Spinal Cord Stimulation Infection Rate and Risk Factors: Results From a United States Payer Database

Steven M Falowski, David A Provenzano, Ying Xia, Alissa H Doth, Steven M Falowski, David A Provenzano, Ying Xia, Alissa H Doth

Abstract

Objective: Surgical site infections can cause negative clinical and economic outcomes. A recent international survey on Spinal Cord Stimulation (SCS) infection control practices demonstrated low compliance with evidence-based guidelines. This study defines infection rate for SCS implants and identifies infection risk factors.

Materials and methods: A retrospective analysis of the MarketScan® Databases identified patients with SCS implant (2009-2014) and continuous health plan enrollment for ≥12-months (12 m) preimplant. For logistic regression analysis, patients were enrolled for 12 m postimplant. Kaplan-Meier and Cox Proportional Hazard survival analyses assessed time to infection, with infection rate reported at 12 m postimplant. Logistic regression characterized risk factors based on demographics, comorbidities, and clinical characteristics.

Results: In the logistic regression (n = 6615), 12 m device-related infection rate was 3.11%. Infection risk factors included peripheral vascular disease (OR, 1.784; 95% CI: 1.011-3.149; p = 0.0457) and infection in 12 m before implant (OR, 1.518; 95% CI: 1.022-2.254; p = 0.0386). The odds of patients experiencing an infection decreased by 3.2% with each additional year of age (OR, 0.968; 95% CI: 0.952-0.984; p < 0.0001). Survival analysis (n = 13,214) identified prior infection (HR, 1.770; 95% CI: 1.342-2.336; p < 0.0001) as a risk factor. Infection was less likely in older patients (HR, 0.974; 95% CI: 0.962-0.986; p < 0.0001). Expected risk factors including obesity, diabetes, and smoking were not identified as risk factors in this analysis. There was no significant difference between infection rate for initial and replacement implants.

Conclusions: The 3.11% SCS-related infection rate within 12 m of implant emphasizes the need for improved infection control practices. Research is needed to limit SCS infections in younger patients and those with infection history.

Keywords: Complication; healthcare utilization; infection; spinal cord stimulation.

© 2018 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Figures

Figure 1
Figure 1
Attrition diagram for study patients.
Figure 2
Figure 2
Kaplan–Meier curves of infection rate among initial and replacement groups.

References

    1. Deer TR, Provenzano DA, Hanes M, et al. The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management. Neuromodulation 2017;20:31–50.
    1. Elsamadicy AA, Sergesketter A, Ren X, et al. Drivers and risk factors of unplanned 30‐day readmission following spinal cord stimulator implantation. Neuromodulation 2018;21:87–92.
    1. Provenzano DA, Deer T, Luginbuhl Phelps A, et al. An international survey to understand infection control practices for spinal cord stimulation. Neuromodulation 2016;19:71–84.
    1. Fitzgibbon DR, Stephens LS, Posner KL, et al. Injury and liability associated with implantable devices for chronic pain. Anesthesiology 2016;124:1384–1393.
    1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20‐year literature review. J Neurosurg 2004;100:254–267.
    1. Eldabe S, Buchser E, Duarte RV. Complications of spinal cord stimulation and peripheral nerve stimulation techniques: a review of the literature. Pain Med 2016;17:325–336.
    1. Hoelzer BC, Bendel MA, Deer TR, et al. Spinal cord stimulator implant infection rates and risk factors: a multicenter retrospective study. Neuromodulation 2017;20:558–562.
    1. Kemler MA, De Vet HCW, Barendse GAM, Van Den Wildenberg FAJM, Van Kleef M. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years’ follow‐up of the randomized controlled trial. Ann Neurol 2004;55:13–18.
    1. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract 2011;11:148–153.
    1. Thomson SJ, Kruglov D, Duarte RV. A spinal cord stimulation service review from a single centre using a single manufacturer over a 7.5 year follow‐up period. Neuromodulation 2017;20:589–599.
    1. Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain 2004;108:137–147.
    1. Johansen JB, Jorgensen OD, Moller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population‐based cohort study of 46299 consecutive patients. Eur Heart J 2011;32:991–998.
    1. Follett KA, Boortz‐Marx RL, Drake JM, et al. Prevention and management of intrathecal drug delivery and spinal cord stimulation system infections. Anesthesiology 2004;100:1582–1594.
    1. Abdallah DY, Jadaan MM, McCabe JP. Body mass index and risk of surgical site infection following spine surgery: a meta‐analysis. Eur Spine J 2013;22:2800–2809.
    1. Blackwood BP, Gause CD, Harris JC, et al. Overweight and obese pediatric patients have an increased risk of developing a surgical site infection. Surg Infect 2017;18:491–497.
    1. Cancienne JM, Mahon HS, Dempsey IJ, Miller MD, Werner BC. Patient‐related risk factors for infection following knee arthroscopy: an analysis of over 700,000 patients from two large databases. Knee 2017;24:594–600.
    1. Harrington G, Russo P, Spelman D, et al. Surgical‐site infection rates and risk factor analysis in coronary artery bypass graft surgery. Infect Control Hosp Epidemiol 2004;25:472–476.
    1. Malinzak RA, Ritter MA, Berend ME, Meding JB, Olberding EM, Davis KE. Morbidly obese, diabetic, younger, and unilateral joint arthroplasty patients have elevated total joint arthroplasty infection rates. J Arthroplast 2009;24:84–88.
    1. Schoenfeld AJ, Ochoa LM, Bader JO, Belmont PJ Jr. Risk factors for immediate postoperative complications and mortality following spine surgery: a study of 3475 patients from the National Surgical Quality Improvement Program. J Bone Joint Surg Am 2011;93:1577–1582.
    1. Schweizer ML, Cullen JJ, Perencevich EN, Vaughan Sarrazin MS. Costs associated with surgical site infections in veterans affairs hospitals. JAMA Surg 2014;149:575–581.
    1. Sohail MR, Eby EL, Ryan MP, Gunnarsson C, Wright LA, Greenspon AJ. Incidence, treatment intensity, and incremental annual expenditures for patients experiencing a cardiac implantable electronic device infection: evidence from a large US payer database 1‐year post implantation. Circ Arrhythm Electrophysiol 2016;9:e003929.
    1. Triantafyllopoulos GK, Soranoglou VG, Memtsoudis SG, Sculco TP, Poultsides LA. Rate and risk factors for periprosthetic joint infection among 36,494 primary total hip arthroplasties. J Arthroplast 2018;33:1166–1170.
    1. Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AGH, van Kleef M . Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long‐term follow‐up. Neuromodulation 2013;16 523–529; discussion 529.
    1. Hayek SM, Veizi E, Hanes M. Treatment‐limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation 2015;18:603–608; discussion 608‐9.
    1. Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med 2000;343:618–624.
    1. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain 2007;132:179–188.
    1. Kumar K, Buchser E, Linderoth B, Meglio M, Van Buyten J‐P. Avoiding complications from spinal cord stimulation: practical recommendations from an international panel of experts. Neuromodulation 2007;10:24–33.
    1. Slavin KV, Vaisman J, Pollack KL, et al. Treatment of chronic, intractable pain with a conventional implantable pulse generator: a meta‐analysis of 4 clinical studies. Clin J Pain 2013;29:78–85.
    1. Althoff A, Cancienne JM, Cooper MT, Werner BC. Patient‐related risk factors for periprosthetic ankle joint infection: an analysis of 6977 total ankle arthroplasties. J Foot Ankle Surg 2018;57:269–272.
    1. Fortis S, Colling KP, Statz CL, Glover JJ, Radosevich DM, Beilman GJ. Obstructive sleep apnea: a risk factor for surgical site infection following colectomy. Surg Infect 2015;16:611–617.
    1. Peng M, Southern DA, Williamson T, Quan H. Under‐coding of secondary conditions in coded hospital health data: impact of co‐existing conditions, death status and number of codes in a record. Health Informatics J 2017;23:260–267.
    1. Martin B‐J, Chen G, Graham M, Quan H. Coding of obesity in administrative hospital discharge abstract data: accuracy and impact for future research studies. BMC Health Serv Res 2014;14:70.
    1. George J, Newman JM, Ramanathan D, Klika AK, Higuera CA, Barsoum WK. Administrative databases can yield false conclusions‐an example of obesity in total joint arthroplasty. J Arthroplast 2017;32:S86–S90.
    1. McLynn RP, Geddes BJ, Cui JJ, et al. Inaccuracies in ICD coding for obesity would be expected to bias administrative database spine studies toward overestimating the impact of obesity on perioperative adverse outcomes. Spine (Phila PA 1976) 2018;43:526–532.
    1. Engle MP, Vinh BP, Harun N, Koyyalagunta D. Infectious complications related to intrathecal drug delivery system and spinal cord stimulator system implantations at a comprehensive cancer pain center. Pain Physician 2013;16:251–257.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera