Spinal cord stimulation with percutaneous leads after loss of coverage with implanted surgical lead
Alexander E. Yakovlev, MD, Beth E. Resch, APNP
Objective: This case report presents an application of percutaneous spinal cord stimulation to a patient with complex regional pain syndrome type 1 involving the bilateral lower extremities with loss of coverage with surgical lead.
Measurements: The patient underwent an uneventful spinal cord stimulator trial with percutaneous placement of two temporal eight-electrode epidural leads (Medtronic Inc, Minneapolis, MN, USA) to level T11.
Results: Upon experiencing excellent pain relief over the next three days, the patient was implanted with permanent leads and rechargeable generator four weeks later and reported sustained pain relief.
Conclusion: Percutaneous spinal cordstimulation offers an alternative treatment option for the patient with loss of coverage with surgical lead.
Keywords: Complex regional pain syndrome (CRPS) type 1, electrode paddle, electrode placement, electrodes, lead migration, spinal cord stimulation (SCS).
Conflict of interest: The authors reported no conflicts of interest.
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INTRODUCTION
Spinal cord stimulation (SCS) elicits chronic pain relieving effects via mechanisms of action poorly understood but theorized to include gate control activation (1), conductance blockade of the spinothalamic tracts, activation of supraspinal mechanisms, blockade of supraspinal sympathetic mechanisms, and activation or release of putative neuromodulators (2,3). As theories continue to evolve, so does the use of SCS for various chronic pain conditions. Since its first use over three decades ago when electrodes were placed subdurally over the dorsal columns of the spinal cord (4), SCS has been further refined and multiple studies have demonstrated its efficacy in the treatment of intractable, chronic pain with a variety of causes (5). SCS has been used to treat chronic pain successfully in patients with failed back syndrome (6,7), ischemic limb pain (8), angina pectoris (9,10), painful peripheral neuropathies (11,12), visceral abdominal pain syndrome, chronic non-alcoholic pancreatitis, generalized abdominal pain, abdominal wall neuromas, and post-traumatic splenectomy (13–19). By placing the SCS electrode array over different segments of the spinal cord, stimulation of C1-2 for facial pain down to T7 for abdominal or T8-9 for low back and radicular pain with resultant analgesia. Percutaneous leads in the epidural space or surgical lead placement over the epidural space following laminectomy procedure are the two methods by which SCS is achieved.
CASE REPORT
The patient is a 43-year-old woman with a history of chronic pain in her right lower extremity after a fall in 1996. Over period of two years the pain spread to her left lower extremity and she was diagnosed with complex regional pain syndrome (CRPS) type 1. Subsequently she underwent numerous interventional pain procedures including lumbar sympathetic blocks. She participated in physical therapy and cognitive behavioral therapy. She tried various nonopioid and opioid analgesics, including ibuprofen, acetaminophen, oxycodone, hydrocodone, morphine, fentanyl patches, gabapentin, topiramate, tizanidine, cyclobenzaprine, clonidine patch, amitriptyline, nonsteroidal anti-inflammatory medications, and topical ointments, all of which failed to provide significant pain relief.
In 1998, the patient underwent successful trial and implantation of percutaneous spinal cord stimulator (SCS) leads and generator. Initial implant was followed by eight revisions due to lead migration and resulting loss of coverage. Because these procedures were performed out of state by another physician, we did not have information regarding the details of each revision. The patient could not identify any event which precipitated change in coverage requiring revisions. In 2001, a Specify 2 ¥ 4 Surgical Paddle Lead and Synergy generator (Medtronic, MN, USA) was implanted and the patient enjoyed great coverage of the left and right lower extremities with satisfactory pain control reported by the patient. Following a motor vehicle accident in 2003 she lost coverage, no longer feeling stimulation in all the areas of pain in her bilateral lower extremities. Her case was reviewed by a neurosurgeon with expertise and experience implanting surgical paddle leads who recommend the patient return to the surgeon who originally implanted the surgical lead. Unfortunately, this was not a feasible option for the patient.
Upon presentation to our clinic the patient’s chronic pain medication regimen included long acting morphine, hydrocodone/APAP for breakthrough pain, cyclobenzaprine, and piroxicam.The patient met all four criteria for CRPS I diagnosis (20). Physical examination revealed typical signs and symptoms of CRPS (21,22) including intense pain which, despite use of medications, she rated as a 9 on the visual analog scale (VAS) at worst and as a 6 at best. Weobserved changes in skin color with blotchy red and pale areas over the bilateral lower extremities, areas of allodynia and hyperpathia, and decreased muscle mass in the both legs. The patient initially had pain in her right lower extremity, but as may occur in cases of CRPS, her pain had crossed over to her left extremity. She reported heightened pain with emotional stress or poor sleep. Distal pulses were 2+ and equal in the bilateral upper and lower extremities.
Analysis of Synergy generator revealed high impedance at electrode 4, but otherwise normal impedance at the other electrodes. Reprogramming of SCS was unsuccessful, with the patient reporting uncomfortably high stimulation in her right thigh but no stimulation to either her distal right lower extremity or entire left lower extremity. Examination under fluoroscopy revealed a Specify 2 ¥ 4 Surgical Paddle Lead located between T9 and T10 deviated to the right side and located in the posterior epidural space (Fig. 1). Electrodes appeared intact without any breaks identified. Migration could not be ruled out because previous films were not available for comparison. She was counseled on alternative treatment options which included repeating the lumbar sympathetic blocks, continuing medications, a trial of percutaneous SCS leads, or intrathecal drug delivery system. She chose to proceed with a trial of percutaneous SCS leads.
Figure 1. The surgical lead located betweenT9 andT10 deviated to the right
side located in the posterior epidural space.
The patient under went successful three-day trial of percutaneous placement of two eight-electrode standard Octad epidural leads (Medtronic Inc., Minneapolis, MN, USA), having already passed psychological evaluation for implantable device. Epidural access was gained through 14-gauge Touhy needles at the T11-T12 interspace with final leads positioned at T11 (Figs. 2 and 3) below the surgical lead. Placement of percutaneous trial leads was technically challenging due to extensive scar tissue at Tuohy needles insertion sites and epidural fibrosis which created resistance during lead positioning and made not feasible the placement of the percutaneous leads next to the surgical paddle lead.
Figure 2. Thoracic epidural placement of two eight-electrode epidural leads
showing the electrodes in position with tips atT11. Right side corresponds with
viewer’s right side. AP view.
Figure 3. Thoracic epidural placement of two eight-electrode epidural leads
showing the electrodes in position with tips at T11. Lateral view.
During the SCS trial, which lasted three days, the patient reported greater than 70% improvement in pain and rated her pain as a 3–4 on the VAS compared with a 6–9 on the VAS before trial leads were placed. Despite epidural fibrosis, the patient did not require higher than normal amplitude use to cover pain. Four weeks later the patient underwent implantation with permanent leads placed through small incision made in upper lumbar area and Restore Ultra (Medtronic Inc.) rechargeable generator placed in a subcutaneous pocked created through an incision in the right supragluteal areas (Fig. 4). Preoperatively we discussed with the patient the options for location of the implanted generator and she chose the right supragluteal area. Each of the two permanent leads was anchored to fibroaponeurotic tissue with 2-0 nonabsorbable suture of braided polyester (Ethibond) and Titan Anchors (Medtronic Inc.). The leads were tunneled to right supragluteal areas where the subcutaneous pocket was created for the generator. Leads were then connected to Restore Ultra (Medtronic Inc.) rechargeable generator. The procedure was performed in an ambulatory surgery center with intravenous sedation and local anesthesia administered by the surgeon. The postoperative course was uneventful for our patient. The initiation of spinal cord stimulation after implantation was uneventful.
Figure 4. Incision in upper lumbar area with anchored to fascia permanent
leads and pocket for the generator made in the right supragluteal area.
Stimulator parameters programmed for amplitude upper limit 10.5 V, pulse width 450 msec, and frequency 60 Hz. The patient’s actual amplitude use ranged from 2.8 to 4.1 V. Amplitude use remained consistent at six-month and 12-month postoperative visits. At her six-month postoperative visit her generator was reprogrammed so she could adjust the frequency with a lower limit of 40 Hz and upper limit of 120 Hz. Actual patient usage of frequency was 50–80 Hz. She decided to keep a non-functioning surgical lead and Synergy generator implanted. After implant surgery the patient was weaned off long acting morphine, cyclobenzaprine, and piroxicam. The patient reported improvement in her ability to perform activities of daily living which were limited prior to percutaneous SCS lead placement. She continued to report 100% paresthesia coverage in the both lower extremities and excellent pain relief one year after this implantation of SCS. The patient has been using her SCS 24 hours per day.
DISCUSSION
Spinal cord stimulation is a good option for patients with CRPS type 1 who failed conservative treatments in the past. Advanced interventional pain procedures including repeated neuromodulation techniques can be considered if the patient has lost existing coverage of the target areas and adequate pain relief. Revisions of previously placed systems for spinal cord stimulation may be especially challenging in the presence of implanted surgical lead, raising justifiable concerns for the surgeon and the patient about technical difficulties which may lead to potential operative complications and increased morbidity. This technique represents alternative to the open surgical re-exploration in the case of existing surgical lead and can be effective and safe procedure.
We present a single case of SCS with percutaneous leads trialed and implanted adjacent to previously implanted surgical lead. Although the patient had lost coverage with implanted surgical lead, coverage of bilateral lower extremity pain and CRPS type 1 symptoms was able to be achieved with placement of percutaneous epidural leads. The patient chose to repeat SCS trial with percutaneous leads in order to make a decision regarding whether to continue pursuing SCS as therapy of choice, considering multiple revisions she had undergone following initial implantation of SCS. She also preferred percutaneous leads as she would then be able to avoid revision of surgical lead and possible laminectomy procedure, which she perceived as a major surgical intervention. The new SCS trial performed with percutaneous leads and after a three-day trial, the patient felt confident to continue with SCS therapy. This technique may be a therapeutic alternative for selective group of patients who in the past exhausted all available treatments and have lost coverage with surgical paddle lead. The new percutaneous leads can be successfully placed in the presence of paddle lead, either positioned next to the surgical lead or placed at a different level. This treatment modality may allow the patient to avoid extensive neurosurgical intervention with more potential complications if revision of surgical paddle lead is chosen. In our opinion, percutaneous SCS is an effective and safe procedure and it is reversible should patients lose its pain-alleviating effect. More-over, if SCS fails to provide the expected level of pain relief, patients are not required to undergo the uncomfortable weaning process associated with intrathecal or epidural pain medications.
SUMMARY
Patients with existing epidural paddle leads, who lost for different reasons target coverage with previously implanted SCS, should not be disregarded as candidates for placement of percutaneous leads. The percutaneous leads can be inserted on different levels with attempt to obtain adequate stimulation if scar tissue precludes them from positioning next to surgical lead.
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COMMENTS
The usual situation is that a trial or implant with percutaneous leads is followed by a revision/implantation with paddle leads.This case shows the opposite situation, where pain coverage by implanted paddle leads was lost, and insertion of percutaneous leads was able to recapture the therapeutic stimulation. Although unusual, I have seen this happen in a few instances. In this particular case, the authors were able to recapture the stimulation pattern by placing the percutaneous leads more caudal than the paddle lead. Had the paddle lead been placed at T11-12, the same approach could have not been utilized. This article points to the fact that the mere presence of epidural paddle leads does not automatically imply that there is absolutely no further role for percutaneous leads.The implant of percutaneous leads was certainly easier than a surgical revision of the paddle leads, and was fully justified.
Giancarlo Barolat, MD
Director
Barolat Neuroscience
Presbyterian / St. Luke’s Medical Center
Denver, Colorado, USA
What if? Having an alternative surgical plan may be a good idea when dealing with complex spinal cord stimulation system revisions. This article (1) describes a common technical problem in spinal cord stimulation and a bold, practical solution taken by experienced implanters. The authors of this article inserted cylindrical, percutaneous lead distally to an existing, non-functioning paddle lead to re-establish effective spinal cord stimulation for the treatment of severe CRPS (Complex Regional Pain Syndrome) type 1.
The ability to predict who will benefit from this unusual and risky approach is both an important clinical and money saving endeavor. What if percutaneous lead could not be placed to achieve an effective stimulation? Trial lead placement, when “technically challenging due to extensive scar tissue at Tuohy needles insertion sites,”could be a negative predictor for the successful system implantation. An alternative surgical plan should be, in my opinion, presented to the patient. Individuals undergoing such an implantation need to know that the revision of a surgical paddle lead could pose similar surgical complication risks after the repeated attempts to place percutaneous lead. Such discussion may then change a patients opinion that the “surgical lead revision is in fact a major surgical intervention” when compared to cylindrical lead implantation.
Leonardo Kapural, MD, PhD
Pain Management Department
Cleveland Clinic
Cleveland, Ohio, USA
1. Yakovlev A, Resch B. Spinal cord stimulation with percutaneous leads after loss of coverage with implanted surgical lead. Neuromodulation 2010, in press.
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