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

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          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.

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          Most cited references27

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          Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients

          Jens Brock Johansen, Ole Jørgensen, Mogens Møller … (2011)
          Aims Infection is a serious complication of pacemaker (PM) systems. Although the rate of infection has been debated, the figures are largely unknown. We therefore studied the incidence of PM infection and its associated risk factors in the Danish population. Methods and results Since 1982, all PM implantation and removal procedures performed in Denmark have been prospectively recorded in the Danish Pacemaker Register. All patients (n = 46299) who underwent implantation between 1982 and 2007 were included. The total length of surveillance was 236 888 PM-years. The incidence of infection was calculated according to the total number of PM-years. The incidence of surgical site infection (≤365 days after PM implantation) was compared with later infection in first implant and replacement procedures. Multiple-record and multiple-event-per-subject proportional hazards analyses were used to identify the independent risk factors of PM infection. Surgical site infection occurred in 192 cases after first implantation (incidence rate 4.82/1000 PM-years), and in 133 cases after replacement (12.12/1000 PM-years). Infections occurring more than 365 days after the first implantation occurred in 153 cases (1.02/1000 PM-years), and in 118 cases after replacement (3.26/1000 PM-years). Independent factors associated with an increased risk of PM infection were a greater number of PM operations (including replacements), male sex, younger age, implantation during the earliest part of the study period, and absence of antibiotics (P< 0.001). Conclusion The overall risk of infection after PM implantation was low. A greater number of operations augmented the risk of infection. This should be taken into account when considering revisions of PM systems.
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            Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications.

            Jessica Turner, Richard A Deyo, John D Loeser … (2004)
            We conducted a systematic review of the literature on the effectiveness of spinal cord stimulation (SCS) in relieving pain and improving functioning for patients with failed back surgery syndrome and complex regional pain syndrome (CRPS). We also reviewed SCS complications. Literature searches yielded 583 articles, of which seven met the inclusion criteria for the review of SCS effectiveness, and 15 others met the criteria only for the review of SCS complications. Two authors independently extracted data from each article, and then resolved discrepancies by discussion. We identified only one randomized trial, which found that physical therapy (PT) plus SCS, compared with PT alone, had a statistically significant but clinically modest effect at 6 and 12 months in relieving pain among patients with CRPS. Similarly, six other studies of much lower methodological quality suggest mild to moderate improvement in pain with SCS. Pain relief with SCS appears to decrease over time. The one randomized trial suggested no benefits of SCS in improving patient functioning. Although life-threatening complications with SCS are rare, other adverse events are frequent. On average, 34% of patients who received a stimulator had an adverse occurrence. We conclude with suggestions for methodologically stronger studies to provide more definitive data regarding the effectiveness of SCS in relieving pain and improving functioning, short- and long-term, among patients with chronic pain syndromes.
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              Treatment-Limiting Complications of Percutaneous Spinal Cord Stimulator Implants: A Review of Eight Years of Experience From an Academic Center Database.

              Salim M Hayek, Elias Veizi, Michael Hanes (2015)
              The study aims to evaluate the long-term implant survival and complications of spinal cord stimulation (SCS) leading to surgical revision or explant in patients treated for chronic noncancer pain.
              Article 0 comments Cited 76 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Steven M. Falowski: sfalowski@gmail.com
                Journal
                Journal ID (nlm-ta): Neuromodulation
                Journal ID (iso-abbrev): Neuromodulation
                Journal ID (doi): 10.1111/(ISSN)1525-1403
                Journal ID (publisher-id): NER
                Title: Neuromodulation
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 1094-7159
                ISSN (Electronic): 1525-1403
                Publication date (Electronic): 17 August 2018
                Publication date (Print): February 2019
                Volume: 22
                Issue: 2 ( doiID: 10.1111/ner.v22.2 )
                Pages: 179-189
                Affiliations
                [ 1 ] St. Luke's University Health Network Bethlehem PA USA
                [ 2 ] Pain Diagnostics and Interventional Care Sewickley PA USA
                [ 3 ] Department of Health Economics and Outcomes Research, Medtronic, Health Economics and Outcomes Research Minneapolis MN USA
                Author notes
                [*] [* ]Address correspondence to: Steven Falowski, MD, Director Functional Neurosurgery, St. Lukes University Health Network, 701 Ostrum Street, Bethlehem, PA 18015, USA. Email: sfalowski@ 123456gmail.com
                Author information
                https://orcid.org/0000-0003-4176-9652
                Article
                Publisher ID: NER12843
                DOI: 10.1111/ner.12843
                PMC ID: 6585777
                PubMed ID: 30117635
                SO-VID: 6e5412e2-368d-48a4-801e-7cf01c4ae017
                Copyright © © 2018 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                Date received : 28 March 2018
                Date revision received : 09 May 2018
                Date accepted : 29 May 2018
                Page count
                Figures: 2, Tables: 5, Pages: 11, Words: 7087
                Categories
                Subject: Clinical Research
                Subject: Spinal Cord Stimulation
                Custom metadata
                source-schema-version-number 2.0
                component-id ner12799
                cover-date February 2019
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.4 mode:remove_FC converted:20.06.2019

                Keywords: complication,healthcare utilization,infection,spinal cord stimulation
                Data availability:
                Keywords: complication, healthcare utilization, infection, spinal cord stimulation

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