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Objectives: To verify the stability of high‐intensity focused ultrasound (HIFU) technology and the feasibility of training programs with learning curve cumulative summation (LC‐CUSUM). Methods: A total of 12 physicians and 720 cases were equally assigned to the learning group and the control group, with 6 physicians and 360 cases per group. The learning group was treated by physicians without HIFU experience and the control group was treated by experienced physicians. Nonperfused volume (NPV) ratio was assessed by contrast‐enhanced magnetic resonance imaging. Technical failure was defined as NPV ratio of uterine fibroids <70% and/or major complication, while <80% was set as a stricter standard of training qualification. LC‐CUSUM was used to analyze the learning curve. Results: Physicians with or without HIFU experience in both groups achieved matchable NPV ratios, where a NPV ratio of 92.52% (16.06) was achieved by experienced physicians and 93.82% (16.95) by inexperienced physicians. No major complication was observed. The results of LC‐CUSUM analysis showed that, with the standards of the NPV ratio of 70% or 80%, the learning group mastered the technique on the 11th case and the 16th case, respectively, while the control group was stable. Conclusions: HIFU technology stayed stable in operation, with good safety and sound effectiveness, and was easy to learn. NPV ratio of 70% was considered as an appropriate indicator of training qualification. HIFU has remarkable prospects in achieving a NPV ratio of ≥80% without safety being compromised. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare the efficacy and safety of focused low-intensity pulsed ultrasound (FLIPUS) with pulsed shortwave diathermy (PSWD) in subjects with painful knee osteoarthritis (OA). In a prospective randomized trial, 114 knee OA patients were randomly allocated to receive FLIPUS or PSWD therapy. The primary outcome was the change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores. Secondary outcomes included the numerical rating scale (NRS) for pain assessment, time up and go (TUG) test, active joint range of motion (ROM) test, and Global Rating of Change (GRC) scale. Data were collected at baseline, 12 days, 12 weeks and 24 weeks. Patients receiving FLIPUS therapy experienced significantly greater improvements in the WOMAC total scores than patients receiving PSWD therapy at 12 days (mean difference, − 10.50; 95% CI − 13.54 to − 7.45; P = 0.000). The results of the NRS, TUG test, ROM test and GRC scale showed that participants treated with FLIPUS reported less pain and better physical function and health status than those treated with PSWD at 12 days (P = 0.011, P = 0.005, P = 0.025, P = 0.011, respectively). Furthermore, patients in the FLIPUS group showed significant improvements in the WOMAC total scores and NRS scores at 12 weeks (mean difference, − 7.57; 95% CI − 10.87 to − 4.26; P = 0.000 and − 1.79; 95% CI − 2.11 to − 1.47, respectively) and 24 weeks (mean difference, − 6.96; 95% CI − 10.22 to − 3.71; P = 0.000 and − 1.37; 95% CI − 1.64 to − 0.96; P = 0.000, respectively) of follow-up. There were no adverse events during or after the interventions in either group. This study concluded that both FLIPUS and pulsed SWD are safe modalities, and FLIPUS was more effective than PSWD in alleviating pain and in improving dysfunction and health status among subjects with knee OA in the short term. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000032735. Registered 08/05/2020, http://www.chictr.org.cn/showproj.aspx?proj=53413. [ABSTRACT FROM AUTHOR]

In terms to investigate the effect of low-intensity pulsed ultrasound (LIPUS) for differentiation of bone marrow mesenchymal stem cells (BMSCs) and the feasibility of simultaneously inducing into osteoblasts and vascular endothelial cells within the cell culture medium in which two inductive agents are added at the same time with or without LIPUS. Cells were divided into a non-induced group, an osteoblast-induced group, a vascular endothelial-induced group, and a bidirectional differentiation-induced group. Each group was further subdivided into LIPUS and non-LIPUS groups. The cell proliferation in each group was measured by MTT assay. Cell morphological and ultrastructural changes were observed by inverted phase contrast microscopy and transmission electron microscopy. The differentiation of BMSCs was detected by confocal microscopy, flow cytometry and quantitative RT-PCR. Results demonstrated that both osteoblast and vascular endothelial cell differentiation markers were expressed in the bidirectional differentiation induction group and early osteogenesis and angiogenesis appeared. The cell proliferation, differentiation rate and expression of osteocalcin and vWF in the LIPUS groups were all significantly higher than those in the corresponding non-LIPUS group (p <.05), suggesting LIPUS treatment can promote the differentiation efficiency and rate of BMSCs, especially in the bidirectional differentiation induction group. This study suggests the combination of LIPUS and dual-inducing agents could induce and accelerate simultaneous differentiation of BMSCs to osteoblasts and vascular endothelial cells. These findings indicate the method could be applied to research on generating vascularized bone tissue with a shape and function that mimics natural bone to accelerate early osteogenesis and angiogenesis. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to investigate the effect of high-intensity focused ultrasound (HIFU) on immune function in patients with uterine fibroids, in a randomised comparison to conventional myomectomy. Methods: The patients were assigned (1:1) to the HIFU group or the myomectomy (MY) group. Venous blood samples were collected 24 h before and 24 h and 72 h after operation. The percentages of CD4+ and CD8+ T cells and natural killer (NK) cells were quantified by flow cytometry (FCM). Serum levels of interleukin-2 (IL-2), IL-6 and IL-10 were determined using enzyme-linked immunosorbent assay. Results: HIFU was associated with early ambulation, fewer post-operative complications, and shorter hospital stay ( p < 0.001). The percentages of CD4+ and CD8+ T cells and NK cells in the HIFU group were not significantly altered after treatment compared with before treatment. In contrast, the numbers of these cells in the MY group decreased significantly 24 h after conventional myomectomy ( p < 0.001). The CD4+/CD8+ T cell ratios were also decreased significantly 24 h and 72 h after conventional myomectomy ( p < 0.001). Serum levels of IL-6 and IL-10 increased after treatment in both groups. Peak IL-6 and IL-10 levels were significantly lower in the HIFU group than in the MY group ( p < 0.001). In contrast, IL-2 level decreased significantly in the MY group compared to the HIFU group at 24 h post-operation ( p < 0.001). Conclusions: Short-term post-operative immune function is better preserved after HIFU treatment. Better preserved immune function may reflect a reduction in tissue trauma after HIFU treatment and contribute to reduced post-operative complications. [ABSTRACT FROM AUTHOR]

This study was aimed at evaluating the feasibility, safety and therapeutic effects of high-intensity focused ultrasound ablation (HIFUA) in the treatment of post-operative recurrent desmoid tumors. From September 2017 to May 2020, 42 consecutive patients with pathologically proven desmoid tumors treated with HIFUA for the first time were enrolled. These were divided into two groups: post-operative recurrent group (30 cases) and non-surgery group (12 cases). The basic characteristics, treatment parameters, ablation efficacy, tolerance and adverse events were recorded and compared between groups. The minimum distance between the tumor and skin surface in the post-operative recurrent group was significantly smaller than that in the non-surgery group (6.9 mm vs. 10.8 mm, p = 0.011), but there was no significant difference in the other basic characteristics (p > 0.05). The average acoustic power and intensity of treatment in the post-operative recurrent group were significantly lower than those in the non-surgery group (p = 0.006 and 0.036, respectively), but there was no significant difference in the remaining parameters or in ablation efficacy between groups (p > 0.05). HIFUA was successfully performed, and a large volume of coagulation necrosis was obtained from all patients without serious or life-threatening adverse events. Furthermore, there was no significant difference in the incidence of moderate adverse events and average length of stay between groups (p > 0.05). The average power and intensity of HIFUA treatment were adversely affected by surgical scar and tumor infiltration along the surgical path. However, HIFUA can still be used as an effective minimally invasive therapy for the local control of post-operative recurrent desmoid tumors. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To evaluate the clinical value of the contrast agent SonoVue in the treatment of uterine fibroids with ultrasound-guided high intensity focused ultrasound (HIFU) therapeutic ablation. Materials and Methods: A total of 291 patients with solitary uterine fibroid from three centers were treated with ultrasound-guided HIFU. Among them, 129 patients from Suining Central Hospital of Sichuan were treated without using SonoVue. 162 patients from the First Hospital of Chongqing Medical University and Chongqing Haifu Hospital were treated with using SonoVue before, during and after HIFU procedure to assess the extent of HIFU. Results: The non-perfused volume (indicative of successful ablation) was observed in all treated uterine fibroids immediately after HIFU ablation; median fractional ablation, defined as non-perfused volume divided by the fibroid volume immediately after HIFU treatment, was 86.0% (range, 28.8–100.0%) in the group with using SonoVue, and 83.0% (8.7–100.0%) without SonoVue. The rate of massive gray scale changes was higher with SonoVue than without the agent. The sonication time to achieve massive gray scale changes was shorter with SonoVue than without. The sonication time for ablating 1cm3 of fibroid volume was significantly shorter with using SonoVue than without. No major complications were observed in any patients. Conclusions: Based on our results, SonoVue may enhance the outcome of HIFU ablation and can be used to assess the extent of treatment. [Copyright &y& Elsevier]

Abstract: Objective: High-intensity focused ultrasound (HIFU) combined with transarterial chemoembolization (TACE) has been used to treat unresectable HCC, but its long-term effects and major prognostic factors remain to be determined. The purpose of this study was to assess its long-term effects and find major prognostic factors to help us select eligible patients in the future. Methods: 73 patients with unresectable HCC received follow-up after HIFU+TACE. The variables of sex, age, AFP level, liver function, tumor location, tumor number, tumor size, TNM staging (5th edition), TNM staging (6th edition), portal vein invasion, ultrasonic pathway of HIFU, TACE session and ablation response were evaluated by univariate analysis. Those variables with significant difference were assessed by multivariate analysis. Results: The mean follow-up time was 11.7±11.1 months (range, 1–60 months). The median survival time and overall survival rates of 1, 2, 3-year were 12 months, 49.1%, 18.8%, 8.4%, respectively. 45.2% patients achieved complete ablation. At the end of follow-up, 51 patients (69.9%) died from tumor progression (27 patients), liver function failure (18 patients), hemorrhage of upper digestive tract (3 patients) and infection (3 patients). 1 with liver abscess, 2 with serious skin burns and 2 with rib fracture were observed after HIFU. On univariate analysis, age (P =0.017), tumor size (P =0.000), tumor number (P =0.039), the 5th edition of TNM staging (P =0.023), portal vein invasion (P =0.02) and ablation response (P =0.000) had significant difference. On multivariate analysis, ablation response (P =0.001) and tumor size (P =0.013) were major prognostic factors. Conclusion: HIFU combined with TACE is a safe method with a low rate of severe complications. As major prognostic factors, ablation response and tumor size may help us predict the survival and select eligible patients clinically. [Copyright &y& Elsevier]

The aim of this study was to explore a law of energy deposition of high-intensity focused ultrasound (HIFU) in various tissues and the expression of such a law. A focused ultrasound (US) tumor therapeutic system was used to apply a focused US beam to tissues both in vivo and in vitro. The formation of individual ellipsoid-shaped regions of coagulative necrosis has been observed. Results showed that the volume of the ellipsoid-shaped coagulative necrosis region was different from that of the acoustic focal region (AFR), both in vitro and in vivo. Acoustic intensities ranging from 7 × 103 W/cm2 to 27.7 × 103 W/cm2 and exposure times from 1 to 20 s gave volumes of ellipsoid-shaped coagulative necrosis of 0.2 to 2000 mm3. Although the HIFU doses applied were identical, the volumes of individual ellipsoid-shaped coagulative necrotic regions varied with the structures of tissues, their functional status and the irradiation depths. Individual ellipsoid-shaped regions of coagulative necrosis induced by HIFU can be added to produce coagulative necrosis of an entire tumor. We define the individual ellipsoid-shaped coagulative necrosis produced by the US energy deposition of a single exposure as the “biological focal region” (BFR) of HIFU. This serves as the basic unit for HIFU ablation of tumors, and is plotted as a function of AFR, acoustic intensity, exposure time, irradiation depth, the tissue structure and its functional status. (E-mail: wangzhibiao@netease.com) [Copyright &y& Elsevier]