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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]

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

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]

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]

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.

Background High intensity focused ultrasound (HIFU) ablation treatment for uterine fibroids and adenomyosis has been long developed. The aim of this study is to investigate miRNA profile changes in vaginal secretions after HIFU treatment and their clinical relevance.Methods We prospectively collected vaginal secretions samples from 8 patients (1 with adenomyosis and 7 with fibroids) before and after HIFU treatment. RNA was isolated and miRNA profiles were analyzed using next-generation sequencing (NGS) sequencing.Results Our study showed miRNA profile change in vaginal secretion samples after HIFU treatment for uterine fibroids/adenomyosis, with 33 miRNAs upregulated and 6 downregulated overall. In fibroid cases, 31 miRNAs were upregulated and 7 downregulated, while in adenomyosis case, 41 miRNAs were upregulated and 71 downregulated. Four miRNAs (hsa-miR-7977, hsa-miR-155-5p, hsa-miR-191-5p, hsa-miR-223-3p) showed significant differences after HIFU treatment in fibroid cases, except in case 5 with the lowest treatment sonications (425 sonications) and energy input (170000 J). hsa-miR-7977 consistently showed downregulation after HIFU treatment. hsa-miR-155-5p were downregulated in case 4 with lowest treatment efficiency (2439.64 J/cm3), while they were upregulated in other cases. hsa-miR-191-5p and hsa-miR-223-3p were downregulated in cases 4 and 7, with case 7 influenced by high sonication and energy due to multiple fibroids.Conclusions HIFU treatment altered miRNA profiles in fibroids/adenomyosis patients. Notably, hsa-miR-7977, hsa-miR-155-5p, hsa-miR-191-5p, and hsa-miR-223-3p showed significant changes in fibroid cases, except in low-energy treatments. hsa-miR-7977 consistently decreased post-treatment, while hsa-miR-155-5p decreased in the least efficient cases. Further research is needed for validation.

Objective This study aims to assess the clinical efficacy and safety of combining high-intensity focused ultrasound (HIFU) with ultrasound-guided suction curettage for the treatment of cesarean scar pregnancy (CSP) at different time intervals.Methods A total of 115 CSP patients were enrolled and divided into two groups based on the time between HIFU ablation and suction curettage. Group A (n = 50) underwent suction curettage 24-48 h after HIFU ablation, while Group B (n = 65) had suction curettage within 6 h of HIFU ablation. The study compared and analyzed the clinical characteristics, treatment success rates, and intraoperative hemorrhage during ultrasound-guided suction curettage.Results The demographic characteristics of the two groups were similar, with no statistically significant differences observed in HIFU parameters, treatment success rates, blood loss, the use of Foley catheter balloons, or hospital expenses (p > 0.05). Importantly, suction curettage performed within 6 h after HIFU ablation resulted in shorter hospitalization times compared to suction curettage performed 24-48 h after the ablation (p

Introduction Pelvic recurrences from rectal cancer present a challenging clinical scenario. Hyperthermia represents an innovative treatment option in combination with concurrent chemoradiation to enhance therapeutic effect. We provide the initial results of a prospective single center feasibility study (NCT02528175) for patients undergoing rectal cancer retreatment using concurrent chemoradiation and mild hyperthermia with MR-guided high intensity focused ultrasound (MR-HIFU).Methods All patients were deemed ineligible for salvage surgery and were evaluated in a multidisciplinary fashion with a surgical oncologist, radiation oncologist and medical oncologist. Radiation was delivered to a dose of 30.6 Gy in 1.8 Gy per fraction with concurrent capecitabine. MR-HIFU was delivered on days 1, 8 and 15 of concurrent chemoradiation. Our primary objective was feasibility and toxicity.Results Six patients (total 11 screened) were treated with concurrent chemoradiation and mild hyperthermia with MR-HIFU. Tumor size varied between 3.1-16.6 cm. Patients spent an average of 228 min in the MRI suite and sonication with the external transducer lasted an average of 35 min. There were no complications on the day of the MR-HIFU procedure and all acute toxicities (no grade >/=3 toxicities) resolved after completion of treatment. There were no late grade >/=3 toxicities.Conclusion Mild hyperthermia with MR-HIFU, in combination with concurrent chemoradiation for appropriately selected patients, is safe for localized pelvic recurrences from rectal cancer. The potential for MR-HIFU to be applied in the recurrent setting in rectal cancer treatment requires further technical development and prospective evaluation.

AbstractIntroduction Magnetic Resonance-guided Focused Ultrasound (MRgFUS) thermal ablation is an effective noninvasive ultrasonic therapy to disrupt in vivo porcine tendon but is prone to inducing skin burns. We evaluated the safety profile of a novel hybrid protocol that minimizes thermal spread by combining long-pulse focused ultrasound followed by thermal ablation.Methods In-vivo Achilles tendons (hybrid N = 15, thermal ablation alone N = 21) from 15 to 20 kg Yorkshire pigs were randomly assigned to 6 treatment groups in two studies. The first (N = 21) was ablation (600, 900, or 1200 J). The second (N = 15) was hybrid: pulsed FUS (13.5 MPa peak negative pressure) followed by ablation (600, 900, or 1200 J). Measurements of ankle range of motion, tendon temperature, thermal dose (240 CEM43), and assessment of skin burn were performed in both groups.Results Rupture was comparable between the two protocols: 1/5 (20%), 5/5 (100%) and 5/5 (100%) for hybrid protocol, compared to 2/7 (29%), 6/7 (86%) and 7/7 (100%) for the ablation-only protocol with energies of 600, 900, and 1200 J, respectively. The hybrid protocol produced lower maximum temperatures, smaller areas of thermal dose, fewer thermal injuries to the skin, and fewer full-thickness skin burns. The standard deviation for the area of thermal injury was also smaller for the hybrid protocol, suggesting greater predictability.Conclusion This study demonstrated a hybrid MRgFUS protocol combining long-pulse FUS followed by thermal ablation to be noninferior and safer than an ablation-only protocol for extracorporeal in-vivo tendon rupture for future clinical application for noninvasive release of contracted tendon.

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]

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]

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]

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]

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.

Simple Summary: Liver malignancy affects thousands of people, and its treatment is constantly evolving. Ablative therapies are a series of minimally invasive modalities that treat these tumors in combination with other established forms of treatment such as chemotherapy and surgery. Ablative therapy is well-studied in the case of the most common type of liver malignancy, hepatocellular carcinoma. There is much less information on ablative therapy in non-hepatocellular carcinoma liver malignancy treatment. Therefore, we have described the available literature, focusing on ablative therapy's promising results, shortcomings, and detail areas for future research on the topic of non-hepatocellular carcinoma of the liver. Surgical extirpation of liver tumors remains a proven approach in the management of metastatic tumors to the liver, particularly those of colorectal origin. Ablative, non-resective therapies are an increasingly attractive primary therapy for liver tumors as they are generally better tolerated and result in far less morbidity and mortality. Ablative therapies preserve greater normal liver parenchyma allowing better post-treatment liver function and are particularly appropriate for treating subsequent liver-specific tumor recurrence. This article reviews the current status of ablative therapies for non-hepatocellular liver tumors with a discussion of many of the clinically available approaches. [ABSTRACT FROM AUTHOR]

The non-perfused volume (NPV) is an important indicator of treatment success immediately after prostate ablation. However, visualization of the NPV first requires an injection of MRI contrast agents into the bloodstream, which has many downsides. Purpose of this study was to develop a deep learning model capable of predicting the NPV immediately after prostate ablation therapy without the need for MRI contrast agents. A modified 2D deep learning UNet model was developed to predict the post-treatment NPV. MRI imaging data from 95 patients who had previously undergone prostate ablation therapy for treatment of localized prostate cancer were used to train, validate, and test the model. Model inputs were T1/T2-weighted and thermometry MRI images, which were always acquired without any MRI contrast agents and prior to the final NPV image on treatment-day. Model output was the predicted NPV. Model accuracy was assessed using the Dice-Similarity Coefficient (DSC) by comparing the predicted to ground truth NPV. A radiologist also performed a qualitative assessment of NPV. Mean (std) DSC score for predicted NPV was 85% ± 8.1% compared to ground truth. Model performance was significantly better for slices with larger prostate radii (> 24 mm) and for whole-gland rather than partial ablation slices. The predicted NPV was indistinguishable from ground truth for 31% of images. Feasibility of predicting NPV using a UNet model without MRI contrast agents was clearly established. If developed further, this could improve patient treatment outcomes and could obviate the need for contrast agents altogether. Trial Registration Numbers Three studies were used to populate the data: NCT02766543, NCT03814252 and NCT03350529. [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. [ABSTRACT FROM AUTHOR]

In 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. [ABSTRACT FROM AUTHOR]

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. 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. 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. This study demonstrated that MRgFUS is able to disrupt porcine tendons in vivo without skin incisions. [ABSTRACT FROM AUTHOR]

Since 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. [ABSTRACT FROM AUTHOR]

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. 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. 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. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

• A novel passive cavitation imaging (PCI) scheme was proposed to tackle two practical problems in monitoring high intensity focused ultrasound (HIFU) treatment. • Firstly, a cavitation detection network (CD-NET) model was introduced for the first time to detect the occurrence of cavitation to avoid false positive visualizations in the PCI procedure. • Secondly, cavitation intensity baseline was derived from experiment data, which can help display the dynamic cavitation activities in a more reliable manner. • The enhanced PCI scheme offer an effective method for monitoring HIFU therapies involving cavitation. Passive cavitation imaging (PCI) is an effective technique for monitoring high intensity focused ultrasound (HIFU) procedure due to the correlation between cavitation activities and the therapeutic effects. Nevertheless, current PCI techniques are unable to recognize noise signals from non-cavitation situations, and they fail to accurately visualize the highly dynamic cavitation activities due to the lack of a stable baseline reference. In this study, a deep learning-based cavitation detection network (CD-NET) was proposed to determine whether passively received channel signals originated from cavitation activities or were merely noises. Additionally, a cavitation intensity baseline was derived to better display the drastically time-varying cavitation activities. The CD-NET model was trained and validated with data collected from in-vitro and ex-vivo HIFU sonication experiments, and then tested by in-vivo rabbit experiments. Both CD-NET models, trained with data from the in-vitro agar phantoms and ex-vivo bovine liver tissues, successfully distinguished between cavitation and non-cavitation activities from the same study object, achieving accuracies as high as 99.7% and 99.5%, respectively. In addition, the models trained on in-vitro and ex-vivo datasets achieved accuracies of 88.1% and 91.4%, respectively, when detecting cavitation events from unseen in-vivo data. The results demonstrate that the improved PCI scheme, utilizing the CD-NET model and a data-derived cavitation baseline, is resistant to noise from non-cavitation situations and can depict the dynamic characteristics of cavitation more reliably. In conclusion, this study addressed two practical challenges in PCI techniques, allowing for better monitoring of cavitation-related HIFU sonication in clinical applications. [ABSTRACT FROM AUTHOR]