Download Patient Selection for Medtronic Pain Therapies

© Medtronic, Inc. 2009
Patient Selection and Outcomes
for Implantable Pain Therapies
Faculty Name
Institution
City State
© Medtronic, Inc. 2009
Learning Objectives
• Describe the treatment continuum model.
• Define pain types effectively treated with implantable
pain therapies.
• Identify patient selection criteria for implantable pain
therapies.
• Describe chronic pain indications, benefits and risks for
neurostimulation and implantable drug delivery
therapies.
• Describe the role of the psychological evaluation.
• Explain the importance of patient expectations.
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© Medtronic, Inc. 2009
Definition of Chronic Pain
• Definitions include the following:1
– “It is not the duration of pain that distinguishes acute from chronic pain,
but more importantly, the inability of the body to restore its physiological
functions to normal homeostatic levels.”
– Chronic pain is commonly triggered by disease or injury.
– Stress, environmental, and affective factors may contribute to the pain
experience.
– Chronic pain will continue when treatment stops.
• Chronic pain has only recently been explored as a
complex condition that requires individual treatment and
a multidisciplinary approach.
1 Loeser JD and Melack R. Pain: an overview. The Lancet
1999; 53(9164):1607-1609.
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Pain Treatment Ladder1
Device therapies are
now considered earlier
in the treatment
continuum
1 Stamatos JM, Forde G, Kechejian P et al. Live Your Life Pain Free:
Medical Discoveries that Stop Chronic Pain. McKinney, TX: Magni
Company; 2005.
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Implantable Pain Therapy Treatment Options
Neurostimulation
Intrathecal Drug Delivery
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Pain Types
Pain types related to implantable pain therapies:
• Neuropathic pain
• Nociceptive pain
• Mixed pain
How do pain types impact therapy selection?
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© Medtronic, Inc. 2009
Neuropathic Pain
• Associated with injury to the peripheral nervous system
or the spinal cord
• Perceived as shooting, shock-like pain with severe
burning or aching sensations
– May have tingling, numbness, or itching
– Severe cases have a ripping or tearing sensation
• May be responsive to neurostimulation
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© Medtronic, Inc. 2009
Nociceptive Pain
• Activated in response to tissue damage or inflammation
arising from receptors sensitive to noxious stimuli
• Can be perceived as:
– Well localized, constant, aching, throbbing, dull, vague, or a
pressured feeling
– Poorly localized and diffuse
• Some patients describe as intermittent and sharp pain
• Often responsive to opioid treatment; may be responsive
to intrathecal drug delivery therapy
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© Medtronic, Inc. 2009
Mixed Pain
• Most chronic pain is mixed pain.
• Mixed pain is a complex condition with neuropathic and
nociceptive characteristics.
• Pain perception depends on the condition.
• Conditions likely to produce mixed pain include:
– Chronic low back pain.
– Some forms of cancer pain and treatment.
• Patient may respond to neurostimulation or intrathecal
drug delivery therapy. Clinical judgment and patient
characteristics guide therapy selection.
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© Medtronic, Inc. 2009
Implantable Pain Therapy Selection
Neurostimulation
•Radiculopathy
•Post laminectomy
pain
•Epidural fibrosis
•Degenerative disc
disease
•Peripheral causalgia
Neurostimulation
or Intrathecal
Drug Delivery
•Failed back surgery
syndrome
• Complex regional pain
syndrome
• Arachnoiditis
Intrathecal
Drug Delivery
•Intractable pain
•Chronic pain due to
cancer
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© Medtronic, Inc. 2009
Patient Selection Criteria for Implantable Pain
Therapies: Non-malignant Pain
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•
•
•
•
Inadequate pain relief and/or
intolerable side effects after
treatment with more conservative
therapies
Physiological origin of the pain
No current signs of drug abuse or
addiction
Appropriate surgical candidate
Additional surgical interventions are
not indicated
•
•
•
•
•
•
•
Patient understands therapy limits
and risks
Patient can articulate goals of
therapy and wants to participate in
treatment
Psychological evaluation and
clearance was obtained
A screening trial has been successful
Patient can properly operate the
system
Patient is ≥ 18 years old
Patient is not pregnant
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© Medtronic, Inc. 2009
Patient Selection Criteria for Implantable Pain
Therapies: Malignant Pain
• Pain unrelieved by more appropriate conservative
therapies1
• Life expectancy >3 months2
• No cerebrospinal fluid obstruction2
• Available network for post-surgical management2
• Trained healthcare providers and pharmacists,
home health, or hospice
– Ability to change dose or drugs
• Appropriate surgical candidate
1 Follett K and Doleys D. Selection of Candidates for Intrathecal Drug Administration to
Treat Chronic Pain: Considerations in Pre-implantation Trials. Minneapolis: Medtronic
Inc., 2002: 1 - 19.
2 Smith T.J. and Coyne P.J. How to Use Implantable Drug Delivery Systems for
Refractory Cancer Pain. J Supportive Oncology 1:1:1-4.
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© Medtronic, Inc. 2009
Neurostimulation
• Delivery of low-voltage electrical
stimulation to the spinal cord to
inhibit or mask the sensation of
pain.
• Treats chronic intractable
neuropathic pain which results
from injury to neural tissue that
is involved in the transduction,
modulation, transmission or
perception of pain
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© Medtronic, Inc. 2009
History of Neurostimulation
•
•
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1962 - First implant of carotid sinus nerve stimulator
1967 - Development of first “dorsal column” stimulator
1970s - Spinal cord stimulator becomes widely used
1980 - Medtronic introduces first programmable electrode
system in U.S.
• 1982 - First clinical implant of Itrel® totally implantable
neurostimulator
• Today - More than 100,000 patients have received
Medtronic neurostimulation therapy for chronic pain
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© Medtronic, Inc. 2009
Neurostimulation Indications
Indicated 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 or Low Back
Syndrome or Failed Back
Radicular Pain Syndrome or
Radiculopathies resulting in pain
secondary to Failed Back Syndrome
or Herniated Disk
Post-laminectomy 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) or Reflex Sympathetic
Dystrophy (RSD) or Causalgia
Refer to the package labeling for a complete
list of indications.
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© Medtronic, Inc. 2009
Potential Benefits of Neurostimulation for Chronic Pain1
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•
May result in a 50% - 70% reduction in pain
May reduce use of narcotics
May increase ability to perform activities of daily living
Increases ability to work
May be trialed to evaluate pain relief and functional
improvement from therapy
• May be reversed
• May achieve long-term cost-effectiveness for batteries
that last over one year
1 Taylor R, Caraway D, Van Buyten JP et al. eds. Spinal Cord Stimulation:
Overcoming Barriers to Successful Outcomes for the Complex Pain Patient.
Minneapolis: Medtronic Inc., 2006: 1-10.
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© Medtronic, Inc. 2009
Risks of Neurostimulation for Chronic Pain1
• The most frequently reported
problems:
–
–
–
–
–
Infection
Lead movement
Pain at the implant site
Loss of therapy effect
Therapy which did not meet
the patient's expectations
• Some of the most severe
reported problems:
– Epidural hemorrhage
– Spinal fluid leakage
– Paralysis
For a complete list of adverse events which have been associated
with neurostimulation, please refer to the product labeling and
information for prescribers.
1 Medtronic Implantable Systems Performance Registry (ISPR).
2007 Annual Report. Protocol NSP0010-10000. Report date:
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October 2, 2008.
© Medtronic, Inc. 2009
Intrathecal Drug Delivery
• An implanted system to
treat chronic pain; the
system delivers precise
doses of prescribed
medication directly into
the cerebrospinal fluid
(CSF) to modulate the
transmission of pain
signals
• Treats intractable pain –
including cancer pain
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© Medtronic, Inc. 2009
History of Intrathecal Drug Delivery
• 1982 - First clinical implant of programmable pump
(became SynchroMed pump) for intrathecal morphine
• 1988 - Market release of implantable programmable
SynchroMed Pump (IV use for cancer chemotherapy)
• 1991 - Market release of SynchroMed Pump (intrathecal
morphine for cancer pain and non-malignant pain)
• Today - More than 100,000 patients worldwide have
received a Medtronic pump for chronic pain
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© Medtronic, Inc. 2009
Intrathecal Drug Delivery Indications
• The SynchroMed® Pump is indicated for use when patient therapy
requires the chronic intrathecal infusion of medications.
• Approved for use with:
– Preservative-free morphine sulfate sterile solution in the treatment of
chronic intractable pain.
– Preservative-free ziconotide sterile solution for the management of
severe chronic pain.
–
Lioresal® Intrathecal (baclofen injection) in the management of
severe spasticity.
–
Chronic intravascular infusion of floxuridine (FUDR), methotrexate,
doxorubicin or cisplatin for the treatment of primary or metastatic
cancer.
Refer to the package labeling for a complete list of indications.
Lioresal® is a registered trademark of Novartis Pharmaceuticals, Inc.
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© Medtronic, Inc. 2009
Intrathecal Drug Delivery Contraindications
• IDD system implant is contraindicated when:
– Infection is present.
– When the pump cannot be implanted at the appropriate depth
from the surface of the skin.
– Body size is insufficient to accommodate the pump.
– Contraindications exist relating to the drug (e.g., allergic reaction).
• Do not use the patient control device to administer opioid to
opioid-naïve patients or to administer ziconotide or baclofen.
Refer to the package labeling for a complete list of contraindications.
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© Medtronic, Inc. 2009
Potential Benefits of Intrathecal Drug Delivery
for Chronic Pain
• Site-specific drug delivery1
– Faster onset and longer lasting analgesia than other routes of
administration
– Equivalent analgesia with lower doses
– Decreased likelihood of side effects because of lower doses
• Noninvasive programmable therapy
– Minimizes patient discomfort
– Can be programmed to meet a patient’s changing needs
• Can be trialed to evaluate pain relief and functional
improvement of therapy
• Reversible
1 Follett K and Doleys D. Selection of Candidates for Intrathecal Drug Administration to
Treat Chronic Pain: Considerations in Pre-implantation Trials. Minneapolis: Medtronic
Inc., 2002: 1 - 19.
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© Medtronic, Inc. 2009
Risks of Intrathecal Drug Delivery1,2
•
The most frequently reported
problems:
– Infection
– Spinal fluid leak
– Pump inversion
– Skin erosion
– Drug side-effects
– Loss of therapy effect
– Therapy which did not meet the
patient's expectations
•
Some of the most severe reported
problems:
– Inflammatory mass
– Spinal cord damage
– Meningitis
– Life threatening drug adverse effects
due to over infusion as a result of
programming or patient monitoring
errors or device malfunction
– Complications due to use of
unapproved drugs and/or not using
drugs in accordance with drug
labeling
For a complete list of adverse events which have been associated with
intrathecal drug delivery, please refer to the product labeling and information
for prescribers.
1 Medtronic Implantable Systems Performance Registry (ISPR). 2007 Annual Report. Protocol NSP001010000. Report date: October 2, 2008.
2 Coffey RJ, Owens, M, Broste, Steven K, et al. Mortality Associated with Intrathecal Opioid Drug Infusion to
Treat Non-Cancer Pain: Risk Factors and Mitigation. Late breaking paper presented at: North American
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Neuromodulation Society 12th Annual Meeting; December 4-7; 2008; Las Vegas, NV.
© Medtronic, Inc. 2009
Patient Evaluation
•
•
•
•
Obtain patient history and conduct physical examination
Assess and document patient’s pain-related symptoms
Evaluate other appropriate and less invasive therapies
Assess patient motivation and commitment to the
therapy
• Establish reasonable goals for the therapy:
–
–
–
–
Reduce pain
Reduce use of oral medication and side effects
Improve function
Improve quality of life
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© Medtronic, Inc. 2009
Psychological Evaluation
A psychological evaluation can be used to identify
patients with characteristics that are positive indicators to
a successful outcome.1
– Assess existence of significant psychological signs, drug
addiction or behavioral problems and unresolved issues of
secondary gain.
– Identify and treat psychological co-morbidities prior to therapy.
– Evaluate patient willingness, understanding, and competency to
actively participate in their therapy.
– Establish a baseline against which to measure improvement.
1Doleys DM. .Psychological factors in spinal cord stimulation therapy: brief
review and discussion. Neurosurgical Focus 2006: 21(6):1-6.
25
© Medtronic, Inc. 2009
Patient Expectations
Candidates must:
• Be able to determine specific, measurable goals, and expectations
for the therapy.
• Want pain to decrease and ability to function to improve.
• Understand that pain has multiple components.
• Express realistic expectations about treatment outcomes.
• Be able and willing to participate in therapy and rehabilitation.
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© Medtronic, Inc. 2009
References
•
•
•
•
•
•
Coffey RJ, Owens, M, Broste, Steven K, et al. Mortality Associated with Intrathecal
Opioid Drug Infusion to Treat Non-Cancer Pain: Risk Factors and Mitigation. Late
breaking paper presented at: North American Neuromodulation Society 12th Annual
Meeting; December 4-7; 2008; Las Vegas, NV.
de Lissovoy G, Brown RE, Halpern M et al. Cost Effectiveness of Long-term
Intrathecal Morphine for Pain Associated with Failed Back Surgery Syndrome.
Clinical Therapeutics 1997;19(1):96–112.
Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic
low back pain: report from the National Outcomes Registry for low back pain. Pain
Med 2004;5(1):6-13.
Doleys DM.Psychological factors in spinal cord stimulation therapy: brief review and
discussion. Neurosurgical Focus 2006: 21(6):1-6.
Doleys DM and Olson K ed. Psychological assessment and intervention in
implantable pain therapies. Minneapolis: Medtronic Inc., 1996: 1-20.
Follett K and Doleys D. Selection of Candidates for Intrathecal Drug Administration to
Treat Chronic Pain: Considerations in Pre-implantation Trials. Minneapolis: Medtronic
Inc., 2002: 1 - 19.
27
© Medtronic, Inc. 2009
References continued
•
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•
•
•
•
•
•
Kumar K, Hunter G, Demaria D. Spinal cord stimulation in treatment of chronic
benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58(3):481-496.
Loeser JD and Melack R. Pain: an overview. The Lancet 1999;353(9164):1607-1609.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus
repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial.
Neurosurgery. 2005;56(1):98-107.
Medtronic Implantable Systems Performance Registry (ISPR). 2007 Annual Report.
Protocol NSP0010-10000. Report date: October 2, 2008.
Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in
chronic non-cancer pain. Eur J Pain. 2001;5(4):353-361.
Smith T.J. and Coyne P.J. How to Use Implantable Drug Delivery Systems for
Refractory Cancer Pain. J Supportive Oncology 1:1:1-4.
Taylor R, Caraway D, Van Buyten JP et al. eds. Spinal Cord Stimulation: Overcoming
Barriers to Successful Outcomes for the Complex Pain Patient. Minneapolis:
Medtronic Inc., 2006: 1-10.
Van Buyten JP, Van Zundert J, Vueghs P, Vanduffel L. Efficacy of spinal cord
stimulation: 10 years of experience in a pain centre in Belgium. Eur J Pain.
2001;5(3):299-307.
28
© Medtronic, Inc. 2009
Neurostimulation Systems for Pain
Therapy Brief Summary (continued)
Contraindications
Diathermy - Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all
now referred to as 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.
Warnings
Sources of strong electromagnetic interference (eg, defibrillation, diathermy, electrocautery, MRI, RF
ablation, and therapeutic ultrasound) can interact with the neurostimulation system, resulting in
serious patient injury or death. These and other sources of EMI can also result in system damage,
operational changes to the neurostimulator or unexpected changes in stimulation. Rupture or piercing
of the neurostimulator can result in severe burns. An implanted cardiac device (eg, pacemaker,
defibrillator) may damage a neurostimulator, and the 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 (patients
under the age of 18), pregnancy, unborn fetus, or delivery. Patients should be detoxified from
narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and
precautions provided in product manuals. Patients should avoid activities that may put undue stress
on the implanted neurostimulation system components. Patients should not scuba dive below 10
meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA).
Electromagnetic interference, postural changes, and other activities may cause shocking or jolting.
© Medtronic, Inc. 2009
Neurostimulation Systems for
Pain Therapy Brief Summary
Product manuals must be reviewed prior to use for detailed disclosure.
Indications
Implantable neurostimulation systems - A Medtronic implantable neurostimulation system is indicated
for spinal cord stimulation (SCS) 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
© Medtronic, Inc. 2009
Neurostimulation Systems for Pain
Therapy Brief Summary (continued)
Adverse Events
Adverse events may include: undesirable change in stimulation described by some
patients as uncomfortable, jolting or shocking; 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, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s
website at www.medtronic.com.
USA Rx Only
Rev 0209
© Medtronic, Inc. 2009
SynchroMed® II Drug Infusion System Brief
Summary:
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed
disclosure.
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:
Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs
with preservatives, drug contraindications, drug formulations with pH < 3, use of catheter access port
(CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications,
use of Personal Therapy Manager to administer opioid to opioid-naïve patients or to administer ziconotide.
© Medtronic, Inc. 2009
SynchroMed® II Drug Infusion System Brief
Summary:(continued)
Warnings:
Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may
be incompatible with and damage the system. Failure to comply with all product instructions, including
use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of
non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased
risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in
therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a
clinically significant or fatal drug under- or overdose. Refer to appropriate drug labeling for indications,
contraindications, warnings, precautions, dosage and administration information, screening procedures and
underdose and overdose symptoms and methods of management. Physicians must be familiar with the drug
stability information in the product technical manuals 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. 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, change in underlying symptoms, or need for rapid dose escalation.
© Medtronic, Inc. 2009
SynchroMed® II Drug Infusion System Brief
Summary:(continued)
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, including prodromal signs and
symptoms of inflammatory mass. Failure to recognize signs and symptoms and seek appropriate medical intervention can result
in serious injury or death. Instruct patients to notify their healthcare professionals of the implanted pump before medical
tests/procedures, to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating
the pump through the skin, to consult with their clinician if the pump alarms and before traveling or engaging in activities that can
stress the infusion system or involve pressure or temperature changes. Strong sources of electromagnetic interference (EMI),
such as short wave (RF) diathermy and MRI, can negatively interact with the pump and cause heating of the implanted pump,
system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical
procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. Avoid using
shortwave (RF) diathermy within 30 cm of the pump or catheter. Effects of other types of diathermy (microwave, ultrasonic, etc.)
on the pump are unknown. Drug infusion is suspended during MRI; for patients who can not safely tolerate suspension, use
alternative drug delivery method during MRI. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events,
as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. Confirm pump status before
and after MRI. Reference product labeling for information on sources of EMI, effects on patient and system, and steps to reduce
risks from EMI.
© Medtronic, Inc. 2009
SynchroMed® II Drug Infusion System Brief
Summary:(continued)
Precautions:
Monitor patients after device or catheter replacement for signs of underdose/overdose. Infuse preservative-free (intraspinal) saline
or, for vascular applications, infuse heparinized solutions therapy at minimum flow rate if therapy is discontinued for an extended
period of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI
from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator,
neurostimulator).
Adverse Events:
Include, but are not limited to, spinal/vascular procedure risks; infection; bleeding; tissue damage, damage to the system or loss of,
or change in, therapy that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically
significant or fatal drug underdose or overdose, due to end of device service life, failure of the catheter, pump or other system
component, pump inversion, technical/programming errors, or improper use, including use of non-indicated formulations and/or not
using drugs or system in accordance with labeling; pocket seroma, hematoma, erosion, infection; post-lumbar puncture (spinal
headache); CSF leak and rare central nervous system pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord
bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; potential serious adverse
effects from catheter fragments in intrathecal space, including potential to compromise antibiotic effectiveness for CSF infection;
anesthesia complications; body rejection phenomena; local and systemic drug toxicity and related side effects; potential serious
adverse effects from catheter placement in intravascular applications.
USA Rx Only Rev 10/09