Advanced Interventional Procedures for Knee Osteoarthritis: What Is the Current Evidence?

The prevalence of knee osteoarthritis (OA) is the highest among all joints and likely to increase over the coming decades. Advances in the repertoire of diagnostic capabilities of imaging and an expansion in the availability and range of image-guided interventions has led to development of more advanced interventional procedures targeting pain related to OA pain while improving the function of patients presenting with this debilitating condition. We review the spectrum of established advanced interventional procedures for knee OA, describe the techniques used to perform these procedures safely, and discuss the clinical evidence supporting each of them.

Intradiscal Steroid Injections for Degenerative Disc Disease With Modic Changes: A Retrospective Study of Therapeutic and Diagnostic Features.

PURPOSE: Anterior column pain refers to axial low back pain (LBP) originating from the intervertebral disc or vertebral endplates (discogenic or vertebrogenic pain). We sought to assess the safety and effectiveness of intradiscal steroid injection (IDSI) in diagnosing and treating patients with LBP arising from the anterior column. PATIENTS AND METHODS: This is a retrospective chart review of 66 patients who underwent 77 injections in an outpatient, private practice setting for the treatment of chronic lower back with history and physical exam findings indicating an origin within the anterior column and magnetic resonance imaging (MRI) findings of Modic changes associated with disc degeneration of grade 4 or above on the modified Pfirrmann scale. Patients reported pain as measured by the numerical rating scale (NRS) before the injection, at the time of their follow-up, and their maximum pain relief. The primary outcome was the change in NRS before and after the injections. The secondary outcome determined if the changes in the subjects' NRS met the minimal clinically important change (MCIC) criteria for LBP. We conducted a statistical analysis using a paired sample t-test. RESULTS: There was a statistically significant difference between the pre-injection and follow-up NRS scores (p < 0.001) and a significant difference between pre-injection and maximum relief NRS scores (p < 0.001). Most subjects (55/77, 71.4%) met the MCIC to relieve their chronic LBP at the time of the follow-up evaluation. CONCLUSION: For patients with chronic LBP and degenerative endplate changes, IDSIs provided these patients with significant short-term pain relief from pain arising from the anterior column.

Polytomous Rasch Analyses of Surgeons' Decision-Making on Choice of Procedure in Endoscopic Lumbar Spinal Stenosis Decompression Surgeries.

BACKGROUND: With the growing prevalence of lumbar spinal stenosis, endoscopic surgery, which incorporates techniques such as transforaminal, interlaminar, and unilateral biportal (UBE) endoscopy, is increasingly considered. However, the patient selection criteria are debated among spine surgeons. OBJECTIVE: This study used a polytomous Rasch analysis to evaluate the factors influencing surgeon decision-making in selecting patients for endoscopic surgical treatment of lumbar spinal stenosis. METHODS: A comprehensive survey was distributed to a representative sample of 296 spine surgeons. Questions encompassed various patient-related and clinical factors, and responses were captured on a logit scale graphically displaying person-item maps and category probability curves for each test item. Using a Rasch analysis, the data were subsequently analyzed to determine the latent traits influencing decision-making. RESULTS: The Rasch analysis revealed that surgeons' preferences for transforaminal, interlaminar, and UBE techniques were easily influenced by comfort level and experience with the endoscopic procedure and patient-related factors. Harder-to-agree items included technological aspects, favorable clinical outcomes, and postoperative functional recovery and rehabilitation. Descriptive statistics suggested interlaminar as the best endoscopic spinal stenosis decompression technique. However, logit person-item analysis integral to the Rasch methodology showed highest intensity for transforaminal followed by interlaminar endoscopic lumbar stenosis decompression. The UBE technique was the hardest to agree on with a disordered person-item analysis and thresholds in category probability curve plots. CONCLUSION: Surgeon decision-making in selecting patients for endoscopic surgery for lumbar spinal stenosis is multifaceted. While the framework of clinical guidelines remains paramount, on-the-ground experience-based factors significantly influence surgeons' selection of patients for endoscopic lumbar spinal stenosis surgeries. The Rasch methodology allows for a more granular psychometric evaluation of surgeon decision-making and accounts better for years-long experience that may be lost in standardized clinical guideline development. This new approach to assessing spine surgeons' thought processes may improve the implementation of evidence-based protocol change dictated by technological advances was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the International Society for Minimal Intervention in Spinal Surgery (ISMISS), the Mexican Spine Society (AMCICO), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Society (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS).

Comparative Analysis of Learning Curve, Complexity, Psychological Stress, and Work Relative Value Units for CPT 62380 Endoscopic Lumbar Spinal Decompression vs Traditional Lumbar Spine Surgeries: A Paired Rasch Survey Study.

BACKGROUND: Effective 1 January 2017, single-level endoscopic lumbar discectomy received a Category I Current Procedural Terminology (CPT) code 62380. However, no work relative value units (RVUs) are currently assigned to the procedure. An international team of endoscopic spine surgeons conducted a study, endorsed by several spine societies, analyzing the learning curve, difficulty, psychological intensity, and estimated work RVUs of endoscopic lumbar spinal decompression compared with other common lumbar spine surgeries. METHODS: A survey comparing CPT 62380 to 10 other comparator CPT codes reflective of common spine surgeries was developed to assess the work RVUs in terms of learning curve, difficulty, psychological intensity, and work effort using a paired Rasch method. RESULTS: The survey was sent to 542 spine specialists. Of 322 respondents, 150 completed the survey for a 43.1% completion rate. Rasch analysis of the submitted responses statistically corroborated common knowledge that the learning curve with lumbar endoscopic spinal surgery is steeper and more complex than with traditional translaminar lumbar decompression surgeries. It also showed that the psychological stress and mental and work effort with the lumbar endoscopic decompression surgery were perceived to be higher by responding spine surgeons compared with posterior comparator decompression and fusion surgeries and even posterior interbody and posterolateral fusion surgeries. The regression analysis of work effort vs procedural difficulty showed the real-world evaluation of the lumbar endoscopic decompression surgery described in CPT code 62380 with a calculated work RVU of 18.2464. CONCLUSION: The Rasch analysis suggested the valuation for the endoscopic lumbar decompression surgery should be higher than for standard lumbar surgeries: 111.1% of the laminectomy with exploration and/or decompression of spinal cord and/or cauda equina (CPT 63005), 118.71% of the laminectomy code (CPT 63047), which includes foraminotomy and facetectomy, 152.1% of the hemilaminectomy code (CPT 63030), and 259.55% of the interlaminar or interspinous process stabilization/distraction without decompression code (CPT 22869). This research methodology was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the Mexican Society of Spinal Surgeons (AMCICO), the International Society For Minimally Invasive Spine Surgery (ISMISS), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Surgery (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS). CLINICAL RELEVANCE: This study provides an updated reimbursement recommendation for endoscopic spine surgery. LEVEL OF EVIDENCE: Level 3.

Bone Cements Used in Vertebral Augmentation: A State-of-the-art Narrative Review.

Vertebral compression fractures (VCFs) are common in osteoporotic patients, with a frequency projected to increase alongside a growing geriatric population. VCFs often result in debilitating back pain and decreased mobility. Cement augmentation, a minimally invasive surgical technique, is widely used to stabilize fractures and restore vertebral height. Acrylic-based cements and calcium phosphate cements are currently the two primary fill materials utilized for these procedures. Despite their effectiveness, acrylic bone cements and calcium phosphate cements have been associated with various intraoperative and postoperative incidents impacting VCF treatment. Over the past decade, discoveries in the field of biomedical engineering and material science have shown advancements toward addressing these limitations. This narrative review aims to assess the potential pitfalls and barriers of the various types of bone cements.

Perspective on Intradiscal Therapies for Lumbar Discogenic Pain: State of the Science, Knowledge Gaps, and Imperatives for Clinical Adoption.

Specific clinical diagnostic criteria have established a consensus for defining patients with lumbar discogenic pain. However, if conservative medical management fails, these patients have few treatment options short of surgery involving discectomy often coupled with fusion or arthroplasty. There is a rapidly-emerging research effort to fill this treatment gap with intradiscal therapies that can be delivered minimally-invasively via fluoroscopically guided injection without altering the normal anatomy of the affected vertebral motion segment. Viable candidate products to date have included mesenchymal stromal cells, platelet-rich plasma, nucleus pulposus structural allograft, and other cell-based compositions. The objective of these products is to repair, supplement, and restore the damaged intervertebral disc as well as retard further degeneration. In doing so, the intervention is meant to eliminate the source of discogenic pain and avoid surgery. Methodologically rigorous studies are rare, however, and based on the best clinical evidence, the safety as well as the magnitude and duration of clinical efficacy remain difficult to estimate. Further, we summarize the US Food and Drug Administration's (FDA) guidance regarding the interpretation of the minimal manipulation and homologous use criteria, which is central to designating these products as a tissue or as a drug/device/biologic. We also provide perspectives on the core evidence and knowledge gaps associated with intradiscal therapies, propose imperatives for evaluating effectiveness of these treatments and highlight several new technologies on the horizon.

Posterior Lateral Arthrodesis as a Treatment Option for Lumbar Spinal Stenosis: Safety and Early Clinical Outcomes.

Introduction: Lumbar spinal stenosis (LSS) is a common condition caused by degenerative changes in the lumbar spine with age. LSS is caused by a variety of factors, including degenerative spondylosis and spondylolisthesis. People suffering with LSS experience neurogenic claudication, which causes severe physical limitations, discomfort, and a decrease in quality of life. Less invasive procedures are now being researched to improve the prognosis, success rate, and safety of LSS treatments. Posterior lateral spinal arthrodesis (PLSA) is a new surgical treatment for LSS. This study looks at the procedural and patient safety of PLSA. Materials and methods: This study is a multicenter retrospective analysis of the safety of PLSA who met the clinical indications for PLSA and underwent the procedure at eight interventional spine practices. Data was collected on demographical information, pre-procedural numeric rating scale score (NRS), post-procedural NRS, and complication reporting. Patients who were included had LSS with or without spondylolisthesis and had failed conservative treatments. A descriptive statistical analysis was performed to report the outcomes. Results were reported as mean and standard deviations for continuous outcomes, and frequency (%) for categorical outcomes. Results: This retrospective analysis involved 191 patients and 202 PLSA implants. The majority of patients were male Caucasians with a mean age of 69.2 years and a BMI of 31.1. A large majority of implants were placed at the L4-5 level, and the average pre-procedural NRS was 6.3 while the average post-procedural NRS was 3.1, indicating a 50.8% reduction in pain (p < 0.0001). Two patients reported complications, but they were unrelated to the device or surgical procedure; no infections, device malfunctions, or migrations were reported in the patient cohort. Conclusion: Preliminary results with PLSA implants indicate that it is a safe treatment option for patients with moderate LSS who do not respond to conservative management.

Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study.

INTRODUCTION: Low back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies. METHODS: In this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short-term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1-S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0-10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function. RESULTS: 3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced >2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001). CONCLUSIONS: In patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management. TRIAL REGISTRATION NUMBER: NCT03601949.

Hydrogel Augmentation of the Lumbar Intervertebral Disc: An Early Feasibility Study of a Treatment for Discogenic Low Back Pain.

PURPOSE: To assess the safety and effectiveness of intradiscal hydrogel in patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional medical management. MATERIALS AND METHODS: Twenty patients aged 22-69 years with numerical rating scale (NRS) pain of ≥4 were enrolled. All patients with CLBP resulting from DDD confirmed by imaging and discography received injections of hydrogel (Hydrafil Intervertebral Disc Augmentation; ReGelTec, Baltimore, Maryland) at 1 or 2 lumbar levels (29 levels treated) from August to December 2020. The primary safety end point was freedom from serious adverse events (SAEs). The primary performance end point was successful gel delivery into the desired disc. Patients were also assessed on the NRS as well as the Oswestry disability index (ODI). RESULTS: Nineteen patients were followed up at a mean of 131 days, and 1 patient was lost to follow-up. Preliminary results showed significant reductions in median NRS back pain from 7 (range 4-10) to 1 (range 0-8) (P <.0001) and median ODI scores from 54 (range 22-58) to 2 (range 0-58) (P <.0001) at 6 months of follow-up. There were 5 SAEs, and 4 of the 2 were determined to be associated with treatment. CONCLUSIONS: This early feasibility study showed that the hydrogel implant was safe with no persistently symptomatic SAEs, and demonstrated effectiveness with significant reduction in pain and improvement in function when used to treat painful DDD and CLBP.

Instrumented Posterior Arthrodesis of the Lumbar Spine: Prospective Study Evaluating Fusion Outcomes in Patients Receiving an Interspinous Fixation Device for the Treatment of Degenerative Spine Diseases.

Purpose: Prospective evaluation of radiographic fusion outcomes in patients receiving instrumented posterior arthrodesis of the lumbar spine using a minimally invasive interspinous fixation device. Patients and Methods: All patients (n = 110) from a single US physician's practice who received instrumented posterior arthrodesis of the lumbar spine with a minimally invasive interspinous fixation device in the calendar year 2020 were invited to return for a follow-up CT scan to radiographically assess fusion. Forty-three patients, representing 69 total treated levels, consented to participate and received a lumbar CT scan at a mean of 459 days post-surgery (177 to 652). The interspinous/interlaminar fusion was assessed by 3 independent radiologists using a novel grading scale. Spinous process fractures were also assessed. Results: 92.8% of the assessed levels were considered fused. There were no intraoperative spinous process fractures. There were 4 spinous process fractures (5.8%) identified on CT imaging, all of which were asymptomatic and healed without subsequent intervention. There were no instances of device mechanical failure or device-related reoperation. Conclusion: Instrumented posterior arthrodesis of the lumbar spine using a minimally invasive interspinous fixation device provides clinically meaningful fusion rates with no reoperations and a low risk of spinous process fracture or other device-related complications.

Defining the Patient with Lumbar Discogenic Pain: Real-World Implications for Diagnosis and Effective Clinical Management.

There is an enormous body of literature that has identified the intervertebral disc as a potent pain generator. However, with regard to lumbar degenerative disc disease, the specific diagnostic criteria lack clarity and fail to capture the primary components which include axial midline low back pain with or without non-radicular/non-sciatic referred leg pain in a sclerotomal distribution. In fact, there is no specific ICD-10-CM diagnostic code to classify and define discogenic pain as a unique source of pain distinct from other recognized sources of chronic low back pain including facetogenic, neurocompressive including herniation and/or stenosis, sacroiliac, vertebrogenic, and psychogenic. All of these other sources have well-defined ICD-10-CM codes. Corresponding codes for discogenic pain remain absent from the diagnostic coding vernacular. The International Society for the Advancement of Spine Surgery (ISASS) has proposed a modernization of ICD-10-CM codes to specifically define pain associated with lumbar and lumbosacral degenerative disc disease. The proposed codes would also allow the pain to be characterized by location: lumbar region only, leg only, or both. Successful implementation of these codes would benefit both physicians and payers in distinguishing, tracking, and improving algorithms and treatments for discogenic pain associated with intervertebral disc degeneration.

An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry.

PURPOSE: To evaluate the efficacy of sacroplasty for treating sacral insufficiency fractures, including the effect on pain relief, patient function and adverse event rates in an as-treated on-label prospective data registry. MATERIALS AND METHODS: Observational data including patient reported outcomes (PROs), patient characteristics, osteoporosis treatment, fracture duration, cause of sacral fractures and image guidance used for treatment were collected for patients undergoing sacroplasty. The PROs were collected at baseline then at one, three, and at six months following the procedure. The primary outcomes were pain as measured by the Numerical Rating Scale (NRS) and function as measured by the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included adverse events, cement leakage, new neurologic events, readmissions and death. RESULTS: The interim results for the first 102 patients included significant pain reduction with mean pain improvement scores at six months decreasing from 7.8 to 0.9 (P < .001) and significant improvement in function with mean RMDQ scores improving from 17.7 to 5.2 (P < .001). Most procedures were performed under fluoroscopy (58%). There was cement leakage in 17.7% of the subjects but only one adverse event which was a new neurologic deficit related to cement extravasation. The readmission rate was 16% mostly due to additional back pain and fractures and there were no subject deaths. CONCLUSIONS: Sacroplasty with cement augmentation for acute, subacute and chronic painful sacral insufficiency fractures caused by osteoporosis or neoplastic disorders results in highly significant improvements in pain and function with very low rate of procedural related adverse events.

The Influence of COVID-19 on Utilization of Epidural Procedures in Managing Chronic Spinal Pain in the Medicare Population.

STUDY DESIGN: A retrospective cohort study of utilization patterns and variables of epidural injections in the fee-for-service (FFS) Medicare population. OBJECTIVES: To update the utilization of epidural injections in managing chronic pain in the FFS Medicare population, from 2000 to 2020, and assess the impact of COVID-19. SUMMARY OF BACKGROUND DATA: The analysis of the utilization of interventional techniques also showed an annual decrease of 2.5% per 100,000 FFS Medicare enrollees from 2009 to 2018, contrasting to an annual increase of 7.3% from 2000 to 2009. The impact of the COVID-19 pandemic has not been assessed. METHODS: This analysis was performed by utilizing master data from the Centers for Medicare and Medicaid Services, physician/supplier procedure summary from 2000 to 2020. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology. RESULTS: Epidural procedures declined at a rate of 19% per 100,000 Medicare enrollees in the FFS Medicare population in the United States from 2019 to 2020, with an annual decline of 3% from 2010 to 2019. From 2000 to 2010, there was an annual increase of 8.3%. This analysis showed a decline in all categories of epidural procedures from 2019 to 2020. The major impact of COVID-19, with closures taking effect from April 1, 2020, through December 31, 2020, will be steeper and rather dramatic compared with April 1 to December 31, 2019. However, monthly data from the Centers for Medicare and Medicaid Services is not available as of now. Overall declines from 2010 to 2019 showed a decrease for cervical and thoracic transforaminal injections with an annual decrease of 5.6%, followed by lumbar interlaminar and caudal epidural injections of 4.9%, followed by 1.8% for lumbar/sacral transforaminal epidurals, and 0.9% for cervical and thoracic interlaminar epidurals. CONCLUSION: Declining utilization of epidural injections in all categories was exacerbated to a decrease of 19% from 2019 to 2020, related, in part, to the COVID-19 pandemic. This followed declining patterns of epidural procedures of 3% overall annually from 2010 to 2019.

Vertebral augmentation: an overview.

Vertebral compression fractures (VCFs) are a common pathologic process seen in 30-50% of individuals over the age of 50 years. Historically, VCFs were first treated with nonsurgical management while vertebral augmentation was reserved for severe cases resulting in deformity or significant disability. Current treatment algorithms based on established appropriateness criteria have changed recommendations towards supporting early vertebral augmentation for the VCFs causing the most clinically difficulty and taking into account the degree of vertebral body height loss, kyphotic deformity, and the degree of clinical progression. Percutaneous vertebroplasty (PVP) involves injecting primarily polymethacrylate (PMMA) bone cement directly into the cancellous bone of the vertebral body. There is recent literature showing the effectiveness of PVP including data comparing vertebroplasty to sham treatment. Vertebroplasty evolved into balloon kyphoplasty (BKP) where a balloon is first inserted into the vertebral body to create a cavity and reduce the fracture followed by an injection of bone cement. Both PVP and BKP have been shown to be significantly more effective at treatment of VCFs compared to nonsurgical management. The benefits shown in the literature have been demonstrated randomized control trials, cohort matched trials, post-market trials, registries, and many other data sources with approximately 250 manuscripts produced per year dedicated to the topic of vertebral augmentation.

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain.

Introduction: Painful lumbar spinal disorders represent a leading cause of disability in the US and worldwide. Interventional treatments for lumbar disorders are an effective treatment for the pain and disability from low back pain. Although many established and emerging interventional procedures are currently available, there exists a need for a defined guideline for their appropriateness, effectiveness, and safety. Objective: The ASPN Back Guideline was developed to provide clinicians the most comprehensive review of interventional treatments for lower back disorders. Clinicians should utilize the ASPN Back Guideline to evaluate the quality of the literature, safety, and efficacy of interventional treatments for lower back disorders. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations. Experts from the fields of Anesthesiology, Physiatry, Neurology, Neurosurgery, Radiology, and Pain Psychology developed the ASPN Back Guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for back-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using United States Preventive Services Task Force (USPSTF) criteria and consensus points are presented. Results: After a comprehensive review and analysis of the available evidence, the ASPN Back Guideline group was able to rate the literature and provide therapy grades to each of the most commonly available interventional treatments for low back pain. Conclusion: The ASPN Back Guideline represents the first comprehensive analysis and grading of the existing and emerging interventional treatments available for low back pain. This will be a living document which will be periodically updated to the current standard of care based on the available evidence within peer-reviewed literature.

Best Practice Guidelines on the Diagnosis and Treatment of Vertebrogenic Pain with Basivertebral Nerve Ablation from the American Society of Pain and Neuroscience.

Chronic low back pain is a worldwide leading cause of pain and disability. Degenerative disc disease has been the presumptive etiology in the majority of cases of chronic low back pain (CLBP). More recent study and treatments have discovered that the vertebral endplates play a large role in CLBP in a term defined as vertebrogenic back pain. As the vertebral endplates are highly innervated via the basivertebral nerve (BVN), this has resulted in a reliable target in treating patients suffering from vertebrogenic low back pain (VLBP). The application of BVN ablation for patients suffering from VLBP is still in its early stages of adoption and integration into spine care pathways. BVN ablation is grounded in a solid foundation of both pre-clinical and clinical evidence. With the emergence of this therapeutic option, the American Society of Pain and Neuroscience (ASPN) identified the need for formal evidence-based guidelines for the proper identification and selection of patients for BVN ablation in patients with VLBP. ASPN formed a multidisciplinary work group tasked to examine the available literature and form best practice guidelines on this subject. Based on the United States Preventative Task Force (USPSTF) criteria for grading evidence, gives BVN ablation Level A grade evidence with high certainty that the net benefit is substantial in appropriately selected individuals.