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Noninvasive Treatment of Uterine Fibroids: Early Mayo Clinic Experience With Magnetic Resonance Imaging-Guided Focused Ultrasound

2006; Elsevier BV; Volume: 81; Issue: 7 Linguagem: Inglês

10.4065/81.7.936

1942-5546

Gina K. Hesley, Joel P. Felmlee, John B. Gebhart, Kelly T. Dunagan, Krzysztof R. Gorny, Jessica B. Kesler, Kathleen R. Brandt, Janel N. Glantz, Bobbie S. Gostout,

Ultrasound and Hyperthermia Applications

Uterine fibroids often cause symptoms of pelvic pain, pressure, and bleeding. Traditional therapies have included medical (eg, hormonal therapy) and surgical (eg, myomectomy, hysterectomy) options. Recently, uterine artery embolization was added to the treatment armamentarium. We describe an exciting new noninvasive treatment option using focused ultrasound with magnetic resonance imaging and summarize the early experience at the Mayo Clinic in Rochester, Minn, during the initial research studies of this new technology. Uterine fibroids often cause symptoms of pelvic pain, pressure, and bleeding. Traditional therapies have included medical (eg, hormonal therapy) and surgical (eg, myomectomy, hysterectomy) options. Recently, uterine artery embolization was added to the treatment armamentarium. We describe an exciting new noninvasive treatment option using focused ultrasound with magnetic resonance imaging and summarize the early experience at the Mayo Clinic in Rochester, Minn, during the initial research studies of this new technology. Uterine fibroids are the most common solid pelvic tumors that affect women during their reproductive years.1ACOG Practice Bulletin Clinical Management Guidelines for Obstetrician-Gynecologists, Number 16, May 2000.The American College of Obstetricians and Gynecologists Compendium of Selected Publications. 2005; : 776-784Google Scholar Fibroids may be asymptomatic and found incidentally on pelvic examination or pelvic imaging studies. However, for some women, fibroids cause distressing symptoms, including heavy bleeding, pelvic pressure, and pain. Fibroids are a common reason for hysterectomy, accounting for at least 160,000 such procedures annually in the United States.2Graves EJ Kozak LJ National hospital discharge survey: annual summary, 1996.Vital Health Stat 13. 1999; 140: 1-46Google Scholar In an effort to decrease the cost, morbidity, and lifestyle impact of hysterectomy, a range of less invasive treatment options, including hormonal therapy, myomectomy, and uterine artery embolization, has been tested and used over the years.3Healy DL Vollenhoven BJ The role of GnRH agonists in the treatment of uterine fibroids.Br J Obstet Gynaecol. 1992; 99: 23-26Crossref PubMed Scopus (26) Google Scholar, 4Spies JB Ascher SA Roth AR Kim J Levy EB Gomez-Jorge J Uterine artery embolization for leiomyomata.Obstet Gynecol. 2001; 98: 29-34Crossref PubMed Scopus (352) Google Scholar, 5Lumsden MA Embolization versus myomectomy versus hysterectomy: which is best, when?.Hum Reprod. 2002; 17: 253-259Crossref PubMed Scopus (89) Google Scholar, 6Mauskopf J Flynn M Thieda P Spalding J Duchane J The economic impact of uterine fibroids in the United States: a summary of published estimates.J Womens Health (Larchmt). 2005; 14: 692-703Crossref PubMed Scopus (44) Google Scholar In this article, we describe our experience at the Mayo Clinic in Rochester, Minn, with use of the first completely noninvasive modality for treatment of uterine fibroids, magnetic resonance imaging (MRI)-guided focused ultrasound (MRgFUS). This technology combines (1) the ability to localize a target tissue in 3 dimensions using MRI with (2) the ability to direct a converging pattern of ultrasound energy to destroy a small volume of tissue while (3) using MRI to monitor the treatment and measure the temperature induced at the target. The purpose of this report is to familiarize health care professionals with this new treatment option for women with symptomatic uterine fibroids. The focused ultrasound system (Exablate 2000; InSightec, Ltd, Haifa, Israel) uses a piezoelectric ultrasound transducer (called a phased-array transducer) made of multiple elements that are focused on a single location. The transducer can operate at a frequency of 1.0 to 1.35 MHz. When the ultrasound energy delivered from each element converges at the focal spot (focus), considerable heat is generated. Cell death occurs through protein denaturation and thermal coagulation when tissues are heated to more than 55°C.7Dewey WC Highfield DP G2 bock in Chinese hamster cells induced by x-irradiation, hyperthermia, cycloheximide, or actinomycin-D.Radiat Res. 1976; 65: 511-528Crossref PubMed Scopus (72) Google Scholar, 8Lele PP Threshold and mechanisms of ultrasonic damage to organized animal tissues: proceedings of a symposium on biological effects and characterization of ultrasound sources, June 1-3, Rockville, Md.Ultrasound Med Biol. 1977; : 224-239Google Scholar, 9Holahan EV Highfield DP Holahan PK Dewey WC Hyperthermic killing and hyperthermic radiosensitization in Chinese hamster ovary cells: effects of pH and thermal tolerance.Radiat Res. 1984; 97: 108-131Crossref PubMed Scopus (56) Google Scholar Heat is generated in both the near field (skin and subcutaneous fat) and the far field (bowel, nerves, and bone) of the treatment area. However, the amount of heat is substantially less in the far field than at the focal spot and is monitored to minimize the possible damage to these tissues. Because ultrasound beams do not penetrate air, bowel cannot be positioned anterior to the area of treatment. The transducer lies within the MRI table surrounded by degassed water and covered by a Mylar membrane. Water, ultrasound gel, and a gel pad on which the patient lies (Figure 1) are used to couple the ultrasound energy. The patient is positioned prone with the area of the fibroid to be treated over the transducer. Before the patient is taken to the MRI suite, all hair is shaved from the umbilicus to the pubic bone, and the patient's skin is cleansed with alcohol to ensure that no oils or powders are present. This step is important because any substance on the skin might form a local pocket of air, resulting in a skin burn when higher-power focused ultrasound is applied. A catheter is placed in the bladder to minimize shifts in pelvic organs during treatment. An intravenous (IV) line is inserted for sedative administration during the treatment and for posttreatment administration of contrast dye. The patient is positioned in the MRI chamber feet first, and 3 plane-localizing MR images with a large field of view (TR/TE, 5/1.4; field of view, 44 cm; matrix size, 256 × 128; section thickness, 7 mmwith 3-mm gap and 31-kHz bandwidth) are obtained to determine whether the position of the fibroids is optimal for treatment and to verify that the beam path does not intersect bowel or areas of scarring. Areas of scarring are avoided because they often are sensitive to the effects of the heat. T2-weighted fast spin echo planing images (TR/TE, 3-4000/90-110 ms; field of view, 36 cm; matrix size, 256 × 192; section thickness, 4 mm with 1-mm gap and 16-kHz bandwidth) are obtained in the axial, sagittal, and coronal planes and transferred to a workstation with special software for treatment planning. The coronal view is used to delineate the location of the fibroid treatment (Figure 2). The location of the skin is traced as a safety parameter to ensure that no treatment is performed within 1 cm of the skin. The area posterior to the site to be treated is specifically evaluated to minimize the possibility of nerve stimulation.FIGURE 2Magnetic resonance image of the pelvis in the coronal plane with the area to be treated outlined in white over the fibroid.View Large Image Figure ViewerDownload (PPT) A treatment plan is determined based on the depth of the fibroid from the skin and on the size of the fibroid. This initial plan provides default settings for power, frequency, and sonication time to begin the treatment. Electronic position markers are placed on images in all 3 planes and used during the treatment to indicate patient or uterine movement during the procedure. Two initial lower-power sonications are performed in separate planes to ensure accurate targeting. The power level used typically generates temperatures of less than 55°C. When all safety parameters have been met and the targeting has been shown to be accurate, the energy setting is increased to deliver a thermal dose sufficient to cause tissue ablation. In our clinical practice, tissue ablation occurs more reliably when the targeted tissue volume temperature is increased beyond 65°C in fibroids. Other investigators have reported treatments performed with temperatures between 60°C and 85°C,10Stewart EA Gedroyc WM Tempany CM et al.Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique.Am J Obstet Gynecol. 2003; 189: 48-54Abstract Full Text Full Text PDF PubMed Scopus (373) Google Scholar, 11Hindley J Gedroyc WM Regan L et al.MRI guidance of focused ultrasound therapy of uterine fibroids: early results [published correction appears in AJR Am J Roentgenol. 2005;184:3348].AJR Am J Roentgenol. 2004; 183: 1713-1719Crossref PubMed Scopus (352) Google Scholar, 12Jacobs MA Herskovits EH Kim HS Uterine fibroids: diffusion-weighted MR imaging for monitoring therapy with focused ultrasound surgery—preliminary study.Radiology. 2005; 236: 196-203Crossref PubMed Scopus (95) Google Scholar, 13Stewart EA Rabinovici J Tempany CM et al.Clinical outcomes of focused ultrasound surgery for the treatment of fibroids.Fertil Steril. 2006; 85: 22-29Abstract Full Text Full Text PDF PubMed Scopus (395) Google Scholar, 14Rabinovici J Inbar Y Eylon SC Schiff E Hananel A Freundlich D Pregnancy and live birth after focused ultrasound surgery for symptomatic focal adenomyosis: a case report.Hum Reprod. 2006; 21: 1255-1259Crossref PubMed Scopus (96) Google Scholar and earlier studies in animal models showed that 60°C was optimal.7Dewey WC Highfield DP G2 bock in Chinese hamster cells induced by x-irradiation, hyperthermia, cycloheximide, or actinomycin-D.Radiat Res. 1976; 65: 511-528Crossref PubMed Scopus (72) Google Scholar, 9Holahan EV Highfield DP Holahan PK Dewey WC Hyperthermic killing and hyperthermic radiosensitization in Chinese hamster ovary cells: effects of pH and thermal tolerance.Radiat Res. 1984; 97: 108-131Crossref PubMed Scopus (56) Google Scholar Each sonication lasts from 12 to 24 seconds, producing heat at the focus and resulting in a small elongated ablated volume. During the sonications, MR images provide the radiologist with information regarding the extent and degree of thermal damage. While sonications are occurring, data are acquired to facilitate identification of high temperature at any region in which the ultrasound beam might be reflected. Of special concern is cavitation, microbubble formation that can produce high heat resulting in potentially uncontrolled and unpredictabletissue destruction. Monitoring for cavitation occurs during each sonication. Thus far, cavitation has not been a problem in our MRgFUS treatments because of the time, frequency, and power parameters currently used during the procedure. Following each sonication, approximately 80 seconds is allowed to elapse for the tissue to return to its baseline temperature. Thermal feedback provided by the MRI helps the radiologist make adjustments in the treatment parameters to achieve temperatures that will cause tissue ablation while minimizing discomfort to the patient. Adjustable parameters that optimize treatment include sonication delivery time, acoustic power, diameter of the focus, and frequency of the transmitted ultrasound beam. Because the patient may feel heat internally or experience cramping during treatment, IV sedatives, typically midazolam hydrochloride and fentanyl citrate, are administered. The most discomfort tends to occur during the last 1 to 2 seconds of each sonication, and patient communication of the severity and location of the discomfort provides useful feedback during treatment. The patient is assessed continuously for severity and location of discomfort. Because the amount of tissue that is destroyed with each sonication is small, an entire treatment is composed of multiple sonications, and 3 or more hours may be required to treat a sphere measuring approximately 5 cm in diameter. Repeat sonications are performed until generally at least 50% of the fibroid is treated. At the conclusion of the procedure, T1-weighted fat-saturated fast-spoiled gradient-echo images (TR/TE, 150-200/minimum [4-10 ms]; field of view, 36 cm; matrix size, 256 × 128; section thickness, 4 mm with 1-mm gap) are obtained in the sagittal and axial planes. An IV gadolinium-based contrast agent is administered, and T1-weighted MR images are repeated to determine how much fibroid tissue has been devascularized. One hour after the last dose of sedative, most patients report mild to no discomfort. Patients occasionally require over-the-counter medication (eg, acetaminophen, 500 mg every 4-6 hours, or an equivalent) on the day after the procedure for pain relief and do not require hospitalization. Most patients return to work the next day. We reevaluate patients treated off the research protocol by telephone follow-up at 1 day, 1 week, 1 month, and 3 months after the procedure. We recommend an office examination at 6 months and at 1 year to assess for any complications and to determine the adequacy of symptom control. Pelvic pain and pressure symptoms tend to resolve quickly, usually within the first 3 months, while approximately 3 menstrual cycles commonly occur before patients note improvement in their menses. Measurable fibroid shrinkage is not immediately evident because the necrotic center absorbs slowly. We emphasize to patients that the measure of treatment success is symptom control rather than fibroid shrinkage. Magnetic resonance imaging-guided focused ultrasound treatment of uterine fibroids was first offered at the Mayo Clinic in Rochester in July 2002 as part of a multi-institutional research protocol funded by InSightec, Ltd.11Hindley J Gedroyc WM Regan L et al.MRI guidance of focused ultrasound therapy of uterine fibroids: early results [published correction appears in AJR Am J Roentgenol. 2005;184:3348].AJR Am J Roentgenol. 2004; 183: 1713-1719Crossref PubMed Scopus (352) Google Scholar, 13Stewart EA Rabinovici J Tempany CM et al.Clinical outcomes of focused ultrasound surgery for the treatment of fibroids.Fertil Steril. 2006; 85: 22-29Abstract Full Text Full Text PDF PubMed Scopus (395) Google Scholar Since that time, more than 100 focused ultrasound treatments/procedures have been performed at our institution. Of these, 43 patients were treated in the context of 2 research protocols. Results from these early trials contributed to the data set that resulted in the Food and Drug Administration approval of MRgFUS for treatment of uterine fibroids in October 2004. Since then, MRgFUS has become more widely available. At the Mayo Clinic in Rochester, the cost of MRgFUS is typically one half the cost of hysterectomy and one third that of uterine artery embolization. Because this is a new procedure, supporting documentation and letters of appeal often are required to obtain insurance approval. The following sections summarize our experience with 42 patients treated as part of the early research trials. One research patient was excluded from this report because she has not completed 6 months of follow-up. To be eligible for this study, patients were required to score above 20 on a validated symptom severity scale.15Juniper EF Guyatt GH Willan A Griffith LE Determining a minimal important change in a disease-specific Quality of Life Questionnaire.J Clin Epidemiol. 1994; 47: 81-87Abstract Full Text PDF PubMed Scopus (1556) Google Scholar, 16Spies JB Coyne K Guaou NG Boyle D Skyrnarz-Murphy K Gonzalves SM The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata.Obstet Gynecol. 2002; 99: 290-300Crossref PubMed Scopus (490) Google Scholar The women were free of other pelvic pathology requiring surgical intervention. Subjects were considered for treatment if their dominant fibroid(s) was greater than 3 cm in diameter and total uterine size was less than that at 24 weeks of gestation. All subjects in this report were premenopausal and indicated that they had completed childbearing. Dominant fibroids were primarily intramural in location, although because of the large size of some of the fibroids, submucosal or subserosal components were present. Initial patient evaluation included solicitation of a history of fibroid-related concerns with detailed quantification of symptoms when possible. Patient evaluation also included a pelvic examination, pelvic MRI (see Radiologic Screening section), and a brief health assessment. We asked about the nature and duration of fibroid symptoms and reviewed the pattern of fibroid growth, being attentive to possible indicators of malignancy. We reviewed the duration and severity of menstrual flow. An endometrial biopsy was mandated within 6 months of treatment if patients reported abnormal menstrual bleeding, including bleeding for more than 7 days, changing protective pads or tampons morethan once every 2 hours at any time, and bleeding between menstrual cycles. Hematology group and serum ferritin levels were obtained to evaluate for anemia and iron deficiency. We required that cervical cancer screening was up-to-date, and any cervical screening abnormalities were investigated and treated according to standard guidelines. Bladder and bowel symptoms were reviewed in addition to general symptoms of pressure, pain, and discomfort. The research protocol includes plans for 3 years of follow-up unless patients exit the trial earlier for additional treatment of fibroid symptoms. From a radiologic standpoint, we evaluated potential patients with contrast-enhanced MRI of the pelvis. T2-weighted images of the pelvis in all 3 planes were performed as described previously to allow visualization of the entire uterus and associated fibroids. Before and after contrast-enhanced T1-weighted images with the same parameters used at the conclusion of treatment (described previously) were then performed to ensure that the fibroids targeted for treatment were well vascularized (perfused) because fibroids with large areas of degeneration (no perfusion) would not benefit from MRgFUS treatment. Magnetic resonance imaging yields optimal anatomic detail regarding fibroid size, number, and location as well as information regarding the accessibility of the fibroids for treatment. The ultrasound beam can penetrate up to approximately 12 cm beyond the skin. Therefore, visualization of the anterior abdominal wall is helpful in evaluating whether fibroids deep in the pelvis will be accessible for treatment. The position of bowel loops relative to the treatment target is important in screening potential patients and in treatment planning. When bowel lies anterior to the uterus, it can sometimes be displaced by adjusting the patient's position, using a convex gel pad for the patient to lie on during treatment, or filling the bladder or rectum with water to move bowel out of the pelvis (Figures FIGURE 3, FIGURE 4). During the research study, treatments could not be performed through the bladder because of protocol restrictions, but such procedures have since been performed with success. If bowel cannot be displaced or the transducer cannot be angled in such a manner to avoid the bowel, the treatment cannot be performed. The fibroids targeted for treatment were those thought to be the cause of the patient's symptoms. The number of treatments required was determined by the number and size of the fibroids to be treated. Two treatment sessions were usually performed when multiple small fibroids or a single large (≥6 cm diameter) fibroid was targeted for ablation. Early in the research study, the protocol was restricted to a single treatment.FIGURE 4Left, Magnetic resonance image (MRI) in the sagittal plane showing patient with a retroverted uterus and bowel (white arrow) anterior to the uterus preventing treatment of fibroid. Right, Sagittal MRI showing the rectum (white arrow) filled with water to displace the uterus forward. Bowel is now superior to the uterus, allowing for treatment of the fibroid.View Large Image Figure ViewerDownload (PPT) Our patients ranged in age from 38 to 54 years, with a mean age of 46 years (Table 1). Twenty-four patients presented with a mix of bleeding and pressure symptoms. Thirteen had isolated pressure symptoms, most commonly urinary frequency and nocturia, and 5 had isolated bleeding symptoms, most commonly heavy bleeding described as "flooding" or "gushing."TABLE 1Data on 42 Patients Undergoing MRgFUS Treatment of Uterine Fibroids*MRgFUS = magnetic resonance imaging–guided focused ultrasound.Total No. of treatments55Patient age (mean) (y)38-54 (46)Symptoms (No. of patients) Mixed24 Pressure only13 Bleeding only5Fibroid characteristics No. per patient1-18 Intramural0-16 Subserosal0-3 Submucosal0-1 No. treated per patient1-4* MRgFUS = magnetic resonance imaging–guided focused ultrasound. Open table in a new tab Fifty-five treatment sessions were performed for the 42 patients, including 9 patients who were treated on 2 consecutivedays for large fibroids and 3 patients who were retreated 12 to 18 months after their initial treatment in an effort to further improve symptom control. Included in this report are 2 patients who received less than one third the usual number of sonications for adequate treatment because of discomfort. A minimum of 6 months of follow-up is available for all except 2 patients who exited the study. As a result of the contrast-enhanced pelvic MRI examination, patients were counseled to consider alternative treatment options if they were found to have adenomyosis, if their fibroids were predominantly submucosal, or if all fibroids were less than 3 cm in maximum diameter. Maximum uterine size permitted in this study group was that of 24 weeks of gestation. The fibroids targeted for treatment ranged from 2.4 × 3.2 × 3 cm to 14.5 × 9.1 × 11.1 cm. The total number of fibroids per patient was as high as 18,although the maximum number treated was 4 per patient. The distribution of the uterine fibroids is summarized in Table 1. The research protocol limited treatment to no more than 150 cm3 per treatment. Therefore, this treatment volume was distributed to the fibroid or fibroids thought to be the most likely source of the patient's symptoms. For most subjects, this policy dictated treatment of the largest fibroid(s). Pretreatment symptoms are described in Table 2. Patients with improvement in bleeding symptoms typically described noticeable improvement by the first, second, or third menstrual cycle after treatment. Before treatment, the 42 women reported menstrual periods lasting from 1.5 to 14 days, with a mean of 6.1 days and median of 5.5 days. After treatment, the described range was primarily unchanged at 1 to 14 days, but the mean number of bleeding days was reduced to 4.9 with a median of 4.5 days. Seven patients described bleeding between menstrual periods before treatment. This symptom was minimally affected by treatment, with 6 patients continuing to report bleeding between periods after treatment.TABLE 2Fibroid Symptoms Before and After MRgFUS Treatment in 42 Patients*Values are number of patients unless indicated otherwise. MRgFUS = magnetic resonance imaging–guided focused ultrasoundMRgFUS treatmentSymptomBeforeAfterExcessive bleeding†Change of protection less than every 2 hours.2913 Menstrual period duration (d) Range1.5-141-14 Mean6.14.9 Median5.54.5Interval between changing protective pad/tampon‡Data available for only 29 patients. 1 h717 Mean interval (h)1.72.25* Values are number of patients unless indicated otherwise. MRgFUS = magnetic resonance imaging–guided focused ultrasound† Change of protection less than every 2 hours.‡ Data available for only 29 patients. Open table in a new tab We used the patient's report of the interval between protective pad or tampon changes during her heaviest menstrual flow to quantify the severity of bleeding symptoms. Before treatment, 22 patients reported changing their protection at least once hourly during their heaviest flow. The mean interval between changes at heaviest flow was 1.7 hours. Details regarding the interval between changes were available for 29 of the 42 patients. After treatment, 12 patients reported requiring protection changes hourly or less than hourly, and the mean reported interval increased to 2.25 hours at peak flow. Eight additional patients described their posttreatment protection change interval as "better" or "normal," suggesting that approximately 25 of the 42 women had adequate control of their heavy bleeding symptoms. Further evidence of improvement in bleeding patterns was suggested by trends in the patients' hematocrit levels. Before treatment, the mean hematocrit level was 35.1%, with a range of 27.6% to 49.9%. Six months after treatment, the mean hematocrit level was 36.1%, with a range of 32.7% to 48.8%. Patients described a range of pressure symptoms, including urinary frequency and nocturia, bloating (tight-fitting clothing), difficulties with exercise and physical activities, dyspareunia, constipation, and rectal pressure. Of the 37 patients experiencing pressure symptoms before treatment, only 1 (3%) reported no improvement after treatment, whereas 18 (49%) described symptomatic improvement and 18 (49%) described complete relief from their pressure symptoms. Nocturia was reported in 25 patients before treatment and resolved completely in 17. Of the remaining 8 patients, 2 described no improvement in nocturia, and 6 indicated that they were better but still had some episodes of nocturia. The time range for improvement in pressure symptoms varied, with some patients reporting feeling less pressure immediately after treatment, whereas others experienced gradual improvement over 3 to 12 months after treatment. Although patients reported a variety of mild symptoms such as fatigue and backache after treatment, most reported returning to full activity within a day or 2 of treatment. Posttreatment discomfort was managed with over-the-counter medication in all cases. Three patients reported mild diarrhea, 1 had passage of mucus rectally, and 1 passed blood-tinged mucus rectally for 2 to 3 days after treatment. One patient developed pain in the distribution of the sciatic nerve after treatment. The pain gradually resolved over the subsequent 12 months. One patient treated initially without complications during the study later underwent additional MRgFUS treatment off study and was diagnosed as having deep venous thrombosis in the right common femoral vein 1 day after the second MRgFUS treatment. She remains on anticoagulation therapy. No skin burns or other adverse events occurred. Serious adverse events are rare in patients undergoing MRgFUS treatment. During the course of treating research patients and more recently nonstudy patients, adverse events experienced have included skin irritation and/orburns,10Stewart EA Gedroyc WM Tempany CM et al.Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique.Am J Obstet Gynecol. 2003; 189: 48-54Abstract Full Text Full Text PDF PubMed Scopus (373) Google Scholar, 12Jacobs MA Herskovits EH Kim HS Uterine fibroids: diffusion-weighted MR imaging for monitoring therapy with focused ultrasound surgery—preliminary study.Radiology. 2005; 236: 196-203Crossref PubMed Scopus (95) Google Scholar, 13Stewart EA Rabinovici J Tempany CM et al.Clinical outcomes of focused ultrasound surgery for the treatment of fibroids.Fertil Steril. 2006; 85: 22-29Abstract Full Text Full Text PDF PubMed Scopus (395) Google Scholar, 17Tempany CM Stewart EA McDannold N Quade BJ Jolesz FA Hynynen K MR imaging-guided focused ultrasound surgery of uterine leiomyomas: a feasibility study.Radiology. 2003; 226: 897-905Crossref PubMed Scopus (520) Google Scholar, 18Leon-Villapalos J Kaniorou-Larai M Dziewulski P Full thickness abdominal burn following magnetic resonance guided focused ultrasound therapy.Burns. 2005; 31: 1054-1055Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar inflammation of the subcutaneous fat or musculature in the anterior abdominal wall,19So MJ, McDannold N, Fennessy FM, et al. Does the thickness of anterior abdominal wall fat affect the treatment of uterine fibroids treated with magnetic resonance guided focused ultrasound surgery (MRgFUS)? Presented at: 5th Interventional MRI Symposium; Boston, Mass; October 15-16, 2004. Available at: www.insightec.com/ExAblateStudies.aspx?region=10&docID=1552&FolderID=67&lang=EN&res=0, Accessed February 9, 2005.Google Scholar diarrhea, temporary nerve damage,11Hindley J Gedroyc WM Regan L et al.MRI guidance of focused ultrasound therapy of uterine fibroids: early results [published correction appears in AJR Am J Roentgenol. 2005;184:3348].AJR Am J Roentgenol. 2004; 183: 1713-1719Crossref PubMed Scopus (352) Google Scholar, 12Jacobs MA Herskovits EH Kim HS Uterine fibroids: diffusion-weighted MR imaging for monitoring therapy with focused ultrasound surgery—preliminary study.Radiology. 2005; 236: 196-203Crossref PubMed Scopus (95) Google Scholar, 13Stewart EA Rabinovici J Tempany CM et al.Clinical outcomes of focused ultrasound surgery for the treatment of fibroids.Fertil Steril. 2006; 85: 22-29Abstract Full Text Full Text PDF PubMed Scopus (395) Google Scholar deep venous thrombosis (with 1 instance of pulmonary embolism), and vaginal discharge. At our institution, these complications have been temporary, and all events except for deep venous thrombosis have required no treatment other than over-the-counter pain relievers. Twenty-three patients remain in the follow-up phase of our study. As stated previously, 2 patients withdrew from the study, both approximately 5 months after treatment. Limited information is available from either of these 2 women. At last contact, one continued to have severe fibroid symptoms, and one was satisfied with her treatment results. Seventeen women exited the study to obtain additional treatments (summarized in Table 3). Our treatment plans have evolved during the course of this study, and these changes are reflected in our treatment success rates. The first 5 women we treated had additional fibroid treatments. The rate of second treatments for the first half of this study was 52%. This rate decreased to 29% during the second half of the study. Six (35%) of the 17 women who required additional treatment elected a second course of MRgFUSfor either gradually progressive symptom recurrence or for incomplete symptom relief. Six women had hysterectomy after MRgFUS treatment. The hysterectomy group includes 1 woman who had only 3 sonications during the MRgFUS treatment because of severe back pain in the prone position, which is necessary for treatment. She had a hysterectomy 1 week after her MRgFUS treatment. Two women in the hysterectomy group had surgery for reasons arguably unrelated to their uterine fibroids, 1 for an enlarging complex adnexal mass and 1 for progressive pelvic organ prolapse. Overall, 86% of the women in this study have been able to avoid hysterectomy, 81% have avoided major surgery, and 79% have avoided hospital admission by undergoing MRgFUS or MRgFUS in combination with other minimally invasive treatment options.TABLE 3Additional Treatments for Persistent or Recurrent Fibroid Symptoms After MRgFUS Treatment in 17 Patients*Values are number of patients unless indicated otherwise. MRgFUS = magnetic resonance imaging–guided focused ultrasound.Time to alternative treatment1 wk-35 moAlternative procedure Hysterectomy6 Myomectomy2 Uterine artery embolization1 Endometrial ablation2 Additional MRgFUS6* Values are number of patients unless indicated otherwise. MRgFUS = magnetic resonance imaging–guided focused ultrasound. Open table in a new tab Magnetic resonance imaging-guided focused ultrasound is a promising new noninvasive treatment option for women with symptomatic uterine fibroids. At our institution, 59.5% of women with heavy bleeding had adequate control of their symptoms after treatment. Patients were noted to have shorter menstrual cycles (from a mean of 6.1 days before treatment to a mean of 4.9 days after treatment) and longer mean intervals between changing protective pads or tampons (from 1.7 hours at peak flow before treatment to 2.25 hours after treatment). Magnetic resonance imaging-guided focused ultrasound treatment was also effective in patients with pressure symptoms: 49% had complete relief of their symptoms, and another 49% had symptomatic improvement.