CT-guided Pulsed Radiofrequency Combined with Steroid Injection for Sciatica from Herniated Disk: A Randomized Trial.

Background Evidence regarding effective nonsurgical management of sciatica remains limited. Purpose To determine a difference in effectiveness between combined pulsed radiofrequency (PRF) and transforaminal epidural steroid injection (TFESI) treatment versus TFESI alone for sciatic pain due to lumbar disk herniation. Materials and Methods This prospective multicenter double-blind randomized clinical trial was conducted between February 2017 and September 2019 in participants with sciatica due to lumbar disk herniation lasting 12 weeks or longer that was not responsive to conservative treatment. Study participants were randomly assigned to undergo one CT-guided treatment with combined PRF and TFESI (n = 174) or TFESI alone (n = 177). The primary outcome was leg pain severity, as assessed with the numeric rating scale (NRS) (range, 0-10) at weeks 1 and 52 after treatment. Secondary outcomes included Roland-Morris Disability Questionnaire (RMDQ) score (range, 0-24) and Oswestry Disability Index (ODI) score (range, 0-100). Outcomes were analyzed according to the intention-to-treat principle via linear regression. Results Mean age of the 351 participants (223 men) was 55 years ± 16 (SD). At baseline, NRS was 8.1 ± 1.1 in the PRF and TFESI group and 7.9 ± 1.1 in the TFESI group. NRS was 3.2 ± 0.2 in the PRF and TFESI group and 5.4 ± 0.2 in the TFESI group (average treatment effect, 2.3; 95% CI: 1.9, 2.8; P < .001) at week 1 and 1.0 ± 0.2 and 3.9 ± 0.2 (average treatment effect, 3.0; 95% CI: 2.4, 3.5; P < .001), respectively, at week 52. At week 52, the average treatment effect was 11.0 (95% CI: 6.4, 15.6; P < .001) for ODI and 2.9 (95% CI: 1.6, 4.3; P < .001) for RMDQ, favoring the combined PRF and TFSEI group. Adverse events were reported in 6% (10 of 167) of participants in the PRF and TFESI group and in 3% (six of 176) of participants in the TFESI group (eight participants did not complete follow-up questionnaires). No severe adverse events occurred. Conclusion In the treatment of sciatica caused by lumbar disk herniation, pulsed radiofrequency combined with transforaminal epidural steroid injection is more effective for pain relief and disability improvement than steroid injection alone. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Jennings in this issue.

Focused Ultrasound and External Beam Radiation Therapy for Painful Bone Metastases: A Phase II Clinical Trial.

Background Recent consensus statements and clinical trials have assessed the value of MRI-guided focused ultrasound surgery for pain palliation of bone metastases; however, a comparison with external beam radiation therapy (EBRT) has not been performed. Purpose To compare safety and effectiveness data of MRI-guided focused ultrasound and EBRT in the treatment of bone metastases. Materials and Methods Participants with painful bone metastases, excluding skull and vertebral bodies, were enrolled in a prospective open-label nonrandomized phase II study between January 2017 and May 2019 and underwent either MRI-guided focused ultrasound or EBRT. The primary end point was the overall response rate at 1-month following treatment, assessed via the numeric rating scale (NRS) for pain (0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"). Secondary end points were improvements at 12-month follow-up in NRS and quality of life (QoL) measures, including the Brief Pain Inventory (BPI), QoL-Questionnaire Cancer-15 Palliative Care (QLQ-C15-PAL), and QoL-Questionnaire Bone Metastases-22 (QLQ-BM22) and analysis of adverse events. Statistical analyses, including linear regression, χ2 test, and Student t test followed the per-protocol principle. Results Among 198 participants, 100 underwent MRI-guided focused ultrasound (mean age, 63 years ± 13 [SD]; 51 women), and 98 underwent EBRT (mean age, 65 years ± 14; 52 women). The overall response rates at 1-month follow-up were 91% (91 of 100) and 67% (66 of 98), respectively, in the focused ultrasound and EBRT arms (P < .001), and complete response rates were 43% (43 of 100) and 16% (16 of 98) (P < .001). The mean baseline NRS score was 7.0 ± 2.1 for focused ultrasound and 6.6 ± 2.4 for EBRT (P = .16); at 1-month follow-up, they were reduced to 3.2 ± 0.3 and 5.1 ± 0.3 (P < .001), respectively. QLQ-C15-PAL for physical function (P = .002), appetite (P < .001), nausea and vomiting (P < .001), dyspnea (P < .001), and QoL (P < .001) scores were lower in the focused ultrasound group. The overall adverse event rates were 15% (15 of 100) after focused ultrasound and 24% (24 of 98) after EBRT. Conclusion MRI-guided focused ultrasound surgery and external beam radiation therapy showed similar improvements in pain palliation and quality of life, with low adverse event rates. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Kelekis in this issue.

Uterine Myomas: Focused Ultrasound Surgery.

Uterine fibroids are the most common neoplasm in women. These lesions may be associated with impaired fertility and adverse obstetric outcomes. Medical treatment, myomectomy, hysterectomy and uterine artery embolization have been employed for the management of uterine fibroids. Focused ultrasound surgery (FUS) is a relatively recent technique that relies on mechanical and thermal energy of ultrasound for the ablation of a target tissue under an imaging guidance, that can be either ultrasound (US-guided FUS, USgFUS) or magnetic resonance (MR-guided FUS, MRgFUS). Pre- and peri-menopausal women are potential candidates for treatment; however, individual criteria need to be evaluated in order to establish the eligibility for the procedure. FUS procedure can be performed in an outpatient setting; it is a safe and effective treatment that has demonstrated to reduce symptoms associated with uterine fibroids. The adverse event rate is 8.7% and only 0.2% of patients experiences major complications. Pregnancy is possible after the treatment, and no damage to the endometrium has been observed following FUS procedure.

STUDY PROTOCOL - pulsed radiofrequency in addition to transforaminal epidural steroid injection in patients with acute and subacute sciatica due to lumbosacral disc herniation: rationale and design of a phase III, multicenter, randomized, controlled trial.

Lumbosacral disc herniation (LDH) represents the most common cause of sciatica. Currently, there is limited evidence about minimally invasive interventional therapies for the treatment of this condition. This paper presents the protocol for a multicenter, prospective, randomized, controlled, phase III trial evaluating if PRF in addition to TFESI leads to better outcomes in patients with sciatica due to LDH, compared to TFESI alone, during the first year after treatment (Pulsed Radiofrequency in Addition to TFESI for Sciatica [PRATS]). Eligible patients are between 18 and 75 years of age, suffer from sciatica of less than 12-week duration with pain intensity >4 on the Visual Analogue Scale (VAS) and have unilateral LDH compatible with symptoms at MRI. The Medical Ethics Committee of participating hospitals approved the study protocol. Patients will be randomized to receive either combined treatment (PRF and TFESI) or TFESI alone. The primary outcome will be the assessment of pain intensity with VAS at different timepoints from week-1 to 52 after treatment; secondary outcomes will include Roland Disability Questionnaire for sciatica and Oswestry Disability Index, evaluated at 4, 12 and 52 weeks. The follow-up will last 52 weeks for each patient. Statistical analysis will be performed on a per-protocol basis.

Role of computed tomography in predicting critical disease in patients with covid-19 pneumonia: A retrospective study using a semiautomatic quantitative method.

BACKGROUND: So far, only a few studies evaluated the correlation between CT features and clinical outcome in patients with COVID-19 pneumonia. PURPOSE: To evaluate CT ability in differentiating critically ill patients requiring invasive ventilation from patients with less severe disease. METHODS: We retrospectively collected data from patients admitted to our institution for COVID-19 pneumonia between March 5th-24th. Patients were considered critically ill or non-critically ill, depending on the need for mechanical ventilation. CT images from both groups were analyzed for the assessment of qualitative features and disease extension, using a quantitative semiautomatic method. We evaluated the differences between the two groups for clinical, laboratory and CT data. Analyses were conducted on a per-protocol basis. RESULTS: 189 patients were analyzed. PaO2/FIO2 ratio and oxygen saturation (SaO2) were decreased in critically ill patients. At CT, mixed pattern (ground glass opacities (GGO) and consolidation) and GGO alone were more frequent respectively in critically ill and in non-critically ill patients (p < 0.05). Lung volume involvement was significantly higher in critically ill patients (38.5 % vs. 5.8 %, p < 0.05). A cut-off of 23.0 % of lung involvement showed 96 % sensitivity and 96 % specificity in distinguishing critically ill patients from patients with less severe disease. The fraction of involved lung was related to lactate dehydrogenase (LDH) levels, PaO2/FIO2 ratio and SaO2 (p < 0.05). CONCLUSION: Lung disease extension, assessed using quantitative CT, has a significant relationship with clinical severity and may predict the need for invasive ventilation in patients with COVID-19.

High-intensity focused ultrasound for prostate cancer.

High-intensity focused ultrasound (HIFU) is a noninvasive procedure that has shown promising results in a wide range of malignant and nonmalignant conditions, including localized prostate cancer (PCa). This review aims to describe the application of HIFU in the management of patients with PCa, explaining its basic therapeutic principles, going through the main phases during aHIFU session, and providing an overview of the main available pieces of evidence from literature. HIFU treatment for prostate cancer is increasingly performed with high success and safety. MR guidance (MR-guided HIFU) has the advantage of real-time intraprocedural thermometric feedback that ensures that the whole region of interest has been covered by critical thermal damage (and that all surrounding healthy tissues have been spared). The absence of comparative long-term trials prevents HIFU from being considered as afirst choice for the treatment of patients with PCa.

Magnetic-resonance-guided focused ultrasound treatment of non-spinal osteoid osteoma in children: multicentre experience.

BACKGROUND: Osteoid osteoma is a benign and painful musculoskeletal tumour that usually affects children. Current standard treatment is CT-guided radiofrequency ablation, a minimally invasive percutaneous procedure, with clinical success rates ranging between 85% and 98%. Though minimally invasive, however, this type of procedure is not free from complications. OBJECTIVE: To investigate the efficacy and safety of magnetic resonance (MR)-guided focused ultrasound (MRgFUS), a needleless procedure of thermal ablation employed in the treatment of non-spinal osteoid osteoma in paediatric patients. MATERIALS AND METHODS: We report the results of 33 procedures of ablation of osteoid osteoma performed with MRgFUS in three university hospitals. To ablate a lesion on the bone surface, MRgFUS employs the ultrasound energy transduced along the soft tissue. The follow-up studies lasted 24 months and were performed combining clinical and imaging data. RESULTS: Mean age of the children was 13.8 years. The clinical outcome showed a primary success of 97%. One case alone was submitted to repeat treatment because the first one failed (secondary success). No major or minor complications were recorded. During the investigation time, no relapse of symptomatology or delayed complications were observed. CONCLUSION: Although our study is preliminary and limited by a low number of patients, our data show that MRgFUS is effective. This suggests that it might be useful as the first-line treatment in paediatric patients with osteoid osteoma.

HIFU for Bone Metastases and other Musculoskeletal Applications.

High-intensity focused ultrasound (HIFU) is a totally noninvasive procedure that has shown promising results in the management of numerous malignant and nonmalignant conditions. Under magnetic resonance or ultrasound guidance, high-intensity ultrasound waves are focused on a small, well-defined target region, inducing biologic tissue heating and coagulative necrosis, thus resulting in a precise and localized ablation. This treatment has shown both great safety and efficacy profiles, and may offer a multimodal approach to different diseases, providing pain palliation, potential local tumor control, and, in some cases, remineralization of trabecular bone. In musculoskeletal field, HIFU received FDA approval for treating bone metastasis, but its application has also been extended to other conditions, such as osteoid osteoma, desmoid tumor, low-flow vascular malformation, and facet joint osteoarthritis. This article illustrates the basic principles of HIFU and its main effects on biologic tissues with particular attention on bone, provides a step-by-step description of the HIFU procedure, and discusses the commonly treated conditions, in particular bone metastases.

High-Intensity Focused Ultrasound for Pain Management in Patients with Cancer.

Cancer-related pain affects up to 80% of patients with malignancies. Pain is an important distressing symptom that diminishes the quality of life and negatively affects the survival of patients. Opioid analgesics are generally the primary therapy for cancer-related pain, with surgery, radiation therapy, chemotherapy, and other interventions used in cases of treatment-resistant pain. These treatments, which can be associated with substantial side effects and systemic toxicity, may not be effective. High-intensity focused ultrasound is an entirely noninvasive technique that is approved for treatment of uterine fibroids, bone metastases, and essential tremors. With magnetic resonance imaging or ultrasonographic guidance, high-intensity ultrasound waves are focused on a small well-demarcated region to result in precise localized ablation. This treatment may represent a multimodality approach to treating patients with malignant diseases-facilitating pain palliation, enhanced local drug delivery and radiation therapy effects, and stimulation of anticancer specific immune responses, and potentially facilitating local tumor control. Focused ultrasound can be used to achieve pain palliation by producing several effects, including tissue denervation, tumor mass reduction, and neuromodulation, that can influence different pathways at the origin of the pain. This technology has several key advantages compared with other analgesic therapies: It is completely noninvasive, might be used to achieve rapid pain control, can be safely repeated, and can be used in combination with chemotherapy and radiation therapy to enhance their effects. Online supplemental material is available for this article. ©RSNA, 2018.

Analysis of CT features and quantitative texture analysis in patients with thymic tumors: correlation with grading and staging.

OBJECTIVES: To evaluate potential relationship between qualitative CT features, quantitative texture analysis (QTA), histology, WHO staging, Masaoka classification and myasthenic syndrome in patients with thymic tumors. MATERIALS AND METHODS: Sixteen patients affected by histologically proven thymic tumors were retrospectively included in the study population. Clinical information, with special regard to myasthenic syndrome and serological positivity of anti-AchR antibodies, were recorded. Qualitative CT evaluation included the following parameters: (a) location; (b) tumor edges; (c) necrosis; (d) pleural effusion; (e) metastases; (f) chest wall infiltration; (g) tumor margins. QTA included evaluation of "Mean" (M), "Standard Deviation" (SD), "Kurtosis" (K), "Skewness" (S), "Entropy" (E), "Shape from Texture" (TX_sigma) and "average of positive pixels" (MPP). Pearson-Rho test was used to evaluate the relationship of continuous non-dichotomic parameters, whereas Mann-Whitney test was used for dichotomic parameters. RESULTS: Histological evaluation demonstrated thymoma in 12 cases and thymic carcinoma in 4 cases. Tumor necrosis was significantly correlated with QTA Mean (p = 0.0253), MPP (p = 0.0417), S (p = 0.0488) and K (p = 0.0178). WHO staging was correlated with Mean (p = 0.0193), SD (p = 0.0191) and MPP (p = 0.0195). Masaoka classification was correlated with Mean (p = 0.0322), MPP (p = 0.0315), skewness (p = 0.0433) and Kurtosis (p = 0.0083). Myasthenic syndrome was significantly associated with Mean (p = 0.0211) and MPP (p = 0.0261), whereas tumor size was correlated with Mean (p = 0.0241), entropy (p = 0.0177), MPP (p = 0.0468), skewness (p = 0.009) and Kurtosis (p = 0.006). CONCLUSION: Our study demonstrates significant relationship between radiomics parameters, histology, grading and clinical manifestations of thymic tumors.

Intradevice misalignment predicts residual leak in patients undergoing left atrial appendage closure.

AIMS: Postdeployment mutual orientation between the disk and the lobe in patients undergoing left atrial appendage closure with Amplatzer cardiac plug/Amulet device might impact on the risk of residual leak during follow-up. Thus, we evaluated in an exploratory, pilot study whether the degree of intradevice misalignment, measured by cardiac computed tomography (CT), discriminates the occurrence of peridevice leak in those patients. METHODS: All patients (N = 15) undergoing percutaneous left atrial appendage closure with those specific devices between April 2013 and January 2015 were prospectively included. All patients received follow-up evaluation by cardiac CT at 6 months after the intervention to calculate the angle of misalignment within the device and to detect presence of residual peridevice leak. RESULTS: The angle of misalignment between the disk and the lobe of the device significantly discriminated between patients with and without peridevice leak (area under the curve 0.96, 95% confidence interval 0.88-1.0; P = 0.003), with an angle more than 20° being associated with nine-fold higher risk of residual leak. This angle of intradevice misalignment calculated by cardiac CT was significantly correlated with that measured by two-dimensional transesophageal echocardiography or X-rays in the cath lab after the device deployment (r = 0.943 and r = 0.938, respectively). CONCLUSION: A marked intradevice misalignment after Amplatzer cardiac plug/Amulet device implantation significantly predicts the occurrence of postprocedural leak in patients with atrial fibrillation; if confirmed by larger studies, these findings may impact on practice patterns.

Noninvasive Therapy for Osteoid Osteoma: A Prospective Developmental Study with MR Imaging-guided High-Intensity Focused Ultrasound.

Purpose To demonstrate that magnetic resonance (MR) imaging-guided high-intensity focused ultrasound (HIFU) is a safe, effective, and durable treatment option for the management of osteoid osteoma in children and young adults. Materials and Methods This prospective study was institutional review board approved and is registered with clinicaltrials.gov (identification number NCT02302651). Written informed consent was obtained from patients or their parents. Patients who had both clinical and radiologic findings that were diagnostic for nonvertebral osteoid osteoma and no contraindications to MR imaging-guided HIFU were enrolled between June 2010 and June 2013. The feasibility, safety, and clinical effectiveness of MR imaging-guided HIFU were considered primary outcomes; tumor control at imaging was considered a secondary outcome. Analyses were conducted on a per-protocol basis. Results Forty-five of the 50 recruited patients underwent MR imaging-guided HIFU. All patients were discharged without treatment-related complications. The median visual analog scale (VAS) pain score (scale, 0-10) decreased from 8 before treatment to 0 at 1-week and 1- , 6- , 12- , 24- , and 36-month follow-up. Similarly, median VAS scores for the degree to which pain interfered with sleep and physical and daily activities decreased to 0 within the 1st month after treatment and remained stable at subsequent follow-up. Overall, 39 (87%) of the 45 patients achieved and maintained a VAS score of 0 during the 3-year observation period. Quality of life, as assessed by using Functional Assessment of Cancer Therapy-Bone Pain (FACT-BP) scores (scale, 0-60 points), improved, with the median FACT-BP score of 28 (points) before treatment increasing to a median score of 55 at 1-week follow-up and 60 at 6-month and subsequent follow-ups. At (final) 36-month follow-up, MR imaging depicted an absence of residual nidus vascularity in 32 (76%) of the 42 patients who were treated with MR imaging-guided HIFU only. Conclusion The durable clinical efficacy and safety of MR imaging-guided HIFU were demonstrated. These features are evidence of the potential of MR imaging-guided HIFU to be part of a routine strategy for the treatment of osteoid osteoma. © RSNA, 2017.

Alternatives to surgery for the treatment of myomas.

Uterine fibroids are benign neoplasms that can cause distressing symptoms in women during their reproductive age. They are often associated with menorrhagia that can determine anemia or bulk-related symptoms. Different treatment options are available: medical therapy has the goal to treat related symptoms, while semi-invasive or non-invasive uterus-sparing procedures aim to treat symptoms and eventually to determine a reduction in fibroids size. In this review we illustrate the current semi-invasive and totally non-invasive most frequently used uterus sparing procedures available. A review of the literature along with personal experience will offer the readers a panoramic view of these up-to-date treatments to be considered as different possibilities to treat women affected by uterine fibroids looking for uterus conserving non-surgical approach.