Transcript Slide 1

Patient selection for the treatment of chronic visceral pain
syndromes using SCS: Angina, Abdominal and Pelvic
Leonardo Kapural, MD, PhD
Carolinas Pain Institute and Center for Clinical Research
Professor of Anesthesiology, Wake Forest University School of Medicine
Disclosure
• Consultant to Boston Scientific
• Consultant to St Jude Medical
Patient Selection
• Failed appropriate conservative therapies
• Pain intractable to less complex, less invasive therapies, including
conventional opioid therapy or intolerable side effects
• Definable cause for his or her pain
• Psychological stability of the patient
• Assessing patient's potential to respond to SCS
• No surgically correctable pathology underlying symptoms
• Risks of surgery to outweigh potential benefit
Best practice tips
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Psychological evaluation for implantable devices
Interdisciplinary Committee for Implantable devices
Family support
Prolonged trial
Functional Capacity Measurement
Abdominal pain: Patient selection and
Implantation
Studies-case series:
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Mesenteric Ischemia (Ceballos et al, 2000)
Irritable Bowel Syndrome (Krames, 2005)
Epigastric abdominal pain (Khan, 2005)
Gastroparesis (Tiede et al., 2006)
Pelvic visceral pain (Kapural et al., 2006)
Familial Mediterranean fever (Kapur et al, 2006)
Non-alcoholic pancreatitis (Kapural, 2008)
Retrospective study –SCS for abdominal visceral pain
(Kapural et al., Pain Medicine, 2010)
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35 patients; Age 17-87
12 man; 23 women
Chronic abdominal pain duration from 1-25 years
Location: 1. epigastric
2. RUQ
3. LUQ
Aching, burning, stabbing, sharp
Chronic pancreatitis, Abdominal adhesions,
Gastroparesis, Mesenteric Ischemia, Post-gastric
bypass chronic pain
Retrospective study (Kapural et al., Pain Medicine, 2010)
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h/o depression 18 patients
h/o alcohol abuse 7
Psych evaluation and IDC passed
Differential block visceral (3 mixed visceral/central)
Splanchnic or hypogastric block (50-100% pain relief)
Abdominal pain of
unclear source
Physical
examination,
history,
location and
referral pattern
Differential
retrograde
epidural block
(if confirmed
visceral pain)
Celiac or/and
splanchnic
nerve block
Splanch
nic RF
Algorithm
Kapural, 2010
SCS
trial
SCS
GI functional
and
cause-specific
studies
Potential diagnostic value
• Ad and C fibers:ratio 1:10 in viscera as opposed to 1:2 in cutaneous
afferents
• Visceral nociceptives extensive overlap among receptive fields
• Majority of patients of unexplained abdominal pain may have nonvisceral chronic pain (4/22 had a positive visceral response to
DDNB) despite a pre-DDNB diagnosis of chronic pancreatitis
• Attempt to diagnose visceral origin of pain- could dictate further
treatment plans
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Janig W, Morrison JF: Functional properties of spinal visceral afferents supplying abdominal and pelvic organs, with special emphasis on
visceral nociception. Prog.Brain Res. 1986; 67: 87-114
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Cervero F: Visceral versus somatic pain: similarities and differences. Dig.Dis. 2009; 27 Suppl 1: 3-10
Cervero F: Sensory innervation of the viscera: peripheral basis of visceral pain. Physiol Rev. 1994; 74: 95-138
Conwell DL, Vargo JJ, Zuccaro G, Dews TE, Mekhail N, Scheman J, Walsh RM, Grundfest-Broniatowski SF, Dumot JA, Shay SS:
Role of differential neuroaxial blockade in the evaluation and management of pain in chronic pancreatitis. Am.J.Gastroenterol.
2001; 96: 431-6
Retrograde phase of DENB
• LA through an epidural catheter to achieve surgical anesthesia
in the dermatomal distribution that overlaps the patient’s site of
pain
• visceral or non-visceral
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significance of abolishment of visceral pain that outlasts the
duration of LA block is important in establishing the diagnosis of
chronic abdominal pains of unclear origin
DENB for unclear source of abdominal pain
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Out of 402 differential NB, 367 complete data
Age 47.3 (median 48)
201 women, 166 men
6.6 years of pain (SD 5)
36 % epigastric; 33 % diffuse
VAS 6.7 (SD 1.7)
52.5 mg MSO4 (SD 75)
24 % diagnosis of depression
4.4% h/o drug abuse
8% alcohol abuse
DENB for unclear source of abdominal pain
• Number of other pain locations:
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1 other site-81 patient
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5 other sites 2 patients
2 other sites- 44 patients
3 other sites 12 patients
4 other sites 2 patients
• 32% on antidepressants
• 26% on membrane stabilizers
DENB for unclear source of abdominal pain
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Most frequent dermatomal level of pain T7
Most frequent catheter placement T9-10
71%-3-chloroprocaine; rest lidocaine
19 patients-no level, technical difficulties
21 patients-first placebo response
12 patients (out of 241)-second placebo response
94 patients-majority of the pain still present with bilateral T4 block
23 patients residual pain (<50%) after bilateral T4 block
126 considered visceral
DENB for unclear source of abdominal pain
• If visceral on DENB? If good predictive value for
splanchnic/celiac blocks/and/or SCS
Initial Evaluation for SCS
(237 patients)
96 Patients: Differential
Retrograde Epidural block
59 Patients: Predominantly
Visceral
101 Patients: Referred to Psych
Rehab Program and/or Detox
16 Patients: Somatosensory
57 Patients Celiac/ Splanchnic
19 Patients: referred to GI/
Colorectal Surgery/ GYN/
Neurology
11 Patients: other
Pain Management Center
Care
2 Patients: Placebo responders not to
return
19 Patients: Central/ or
Psychogenic or Malingering
2 patients lost to follow-up
48 Patients: Positive/ >50% response to
Celiac/Splanchnic
5 Patients: Negative Response/ <50%
or no pain improvement
46 Patients: Psychological Evaluation
for Implantable Devices
4 Patients: lost to follow-up
2 patients lost to follow-up
41 Patients: Proceed to
Trial
5 Patients: Psychological
Care
Interdisciplinary Committee for Implantable
Devices
40 Patients: Yes
1 Patient: No
35 Patients: SCS Trial Approved by Insurance
Providers
30 Patients: Successful
Trial
5 Patients: Denied by Insurance
Providers
5 Patients: Unsuccessful trial
Lead placement
•Entry point T10-11 or higher
•Tip placed at T5 or lower
•We regularly achieve
paresthesias over the painful
areas
•Midline placement
•(Kapural et al., Pain Medicine, 2010)
Trial success (Kapural et al., Pain Medicine, 2010)
10
Pain Score (VAS)
8
6
4
2
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Baseline
End of trial
Successful trial (n=30)
Baseline
End of trial
Unsuccesful trial (n=5)
Pain relief (Kapural et al., Pain Medicine, in press)
10
• One lost to follow-up after the
implant
Pain Scores (VAS)
8
• 3 patients not completed one year
follow-up
6
• 3 infections
• 1 explant dissatisfied with
4
treatment
• 1 lead migration
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Baseline (n=27)
6 months (n=25)
12 months (n= 19)
Opioid use (Morphine equivalents)
300
Opioid use MSO4 mg eqv
250
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50
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Baseline
End of Trial
N=19
One year
Survey (Kapural et al., Pain Medicine, 2010)
• Patients 16-85 years of age; 47.3 years (median 47)
• identifiable causes: chronic pancreatitis (23), post-surgical
intraabdominal adhesions (20), gastroparesis (9)
• post-surgical-following: cholecystectomy, bowel resection, gastric
bypass, endometriosis-related surgical procedures and Nissen’s
• 9 patients: no cause could be determined
• Celiac plexus blocks, opoids, anticonvulsants, antidepressants, multiple
explorative surgeries
• 76 case reports-23 responding physicians: 6 incompletely filled-excluded; 70
reported
• Characteristics: burning and aching then throbbing, stabbing, cramping, dull
and sharp
• Most frequent areas epigastric and periumbilical
Survey (Kapural et al., Pain Medicine, 2010)
• Conservative: most of the patients opioids
• membrane stabilizers, antidepressants
• Interventions: sympathetic blocks prevailed (only 53%)
• pancreatic resection, ileostomy closures, ERCP,
gastric pacemakers (5 patients) and multiple
laparoscopic adhesiolysis
• 62 out of 70 psychological evaluation
• Only 24 out of 70 (34%) evaluated by multidisciplinary
committee for appropriateness of implantable devices
Pelvic pain: Patient selection
Patient selection
• Early h/o physical and/or sexual abuse and victimization relevant in
painful disorders (Schofferman et al., 1992; McMahon et al. 1997)
• Depression and anxiety or common psychological co-morbidities
are associated with pain and disability (Covington et al., 2005).
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Schofferman, J., Anderson, D., Hines, R. et al. (1992) Childhood psychological trauma correlates with unsuccessful lumbar spine
surgery. Spine 17 (6, Suppl.): S1380-S1384.
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McMahon, M.J., Gatchel, R.J., Polatin, P.B. and Mayer, T.J. (1997) Early childhood abuse in chronic spinal disorder patients: A major
barrier to treatment success. Spine 22: 2408-24.
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Covington, E.C., Gallagher, R.M. and Doleys, D.M. (2005) The association between chronic pain and mood and anxiety disorders. Pain
Medicine News, Oct: 1-7.
Patient selection
• Pre-SCS evaluation
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Beck Depression Inventory
Pain Questionnaire such as MPQ
QOL Instrument SF 36
Pain Map and Diary
– “It is important to remember that many of these scales are
self-administered and represent the patient’s perception,
which may or may not reflect reality.” (Doleys et al, 2007)
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Doleys, D.M. and Kraus, T.J. (2007) Trialing for intrathecal therapy: comments and considerations. Practical
Pain Manag. 7 (5): 48-9.
Patient and physician expectations
• Physician expectations- impact outcomes (Graz et al., 2005)
• Positive outcomes from “sham” surgeries (Flum, 2006)
• Possible solution: different practitioners in patient selection,
pre-implant trial, and post-implant management
• dependent, obsessive, and suggestible the patient, the
greater effect expectations are likely to have.
• Internet, patient testimonials, public media
Graz, B., Wietisbach, V., Porchet, F. and Vader, J.P. (2005) Prognosis or “curabo effect?” Physician prediction
and patients outcome of surgery fir low back pain and sciatica. Spine 30: 1448-52.
Flum, D.R. (2006) Interpreting surgical trials with subjective outcomes: avoiding UnSPORTsmanlike conduct.
JAMA 296: 2483-5.
SCS for visceral pelvic pain
Kapural et al, Pain Medicine 2006
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severe visceral pelvic pains
Treated for an average of 14.8 years (from 4 to 38)
series of hypogastric blocks (in average 5.3)
All received SCS systems with two leads implanted
Pain Disability Index (PDI) questionnaires before the
implant and recently following implant
• Opioid use calculated as MSO4 milligram equivalents.
Retrograde or anterograde implantation
• Anterograde: Posterior pelvic wall, post-hysterectomy,
visceral pelvic adhesions; endometriosis remission
with persistent visceral pain
• Retrograde: interstitial cystitis, pelvic floor issues
Patient selection: SCS for Intractable Angina
Indications:
• severe angina despite optimum medical and surgical treatment
• angina pectoris in syndrome X (angina pectoris, normal coronary
arteriograms, objective signs of myocardial ischemia)
• patients with angina and no prognostic benefit from coronary
bypass
• current reversible myocardial ischemia in good psychological
condition
• cognitive dysfunction or somatization disorder should be excluded
Eliasson T, Augustinsson LE, Mannheimer C: Spinal cord stimulation in severe angina pectoris: presentation of
current studies, indications and clinical experience. Pain 1996,65:169–179.
Jessurun GA, TenVaarwerk IA, DeJongste MJ, et al.: Sequelae of spinal cord stimulation for refractory angina
pectoris. Reliability and safety profi le of long-term clinical application. Coron Artery Dis 1997, 8:33–38.
Mannheimer C, Eliasson T, Andersson B, et al.: Effects of spinal cord stimulation in angina pectoris induced bypacing
and possible mechanisms of action. BMJ 1993, 307:477–480.
General characteristics:
• small group of patients with angina refractory to all
treatments- including revascularization
• Usually are classified under the NYHA (New York Heart
Association) functional class 3-4 and have angina at rest or
with minimal exertion
• (Murphy& Giles, 1987; Augustinsson et al, 1989; Sanderson et al,1994; Andersen et al1994;
DeJongste et al 1994; Mannheimer el al,1998; Hautvast et al 1998; Bagger, et al, 1998)
Krames, 2005
Angina Trial
• Implanted electrode or electrodes between C7-T2
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ascertaining concordant paresthesia
Implant if:
intensity of episodes are decreased by 50%
exercise tolerance increases by 50%
• time interval between anginal episodes increases significantly
• SCS system use: continuously or to turn stimulation on when
anginal episode begins
What is different when stimulating for angina
• Collaboration with cardiac team if implantation is proper
• Cardiologist-blood pressure control, ejection fraction, and ability to
tolerate SCS
• Clearance for procedure and anesthetic
• Ongoing anticoagulation- aspirin, warfarin, antiplatelet drugsclearance
• Clopidogrel-discontinued10 days before implant and remain
discontinued until trial end
• Inpatient using heparin infusion, discontinuing 6 hours before,
restarting 6 hours after
• Deer T. Current Pain and Headache Reports 2009, 13:18–23
In conclusion:
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Proper patient selection-better outcome
Appropriate trial required
Psychological evaluation for implantable devices
Interdisciplinary committee for implantable devices
Collaboration and consultation with referring physician
Continued exchange of information on implantation
techniques
Thank you
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