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Perioperative Management of Patients Receiving Interventional Techniques and Antiplatelet and Anticoagulant Therapy: A Balancing Act

Manchikanti, Laxmaiah; Kaye, Alan D; Nampiaparampil, Devi E; Sanapati, Mahendra R; Abd-Elsayed, Alaa; Shekoohi, Sahar; Hirsch, Joshua A
PURPOSEOF REVIEW/OBJECTIVE:This article aims to evaluate current evidence and guidelines on anticoagulant and antiplatelet therapy for patients undergoing interventional procedures. It provides recommendations for managing these therapies with either continuation or withholding of these drugs in the perioperative period to minimize the risk of bleeding and thromboembolism in clinical practice. RECENT FINDINGS/RESULTS:Newly published guidelines and research underscore the crucial role of antiplatelet and anticoagulant therapy in interventional procedures, emphasizing the importance of decisions regarding whether to continue or temporarily stop these medications. Studies have categorized procedures into low-, moderate-, and high-risk groups, offering specific guidance on managing anticoagulant and antiplatelet therapy accordingly. The American Society of Interventional Pain Physicians (ASIPP) has developed consensus guidelines based on a synthesis of the best available evidence, incorporating risk stratification and practical recommendations. This review provides an in-depth analysis of medical, surgical, and interventional pain management literature. It highlights the updated ASIPP guidelines and summarizes the society's evidence-based recommendations for clinical practice.
PMID: 40965759
ISSN: 1534-3081
CID: 5935392

Physician Payment Reform in Interventional Pain Management: Balancing Cost, Quality, Access, and Survival of Independent Practices

Manchikanti, Laxmaiah; Sanapati, Mahendra; Pampati, Vidyasagar; Hubbell Iii, Paul J; Conn, Ann; Pasupuleti, Ramarao; Gupta, Mayank; Kaye, Alan D; Abd-Elsayed, Alaa; Navani, Annu; Day, Miles; Nampiaparampil, Devi; Gharibo, Christopher G; Hirsch, Joshua A
On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the 2026 Physician Proposed Payment Rule aimed at reducing wasteful spending, enhancing quality measures, improving chronic disease management, and protecting independent practices from systemic financial pressures that have favored large healthcare systems and plagued independent practices. The goals are admirable, but the proposed measures with uniform reductions of 2.5% in physician payments based on efficiency adjustments apply across the board to all physicians. Further, practice expense (PE) reductions of 4% to 6%, meant to apply for hospital-based physicians will inadvertently apply to independent physicians constituting 43% of the physician workforce providing services in ambulatory surgery centers (ASCs), as well as hospitals. Thus, reductions of work relative value unit (wRVU) based on efficiency adjustment of 2.5% and PE reductions of 4% to 6%, with total reductions of 7% to 9%, compromise and limit patient care by putting additional pressure on independent physicians. Further, CMS' proposal to start Ambulatory Specialty Model (ASM) for low back pain with specialties of interventional pain management (IPM) and pain management involved. These specialties have no control over costs incurred as an overwhelming majority of patients are chronic pain patients and managed by family physicians, chiropractors, physical therapists, neurosurgeons, and others, resulting in 9% reductions, or increase in reimbursement over a period of 3 years with recurring changes of 3% each year.The proposal includes a 3.8% conversion factor (CF) payment update and increased reimbursement for office-based services, including evaluation, management, and procedures. The changes will increase reimbursement by 8% to 10% for office-based services, but they also decrease reimbursement for all procedures performed outside offices by 7% to 9%. These proposals arrive at a time when non-physician health care providers are striking for wage increase tied to inflation, and ironically, physicians have experienced repeated cuts in reimbursement with occasional stagnation, leading to 33% reduction from 2001 to 2025 in general, and 41% reductions in reimbursement for interventional pain physicians. In addition, there is an additional 2% sequester cut each year from 2011 to last until 2031, and there is a potential for 4% PAYGO cuts starting next year. Further, supply costs have increased 56% to 80% during these years. Further, despite technological advancements such as EMRs and AI, administrative burdens have intensified rather than improved. Independent physicians contend with complex prior authorizations, evolving Medicare coverage policies, growing audit risk with increased documentation and compliance demands from all payers' sources, 30% of interventional pain physicians under audit at any time. Our data on interventional pain physicians and published data on other physicians shows that efficiency has decreased and PEs have been skyrocketing.Ironically, CMS has proposed on January 10, 2025, a 4.3% payment increase to Medicare Advantage Plans, amounting to $21 billion in 2026. To add fuel to the fire, CMS on April 7, 2025, issued a final rule of increasing on average by 5.06% from 2025 to 2026. These proposals come amid growing concerns about Medicare Advantage over payments, including $44 billion due to favorable selection, $40 billion from risk adjustment discrepancies, and $15 billion for duplicative coverage of veterans who already receive benefits through the Veterans Administration (VA). In addition, according to the Medicare Payment Advisory Commission (MedPAC), traditional Medicare beneficiaries also face higher costs, contributing an additional $198 annually, totaling roughly $13 billion per year. All of these added together, CMS is spending on Medicare Advantage over $110 billion a year.Thus, as independent practice continues to come under assault, the American Society of Interventional Pain Physicians (ASIPP) and other societies urge CMS to create a separate identifier for independent pain physicians to distinguish them from hospital-based physicians and prevent these cuts from harming independent practices. This separate but equal treatment of independent physician practices ultimately interferes with patient care.
PMID: 40986899
ISSN: 2150-1149
CID: 5937672

Diagnostic Guidance for Chronic Complex Regional Pain Syndrome Type I and Type II from The American Society of Interventional Physicians (ASIPP)

Gharibo, Christopher; Day, Miles; Aydin, Steve M; Kaye, Alan D; Abdi, Salahadin; Diwan, Sudhir; Doan, Lisa V; Feng, Danielle; Ferguson, Kris; Georges, Kirolos; Kaufman, Andrew; Knezevic, Nebojsa Nick; Li, Sean; Liongson, Franzes A; Nampiaparampil, Devi; Navani, Annu; Sanapati, Mahendra; Schatman, Michael E; Soin, Amol; Staats, Peter S; Varrassi, Giustino; Wang, Jing; Manchikanti, Laxmaiah
BACKGROUND:Complex Regional Pain Syndrome (CRPS) is a challenging and often disabling condition marked by persistent pain, most commonly in a limb following injury or surgery. It presents with a wide array of symptoms, including intense pain, swelling, alterations in skin color and temperature, motor dysfunction, and trophic changes such as skin and tissue atrophy. While the precise cause of CRPS is not fully understood, it is thought to stem from abnormal nervous system activity, leading to heightened pain sensitivity and inflammatory responses. A thorough understanding of CRPS is essential for accurate diagnosis, effective treatment, and enhancing patients' quality of life.Although attempts have been made to distinguish between acute and chronic CRPS, there are currently no established diagnostic criteria specific to chronic CRPS in medical literature. OBJECTIVE:This ASIPP guidance document offers updated, evidence-based recommendations for the diagnosis and management of Chronic Complex Regional Pain Syndrome (CRPS), with a primary focus on introducing novel, time-based diagnostic criteria specific to the chronic phase. These proposed criteria address significant gaps in the current literature, where existing standards, such as the Budapest Criteria, do not sufficiently differentiate between the acute and chronic stages of the condition. METHODS:An expert panel convened by the American Society of Interventional Pain Physicians (ASIPP) conducted a comprehensive literature review and employed a structured consensus process to develop recommendations. Acknowledging that the clinical and pathological characteristics of CRPS change significantly beyond 12 months, the panel proposed chronic-specific diagnostic criteria based on disease duration, clinical history, physical examination findings, and optional diagnostic tests. These draft criteria were refined through multidisciplinary input and expert consensus. RESULTS:The diagnostic framework for chronic CRPS consists of four key components:General Criteria - Require fulfillment of the Budapest Criteria for at least 12 months, continued recognition of CRPS as a diagnosis of exclusion, and differentiation from generalized nociplastic pain syndromes.History-Based Criteria - Mandate the presence of at least three out of five specific historical features.Physical Examination Criteria - Include asymmetric limb findings, sensory disturbances, and musculoskeletal changes.Optional Diagnostic Testing - May involve assessments such as intraepidermal nerve fiber density (IENFD) and imaging evidence of regional bone demineralization.This framework builds upon the Budapest Criteria by incorporating time-dependent features of chronic CRPS, including musculoskeletal dystrophy, neurogenic inflammation, and sympathetic dysfunction. Emerging objective tools-such as quantitative sensory testing (QST), skin biopsy for IENFD, functional MRI, and serum biomarkers of neuroinflammation-may further support diagnosis in complex or uncertain cases.Treatment recommendations highlight a multimodal strategy that integrates physical rehabilitation, pharmacologic management of neuropathic pain, sympathetic nerve blocks, and advanced neuromodulation. Emphasis is placed on individualized care pathways tailored to disease stage and patient-specific characteristics. CONCLUSIONS:This article presents the first structured, time-sensitive diagnostic criteria for chronic CRPS, aimed at improving diagnostic accuracy and informing treatment strategies. Adoption of these criteria may enhance clinical outcomes and promote further research into the natural history and pathophysiology of CRPS progression.
PMID: 40773629
ISSN: 2150-1149
CID: 5905312

A 24% Decline in the Utilization of Epidural Procedure Visits for Chronic Spinal Pain Management in the Medicare Population from 2019 to 2022: Updated Analysis of the Effect of Multiple Factors

Manchikanti, Laxmaiah; Sanapati, Mahendra R; Pampati, Vidyasagar; Kaye, Alan D; Abd-Elsayed, Alaa; Soin, Amol; Nampiaparampil, Devi E; Knezevic, Nebojsa Nick; Gharibo, Christopher G; Hirsch, Joshua A
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/METHODS: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/CONCLUSIONS: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/CONCLUSIONS: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.
PMID: 39688821
ISSN: 2150-1149
CID: 5764362

Escalating Growth to Rapid Decline of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain in the Medicare Population: Updated Analysis of the Effect of Multiple Factors from 2000 To 2022

Manchikanti, Laxmaiah; Abd-Elsayed, Alaa; Kaye, Alan D; Pampati, Vidyasagar; Sanapati, Mahendra R; Nampiaparampil, Devi E; Knezevic, Nebojsa Nick; Soin, Amol; Gharibo, Christopher G; Hirsch, Joshua A
BACKGROUND:The use of facet joint interventions for spinal pain management experienced rapid growth between 2000 and 2010, with an annual increase of 14.2%. However, this trend slowed significantly from 2010 to 2019, with a reduced growth rate of just 2.9% annually. A more recent analysis highlighted a steep decline in facet joint interventions and sacroiliac joint injections, with an overall decrease of 33.2% and an annual decline rate of 12% per 100,000 Medicare beneficiaries between 2019 and 2022. OBJECTIVE:This study aims to update and analyze utilization patterns of facet joint interventions for chronic pain management in the U.S. Medicare population over three periods: 2000-2010, 2010-2019, and 2019-2022. STUDY DESIGN/METHODS:A retrospective cohort study analyzing utilization trends and influencing factors for facet joint interventions in the FFS Medicare population in the United States from 2000 to 2022. METHODS:Data were obtained from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary database (2000-2022). Utilization rates were calculated based on Medicare beneficiaries for each year and expressed as procedures per 100,000 beneficiaries. Episodes or procedural visits included only primary codes, while services encompassed all procedure levels, including add-on codes. RESULTS:Utilization patterns showed substantial fluctuations. From 2000 to 2010, facet joint intervention rates grew at 14.4% annually, slowing to 2.2% from 2010 to 2019. The COVID-19 pandemic led to a 19.3% decline in episodes. From 2019 to 2022, episodes of facet joint interventions decreased by 21.2% per 100,000 beneficiaries, while the rate of services dropped by 37%, with an annual decrease of 14.3%. Specific declines included lumbar and cervical facet joint injections (38.8% and 40.2%, respectively) and lumbosacral and cervicothoracic facet joint neurolysis (33.6% and 30.8%, respectively). The reduction in facet joint injections and nerve blocks was greater than that observed for neurolytic procedures. LIMITATIONS/CONCLUSIONS:Data were limited to the FFS Medicare population and were available only through 2022, excluding patterns for Medicare Advantage Plans, which covered nearly half of Medicare enrollees in 2022. Additionally, this study shares the common limitations of retrospective claims-based reviews. CONCLUSION/CONCLUSIONS:This retrospective analysis reveals a substantial decline in facet joint intervention episodes, with an overall decrease of 21.2% per 100,000 Medicare beneficiaries and an annual decline rate of 7.6% for episodes from 2019 to 2022.
PMID: 39688820
ISSN: 2150-1149
CID: 5764352

Exponential Decline of 28.9% in Utilization of Interventional Pain Management Techniques Among Medicare Beneficiaries From 2019 to 2022: Updated Analysis on the Ongoing Effects of COVID-19, Economic Decline, the Affordable Care Act (ACA), and Medical Policies

Manchikanti, Laxmaiah; Pampati, Vidyasagar; Sanapati, Mahendra R; Nampiaparampil, Devi E; Knezevic, Nebojsa Nick; Kaye, Alan D; Soin, Amol; Gharibo, Christopher G; Abd-Elsayed, Alaa; Hirsch, Joshua A
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.
PMID: 39621971
ISSN: 2150-1149
CID: 5763682

Comprehensive Evidence-Based Guidelines for Implantable Peripheral Nerve Stimulation (PNS) in the Management of Chronic Pain: From the American Society Of Interventional Pain Physicians (ASIPP)

Manchikanti, Laxmaiah; Sanapati, Mahendra R; Soin, Amol; Kaye, Alan D; Kaye, Adam M; Solanki, Daneshvari R; Chen, Grant H; Nampiaparampil, Devi; Knezevic, Nebojsa Nick; Christo, Paul; Bautista, Alexander; Karri, Jay; Shah, Shalini; Helm Ii, Standiford; Navani, Annu; Wargo, Bradley W; Gharibo, Christopher G; Rosenblum, David; Luthra, Komal; Patel, Kunj G; Javed, Saba; Reuland, Warren; Gupta, Mayank; Abd-Elsayed, Alaa; Limerick, Gerard; Pasupuleti, Ramarao; Schwartz, Gary; Chung, Matthew; Slavin, Konstantin V; Pampati, Vidyasagar; Hirsch, Joshua A
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/METHODS: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/CONCLUSIONS:The primary limitation of these guidelines is the paucity of the available literature. CONCLUSION/CONCLUSIONS: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.
PMID: 39565237
ISSN: 2150-1149
CID: 5758552

Perioperative Management of Antiplatelet and Anticoagulant Therapy in Patients Undergoing Interventional Techniques: 2024 Updated Guidelines from the American Society of Interventional Pain Physicians (ASIPP)

Manchikanti, Laxmaiah; Sanapati, Mahendra R; Nampiaparampil, Devi; Schneider, Byron J; Bautista, Alexander; Kaye, Alan D; Knezevic, Nebojsa Nick; Abd-Elsayed, Alaa; Navani, Annu; Christo, Paul J; Helm Ii, Standiford; Kaye, Adam M; Karri, Jay; Pampati, Vidyasagar; Gupta, Sanjeeva; Manocha, Vivekanand A; Soin, Amol; Gupta, Mayank; Bakshi, Sanjay; Gharibo, Christopher G; Candido, Kenneth D; Bux, Anjum; Vinayakan, Anilkumar; Belamkar, Vinayak; Stayner, Scott; Atluri, Sairam; Nashi, Sara E; Applewhite, Megan K; Flanagan, Chelsi; Rakhamimova, Emiliya; Limerick, Gerard; Patel, Kunj G; Willeford, Sierra; Hirsch, Joshua A
BACKGROUND:The frequency of performance of interventional techniques in chronic pain patients receiving anticoagulant and antiplatelet therapy continues to increase. Understanding the importance of continuing chronic anticoagulant therapy, the need for interventional techniques, and determining the duration and discontinuation or temporary suspension of anticoagulation is crucial to avoiding devastating complications, primarily when neuraxial procedures are performed. Anticoagulants and antiplatelets target the clotting system, increasing the bleeding risk. However, discontinuation of anticoagulant or antiplatelet drugs exposes patients to thrombosis risk, which can lead to significant morbidity and mortality, especially in those with coronary artery or cerebrovascular disease. These guidelines summarize the current peer reviewed literature and develop consensus-based guidelines based on the best evidence synthesis for patients receiving anticoagulant and antiplatelet therapy during interventional procedures. STUDY DESIGN/METHODS:Review of the literature and development of guidelines based on best evidence synthesis. OBJECTIVES/OBJECTIVE:To provide a current and concise appraisal of the literature regarding the assessment of bleeding and thrombosis risk during interventional techniques for patients taking anticoagulant and/or antiplatelet medications. METHODS:Development of consensus guidelines based on best evidence synthesis included review of the literature on bleeding risks during interventional pain procedures, practice patterns, and perioperative management of anticoagulant and antiplatelet therapy. A multidisciplinary panel of experts developed methodology, risk stratification based on best evidence synthesis, and management of anticoagulant and antiplatelet therapy. It also included risk of cessation of anticoagulant and antiplatelet therapy based on a multitude of factors. Multiple data sources on bleeding risk, practice patterns, risk of thrombosis, and perioperative management of anticoagulant and antiplatelet therapy were identified. The relevant literature was identified through searches of multiple databases from 1966 through 2023. 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 on approving 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 34 authors participated in the development of these guidelines. Of these, 29 participated in the voting process. A total of 20 recommendations were developed. Overall, 100% acceptance was obtained for 16 of 20 items. Total items were reduced to 18 with second and third round voting. The final results were 100% acceptance for 16 items (89%). There was disagreement for 2 statements (statements 6 and 7) and recommendations by 3 authors. These remaining 2 items had an acceptance of 94% and 89%. The disagreement and dissent were by Byron J. Schneider, MD, with recommendation that all transforaminals be classified into low risk, whereas Sanjeeva Gupta, MD, desired all transforaminals to be in intermediate risk. The second disagreement was related to Vivekanand A. Manocha, MD, recommending that cervical and thoracic transforaminal to be high risk procedures.Thus, with appropriate literature review, consensus-based statements were developed for the perioperative management of patients receiving anticoagulants and antiplatelets These included the following: estimation of the thromboembolic risk, estimation of bleeding risk, and determination of the timing of restarting of anticoagulant or antiplatelet therapy.Risk stratification was provided classifying the interventional techniques into three categories of low risk, moderate or intermediate risk, and high risk. Further, on multiple occasions in low risk and moderate or intermediate risk categories, recommendations were provided against cessation of anticoagulant or antiplatelet therapy. LIMITATIONS/CONCLUSIONS:The continued paucity of literature with discordant recommendations. CONCLUSION/CONCLUSIONS:Based on the review of available literature, published clinical guidelines, and recommendations, a multidisciplinary panel of experts presented guidelines in managing interventional techniques in patients on anticoagulant or antiplatelet therapy in the perioperative period. These guidelines provide a comprehensive assessment of classification of risk, appropriate recommendations, and recommendations based on the best available evidence.
PMID: 39133736
ISSN: 2150-1149
CID: 5726762

Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines

Manchikanti, Laxmaiah; Knezevic, Nebojsa Nick; Navani, Annu; Christo, Paul J; Limerick, Gerard; Calodney, Aaron K; Grider, Jay; Harned, Michael E; Cintron, Lynn; Gharibo, Christopher G; Shah, Shalini; Nampiaparampil, Devi E; Candido, Kenneth D; Soin, Amol; Kaye, Alan D; Kosanovic, Radomir; Magee, Trevor R; Beall, Douglas P; Atluri, Sairam; Gupta, Myank; Helm Ii, Standiford; Wargo, Bradley W; Diwan, Sudhir; Aydin, Steve M; Boswell, Mark V; Haney, Bill W; Albers, Sheri L; Latchaw, Richard; Abd-Elsayed, Alaa; Conn, Ann; Hansen, Hans; Simopoulos, Thomas T; Swicegood, John R; Bryce, David A; Singh, Vijay; Abdi, Salahadin; Bakshi, Sanjay; Buenaventura, Ricardo M; Cabaret, Joseph A; Jameson, Jessica; Jha, Sunny; Kaye, Adam M; Pasupuleti, Ramarao; Rajput, Kartic; Sanapati, Mahendra R; Sehgal, Nalini; Trescot, Andrea M; Racz, Gabor B; Gupta, Sanjeeva; Sharma, Manohar Lal; Grami, Vahid; Parr, Allan T; Knezevic, Emilija; Datta, Sukdeb; Patel, Kunj G; Tracy, Deborah H; Cordner, Harold J; Snook, Lee T; Benyamin, Ramsin M; Hirsch, Joshua A
BACKGROUND:Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines. OBJECTIVE:To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine. METHODS:The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and  recommendations were provided. RESULTS:In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. LIMITATIONS/CONCLUSIONS:The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain. CONCLUSIONS:These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations.
PMID: 33492918
ISSN: 2150-1149
CID: 4766982

Triaging Interventional Pain Procedures During COVID-19 or Related Elective Surgery Restrictions: Evidence-Informed Guidance from the American Society of Interventional Pain Physicians (ASIPP)

Gharibo, Christopher; Sharma, Amit; Soin, Amol; Shah, Shalini; Diwan, Sudhir; Buenaventura, Ricardo; Nampiaparampil, Devi E; Aydin, Steve; Bakshi, Sanjay; Abdi, Salahadin; Jha, Sachin Sunny; Cordner, Harold; Kaye, Alan D; Abd-Elsayed, Alaa; Candido, Kenneth D; Knezevic, Nebojsa Nick; Atluri, Sairam; Wargo, Bradley W; Sanapati, Mahendra R; Datta, Sukdeb; Hirsch, Joshua A; Manchikanti, Laxmaiah; Rajput, Kartic
BACKGROUND:The COVID-19 pandemic has worsened the pain and suffering of chronic pain patients due to stoppage of "elective" interventional pain management and office visits across the United States. The reopening of America and restarting of interventional techniques and elective surgical procedures has started. Unfortunately, with resurgence in some states, restrictions are once again being imposed. In addition, even during the Phase II and III of reopening, chronic pain patients and interventional pain physicians have faced difficulties because of the priority selection of elective surgical procedures.Chronic pain patients require high intensity care, specifically during a pandemic such as COVID-19. Consequently, it has become necessary to provide guidance for triaging interventional pain procedures, or related elective surgery restrictions during a pandemic. OBJECTIVES:The aim of these guidelines is to provide education and guidance for physicians, healthcare administrators, the public and patients during the COVID-19 pandemic. Our goal is to restore the opportunity to receive appropriate care for our patients who may benefit from interventional techniques. METHODS:The American Society of Interventional Pain Physicians (ASIPP) has created the COVID-19 Task Force in order to provide guidance for triaging interventional pain procedures or related elective surgery restrictions to provide appropriate access to interventional pain management (IPM) procedures in par with other elective surgical procedures. In developing the guidance, trustworthy standards and appropriate disclosures of conflicts of interest were applied with a section of a panel of experts from various regions, specialties, types of practices (private practice, community hospital and academic institutes) and groups. The literature pertaining to all aspects of COVID-19, specifically related to epidemiology, risk factors, complications, morbidity and mortality, and literature related to risk mitigation and stratification was reviewed. The evidence -- informed with the incorporation of the best available research and practice knowledge was utilized, instead of a simplified evidence-based approach. Consequently, these guidelines are considered evidence-informed with the incorporation of the best available research and practice knowledge. RESULTS:The Task Force defined the medical urgency of a case and developed an IPM acuity scale for elective IPM procedures with 3 tiers. These included emergent, urgent, and elective procedures. Examples of emergent and urgent procedures included new onset or exacerbation of complex regional pain syndrome (CRPS), acute trauma or acute exacerbation of degenerative or neurological disease resulting in impaired mobility and inability to perform activities of daily living. Examples include painful rib fractures affecting oxygenation and post-dural puncture headaches limiting the ability to sit upright, stand and walk. In addition, urgent procedures include procedures to treat any severe or debilitating disease that prevents the patient from carrying out activities of daily living. Elective procedures were considered as any condition that is stable and can be safely managed with alternatives. LIMITATIONS:COVID-19 continues to be an ongoing pandemic. When these recommendations were developed, different stages of reopening based on geographical regulations were in process. The pandemic continues to be dynamic creating every changing evidence-based guidance. Consequently, we provided evidence-informed guidance. CONCLUSION:The COVID-19 pandemic has created unprecedented challenges in IPM creating needless suffering for pain patients. Many IPM procedures cannot be indefinitely postponed without adverse consequences. Chronic pain exacerbations are associated with marked functional declines and risks with alternative treatment modalities. They must be treated with the concern that they deserve. Clinicians must assess patients, local healthcare resources, and weigh the risks and benefits of a procedure against the risks of suffering from disabling pain and exposure to the COVID-19 virus.
PMID: 32942785
ISSN: 2150-1149
CID: 4609582