Upload
salvatore-pelter
View
225
Download
3
Tags:
Embed Size (px)
Citation preview
© Medtronic, Inc. 2008
1
Medtronic Pain Therapies
Referral Strategies forManaging Chronic Pain
© Medtronic, Inc. 2008
2
Agenda
• Types of Pain• Common Chronic Pain Conditions• Introduction to Medtronic Neurostimulation• Introduction to Medtronic Intrathecal Drug Delivery• Patient Selection• Neurostimulation Clinical Evidence • Intrathecal Drug Delivery Clinical Evidence • Role of Interventional Pain Specialist• Case Study
© Medtronic, Inc. 2008
3
Types of Pain
© Medtronic, Inc. 2008
4
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
© Medtronic, Inc. 2008
5
• 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
© Medtronic, Inc. 2008
6
• 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
© Medtronic, Inc. 2008
7
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
© Medtronic, Inc. 2008
8
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
© Medtronic, Inc. 2008
9
Introduction to Medtronic Neurostimulation
© Medtronic, Inc. 2008
10
• Delivers small electrical signals to the epidural space
• Inhibits pain signals before they reach the brain and replaces them with a tingling sensation that covers the specific areas where pain was felt
• Indicated for treatment of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain
Neurostimulation Therapy
© Medtronic, Inc. 2008
11
• An effective method of pain control for many patients
• Reduces or eliminates pain medications• Non-destructive and less invasive than surgical
alternatives• Reversible – can be discontinued or surgically
removed• Systems reprogrammable without surgery• Trial helps assess patient response • Patient control within physician-set limits
Benefits of Neurostimulation
Kumar K, Nath RK, Toth C. Deep Brain Stimulation for Intractable Pain: A 15-year experience. Neurosurgery. 1997
© Medtronic, Inc. 2008
12
• Pain Therapy Trial provides an opportunity to measure the effectiveness of neurostimulation without making a long-term commitment– Gauge patient response– Provide an adjustment period– Explore therapy parameters– Improve therapy cost-effectiveness
• The goal is at least a 50% reduction in pain without intolerable side effects– Patient-specific goals may include less pain
reduction but improved quality of life
Neurostimulation Trial
Kumar K, et al. Neurosurgery. 2006;58:481-496
© Medtronic, Inc. 2008
13
• Lead migration resulting in loss of pain relief
• Intermittent or uncomfortable stimulation • Stimulation in the wrong location • Neurological damage during procedure• Risk of infection at implantation
Some Risks of Neurostimulation
North R, Kidd D, Zahurak M, et al. Neurosurgery. 1993;32:384-395.
For complete list of risks/complications, refer to product package insert
© Medtronic, Inc. 2008
14
Introduction to Medtronic Intrathecal Drug Delivery (IDD)
© Medtronic, Inc. 2008
15
• 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
© Medtronic, Inc. 2008
16
• 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.
© Medtronic, Inc. 2008
17
Route of Administration Relative Potency (mg)*
Oral
Intravenous
Epidural
Intrathecal
300
100
20
1
*Relative approximations based on clinical observations
Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80.
Approximate Equivalent Daily Doses of Morphine
© Medtronic, Inc. 2008
18
• 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.
© Medtronic, Inc. 2008
19
• 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
© Medtronic, Inc. 2008
20
• 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.
© Medtronic, Inc. 2008
21
Patient Selection
© Medtronic, Inc. 2008
22
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
© Medtronic, Inc. 2008
23
• 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.
© Medtronic, Inc. 2008
24
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
© Medtronic, Inc. 2008
25
Neurostimulation Clinical Evidence
© Medtronic, Inc. 2008
26
• 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
© Medtronic, Inc. 2008
27
Clinically Significant Leg Pain ReliefKey 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
© Medtronic, Inc. 2008
28
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
© Medtronic, Inc. 2008
29
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)
© Medtronic, Inc. 2008
30
High Satisfaction
Kumar, et al. Pain 2007; n = 100
Key Findings:
Treatment satisfaction among patients continuing SCS+CMM at 24 months
© Medtronic, Inc. 2008
31
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%
61.3 59.3
0
25
50
75
100
Patients (%)
Pain
Relief (%
)
FBSS with unilateral limb pain FBSS with bilateral limb pain
© Medtronic, Inc. 2008
32
Neurostimulation is Most Effective When Considered Early
Kumar K, et al. Neurosurg. 2006;58;481-496
85%78%
42%35%
10% 9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Time Until Intervention (Yrs)
<2 2-5 5-8 8-11 11-15 >15
Su
cces
s R
ate
(%)
© Medtronic, Inc. 2008
33
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
© Medtronic, Inc. 2008
34Van 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
Increased Independence
DailyActivities
LeisureTime
Social Activities
Ability to Relax
0%5%
10%15%20%25%30%35%40%45%50%
QoL Parameters
Imp
rovem
en
t %
27% 27% 30% 42% 44%
© Medtronic, Inc. 2008
35
Intrathecal Drug Delivery Clinical Evidence
© Medtronic, Inc. 2008
36
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
© Medtronic, Inc. 2008
37
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
© Medtronic, Inc. 2008
38
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
© Medtronic, Inc. 2008
39
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)
Nu
mb
er
of
Pa
tie
nts
Global Pain Relief (%)
© Medtronic, Inc. 2008
40
Clinical Evidence Risks
1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature reviewJ 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.
© Medtronic, Inc. 2008
41
Role of Interventional Pain Specialist
© Medtronic, Inc. 2008
42
Practice Management Collaboration
© Medtronic, Inc. 2008
43
Interventional Pain SpecialistPain Management Approach
• Recognizes unique benefits of technological advances and interventions
• Communicates with all concerned parties to ensure best treatment possible
• Develops follow-up plan once pain successfully treated
• Collaborates with referring physician when treatment overlaps with general health care
• Follows up with referring physician once pain is controlled
© Medtronic, Inc. 2008
44
Interventional Pain Specialist Referral Criteria
• Multiple symptoms or pain sources• Conservative therapies not working• Patient’s functional status deteriorated• Uncomfortable prescribing or monitoring
opioids
© Medtronic, Inc. 2008
45
Device Therapy Referral Interventional Pain Specialist Role
• Conduct a thorough patient history and physical exam
• Develop an interventional pain treatment plan• Conduct a Medtronic Pain Therapy trial• Perform the Medtronic Pain Therapy
implantation or refer after the trial• Develop a follow-up plan with the patient
© Medtronic, Inc. 2008
46
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
© Medtronic, Inc. 2008
47
Case StudyMale, 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
© Medtronic, Inc. 2008
48
SynchroMed® Infusion System Brief Summary• Indications:• US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the
treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.
• Contraindications:• When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when
body size is not sufficient to accept pump bulk and weight; when contraindications exist relating to the drug; drugs with preservatives. Do not use the Personal Therapy Manager accessory to administer opioid to opioid-naïve patients or to administer ziconotide.
• Warnings:• Comply with all product instructions for initial preparation and filling, implantation, programming, refilling,
and injecting into the catheter access port (CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over infuse the drug, potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been aspirated.
© Medtronic, Inc. 2008
49
SynchroMed® Infusion System Brief Summary continued
Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. Physicians must be familiar with the drug stability information in the technical manual and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system. Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities such as strenuous exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid manipulating the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients must consult their physician before engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs, hyperbaric chambers, flights, skydiving, etc.) Inform patients that pump has an Elective Replacement Indicator (ERI) that sounds when the pump is nearing its end of service. When the alarm sounds, patients must contact their doctor to schedule pump replacement.
Precautions:The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date has expired. Do not reuse or resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or below 5°C. Consider use of peri- and post-operative antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is present. For patients prone to CSF leaks, clinicians should consider special procedures, such as a blood patch. Follow instructions for emptying and filling the pump during a replacement or revisions that require removal of the pump from the pocket. Explant the pump postmortem if incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices to Medtronic for analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5 cm from the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away from pump ports before suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an extended period of time, fill the reservoir with preservative-free saline in intraspinal applications or appropriate heparinized solution (if not contraindicated) in vascular applications. The magnetic field or telemetry signals produced by the programmer may cause sensing problems and inappropriate device responses with an implantable pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field generated by equipment found in the home, work, medical, or public environments. Most EMI normally encountered will not affect the operation of the pump. Exceptions include: injury resulting from heating of the pump which can damage surrounding tissue (diathermy, MRI), system damage which can require surgical replacement or result in loss/change in symptom control (defibrillation, electrocautery, high-output ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying symptoms, and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance imaging (MRI)). MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during MRI exposure which will cause the pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior to MRI, the physician should determine if the patient can safely be deprived of drug delivery. If not, alternative delivery methods for the drug can be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed.
© Medtronic, Inc. 2008
50
SynchroMed® Infusion System Brief Summary continued
Adverse Events:Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow
performance due to component failure, inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter.
!USA Rx Only
© Medtronic, Inc. 2008
51
Neurostimulation Systems for Pain Therapy DisclosureBrief Summary: Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed
disclosure.Indication for Use - Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks.
For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com. Rx Only. November, 2007
© Medtronic, Inc. 2008
52
Thank You