Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. DESIGN: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial. SETTING: Primary care clinics within four integrated health care systems in the United States. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.

Association of local anesthesia versus conscious sedation with functional outcome of acute ischemic stroke patients undergoing embolectomy.

PURPOSE: Compare functional outcomes of acute ischemic stroke patients undergoing embolectomy with either local anesthesia or conscious sedation. Secondarily, identify differences in hemodynamic parameters and complication rates between groups. MATERIALS AND METHODS: Single institution, retrospective review of all acute ischemic stroke patients undergoing embolectomy between January 2014 and July 2018 (n = 185). Patients receiving general anesthesia (n = 27) were excluded. One-hundred and eleven of 158 (70.3%) composed the local anesthesia group, and 47 (29.7%) composed the conscious sedation group. Median age was 71 years (interquartile range 59-79). Seventy-eight (49.4%) were male. The median National Institute of Health stroke scale score was 17.5 (interquartile range 11-21). Hemodynamic, medication, complication, and functional outcome data were collected from the anesthesia protocol and medical records. Good functional outcome was defined as a three-month modified Rankin Scale < 2. A multivariate analysis was performed to estimate the association of anesthesia type on three-month modified Rankin Scale score. RESULTS: Three-month modified Rankin Scale score <2 was similar between groups (p = 0.5). Patients receiving conscious sedation were on average younger than patients receiving local anesthesia (p = 0.01). Conscious sedation patients were more likely to receive intravenous thrombolytic prior to embolectomy (p = 0.025). The complication rate and hemodynamic parameters were similar between groups. CONCLUSION: Functional outcome of acute ischemic stroke patients undergoing embolectomy appears to be similar for patients receiving local anesthesia and conscious sedation. This similarity may be beneficial to a future study comparing general anesthesia to local anesthesia and conscious sedation. The use of local anesthesia or conscious sedation does not significantly impact hemodynamic status.

Anesthesia-Related Outcomes for Endovascular Stroke Revascularization: A Systematic Review and Meta-Analysis.

BACKGROUND AND PURPOSE: There is currently controversy on the ideal anesthesia strategy during mechanical thrombectomy for acute ischemic stroke. We performed a systematic review and meta-analysis of studies comparing clinical and angiographic outcomes of patients undergoing general anesthesia (GA group) and those receiving either local anesthesia or conscious sedation (non-GA group). METHODS: A literature search on anesthesia and endovascular treatment of acute ischemic stroke was performed. Using random-effects meta-analysis, we evaluated the following outcomes: recanalization rate, good functional outcome at 90 days (modified Rankin Score≤2), symptomatic intracranial hemorrhage, death, vascular complications, respiratory complications, procedure time, and time to groin puncture. RESULTS: Twenty-two studies (3 randomized controlled trials and 19 observational studies), including 4716 patients (1819 GA and 2897 non-GA) were included. In the nonadjusted analysis, patients in the GA group had higher odds of death (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.66-2.45) and respiratory complications (OR, 1.70; 95% CI, 1.22-2.37) and lower odds of good functional outcome (OR, 0.58; 95% CI, 0.48-0.64) compared with the non-GA group. There was no difference in procedure time between the 2 primary comparison groups. When adjusting for baseline National Institutes of Health Stroke Scale, GA was still associated with lower odds of good functional outcome (OR, 0.59; 95% CI, 0.29-0.94). When considering studies performed in the stent-retriever/aspiration era, there was no significant difference in good neurological outcome rates (OR, 0.84; 95% CI, 0.67-1.06). CONCLUSIONS: Acute ischemic stroke patients undergoing intra-arterial therapy may have worse outcomes when treated with GA as compared with conscious sedation/local anesthesia. However, major limitations of current evidence (ie, retrospective studies and selection bias) indicate a need for adequately powered, multicenter randomized controlled trials to answer this question.

Association Between Vitamin D Deficiency and Outcomes Following Spinal Fusion Surgery: A Systematic Review.

BACKGROUND: Vitamin D deficiency is a relatively common occurrence in patients presenting for spinal surgery; however, whether this abnormality has any effect on spinal fusion outcomes remains unclear. We performed a systematic review of the available literature relevant to the association between vitamin D deficiency and spinal fusion outcomes. METHODS: We conducted a systematic and critical review of recent literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following databases were searched: MEDLINE/PubMed, Google Scholar, Cochrane, Web of Science, and Scopus. Key search terms were "vitamin D," "spinal surgery outcomes," "spinal fusion," and "pseudarthrosis." Papers included in the review were original research articles in peer-reviewed journals. The articles were thoroughly examined and compared on the basis of study design, outcomes, and results. RESULTS: A total of 5 studies were included in the qualitative analysis. In these studies, patients presenting with vitamin D deficiency achieved lower fusion rates and suffered higher rates of recurrent-persistent low back pain compared with patients with normal vitamin D levels. Studies examining the effect of postoperative vitamin D supplementation in deficient patients reported significant improvements in low back pain intensity, patient-reported outcomes scores, and fusion rates compared with baseline as well as with control groups. CONCLUSIONS: The literature suggests that patients presenting for spinal fusion may benefit from correction of vitamin D deficiency to maximize the chance of a successful arthrodesis and to achieve optimal surgical outcomes. Future prospective studies are needed to determine whether routine preoperative treatment of this metabolic derangement is warranted.

Healing of saccular aneurysms following platinum coil embolization: lack of improved efficacy with vitamin C supplementation.

BACKGROUND AND PURPOSE: To test the hypothesis that systemic administration of vitamin C, through its action of stimulating collagen synthesis and crosslinking, would decrease the recurrence and improve the occlusion of experimental aneurysms treated with platinum coils. METHODS: Experimental aneurysms were created in female rabbits and were embolized with platinum coils (>30% packing density). The animals were divided into three groups: group 1 (n=6) rabbits served as controls, group 2 (n=5) rabbits were fed with a vitamin C supplemented feed and group 3 (n=8) rabbits were medicated with vitamin C pills. Digital subtraction angiography was used to evaluate stability after embolization. Subjects were euthanized at 12 weeks after coil implantation, and serum vitamin C levels were then measured. Histological samples were examined with a grading system (range 0-12) based on the neck and dome features. Masson Trichrome staining was used to evaluate collagen deposition. Parametric data were analyzed with one way analysis of variance and non-parametric data were examined using a Kruskal-Wallis test. RESULTS: There were no significant differences between groups in mean aneurysm size. Mean serum vitamin C concentration was significantly higher in group 3 and group 2 compared with group 1, while vitamin C levels between group 2 and group 3 were statistically comparable. Coil compaction was noted in one of six subjects in group 1 and in three of eight subjects in group 3. All of the remaining aneurysms in the test and control groups showed stable occlusion. There were no significant differences in histological scores or collagen deposition among groups. CONCLUSIONS: Vitamin C supplementation following platinum coil embolization does not demonstrate improvement of long term occlusion rates of aneurysms.

INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplasty.

BACKGROUND: The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. METHODS/DESIGNS: Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma), tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12). Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12) to determine subsequent fracture rates. Our co-primary outcomes are the modified Roland score and pain numerical rating scale at 1 month. DISCUSSION: Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty. TRIAL REGISTRATION: Current Controlled Trials ISRCTN81871888.