Dual-Applicator MR Imaging-Guided Microwave Ablation with Real-Time MR Thermometry: Phantom and Porcine Tissue Model Experiments.

PURPOSE: To investigate the effect of simultaneous use of dual applicators on the image quality of real-time magnetic resonance (MR) thermometry and to characterize the dual-applicator treatment zone pattern during MR imaging-guided microwave ablation (MWA). MATERIALS AND METHODS: MWA experiments were performed on a 1.5-T MR scanner with 2 commercial microwave systems (902-928 MHz). Phantom experiments were first performed to evaluate the effect of dual-applicator MWA on the image quality of MR. Then, porcine tissue model experiments were conducted with real-time MR thermometry using either a single applicator or dual applicators inserted 2.6, 3.6, and 4.6 cm apart. Fiberoptic thermal probes were used to measure the temperature changes at the tissue surface. RESULTS: Simultaneous use of dual applicators resulted in a decrease in the relative signal-to-noise ratio (SNR) in the MR thermometry images to 55% ± 2.9% when compared with that of a single applicator (86.2% ± 2.0%). Despite the lower SNR, the temperature and ablation zone maps were of adequate quality to allow visualization of the ablation zone(s). The extents of increase in the temperature at the tissue surface using dual applicators (19.7 °C ± 2.6 °C) and a single applicator (18.2 °C ± 3.3 °C) were not significantly different (P = .40). Treatment zones were significantly larger (P < .05) in dual-applicator ablations (29.4 ± 0.4, 39.9 ± 0.6, and 42.6 ± 0.9 cm2 with 2.6-, 3.6-, and 4.6-cm spacing, respectively) at the end of the ablation procedure than in the single-applicator MWA (18.6 ± 0.9 cm2). CONCLUSIONS: MR imaging-guided dual-applicator MWA produced larger ablation zones while allowing adequate real-time MR thermometry image quality for monitoring the evolution of the treatment zone.

MRI-guided focused ultrasound ablation of painful lumbar facet joints: a retrospective assessment of safety and tolerability in human subjects.

OBJECTIVE: To evaluate the safety and tolerability of MRI-guided focused ultrasound (MRgFUS) for the treatment of facet joint-mediated pain in human subjects for whom conventional treatment had failed. Secondarily, to evaluate effectiveness of the procedure. METHODS: Consecutive patients who underwent MRgFUS at our institution were retrospectively identified. Chart review was performed to obtain relevant clinical and technical data. All patients had chronic low back pain and positive comparative medial branch blocks. RESULTS: Twenty-six MRgFUS treatments in 20 patients were included. Mean sonication energy was 1436.6 Joules. The procedure was technically successful in all patients. Of the treated patients, 29.6% experienced short-term worsening of low back pain immediately after the procedure, all by 1-4 points on a 0-10 scale. One patient (3.8%) reported temporary worsening of preexisting radicular symptoms after the procedure. Of 21 treatments with clinical follow-up of at least 3 months available, 12 (57.1%) had >3 months' pain relief, 2 (10%) had <3 months' benefit, 6 (30%) reported no benefit, and 1 (5%) patient was lost to follow-up. In patients who reported at least some benefit with prior conventional radiofrequency ablation, 8/10 (80%) benefited from the MRgFUS procedure. CONCLUSION: The present study demonstrates that MRgFUS ablation of the lumbar facet joints is a safe and tolerable procedure in human subjects and could provide another option for patients for whom radiofrequency ablation had failed. More than half of all patients received significant durable pain relief, which jumped to 80% for patients who had experienced at least some benefit from prior radiofrequency ablations.

Aqueous Dispersion of Manganese-Zinc Ferrite Nanoparticles Protected by PEG as a T2 MRI Temperature Contrast Agent.

Mixed manganese-zinc ferrite nanoparticles coated with PEG were studied for their potential usefulness in MRI thermometry as temperature-sensitive contrast agents. Particles in the form of an 8.5 nm core coated with a 3.5 nm layer of PEG were fabricated using a newly developed, one-step method. The composition of Mn0.48Zn0.46Fe2.06O4 was found to have a strong thermal dependence of magnetization in the temperature range between 5 and 50 °C. Nanoparticles suspended in an agar gel mimicking animal tissue and showing non-significant impact on cell viability in the biological test were studied with NMR and MRI over the same temperature range. For the concentration of 0.017 mg/mL of Fe, the spin-spin relaxation time T2 increased from 3.1 to 8.3 ms, while longitudinal relaxation time T1 shows a moderate decrease from 149.0 to 125.1 ms. A temperature map of the phantom exposed to the radial temperature gradient obtained by heating it with an 808 nm laser was calculated from T2 weighted spin-echo differential MR images. Analysis of temperature maps yields thermal/spatial resolution of 3.2 °C at the distance of 2.9 mm. The experimental relaxation rate R2 data of water protons were compared with those obtained from calculations using a theoretical model incorporating the motion averaging regime.

Experimental Investigation of Cryoneedle Heating during MR-Guided Cryoablation in Ex Vivo Tissue Samples at 1.5-Tesla.

PURPOSE: To investigate cryoneedle heating risks during magnetic resonance (MR)-guided cryoablation and potential strategies to mitigate these risks. MATERIALS AND METHODS: Ex vivo experiments were performed on a 1.5-Tesla (T) MR scanner using an MR conditional cryoablation system on porcine tissue phantoms. Cryoneedles were placed inside the tissue phantom either with or without an angiocatheter. Typical cryoneedle geometric configurations (including gas supply line) encountered in clinical procedures with low to high expected heating risks were investigated. Up to 4 fiber optic temperature sensors were attached to the cryoneedle/angiocatheter to measure the MR-induced cryoneedle heating at different locations during MR with different estimated specific absorption rates (SARs). The impact of cryoneedle heating on cryoablation treatment was studied by comparing temperature changes during 10-min freeze-thaw cycles with and without MR. RESULTS: Rapid temperature increases of >100 °C in < 2 minutes were observed during MR with a SAR of 2.1 W/kg. The temperature changes during a typical freeze-thaw cycle were also affected by cryoneedle heating when MR was used to monitor the ice-ball evolution. The observed cryoneedle heating was affected by multiple factors; including cryoneedle geometric configurations, sequence SAR, whether an angiocatheter was used, and whether the cryoneedle was connected to the rest of the cryoablation system. CONCLUSIONS: The ex vivo experiments demonstrated that MR could induce significant cryoneedle heating risks. Furthermore, MR-induced cryoneedle heating can affect temperatures in the ice-ball evolution during the freeze-thaw cycle. Several practical strategies to reduce the cryoneedle heating have been proposed.

Body Interventional MRI for Diagnostic and Interventional Radiologists: Current Practice and Future Prospects.

Clinical use of MRI for guidance during interventional procedures emerged shortly after the introduction of clinical diagnostic MRI in the late 1980s. However, early applications of interventional MRI (iMRI) were limited owing to the lack of dedicated iMRI magnets, pulse sequences, and equipment. During the 3 decades that followed, technologic advancements in iMRI magnets that balance bore access and field strength, combined with the development of rapid MRI pulse sequences, surface coils, and commercially available MR-conditional devices, led to the rapid expansion of clinical iMRI applications, particularly in the field of body iMRI. iMRI offers several advantages, including superior soft-tissue resolution, ease of multiplanar imaging, lack of ionizing radiation, and capability to re-image the same section. Disadvantages include longer examination times, lack of MR-conditional equipment, less operator familiarity, and increased cost. Nonetheless, MRI guidance is particularly advantageous when the disease is best visualized with MRI and/or when superior soft-tissue contrast is needed for treatment monitoring. Safety in the iMRI environment is paramount and requires close collaboration among interventional radiologists, MR physicists, and all other iMRI team members. The implementation of risk-limiting measures for personnel and equipment in MR zones III and IV is key. Various commercially available MR-conditional needles, wires, and biopsy and ablation devices are now available throughout the world, depending on the local regulatory status. As such, there has been tremendous growth in the clinical applications of body iMRI, including localization of difficult lesions, biopsy, sclerotherapy, and cryoablation and thermal ablation of malignant and nonmalignant soft-tissue neoplasms. Online supplemental material is available for this article. ©RSNA, 2021.

MRI and tractography techniques to localize the ventral intermediate nucleus and dentatorubrothalamic tract for deep brain stimulation and MR-guided focused ultrasound: a narrative review and update.

The thalamic ventral intermediate nucleus (VIM) can be targeted for treatment of tremor by several procedures, including deep brain stimulation (DBS) and, more recently, MR-guided focused ultrasound (MRgFUS). To date, such targeting has relied predominantly on coordinate-based or atlas-based techniques rather than directly targeting the VIM based on imaging features. While general regional differences of features within the thalamus and some related white matter tracts can be distinguished with conventional imaging techniques, internal nuclei such as the VIM are not discretely visualized. Advanced imaging methods such as quantitative susceptibility mapping (QSM) and fast gray matter acquisition T1 inversion recovery (FGATIR) MRI and high-field MRI pulse sequences that improve the ability to image the VIM region are emerging but have not yet been shown to have reliability and accuracy to serve as the primary method of VIM targeting. Currently, the most promising imaging approach to directly identify the VIM region for clinical purposes is MR diffusion tractography.In this review and update, the capabilities and limitations of conventional and emerging advanced methods for evaluation of internal thalamic anatomy are briefly reviewed. The basic principles of tractography most relevant to VIM targeting are provided for familiarization. Next, the key literature to date addressing applications of DTI and tractography for DBS and MRgFUS is summarized, emphasizing use of direct targeting. This literature includes 1-tract (dentatorubrothalamic tract [DRT]), 2-tract (pyramidal and somatosensory), and 3-tract (DRT, pyramidal, and somatosensory) approaches to VIM region localization through tractography.The authors introduce a 3-tract technique used at their institution, illustrating the oblique curved course of the DRT within the inferior thalamus as well as the orientation and relationship of the white matter tracts in the axial plane. The utility of this 3-tract tractography approach to facilitate VIM localization is illustrated with case examples of variable VIM location, targeting superior to the anterior commissure-posterior commissure plane, and treatment in the setting of pathologic derangement of thalamic anatomy. Finally, concepts demonstrated with these case examples and from the prior literature are synthesized to highlight several potential advantages of tractography for VIM region targeting.

FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery.

BACKGROUND: Uterine leiomyomas (fibroid tumors) cause considerable symptoms in 30-50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroid tumors often seek uterine-preserving treatments, but comparative effectiveness trials are lacking. OBJECTIVE: The purpose of this study was to report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study. STUDY DESIGN: The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study, which is a randomized controlled trial of uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroid tumors; women who declined randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroid tumors within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function. RESULTS: From 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging-guided focused ultrasound surgery [27 randomized]; 40 for uterine artery embolization [22 randomized]); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging-guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01-7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging-guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention. CONCLUSION: Our study demonstrates a lower reintervention rate and greater improvement in symptoms after uterine artery embolization, although some of the effectiveness may come through impairment of ovarian reserve. Both pretreatment anti-Müllerian hormone level and age are associated with risk of reintervention. CLINICAL TRIAL REGISTRATION NUMBER: NCT00995878, clinicaltrials.gov.

A quantitative alternative to the Goutallier classification system using Lava Flex and Ideal MRI techniques: volumetric intramuscular fatty infiltration of the supraspinatus muscle, a cadaveric study.

OBJECTIVE: The Goutallier classification system is the most commonly used method for grading intramuscular fatty infiltration in rotator cuff tears. This grading system presents low inter-observer reliability and an inability to provide quantitative and repeatable outcomes for intramuscular fat. We determined the correlation and reliability of two methods, the Lava Flex and Ideal IQ MRI techniques, in quantifying volumetric intramuscular fat, while also comparing to the Goutallier method. MATERIALS AND METHODS: The supraspinatus muscles of seventeen cadaveric shoulders were scanned using the Lava Flex and Ideal IQ MRI imaging protocols. Histological analysis was performed on the same muscles. Agreement, reliability, and correlation analyses were performed to compare all outcomes. RESULTS: The Lava Flex protocol took an average of ~ 4 min, while the Ideal IQ required about ~ 11 min to complete. Bland-Altman analysis showed good agreement between the Lava Flex and Ideal IQ [LOA (- 0.10 and 0.05)], and ICC analyses showed excellent reliability (ICC (1,1) 0.948; ICC (2,1) 0.947). There was a 91% correlation between the Lava Flex and Ideal IQ MR protocols. Weighted Kappa analysis between histology and the Goutallier classification showed fair-to-moderate agreement. DISCUSSION: The Lava Flex technique, taking about 30% of the acquisition time, may prevent motion artifacts in outcomes associated with the longer Ideal IQ technique. However, potential magnetic field inhomogeneities should be considered. The Lava Flex technique may be a faster and valid alternative to the Goutallier classification system.

Intramuscular fat infiltration evaluated by magnetic resonance imaging predicts the extensibility of the supraspinatus muscle.

INTRODUCTION: Rotator cuff (RC) tears result in muscle atrophy and fat infiltration within the RC muscles. An estimation of muscle quality and deformation, or extensibility, is useful in selecting the most appropriate surgical procedure. We determined if noninvasive quantitative assessment of intramuscular fat using MRI could be used to predict extensibility of the supraspinatus muscle. METHODS: Seventeen cadaveric shoulders were imaged to assess intramuscular fat infiltration. Extensibility and histological evaluations were then performed. RESULTS: Quantitative fat infiltration positively correlated with histological findings and presented a positive correlation with muscle extensibility (r = 0.69; P = 0.002). Extensibility was not significantly different between shoulders graded with a higher fat content versus those with low fat when implementing qualitative methods. DISCUSSION: A noninvasive prediction of whole-muscle extensibility may directly guide pre-operative planning to determine if the torn edge could efficiently cover the original footprint while aiding in postoperative evaluation of RC repair. Muscle Nerve 57: 129-135, 2018.

The Impact of Mirth-Inducing Ventral Striatal Deep Brain Stimulation on Functional and Effective Connectivity.

Deep brain stimulation (DBS) of the ventral capsule/ventral striatum (VC/VS) is an investigational therapy for treatment-resistant obsessive-compulsive disorder. The ability of VC/VS DBS to evoke spontaneous mirth in patients, often accompanied by smiling and laughter, is clinically well documented. However, the neural correlates of DBS-evoked mirth remain poorly characterized. Patients undergoing VC/VS DBS surgery underwent intraoperative evaluation in which mirth-inducing and non-mirth-inducing stimulation localizations were identified. Using dynamic causal modeling (DCM) for fMRI, the effect of mirth-inducing DBS on functional and effective connectivity among established nodes in limbic cortico-striato-thalamo-cortical (CSTC) circuitry was investigated. Both mirth-inducing and non-mirth-inducing VC/VS DBS consistently resulted (conjunction, global null, family-wise error-corrected P < 0.05) in activation of amygdala, ventral striatum, and mediodorsal thalamus. However, only mirth-inducing DBS resulted in functional inhibition of anterior cingulate cortex. Dynamic causal modeling revealed that mirth-inducing DBS enhanced effective connectivity from anterior cingulate to ventral striatum, while attenuating connectivity from thalamus to ventral striatum relative to non-mirth-inducing stimulation. These results suggest that DBS-evoked mood elevation is accompanied by distinct patterns of limbic thalamocortical connectivity. Using the novel combination of DBS-evoked mood alteration and functional MRI in human subjects, we provide new insights into the network-level mechanisms that influence affect.

Targeted Prostate Biopsy and MR-Guided Therapy for Prostate Cancer.

In 2018, the American Cancer Society (ACS) estimates that 164,690 new cases of prostate cancer will be diagnosed and 29,430 will die due to the prostate cancer in the United States (Siegel et al., CA Cancer J Clin 67:7-30, 2018). Many men with prostate cancer are often managed with aggressive therapy including radiotherapy or surgery. No matter how expertly done, these therapies carry significant risk and morbidity to the patient's health related quality of life with impact on sexual, urinary and bowel function (Potosky et al., J Natl Cancer Inst 96:1358-1367, 2004). A recent meta-analysis of 19 studies reviewing the use of surgery and radiation for prostate cancer demonstrated patients who received radiation were more likely to die from their disease as compared to surgery (Wallis et al., Eur Urol 70:21-30, 2016). Furthermore, screening programs using prostatic specific antigen (PSA) and transrectal ultrasound (TRUS) guided systematic biopsy have identified increasing numbers of low risk, low grade "localized" prostate cancer. This indolent nature of many prostate cancers presents a difficult decision of when to intervene given the possible comorbidities of aggressive treatment. Active surveillance has been increasingly instituted in order to balance cancer control versus treatment side effects (Jemal et al., CA Cancer J Clin 56:106-130, 2006). Although active debate continues on the suitability of focal or regional therapy for these low or intermediate risk prostate cancer patients, many unresolved issues remain which complicate this approach of management. Some of the largest unresolved issues are: prostate cancer multifocality, limitations of current biopsy strategies, suboptimal staging by accepted imaging modalities, less than robust prediction models for indolent prostate cancers and whether established curative therapies can be safely and effectively used following focal therapy for prostate cancer. In spite of these restrictions focal therapy continues to confront the current paradigm of therapy for low and even intermediate risk disease (Onik, Tech Vasc Interv Radiol 10:149-158, 2017). It has been proposed that early detection and proper characterization may play a role in preventing the development of metastatic disease (Vickers et al., BMJ 346:f2023, 2013). There is Level 1 evidence supporting detection and subsequent aggressive treatment of intermediate and high-risk prostate cancer (Bill-Axelson et al., N Engl J Med 370:932-942, 2014). Therefore accurate assessment of cancer risk (i.e. grade and stage) using imaging and targeted biopsy is critical. Advances in prostate imaging with MRI have been accompanied with advances in MR guided therapy propelling prostate treatment solutions forward faster than ever.

Evaluations of UltraiQ software for objective ultrasound image quality assessment using images from a commercial scanner.

We evaluated a commercially available software package that uses B-mode images to semi-automatically measure quantitative metrics of ultrasound image quality, such as contrast response, depth of penetration (DOP), and spatial resolution (lateral, axial, and elevational). Since measurement of elevational resolution is not a part of the software package, we achieved it by acquiring phantom images with transducers tilted at 45 degrees relative to the phantom. Each measurement was assessed in terms of measurement stability, sensitivity, repeatability, and semi-automated measurement success rate. All assessments were performed on a GE Logiq E9 ultrasound system with linear (9L or 11L), curved (C1-5), and sector (S1-5) transducers, using a CIRS model 040GSE phantom. In stability tests, the measurements of contrast, DOP, and spatial resolution remained within a ±10% variation threshold in 90%, 100%, and 69% of cases, respectively. In sensitivity tests, contrast, DOP, and spatial resolution measurements followed the expected behavior in 100%, 100%, and 72% of cases, respectively. In repeatability testing, intra- and inter-individual coefficients of variations were equal to or less than 3.2%, 1.3%, and 4.4% for contrast, DOP, and spatial resolution (lateral and axial), respectively. The coefficients of variation corresponding to the elevational resolution test were all within 9.5%. Overall, in our assessment, the evaluated package performed well for objective and quantitative assessment of the above-mentioned image qualities under well-controlled acquisition conditions. We are finding it to be useful for various clinical ultrasound applications including performance comparison between scanners from different vendors.

Development of a robust MRI fiducial system for automated fusion of MR-US abdominal images.

We present the development of a two-component magnetic resonance (MR) fiducial system, that is, a fiducial marker device combined with an auto-segmentation algorithm, designed to be paired with existing ultrasound probe tracking and image fusion technology to automatically fuse MR and ultrasound (US) images. The fiducial device consisted of four ~6.4 mL cylindrical wells filled with 1 g/L copper sulfate solution. The algorithm was designed to automatically segment the device in clinical abdominal MR images. The algorithm's detection rate and repeatability were investigated through a phantom study and in human volunteers. The detection rate was 100% in all phantom and human images. The center-of-mass of the fiducial device was robustly identified with maximum variations of 2.9 mm in position and 0.9° in angular orientation. In volunteer images, average differences between algorithm-measured inter-marker spacings and actual separation distances were 0.53 ± 0.36 mm. "Proof-of-concept" automatic MR-US fusions were conducted with sets of images from both a phantom and volunteer using a commercial prototype system, which was built based on the above findings. Image fusion accuracy was measured to be within 5 mm for breath-hold scanning. These results demonstrate the capability of this approach to automatically fuse US and MR images acquired across a wide range of clinical abdominal pulse sequences.

Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis.

BACKGROUND: Uterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery are minimally invasive therapies approved by the US Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments. OBJECTIVE: The objective of the study was to summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment. STUDY DESIGN: Premenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n = 57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n = 34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected. RESULTS: Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P <.001). Of women undergoing focused ultrasound (n = 43), 23 (53%) underwent 2 treatment days. Immediate self-rated postprocedure pain was higher after uterine artery embolization than focused ultrasound (median [interquartile range], 5 [1-7] vs 1 [1-4]; P = .002). Compared with those having focused ultrasound (n = 39), women undergoing embolization (n = 36) were more likely to use outpatient opioid (75% vs 21%; P < .001) and nonsteroidal antiinflammatory medications (97% vs 67%; P < .001) and to have a longer median (interquartile range) recovery time (days off work, 8 [6-14] vs 4 [2-7]; P < .001; days until return to normal, 15 [10-29] vs 10 [10-15]; P = .02). There were no significant differences in the incidence or severity of adverse events between treatment arms; 86% of adverse events (42 of 49) required only observation or nominal treatment, and no events caused permanent sequelae or death. After adjustment for baseline pain and uterine fibroid load, uterine artery embolization was still significantly associated with higher opioid use and longer time to return to work and normal activities (P < .001 for each). Results were similar when restricted to the randomized controlled trial. CONCLUSION: Women undergoing uterine artery embolization have longer recovery times and use more prescription medications, but women undergoing focused ultrasound have longer treatment times. These findings were independent of baseline pain levels and fibroid load.

Fibroid interventions: reducing symptoms today and tomorrow: extending generalizability by using a comprehensive cohort design with a randomized controlled trial.

BACKGROUND: Uterine fibroids are an important source of morbidity for reproductive-aged women. Despite an increasing number of alternatives, hysterectomies account for about 75% of all fibroid interventional treatments. Evidence is lacking to help women and their health care providers decide among alternatives to hysterectomy. Fibroid Interventions: Reducing Symptoms Today and Tomorrow (NCT00995878, clinicaltrials.gov) is a randomized controlled trial to compare the safety, efficacy, and economics of 2 minimally invasive alternatives to hysterectomy: uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery. Although randomized trials provide the highest level of evidence, they have been difficult to conduct in the United States for interventional fibroid treatments. Thus, contemporaneously recruiting women declining randomization may have value as an alternative strategy for comparative effectiveness research. OBJECTIVE: We sought to compare baseline characteristics of randomized participants with nonrandomized participants meeting the same enrollment criteria and to determine whether combining the 2 cohorts in a comprehensive cohort design would be useful for analysis. STUDY DESIGN: Premenopausal women with symptomatic uterine fibroids seeking interventional therapy at 3 US academic medical centers were randomized (1:1) in 2 strata based on calculated uterine volume (<700 and ≥700 cc(3)) to undergo embolization or focused ultrasound surgery. Women who met the same inclusion criteria but declined randomization were offered enrollment in a parallel cohort. Both cohorts were followed up for a maximum of 36 months after treatment. The measures addressed in this report were baseline demographics, symptoms, fibroid and uterine characteristics, and scores on validated quality-of-life measures. RESULTS: Of 723 women screened, 57 were randomized and 49 underwent treatment (27 with focused ultrasound and 22 with embolization). Seven of the 8 women randomized but not treated were assigned to embolization. Of 34 women in the parallel cohort, 16 elected focused ultrasound and 18 elected embolization. Compared with nonrandomized participants, randomized participants had higher mean body mass index (28.7 vs 25.3 kg/m(2); P = .01) and were more likely to be gravid (77% vs 47%; P = .003) and smokers (42% vs 12%; P = .003). Age, race, uterine volume, number of fibroids, and baseline validated measures of general and disease-specific quality of life, pain, depression, and sexual function did not differ between the groups. When we performed a comprehensive cohort analysis and analyzed by treatment arm, the only baseline difference observed was a higher median McGill Pain Score among women undergoing focused ultrasound (10.5 vs 6; P = .03); a similar but nonsignificant trend was seen in visual analog scale scores for pain (median, 39.0 vs 24.0; P = .06). CONCLUSION: Using a comprehensive cohort analysis of study data could result in additional power and greater generalizability if results are adjusted for baseline differences.

Magnetic resonance imaging-guided laser interstitial thermal therapy for previously treated hypothalamic hamartomas.

OBJECTIVE Hypothalamic hamartomas (HHs) are associated with gelastic seizures and the development of medically refractory epilepsy. Magnetic resonance imaging-guided laser interstitial thermal therapy (MRg-LITT) is a minimally invasive ablative treatment that may have applicability for these deep-seated lesions. Here, the authors describe 3 patients with refractory HHs who they treated with MRg-LITT. METHODS An institutional review board-approved prospective database of patients undergoing Visualase MRg-LITT was retrospectively reviewed. Demographic and historical medical data, including seizure and medication histories, previous surgeries, procedural details, and surgical complications, along with radiological interpretation of the HHs, were recorded. The primary outcome was seizure freedom, and secondary outcomes included medication reduction, seizure frequency, operative morbidity, and clinical outcome at the latest follow-up. RESULTS All 3 patients in the multi-institutional database had developed gelastic seizures related to HH at the ages of 7, 7, and 9 years. They presented for further treatment at 25, 28, and 48 years of age, after previous treatments with stereotactic radiosurgery in all cases and partial hamartoma resection in one case. One ablation was complicated by a small tract hemorrhage, which was stable on postoperative imaging. One patient developed hyponatremia and experienced weight gain, which were respectively managed with fluid restriction and counseling. At the most recent follow-up at a mean of 21 months (range 1-32 months), one patient was seizure free while another had meaningful seizure reduction. Medication was reduced in one case. CONCLUSIONS Adults with gelastic seizures despite previous treatments can undergo MRg-LITT with reasonable safety and efficacy. This novel therapy may provide a minimally invasive alternative for primary and recurrent HH as the technique is refined.

Incidence of additional treatments in women treated with MR-guided focused US for symptomatic uterine fibroids: review of 138 patients with an average follow-up of 2.8 years.

PURPOSE: To assess long-term outcomes of magnetic resonance (MR)-guided focused ultrasound (US) treatments of uterine fibroids. MATERIALS AND METHODS: A retrospective follow-up of 138 patients treated at a single institution between March 2005 and November 2011 was conducted. The patients were not part of a clinical study and were followed through retrospective review of their medical records and telephone interviews to assess additional treatments for fibroid-related symptoms. Survival methods, including Cox proportional hazards models, were used to assess the association between incidence of additional treatments and patient data obtained during screening before treatment. RESULTS: The average length of follow-up was 2.8 years (range, 1-7.2 y). The cumulative incidence of additional treatments at 36 months and 48 months after MR-guided focused US was 19% and 23%, respectively. Women who did not need additional treatment were older than women who did (46.3 y ± 5.6 vs 43.0 y ± 5.8; P = .006; hazard ratio, 0.855; 95% confidence interval, 0.789-0.925). Additionally, women with heterogeneous or bright fibroids on T2-weighted MR imaging were more likely to require additional treatment compared with women with homogeneously dark fibroids (hazard ratio, 5.185 or 5.937, respectively; 95% confidence interval, 1.845-14.569 or 1.401-25.166, respectively). Physician predictions of treatment success, recorded during the screening process, had significant predictive value (P = .018). CONCLUSIONS: The long-term rates of additional interventions after MR-guided focused US of symptomatic uterine fibroids were found to be comparable with other uterine-sparing procedures, such as uterine artery embolization or myomectomy. Older patient age and homogeneously dark fibroids were associated with fewer additional treatments. Physician assessment of treatment success was found to be a valuable tool in patient screening.

Uterine and Fibroid Imaging Analysis from the FIRSTT Study.

Background: Women with uterine fibroids often seek uterine-preserving treatments, rather than hysterectomy. Imaging-defined endpoints following nonsurgical treatments for fibroids are limited. Materials and Methods: Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT), a randomized controlled trial of uterine artery embolization (UAE) versus magnetic resonance imaging-guided focused ultrasound surgery (MRgFUS), enrolled premenopausal women with symptomatic uterine fibroids. In this subanalysis, we report imaging results up to 36 months after UAE or MRgFUS. Magnetic resonance imaging (MRI) was performed at baseline for all women and during the 36 months after treatment if they did not meet other study endpoints. The main outcome of this subanalysis was fibroid volume reduction (defined both in terms of total fibroid load and volume of the largest fibroid), uterine volume reduction, and nonperfused volume. Results: During 2010-2014, 25 of the 37 women who were randomized and treated at Mayo Clinic had a 24-month follow-up MRI (11 UAE; 14 MRgFUS); among these women, 15 (7 UAE and 8 MRgFUS) had a 36-month follow-up MRI. Average age for the cohort was 44.1 (standard deviation, SD = 4.4) years. Nine patients had a second fibroid procedure by 36 months (seven in the MRgFUS arm and two in UAE arm). Median total fibroid load reduction was ∼50% in both treatment arms at both 24- and 36-month follow-up. Volume of the largest fibroid decreased more in the MRgFUS arm, whereas uterine volume decreased more in the UAE arm (neither reached statistical significance). At 24 months, median nonperfused volume was higher in the UAE arm (92%) than the MRgFUS arm (10%). Conclusions: Similar fibroid volume reduction was seen for the MRgFUS and UAE treatments in this comparative effectiveness study. Nonperfused volume 24 months after the procedure was higher in the UAE arm than in the MRgFUS arm. Clinical Trial Registration Number: NCT00995878, clinicaltrials.gov.

Novel Focal Therapeutic Hypothermia Device for Treatment of Acute Neurologic Injury: Large Animal Safety and Efficacy Trial.

Objective Therapeutic hypothermia is a potentially powerful and controversial clinical tool for neuroprotection following acute neurologic pathology, particularly vascular injury. Indeed, therapeutic hypothermia remains a standard of care for postcardiac arrest ischemia and acute neonatal hypoxic-ischemic encephalopathy, improving both survival and outcomes. Although therapeutic hypothermia remains promising for cellular and systems-based neuronal protection in other neurologic injury states, the systemic side effects have limited clinical utility, confounded analysis of potential neurologic benefits, and precluded the completion of meaningful clinical trials. Methods To address such limitations, we developed and tested a novel, minimally invasive, neurocritical care device that employs continuous circulation of cold saline through the pharyngeal region to deliver focal cerebrovascular cooling. We conducted a preclinical safety and efficacy trial in six adult porcine animals to assess the validity and functionality of the NeuroSave device, and assess cooling potential following middle cerebral artery occlusion ( n = 2). Results NeuroSave consistently lowered brain parenchymal temperature by a median of 9°C relative to core temperature within 60 minutes of initiation, including in ischemic cerebral parenchyma. The core body temperature experienced a maximal reduction of 2°C, or 5% of body temperature, with no associated adverse effects identified. Conclusion The present study uses a large animal preclinical model to demonstrate the safety and efficacy of a novel, noninvasive device for the induction of robust and systemically safe hypothermia within the brain.

3.0T MR-guided laser ablation of a prostate cancer recurrence in the postsurgical prostate bed.

Biochemical recurrence of prostate cancer after definitive therapy with radical prostatectomy occurs in 25%-30% of cases. The first known case of magnetic resonance (MR) imaging-guided ablation using laser interstitial thermal therapy (LITT) for locally recurrent prostate cancer after radical prostatectomy is presented. Using 3.0T MR guidance, two laser applicators were placed via a transperineal approach. Laser ablation was performed using MR thermometry to determine the ablation endpoint and lesion coverage. Dynamic contrast-enhanced MR imaging after the procedure showed no definitive abnormal enhancement. The patient had no change in continence or potency after the procedure.