Joshua A Hirsch’s research while affiliated with Massachusetts General Hospital and other places

Purpose of Review This retrospective, case controlled, comparative evaluation review of radiation exposure during epidural procedures in interventional pain management assessed variations in radiation exposure based on obesity, race, and gender. Recent Findings Numerous publications have shown increasing radiation exposure based on body mass index (BMI). However, the influence of race and gender have not been studied. A recent study assessing radiation exposure for epidural procedures with mandated 2 views, compared to a single view or optional 2 views, showed an increase in exposure time of 21%, with radiation dose increases of 133%. The influence of obesity, has been studied, but potential influence of race, and gender on radiation exposure for epidural procedures has not been studied. Summary The present review shows a prevalence of total obesity with BMI of 30 or above of 50.9%, with a higher prevalence in patients below the age of 45, female gender, and African Americans. Mean fluoroscopy time and dose increased significantly from 6.9 s to 0.925 milligray (mGy) for all epidural procedures for those who are underweight to 10.0 s and 6.7 mGy for those with Class 3 obesity above BMI of 40. However, after adjusting for body mass index, no significant differences were noted in race for both fluoroscopy time and radiation dose across multiple epidural procedures. Fluoroscopy time and radiation dose increased in males in cervical interlaminar and lumbar transforaminal procedures.

Background: The analysis of epidural procedure utilization has revealed several notable trends over recent years. Utilization increased significantly until 2004, then rose minimally until 2011, followed by gradual declines up to 2019 in the Medicare population. The COVID-19 pandemic led to a marked 19% decline in usage from 2019 to 2020. Additionally, recent studies of interventional pain management techniques showed a 28.9% reduction in use from 2019 to 2022, leading to an average annual decline of 10.9%. Objective: The present investigation aims to provide an updated evaluation of epidural procedure usage for chronic pain management in the U.S. Medicare population. Study design: A retrospective cohort study examining utilization patterns and variables for epidural injections in the fee-for-service (FFS) Medicare population in the U.S. from 2000 to 2022. Methods: Data was obtained from the Centers for Medicare & Medicaid Services (CMS) master database, specifically using the physician/supplier procedure summary for 2000-2022. Episodes or procedure visits were defined as one per region using primary codes only, while services included all procedure levels and any add-on codes. Results: Between 2000 and 2010, epidural episodes rose by 6.7% annually but then declined by 3% each year from 2010 to 2019. The COVID-19 pandemic led to a 19.3% reduction in procedures from 2019 to 2020, followed by a partial recovery of 5.5% in 2021, then another 10.9% drop in 2022. During 2019-2022, lumbar interlaminar and caudal procedures decreased by 26.9%, while cervical/thoracic interlaminar procedures declined by 24.2%. By 2022, transforaminal procedures surpassed interlaminar procedures, reversing the trend from 2000. Limitations: This analysis includes data only through 2022 and is limited to the FFS Medicare population; it does not account for Medicare Advantage Plan enrollees, who made up nearly half of Medicare participants by 2022. Additionally, the study is subject to limitations inherent in retrospective claims data analysis. Conclusion: This two-decade analysis indicates significant shifts in epidural procedure utilization, with steady increases until 2010, followed by a general decline affected by COVID-19 and other contributing factors. An approximate 24% decline in epidural procedure visits for chronic spinal pain management was noted from 2019 to 2022.

The purpose of this study was to determine the real-world incidence and predictors of additional vertebroplasty or balloon kyphoplasty after initial vertebral augmentation, as a proxy for subsequent symptomatic vertebral fracture. Of patients, 15.5% underwent subsequent vertebral augmentation. The patient’s comorbidities are strongly associated with risk of subsequent treatment. To determine the real-world incidence and predictors of additional vertebroplasty or balloon kyphoplasty after initial vertebral augmentation, as a proxy for subsequent symptomatic and disabling vertebral fracture. We conducted a retrospective cohort study using commercial insurance claims data (Optum’s de-identified Clinformatics® Data Mart Database). Adult patients who underwent subsequent treatment for vertebral fracture within 24 months of initial balloon kyphoplasty (BKP) or vertebroplasty (VP) were classified into “subsequent treatment” or “no subsequent treatment” cohorts. Survival analysis was applied to investigate the effect of risk factors on subsequent treatment. Between 1 January 2008 and 30 June 2020, a total of 32,513 adult patients underwent a BKP/VP procedure following a diagnosis of vertebral compression fracture in the preceding 12 months. Five thousand thirty-five patients (15.5%) underwent a subsequent BKP/VP treatment within 2 years; 90% had a single fracture level treated. An increased hazard of subsequent treatment was associated with a number of fractures treated at initial BKP/VP (≥ 4 levels, adjusted hazard ratio (AHR) 1.68 (95% CI 1.24–2.26); steroid use, AHR 1.9 (95% CI 1.31–1.48); Elixhauser Comorbidity Index ≥ 4, AHR 1.44 (95% CI 1.17–1.77); and multiple myeloma, AHR 1.31 (95% CI 1.13–1.53)). Age < 70 years was associated with reduced hazard of subsequent treatment (AHR 0.81, 95% CI 0.74–0.89). One in seven patients underwent subsequent treatment for vertebral fracture after initial vertebral augmentation. Baseline patient characteristics were associated with increased risk of subsequent fracture within 2 years, suggesting that a patient’s natural history is strongly associated with risk of subsequent treatment rather than the initial surgical procedure itself.

Background: Patients receiving standard treatment for chronic subdural hematoma have a high risk of treatment failure. The effect of adjunctive middle meningeal artery embolization on the risk of treatment failure in this population remains unknown. Methods: We randomly assigned patients with symptomatic chronic subdural hematoma to undergo middle meningeal artery embolization as an adjunct to standard treatment (embolization group) or to receive standard treatment alone (control group). Either surgical or nonsurgical standard treatment had been chosen for each patient before randomization. The primary efficacy outcome was a composite of the following events: recurrent or residual chronic subdural hematoma (measuring >10 mm) at 180 days; reoperation or surgical rescue within 180 days; or major disabling stroke, myocardial infarction, or death from neurologic causes within 180 days. The primary safety outcome was a composite of major disabling stroke or death from any cause within 30 days. Results: Among 310 enrolled patients, 149 were randomly assigned to the embolization group and 161 to the control group; 189 patients were to receive surgical standard treatment and 121 nonsurgical standard treatment. The mean age of the patients was 73 years, and 70% were men. In the primary efficacy analysis, a primary-outcome event occurred in 19 of 120 patients (16%) in the embolization group, as compared with 47 of 129 patients (36%) in the control group (odds ratio, 0.36; 95% confidence interval, 0.20 to 0.66; P = 0.001). In the primary safety analysis, 4 of 144 patients (3%) in the embolization group and 5 of 166 patients (3%) in the control group either had a major disabling stroke or died within 30 days. Through 180 days, 12 patients (8%) in the embolization group and 9 patients (5%) in the control group had died, with death from neurologic causes occurring in 1 patient (1%) in the embolization group and in 3 patients (2%) in the control group. Conclusions: Among patients with symptomatic chronic subdural hematoma, adjunctive middle meningeal artery embolization resulted in a lower risk of treatment failure than standard treatment alone, without resulting in an increased incidence of disabling stroke or death in the short term. Further study of longer-term safety outcomes is warranted. (Funded by Balt USA; STEM ClinicalTrials.gov number, NCT04410146.).

Background: Peripheral nerve stimulation (PNS) has been used for over 50 years to treat chronic pain by delivering electrical pulses through small electrodes placed near targeted peripheral nerves those outside the brain and spinal cord. Early PNS systems often required invasive neurosurgical procedures. However, since 2015, the Food and Drug Administration (FDA) approved percutaneously implanted PNS leads and neurostimulators offering a much less invasive, non-opioid option for managing recalcitrant chronic pain. The following FDA-cleared PNS systems are commercially available in the United States for the management of chronic, intractable pain:• Freedom® Peripheral Nerve Stimulator (PNS) System (Curonix LLC, 2017) • StimRouter® Neuromodulation System (Bioness, now Bioventus, 2015)• SPRINT® PNS System (SPR® Therapeutics, Inc., 2016) • Nalu™ Neurostimulation System (Nalu Medical Inc., 2019)• ReActiv8® Implantable Neurostimulation System (Mainstay Medical Limited, 2020) The American Society of Interventional Pain Physicians (ASIPP) has published evidence-based consensus guidelines for the application of PNS systems in managing chronic pain. Objective: The guidelines aim to provide evidence-based recommendations for the utilization of peripheral nerve stimulation (PNS) in the management of moderate to severe chronic pain. These guidelines exclude field stimulation, or sacral nerve stimulation. Methods: A multidisciplinary panel of experts in various medical and pharmaceutical fields, convened by ASIPP, reviewed the evidence, considered patient perspectives, and formulated recommendations for implantable peripheral nerve stimulation in chronic pain management. The methodology included developing key questions with evidence-based statements and recommendations. The grading of evidence and recommendations followed a modified approach described by ASIPP, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method, and the Agency for Healthcare Research and Quality (AHRQ) strength of recommendations methods. The evidence review includes existing guidelines, systematic reviews, comprehensive reviews, randomized controlled trials (RCTs), and observational studies on the effectiveness and safety of implantable peripheral nerve stimulation in managing chronic pain. The quality of published studies was assessed using appropriate instruments for systematic reviews, RCTs, and observational studies.In the development of consensus statements and guidelines, we used a modified Delphi technique, which has been described to minimize bias related to group interactions. Panelists without a primary conflict of interest voted to approve specific guideline statements. Each panelist could suggest edits to the guideline statement wording and could suggest additional qualifying remarks or comments as to the implementation of the guideline in clinical practice to achieve consensus and for inclusion in the final guidelines, each guideline statement required at least 80% agreement among eligible panel members without primary conflict of interest. Results: A total of 31 authors participated in the development of these guidelines. Of these, 23 participated in the voting process. A total of 8 recommendations were developed. Overall, 100% acceptance was obtained for 8 of 8 items. Thus, with appropriate literature review, consensus-based statements were developed for implantable peripheral nerve stimulation in chronic pain management. In preparation of these guidelines, evidence synthesis included 7 systematic reviews, 8 RCTs, and 9 observational studies covering all PNS treatments. The evidence was developed using GRADE criteria or certainty of evidence, and qualitative synthesis based on the best available evidence. The evidence level and recommendations are as follows: For implantable peripheral nerve stimulation systems following a trial or selective lumbar medial branch stimulation without a trial, the evidence is Level III or fair with moderate certainty. Evidence Level: Fair; Strength of Recommendation: ModerateFor temporary peripheral nerve stimulation for 60 days, the evidence is Level III or fair, with moderate certainty. Evidence level: Fair; Strength of Recommendation: ModerateBased on the available evidence, it is our recommendation to expand the existing PNS related local coverage determination (LCD) to include craniofacial pain, phantom limb pain, and nociceptive pain in the lower back as present evidence shows Level III or fair with moderate certainty. Limitations: The primary limitation of these guidelines is the paucity of the available literature. Conclusion: These evidence-based guidelines support the use of implantable peripheral nerve stimulation leads and neurostimulators in patients with moderate to severe chronic pain refractory to two or more conservative treatments. These guidelines aim to optimize patient outcomes and promote health equity through the integration of PNS technology in clinical practice.

Background: Numerous studies have highlighted the escalating costs associated with managing low back and neck pain, as well as other musculoskeletal disorders. In the past, there was a notable increase in the use of interventional techniques to address these disorders. However, the COVID-19 pandemic disrupted various chronic pain treatment approaches, including interventional procedures and opioid use, following a broader trend of reduced healthcare services. Consequently, there was an 18.7% decline in the use of interventional techniques per 100,000 Medicare beneficiaries between 2019 and 2020, a stark contrast to the previous growth patterns, despite some initial declines observed starting in 2017. Objectives: This analysis aims to provide an updated evaluation of the utilization of interventional techniques for chronic pain management in the U.S. Medicare population. Study design: A retrospective cohort study examining utilization patterns and factors affecting interventional techniques for chronic pain management in the FFS Medicare population in the United States from 2000 to 2022. Methods: Data for this analysis was obtained from the Centers for Medicare & Medicaid Services (CMS) master database, specifically the physician/supplier procedure summary, spanning the years 2000 to 2022. Results: This retrospective cohort study found that the rate of interventional pain management services per 100,000 Medicare beneficiaries showed a cumulative decline between 2019 and 2022 of 28.9%, with an annual decrease of 10.7%. This contrasts sharply with the 2010-2019 period, which saw a small annual decline of 0.4%. Particularly significant was the sharp reduction of 18.7% from 2019 to 2020, coinciding with the pandemic. From 2020 to 2021, the decline slowed to 1.1%, before accelerating again with an 11.5% drop between 2021 and 2022. Limitations: Data were available only through 2022 and were limited to the FFS Medicare population; utilization patterns for Medicare Advantage Plans, which accounted for nearly 50% of Medicare enrollment in 2022, were not included. Additionally, this analysis shares the inherent limitations of all retrospective reviews based on claims data. Conclusion: This retrospective analysis demonstrates a significant reduction in the use of interventional pain management techniques from 2019 to 2022. Contributing factors to this decline likely include the lasting effects of COVID-19, economic challenges, the Affordable Care Act (ACA), and evolving local coverage determination policies.