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Slide 1-

Spinal Cord Stimulators and Failed Back Syndrome Mark Stern, MD Neurosurgeon
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Topics Part 1: Chronic Pain Conditions Part 2: Spinal Cord Stimulation (SCS)/ Neurostimulation Part 3: Prevention and Management of Neurostimulation Complications Part 4: Intrathecal Drug Delivery (IDD)
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Types of Neuropathic Pain Direct nerve root injury: radiculopathy Battered root syndrome Perineural fibrosis Intrafascicular fibrosis Adhesive arachnoiditis Peripheral deafferentation Phantom limb pain Sympathetic-mediated pain syndrome Herpetic neuralgia Diabetic polyneuropathy Central deafferentation-thalamic stroke Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
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Mechanical low back pain Discogenic pain Joint pain Facet joint Sacroiliac joint Pseudoarthrosis Osteoporosis Musculoskeletal trauma Types of Nociceptive Pain Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
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Failed Back Surgery Syndrome (FBSS)* Idiopathic chronic pain syndrome Cancer pain *Also referred to as “post-surgical chronic back pain” Combined Nociceptive and Neuropathic Pain Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
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Chronic Pain Conditions Post-surgical chronic back pain or failed back Radicular pain syndrome or radiculopathies resulting in pain secondary to failed back or herniated disk Postlaminectomy pain Multiple back operations Unsuccessful disk surgery Degenerative disk disease, herniated disk pain refractory to conservative and surgical interventions Peripheral causalgia Epidural fibrosis Arachnoiditis or lumbar adhesive arachnoiditis Complex regional pain syndrome, reflex sympathetic dystrophy or causalgia
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Device therapies are now considered earlier in the treatment continuum Stamatos JM, et al. Live Your Life Pain Free, October 2005. Based on the interventional pain management experience of Dr. John Stamatos Pain Treatment Ladder
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Part 2: Spinal Cord Stimulation / Neruostimulation
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Spinal Cord Stimulation: Indication MR15993 ©2016 Medtronic, Inc. All Rights Reserved. To aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
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Choosing Candidates for Spinal Cord Stimulation Indicated for spinal cord stimulation (SCS) system as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk Postlaminectomy pain Multiple back operations Unsuccessful disk surgery Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions Peripheral causalgia Epidural fibrosis Arachnoiditis or lumbar adhesive arachnoiditis Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia
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Choosing Candidates for Spinal Cord Stimulation Chronic, intractable pain1 Objective evidence of pathology2 Lack of adequate relief from conventional treatments3 Initial or further surgical intervention not indicated3 At least 18 years of age2 Patient can properly operate the system2 Patient understands therapy risks2 Satisfactory screening test results2 Patient is not pregnant2 Completion of psychological evaluation3 Medtronic, Inc. Indications, Implantable Neurostimulation Systems. 2004. Medtronic, Inc. Medtronic Pain Therapy: Information for Prescribers. 2012. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). Published August 7, 1995. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=240&ncdver=1&bc=AAAAgAAAAAAAAA%3d%3d&. Accessed May 19, 2016.
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Failed Back Surgery Syndrome (FBSS) Defined as persistence or development of low back or leg pain following surgery on the lumbosacral spine Most common indication for neurostimulation therapy for chronic pain in the United States FBSS occurs in patients who have typically undergone multiple lumbosacral spine operations for conditions such as disk herniation, lumbar stenosis, or spinal instability1,2,3,4 Approximately 300,000 back surgeries are performed in USA/year to treat chronic lumbar pain5 Failure rates as high as 40%5 Success rate decreases significantly with each subsequent back surgery 6
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Complex Regional Pain Syndrome (CRPS) Second most common use of neurostimulation therapy for chronic pain in the United States is for the symptomatic management of complex regional pain syndrome (CRPS) CRPS is a neuropathic pain syndrome precipitated most commonly by minor limb trauma1,2,4 Continuous, severe pain, disproportionate to the inciting event, occurs in the limb and may be accompanied by allodynia, hyperalgesia, skin color changes, edema, joint stiffness, and bone demineralization1,2,3,4 Type I (reflex sympathetic dystrophy) Minor injuries or fractures of a limb precede the onset of symptoms Type II (causalgia) Develops after injury to a major peripheral nerve
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Contraindications for Spinal Cord Stimulation Diathermy- Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted electrodes, resulting in severe injury or death. Refer to the package labeling for a complete list of indications and contraindications for comprehensive details regarding product safety.
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Potential Benefits of Spinal Cord Stimulation Long-term pain relief1,2 Improved quality of life1,2 More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery3 Successful pain disability reduction2 More cost-effective than conventional medical management and reoperation4,5 Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary in the course book for important risk and safety information Percentage of Patients with FBSS Who Achieved ≥50% Pain Relief at 24 Months1
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Medtronic Registry Product Performance-related Events for SCS1 1. Medtronic Product Performance Report 2013. For a complete list of adverse events which have been associated with SCS, refer to the manufacturer labeling for the specific device. Leada,b Lead migration/dislodgements (n=314) High impedance (n=78) Lead fracture (n=46) Undesirable change in stimulation (n=43) Medical device complication (n=25) Low impedance (n=17) Device malfunction (n=11) Neurostimulatorc Medical device complication (n=3) Device malfunction (n=2) Undesirable change in stimulation (n=2) High impedance (n=1) Paresthesia (n=1) Recharging unable to recharge (n=1) Broken bond wire (n=1) a. 4962 leads followed from June 2004 through July 31, 2013 b. Includes events with 5 or more occurrences c. 2841 neurostimulators followed from June 2004 through July 31, 2013
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Appropriate patient selection is critical for: Therapy success Patient satisfaction Goal of patient selection Choose patients most likely to experience therapeutic success Minimize likelihood of risks, complications, and adverse events Importance of Patient Selection
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Part 3: Prevention and Management of Neurostimulation Complications
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Complications in Neurostimulation for Chronic Pain Preoperative considerations Intraoperative considerations Postoperative considerations
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Preoperative
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Undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking Hematoma Epidural hemorrhage Paralysis Seroma CSF leakage Informed Consent: Risks Infection Erosion Allergic response Hardware malfunction or migration Pain at implant site Loss of pain relief Chest wall stimulation Surgical risks For additional safety information, please refer to the brief summary of safety information at www.professional.medtronic.com For current product advisories, refer to http://professional.medtronic.com/pt/neuro/scs/ind/product-advisories/index.htm
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Risk-based discussion Discuss both early and late complications Provide information on the frequency and severity of event, identifying those which are most common, and how the events may be prevented or managed Informed Consent Discussion
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Difficult Anatomy Scoliosis, Morbid Obesity, Prior Surgery Inability to access the epidural space or place the lead Pacemaker Implantation Need for intra-op and post-op cardiac monitoring Recommendation for pacemaker representative involvement Infection History of MRSA Systemic vs. local infection Diabetes SMOKING Anticoagulation Future medical requirements (ie, MRI compatibility) Physiological Considerations
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Intraoperative
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Intraoperative Considerations Needle insertion angle (< 45) Dural puncture LOR to air Pneumocephalus Lead placement Intrathecal Anterior epidural Lateral epidural Anchoring Strain relief loop of lead Strict hemostasis IPG placement Depth and anchoring Wound closure
Slide 26-

Postoperative Hardware Biological Stimulation
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Incidence of Hardware Complications1 *Rate is based on the number of subjects implanted. n= 42 to 2972
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Incidence of Biologic Adverse Events n= 42 to 2972 Note: Epidural Hemorrhage has not been reported in this cited literature, but is listed as a potential risk in labeling *Rate is based on the number of subjects implanted.
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Incidence of Stimulation Complications *Rate is based on the number of subjects implanted. n= 42 to 2972
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Best Practices to Minimize and manage Complications
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Minimizing Infection Several weeks before surgery Manage coexisting conditions & risks Control blood glucose Recognize and treat remote infections Consider consultation with an infectious disease specialist Reduce or eliminate smoking Manage anticoagulation Discuss surgical risks and management with the patient 1-2 days before surgery Patient instructed to bath/clean surgical sites with a antimicrobial scrub Follett KA, Boortz-Marx RL, Drake JM, et al. 2004.
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Minimizing Infection Perioperative: 1 hour, administer prophylactic antibiotic1 Intraoperative1,2 1Follett KA, Boortz-Marx RL, Drake JM, et al. 2004. 2Deer TR, Stewart CD. 2008.
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Device Selection and Implant Techniques Complications that may be minimized through device selection and implant technique best practices Undesirable stimulation Lead migration Lead wire breakage Connection problems Kumar K, Buchser E, Linderoth B, et al. 2007.
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Minimizing Undesirable Stimulation with RestoreSensor ® and AdaptiveStim ® AdaptiveStim technology addresses these needs by automatically changing amplitude as needed in appropriate patients RestoreSensor with AdaptiveStim Automatically detects changes in body position Adapts stimulation settings to patient preferences up to 6 positions
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Implant Technique: Minimizing Lead Migration and Wire Breakage Lead placement1 Patient prone, pillow Conscious sedation Both AP & lateral images Adequate length for lead & extension Percutaneous lead Needle entry: paramedian oblique, less than 45o angle1 Soft silicone anchor2 Anchor end is pushed through fascia2 1Kumar K, Buchser E, Linderoth B, et al. 2007. 2Henderson JM, Schade CM, Sasaki J, et al. 2006. InjexTM Anchors
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Strain relief loop1 Nonabsorbable sutures2 Circular loop1, greater than 2 cm diameter Surgical lead: instead of anchor1 Percutaneous lead: between anchor and extension1 Neurostimulator in abdominal wall1 Implant Technique: Minimizing Lead Migration and Wire Breakage (continued) 1Kumar K, Buchser E, Linderoth B, et al. 2007. 2Henderson JM, Schade CM, Sasaki J, et al. 2006.
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Implant Technique: Minimizing Connection Problems Use adequate length for lead & extension Some physicians prefer a longer lead to avoid a lead-extension connection1 Tighten setscrews securely; use appropriate wrench Protect connections from body fluids Lead to extension - use tissue adhesive in boot2 Neurostimulator eg, Make sure self-sealing grommet closes after wrench removed 1Renard VM, North RB. 2006. 2Kumar K, Wilson JR, Taylor RS, et al. 2006.
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Minimizing Pain and Skin Erosion at Anchor & Extension Connection Select appropriate anchor1 Anchor at unobstructed location1 Not over bony structures Secure anchor to deep fascia Bury extension connector in an existing pocket (anchor or neurostimulator)2 Not in a new pocket 1Kumar K, Wilson JR, Taylor RS, et al. 2006. 2 Renard VM, North RB. 2006. InjexTM Bi-wing Anchor
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Minimizing Pain and Skin Erosion at Neurostimulator Site Neurostimulator location Away from obstructions1,2 eg, not over rib cage; avoid belt line and other clothing restrictions No deeper than specified in product labeling Neurostimulator pocket Blunt dissection Snug fit2 Secure neurostimulator 1Kumar K, Wilson JR, Taylor RS, et al. 2006. 2Follett KA, Boortz-Marx RL, Drake JM, et al. 2004.
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Management of Postsurgical Complications 1Eldrige JS, Weingarten TN, Rho RH. 2006. 2Deer TR, Stewart CD. 2008. 3Kumar K, Wilson JR, Taylor RS, et al. 2006.
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Management of Postsurgical Complications1 1Deer TR, Stewart CD. 2008. 2Follett KA, Boortz-Marx RL, Drake JM, et al.. 2004.
Slide 42-

Management of System Complications
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Part 4: Intrathecal Drug Delivery (IDD)
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IDD therapy involves the delivery of pain medicine in the intrathecal space The pump is connected to a thin, flexible catheter; both are implanted under the skin Smaller doses of medication are needed for effective pain relief because drug is delivered directly to the pain receptors Intrathecal Drug Delivery (IDD) Therapy
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Chronic intrathecal infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Also indicated for chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for severe spasticity, chronic epidural infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, and chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain Synchromed® II Drug Infusion System Indications Lioresal® is a registered trademark of Novartis Pharmaceuticals, Inc.
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*Relative approximations based on clinical observations Approximate Equivalent Daily Doses of Morphine
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Pain relief for patients who have not received adequate relief with conventional therapies Reduction in adverse effects from oral opioids such as nausea, vomiting, sedation, and constipation Decreased or elimination of oral analgesics Increased ability to perform activities of daily living Patient control within physician-set limits May be effective for patients who do not experience relief from neurostimulation therapy Benefits of IDD Therapy Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80.; Paice JA, et al: J Pain Symptom Manage.1996;11(2):71-80.
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The purpose of the trial is to assess the efficacy and side effects of intrathecal morphine Trialing methods include Continuous epidural Continuous intrathecal Bolus epidural Bolus intrathecal Patients who report at least 50% reduction in pain may be candidates for long-term therapy IDD Trial
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Programming error Drug concentration error Surgical complications, such as infection Catheter could become dislodged or blocked The pump could stop working Other side effects may occur IDD Therapy Risks For complete list of risks/complications, refer to product package insert Onofrio BM, Yaksh TL. J Neurosurg 1990;72:200-209.; Winkelmueller M, Winkelmueller W. J Neurosurg 1996;85:458-467.; Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2):71-80.
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Patient Selection
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Indications for Neurostimulation and Intrathecal Drug Delivery Therapy Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362. Refer to full prescribing information for Medtronic Neurostimulation Systems and Synchromed® II and Isomed® Drug Infusion Systems
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Patients who have neuropathic pain in a concordant anatomic distribution respond best to neurostimulation (NS) therapy Patients who have nociceptive pain in a concordant distribution respond best to Intrathecal Drug Delivery (IDD) Patients who do not respond well to NS may be candidates for IDD therapy Patient Selection Considerations Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.
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Patient Selection Checklist Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362. Refer Patient for a Pain Therapy Trial Failure of oral/transdermal opiate use or undesirable side effects More conservative therapies have failed An observable pathology exists that is concordant with the pain complaint Further surgical intervention is not indicated No serious untreated drug habituation exists Psychological evaluation and clearance for implantation has been obtained No contraindications to implantation exist
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Neurostimulation Clinical Evidence
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Primary outcome Number of patients with ≥50% leg pain relief at 6 months (≥50% reduction in leg VAS) Secondary outcomes evaluated at 1, 3, 6, 9, 12, 18 and 24 months Pain relief (leg and axial back VAS) Quality of life (SF-36 and EQ-5D) Function (Oswestry Disability Index) Patient satisfaction Need for drug or non-drug therapy for pain Time away from work Adverse events Medtronic PROCESS Study Kumar, et al. Pain 2007
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Clinically Significant Leg Pain Relief Key Findings:≥50% leg pain relief at 24 months, continued greater effect with SCS* in the per treatment/ITT analyses over 24 months *SCS (spinal cord stimulation) is a term for neurostimulation Kumar, et al. Pain 2007; n = 100
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Significant Improvement in Function Key Findings: Significant improvement in function (Oswestry Disability Index) in SCS+CMM group over 24 months Kumar, et al. Pain 2007; n = 100
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Significant Improvement in Quality of Life Kumar, et al. Pain 2007 Key Findings:Significant improvement in SCS+CMM group in 7/8 domains of QoL (SF-36) over 24 months Visual Analog Scale (VAS)
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High Satisfaction Kumar, et al. Pain 2007; n = 100 Key Findings: Treatment satisfaction among patients continuing SCS+CMM at 24 months
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Long-Term Pain Relief Kumar, et al. Neurosurgery 2006 Key Findings: 61.3% of failed back surgery syndrome patients with bilateral limb pain and 59.3% of patients with unilateral limb pain reported >50%
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Neurostimulation is Most Effective When Considered Early Kumar K, et al. Neurosurg. 2006;58;481-496 <2 2-5 5-8 8-11 11-15 >15 Success Rate (%)
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More Effective than Repeat Surgery North, et al. Neurosurgery 2005 ; n=45 Key Findings: Among patients available for long-term follow up, SCS was significantly more successful than reoperation: 9 (47%) of 19 patients randomized to SCS and 3 (12%) of 26 patients randomized to reoperation achieved at least 50% pain relief and were satisfied with treatment
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Van Buyten J-P, et al. Eur J Pain 2001;5:299-307; n=125 pain cases; P<0.01 for all activities 10-Year Experience: Neurostimulation Improves Quality of Life 27% 27% 30% 42% 44%
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Intrathecal Drug Delivery Clinical Evidence
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Back and Leg Pain Relief Deer, et al. Pain Medicine 2004; n=136 Key Findings: Numeric back pain ratings decreased >48%, and leg pain ratings decreased by 32% at 12-month follow up
Slide 66-

Successful Disability Reduction Deer, et al. Pain Medicine 2004; n=136 Key Findings: Successful disability reduction was reported in 60% of patients at 6 months and in 66% at 12 months
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Decreased Use of Pain Medications Deer, et al. Pain Medicine 2004; n=136 Key Findings: At 6 months, 65% of patients decreased their use of systemic opioids from baseline At 12 months, 42% of patients decreased their usage compared with the 6-month follow up 88.2% of patients were taking systemic opioids at baseline
Slide 68-

Overall Global Pain Relief Roberts, et al., European Journal of Pain; n=88 Key Findings: Overall pain relief of ≥50% was reported by 82% of patients (40 of 49) Number of Patients Global Pain Relief (%)
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Clinical Evidence Risks 1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review J Neurosrug (Spine 3) 100:254-267, 2004; 2. Staats P. Complications of intrathecal therapy. Pain Medicine 2008; 9(S1):S102-S107 As with any surgical procedure, neurostimulation and IDD involve the risk of infection. Lead migration is the most common complication associated with neurostimulation,1 while intrathecal catheters can fracture, kink, and migrate.2 For a complete list of adverse events for implantable therapies, see the appropriate product labeling.
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Summary With today’s treatments, patients should not have to wait for effective pain relief By partnering, we can help patients find the right pain treatment Together we can improve the quality of life for chronic pain patients Our decisions may change the course of a patient’s life
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Case Study Male, 45, office manager, no major psychosocial issues One spine surgery to treat herniated disc Referred from primary care physician to address axial back pain and secondary radicular pain that persists six months following anatomically corrective surgery Average back pain score (VAS) of 80/100 with diminished functional capacity Relief from physical rehabilitation therapy was not satisfactory Unsuccessfully treated with neuropathic pain agents and two systemic opioids, patient experienced extreme sedation and constipation Treated with nerve block series but relief was temporary