Emerging Therapies in IPM FOMA 2019 Weston, FL

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Aldous Hicks
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1 Emerging Therapies in IPM FOMA 2019 Weston, FL

3 Robert David Ball, D.O.,M.S. Board Certified in Anesthesiology Board Certified in Pain Management by the American Board of Anesthesiology Residency Training at State University of New York/Upstate Medical University in Syracuse, NY OB Anesthesiology at Brigham and Women s, Harvard Medical School, Boston, MA Fellowship in Interventional Pain Management in Upstate Medical University, Syracuse, NY

6 What is a Our Value Proposition?

8 Prevalence Low back pain affects at least 80% of people at sometime throughout our lives and is the 5 th most common reason for physician visits. In any given year 90% of men and 95% of woman have at least one headache. 15% have had a severe migraine Manchikanti L. Singh V, Datta S,,Cohen SP, Hirsch JA. Comprehensive Review of Epidemiology, Scope, and Impact of Spinal Pain. Pain Physician 2009: 12:E35-E70. Nett RB. Advances in migraine management. Program and abstracts of the 5th Annual Association of Family Practice Physician Assistants Conference; November 19-23, 2003; San Antonio, Texas.

9 Cost in billions of dollars (2010) 9 Economic Burden $700 $600 $500 $400 $300 $200 $ $0 Chronic pain Heart disease Cancer Diabetes Obesity 1. Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research Wang Y, et al. Obesity 2008;16(10):

10 10 Complications with Chronic Pain Depression 3 Suicide 4 Hypertension 5 Insomnia 6 Overweight/obese 9 Opioid misuse/abuse 7,8 In addition to the significant economic burden 1 and negative impact on quality of life, 2 untreated chronic pain is associated with physical and psychological complications 3-6 Suicide ideation lifetime prevalence in chronic pain patients, ~20% vs 13.5% in the general population 35% of chronic pain patients vs 4.6% of the general study population 39% of chronic pain patients vs 21% of the general population 53% of chronic pain patients vs 3% of pain-free controls 62.7% of patients with low back/neck pain vs 56.5% of the general population 20-24% of chronic pain patients vs 3.8% of the general population Indications for Use: Spinal cord stimulation as an aid in the management of chronic, intractable pain of the trunk and limbs Suicide attempts lifetime prevalence in chronic pain patients, 5-14% vs 4.6% of the general population 1. Institute of Medicine. Relieving pain in America: A blueprint for transforming prevention, care, education, and research Reid KJ, et al. Curr Med Res Opin. 2011;27: Miller LR, Cano A. J Pain. 2009; 10(6): Tang NKY, et al. Psych Med. 2006;36: Bruehl S, et al. Clin J Pain. 2005;21(2): Tang NKY, et al. J Sleep Res. 2007;16: Sullivan MD, et al. Pain. 2010;150(2): Behavioral Health Coordinating Committee Prescription Drug Abuse Subcommittee. Addressing prescription drug abuse in the United States: current activities and future opportunities. Accessed June 4, Strine TW, Hootman JM. Arthritis Rhem. 2007;57(4):

11 Risk of Doing Nothing

12 Pain Management is Essential Treating pain SAVES LIVES Untreated pain ENDS LIVES

13 Few Patients with Chronic Pain Are Treated by Pain Management Specialists Treatment of chronic pain patients by a pain specialist often results in improved patient care Recommended for patients who don t respond to first-line treatment Partnership with Community and creating Referral Health Care Providers Treating Chronic Pain Patients General/family practitioner 70% Orthopedist/orthopedic surgeon 27% Neurologist/neurosurgeon 10% Rheumatologist 9% Internist 7% Physiotherapist 6% General surgeon 3% Osteopath 2% Pain Specialist 2% Network 1. Davies HTO, et al. J R Soc Med. 1994;87(7): Dworkin RH, et al. Mayo Clin Proc. 2010;85(3 suppl): S3-S Schulte E, et al. Eur J Pain. 2010;14(3):308.e1-308.e Breivik H, et al. Eur J Pain. 2006;10(4):

21 What is a Our Value Proposition? CONSTANT EMPHASIS ON INNOVATION AND ADOPTION OF NEW TECHNOLOGIES BOTH MEDICAL AD PATIENT ENGAGEMENT TECHNOLOGIES. MAINTAINING AN URGENT REFERRALS WELCOMED CULTURE

31 Dr. Robert Ball Cook Dr. Andrew

35 Treating Spinal Stenosis

37 MILD (Minimally Invasive Lumbar Decompression

39 Ligamentum Flavum Hypertrophy

40 Superion Animation

42 Lumbar Spinal Stenosis Continuum of Care Conservative Treatment Vertiflex Bridges the MIS Gap Traditional Treatment Mild Moderate Severe

43 Superion Indirect Decompression System 1. Minimally Invasive Access through a tube the size of a dime 2. Extension Blocking Mechanism - in a single step deployment 3. Provides Indirect Decompression requiring only two stitches Tissue-sparing midline approach no removal of anatomical structures Outpatient/ASC friendly procedure Minimal blood loss and minute operative time Short recovery period; home within hours 43

44 Superion A Least Invasive Option A World of Difference in Invasiveness

Patients lean forward while walking to ambulate more

45 Clinical Presentation of Lumbar Spinal Stenosis Extension provokes symptoms Pain / weakness in legs Patients lean forward while walking to ambulate more comfortably, Shopping Cart sign Sitting (flexion) relieves symptoms

46 Superion Indications and Exclusions Key Indications Persistent leg/buttock/groin pain (neurogenic intermittent claudication) secondary to dx of moderate lumbar spinal stenosis Symptoms relieved in flexion Radiographic confirmation of moderate stenosis Significant Exclusions Conditions warranting consideration of decompression or fusion, e.g., significant instability, spondy >grade 1, spondylolysis Axial back pain only, fixed motor deficit, unremitting pain in any spinal position, significant peripheral neuropathy Severe osteoporosis, defined as DEXA score >2.5 below normal adult mean

47 Superion Data from IDE Trial 47

Reimagining Spinal Stenosis Treatment 49

51 Disc Biacuplasty

that form the primary afferent sensory nerve DRG L4 Ventral Dorsal DRG L5 Image from:

59 The Dorsal Root Ganglion: Review of Anatomy The DRG: A collection of bipolar cell bodies of neurons surrounded by glial cells and the axons of the DRG sensory cells that form the primary afferent sensory nerve DRG L4 Ventral Dorsal DRG L5 Image from: Gray s Anatomy (2005). Standring, S. (Ed.). Image from: Hogan Q. Reg Anesth Pain Med

60 Pathological Cascade Leading to Neuropathic Pain Dorsal horn Increased neuronal discharge from primary sensory neurons Increase EAA release Increased ATP, NO release Increased neural peptide release DRG Activate surrounding glia Release proinflammatory cytokines Ultimately stimulates neurons Increased membrane excitability Nerve Injury at periphery

The Peculiar Properties of the Dorsal Root Ganglion Special

unique in the nervous system Unique Function: T- junctions act

neuromodulation target Devor, Pain Supplement 6. 1999.

61 The Peculiar Properties of the Dorsal Root Ganglion Special structure: DRG neurons have a peculiar pseudounipolar morphology unique in the nervous system Unique Function: T- junctions act as the filter function for cell transduction and potential neuromodulation target Devor, Pain Supplement Proximal Axon Soma Ramon y Cajal, et al. (Eds.) Histology T-Junction Distal Axon

62 The Importance of the T-Junction Krames ES. Pain Medicine

neural foramen: easy target for neuromodulation by adapting current SCS needle techniques Limited Cerebrospinal Fluid (CSF) around the

63 Why target the drg? Known mechanisms & processes: DRGs are known target for pain relief Predictable & accessible location in the epidural space within the neural foramen: easy target for neuromodulation by adapting current SCS needle techniques Limited Cerebrospinal Fluid (CSF) around the DRG allows the leads to be closer to the anatomical target & requires less energy to stimulate (compared to conventional SCS) Image from: Gray s Anatomy (2005). Standring, S. (Ed.). Separation of sensory & motor nerve fibers prevents unintentional stimulation

64 Why target the drg? (cont d) DRGs Spinal Column T12 L1 L2 L3 L4 L5 Abdomen/Groin/Back Hip/Groin/Waist/Back Upper Leg & Low Back Lower & Upper Leg/Low Back Leg & Low Back Well mapped & organized to corresponding anatomies allowing for highly focused treatment of pain Foot/Lower Leg/Low Back

65 DRG stimulation & Somatosympathetic Reflexes Baseline Sympathetic Pre-Motor Neuron 1 month Adapted from: Loewy and Spyer, Central Regulation of Autonomic Function, 1990.

66 Neuromodulation The Future Spinal Cord Stimulation DRG 1. Deer et al, Neuromodulation Cameron T. J Neurosurg Kim DD, et al. Pain Physician. 2011

67 SHEATH delivery

Current limitations of conventional scs Unstable Stimulation Susceptible to body position due to variations in distance between stimulation lead & target Lead migrations rates (percutaneous) reported

70 Current limitations of conventional scs Unstable Stimulation Susceptible to body position due to variations in distance between stimulation lead & target Lead migrations rates (percutaneous) reported between 9-27% 1,2,3 Conventio nal SCS Unspecific Stimulation Broad Stimulation Coverage: targeting spinal cord sensory nerves Unspecific to anatomical location of pain/disease Energy is delivered to multiple types of nerves, not just pain- or disease-specific nerves DRG 1. Deer et al, Neuromodulation Cameron T. J Neurosurg Kim DD, et al. Pain Physician High Energy Usage Significant energy loss to surrounding anatomy (i.e. cerebral spinal fluid, CSF) before stimulation reaches target in spinal cord

71 SYSTEM INITIALS DIAGNOSIS DRG M.H. Bilateral Diabetic Neuropathy DRG A.B. Right Knee Post Surgical Chronic Pain DRG H.H. Bilateral Neuropathy SCS J.B. Replacement Competitive SCS system SCS J.W. Low back and Limbs SCS DRG C.R. Off label Chest T10 T8 placement DRG R.E. Bilateral Neuropathy DRG J.R. Right foot CRPS SCS J.S. Low back and Limbs SCS DRG L.C. Left Foot CRPS DRG R.K. Right foot CRPS DRG M.C. Right Knee Post Surgical Chronic Pain SCS J.W. Bilateral Neuropathy SCS S.P. Right Knee Post Surgical Chronic Pain DRG B.P. Right Phantom limb pain SCS D.E. Low back and Limbs SCS SCS J.S. Right leg CRPS DRG D.D Right foot post crush limb (fell off ladder) DRG A.K. Right foot CRPS DRG G.H. Groin SCS J.W. Low back and Limbs SCS DRG J.H. Right Foot post surgical DRG S.H. Left Knee post surgical Chronic pain DRG J.W. Right Hip Post Hip Replacement DRG P.M. Right foot CRPS DRG T.P. Right leg CRPS DRG J.S. Right foot CRPS DRG J.S. Groin Post Shoulder surgery pain DRG K.T Right Knee Post Surgical Chronic Pain DRG M.M. Left Foot CRPS DRG J.W. Right Knee Post Surgical Chronic Pain DRG M.H. Right foot post crush limb DRG K.H. Right Knee Post Surgical Chronic Pain DRG J.F. Post Laparoscopic Abdominoperineal Resection SCS S.B. Low back and Limbs SCS SCS G.M. Low back and Limbs SCS Dr. Ball Southwest Florida Pain Case Data 86% trial to perm conversion including Off label cases 91% trial to perm conversion excluding off label

82 Innovation As Part of our Mission Statement and Value Proposition: Innovation is key. Evaluate PRP and Stem Cell technologies and how this technology fits into our practice.

83 Thank you for your time! Thank you for all that you do!

87 Pudendal Nerve Block Pelvic Pain

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