Clinical and Technical Aspects of MR-Guided High Intensity Focused Ultrasound for Treatment of Symptomatic Uterine Fibroids.
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SUBMITTER: Rueff LE
PROVIDER: S-EPMC3835439 | biostudies-other | 2013 Dec
REPOSITORIES: biostudies-other
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Project description:BackgroundAlthough promising results have been reported for Magnetic Resonance image-guided High-Intensity Focused Ultrasound (MR-HIFU) treatment of uterine fibroids, this treatment is not yet widely implemented in clinical practice. During the implementation of a new technology, lessons are learned and an institutional learning-curve often has to be completed. The primary aim of our prospective cohort study was to characterize our learning-curve based on our clinical outcomes. Secondary aims included identifying our lessons learned during implementation of MR-HIFU on a technical, patient selection, patient counseling, medical specialists and organizational level.ResultsOur first seventy patients showed significant symptom reduction and improvement of quality of life at 3, 6 and 12 months after MR-HIFU treatment compared to baseline. After the first 25 cases, a clear plateau phase was reached in terms of failed treatments. The median non-perfused volume percentage of these first 25 treatments was 44.6% (range: 0-99.7), compared to a median of 74.7% (range: 0-120.6) for the subsequent treatments.ConclusionsOur findings describe the learning-curve during the implementation of MR-HIFU and include straightforward suggestions to shorten learning-curves for future users. Moreover, the lessons we learned on technique, patient selection, patient counseling, medical specialists and organization, together with the provided supplements, may be of benefit to other institutions aiming to implement MR-HIFU treatment of uterine fibroids. Trial registration ISRCTN14634593. Registered January 12, 2021-Retrospectively registered, https://www.isrctn.com/ISRCTN14634593 .
| S-EPMC8684568 | biostudies-literature
Project description:BackgroundMagnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) is a noninvasive uterine-preserving treatment alternative to hysterectomy for women with symptomatic uterine leiomyomas (fibroids). Uterine fibroids commonly occur, have a broad impact on women's health and lifestyle, continue to be the main indication for hysterectomy, and represent a costly public health burden.ObjectivesThe objectives of the analysis were to evaluate patients' eligibility for MRgHIFU treatment of symptomatic uterine fibroids and the technical success, safety, effectiveness, and durability of this treatment. The review also compared the safety and effectiveness of MRgHIFU with other minimally invasive uterine-preserving treatments and surgeries for uterine fibroids.MethodsA literature search was performed on March 27, 2014, using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), and EBM Reviews, for studies published from January 1, 2000, to March 27, 2014.ResultsThe evidence review identified 2 systematic reviews, 2 RCTs, 45 cohort study reports, and 19 case reports involving HIFU treatment of symptomatic uterine fibroids. Eligibility for MRgHIFU treatment was variable, ranging from 14% to 74%. In clinical cohort studies involving 1,594 patients, 26 major complications (1.6%) were reported. MRgHIFU resulted in statistically and clinically significant reductions in fibroid-related symptoms in studies conducted in 10 countries, although few involved follow-up longer than 1 year. Retreatment rates following MRgHIFU were higher in early clinical studies involving regulated restrictions in the extent of fibroid ablation than in later reports involving near-complete ablation. Emergent interventions, however, were rare. Although a desire for fertility was an exclusion criteria for treatment, spontaneous term pregnancies did occur following HIFU. There were no randomized trials comparing MRgHIFU and other guidance methods, other minimally invasive treatments, or surgeries for symptomatic uterine fibroids. Limitations with MRgHIFU included restricted eligibility, requirement for a dedicated MR device to guide the treatment, lengthy procedure time, and loss of MR opportunity time.ConclusionsFor women failing medical therapy and seeking alternatives to hysterectomy for symptomatic uterine fibroids, MRgHIFU provides a safe and effective, noninvasive, uterine-preserving treatment from which they rapidly recover. The treatment advantages of MRgHIFU are potentially offset by restrictive eligibility, lengthy procedure time, and dependence on availability of an MR device. The lack of comparative evidence between MRgHIFU and other, more established uterine-preserving treatments limits informed decision making among treatment options.
| S-EPMC4558769 | biostudies-literature
Project description:BACKGROUND This study investigated uterine peristalsis before and after ultrasound-guided high-intensify focused ultrasound (USgHIFU) treatment for symptomatic uterine fibroids by cine magnetic resonance imaging (cine MRI). MATERIAL AND METHODS A total of 30 patients with symptomatic uterine fibroids were treated by USgHIFU, who were subjected to cine MRI before and after USgHIFU treatment in the periovulatory phase. The images were analyzed for the existence, direction, and frequency of uterine peristalsis. The effects of uterine volume, the largest fibroid volume and location, and the fibroid number were examined before and after USgHIFU treatment. RESULTS The incidence of uterine peristalsis was significantly increased after USgHIFU treatment. The main direction of uterine peristalsis before and after USgHIFU was cervix-to-fundus. In 12 cases, uterine peristalsis newly emerged after USgHIFU, and the largest fibroid volumes in these 12 cases were significantly smaller than in the remaining 18 cases before and after USgHIFU. The reduction rates of the largest fibroid volume in the 12 cases were significantly higher than in the remaining 18 cases. The largest fibroids were mainly located in the intramural area before and after USgHIFU. CONCLUSIONS USgHIFU treatment may contribute to the recovery of uterine peristalsis in patients with symptomatic fibroids, as detected by cine MRI. Uterine peristalsis recovery was related to the largest fibroid volume, especially for intramural fibroids.
| S-EPMC6698095 | biostudies-literature
Project description:Rationale and objectivesTo investigate the response after magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment of uterine fibroids (UF) using a three-dimensional (3D) quantification of total and enhancing lesion volume (TLV and ELV, respectively) on contrast-enhanced MRI (ceMRI) scans.Methods and materialsIn a total of 24 patients, ceMRI scans were obtained at baseline and 24 hours, and 6, 12, and 24 months after MRgHIFU treatment. The dominant lesion was assessed using a semiautomatic quantitative 3D segmentation technique. Agreement between software-assisted and manual measurements was then analyzed using a linear regression model. Patients were classified as responders (R) or nonresponders (NR) on the basis of their symptom report after 6 months. Statistical analysis included the paired t-test and Mann-Whitney test.ResultsPreprocedurally, the median TLV and ELV were 263.74 cm(3) (30.45-689.56 cm(3)) and 210.13 cm(3) (14.43-689.53 cm(3)), respectively. The 6-month follow-up demonstrated a reduction of TLV in 21 patients (87.5%) with a median TLV of 171.7 cm(3) (8.5-791.2 cm(3); P < .0001). TLV remained stable with significant differences compared to baseline (P < .001 and P = .047 after 12 and 24 months). A reduction of ELV was apparent in 16 patients (66.6%) with a median ELV of 158.91 cm(3) (8.55-779.61 cm(3)) after 6 months (P = .065). Three-dimensional quantification and manual measurements showed strong intermethod agreement for fibroid volumes (R(2) = .889 and .917) but greater discrepancy for enhancement calculations (R(2) = .659 and .419) at baseline and 6 months. No significant differences in TLV or ELV were observed between clinical R (n = 15) and NR (n = 3).ConclusionsThe 3D assessment has proven feasible and accurate in the quantification of fibroid response to MRgHIFU. Contrary to ELV, changes in TLV may be representative of the clinical outcome.
| S-EPMC4546360 | biostudies-literature
Project description:IntroductionVaginal microbiota dysbiosis is closely related to diseases of the vagina and uterus. Uterine fibroids (UF) are the most common benign neoplasms of the uterus, and increased diversity in vaginal microbial of UF patients. High-intensity focused ultrasound (HIFU) is effective invasive treatment for fibroids in women who are not good surgical candidates. Whether HIFU of uterine fibroids will cause the change in vaginal microbiota has not been reported. We aimed to investigate the vaginal microbiota of UF patients with/without HIFU treatment using 16S rRNA gene sequencing.MethodsVaginal secretions were collected from 77 UF patients (pre-operative and post-operative) and were used for comparative composition, diversity, and richness analyses of microbial communities.ResultsThe microbial α-diversity was significantly lower in the vaginal of UF patients with HIFU treatment. The relative abundance of some pathogenic bacteria of UF patients with HIFU treatment were significantly decreased in the bacterial phylum and genus level. Proteobacteria were found to be significantly upregulated as a biomarker in the HIFU treatment group in our study.ConclusionThese findings might confirm the effectiveness of HIFU treatment from the point of view of microbiota.
| S-EPMC10150040 | biostudies-literature
Project description:Background:Magnetic resonance guided high-intensity focused ultrasound (MR-HIFU) therapy is not feasible in all patients with uterine fibroids because of limiting anatomical factors such as scar tissue, bowel loops or other obstacles in the sonication path. These may prevent the treatment or limit the treatment window, and therefore, also the volume where HIFU therapy can be delivered. Bowel loops present a particular problem because of bowel gas bubbles and hard particles which may cause reflection or absorption of ultrasound energy, potentially leading to thermal damage and even bowel perforation. Most commonly used techniques for bowel repositioning are bladder and/or rectum filling but these are not always sufficient to reposition the bowel loops. With more efficient bowel repositioning technique, the number of eligible patients for MR-HIFU treatment could be increased, and therapy efficacy be improved in cases where bowel loops limit the treatment window. Case presentation:A wedged exterior gel pad was used in two patients presented with in total of four symptomatic fibroids undergoing MR-HIFU treatment when bladder and/or rectum filling was not sufficient to reposition the bowel loops. No severe adverse effects were observed in these cases. The non-perfused volume ratios (NPVs) immediately after treatment were 86% and 39% for the first patient, and 3% for the second patient. Conclusions:Our preliminary experience suggests that the use of a wedged gel pad during MR-HIFU treatment could be an effective tool to manipulate the bowels in cases where the bladder and/or rectum filling is not sufficient to reposition the bowel loops. A wedged gel pad could also be used in other situations to achieve better treatment coverage to the uterine fibroid.
| S-EPMC6260726 | biostudies-literature
Project description:ObjectiveThe purpose of this prospective multicenter study was to assess the safety and technical feasibility of volumetric Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) ablation for treatment of patients with symptomatic uterine fibroids.MethodsThirty-three patients with 36 fibroids were treated with volumetric MR-HIFU ablation. Treatment capability and technical feasibility were assessed by comparison of the Non-Perfused Volumes (NPVs) with MR thermal dose predicted treatment volumes. Safety was determined by evaluation of complications or adverse events and unintended lesions. Secondary endpoints were pain and discomfort scores, recovery time and length of hospital stay.ResultsThe mean NPV calculated as a percentage of the total fibroid volume was 21.7%. Correlation between the predicted treatment volumes and NPVs was found to be very strong, with a correlation coefficient r of 0.87. All patients tolerated the treatment well and were treated on an outpatient basis. No serious adverse events were reported and recovery time to normal activities was 2.3?±?1.8 days.ConclusionThis prospective multicenter study proved that volumetric MR-HIFU is safe and technically feasible for the treatment of symptomatic uterine fibroids.Key points• Magnetic-resonance-guided high intensity focused ultrasound allows non-invasive treatment of uterine fibroids. • Volumetric feedback ablation is a novel technology that allows larger treatment volumes • MR-guided ultrasound ablation of uterine fibroids appears safe using volumetric feedback.
| S-EPMC3249029 | biostudies-literature
Project description:BACKGROUND:Abdominal scars pose a challenge in magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapies, limiting patient selection and increasing the risk of skin burns. Especially, scars arising from longitudinal incisions are problematic as they usually lie medially at the lower abdomen where the ultrasound beam has to go through. Volumetric sonication has been shown to efficiently enlarge the ablated volume per sonication, but they nevertheless require more thermal energy to be deposited per sonication which increases the temperature in the near-field area located between the transducer and the target region. CASE PRESENTATION:The scar patch was used in three patients undergoing MR-HIFU ablation of fibroids using volumetric technique, one with transverse incision and the other two with longitudinal incision. No severe adverse effects were observed. The relative shrinkage of the fibroid of these patients at 6-month follow-up were 67, 78, and 59 %, respectively. CONCLUSIONS:Our preliminary experience suggests that the use of scar patch on MR-HIFU ablation of fibroids using volumetric technique provides an effective treatment option for patients who were previously excluded from MR-HIFU treatment due to the abdominal scars.
| S-EPMC4982143 | biostudies-literature
Project description:BackgroundUterine fibroids are the most common benign tumor in women, and surgical intervention is still the main fibroid treatment. Patient demands have encouraged development of less-invasive methods such as high-intensity focused ultrasound (HIFU). This study aimed to evaluate the safety and effectiveness of magnetic resonance-guided high-intensity focused ultrasound therapy using a volumetric ablation technique in the treatment of symptomatic uterine fibroids in China.MethodsOne hundred and seven patients were enrolled and treated with magnetic resonance-guided high-intensity focused ultrasound in this study. Clinical efficacy was based on the proportion of patients with fibroid shrinkage (10 % volume reduction or more compared to baseline) at 6 months post treatment as measured with magnetic resonance imaging. The quality of life and symptom outcome was assessed using the uterine fibroid symptom and quality of life questionnaire with symptom severity scoring. Safety was primarily assessed by evaluating the reported adverse events.ResultsNinety nine of the 107 treated patients had fibroid shrinkage at 6 months post treatment. Resulting in an overall 93 % (95 % confidence interval 86-97 %) treatment success rate, p value <0.001; the symptom severity scoring and health-related quality of life at 6 months was statistically different from the screening symptom severity scoring at 0.05 level. Of 366 adverse events reported, there were no study procedure-related or device-related serious adverse events were in the study.ConclusionsThis study demonstrated that the volumetric magnetic resonance-guided high-intensity focused ultrasound device is safe and technically effective and can be utilized in clinically efficient treatments of symptomatic uterine fibroids.Trial registrationNCT01588899.
| S-EPMC5094072 | biostudies-literature
Project description:ObjectiveThe purpose of this study was to compare efficacy, sonication energy efficiency, treatment time and safety of magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) and those of ultrasound-guided high-intensity focused ultrasound (USgHIFU) for ablation of uterine fibroids.Materials and methodsThis study included 43 patients with 44 symptomatic uterine fibroids treated with MRgHIFU and 51 patients with 68 symptomatic uterine fibroids treated with USgHIFU. After therapy, contrast-enhanced MRI was conducted and complete ablation was defined as 100% non-perfused volume (NPV) of fibroids. Patients with completely ablated fibroids were selected for the comparison of the treatment data and sonication parameters between MRgHIFU and USgHIFU treated groups.ResultsThirteen completely ablated fibroids in 10 patients (23.3%, 10/43) were achieved with MRgHIFU and 28 completely ablated fibroids in 22 patients (43.1%, 22/51) were achieved with USgHIFU. In completely ablated fibroids, the energy-efficiency factor (EEF) was 5.1 ± 3.0 J/mm3 and 4.7 ± 2.5 J/mm3 in the MRgHIFU and USgHIFU, respectively (p = 0.165). There was a negative linear correlation between EEF and the NPV of fibroids for MRgHIFU (p = 0.016) and USgHIFU (p = 0.001). The mean treatment time was 174.5 ± 42.2 minutes and 114.4 ± 39.2 minutes in the MRgHIFU and USgHIFU procedures, respectively (p = 0.021). There were no severe adverse events and major complications after treatment.ConclusionMRgHIFU and USgHIFU are safe and effective with the equivalent energy efficiency for complete ablation of fibroids. USgHIFU has shorter treatment time than MRgHIFU.
| S-EPMC6005948 | biostudies-literature