UAE

Scientific Session 7 Embolization/UAE Monda~ApriI8,2002

12:30 PM - 2:00 PM Moderator(s): Scott C. Goodwin, MD

12:30 PM

Abstract No. 49

Uterine Fibroid Embolisation: Results in 400 Women with Imaging FoJlow-Up. W] Walker, Royal Surrey County Hospital, Guildford, United Kingdom·] P Pelage

PURPOSE: To evaluate the mid-term efficacy and complications of uterine artery embolisation in women with symptomatic fibroids. To assess reduction in uterine and dominant fibroid volumes using ultrasound imaging and magnetic resonance imaging (MRl). MATERIALS AND METHODS: Four hundred women entered the study between December 1996 and February 2001. Indications for treatment were menorrhagia, menstrual pain, abdominal swelling or bulk-related symptoms. Imaging was performed before embolisation and at regular intervals thereafter. Clinical evaluation was made at regular intervals after embolisation to assess patient outcome. RESULTS: Bilateral uterine artery embolisation was performed in 395 women. With a mean clinical follow-up of16.7 months, menorrhagia was improved in 84% of women and menstrual pain in 79%. The mean changes in uterine and dominant fibroid volumes were 55 and 73% with ultrasound and 53 and 64% with MRI. Three (l %) infective complications requiring emergency hysterectomy occured. Twenty three (6%) patients had clinical failure or recurrence and nine (2%) had a hysterectomy. Twenty six (7%) women had permanent amenorrhea after embolisation including 4 patients under the age of 45 (2%). Fifteen (6%) women had chronic vaginal discharge considered as a major irritant. Thirteen pregnancies occurred in 12 patients. Ninety seven percent of women were pleased with the outcome and would reconunend this treatment to others. CONCLUSION: Uterine artery embolisation is associated with a high clinical success rate and good fibroid volume reduction. Infective complications requiring hysterectomy, amenorrhea under the age of45 and chronic vaginal discharge may complicate the procedure. 12:41 PM

Abstract No. 50

Uterine Fibroid Embolization Using Tris-Acryl Gelatin Microspheres. R.J. Min, Weill Medical College ofCornell University, New York, NY, USA· R. Troiano· K. Kandarpa • N. Khilnani • D. Trost· P Winchester, et at.

PURPOSE: The purpose of this study is to evaluate the safety and efficacy of tris-acryl gelatin embosphere microspheres (BioSphere Medical, Rockland, MA) as an embolic agent for treatment of symptomatic uterine leiomyomata.

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MATERIALS AND METHODS: During a twelve month period, approximately 300 women were evaluated for potential uterine fibroid embolization (UFE). Evaluation consisted of medical history, physical examination and pelvic MRl. Patients deemed acceptable candidates for UFE were given the choice of the following embolic materials: gelfoam (Pharmacia &

Upjohn, Kalamazoo, MI), polyvinyl alcohol particles (Target Therapeutics, Fremont, CA) or embosphere microspheres. Embolization of both uterine arteries was performed via a right common femoral artery puncture under conscious sedation. Endpoint of embolization was sluggish flow within the uterine arteries with absence offilling of the small fibroid feeding vessels. All patients were discharged following a 23 hour outpatient admission. Follow-up patient questionnaires and pelvic MRI were obtained at 3 months post-DFE.

RESULTS: UFE was performed in 75 patients using embosphere particles. Bilateral uterine artery embolization was successful in all 75 patients. 74/75 (99%) of patients reported marked improvement or resolution of symptoms, including menorrhagia, pelvic pain/pressure and urinary frequency. Three month follow-up MRI demonstrated reduction in all 74 patients reporting symptomatic improvement. Mean uterine volume reduction 3 months postUFE was 35% (range of 11%-72%). Fibroids demonstrated hemorrhagic degeneration on follow-up MRl imaging with a mean volume reduction of 59% three months post-UFE. There were no minor or major complications. CONCLUSION: Early experience with tris-acryl embosphere microspheres has been extremely favorable with dramatic symtomatic improvement and fibroid shrinkage at three month follow-up MRl. Our preliminary results also suggest that the optimal endpoint for UFE may be a "pruned tree" appearance with sluggish, but not stagnant, flow within the uterine a11eries. 12:52PM

Abstract No. 51

Tris-Acryl Gelatin Microspheres Versus Polyvinyl Alcohol Particles for Uterine Artery Embolization. R.K. Ryu, Northwestern University Medical School, Chicago,IL, USA· R.A. Omary· H.B. Chrisman· A.A. Nemcek Jr. • A. Siddiqi· R. L. Vogelzang, et al.

PURPOSE: When compared in a uterine artery embolization (DAE) animal model, Embospheres (ES) (Biosphere Medical, Rockland, MA) were found to induce less uterine ischemia than polyvinyl alcohol (PYA) particles. Given this finding, we aimed to test the hypothesis that use of ES is also associated with less pain than PYA after UAE. MATERIALS AND METHODS: Data on 72 consecutive DAE patients were collected from a prospectively acquired database. We compared patient controlled analgesia (PCA) pumpdelivered morphine sulfate (MS) dosages between patients who received ES versus PYA. Subjective pain scores (SPS) were also compared between the two groups. We used paired t-tests to assess the differences between the ES and PYA samples, with the null hypothesis rejected at the p<0.05 level. RESULTS: Mean follow-up period in the PYA sample was 177 days (range 28-426) versus 95 days (range 24-197) in the ES sample. The mean MS doses used by ES and PYA patients were 37.2 mg (s.d. 23.5) versus 47.1 mg (s.d. 26.8), respectively. This difference was not significant (p>0.15). Using a standard 0-10 pain scale, the mean peak SPS for the ES and PYA sample were 5.58 (s.d. 2.77) and 5.07 (s.d. 2.99), respectively. The difference was not significant (p>0.51). The mean amounts of embolic material used in each ES and PYA patient were 4.9 cc (s.d. 3.0) and 3.5 cc (s.d. 1.6), respectively. The difference revealed a strong trend toward statistical significance (p=0.05). There was one treatment failure in each group. CONCL USION: There is no subjective or objective difference in pain between ES and PYA after DAE.

1:03PM

Abstract No. 52

A Multi-Center Study Evaluating the Use of Gelfoam Only for Uterine Artery Embolization for Symptomatic Leiomyomata. KM Sterling, Inova Alexandria Hospital, Alexandria, VA, USA· G.P Siskin· MM Ponturo • K Mandato· KS. Rholl • J.M Cooper

PURPOSE: To evaluate the safety and efficacy of perfonning uterine artery embol ization with gelfoam alone in women with symptomatic uterine leiomyomata who have a desire for future fertility. MATERIALS AND METHODS: From August 1998 to September 200 I, bilateral uterine artery embolization was perfonned in 50 women at two institutions using gelfoam alone as the embolic agent. Patients had imaging with ultrasound or MR before and after the procedure. Clinical follow-up of the patient's fibroid-related symptoms and pregnancy status was recorded and analyzed. RESULTS: The mean age of the patients was 37.3 years (age range 23-52 years). Forty-four (88%) ofthe patients expressed a significant desire for future fertility. Bilateral embolization was technically successful in 50 of 50 patients (100%). There were no immediate complications. Complications occurred in two patients during the follow-up period. This included a readmission for pain control in one patient and a delayed postembolization syndrome in the other patient. There were no cases of procedure-induced menopause or infection. Imaging follow-up was available in 34 of 50 (68%) patients. The average decrease in uterine volume was 47% at a mean of6.4 months (range 3-16 months) post-procedure. The average decrease in dominant fibroid volume was 57% at the same time interval. Clinical follow-up was available in 42 of 50 (84%) patients at a mean of 10.7 months (range 3-30 months) post-procedure. Symptoms of menorrhagia resolved in 94% of patients. Bulk-related symptoms resolved or were significantly improvcd in 91 %. There were 3 viable pregnancies and one miscarriage at 8 weeks during the follow-up period. CONCLUSION: Uterine artery embolization with gelfoam alone is a safe and effective alternative in treating yOlmg women with symptomatic uterine leiomyomata.

1:14 PM

Abstract No. 53

A Comparison of Estimated Costs for Uterine Artery Embolization and Abdominal Myomectomy at a Single Institution. C.M Baker, Georgetown University Medical Center, Washington D.C., USA· C.A. Winkel· S. Subramanian· J.E. Spies

PURPOSE: To estimate and compare the costs associated with uterine artery embolization (UAE) and abdominal myomectomy (AM) for the treatment of symptomatic leiomyomata. MATERIALS AND METHODS: A retrospective study was perfonned using billing infonnation from 23 UAE and 17 AM patients consecutively treated in a single institution during the first halfof200 I. The charges were grouped into 6 charge categories for UAE and 8 categories for AM. The mean charges for each category were calculated. Cost-to-charge ratios were then applied to the mean charge for each of these categories to estimate the mean cost for each category. These were summed to detennine the hospital costs for each intervention. The physician billing infonnation provided a record oftotal RVUs for the radiologist for the UAEs and for the gynecologist, anesthesiologist and pathologist for the AM. The total RVUs

were multiplied by the appropriate conversion factors to estimate Medicare reimbursement. Finally, to estimate associated imaging charges pre and post procedure, Medicare global charges for a transabdominal and transvaginal sonogram for the AM patients and 2 pelvic MRJs (I pre and I postprocedure) for the UAE patients were added. The Student's t-test was used to detennine the significance of the estimated cost differences between UAE and AM.

RESULTS: The estimated hospital cost for UAE was $3194.50, which was significantly lower than the $5597.80 estimated for abdominal myomectomy (p=0.001), primarily due to increased hospital care and operating room costs for AM. The total professional costs were not signi ficantly higher for UAE ($2219.90) than for AM ($ I 938.00)(p=0.06), although there was a trend in that direction. With the use of pre and post-embolization MRJ, typical imaging costs were significantly higher for UAE than AM ($l337.00 versus $224.81). When all associated costs were considered, UAE was estimated to be $6,713.60, 18% less than for AM ($8,204.80)(P=0.0 1). CONCLUSION: UAE has a total lower cost than abdominal myomectomy, with primary cost benefit associated with decreased length of stay and lower operating room charges. This is despite higher associated imaging costs and a trend toward higher physician costs.

1:25PM

Abstract No. 54

MRI Characteristics of Uterine Enhancement and Arterial Patency in Patients Undergoing Uterine Artery Embolization. M Itkin, University ofPennsylvania Medical Center, Philadelphia, PA, USA ·J.A. Leon· D.C. Bloomgarden • R.D. Shlansky-Goldberg

PURPOSE: Uterine arterial embolization (UAE) is a relatively new treatment of symptomatic uterine fibroids, in which embolic particles are injected into the uterine arteries until stasis occurs. A theoretical concern is ischemic injury to the myometrium that may result in infertility or infection. We hypothesized that changes in signal enhancement on gadolinium enhanced (Gd) MR1 correlate with tissue perfusion. Therefore, we studied MR signal characteristics of the myometrium and fibroids with Gd MRJ, before and after UAE, and the rate of uterine artery patency with MR!. MATERIALS AND METHODS: 67 women who underwent UAE at our institution, completed Gd MR! examinations before and after UAE. These MRIs were evaluated by calculating signal enhancement in ROIs in the myometrium and dominant fibroid before and after treatment. The enhancement ratio was calculated as the difference in the signal intensity (SI) before and after administration ofgadolinium in a 3D Tl-weighted image, nonnalized to the pre-gadolinium S1. The uterus and dominant fibroid volumes were also calculated. Uterine arteries were considered patent if at least one uterine artery or collateral vessels were visible on the 3D MRA obtained after the procedure. RESULTS: Post-embolization MRIs were completed an average of 146 days post procedure (range 32 - 667 days). The average enhancement ratio was 3.9 prior to UAE. After the procedure, there was no change in the enhancement ratio. Only 8 patients had no myometrial enhancement post-UAE. In contrast, the fibroid enhancement decreased from 2.5 to 0.4 post-UAE (p
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difference between patients with patent or non-patent arteries in myometrial enhancement, uterine size, or dominant fibroid size.

PURPOSE: To determine the safety and effectiveness of uterine embolization for leiomyomata using Embospheres Microspheres when compared to hysterectomy.

CONCLUSION: In spite ofembolization ofthe uterine arteries with permanent agents, most patients show no change in myometrial enhancement, suggesting minimal ischemic effects on the myometrium.

MATERIALS AND METHODS: This is a multi-center prospective parallel cohort study comparing uterine artery embolization with hysterectomy for the treatment of patients with menorrhagia. Each patient completed a baseline symptom severity questionnaire, a menorrhagia questionnaire, and a SF-12 health survey. Each UAE patient had baseline imaging. Bilateral uterine embolization was performed in the standard fashion using Embosphere Microspheres. Hysterectomy was performed using standard surgical techniques. Clinical followup occurred during the first month, at 3 months, 6 months and 12 months after treatment, with imaging at 3 and 6 months.

1:36PM

Abstract o. 55

MR Imaging Outcome after Uterine Artery Embolization for Leiomyomata Using Tris-Acryl Gelatin Microspheres. F. Banovac, Georgetown University, Washington DC, USA' S.M. Ascher· D.A. Jones' M. D. Black· 1. C. Smith' 1.B. Spies PURPOSE: To determine the frequency and extent of leiomyomata infarction and shrinkage after uterine artery embolization (UAE) using tris-acryl gelatin microsphercs (Embospheres). MATERIALS AND METHODS: A retrospective analysis of MR images of the pelvis was performed comparing studies completed approximately 3-4 months after UAE to those obtained before UAE. Twenty three (23) patients with a total of 61 leiomyomata were examined (up to 3 fibroids per patient). Orthogonal T2 HASTE, axial TlW fat saturated spoiled gradient echo, sagittal T2 FSE, and dynamic T IW sagittal images post-gadoliniuJl1 were analyzed Two abdominal imaging specialists characterized each leiomyoma and the uterus for total volume using equation for prolate ellipse. They also examined perfusion by assessing enhancement relative to myometrium. Total fibroid volume perfused before and after UAE was calculated. Readers were blinded and disagreements in interpretation were resolved by consensus. Paired Student-t test was used for inferences in uterine and leiomyoma size difference, percent infarction, and volume of fibroid tissue perfused before and after UAE. RESULTS: Mean volume ofall leiomyomata (n=61) decreased from 91 ± 143 cc to 52 ± 106 cc (p<0.001) with mean 49% decrease in volume. When dominant fibroids were considered alone (n=23) a mean 53% volume decrease (p<0.001) was noted. Uterine volume decreased from 651 ± 423 cc to 469 ± 344 cc (p<0.00 I) with mean 32% decrease in volume. Perfused volume of all fibroids (n=61) decreased from 84 ± 138 cc to 3 ± 8 cc (p<0.001) with mean 93% decrease in volume, and 117 ± 190 cc to 4 ± 9 cc (p<0.001) with mean 95% decrease in perfused volume for dominant fibroids alone (n=23). Average percent of infarcted tissue volume for all leiomyomata increased from 8% to 89% after treatment, and 9% to 92% for dominant leiomyomata. Fifty-two (52) out of all 61 fibroids (85%), and 20 of 23 dominant fibroids (87%) were completely devascularized by UAE using Embospheres. One fibroid disappeared completely after treatment. There was no myometrial ischemia or injury identified. CONCLUSION: Tris-acryl gelatin microspheres (Embospheres) are an effective embolic agent for UAE, causing infarction and significant decrease in leiomyoma volume.

1:47PM

Abstract No. 56

FEAI UREIlARSTR \CT Commcntahll': I{ichard Shlansl{) -Goldberg. M D

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Uterine Artery Embolization (UAE) Using Embospheres: Initial Results of a Phase II Comparative Study. 1.B. Spies, Georgetown University Hospital, Washington DC, USA· 1.M. Cooper' R.L. Worthington-Kirsch' 1. C. Lipman· J.F. Benenati· B. McLucas

RESULTS: To date, 67 patients have been treated with UAE and 20 with the hysterectomy. Among the patients treated with UAE available for 3 month imaging follow-up (N=27), there was a mean reduction of29% (SD 29) in uterine volume and the dominant leiomyoma 42% (SD 36). In those patients available for 3 month clinical follow-up (N=29), 83% of patients had improved menstrual bleeding 3 months posttreatment. At baseline, 61 % of UAE patients rated their bleeding as extremely heavy, while only 7% similarly rated their bleeding 3 months after treatment. The menstrual bleeding score reduced on average 60% (p less than 0.0001). For the UAE patients, the SF-12 physical score increased from 45 to 52 (p=0.0006) and the SF-12 mental score mean increased from 45 to 53 (p=0.0004). Only 7 hysterectomy patients were available for follow-up. Among these, the SF-12 physical scores increased from 35 to 52 (p=O.0119) willIe the SF-12 mental scores did not change (pre 41, post 42, p=0.7099). Among the UAE patients, there were no major complications. Minor complications occurred in 12 patients (17%). Hysterectomy was performed in one patient who developed pelvic inflammatory disease 9 weeks after UAE, which was unrelated directly to UAE. Complications occurred in 4 of20 hysterectomy patients. CONCLUSION: Initial results suggest that UAE using Embospheres is safe and effective when compared to hysterectomy.

Scientific Session 8 Vascular Stents Monday, April 8, 2002 12:30 PM - 2:00 PM Moderator(s): Klemens H. Barth, MD 12:30 PM

Abstract No. 57

Vascular Stent Surface Composition Differs Significantly from the Bulk Material. C. Fuss, UTHSC San Antonio, San Antonio, TX, USA· 1. C. Palmaz • S.R. Bailey· E.A. Sprague· D. Marton PURPOSE: To determine the surface chemical composition ofstents, currently available and widely used in the US, using X-ray Photoelectron Spectroscopy (XPS). MATERIALS AND METHODS: Nine coronary and three peripheral stent brands were examined in groups of 3 each. The sterile devices were handled in compliance with proper surface-sensitive analytical techniques. The bulk stent material was stainless steel (88) in eight, Nitinol in three and goldcoated SS in one. A five-point analysis pattern per stent was evaluated for eminent atomic peaks and quantitative acquisition was targeted accordingly. Quantitative analysis