CLINICAL GUIDELINES. Update Summary

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1 CLINICAL GUIDELINES CDI Quality Institute Anticoagulation and Antiplatelet Guidelines for Patients Undergoing Percutaneous Image-Guided Needle Procedures: An Update Concerning Facet Joint Injections, Medial Branch Blocks and Facet Nerve Ablation Thomas J. Gilbert M.D., M.P.P. 11/29/2017 Update Summary Medial Branch Blocks (MBB) appear to be safe in patients who are on anticoagulant therapy. They appear to have a low risk for bleeding and antithrombotic/antiplatelet therapy may not need to be held for these procedures. Procedures should only be performed on patients if the coagulation status is at therapeutic or subtherapeutic levels. (Very low level of evidence) Intra-articular facet joint injections appear to be safe in patients who are on anticoagulant therapy. They appear to have a low risk for bleeding and antithrombotic/antiplatelet therapy may not need to be held for these procedures. Care should be taken, however, to avoid rupturing the joint capsule in these patients. Procedures should only be performed on patients if the coagulation status is at therapeutic or subtherapeutic levels. Antithrombotic and antiplatelet therapy still need to be withheld for facet cyst ruptures. (Very low level of evidence) Facet Nerve Ablation/Radiofrequency neurotomy procedures, while low risk, may have an increased risk compared to MBB and facet joint injections as these procedures utilize larger needles and multiple stabs. The decision to withhold or continue anticoagulant/antiplatelet medications in these patients should be made on a case-by-case basis. Consideration should be given to the risk of a thromboembolic event as determined by the prescribing practitioner. (Very low level of evidence) Background Three recent 2017 publications and an older 2011 publication address the need to withhold anticoagulation for patients undergoing facet joint injections, medial branch blocks and facet nerve ablation procedures. (Endres, Goodman, Van Helmond) The risk of serious neurologic damage with these procedures may be decreased as the injections are directed to targets outside the spinal canal and can be performed with small bore 25 gauge needles. The risk of a thromboembolic event may be greater than the risk of bleeding associated with discontinuing anticoagulant therapy for patients undergoing these procedures. The American Society of Regional Anesthesia and Pain Medicine (ARSA) and Spine Intervention Society (SIS) guidelines differ in their recommendations concerning the management of anticoagulation therapy in patients undergoing facet joint injections, medial

2 branch blocks and facet nerve ablations. The 2015 ASRA anticoagulation guidelines classify medial branch blocks and facet nerve radiofrequency ablation procedures as intermediate risk procedures and recommend withholding anticoagulant therapy for them. The SIS guidelines state that it is not necessary to cease anticoagulants while performing medial branch blocks and intra-articular injections, and that it is probably not necessary to stop anticoagulants for cervical or lumbar medial branch radiofrequency neurotomies. The March 21, 2017 CDI Quality Institute Anticoagulation/Antiplatelet Guidelines are based primarily on the 2015 ASRA anticoagulation guidelines. Endres et al This retrospective study was performed to determine if continuing or discontinuing anticoagulants were associated with. The study was performed in a private practice office in which one of the senior partners elected to continue anticoagulants in all patients undergoing transforaminal injections, medial branch blocks, SIJ blocks, trigger point injections and peripheral joint injections. Anticoagulants were continued in patients undergoing radiofrequency neurotomy for whom anticoagulants could not be discontinued on the advice of the cardiologist. Informed consent was obtained in all patients for whom anticoagulant medications were continued and the procedure was only undertaken if coagulation status was at therapeutic levels. A second senior partner adopted this same practice after 18 months. Five associates withheld anticoagulant medications according to the ASRA guidelines. Endres et al All procedures MBB Facet joint injections RF neurotomy Other AC + continued/ AC + discontinued 4766/ / / 504 Bleeding 0/0 0/0-0/0 0/0 0/9 0/1-0/1 0/7 + Anticoagulant medications 2635/ 1156 were seen in 9 patients. All thromboembolic events occurred while warfarin was being withheld: 3 patients for a cervical ESI; 1 for a cervical MBB; 3 for a lumbar ESI/intrathecal injection; 1 for a lumbar TFESI; and 1 for a lumbar RFN. One patient had a thromboembolic event the morning of the procedure, and 8 patients between 2-7 days after the procedure. Goodman et al This prospective observational study evaluated the complication rate in patients following a modified SIS/ARSA protocol in a single center, single provider practice. The authors did not specify whether the patients were consecutive or not. They did withhold eptifibatide, tirofiban and abciximab in all patients. Procedures were only performed if the coagulation status was within therapeutic levels. 2

3 Goodman et al All procedures MBB Facet joint injections RF neurotomy Other AC + continued/ Total procedures 197/ / / 137 Bleeding 0/1-0/0 0/0 0/1 0/0-0/0 0/0 0/0 + Anticoagulant medications The authors reported one spinal epidural hematoma in a patient not on anticoagulant/antiplatelet medications undergoing a lumbar interlaminar injection. No thromboembolic events were noted in their patients at hours after the procedure. This retrospective cohort study evaluated the rate of adverse events in patients undergoing spine procedures while continuing their anti-thrombotic medications. The study was performed in a private practice setting in which some practitioners routinely continued anticoagulant therapy, while others did not. All procedures MBB Facet joint RF Other injections neurotomy AT + continued*/ AT + 205/ / 34-45/ 10 18/ 7 discontinued* Bleeding 0/0 0/0-1/0 1/ *Warfarin, P2Y12 inhibitors, heparin, and factor Xa inhibitors. Data in the original study included ASA. + Antithrombotic medications 109/ 3452 One bleeding complication was noted in a patient on clopidogrel and aspirin following a lumbar radiofrequency ablation. No bleeding were seen in the 1661 patients not on antithrombotics. The center did not comment on thromboembolic events. 3

4 Manchikanti L. et al This prospective study evaluated the complication rate in 3,179 patients undergoing interventional techniques with or without cessation of antithrombotic therapy. The study was performed in a private interventional pain practice. The author did not indicate why anticoagulant medications were withheld in some patients and not in others. All procedures MBB Facet joint RF Other injections neurotomy AT + continued*/ AT / / / 559 discontinued* Major Bleeding 0/0-0/0-0/ *Warfarin or clopidogrel. Data in the original study included ASA. + Antithrombotic medications No significant prevalence of adverse effects was seen in patients who continued or stopped their antithrombotic medications. Summary Each of these studies are very low-quality studies. They were each performed in a private practice setting and were observational or retrospective in design. In two studies, the procedures were performed by 1-2 interventionalists. The criteria as to when to hold or continue anticoagulant therapy, when described, appears to be based on individual physician preference and the techniques used (e.g. needle size and type) were not specified in two of the studies. Outcome assessment also differed substantially between the studies, particularly with respect to the assessment for thromboembolic events. Finally, the majority of procedures cited in the studies above were performed in the lumbar spine. While fewer procedures were performed in the cervical and thoracic spine, no major bleeding were seen in the patients who underwent injections at these levels. This is a guideline, not a policy. It is a summary and distillation of relevant subspecialty guidelines. The purpose of the CDI Quality Institute guidelines is to facilitate and accelerate the integration of medical evidence and best practices into daily clinical practices. Guidelines provide relevant medical evidence to support the development of policies within each individual practice. Guidelines should be adjusted for local standards of care, associated hospital or network policies, hospital versus outpatient settings, different patient populations, availability of resources, different experience levels, individual patient circumstances and different risk-tolerance profiles. Local practice policies should also be modified to account for new information or publications that become available between guideline revisions. 4

5 Bibliography Narouze S, Benzon HT, Provenzano DA, et al. Interventional spine and pain procedures in patients on antiplatelet and anticoagulation medications: Guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain. Regional Anesthesia and pain Medicine 2015;40: Interventional Spine Intervention Society. Anticoagulants. In: Bogduk N (ed). Practice guidelines for spinal diagnostic and treatment procedures, 2 nd edn. International Spine Intervention Society, San Franscisco, Endres S, Shufelt A, and Bogduk N. The risks of continuing or discontinuing anticoagulants for patients undergoing common interventional pain procedures. Pain Medicine 2017;18: Goodman BS, McLean House L, Vallabhaneni S, et al. Anticoagulation and antiplatelet management for spinal procedures: A prospective, descriptive study and interpretation of guidelines. Pain Medicine 2017;18: Van Helmond N, Day W, and Chapman KB. Continuing anti-thrombotic medication during lowto-intermediate risk spinal procedures: A retrospective evaluation. Pain Medicine 2017;20: Manchikanti L, Malla Y, Wargo BW, et al. A prospective evaluation of bleeding risk of interventional techniques in chronic pain. Pain Physician 2011;14: