scholarly journals Comparison of (Cost-)Effectiveness of Magnetic Resonance Image–Guided High-Intensity–Focused Ultrasound With Standard (Minimally) Invasive Fibroid Treatments: Protocol for a Multicenter Randomized Controlled Trial (MYCHOICE) (Preprint)

2021 ◽  
Author(s):  
Kimberley J Anneveldt ◽  
Ingrid M Nijholt ◽  
Joke M Schutte ◽  
Jeroen R Dijkstra ◽  
Geert W J Frederix ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Uterine Fibroid ◽  
Focused Ultrasound ◽  
Controlled Trial ◽  
Uterine Fibroids ◽  
High Intensity Focused Ultrasound ◽  
Hifu Treatment ◽  
Image Guided ◽  
Randomized Controlled

BACKGROUND Magnetic resonance image–guided high-intensity–focused ultrasound (MR-HIFU) is a rather new, noninvasive option for the treatment of uterine fibroids. It is safe, effective, and has a very short recovery time. However, a lack of prospectively collected data on long-term (cost-)effectiveness of the MR-HIFU treatment compared with standard uterine fibroid care prevents the MR-HIFU treatment from being reimbursed for this indication. Therefore, at this point, when conservative treatment for uterine fibroid symptoms has failed or is not accepted by patients, standard care includes the more invasive treatments hysterectomy, myomectomy, and uterine artery embolization (UAE). Primary outcomes of currently available data on MR-HIFU treatment often consist of technical outcomes, instead of patient-centered outcomes such as quality of life (QoL), and do not include the use of the latest equipment or most up-to-date treatment strategies. Moreover, data on cost-effectiveness are rare and seldom include data on a societal level such as productivity loss or use of painkillers. Because of the lack of reimbursement, broad clinical implementation has not taken place, nor is the proper role of MR-HIFU in uterine fibroid care sufficiently clear. OBJECTIVE The objective of our study is to determine the long-term (cost-)effectiveness of MR-HIFU compared with standard (minimally) invasive fibroid treatments. METHODS The MYCHOICE study is a national, multicenter, open randomized controlled trial with randomization in a 2:1 ratio to MR-HIFU or standard care including hysterectomy, myomectomy, and UAE. The sample size is 240 patients in total. Women are included when they are 18 years or older, in premenopausal stage, diagnosed with symptomatic uterine fibroids, conservative treatment has failed or is not accepted, and eligible for MR-HIFU. Primary outcomes of the study are QoL 24 months after treatment and costs of treatment including direct health care costs, loss of productivity, and patient costs. RESULTS Inclusion for the MYCHOICE study started in November 2020 and enrollment will continue until 2024. Data collection is expected to be completed in 2026. CONCLUSIONS By collecting data on the long-term (cost-)effectiveness of the MR-HIFU treatment in comparison to current standard fibroid care, we provide currently unavailable evidence about the proper place of MR-HIFU in the fibroid treatment spectrum. This will also facilitate reimbursement and inclusion of MR-HIFU in (inter)national uterine fibroid care guidelines. CLINICALTRIAL Netherlands Trial Register NL8863; https://www.trialregister.nl/trial/8863 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/29467

An image-guided high intensity focused ultrasound device for uterine fibroids treatment

2002 ◽  
Vol 29 (11) ◽  
pp. 2611-2620 ◽  
Author(s):  
Arthur H. Chan ◽  
Victor Y. Fujimoto ◽  
Donald E. Moore ◽  
Roy W. Martin ◽  
Shahram Vaezy
Keyword(s):  
High Intensity ◽  
Focused Ultrasound ◽  
Uterine Fibroids ◽  
High Intensity Focused Ultrasound ◽  
Image Guided ◽  
Ultrasound Device

scholarly journals Lessons learned during implementation of MR-guided High-Intensity Focused Ultrasound treatment of uterine fibroids

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
K. J. Anneveldt ◽  
I. M. Verpalen ◽  
I. M. Nijholt ◽  
J. R. Dijkstra ◽  
R. D. van den Hoed ◽  
...  
Keyword(s):  
Learning Curve ◽  
Patient Selection ◽  
High Intensity ◽  
Focused Ultrasound ◽  
Uterine Fibroids ◽  
Lessons Learned ◽  
High Intensity Focused Ultrasound ◽  
Patient Counseling ◽  
Hifu Treatment ◽  
Medical Specialists

Abstract Background Although 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. Results Our 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. Conclusions Our 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.

scholarly journals A Novel High-Intensity Focused Ultrasound-Treated Herpes Simplex Virus 2 Vaccine Induces Long-Term Protective Immunity against Lethal Challenge in Mice

mSphere ◽  
2020 ◽  
Vol 5 (6) ◽  
pp. e00859-20
Author(s):  
Juhua Xiao ◽  
Xin Zhou ◽  
Ye Luo ◽  
Shuang Wang ◽  
Zhili Yang ◽  
...  
Keyword(s):  
High Intensity ◽  
Protective Immunity ◽  
Focused Ultrasound ◽  
High Intensity Focused Ultrasound ◽  
The Novel ◽  
Hifu Treatment ◽  
Lethal Challenge ◽  
Simplex Virus ◽  
Herpes Simplex Virus 2

ABSTRACTHigh-intensity focused ultrasound (HIFU), a noninvasive ablation therapy that has been widely used clinically in ablation of solid tumors, induces immune sensitization. We therefore in this study investigated whether HIFU treatment could enhance the efficacy of a herpes simplex virus 2 (HSV-2) vaccine. First, we observed that in HSV-2-positive cervical intraepithelial neoplasia (CIN) II patients, HIFU treatment induced significantly higher anti-HSV-2 neutralization response than surgical removal. Next, we tested the efficacy of HIFU-treated, UV-inactivated HSV-2-infected cells as a proof-of-concept vaccine in mice. Our data showed that HIFU-treated formulation significantly enhanced HSV-2 antibody titers and neutralization titers, compared to UV-, microwave (MW)-, or freeze-thaw (FT)-treated formulations. HIFU treatment also promoted the Th1/2 cell-mediated response. A long-term full protection was observed in mice that received the HIFU-treated formulation, and no weight loss was detected. Our findings indicate that the novel application of HIFU in vaccine production may represent a rational way to improve vaccine efficacy.IMPORTANCE High-intensity focused ultrasound (HIFU) is mainly used in tumor ablation and tumor vaccinology study. It has been shown to induce immune sensitization and enhance tumor responsiveness to other therapies. Our study has shown enhanced anti-HSV-2 response in HIFU-treated CIN II patients. Furthermore, in a murine model, we have demonstrated that HIFU-treated HSV-2 vaccine induced long-term protective immunity against lethal challenge. Our findings indicate that the novel application of HIFU in vaccine production may represent a rational way to improve vaccine efficacy.

scholarly journals Magnetic resonance-guided high-intensity focused ultrasound of uterine fibroids: whole-tumor quantitative perfusion for prediction of immediate ablation response

2019 ◽  
Vol 61 (8) ◽  
pp. 1125-1133
Author(s):  
Chenxia Li ◽  
Chao Jin ◽  
Ting Liang ◽  
Xiang Li ◽  
Rong Wang ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
High Intensity ◽  
Focused Ultrasound ◽  
Uterine Fibroids ◽  
Blood Perfusion ◽  
High Intensity Focused Ultrasound ◽  
Hifu Treatment ◽  
Quantitative Perfusion ◽  
Contrast Enhanced ◽  
Contrast Enhanced Mri

Background In magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) treatment of uterine fibroids, the immediate ablation response is significantly affected by blood perfusion. The variability of measurement for blood perfusion is critical due to the inherent non-uniformity of tumor perfusion and its dependence on reproducible region of interest (ROI) placement. Purpose To investigate the value of whole-tumor ROI (ROIwt) analysis for quantitative perfusion in predicting immediate ablation response of uterine fibroids in MR-HIFU. Material and Methods Thirty-one fibroids in 28 eligible patients were treated with MR-HIFU. Quantitative perfusion parameters (Ktrans, Kep, and Vp) derived from dynamic contrast-enhanced MRI were obtained before MR-HIFU treatment. The ROIwt and single-layer ROI (ROIsl) were used for quantitative perfusion analysis. T1 contrast-enhanced MRI immediately after MR-HIFU treatment was conducted to determine the non-perfused volume ratio (NPVR). Intraclass correlation coefficient (ICC) was used for consistency test. Spearman’s correlation and multivariate linear regression were used to investigate the predictors of the NPVR. Received operating characteristic (ROC) curve was used to test the predictive efficacy of quantitative perfusion parameter. Results The intra- and inter-observer ICC of the quantitative perfusion parameters from ROIwt were higher than those from ROIsl. Multivariate analysis showed that the Ktrans of ROIwt was a predictor of the immediate ablation response. ROC analysis displayed that the AUC of Ktrans of ROIwt is 0.817 in predicting the ablation response. Conclusion Pretreatment Ktrans of ROIwt is more reliable and stable than that of ROIsl. It could be a predictor for the immediate ablation response of uterine fibroids in MR-HIFU.

High-intensity focused ultrasound: opportunities and prospects in the treatment of uterine fibroid and deep infiltrative endometriosis

2021 ◽  
Vol 70 (2) ◽  
pp. 129-138
Author(s):  
Dmitriy S. Sudakov ◽  
Igor P. Nikolayenkov ◽  
Yulia R. Dymarskaya ◽  
Diana V. Bubnova
Keyword(s):  
Surgical Treatment ◽  
Literature Review ◽  
Uterine Fibroid ◽  
Focused Ultrasound ◽  
Uterine Fibroids ◽  
High Intensity Focused Ultrasound ◽  
Deep Infiltrating Endometriosis ◽  
Unplanned Pregnancies ◽  
Infiltrating Endometriosis ◽  
Deep Infiltrative Endometriosis

This literature review is devoted to the use of focused ultrasound in gynecological practice as an alternative to the traditional surgical treatment of uterine fibroids and deep infiltrating endometriosis. According to available data, the effectiveness of the treatment of uterine fibroids with focused ultrasound varies widely, ranging from 16.4% to 93.0%. Due to the lack of prospective studies, it is not possible to draw reliable conclusions about the effect of ablation of uterine fibroid with focused ultrasound on fertility. However, unplanned pregnancies after such treatment occurred up to 19.5%, and in 66.3% of cases, pregnancies ended with the childbirth. Research results demonstrate that in 87% of cases, treatment of retrocervical infiltrative endometriosis using focused ultrasound is feasible. Further data accumulation is required to determine the range of patients with uterine fibroids and deep infiltrating endometriosis, to whom the treating technique could be most effective and safe.

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