Spinal cord stimulation (SCS) offers improvement in pain and function for several chronic pain conditions. There are concerns regarding bacterial colonization of the temporary lead extensions and subsequent infection risk in a two-session implantation procedure. Although there is no standardized evaluation of SCS lead contamination, this study evaluates the infection rate and microbial colonization of SCS lead extensions with sonication, a method that is established in implant-related infection diagnostics.
Materials and Methods
This prospective observational study comprised 32 patients with a two-stage SCS implantation procedure. Microbial colonization of the lead extensions was assessed with sonication. The presence of organisms in the subcutaneous tissue was evaluated separately. Surgical-site infections were recorded. Patient demographics and risk factors including diabetes, tobacco use, obesity, trial length, and infection parameters in serum were recorded and analyzed.
The mean age of the patients was 55 years. On average, the trial length was 13 days. In seven cases (21.9%), a microbial lead colonization was found with sonication. In contrast, there was one positive culture (3.1%) from the subcutaneous tissue samples. The C-reactive protein and leukocyte count remained at the preoperative level. One early surgical-site infection (3.1%) occurred. No other late infections occurred six months after surgery.
There is a discrepancy between the presence of microbial colonization and the occurrence of clinically relevant infections. Although the rate of microbial colonization of the lead extensions is high (21.9%), the surgical-site infection rate remained low (3.1%). Therefore, we can conclude that the two-session procedure is a safe approach that is not associated with a higher incidence of infection. Although the sonication method cannot be used as the sole tool for detecting infections in patients with SCS, it can provide additional value in microbial diagnostics in combination with clinical and laboratory parameters and conventional microbiological methods.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- Spinal cord stimulation vs conventional therapies for the treatment of chronic low back and leg pain: a systematic review of health care resource utilization and outcomes in the last decade.Pain Med. 2019; 20: 2479-2494https://doi.org/10.1093/pm/pnz185
- Spinal cord stimulator related infections: findings from a multicenter retrospective analysis of 2737 implants.Neuromodulation. 2017; 20: 553-557https://doi.org/10.1111/ner.12636
- Infection rate of spinal cord stimulators after a screening trial period. A 53-month third party follow-up.Neuromodulation. 2011; 14 ([discussion: 141]. https://doi.org/10.1111/j.1525-1403.2010.00317.x): 136-141
- Spinal cord stimulation infection rate and risk factors: results from a United States payer database.Neuromodulation. 2019; 22: 179-189https://doi.org/10.1111/ner.12843
- Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome.Pain. 2007; 132: 179-188https://doi.org/10.1016/j.pain.2007.07.028
- A temporary vs. permanent anchored percutaneous lead trial of spinal cord stimulation: a comparison of patient outcomes and adverse events.Neuromodulation. 2018; 21: 508-512https://doi.org/10.1111/ner.12687
- An international survey to understand infection control practices for spinal cord stimulation.Neuromodulation. 2016; 19: 71-84https://doi.org/10.1111/ner.12356
- Epidural abscess during a spinal cord stimulator trial: a case report.Pain Pract. 2019; 19: 57-60https://doi.org/10.1111/papr.12691
- Sonication of removed hip and knee prostheses for diagnosis of infection.N Engl J Med. 2007; 357: 654-663https://doi.org/10.1056/NEJMoa061588
- High frequency of low-virulent microorganisms detected by sonication of pedicle screws: a potential cause for implant failure.J Neurosurg Spine. 2019; 31: 424-429https://doi.org/10.3171/2019.1.SPINE181025
- Sonication of arthroplasty implants improves accuracy of periprosthetic joint infection cultures.Clin Orthop Relat Res. 2017; 475: 1827-1836https://doi.org/10.1007/s11999-017-5315-8
- Sonication of orthopaedic implants: a valuable technique for diagnosis of prosthetic joint infections.J Microbiol Methods. 2018; 146: 51-54https://doi.org/10.1016/j.mimet.2018.01.015
- Superiority of the sonication method against conventional periprosthetic tissue cultures for diagnosis of prosthetic joint infections.Eur J Orthop Surg Traumatol. 2018; 28: 51-57https://doi.org/10.1007/s00590-017-2012-y
- ASA class is a reliable independent predictor of medical complications and mortality following surgery.Int J Surg. 2015; 18: 184-190https://doi.org/10.1016/j.ijsu.2015.04.079
- Comparison of bacterial growth in sonication fluid cultures with periprosthetic membranes and with cultures of biopsies for diagnosing periprosthetic joint infection.Diagn Microbiol Infect Dis. 2016; 84: 112-115https://doi.org/10.1016/j.diagmicrobio.2015.09.007
- Staphylococcal biofilms.Microbiol Spectr. 2018; 6https://doi.org/10.1128/microbiolspec.GPP3-0023-2018
- Comparison of biofilm-producing ability of clinical isolates of Candida parapsilosis species complex.J Mycol Med. 2019; 29: 140-146https://doi.org/10.1016/j.mycmed.2019.02.003
- Molecular mechanisms involved in Bacillus subtilis biofilm formation.Environ Microbiol. 2015; 17: 555-565https://doi.org/10.1111/1462-2920.12527
- Comparative analyses of biofilm formation among different Cutibacterium acnes isolates.Int J Med Microbiol. 2018; 308: 1027-1035https://doi.org/10.1016/j.ijmm.2018.09.005
- What's new in musculoskeletal infection: update on biofilms.J Bone Joint Surg Am. 2016; 98: 1226-1234https://doi.org/10.2106/JBJS.16.00300
- Microbiological evaluation of the extension wire and percutaneous epidural lead anchor site following a "2-stage Cut-Down" spinal cord stimulator procedure.Pain Pract. 2017; 17: 886-891https://doi.org/10.1111/papr.12537
- Microbiological tined-lead examination: does prolonged sacral neuromodulation testing induce infection?.BJU Int. 2009; 104 ([discussion: 650]. https://doi.org/10.1111/j.1464-410X.2009.08501.x): 646-650
- Bacterial colonization of stimulation electrode wires in patients undergoing temporary sacral nerve stimulation.Colorectal Dis. 2010; 12: 141-143https://doi.org/10.1111/j.1463-1318.2009.01896.x
- Prolonged percutaneous SNM testing does not cause infection-related explanation.BJU Int. 2013; 111: 485-491https://doi.org/10.1111/j.1464-410X.2012.11263.x
- Postoperative infections associated with prolonged spinal cord stimulation trial duration (PROMISE RCT).Neuromodulation. 2020; 23: 620-625https://doi.org/10.1111/ner.13141
- Care bundle approach to minimizing infection rates after neurosurgical implants for neuromodulation: a single-surgeon experience.World Neurosurg. 2019; 128: e87-e97https://doi.org/10.1016/j.wneu.2019.04.003
- The neurostimulation appropriateness consensus committee (NACC) recommendations for infection prevention and management.Neuromodulation. 2017; 20: 31-50https://doi.org/10.1111/ner.12565
Published online: March 29, 2023
Accepted: February 13, 2023
Received in revised form: January 31, 2023
Received: November 4, 2022
Publication stageIn Press Corrected Proof
Source(s) of financial support: The authors reported no funding sources.
Conflict of Interest: The authors reported no conflict of interest.
© 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.