FAISAL R. JAHANGIRI A BRIEF OVERVIEW OF SCIENCE & BENEFITS INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING (IONM)

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1 INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING (IONM) A BRIEF OVERVIEW OF SCIENCE & BENEFITS FAISAL R. JAHANGIRI MD, CNIM, D.ABNM, FASNM VICE PRESIDENT OF CLINICAL AFFAIRS AXIS NEUROMONITORING LLC RICHARDSON, TX

2 LEARNING OUTCOME Intraoperative Neurophysiological Monitoring (IONM) helps in better patient outcomes by minimizing risks related to the functional status of the nervous system during surgical procedures. An IONM alert to the surgical team during the surgery can help them to identify the cause and take an immmediate corrective action. Learning about the advantages of IONM, as well as the potential legal risks.

3 INTRODUCTION

4 INTRODUCTION The term "neurophysiological monitoring" is defined by the American Society of Neurophysiological Monitoring (ASNM) as: Any measure that is used to assess the functional integrity of the peripheral or central nervous system either in the Operating Room, the Intensive Care Unit or other Acute Care setting.

5 PURPOSE The purpose of IONM is to reduce the incidence of iatrogenic and randomly induced neurological injuries to patients during surgical procedures. IONM consequently confers possible benefits at many levels including: Improved patient care Reduced time of temporary deficits Reduced revision procedures Reduced rehabilitation and recovery times Reduced hospital stay and medical costs Reduced overall insurance burden Reduce liability (maximum protection of patient nervous system)

6 BENEFITS OF IONM 1. Increased safety of the surgical procedure. IONM has been shown to play a significant role in reducing patient morbidity and mortality. Early irritation or impending injury can often be detected by measuring spontaneous or elicited (evoked) electrical signals produced by the nervous system or attached muscle groups during surgery. 2. Increased ability to accommodate more complex cases. IONM helps to identify new neurological impairment early enough to allow prompt intraoperative correction of the cause. This "early warning" system provides surgeons with the comfort necessary to perform complex cases. 3. Decreased risk of adverse surgical outcomes. IONM guides the degree of surgical intervention and provides a means for assessing the likelihood of post-operative complications.

7 NEUROPHYSIOLOGICAL MONITORING Diagnostic / Clinical: NM can be used clinically for diagnosis of various diseases. Such as: Epilepsy, Multiple Sclerosis, Neuropathies, Myopathies, Hearing Deficits, Visual Deficits, Intracranial Vasospasms, etc. Prognostic: NM can be used in an Intensive Care Units (ICU) for diagnosis and prognosis of various diseases. Such as: Status Epilepticus, Sub-clinical Seizures, Induced Coma, Brain Death studies, Stroke, etc. Therapeutic: NM can be clinically for therapeutic purpose. Such as treatment of: Parkinson s, Spasticity, Acute Stroke, Trigeminal Neuralgia, etc. Intraoperative (IONM): NM is used intraoperatively for protection of neural pathways. Such as preventing mechanical & ischemic injuries.

8 MODALITIES

9 MODALITIES IN IONM Modalities are specific types of electrophysiological tests that can used for testing specific neurological / functional pathways during different types of surgeries. Various modalities are utilized intraoperatively for protection of neural pathways in high risk surgical procedures, such as: SSEP - for protecting Sensory (Ascending) pathways TCeMEP - for protecting Motor (Descending) pathways EMG - for protecting Cranial and Peripheral nerves Free Run EMG (s-emg) Triggered EMG (t-emg) EEG/ECoG - for protecting brain ischemia BAER - for protecting auditory pathway VEP - for protecting visual pathway TCD - for protecting brain ischemia DECS - for protecting motor cortex MER - for microelectrode recordings

10 MULTIMODALITY IONM Multi-modality intraoperative neurophysiologic monitoring (IONM), in general, can prevent or lower the risk of devastating neurologic deficit in a wide variety of cases which place neural structures at risk. And although they all have advantages and disadvantages, they are, in combination, an effective means for providing patient protection.

11 Multiple Modalities Monitoring SSEP TCeMEP BAEP EMG TOF EEG

12 INTERVENTION Surgical Site No Intervention Needed Injury Intervention Needed

13 SOMATOSENSORY EVOKED POTENTIALS (SSEP) This test stimulates the patient distally (hands & feet) and records along the pathway as the nerve pulse travels to the brain. By recording at multiple locations we can determine the anatomic and functional integrity at different locations along the somatosensory pathway as the pulse travel from periphery to the cortex. Optimal for protection of the patient s ascending sensory spinal pathways Useful in detection of mechanical and ischemic changes in the peripheral nerves, spinal cord and somatosensory cortex. Particularly in posterior spinal cord. 95 to 98% specificity to sensory neurological events

14 SOMATOSENSORY EVOKED POTENTIALS (SSEP)

15 MOTOR EVOKED POTENTIALS (TCeMEP) Trans Cranial Electrical Motor Evoked Potentials (TCeMEPs): Transcranial electrical stimulation of the cerebral cortex has existed for nearly five decades. A variety of stimulation and recording techniques have been used to transcranially produce a motor potential. Merton and Morton, Nature 285(5762):227, Zentner, Funct Neurol 4(30): , Kothbauer et al., Pediatr Neurosurg 26(5):247-54, Calancie et al., J Neurosurg 88(3): , Deletis et al., Clin Neurophysiol 112(3): , Osburn, Am J Electroneurodiagnostic Technol 46:98-158, Szelenyi et al., Clin Neurophysiol 118(7): , Contraindicated in patients with epilepsy, cardiac pacemakers or other implanted pumps Require that neuromuscular blockade be minimized or avoided. Can be obtained with seconds.

16 MOTOR EVOKED POTENTIALS (TCeMEP) Epidural D-Wave Muscle MEPs 20 ms 100 ms

17 LOSS OF TCeMEP DUE TO A MALPOSITIONED SCREW (Jahangiri, FR et al 2014)

18 ELECTROMYOGRAPHY (EMG) Electromyography (EMG) are recorded from the distal muscles. Activity recorded is associated with nerve and nerve root mechanical insult. Used when Spinal Roots, Peripheral Nerves or Cranial Nerves are at risk Free-Run EMG (S-EMG) Passive continuous recording of activity in muscle Mechanical or thermal nerve irritation causes s-emg activity Evoked or Triggered EMG (CMAP/T-EMG)) Monopolar, Bipolar or Tripolar stimulation Identification of nerve tissue Testing pedicle screws Electrical stimulation with a probe can activate nerve fibers in the surgical field causing a muscle response

19 BRAINSTEM AUDITORY EVOKED POTENTIALS (BAER) Preservation of Hearing It measures the auditory nerve and brainstem pathways It is useful during posterior or middle fossa cranial procedures for hearing preservation in acoustic neuroma surgeries Neurological Protection: o Cochlea Protection o Cranial Nerve Protection o Brainstem Protection I VI V IV III II VII An abnormal or absent BAER is often seen even in patients with minor preoperative hearing loss.

20 It is a continuous recording of brain activity from the scalp Useful measurement of the cortical perfusion (EEG) ELECTROENCEPHALOGRAPHY Can also provide gross measure of depth of anesthetic

21 PEDICLE SCREW STIMULATION T-EMG Triggered electromyography are recorded from the distal muscles. Activity recorded is associated with nerve, nerve root and pedicle screw electrical stimulation. T-EMG 4 ma triggered pedicle stimulation response. Indicating probably pedicle wall breach

22 Pedicle Screw Stimulation Outcome Studies Edward C. Benzel, SPINE Surgery; Volume 2, Techniques, Complication, Avoidance and Management, Chapter 95, Intraoperative Electromyography Monitoring Monitored and non-monitored outcome studies Separated into 2 groups Group I(n=185) without monitoring Group II (n=205) with monitoring Group I: Incidence of surgically induced radiculopathies was 9.6% Group II: Incidence of surgically induced radiculopathies was <1.0%

23 CNS at Risk in Skull Base Surgeries The goal of CN monitoring is to Identify, Trace, Protect and confirm the Integrity of the nerves. Below are the cranial nerves at risk during skull base surgeries (posterior fossa surgeries): V: Trigeminal VI: Abducens VII: Facial VIII: VestibuloCochlear IX: Glossopharyngeal X: Vagus XI: Accessory XII: Hypoglossal SOURCE: NETTER MEDICAL ILLUSTRATION

24 CORTICAL MAPPING Intra-operative neurophysiological monitoring (IONM) with sensory & motor mapping, as well as Electrocorticography (ECoG) is a well recognized method to identify the central sulcus & surrounding eloquent tissues in order to decrease the risk of neurological injury. IONM provides real-time feedback to the surgeon during resection & is advantageous over pre-operative imaging modalities.

25 WHAT IS FUNCTIONAL CORTICAL MAPPING? Mapping of the Somatosensory Cortex Mapping of the Motor Cortex Mapping of the Language Cortex Mapping of the Epilepsy Foci Microelectrode Recordings (MER)

26 Cortical Sensory Mapping Phase Reversal Jahangiri, FR et al, Dec 2011

27 IONM: EPILEPSY SURGERIES MAPPING

28 EPIDURAL RECORDINGS/ D-WAVES Intramedullary tumors Epidural Recordings Inomed IONM Meeting. Faisal R. Jahangiri, MD

29 FOURTH VENTRICLE TUMORS Inomed IONM Meeting. Faisal R. Jahangiri, MD Image from Surgical Neurophysiology, 2 nd Edition, Faisal R. Jahangiri, 2012

30 FOURTH VENTRICLE TUMOR - REFERENCE Inomed IONM Meeting. Jahangiri FR et al, 2012

31 NERVE GRAFTING

32 INTERVENTIONAL PROCEDURES (INR) Neurophysiological monitoring has guided endovascular teams and provided valuable information to guide management. Application 1: Monitoring adds a level of confidence regarding the occlusion time that can be taken when treating an aneurysm utilizing balloon remodeling techniques or when multiple catheters are occlusive to a parent vessel. Application 2: Monitoring can provide the interventionalist with important information when aneurysm rupture occurs. This can allow for immediate evaluation concerning the need for an EVD and relate the effects of CSF diversion on CBF. Application 3: Changes during coiling can represent distal embolization. Moreover transient changes may portend the potential or propensity to embolize to distal arterial beds during or even after aneurysm treatment. Application 4: SSEP changes are predictive of outcome. When significant changes in evoked potentials and EEG occurred but returned to near baseline prior to procedures end, the patient ultimately returned to near neurologic baseline Application 5:Vasospasm in proximal vessels through which the catheter has been passed may go undetected similar to embolic occlusions in arterial beds distal to the aneurysm.

33 SURGICAL APPLICATIONS OF IONM Neurosurgeries: Brain tumors Brainstem tumors Aneurysms Microvascular Decompressions Spinal Tumors Peripheral nerve Cortical Stimulators Spinal Cord Stimulator Parkinson s - DBS Cardiovascular surgeries: CABG Carotid Aortic Aneurysm Repais Orthopedic surgeries: Any Spine Sx where CNS is at risk Scoliosis Minimally Invasive Surgeries (MIS) Hip Tibial/Fibular Osteotomy ENT surgeries: Parotid Tumor Thyroid Tumor Facial Nerve Tumor Cochlear Implants General surgeries: Nephrology OB/GYN Research in progress: Prostate

34 KEY FACTORS IONM reduces the risk of post-operative neurological deficits Provide consistent standard of care for all patients Monitor neural structures at risk during the surgery Notify surgeon immediately when necessary to allow for intervention Reduces chance of patient deficit during surgery Certification & Continuing Education of highly trained technical staff Credentialing of physician supervision Joint Commission accreditation Provide coverage 24/7

35 QUALITY OF IONM SERVICE In a survey of 173 spinal surgeons in the United States, 86% indicated that they used IONM for over 51,000 cases, and experienced operative teams (300 cases monitored) had less than half of the rate of neurological deficits from surgery than those with the least experience (100 cases monitored). (Nuwer 1996). An analysis of over 100,000 routine (non-trauma, non-tumor) spinal surgeries found that cases where IONM was used were significantly less likely to have neurological complications (odds ratio 0.7, p0.01) and in hospital mortality (odds ratio 0.36, p0.016).* (Nuwer 1996)

36 QUALITY METRICS, STAFF COMPETENCY, CREDENTIALING AND COMPLIANCE Poor monitoring is more dangerous to patient safety than no monitoring at all, that s why provide superior monitoring. Jack M. Kartush, M.D. Practicing Neuro-Otologist Founding President American Society of Neurophysiological Monitoring

37 QUALITY METRICS, STAFF COMPETENCY, CREDENTIALING AND COMPLIANCE Quality Assurance programs/quality Metrics are important systems to have in place. Must be obsessed with finding and eliminating areas of weakness. Teams need to be well supported Professional Interpretation o Physician interpretation of intra-operative neuro-physiological monitoring data goes through a peer review process of random chart review and significant changes case review of each physician. Providing surgeon and hospital with specific metrics for the individual departments and CMS quality of care payment incentives. o o o o o Case was monitored real time IONM interpretation appropriate Reporting to the surgeon appropriate Reporting to anesthesia appropriate Documentation of IONM interpretation accurate

38 QUALITY METRICS, STAFF COMPETENCY, CREDENTIALING AND COMPLIANCE Education of all IONM staff (Technologists, Interpreting Physicians, Support): Technical/troubleshooting skills Clinical skills/continuing education Communication skills Workplace hazards training needlesticks, bloodborne pathogens, etc. Standardized procedures Proper documentation Technical/IT skills Data protection and transmission/hipaa

39 LEGAL & COMPLIANCE ISSUES Excerpt from Medicare LCD Intraoperative Neurophysiological Testing (L35003): History/Background and/or General Information: Intraoperative neurophysiological testing may be used to identify/prevent complications during surgery on the nervous system, its blood supply, or adjacent tissue. Monitoring can identify new neurologic impairment, identify or separate nervous system structures (e.g., around or in a tumor) and can demonstrate which tracts or nerves are still functional. Intraoperative neurophysiological testing may provide relative reassurance to the surgeon that no identifiable complication has been detected up to a certain point, allowing the surgeon to proceed further and provide a more thorough or careful surgical intervention than would have been provided in the absence of monitoring. Monitoring, if used to assess sensory or motor pathways, should assess the appropriate sensory or motor pathways. Incorrect pathway monitoring could miss detection neural compromise and has been shown to have resulted in adverse outcomes. Some high-risk patients may be candidates for a surgical procedure only if monitoring is available. It is also required that a specifically trained technician, preferably registered with one of the credentialing organization such as the American Board of Neurophysiologic Monitoring or the American Board of Registration of Electrodiagnostic Technologists will be in continuous attendance in the operating room, recording and monitoring a single surgical case, with either the physical or electronic capacity for real-time communication with the supervising neurologist or other physician trained in neurophysiology.

40 LEGAL & COMPLIANCE ISSUES Proper credentialing of both Technical and Interpreting physician staff. Appropriate liability coverage for IONM team to ensure maximum protection to hospital IONM is considered a very safe procedure, however, some electrodes are invasive and equipment can cause injuries if not used properly IT Security/ Telemedicine protocols care must be taken to ensure proper security protocols are in place MSO Models for providing IONM Technical or Professional services may be problematic: Practical effect is that under arrangements become problematic. For example, if a hospital contracts with a physician-owned entity to perform a service that the hospital bills for under arrangement, the physician-owned entity could be considered a DHS entity. If the physician owner makes a referral for DHS to the entity, there is potentially no applicable Stark exception (e.g., there is no small investor safe harbor under Stark). Compliance with Hospital by-laws and State/Federal applicable laws Follow peer association best practices ASNM,ABRET,ACNS, Joint Commission Billing compliance with independent oversight and QA

41 SUMMARY The benefits and applications of IONM for various surgeries (neurosurgery, orthopedic, ENT, vascular, general surgeries and interventional neuroradiological procedures) according to evidence base literature. A clear understanding of the methodologies and practice of IONM from the hospital risk management perspective must be present. Identification of the postoperative neurologic deficits commonly seen after high risk surgical procedures. How can we identify them and utilize IONM practice to minimize these neurological deficits? Hence, minimizing prolonged hospital stays, unnecessary rehabilitations and legal issues. Information about the current research and evidence for IONM and a stronger understanding of how a highly skilled IONM team during high risk surgical procedures will make a better patient outcome.

42 HOW IONM CAN MINIMIZE RISK FACTORS?

43 RISK REDUCTION Conclusion. Based on strong evidence that multimodality intraoperative neuromonitoring (MIOM) is sensitive and specific for detecting intraoperative neurologic injury during spine surgery, it is recommended that the use of MIOM be considered in spine surgery where the spinal cord or nerve roots are deemed to be at risk, including procedures involving deformity correction and procedures that require the placement of instrumentation. Spine 2010

44 RISK REDUCTION Conclusion. The knowledge and experience of the clinical neurophysiologist in basic electrophysiology and electrophysiology in the operating room, comprehensive training of the monitoring technologist, active communication between members of the IOM team, and a tailored approach suited to the aim of IOM in specific surgeries will contribute greatly to the accuracy of IOM. JKMS 2013

45 RISK REDUCTION Conclusion. In an effort to reduce postoperative C5 nerve root palsy, the clinician should consider intraoperative deltoid and biceps transcranial electrical motor-evoked potential and spontaneous electromyography monitoring whenever there is potential for iatrogenic C5 nerve root injury. Spine 2010

46 RISK REDUCTION Conclusion. The present study demonstrates that upper-limb SSEP monitoring could detect position-related ulnar neuropathy in 5.2% of the patients undergoing lumbosacral spine surgery. Spine 2009

47 RISK REDUCTION Conclusion. Intraoperative nerve monitoring of the RLN during thyroid and other neck surgeries can aid in the nerve mapping, nerve identification, and prognostication of postoperative vocal cord function, which in turn can influence the surgeon's decision to proceed to bilateral surgery. Laryngoscope. 2017

48 RISK REDUCTION Conclusion. Technologist must have a bachelor s degree or prior electrodiagnostic credentials with documented participation in a minimum of 150 surgeries using IONM. The physician component, as recommended by the American Academy of Neurology, should be an experienced MD clinical neurophysiologist, which requires 4 years of postgraduate neurology training plus a 1 2-year fellowship. TELEMEDICINE and e-health. 2013

49 RISK REDUCTION Conclusion. Experienced SEP spinal cord monitoring teams had fewer than one-half as many neurologic deficits per 100 cases compared to teams with relatively little monitoring experience. Experienced SEP monitoring teams also had fewer neurologic deficits than were seen in previous surveys of this group. Definite neurologic deficits, despite stable SEPs (false negative monitoring), occurred during surgery in only 0.063% of patients. EEG & Clinical Neurophysiology. 1995

50 CONCLUSION

51 FAISAL RIAZ JAHANGIRI MD, CNIM, D.ABNM, FASNM Vice President of Clinical Affairs AXIS Neuromonitoring LLC, Richardson, TX. Diplomate American Board of Neurophysiological Monitoring (D.ABNM). Fellow, American Society of Neurophysiological Monitoring (FASNM). President & CEO, Jahangiri Consulting LLC, Charlottesville, Virginia. Board Member-at-Large, American Society of Neurophysiological Monitoring (ASNM). Senior Consultant, Dept. of Neurosurgery, Neuroscience Institute, Doha, Qatar Founding Member, Saudi Spine Society, KSA. Chairman, ASNM Membership & Awards Committee. Adjunct Professor, Labouré College, Milton, MA. Assist Editor, Neurodiagnostic Journal.

52 Reference Papers follow this slide. THANK YOU

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