Study Design: Retrospective cohort study. Objectives: Racial disparities in postoperative outcomes are unfortunately common. We present data assessing race as an independent risk factor for postoperative complications after spine surgery for Native American (NA) and African American (AA) patients compared with Caucasians (CA). Methods: The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was queried for spine procedures performed in 2015. Data was subdivided by surgery, demography, comorbidity, and 30-day postoperative outcomes, which were then compared by race. Regression was performed holding race as an independent risk factor. Results: A total of 4803 patients (4106 CA, 522 AA, 175 NA) were included in this analysis. AA patients experienced longer length of stay (LOS) and operative times ( P < .001) excluding lumbar fusion, which was significantly shorter ( P = .035). AA patients demonstrated higher comorbidity burden, specifically for diabetes and hypertension ( P < .005), while NA individuals were higher tobacco consumers ( P < .001). AA race was an independent risk factor associated with longer LOS across all cervical surgeries (β = 1.54, P <.001), lumbar fusion (β = 0.77, P = .009), and decompression laminectomy (β = 1.23, P < .001), longer operative time in cervical fusion (β = 12.21, P = .032), lumbar fusion (β = -24.00, P = .016), and decompression laminectomy (OR = 20.95, P < .001), greater risk for deep vein thrombosis in lumbar fusion (OR = 3.72, P = .017), and increased superficial surgical site infections (OR = 5.22, P = .001) and pulmonary embolism (OR = 5.76, P = .048) in decompression laminectomy. NA race was an independent risk factor for superficial surgical site infections following cervical fusion (OR = 14.58, P = .044) and decompression laminectomy (OR = 4.80, P = .021). Conclusion: AA and NA spine surgery patients exhibit disproportionate comorbidity burden and greater 30-day complications compared with CA patients. AA and NA race were found to independently affect rates of complications, LOS, and operation time.
This paper investigates the safety of a novel 'magnetic injection' method of delivering therapy to the cochlea, in a rodent model. In this method of administration, a magnetic field is employed to actively transport drug-eluting superparamagnetic iron-oxide core nanoparticles into the cochlea, where they then release their drug payload (we delivered the steroid prednisolone). Our study design and selection of control groups was based on published regulatory guidance for safety studies that involve local drug delivery. We tested for both single and multiple delivery doses to the cochlea, and found that magnetic delivery did not harm hearing. There was no statistical difference in hearing between magnetically treated ears versus ears that received intra-tympanic steroid (a mimic of a standard-of-care for sudden sensorineural hearing loss), both 2 and 30 days after treatment. Since our treatment is local to the ear, the levels of steroid and iron circulating systemically after our treatment were low, below mass-spectrometry detection limits for the steroid and no different from normal for iron. No adverse findings were observed in ear tissue histopathology or in animal gross behavior. At 2 and 30 days after treatment, inflammatory changes examined in the ear were limited to the middle ear, were very mild in severity, and by day 90 there was ongoing and almost complete reversibility of these changes. There were no ear tissue scarring or hemorrhage trends associated with magnetic delivery. In summary, after conducting a pre-clinical safety study, no adverse safety issues were observed.
Study Design. Retrospective cohort. Objective. We present a universal model of risk prediction for patients undergoing elective cervical and lumbar spine surgery. Summary of Background Data. Previous studies illustrate predictive risk models as possible tools to identify individuals at increased risk for postoperative complications and high resource utilization following spine surgery. Many are specific to one condition or procedure, cumbersome to calculate, or include subjective variables limiting applicability and utility. Methods. A retrospective cohort of 177,928 spine surgeries (lumbar (L) Ln = 129,800; cervical (C) Cn = 48,128) was constructed from the 2012 to 2016 American College of Surgeons National Surgical Quality Improvement Project (ACS-NSQIP) database. Cases were identified by Current Procedural Terminology (CPT) codes for cervical fusion, lumbar fusion, and lumbar decompression laminectomy. Significant preoperative risk factors for postoperative complications were identified and included in logistic regression. Sum of odds ratios from each factor was used to develop the Universal Spine Surgery (USS) score. Model performance was assessed using receiver-operating characteristic (ROC) curves and tested on 20% of the total sample. Results. Eighteen risk factors were identified, including sixteen found to be significant outcomes predictors. At least one complication was present among 11.1% of patients, the most common of which included bleeding requiring transfusion (4.86%), surgical site infection (1.54%), and urinary tract infection (1.08%). Complication rate increased as a function of the model score and ROC area under the curve analyses demonstrated fair predictive accuracy (lumbar = 0.741; cervical = 0.776). There were no significant deviations between score development and testing datasets. Conclusion. We present the Universal Spine Surgery score as a robust, easily administered, and cross-validated instrument to quickly identify spine surgery candidates at increased risk for postoperative complications and high resource utilization without need for algorithmic software. This may serve as a useful adjunct in preoperative patient counseling and perioperative resource allocation. Level of Evidence: 3
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