Multicenter Retrospective Study of Neurostimulation With Exit of Therapy by Explant.

INTRODUCTION: Spinal cord stimulation (SCS) devices are cost effective and improve function as well as quality of life. Despite the demonstrated benefits of SCS, some patients have the device explanted. We are interested in exploring the patient characteristics of those explanted. METHODS: This is a retrospective chart review of neurostimulation patients who underwent explantation at 18 centers across the United States within the previous five years. RESULTS: Data from 352 patients were collected and compiled. Failed Back Surgery syndrome was the most common diagnosis (38.9%; n = 136/350) and over half of the patients reported numerical rating scale (NRS) scores ≥8 prior to implant (64.3%; n = 207/322). All patients reported changes in NRS scores across time, with an initial decrease after implant followed by a pre-explant increase (F (2, 961) = 121.7, p < 0.001). The most common reason for device explant was lack or loss of efficacy (43.9%; 152/346) followed by complications (20.2%; 70/346). Eighteen percent (18%; 62/343) of patients were explanted by a different physician than the implanting one. Rechargeable devices were explanted at a median of 15 months, whereas primary cell device explants occurred at a median of 36 months (CI 01.434, 2.373; median endpoint time ratio = 2.40). DISCUSSION: Loss or lack of efficacy and complications with therapy represent the most frequent reasons for neurostimulation explantation. Of the devices that were explanted, therapy was terminated earlier when devices were rechargeable, when complications occurred, or when pain relief was not achieved or maintained. Furthermore, in nearly 20% of the cases, a different provider than the implanting physician performed device removal. CONCLUSIONS: SCS is largely a safe and efficacious strategy for treating select chronic refractory pain syndromes. Further prospective data and innovation are needed to improve patient selection, maintain SCS therapeutic efficacy and reduce the reasons that lead to device explant.

Intraoperative powdered vancomycin use with paddle lead placement.

OBJECTIVES: This is a prospective case-control study that was conducted to determine if the addition of intraoperative powdered vancomycin placed directly into the wounds at the time of closure might decrease the rate of acute postoperative infection after the placement of spinal cord stimulator paddle leads. MATERIALS AND METHODS: A retrospective analysis of the author's practice from January 1, 2009 through July 31, 2012 (Table 1) showed that those patients requiring a laminectomy instead of a laminotomy to insert a paddle lead had an increased rate of acute postop infection. All patients receiving a thoracic spinal cord stimulator paddle from January 1, 2013 through December 31, 2013 were then followed prospectively. Those patients whose paddle leads could be inserted with a laminotomy were treated in a standard fashion. Those patients who required a laminectomy for insertion of the paddle lead received powdered vancomycin placed directly into the wounds prior to closure. RESULTS: One hundred and nine patients underwent implantation of a permanent spinal cord stimulator paddle lead and battery between January 1 and December 31, 2013. Thirty-two of those patients required a laminectomy for implantation of the paddle and received intraoperative powdered vancomycin placed directly into both wounds at the time of closure. The remaining 77 patients were treated in a standard fashion. There were no infections in the laminectomy group and two infections in the laminotomy group. CONCLUSION: This study indicates that intraoperative powdered vancomycin placed directly into the wounds at the time of closure can produce similar infection rates between the groups of patients requiring a laminectomy vs. a laminotomy for implantation of a thoracic paddle lead. These findings need confirmation by a randomized controlled design study.

A novel technique for the implantation of paddle leads in the cervical spine.

OBJECTIVES: Electrical spinal cord stimulators are routinely used in the thoracic spine for back and lower extremity pain. The anatomy of the cervical spine differs significantly from that of the thoracic spine and deserves special considerations if these implants are to be inserted safely in the neck. This paper explores the technical challenges of implanting paddle leads in the cervical spine and offers a novel technique for implantation. MATERIALS AND METHODS: Thirty-four patients underwent implantation of permanent spinal cord stimulators in the cervical spine by the same surgeon. The ages ranged from 26 to 59 with an average age of 45 years. Fifty-three percent of the patients were female, and 47% were male. Nineteen patients received St. Jude Exclaim leads; 15 patients received Boston Scientific Artisan leads. Mechanical failure of the device was the end point. RESULTS: Eleven of the 34 patients (32%) required removal or revision of the device for mechanical failure. Forty percent of the Boston Scientific patients had mechanical failures compared with 25% of the St. Jude patients (p = 0.73). When the Boston Scientific patients were compared with the St. Jude patients with the newer technique of implantation (mechanical failure = 0), the p value was 0.06. CONCLUSION: A new technique is presented that allows easy and reliable implantation of cervical paddle leads in the neck with a low risk of iatrogenic complications.

An innovative case report detailing the successful treatment of post-thoracotomy syndrome with peripheral nerve field stimulation.

INTRODUCTION: The detrimental effects of post-thoracotomy pain syndrome is experienced worldwide; however, an effective treatment regimen remains elusive. METHODS: We report a case of post-thoracotomy pain syndrome effectively treated with peripheral nerve field stimulation (PNfS). RESULTS: In the presented case, the patient underwent permanent placement of the PSfS device after a successful trial period. Upon follow-up the patient has reported even better coverage over her painful areas and admits to 80% and higher reductions in her painful symptoms. CONCLUSION: Although the data are limited, in the aforesaid case report, post-thoracotomy syndrome was effectively treated with the use of PNfS. This resulted in a significant pain perception reduction, increased quality of life and mobility, as well as decreased usage of oral pain medications. This adds to the accumulating case report and case series data that suggest PNfS is showing great promise as a pain reduction modality. Further, it is minimally invasive, can be trialled prior to implantation, and is reversible. Large prospective studies will be required in the future to further evaluate its efficacy before it can be widely accepted and adopted.