Utilization of

Implantable Devices for

Chronic Pain LISA STEARNS

CENTER FOR PAIN AND SUPPORTIVE CARE

PHOENIX, ARIZONA

Objectives

u Neurostimulation

u Indications/Contraindications

u Trialing and Maintenance

u Risks

u Intrathecal Drug Delivery

u Indications/Contraindications

u Trialing and Maintenance

u Risks

u Intrathecal Drug Delivery PACC Guidelines

Neurostimulation

u Spinal, peripheral nerve, field and brain stimulation

u A generator (about the size of a pocket watch)

sends electrical signals through small implanted

wires/leads

u Leads are either placed percutaneously or surgically

u percutaneous lead via needle

u paddle lead via laminectomy or burr hole

u Signals travel faster than pain fibers and replace the

pain signal with a tingling sensation

u signals can vary in amplitude, voltage and frequency

of wave signals which can be programmed for pain

optimization and patient comfort

Neurostimulation

u Companies:

u Medtronic

u St. Jude

u Boston Scientific

u Spinal Modulation (clinical trials)

u Nevro (at FDA)

Neurostimulation

u Potential Benefits

u Improved pain relief

u Decreased medications

u Able to perform trial first to test therapy

u Programmable to each patient

u Patient can control frequency and intensity

u If necessary, can explant

Neurostimulation

u Indications

The decision to offer a patient surgery should be based on consideration of their clinical symptoms, and their potential for functional benefits.

Implantation of a spinal cord stimulation device in adults with chronic, intractable, neuropathic pain is justified and appropriate in the following situations:

failure of an improvement in symptoms following at least six months of conservative management

successful completion of a physical and psychological assessment

successful outcome from a trial of stimulation as part of the assessment by a multidisciplinary team experienced in chronic pain management and the management and ongoing support of those with spinal cord stimulation devices AND clinical symptoms and diagnostic imaging compatible with failed back surgery syndrome

OR clinical symptoms and diagnostic imaging compatible with complex regional pain

syndrome Type 1.A patient should not be referred for spinal cord stimulation if: The patient’s quality of life or ability to function is not compromised.

Health Technology Assessment of Scheduled Procedures: Spinal Cord Stimulation for chronic pain

Health Information and Quality Authority 2014 (Dublin Ireland)

Neurostimulation for Pain

u Deep brain stimulation

u Spinal cord stimulation

u Dorsal column stimulation

u Spinal stimulation

u Dorsal root ganglion stimulation

u Peripheral nerve stimulation

u Gastric stimulation

u Sacral stimulation

Deep Brain Stimulation

u Lead placement

u Indications (not FDA approved)

u Complex facial pain

u Central pain syndromes

u Complex peripheral pain

Dorsal Column Stimulation

u Indications:

u Intractable pain of the trunk and/or limbs

u Failed back syndrome

u Post-laminectomy syndrome

u Radicular pain

u Complex regional pain syndrome

u Peripheral vascular disease/non healing wounds

u Angina (not FDA approved)

Peripheral Nerve Stimulation

u Indications:

u Patient cannot tolerate DCS or adequate pain relief

was not obtained with DCS trial

u Pain is localized to a small region in the distribution of

a single nerve

u Complex regional pain syndrome

u Post-herpetic neuralgia

u C2 headaches (occipital neuralgia)

u Ilioinguinal neuritis

Gastric Stimulation

u Gastric

u Lead placement

u Indications

u Gastric and small bowel dysmotility

u Pain lessens secondary to decreased gut

distention

Sacral Stimulation

u Sacral

u Lead placement

u Indications

u Interstitial cystitis

u Pain with micturition and/or defecation

(+FDA)

u Pudendal neuralgia

u Complex pelvic pain syndromes

Neurostimulation

u Absolute Contraindications

u Untreated depression/anxiety disorder or major

psychosis/personality disorder

u Relative Contraindications

u Chronic infections not resulting in sepsis

u Coagulopathies

u History of psychological disorders

u Anatomical aberrations which would prevent

percutaneous lead placement

Neurostimualtion

u Trialing neurostimulation

u Able to test the therapy prior to implant

u Behavioral Health Evaluation prior to trial to identify

any contraindications.

u Temporary system with implanted leads and an

external generator

u Patient can return to the clinic for reprogramming

u Duration of trial is variable, usually 2-10 days

u Outcome: Greater than 50% pain relief for implant

Neurostimulation Maintenance

u Little maintenance required

u Patient’s return to clinic for reprogramming, as needed

u Document usage in chart for revisions or replacements

u Loss of pain relief

u Lead tip migration

u Scar tissue

u Pain remodeling

Neurostimulation

u Risks

u Surgical risks

u System failure

u Lead complications

u Lead migration or fracture

u Generator complications

u Inversion, battery failure, pocket necrosis

u Stimulation side effects

u Over or under stimulation, change in stimulation

effect

Implantable Drug Delivery Device

u An implanted pump delivers medication through a catheter.

u Intrathecal

u Epidural

u Peripheral

u Plexus or neural delivery

u Sympathetic ganglia

u Other potential targets

u Programmable or non-programmable

Intrathecal Drug Delivery

Intrathecal Drug Delivery

u Companies: Medtronic, Flowonics, Codman (non-programmable)

u Potential Benefits

u Lower doses of medication required

u Decreased side effects

u Clinician programmed - does not rely on patient

compliance

u Patients can self-administer a bolus dose within

clinician set parameters

Intrathecal Drug Delivery

u Candidates

u Chronic cancer or non-cancer related pain

u Patient that have not responded to conservative treatments: medication management, physical therapy, injections therapy

u Patients with intolerable side effects with conservative treatment

u Patients unable to comply with treatment plan secondary to cognitive dysfunction or family/caregiver interference

u Patients with reasonable expectations

Intrathecal Drug Delivery

u Contraindications

u Absolute Contraindications

u Untreated depression/anxiety disorder or major psychosis/personality disorder

u Sepsis

u Anticoagulation cannot be interrupted

u Unable to meet maintenance requirements

u Relative Contraindications

u Chronic infections not resulting in sepsis

u Coagulopathies

u History of psychological disorders

u Anatomical aberrations which would prevent percutaneous lead placement

Intrathecal Drug Delivery

u Trialing the Therapy

u Behavioral Health Evaluation prior to trial to identify

any contraindications.

u Single-shot intrathecal or epidural injection

u Continuous infusion through epidural or intrathecal

catheter

u Usually last 2-7 days

u Can adjust the medication/dose during the trial

u Greater than 50% pain relief to implant

Intrathecal Drug Delivery

u Maintenance

u Pump requires refill every 1-6 months

u Documentation of Use of Patient bolus device

u Monitoring for inflammatory mass formation

u Recommended physical exam by provider every 3

months

u Monitoring battery life

u Monitoring for system failure

u Electronic logs

u System review for signs of under or over infusion

Intrathecal Drug Delivery

u Risks

u Surgical risks

u Medication side effects

u Catheter complications

u Catheter kink or leak

u Catheter dislodgement

u Pump complications

u Motor stall

u Pump inversion

Safety Concerns

u Immuosupression

u Respiratory Depression

u Peripheral Edema

u Granulomas/Inflammatory Masses

u Tolerance

u Tissue necrosis around device

PACC Guidelines

u Pump Medications for Neuropathic Pain

u Pump Medications for Nociceptive Pain

u Recommended Starting Doses

u Maximum Concentrations

u Maximum Dose Per Day

u Complication Management

u Trialing recommendations

PACC Guidelines

u New guidelines to be published late 2015

u Historical PACC Guidelines:

u Deer, T. R., Et al.(2012), Neuromodulation: Technology at

the Neural Interface, 15: 436–466. doi: 10.1111/j.1525-

1403.2012.00476.x

u Deer, T. R., Et al.(2007) Neuromodulation. T2007

Oct;10(4):300-28. doi: 10.1111/j.1525-1403.2007.00128.x.

u Hassenbusch SJ. Et al. (2003) Journal of Pain and

Symptom Management. 2004 Jun;27(6):540-63.

u Portenoy, Russell K et al. (2000) Journal of Pain and

Symptom Management , Volume 20 , Issue 2 , S3