Dataset Information

Root cause analysis of epidural spinal cord stimulator implant infections with resolution after implementation of an improved protocol for surgical placement.

ABSTRACT:

Background

Placing a spinal stimulator for the purpose of restoring paralysed function is a novel procedure; however, paralysis predisposes people to infection. Preventing surgical site infections is critical to benefit this population.

Objective

The objective of this study was to review the root cause analysis of postoperative wound infections by a hospital epidemiology team following implantation of epidural spinal cord neurostimulators in patients with chronic spinal cord injury.

Methods

A team was assembled to review the case of every individual who had been enrolled to receive a neurostimulator at the facility. A root cause analysis was performed evaluating five categories: the patient; equipment; facility/environment; procedure; and personnel.

Findings

The root cause analysis included 11 patients. Two patients became infected. Three others dehisced their wound without becoming infected. All patients were given preoperative antibiotics on time. A mean of 17 personnel were in the operating room during surgery. Vancomycin powder was used in the patients who either dehisced their wound or became infected.

Conclusions

The root cause analysis provides guidance for other institutions performing the same novel procedure. This analysis did not reveal a direct association, but did generate several areas for improvement including increasing pre-surgical screening, cleaning transient equipment (e.g., computer screens), limiting traffic in the operating room, using new sterile instruments for each stage of the procedure, not reopening the back incision, not applying vancomycin powder, and using an antimicrobial envelope for the stimulator.

SUBMITTER: Arnold FW

PROVIDER: S-EPMC6683604 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Root cause analysis of epidural spinal cord stimulator implant infections with resolution after implementation of an improved protocol for surgical placement.

Arnold Forest W FW Bishop Sarah S Johnson David D Scott LaShawn L Heishman Crystal C Oppy Leah L Ball Tyler T Sharma Mayur M Angeli Claudia C Ferreira Christie C Chen Yangsheng Y Harkema Susan S Boakye Maxwell M

Journal of infection prevention 20190502 4

<h4>Background</h4>Placing a spinal stimulator for the purpose of restoring paralysed function is a novel procedure; however, paralysis predisposes people to infection. Preventing surgical site infections is critical to benefit this population.<h4>Objective</h4>The objective of this study was to review the root cause analysis of postoperative wound infections by a hospital epidemiology team following implantation of epidural spinal cord neurostimulators in patients with chronic spinal cord injur ...[more]

PMID: 31428199

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Project description:Epidural electrical stimulation of the lumbar spinal cord is currently regaining momentum as a neuromodulation intervention in spinal cord injury (SCI) to modify dysregulated sensorimotor functions and augment residual motor capacity. There is ample evidence that it engages spinal circuits through the electrical stimulation of large-to-medium diameter afferent fibers within lumbar and upper sacral posterior roots. Recent pilot studies suggested that the surface electrode-based method of transcutaneous spinal cord stimulation (SCS) may produce similar neuromodulatory effects as caused by epidural SCS. Neurophysiological and computer modeling studies proposed that this noninvasive technique stimulates posterior-root fibers as well, likely activating similar input structures to the spinal cord as epidural stimulation. Here, we add a yet missing piece of evidence substantiating this assumption. We conducted in-depth analyses and direct comparisons of the electromyographic (EMG) characteristics of short-latency responses in multiple leg muscles to both stimulation techniques derived from ten individuals with SCI each. Post-activation depression of responses evoked by paired pulses applied either epidurally or transcutaneously confirmed the reflex nature of the responses. The muscle responses to both techniques had the same latencies, EMG peak-to-peak amplitudes, and waveforms, except for smaller responses with shorter onset latencies in the triceps surae muscle group and shorter offsets of the responses in the biceps femoris muscle during epidural stimulation. Responses obtained in three subjects tested with both methods at different time points had near-identical waveforms per muscle group as well as same onset latencies. The present results strongly corroborate the activation of common neural input structures to the lumbar spinal cord-predominantly primary afferent fibers within multiple posterior roots-by both techniques and add to unraveling the basic mechanisms underlying electrical SCS.

Project description:ObjectiveSpinal cord stimulation (SCS) has become a popular nonopioid pain intervention. However, the treatment failure rate for SCS remains significantly high and many of these patients have poor sagittal spinopelvic balance, which has been found to correlate with increased pain and decreased quality of life. The purpose of this study was to determine if poor sagittal alignment is correlated with SCS treatment failure.Materials and methodsComparative retrospective analysis was performed between two cohorts of patients who had undergone SCS placement, those who had either subsequent removal of their SCS system (representing a treatment failure cohort) and those that underwent generator replacement (representing a successful treatment cohort). The electronic medical record was used to collect demographic and surgical characteristics, which included radiographic measurements of lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT), and sacral slope (SS). Also included were data on pain medication usage including opioid and nonopioid therapies.ResultsEighty-one patients met inclusion criteria, 31 had complete removal, and 50 had generator replacements. Measurement of sagittal balance parameters demonstrated that many patients had poor alignment, with 34 outside normal range for LL (10 vs 24 in removal and replacement cohorts, respectively), 30 for PI (12 [38.7%] vs 18 [36.0%]), 46 for PT (18 [58.1%] vs 28 [56.0%]), 38 for SS (18 [58.1%] vs 20 [40.0%]), and 39 for PI-LL mismatch (14 [45.2%] vs 25 [50.0%]). There were no significant differences in sagittal alignment parameters between the two cohorts.ConclusionsThis retrospective cohort analysis of SCS patients did not demonstrate any relationship between poor sagittal alignment and failure of SCS therapy. Further studies of larger databases should be performed to determine how many patients ultimately go on to have additional structural spinal surgery after failure of SCS and whether or not those patients go on to have positive outcomes.

Dataset Information

Root cause analysis of epidural spinal cord stimulator implant infections with resolution after implementation of an improved protocol for surgical placement.

Background

Objective

Methods

Findings

Conclusions

Publications

Root cause analysis of epidural spinal cord stimulator implant infections with resolution after implementation of an improved protocol for surgical placement.

Similar Datasets

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