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To compare the quality of life (QOL), cosmesis and cost-utility of open surgery (OS), vacuum-assisted breast biopsy (VABB) and high intensity focused ultrasound (HIFU) for fibroadenoma (FA). A total of 162 patients with 267 FAs were enrolled. Baseline characteristics and treatment information were recorded. Patients were followed up at 3-, 6- and 12-month post-treatment. QOL was evaluated by health survey. Breast cosmesis was evaluated by self-rating survey and Harvard Scale. A decision-analytic model was established and incremental cost was calculated for cost-utility analysis. For QOL evaluation, there was no difference of physical component summary (PCS) score in three groups (P > 0.05), while the mental component summary (MCS) score was significantly higher in HIFU group than the other two groups at 3- and 6-month post-treatment (P < 0.05). The proportion of patients satisfied with breast cosmesis was significantly higher in HIFU group (96.49%) than in VABB group (54.90%) and OS group (49.99%) (P < 0.05). By Harvard Scale, 27.78%, 78.42% and 100.00% of patients were rated as excellent and good in OS group, VABB group and HIFU group, respectively (P < 0.05). To acquire a quality-adjusted life year (QALY), cost of OS, VABB and HIFU was 1034.31 USD, 1776.96 USD and 1277.67 USD, respectively. When compared to OS, incremental cost analysis showed HIFU was cost-effective, while VABB was not. OS, VABB and HIFU were all effective and safe for FA, but among these three treatments, HIFU had the best QOL improvement, breast cosmesis and cost-effectiveness. [ABSTRACT FROM AUTHOR]

To evaluate the impact of high-intensity focused ultrasound (HIFU) ablation on the histopathological features of locally recurrent fibroids tissue. Patients who underwent transabdominal hysterectomy or myomectomy for uterine fibroids from January 1, 2021 to July 1, 2023 at a teaching hospital in China were enrolled in this prospective study. The patients who underwent surgery for local recurrence of uterine fibroids after HIFU ablation were categorized as the HIFU group, and patients who had not undergone HIFU ablation for uterine fibroids were the control group. Hematoxylin-eosin (HE) staining, Masson staining, and immunohistochemical staining were performed to analyze the counts of smooth muscle cells (SMCs), collagen content, microvascular count, and the expression levels of estrogen receptor (ER) and progesterone receptor (PR) in the fibroid tissue specimens. The mean SMC counts in the HIFU and control groups were 337.68/field and 328.52/field respectively. The mean collagen content in the HIFU group and control group were 46.06% and 41.69% respectively. The mean microvessel counts in the HIFU group and control group were 13.66/field and 14.08/field respectively. The mean ER scores in the HIFU and control groups were 6.9 and 7.47 respectively, and the mean PR scores were 7.3 and 7.56 respectively. Overall, there were no significant differences in the SMC counts, collagen content, microvascular counts, and the ER and PR expression levels between the HIFU group and control group (p > 0.05). HIFU ablation has no effect on the pathological characteristics of local recurrent fibroid tissue, and is an ideal non-invasive treatment option. [ABSTRACT FROM AUTHOR]

Abstract Liver fibrosis is a hallmark of chronic liver disease which could lead to liver cirrhosis or liver cancer. However, there is currently lack of a direct treatment for liver fibrosis. Boiling histotripsy (BH) is an emerging non-invasive high-intensity focused ultrasound technique that can be employed to mechanically destruct solid tumour at the focus via acoustic cavitation without significant adverse effect on surrounding tissue. Here, we investigated whether BH can mechanically fractionate liver fibrotic tissue thereby exhibiting an anti-fibrotic effect in an animal model of liver fibrosis. BH-treated penumbra and its identical lobe showed reduced liver fibrosis, accompanied by increased hepatocyte specific marker expression, compared to the BH-untreated lobe. Furthermore, BH treatment improved serological liver function markers without notable adverse effects. The ability of BH to reduce fibrosis and promote liver regeneration in liver fibrotic tissue suggests that BH could potentially be an effective and reliable therapeutic approach against liver fibrosis.

Barsha Shrestha,1 Sheetal Maria Rajan,1 Sultan Aati,1,2 Emielda Yusiharni,3 Omar Kujan,1 Martin Saunders,4 Amr Fawzy1 1UWA Dental School, The University of Western Australia, Perth, WA, Australia; 2Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia; 3UWA XRD Facility, Material & Environmental Analysis Platform, The University of Western Australia, Perth, WA, Australia; 4Centre for Microscopy, Characterisation and Analysis, The University of Western Australia, Perth, WA, AustraliaCorrespondence: Amr Fawzy, UWA Dental School, The University of Western Australia, 17 Monash Avenue, Nedlands, WA, 6009, Australia, Tel +61894572434, Email amr.fawzy@uwa.edu.auBackground: Remineralization of dental enamel is an important intervention strategy for the treatment of demineralized lesions. Existing approaches have limitations such as failure to adequately reproduce both the ideal structural and mechanical properties of the native tooth. The ability of ultrasound to control and accelerate the crystallization processes has been widely reported. Therefore, a new approach was explored for in-vitro enamel remineralization involving the synergistic effect of high-intensity focused ultrasound (HIFU) coupled with calcium phosphate ion clusters (CPICs).Methods: The demineralized enamel was treated with CPICs, with or without subsequent HIFU exposure for different periods (2.5, 5, and 10 min). The specimens were characterized by scanning electron microscopy (SEM), atomic force microscopy (AFM), and Raman spectroscopy. The surface hardness and crystallographic properties of the treated specimens were evaluated using Vickers microhardness testing and X-ray diffraction (XRD), respectively.Results: SEM revealed distinct, organized, and well-defined prismatic structures, showing clear evidence of remineralization in the combined CPIC/HIFU treatment groups. AFM further revealed a decrease in the surface roughness values with increasing HIFU exposure time up to 5 min, reflecting the obliteration of interprismatic spaces created during demineralization. The characteristic Raman band at 960 cm− 1 associated with the inorganic phase of enamel dominated well in the HIFU-treated specimens. Importantly, microhardness testing further demonstrated that new mineral growth also recovered the mechanical properties of the enamel in the HIFU-exposed groups. Critical to our aspirations for developing this into a clinical process, these results were achieved in only 5 min.Conclusion: HIFU exposure can synergise and significantly accelerate in-vitro enamel remineralization process via calcium phosphate ion clusters. Therefore, this synergistic approach has the potential for use in future clinical interventions. Keywords: enamel remineralization, high intensity focused ultrasound, calcium phosphate ion cluster

AbstractThe major aim of this research hyperthermia and magnetic resonance-high intensity focused ultrasound (MR-HIFU) focused on investigating the potential of aloe vera leaf extract-mediated gold-coated iron oxide nanohybrids (Au-IONPs) as a modern theragnostic material for the treatment of uterine myoma. To assess the cytotoxicity of Au-IONPs, induce hyperthermia, and apply radiotherapy to determine the level of apoptosis in the human ht-UtLM cells. Subsequently, it evaluated the cytotoxicity of the nanoparticles on human ht-UtLM cells by exposing the cells to various concentrations of Au-IONPs for a 4-hour incubation period. Based on the results, concentrations of 10 and 15 µg/mL were selected for further investigation. The MTT assay and flow cytometry results demonstrated that Au-IONPs significantly induce cell apoptosis. It allows the Au-IONPs to turn as an effective development mediator in the ablation of high-intensity focused ultrasound (HIFU) treatment. Finally, it could be suggested to developed material have excellent systemic toxicity, which promises well for treatment of uterine fibroids.HIGHLIGHTSBiosynthesis of gold – iron oxide nanohybrids (Au-IONPs) through a green approach.Physio-chemical properties of Au-IONPs have been characterized through various techniques.Investigating the anti-tumor effects of Au-IONPs in combination with thermo-radiotherapy for uterine myoma.Determine the level of apoptosis in the human myoma cells by inducing hyperthermia and radiotherapy.Observed the correlation behavior between the dose of the cell viability and Au-IONP nanoparticles.Au-IONPs had a significant impact on enhancing the effects of both hyperthermia and radiation therapies.Biosynthesis of gold – iron oxide nanohybrids (Au-IONPs) through a green approach.Physio-chemical properties of Au-IONPs have been characterized through various techniques.Investigating the anti-tumor effects of Au-IONPs in combination with thermo-radiotherapy for uterine myoma.Determine the level of apoptosis in the human myoma cells by inducing hyperthermia and radiotherapy.Observed the correlation behavior between the dose of the cell viability and Au-IONP nanoparticles.Au-IONPs had a significant impact on enhancing the effects of both hyperthermia and radiation therapies. [ABSTRACT FROM AUTHOR]

Background: To investigate the use of high intensity focused ultrasound (HIFU) for great saphenous vein (GSV) incompetence. Material and methods: Patients with GSV incompetence underwent HIFU. The primary endpoint was the rate of GSV target segment shrinkage or closure after 1 year. Results: Out of 188 limbs treated, the GSV treated segment shrinkage/closure rate at 1 week, 3 months, 6 months, and 12 months was 93.3%, 98.2%, 97.6%, and 98.3%, respectively. Conclusion: These preliminary results suggest that HIFU holds promise for the treatment of GSV incompetence. Further trials are needed to compare it with other techniques and assess long-term outcomes. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study is to describe the anatomical and functional changes observed in multiparametric magnetic resonance imaging (mpMRI) during follow-up after focal therapy (FT) for localized prostate cancer (PCa). Materials and methods: In this prospective study, we analyzed pre- and postoperatively acquired mpMRI of 10 patients after FT (7 days; 3, 6, 9, 12 months). 7/10 (70%) patients underwent vascular-targeted photodynamic therapy (VTP). 3/10 (30%) patients underwent high-intensity focused ultrasound (HIFU). MpMR image analysis was performed using a semi-automatic software for segmentation of the prostate gland (PG) and tumor zones. Signal intensities (SI) of T2-weighted (T2w), T1-weighted (T1w),diffusion-weighted (DWI) and dynamic contrast-enhanced (DCE) images as well as volumes of the prostate gland (PGV) and tumor volumes (TV) were evaluated at each time point. Results: The results showed a significant increase of PGV 7 days after FT (p = 0.042) and a significant reduction of PGV between 7 days and 6, 9 and 12 months after FT (p < 0.001). The TV increased significantly 7 days after FT (p < 0.001) and decreased significantly between 7 days and 12 months after FT (p < 0.001). There was a significant increase in SI of the ADC in the ablation zone after 6, 9 and 12 months after FT (p < 0.001). 1/9 patients (11%) had recurrent tumor on rebiopsy characterized as a a small focal lesion on mpMRI with strong diffusion restriction (low SI on ADC map and high SI on b-value DWI). Conclusion: MpMRI is able to represent morphologic changes of the ablated zone after FT and might be helpful to detect recurrent tumor. [ABSTRACT FROM AUTHOR]

Liver fibrosis is a hallmark of chronic liver disease which could lead to liver cirrhosis or liver cancer. However, there is currently lack of a direct treatment for liver fibrosis. Boiling histotripsy (BH) is an emerging non-invasive high-intensity focused ultrasound technique that can be employed to mechanically destruct solid tumour at the focus via acoustic cavitation without significant adverse effect on surrounding tissue. Here, we investigated whether BH can mechanically fractionate liver fibrotic tissue thereby exhibiting an anti-fibrotic effect in an animal model of liver fibrosis. BH-treated penumbra and its identical lobe showed reduced liver fibrosis, accompanied by increased hepatocyte specific marker expression, compared to the BH-untreated lobe. Furthermore, BH treatment improved serological liver function markers without notable adverse effects. The ability of BH to reduce fibrosis and promote liver regeneration in liver fibrotic tissue suggests that BH could potentially be an effective and reliable therapeutic approach against liver fibrosis. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of gonadotropin releasing hormone agonist (GnRH-a) pretreatment combined with high intensity focused ultrasound in the treatment of adenomyosis. Methods: 298 patients with adenomyosis admitted to our hospital from January 2019 to May 2021 were randomly divided into the control group and the experimental group using a random number table method, with 149 patients in each group. The control group received high intensity focused ultrasound treatment, while the experimental group received GnRH-a pretreatment, after 2 consecutive menstrual cycles, high intensity focused ultrasound treatment was combined. Both groups were followed up for 2 years after treatment. The lesion volume, uterine volume, menstrual volume, pain level, levels of hormones, serum cytokine before and 3 months after treatment, adverse reactions during treatment, recurrence and pregnancy outcomes during followed up between the two groups were compared. Results: Compared with before treatment, after 3 months of treatment, the lesion volume and uterine volume of the two groups decreased, experimental group was smaller(P<0.05); the menstrual volume, score of numeric rating scale (NRS), serum levels of estradiol (E2), luteinizing hormone (LH), follicle stimulating hormone (FSH), and transforming growth factor β2(TGF-β2), vascular endothelial growth factor(VEGF) of the two groups decreased, the experimental group compared to the control group was lower (P<0.05); the level of serum adiponectin (ADP) increased in both groups, experimental group was higher (P<0.05). There was no significant difference in the incidence of sacrococcygeal pain, radiating pain, lower abdominal pain, and irregular vaginal bleeding between the experimental group and the control group during the treatment period(P>0.05); the recurrence rate and abortion rate during the followed up period in the experimental group were 6.04% and 10.58%, respectively, lower than the control group's 17.45% and 35.21% (P<0.05); the clinical pregnancy rate during the followed up period in the experimental group was 69.80%, which was higher than 47.65% in the control group(P<0.05). Conclusion: GnRH-a pretreatment combined with high intensity focused ultrasound could regulate levels of hormone and serum cytokine in patients with adenomyosis, reduce lesion volume and uterine volume, reduce menstrual flow, alleviate pain, and improve pregnancy outcomes, with good safety. [ABSTRACT FROM AUTHOR]

To investigate whether the quantitative index of signal intensity (SI) heterogeneity on T2-weighted (T2W) magnetic resonance images can predict the difficulty and efficacy of high-intensity focused ultrasound (HIFU) ablation for uterine fibroids. The standard deviation (SD) of T2W image (T2WI) SI was used to quantify SI heterogeneity. The correlation between SD and the non-perfused volume ratio (NPVR) in 575 patients undergoing HIFU treatment was retrospectively analyzed, and the efficacy of SD in predicting NPVR was discussed. Three classifications were made based on the SD, and the ablation difficulty and ablation effect of different grades were compared. A total of 65 cases from another center were used as an external validation set to verify the classification performance of SD. The SD of SI was negatively correlated with NPVR (r = −0.460, p < 0.001). The predictive efficiency of SD for the ablation effect was higher than that of the scaled signal intensity (0.767 vs. 0.701, p = 0.006). Univariate and multivariate logistic regression analyses showed that SD was an independent predictor of ablation effect. Based on SD, the three classifications were divided into SD I: SD < 101.0, SD II: 101.0 ≤ SD < 138.7, and SD III: SD ≥ 138.7. The treatment time, sonication time, treatment intensity, and total energy of SD I were lower than those of SD II and III (p < 0.05). The heterogeneity of T2WI SI of uterine fibroids is negatively correlated with NPVR. The SD of SI can be used to predict the ablation difficulty and ablation effect of HIFU. [ABSTRACT FROM AUTHOR]

• High intensity focused ultrasound (HIFU) is an effective and safe treatment option for abdominal wall endometriosis. • Pain score and lesion size reduction is accomplished without major complications and with a pooled recurrence rate of 12.8%. • There were no significant differences in pain scores, complications and recurrences after surgical excision and USgHIFU. • High-quality randomized controlled trials comparing HIFU to standard care are needed to provide more conclusive evidence. In this review, a systematic literature search on the effectiveness and complication rates of ultrasound-guided and magnetic resonance-guided high-intensity focused ultrasound (USg-/MRgHIFU) for abdominal wall endometriosis (AWE) was conducted in six databases in May/June 2023. Original articles of (non)randomized trials, cohort studies, case-control studies and case series published in peer-reviewed journals were included. Of the included studies the level of evidence (LoE) and methodological quality using the ROBINS-I and IHE-QAT was assessed. Primary outcomes were non-perfused volume ratio (NPV%), lesion size, pain scores, side effects and complication rates according to Society of Interventional Radiology (SIR) guidelines. Secondary outcomes were recurrence and re-intervention rates. Seven cohort studies (one of good methodological quality) (LoE 3) on USgHIFU were included (n = 212, AWE lesions = 240–245). Six months after USgHIFU treatment, pain scores were reduced with 3.3–5.2 points (baseline: 5.1–6.8, n = 135). Self-limiting side effects were pain (85.7 % (114/133)) and swelling (34.6 % (46/133)) in the treatment area. Complications occurred in 17.7 % (32/181), all of which were minor. Recurrence occurred in 12.8 % (11/86). Three of these seven cohort studies compared USgHIFU (n = 61) with surgical excision (n = 74). Pooled results showed no significant differences in pain scores, complications (resp. 26.3 % (10/38) vs. 32.6 % (15/46) (p = 0.53)) and recurrences (resp. 4.9 % (3/61) vs. 5.4 % (4/74) (p = 0.90)). This systematic review suggests that HIFU is an effective and safe treatment option for AWE. USgHIFU treatment led to reduced pain scores and lesion size, was free of major complications and had a pooled recurrence rate of 12.8 %. Compared to surgical excision pooled results showed no significant differences in pain scores, complications and recurrences after USgHIFU. However, many of the included studies had limitations in their methodological quality and therefore the results should be interpreted with caution. Well-structured high-quality randomized controlled trials comparing HIFU to standard care should be conducted to provide more conclusive evidence. [ABSTRACT FROM AUTHOR]

Abstract Introduction In dermatology, inflammatory skin conditions impose a substantial burden worldwide, with existing therapies showing limited efficacy and side effects. This report aims to compare a novel immunological activation induced by hyperthermic 20 MHz high intensity focused ultrasound (HIFU) with conventional cryotherapy. The bioeffects from the two methods are initially investigated by numerical models, and subsequently compared to clinical observations after treatment of a patient with the inflammatory disease granuloma annulare (GA). Methods Clinical responses to moderate energy HIFU and cryotherapy were analysed using numerical models. HIFU-induced pressure and heat transfer were calculated, and a three-layer finite element model simulated temperature distribution and necrotic volume in the skin. Model output was compared to 22 lesions treated with HIFU and 10 with cryotherapy in a patient with GA. Results Cryotherapy produced a necrotic volume of 138.5 mm3 at − 92.7 °C. HIFU at 0.3–0.6 J/exposure and focal depths of 0.8 or 1.3 mm generated necrotic volumes up to only 15.99 mm3 at temperatures of 68.3–81.2 °C. HIFU achieved full or partial resolution in all treated areas, confirming its hyperthermic immunological activation effect, while cryotherapy also resolved lesions but led to scarring and dyspigmentation. Conclusion Hyperthermic immunological activation of 20 MHz HIFU shows promise for treating inflammatory skin conditions as exemplified by GA. Numerical models demonstrate minimal skin necrosis compared to cryotherapy. Suggested optimal HIFU parameters are 1.3 mm focal depth, 0.4–0.5 J/exposure, 1 mm spacing, and 1 mm margin. Further studies on GA and other inflammatory diseases are recommended.

Introduction: In dermatology, inflammatory skin conditions impose a substantial burden worldwide, with existing therapies showing limited efficacy and side effects. This report aims to compare a novel immunological activation induced by hyperthermic 20 MHz high intensity focused ultrasound (HIFU) with conventional cryotherapy. The bioeffects from the two methods are initially investigated by numerical models, and subsequently compared to clinical observations after treatment of a patient with the inflammatory disease granuloma annulare (GA). Methods: Clinical responses to moderate energy HIFU and cryotherapy were analysed using numerical models. HIFU-induced pressure and heat transfer were calculated, and a three-layer finite element model simulated temperature distribution and necrotic volume in the skin. Model output was compared to 22 lesions treated with HIFU and 10 with cryotherapy in a patient with GA. Results: Cryotherapy produced a necrotic volume of 138.5 mm3 at − 92.7 °C. HIFU at 0.3–0.6 J/exposure and focal depths of 0.8 or 1.3 mm generated necrotic volumes up to only 15.99 mm3 at temperatures of 68.3–81.2 °C. HIFU achieved full or partial resolution in all treated areas, confirming its hyperthermic immunological activation effect, while cryotherapy also resolved lesions but led to scarring and dyspigmentation. Conclusion: Hyperthermic immunological activation of 20 MHz HIFU shows promise for treating inflammatory skin conditions as exemplified by GA. Numerical models demonstrate minimal skin necrosis compared to cryotherapy. Suggested optimal HIFU parameters are 1.3 mm focal depth, 0.4–0.5 J/exposure, 1 mm spacing, and 1 mm margin. Further studies on GA and other inflammatory diseases are recommended. [ABSTRACT FROM AUTHOR]

The heterogeneity of triple‐negative breast cancers (TNBC) remains challenging for various treatments. Ferroptosis, a recently identified form of cell death resulting from the unrestrained peroxidation of phospholipids, represents a potential vulnerability in TNBC. In this study, a high intensity focused ultrasound (HIFU)‐driven nanomotor is developed for effective therapy of TNBC through induction of ferroptosis. Through bioinformatics analysis of typical ferroptosis‐associated genes in the FUSCCTNBC dataset, gambogic acid is identified as a promising ferroptosis drug and loaded it into the nanomotor. It is found that the rapid motion of nanomotors propelled by HIFU significantly enhanced tumor accumulation and penetration. More importantly, HIFU not only actuated nanomotors to trigger effective ferroptosis of TNBC cells, but also drove nanomotors to activate ferroptosis‐mediated antitumor immunity in primary and metastatic TNBC models, resulting in effective tumor regression and prevention of metastases. Overall, HIFU‐driven nanomotors show great potential for ferroptosis‐immunotherapy of TNBC. [ABSTRACT FROM AUTHOR]

High Intensity Focused Ultrasound (HIFU) is a noninvasive technique that can be applied for the thermal ablation of tumors with minimum side effects. Numerical simulations have been used for the selection of individualized thermal ablation treatments, but mathematical models depend on several parameters that are commonly known with large uncertainties. This computational work presents the design of the thermal ablation of tumors heated with HIFU by using the Markov Chain Monte Carlo method, implemented via the Metropolis-Hastings algorithm with sequential sampling of two blocks of parameters. Two-dimensional regions with tumors of different sizes were considered. The heating period and the position of the HIFU transducer were considered as the design variables, with priors modeled by uniform distributions. Other model parameters that appeared in the mathematical formulation were assumed Gaussian. The likelihood function, which represented the desired outcome of the thermal ablation treatment and its associated uncertainties, was modeled by a beta distribution for the probability of cell death due to heating. The obtained results revealed that the version of the Metropolis-Hastings algorithm used in this work could deal with uncertainties in the model parameters and allowed the robust design of the HIFU thermal ablation of the region of interest. [ABSTRACT FROM AUTHOR]

Objective To evaluate the efficacy and safety of high intensity focused ultrasound (HFIU) combined with endometrial ablation in the treatment of adenomyosis (AM) patients with heavy menstrual bleeding (HMB). Method A total of 199 patients with AM combined with HMB who underwent HIFU treatment at the Obstetrics and Gynecology Center of Affiliated Hospital of Chengdu University of TCM from July 2020 to September 2022 were selected and divided into two groups according to the ablation range. The combined ablation group included 80 cases with lesion and endometrial ablation (endometrial ablation rate ≥ 30%), while the lesion ablation group 119 cases with simple lesion ablation. A 1:1 propensity score matching was performed on the two groups, resulting in 59 patients in each group. A 6-month follow-up was conducted. The clinical manifestations (menstrual volume, degree of dysmenorrhea, uterine and lesion volume), quality of life (MS-QOL, UFS-QOL), and postoperative adverse reactions between the two groups before and 6 months after surgery was compared. Results Menstrual volume, degree of dysmenorrhea, uterine and lesion volume, MS-QOL score, and UFS-QOL score of the both groups were improved 6 months after surgery, when compared to those before surgery (P < 0.05). Significantly reduced menstrual volume, degree of dysmenorrhea, and lower MS-QOL score were observed in the combined ablation group when compared with the lesion ablation group (P < 0.05), but there was no statistical significance in uterine and lesion volume and UFS-QOL score (P > 0.05). There was no difference in the incidence of adverse reactions between the two groups (P > 0.05), but the combined ablation group had longer vaginal bleeding and fluid flow time (P < 0.05). Conclusion The combined HIFU and endometrial ablation can effectively reduce menstrual flow, alleviate dysmenorrhea, and improve quality of life in patients with AM combined with HMB. Although it increases vaginal bleeding and fluid flow time, reasonable symptomatic management can effectively prevent the occurrence of adverse consequences such as infection. [ABSTRACT FROM AUTHOR]

Summary: Focal therapy is a treatment option for clinically localized prostate cancer, finding increased use in recent years. It is generally associated with very good functional outcome regarding pad-free continence and preservation of erections. Oncologic outcomes are controversial, especially depending on the ideal endpoint. Both the presence of clinically significant prostate cancer (csPCA) on biopsy and the absence of any whole-gland or systemic treatment as "failure-free survival" (FFS) have been used. While salvage whole-gland and systemic therapy is rare, a substantial number of patients will have csPCA on follow-up biopsies after focal therapy, either in-field or out of field. Generally, patients selected for focal therapy are considered intermediate-risk, although some patients with high-risk features have been included into focal therapy studies. With the data currently available focal therapy presents a good treatment option for patients with feasible intermediate-risk prostate cancer, interested in functional outcome, after proper counseling on the higher recurrence rate, and the need for surveillance biopsies during follow-up. [ABSTRACT FROM AUTHOR]

Abstract The heterogeneity of triple‐negative breast cancers (TNBC) remains challenging for various treatments. Ferroptosis, a recently identified form of cell death resulting from the unrestrained peroxidation of phospholipids, represents a potential vulnerability in TNBC. In this study, a high intensity focused ultrasound (HIFU)‐driven nanomotor is developed for effective therapy of TNBC through induction of ferroptosis. Through bioinformatics analysis of typical ferroptosis‐associated genes in the FUSCCTNBC dataset, gambogic acid is identified as a promising ferroptosis drug and loaded it into the nanomotor. It is found that the rapid motion of nanomotors propelled by HIFU significantly enhanced tumor accumulation and penetration. More importantly, HIFU not only actuated nanomotors to trigger effective ferroptosis of TNBC cells, but also drove nanomotors to activate ferroptosis‐mediated antitumor immunity in primary and metastatic TNBC models, resulting in effective tumor regression and prevention of metastases. Overall, HIFU‐driven nanomotors show great potential for ferroptosis‐immunotherapy of TNBC.

Prostate cancer is the second most common malignant tumor in men worldwide, and its incidence is increasing in China. Treatment methods of prostate cancer include surgery, radiotherapy, chemotherapy, endocrine therapy, and local therapy. Compared to all treatment options for prostate cancer, local treatment has the advantage of less trauma and fewer complications. With the wide application of PSA screening, improvement and enhancement of transperineal puncture technology under template positioning and the development of multi-parameter MRI, more and more low-grade and localized prostate cancer are detected. Most prostate cancer patients receive total gland therapy after diagnosis, but patients with localized prostate cancer may not benefit from treatment because of the side effects of total gland therapy. With the development of imaging technology and the "main focus" theory, focal therapy techniques have been greatly developed. Focal therapy (FT) is a treatment method for localized prostate cancer (Pca), which mainly targets low and medium-risk localized disease to reduce whole-gland treatment. Such as radical prostatectomy (RP) or the adverse effects of radical external radiotherapy, FT has the advantage of preserving more sexual and bladder function while controlling the tumor. The current focal therapy techniques used in clinic mainly include high-intensity focused ultrasound, focal laser ablation, cryotherapy, irreversible electroporation, and photodynamic therapy. In this study, we reviewed the clinical trials of focal therapy in recent years and found that high-intensity focused ultrasound and focal laser ablation have better failure-free survival and postoperative functional control.

AbstractIn transabdominal histotripsy, ultrasound pulses are focused into the body to noninvasively destroy soft tissues via cavitation. However, the ability to focus is limited by phase aberration, or decorrelation of the ultrasound pulses due to spatial variation in the speed of sound throughout heterogeneous tissue. Phase aberration shifts, broadens, and weakens the focus, thereby reducing the safety and efficacy of histotripsy therapy. This paper reviews and discusses aberration effects in histotripsy and in related therapeutic ultrasound techniques (e.g., high intensity focused ultrasound), with an emphasis on aberration by soft tissues. Methods for aberration correction are reviewed and can be classified into two groups: model-based methods, which use segmented images of the tissue as input to an acoustic propagation model to predict and compensate phase differences, and signal-based methods, which use a receive-capable therapy array to detect phase differences by sensing acoustic signals backpropagating from the focus. The relative advantages and disadvantages of both groups of methods are discussed. Importantly, model-based methods can correct focal shift, while signal-based methods can restore substantial focal pressure, suggesting that both methods should be combined in a 2-step approach. Aberration correction will be critical to improving histotripsy treatments and expanding the histotripsy treatment envelope to enable non-invasive, non-thermal histotripsy therapy for more patients.

AbstractPurpose Surgical resection of the tendon is an effective treatment for severe contracture. Magnetic Resonance-guided Focused Ultrasound (MRgFUS) is a non-invasive ultrasonic therapy which produces a focal increase in temperature, subsequent tissue ablation and disruption. We evaluated MRgFUS as a clinically translatable treatment modality to non-invasively disrupt in vivo porcine tendons.Material and methods In vivo Achilles tendons (n = 28) from 15–20kg Yorkshire pigs (n = 16) were randomly assigned to 4 treatment groups of 600, 900, 1200 and 1500 J. Pretreatment range of motion (ROM) of the ankle joint was measured with the animal under general anesthesia. Following MRgFUS treatment, success of tendon rupture, ROM increase, temperature, thermal dosage, skin burn, and histology analyses were performed.Results Rupture success was found to be 29%, 86%, 100% and 100% for treatment energies of 600, 900, 1200 and 1500 J respectfully. ROM difference at 90° flexion showed a statistically significant change in ROM between 900 J and 1200 J from 16° to 27°. There was no statistical significance between other groups, but there was an increase in ROM as more energy was delivered in the treatment. For each of the respective treatment groups, the maximal temperatures were 58.4 °C, 63.3 °C, 67.6 °C, and 69.9 °C. The average areas of thermal dose measured were 24.3mm2, 53.2mm2, 77.8mm2 and 91.6mm2. The average areas of skin necrosis were 5.4mm2, 21.8mm2, 37.2mm2, and 91.4mm2. Histologic analysis confirmed tissue ablation and structural collagen fiber disruption.Conclusions This study demonstrated that MRgFUS is able to disrupt porcine tendons in vivo without skin incisions.

AbstractSince its inception about two decades ago, histotripsy – a non-thermal mechanical tissue ablation technique – has evolved into a spectrum of methods, each with distinct potentiating physical mechanisms: intrinsic threshold histotripsy, shock-scattering histotripsy, hybrid histotripsy, and boiling histotripsy. All methods utilize short, high-amplitude pulses of focused ultrasound delivered at a low duty cycle, and all involve excitation of violent bubble activity and acoustic streaming at the focus to fractionate tissue down to the subcellular level. The main differences are in pulse duration, which spans microseconds to milliseconds, and ultrasound waveform shape and corresponding peak acoustic pressures required to achieve the desired type of bubble activity. In addition, most types of histotripsy rely on the presence of high-amplitude shocks that develop in the pressure profile at the focus due to nonlinear propagation effects. Those requirements, in turn, dictate aspects of the instrument design, both in terms of driving electronics, transducer dimensions and intensity limitations at surface, shape (primarily, the F-number) and frequency. The combination of the optimized instrumentation and the bio-effects from bubble activity and streaming on different tissues, lead to target clinical applications for each histotripsy method. Here, the differences and similarities in the physical mechanisms and resulting bioeffects of each method are reviewed and tied to optimal instrumentation and clinical applications.

AbstractObjectives Our study aims at the comprehensive analysis of adverse events (AEs) in patients with symptomatic uterine fibroids (UFs) who underwent magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) in the last 6 years in one of the major Polish centers performing this type of therapy.Methods The presented retrospective case-control study was conducted in the Department of Obstetrics and Gynecology, Pro-Familia Hospital, Rzeszów in cooperation with the Second Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw. The study enrolled 372 women with symptomatic UFs who underwent MR-HIFU and reported AEs during or after the procedure. The occurrence of particular AEs was analyzed. Statistical comparison of two cohorts (patients with and without AEs) was conducted based on epidemiological factors, UF characteristics, fat layer thickness, the presence of abdominal scars and technical parameters of the procedure.Results The overall mean occurrence rate of AEs was 8.9% (n = 33). No major AEs were reported. The only statistically significant risk factor of AEs was the treatment of type II UFs according to Funaki (OR 2.12, CI 95%, p = 0.043). Other investigated factors did not have a statistically significant influence on AE occurrence. Abdominal pain was the most common AE.Conclusion Our data showed that MR-HIFU seemed to be a safe procedure. The AE rate after the treatment is relatively low. According to the obtained data it seems that the occurrence of AEs does not depend on the technical parameters of the procedure and the volume, position and location of UFs. Further prospective, randomized studies and with long follow-up are necessary to confirm the final conclusions.

AbstractBackground Due to resistance and intolerance to chemotherapy, localized lesion resection may be required in some patients with Gestational trophoblastic neoplasia (GTN), which may lead to massive bleeding. In this case report, we describe the successful use of high-intensity focused ultrasound (HIFU) as an effective pretreatment method for surgical procedure in a patient with GTN to reduce the perioperative risk and the impact on fertility.Case presentation A 26-year-old woman was diagnosed with high-risk GTN (FIGO Stage III: 12 prognostic scores) after a hydatidiform mole. The fifth chemotherapy cycle was interrupted due to severe chemotherapy toxicity. However, the uterine lesion was still present and the beta-human chorionic gonadotropin (β-hCG) level was not restored to normal. Therefore, ultrasound-guided HIFU was performed as a pretreatment method to shrink the lesion and prevent massive bleeding during localized lesion resection. The effectiveness of ablation was evaluated immediately using contrast-enhanced ultrasound and Color Flow Doppler ultrasonography. One month after HIFU treatment, the uterine lesion was completely resected under hysteroscopic surgery. During the surgery, HIFU was found to have shrunk the lesion and there was minimal bleeding (5 mL). The uterine cavity morphology and menstruation returned to normal after surgery. The patient has showed no signs of recurrence as of one-year follow-up.Conclusion Ultrasound-guided HIFU ablation may be a new choice for high-risk GTN patients with chemoresistance or chemo-intolerance. As a noninvasive pretreatment method, HIFU can shrink the uterine lesion, and reduce the risk of bleeding with no obvious effect on fertility.

Background: High‐intensity focused ultrasound (HIFU) and radiofrequency (RF) are non‐invasive modalities for skin rejuvenation, but their combined effects have not been evaluated. Objective: We evaluated and compared the efficacy of HIFU alone and combined HIFU and bipolar RF using a newly designed probe. Methods: Twenty‐two Korean adults with facial wrinkles and aging underwent treatment on both sides of their face: HIFU‐only on the left and HIFU combined with RF on the right. Skin parameters were measured at different time points to evaluate the improvement in skin rejuvenation. Results: HIFU treatment significantly improved skin parameters, including pore volume and number, skin elasticity, depth of eye wrinkles, degree of sagging in the eye area, nasolabial folds and cheeks, volume of the jawline, skin density, and permittivity. Furthermore, combining bipolar RF with HIFU treatment enhanced efficacy in reducing pore number, improving skin elasticity, diminishing eye wrinkle depth, and increasing skin moisturization. These findings indicate that bipolar RF can synergically improve skin rejuvenation by providing a thermal effect to the upper papillary dermis, which is more superficial than the target area of HIFU. Conclusion: Combining HIFU with bipolar RF synergistically improves skin rejuvenation, including pore reduction, periorbital wrinkle improvement, skin elasticity, and skin moisturization. [ABSTRACT FROM AUTHOR]

PurposeThe ExAblate body MRgFUS system requires advanced beamforming strategies for volumetric hyperthermia. This study aims to develop and evaluate electronic beam steering, multi-focal patterns, and sector vortex beamforming approaches in conjunction with partial array activation using an acoustic and biothermal simulation framework along with phantom experiments.MethodsThe simulation framework was developed to calculate the 3D acoustic intensity and temperature distribution resulting from various beamforming and scanning strategies. A treatment cell electronically sweeping a single focus was implemented and evaluated in phantom experiments. The acoustic and thermal focal size of vortex beam propagation was quantified according to the vortex modes, number of active array elements, and focal depth.ResultsTurning off a percentage of the outer array to increase the f-number increased the focal size with a decrease in focal gain. 60% active elements allowed generating a sonication cell with an off-axis of 10 mm. The vortex mode number 4 with 60% active elements resulted in a larger heating volume than using the full array. Volumetric hyperthermia in the phantom was evaluated with the vortex mode 4 and respectively performed with 100% and 80% active elements. MR thermometry demonstrated that the volumes were found to be 18.8 and 29.7 cm3, respectively, with 80% array activation producing 1.58 times larger volume than the full array.ConclusionsThis study demonstrated that both electronic beam steering and sector vortex beamforming approaches in conjunction with partial array activation could generate large volume heating for HT delivery using the ExAblate body array.

Background: Our previous studies found that high-intensity focused ultrasound (HIFU) stimulated tumor-specific T cells in a mouse H22 tumor model, and adoptive transfer of the T cells from HIFU-treated mice could subsequently elicit stronger inhibition on the growth and progression of the implanted tumors. The aim of this study was to investigate the mechanism of T cells from focused ultrasound ablation in HIFU-mediated immunomodulation. Methods: Sixty H22 tumor-bearing mice were treated by either HIFU or sham- HIFU, and 30 naïve syngeneic mice served as controls. All mice were euthanized on day 14 after HIFU and splenic T cell suspensions were obtained in each group. Using an adoptive cell transfer model, a total of 1 × 106 T cells from HIFU treatedmice were intravenously injected into each syngeneic H22 tumor-bearing mouse twice on day 3 and 4, followed by the sacrifice for immunological assessments at 14 days after the adoptive transfer. Results: T cells from HIFU-treated mice could significantly enhance the cytotoxicity of CTLs (p < 0.001), with a significant increase of TNF-a (p < 0.001) and IFN-g secretion (p < 0.001). Compared to control and sham-HIFU groups, the number of Fas ligand+ and perforin+ tumor-infiltrating lymphocytes (TILs) and apoptotic H22 tumor cells were significantly higher (p < 0.001) in the HIFU group. There were linear correlations between apoptotic tumor cells and Fas ligand+ TILs (r = 0.9145, p < 0.001) and perforin+ TILs (r = 0.9619, p < 0.001). Conclusion: T cells from HIFU-treated mice can subsequently mediate cellular antitumor immunity, which may play an important role in the HIFU-based immunomodulation. [ABSTRACT FROM AUTHOR]

Objective: To investigate the changes of immunological status and imaging evaluation of high intensity focused ultrasound(HIFU) in the treatment of adenomyosis(AM). Methods: 186 patients with AM admitted to Shijiazhuang People’s Hospital from December 2020 to December 2021 were selected. Before and after HIFU ablation, serum complement C3, C4, the ratio of helper T cell17 to regulatory T cell(Th17/Treg) and magnetic resonance imaging(MRI) were detected.Compare the differences of ultrasound characteristics, MRI measurement parameters, serum complement C3, C4, Th17/Treg levels in AM patients before and after treatment; Spearman correlation was used to analyze the correlation between the levels of serum complement C3, C4, Th17/Treg and the ablation rate and MRI parameters of the non-perfusion area after treatment. Results: Before HIFU treatment in AM patients, ultrasound showed that the echo of the myometrium of the uterine wall was uneven, the blood flow signal of the myometrium was rich, and the blood flow of the focus was rich; MRI showed that the uterus was non-uniformly enlarged, the uterine wall was significantly thickened, the boundary with the uterine junction was unclear, and the signal was uneven. The dynamic enhancement scan showed that the focus was non-uniformly enhanced, and the degree of enhancement was slightly lower than that of the normal myometrium nearby. VAS score of AM patients after HIFU treatment was significantly lower than that before treatment(P＜0.05); Ultrasound showed that the echo of the myometrium of the uterus was uneven, and the blood supply of the myometrium was significantly reduced. MRI showed that the thickening of the uterine wall was reduced, and the signal was uneven. The enhancement scan showed that the central perfusion area was not enhanced, and the peripheral nodular or irregular enhancement was the residual focus, and the ablation rate was about 90%. After HIFU treatment, the levels of serum complement C3 and C4, ADC value and MSI value of residual lesions increased significantly(P＜0.05), while Th17/Treg,ADC value and MSI value of non-perfusion zone decreased significantly(P＜0.05). After HIFU treatment, serum complement C3 and C4levels were significantly negatively correlated with ablation rate, ADC value and MSI value in non-perfusion zone(P＜0.05), while Th17/Treg was significantly positively correlated with ablation rate, ADC value and MSI value in non-perfusion zone(P＜0.05). Conclusion: The changes of immunologic status and MRI evaluation after HIFU treatment of AM patients can help predict the prognosis of AM patients, and guide clinicians to provide objective and realistic basis for the choice of follow-up treatment plan for AM patients. [ABSTRACT FROM AUTHOR]

Introduction: Fibroadenomas are solid, mobile, and non-tender benign breast lumps, with highest prevalence amongst young women aged between 15 and 35. Symptoms can include discomfort, and they can become problematic, particularly when they enlarge, resulting in many referrals for biopsies, with fibroadenomas accounting for 30–75% of the cases. Diagnosis is based on triple assessment that involves a clinical examination, ultrasound imaging, and mammography, as well as core needle biopsies. Current management includes observation for 6–12 months, with the indication of definitive surgery, in cases that are older than 35 years or with fibroadenoma persistence. Serious adverse effects of surgery might include nipple areolar distortion, scarring, and damage to the breast tissue, as well as the risks associated with surgery and anesthesia, making it a non-feasible option. Methods: A literature search was performed on the databases Embase, MEDLINE/PubMed, Google Scholar, and Ovid for English language papers published between January 1, 2000, and March 17, 2021. A structured protocol was employed to devise a comprehensive search strategy with keywords and Boolean operators defined by the research question. The keywords used for the search were "HIFU", "High Intensity Focused Ultrasound," "Fibroadenoma," "Breast," "Lesion." This review was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: Recently, a thermal ablative technique, high intensity focused ultrasound (HIFU), was found to be a safe, noninvasive, and technically successful alternative, having displayed promising outcomes in reducing the volume of fibroadenomas, pain experienced by patients, and the length of hospitalization. Quality of life improvement was also evidenced, exhibited by the disappearance of symptoms, and enhanced physical activity post-intervention, in addition to patients' satisfaction with the cosmetic results and future recommendation of the procedure to other patients. Conclusion: Overall, HIFU is a well-tolerated treatment associated, with low risk of complications, that can potentially include erythema, skin discoloration, and bruising with the majority of these self-resolving shortly after the procedure. [ABSTRACT FROM AUTHOR]

Background: Mild hyperthermia has been demonstrated to improve the efficacy of chemotherapy, radiation, and immunotherapy in various cancer types. One localized, non‐invasive method of administering mild hyperthermia is magnetic resonance‐guided high‐intensity focused ultrasound (MRgHIFU). However, challenges for ultrasound such as beam deflection, refraction and coupling issues may result in a misalignment of the HIFU focus and the tumor during hyperthermia. Currently, the best option is to stop the treatment, wait for the tissue to cool, and redo the treatment planning before restarting the hyperthermia. This current workflow is both time‐consuming and unreliable. Purpose: An adaptive targeting algorithm was developed for MRgHIFU controlled hyperthermia treatments for cancer therapeutics. This algorithm executes in real time while hyperthermia is being administered to ensure that the focus is within our target region. If a mistarget is detected, the HIFU system will electronically steer the focus of the HIFU beam to the correct target. The goal of this study was to quantify the accuracy and precision of the adaptive targeting algorithm's ability to correct a purposely misplanned hyperthermia treatment in real‐time using a clinical MRgHIFU system. Methods: A gelatin phantom with acoustic properties matched to the average speed of sound in human tissue was used to test the adaptive targeting algorithm's accuracy and precision. The target was purposely offset 10 mm away from the focus at the origin, in four orthogonal directions, allowing the algorithm to correct for this mistarget. In each direction, 10 data sets were collected for a total sample size of 40. Hyperthermia was administered with a target temperature set at 42°C. The adaptive targeting algorithm was run during the hyperthermia treatment and 20 thermometry images were collected after the beam steering occurred. The location of the focus was quantified by calculating the center of heating on the MR thermometry data. Results: The average calculated trajectory passed to the HIFU system was 9.7 mm ± 0.4 mm where the target trajectory was 10 mm. The accuracy of the adaptive targeting algorithm after the beam steering correction was 0.9 mm and the precision was 1.6 mm. Conclusion: The adaptive targeting algorithm was implemented successfully and was able to correct the 10 mm mistargets with high accuracy and precision in gelatin phantoms. The results demonstrate the capability to correct the MRgHIFU focus location during controlled hyperthermia. [ABSTRACT FROM AUTHOR]

Abstract Background The treatment of gestational trophoblastic neoplasia (GTN) is one of the success stories in medical oncology. GTN in the cesarean scar is a rare entity, but most cases need to be treated with hysterectomy or localized uterine lesion resection because of chemoresistant lesions and/or massive bleeding. We present a patient with post-molar GTN in the cesarean scar who was non-invasively treated with ultrasound-guided high intensity focused ultrasound (HIFU) to preserve the uterus and fertility. Case presentation A 32-year-old woman was diagnosed with low-risk GTN (FIGO Stage I: 2 prognostic score) after partial hydatidiform mole. The 5th cycle of chemotherapy was interrupted because of persistent hepatic toxicity and impaired ovarian reserve function. However, the uterine lesion persisted (diameter of residual uterine lesion in the cesarean scar: 2.0 cm). Therefore, ultrasound-guided HIFU treatment was performed. A significant gray-scale change was observed during the HIFU treatment. Color Doppler ultrasonography and contrast-enhanced ultrasound (CEUS) was performed to evaluate the ablation effectiveness. Color Doppler ultrasonography showed disappearance of the signal of vascularity and CEUS showed no perfusion in the lesion located in the cesarean scar. The uterine lesion was obviously shrunken one month after HIFU treatment. Menstrual cycle resumed 48 days after HIFU. HIFU treatment decreased the number of chemotherapy cycles and there was complete disappearance of the GTN lesion at 4-month follow-up. The patient has shown no signs of recurrence as of 58-month follow-up. Conclusion Ultrasound-guided HIFU may be a useful alternative to lesion resection for GTN in the cesarean scar in patients who show chemoresistance or are not suitable for chemotherapy. It has the potential to ablate the residual uterine lesion noninvasively to preserve the uterus and fertility, avoiding perioperative risks of lesion resection, especially acute bleeding.

Objective To investigate the clinical efficacy and safety of high intensity focused ultrasound (HIFU) combined with ultrasound-guided suction curettage in patients with type I/II/III cesarean scar pregnancy (CSP).Methods A total of 153 patients with CSP were enrolled and classified according to the type of CSP. All of them were treated by HIFU combined with ultrasound-guided suction curettage. When active uterine bleeding was observed after curettage, a Foley balloon was used for hemostasis by compression. Baseline characteristics, technical parameters of HIFU, intraoperative blood loss in suction curettage, the time for serum β-HCG to return to normal levels, reproductive outcomes, and adverse effects were recorded and analyzed.Results 152 patients completed one session of HIFU combined with suction curettage except one patient transferred to surgery. Total energy used for ablation and the time for serum β-HCG return to normal level in type II and III were significantly higher than type I (p < .05). The treatment time and sonication time of HIFU in type III were significantly longer than type I (p < .05). Vaginal bleeding after curettage and the rate of using Foley catheter balloon in type III was larger than type I and II.Conclusions HIFU combined with ultrasound-guided suction curettage is a safe and effective treatment option for patients with type I/II/III CSP and desire for fertility. Patients with type III CSP were more dependent on Foley catheter balloon compression therapy than the other two types after HIFU combined with curettage.

Objective To investigate the effectiveness and safety of high-intensity focused ultrasound (HIFU) ablation for patients with colorectal liver metastases (CRLMs) who were unsuitable for hepatectomy.Methods This is a multicenter retrospective study. 238 CRLM patients underwent ultrasound-guided HIFU (USgHIFU) ablation in three medical centers from October 2014 to December 2020. Patients who had complete colorectal cancer resection, but exhibited extra-hepatic metastasis were excluded from this study. HIFU ablation procedure was performed, and contrast-enhanced MR imaging and/or contrast-enhanced CT examinations were conducted and mRECIST was used for the assessment of tumor ablation effectiveness before and after treatment, and every 3 months thereafter. Adverse events and complications were recorded.Results 43 CRML patients (27 male, 16 female, aged 29–82 years) were enrolled and underwent a USgHIFU ablation procedure. CR (complete response) was achieved in 21 patients, while PR (partial response) was observed in 21 patients and SD (stable disease) was achieved in one patient, respectively. The objective response rate was 97.7%. Median OS (overall survival) was estimated to be 31 months, and1-year and 18-month overall survival was 90.7% (39/43) and 72.1% (31/43), respectively. For CR and PR patients, the median OS was 35 months and 23 months, respectively (p = 0.00). The majority of adverse events were pain in 22 cases (51.2%) and local skin edema in 33 cases (76.7%). No severe adverse events or complications were reported and recorded.Conclusions USgHIFU ablation is a safe and effective treatment option for CRLM patients, especially for patients who are unsuitable for hepatectomy.

Objective To explore the learning curve of high intensity focus ultrasound (HIFU) treatment for breast fibroadenoma.Methods A database of 110 patients with 255 breast fibroadenomas who underwent HIFU treatment at two different clinical centers (Center 1 and 2) were retrospectively analyzed. The learning curves of HIFU treatment for breast fibroadenoma were drawn by CUSUM analysis in two centers, respectively. According to the inflection point of the learning curves, the treatment was divided into two groups: initial phase and consolidation phase. HIFU treatment parameters were compared between two groups. The effectiveness and safety results were also evaluated.Results The inflection points of the learning curves were the 60th treatment in Center 1 and the 65th treatment in Center 2. The screening time, treatment time, sonication time and hyperechoic scale change time were significantly shorter in consolidation phase than those in initial phase of the two centers (p

Background Abdominal wall endometriosis（AWE）is an unusual extra-pelvic endometriosis. Currently, multiple treatment modalities are available, but no clear guidelines exist for the management of large AWE.Materials and methods We present a 36-year-old female patient with a large AWE lesion who underwent cesarean section due to abnormal fetal position 8 years ago. The mass lesion of AWE located in rectus muscle fascia and rectus muscle with a size of 61 × 25 × 49mm.Results HIFU treatment was completed in one session. One day post-HIFU MRI showed the mass was completely ablated. After HIFU treatment, the cyclical abdominal pain disappeared. The mass lesion shrank during follow-up period and disappeared in 1 year after HIFU. No complication was observed after HIFU.Conclusion Surgical resection of AWE remains the standard of care. In patients with large AWE lesion located in rectus muscle fascia and rectus muscle where the muscle and fascia must be excised, HIFU treatment should be considered to avoid mesh implantation.

Objective To investigate the factors influencing the sonication dosage and efficiency of ultrasound-guided high intensity focused ultrasound (USgHIFU) for breast fibroadenomas.Materials and Methods Forty-nine patients with 78 breast fibroadenomas who underwent USgHIFU were retrospectively analyzed. The energy efficiency factor (EEF) was set as dependent variable, and the factors possibly influencing the sonication dosage, including age, body mass index (BMI), fibroadenoma size, distance from the shallow margin of the fibroadenoma to skin, distance from the deep margin of the fibroadenoma to pectoralis major, types of near field acoustic pathway, and Adler blood flow classification of ultrasound, were set as independent variables. The correlation between EEF and these independent variables were analyzed, and an optimal scaling regression model was established.Results Fibroadenoma size, distance from the shallow margin of the fibroadenoma to skin and type of near field acoustic pathway had significant correlation with EEF (p

Introduction: Boiling histotripsy (BH) is a promising High Intensity Focused Ultrasound (HIFU) technique that can be used to mechanically fractionate solid tumours at the HIFU focus noninvasively, promoting tumour immunity. Because of the occurrence of shock scattering phenomenon during BH process, the treatment accuracy of BH is, however, somewhat limited. To induce more localised and selective tissue destruction, the concept of pressure modulation has recently been proposed in our previous in vitro tissue phantom study. The aim of the present study was therefore to investigate whether this newly developed histotripsy approach termed pressure-modulated shockwave histotripsy (PSH) can be used to induce localised mechanical tissue fractionation in in vivo animal model. Methods: In the present study, 8 Sprague Dawley rats underwent the PSH treatment and were sacrificed immediately after the exposure for morphological and histological analyses (paraffin embedded liver tissue sections were stained with H&E and MT). Partially exteriorised rat's left lateral liver lobe in vivo was exposed to a 2.0 MHz HIFU transducer with peak positive (P +) and negative (P-) pressures of 89.1 MPa and -14.6 MPa, a pulse length of 5 to 34 ms, a pressure modulation time at 4 ms where P+ and P-decreased to 29.9 MPa and - 9.6 MPa, a pulse repetition frequency of 1 Hz, a duty cycle of 1% and number of pulses of 1 to 20. Three lesions were produced on each animal. For comparison, the same exposure condition but no pressure modulation was also employed to create a number of lesions in the liver. Results and Discussion: Experimental results showed that a partial mechanical destruction of liver tissue in the form of an oval in the absence of thermal damage was clearly observed at the HIFU focus after the PSH exposure. With a single pulse length of 7 ms, a PSH lesion created in the liver was measured to be a length of 1.04 ± 0.04mm and a width of 0.87 ± 0.21mmwhich was 2.37 times in length (p = 0.027) and 1.35 times in width (p = 0.1295) smaller than a lesion produced by no pressure modulation approach (e.g., BH). It was also observed that the length of a PSH lesion gradually grew towards the opposite direction to the HIFU source along the axial direction with the PSH pulse length, eventually leading to the generation of an elongated lesion in the liver. In addition, our experimental results demonstrated the feasibility of inducing partial decellularisation effect where liver tissue was partially destructed with intact extracellular matrix (i.e., intact fibrillar collagen) with the shortest PSH pulse length. Taken together, these results suggest that PSH could be used to induce a highly localised tissue fractionation with a desired degree of mechanical damage from complete tissue fractionation to tissue decellularisation through controlling the dynamics of boiling bubbles without inducing the shock scattering effect. [ABSTRACT FROM AUTHOR]

Purpose: Focal therapy (FT) for localized prostate cancer (PCa) is only recommended within the context of clinical trials by international guidelines. We aimed to investigate oncological follow-up and safety data of focal high-intensity focused ultrasound (HIFU) treatment. Methods: We conducted a single-center prospective study of 29 patients with PCa treated with (focal) HIFU between 2016 and 2021. Inclusion criteria were unilateral PCa detected by mpMRI-US-fusion prostate biopsy and maximum prostate specific antigen (PSA) of 15 ng/ml. Follow-up included mpMRI-US fusion-re-biopsies 12 and 24 months after HIFU. No re-treatment of HIFU was allowed. The primary endpoint was failure-free survival (FFS), defined as freedom from intervention due to cancer progression. Results: Median follow-up of all patients was 23 months, median age was 67 years and median preoperative PSA was 6.8 ng/ml. One year after HIFU treatment PCa was still detected in 13/ 29 patients histologically (44.8%). Two years after HIFU another 7/29 patients (24.1%) were diagnosed with PCa. Until now, PCa recurrence was detected in 11/29 patients (37.93%) which represents an FFS rate of 62%.One patient developed local metastatic disease 2 years after focal HIFU. Adverse events (AE) were low with 70% of patients remaining with sufficient erectile function for intercourse and 97% reporting full maintenance of urinary continence. Conclusion: HIFU treatment in carefully selected patients is feasible. However, HIFU was oncologically not as safe as expected because of progression rates of 37.93% and risk of progression towards metastatic disease. Thus, we stopped usage of HIFU in our department. [ABSTRACT FROM AUTHOR]

Objectives: This study intended to compare the safety and clinical efficacy between two treatments of uterine fibroids: laparoscopic myomectomy (LM) and high intensity focused ultrasound (HIFU). Material and methods: Clinical data were collected from 587 uterine fibroid patients who were treated in The People's Hospital of Nanchuan, Chongqing from January 1, 2018 to December 31, 2019. Among the patients, 287 cases were treated with HIFU (observation group), and 300 cases were treated with LM (control group). The progression-free survival (PFS) was taken as the primary endpoint. The secondary endpoints included operation results (including operative time, intraoperative blood loss, and intraoperative fluid replacement), complications, hemoglobin level one month after surgery and clinical efficacy. In addition, the fibroid volume of the observation group before treatment and 3, 6, and 12 months after treatment were also analyzed. Results: The operative time of observation group was evidently shortened compared to the control group, and the intraoperative blood loss and intraoperative fluid replacement of observation group were also considerably reduced (all p < 0.05), but there was no significant difference in the hemoglobin level between the two groups one month after surgery (p > 0.05). In terms of curative effect, the total effective rate of HIFU group and LM group was 98.6% (283/287) and 95.3% (286/300) respectively, with statistically significant difference (p < 0.05). In terms of complications, the incidence of bleeding and infection in HIFU group was obviously lower than that in LM group (both p < 0.05), while no significant differences were observed in the remaining complications (all p > 0.05). Fibroid volume comparisons before treatment and 3, 6 and 12 months after operation in observation group showed that fibroid volume decreased significantly (all p < 0.05). The median follow-up time was 30.6 months. The mean PFS of patients in the observation group and control group was 29.71 months (95% CI 28.24-29.75) and 26.74 months (95% CI 26.49-28.33), respectively (HR 0.47; 95% CI, 0.29 to 0.76; Log-rank p = 0.0019). Conclusions: HIFU could improve the intraoperative efficacy and reduce the complications of patients with uterine fibroids and has excellent performance in improving clinical efficacy and prolonging PFS. HIFU can be used as an alternative to surgical treatment. [ABSTRACT FROM AUTHOR]

Background and objective. The combination of minimally invasive techniques is very common to treat aging skin. The objective of this trial is to evaluate an intensive treatment protocol for facial rejuvenation, in a single, combined and sequential session, using high intensity focused ultrasound (HIFU), fractional CO2 laser and autologous platelet rich plasma (PRP). Methods. Pilot trial to evaluate the efficacy and safety of the combined treatment in a selected sample of 15 patients (phototypes III-V) with evident signs of facial aging. Efficacy was assessed blinded by 2 independent experts by comparing photographs before treatment and 3 months later. The variables analyzed (degree of pain, laxity, global rejuvenation and satisfaction) were quantified using ordinal quantitative or qualitative scales. Safety is assessed by follow-up notes in medical records. Results. Significant improvements in laxity reduction were achieved in the upper, middle, and lower thirds of the face (p=0.026, p=0.011, p=0.003). On the scale of global aesthetic improvement, according to the expert evaluators, 14 participants (93%) consider themselves "improved" or "very improved". All patients recognized some kind of improvement, 9 indicated being "very satisfied", 3 "satisfied" and 3 "moderately satisfied". The treatment was painful, but sufficiently tolerated by the majority of patients. There were no unexpected side effects or major complications, with good postoperative recovery. In general, the patients returned to their work activities 10 days after treatment. Conclusions. The efficacy/safety profile of the tested method has been very favorable in the series investigated. [ABSTRACT FROM AUTHOR]

The biological focal region (BFR) induced by a single high-intensity focused ultrasound (HIFU) exposure is considered to be the foundation of the ultrasound ablation of tumor lesions. The purpose of this study was to explore the relationship between the acoustic focal region (AFR) and the BFRs with different combinations of power and time in low-power cumulative HIFU treatment. The finite-difference time-domain (FDTD) method was used to simulate AFR and BFR during HIFU ablation. The acoustic fields, the temperature profiles, and the shapes of BFRs were calculated by the Westervelt equation, Pennes' equation, and the equivalent thermal dose model. In order to verify the simulation rules, phantom and ex vivo bovine livers were exposed by HIFU with a different power and time. The results demonstrated that in the low-power cumulative HIFU treatment, when the lengths of BFRs and the length of AFR were approximately equal, the shape of the BFR induced by 'high power × short time' exposure was closer to that of AFR than the shape of the BFR induced by 'low power × long time' exposure, and the exposure energy required was significantly reduced. The analysis revealed the relationship between the BFR and the AFR with different acoustic power. This study provides a reference for doctors to determine power, time, and movement distance in clinical treatment. [ABSTRACT FROM AUTHOR]

Breast cancer (BC) is the most frequently diagnosed malignancy among women. In the past two decades, new technologies and BC screening have led to the diagnosis of smaller and earlier-stage BC (ESBC). Therefore, percutaneous minimally invasive techniques (PMIT) were adopted to treat patients unfit for surgery, women who refuse it, or elderly patients with comorbidities that could make surgery a difficult and life-threatening treatment. The target of PMIT is small-size ESBC with the scope of obtaining similar efficacy as surgery. Minimally invasive treatments are convenient alternatives with promising effectiveness, lower morbidity, less cost, less scarring and pain, and more satisfying cosmetic results. Ablative techniques used in BC are cryoablation, radiofrequency ablation, microwave ablation, high-intensity focused ultrasound (US), and laser ablation. The aim of our study is to discuss the current status of percutaneous management of BC, evaluate the clinical outcomes of PMIT in BC, and analyze future perspectives regarding ablation therapy in BC. [ABSTRACT FROM AUTHOR]

The formation of pathological scars is a common medical and aesthetic problem worldwide. Surgical interventions, burns and injuries are the most common cause. Treating these scars is a challenge for any surgeon. The Clinic of Plastic-Reconstructive and Aesthetic Surgery with Thermal Trauma and Imaging Diagnostics applied an innovative method of thermotherapy with high-intensity, focused ultrasound in 20 patients with hypertrophic scars and keloids of different age, etiology and parameters. After a series of procedures, we got excellent results, reducing scar size, pigmentation, pain and itching. This type of thermotherapy is successfully applied to pathological scars. In this way, a change in scar density is achieved by converting hard collagen into a gelatin-like mass. As a subsequent procedure, moderately compressive massages are applied for faster resorption of the pathological collection. Our results show that high-intensity focused ultrasound thermotherapy of pathological scars is a non-invasive method of treatment with reasonably good results as regards both aesthetic and functional aspects. [ABSTRACT FROM AUTHOR]

Objectives: Microfocused ultrasound (MFU) and hyaluronic acid (HA) filler injection are increasingly popular aesthetic procedures. HA filler injection is generally recommended after MFU if combined treatment is required in a single visit. However, data regarding the safe and optimal time of MFU treatment after HA injection is still limited. The purpose of this study was to evaluate the degree of HA loss when performing MFU treatment after dermal filler injection. Methods: Fourteen subjects were recruited in this pilot study. HA was injected intradermally on four 2 × 2 cm areas at the abdomen (0.25 ml/site). Site A was served as control whereas site B, C, D were treated with MFU using 1.5 mm transducer at 60 min, Day 14, and Day 28 after the injection, respectively. All experimental sites were biopsied using a 3‐mm punch biopsy to evaluate the histopathological profile at baseline and Day 56. Grading of the quantity of retained HA was evaluated by a blinded experienced dermatopathologist. Results: All 14 subjects completed the study. One subject has been excluded due to the poor quality of histopathologic slides. Seven subjects (53.9%) at site B and 6 subjects (46.2%) at site C had HA loss at Day 56 compared with baseline. The mean HA grading at baseline and Day 56 was 3.7 vs. 2.8 (p < 0.001) at site B and 3.7 vs. 3.0 (p = 0.001) at site C, respectively. There was no statistical difference between the mean HA grading at baseline and Day 56 at site D (3.7 vs. 3.3, p = 0.073). No inflammation or granuloma was observed on Day 56 of the study. Conclusions: MFU treatment after HA injection appears to be safe. However, some degree of HA loss was observed if MFU treatment was done within 2 weeks after HA injection. [ABSTRACT FROM AUTHOR]

This review article reviews the published results of the clinical use of intravaginal non-invasive HIFU therapy for the treatment of urogenital atrophy, stress urinary incontinence, and wide vagina syndrome. Vaginal distension and genitourinary syndromes of menopause create physical, psychological, and functional problems for women and their partners. Existing invasive treatments can lead to certain complications, so safer and more effective minimally invasive medicine is desirable. Our goal was to evaluate the efficacy and safety of microfocus ultrasound therapy as a form of non-invasive HIFU therapy administered in the vaginal canal in female patients. This review uses the results of a number of recent studies from Argentina, Poland, Japan and other countries using medical devices: Feminine HIFU, manufactured by Sveltia, Argentina, and Ultra Vera, manufactured by Hironic, Republic of Korea.The purpose of the study is to study the results of the clinical application of high-intensity focused ultrasound as a new treatment method in the field of gynecology.High Intensity Focused Ultrasound (HIFU) is a new technology in gynecology that involves regenerative thermal effects on deeper layers of vaginal tissues that cannot be achieved with laser and radio frequency equipment. The results of studies with a total number of participants in more than 100 patients from several groups who underwent clinical examination support suggestions for a potential therapeutic effect as a preferred method of therapy or an addition to laser and other methods of treatment, supported by an evidence base.The value of the study is to provide effective treatment of pathologies due to the formation of new collagen fibers that create a structural framework in the fascial plate of the vagina and adjacent fascia, and the muscles of the small pelvis due to a certain mode of HIFU exposure. The results are promising and motivate further research.

Whilst sonothrombolysis is a promising and noninvasive ultrasound technique for treating blood clots, bleeding caused by thrombolytic agents used for dissolving clots and potential obstruction of blood flow by detached clots (i.e., embolus) are the major limitations of the current approach. In the present study, a new sonothrombolysis method is proposed for treating embolus without the use of thrombolytic drugs. Our proposed method involves (a) generating a spatially localised acoustic radiation force in a blood vessel against the blood flow to trap moving blood clots (i.e., generation of an acoustic net), (b) producing acoustic cavitation to mechanically destroy the trapped embolus, and (c) acoustically monitoring the trapping and mechanical fractionation processes. Three different ultrasound transducers with different purposes were employed in the proposed method: (1) 1-MHz dual focused ultrasound (dFUS) transducers for capturing moving blood clots, (2) a 2-MHz High Intensity Focused Ultrasound (HIFU) source for fractionating blood clots and (3) a passive acoustic emission detector with broad bandwidth (10 kHz to 20 MHz) for receiving and analysing acoustic waves scattered from a trapped embolus and acoustic cavitation. To demonstrate the feasibility of the proposed method, in vitro experiments with an optically transparent blood vessel-mimicking phantom filled with a blood mimicking fluid and a blood clot (1.2 to 5 mm in diameter) were performed with varying the dFUS and HIFU exposure conditions under various flow conditions (from 1.77 to 6.19 cm/s). A high-speed camera was used to observe the production of acoustic fields, acoustic cavitation formation and blood clot fragmentation within a blood vessel by the proposed method. Numerical simulations of acoustic and temperature fields generated under a given exposure condition were also conducted to further interpret experimental results on the proposed sonothrombolysis. Our results clearly showed that fringe pattern-like acoustic pressure fields (fringe width of 1 mm) produced in a blood vessel by the dFUS captured an embolus (1.2 to 5 mm in diameter) at the flow velocity up to 6.19 cm/s. This was likely to be due to the greater magnitude of the dFUS-induced acoustic radiation force exerted on an embolus in the opposite direction to the flow in a blood vessel than that of the drag force produced by the flow. The acoustically trapped embolus was then mechanically destructed into small pieces of debris (18 to 60 μm sized residual fragments) by the HIFU-induced strong cavitation without damaging the blood vessel walls. We also observed that acoustic emissions emitted from a blood clot captured by the dFUS and cavitation produced by the HIFU were clearly distinguished in the frequency domain. Taken together, these results can suggest that our proposed sonothrombolysis method could be used as a promising tool for treating thrombosis and embolism through capturing and destroying blood clots effectively.

Magnetic resonance-guided focused ultrasound (MRgFUS) is a novel non-invasive ablation technique that uses focused sound energy to destroy focal tumors, primarily via heat deposition. It is widely used for palliation of pain from bone metastases and has also recently gained popularity as a technique for ablation of benign bone tumors and facet degenerative joint disease (rhizotomy). Clinically, in a subset of patients who have undergone MRgFUS of bone, a variety of treatment responses have been noted on follow-up imaging, including focal sclerosis within the target lesion or more exuberant proliferative changes associated with the periosteum. In this study, high resolution peripheral quantitative CT (HR-pQCT) was used to evaluate remodeling of bone following ablation in a swine model of MRgFUS and compared to samples from a control, non-treated femur. Within each treated femur, two lesions were created: a higher energy focused ultrasound dose was used for one lesion compared to a lower energy dose for the second lesion. Exuberant, extra-cortical bone formation was detected at the higher energy ablation zones, with volumes ranging from 340 mm3 to 1040 mm3. More subtle endosteal and cortical changes were detected in the lower energy ablation zones, however cortical thickness was significantly increased at these sites compared to control bone. For both high and low energy lesions, lower bone mineral density and tissue mineral density was noted in treated regions compared to control regions, consistent with the formation of newly mineralized tissue. Following HR-pQCT analysis, Fourier transform infrared (FTIR) spectroscopy was subsequently used to detect biochemical changes associated with remodeling of bone following MRgFUS, and compared to samples from the control, non-treated femur. Findings were compared with histopathologic examination following hematoxylin-eosin staining. FTIR analysis demonstrated lower mineral/phosphate ratio and increased crystallinity compared to the control samples (p = 0.013). Histopathologic review demonstrated associated areas of endosteal inflammation, scarring, fat necrosis, and new extra-cortical bone formation associated with the ablations. Overall, these findings provide novel characterization of new bone formation following MRgFUS ablation.

Abstract Objective To investigate the safety and feasibility of high intensity focused ultrasound (HIFU) ablation followed by ultrasound-guided dilation and curettage (USg-D&C) for two types patients with cesarean scar pregnancy (CSP-I and CSP-II). Materials and methods This study was a retrospective analysis of 101 CSP-I patients and 52 CSP-II patients who received HIFU ablation followed by USg-D&C from Jun 2014 to Oct 2020. The diameter of gestational sac/mass, thickness of the intervening myometrium, intraoperative blood loss, operation time, length of hospital stays, adverse effects and β-HCG level in the two groups were compared. Results All patients successfully received HIFU ablation under conscious sedation. The median total treatment time of HIFU ablation and median USg-D&C time in the CSP-I group were statistically longer than those in the CSP-II group (P 0.05). The average time needed for β-HCG return to normal levels was 26.08 ± 5.02. and 28.15 ± 4.99 days for CSP-I and CSP-II, respectively (P > 0.05). The percentage of adverse effects and complications was not significantly different between the two groups (P > 0.05). Conclusions HIFU ablation followed by USg-D&C was safe and effective in treating the CSP-I patients and CSP-II patients, which may be a potential noninvasive therapeutic option for patients with CSP.