Spinal Cord Stimulator Implant Infection Rates and Risk Factors: A Multicenter Retrospective Study
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Sources of financial support: No financial support was received for this manuscript.
Conflict of Interest: Timothy Deer is a consultant for Axonics, Bioness, St. Jude Medical, Nevro Corp., Spinethera, Saluda, Flowonix, Jazz Pharmaceuticals. Dr. Deer held previous stock holdings in Nevro Corp. and Spinal Modulation. He has current stock holdings (minor) with Axonics, Bioness and Saluda. Dr. Deer receives funded Research from Mainstay Medical, Nevro Corp. and Abbott. Salim Hayek serves on the Medical Advisory Board for Boston Scientific. Imanuel Lerman has received investigator grants from Nevro Corp., Boston Scientific, and Electrocore. Thomas Simopoulos serves as a consultant for Boston Scientific, St. Jude Medical and Nevro Corp. Steven Falowski serves as a consultant for Abbott, Medtronic and Nevro Corp. Joshua Rosenow is a consultant for Boston Scientific. Nagy Mekhail was a medical monitor for the ACCURATE Study (Spinal Modulation) and the EVOKE Study (Saluda Medical). Dr. Mekhail serves as a consultant for StimWave, St. Jude Medical and Saluda Medical. Dr. Mekhail receives research support from Mesoblast, Halyard, Inc., Mallinckrodt, Axsome and Boston Scientific, Inc. All remaining authors have nothing to disclose.
Abstract
Objectives
Spinal cord stimulation is an evidence-based treatment for a number of chronic pain conditions. While this therapy offers improvement in pain and function it is not without potential complications. These complications include device failure, migration, loss of therapeutic paresthesia, and infection. This article looked to establish a modern infection rate for spinal cord stimulators, assess the impact of known risk factors for surgical site infections and to determine the impact of certain preventative measures on the rate of infection.
Methods
After institutional review board approval, a multisite, retrospective review was conducted on 2737 unique implants or revisions of SCS systems. Patient demographics, risk factors including diabetes, tobacco use, obesity, revision surgery, trial length, implant location, implant type, surgeon background, prophylactic antibiotic use, utilization of a occlusive dressing, and post-operative antibiotic use were recorded and analyzed.
Results
The overall infection rate was 2.45% (n = 67). Diabetes, tobacco use, and obesity did not independently increase the rate of infection. Revision surgeries had a trend toward higher infection rate; however, this did not meet statistical significance. There was no difference in the rate of infection between implants performed by physicians of different base specialties, cylinder leads vs. paddle leads, or between different prophylactic antibiotics. Implants performed at academic centers had a higher rate of infection when compared to implants performed in nonacademic settings. When patients received an occlusive dressing or post-operative antibiotics they had a lower rate of infection.
Conclusions
The infection rate (2.45%) reported in this study is lower than the previously reported rates (3–6%) and are on par with other surgical specialties. This study did not show an increased rate of infection for patients that used tobacco, had diabetes or were obese. It's possible that given the low overall infection rate a larger study is needed to establish the true impact of these factors on infection. In addition, this study did not address the impact of poorly controlled diabetes mellitus (elevated hemoglobin A1c) vs. well-controlled diabetes. It can be concluded from this study that utilizing an occlusive dressing over the incision in the post-operative period decreases the rate of infection and should become the standard of care. This study also demonstrated the positive impact of post-operative antibiotics in decreasing the rate of infection. Studies in other surgical specialties have not shown this impact which would suggest that further research is needed.
