Download New Paradigms in Spinal Cord Stimulation

New Paradigms in
Spinal Cord Stimulation
Steven Falowski MD
Objectives
Background of SCS
Mechanisms of Action
Indications
Equipment
Placement
Introduction
Spinal cord stimulation (SCS) delivers
electrical current to the spinal cord
Ideal for Neuropathic Pain
Adjustable
Non- Destructive
Neuromodulatory
Indications
Most Common
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Post-laminectomy syndrome
Complex regional pain syndrome (CRPS)
Ischemic limb pain
Angina
Other
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visceral/abdominal pain
cervical neuritis pain
spinal cord injury pain
post-herpetic neuralgia
neurogenic thoracic outlet syndrome
Background
Initially all unipolar electrodes
Set Programming
Only radio-frequency (RF) driven passive
receivers were available.
Background
1970’s: Pulse Generator
1980’s: Percutaneous electrode
Waltz et al 1982: First percutaneous
quadripolar electrode
2004: Rechargeable Battery
Mechanism of Action
1980-1990
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Holsheimer, Coburn, and Strujik:
Distribution of the electrical fields within the
spinal structures
1997- Holsheimer et al: Effect of anodecathode configuration on paresthesia coverage
in spinal cord stimulation
Mechanism Of Action
Barolat 1993: Mapping of sensory
responses
Barolat 1998: Anatomical and electrical
properties of the intraspinal structures and
clinical correlations
Mechanism of Action
Foreman et al. 1976 Primate Studies
Linderoth et al. 1992 Rat Studies
At the chemical level, animal studies
suggest that the SCS triggers the release
of serotonin, substance P, and GABA
within the dorsal horn
?Descending Inhibition
Mechanism of Action-Electrodes
Indications
Post Laminectomy
Syndrome
CRPS
Angina
Abdominal/Visceral
Pain
50% pain relief in 5060% of the patients
Maintained over
several years
Post- Laminectomy Syndrome
Etiology:
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Pain in Center Lower
Lumbar Area
Pain in Buttocks
Radicular Pain
Also included:
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Arachnoiditis
Epidural Fibrosis
Radiculitis
Microinstability
Recurrents Disc
Herniations
Infections
Stimulation of the Low Back
Single vs Dual Electrode
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Law et al: Multiple Bipole Arrays
North et al: Midline Quadripolar Electrode
Tripole Electrode
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Steer Current
Sharan 2007: Lateral anodes increase
discomfort threshold
Post- Laminectomy Syndrome
Marchand et al: Pain scores reduced with
SCS
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Prospective RCT
Acted as Own Control
Small Study Group
Post- Laminectomy Syndrome
North et al-1991:
SCS is superior to
repeat surgery
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50 patients
Average 3 surgeries
for FBSS prior to SCS
53% of patients had
pain relief at 2.2 years
Patient Satisfaction
North et al-1995:
Better outcomes with
SCS
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Prospective RCT
Repeat back surgery
vs SCS
Allowed Crossover
Post- Laminectomy Syndrome
Turner-1995: Systematic Review of
Literature
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41 articles from 1966-1994
50-60% of patients had greater than 50% pain
relief
Burchiel et al-1996: 55% Successful
Stimulation
Prospective Multi- Center one year trial
Post- Laminectomy Syndrome
Cameron 2004-JNS:
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51 studies
Total of 3,700 patients
SCS had a positive, symptomatic, long-term
effect in cases of:
refractory angina pain, severe ischemic limb pain
secondary to peripheral vascular disease,
peripheral neuropathic pain, and chronic low-back
pain
Complex Regional Pain
Syndrome
Pain and swelling in a
single body part
Pain may start after
an injury
Pain will usually
gradually worsen
Usually affects the
hands, feet, elbows or
knees
Two Types:
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Type I: May not have
cause
Type II: Always follows
an injury
Complex Regional Pain
Syndrome
Complex Regional Pain Syndrome
Challenges:
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Pain is not well defined
Difficult to cover affected area with stimulation
May aggravate original pain
CRPS-Early Work
Barolat et at-1989
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Pain reduction in 10 of 13 patients
Short follow up
Kumar et al- 1997
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41 month follow up of 12 patients
All patients with pain relief
CRPS-More Recent Data
Kemlar -1999: 78% pain relief
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23 patients
Kemlar- 2000: SCS vs Physical Therapy
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54 Patients randomized
67% pain relief at 6 months
Improved VAS scores
Kemlar- 2006: Diminished effectiveness
over 5 year follow up
CRPS-Limitations
Difficult to cover affected area with
stimulation
Long- term efficacy is yet to be determined
Improvement in pain scores, but not
necessarily improvement in functional
impairment
Angina
Factors Involved
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EKG changes
Time to Angina
Exercise Capacity
Recovery Time
Use of Nitrates
Anginal Attacks
End Results
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Ischemia
Myocardial Flow
MI
Arrhythmias
Angina-Use of SCS
Lower cervical and upper thoracic region
Continuous vs cyclical use
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Often use a low intensity stimulation for
several hours per day for prophylactic
purposes
Eddicks S et al(2007): Continuous sub
threshold stimulation
RCT demonstrating improved functional status and
symptoms
“Blinded”
Angina-Efficacy of SCS
DeJongste et al 1994: decrease in
anginal attacks and nitrate consumption
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Treatment group as Control
DiPede 2003: Immediate and long- term
clinical outcome with SCS
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Prospective
104 pts with SCS for refractory angina
Decrease anginal episodes at rest and with
activity
Angina-Efficacy of SCS
Vulink et al -1998: Improved pain and
quality of life
Hauvast et al-1998:
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Increased exercise duration and time to
Angina
Decreased Anginal Attacks
Decreased use of Nitrates
Decreased Ischemic episodes on EKG
Angina-ESBY Study
Mannheimer et al 1998-2002:
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RCT: CABG vs SCS
Prospective Non- Blinded Trial
SCS/CABG: Both with 30% Improvement
NHP scores
5 year Mortality: 27% in both groups
No difference in the percentage of cardiac deaths
Angina-ESBY Study
Mannheimer et al 1998-2002:
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Cardiac Events were similar across the
groups
*More Cerebrovascular events observed in
CABG group*
Eight in CABG group/Two in SCS group
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Both groups had decrease in anginal attacks
and decreased nitrate use
No significant inter-group difference
Angina- ESBY Study
Study Limitations:
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Limited number of patients
Limited follow-up time
Not Blinded
Conclusion of ESBY Study
CABG and SCS appear to be equivalent
methods in terms of symptom relief
SCS may be a therapeutic alternative for
patients with an increased risk of surgical
complications
Angina-Mechanism of SCS
Homogenization of myocardial blood perfusion
with SCS
Augustinsson et al-1995: SCS patients have
improved heart muscle lactate metabolism,
oxygen demand, and blood flow in the coronary
sinus
Hautvast et al: No change in HR variability after
6 weeks
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i.e. autonomic modulation may not be the explanatory
mechanism of action
Angina-Mechanism of SCS
Foreman/Linderoth: Pain Relief from direct
inhibition of signal or decrease in ischemia?
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Decreased activity in Spinothalamic/Sympathetic
Tracts in Rat Model
Hautvast et al-1996: Positron emission
tomography study
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Redistribution of myocardial flow in favor of ischemic
parts of the myocardium
Both at rest and after pharmacologic stress induction
Demonstrated as a long- term effect of SCS
Angina
The role of SCS in the management of
refractory angina pectoris seems to be
very promising
Uniformly good results in the relief of
Anginal pain shown in the literature
Results maintained in long- term follow up
Effects go beyond pain relief
Abdominal/Visceral Pain
20% of the population
in United States has
abdominal pain
Many etiologies
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gastrointestinal
genitourinary
musculoskeletal
nervous system
Treatment modalities
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Cognitive- behavioral
Physical
Pharmacological
therapies
More Invasive:
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Celiac plexus blocks
Celiac ganglia
destruction
Abdominal/Visceral Pain-Initial
Interest
Some studies have demonstrated some
localization in the spinal cord for visceral
pain secondary to malignancy
Hirschberg-1996: Increased Dorsal
Column Activity
Midline Myelotomy
Abdominal/Visceral Pain-Initial
Interest
Case Reports:
Ceballos et al-2000: Mesenteric Ischemia
„ Reduction in pain scores
„ Decrease Narcotic Use
Krames et al-2004: Irritable Bowel Syndrome
„ Reduction in diarrhea
„ Initial reduction in pain
Abdominal/Visceral Pain
Khan et al-2005: Refractory Abdominal
Pain
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Non- alcoholic pancreatitis, abdominal wall
neuromas, post splenectomy pain
All patients(9) had a significant improvement
in VAS scores
Decreased narcotic use
Placement of the leads at the T5-7 level
8 month follow up
Abdominal/Visceral Pain
Tiede et al: Multiple
abdominal surgeries
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2 patients
Placed at T2
Relieved postprandial
pain
Decrease Narcotic
Use
Patients returned to
work
Kapural et al:
Chronic visceral
pelvic pain
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6 females
Endometriosis/Multiple
Surgical Explorations
>50% Pain relief
Decrease opiate use
Decrease VAS score
30 month follow up
Abdominal/Visceral PainMechanism
Viscerotomes
Sympathetic and Parasympathetic
Pathways
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The sympathetic afferents in the lower
thoracic/upper lumbar spinal segments have
been shown to transmit painful impulses from
the viscera
Equipment
Equipment
Rapidly Changing
Multiple Stimulation Parameters
Multiple Types of Electrodes and
Combinations
Increased Uses
Pulse Generators
Two basic types
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Internal Pulse Generator
Radiofrequency coupled pulse generator
Rechargeable Pulse Generator
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Power Requirement Issues
Pulse Generators
IPG:
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Lithium Battery
Activation/Control occur through an external
transcutaneous telemetry device
Control by patient and physician
Battery life: 2.5 to 4.5 years
Outpatient surgery to replace
Pulse Generators
Rechargeable Systems
SCS Model
• Large fibers activated near the
cathode
Transverse tripolar stimulation (4 pts)
Central cathode and two lateral anodes
Anodes increase the discomfort threshold
over the roots compared to the
paresthesia threshold (thus increasing the
therapeutic range)
Lateral/medial steering advantage by
setting different voltages of the flanking
anodes
Closer spacing = More effective fiber
activation
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Electrode Configurations
UB
GC
LTS-2A
2 anodes
LTS-4A
4 anodes
LTS-6A
6 anodes
+
Tripole Paddle-Summary
Similar activation ratios were obtained as
with trialed percutaneous leads
Lower paresthesia thresholds and energy
per pulse were seen with the paddle than
with the percutaneous array.
Trialing with one or more percutaneous
arrays can aid in determining the
effectiveness of paddle arrays.
Awake versus non-Awake
Surgery for Placement of
Spinal Cord Stimulators
Study Design
A retrospective review of 291
internalization operations to determine
whether first time awake surgery for
placement of spinal cord stimulators is
preferable to non-awake placement
Electrode implantation can be performed
either under monitored (local anesthetic
and intravenous sedation) or under
general anesthesia
REPOSITION
NEW
STIMULATOR
INFECTION
FAILURE
BATTERY EOL
Surgeries Performed
61% New
Implantation
16% Failure
10% Repositioning of
the battery or
stimulator
7% EOL of the battery
6% are due to
infection
Placement of Stimulator
35
30
# cases
25
20
15
10
5
0
-5
2002
2003
2004
2005
Y ear
Y
# No Wakeup
# Wakeup
2006
Monitoring
Failure Rate
Non Awake Surgical
Failure Rate 16%
Awake Surgical
Failure Rate 31%
90
80
70
#cases
60
50
No Failure
Failure
40
30
*
20
10
0
Wakeup
* = p<.05
No Wakeup
Repositioning
90
80
70
#cases
60
50
No Reposition
Reposition
40
30
20
10
0
Wakeup
No Wakeup
Non Awake Surgical
Repositioning Rate
16%
Awake Surgical
Repositioning Rate
17%
Infection
90
80
70
60
#cases
Non Awake Surgical
Infection Rate 7%
Awake Surgical
Infection Rate 7%
50
No Infection
Infection
40
30
20
10
0
Wakeup
No Wakeup
Summary
Important Points:
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Radiographical position and motor stimulation
responses to assure proper electrode positioning
under general anesthesia
Performed after a percutaneous trial
Conclusion:
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Non-awake surgery is associated with fewer
failure rates and therefore fewer reoperations, making it a viable alternative
SCS-Conclusions
SCS Technology is improving
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Equipment and stimulation parameters
Reliable and safe modality
Goal of neurostimulation is to reduce pain
rather than to eliminate pain
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50% improvement in pain relief
Reduce use of pain medications
Increasing amount of uses
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Importance of selection criteria
Thank You
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