Volumetric MR-guided high-intensity focused ultrasound versus uterine artery embolisation for treatment of symptomatic uterine fibroids: comparison of symptom improvement and reintervention rates.

PURPOSE: To compare the effectiveness of magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) with that of uterine artery embolisation (UAE) for treatment of uterine fibroids. METHODS: Between January 2010 and January 2013, 51 women with symptomatic uterine fibroids underwent MR-HIFU. Follow-up and MR imaging were compared to 68 women treated with UAE, who fulfilled eligibility criteria for MR-HIFU - e.g., size (≤ 12 cm) and number (≤ 5) of fibroids. We compared median symptom severity (tSSS), total health-realted quality of life (HRQoL) scores, and reintervention rates. The adjusted effect on symptom relief and HRQoL improvement was calculated using multivariable linear regression. Cox regression was applied to calculate the adjusted risk of reintervention between both treatments. RESULTS: Median tSSS improved significantly from baseline to three-month follow-up (P < 0.001) for both MR-HIFU (53.1 (IQR [40.6-68.8]) to 34.4 (IQR [21.9-46.9]) and UAE (65.3 (IQR [56.3-74.2]) to 21.9 (IQR [9.4-34.4]). In addition, significantly better HRQoL scores were observed after three months (P < 0.001). However, in multivariate analysis, UAE had a stronger effect on symptom relief and HRQoL improvement than MR-HIFU (P < 0.001). Patients treated with MR-HIFU had a 7.1 (95 % CI [2.00-25.3]; P = 0.002) times higher risk of reintervention within 12 months (18/51 vs. 3/68). CONCLUSION: Both MR-HIFU and UAE result in significant symptom relief related to uterine fibroids. However, MR-HIFU is associated with a higher risk of reintervention. KEY POINTS: • This study compared outcomes between volumetric MR-HIFU and UAE for uterine fibroids. • Both MR-HIFU and UAE result in significant symptom relief and quality of life improvement. • UAE had a stronger positive effect on the clinical outcomes. • Reintervention rate after MR-HIFU ablation was significantly higher than after UAE.

Diffusion-weighted magnetic resonance imaging using different b-value combinations for the evaluation of treatment results after volumetric MR-guided high-intensity focused ultrasound ablation of uterine fibroids.

OBJECTIVES: To assess the value of diffusion-weighted magnetic resonance imaging (DWI) and apparent diffusion coefficient (ADC) mapping using different b-value combinations for treatment evaluation after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) of uterine fibroids. METHODS: Fifty-six patients with 67 uterine fibroids were treated with volumetric MR-HIFU. Pre-treatment and post-treatment images were obtained using contrast-enhanced T1-weighted MRI (CE-T1WI) and DWI using b = 0, 200, 400, 600, 800 s/mm(2). ADC maps were generated using subsets of b-values to investigate the effects of tissue ablation on water diffusion and perfusion in fibroids treated with MR-HIFU. Four combinations of b-values were used: (1) all b-values; (2) b = 0, 200 s/mm(2); (3) b = 400, 600, 800 s/mm(2); and (4) b = 0, 800 s/mm(2). RESULTS: Using the lowest b-values (0 and 200 s/mm(2)), the mean ADC value in the ablated tissue reduced significantly (p < 0.001) compared with baseline. Calculating the ADC value with the highest b-values (400, 600, 800 s/mm(2)), the ADC increased significantly (p < 0.001) post-treatment. ADC maps calculated with the lowest b-values resulted in the best visual agreement of non-perfused fibroid tissue detected on CE images. Other b-value combinations and normal myometrium showed no difference in ADC after MR-HIFU treatment. CONCLUSIONS: A decrease in contrast agent uptake within the ablated region on CE-T1WI was correlated to a significantly decreased ADC when b = 0 and 200 s/mm(2) were used. KEY POINTS: DWI could be useful for treatment evaluation after MR-HIFU of uterine fibroids. The ADC in fibroid tissue is influenced by the choice of b- values. Low b-values seem the best choice to emphasise perfusion effects after MR-HIFU.

Mid-term clinical efficacy of a volumetric magnetic resonance-guided high-intensity focused ultrasound technique for treatment of symptomatic uterine fibroids.

OBJECTIVE: To assess the mid-term efficacy of magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) using a volumetric ablation technique for treating uterine fibroids. METHODS: Forty-six premenopausal women with 58 symptomatic uterine fibroids were prospectively included for MR-HIFU. After treatment, CE-MRI allowed measurement of the non-perfused volume (NPV) ratio, defined as the non-enhancing part of the fibroid divided by fibroid volume. Clinical symptoms and fibroid size on T2W-MRI were quantified at 3 and 6 months' follow-up. The primary endpoint was a clinically relevant improvement in the transformed Symptom Severity Score (tSSS) of the Uterine Fibroid Symptom and Quality of Life questionnaire, defined as a 10-point reduction. RESULTS: Volumetric ablation resulted in a mean NPV ratio of 0.40 ± 0.22, with a mean NPV of 141 ± 135 cm(3). Mean fibroid volume was 353 ± 269 cm(3) at baseline, which decreased to 271 ± 225 cm(3) at 6 months (P < 0.001), corresponding to a mean volume reduction of 29 % ± 20 %. Clinical follow-up showed that 54 % (25/46) of the patients reported a more than 10-point reduction in the tSSS. Mean tSSS improved from 50.9 ± 18.4 at baseline to 34.7 ± 20.2 after 6 months (P < 0.001). CONCLUSION: Volumetric MR-HIFU is effective for patients with symptomatic uterine fibroids. At 6 months, significant symptom improvement was observed in 54 % of patients. KEY POINTS: • Volumetric MR-guided high-intensity focused ultrasound is a novel ablation technique for leiomyomatosis. • We prospectively evaluated the outcome of volumetric MR-HIFU ablation for symptomatic fibroids. • This study showed that volumetric MR-HIFU results in an effective treatment. • A randomised controlled trial would set this technique in an appropriate context.

MR thermometry analysis of sonication accuracy and safety margin of volumetric MR imaging-guided high-intensity focused ultrasound ablation of symptomatic uterine fibroids.

PURPOSE: To evaluate the accuracy of the size and location of the ablation zone produced by volumetric magnetic resonance (MR) imaging-guided high-intensity focused ultrasound ablation of uterine fibroids on the basis of MR thermometric analysis and to assess the effects of a feedback control technique. MATERIALS AND METHODS: This prospective study was approved by the institutional review board, and written informed consent was obtained. Thirty-three women with 38 uterine fibroids were treated with an MR imaging-guided high-intensity focused ultrasound system capable of volumetric feedback ablation. Size (diameter times length) and location (three-dimensional displacements) of each ablation zone induced by 527 sonications (with [n=471] and without [n=56] feedback) were analyzed according to the thermal dose obtained with MR thermometry. Prospectively defined acceptance ranges of targeting accuracy were ±5 mm in left-right (LR) and craniocaudal (CC) directions and ±12 mm in anteroposterior (AP) direction. Effects of feedback control in 8- and 12-mm treatment cells were evaluated by using a mixed model with repeated observations within patients. RESULTS: Overall mean sizes of ablation zones produced by 4-, 8-, 12-, and 16-mm treatment cells (with and without feedback) were 4.6 mm±1.4 (standard deviation)×4.4 mm±4.8 (n=13), 8.9 mm±1.9×20.2 mm±6.5 (n=248), 13.0 mm±1.2×29.1 mm±5.6 (n=234), and 18.1 mm±1.4×38.2 mm±7.6 (n=32), respectively. Targeting accuracy values (displacements in absolute values) were 0.9 mm±0.7, 1.2 mm±0.9, and 2.8 mm±2.2 in LR, CC, and AP directions, respectively. Of 527 sonications, 99.8% (526 of 527) were within acceptance ranges. Feedback control had no statistically significant effect on targeting accuracy or ablation zone size. However, variations in ablation zone size were smaller in the feedback control group. CONCLUSION: Sonication accuracy of volumetric MR imaging-guided high-intensity focused ultrasound ablation of uterine fibroids appears clinically acceptable and may be further improved by feedback control to produce more consistent ablation zones.

Obstacles to Successful Implementation of eHealth Applications into Clinical Practice.

eHealth can improve healthcare worldwide, and scientific research should provide evidence on the efficacy, safety and added value of such interventions. For successful implementation of eHealth interventions into clinical practice, barriers need to be anticipated. We identified seven barriers by interviewing health professionals in the Dutch healthcare system. These barriers covered three topics: financing, human factors and organizational factors. This paper discusses their potential impact on eHealth uptake. Bridging the gap between studies to assess effective eHealth interventions and their value-based implementation in healthcare is much needed.

Targeted vessel ablation for more efficient magnetic resonance-guided high-intensity focused ultrasound ablation of uterine fibroids.

PURPOSE: To report the first clinical experience with targeted vessel ablation during magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) treatment of symptomatic uterine fibroids. METHODS: Pretreatment T1-weighted contrast-enhanced magnetic resonance angiography was used to create a detailed map of the uterine arteries and feeding branches to the fibroids. A three-dimensional overlay of the magnetic resonance angiography images was registered on 3D T2-weighted pretreatment imaging data. Treatment was focused primarily on locations where supplying vessels entered the fibroid. Patients were followed 6 months after treatment with a questionnaire to assess symptoms and quality of life (Uterine Fibroid Symptom and Quality of Life) and magnetic resonance imaging to quantify shrinkage of fibroid volumes. RESULTS: In two patients, three fibroids were treated with targeted vessel ablation during MR-HIFU. The treatments resulted in almost total fibroid devascularization with nonperfused volume to total fibroid volume ratios of 84, 68, and 86%, respectively, of treated fibroids. The predicted ablated volumes during MR-HIFU in patients 1 and 2 were 45, 40, and 82 ml, respectively, while the nonperfused volumes determined immediately after treatment were 195, 92, and 190 ml respectively, which is 4.3 (patient 1) and 2.3 (patient 2) times higher than expected based on the thermal dose distribution. Fibroid-related symptoms reduced after treatment, and quality of life improved. Fibroid volume reduction ranged 31-59% at 6 months after treatment. CONCLUSION: Targeted vessel ablation during MR-HIFU allowed nearly complete fibroid ablation in both patients. This technique may enhance the use of MR-HIFU for fibroid treatment in clinical practice.

Uterine fibroid embolisation for symptomatic uterine fibroids: a survey of clinical practice in Europe.

PURPOSE: To assess current uterine fibroid embolisation (UFE) practice in European countries and determine the clinical environment for UFE in different hospitals. MATERIAL AND METHODS: In May 2009, an invitation for an online survey was sent by e-mail to all members of the Cardiovascular and Interventional Radiologic Society of Europe, representing a total number of 1,250 different candidate European treatment centres. The survey covered 21 questions concerning local UFE practice. RESULTS: A total of 282 respondents completed the questionnaire. Fifteen questionnaires were excluded because they were doubles from centres that had already returned a questionnaire. The response rate was 267 of 1,250 centres (21.4%). Ninety-four respondents (33%) did not perform UFE and were excluded, and six centres were excluded because demographic data were missing. The remaining 167 respondents from different UFE centres were included in the study. Twenty-six percent of the respondents were from the United Kingdom (n = 43); 16% were from Germany (n = 27); 11% were from France (n = 18); and the remaining 47% (n = 79) were from other European countries. Most centres (48%, n = 80) had 5 to 10 years experience with UFE and performed 10 to 50 procedures annually (53% [n = 88]) of respondents). Additional demographic data, as well as specific data on referral of patients, UFE techniques used, and periprocedural and postprocedural, care will be provided. CONCLUSION: Although UFE as an alternative treatment for hysterectomy or myomectomy is widespread in Europe, its impact on the management of the patient with symptomatic fibroids seems, according to the overall numbers of UFE procedures, somewhat disappointing. Multiple factors might be responsible for this observation.

[MRI-guided 'high-intensity focused ultrasound': non-invasive thermoablation of tumours]. / MRI-geleide 'high-intensity focused ultrasound': non-invasieve thermoablatie van tumoren.

MRI-guided 'high-intensity focused ultrasound' (MR-HIFU) is a new, image-guided, non-invasive technique which enables treatment of benign and malignant tumours by thermoablation by ultrasound waves. The treatment is completely guided by MRI, which offers advantages for therapy planning, monitoring and visualisation of the treatment result. MR-HIFU has a broad spectrum of applications, including ablation of uterine fibroids, breast cancer, and liver metastases. Most of these applications are still under research. The advantage of the non-invasive character of the treatment is that it can be performed on an outpatient basis and that recovery is fast. The University Medical Center Utrecht, the Netherlands, has a MR-HIFU system that, as well as for pre-clinical experimental applications, is used for clinical treatment of uterine fibroids.

Sexual functioning and psychological well-being after uterine artery embolization in women with symptomatic uterine fibroids.

OBJECTIVE: To assess the effects of uterine artery embolization (UAE) on psychological and sexual well-being 3 months after treatment. DESIGN: Prospective study. SETTING: Large teaching hospital in Tilburg, the Netherlands. PATIENT(S): 141 Premenopausal women with symptomatic uterine fibroids. INTERVENTION(S): UAE for symptomatic fibroids. MAIN OUTCOME MEASURE(S): Changes in scores on a questionnaire concerning sexual well-being (ranging from 0 to 32, a higher score indicating better functioning) and a questionnaire concerning psychological well-being (SCL-90, ranging from 0 to 360, a higher score indicating more emotional and somatic concerns). RESULT(S): The total score for sexual functioning showed a statistically significant increase from 20.3 to 22.7, 3 months after UAE, indicating that sexual functioning improved. Thirty-four percent and 37% of women reported an increase in sexual activity and desire. The percentage of women reporting sexual problems of lubrication, orgasm, or pain decreased 7%, 36%, and 14%, respectively. The total SCL-90 score showed a statistically significant decrease from 133 to 116, 3 months after UAE, indicating a decrease in emotional and somatic concerns. CONCLUSION(S): Sexual and psychological well-being improved significantly 3 months after UAE in women with symptomatic uterine fibroids. Sixty-eight percent had an increase in the total score for sexual functioning. Problems with sexual functioning were statistically significantly decreased.

Long-term outcome of uterine artery embolization for symptomatic uterine leiomyomas.

PURPOSE: To evaluate long-term outcomes and factors associated with treatment failure after uterine artery embolization (UAE) in women with symptomatic uterine leiomyomas. MATERIALS AND METHODS: One hundred consecutive women treated with UAE for symptomatic uterine leiomyomas participated. Clinical outcome data (ie, changes in symptoms, menstrual status, subsequent therapies) and satisfaction data were collected. Treatment failure was defined by subsequent major surgery (ie, hysterectomy or myomectomy), a second embolization, or a lack of symptom improvement at the patient's final follow-up interval. Possible predictors of failure were age, clinical baseline characteristics (ie, bleeding, pain, and bulk), and imaging results (eg, percent volume reduction of the dominant tumor). Cox proportional-hazards analysis was used to determine factors associated with failure. RESULTS: Follow-up was available in 93 women (median follow-up, 54 months; range, 45-87 y). Continued symptom relief was observed in 72% of patients (n = 67). Among the 26 women with treatment failure (28%), 11 (42%) underwent hysterectomy, four (15%) myomectomy, and eight (31%) repeat embolization. Three (12%) reported no improvement. In women without any additional surgery (n = 70), heavy menstrual bleeding, pain, and bulk-related symptoms improved in 97%, 93%, and 92%. Ninety percent of all women (n = 93) were satisfied or very satisfied at final follow-up. Predictors of failure were a lack of improvement in bleeding (hazard ratio [HR], 9.0; 95% CI, 3.1-26.3; P < .001) or pain (HR, 7.4; 95% CI, 2.2-24.4; P < .001) at 1 year after UAE and the percent reduction in dominant tumor volume (HR, 0.97; 95% CI, 0.95-0.99; P = .007). CONCLUSIONS: UAE in women with symptomatic leiomyomas leads to long-term symptom improvement. Predictors of failure were a lack of improvement in bleeding or pain at 1 year and the percent reduction in dominant tumor volume.