Download S-Series™ Leads Case Study #6

S-Series™ Leads Case Study #6
A Percutaneously Implanted Surgical Lead for the Pain Management of FBSS After Failed
Percutaneous Lead Implantations
G. Colini-Baldeshi, MD
Pain Therapy Unit, S. Giovanni-Addolorata Hospital
Rome, Italy
Introduction and Patient History
Materials and Methods
In November 2009, a 41-year-old man (Table 1) presented
at our department with severe low back and leg pain that
began following a traffic accident in October 2005.
In November 2009, the patient underwent the revision to
an S-Series paddle lead. With the patient placed in a prone
position, the existing lead was removed.
In February 2006, the patient underwent a posterior spinal
decompression at L5-S1 to remove the stenosis found at the
right lateral recess. Three months later, the patient began
to complain of back pain and sciatica in the right leg. As
a result, the patient was treated with physical therapy and
pain medication.
A Tuohy needle was inserted using an almost-parallel-tomidline paramedian approach and a flat angle (<30°) to enter
the posterior epidural canal at L1-L2. The guide wire was
inserted (Figure 1) and steered up a few segments. The Tuohy
needle was removed and the 13-cm Epiducer™ lead delivery
system (St. Jude Medical, Plano, TX) was introduced over
the guide wire under fluoroscopic guidance (Figure 2). Both
the inner dilator of the Epiducer system and the guide wire
were retracted, and the S-Series paddle lead was introduced.
The lead was passed into the epidural canal and steered
cephalad to the desired target level, with the tip at T9 and
the lead positioned over the physiological midline (Figures
3 and 4).
Gender
Age at time of implantation
Male
41
Height
182 cm
Weight
76 kg
Table 1. Demographic data
Pharmacotherapy, physical therapy, and interventions such
as epidural injections and facet blocks did not improve his
ongoing symptoms.
The patient was then diagnosed with failed back surgery
syndrome (FBSS). Magnetic resonance imaging (MRI)
showed a foraminotomy and laminectomy at L5-S1, together
with epidural fibrosis at this level. Electromyography (EMG)
revealed a bilateral radiculopathy of L5 and S1.
Due to the persistent nature of the patient’s pain complaints
and the fact that no psychological or other exclusion criteria
were apparent, the patient was scheduled for a spinal cord
stimulation trial at another hospital.
In February 2008, the patient was implanted with a
quadrapolar percutaneous lead and received a permanent
implant after the trial period. Two months post-implantation,
there was a recurrence of the pain. Investigation revealed
lead migration. A revision procedure was scheduled,
and this time an octapolar lead was implanted, with
complete paresthesia coverage of the painful area. The
patient reported moderate pain relief in the extremities,
but not in the back. Five months later, another lead
migration occurred; and this time, the octapolar lead was
repositioned. Pain improvement was good for the lower
extremities, but the back could only be reached if the
patient used high stimulation parameters, which were
perceived as unpleasant. A year later, the lead migrated
again; and at this time, the patient was referred to our
department for the implantation of an S-Series (Lamitrode™
S-8) paddle lead (St. Jude Medical, Plano, TX), also known
as a perc-paddle lead.
Figure 1. Fluoroscopic image of the Tuohy needle
while the guide wire is being introduced
Figure 2. Epiducer system being threaded over the guide wire
Result
In the immediate postoperative period, the patient reported
a dramatic improvement in pain coverage and greater
pain reduction.
During follow-up visits at 1, 3, and 6 months, a significant
reduction in VAS scores was shown, dropping from 8 to 2
(Table 2).
VAS Score
Baseline
8
VAS score with percutaneous leads
Figure 3. AP fluoroscopic view of the S-Series perc-paddle lead
Post implant
2 (legs only)
VAS score with S-Series lead
Post implant (1 month)
2
Follow-up (3 months)
2
Follow-up (6 months)
2
Follow-up (15 months)
2
Table 2. Pre- and postoperative pain scores
Parameters were programmed as follows in Table 3:
Frequency (Hz)
60
Pulse width (μs)
273
Electrode polarities
Figure 4. Lateral fluoroscopic view of the
S-Series perc-paddle lead
Intraoperative stimulation was performed using a Rapid
Programmer™ system (St. Jude Medical, Plano, TX) to
confirm adequate paresthesia overlap in the patient’s
painful areas. Paresthesia was felt both in the legs as well
as in the back. The patient reported that the electrical
current felt “different and better” compared to that with
the previously implanted leads. After patient confirmation,
the lead was securely anchored to the lumbar fascia, and
due to the patient’s history and previous experiences with a
neurostimulation device, a full implantation was performed.
The lead was connected to a Genesis™ implantable pulse
generator (IPG) (St. Jude Medical, Plano, TX), which was
implanted in the right upper buttock.
000+0-000
Perception amplitude (mA)
2,6
Maximum tolerable
amplitude (mA)
5,0
Mode
Cycle: 5 seconds on/5 seconds
off
Table 3. Stimulation parameter settings
Furthermore, the physical and mental health components
of the SF-36 questionnaire improved (Table 4). The patient
was able to engage in his normal daily activities with no
limitations and could resume his profession.
Medications were also reduced by 100%.
SF-36 Before
Physical Health
Mental Health
PF
RP
BP
GH
VT
SF
RE
MH
35
0
12
30
20
12
0
32
SF-36 After
Physical Health
Mental Health
PF
RP
BP
GH
VT
SF
RE
MH
90
75
74
56
60
75
100
64
Table 4. SF-36 outcomes before and after (PF=physical functioning,
RP=role-physical, BP=bodily pain, GH=general health, VT=vitality, SF=
social functioning, RE=role-emotional, and MH=mental health)
At 15 months, the patient was still reporting stimulation as
stable and efficient, and his VAS score was reported to be a 2.
X-ray examination revealed no displacement of the S-Series
perc-paddle lead compared to the intraoperative fluoro image.
Conclusion
This report describes the case of a 41-year-old male patient
diagnosed with FBSS and suffering from debilitating pain
in the legs and back after trauma and subsequent surgery.
Despite surgery, conventional medical treatment, and
minimally invasive pain treatment, no satisfactory outcome
was achieved, causing the patient to stop his professional
activities and other normal daily activities.
After several failed percutaneous implantations and revisions,
this patient showed a remarkably good response with a
percutaneously implanted paddle lead.
As of the 15-month follow-up visit, having sustained the
benefits of the spinal cord stimulation, the patient has been
able to resume his former professional and private activities.
I believe that the percutaneous introduction of S-Series
perc-paddle leads with the Epiducer lead delivery system
is a safe and effective procedure for patients suffering
from low back and leg pain, as the S-Series lead enables
easier recruitment of the low back nerve fibers.
In this patient, it was possible to use lower amplitudes
as compared to the amplitudes used with the formerly
implanted percutaneous leads.
The paresthesia was felt in a larger area and was
reported by the patient to be much more comfortable.
Furthermore, in my experience, the S-Series perc-paddle
leads appear to reduce migration rates compared to the
cylindrical percutaneous leads.*
–G. Colini-Baldeshi, MD
St. Jude Medical is focused on reducing risk by
continuously finding ways to put more control into
the hands of those who save and enhance lives.
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*The views and opinions expressed in this case study are those of the aforementioned physician and represents his experience only.
Not all products are approved in all countries. Please ask your local representative.
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St. Jude Medical SCS devices are intended to aid in the management of chronic, intractable pain of the trunk and/or limbs, which may have derived from specific
disease states or diagnoses. St. Jude Medical neurostimulation systems are not intended to treat or cure specific disease states or diagnoses.
Indications for Use: Spinal cord stimulation as an aid in the management of chronic, intractable pain of the trunk and limbs. Contraindications: Demand-type
cardiac pacemakers, patients who are unable to operate the system or who fail to receive effective pain relief during trial stimulation. Warnings/Precautions:
Diathermy therapy, cardioverter defibrillators, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead
movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple
illnesses, or with active general infections should not be implanted. Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Clinician’s
manual must be reviewed prior to use for detailed disclosure. Rx only.
Epiducer, Genesis, Lamitrode, Rapid Programmer, and S-Series are trademarks of Advanced Neuromodulation Systems, Inc. doing business as St. Jude Medical
Neuromodulation Division. ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS RISK. are trademarks and service marks of St. Jude Medical,
Inc. and its related companies. ©2011 St. Jude Medical Neuromodulation Division. All rights reserved.
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