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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. ATRIAL FIBRILLATION CARDIAC RHYTHM MANAGEMENT Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota 55117 USA +1 651 756 2000 +1 651 756 3301 Fax Neuromodulation Division 6901 Preston Road Plano, Texas 75024 USA +1 972 309 8000 +1 972 309 8150 Fax CARDIOVASCULAR NEUROMODULATION St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11 +32 2 772 83 84 Fax sjmneuropro.com *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. (0824-01) 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. 0824-01