NANS Conference 2017 Highlights Matthew R. Kohler, MD January 2017

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1 NAN Conference 2017 Highlights Matthew R. Kohler, MD January 2017

2 timulation

3 timulation A dorsal root ganglion (or spinal ganglion) (also known as a posterior root ganglion), is a cluster of nerve cell bodies (a ganglion) in a posterior root of a spinal nerve. The dorsal root ganglia contain the cell bodies of sensory neurons (afferent).

timulation Fine electrodes with 4 contacts are threaded via the epidural space part way through the intervertebral foramen and allowed to lie up against the sensory dorsal root

4 timulation Fine electrodes with 4 contacts are threaded via the epidural space part way through the intervertebral foramen and allowed to lie up against the sensory dorsal root ganglia. Electrical fields are generated that can selectively stimulate different parts of the dorsal root ganglia, which allows stimulation onto specific nerve roots or parts of nerve roots

5 timulation Technique: kin entry 2 to 3 pedicles below the desired target DRG on the contralateral side. Preferred entry point into the epidural space is midline, one level below the target DRG. Target is the medial aspect of the inferior border of the pedicle above the targeted DRG Lawarence Poree eattleciencefoundation.o rg

6 timulation For placement at L4 and L5 level trajectory tends to be more contralateral with skin entry typically in the same area (lateral to 1/2), and epidural entry pain

7 timulation Axium system is preloaded with big curve delivery sheath with a straight stylet. Frontload either the limtip lead or the guidewire into chosen sheath and ensure the tip of the lead or guidewire is slightly protruding fro the sheath and tighten lead stabilizer hub

8 timulation Can run into trouble with advancing lead out of foramen because of meshwork of ligaments creating significant pain. Can put pressure on the ligament as advancing through foramen until it gives. Retract the sheath without removing the lead, then retract the stylet 5-10mg from the tip of the lead, rotate needle and sheath from the 3 oclock to 1 oclock position. Gently advance the lead and sheath combination into the epidural space. This creates the epidural lead strain relief.

9 timulation The lead should ideally wrap around the medial aspect of the pedicle as it advance superiorly. This creates the upward curve of the -Currve Retract the sheath just into the needle and rotate the sheath from 1 o clock to 3 o clock and advance the sheath and lead into the epidural space in the lateral direction to form the lower part of the -Curve. This prevents need for anchors.

10 timulation Advantages of DRG timulation Because there is minimal CF thickness there is very little variation in stimulation intensity on movement. CF acts as an energy sink and can unintentionally transmit signals to other neural structures. Amplitude thresholds are so low that non-rechargeable implantable pulse generators will suffice with excellent device longevity. Altered membrane properties can make primary sensory neurons in the DRG more susceptible to neuromodulation. ingle DRG Lead can cover multiple dermatome levels due to fibers covering multiple levels. Paresthesia mapping is not necessary. Equal outcomes.

11 timulation ACCURATE tudy: A Prospective, Randomized, Multi- Center, Controlled Clinical Trial to Assess the afety and Efficacy of the Axium Neurostimulator ystem in the Treatment of Chronic Intractable Pain Largest randomized, controlled neuromodulation trial conducted in CRP and peripheral causalgia patients to provide evidence of safety and efficacy for market approval Objective: Assess the safety and efficacy of DRG stim compared to traditional C stim

12 timulation ACCURATE tudy 152 subjects with chronic, intractable pain of the lower limbs were randomized to a DRG stim group or a control group across 22 sites. Composite of safety and efficacy was used to define primary endpoint success provided the subjects met the following criteria >50% pain relief at end of trial >50% pain relief at end of three months Freedom from stimulation-induced neurological deficit through three months

13 timulation ACCURATE tudy econdary and Tertiary endpoints included: timulation specificity HR-QoL Psychological disposition Functional status (Brief pain inventory) Patient atisfaction

14 timulation ACCURATE tudy 152 subjects randomized. 139 received a trial stimulator. 114 received a fully implantable system. At 3 months 81.2% of patients receiving DRG stimulation achieved the primary endpoint versus 55.7% of patients receiving traditional C stimulation The durability of DRG stimulation was confirmed at 12 months with 74.2% of the patients receiving DRG stimulation (n=66) compared to 53% of traditional C No stimulation-induced neurologic deficits in either group and no unanticipated adverse events in either group.

15 timulation

16 timulation

timulation ACCURATE tudy Met its primary endpoint demonstrating non- inferiority and superiority over traditional C at three months Results sustained at 12

17 timulation ACCURATE tudy Met its primary endpoint demonstrating non- inferiority and superiority over traditional C at three months Results sustained at 12 months: 74.2% vs 53% (traditional C) effective pain relief DRG stimulation confined sensation to the primary area of pain in 94.5% of subjects vs. 61.2% in the control.

HF-10 Upper Extremity and Neck Pain : ENZA-ULN Trial Ongoing study for treatment of UE and Neck pain with Nevro HF-10 therapy Neck timulation is typically very difficult with traditional C

18 HF-10 Upper Extremity and Neck Pain : ENZA-ULN Trial Ongoing study for treatment of UE and Neck pain with Nevro HF-10 therapy Neck timulation is typically very difficult with traditional C Traditionally paddle leads placed at C1-C2 for axial neck pain less than 40% capture. CF thickness higher at C1-2 compared to C3-6 Magnitude and location of sensation highly sensitive to postural changes Unwanted paresthesias more easily elicited in the cervical spine Possible faster relief due to thinner CF Performed with percutaneous perm leads No need to turn off with driving (no paresthesias)

19 HF-10 Upper Extremity and Neck Pain : ENZA-ULN Trial Prospective, Multi-Center Feasibility tudy afety and efficacy of high frequency spinal cord stimulation at 10 khz in subjects with chronic, intractable pain of the upper limbs and/or neck 48 subjects with permanent implants Inclusion Criteria: Chronic, intractable pain of the upper limb and or neck Refractory to conservative therapy for >3months Average upper limb and/or neck pain VA intensity of >5/10cm Exclusion Criteria: Mechanical pine Instability ignificant Cervical tenosis, objective evidence of epidural scarring and or any signs or symptoms of myelopathy History of urgery on posterior elements (laminectomy/posterior fusion)

20 HF-10 Upper Extremity and Neck Pain : ENZA-ULN Trial Methods: Octopolar leads span C2-C6 timulation: Frequency: 10 khz Pulse width: 30microsec Amplitude: Individualized per subject Disability Assessment Reduced Disability Demonstrated at 3 months

9cm reduction for arm pain 2.5cm reduction for neck pain Disability reduction of 17.

21 HF-10 Upper Extremity and Neck Pain : ENZA-ULN Trial Conclusions: Promising Early Results Using High-Frequency C for UE/Neck Pain Clinically meaningful improvements for UE and Neck pain at 3 months Responder Rate 75% for axial neck pain ignificant pain reduction observed at 3 months 1.9cm reduction for arm pain 2.5cm reduction for neck pain Disability reduction of 17.8 PDI ubjects felt no paresthesias Demonstrated afety First prospective study fo cervical C to provide complete and clinically significant data. Will continue to 12 months Australian ULN study currently underway

22 Nuvectra Algovita C

23 Nuvectra Algovita C User-friendly, highly versatile, patient-centric therapy Rechargeable Pulse Generators with 24 Current sources for flexible coverage and expanded programming options Frequencies of to 2k Hz, pulse widths up to 1500 microsecs and amplitudes up toe 30mA tretchable C leads to help minimize risk of lead migration and fracture 12 lead contact with 3 level coverage Wireless patient programming system timulation and field intensification can be fine-tuned for precisely focused pain coverage

24 aluda Medical: Evoke pinal Cord timulation ystem

25 aluda Medical: Evoke pinal Cord timulation ystem The Evoke C ystem is an investigational device currently being offered at select U.. centers through the Evoke Clinical tudy. Designed to continuously measure the body s response to stimulation, and can be programmed to automatically adjust stimulation levels to the patient s preferred level. Closed loop neuromodulation technology that records signals from the nerve (evoked compound action potentials, ECAP) and adjusts stimulation levels in real time to maintain a constant evoked potential Designed to reduce or eliminate the need for patients to manually adjust stimulation levels Early clinical results indicate that closed loop neuromodulation proveds patietns with more consistent and accurate stimulation levels, resulting in more effective blocking of pain.

26 aluda Medical: Evoke pinal Cord timulation ystem

27 Infection and Diabetes A1C less than 8.0 to 9.0 for trials and implants, with 6-7 being ideal Neutrophils do not function as well with blood glucose levels >150. hould optimize first to avoid risk of complications

28 Neuromodulation for Rheumatoid Arthritis Vagus nerve stimulation can decrease inflammatory mediators Cyberonics VN Devices 60 secs per day, 10 hrz Reduced IL-6 Maybe for Crohn s disease as well Cholinergic antinflammatory pathway

29 Evidence Based Medicine Three principles should be prioritized when trying to provide the best care for our patients: Clinical Experience Patient Values Best Available Evidence

30 Precision Medicine Initiative Treatments should be guided based on a better understanding on etiology, biology, and genetics Evolved in face of opioid epidemic and goal to reduce opioid use across the country. Announced in early 2015 by President Obama to better understand disease and finding improved ways to diagnose and treat them There are no safe drugs, only safe doses and concentrations: Medications are maximally invasive

Innovations In Neuromodulation. Maged Guirguis, MD Director Of Research Pain Management

Innovations In Neuromodulation Maged Guirguis, MD Director Of Research Pain Management 1 2 Pain Pathway 3 Gate Theory In the dorsal horn (where pain signals relay), there is a gate that opens and closes