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Purpose The OsteoCool Tumor Ablation Post-Market Study (OPuS One) was a prospective, multi-national, single-arm study to investigate safety and effectiveness of radiofrequency ablation (RFA) for palliation of painful lytic bone metastases with 12 months of follow-up. RFA has demonstrated effective palliation of osseous metastases in small clinical studies with short-term follow-up; however, a long-term assessment with robust subject numbers is lacking. Materials and Methods Prospective assessments were conducted at Baseline, 3 days, 1 week, and 1, 3, 6, and 12-months. Pain and quality of life were measured prior to RFA and postoperatively using the Brief Pain Inventory, European Quality of Life—5 Dimension, and European Organization for Research and Treatment of Cancer Care Quality of Life Questionnaire for palliative care. Radiation, chemotherapy and opioid usage, and related adverse events were collected. Results 206 subjects were treated with RFA at 15 institutions in OPuS One. Worst pain, average pain, pain interference and quality of life significantly improved at all visits starting 3 days post-RFA and sustained to 12 months (P Conclusion RFA for lytic metastases provides rapid (within 3 days) and statistically significant pain and quality of life improvements with sustained long-term relief through 12 months and a high degree of safety, independent of radiation. Level of Evidence: 2b, Prospective, Non-Randomized, Post-Market study This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

To evaluate the safety and efficacy of arterial embolization to relieve shoulder pain secondary to adhesive capsulitis (AC).In total, 20 patients (18 females, 2 males; mean age, 51 years) with AC resistant to30 days of conservative treatment were enrolled in a multicenter prospective study. Adhesive capsulitis embolization was performed with 75-μm or 200-μm spherical particles. Subjects were assessed before and after the procedure with magnetic resonance imaging, visual analog scale (VAS; 0-100 mm) scores, Single Assessment Numeric Evaluation (SANE; 0-100) scores, and American Shoulder and Elbow Surgeons (ASES; 0-100) scores. Adverse events were recorded at all follow-up time points.Hypervascularity was identified and embolization was technically successful in all patients, with 83 arteries embolized in 20 patients. Baseline VAS, SANE, and ASES scores before the procedure were 89.2 mm, 27.2, and 30.9, respectively. The 1-month (n = 19), 3-month (n = 18), and 6-month (n = 12) follow-ups demonstrated significant improvements. At the 1-month follow-up, VAS score decreased by 31.8 (P = 1.2E-11), SANE score increased by 22.1 (P = 1.8E-8), and ASES score increased by 14.2 (P = 4.3E-5). At the 6-month follow-up, VAS score decreased by 62.1 (P = 7.0E-11), SANE score increased by 55.4 (P = 4.1E-10), and ASES score increased by 44.5 (P = 1.8E-6). Due to the coronavirus pandemic, the study ended early; 6 patients did not complete the 6-month follow-up. No major adverse events were noted.Interim findings suggest that arterial embolization is safe and effective for patients with AC refractory to conservative treatment.

Symptomatic knee pain is one of the most common joint diseases that affects millions of people worldwide. The treatment for knee pain secondary to osteoarthritis (OA) begins with conservative therapy and progresses to surgical intervention when conservative therapy fails. Genicular artery embolization (GAE) offers an alternative option for patients who are poor surgical candidates. Multiple studies have been conducted worldwide demonstrating the safety and efficacy of GAE in patients with mild to moderate OA. The purpose of this article is to describe the current literature on GAE and highlight the latest findings from a randomized controlled trial comparing GAE versus sham embolization.

There is a lack of adjudicated and prospectively randomized published outcomes on the use of drug-coated balloons (DCB) to treat dysfunctional arteriovenous fistula in Asian patients. This post-hoc subgroup analysis of 112 Japanese participants from the global IN.PACT AV Access trial reports outcomes through 12 months.Participants were treated with DCB (n=58) or standard non-coated percutaneous transluminal angioplasty (PTA) balloons (n=54). Outcomes included target lesion primary patency (TLPP), access circuit primary patency, and safety.Through six months, TLPP was 86.0% (49/57) in the DCB group and 49.1% (26/53) in the PTA group (p0.001). Through twelve months, TLPP was 67.3% (37/55) in the DCB group and 43.4% (23/53) in the PTA group (p=0.013).In this post-hoc analysis of Japanese participants from the IN.PACT AV Access trial, participants treated with DCB had higher TLPP through 6 and 12 months compared to PTA. This article is protected by copyright. All rights reserved.

Interventional radiology procedures are being increasingly used to mitigate chronic pain. In addition to established therapies such as thermal bone lesion ablation, kyphoplasty, and chemical neurolysis, ongoing research has shown promising results for the use of embolization in treatment of osteoarthritic knee pain and chronic pain secondary to adhesive shoulder capsulitis. This review will highlight some of the most common interventional radiology pain procedures, as well as provide insight into future pain-relieving embolization.

Adhesive capsulitis (AC) is an inflammatory process characterized by limited shoulder mobility and pain. The prevalence of AC is as high as 5% in the general population but increases up to 20% in patients with diabetes. The current management algorithm for AC consists of physical therapy followed by pharmacological treatment. Surgical options are reserved for those with refractory pain. Adhesive capsulitis embolization (ACE) is a new minimally invasive procedure that involves particle embolization of the inflammatory vessels linked to chronic shoulder pain. Early studies show promising results with significant improvement in shoulder pain and mobility. The present case describes a 40-year-old woman who underwent ACE for refractory shoulder pain and discusses the postoperative management of ACE.

Chronic inflammation leading to musculoskeletal pain has garnered interest in the past decade with the success of genicular artery embolization for knee pain secondary to osteoarthritis. Outside the knee joint, musculoskeletal embolization has been applied to other anatomical locations, mainly shoulder pain secondary to adhesive capsulitis and elbow pain secondary to lateral epicondylitis. The success of these early trials and other case reports highlights the efficacy of musculoskeletal embolization and its future potential.

An 88-year-old catheter-dependent patient with peripheral vascular disease and benign prostatic hyperplasia was referred for prostatic artery embolization (PAE). Selective angiography of the left internal iliac artery (IIA) revealed a 2.5-cm aneurysm and a single artery comprising the anterior division of the IIA (inferior gluteal artery). No prostatic artery (PA) was identified on the left. Additional angiography of the left external iliac artery (EIA), right IIA, and right EIA did not demonstrate prostatic perfusion. The right profunda femoris artery was then selected given previously reported atherosclerotic collaterals, which revealed an ascending branch of the medial circumflex femoral artery coursing through the upper thigh into the pelvis and reconstituting the right anterior division of the IIA. A 2.4-French microcatheter (Terumo) and 0.018-inch wire (Transcend, Boston Scientific) were used to enter the pelvic vasculature, right PA was identified, and a 2-mm coil was used to perform embolization of a potential nontarget anterior division branch. Embolization of the right PA was then performed with 250-µm particulate and Gelfoam slurry. Two-week follow-up revealed spontaneous voiding and catheter independence.

To review and to compare indirectly the outcomes of minimally invasive therapies for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.A literature search via Medline and Cochrane Central databases was completed for randomized control studies published between January 2000 to April 2020 for the following therapies: Rezum, Urolift, Aquablation, and prostatic artery embolization (PAE). Data on the following variables were included: International prostate symptom score (IPSS), maximum urinary flow rate, quality of life, and postvoid residual (PVR). Standard mean differences between treatments were compared through a meta-analysis using transurethral resection of the prostate (TURP) to assess differences in treatment effect.There was no significant difference in outcomes between therapies for IPSS at the 3, 6, and 12-month follow ups. Although outcomes for Rezum were only available out to 3 months, there were no consistently significant differences in outcomes when comparing Aquablation versus PAE versus Rezum. TURP PVR was significantly better than Urolift at 3, 6, and 12 months. No significant differences in minor or major adverse events were noted.Although significant differences in outcomes were limited, Aquablation and PAE were the most durable at 12 months. PAE has been well studied on multiple randomized control trials with minimal adverse events while Aquablation has limited high quality data and has been associated with bleeding-related complications.

This study evaluated detectable nontarget embolization (NTE) during prostatic artery embolization (PAE) and the safety and efficacy of using radiopaque particles in PAE. Ten patients aged40 years with prostate glands of50 mL and refractory lower urinary tract symptoms were analyzed. Unenhanced computed tomography scans at baseline and at 3 months after PAE, using 40-90-μm radiopaque spherical embolic beads, were compared to assess the NTE. Growth models evaluated changes from baseline to 3, 6, and 12 months in International Prostate Symptom Score (IPSS), peak urine flow rate (Qmax), quality of life (QoL), International Index of Erectile Function (IIEF), and postvoid residual (PVR). The IPSS, QoL, and Qmax improved at all time points (P.05), with no trend in PVR or IIEF. Adverse events that occurred were minor. Radiographic NTE was seen in all patients, correlating at times with postprocedural symptoms (eg, rectal pain). Symptoms were not correlated with the NTE in some patients, whereas other patients remained asymptomatic despite NTE.

Initial research into the treatment of pain secondary to knee osteoarthritis and shoulder adhesive capsulitis with embolization have yielded promising results. With further investigation, embolization may become a mainstay of treatment for pain from these two conditions.

PURPOSE To assess the safety and efficacy of genicular artery embolization (GAE) compared with a sham procedure in the treatment of knee pain secondary to mild to moderate osteoarthritis (OA). MATERIALS AND METHODS A multicenter, single-blinded, randomized controlled trial was conducted to evaluate knee OA symptom reduction after GAE versus sham procedure. Subjects (n = 21) with mild to moderate OA and intractable knee pain were randomized 2:1 to either GAE or a sham procedure. Subjects who were randomized to the sham procedure and did not report clinical improvement in both the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analog scale (VAS) scores were unblinded and able to crossover to treatment at 1 month. Longitudinal data were collected for 12 months, and subjects were excluded if they required additional analgesics at follow-up. Reductions in the VAS and total WOMAC scores were compared using mixed-effects linear regression models. RESULTS All subjects in the sham group failed to show significant improvements at 1 month and crossed over to the treatment arm. There was a statistically significantly greater pain reduction in the treatment group than in the sham group at 1 month (VAS, 50.1 mm; standard error [SE], 10.6; 95% confidence interval [CI], 29.0, 72.3; P

Purpose To review and indirectly compare the outcomes of minimally invasive therapies for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Materials and Methods A literature search via Medline and Cochrane Central databases was completed for randomized control studies published between January 2000 to April 2020 for the following therapies: Rezum, Urolift, Aquablation, and prostate artery embolization (PAE). Data on the following variables were included: international Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), quality of life (QoL), and post-void residual (PVR). Standard mean differences between treatments were compared through a meta-analysis using transurethral resection of the prostate (TURP) to assess differences in treatment effect. Results No significant difference in outcomes between therapies were noted for IPSS at the 3-, 6-, and 12-month follow-ups. Although outcomes for rezum were only available out to 3 months, there were no consistently significant differences in outcomes when comparing Aquablation vs PAE vs Rezum. TURP PVR was significantly better than Urolift at 3-, 6-, and 12 months. No significant differences in minor or major AEs were noted. Conclusion Although significant differences in outcomes were limited, aquablation and PAE were the most durable at 12 months. PAE has been well studied on multiple randomized control trials with minimal adverse events while aquablation has limited high quality data and has been associated with bleeding-related complications.

International audience; Purpose To evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone metastases. Materials and Methods One hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects’ pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected. Results Eighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n = 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P < .0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure. Conclusions Results from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.

12086 Background: Patients with bone metastases may experience pain and decreased quality of life. Standard of care therapies such as radiation therapy could take weeks for pain relief and carry a risk of radiation induced fracture. Minimally invasive percutaneous radiofrequency ablation (RFA) have been shown in small observational studies to be an alternative treatment for bone metastases. We report the results of the OPuS One trial evaluating RFA for the palliative treatment of patients with painful bone metastases. Methods: OPuS One (NCT03249584) was a multicenter prospective trial. 218 subjects with painful bone metastases (≥ 4/10 worst pain scores, Brief Pain Inventory [BPI], at target treated site) were enrolled from 15 sites. RFA was performed under image guidance at one or two locations. Vertebral augmentation was followed based on physician’s discretion. Subjects’ pain (BPI) and quality of life (EQ-5D) scores were calculated in subjects at three days, one week, and one, three, six, and 12 months post RFA. Rate of complete (0 pain score at treated site with no concomitant analgesic increase) and partial responders (≥ 2 pain score reduction without analgesic increase or analgesic reduction of ≥ 25% from baseline) were calculated. Device-, procedure-, and/or therapy-related adverse events (AEs) were collected. Results: 206 subjects, 113 (55%) female and 93 (45%) males (mean age was 63.7 years) were treated with RFA. Most common primary cancers were breast (23%), lung (23%), and kidney (10%). 184 (89%) subjects were treated for metastatic lesions involving the thoracolumbar spine and 22 (11%) subjects were treated for iliac crest, periacetabulum, sacrum or mixed vertebral and pelvic location. 99% (262/264) of RFA procedures were technically successful and 97% were followed by vertebral augmentation. Subjects reported significant improvement in worst pain from baseline at 7.8 to 5.5, 4.7, 3.6, 3.2, 2.4, and 2.6 at three days, one week and one, three, six, and 12 months post RFA, respectively (p < 0.0001 for all visits). Significant improvements were also seen in average pain (p < 0.0001 for all visits), pain interference (p < 0.0001 for all visits), and quality of life scores (p < 0.0001 for all visits). Overall response rates were 53%, 58%, 61%, 63%, 70%, and 75% at three days, one week, one month, three months, six months, and twelve months post RFA, respectively. Six AEs were reported with three as serious: intra-abdominal fluid collection, pneumonia and respiratory failure. 82 deaths were reported during the study, none were related to the device, therapy, and/or procedure. No skeletal related events were reported. Conclusions: In a large prospective multicenter trial, OPuS One, RFA provided rapid, significant, and durable improvements in pain relief and quality of life up to 12 months. Clinical trial information: NCT03249584.

Prostatic artery embolization (PAE) is a safe and efficacious procedure for benign prostatic hyperplasia (BPH), though is technically challenging. We present our experience of technical and clinical outcomes of robotic and manual PAE in patients with BPH. IRB-approved retrospective study of 40 consecutive patients 49–81 years old with moderate or severe grade BPH from May 2014 to July 2015: 20 robotic-assisted PAE (group 1), 20 manual PAE (group 2). Robotic-assisted PAE was performed using the Magellan Robotic System. American Urological Association (AUA-SI) score, cost, technical and clinical success, radiation dose, fluoroscopy, and procedure time were reviewed. Statistical analysis was performed within and between each group using paired t test and one-way analysis of variance respectively, at 1 and 3 months. No significant baseline differences in age and AUA-SI between groups. Technical success was 100% (group 1) and 95% (group 2). One unsuccessful subject from group 2 returned for a successful embolization using robotic assistance. Fluoroscopy and procedural times were similar between groups, with a non-significant lower patient radiation dose in group 1 (30,632.8 mGy/cm2 vs 35,890.9, p = 0.269). Disposable cost was significantly different between groups with the robotic-assisted PAE incurring a higher cost (group 1 $4530.2; group 2 $1588.5, p

Objective To assess the safety and local recurrence-free survival in patients after cryoablation for treatment of pulmonary metastases. Methods This multicenter, prospective, single-arm, phase 2 study included 128 patients with 224 lung metastases treated with percutaneous cryoablation, with 12 and 24 months of follow-up. The patients were enrolled on the basis of the outlined key inclusion criteria, which include one to six metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), metastatic disease, and overall survival rates were estimated using the Kaplan–Meier method. Complications were captured for 30 days after the procedure, and changes in performance status and quality of life were also evaluated. Results Median size of metastases was 1.0 plus or minus 0.6 cm (0.2–4.5) with a median number of tumors of 1.0 plus or minus 1.2 cm (one to six). Local recurrence-free response (local tumor efficacy) of the treated tumor was 172 of 202 (85.1%) at 12 months and 139 of 180 (77.2%) at 24 months after the initial treatment. After a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) was 184 of 202 (91.1%) at 12 months and 152 of 180 (84.4%) at 24 months. Kaplan–Meier estimates of 12- and 24-month overall survival rates were 97.6% (95% confidence interval: 92.6–99.2) and 86.6% (95% confidence interval: 78.7–91.7), respectively. Rate of pneumothorax that required pleural catheter placement was 26% (44/169). There were eight grade 3 complication events in 169 procedures (4.7%) and one (0.6%) grade 4 event. Conclusion Percutaneous cryoablation is a safe and effective treatment for pulmonary metastases.

Prostatic artery embolization (PAE) has been shown to have high clinical success rates in the short, medium, and long term. However, some patients will require a repeat procedure due to technical failure or recurrence of lower urinary tract symptoms (LUTS) after initial success. This patient population presents with a unique set of challenges and considerations when performing PAE, which will be highlighted in this chapter.

PAE is a technically challenging procedure due to multiple factors including variability of arterial anatomy and difficulty traversing small tortuous arteries. Considerations such as access site determination, cross-sectional angiography and advanced wire-catheter technique can improve success rates.

To evaluate the efficacy and safety of embolization of hyperemic synovial tissue for the treatment of knee pain secondary to osteoarthritis (OA).Twenty patients with radiographic knee OA and moderate-to-severe pain refractory to conservative therapy were enrolled in a prospective, 2-site pilot study. Genicular artery embolization (GAE) was performed with 75- or 100-μm spherical particles. Patients were assessed with magnetic resonance imaging at baseline and at 1 month and with the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and at 1, 3, and 6 months. Adverse events were recorded at all timepoints.Embolization of at least 1 genicular artery was achieved in 20/20 (100%) patients. Mean VAS improved from 76 mm ± 14 at baseline to 29 mm ± 27 at 6-month follow-up (P.01). Mean WOMAC score improved from 61 ± 12 at baseline to 29 ± 27 at 6-month follow-up (P.01). Self-limiting skin discoloration occurred in 13/20 (65%) patients. Two of 20 (10%) patients developed plantar sensory paresthesia that resolved within 14 days.GAE to treat knee pain secondary to OA can be performed safely and demonstrates potential efficacy. Further randomized comparative studies are needed to determine true treatment effect versus placebo effect.

Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p

To determine the role of prostate volume as a predictor of outcome after prostatic artery embolization (PAE).From January 2012 to September 2014, 78 consecutive patients undergoing PAE were evaluated at baseline and 1, 3, and 6 months. Analysis was performed comparing prostate volume groups (group 1,50 cm3; group 2, 50-80 cm(3); group 3,80 cm3) at baseline and follow-up to assess for differences in outcomes of American Urological Association (AUA) symptom index, quality of life (QOL)-related symptoms, and International Index of Erectile Function (IIEF).Mean baseline prostate volumes were 37.5 cm(3) in group 1 (n = 16), 65.7 cm3 in group 2 (n = 26), and 139.4 cm3 in group 3 (n = 36). There were no significant differences in baseline age, AUA symptom index, QOL, or IIEF between groups. Bilateral embolization was successful in 75 of 78 patients (96%). Two patients underwent unilateral embolization, and treatment failed in one patient as a result of bilateral atherosclerotic occlusion. A significant reduction in AUA symptom index was achieved within groups from baseline to 1, 3, and 6 months (n = 77): in group 1, from 27.2 to 14.0, 12.9, and 15.9, respectively (P = .002); in group 2, from 25.6 to 17.1, 16.3, and 13.5, respectively (P.0001); and in group 3, from 26.5 to 15.2, 12.5, and 13.6, respectively (P.0001). There was also a significant improvement in QOL. Comparative analysis demonstrated no statistically significant differences in AUA symptom index, QOL, or IIEF between groups. Two minor complications occurred: groin hematoma and a urinary tract infection.PAE offers similar clinical benefits to patients with differing gland sizes and may offer a reasonable alternative for poor candidates for urologic surgery.

Recurrent hemarthrosis is an uncommon but troublesome complication following knee arthroplasty. This study reports the results for 13 patients with spontaneous recurrent hemarthrosis after knee arthroplasty treated with arterial embolization. The average interval between arthroplasty and embolization was 47 months (range, 2-103 months), and the average time from onset of hemarthrosis to embolization was 4.1 months (range, 1-11 months). Geniculate arterial embolization lead to resolution of hemarthrosis in 12 of 13 patients (92.3%). The one clinical failure likely represented a case of misdiagnosed periprosthetic joint infection. Two patients experienced transient cutaneous ischemia related to distal particulate embolization that resolved spontaneously. Selective geniculate arterial embolization is an effective and safe treatment modality for recurrent hemarthrosis after knee arthroplasty.

The purpose of this paper is to review the percutaneous interventions available for the treatment of osteoarthrosis of the knee that address pain and prolong the time to arthroplasty. Corticosteroid injection and viscosupplementation have been the most studied, but there is still no consensus about their value. Thermal nerve ablation, including both radiofrequency ablation and cryoneurolysis, is a promising new modality of therapy that may increase in clinical use given current data showing favorable outcomes. Of the future therapies that are currently under investigation, synovial embolization via the geniculate arteries represents an exciting new approach that may soon be available clinically. There are various percutaneous interventions available for the treatment of osteoarthrosis of the knee that address pain and prolong the time to arthroplasty.

Twelve patients underwent balloon-occlusion prostatic artery embolization (PAE) at a single center. Bilateral prostatic artery catheterization was achieved in all patients, but unilateral embolization was performed in 1 patient as a result of the presence of a prostatic arteriovenous fistula. Mean International Prostate Symptom Score and quality-of-life score decreased by 15 ± 7 (P < .01) and 4 ± 1 (P < .01) points, respectively, over a mean follow-up period of 22 weeks ± 8. Only self-limiting minor complications were encountered. The initial experience with balloon-occlusion PAE suggests that it is technically feasible and can be performed safely.

11605 Background: To report the preliminary outcomes from the prospective, nonrandomized, multicenter study of the OsteoCool Radiofrequency Ablation system used for the palliative treatment of patients with painful bone metastases (OPuS One Study). Methods: Subjects were prospectively enrolled (NCT03249584) from October 2017 through August 2018. Inclusion criteria were: 2 or less painful target sites involving the thoracolumbar spine, pelvis and/or sacrum, with a worst pain ≥4/10 measured by the Brief Pain Inventory (BPI) within the previous 24 hours. RFA was performed with the OsteoCool device (Medtronic) under imaging guidance and followed by cementoplasty at operator discretion. Subjects were evaluated prior to RFA, at discharge, 3 days, 1 week, and 1-, 3-, 6-, and 12-months. Demographics and disease characteristics were collected at baseline and outcomes were assessed using validated measures. Device-, procedure- and/or therapy-related adverse events (AEs) were collected. Results: At the time of the analysis, 37 subjects at 8 US centers underwent RFA. The mean age was 64 years (range 30-89) and 68% were female. Mean baseline BPI worst pain was 8.6. The most common histology was adenocarcinoma; breast (32%) and lung (24%) were reported as the most common primary cancer. Thirty-one subjects (84%) were treated for lesions involving the thoracolumbar spine, while 6 subjects (16%) were treated for lesions located the pelvis and/or sacrum. All RFA procedures were technically successful. Of the 14 subjects presenting at the 3-month visit, 93% did not undergo radiation therapy at the targeted site(s) between baseline and 3 months. Seventy-four percent (25/34) of subjects at 1 week and 93% (13/14) of subjects at 3 months reported a clinically significant change from baseline in worst pain of ≥ 2 points. One AE, drug hypersensitivity, resolved without intervention. All eleven deaths reported were attributed to the subjects underlying malignancy and not related to RFA. Conclusions: The preliminary results of the OPuS One study show rapid pain improvement at 1 week and sustained long-term relief through 3 months in patients with metastatic bone disease. Clinical trial information: NCT03249584.