Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.

BACKGROUND: Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. METHODS: In this multicenter, site-level, randomized, double-blind trial, patients aged 18-85 years received a single dose of SA4Ag or placebo 10-60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. RESULTS: Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. CONCLUSIONS: In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165.

Differences in Long-Term Outcomes in End-Stage Kidney Disease Patients with Chronic Limb-Threatening Ischemia.

BACKGROUND: End-stage kidney disease (ESKD) is a risk factor for peripheral arterial disease and major adverse limb events following infra-inguinal bypass. Despite comprising an important patient population, ESKD patients are rarely analyzed as a subgroup and are underrepresented in vascular surgery guidelines. This study aims to compare the long-term outcomes of patients with and without ESKD undergoing endovascular peripheral vascular intervention (PVI) for chronic limb-threatening ischemia (CLTI). METHODS: CLTI patients with and without ESKD from 2007-2020 were identified in the Vascular Quality Initiative PVI dataset. Patients with prior bilateral interventions were excluded. Patients undergoing femoral-popliteal and tibial interventions were included. Mortality, reintervention, amputation, and occlusion rates at 21 months following intervention were examined. Statistical analyses were completed with the t-test, chi-square, and Kaplan-Meier curves. RESULTS: The ESKD cohort was younger (66.4 ± 11.8 vs. 71.6 ± 12.1 years, P < 0.001) with higher rates of diabetes (82.2 vs. 60.9%, P < 0.001) the non-ESKD cohort. Long-term follow-up was available for 58.4% (N = 2,128 procedures) of ESKD patients and 60.8% (N = 13,075 procedures) of non-ESKD patients. At 21 months, ESKD patients had a higher mortality (41.7 vs. 17.4%, P < 0.001) and a higher amputation rate (22.3 vs. 7.1%, P < 0.001); however, they had a lower reintervention rate (13.2 vs. 24.6%, P < 0.001). CONCLUSIONS: CLTI patients with ESKD have worse long-term outcomes at 2 years following PVI than non-ESKD patients. Mortality and amputation are higher with ESKD, while the reintervention rate is lower. Development of guidelines within the ESKD population has the potential to improve limb salvage.

Does hinge sidedness influence laterality of C5 palsy after expansile open-door cervical laminoplasty?

OBJECTIVE: Cervical expansile open-door laminoplasties (EOLPs) have an open side and a hinge side, with the open side being bridged by grafts or miniplates. The authors explored the possibility that the open-door side might have a greater incidence of C5 palsy due to a greater stretch of the ipsilateral C5 nerve root. METHODS: This study was a retrospective review of prospectively collected data over a period of 25 years specifically assessing surgical complications. Included were patients who underwent EOLP for myelopathy, radiculopathy, or mild central cord injuries (American Spinal Injury Association Impairment Scale [AIS] grade D). Exclusion criteria included preexisting C5 weakness; patients with AIS grade A, B, or C injury; and added instrumentation or additional surgical procedures. Patients were monitored postoperatively for C5 palsy or any other complications. A comparison group included patients who underwent cervical laminectomy and fusion (CLF). RESULTS: A total of 327 laminoplasties were collected, and 31 patients were excluded because of severe spinal cord injury (AIS grades A-C), 3 for preoperative C5 weakness, and 21 for instrumentation or additional surgical procedures. Thus, 272 patients were analyzed with a mean age of 59.9 years (range 22-88 years). Diagnoses at presentation were cervical myelopathy (84.1%), central cord syndrome (7.2%), cervical myeloradiculopathy (3.4%), ossification of the posterior longitudinal ligament (1.9%), and other (3.4%). The most common complications were C5 palsy (n = 7, 2.6%) and wound infection (n = 7, 2.6%). Of the 7 cases of postoperative C5 palsies in this study, 6 occurred on the side of the open door. Of the C5 palsies, 2 were mild, 3 were moderate, and 2 were severe. Two of the 7 C5 palsies had a delayed (> 24 hours) onset. The C5 palsy incidence after CLF was 2.7% with no side preference. CONCLUSIONS: C5 palsy after cervical decompression for myelopathy is a known occurrence, with a rate of 2.6% in the current study. The authors found that C5 palsies more commonly occur on the open side of the laminoplasty. This could be due to a greater manipulation of the nerve root on the side of the open door or greater stretch of the C5 root on the open-door side. If clinical symptoms and anatomical stenosis are symmetric, the authors recommend creating the laminoplasty hinge on the patient's dominant side to minimize potential loss of dominant proximal arm function.

Minimally invasive versus open transforaminal lumbar interbody fusion for grade I lumbar spondylolisthesis: 5-year follow-up from the prospective multicenter Quality Outcomes Database registry.

OBJECTIVE: Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) has been used to treat degenerative lumbar spondylolisthesis and is associated with expedited recovery, reduced operative blood loss, and shorter hospitalizations compared to those with traditional open TLIF. However, the impact of MI-TLIF on long-term patient-reported outcomes (PROs) is less clear. Here, the authors compare the outcomes of MI-TLIF to those of traditional open TLIF for grade I degenerative lumbar spondylolisthesis at 60 months postoperatively. METHODS: The authors utilized the prospective Quality Outcomes Database registry and queried for patients with grade I degenerative lumbar spondylolisthesis who had undergone single-segment surgery via an MI or open TLIF method. PROs were compared 60 months postoperatively. The primary outcome was the Oswestry Disability Index (ODI). The secondary outcomes included the numeric rating scale (NRS) for back pain (NRS-BP), NRS for leg pain (NRS-LP), EQ-5D, North American Spine Society (NASS) satisfaction, and cumulative reoperation rate. Multivariable models were constructed to assess the impact of MI-TLIF on PROs, adjusting for variables reaching p < 0.20 on univariable analyses and respective baseline PRO values. RESULTS: The study included 297 patients, 72 (24.2%) of whom had undergone MI-TLIF and 225 (75.8%) of whom had undergone open TLIF. The 60-month follow-up rates were similar for the two cohorts (86.1% vs 75.6%, respectively; p = 0.06). Patients did not differ significantly at baseline for ODI, NRS-BP, NRS-LP, or EQ-5D (p > 0.05 for all). Perioperatively, MI-TLIF was associated with less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 ml, p < 0.001) and longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 minutes, p < 0.001) but had similar lengths of hospitalizations (MI-TLIF 2.9 ± 1.8 vs open TLIF 3.3 ± 1.6 days, p = 0.08). Discharge disposition to home or home health was similar (MI-TLIF 93.1% vs open TLIF 91.1%, p = 0.60). Both cohorts improved significantly from baseline for the 60-month ODI, NRS-BP, NRS-LP, and EQ-5D (p < 0.001 for all comparisons). In adjusted analyses, MI-TLIF, compared to open TLIF, was associated with similar 60-month ODI, ODI change, odds of reaching ODI minimum clinically important difference, NRS-BP, NRS-BP change, NRS-LP, NRS-LP change, EQ-5D, EQ-5D change, and NASS satisfaction (adjusted p > 0.05 for all). The 60-month reoperation rates did not differ significantly (MI-TLIF 5.6% vs open TLIF 11.6%, p = 0.14). CONCLUSIONS: For symptomatic, single-level grade I degenerative lumbar spondylolisthesis, MI-TLIF was associated with decreased blood loss perioperatively, but there was no difference in 60-month outcomes for disability, back pain, leg pain, quality of life, or satisfaction between MI and open TLIF. There was no difference in cumulative reoperation rates between the two procedures. These results suggest that in appropriately selected patients, either procedure may be employed depending on patient and surgeon preferences.

Developing nonlinear k-nearest neighbors classification algorithms to identify patients at high risk of increased length of hospital stay following spine surgery.

OBJECTIVE: Spondylolisthesis is a common operative disease in the United States, but robust predictive models for patient outcomes remain limited. The development of models that accurately predict postoperative outcomes would be useful to help identify patients at risk of complicated postoperative courses and determine appropriate healthcare and resource utilization for patients. As such, the purpose of this study was to develop k-nearest neighbors (KNN) classification algorithms to identify patients at increased risk for extended hospital length of stay (LOS) following neurosurgical intervention for spondylolisthesis. METHODS: The Quality Outcomes Database (QOD) spondylolisthesis data set was queried for patients receiving either decompression alone or decompression plus fusion for degenerative spondylolisthesis. Preoperative and perioperative variables were queried, and Mann-Whitney U-tests were performed to identify which variables would be included in the machine learning models. Two KNN models were implemented (k = 25) with a standard training set of 60%, validation set of 20%, and testing set of 20%, one with arthrodesis status (model 1) and the other without (model 2). Feature scaling was implemented during the preprocessing stage to standardize the independent features. RESULTS: Of 608 enrolled patients, 544 met prespecified inclusion criteria. The mean age of all patients was 61.9 ± 12.1 years (± SD), and 309 (56.8%) patients were female. The model 1 KNN had an overall accuracy of 98.1%, sensitivity of 100%, specificity of 84.6%, positive predictive value (PPV) of 97.9%, and negative predictive value (NPV) of 100%. Additionally, a receiver operating characteristic (ROC) curve was plotted for model 1, showing an overall area under the curve (AUC) of 0.998. Model 2 had an overall accuracy of 99.1%, sensitivity of 100%, specificity of 92.3%, PPV of 99.0%, and NPV of 100%, with the same ROC AUC of 0.998. CONCLUSIONS: Overall, these findings demonstrate that nonlinear KNN machine learning models have incredibly high predictive value for LOS. Important predictor variables include diabetes, osteoporosis, socioeconomic quartile, duration of surgery, estimated blood loss during surgery, patient educational status, American Society of Anesthesiologists grade, BMI, insurance status, smoking status, sex, and age. These models may be considered for external validation by spine surgeons to aid in patient selection and management, resource utilization, and preoperative surgical planning.

Three-level ACDF versus 3-level laminectomy and fusion: are there differences in outcomes? An analysis of the Quality Outcomes Database cervical spondylotic myelopathy cohort.

OBJECTIVE: The authors sought to compare 3-level anterior with posterior fusion surgical procedures for the treatment of multilevel cervical spondylotic myelopathy (CSM). METHODS: The authors analyzed prospective data from the 14 highest enrolling sites of the Quality Outcomes Database CSM module. They compared 3-level anterior cervical discectomy and fusion (ACDF) and posterior cervical laminectomy and fusion (PCF) surgical procedures, excluding surgical procedures crossing the cervicothoracic junction. Rates of reaching the minimal clinically important difference (MCID) in patient-reported outcomes (PROs) were compared at 24 months postoperatively. Multivariable analyses adjusted for potential confounders elucidated in univariable analysis. RESULTS: Overall, 199 patients met the inclusion criteria: 123 ACDF (61.8%) and 76 PCF (38.2%) patients. The 24-month follow-up rates were similar (ACDF 90.2% vs PCF 92.1%, p = 0.67). Preoperatively, ACDF patients were younger (60.8 ± 10.2 vs 65.0 ± 10.3 years, p < 0.01), and greater proportions were privately insured (56.1% vs 36.8%, p = 0.02), actively employed (39.8% vs 22.8%, p = 0.04), and independently ambulatory (14.6% vs 31.6%, p < 0.01). Otherwise, the cohorts had equivalent baseline modified Japanese Orthopaedic Association (mJOA), Neck Disability Index (NDI), numeric rating scale (NRS)-arm pain, NRS-neck pain, and EQ-5D scores (p > 0.05). ACDF patients had reduced hospitalization length (1.6 vs 3.9 days, p < 0.01) and a greater proportion had nonroutine discharge (7.3% vs 22.8%, p < 0.01), but they had a higher rate of postoperative dysphagia (13.5% vs 3.5%, p = 0.049). Compared with baseline values, both groups demonstrated improvements in all outcomes at 24 months (p < 0.05). In multivariable analyses, after controlling for age, insurance payor, employment status, ambulation status, and other potential clinically relevant confounders, ACDF was associated with a greater proportion of patients with maximum satisfaction on the North American Spine Society Patient Satisfaction Index (NASS) (NASS score of 1) at 24 months (69.4% vs 53.7%, OR 2.44, 95% CI 1.17-5.09, adjusted p = 0.02). Otherwise, the cohorts shared similar 24-month outcomes in terms of reaching the MCID for mJOA, NDI, NRS-arm pain, NRS-neck pain, and EQ-5D score (adjusted p > 0.05). There were no differences in the 3-month readmission (ACDF 4.1% vs PCF 3.9%, p = 0.97) and 24-month reoperation (ACDF 13.5% vs PCF 18.6%, p = 0.36) rates. CONCLUSIONS: In a cohort limited to 3-level fusion surgical procedures, ACDF was associated with reduced blood loss, shorter hospitalization length, and higher routine home discharge rates; however, PCF resulted in lower rates of postoperative dysphagia. The procedures yielded comparably significant improvements in functional status (mJOA score), neck and arm pain, neck pain-related disability, and quality of life at 3, 12, and 24 months. ACDF patients had significantly higher odds of maximum satisfaction (NASS score 1). Given comparable outcomes, patients should be counseled on each approach's complication profile to aid in surgical decision-making.

Which supervised machine learning algorithm can best predict achievement of minimum clinically important difference in neck pain after surgery in patients with cervical myelopathy? A QOD study.

OBJECTIVE: The purpose of this study was to evaluate the performance of different supervised machine learning algorithms to predict achievement of minimum clinically important difference (MCID) in neck pain after surgery in patients with cervical spondylotic myelopathy (CSM). METHODS: This was a retrospective analysis of the prospective Quality Outcomes Database CSM cohort. The data set was divided into an 80% training and a 20% test set. Various supervised learning algorithms (including logistic regression, support vector machine, decision tree, random forest, extra trees, gaussian naïve Bayes, k-nearest neighbors, multilayer perceptron, and extreme gradient boosted trees) were evaluated on their performance to predict achievement of MCID in neck pain at 3 and 24 months after surgery, given a set of predicting baseline features. Model performance was assessed with accuracy, F1 score, area under the receiver operating characteristic curve, precision, recall/sensitivity, and specificity. RESULTS: In total, 535 patients (46.9%) achieved MCID for neck pain at 3 months and 569 patients (49.9%) achieved it at 24 months. In each follow-up cohort, 501 patients (93.6%) were satisfied at 3 months after surgery and 569 patients (100%) were satisfied at 24 months after surgery. Of the supervised machine learning algorithms tested, logistic regression demonstrated the best accuracy (3 months: 0.76 ± 0.031, 24 months: 0.773 ± 0.044), followed by F1 score (3 months: 0.759 ± 0.019, 24 months: 0.777 ± 0.039) and area under the receiver operating characteristic curve (3 months: 0.762 ± 0.027, 24 months: 0.773 ± 0.043) at predicting achievement of MCID for neck pain at both follow-up time points, with fair performance. The best precision was also demonstrated by logistic regression at 3 (0.724 ± 0.058) and 24 (0.780 ± 0.097) months. The best recall/sensitivity was demonstrated by multilayer perceptron at 3 months (0.841 ± 0.094) and by extra trees at 24 months (0.817 ± 0.115). Highest specificity was shown by support vector machine at 3 months (0.952 ± 0.013) and by logistic regression at 24 months (0.747 ± 0.18). CONCLUSIONS: Appropriate selection of models for studies should be based on the strengths of each model and the aims of the studies. For maximally predicting true achievement of MCID in neck pain, of all the predictions in this balanced data set the appropriate metric for the authors' study was precision. For both short- and long-term follow-ups, logistic regression demonstrated the highest precision of all models tested. Logistic regression performed consistently the best of all models tested and remains a powerful model for clinical classification tasks.

Greater improvement in Neck Disability Index scores in women after surgery for cervical myelopathy: an analysis of the Quality Outcomes Database.

OBJECTIVE: There is a high prevalence of cervical myelopathy that requires surgery; as such, it is important to identify how different groups benefit from surgery. The American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry, that includes demographic, clinical, and patient-reported outcome data to measure the safety and quality of neurosurgical procedures. In this study, the authors assessed the impact of gender on patient-reported outcomes in patients who underwent surgery for cervical myelopathy. METHODS: The authors analyzed 1152 patients who underwent surgery for cervical myelopathy and were included in the QOD cervical module. Univariate comparison of baseline patient characteristics between males and females who underwent surgery for cervical spondylotic myelopathy was performed. Baseline characteristics that significantly differed between males and females were included in a multivariate generalized linear model comparing baseline and 1-year postoperative Neck Disability Index (NDI) scores. RESULTS: This study included 546 females and 604 males. Females demonstrated significantly greater improvement in NDI score 1 year after surgery (p = 0.036). In addition to gender, the presence of axial neck pain and insurance status were also significantly predictive of improvement in NDI score after surgery (p = 0.0013 and p = 0.0058, respectively). CONCLUSIONS: Females were more likely to benefit from surgery for cervical myelopathy compared with males. It is important to identify gender differences in postoperative outcomes after surgery in order to deliver more personalized and patient-centric care.

Big Data in the Clinical Neurosciences.

The clinical neurosciences have historically been at the forefront of innovation, often incorporating the newest research methods into practice. This chapter will explore the adoption, implementation, and refinement of big data and predictive modeling using machine learning within neurosurgery. Initial development of national databases arose from surgeons aiming to improve outcome predictions for patients with traumatic brain injury in the 1960s. In the following decades, other surgical specialties began building databases that left a lasting impact on the current national neurosurgical databases, particularly in spine surgery. Significant contributions to the literature have been made as a result of the numerous registries today, leading to broad quality improvements for neurosurgical patients. Important limitations of large databases do exist, including lack of standardized reporting and challenges in data extraction from medical records. New vistas will include the use of metadata to track human function, performance, and pain in a real-time manner to augment the reliance on traditional patient-reported outcome measures (PROMs). Overall, big data has demonstrated significant utility within neurosurgical research and machine learning-powered analyses have highlighted several promising areas of interest for future exploration.

Data-driven phenotyping of preoperative functional decline patterns in patients undergoing lumbar decompression and lumbar fusion using smartphone accelerometry.

OBJECTIVE: Treatment of degenerative lumbar spine pathologies typically escalates to surgical intervention when symptoms begin to significantly impair patients' functional status. Currently, surgeons rely on subjective patient assessments through patient-reported outcome measures to estimate the decline in patient wellness and quality of life. In this analysis, the authors sought to use smartphone-based accelerometry data to provide an objective, continuous measurement of physical activity that might aid in effective characterization of preoperative functional decline in different lumbar spine surgical indications. METHODS: Up to 1 year of preoperative activity data (steps taken per day) from 14 patients who underwent lumbar decompression and 15 patients who underwent endoscopic lumbar fusion were retrospectively extracted from patient smartphones. A data-driven algorithm was constructed based on 10,585 unique activity data points to identify and characterize the functional decline of patients preceding surgical intervention. Algorithmic estimation of functional decline onset was compared with reported symptom onset in clinical documentation across patients who presented acutely (≤ 5 months of symptoms) or chronically (> 5 months of symptoms). RESULTS: The newly created algorithm identified a statistically significant decrease in physical activity during measured periods of functional decline (p = 0.0020). To account for the distinct clinical presentation phenotypes of patients requiring lumbar decompression (71.4% acute and 28.6% chronic) and those requiring lumbar fusion (6.7% acute and 93.3% chronic), a variable threshold for detecting clinically significant reduced physical activity was implemented. The algorithm characterized functional decline (i.e., acute or chronic presentation) in patients who underwent lumbar decompression with 100% accuracy (sensitivity 100% and specificity 100%), while characterization of patients who underwent lumbar fusion was less effective (accuracy 26.7%, sensitivity 21.4%, and specificity 100%). Adopting a less-permissive detection threshold in patients who underwent lumbar fusion, which rendered the algorithm robust to minor fluctuations above or below the chronically decreased level of preoperative activity in most of those patients, increased functional decline classification accuracy of patients who underwent lumbar fusion to 66.7% (sensitivity 64.3% and specificity 100%). CONCLUSIONS: In this study, the authors found that smartphone-based accelerometer data successfully characterized functional decline in patients with degenerative lumbar spine pathologies. The accuracy and sensitivity of functional decline detection were much lower when using non-surgery-specific detection thresholds, indicating the effectiveness of smartphone-based mobility analysis in characterizing the unique physical activity fingerprints of different lumbar surgical indications. The results of this study highlight the potential of using activity data to detect symptom onset and functional decline in patients, enabling earlier diagnosis and improved prognostication.

Spinal anesthesia in awake surgical procedures of the lumbar spine: a systematic review and meta-analysis of 3709 patients.

OBJECTIVE: Awake surgery has previously been found to improve patient outcomes postoperatively in a variety of procedures. Recently, multiple groups have investigated the utility of this modality for use in spine surgery. However, few current meta-analyses exist comparing patient outcomes in awake spinal anesthesia with those in general anesthesia. Therefore, the authors sought to present an updated systematic review and meta-analysis investigating the utility of spinal anesthesia relative to general anesthesia in lumbar procedures. METHODS: Following a comprehensive literature search of the PubMed and Cochrane databases, 14 clinical studies were included in our final qualitative and quantitative analyses. Of these studies, 5 investigated spinal anesthesia in lumbar discectomy, 4 discussed lumbar laminectomy, and 2 examined interbody fusion procedures. One study investigated combined lumbar decompression and fusion or decompression alone. Two studies investigated patients who underwent discectomy and laminectomy, and 1 study investigated a series of patients who underwent transforaminal lumbar interbody fusion, posterolateral fusion, or decompression. Odds ratios, mean differences (MDs), and 95% confidence intervals were calculated where appropriate. RESULTS: A meta-analysis of the total anesthesia time showed that time was significantly less in patients who received spinal anesthesia for both lumbar discectomies (MD -26.53, 95% CI -38.16 to -14.89; p = 0.00001) and lumbar laminectomies (MD -11.21, 95% CI -19.66 to -2.75; p = 0.009). Additionally, the operative time was significantly shorter in patients who underwent spinal anesthesia (MD -14.94, 95% CI -20.43 to -9.45; p < 0.00001). Similarly, when analyzing overall postoperative complication rates, patients who received spinal anesthesia were significantly less likely to experience postoperative complications (OR 0.29, 95% CI 0.16-0.53; p < 0.0001). Furthermore, patients who received spinal anesthesia had significantly lower postoperative pain scores (MD -2.80, 95% CI -4.55 to -1.06; p = 0.002). An identical trend was seen when patients were stratified by lumbar procedures. Patients who received spinal anesthesia were significantly less likely to require postoperative analgesia (OR 0.06, 95% CI 0.02-0.25; p < 0.0001) and had a significantly shorter hospital length of stay (MD -0.16, 95% CI -0.29 to -0.03; p = 0.02) and intraoperative blood loss (MD -52.36, 95% CI -81.55 to -23.17; p = 0.0004). Finally, the analysis showed that spinal anesthesia cost significantly less than general anesthesia (MD -226.14, 95% CI -324.73 to -127.55; p < 0.00001). CONCLUSIONS: This review has demonstrated the varying benefits of spinal anesthesia in awake spine surgery relative to general anesthesia in patients who underwent various lumbar procedures. The analysis has shown that spinal anesthesia may offer some benefits when compared with general anesthesia, including reduction in the duration of anesthesia, operative time, total cost, and postoperative complications. Large prospective trials will elucidate the true role of this modality in spine surgery.

The role of an anterior approach in the treatment of ankylosing spondylitis-associated cervical fractures: a systematic review and meta-analysis.

OBJECTIVE: Cervical fractures in patients with ankylosing spondylitis can have devastating neurological consequences. Currently, several surgical approaches are commonly used to treat these fractures: anterior, posterior, and anterior-posterior. The relative rarity of these fractures has limited the ability of surgeons to objectively determine the merits of each. The authors present an updated systematic review and meta-analysis investigating the utility of anterior surgical approaches relative to posterior and anterior-posterior approaches. METHODS: After a comprehensive literature search of the PubMed, Cochrane, and Embase databases, 7 clinical studies were included in the final qualitative and 6 in the final quantitative analyses. Of these studies, 6 compared anterior approaches with anterior-posterior and posterior approaches, while 1 investigated only an anterior approach. Odds ratios and 95% confidence intervals were calculated where appropriate. RESULTS: A meta-analysis of postoperative neurological improvement revealed no statistically significant differences in gross rates of neurological improvement between anterior and posterior approaches (OR 0.40, 95% CI 0.10-1.59; p = 0.19). However, when analyzing the mean change in neurological function, patients who underwent anterior approaches had a significantly lower mean change in postoperative neurological function relative to patients who underwent posterior approaches (mean difference [MD] -0.60, 95% CI -0.76 to -0.45; p < 0.00001). An identical trend was seen between anterior and anterior-posterior approaches; there were no statistically significant differences in gross rates of neurological improvement (OR 3.05, 95% CI 0.84-11.15; p = 0.09). However, patients who underwent anterior approaches experienced a lower mean change in neurological function relative to anterior-posterior approaches (MD -0.46, 95% CI -0.60 to -0.32; p < 0.00001). There were no significant differences in complication rates between anterior approaches, posterior approaches, or anterior-posterior approaches, although complication rates trended lower in patients who underwent anterior approaches. CONCLUSIONS: The results of this review and meta-analysis demonstrated the varying benefits of anterior approaches relative to posterior and anterior-posterior approaches in treatment of cervical fractures associated with ankylosing spondylitis. While reports demonstrated lower degrees of neurological improvement in anterior approaches, they may benefit patients with less-severe injuries if lower complication rates are desired.

Antiresorptive and anabolic medications used in the perioperative period of patients with osteoporosis undergoing spine surgery: their impact on the biology of fusion and systematic review of the literature.

OBJECTIVE: Osteoporosis represents the most common metabolic disease of the bone, with an estimated 10% of adults aged 50 years or older affected in the United States. This patient population is at increased risk for spine fracture and instrumentation-related complications after spine surgery. Surgeon knowledge of the available treatments for patients with low bone mineral density (BMD) and how they impact biology of fusion may help mitigate negative effects in the postoperative period. Recombinant parathyroid hormone, which is sold under the name teriparatide, is the most extensively studied bone-protecting agent in humans. Additionally, the success of the monoclonal antibody denosumab has led to further clinical investigations of human patients undergoing spine surgery. Another monoclonal antibody, romosozumab, was recently approved by the US FDA for human use in patients with osteoporosis. Although studies of romosozumab in patients undergoing spine surgery have not been conducted, this is a promising potential therapeutic agent based on its early success in preclinical and clinical trials. Here, the authors aimed to review the mechanisms of action and evidence of use of antiresorptive and anabolic agents in patients with osteoporosis undergoing spine surgery. METHODS: In accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a systematic review was conducted to explore the antiresorptive and anabolic agents used in the perioperative period in patients with osteoporosis undergoing spinal surgery. The search was performed by using the PubMed, Embase, and Cochrane Library databases. Titles and abstracts were screened and subsequently selected for full review. RESULTS: The initial search returned 330 articles. Of these articles, 23 final articles were included and reviewed. Many of these articles reported that use of adjuvant agents in the perioperative period improved radiographic evidence of bony fusion and bone fusion rates. These agents tended to improve BMD postoperatively. CONCLUSIONS: Although antiosteoporosis agents are effective to varying degrees as treatments of patients with low BMD, teriparatide and bisphosphonates have been the most extensively studied with respect to spinal instrumentation. The advent of newer agents represents an area for further exploration, especially due to the current paucity of controlled investigations. It is imperative for spine surgeons to understand the mechanisms of action of these drugs and their effects on biology of fusion.

Osteoporosis treatment in patients undergoing spinal fusion: a systematic review and meta-analysis.

OBJECTIVE: Bisphosphonates and teriparatide are the most common therapies used in the treatment of osteoporosis. Their impact on fusion rates in osteoporotic patients following spinal fusion has yet to be concretely defined, with previous systematic reviews focusing heavily on bisphosphonates and lacking clinical insight on the utility of teriparatide. Herein the authors present an updated meta-analysis of the utility of both bisphosphonates and teriparatide in improving spinal fusion outcomes in osteoporotic patients. METHODS: After a comprehensive search of the English-language literature in the PubMed and Embase databases, 11 clinical studies were included in the final qualitative and quantitative analyses. Of these studies, 9 investigated bisphosphonates, 7 investigated teriparatide, and 1 investigated a combination of teriparatide and denosumab. Odds ratios and 95% confidence intervals were calculated where appropriate. RESULTS: A meta-analysis of the postoperative use of bisphosphonate demonstrated better odds of successful fusion as compared to that in controls during short-term monitoring (OR 3.33, 95% CI 1.72-6.42, p = 0.0003) but not long-term monitoring (p > 0.05). Bisphosphonate use was also shown to significantly reduce the likelihood of postoperative vertebral compression fracture (VCF; OR 0.07, 95% CI 0.01-0.59, p = 0.01) and significantly reduce Oswestry Disability Index scores (mean difference [MD] = -2.19, 95% CI -2.94 to -1.44, p < 0.00001) and visual analog scale pain scores (MD = -0.58, 95% CI -0.79 to -0.38, p < 0.00001). Teriparatide was found to significantly increase fusion rates at long-term postoperative periods as compared to rates after bisphosphonate therapy, with patients who received postoperative teriparatide therapy 2.05 times more likely to experience successful fusion (OR 2.05, 95% CI 1.17-3.59, p = 0.01). CONCLUSIONS: The authors demonstrate the benefits of bisphosphonate and teriparatide therapy independently in accelerating fusion during the first 6 months after spinal fusion surgery in osteoporotic patients. In addition, they show that teriparatide may have superior benefits in spinal fusion during long-term monitoring as compared to those with bisphosphonates. Bisphosphonates may be better suited in preventing VCFs postoperatively in addition to minimizing postoperative disability and pain.

Awake spinal surgery: simplifying the learning curve with a patient selection algorithm.

OBJECTIVE: There is a learning curve for surgeons performing "awake" spinal surgery. No comprehensive guidelines have been proposed for the selection of ideal candidates for awake spinal fusion or decompression. The authors sought to formulate an algorithm to aid in patient selection for surgeons who are in the startup phase of awake spinal surgery. METHODS: The authors developed an algorithm for selecting patients appropriate for awake spinal fusion or decompression using spinal anesthesia supplemented with mild sedation and local analgesia. The anesthetic protocol that was used has previously been reported in the literature. This algorithm was formulated based on a multidisciplinary team meeting and used in the first 15 patients who underwent awake lumbar surgery at a single institution. RESULTS: A total of 15 patients who underwent decompression or lumbar fusion using the awake protocol were reviewed. The mean patient age was 61 ± 12 years, with a median BMI of 25.3 (IQR 2.7) and a mean Charlson Comorbidity Index of 2.1 ± 1.7; 7 patients (47%) were female. Key patient inclusion criteria were no history of anxiety, 1 to 2 levels of lumbar pathology, moderate stenosis and/or grade I spondylolisthesis, and no prior lumbar surgery at the level where the needle is introduced for anesthesia. Key exclusion criteria included severe and critical central canal stenosis or patients who did not meet the inclusion criteria. Using the novel algorithm, 14 patients (93%) successfully underwent awake spinal surgery without conversion to general anesthesia. One patient (7%) was converted to general anesthesia due to insufficient analgesia from spinal anesthesia. Overall, 93% (n = 14) of the patients were assessed as American Society of Anesthesiologists class II, with 1 patient (7%) as class III. The mean operative time was 115 minutes (± 60 minutes) with a mean estimated blood loss of 46 ± 39 mL. The median hospital length of stay was 1.3 days (IQR 0.1 days). No patients developed postoperative complications and only 1 patient (7%) required reoperation. The mean Oswestry Disability Index score decreased following operative intervention by 5.1 ± 10.8. CONCLUSIONS: The authors propose an easy-to-use patient selection algorithm with the aim of assisting surgeons with patient selection for awake spinal surgery while considering BMI, patient anxiety, levels of surgery, and the extent of stenosis. The algorithm is specifically intended to assist surgeons who are in the learning curve of their first awake spinal surgery cases.

Biographies of international women leaders in neurosurgery.

We received so many biographies of women neurosurgery leaders for this issue that only a selection could be condensed here. In all of them, the essence of a leader shines through. Many are included as "first" of their country or color or other achievement. All of them are included as outstanding-in clinical, academic, and organized neurosurgery. Two defining features are tenacity and service. When faced with shocking discrimination, or numbing indifference, they ignored it or fought valiantly. When choosing their life's work, they chose service, often of the most neglected-those with pain, trauma, and disability. These women inspire and point the way to a time when the term "women leaders" as an exception is unnecessary.-Katharine J. Drummond, MD, on behalf of this month's topic editors.

Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry.

The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N2QOD), was established by the NeuroPoint Alliance (NPA) in collaboration with relevant national stakeholders and experts. The overarching goal of this project was to develop a centralized, nationally coordinated effort to allow individual surgeons and practice groups to collect, measure, and analyze practice patterns and neurosurgical outcomes. Specific objectives of this registry program were as follows: "1) to establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical procedures, 2) to allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real time, 3) to generate both quality and efficiency data to support claims made to public and private payers and objectively demonstrate the value of care to other stakeholders, 4) to demonstrate the comparative effectiveness of neurosurgical and spine procedures, 5) to develop sophisticated 'risk models' to determine which subpopulations of patients are most likely to benefit from specific surgical interventions, and 6) to facilitate essential multicenter trials and other cooperative clinical studies." The NPA has launched several neurosurgical specialty modules in the QOD program in the 7 years since its inception including lumbar spine, cervical spine, and spinal deformity and cerebrovascular and intracranial tumor. The QOD Spine modules, which are the primary subject of this paper, have evolved into the largest North American spine registries yet created and have resulted in unprecedented cooperative activities within our specialty and among affiliated spine care practitioners. Herein, the authors discuss the experience of QOD Spine programs to date, with a brief description of their inception, some of the key achievements and milestones, as well as the recent transition of the spine modules to the American Spine Registry (ASR), a collaboration between the American Association of Neurological Surgeons and the American Academy of Orthopaedic Surgeons (AAOS).

Correlation of return to work with patient satisfaction after surgery for lumbar spondylolisthesis: an analysis of the Quality Outcomes Database.

OBJECTIVE: Return to work (RTW) and satisfaction are important outcome measures after surgery for degenerative spine disease. The authors queried the prospective Quality Outcomes Database (QOD) to determine if RTW correlated with patient satisfaction. METHODS: The QOD was queried for patients undergoing surgery for degenerative lumbar spondylolisthesis. The primary outcome of interest was correlation between RTW and patient satisfaction, as measured by the North American Spine Society patient satisfaction index (NASS). Secondarily, data on satisfied patients were analyzed to see what patient factors correlated with RTW. RESULTS: Of 608 total patients in the QOD spondylolisthesis data set, there were 292 patients for whom data were available on both satisfaction and RTW status. Of these, 249 (85.3%) were satisfied with surgery (NASS score 1-2), and 224 (76.7%) did RTW after surgery. Of the 68 patients who did not RTW after surgery, 49 (72.1%) were still satisfied with surgery. Of the 224 patients who did RTW, 24 (10.7%) were unsatisfied with surgery (NASS score 3-4). There were significantly more people who had an NASS score of 1 in the RTW group than in the non-RTW group (71.4% vs 42.6%, p < 0.05). Failure to RTW was associated with lower level of education, worse baseline back pain (measured with a numeric rating scale), and worse baseline disability (measured with the Oswestry Disability Index [ODI]). CONCLUSIONS: There are a substantial number of patients who are satisfied with surgery even though they did not RTW. Patients who were satisfied with surgery and did not RTW typically had worse preoperative back pain and ODI and typically did not have a college education. While RTW remains an important measure after surgery, physicians should be mindful that patients who do not RTW may still be satisfied with their outcome.

Intermediate-term clinical and radiographic outcomes with less invasive adult spinal deformity surgery: patients with a minimum follow-up of 4 years.

BACKGROUND: Little information exists regarding longer-term outcomes with minimally invasive spine surgery (MISS), particularly regarding long-segment and deformity procedures. We aimed to evaluate intermediate-term outcomes of MISS for adult spinal deformity (ASD). METHODS: This retrospective review of a prospectively collected multicenter database examined outcomes at 4 or more years following circumferential MIS (cMIS) or hybrid (HYB) surgery for ASD. A total of 53 patients at 8 academic centers satisfied the following inclusion criteria: age > 18 years and coronal Cobb > 20°, pelvic incidence-lumbar lordosis (PI-LL) > 10°, or sagittal vertical axis (SVA) > 5 cm. RESULTS: Radiographic outcomes demonstrated improvements of PI-LL from 16.8° preoperatively to 10.8° and coronal Cobb angle from 38° preoperatively to 18.2° at 4 years. The incidence of complications over the follow-up period was 56.6%. A total of 21 (39.6%) patients underwent reoperation in the thoracolumbar spine, most commonly for adjacent level disease or proximal junctional kyphosis, which occurred in 11 (20.8%) patients. Mean Oswestry Disability Index (ODI) at baseline and years 1 through 4 were 49.9, 33.1, 30.2, 32.7, and 35.0, respectively. The percentage of patients meeting minimal clinically important difference (MCID) (defined as 12% or more from baseline) decreased over time, with leg pain reduction more durable than back pain reduction. CONCLUSIONS: Intermediate-term clinical and radiographic improvement following MISS for ASD is sustained, but extent of improvement lessens over time. Outcome variability exists within a subset of patients not meeting MCID, which increases over time after year two. Loss of improvement over time was more notable in back than leg pain. However, average ODI improvement meets MCID at 4 years after MIS ASD surgery.

Endoscopic transforaminal lumbar interbody fusion without general anesthesia: operative and clinical outcomes in 100 consecutive patients with a minimum 1-year follow-up.

OBJECTIVEOpen spinal fusion surgery is often associated with significant blood loss, postoperative pain, and prolonged recovery times. Seeking to minimize surgical and perioperative morbidity, the authors adopted an endoscopic minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) technique performed without general anesthesia. In this report, they present data on the first 100 patients treated with this procedure.METHODSThe authors conducted a retrospective review of the first 100 patients who underwent awake endoscopic MIS-TLIF at a single institution between 2014 and 2017. Surgery was performed while the patient was sedated but without intubation or the use of general anesthetic or narcotic agents. Long-lasting (liposomal) bupivacaine was used for local analgesia. The discectomy and placement of an expandable interbody graft were performed endoscopically, followed by percutaneous pedicle screw implantation. Inclusion criteria for the procedure consisted of diagnosis of degenerative disc disease with grade I or II spondylolisthesis and evidence of spinal stenosis or nerve impingement with intractable symptomatology.RESULTSOf the first 100 patients, 56 were female and 44 were male. Single-level fusion was performed in 84 patients and two-level fusion in 16 patients. The most commonly fused level was L4-5, representing 77% of all fused levels. The mean (± standard deviation) operative time was 84.5 ± 21.7 minutes for one-level fusions and 128.1 ± 48.6 minutes for two-level procedures. The mean intraoperative blood loss was 65.4 ± 76.6 ml for one-level fusions and 74.7 ± 33.6 ml for two-level fusions. The mean length of hospital stay was 1.4 ± 1.0 days. Four deaths occurred in the 100 patients; all four of those patients died from complications unrelated to surgery. In 82% of the surviving patients, 1-year follow-up Oswestry Disability Index (ODI) data were available. The mean preoperative ODI score was 29.6 ± 15.3 and the mean postoperative ODI score was 17.2 ± 16.9, which represents a significant mean reduction in the ODI score of -12.3 using a two-tailed paired t-test (p = 0.000001). In four cases, the surgical plan was revised to include general endotracheal anesthesia intraoperatively and was successfully completed. Other complications included two cases of cage migration, one case of osteomyelitis, and one case of endplate fracture; three of these complications occurred in the first 50 cases.CONCLUSIONSThis series of the first 100 patients to undergo awake endoscopic MIS-TLIF demonstrates outcomes comparable to those reported in our earlier papers. This procedure can provide a safe and efficacious option for lumbar fusion with less morbidity than open surgery. Further refinements in surgical technique and technologies will allow for improved success.