Advertisement
The Neurostimulation Appropriateness Consensus Committee (NACC)| Volume 20, ISSUE 1, P15-30, January 2017

Download started.

Ok

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury

      Introduction

      Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation.

      Methods

      The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus.

      Results

      The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices.

      Conclusions

      On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.

      Keywords:

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      REFERENCES

        • Levy R
        • Henderson J
        • Slavin K
        • et al.
        Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads.
        Neuromodulation. 2011; 14 (discussion 422): 412-422
        • Deer TR
        • Pope JE
        • Veizi IE
        • et al.
        Polyanalgesic Consensus Conference recommendations for intrathecal drug delivery: guidance for improving safety and mitigating risk.
        Neuromodulation. 2017; 20: 155-175
        • Harris RP
        • Helfand M
        • Woolf SH
        • et al.
        • for the Methods Work Group, Third U.S. Preventive Services Task Force
        Current methods of the US Preventive Services Task Force: a review of the process.
        Am J Prev Med. 2001; 20: 21-35
        • Mangram AJ
        • Horan TC
        • Pearson ML
        • Silver LC
        • Jarvis WR.
        Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee.
        Infect Control Hosp Epidemiol. 1999; 20: 250-278
        • Deer TR
        • Mekhail N
        • Provenzano D
        • et al.
        The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain.
        Neuromodulation. 2014; 17: 571-597
        • Deer TR
        • Narouze S
        • Provenzano D
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations on bleeding and coagulation management in neurostimulation devices.
        Neuromodulation. 2017; 20: 51-62
        • Deer TR
        • Provenzano D
        • Hanes M
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management.
        Neuromodulation. 2017; 20: 31-50
        • Petraglia FW
        • Farber SH
        • Gramer R
        • et al.
        The incidence of spinal cord injury in implantation of percutaneous and paddle electrodes for spinal cord stimulation.
        Neuromodulation. 2016; 19: 85-90
        • Liem L
        • Russo M
        • Huygen FJ
        • et al.
        One-year outcomes of spinal cord stimulation of the dorsal root ganglion in the treatment of chronic neuropathic pain.
        Neuromodulation. 2015; 18 (discussion 48–49): 41-48
        • Neal JM
        • Barrington MJ
        • Brull R
        • et al.
        The Second ASRA Practice Advisory on Neurologic Complications Associated With Regional Anesthesia and Pain Medicine: executive summary 2015.
        Reg Anesth Pain Med. 2015; 40: 401-430
        • Schievink WI
        • Maya MM.
        Diffuse non-aneurysmal SAH in spontaneous intracranial hypotension: sequela of ventral CSF leak?.
        Cephalalgia. 2016; 36: 589-592
        • Mokri B.
        Spontaneous intracranial hypotension.
        Continuum. 2015; 21: 1086-1108
        • Bezov D
        • Ashina S
        • Lipton R.
        Post-dural puncture headache. II. Prevention, management, and prognosis.
        Headache. 2010; 50: 1482-1498
        • Deer TR
        • Krames E
        • Mekhail N
        • et al.
        The appropriate use of neurostimulation: new and evolving neurostimulation therapies and applicable treatment for chronic pain and selected disease states.
        Neuromodulation. 2014; 17: 599-615
        • Fitzgibbon DR
        • Posner KL
        • Domino KB
        • Caplan RA
        • Lee LA
        • Cheney FW.
        Chronic pain management: American Society of Anesthesiologists Closed Claims Project.
        Anesthesiology. 2004; 100: 98-105
        • McGrath JM
        • Schaefer MP
        • Malkamaki DM.
        Incidence and characteristics of complications from epidural steroid injections.
        Pain Med. 2011; 12: 726-731
        • Bendersky D
        • Yampolsky C.
        Is spinal cord stimulation safe? A review of its complications.
        World Neurosurgery. 2014; 82: 1359-1368
        • Deer TR
        • Stewart CD.
        Complications of spinal cord stimulation: identification, treatment, and prevention.
        Pain Med. 2008; 9: S93-S101
        • Eldrige JS
        • Weingarten TN
        • Rho RH.
        Management of cerebral spinal fluid leak complicating spinal cord stimulator implantation.
        Pain Pract. 2006; 6: 285-288
        • Slangen R
        • Schaper NC
        • Faber CG
        • et al.
        Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial.
        Diabetes Care. 2014; 37: 3016-3024
        • Cameron T.
        Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review.
        J Neurosurg. 2004; 100: 254-267
        • Mekhail NA
        • Mathews M
        • Nageeb F
        • Guirguis M
        • Mekhail MN
        • Cheng J.
        Retrospective review of 707 cases of spinal cord stimulation: indications and complications.
        Pain Pract. 2011; 11: 148-153
        • Kemler MA
        • Barendse GA
        • van Kleef M
        • et al.
        Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy.
        New Engl J Med. 2000; 343: 618-624
        • Simopoulos TT
        • Sharma S
        • Aner M
        • Gill JS.
        The incidence and management of postdural puncture headache in patients undergoing percutaneous lead placement for spinal cord stimulation.
        Neuromodulation. 2016; 19: 738-743
        • Baysinger CL
        • Pope JE
        • Lockhart EM
        • Mercaldo ND.
        The management of accidental dural puncture and postdural puncture headache: a North American survey.
        J Clin Anesth. 2011; 23: 349-360
        • Chiravuri S
        • Wasserman R
        • Chawla A
        • Haider N.
        Subdural hematoma following spinal cord stimulator implant.
        Pain Physician. 2008; 11: 97-101
        • Neal JM
        • Bernards CM
        • Hadzic A
        • et al.
        ASRA Practice Advisory on Neurologic Complications in Regional Anesthesia and Pain Medicine.
        Reg Anesth Pain Med. 2008; 33: 404-415
        • Giberson CE
        • Barbosa J
        • Brooks ES
        • et al.
        Epidural hematomas after removal of percutaneous spinal cord stimulator trial leads: two case reports.
        Reg Anesth Pain Med. 2014; 39: 73-77
        • Navarro P
        • Mena J.
        Epidural hematoma and paraplegia after spinal cord stimulator trial lead removal: a case report.
        PM R. 2014; 1: S361-S362
        • Brown MW
        • Yilmaz TS
        • Kasper EM.
        Iatrogenic spinal hematoma as a complication of lumbar puncture: what is the risk and best management plan?.
        Surg Neurol Int. 2016; 7: S581-S589
        • Kumar K
        • Hunter G
        • Demeria D.
        Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience.
        Neurosurgery. 2006; 58 (discussion 481–496): 481-496
        • Kapural L
        • Yu C
        • Doust MW
        • et al.
        Novel 10-kHz High-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial.
        Anesthesiology. 2015; 123: 851-860
        • Narouze S
        • Benzon HT
        • Provenzano DA
        • et al.
        Interventional spine and pain procedures in patients on antiplatelet and anticoagulant 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.
        Reg Anesth Pain Med. 2015; 40: 182-212
        • Fitzgibbon DR
        • Stephens LS
        • Posner KL
        • et al.
        Injury and liability associated with implantable devices for chronic pain.
        Anesthesiology. 2016; 124: 1384-1393
        • Pope JE.
        Complications of spinal cord stimulation.
        in: Ranson M Pope JE Deer T Reducing Risks and Complications of Interventional Pain Procedures. Saunders, Philadelphia2012: 3-10
        • Kumar K
        • Wilson JR
        • Taylor RS
        • Gupta S.
        Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact.
        J Neurosurg Spine. 2006; 5: 191-203
        • Rauchwerger JJ
        • Zoarski GH
        • Waghmarae R
        • et al.
        Epidural abscess due to spinal cord stimulator trial.
        Pain Pract. 2008; 8: 324-328
        • Bara G
        • Kowatz L
        • Schu S
        • Vesper J.
        Infection rates of percutaneously implanted leads for SCS after a trial phase: three-year follow up [abstr].
        Neuromodulation. 2013; 16: e106
        • Engle MP
        • Vinh BP
        • Harun N
        • Koyyalagunta D.
        Infectious complications related to intrathecal drug delivery system and spinal cord stimulator system implantations at a comprehensive cancer pain center.
        Pain Physician. 2013; 16: 251-257
        • Hayek SM
        • Veizi E
        • Hanes M.
        Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database.
        Neuromodulation. 2015; 18 (discussion 608–609): 603-608
        • Fritz AK
        • Bhagwat P.
        Management of thoracic epidural abscess post spinal cord stimulator insertion-a case report [abstr].
        Neuromodulation. 2013; 16: e70
        • Quigley DG
        • Arnold J
        • Eldridge PR
        • et al.
        Long-term outcome of spinal cord stimulation and hardware complications.
        Stereo Funct Neurosurg. 2003; 81: 50-56
        • Burgher AH
        • Barnett CF
        • Obray JB
        • Mauck WD.
        Introduction of infection control measures to reduce infection associated with implantable pain therapy devices.
        Pain Pract. 2007; 7: 279-284
        • Follett KA
        • Boortz-Marx RL
        • Drake JM
        • et al.
        Prevention and management of intrathecal drug delivery and spinal cord stimulation system infections.
        Anesthesiology. 2004; 100: 1582-1594
        • Cicuendez M
        • Munarriz PM
        • Castano-Leon AM
        • Paredes I.
        Dorsal myelopathy secondary to epidural fibrous scar tissue around a spinal cord stimulation electrode.
        J Neurosurg Spine. 2012; 17: 598-601
        • Dam-Hieu P
        • Magro E
        • Seizeur R
        • Simon A
        • Quinio B.
        Cervical cord compression due to delayed scarring around epidural electrodes used in spinal cord stimulation.
        J Neurosurg Spine. 2010; 12: 409-412
        • Lennarson PJ
        • Guillen FT.
        Spinal cord compression from a foreign body reaction to spinal cord stimulation: a previously unreported complication.
        Spine. 2010; 35: E1516-E1519
        • Scranton RA
        • Skaribas IM
        • Simpson RK.
        Spinal stimulator peri-electrode masses: case report.
        J Neurosurg Spine. 2015; 22: 70-74
        • Meyer SC
        • Swartz K
        • Johnson JP.
        Quadriparesis and spinal cord stimulation: case report.
        Spine. 2007; 32: E565-E568
        • Franzini A
        • Ferroli P
        • Marras C
        • Broggi G.
        Huge epidural hematoma after surgery for spinal cord stimulation.
        Acta Neurochirurg. 2005; 147: 565-567; discussion 567
        • Takawira N
        • Han RJ
        • Nguyen TQ
        • Gaines JD
        • Han TH.
        Spinal cord stimulator and epidural haematoma.
        Br J Anaesth. 2012; 109: 649-650
        • Smith CC
        • Lin JL
        • Shokat M
        • Dosanjh SS
        • Casthely D.
        A report of paraparesis following spinal cord stimulator trial, implantation and revision.
        Pain Physician. 2010; 13: 357-363
        • Falowski S
        • Dianna A.
        Neuromonitoring protocol for spinal cord stimulator cases with case descriptions.
        Int J Acad Med. 2016; 3
        • Falowski SM
        • Celii A
        • Sestokas AK
        • Schwartz DM
        • Matsumoto C
        • Sharan A.
        Awake vs. asleep placement of spinal cord stimulators: a cohort analysis of complications associated with placement.
        Neuromodulation. 2011; 14 (discussion 134–135): 130-134
        • Shils JL
        • Arle JE.
        Intraoperative neurophysiologic methods for spinal cord stimulator placement under general anesthesia.
        Neuromodulation. 2012; 15 (discussion 571–562): 560-571
        • Ben-Haim S
        • Asaad WF
        • Gale JT
        • Eskandar EN.
        Risk factors for hemorrhage during microelectrode-guided deep brain stimulation and the introduction of an improved microelectrode design.
        Neurosurgery. 2009; 64 (discussion 762–753): 754-762
        • Binder DK
        • Rau GM
        • Starr PA.
        Risk factors for hemorrhage during microelectrode-guided deep brain stimulator implantation for movement disorders.
        Neurosurgery. 2005; 56 (discussion 722-732): 722-732
        • Favre J
        • Taha JM
        • Burchiel KJ.
        An analysis of the respective risks of hematoma formation in 361 consecutive morphological and functional stereotactic procedures.
        Neurosurgery. 2002; 50 (discussion 56–47): 48-56
        • Piacentino M
        • Pilleri M
        • Bartolomei L.
        Hardware-related infections after deep brain stimulation surgery: review of incidence, severity and management in 212 single-center procedures in the first year after implantation.
        Acta Neurochir. 2011; 153: 2337-2341
        • Rughani AI
        • Hodaie M
        • Lozano AM.
        Acute complications of movement disorders surgery: effects of age and comorbidities.
        Mov Disord. 2013; 28: 1661-1667
        • Sansur CA
        • Frysinger RC
        • Pouratian N
        • et al.
        Incidence of symptomatic hemorrhage after stereotactic electrode placement.
        J Neurosurg. 2007; 107: 998-1003
        • Sillay KA
        • Larson PS
        • Starr PA.
        Deep brain stimulator hardware-related infections: incidence and management in a large series.
        Neurosurgery. 2008; 62 (discussion 366–367): 360-366
        • Sixel-Doring F
        • Trenkwalder C
        • Kappus C
        • Hellwig D.
        Skin complications in deep brain stimulation for Parkinson’s disease: frequency, time course, and risk factors.
        Acta Neurochir. 2010; 152: 195-200
        • Tsubokawa T
        • Katayama Y
        • Yamamoto T
        • Hirayama T
        • Koyama S.
        Chronic motor cortex stimulation for the treatment of central pain.
        Acta Neurochir Suppl. 1991; 52: 137-139
        • Saitoh Y
        • Kato A
        • Ninomiya H
        • et al.
        Primary motor cortex stimulation within the central sulcus for treating deafferentation pain.
        Acta Neurochir Suppl. 2003; 87: 149-152
        • Monsalve GA.
        Motor cortex stimulation for facial chronic neuropathic pain: a review of the literature.
        Surg Neurol Int. 2012; 3: S290-S311
        • Nguyen JP
        • Lefaucheur JP
        • Decq P
        • et al.
        Chronic motor cortex stimulation in the treatment of central and neuropathic pain. Correlations between clinical, electrophysiological and anatomical data.
        Pain. 1999; 82: 245-251
        • Sachs AJ
        • Babu H
        • Su YF
        • Miller KJ
        • Henderson JM.
        Lack of efficacy of motor cortex stimulation for the treatment of neuropathic pain in 14 patients.
        Neuromodulation. 2014; 17 (discussion 310–301): 303-310
        • Nuti C
        • Peyron R
        • Garcia-Larrea L
        • et al.
        Motor cortex stimulation for refractory neuropathic pain: four year outcome and predictors of efficacy.
        Pain. 2005; 118: 43-52
        • Nguyen JP
        • Nizard J
        • Keravel Y
        • Lefaucheur JP.
        Invasive brain stimulation for the treatment of neuropathic pain.
        Nat Rev Neurol. 2011; 7: 699-709
        • Henderson JM
        • Heit G
        • Fisher RS.
        Recurrent seizures related to motor cortex stimulator programming.
        Neuromodulation. 2010; 13: 37-43
        • Rasche D
        • Ruppolt M
        • Stippich C
        • Unterberg A
        • Tronnier VM.
        Motor cortex stimulation for long-term relief of chronic neuropathic pain: a 10 year experience.
        Pain. 2006; 121: 43-52
        • Velasco F
        • Arguelles C
        • Carrillo-Ruiz JD
        • et al.
        Efficacy of motor cortex stimulation in the treatment of neuropathic pain: a randomized double-blind trial.
        J Neurosurg. 2008; 108: 698-706
        • Lefaucheur JP
        • Drouot X
        • Cunin P
        • et al.
        Motor cortex stimulation for the treatment of refractory peripheral neuropathic pain.
        Brain. 2009; 132 (Part 6): 1463-1471
        • Nguyen JP
        • Lefaucheur JP
        • Raoul S
        • Roualdes V
        • Keravel Y
        Motor cortex stimulation for the treatment of neuropathic pain.
        in: Krames ES Peckham PH Rezai AR Neuromodulation. Elsevier, Amsterdam2009: 515-526
        • Lefaucheur JP
        • Keravel Y
        • Nguyen JP.
        Treatment of poststroke pain by epidural motor cortex stimulation with a new octopolar lead.
        Neurosurgery. 2011; 68 (discussion 187): 180-187
        • Leveque M
        • Weil AG
        • Nguyen JP.
        Simultaneous deep brain stimulation/motor cortex stimulation trial for neuropathic pain: fishing with dynamite?.
        Stereotact Funct Neurosurg. 2015; 93: 219
        • Nguyen JP
        • Velasco F
        • Brugieres P
        • et al.
        Treatment of chronic neuropathic pain by motor cortex stimulation: results of a bicentric controlled crossover trial.
        Brain Stim. 2008; 1: 89-96
        • Huntoon MA
        • Burgher AH.
        Ultrasound-guided permanent implantation of peripheral nerve stimulation (PNS) system for neuropathic pain of the extremities: original cases and outcomes.
        Pain Med. 2009; 10: 1369-1377
        • Nashold BS
        • Goldner JL
        • Mullen JB
        • Bright DS.
        Long-term pain control by direct peripheral-nerve stimulation.
        J Bone Joint Surg Am. 1982; 64: 1-10
        • Waisbrod H
        • Panhans C
        • Hansen D
        • Gerbershagen HU.
        Direct nerve stimulation for painful peripheral neuropathies.
        J Bone Joint Surg Br. 1985; 67: 470-472
        • Stanton-Hicks M
        • Panourias IG
        • Sakas DE
        • Slavin KV.
        The future of peripheral nerve stimulation.
        Prog Neurol Surg. 2011; 24: 210-217
        • Rasskazoff SY
        • Slavin KV.
        An update on peripheral nerve stimulation.
        J Neurosurg Sci. 2012; 56: 279-285
        • Dodick DW
        • Silberstein SD
        • Reed KL
        • et al.
        Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: long-term results from a randomized, multicenter, double-blinded, controlled study.
        Cephalalgia. 2015; 35: 344-358
        • Ishizuka K
        • Oaklander AL
        • Chiocca EA.
        A retrospective analysis of reasons for reoperation following initially successful peripheral nerve stimulation.
        J Neurosurg. 2007; 106: 388-390
        • Stevanato G
        • Devigili G
        • Eleopra R
        • et al.
        Chronic post-traumatic neuropathic pain of brachial plexus and upper limb: a new technique of peripheral nerve stimulation.
        Neurosurg Rev. 2014; 37 (discussion 479–480): 473-479
        • Deer TR
        • Pope J
        • Benyamin R
        • et al.
        Prospective, multicenter, randomized, double-blind, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin.
        Neuromodulation. 2016; 19: 91-100
        • Morch CD
        • Nguyen GP
        • Wacnik PW
        • Andersen OK.
        Mathematical model of nerve fiber activation during low back peripheral nerve field stimulation: analysis of electrode implant depth.
        Neuromodulation. 2014; 17 (discussion 225): 218-225
        • Frahm KS
        • Hennings K
        • Vera-Portocarrero L
        • Wacnik PW
        • Morch CD.
        Muscle activation during peripheral nerve field stimulation occurs due to recruitment of efferent nerve fibers, not direct muscle activation.
        Neuromodulation. 2016; 19: 587-596
        • Frahm KS
        • Hennings K
        • Vera-Portocarrero L
        • Wacnik PW
        • Morch CD.
        Nerve fiber activation during peripheral nerve field stimulation: importance of electrode orientation and estimation of area of paresthesia.
        Neuromodulation. 2016; 19: 311-318
        • Kloimstein H
        • Likar R
        • Kern M
        • et al.
        Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study.
        Neuromodulation. 2014; 17: 180-187
        • McRoberts WP
        • Wolkowitz R
        • Meyer DJ
        • et al.
        Peripheral nerve field stimulation for the management of localized chronic intractable back pain: results from a randomized controlled study.
        Neuromodulation. 2013; 16 (discussion 574–565): 565-574
        • Lee PB
        • Horazeck C
        • Nahm FS
        • Huh BK.
        Peripheral nerve stimulation for the treatment of chronic intractable headaches: long-term efficacy and safety study.
        Pain Physician. 2015; 18: 505-516
        • Provenzano DA
        • Deer T
        • Luginbuhl Phelps A
        • et al.
        An international survey to understand infection control practices for spinal cord stimulation.
        Neuromodulation. 2015; 19: 71-84
        • Goroszeniuk T
        • Pang D
        • Shetty A
        • Eldabe S
        • O’Keeffe D
        • Racz G.
        Percutaneous peripheral neuromodulation lead insertion using a novel stimulating Coude needle.
        Neuromodulation. 2014; 17: 506-509
        • Shellock FG
        • Audet-Griffin AJ.
        Evaluation of magnetic resonance imaging issues for a wirelessly powered lead used for epidural, spinal cord stimulation.
        Neuromodulation. 2014; 17 (discussion 339): 334-339
        • Lad SP
        • Babu R
        • Bagley JH
        • et al.
        Utilization of spinal cord stimulation in patients with failed back surgery syndrome.
        Spine. 2014; 39: E719-E727

      COMMENTS