Four to six million patients a year in the United States suffer from chronic pain caused by facet joint degeneration. Thermal ablation of the affected facet joint's sensory nerve using radiofrequency electrodes is the therapeutic standard of care. High-intensity focused ultrasound (HIFU) is a novel technology enabling imageguided non-invasive thermal ablation of tissue. Six pigs underwent fluoroscopy-guided HIFU of the medial branch nerve and were followed up for 1 wk (two pigs), 1 mo (two pigs) and 3 mo (two pigs). At the end of each follow-up period, the animals were sacrificed, and targeted tissue was excised and evaluated with computed tomography scans as well as by macro-and micropathology. No significant adverse events were recorded during the procedure or follow-up period. All targets were successfully ablated. X-Ray-guided HIFU is a feasible and promising alternative to radiofrequency ablation of the lumbar facet joint sensory nerve.
Objective To investigate the safety and feasibility of a fluoroscopy-guided, high-intensity focused ultrasound system for zygapophyseal joint denervation as a treatment for chronic low back pain. Methods The clinical pilot study was performed on ten participants diagnosed with lumbar zygapophyseal joint syndrome. Each participant had a documented positive response to a diagnostic block or a previous, clinically beneficial radiofrequency ablation. For a descriptive study, the primary outcome was the safety question. All device- or procedure-related adverse events were collected. Secondary outcome variables included the average numeric rating scale for pain, Roland-Morris disability questionnaire, Brief Pain Inventory, Patient Global Impression of Change, morphine equivalent dose, and the finding of the neurologic examination. Results All participants tolerated the procedure well with no significant device- or procedure-related adverse events; there was one episode of transient pain during the procedure. The average numeric rating scale score for pain decreased from 6.2 at baseline to 2.1 (N = 10) after one month, 4.9 (N = 9) after 3 months, 3.0 (N = 8) after 6 months, and 3.0 (N = 6) after 12 months. The ratio of participants who were considered a treatment success was 90% at 1 month, 50% at 3 months, 60% at 6 months, and 40% at 12 months. Conclusions The first clinical pilot study using a noninvasive, fluoroscopy-guided, high-intensity focused ultrasound lumbar zygapophyseal neurotomy resulted in no significant device- or procedure-related adverse events and achieved clinical success comparable with routine radiofrequency ablation.
Objectives Essential Tremor (ET) is one of the most common neurologic conditions, and conservative measures are frequently suboptimal. Recent data from a multi-institution, randomized controlled clinical trial demonstrated that Magnetic Resonance-guided Focused Ultrasound (MRgFUS) thalamotomy improves upper limb tremor in medically refractory ET. This study assesses the cost-effectiveness of this novel therapy in comparison to existing procedural options. Methods PubMed and Cochrane Library searches were performed for studies of MRgFUS, Deep Brain Stimulation (DBS), and Stereotactic Radiosurgery (SRS) for ET. Pre-and post-operative tremor-related disability scores were collected from 32 studies involving 83 MRgFUS, 615 DBS, and 260 SRS cases. Utility (defined as percent change in functional disability) was calculated, and Medicare reimbursements were collected as a proxy for societal cost -costs of MRgFUS for ET were derived from a combination of available costs of approved indications and SRS costs where appropriate. A decision and cost-effectiveness analysis was then constructed, implementing meta-analytic techniques. Results MRgFUS thalamotomy resulted in significantly higher utility scores compared with DBS and SRS based on estimates of Medicare reimbursement (p < 0.001). MRgFUS was also the most inexpensive procedure out of the three (p < 0.001). Conclusions Preliminary experience with MRgFUS for ET suggests that this novel therapeutic may be more effective than available alternatives and potentially less costly for society. It thus will likely "dominate" DBS and SRS as a more cost-effective option for medically refractory ET. Our findings support further investigation of MRgFUS for ET and broad adoption. Objectives The ventral intermediate nucleus (VIM) is not visible on conventional Magnetic Resonance Imaging (MRI).A novel method for tractography-based VIM identification has recently been described. We report the short-term clinical results of prospective VIM targeting with tractography in a cohort of patients undergoing Focused Ultrasound thalamotomy. Methods All patients underwent structural and diffusion weighted imaging (60 diffusion directions, 2 mm isovoxel) with 3 Tesla MRI scanner (Philips Ingenia CX). The images were processed using streamline tractography (Stealth Viz, Medtronic Inc.). The lateral and posterior borders of VIM were defined by tracking the pyramidal tract and medial lemniscus respectively. A VIM region of interest (ROI) was placed 3 mm away from these borders (Figs. 1, 2 and 3). The structural connectivity of this VIM ROI was confirmed to the motor cortex (M1) and cerebellum. The coordinates of tractography-based VIM in relation to posterior commissure were noted for surgical targeting. The parameters analyzed include a clinical tremor scale (pre-, intraoperative, and post operative), operative time, and number of sonications. Results Tractography-based VIM targeting was successful in 7 out of 8 patients. The coordinates of tractography-based VIM were significantly different from...
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