Spinal Cord Stimulators and Failed Back Syndrome Mark
Spinal Cord Stimulators and Failed Back Syndrome Mark Stern, MD Neurosurgeon 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) 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
Types of Nociceptive Pain Mechanical low back pain Discogenic pain Joint pain Facet joint Sacroiliac joint Pseudoarthrosis Osteoporosis Musculoskeletal trauma Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374 Combined Nociceptive and Neuropathic Pain Failed Back Surgery Syndrome (FBSS)* Idiopathic chronic pain syndrome
Cancer pain *Also referred to as post-surgical chronic back pain Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374 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 Pain Treatment Ladder 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 Part 2: Spinal Cord Stimulation / Neruostimulation Spinal Cord Stimulation: Indication To aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. MR15993 2016 Medtronic, Inc. All Rights Reserved. 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 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 1. Medtronic, Inc. Indications, Implantable Neurostimulation Systems. 2004.
2. Medtronic, Inc. Medtronic Pain Therapy: Information for Prescribers. 2012. 3. 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. 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 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 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. 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 Medtronic Registry Product 1 Performance-related Events for SCS Leada,b Neurostimulatorc
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) 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 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. Importance of Patient Selection 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 Part 3:
Prevention and Management of Neurostimulation Complications Complications in Neurostimulation for Chronic Pain Preoperative considerations Intraoperative considerations Postoperative considerations PREOPERATIVE Informed Consent: Risks Undesirable change in stimulation described by some patients as uncomfortable,
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 Informed Consent Discussion 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 Physiological Considerations 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) INTRAOPERATIVE 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 Postoperative Hardware Biological Stimulation n= 42 to 2972 Incidence of Hardware Complications1 Complication Rate* Lead migration1,2,4,5,7,8,9
0.2 4.0% Paralysis 6 1 in 10,000 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. n= 42 to 2972 Incidence of Stimulation Complications Complication Rate* Loss of Pain Relief 1
12.71% Undesirable stimulation 1,3,4,5,9 1.36 12.0% Chest wall stimulation3,4,5 0.58% *Rate is based on the number of subjects implanted. BEST PRACTICES TO MINIMIZE AND MANAGE COMPLICATIONS
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. Minimizing Infection
Perioperative: 1 hour, administer prophylactic antibiotic1 1,2 Intraoperative Operating room During procedure Drape fluoroscopic C-arm within sterile field Limit entry & exit to OR Patient prep Scrub with antiseptic solution Use antimicrobial incision drape Drape large sterile field
1 2 Minimize number of people Double-glove, minimal touch Strict hemostasis Minimize tissue trauma Closing the incision Suture in anatomical layers Apply sterile occlusive dressing
Follett KA, Boortz-Marx RL, Drake JM, et al. 2004. Deer TR, Stewart CD. 2008. 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. 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 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 1 2 Kumar K, Buchser E, Linderoth B, et al. 2007. Henderson JM, Schade CM, Sasaki J, et al. 2006. InjexTM Anchors Implant Technique: Minimizing Lead Migration and Wire Breakage (continued)
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 1 2 Kumar K, Buchser E, Linderoth B, et al. 2007. Henderson JM, Schade CM, Sasaki J, et al. 2006. 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 1 2 Renard VM, North RB. 2006. Kumar K, Wilson JR, Taylor RS, et al. 2006.
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 InjexTM Bi-wing Anchor Not in a new pocket 1 2 Kumar K, Wilson JR, Taylor RS, et al. 2006.
Renard VM, North RB. 2006. 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 1 2 Kumar K, Wilson JR, Taylor RS, et al. 2006. Follett KA, Boortz-Marx RL, Drake JM, et al. 2004. Management of Postsurgical Complications Complication Management CSF leak: dural puncture
Subcutaneous hematoma (or seroma) Conservative management1 Flat bed rest, hydrate, analgesics Caffeine Abdominal binder Some physicians perform epidural blood patch1 Apply binder2 May resolve spontaneously3 May need to aspirate2,3
Eldrige JS, Weingarten TN, Rho RH. 2006. Deer TR, Stewart CD. 2008. 3 Kumar K, Wilson JR, Taylor RS, et al. 2006. 1 2 Management of Postsurgical Complications1 Complication Pain over component Management May improve with conservative measures1 Lidocaine patch Cushion site Surgically revise component1
Deeper, if appropriate Away from irritation Skin erosion over component Revise component 2 Deeper, if appropriate1 Away from irritation Consider antibiotics 1 2 Deer TR, Stewart CD. 2008.
Follett KA, Boortz-Marx RL, Drake JM, et al.. 2004. Management of System Complications Complication Management Lead migration Reprogram Revise surgically Lead wires broken Hardware malfunction Undesirable paresthesia Replace lead Replace component
Revise surgically Part 4: Intrathecal Drug Delivery (IDD) Intrathecal Drug Delivery (IDD) Therapy 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 Synchromed II Drug Infusion System
Indications 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 preservativefree 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 Lioresal is a registered trademark of Novartis Pharmaceuticals, Inc. Approximate Equivalent Daily Doses of Morphine Route of Administration Relative Potency (mg)*
Oral Intravenous Epidural Intrathecal 300 100 20 1 *Relative approximations based on clinical observations Benefits of IDD Therapy 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 Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80.; Paice JA, et al: J Pain Symptom Manage.1996;11(2):71-80. IDD Trial 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 Therapy Risks 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 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;85:458467.; Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2):71-80.
Patient Selection 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 Patient Selection Considerations 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 Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.
Patient Selection Checklist 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 Refer Patient for a Pain Therapy Trial Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362. Neurostimulation Clinical Evidence
Medtronic PROCESS Study 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
Kumar, et al. Pain 2007 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
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 Significant Improvement in Quality of Life Key Findings: Significant improvement in SCS+CMM group in 7/8 domains of QoL (SF-36) over 24 months
Visual Analog Scale (VAS) Kumar, et al. Pain 2007 High Satisfaction Key Findings: Treatment satisfaction among patients continuing SCS+CMM at 24 months Kumar, et al. Pain 2007; n = 100 Long-Term Pain Relief Pain Relief (%)
100 75 Key Findings: 61.3 59.3 50 25 0 Patients (%) FBSS with unilateral limb pain Kumar, et al. Neurosurgery 2006 FBSS with bilateral limb pain
61.3% of failed back surgery syndrome patients with bilateral limb pain and 59.3% of patients with unilateral limb pain reported >50% Neurostimulation is Most Effective When Considered Early 90% 85% 78% 80% Success Rate (%)
70% 60% 50% 42% 40% 35% 30% 20% 10% 10% 9%
11-15 >15 0% <2 2-5 5-8 8-11 Time Until Intervention (Yrs) Kumar K, et al. Neurosurg. 2006;58;481-496 More Effective than Repeat Surgery
Key Findings: Among patients available for longterm 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 North, et al. Neurosurgery 2005 ; n=45 10-Year Experience: Improvement % Neurostimulation Improves Quality of Life
27% Leisure Time 27% Social Activities 30% 42% QoL Parameters Van Buyten J-P, et al. Eur J Pain 2001;5:299-307; n=125 pain cases; P<0.01 for all activities
44% Intrathecal Drug Delivery Clinical Evidence Back and Leg Pain Relief Key Findings: Numeric back pain ratings decreased >48%, and leg pain ratings decreased by 32% at 12-month follow up Deer, et al. Pain Medicine 2004; n=136 Successful Disability Reduction
Key Findings: Successful disability reduction was reported in 60% of patients at 6 months and in 66% at 12 months Deer, et al. Pain Medicine 2004; n=136 Decreased Use of Pain Medications 88.2% of patients were taking systemic opioids at baseline 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 Deer, et al. Pain Medicine 2004; n=136 Overall Global Pain Relief Key Findings: Number of Patients Overall pain relief of 50% was reported by 82% of patients (40 of 49)
Global Pain Relief (%) Roberts, et al., European Journal of Pain; n=88 Clinical Evidence Risks 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. 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 Summary
With todays 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 patients life 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
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