Magnetic Resonance-guided Focused Ultrasound Surgery Treatment Research Articles

Cytoreductive Surgical Treatment of Pleural Mesothelioma in a Porcine Model Using Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) and Radiofrequency Ablation (RFA)

A combination of surgery and chemotherapy is the most effective treatment available for Malignant Pleural Mesothelioma (MPM). However, both cause significant collateral damage and cannot eliminate residual microscopic disease. This investigation aimed to compare and determine the feasibility of utilizing Radiofrequency Ablation (RFA) and Magnetic-Resonance-guided Focused Ultrasound Surgery (MRgFUS) as alternative treatments for MPM. A large animal tumor model was developed in 13 Yorkshire female pigs using the MSTO211H cell line. Two pigs were initially used to determine the cyclosporine dose required for immunosuppression and tumor development. Subsequently, 11 other pigs underwent tumor development. Of these 11, 2 died during cell inoculation. Small tumor masses and adhesions were present in the other 9, indicating mesothelioma development. Five pigs then received RFA treatment, and 4 pigs received MRgFUS treatment. Tumor model development and effect of the two treatments were examined using MRI and by necropsy. RFA and MRgFUS both successfully ablated approximately the same sized area in the same treatment time. This study demonstrates that RFA and MRgFUS are feasible for tumor debulking, and while MRgFUS requires more pretreatment planning compared to RFA, MRgFUS is a completely noninvasive procedure.

Comparison of computer simulations and clinical treatment results of magnetic resonance-guided focused ultrasound surgery (MRgFUS) of uterine fibroids.

PurposeMagnetic resonance‐guided focused ultrasound surgery (MRgFUS) can be used to noninvasively treat symptomatic uterine fibroids by heating with focused ultrasound sonications while monitoring the temperature with magnetic resonance (MR) thermometry. While prior studies have compared focused ultrasound simulations to clinical results, studies involving uterine fibroids remain scarce. In our study, we perform such a comparison to assess the suitability of simulations for treatment planning.MethodsSonications (N = 67) were simulated retrospectively using acoustic and thermal models based on the Rayleigh integral and Pennes bioheat equation followed by MR‐thermometry simulation in seven patients who underwent MRgFUS treatment for uterine fibroids. The spatial accuracy of simulated focus location was assessed by evaluating displacements of the centers of mass of the thermal dose distributions between simulated and treatment MR thermometry slices. Temperature–time curves and sizes of 240 equivalent minutes at 43°C (240EM43) volumes between treatment and simulation were compared.ResultsThe simulated focus location showed errors of 2.7 ± 4.1, −0.7 ± 2.0, and 1.3 ± 1.2 mm (mean ± SD) in the anterior–posterior, foot–head, and right–left directions for a fibroid absorption coefficient of 4.9 Np m–1 MHz–1 and perfusion parameter of 1.89 kg m–3 s–1. Linear regression of 240EM43 volumes of 67 sonications of patient treatments and simulations utilizing these parameters yielded a slope of 1.04 and a correlation coefficient of 0.54. The temperature rise ratio of simulation to treatment near the end of sonication was 0.47 ± 0.22, 1.28 ± 0.60, and 1.49 ± 0.71 for 66 sonications simulated utilizing fibroid absorption coefficient of 1.2, 4.9, and 8.6 Np m–1 MHz–1, respectively, and the aforementioned perfusion value. The impact of perfusion on peak temperature rise is minimal between 1.89 and 10 kg m–3 s–1, but became more substantial when utilizing a value of 100 kg m–3 s–1.ConclusionsThe results of this study suggest that perfusion, while in some cases having a substantial impact on thermal dose volumes, has less impact than ultrasound absorption for predicting peak temperature elevation at least when using perfusion parameter values up to 10 kg m–3 s–1 for this particular array geometry, frequencies, and tissue target which is good for clinicians to be aware of. The results suggest that simulations show promise in treatment planning, particularly in terms of spatial accuracy. However, in order to use simulations to predict temperature rise due to a sonication, knowledge of the patient‐specific tissue parameters, in particular the absorption coefficient is important. Currently, spatially varying patient‐specific tissue parameter values are not available during treatment, so simulations can only be used for planning purposes to estimate sonication performance on average.

Weakening or Structural Strengthening? An Evaluation of Bone Density after MRgFUS Ablation for Treatment of Benign Bone Lesions.

Previous studies suggest that interventional ablative procedures on bone lesions may weaken the bone, especially when performed through the needle approach. Our purpose was to evaluate, through Computed Tomography (CT), the effects of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) ablation on painful osteoid osteomas and osteoblastomas in terms of bone density and morphological changes. We retrospectively evaluated patients treated at our institution with MRgFUS for superficial, painful osteoid osteoma or osteoblastoma during the last 9 years. Inclusion criteria were procedural and clinical success, as well as the availability of pre- and postprocedural CT examinations. Imaging features assessed were perilesional/nidus density changes and the occurrence of pathological fractures during the follow-up period. Our study population included 31 osteoid osteomas and 5 intra-articular osteoblastomas in 36 treated patients. We found an increased bone density of the lesions when pre and post-treatment CT- values were compared: these differences were statistically significant, and this finding is consistent with significant bone densification at the post-treatment imaging follow-up. No pathological fractures were observed after ablation during the follow-up. MRgFUS can be considered to be the treatment of choice for benign superficial bone lesions, thanks to its minimal invasiveness, excellent effectiveness, and safety. Pathological fractures, reported in literature as a rare event using needle ablation, never occurred in our MRgFUS treatment series.

Effect of MRgFUS treatment on cortical activity in Parkinson's disease: a fNIRS study

n this paper, a new combined approach, based on Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) technique and functional Near Infrared Spectroscopy (fNIRS), was applied for treatment and monitoring of patients affected by bilateral Parkinson’s disease (PD). On one side, MRgFUS enables non-invasive thalamotomy by combining FUS for tissue ablation and MR for targeting and monitoring. On the other side, fNIRS allows to monitor, non-invasively and without strict motion restriction even in a daily life environment, cortical neural activity related dynamics of both oxygenated and deoxygenated haemoglobin (HbO and HbR, respectively). In particular, the changes of cortical activation pattern in PD patients, with respect to age matched healthy control subjects, were analysed, while performing left and right hand finger tapping (LFT and RFT, respectively), before MRgFUS treatment, and at two different time intervals after the treatment. By comparison with the pre-treatment session, significant activations were predominantly observed one week after the treatment, with patterns recalling those of control group, and partially lost one month later, likely because of the neurodegenerative nature of PD. In addition, activations were more marked for LFT task, being the treatment performed on the right hemisphere. These results appear promising in view of the application of fNIRS for neurorehabilitation, especially in those clinical settings where traditional neuroimaging techniques cannot be applied.

Utilization of radiomics to predict long-term outcome of magnetic resonance-guided focused ultrasound ablation therapy in adenomyosis.

To develop and evaluate a T2 MR-based radiomics prediction model incorporating radiomics features and clinical parameters to predict the response to magnetic resonance-guided focused ultrasound surgery (MRgFUS) in patients with adenomyosis. Sixty-nine patients (mean age, 38.6years; age range, 26-50years) with adenomyosis treated by MRgFUS were reviewed and allocated to training (n = 48) and testing cohorts (n = 21). One thousand one hundred eighteen radiomics features were extracted from T2-weighted imaging before MRgFUS. The radiomics features' dimension was reduced by Pearson correlation coefficient after normalization. Analysis of variance and logistical regression were used for feature selection by fivefold cross-validation in the training cohort, and the machine learning model was constructed for comparing the clinical model, radiomics model, and radiomics-clinical model which combined survived radiomics features and clinical parameters. The discrimination result of the model was obtained by bootstrap; receiver operating characteristic curve, area under the curve (AUC), and decision curve analyses were performed to illustrate the model performance in both the training and testing cohorts. Good response was achieved in 47 patients (68.1%) and failed in 22 patients (38.9%). The radiomics model comprised four selected features and demonstrated a degree of prediction capability of patients' poor response to MRgFUS treatment. The radiomics-clinical model showed good discrimination, with an AUC of 0.81 (95% confidence interval, 0.592-0.975) in the testing cohort. The decision curve analysis also showed favorable performance of the radiomics-clinical model. A prediction model composed of T2WI-based radiomics features and clinical parameters could be applied to guide the radiologist to evaluate MRgFUS for patients with adenomyosis who will achieve good response. • Magnetic resonance imaging-guided focused ultrasound surgery represents an alternative treatment for adenomyosis, but nearly one third of patients remain symptomatic 6months after MRgFUS. • Combining four radiomics features of T2-weighted MRI with eight clinical features further improves prediction of poor responders to MR-guided focused ultrasound treatment of uterine adenomyosis (AUC = 0.81 in the testing cohort). • The radiomics model based on T2-weighted imaging combined with clinical parameters can help predict which patients are likely to have a good response to MRgFUS for adenomyosis.

Short-term efficacy and safety of MR-guided focused ultrasound surgery for analgesia in children with metastatic bone tumors.

Short-term efficacy and safety of magnetic resonance-guided focused ultrasound surgery (MRgFUS) for analgesia in children with metastatic bone tumors were studied. Thirty children with pediatric bone metastases admitted to Jinan Maternity and Child Care Hospital from March 2015 to March 2018 and who received MRgFUS treatment of the bone metastasis lesions were collected. The postoperative efficacy was assessed. The observation indicators included the Numerical Rating Scale (NRS) scores, European Organization for Research and Treatment of Cancer (EORTC) and Quality of Life Questionnaire (QLQ) scores before surgery, and 1 week, 1, 2, and 3 months after surgery and the Karnofsky Performance Status (KPS) scores before surgery, and 1 week and 3 months after surgery. The adverse reactions and medications of the children after the surgery were also under observation. NRS and VAS scores of all different observation time-points after surgery were statistically lower than those before surgery (P<0.05), and the NRS scores and Visual Analog Scale (VAS) scores 3 months after surgery were lower than those 1 week after surgery (P<0.05). Compared with the preoperative conditions, the QLQ-C30 scores of terms like physical function, cognitive function, nausea and vomiting, and degree of pain 1 week, 1, 2, and 3 months after surgery were decreased, and the clinical symptoms of the children were relieved (P<0.05). There was a statistical difference between the total QLQ-C30 scores 3 months after operation and the total QLQ-C30 scores 3 months before operation (P<0.05). No serious adverse reactions related to treatment were reported, and the application of analgesics was reduced. MRgFUS relieves bone metastasis pain in children with good curative effect and high safety.

Feasibility and safety of MRgFUS ablation for uterine fibroids and adenomyosis: a preliminary study

Objective: To investigate the feasibility and safety of magnetic resonance guided focused ultrasound surgery (MRgFUS) ablation treatment for uterine fibroids and adenomyosis. Methods: From February 2017 to July 2018, a total of 61 women in Foshan Hospital of Traditional Chinese Medicine with uterine fibroids or adenomyosis (36 cases of fibroids and 25 cases of adenomyosis) were included for treatment of MRgFUS, mean age was 27-48 (39±5) years. The treatment status, treatment effect and complications were recorded, and the differences between myoma and adenomyosis were compared. Results: Thirty-two (88.9%) patients of fibroid group and twenty-one (84.0%) patients of adenomyosis group were completed MRgFUS treatment respectively (P>0.05). The spot energy of adenomyosis group was 1 039-5 698(2 852±991) J, which was higher than 600-6 466(2 485±1 137) J of fibroid group (P<0.01). There was no significant statistical difference in mean temperature of spot and ablation time between the two groups (P>0.05).The non-perfusion volume ratio (NPVR) of the fibroid and adenomyosis group was 54%-99%(84%±15%) and 60%-98%(82%±12%) and there was no significant statistical difference (P>0.05), but the ablation efficiencies of adenomyosis group was less than fibroid group (0.8-4.3(2.1±0.9) cm(3)/min vs 1.3-7.8(3.6±1.5)cm(3)/min, P<0.01).The incidence of complications of adenomyosis group was 47.6%(10/21), it was higher than fibroid group 18.8%(6/32) (P<0.05). Conclusions: MRgFUS is a non-invasive, safe and effective treatment for both uterine fibroids and adenomyosis. Compared with uterine fibroids, MRgFUS treatment of adenomyosis has some disadvantages such as higher energy, lower ablation efficiency and more adverse reactions, and further optimization is needed.

Outcome of magnetic resonance–Guided focused ultrasound surgery (MRgFUS) for FIGO class 1 fibroids

ObjectiveIntracavitary uterine fibroids and fibroids that distort the uterine cavity are associated with excessive vaginal bleeding and infertility. While intracavitary fibroids smaller than 4 cm are usually treated safely by operative hysteroscopy, larger fibroids may require multiple surgeries or more extensive surgery with possible damage to the integrity of the uterine wall. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a noninvasive approach for treating uterine fibroids, mainly the intramural type. We present the outcome of MRgFUS treatment for intracavitary fibroids (FIGO class 1) in cases that could not be treated by hysteroscopy due to either fibroid size or patient refusal. (Canadian Task Force II-1). Study designA retrospective cohort study from a single tertiary referral center. A total of 68 patients were treated by MRgFUS for symptomatic uterine fibroids from January 2013 to December 2016. Six of them had FIGO class 1 fibroids.Adverse effects and short- and long-term outcomes (quality of life issues and need for additional surgical intervention) were assessed during ambulatory clinic visits and by phone interviews. ResultsThe mean ± SD fibroid volume on MRI screening was 86.3 ± 60.9 cm3. Six of those patients underwent the procedure (mean age 40.5 ± 5.6 years, range 33–48). The follow-up duration was 24.1 ± 12.0 months. Four patients were not interested in future fertility and did not undergo additional treatment, while the two who planned to conceive underwent another surgical intervention (one underwent operative hysteroscopy after reduction of fibroid size and the other underwent laparoscopic myomectomy). ConclusionThis preliminary study shows that MRgFUS can be a feasible treatment option for FIGO class 1 uterine fibroids. Shrinkage of fibroids by MRgFUS can obviate or facilitate subsequent surgical intervention in selected cases.

Magnetic Resonance-Guided Focused Ultrasound Surgery (MRgFUS) of Uterine Fibroids in Singapore

Uterine fibroids are the most common type of gynaecologic benign tumours, occurring in 25% to 50% of women during their reproductive lives. About half of the affected women have clinically significant symptoms, including abnormal bleeding, menstrual pain, frequent urination, constipation and abdominal distension. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) has been used to treat patients with benign lesions and a variety of malignancies. The objective of this study is to evaluate symptom relief before and after MR-guided ultrasound ablation of fibroids. A total of 37 patients with symptomatic uterine fibroids were treated in this study. MRgFUS treatment led to a significant, time-dependent decrease in not only Symptom Severity Scores (SSS), but also the mean fibroid volume. The average reductions in volume were 41.6% and 52.6% at 6 months and 12 months respectively (P <0.05). The mean SSS of the 37 patients was 41.7 ± 2.8 before treatment whereas the average SSS was 26.9 ± 3.6, 20.7 ± 3.4, 18.5 ± 3.6, 16.5 ± 7.1, 9.8 ± 3.6 at 3 months, 6 months, 1 year, 2 years, and 3 to 4 years respectively. The decrease in scores was significant at all time points up to 3 to 4 years (P <0.05 and P <0.001). MRgFUS is a safe and effective non-invasive treatment for patients with symptomatic fibroids.

Technical Eligibility for Treatment of Magnetic Resonance-guided Focused Ultrasound Surgery

This study was designed to evaluate the technical eligibility for magnetic resonance-guided focused ultrasound surgery (MRgFUS) treatment of women with symptomatic fibroids. Technical eligibility for MRgFUS treatment without mitigation techniques was evaluated retrospectively in 783 premenopausal women (median age, 44.2 years) with symptomatic fibroids who applied for uterine artery embolization (UAE) at our institution from 2001 to 2012. Technical eligibility for MRgFUS was defined as primary study endpoint. Technical ineligibility was assessed on the basis of MRI criteria, such as bowel interposition/foreign material in the ultrasound beam path, more than five fibroids, distance from fibroid to sacral bone surface, fibroid size/shape, severe concomitant adenomyosis or extensive cutaneous scars in accordance to the US Food and Drug Administration approvals. Secondary study endpoint was defined as evaluation of the most frequent exclusion criteria and differences in technical eligibility for MRgFUS and UAE. On the basis of MRI, 38.9% of women who applied for UAE were found to be technically eligible for MRgFUS treatment without mitigation techniques. Most frequent reason for ineligibility was bowel interposition in the ultrasound beam path (60.4%). Differences in technical eligibility for MRgFUS (38.9%) and UAE (99.2%) were significant (P < 0.001). MRgFUS treatment is technically possible in up to 40% of women with symptomatic fibroids. The most frequent exclusion criterion is the presence of bowel in the ultrasound beam path.

Magnetic resonance guided focused ultrasound surgery for palliation of painful bone metastasis: Results of a multicenter phase III trial.

9500 Background: Pain due to bone metastases is a common cause of cancer-related morbidity. Magnetic resonance guided focused ultrasound surgery (MRgFUS) is a non-invasive approach to thermal tissue ablation. This multi-center phase III trial assessed efficacy of MRgFUS compared with sham treatment to alleviate pain due to bone metastases. Methods: Subjects with a painful bone metastasis amenable to MRgFUS treatment for whom radiation therapy was ineffective or contraindicated were randomized 3:1 to MRgFUS or sham treatment in a single blind design. Un-blinding of sham subjects who did not experience significant pain relief within 2 weeks was permitted with crossover allowed to salvage MRgFUS treatment. Pain response and impact on quality of life (QOL) were assessed using the numerical rating scale (NRS) and Brief Pain Inventory-Quality of Life (BPI-QOL). Safety was also assessed. Results: 142 randomized subjects were included in an intent-to-treat analysis. 67% (95%CI: 57.5-76.0%) of 107 subjects in the MRgFUS arm experienced clinically significant pain relief, equating with an anchor descriptor of “much improved” or better at 3 months compared to 20% of 35 sham arm subjects (p&lt;0.0001). Median baseline and 3 month NRS scores were 7.0 and 2.0 for the MRgFUS arm vs. 7.0 and 6.0 for the sham arm. A clinically significant improvement at 3 months in BPI-QOL score for MRgFUS but not sham treatment was noted [average change: 2.4 vs. 0.2 respectively, (p&lt;0.0001)]. MRgFUS treatment was well tolerated. Conclusions: MRgFUS, as demonstrated by this phase III trial, results in excellent rates of pain relief and improvement in QOL for patients with oncologic related bone pain who are not candidates for radiation therapy. Given these excellent results coupled with a favorable side effect profile, MRgFUS should be considered a primary choice for this patient population. Clinical trial information: NCT00656305.

Klinische Ergebnisse der Behandlung symptomatischer Uterusmyome mittels MRgFUS (Magnetresonanztomografie-gesteuerter fokussierter Ultraschall)

To investigate the clinical outcome of magnetic-resonance-guided focused ultrasound surgery (MRgFUS) treatment for symptomatic uterine fibroids in premenopausal women using the validated USF-QOL (Uterine Fibroid Symptom and Quality of Life) Questionnaire. 54 patients with symptomatic uterine fibroids were enrolled in this prospective study. The patients completed the UFS-QOL Questionnaire prior to MRgFUS treatment as well as after 3, 6, and 12 months. The rate of technical success was 91.5 % (95.2 % after subtraction of screening errors). 6/54 patients (11 %) had other treatments (surgery, n = 4; UAE, n = 2), 8/54 (15 %) dropped out due to pregnancy, and 8/54 were lost to follow-up. The remaining group showed considerable symptom relief as early as after 3 months. The median overall quality of life score increased from 64.7 (quartile range QR: 49.8 - 77.6) before treatment to 77.6 (QR: 61.4 - 87.1) (p < 0.001), 78.4 (QR: 66.4 - 89.7) (p < 0.001), and 82.8 (QR: 69.8 - 92.2) (p < 0.001) at 3, 6, and 12 months, respectively. The corresponding median symptom severity score decreased from 46.9 (QR: 28.1 - 56.2) to 34.4 (QR: 21.9 - 43.7) at 3 months (p = 0.003) and 28.1 at 6 and 12 months (QR: 18.7 - 38.3, QR: 15.6 - 34.4) (p < 0.001, p = 0.002). The rate of complications requiring treatment was 9 %, and the rate of overall complications was 39 %. No major complications occurred. Our results indicate significant alleviation of fibroid-related symptoms within 12 months of MRgFUS with improvement beginning as early as 3 months after treatment. We observed no major complications, and some women became pregnant after MRgFUS. There was a low treatment failure rate of 11 %.

Successful Use of Magnetic Resonance-Guided Focused Ultrasound Surgery for Long-Term Pain Palliation in a Patient Suffering from Metastatic Bone Tumor

Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) is a non-invasive thermo-ablative technique for the treatment of various benign and malignant soft tissue and bone tumors, using focused ultrasound under real-time magnetic resonance imaging (MRI) guidance and control (1). This method of thermal ablation has proved effective in more than 5,000 uterine fibroid treatments and in more than 500 treatments of various other tumors (2). Recently, MRgFUS was tested for the palliation of pain caused by bone metastases, utilizing the acoustic properties of bone for absorption of ultrasonic energy to achieve palliation and has yielded very promising initial results (3, 4). Applying acoustic energy on the bone surface allows the creation of temperature rise in the part of the bone cortex enclosed in the beam path zone, thus indirectly ablating the adjacent periosteum and tumor tissue (4). Since the periosteum is considered to be a major source of pain in patients with metastatic bone lesions, ablating the source of pain should produce lasting pain relief. High absorption of energy in the bone allows using lower energies (compared to soft tissue MRgFUS treatment), thereby enhancing the safety profile of this procedure. Thus, MRgFUS offers a novel, alternative treatment option for painful bone metastases. The present report briefly discusses the successful use of Case Report pISSN 1738-2637 J Korean Soc Radiol 2011;65(2):133-138

Short-term results of magnetic resonance imaging-guided focused ultrasound surgery for patients with adenomyosis: symptomatic relief and pain reduction

The objective of this study was to evaluate the degree of symptomatic relief obtained after treatment with magnetic resonance-guided focused ultrasound surgery in patients with adenomyosis. Quality of life and pain assessment questionnaires from 35 women, collected on the day of treatment and up to 6 months after treatment, indicated that the treatment was safe and there was a significant reduction in symptoms.

Pregnancy Outcome After Magnetic Resonance-Guided Focused Ultrasound Surgery for Conservative Treatment of Uterine Fibroids

Uterine fibroids (leiomyomata)—the most common tumors of the female reproductive tract—are associated with impaired fertility and specific complications of pregnancy. The fibroids are found in 20% to 25% in reproductive-age women. Surgical myomectomy is the treatment of choice for women who wish to remain fertile and there is long experience with this procedure. In some patients, however, rare but serious complications have been reported with surgical approaches. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a noninvasive myomaspecific treatment for symptomatic uterine fibroids that employs coagulative necrosis to destroy leiomyoma tissue. More than 4000 women have undergone MRgFUS globally, and the procedure has been reported to be safe and effective. This preliminary report reviews the outcome data of all known pregnancies occurring after MRgFUS recorded in a prospective registry maintained by the manufacturer and reported to the Food and Drug Administration. The database contains information on pregnancy outcomes from 13 sites in 7 countries. Outcome data were examined from 54 pregnancies of 51 mothers who had undergone MRgFUS treatment for symptomatic uterine leiomyomas. The mean time to pregnancy after the procedure was 8 ± 7 months (range, 0-30 months). Of the 54 pregnancies, 22 (41%) resulted in live births and 11 (20%) were ongoing >20 weeks. The spontaneous abortion rate was 27% and the rate of therapeutic abortion was 11%. The mean birth weight was 3.3 kg and 64% of the women had a vaginal delivery. These findings demonstrate that both normal vaginal deliveries and outcomes are possible following MRgFUS, which is reassuring information for pregnant women who wish to conceive after the procedure.

Magnetic resonance-guided focused ultrasound surgery (MRgFUS) treatment for uterine fibroids

Magnetic Resonance-guided focused Ultrasound Surgery (MRgFUS) is gaining popularity as an alternative to medical and surgical interventions in the management of symptomatic uterine fibroids. Studies have shown that it is an effective non-invasive treatment with minimal associated risks as compared to myomectomy and hysterectomy. MRgFUS can be offered to a majority of patients suffering from symptomatic uterine fibroids. It has been suggested that the use of broader inclusion criteria as well as the mitigation techniques makes it possible to offer MRgFUS to a much larger subset of patients than previously believed. This paper will describe how MRgFUS treatment for uterine fibroids is performed at the University of Malaya Medical Centre, Kuala Lumpur, Malaysia.

Decreasing margins to the uterine serosa as a method for increasing the volume of fibroids ablated with magnetic resonance-guided focused ultrasound surgery

Objective To demonstrate the safety of magnetic resonance-guided focused ultrasound surgery (MRgFUS) treatments regardless of the distance between the treatment region and the uterine serosa. Study design 83 pre-menopausal women with symptomatic uterine fibroids were treated with MRgFUS in 88 treatments. Treatment data was analyzed, measuring the distance between the treatment spots (sonications) and the serosa. Patients were followed up for 1 year and adverse events were collected. Results 79% and 37% of the sonications were less than 15 mm and 10 mm from the serosa, respectively. Treatment was always confined to the fibroid capsule. There were no unexpected or serious adverse events. Conclusion Reducing the margin between the fibroid treatment area and the uterine serosa, when possible, enables MRgFUS treatment of greater fibroid volume, while maintaining a high safety profile. Special attention should be paid when the uterus lies adjacent to other sensitive organs to avoid unintentional heating of these organs, using the planning and real-time MR images.

Pregnancy outcome after magnetic resonance–guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids

To report all pregnancies to date after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for the conservative treatment of clinically significant uterine fibroids. Prospective registry of all known pregnancies occurring after MRgFUS maintained by the device manufacturer and reported to the Food and Drug Administration. World experience of pregnancies after treatment with reports from 13 sites in seven countries. Fifty-one reproductive-age women with uterine leiomyomas. Women underwent MRgFUS treatment for symptomatic uterine leiomyomas before this report. Pregnancy outcomes and complications. Fifty-four pregnancies in 51 women have occurred after MRgFUS treatment of uterine leiomyomas. The mean time to conception was 8 months after treatment. Live births occurred in 41% of pregnancies, with a 28% spontaneous abortion rate, an 11% rate of elective pregnancy termination, and 11 (20%) ongoing pregnancies beyond 20 gestational weeks. The mean birth weight was 3.3 kg, and the vaginal delivery rate was 64%. Preliminary pregnancy experience after MRgFUS is encouraging, with a high rate of delivered and ongoing pregnancies.

Cost-Effectiveness of Magnetic Resonance-Guided Focused Ultrasound Surgery for Treatment of Uterine Fibroids

The search for cost-effective alternatives to hysterectomy in treating uterine fibroids has extended to magnetic resonance-guided focused ultrasound surgery (MRgFUS), in which a noninvasive thermal ablation device is integrated with MR imaging to ablate soft tissue. A small bean-shaped volume of focused ultrasound energy is directed into the target for about 15 seconds to heat the tissue to 60-90° and induce thermal coagulation. Cost utility analysis was based on a Markov model, the parameters of which were drawn from a series of clinical studies of MRgFUS and from literature dealing with clinical efficacy. Costs were estimated from the perspective of the National Health Service Trusts in England and Wales. The major outcome measure was incremental cost-effectiveness, estimated by cost per quality-adjusted life-year (QALY) gained. The base-case results imply a cost saving and a small QALY gain per woman resulting from MRgFUS treatment. The cost per QALY gained was sensitive to the cost of MRgFUS relative to other treatments such as hysterectomy, myomectomy, and uterine artery embolization. It also was sensitive to patient age and to the nonperfused volume relative to the total volume of fibroids. The investigators conclude that MRgFUS is likely to be a cost-effective initial strategy for treating symptomatic uterine fibroids.

Cost‐effectiveness of magnetic resonance‐guided focused ultrasound surgery for treatment of uterine fibroids

ObjectiveTo estimate the cost-effectiveness of a treatment strategy for symptomatic uterine fibroids, which starts with Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) as compared with current practice comprising uterine artery embolisation, myomectomy and hysterectomy.DesignCost-utility analysis based on a Markov model.SettingNational Health Service (NHS) Trusts in England and Wales.PopulationWomen for whom surgical treatment for uterine fibroids is being considered.MethodsThe parameters of the Markov model of the treatment of uterine fibroids are drawn from a series of clinical studies of MRgFUS, and from the clinical effectiveness literature. Health-related quality of life is measured using the 6D. Costs are estimated from the perspective of the NHS. The impact of uncertainty is examined using deterministic and probabilistic sensitivity analysis.Main outcome measuresIncremental cost-effectiveness measured by cost per quality-adjusted life-year (QALY) gained.ResultsThe base-case results imply a cost saving and a small QALY gain per woman as a result of an MRgFUS treatment strategy. The cost per QALY gained is sensitive to cost of MRgFUS relative to other treatments, the age of the woman and the nonperfused volume relative to the total fibroids volume.ConclusionsA treatment strategy for symptomatic uterine fibroids starting with MRgFUS is likely to be cost-effective.Please cite this paper as: Zowall H, Cairns J, Brewer C, Lamping D, Gedroyc W, Regan L. Cost-effectiveness of magnetic resonance-guided focused ultrasound surgery for treatment of uterine fibroids. BJOG 2008;115:653–662.