Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients.

STUDY QUESTION: Is increasing the intensity of high-intensity focused ultrasound (HIFU) by 30% in the treatment of rectal endometriosis a safe procedure? SUMMARY ANSWER: This study demonstrates the safety of a 30% increase in the intensity of HIFU in the treatment of rectal endometriosis, with no Clavien-Dindo Grade III complications overall, and namely no rectovaginal fistulae. WHAT IS KNOWN ALREADY: A feasibility study including 20 patients with rectal endometriosis demonstrated, with no severe complications, a significant improvement in digestive disorders, dysmenorrhoea, dyspareunia, and health status, although the volume of the endometriosis nodule did not appear to be reduced. STUDY DESIGN, SIZE, DURATION: A prospective multicentre cohort study was conducted between 2020 and 2022 with 60 patients with symptomatic rectal endometriosis. Following the failure of medical treatment, HIFU treatment was offered as an alternative to surgery. PARTICIPANTS/MATERIALS, SETTING, METHODS: As the main objective of this study was to examine safety, all adverse events observed during the 6 months of follow-up were analysed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and Clavien-Dindo classifications. Secondary objectives included evaluating the evolution of symptoms using validated questionnaires: gynaecological and digestive pain symptoms with a visual analogue scale, health status with the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire, average post-operative daily pain level, and analgesic medication required in the 10 days following treatment. MRI was also performed at Day 1 to detect early complications. Finally, we performed a blinded MRI review of the evolution of the nodule at 6 months post-treatment. MAIN RESULTS AND THE ROLE OF CHANCE: The procedure was performed under spinal anaesthesia for 30% of the patients. The median duration of treatment was 32 min. Fifty-five patients left the hospital on Day 1. MRI scans performed on Day 1 did not highlight any early-onset post-operative complication. Using the Clavien-Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. At 1, 3, and 6 months, all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. The evolution of the nodule was also significant (P < 0.001) with a 28% decrease in volume. LIMITATIONS, REASONS FOR CAUTION: The main objective was safety and not effectiveness. The study was not randomized and there was no control group. WIDER IMPLICATIONS OF THE FINDINGS: HIFU treatment for rectal endometriosis results in an improvement of symptoms with low morbidity; as such, for selected patients, it could be a valuable alternative to surgical approaches following the failure of medical treatment. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the company EDAP TMS. Professors Dubernard and Rousset are consultants for EDAP TMS. Dubernard received travel support from EDAP-TMS. Dr F. Chavrier received industrial grants from EDAP-TMS. He has developed a device for generating focused ultrasonic waves with reduced treatment time. This device has been patented by EDAP-TMS. Dr Lafon received industrial grants from EDAP-TMS; he declares that EDAP-TMS provided funding directly to INSERM to support a young researcher chair in therapeutic ultrasound, which is unrelated to the current study. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT04494568.

Complications and adverse events of high-intensity focused ultrasound in its application to gynecological field - a systematic review and meta-analysis.

OBJECTIVE: To analyze and summarize the types, incidence rates and relevant influencing factors of adverse events (AEs) after high-intensity focused ultrasound ablation of gynecological diseases and provide reference and basis for handling such events in clinical practice. METHOD: We searched PubMed, Cochrane Library, Web of Science and Embase databases to retrieve all literature since its establishment until February 2024. We evaluated the quality of included literature and publication bias and conducted a meta-analysis of single group rates for various AEs using Stata 17.0. RESULTS: This systematic review finally included 41 articles. We summarized 34 kinds of AEs in 7 aspects and conducted a single group rate meta-analysis and sub-group analysis of 16 kinds of AEs. Among the common AEs of High-Intensity Focused Ultrasound (HIFU), the incidence of lower abdominal pain/pelvic pain is 36.1% (95% CI: 24.3%∼48.8%), vaginal bleeding is 20.6% (95% CI: 13.9%∼28.0%), vaginal discharge is 14.0% (95% CI: 9.6%∼19.1%), myoma discharge is 24% (95% CI: 14.6%∼34.8%), buttock pain is 10.8% (95% CI: 6.0%∼16.5%) and sacral pain is 10% (95% CI: 8.8%∼11.2%). Serious complications include uterine rupture, necrotic tissue obstruction requiring surgical intervention, third degree skin burns and persistent lower limb pain or movement disorders. CONCLUSION: The common AEs after HIFU surgery are mostly mild and controllable, and the incidence of serious complications is extremely low. By reasonable prevention and active intervention, these events can be further reduced, making it a safe and effective treatment method. It is a good choice for patients who crave noninvasive treatment or have other surgical contraindications.

Efficacy and influencing factor analysis of high-intensity focused ultrasound therapy for abdominal wall endometriosis: a case series.

OBJECTIVE: The aim of this retrospective study was to investigate the short-term and long-term efficacy of high-intensity focused ultrasound (HIFU) therapy for abdominal wall endometriosis (AWE) and explore its potential influencing factors. MATERIALS AND METHODS: A total of 80 patients with AWE who underwent HIFU therapy were retrospectively analyzed. Follow-ups were also conducted to evaluate the changes in lesion size and pain relief. Multivariate logistic regression analysis was applied to investigate factors influencing HIFU therapy for AWE. RESULTS: Among the 80 patients with AWE who received HIFU therapy, the effective rates were 76.3%, 80.5%, and 90.5% after 3, 12 and 24 months of follow-up, respectively. Multivariate logistic regression analysis revealed that the AWE lesion diameter and sonication intensity had statistically significant effects on the 3-month and 12-month efficacy of HIFU therapy for AWE, while age, BMI, disease duration, average sonication power and grey-scale changes did not have statistically significant effects. Four patients with AWE experienced recurrence after HIFU therapy, for a three-year cumulative recurrence rate of 6.3%. Furthermore, ten patients required reintervention after treatment, for a five-year cumulative reintervention rate of 13.9%. CONCLUSIONS: This study further confirmed the safety and effectiveness of HIFU therapy for AWE. Factors such as AWE lesion diameter and sonication intensity have been identified as key influencers affecting the short-term and long-term efficacy of HIFU therapy for AWE. The first two years following HIFU therapy constitute crucial periods for observation, and judiciously extending follow-up intervals during this timeframe is advised.

Factors associated with thermal injury of abdominal skin in focused ultrasound ablation of uterine fibroids.

OBJECTIVE: To investigate the factors which may cause thermal injury of abdominal skin in patients with uterine fibroids (UFs) who underwent ultrasound-guided focused ultrasound ablation surgery (FUAS). METHOD: A total of 123 patients were enrolled in the injury group. In contrast, 246 patients without thermal injury were assigned to the non-injury group. The relationship between patient and treatment parameters and injury were explored using univariate analysis and multiple logistic regression analyses. In addition, the factors influencing the degree of thermal injury were analyzed using Kruskal-Wallis H. RESULTS: (1) Abdominal scars (p = .007, OR = 2.187, 95% CI: 1.242-3.849), abdominal wall thickness (p < .001, OR = 1.042, 95% CI: 1.019-1.067), fundus fibroids (p = .038, OR = 1.790, 95% CI: 1.033-3.100), UFs with hyperintense/mixed T2-weighted imaging (T2WI) signals (p = .022, OR = 1.843, 95% CI: 1.091-3.115), average sonication power (AP) (p = .025, OR = 1.021, 95% CI: 1.003-1.039), and treatment time (TT) (p < .001, OR = 1.017, 95% CI: 1.011-1.023) were independent risk factors for thermal injury, while treatment volume (TV) (p = .002, OR = 0.775, 95% CI: 0.661-0.909) was a protective factor for injury. (2) Four groups were subdivided according to the degree of thermal injury(Group A: without skin injury. Group B: with changed T2WI signal in the abdominal wall, Group C: mild skin injury, Group D: severe skin injury), comparison of each with every other showed that the abdominal wall in Groups A and D was thinner than Groups B and C, with statistically significant differences (PAB<0.05, PAC<0.01, PDC<0.05, PDB<0.05); Group A was slightly thicker than D, however, without statistical difference. The ratio of sonication time (ST) to TV in Group A was the lowest of all (PAB, PAC, PAD all < 0.05). And as the level of thermal injury rose, the ratio gradually increased, however, without statistical difference. CONCLUSIONS: Based on our limited results, the following conclusion was made. (1) Abdominal scars, abdominal wall thickness, fundus fibroids, UFs with T2WI hyperintense/mixed signals, AP and TT were independent risk factor. (2) Neither too thick nor too thin abdominal walls would be recommended, as both might increase the risk of skin injury. (3) Noticeably, the risk of skin injury might increase considerably when the ST was longer and the sonication area was more fixed.

Eye injuries caused by high intensity macro and micro focused ultrasound treatment: a case report.

BACKGROUND: High Intensity Macro and Micro Focused Ultrasound ( HIFU) is a safe and effective method for the treatment of skin laxity. However, the application of high-intensity focused ultrasound energy on eyelids has been associated with potential ocular complications including traumatic cataract, iridocyclitis, and conjunctival hemorrhage, among others. CASE PRESENTATION: A 40-year-old female developed blurred vision in her left eye after receiving HIFU treatment on binocular eyelids, and her left far vision was 20/66. The examination revealed left eye iris depigmentation and conjunctival hemorrhage. Both eyes exhibited multiple white streaking or tadpole-shaped opacities in the lenses. CONCLUSION: Excessive ultrasonic energy generated by HIFU can cause protein denaturation, leading to conditions such as traumatic cataract, visual impairment, injuries to the iris and conjunctiva when applied to the eyes. We recommend that individuals undergoing cosmetic treatment in the periorbital region should be highly aware of the possible ocular side effects.

Randomized Trial of Focused Ultrasound Subthalamotomy for Parkinson's Disease.

BACKGROUND: The subthalamic nucleus is the preferred neurosurgical target for deep-brain stimulation to treat cardinal motor features of Parkinson's disease. Focused ultrasound is an imaging-guided method for creating therapeutic lesions in deep-brain structures, including the subthalamic nucleus. METHODS: We randomly assigned, in a 2:1 ratio, patients with markedly asymmetric Parkinson's disease who had motor signs not fully controlled by medication or who were ineligible for deep-brain stimulation surgery to undergo focused ultrasound subthalamotomy on the side opposite their main motor signs or a sham procedure. The primary efficacy outcome was the between-group difference in the change from baseline to 4 months in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor score (i.e., part III) for the more affected body side (range, 0 to 44, with higher scores indicating worse parkinsonism) in the off-medication state. The primary safety outcome (procedure-related complications) was assessed at 4 months. RESULTS: Among 40 enrolled patients, 27 were assigned to focused ultrasound subthalamotomy (active treatment) and 13 to the sham procedure (control). The mean MDS-UPDRS III score for the more affected side decreased from 19.9 at baseline to 9.9 at 4 months in the active-treatment group (least-squares mean difference, 9.8 points; 95% confidence interval [CI], 8.6 to 11.1) and from 18.7 to 17.1 in the control group (least-squares mean difference, 1.7 points; 95% CI, 0.0 to 3.5); the between-group difference was 8.1 points (95% CI, 6.0 to 10.3; P<0.001). Adverse events in the active-treatment group were dyskinesia in the off-medication state in 6 patients and in the on-medication state in 6, which persisted in 3 and 1, respectively, at 4 months; weakness on the treated side in 5 patients, which persisted in 2 at 4 months; speech disturbance in 15 patients, which persisted in 3 at 4 months; facial weakness in 3 patients, which persisted in 1 at 4 months; and gait disturbance in 13 patients, which persisted in 2 at 4 months. In 6 patients in the active-treatment group, some of these deficits were present at 12 months. CONCLUSIONS: Focused ultrasound subthalamotomy in one hemisphere improved motor features of Parkinson's disease in selected patients with asymmetric signs. Adverse events included speech and gait disturbances, weakness on the treated side, and dyskinesia. (Funded by Insightec and others; ClinicalTrials.gov number, NCT03454425.).

Mid-term efficacy grading evaluation and predictive factors of magnetic resonance-guided focused ultrasound surgery for painful bone metastases: a multi-center study.

OBJECTIVES: MR imaging-guided focused ultrasound surgery (MRgFUS) is an emerging non-invasive treatment. It is helpful in investigating the mid-term grading efficacy and safety of MRgFUS, and possible risk factors in participants with painful bone metastases. METHODS: This four-center prospective study enrolled 96 participants between June 2016 and May 2019 with painful bone metastases. The Numerical Rating Scale (NRS), Brief Pain Inventory-Quality of Life (BPI-QoL) score, morphine equivalent daily dose (MEDD), and the adverse events (AEs) were recorded before and at 1 week, 1 month, 2 months, and 3 months after MRgFUS. The repeated ANOVA tests were used to analyze the change in NRS and BPI-QoL, and logistic regression analysis was used to analyze the possible risk factors. RESULTS: A total of 82 participants completed the 3-month follow-up period. And 16 (19.5%) participants were complete responders (CR), 46 (56.1%) participants were effective responders (ER), and the other 20 (24.4%) participants were non-responders (NR). The NRS (2.67 ± 2.47 at 3 months compared to 6.38 ± 1.70 before treatment) and BPI-QoL score (3.11 ± 2.51 at 3 months compared to 5.40 ± 1.85 before treatment) significantly decreased after the treatment at all time points (p < 0.001). Eleven adverse events were recorded and they were all cured within 1 to 52 days after treatment. The non-perfused volume (NPV) ratio (p = 0.001) and the bone metastases lesion type (p = 0.025) were the key risk factors. CONCLUSIONS: MRgFUS can be used as a non-invasive, effective, and safe modality to treat painful bone metastases. NPV ratio and the lesion type may be used as affecting factors to predict the mid-term efficacy of MRgFUS. KEY POINTS: • MRgFUS can be considered a non-invasive, effective, and safe modality to treat painful bone metastases. • The NRS and BPI-QoL score at 1 week, 1 month, 2 months, and 3 months all decreased significantly (p < 0.001) after receiving MRgFUS. Among 82 participants, 16 (19.5%) were complete responders, 46 (56.1%) were effective responders, and the other 20 (24.4%) were non-responders. • According to logistic regression analysis, non-perfused volume ratio and the bone metastases lesion type were the affecting factors to predict the mid-term efficacy of MRgFUS. The adjusted OR of non-perfused volume ratio was 0.86 (p = 0.001), and osteoblastic lesion type was 0.06 (p = 0.025).

Hepatic and Renal Histotripsy in an Anticoagulated Porcine Model.

PURPOSE: To determine the risk of mechanical vessel wall damage resulting in hemorrhage during and after hepatic and renal histotripsy in an anticoagulated in vivo porcine model. MATERIALS AND METHODS: Non-tumor-bearing pigs (n = 8; mean weight, 52.5 kg) were anticoagulated with warfarin (initial dose, 0.08 mg/kg) to a target prothrombin time (PT) of 30%-50% above baseline. A total of 15 histotripsy procedures were performed (kidney: n = 8, 2.0-cm sphere; liver: n = 7, 2.5-cm sphere). Treatments were immediately followed by computed tomography (CT) imaging. Animals were observed for 7 days while continuing anticoagulation, followed by repeat CT and necropsy. RESULTS: All animals survived to complete the entire protocol with no signs of disability or distress. Three animals had hematuria (pink urine without clots). Baseline PT values (mean, 16.0 seconds) were elevated to 22.0 seconds (37.5% above baseline, P = .003) on the day of treatment and to 28.8 seconds (77.8% above baseline, P < .001) on the day of necropsy. At the time of treatment, 5 of 8 (63%) animals were at a therapeutic anticoagulation level, and all 8 animals (100%) reached therapeutic levels by the time of necropsy. There were no cases of intraparenchymal, peritoneal, or retroperitoneal hemorrhage associated with any treatments despite 5 of 7 (71%) liver and all 8 (100%) kidney treatments extending to the organ surface. CONCLUSIONS: Liver and kidney histotripsy seems safe with no elevated bleeding risk in this anticoagulated animal model, supporting the possibility of histotripsy treatments in patients on anticoagulation.

Uterine rupture after high-intensity focused ultrasound ablation of adenomyosis: a case report and literature review.

AIM: High-intensity focused ultrasound (HIFU) is a non-invasive treatment of adenomyosis. Uterine rupture during pregnancy is a rare adverse event after HIFU treatment, because HIFU treatment results in tissue coagulative necrosis. METHODS: We reported a case of uterine rupture in a 34-year-old woman. The woman had HIFU treatment for adenomyosis eight months before unplanned pregnancy. She was closely monitored during the pregnancy and the antenatal course was uneventful. At the gestational age of 38 weeks and 2 days, an emergency lower segment cesarean section was performed because of inexplainable abdominal pain. After delivery of the fetus, a 2 × 2 cm serous membrane rupture was observed in the HIFU treatment area. CONCLUSION: Uterine rupture during pregnancy after HIFU is a rare adverse event, however, attention is required during the whole pregnancy in case of unexpected uterine rupture.

Factors influencing USgHIFU ablation for adenomyosis with NPVR ≥ 50.

OBJECTIVE: To investigate the influencing factors of ultrasound-guided HIFU (USgHIFU) ablation for adenomyosis with a non-perfused volume ratio (NPVR)≥50%. METHODS: A total of 299 patients with adenomyosis who underwent USgHIFU ablation were enrolled. Quantitative signal intensity (SI) analysis was performed on T2WI and dynamic enhancement type. The energy efficiency factor (EEF) was defined as the ultrasound energy delivered for ablating 1 mm3 of tissue. NPVR ≥ 50% was used as the criterion for technical success. Adverse effects and complications were recorded. Logistic regression analyses of variables were conducted to identify the factors affecting NPVR ≥ 50%. RESULTS: The median NPVR was 53.5% (34.7%). There were 159 cases in the NPVR ≥ 50% group and 140 cases in the NPVR < 50% group. The EEF in NPVR < 50.0% group was significantly higher than that in NPVR ≥ 50% group (p < 0.05). The incidence of intraoperative adverse effects and postoperative adverse events in the NPVR < 50% group were higher than those in the NPVR ≥ 50% group (p < 0.05 for both). Logistic regression analysis showed that abdominal wall thickness, SI difference on T2WI between adenomyosis and rectus abdominis, and enhancement type on T1WI were protective factors for NPVR ≥ 50% (p < 0.05), while the history of childbirth was an independent risk factor (p < 0.001). CONCLUSIONS: Compared with NPVR < 50%, NPVR ≥ 50% did not increase the intraprocedural and postprocedural adverse reactions. The possibility of NPVR ≥ 50% was higher in patients with thinner abdominal walls, showed slight enhancement of adenomyosis on T1WI, with a history of childbirth, or in whom the SI difference on T2WI between adenomyosis and rectus abdominis was more minor.

Adverse events and complications after magnetic resonance-guided focused ultrasound (MRgFUS) therapy in uterine fibroids - a systematic review and future perspectives.

OBJECTIVES: The aim of this review was to analyze and summarize the most common adverse events (AEs) and complications after magnetic resonance-guided focused ultrasound (MRgFUS) therapy in uterine fibroids (UFs) and to establish the risk factors of their occurrence. METHODS: We searched for original research studies evaluating MRgFUS therapy in UFs with outcomes containing AEs and/or complications in different databases (PubMed/MEDLINE, SCOPUS, COCHRANE) until March 2022. Reviews, editorials, opinions or letters, case studies, conference papers and abstracts were excluded from the analysis. The systematic literature search identified 446 articles, 43 of which were analyzed. RESULTS: According to available evidence, the overall incidence of serious complications in MRgFUS therapy is relatively low. No AEs/complications were reported in 11 out of 43 analyzed studies. The mean occurrence of all AEs in the analyzed material was 24.67%. The most commonly described AEs included pain, skin burns, urinary tract infections and sciatic neuropraxia. Major AEs, such as skin ulcerations or deep vein thrombosis, occurred in 0.41% of cases in the analyzed material. CONCLUSION: MRgFUS seems to be safe in UF therapy. The occurrence of AEs, especially major ones, is relatively low in comparison with other methods. The new devices and more experience of their users seem to reduce AE rate. The lack of unification in AE reporting and missing data are the main issues in this area. More prospective, randomized studies with unified reporting and long follow-up are needed to determine the safety in a long-term perspective.

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids-a retrospective case-control study.

OBJECTIVES: 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.

Numerical study of high-intensity focused ultrasound (HIFU) in fat reduction.

INTRODUCTION: This study aimed to investigate the effect of fat-layer thickness and focal depth on the pressure and temperature distribution of tissue. METHODS: Computer simulations were performed for the skin-fat layer models during high-intensity focused ultrasound (HIFU) treatment. The acoustic pressure field was calculated using the nonlinear Westervelt equation and coupled with the Pennes bioheat transfer equation to obtain the temperature distribution. To investigate the effect of the thickness of the fat layer on pressure and thermal distributions, the thickness of the fat layer behind the focal point (z = 13.5 mm) changed from 8 to 24 mm by 2 mm step. The pressure and temperature distribution spectra were extracted. RESULTS: The simulated results were validated using the experimental results with a 98% correlation coefficient (p < 0.05). There was a significant difference between the pressure amplitude and temperature distribution for the 8-14 mm thickness of the fat layer (p < 0.05). By changing the focal point from 11.5 to 13.5 mm, the maximum acoustic pressure at the focal point increased 66%, and the maximum temperature was 56%, respectively. CONCLUSION: Considering the specific treatment plan for each patient, according to the skin and fat layer thicknesses, can help prevent side effects and optimize the treatment process of HIFU.

High Intensity Focused Ultrasound Ablation for Patients With Locally Advanced Pancreatic Adenocarcinoma: A Propensity Score-Matching Analysis.

OBJECTIVES: This retrospective study was conducted to assess the efficacy and safety of high intensity focused ultrasound (HIFU) in combination with chemotherapy compared with chemotherapy alone in treating patients with unresectable locally advanced pancreatic cancer (LAPC). METHODS: The data of unresectable LAPC patients who received chemotherapy with or without HIFU ablation were retrieved retrospectively. The overall survival (OS), objective response rate (ORR), cancer antigen 19-9 response rate, and safety were compared between these two groups before and after propensity score matching (PSM). RESULTS: Overall, 254 patients with LAPC were included, of whom 92 underwent HIFU ablation. After PSM to control for potential biases, HIFU was associated with improved OS (12.8 versus 12.2 months, log-rank P = .046), as compared to patients without HIFU ablation. Patients with numeric rating scale (NRS) less than 4, and receiving HIFU ablation were significantly associated with improved OS (adjusted hazard ratio [aHR] = 0.365 [95% confidence interval (CI) = 0.148-0.655], P = .002; aHR = 0.490 [95% CI = 0.250-0.961], P = .038; respectively) by multivariate analyses with the adjustment of age, NRS, and tumor size. ORR was also observed to be higher in HIFU group of 30.0% than in the chemotherapy group of 13.3% (P = .039). No severe adverse events of special interest or HIFU-caused deaths were observed. CONCLUSIONS: Patients with unresectable LAPC who received gemcitabine-based chemotherapy might benefit from additional HIFU ablation.

Prospective clinical trial on the learning curve of high-intensity-focused ultrasound for the treatment of breast fibroadenoma.

INTRODUCTION: High-intensity-focused ultrasound (HIFU) is a safe and feasible treatment option for breast fibroadenoma. However, its learning curve has not been described in the medical literature. METHODS: All patients with biopsy-proven fibroadenoma considered indicated for HIFU were screened for eligibility for HIFU treatment. A total of 60 patients were recruited according to the pre-defined sample size calculation. RESULTS: Sixty consecutive patients were divided into three cohorts in chronological order. The mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 6 months post-HIFU ablation were 38%, 34%, and 59%, respectively. Significant tumor shrinkage was observed from case 41 onward (p < 0.0001). Similarly, the mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 12 months post-HIFU ablation were 45%, 51%, and 71%, respectively. Significant tumor shrinkage was observed from case 41 onwards (p < 0.0473). The mean procedure time for the first 20 patients was 48.5 (range 45-75) minutes, while that in the second 20 patients was 39.7 (range 20-60) minutes, and that in the last 20 patients was 28.9 (range 15-45) minutes. The treatment time was significantly shorter from case 41 onwards (p = 0.0481). CONCLUSION: Treatment outcomes and treatment time improved significantly after performing approximately 40 HIFU procedures.

[Clinical effect and influencing factors of focused ultrasound ablation surgery combined with suction curettage for the treatment of mass-type cesarean scar pregnancy].

Objective: To investigate the clinical effect of focused ultrasound ablation surgery (FUAS) combined with suction curettage for mass-type cesarean scar pregnancy (CSP) and to analyze the influencing factors of vaginal bleeding and readmission. Methods: From January 2014 to December 2020, 88 patients with mass-type CSP were treated by FUAS combined with suction curettage in the Third Xiangya Hospital of Central South University. The clinical results and the influencing factors of bleeding and readmission for mass-type CSP were analyzed. Results: All the patients underwent one time FUAS treatment successfully. Immediately after FUAS treatment, color Doppler ultrasound showed obvious necrosis and no perfusion area in all lesions, and the blood flow in the mass-type CSP tissue significantly decreased. The median volume of blood loss in the procedure was 20 ml (range: 5-950 ml). Thirteen patients (15%, 13/88) had vaginal bleeding≥200 ml, and 15 patients (17%, 15/88) were hospitalized again. The average time for menstruation recovery was (28±8) days (range: 18-66 days). The average time needed for serum human chorionic gonadotropin-beta subunit to return to normal levels was (22±6) days (range: 7-59 days). The risk of large vaginal bleeding of patients were related to the blood supply of the mass (OR=5.280, 95%CI: 1.335-20.858, P=0.018) and the largest diameter of the mass (OR=1.060, 95%CI: 1.010-1.120, P=0.030). The risk of readmission were related to the largest diameter of the mass (OR=1.055, 95%CI: 1.005-1.108, P=0.030) and the depth of the uterus cavity (OR=1.583, 95%CI: 1.015-2.471, P=0.043). No serious complications such as intestinal and nerve injury occurred during and after FUAS treatment. Conclusions: FUAS combined with suction curettage is safe and effective in treating patients with mass-type CSP through this preliminary study. The volume of vaginal bleeding are associated with the blood supply of the mass and the largest diameter of the mass, the risk of readmission are related to the largest diameter of the mass and the depth of the uterus cavity.

[Clinical efficacy of focused ultrasound ablation surgery in the treatment of internal adenomyosis].

Objective: To investigate the relationship between the clinical efficacy and the ablated area of endometrium in patients with internal adenomyosis treated with focused ultrasound ablation surgery (FUAS). Methods: From January 2015 to December 2018, 122 patients in Chongqing Haifu Hospital who were diagnosed as internal adenomyosis through history, clinical symptoms and enhanced magnetic resonance imaging (MRI) and treated with FUAS were enrolled in this study. According to the patient's wishes, patients were given whether to ablate the adenomyotic lesion alone or ablate the adenomyotic lesion and the endometrium that involved in adenomyotic lesions together. The ablated area of adenomyotic lesions and endomitrium were evaluated by post-FUAS enhanced MRI. The adverse events and the changes of dysmenorrhea and menstrual volume at different follow-up points within 24 months were recorded. Results: Among the 122 patients, 32 patients chose to ablate adenomyotic lesion alone, and 90 patients chose to ablate the adenomyotic lesion and the endometrium during FUAS. No major complications such as bowel injury and nerve injury occurred after FUAS. The median non-perfused volume ratio of adenomyotic lesions was 31.7% in the group without endometrial ablation and it was 60.0% in the group with endometrium ablation (P<0.01). The improvement of dysmenorrhea in the group with endometrium ablation was significantly better than the group without endometrial ablation (P<0.01). The average menstrual volume score (3.4±0.9) before FUAS in the group with endometrial ablation was higher than that in the group without endometrial ablation (2.5±0.6; P<0.01), but it decreased significantly after FUAS treatment, reaching the similar menstrual volume score of the group without endometrial ablation (P>0.05). The proportions of abnormal vaginal discharge (34.4%, 31/90) and bleeding (16.7%, 15/90) were significantly higher in the group with endometrium ablation than those in the group without endometrial ablation (all P<0.01). Conclusions: FUAS could be safely and effectively used in the treatment of patients with internal adenomyosis. It seems that ablation of adenomyotic lesion and endometrium together could obtain better therapeutic effects.

Impact of Focal Versus Whole Gland Ablation for Prostate Cancer on Sexual Function and Urinary Continence.

PURPOSE: Focal instead of whole gland ablation for prostate cancer has been proposed to decrease treatment morbidity. We sought to determine differences in erectile function and urinary continence after focal and whole gland ablation for prostate cancer. MATERIALS AND METHODS: From 2009 to 2018, 346 patients underwent high intensity focused ultrasound or cryotherapy for prostate cancer. Urinary continence was defined as use of no pads and sexual potency as enough erection for sexual penetration. Logistic regressions to treatment groups and covariates age, prostate specific antigen, International Society of Urological Pathology grading, prostate volume and energy modality were performed to access the effect of focal therapy in sexual potency and urinary continence after 3 and 12 months. IIEF-5 (International Index of Erectile Function) and I-PSS (International Prostate Symptom Score) questionnaires were evaluated. Propensity score matching was performed to adjust for potential baseline differences between groups. RESULTS: After exclusion, 195 post-focal therapy and 105 post-whole gland therapy patients were included in analysis. No significant difference was seen in baseline I-PSS and IIEF-5 scores. In multivariate models focal therapy was the most important factor related to sexual potency at 3 (OR 7.7) and 12 months (OR 3.9). Median IIEF-5 score at 3 months was 12 and 5 (p <0.001), and at 12 months was 13 and 9 (p=0.04) in focal therapy and whole gland therapy groups, respectively. Focal therapy was the only factor related to continence (OR 0.7, p <0.001). Results remained significant after propensity score matching. CONCLUSIONS: Focal ablation instead of whole gland therapy is the most important factor related to better sexual and urinary continence recovery after high intensity focused ultrasound and cryotherapy for prostate cancer.

Magnetic resonance imaging-guided transurethral ultrasound ablation in patients with localised prostate cancer: 3-year outcomes of a prospective Phase I study.

OBJECTIVES: To report the 3-year follow-up of a Phase I study of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) in 30 men with localised prostate cancer. Favourable 12-month safety and ablation precision were previously described. PATIENTS AND METHODS: As a mandated safety criterion, TULSA was delivered as near whole-gland ablation, applying 3-mm margins sparing 10% of peripheral prostate tissue in 30 men. After 12-month biopsy and MRI, biannual follow-up included prostate-specific antigen (PSA), adverse events (AEs), and functional quality-of-life assessment, with repeat systematic biopsy at 3 years. RESULTS: A 3-year follow-up was completed by 22 patients. Between 1 and 3 years, there were no new serious or severe AEs. Urinary and bowel function remained stable. Erectile function recovered by 1 year and was stable at 3 years. The PSA level decreased 95% to a median (interquartile range) nadir of 0.33 (0.1-0.4) ng/mL, stable to 0.8 (0.4-1.6) ng/mL at 3 years. Serial biopsies identified clinically significant disease in 10/29 men (34%) and any cancer in 17/29 (59%). By 3 years, seven men had recurrence (four histological, three biochemical) and had undergone salvage therapy without complications (including six prostatectomies). At 3 years, three of 22 men refused biopsy, and two of the 22 (9%) had clinically significant disease (one new, one persistent). Predictors of salvage therapy requirement included less extensive ablation coverage and higher PSA nadir. CONCLUSION: With 3-year Phase I follow-up, TULSA demonstrates safe and precise ablation for men with localised prostate cancer, providing predictable PSA and biopsy outcomes, without affecting functional abilities or precluding salvage therapy.

Primary Focal Therapy for Localized Prostate Cancer: A Review of the Literature.

This article describes the available focal therapy options for primary treatment of localized PCa, along with their respective outcomes, drawbacks, and applicability.