Spinal Cord Stimulation Infection Rate and Incremental Annual Expenditures: Results From a United States Payer Database

Provenzano, David; Falowski, Steven; Xia, Ying; Doth, Alissa H.

doi:10.1111/ner.12939

Cited by 14 publications

(12 citation statements)

References 43 publications

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“…Mortality rates associated with cardiac implantable electronic device infections, knee implant infections, hip implant infections, and SSIs after spine surgery from published studies are listed in Table 5 (21–24). Prior studies showed annual incremental costs associated with SCS infection are upwards of US $50,000 (25). It is not surprising to see increased costs related to each CPSIED hospitalization in our study.…”

Section: Discussionmentioning

confidence: 99%

“…It is not surprising to see increased costs related to each CPSIED hospitalization in our study. Reimplantation of devices occurred only in 25% of patients in other large series and may deprive the patient of effective modalities to treat chronic pain after device infection (25). The increased rates of complications among patients without surgical intervention may be due to an increased contribution from sicker patients who were unable to undergo surgical procedures.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Outcomes Associated With Infection of Chronic Pain Spinal Implantable Electronic Devices: Insights From a Nationwide Inpatient Sample Study

Goel

Kumar

Agrawal

et al. 2021

Neuromodulation: Technology at the Neural Interface

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Outcomes Associated With Infection of Chronic Pain Spinal Implantable Electronic Devices: Insights From a Nationwide Inpatient Sample Study

Goel

Kumar

Agrawal

et al. 2021

Neuromodulation: Technology at the Neural Interface

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“…SCS infection risks might be affected by patient characteristics (e.g., diabetes, obesity, immunodeficiency, and smoking) and by choice of perioperative techniques (e.g., antisepsis, prophylactic antibiotics, and trial protocols), and risk mitigation has been the subject of many publications . Trial duration has been identified as an important risk factor for infection .…”

Section: Discussionmentioning

confidence: 99%

Postoperative Infections Associated With Prolonged Spinal Cord Stimulation Trial Duration (PROMISE RCT)

North

Desai

Vangeneugden

et al. 2020

Neuromodulation: Technology at the Neural Interface

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; on behalf of the PROMISE Study Group Introduction: In the PROMISE study, a multinational randomized controlled trial (RCT) of the effectiveness of spinal cord stimulation (SCS) with multicolumn surgical leads as a treatment of low back pain, clinicians followed their usual practice. An early, unplanned safety analysis revealed that the infection rate in Belgium (5/23), where trial duration was a median 21.5 days, was significantly higher than the 1/64 rate observed in the other study countries (median 5.8 days, p < 0.01). This report reviews infections observed in the PROMISE study after study completion. Materials and Methods: For all infections related to SCS, we used descriptive statistics and tests of independent variables to analyze potentially contributing factors (age, sex, coexisting medical conditions, tobacco use, lead type, and trial duration) between subjects with infections versus those without. Cumulative incidence curves were created using the Kaplan-Meier method and compared between the two strata using a log-rank test. Results: Among nine (5.2%) infections in 174 subjects trialed, the only significant contributing factor to infection was trial duration: median 21 days (range 3-56) for those with infection vs. six days (1-41) for those without (p = 0.001; Wilcoxon rank-sum test). The cumulative incidence of infection for subjects trialed >10 days was 24.1% vs. 1.4% for subjects trialed ≤10 days (p < 0.001). After the protocol was amended to limit trial duration to 10 days, 14 infection-free trials were performed in Belgium. Conclusions: Although not part of the preplanned analysis, our observation supports the hypothesis of a cause-effect relationship between trial duration and the risk of infection and the conclusion that prolonged SCS trials should be avoided.

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“… 1 , 2 Not only does this lead to increased healthcare expenditures by greater than $60,000 per SSI event, it often leads to device explant, therapy discontinuation, and decreased patient quality of life. 3 In fact, only 26% of patients will be re-implanted after SCS explant for SSI. 3 While the Neurostimulation Appropriateness Consensus Committee (NACC) guidelines, US Centers for Disease Control and Prevention (CDC), United Kingdom National Institute for Health and Care Excellence (NICE), and Surgical Care Improvement Project (SCIP) have all defined infection control recommendations, physician compliance remains less than ideal and SSI rates have not changed significantly with time.…”

Section: Introductionmentioning

confidence: 99%

“…3 In fact, only 26% of patients will be reimplanted after SCS explant for SSI. 3 While the Neurostimulation Appropriateness Consensus Committee (NACC) guidelines, US Centers for Disease Control and Prevention (CDC), United Kingdom National Institute for Health and Care Excellence (NICE), and Surgical Care Improvement Project (SCIP) have all defined infection control recommendations, physician compliance remains less than ideal and SSI rates have not changed significantly with time. [4][5][6][7][8][9][10] However, this does not change the overriding goal: to achieve optimal patient care and overall healthcare stewardship, the field of neuromodulation must continue to strive for lower infection rates and find methods that are easily adoptable into a variety of clinical settings.…”

Section: Introductionmentioning

confidence: 99%

Antibacterial Envelope Use for the Prevention of Surgical Site Infection in Spinal Cord Stimulator Implantation Surgery: A Retrospective Review of 52 Cases

Hagedorn

Canzanello

Pittelkow

et al. 2021

JPR

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Objective Surgical site infection in patients who undergo spinal cord stimulator implant surgery represents a significant concern in terms of increased health care costs and patient morbidity. The use of antibacterial envelopes in spinal cord stimulator implant surgeries has not been previously described. The aim of this retrospective review was to evaluate the effectiveness of the antibacterial envelope in reducing surgical site infection in spinal cord stimulator implant surgeries when used adjunctively to standard infection prevention measures. Materials and Methods The study included 52 patients, all of whom were implanted with a spinal cord stimulator between January 2015 and November 2020. To be included, patients were required to have had an antibacterial envelope utilized at the time of surgery. Patient records were retrospectively reviewed. All patients who received an antibacterial envelope at the time of implant surgery were included. Results Data was collected and analyzed on 52 permanent SCS implantations, including primary implantation (n=26) and revision surgery (n=26). All patients were at least three months post-operative from the implant surgery (average follow-up time period was 518.4 days). There were no surgical site infections reported in the 52 patient cohort. Conclusion Antibiotic impregnated envelopes appear to be a safe and effective modality to decrease surgical site infection risk in spinal cord stimulation implant surgeries.

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Spinal Cord Stimulation Infection Rate and Incremental Annual Expenditures: Results From a United States Payer Database

Cited by 14 publications

References 43 publications

Outcomes Associated With Infection of Chronic Pain Spinal Implantable Electronic Devices: Insights From a Nationwide Inpatient Sample Study

Outcomes Associated With Infection of Chronic Pain Spinal Implantable Electronic Devices: Insights From a Nationwide Inpatient Sample Study

Postoperative Infections Associated With Prolonged Spinal Cord Stimulation Trial Duration (PROMISE RCT)

Antibacterial Envelope Use for the Prevention of Surgical Site Infection in Spinal Cord Stimulator Implantation Surgery: A Retrospective Review of 52 Cases

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