Initiating Treatment with Low Fluorouracil Dose and Titrating According to Blood Levels in Patients Treated with a 46-Hour Continuous Infusion.

INTRODUCTION: Fluorouracil (5-FU) pharmacokinetics are variable, leading to a risk of toxicity in some patients and underdosing in others. Therapeutic drug monitoring of 5-FU was shown to reduce toxicity and increase efficacy. This study assessed the clinical utility of starting treatment with 70-80% of BSA calculated dose and titrating according to 5-FU blood levels and toxicity. METHODS: A retrospective analysis of a prospectively collected database of 126 patients treated with regimens containing 5-FU bolus and continuous infusion for 46 h for whom the 5-FU blood level was collected at least once. Response,and date of progression, and death were collected for patients with colon and pancreatic cancer. RESULTS: In multivariate analysis, 5-FU blood levels were correlated with 5-FU dose and with age, albeit a small effect size (coefficient = 0.007). Of patients with colon cancer treated with an initial lower 5-FU dose, 18% had a therapeutic 5-FU blood level. The median survival was similar in patients with metastatic colon cancer treated with lower doses and those treated with a full dose. Of patients with pancreatic cancer treated with lower doses, 40% had therapeutic blood levels. The median survival was 13 months in patients with metastatic pancreatic cancer treated with lower 5-FU doses. CONCLUSION: Starting treatment with low 5-FU dose was associated with patient survival comparable to other published data, and a sizeable percentage of patients had therapeutic blood levels. This approach can be considered, especially in elderly and frail patients.

"Reverse roussouly": cervicothoracic curvature ratios define characteristic shapes in adult cervical deformity.

PURPOSE: To investigate normal curvature ratios of the cervicothoracic spine and to establish radiographic thresholds for severe myelopathy and disability, within the context of shape. METHODS: Adult cervical deformity (CD) patients undergoing cervical fusion were included. C2-C7 Cobb angle (CL) and thoracic kyphosis (TK), using T2-T12 Cobb angle, were used as a ratio, ranging from -1 to + 1. Pearson bivariate r and univariate analyses analyzed radiographic correlations and differences in myelopathy(mJOA > 14) or disability(NDI > 40) across ratio groups. RESULTS: Sixty-three CD patients included. Regarding CL:TK ratio, 37 patients had a negative ratio and 26 patients had a positive ratio. A more positive CL:TK correlated with increased TS-CL(r = 0.655, p = < 0.001)and mJOA(r = 0.530, p = 0.001), but did not correlate with cSVA/SVA or NDI scores. A positive CL:TK ratio was associated with moderate disability(NDI > 40)(OR: 7.97[1.22-52.1], p = 0.030). Regression controlling for CL:TK ratio revealed cSVA > 25 mm increased the odds of moderate to severe myelopathy and cSVA > 30 mm increased the odds of significant neck disability. Lastly, TS-CL > 29 degrees increased the odds of neck disability by 4.1 × with no cutoffs for severe mJOA(p > 0.05). CONCLUSIONS: Cervical deformity patients with an increased CL:TK ratio had higher rates of moderate neck disability at baseline, while patients with a negative ratio had higher rates of moderate myelopathy clinically. Specific thresholds for cSVA and TS-CL predicted severe myelopathy or neck disability scores, regardless of baseline neck shape. A thorough evaluation of the cervical spine should include exploration of relationships with the thoracic spine and may better allow spine surgeons to characterize shapes and curves in cervical deformity patients.

Health-related quality of life measures in adult spinal deformity: can we replace the SRS-22 with PROMIS?

PURPOSE: To determine the validity and responsiveness of PROMIS metrics versus the SRS-22r questionnaire in adult spinal deformity (ASD). METHODS: Surgical ASD patients undergoing ≥ 4 levels fused with complete baseline PROMIS and SRS-22r data were included. Internal consistency (Cronbach's alpha) and test-retest reliability [intraclass correlation coefficient (ICC)] were compared. Cronbach's alpha and ICC values ≥ 0.70 were predefined as satisfactory. Convergent validity was evaluated via Spearman's correlations. Responsiveness was assessed via paired samples t tests with Cohen's d to assess measure of effect (baseline to 3 months). RESULTS: One hundred and ten pts are included. Mean baseline SRS-22r score was 2.62 ± 0.67 (domains = Function: 2.6, Pain: 2.5, Self-image: 2.2, Mental Health: 3.0). Mean PROMIS domains = Physical Function (PF): 12.4, Pain Intensity (PI): 91.7, Pain Interference (Int): 55.9. Cronbach's alpha, and ICC were not satisfactory for any SRS-22 and PROMIS domains. PROMIS-Int reliability was low for all SRS-22 domains (0.037-0.225). Convergent validity demonstrated strong correlation via Spearman's rho between PROMIS-PI and overall SRS-22r (- 0.61), SRS-22 Function (- 0.781), and SRS-22 Pain (- 0.735). PROMIS-PF had strong correlation with SRS-22 Function (0.643), while PROMIS-Int had moderate correlation with SRS-22 Pain (- 0.507). Effect size via Cohen's d showed that PROMIS had superior responsiveness across all domains except for self-image. CONCLUSIONS: PROMIS is a valid measure compared to SRS-22r in terms of convergent validity, and has greater measure of effect in terms of responsiveness, but failed in reliability and internal consistency. Surgeons should consider the lack of reliability and internal consistency (despite validity and responsiveness) of the PROMIS to SRS-22r before replacing the traditional questionnaire with the computer-adaptive testing.

Efficient removal of formaldehyde using metal-biochar derived from acid mine drainage sludge and spent coffee waste.

A novel metal-biochar (Biochar/AMDS) composite were fabricated by co-pyrolysis of spent coffee waste (SCW)/acid mine drainage sludge (AMDS), and their effective application in adsorptive removal of air pollutants such as formaldehyde in indoor environments was evaluated. The physicochemical characteristics of Biochar/AMDS were analyzed using SEM/EDS, XRF, XRD, BET, and FTIR. The characterization results illustrated that Biochar/AMDS had the highly porous structure, carbonaceous layers, and heterogeneous Fe phases (hematite, metallic Fe, and magnetite). The fixed-bed column test showed that the removal of formaldehyde by Biochar/AMDS was 18.4-fold higher than that by metal-free biochar (i.e., SCW-derived biochar). Changing the ratio of AMDS from 1:6 to 1:1 significantly increased the adsorption capacity for formaldehyde from 1008 to 1811 mg/g. In addition, thermal treatment of used adsorbent at 100 °C effectively restored the adsorptive function exhausted during the column test. These results provide new insights into the fabrication of practical, low-cost and ecofriendly sorbent for formaldehyde.

Perinatal Mental Health in Kashmir, India During The COVID-19 Pandemic.

The current COVID-19 pandemic in Kashmir along with lockdown measures-ordered to prevent the spread of the disease-has added further trauma to the fragile mental health system in Kashmir. There may be unquantifiable repercussions of the current epidemic on the emotional status of women during the perinatal period. There are numerous challenges in the perinatal period arising out of COVID-19 directly or indirectly because of lockdown measures that has been put in place to prevent the spread of disease.

Medical magnetic resonance imaging publications in Arab countries: A 25-year bibliometric analysis.

Magnetic Resonance Imaging (MRI) is increasingly becoming a cornerstone in modern diagnostic healthcare, offering unparalleled capabilities in stroke, dementia, and cancer screening. Therefore, this study aims to map medical MRI literature affiliated with Arab countries, focusing on publication trends, top journals, author affiliations, study countries, and authors' collaboration, and keyword analysis. The scientific database used is the Scopus database. Microsoft Excel, VOSviewer software, and Biblioshiny for the Bibliometrix R package are the bibliometric tools used in this analysis. A total of 2592 publications were published between 1988 and 2022, with total citations of 22,115. Most of them were original articles (91,7%) and 89.9% were published in traditional journals. The number of total publications exhibited a steady increase over time, whereas total citations showed fluctuations, peaking in 2015 with 1571 citations for publications from that year. The most cited article was authored by Yaseen M. Arabi, receiving 286 citations. Saudi Arabia was the top active country. In addition, the most prolific author was Maha S Zaki, and the most prolific source was the "Egyptian Journal of Radiology and Nuclear Medicine". The most prolific affiliation was Cairo University. The "multiple sclerosis" and "case report" were the most trending keywords. The analysis revealed a significant growth in MRI research inside Arab countries, as shown by an increase in the total number of publications and international collaborations. Despite these developments, the results of this study suggest that there is still room for MRI research in the Arab region to advance. This can be achieved through increasing international collaboration and multidisciplinary work.

Adult cervical spine deformity: a state-of-the-art review.

Adult cervical deformity is a structural malalignment of the cervical spine that may present with variety of significant symptomatology for patients. There are clear and substantial negative impacts of cervical spine deformity, including the increased burden of pain, limited mobility and functionality, and interference with patients' ability to work and perform everyday tasks. Primary cervical deformities develop as the result of a multitude of different etiologies, changing the normal mechanics and structure of the cervical region. In particular, degeneration of the cervical spine, inflammatory arthritides and neuromuscular changes are significant players in the development of disease. Additionally, cervical deformities, sometimes iatrogenically, may present secondary to malalignment or correction of the thoracic, lumbar or sacropelvic spine. Previously, classification systems were developed to help quantify disease burden and influence management of thoracic and lumbar spine deformities. Following up on these works and based on the relationship between the cervical and distal spine, Ames-ISSG developed a framework for a standardized tool for characterizing and quantifying cervical spine deformities. When surgical intervention is required to correct a cervical deformity, there are advantages and disadvantages to both anterior and posterior approaches. A stepwise approach may minimize the drawbacks of either an anterior or posterior approach alone, and patients should have a surgical plan tailored specifically to their cervical deformity based upon symptomatic and radiographic indications. This state-of-the-art review is based upon a comprehensive overview of literature seeking to highlight the normal cervical spine, etiologies of cervical deformity, current classification systems, and key surgical techniques.

Endocrown Feasibility for Primary Molars: A Finite Element Study.

OBJECTIVE: To study the possibility of using pediatric endocrowns to restore the second primary molar using three-dimensional (3D) finite element analysis. DESIGN: A 3D finite element model was built for a pediatric mandibular molar, starting with laser scanning a naturally extracted tooth. The access cavity had an elliptic shape with 6 mm width, 4 mm height, and 2 mm depth with a wall taper angle of 5 degrees.Two materials (Zr and E-max) were tested for the endocrown and two cementing materials (glass ionomer and resin cement) with 20 to 40 µm thickness. Twelve case studies were reported within this research as the applied load of 330 N was tested with three angulations vertical, oblique at 45 degrees, and laterally. RESULTS: Twelve linear static stress analyses were performed. The resultant stresses and deformations' distribution patterns did not alter much, and values were within the threshold of physiological tolerance. Deformations were negligibly changed with changing endocrown and cement materials. In contrast, endocrown stresses indicated zirconia endocrown would have a long lifetime, while E-max one will have a relatively short lifetime. CONCLUSIONS: Analysis results indicated that bone was negligibly affected by changing endocrowns and cementing materials. Both tested endocrown materials can be used safely. Zirconia endocrowns may have a much longer lifetime than E-max.

Risk of spinal surgery among individuals who have been re-vascularized for coronary artery disease.

HYPOTHESIS: Revascularization is a more effective intervention to reduce future postop complications. METHODS: Patients undergoing elective spine fusion surgery were isolated in the PearlDiver database. Patients were stratified by having previous history of vascular stenting (Stent), coronary artery bypass graft (CABG), and no previous heart procedure (No-HP). Means comparison tests (chi-squared and independent samples t-tests, as appropriate) compared differences in demographics, diagnoses, and comorbidities. Binary logistic regression assessed the odds of 30-day and 90-day postoperative (postop) complications associated with each heart procedure (Odds Ratio [95 % confidence interval]). Statistical significance was set p < 0.05. RESULTS: 731,173 elective spine fusion patients included. Overall, 8,401 pts underwent a CABG, 24,037 pts Stent, and 698,735 had No-HP prior to spine fusion surgery. Compared to Stent and No-HP patients, CABG patients had higher rates of morbid obesity, chronic kidney disease, and diabetes (p < 0.001 for all). Meanwhile, stent patients had higher rates of PVD, hypertension, and hyperlipidemia (all p < 0.001). 30-days post-op, CABG patients had significantly higher complication rates including pneumonia, CVA, MI, sepsis, and death compared to No-HP (all p < 0.001). Stent patients vs. No-HF had higher 30-day post-op complication rates including pneumonia, CVA, MI, sepsis, and death. Furthermore, adjusting for age, comorbidities, and sex Stent was significantly predictive of a MI 30-days post-op (OR: 1.90 [1.53-2.34], P < 0.001). Additionally, controlling for levels fused, stent patients compared to CABG patients had 1.99x greater odds of a MI within 30-days (OR: 1.99 [1.26-3.31], p = 0.005) and 2.02x odds within 90-days postop (OR: 2.2 [1.53-2.71, p < 0.001). CONCLUSION: With regards to spine surgery, coronary artery bypass graft remains the gold standard for risk reduction. Stenting does not appear to minimize risk of experiencing a post-procedure cardiac event as dramatically as CABG.

Impact of congestive heart failure on patients undergoing lumbar spine fusion for adult spine deformity.

Background: With the increasing amount of elective spine fusion patients presenting with cardiac disease and congestive heart failure, it is becoming difficult to assess when it is safe to proceed with surgery. Assessing the severity of heart failure (HF) through ejection fraction may provide insight into patients' short- and long-term risks. Purpose: The purpose of this study was to assess the severity of HF on perioperative outcomes of spine fusion surgery patients. Study Design/Setting: This was a retrospective cohort study of the PearlDiver database. Patient Sample: We enrolled 670,526 patients undergoing spine fusion surgery. Outcome Measures: Thirty-day and 90-day complication rates, discharge destination, length of stay (LOS), physician reimbursement, and hospital costs. Methods: Patients undergoing elective spine fusion surgery were isolated and stratified by preoperative HF with preserved ejection fraction (P-EF) or reduced ejection fraction (R-EF) (International Classification of Diseases-9: 428.32 [chronic diastolic HF] and 428.22 [chronic systolic HF]). Means comparison tests (Chi-squared and independent samples t-tests, as appropriate) compared differences in demographics, diagnoses, comorbidities, procedural characteristics, LOS, 30-day and 90-day complication outcomes, and total hospital charges between those diagnosed with P-EF and those not R-EF. Binary logistic regression assessed the odds of complication associated with HF, controlling for levels fused (odds ratio [OR] [95% confidence interval]). Statistical significance was set at P < 0.05. Results: Totally 670,526 elective spine fusion patients were included. Four thousand and seventy-seven were diagnosed with P-EF and 2758 R-EF. Overall, P-EF patients presented with higher rates of morbid obesity, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and hypertension (all P < 0.001). In relation to No-HF, P-EF patients had higher rates of 30-day major complications including pulmonary embolism, pneumonia, cerebrovascular accident (CVA), myocardial infarctions (MI), sepsis, and death (all P < 0.001). Furthermore, P-EF was associated significantly with increased odds of pneumonia (OR: 2.07 [1.64-2.56], P < 0.001) and sepsis (OR: 2.09 [1.62-2.66], P < 0.001). Relative to No-HF, R-EF was associated with significantly higher odds of MI (OR: 3.66 [2.34-5.47]), CVA (OR: 2.70 [1.67-4.15]), and pneumonia (OR: 1.85 [1.40-2.40]) (all P < 0.001) postoperative within 30 days. Adjusting for prior history of MI, CAD, and the presence of a pacemaker R-EF was a significant predictor of an MI 30 days postoperatively (OR: 2.2 [1.14-4.32], P = 0.021). Further adjusting for history of CABG or stent placement, R-EF was associated with higher odds of CVA (OR: 2.11 [1.09-4.19], P = 0.028) and MI (OR: 2.27 [1.20-4.43], P = 0.013). Conclusions: When evaluating the severity of HF before spine surgery, R-EF was associated with a higher risk of major complications, especially the occurrence of a myocardial infarction 30 days postoperatively. During preoperative risk assessment, congestive HF should be considered thoroughly when thinking of postoperative outcomes with emphasis on R-EF.

Efficacy of Varying Surgical Approaches on Achieving Optimal Alignment in Adult Spinal Deformity Surgery.

BACKGROUND: The Roussouly, SRS-Schwab, and Global Alignment and Proportion (GAP) classifications define alignment by spinal shape and deformity severity. The efficacy of different surgical approaches and techniques to successfully achieve these goals is not well understood. PURPOSE: Identify the impact of surgical approach and/or technique on meeting complex realignment goals in adult spinal deformity (ASD) corrective surgery. STUDY DESIGN/SETTING: Retrospective study. MATERIALS AND METHODS: Included patients with ASD fused to pelvis with 2-year data. Patients were categorized by: (1) Roussouly: matching current and theoretical spinal shapes, (2) improving in SRS-Schwab modifiers (0, +, ++), and (3) improving GAP proportionality by 2 years. Analysis of covariance and multivariable logistic regression analyses controlling for age, levels fused, baseline deformity, and 3-column osteotomy usage compared the effect of different surgical approaches, interbody, and osteotomy use on meeting realignment goals. RESULTS: A total of 693 patients with ASD were included. By surgical approach, 65.7% were posterior-only and 34.3% underwent anterior-posterior approach with 76% receiving an osteotomy (21.8% 3-column osteotomy). By 2 years, 34% matched Roussouly, 58% improved in GAP, 45% in SRS-Schwab pelvic tilt (PT), 62% sagittal vertical axis, and 70% pelvic incidence-lumbar lordosis. Combined approaches were most effective for improvement in PT [odds ratio (OR): 1.7 (1.1-2.5)] and GAP [OR: 2.2 (1.5-3.2)]. Specifically, anterior lumbar interbody fusion (ALIF) below L3 demonstrated higher rates of improvement versus TLIFs in Roussouly [OR: 1.7 (1.1-2.5)] and GAP [OR: 1.9 (1.3-2.7)]. Patients undergoing pedicle subtraction osteotomy at L3 or L4 were more likely to improve in PT [OR: 2.0 (1.0-5.2)] and pelvic incidence-lumbar lordosis [OR: 3.8 (1.4-9.8)]. Clinically, patients undergoing the combined approach demonstrated higher rates of meeting SCB in Oswestry Disability Index by 2 years while minimizing rates of proximal junctional failure, most often with an ALIF at L5-S1 [Oswestry Disability Index-SCB: OR: 1.4 (1.1-2.0); proximal junctional failure: OR: 0.4 (0.2-0.8)]. CONCLUSIONS: Among patients undergoing ASD realignment, optimal lumbar shape and proportion can be achieved more often with a combined approach. Although TLIFs, incorporating a 3-column osteotomy, at L3 and L4 can restore lordosis and normalize pelvic compensation, ALIFs at L5-S1 were most likely to achieve complex realignment goals with an added clinical benefit and mitigation of junctional failure.

Unveiling the role of supply chain parameters approved by blockchain technology towards firm performance through trust: The moderating role of government support.

This research study aims to reveal the role of supply chain parameters approved by blockchain technology toward firm performance through trust. This study has also examined the moderating role of government support between trust and firm performance. The underlying theories reinforce the usefulness and flexibility of a supply chain in regulating daily fluctuations and uncertainties in supply and demand. Blockchain technology adoption with supply chain tactics provides a more suitable environment for better firm performance. Governments address legal and security concerns related to blockchain technology and provide clear guidelines and standards for its use in supply chains, which build trust among firms and stakeholders. A conceptual model has been developed with the assistance of past empirical research studies and associated theories. This research study has examined the following relationships from a sample of 465 employees from textile industrial firms listed on the Pakistan Stock Exchange. The current research study assesses these parameters using the partial least squares structural equation modeling (PLS-SEM) method. The analysis showed that supply chain parameters (alignment, agility, adaptability) approved by blockchain technology positively correlate with firm performance. Trust positively mediated the relationship between supply chain parameters approved by blockchain technology and firm performance. Furthermore, government support positively moderated the relationship between trust and firm performance. The study would provide directions for further research. These findings will give the global supply chain industry valuable insights into blockchain technology for firm performance. In theory, this research study would contribute to the scientific literature by answering how trust and government support affect the overall firm performance.

Predicting five-year mortality in soft-tissue sarcoma patients.

Aims: The aim of this study was to identify factors associated with five-year cancer-related mortality in patients with limb and trunk soft-tissue sarcoma (STS) and develop and validate machine learning algorithms in order to predict five-year cancer-related mortality in these patients. Methods: Demographic, clinicopathological, and treatment variables of limb and trunk STS patients in the Surveillance, Epidemiology, and End Results Program (SEER) database from 2004 to 2017 were analyzed. Multivariable logistic regression was used to determine factors significantly associated with five-year cancer-related mortality. Various machine learning models were developed and compared using area under the curve (AUC), calibration, and decision curve analysis. The model that performed best on the SEER testing data was further assessed to determine the variables most important in its predictive capacity. This model was externally validated using our institutional dataset. Results: A total of 13,646 patients with STS from the SEER database were included, of whom 35.9% experienced five-year cancer-related mortality. The random forest model performed the best overall and identified tumour size as the most important variable when predicting mortality in patients with STS, followed by M stage, histological subtype, age, and surgical excision. Each variable was significant in logistic regression. External validation yielded an AUC of 0.752. Conclusion: This study identified clinically important variables associated with five-year cancer-related mortality in patients with limb and trunk STS, and developed a predictive model that demonstrated good accuracy and predictability. Orthopaedic oncologists may use these findings to further risk-stratify their patients and recommend an optimal course of treatment.

Prediction of suitable outpatient candidates following revision total knee arthroplasty using machine learning.

Aims: To identify variables independently associated with same-day discharge (SDD) of patients following revision total knee arthroplasty (rTKA) and to develop machine learning algorithms to predict suitable candidates for outpatient rTKA. Methods: Data were obtained from the American College of Surgeons National Quality Improvement Programme (ACS-NSQIP) database from the years 2018 to 2020. Patients with elective, unilateral rTKA procedures and a total hospital length of stay between zero and four days were included. Demographic, preoperative, and intraoperative variables were analyzed. A multivariable logistic regression (MLR) model and various machine learning techniques were compared using area under the curve (AUC), calibration, and decision curve analysis. Important and significant variables were identified from the models. Results: Of the 5,600 patients included in this study, 342 (6.1%) underwent SDD. The random forest (RF) model performed the best overall, with an internally validated AUC of 0.810. The ten crucial factors favoring SDD in the RF model include operating time, anaesthesia type, age, BMI, American Society of Anesthesiologists grade, race, history of diabetes, rTKA type, sex, and smoking status. Eight of these variables were also found to be significant in the MLR model. Conclusion: The RF model displayed excellent accuracy and identified clinically important variables for determining candidates for SDD following rTKA. Machine learning techniques such as RF will allow clinicians to accurately risk-stratify their patients preoperatively, in order to optimize resources and improve patient outcomes.

Concurrent Presence of Thoracolumbar Scoliosis and Chiari Malformation: Is Operative Risk Magnified?

STUDY DESIGN: Retrospective review of Kids' Inpatient Database (KID). PURPOSE: Identify the risks and complications associated with surgery in adolescents diagnosed with Chiari and scoliosis. OVERVIEW OF LITERATURE: Scoliosis is frequently associated with Chiari malformation (CM). More specifically, reports have been made about this association with CM type I in the absence of syrinx status. METHODS: The KID was used to identify all pediatric inpatients with CM and scoliosis. The patients were stratified into three groups: those with concomitant CM and scoliosis (CMS group), those with only CM (CM group), and those with only scoliosis (Sc group). Multivariate logistic regressions were used to assess association between surgical characteristics and diagnosis with complication rate. RESULTS: A total of 90,707 spine patients were identified (61.8% Sc, 37% CM, 1.2% CMS). Sc patients were older, had a higher invasiveness score, and higher Charlson comorbidity index (all p<0.001). CMS patients had significantly higher rates of surgical decompression (36.7%). Sc patients had significantly higher rates of fusions (35.3%) and osteotomies (1.2%, all p<0.001). Controlling for age and invasiveness, postoperative complications were significantly associated with spine fusion surgery for Sc patients (odds ratio [OR], 1.8; p<0.05). Specifically, posterior spinal fusion in the thoracolumbar region had a greater risk of complications (OR, 4.9) than an anterior approach (OR, 3.6; all p<0.001). CM patients had a significant risk of complications when an osteotomy was performed as part of their surgery (OR, 2.9) and if a spinal fusion was concurrently performed (OR, 1.8; all p<0.05). Patients in the CMS cohort were significantly likely to develop postoperative complications if they underwent a spinal fusion from both anterior (OR, 2.5) and posterior approach (OR, 2.7; all p<0.001). CONCLUSIONS: Having concurrent scoliosis and CM increases operative risk for fusion surgeries despite approach. Being independently inflicted with scoliosis or Chiari leads to increased complication rate when paired with thoracolumbar fusion and osteotomies; respectively.

Trends in usage of navigation and robotic assistance in elective spine surgeries: a study of 105,212 cases from 2007 to 2015.

OBJECTIVE: Identify trends of navigation and robotic-assisted elective spine surgeries. METHODS: Elective spine surgery patients between 2007 and 2015 in the Nationwide Inpatient Sample (NIS) were isolated by ICD-9 codes for Navigation [Nav] or Robotic [Rob]-Assisted surgery. Basic demographics and surgical variables were identified via chi-squared and t tests. Each system was analyzed from 2007 to 2015 for trends in usage. RESULTS: Included 3,759,751 patients: 100,488 Nav; 4724 Rob. Nav were younger (56.7 vs 62.7 years), had lower comorbidity index (1.8 vs 6.2, all p < 0.05), more decompressions (79.5 vs 42.6%) and more fusions (60.3 vs 52.6%) than Rob. From 2007 to 2015, incidence of complication increased for Nav (from 5.8 to 21.7%) and Rob (from 3.3 to 18.4%) as well as 2-3 level fusions (from 50.4 to 52.5%) and (from 1.3 to 3.2%); respectively. Invasiveness increased for both (Rob: from 1.7 to 2.2; Nav: from 3.7 to 4.6). Posterior approaches (from 27.4 to 41.3%), osteotomies (from 4 to 7%), and fusions (from 40.9 to 54.2%) increased in Rob. Anterior approach for Rob decreased from 14.9 to 14.4%. Nav increased posterior (from 51.5% to 63.9%) and anterior approaches (from 16.4 to 19.2%) with an increase in osteotomies (from 2.1 to 2.7%) and decreased decompressions (from 73.6 to 63.2%). CONCLUSIONS: From 2007 to 2015, robotic and navigation systems have been performed on increasingly invasive spine procedures. Robotic systems have shifted from anterior to posterior approaches, whereas navigation computer-assisted procedures have decreased in rates of usage for decompression procedures.

Establishment of an Individualized Distal Junctional Kyphosis Risk Index following the Surgical Treatment of Adult Cervical Deformities.

STUDY DESIGN: A retrospective review of a multicenter comprehensive cervical deformity (CD) database. OBJECTIVE: To develop a novel risk index specific to each patient to aid in patient counseling and surgical planning to minimize postop distal junctional kyphosis (DJK) occurrence. BACKGROUND: DJK is a radiographic finding identified after patients undergo instrumented spinal fusions which can result in sagittal spinal deformity, pain and disability, and potentially neurological compromise. DJK is considered multifactorial in nature and there is a lack of consensus on the true etiology of DJK. MATERIALS AND METHODS: CD patients with baseline (BL) and at least one-year postoperative radiographic follow-up were included. A patient-specific DJK score was created through use of unstandardized Beta weights of a multivariate regression model predicting DJK (end of fusion construct to the second distal vertebra change in this angle by <-10° from BL to postop). RESULTS: A total of 110 CD patients included (61 yr, 66.4% females, 28.8 kg/m 2 ). In all, 31.8% of these patients developed DJK (16.1% three males, 11.4% six males, 62.9% one-year). At BL, DJK patients were more frail and underwent combined approach more (both P <0.05). Multivariate model regression analysis identified individualized scores through creation of a DJK equation: -0.55+0.009 (BL inclination)-0.078 (preinflection)+5.9×10 -5 (BL lowest instrumented vertebra angle) + 0.43 (combine approach)-0.002 (BL TS-CL)-0.002 (BL pelvic tilt)-0.031 (BL C2 - C7) + 0.02 (∆T4-T12)+ 0.63 (osteoporosis)-0.03 (anterior approach)-0.036 (frail)-0.032 (3 column osteotomy). This equation has a 77.8% accuracy of predicting DJK. A score ≥81 predicted DJK with an accuracy of 89.3%. The BL reference equation correlated with two year outcomes of Numeric Rating Scales of Back percentage ( P =0.003), reoperation ( P =0.04), and minimal clinically importance differences for 5-dimension EuroQol questionnaire ( P =0.04). CONCLUSIONS: This study proposes a novel risk index of DJK development that focuses on potentially modifiable surgical factors as well as established patient-related and radiographic determinants. The reference model created demonstrated strong correlations with relevant two-year outcome measures, including axial pain-related symptoms, occurrence of related reoperations, and the achievement of minimal clinically importance differences for 5-dimension EuroQol questionnaire.

Failure to Normalize Risk Profile of Spine Fusion Patients With Coronary Artery Disease Previously Treated With Percutaneous Stent Revascularization.

BACKGROUND: The impact of an initially less invasive cardiac intervention on outcomes of future surgical spine procedures has been understudied; therefore, we sought to investigate the effect of coronary stents on postoperative outcomes in an elective spine fusion cohort. METHODS: Elective spine fusion patients were isolated with International Classification of Diseases-Ninth Edition and current procedural terminology procedure codes in the PearlDiver database. Patients were stratified by number of coronary stents: (1) 1 to 2 stents (ST12); (2) 3 to 4 stents (ST34); (3) no stents. Mean comparison tests compared differences in demographics, diagnoses, comorbidities, and 30-day and 90-day complication outcomes. Logistic regression assessed the odds of complications associated with coronary stents, controlling for levels fused, age, sex, and comorbidities (odds ratio [95% confidence interval]). Statistical significance was P < 0.05. RESULTS: A total of 726,061 elective spine fusion patients were isolated. Of those patients, 707,396 patients had no stent, 17,087 ST12, and 1578 ST34. At baseline (BL), ST12 patients had higher rates of morbid obesity, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, and diabetes mellitus compared with no stent and ST34 patients (all P < 0.001). Relative to no stent patients, ST12 patients had a longer length of stay and, at 30 days, significantly higher complication rates, including pneumonia, myocardial infarction (MI), sepsis, acute kidney injury, urinary tract infection (UTI), wound complications, transfusions, and 30-day readmissions (P < 0.05). Controlling for age, sex, comorbidities, and levels fused, ST12 was a significant predictor of MI within 30 days (OR 2.15 [95% CI 1.7-2.7], P < 0.001) and 90 days postoperatively (OR 1.87 [95% CI 1.6-2.2], P < 0.001). ST34 patients compared with no stent patients at 30 days presented with increased rates of complication, including pneumonia, MI, sepsis, UTI, wound complications, and 30-day readmissions. Regression analysis showed no significant differences in complications between ST12 vs ST34 at 30 days, but at 90 days, ST34 was associated with significantly increased rate and odds of death (1.1% vs 0.3%, P = 0.021; OR 1.94 [95% CI 1.13-3.13], P = 0.01). CONCLUSION: Cardiac stents failed to normalize risk profile of patients with coronary artery disease. Postoperatively at 90 days, elective spine fusion patients with 3 or more stents were significantly at risk of mortality compared with patients with fewer or no stents.

Identifying Subsets of Patients With Adult Spinal Deformity Who Maintained a Positive Response to Nonoperative Management.

BACKGROUND: Adult spinal deformity (ASD) represents a major cause of disability in the elderly population in the United States. Surgical intervention has been shown to reduce disability and pain in properly indicated patients. However, there is a small subset of patients in whom nonoperative treatment is also able to durably maintain or improve symptoms. OBJECTIVE: To examine the factors associated with successful nonoperative management in patients with ASD. METHODS: We retrospectively evaluated a cohort of 207 patients with nonoperative ASD, stratified into 3 groups: (1) success, (2) no change, and (3) failure. Success was defined as a gain in minimal clinically importance difference in both Oswestry Disability Index and Scoliosis Research Society-Pain. Logistic regression model and conditional inference decision trees established cutoffs for success according to baseline (BL) frailty and sagittal vertical axis. RESULTS: In our cohort, 44.9% of patients experienced successful nonoperative treatment, 22.7% exhibited no change, and 32.4% failed. Successful nonoperative patients at BL were significantly younger, had a lower body mass index, decreased Charlson Comorbidity Index, lower frailty scores, lower rates of hypertension, obesity, depression, and neurological dysfunction (all P < .05) and significantly higher rates of grade 0 deformity for all Schwab modifiers (all P < .05). Conditional inference decision tree analysis determined that patients with a BL ASD-frailty index ≤ 1.579 (odds ratio: 8.3 [4.0-17.5], P < .001) were significantly more likely to achieve nonoperative success. CONCLUSION: Success of nonoperative treatment was more frequent among younger patients and those with less severe deformity and frailty at BL, with BL frailty the most important determinant factor. The factors presented here may be useful in informing preoperative discussion and clinical decision-making regarding treatment strategies.

Economic burden of nonoperative treatment of adult spinal deformity.

OBJECTIVE: The purpose of this study was to investigate the cost utility of nonoperative treatment for adult spinal deformity (ASD). METHODS: Nonoperatively and operatively treated patients who met database criteria for ASD and in whom complete radiographic and health-related quality of life data at baseline and at 2 years were available were included. A cost analysis was completed on the PearlDiver database assessing the average cost of nonoperative treatment prior to surgical intervention based on previously published treatments (NSAIDs, narcotics, muscle relaxants, epidural steroid injections, physical therapy, and chiropractor). Utility data were calculated using the Oswestry Disability Index (ODI) converted to SF-6D with published conversion methods. Quality-adjusted life years (QALYs) used a 3% discount rate to account for residual decline in life expectancy (78.7 years). Minor and major comorbidities and complications were assessed according to the CMS.gov manual's definitions. Successful nonoperative treatment was defined as a gain in the minimum clinically importance difference (MCID) in both ODI and Scoliosis Research Society (SRS)-pain scores, and failure was defined as a loss in MCID or conversion to operative treatment. Patients with baseline ODI ≤ 20 and continued ODI of ≤ 20 at 2 years were considered nonoperative successful maintenance. The average utilization of nonoperative treatment and cost were applied to the ASD cohort. RESULTS: A total of 824 patients were included (mean age 58.24 years, 81% female, mean body mass index 27.2 kg/m2). Overall, 75.5% of patients were in the operative and 24.5% were in the nonoperative cohort. At baseline patients in the operative cohort were significantly older, had a greater body mass index, increased pelvic tilt, and increased pelvic incidence-lumbar lordosis mismatch (all p < 0.05). With respect to deformity, patients in the operative group had higher rates of severe (i.e., ++) sagittal deformity according to SRS-Schwab modifiers for pelvic tilt, sagittal vertical axis, and pelvic incidence-lumbar lordosis mismatch (p < 0.05). At 2 years, patients in the operative cohort showed significantly increased rates of a gain in MCID for physical component summary of SF-36, ODI, and SRS-activity, SRS-pain, SRS-appearance, and SRS-mental scores. Cost analysis showed the average cost of nonoperative treatment 2 years prior to surgical intervention to be $2041. Overall, at 2 years patients in the nonoperative cohort had again in ODI of 0.36, did not show a gain in QALYs, and nonoperative treatment was determined to be cost-ineffective. However, a subset of patients in this cohort underwent successful maintenance treatment and had a decrease in ODI of 1.1 and a gain in utility of 0.006 at 2 years. If utility gained for this cohort was sustained to full life expectancy, patients' cost per QALY was $18,934 compared to a cost per QALY gained of $70,690.79 for posterior-only and $48,273.49 for combined approach in patients in the operative cohort. CONCLUSIONS: Patients with ASD undergoing operative treatment at baseline had greater sagittal deformity and greater improvement in health-related quality of life postoperatively compared to patients treated nonoperatively. Additionally, patients in the nonoperative cohort overall had an increase in ODI and did not show improvement in utility gained. Patients in the nonoperative cohort who had low disability and sagittal deformity underwent successful maintenance and cost-effective treatment.