Consensus Guidelines of Irreversible Electroporation for Pancreatic Tumors: Protocol Standardization Using the Modified Delphi Technique.

Since no uniform treatment protocol for pancreatic irreversible electroporation (IRE) exists, the heterogeneity throughout literature complicates the comparison of results. To reach agreement among experts, a consensus study was performed. Eleven experts, recruited according to predefined criteria regarding previous IRE publications, participated anonymously in three rounds of questionnaires according to a modified Delphi technique. Consensus was defined as having reached ≥80% agreement. Response rates were 100, 64, and 64% in rounds 1 to 3, respectively; consensus was reached in 93%. Pancreatic IRE should be considered for stage III pancreatic cancer and inoperable recurrent disease after previous local treatment. Absolute contraindications are ventricular arrhythmias, implantable stimulation devices, congestive heart failure NYHA class 4, and severe ascites. The inter-electrode distance should be 10 to 20 mm and the exposure length should be 15 mm. After 10 test pulses, 90 treatment pulses of 1,500 V/cm should be delivered continuously, with a 90-µs pulse length. The first postprocedural contrast-enhanced computed tomography should take place 1 month post-IRE, and then every 3 months. This article provides expert recommendations regarding patient selection, procedure, and follow-up for IRE treatment in pancreatic malignancies through a modified Delphi consensus study. Future studies should define the maximum tumor diameter, response evaluation criteria, and the optimal number of preoperative FOLFIRINOX cycles.

Radiofrequency Ablation Provides Rapid and Durable Pain Relief for the Palliative Treatment of Lytic Bone Metastases Independent of Radiation Therapy: Final Results from the OsteoCool Tumor Ablation Post-Market Study.

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 < 0.0001). Post hoc analysis found neither systemic chemotherapy nor local radiation therapy at the index site of RFA influenced worst pain, average pain, or pain interference. Six subjects had device/procedure-related adverse events. 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 .

Angiographic Analysis of Anatomical Variants in Adhesive Capsulitis Embolization.

PURPOSE: To analyze the complex shoulder vasculature and identify potential challenges during adhesive capsulitis embolization (ACE). MATERIALS AND METHODS: Two interventional radiologists evaluated angiographic findings from 21 ACE procedures. The suprascapular artery (SSA), thoracoacromial artery (TAA), coracoid branch (CB), circumflex scapular artery (CSA), and anterior/posterior circumflex humeral artery (ACHA/PCHA) were assessed for their presence, course, diameter within 1 cm of origin, angle to the proximal parent vessel, and distance from the clavicle. RESULTS: 83 arteries were embolized: CB (20.5%), TAA (19.3%), PCHA (19.3%), ACHA (16.9%), CSA (14.5%), and SSA (9.6%). The CSA had the largest diameter (4.3 mm), while CB had the smallest diameter (1.0 mm). An acute angle to the parent vessel was noted with the SSA, TAA, ACHA, and PCHA. A common origin for CSA and PCHA was noted in 2 patients. A common origin for TAA and SSA was also noted in one patient. The CB appears perpendicular to the axillary artery and courses vertically toward the coracoid process. The TAA branches off the axillary artery and courses along the medial border of the pectoralis minor. The PCHA and ACHA originate from the axillary artery. The CSA is located on the medial side of axillary artery. The SSA originates from the thyrocervical trunk and courses laterally toward the superior border of the scapula. CONCLUSION: An anatomical-technical guide is provided to help interventional radiologists during ACE to treat adhesive capsulitis.

Outcomes of Hemorrhoidal Artery Embolization from a Multidisciplinary Outpatient Interventional Center.

PURPOSE: To evaluate the safety and efficacy of outpatient transarterial embolization for symptomatic refractory internal hemorrhoids. MATERIALS AND METHODS: Retrospective analysis of 134 patients who underwent hemorrhoidal artery embolization (HAE) for symptomatic internal hemorrhoids between August 2021 and June 2022 (76 men and 58 women) was performed. The mean age was 54.9 years, with a mean Goligher hemorrhoid grade (HG) of 2.1. Branches of the superior rectal artery (SRA) or middle rectal artery supplying the corpus cavernosum recti were embolized with both spherical particles and microcoils. Standard-of-care evaluations were performed at baseline and the 1 month follow-up, which included hemorrhoid-related pain (HRP) (0-10), hemorrhoid symptoms score (HSS) (5-20), quality of life (QoL) (0-4), French bleeding score (FBS) (0-9), and HG (0-4). Clinical success was defined as improvement of symptoms without additional treatment. RESULTS: Embolization of at least 1 hemorrhoidal artery was achieved in 133 (99%) of the 134 patients. The mean number of SRA branches embolized per patient was 2.9 ± 1.0. Clinical success was seen in 93% (124 of 134) of patients at the 1-month follow-up, with 10 patients requiring repeat embolization. There were significant improvements in all mean outcomes at 1 month: HSS (11-7.8; P < .01), HRP (4.1-1.3; P < .01), QoL (2.2-0.8; P < .01), FBS (4.4-2.2; P < .01), and HG (2.3-1.2; P < .05). There were no severe adverse events. CONCLUSIONS: HAE is a safe and effective outpatient treatment for refractory symptomatic internal hemorrhoids in the short term.

Interventional Management of Painful Vertebral Body Metastases.

Management of osseous metastatic disease has advanced over the years with the advent of ablation and interventional technologies. Painful metastatic vertebral body lesions have been particularly studied in the recent years, as open surgery is usually reserved for emergent cord compression. Minimally invasive options in managing these lesions include percutaneous vertebral augmentation, percutaneous ablation, and embolization. This article will include an overview of these procedures including the most recent literature.

Nontarget Radiopaque Embolic Deposition during Prostatic Artery Embolization.

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 aged >40 years with prostate glands of >50 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.

Minimally Invasive Treatments for Benign Prostatic Hyperplasia: Systematic Review and Network Meta-Analysis.

PURPOSE: 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. 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 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. RESULTS: 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. 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.

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis.

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<.01). Disability improvement was also significantly greater in the treatment group (WOMAC, 24.7 points; SE, 10.4; 95% CI, 3.5, 45.9; P=.02). Only minor adverse events were reported. Five subjects were excluded after increased analgesic use. Sensitivity analysis with all excluded patients confirmed significant improvements at 1 and 12 months. CONCLUSION: In patients with mild to moderate knee OA, GAE results in symptomatic improvement greater than the sham procedure with clinically significant reduction in pain and disability.

Results from a United States Investigational Device Study of Adhesive Capsulitis Embolization in the Treatment of Shoulder Pain: The Adhesive Capsulitis Embolization Study.

PURPOSE: To evaluate the safety and efficacy of arterial embolization to relieve shoulder pain secondary to adhesive capsulitis (AC). MATERIALS AND METHODS: In total, 20 patients (18 females, 2 males; mean age, 51 years) with AC resistant to >30 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. RESULTS: 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. CONCLUSIONS: Interim findings suggest that arterial embolization is safe and effective for patients with AC refractory to conservative treatment.

Comparison of Minimally Invasive Procedures to Treat Knee Pain Secondary to Osteoarthritis: A Systematic Review and Meta-Analysis.

PURPOSE: To review and indirectly compare the outcomes of genicular artery embolization (GAE), radiofrequency (RF) ablation, and intra-articular (IA) injection for the treatment of knee pain secondary to osteoarthritis (OA). MATERIALS AND METHODS: A literature review of the MEDLINE and Cochrane databases was conducted with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement in June 2020. The visual analog scale (VAS) was recorded at baseline and at all available time points for each therapy. Standard mean differences were calculated at each time point and compared between treatments to assess the magnitude of the treatment effect. RESULTS: All 3 treatments demonstrated significant differences in VAS scores after therapy. RF ablation produced the greatest significant mean reduction in relative VAS score from baseline at 1 year of follow-up (mean, 0.49; 95% confidence interval, 0.4-0.59; P = .03). GAE reported the most significant reductions in VAS scores across all measured time points. Overall, the comparison did not demonstrate a significant difference in VAS scores among patients receiving IA injections, RF ablation, and GAE. CONCLUSIONS: The current evidence does not suggest a significant difference in outcomes among IA injection, RF ablation, and GAE for knee pain secondary to OA.

Musculoskeletal Interventions: A Review on Genicular Artery Embolization.

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.

A Review of Musculoskeletal Embolization to Treat Pain Outside of the Knee.

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.

Effectiveness and Safety of Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia in Men with Concurrent Localized Prostate Cancer.

PURPOSE: To assess the effectiveness and safety of prostatic artery embolization (PAE) on lower urinary tract symptoms (LUTS) in the setting of localized prostate cancer (PCa). MATERIALS AND METHODS: This was a retrospective, single-center, institutional review board-approved study from December 2016 to June 2020 of 21 patients (median age, 72; range, 63-83 years) with moderate LUTS and localized PCa. Clinical effectiveness was evaluated at 6 and 12 weeks using International Prostate Symptom Score (IPSS) and quality of life (QoL) improvement. Seventeen patients were scheduled to receive definitive radiotherapy (RT) after PAE; 13 patients completed RT. Short-term imaging signs of oncologic progression were evaluated at 6 and 12 weeks defined by at least one of the following on magnetic resonance imaging: increased Prostate Imaging-Reporting and Data System score of index lesion(s) to at least 4, new extracapsular extension, seminal vesicle involvement, or pelvic lymphadenopathy. Nonparametric Wilcoxon signed-rank test was used for analysis. RESULTS: IPSS improved by a median of 12 (n = 19, P < .0001) and 14 (n = 14, P < .0001) at 6 and 12 weeks, respectively. QoL improved by a median of 2 (n = 19, P < .0001) and 3 (n = 3, P < .0001) at 6 and 12 weeks. Prostate volume decreased by a median of 24% (n = 19, P < .0001) and 36% (n = 12, P = .015) at 6 and 12 weeks. No patients demonstrated disease progression at 6 (n = 16) or 12 (n = 8) weeks by imaging. No patients experienced increased prostate-specific antigen after RT, grade ≥3 adverse events, or greater genitourinary toxicity. CONCLUSIONS: PAE is effective and safe for the treatment of men with LUTS from benign prostatic hyperplasia in the setting of concomitant, localized, non-obstructive PCa.

Non-neoplastic Disease Outside the Spine-Genicular Artery Embolization and Adhesive Capsulitis Embolization.

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.

Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients.

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.