlusion was the rule with EMBOLYX; while all uterine arteries remained patent following the use of PYA.

CONCLUSION: EMBOLYX appears to be safe, causing similar microscopic changes when compared to PYA. uterine infarction did not occur with the use of EMBOLYX. Although both agents penetrated to similar levels, the distribution of EMBOLYX throughout the uterus was more sporadic. In addition, Embolyx causes more proXimal occlusion when compared to PYA. 12:52 pm

Abstract No. 51

Uterine Fibroid Embolization: Choice of an Embolic Particle

Jj. Pelage, Parts, France • A. Lau1'ent • M. Wassel. M. Bonneau • R. Rymer. j. Merland PURPOSE: To determine the optimal embolic panicle to achieve complete devascularization of the fibroids without necrotic effect on adjacent normal myometrium and ischemic damage to the ovaries. MATERIALS AND MEmODS: Non-pregnant adulr sheep with hormonal control were chosen to perform ex-

189

peri peri mental mental uterine embolization because of uterine blood blood supply similar ro that of human. Four different sizes, 400--<)00 and 600-1000~m 600-1000~m of sizes, 150-250, 250-400, 400--600 PYA PYA pal1icles pal1icles (Ultra-Ivalon, Nycomed, France) and four sizes, sizes, 100-300, 300-500, 500-700 and 700-900~m 700-900~m of calibrated calibrated microspheres (Embosphere, (Embosphe re , Biosphere Medical, ical, USA) USA) were compared in 8 groups of animals sacrificed ficed 55 days after embolization. Ease of injection and angiographic angiographic occlusion were compared. com pared. Embolic particles cles were were also compared according ro MR imaging studies ies and and histopathologic histopa thologic fearures (uterine necrosis and location location of the particles). RESULTS: RESULTS: No occlusion of the 5-French catheter was observed 700--900pm diameter. served with microspheres even of 70G-900pm Score Score of uterine urerine necrosis necroSis was higher with small panicles (diameter<300~m) (diameter<300~m) than with larger particles (p=O.02). Necrosis 150-250pm PYA particles Necrosis was higher with 15D-250pm (500/0 mi-(SO% of the uterus) than with lOQ-300pm 100--300pm calibrated mi crospheres (300/0 of the tbe uterus) (p<0.05)' (p
Su pported in part by a grant from the French Society of Supported Radiology (SFR) Radiology 1:03 pm

Abstr.u..1: Abstr.u. 1: . No. 52

Measurements of Skin Dose and Estimated Measurements Ovarian Dose Associated With Uterine Fibroid Ovarian EmboUzatioll! A Follow-Up Study With Rerrned EmbolJzation: Technique and State of the Art Equipment Technique B. Nikolic, Nikolic, Washington, Washington, DC • j.B. IE. Spies. Spies . B. S.M. Walsh. Walsh. M.L. ML Lundsten. Lundsten . A.R. AR. Roth S.M. PURPOSE: To determine the absorbed skin dose (ASD) PURPOSE: and and estimated absorbed ovarian dose (EAOD) that occu rs during uterine fibroid embolization (UFE) using recurs fined technique and st3te-of-the-al1 srate-of-the-al1 equipment. fined METHOD AND MATERIAL The absorbed dose was MEIHOD measured in 12 12 patienrs patienrs who who underwent underwent UFE UFE proceprocemeasured in

190 190

All UFE UFE procedures procedures were were performed performed using using low dures. All low dures. on limitation limitation frequency pulsed pulsed fluoroscopy fluoroscopy with with focus focus on frequency of magnified magnified and and oblique oblique fluoroscopy. fluoroscopy . Lithium Lithium fluoride fluoride of

dosimeters were placed both in the posterior posterior vaginal vaginal entrance site. site. The The fornix and on the skin at the beam entrance EAOD. Flu Fluoapproximate the the EAOD. ovaginal dose was used to approximate The mean mean recorded. The roscopy time and exposures were recorded. calculated and compa compared to values for all patients were calcu lated and red to radiographic and and published EAODs for other conunon radiographic [0 threshold threshold doses doses for for ininradiotherapeutic procedures, to and to to our our previous previous duc[ion of deterministic skin injury and duction measurements from UFE procedures procedures mat that were were obtained obtained with non-pulsed fluoroscopy. was 13 13 min. min. (ra (range RESULTS: Mean fluoroscopy time was nge angiographic expoexpo7.6-21.3 min) and mean number of angiographic mean EAOD EAOD was was 11.0 11.0 (rartge 14-22). The mean sures was 17 (ra nge 14--22). mean ASD ASD was was 57.42 57.42 2.2-23.2 cGy (range 2.223.2 cGy) and the mean compares to to published published 12.9-110.1). cGy (range 12.9110. 1). This compares contrast BE BE (0.311-0.79 (0.311-0.79 values of EAOD for double contrast cGy), hysterosalpingiography (0.075-0.374 (0.075-0.374 cGy), cGy), fallopfallopUFE with with non-pulsed non-pulsed ian tube recanalization (0.85 cGy), UFE 4.25-65.08 cGy) cGy) and and fluorosocpy (22.34 cGy, range 4.25-65.08 determirtistic radiation radiation threshold doses for induction of determirtistic injury to the skin (300-500 cGy). from UFE UFE proceproceCONCLUSION The ASD and EAOD from of and the the use use of dures performed with refined technique and an order order of of magnimagnistate-of-the-alt equipment remains an greater procetude grea ter than from common fluoroscopic procedures. However, using pulsed fluorosocpy with emphawith emphasis on reduction of absorbed radiatio n dose radiation dose,, can can y reduce ASD and EAOD substantiall substantially EAOD to to 1/3 1/3 and and 112 1/2 when compared to UFE performed with non-pulsed non-pulsed flufluoroscopy. 1:14 pm

Abstract Abstract No_ No. 53 53

The Impact of a Public Awareness Campaign Campaign on on Referrals for Uterine Fibroid Flbroid EmboUzation EmbolIzation GP. G.P. Siskin, Siskin, Albany, NY • B.F. B.F Stainken Stainken •• K. K. Dowling. Dowling. Ij. Ahn • E.G. Dolen Dolen·· P P. Moo PURPOSE: To determine the impact of of aa public public awareawareness campaign regarding uterine fibroid fibroid embolization embolization on referral patterns for this procedure. procedure. MATERIALS AND ME'flfODS: ME71-IODS: A retrospective retrospective analysis analysis was performed on all patienrs ultations patients arranging arranging cons consultations regarding uterine fibroid embolization. All patients patients were were embolization. All asked where they first uterine fibroid fibroid ememfirst learned about uterine bolization and the source(s) of their their referraL referral. Referral Referral patterns and the effects of the techniques techniques utilized utilized to to raise public awareness were then determined. determined.

RESULTS: RESULTS: 114 patients (mean age 43.9 43.9 years; years; range range 28-59 years) were included induded in this srudy. srudy. All All patients patients were seen in consultatio n by an lnterventional consultation interventional radioloradiologist [Q to discuss uterine fibroid embolization. embolization. A A gynecologynecologist referred 43/114 (37.7%) patients for for consultation; consultation; 33/ 43 (76.7%) were referred by private private practice practice gynegyne33/43 cologists 43 (23.3%) cologists and and 10/ 10/43 (23.3%) were were referred referred by by academic academic / 11 4 (62.3%) staff staff gynecologists. gynecologists. 71 71/114 (62.3%) patients patients were were self-reself-referred after learning about the procedure from televiteleviferred after learning about the procedure from 114; 28.1%), sion news (32/ (32/114; 28.1%), the the internet internet (211114; (21/114; 18.4%), 18.4%), sion news

a family member of friend (9/114; 7.9%), newspaper articles (8/114; 7.0%), or other other sources including radio broadcasts, magazines, health fairs, and primary care physicians. 78/114 (68.4%) of patients undergoing a consultation decided to undergo this procedure. The mean delay between the consultation and procedure was 54.1 days. There was no significant difference in the distribution of referral sources between the patients scheduling or not scheduling the procedure after consultation (X2=2.023; p~0.20). CONCLUSION- Most patients arranging a consultation to discuss uterine fibroid embolization were self-referred after learning about the procedure from television news, newspaper articles, and the Internet. Utilizing a hospital's public relations resources and establishing a presence on the Internet are therefore critical first steps in starting a uterine fibroid embolization service. The single largest referral source remains the gynecologist, stressing the importance of educating and developing ties with staff and community gynecologists. 1:25 pm

Abstract No. 54

Uterine Fibroid Embolization in Patients With Leiomyomata and Concomitant Adenomyosis: Experience in Thirteen Patients I W Thomas, Washington, DC • IT Gomez-jorge • TC. Chang • R.C.]ha • S.M. Walsh • lB. Spies PURPOSE- To determine the efficacy and safety of treatment of uterine leiomyomata and concomitant adenomyosis with uterine fibroid embolization (UFE). MATERIALS AND METHODS: One hundred and seventyone patients with symptomatic leiomyomata were treated at our institution between 1997 and 1999. Thirteen (13) of these patients had concomitant adenomyosis on baseline MRI evaluation. Bilateral UFE was performed and follow up questionnaires were obtained at 3 months (n=13), 6 months (n=10) and 1 year (n=5) and follow up Mill examinations were obtained at 3 months (n=13) and one year (n=4). RESULTS: Technical success was achieved in all patients with uterine leiomyomata and concomitant adenomyosis, without complications (n=13). At 3 months, 92% (12/13) reported moderate to marked improvement in bleeding, 92% (11/12) moderate to marked improvement in pain/pressure, and 92% (12/13) overall satisfaction with treatment. At 6 months, 90% (9/10) reported moderate to marked improvement in bleeding, 750/0 (6/8) moderate to marked improvement in pain/pressure, and 67% (6/9) overall satisfaction with the procedure. At one year, 80% (4/5) reported moderate to marked improvement in bleeding, 100% (3/3) moderate to marked improvement in pain/pressure, and 60% (3/5) overall satisfaction with procedure. MRI at 3 months showed a mean decrease in uterine volume of 39% (n=12), and mean decrease in dominant leiomy-

oma of 52% (n=13). MRI at one year (n=4) showed a mean decrease in uterine volume of 44%, and decrease in volume of dominant leiomyoma was 87%. No significant change in the MRI appearance of adenomyosis was noted at 3 months and one year. CONCLUSIONS: Our limited experience suggests that uterine artery embolization may be effective in treating symptomatic uterine leiomyomata despite the presence of adenomyosis. The majority of patients experience symptomatic relief, decrease in size of leiomyomata and uterine volume despite stable appearance of the adenomyosis.

1:36 pm

Abstract No. 55

Bilateral Uterine Artery Embolization for the Treatment of Menorrhagia Due to Adenomyosis G.P. Siskin, Albany, NY • ME Tublin • B.P. Stainken • K. Dowling • I Ahn • E. G. Dolen PURPOSE- To evaluate the use of bilateral uterine artery embolization in the treatment of menorrhagia due to adenomyosis. MATERIALS AND MElliODS: 14 patients (mean age 46.7 years, range 37-56 years) with adenomyosis and menorrhagia underwent bilateral uterine artery embolization. The diagnosis of diffuse adenomyosis was based on a maximum junctional zone thickness ~12 rom. at fast spin echo imaging. Focal adenomyosis was diagnosed if there was focal thickening of the junctional zone. Uterine artery embolization was performed with standard technique, utilizing 350-5001l polyvinyl alcohol particles. Clinical response was measured with a questionnaire administered 3 and 6 months follOWing embolization. Follow-up MRI was performed 6 months after embolization. RESULTS: Bilateral uterine artery embolization was technically successful in all patients. Diffuse adenomyosis was present in 10/14 patients with a mean junctional zone thickness of 18.1 mm. (range 12-30 rom.). Focal adenomyomas were present in 4/14 patients. 9/14 patients had uterine fibroids in addition to adenomyosis. 3-month clinical follow-up is available in 11/14 patients. 6-month clinical and imaging follow-up is available in 6/14 patients. At 3 months, 10/11 patients (90.1 %) reported significant improvement of their presenting symptoms while 1/11 reported no change. Follow-up imaging at 6 months demonstrated a mean decrease in uterine volume of 47.6% (range 27.9-65.0%). The mean decrease in volume of the 3 focal adenomyomas imaged at 6 months was 74.3%. In 3 patients with diffuse adenomyosis, the mean decrease in junctional zone thickness was 39.4% at 6 months. 5/6 patients imaged at 6 months had fibroids as weJJ as adenomyosis; the mean decrease in fibroid volume was 57.4%.

CONaUSIONS: Bilateral uterine artery embolization effectively proVides symptomatic relief in patients with adenomyosis and menorrhagia. In addition, embolization results

191

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 of Symptomatic Adenomyosis of the Uterus C. Ahn, Sungnam, South Korea • WH. Lee· T. W Sunwoo • YS. Kho PURPOSE: To evaluate the potential usefulness of transcatheter uterine artery embolization as a treatment for symptomatic adenomyosis oUhe utefl.ls. MATERIALS & ME71iODS: 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) w(th dysmenorrhea, menorrhagia, or bulk-related symptoms (heaviness, urinary frequency) due to adenomyosis. All patieats were evaluated with contrast enhanced dynamic magnetic resonance imaging (MRl) before the procedure and 35 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 1'atients(93.8%) reported improvement of the symptoms. Contrast enhanced dynamic MRI revealed non-enhancing ·areas at the previously noted adenomyosis 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 embolization is an effective therapy for the 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

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

192

Abstract No. 57

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

PURPOSE: To report our single-center results of abdominal aortic aneurysm (AAA) repair by transluminal endografting (TE). ME71-JODS: ]80 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 JR 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 1581.360 (43.9%) men, but only 7/32 (21.9%) women undetwent 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 (1.1%); 5/7 were simply aborted. Though 3/392 AAAs ruptured during the preliminary workup and planning (2 died, 1 survived emergency operation elsewhere), no patient (0%) has experienced AAA rupture after TE. Operative mortality (30d) was 7/180 (3.9%), Major non-fatal perioperative complications occurred in 29/180 06.1%). Averages for LOS were: median=3d, mode=2d, mean=4.0±3.1d. There were 9 late deaths unrelated to TE. Of .32 (17.8%) patients with endoleaks, 3 self-resolved, 5 died of unrelated causes, 5 undetwent 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 RA. White, Torrance, CIl • C.E. Donayre • I. 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). ME7HODS: Endovascular t.reatment of infrarenal AAA was attempted in 171 patients (155 male/16 female) ranging in age from 46-90 years (mean 73.4 years).