Introduction
The Neurostimulation Appropriateness Consensus Committee (NACC) was formed by the
International Neuromodulation Society (INS) in 2012 to evaluate the evidence to reduce
the risk of complications and improve the efficacy of neurostimulation. The first
series of papers, published in 2014, focused on the general principles of appropriate
practice in the surgical implantation of neurostimulation devices. The NACC was reconvened
in 2014 to Address specific patient care issues, including bleeding and coagulation.
Methods
The INS strives to improve patient care in an evidence-based fashion. The NACC members
were appointed or recruited by the INS leadership for diverse expertise, including
international clinical expertise in many areas of neurostimulation, evidence evaluation,
and publication. The group developed best practices based on peer-reviewed evidence
and, in the absence of specific evidence, on expert opinion. Recommendations were
based on international evidence in accordance with guideline creation.
Conclusions
The NACC has recommended specific measures to reduce the risk of bleeding and neurological
injury secondary to impairment of coagulation in the setting of implantable neurostimulation
devices in the spine, brain, and periphery.
Keywords:
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REFERENCES
- The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain.Neuromodulation. 2014; 17 (discussion 597-578): 571-597
- Clinical guidelines for intraspinal infusion: report of an expert panel. PolyAnalgesic Consensus Conference 2000.J Pain Symptom Manage. 2000; 20: S37-S43
- The Polyanalgesic Consensus Conference (PACC) recommendations on intrathecal drug infusion systems best practices and guidelines.Neuromodulation. 2017; 20: 96-132
- The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee.Neuromodulation. 2014; 17: 515-550
- The appropriate use of neurostimulation: stimulation of the intracranial and extracranial space and head for chronic pain.Neuromodulation. 2014; 17: 551-570
- 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
- Intraoperative magnetic resonance imaging findings during deep brain stimulation surgery.J Neurosurg. 2011; 115: 852-857
- Fatal hemorrhage from AVM after DBS surgery: case report.Neuromodulation. 2013; 16 (discussion 417): 414-417
- Delayed clinical improvement after deep brain stimulation-related subdural hematoma.Report of 4 Cases. J Neurosurg. 2011; 115: 289-294
- 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
- Epidural hematomas following removal of percutaneous spinal cord stimulator trial leads: two case reports.Reg Anesth Pain Med. 2014; 39: 73-77
- Spinal epidural hematoma following spinal cord stimulator trial lead placement in a patient taking aspirin.Reg Anesth Pain Med. 2014; 39: 70-72
Ghaly RF. Recovery after high-dose methylprednisolone and delayed evacuation: a case of spinal epidural hematoma. J Neurosurg Anesthesiol 2001;323–328.
- Acute epidural haematoma following epidural steroid injection in a patient with spinal stenosis.Anaesthesia. 2011; 66: 837-839
- Do we need new guidelines for interventional pain procedures in patients on anticoagulants?.Reg Anesth Pain Med. 2014; 39: 1-3
- Spinal hematoma: a literature survey with meta-analysis of 613 patients.Neurosurg Rev. 2003; 26: 1-49
- Clinical implications of epidural fat in the spinal canal. A scanning electron microscopic study.Acta Anaesthesiol Belg. 2009; 60: 7-17
- The width of the posterior epidural space in obstetric patients.Anaesthesia. 1986; 41: 432-433
- Lumbar epidural anatomy. A new look by cryomicrotome section.Anesthesiology. 1991; 75: 767-775
- Sophistry in medicine: lessons from the epidural space.Reg Anesth Pain Med. 2005; 30: 56-66
- Computed tomography of the lumbar epidural veins.Radiology. 1982; 145: 687-691
- The lumbar extradural structure changes with increasing age.Br J Anaesth. 1997; 78: 149-152
- A report of paraparesis following spinal cord stimulator trial, implantation and revision.Pain Physician. 2010; 13: 357-363
- Delayed postoperative spinal epidural hematomas.Spine J. 2003; 3: 125-129
- Risks of common complications in deep brain stimulation surgery: management and avoidance.J Neurosurg. 2014; 120: 132-139
- Deep brain stimulation for Parkinson’s disease.Acta Neurochir Suppl. 2007; 97: 171-184
- Clinical motor outcome of bilateral subthalamic nucleus deep-brain stimulation for Parkinson’s disease using image-guided frameless stereotaxy.Neurosurgery. 2010; 67 (discussion 1093): 1088-1093
- Delayed thalamic intracranial hemorrhage in an essential tremor patient following deep brain stimulation.Eur Neurol. 2008; 59: 187-189
- Deep brain stimulation complication avoidance.in: Goodman RR Surgery for Parkinson’s Disease. Springer, New York2016
- Risk factors for hemorrhage during microelectrode-guided deep brain stimulator implantation for movement disorders.Neurosurgery. 2005; 56 (discussion 722–32): 722-732
- Catatonia during deep brain stimulator implantation complicated by intracranial hemorrhage.Mov Disord. 2010; 25: 1097-1098
- Factors related to extended hospital stays following deep brain stimulation for Parkinson’s disease.Parkinsonism Relat Disord. 2010; 16: 324-328
- Surgical adverse events of deep brain stimulation in the subthalamic nucleus of patients with Parkinson’s disease. The learning curve and the pitfalls.Acta Neurochir (Wien). 2014; 156 (discussion 1512): 1505-1512
- Pallidal versus subthalamic deep-brain stimulation for Parkinson’s disease.N Engl J Med. 2010; 362: 2077-2091
- Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson’s disease.N Engl J Med. 2001; 345: 956-963
- A randomized trial of deep-brain stimulation for Parkinson’s disease.N Engl J Med. 2006; 355: 896-908
- Neuropsychological outcome after deep brain stimulation for Parkinson disease.Neurology. 2015; 84: 1355-1361
- Long-term results of a multicenter study on subthalamic and pallidal stimulation in Parkinson’s disease.Mov Disord. 2010; 25: 578-586
- Subthalamic nucleus deep brain stimulation: summary and meta-analysis of outcomes.Mov Disord. 2006; 21: S290-S304
- Risk of surgical delivery to deep nuclei: a meta-analysis.Mov Disord. 2011; 26: 1415-1421
- Risk factors for hemorrhage during microelectrode-guided deep brain stimulation and the introduction of an improved microelectrode design.Neurosurgery. 2009; 64 (discussion 762-763): 754-762
- Surgical complications of deep brain stimulation. A longitudinal single surgeon, single institution study.Stereotact Funct Neurosurg. 2008; 86: 367-372
- Surgical and hardware complications of deep brain stimulation. A seven-year experience and review of the literature.Acta Neurochir (Wien). 2010; 152: 2053-2062
- Sulcal and ventricular trajectories in stereotactic surgery.J Neurosurg. 2009; 110: 201-207
- An evaluation of hardware and surgical complications with deep brain stimulation based on diagnosis and lead location.Stereotact Funct Neurosurg. 2012; 90: 173-180
- Operative techniques and morbidity with subthalamic nucleus deep brain stimulation in 100 consecutive patients with advanced Parkinson’s disease.J Neurol Neurosurg Psychiatry. 2006; 77: 12-17
- Avoidance and management of surgical and hardware-related complications of deep brain stimulation.Stereotact Funct Neurosurg. 2010; 88: 296-303
- Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders.J Neurosurg. 2007; 106: 621-625
- Treatment of chronic pain by deep brain stimulation: long term follow-up and review of the literature.Neurosurgery. 1987; 21: 885-893
- Comparison of the incidence of intracranial hemorrhage in two different planning techniques for stereotactic electrode placement in the deep brain stimulation.J Neurosurg Sci. 2013; 57: 63-67
- Incidence of symptomatic hemorrhage after stereotactic electrode placement.J Neurosurg. 2007; 107: 998-1003
- Complications of subthalamic nucleus stimulation in Parkinson’s disease.Neurol Med Chir (Tokyo). 2011; 51: 749-755
- Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for Parkinson disease.World Neurosurg. 2010; 73: 338-344
- Subthalamic nucleus deep brain stimulation in elderly patients–analysis of outcome and complications.BMC Neurol. 2007; 7: 7
- Deep-brain stimulation: long-term analysis of complications caused by hardware and surgery–experiences from a single centre.J Neurol Neurosurg Psychiatry. 2006; 77: 868-872
- Risks of intracranial hemorrhage in patients with Parkinson’s disease receiving deep brain stimulation and ablation.Parkinsonism Relat Disord. 2010; 16: 96-100
- Reducing hemorrhagic complications in functional neurosurgery: a large case series and systematic literature review.J Neurosurg. 2012; 116: 84-94
- Thirty days complication rate following surgery performed for deep-brain-stimulation.Mov Disord. 2007; 22: 1486-1489
- Incidence of hemorrhage associated with electrophysiological studies performed using macroelectrodes and microelectrodes in functional neurosurgery.J Neurosurg. 2005; 102: 88-96
- Acute complications of movement disorders surgery: effects of age and comorbidities.Mov Disord. 2013; 28: 1661-1667
- Neuromodulation in cluster headache.Adv Tech Stand Neurosurg. 2015; 42: 3-21
- Hypothalamic stimulation in chronic cluster headache: a pilot study of efficacy and mode of action.Brain. 2005; 128: 940-947
- Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage.Neurosurgery. 2009; 65 (discussion 201-202): 196-201
- Intracranial hemorrhage after removal of deep brain stimulation electrodes.J Neurosurg. 2012; 116: 525-528
- Surgical and hardware complications of subthalamic stimulation: a series of 160 procedures.Neurology. 2004; 63: 612-616
- Spinal cord stimulation for chronic pain management.Arch Med Res. 2000; 31: 258-262
- Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review.J Neurosurg. 2004; 100: 254-267
- Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads.Neuromodulation. 2011; 14: 412-422
- The incidence of spinal cord injury in implantation of percutaneous and paddle electrodes for spinal cord stimulation.Neuromodulation. 2016; 19: 85-90
- Epidural hematoma following implantation of a permanent spinal cord stimulator paddle.Neuromodulation. 2014; 17: 279-281
- Spinal cord stimulator and epidural haematoma.Br J Anaesth. 2012; 109: 649-650
- Subdural hematoma following spinal cord stimulator implant.Pain Physician. 2008; 11: 97-101
- Dorsal epidural hematoma after implantation of a dorsal nerve stimulator.Rev Esp Anestesiol Reanim. 2005; 52: 440-441
- Huge epidural hematoma after surgery for spinal cord stimulation.Acta Neurochir (Wien). 2005; 147 (discussion 567): 565-567
- Epidural hematoma following spinal cord stimulator implant.Int J Emerg Med. 2010; 3: 483-484
- Technical aspects of peripheral nerve stimulation: hardware and complications.Prog Neurolog Surg. 2011; 24: 189-202
- Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy.Chest. 2004; 126: 1177-1186
- High incidence of device-related and lead-related complications in the dual-chamber implantable cardioverter defibrillator compared with the single-chamber version.Circulation J. 2002; 66: 746-750
- Influence of oral antiplatelet therapy on hemorrhagic complications of pacemaker implantation.Clin Res Cardiol. 2013; 102: 345-349
- Perioperative anticoagulation in patients having implantation of a cardiac pacemaker or defibrillator: a systematic review and practical management guide.J Thromb Haemost. 2008; 6: 1615-1621
- Pacemaker or defibrillator surgery without interruption of anticoagulation.New Engl J Med. 2013; 368: 2084-2093
- Platelet function recovery after cessation of aspirin: preliminary study of volunteers and surgical patients.Eur J Anaest. 2010; 27: 617-623
- Intracranial neurostimulation for pain control: a review.Pain Physician. 2010; 13: 157-165
- Deep brain stimulation for chronic neuropathic pain: long-term outcome and the incidence of insertional effect.Pain. 2006; 125: 188-196
- Treatment of thalamic pain by chronic motor cortex stimulation.Pacing Clin Electrophysiol. 1991; 14: 131-134
- Chronic motor cortex stimulation for the treatment of central pain.Acta Neurochir (Wein). 1991; 52: 137-139
- Motor cortex stimulation in a patient with intractable complex regional pain syndrome type II with hemibody involvement. Case report.J Neurosurg. 2003; 98: 175-179
- Aspirin withdrawal increases risk of heart problems.Lancet. 2003; 362: 1558
- Management of aspirin discontinuation in stable coronary heart disease prior to elective surgery.Ann Cardiol Angieol (Paris). 1999; 48: 652-655
- Low-dose aspirin for secondary cardiovascular prevention - cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation - review and meta-analysis.J Intern Med. 2005; 257: 399-414
- Antiplatelet drug discontinuation is a risk factor for ischemic stroke.Neurology. 2004; 63 (author reply 1761): 1761
- Antiplatelet drug discontinuation is a risk factor for ischemic stroke.Neurology. 2004; 62: 1187-1189
- Extensive gluteal hematoma following InterStim implant: a case report.Int Urogynecol J. 2012; 23: 1805-1807
- Clinical pharmacology of platelet cyclooxygenase inhibition.Circulation. 1985; 72: 1177-1184
- Should more patients continue aspirin therapy perioperatively? Clinical impact of aspirin withdrawal syndrome.Ann Surgery. 2012; 255: 811-819
- The efficacy and safety of perioperative antiplatelet therapy.J Thromb Thrombolysis. 2004; 17: 21-27
- Platelet function and pharmacologic inhibition.Vasc Endovasc Surg. 2006; 40: 261-267
- Platelet-active drugs: the relationships among dose, effectiveness, and side effects: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest. 2004; 126: 234S-264S
- Aspirin inhibits platelet function independent of the acetylation of cyclo-oxygenase.Thromb Res. 1982; 25: 363-373
- Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials.Lancet. 2009; 373: 1849-1860
- To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial.Br J Anaest. 2010; 104: 305-312
- The hazards of discontinuing acetylsalicylic acid therapy in those at risk of coronary artery disease.Curr Opin Cardiol. 2008; 23: 487-493
- Elimination half-life of drugs: value and limitations.Annu Rev Med. 1985; 36: 421-427
- Effects of celecoxib, a novel cyclooxygenase-2 inhibitor, on platelet function in healthy adults: a randomized, controlled trial.J Clin Pharmacol. 2000; 40: 124-132
- Managing new oral anticoagulants in the perioperative and intensive care unit setting.Anesthesiology. 2013; 118: 1466-1474
- Management of antithrombotic therapy in patients undergoing invasive procedures.N Engl J Med. 2013; 368: 2113-2124
- New oral anticoagulants and regional anaesthesia.Br J Anaesth. 2013; 111: i96-i113
- Practical issues, limitations, and periprocedural management of the NOAC’s.J Thromb Thrombolysis. 2013; 36: 212-222
- Perioperative management of patients who are receiving a novel oral anticoagulant.Intern Emerg Med. 2013; 8: 477-484
- Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate.Clin Pharmacokinet. 2008; 47: 285-295
- Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate. An open label, parallel-group single centre study.Clin Pharmacokinet. 2010; 49: 259-268
- Preclinical and clinical characteristics of rivaroxaban: a novel, oral, direct factor Xa inhibitor.Sem Thromb Hemost. 2007; 33: 515-523
- Population pharmacokinetics and pharmacodynamics of rivaroxaban-an oral direct factor Xa inhibitor-in patients undergoing major orthopedic surgery.Clin Pharmacokinet. 2008; 47: 203-216
- Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies.J Throm Haemost. 2008; 6: 820-829
- Apixaban metabolism and pharmacokinetics after oral administration to humans.Drug Metab Dispos. 2009; 37: 74-81
- New oral anticoagulants in patients with nonvalvular atrial fibrillation: a review of pharmacokinetics, safety, efficacy, quality of life, and cost effectiveness.Drug Des Devel Ther. 2014; 8: 789-798
- American College of Physicians. Perioperative management of antithrombotic therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2012; 141: e326-350S
- Pharmacology and management of the vitamin K antagonists: American college of chest physicians evidence-based clinical practice guidelines (8th ed.).Chest. 2008; 133: 160S-198S
- The laboratory and the direct oral anticoagulants.Blood. 2013; 121: 4032-4035
- Laboratory assessment of the anticoagulant effects of the next generation of oral anticoagulants.J Thromb Haemost. 2013; 11: 245-252
- Direct oral anticoagulants: correlation of laboratory monitoring with safe interventional pain procedures.Reg Anesth Pain Med. 2016; 41: 123-124
- Acute management of bleeding in patients on novel oral anticoagulants.Eur Heart J. 2013; 34: 489-500
- Newer oral anticoagulants: a review of laboratory monitoring options and reversal agents in the hemorrhagic patient.Am J Health Syst Pharm. 2012; 69: 1473-1484
- Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo controlled, crossover study in healthy subjects.Circulation. 2011; 124: 1573-1579
- Antidotes for novel oral anticoagulants: current status and future potential.Aterioscler Thromb Vasc Biol. 2015; 35: 1736-1745
- Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial.Lancet. 2015; 386: 680-690
- A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran.Thromb Haemost. 2015; 13: 943-951
- Idarucizumab for dabigatran reversal.N Engl J Med. 2015; 373: 511-520
- A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa.Nat Med. 2013; 19: 446-451
- A phase 2 randomized, double-blind, placebo-controlled trial of PRT064445, a novel, universal antidote for direct and indirect factor Xa inhibitors.J Thromb Haemost. 2013; 11: OC 20.1
- Reversal of factor Xa inhibitors-induced anticoagulation in healthy subjects by andexanet alfa.Crit Care Med. 2014; 42: A1469
- Andexanet alfa for the reversal of Factor Xa inhibitor activity.N Engl J Med. 2015; 373: 2413-2424
COMMENTS
Article info
Publication history
Accepted:
September 15,
2016
Received in revised form:
September 15,
2016
Received:
August 10,
2016
Footnotes
For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/WileyCDA/Section/id-301854.html
Source(s) of financial support: NACC was initiated by the INS and funded through unrestricted educational grants from corporate sponsors, none of whom had any direct input into the contents of the manuscript or conclusions of the authors.
Identification
Copyright
© 2017 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.
