Complications of Interventional Pain Medicine

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1 Complications of Interventional Pain Medicine Richard W. Rosenquist, M.D., Chairman Cleveland Clinic Department of Pain Management Disclosure EMMI Patient Educational Materials Consultant UpToDate Educational Material Development Spouse Section Editor

2 Learning Objectives At the conclusion of this activity, participants should be able to: List factors associated with infectious, vascular, needle-stick injuries and other types of injuries Identify approaches to reduce patient risk Assess potential treatments for certain complications in order to reduce morbidity and mortality Scope of the Problem The practice of Pain Medicine is associated with increased patient risk Issues and trends are identified through numerous venues - Case reports - Peer reviewed publications - ASA closed claims analysis - Malpractice cases under review - Outcomes data - Internal billing data from insurance organizations - Government agencies FDA, CDC, CMS - News media

3 Are we seeing more complications? Fitzgibbon et al chronic pain claims Rathmell et al chronic pain claims Can We Avoid Complications??? Improved training Treatment algorithms Interventional treatment checklists Modified imaging and drug choices Advanced assessment Modified incentives related to performance of procedures leading to reduced numbers of procedures performed for better indications

4 Infectious Complications Personal hygiene Contamination Inadequate preparation Poor aseptic technique Contaminated medications Inadequate/inappropriate antibiotics Paraspinal Abscess Complicated by Endocarditis Following a Facet Joint Injection Hoelzer BC, Weingarten TN, Hooten WM, Wright RS, Wilson WR, Wilson PR European Journal of Pain 2008;12:261-5

5 Hoelzer BC et al 65-yr-old male with low back pain for repeat L5-S1 facet injection and infiltration of L5-S1 intraspinal ligament 2 weeks later he had increased pain after lifting heavy objects and a repeat L5-S1 facet injection and L5-S1 interlaminar ESI was performed 6-8 hrs after the procedure the patient developed fever and chills 1 day later he had malaise, myalgias, lower extremity edema, blisters on his forehead and worsening pain Hoelzer BC et al 2 days after the procedure he presented to the ED and was admitted. Vital signs stable, temp 37.8 Exam demonstrated Janeway lesions and Osler s nodes Blood cultures positive for methicillin sensitive staphylococcus aureus and diagnosed with L5-S1 paraspinal abscess and infective endocarditis Treated with IV Vancomycin 1 day, Cefazolin 9 day with Gentamicin 4 days and then Nafcillin for 6 weeks 2 years after infection he still has renal insufficiency but has no back pain and no neurologic sequela

6 Vascular Injuries Embolic Chemical Mechanical disruption

7 Posterior Circulation Stroke after C1-C2 Intraarticular Facet Steroid Injection: Evidence for Diffuse Microvascular Injury Edlow BL, Wainger BJ, Frosch MP, Copen WA, Rathmell JP, Rost NS. Anesthesiology 2010;112: Edlow BL et al 64-yr-old man with chronic cervical pain consented to a C1-C2 intraarticular facet steroid injection 25-gauge needle advanced with fluoroscopic guidance, iohexol contrast was injected followed by AP and lateral radiographs Neither live fluoroscopy or digital subtraction was used 2 mls of 40-mg/ml triamcinolone acetonide suspension was then injected

8 Edlow BL et al Immediate loss of consciousness with extensor posturing of the limbs, brief period of apnea and BP from 144/85 to 219/110 with a HR of 46. Initial CT angiography was normal MRI demonstrated multiple hyperintensities reflecting infarction of the thalami, pons, occipital lobes, hippocampi, splenium of the corpus callosum and cerebellum On day 4 the patient remained comatose. Given the poor prognosis, the family withdrew support and he died shortly thereafter Anatomic Considerations Anesthesiology, V 112 No 6 June 2010

9 Brain MRI Acutely and on Day 3 Anesthesiology, V 112 No 6 June 2010 Edlow BL et al - Conclusions It is clear that devastating neurologic injury can occur during cervical transforaminal or facet injection because of particulate steroid entering the posterior cerebral circulation. We call on all practitioners to perform cervical procedures only when the benefits clearly outweigh the risks, to provide adequate explanation of these risks during the informed consent process, and to adopt safety measures to minimize risk. In the specific case of cervical intraarticular facet injections, the benefit of this treatment is unclear; thus, practitioners should stop performing these injections altogether until further scientific evidence is available.

10 Cerebellar Herniation After Cervical Transforaminal Epidural Injection Beckman WA, Mendez RJ, Paine GF, Mazzilli MA. Reg Anes Pain Med 2006;31:282-5 Beckman WA, et al. 31-year-old with cervical radicular pain and right upper extremity radicular symptoms Transforaminal epidural steroid injection at the right C8 nerve root Following the TFESI he developed a cerebellar infarct and brainstem herniation He survived but had residual deficits: - Persistent diplopia on right lateral gaze - Difficulties with short-term memory loss and concentration

11 Lumbar Transforaminal Epidural Steroid Injection Nerve injury Spinal cord infarction Reg Anes Pain Med 2006;31:282-5 Paraplegia Following Image- Guided Transforaminal Lumbar Spine Epidural Steroid Injection: Two Case Reports Kennedy DJ, Dreyfuss P, Aprill CN, Bogduk N Pain Medicine 2009;10:

12 Preventing Vascular Complications Checklist - Image guidance - Accurate anatomic placement - Appropriate needle selection? Sharp, round tip, Whitacre or Sprotte configuration - Aspiration test - Contrast administration Live +/- digital subtraction angiography - Local anesthetic test dose followed by clinical examination - Appropriate drug selection? Particulate, small particulate or non-particulate Injections Most common class of procedure Associated with the greatest number of complications Procedures - Trigger point injections - Facet injections - Epidural steroid injections Interlaminar Transforaminal

13 Trigger Point Injections Seemingly innocuous Bleeding Pneumothorax 51% of all claims Epidural Steroid Injections Accidental dural puncture Epidural hematoma Nerve injury Spinal cord injury

14 Perineural Hematoma Following Lumbar Transforaminal Steroid Injection Causing Acute-on-Chronic Lumbar Radiculopathy: A Case Report Desai MJ, Dua S. Pain Practice 2013;Mar 6. doi: /papr Injury and Liability Associated with Cervical Procedures for Chronic Pain Rathmell JP, Michna E, Fitzgibbon DR, Stephens LS, Posner KL, Domino KB. Anesthesiology 2011;114:918-26

15 Rathmell JP, et al Compared claims for cervical pain treatments to all other chronic pain complaints from Claims for spinal cord injury underwent in-depth analysis for mechanisms of injury and use of sedation during the procedure. Rathmell JP, et al Claims related to cervical procedures 22% (64/294) Cervical procedure characteristics - Healthier ASA More frequently women Cervical procedure 59% experienced spinal cord injury compared with 11% of those with other chronic pain Direct needle trauma was the predominant cause (31%)

16 Rathmell JP, et al General anesthesia or sedation was used in 67% of cervical procedure claims associated with spinal cord injuries but only 19% of cervical procedure claims not associated with spinal cord injuries Of the patients who underwent cervical procedures and had spinal cord injuries, 25% were nonresponsive during the procedure compared with 5% of the patients who underwent cervical procedures and did not have spinal cord injuries Injury and Liability Associated with Cervical Procedures for Chronic Pain Copyright 2011 Anesthesiology. Published by Lippincott Williams & Wilkins

17 Rathmell JP, et al Injuries related to cervical interventional pain treatment were often severe and related to direct needle trauma to the spinal cord. Traumatic spinal cord injury was more common in patients who received sedation or general anesthesia and in those who were unresponsive during the procedure. Further studies are crucial to define the usefulness of cervical interventions and to improve their safety. Intradiscal Procedures

18 Cauda Equina Compression Post Lumbar Discography Phillips H, Glazebrook JJ, Timothy J. Acta Neurochir 2012;154: Phillips GH, et al. 29-year-old female dancer with LBP MRI and CT myelography demonstrated DDD at L4-5 and L5-S1 3-level discogram with fentanyl/midazolam sedation L4-5 severe concordant pain L5-S1 milder concordant pain 3 weeks after the procedure, admitted with urinary incontinence for 3 weeks, fecal incontinence for 48 hours, lower extremity weakness 3-4/5 and decreased sensation globally on the right and L4-S2 on the left.

19 Pre-Procedural Imaging and Discogram Acta Neurochir (2012) 154: MRI Imaging 3-weeks Post- Discography

20 Phillips GH, et al. Lumbar laminectomy and L4-5, L5-S1 microdiscectomy She subsequently underwent elective L4-5, L5-S1 ALIF with removal of the discs followed by bilateral L4-5, L5-S1 facet joint screw fixation Discharged from clinic 4 years and 1 month after initial presentation with no pain and no residual neurologic deficits Epidural Abscess and Cauda Equina Syndrome after Percutaneous Intradiscal Therapy in Degenerative Lumbar Disc Disease Subach BR, Copay AG, Martin MM, Schuler TC, DeWolfe DS The Spine Journal 2012;12:e1-4

21 Subach BR, et al. 61-year-old male with LBP due to DDD involving the lumbar spine (annular tears L3-4, L4-5 and L5-S1) No response to conservative treatment or strong analgesics Underwent bone marrow aspiration from the left iliac crest and aspiration of autologous fat The bone marrow aspirate, unseparated adipose tissue and plasma from a peripheral blood draw were combined and injected into the L3-4 and L5-S1 disc spaces. 2 weeks later he developed fever, increasing low back pain and new onset left lower extremity radicular pain associated with weakness and urinary retention cauda equina syndrome MRI discitis, myelitis, epidural abscess and paraspinal abscess Surgical treatment X 2 with evidence of herniated disc material found at the L3 pedicle One year later normal strength, hypoactive reflexes, patchy sensory loss and normal bladder function Vertebroplasty and Kyphoplasty

22 Pericardial Tamponade and Right Ventricular Cement Embolus due to Right Ventricle Perforation During Kyphoplasty Tran I, Gerckens U, Remig J, Zintl G, Textor J. Spine 2013;38:E316-8 Intrathecal or Epidural Procedural complications Infection Direct neural trauma Pump errors - Programming error - Drug overdose - Drug error or contamination Granuloma formation Catheter breakage or disconnect

23 Spinal Cord Stimulation Devices Infection Epidural hematoma Nerve injury Spinal cord injury Equipment failure - Lead breakage - Disconnect Battery failure A Report of Paraparesis Following Spinal Cord Stimulator Trial, Implantation and Revision Smith CC, Lin JL, Shokat M, Dosanjh SS, Casthely D Pain Physician 2010;13:357-63

24 Smith CC, et al 4 cases - 1 cord contusion - 3 cord compression 2 epidural hematoma 1 implantation in the setting of broad based thoracic disc herniations - All electrodes and neurostimulators successfully removed 1 complete paraplegia 2 incomplete paraparesis 1 complete recovery of neurologic function Cervical Myelopathy due to an Epidural Cervical Mass after Chronic Cervical Spinal Cord Stimulation Wloch A, Capelle HH, Saryyeva A, Krauss JK. Stereotact Funct Neurosurg 2013;91:265-9

25 Retrospective Review of 707 Cases of Spinal Cord Stimulation: Indications and Complications Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J Pain Practice 2011;11: Mekhail NA, et al Trials - Lead migration 0.7% Permanent Implants - Hardware related complications Lead migration 22.6% Lead connection failure 9.5% Lead breakage 6% - Biological complications Pain at the generator site 12% Clinical infection 4.5% Failed back surgery and diabetics were at highest risk

26 Reducing Neuromodulation Complications Appropriate training, credentialing and privileging Algorithmic approach to patient selection Checklist procedural approach Algorithmic trial and postoperative management Conclusions I Complications of Pain Medicine practice are common Interventional techniques carry significant complications and risk Careful patient selection, excellent anatomic knowledge and meticulous technique may reduce risk and maximize benefit

27 Conclusions II We must codify and enforce the basics We must develop and use a uniform set of outcome measures that allows broad comparisons We must develop and implement a method of tracking outcomes and complications to improve patient safety We must innovate to survive healthcare reform without sacrificing patient safety

28

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