Predictors of Complication Severity Following Adult Spinal Deformity Surgery: Smoking Rate, Diabetes, and Osteotomy Increase Risk of Severe Adverse Events.

BACKGROUND: Given the physical and economic burden of complications in spine surgery, reducing the prevalence of perioperative adverse events is a primary concern of both patients and health care professionals. This study aims to identify specific perioperative factors predictive of developing varying grades of postoperative complications in adult spinal deformity (ASD) patients, as assessed by the Clavien-Dindo complication classification (Cc) system. METHODS: Surgical ASD patients ≥18 years were identified in the American College of Surgeons' National Surgical Quality Improvement Program from 2005 to 2015. Postoperative complications were stratified by Cc grade severity: minor (I, II, and III) and severe (IV and V). Stepwise regression models generated dataset-specific predictive models for Cc groups. Model internal validation was achieved by bootstrapping and calculating the area under the curve (AUC) of the model. Significance was set at P < 0.05. RESULTS: Included were 3936 patients (59 ± 16 years, 63% women, 29 ± 7 kg/m2) undergoing surgery for ASD (4.4 ± 4.7 levels, 71% posterior approach, 11% anterior, and 18% combined). Overall, 1% of cases were revisions, 39% of procedures involved decompression, 27% osteotomy, and 15% iliac fixation. Additionally, 66% of patients experienced at least 1 complication, 0% of which were Cc grade I, 51% II, 5% III, 43% IV, and 1% V. The final model predicting severe Cc (IV-V) complications yielded an AUC of 75.6% and included male sex, diabetes, increased operative time, central nervous system tumor, osteotomy, cigarette pack-years, anterior decompression, and anterior lumbar interbody fusion. Final models predicting specific Cc grades were created. CONCLUSIONS: Specific predictors of adverse events following ASD-corrective surgery varied for complications of different severities. Multivariate modeling showed smoking rate, osteotomy, diabetes, anterior lumbar interbody fusion, and higher operative time, among other factors, as predictive of severe complications, as classified by the Clavien-Dindo Cc system. These factors can help in the identification of high-risk patients and, consequently, improve preoperative patient counseling. CLINICAL RELEVANCE: The findings of this study provide a foundation for identifying ASD patients at high risk of postoperative complications .

Defining age-adjusted spinopelvic alignment thresholds: should we integrate BMI?

PURPOSE: To develop age- and BMI-adjusted alignment targets to improve patient-specific management and operative treatment outcomes. METHODS: Retrospective review of a single-center stereographic database. ASD patients receiving operative or non-operative treatment, ≥ 18y/o with complete baseline (BL) ODI scores and radiographic parameters (PT, SVA, PILL, TPA) were included. Patients were stratified by age consistent with US-Normative values (norms) of SF-36(< 35, 35-55, 45-54, 55-64, 65-74, ≥ 75y/o), and dichotomized by BMI (Non-Obese < 30; Obese ≥ 30). Linear regression analysis established normative age- and BMI-specific radiographic thresholds, utilizing previously published age-specific US-Normative ODI values converted from SF-36 PCS (Lafage et al.), in conjunction with BL age and BMI means. RESULTS: 486 patients were included (Age: 52.5, Gender: 68.7%F, mean BMI: 26.2, mean ODI: 32.7), 135 of which were obese. Linear regression analysis developed age- and BMI-specific alignment thresholds, indicating PT, SVA, PILL, and TPA to increase with both increased age and increased BMI (all R > 0.5, p < 0.001). For non-obese patients, PT, SVA, PILL, and TPA ranged from 10.0, - 25.8, - 9.0, 3.1 in patients < 35y/o to 27.8, 53.4, 17.7, 25.8 in patients ≥ 75 y/o. Obese patients' PT, SVA, PILL, and TPA ranged from 10.5, - 7.6, - 7.1, 5.8 in patients < 35 y/o to 28.3, 67.0, 19.15, 27.7 in patients ≥ 75y/o. Normative SVA values in obese patients were consistently ≥ 10 mm greater compared to non-obese values, at all ages. CONCLUSION: Significant associations exist between age, BMI, and sagittal alignment. While BMI influenced age-adjusted alignment norms for PT, SVA, PILL, and TPA at all ages, obesity most greatly influenced SVA, with normative values similar to non-obese patients who were 10 years older. Age-adjusted alignment thresholds should take BMI into account, calling for less rigorous alignment objectives in older and obese patients.

Bariatric Surgery Lowers Rates of Spinal Symptoms and Spinal Surgery in a Morbidly Obese Population.

STUDY DESIGN: Retrospective analysis of New York State Inpatient Database years 2004-2013. OBJECTIVE: Assess rates of spinal diagnoses and procedures before and after bariatric surgery (BS). SUMMARY OF BACKGROUND DATA: BS for morbid obesity helps address common comorbidity burdens and improves quality of life for patients. The effects of BS on spinal disorders and surgical intervention have yet to be investigated. MATERIALS AND METHODS: Patients included in analysis if they underwent BS and were seen at the hospital before and after this intervention. Spinal conditions and rates of surgery assessed before and after BS using χ 2 tests for categorical variables. Multivariable logistic regression analysis used to compare rates in BS patients to control group of nonoperative morbidly obese patients. Logistic testing controlled for comorbidities, age, biological sex. RESULTS: A total of 73,046 BS patients included (age 67.88±17.66 y, 56.1% female). For regression analysis, 299,504 nonbariatric, morbidly obese patients included (age 53.45±16.52 y, 65.6% female). Overall, rates of spinal symptoms decreased following BS (7.40%-5.14%, P <0.001). Cervical, thoracic, lumbar spine diagnoses rates dropped from 3.28% to 2.99%, 2.91% to 2.57%, and 5.39% to 3.92% (all P <0.001), respectively. Most marked reductions seen in cervical spontaneous compression fractures, cervical disc herniation, thoracic radicular pain, spontaneous lumbar compression fractures, lumbar spinal stenosis, lumbar spondylosis. Controlling for comorbidities, age and sex, obese nonbariatric patients more likely to have encounters associated with several cervical, thoracic or lumbar spinal diagnoses and procedures, especially for cervical spontaneous compression fracture, radicular pain, lumbar spondylosis, lumbar spinal stenosis, posterior procedures. BS significantly lowered comorbidity burden for many specific factors. CONCLUSIONS: BS lowered rates of documented spinal disorders and procedures in a morbidly obese population. These findings provide evidence of additional health benefits following BS, including reduction in health care encounters for spinal disorders and rates of surgical intervention.

Cervical and spinopelvic parameters can predict patient reported outcomes following cervical deformity surgery.

Background: Recent studies have evaluated the correlation of health-related quality of life (HRQL) scores with radiographic parameters. This relationship may provide insight into the connection of patient-reported disability and disease burden caused by cervical diagnoses. Purpose: To evaluate the association between spinopelvic sagittal parameters and HRQLs in patients with primary cervical diagnoses. Methods: Patients ≥18 years meeting criteria for primary cervical diagnoses. Cervical radiographic parameters assessed cervical sagittal vertical axis, TS-CL, chin-to-brow vertical angle, C2-T3, CL, C2 Slope, McGregor's slope. Global radiographic alignment parameters assessed PT, SVA, PI-LL, T1 Slope. Pearson correlations were run for all combinations at baseline (BL) and 1 year (1Y) for continuous BL and 1Y modified Japanese Orthopaedic Association scale (mJOA) scores, as well as decline or improvement in those HRQLs at 1Y. Multiple linear regression models were constructed to investigate BL and 1Y alignment parameters as independent variables. Results: Ninety patients included 55.6 ± 9.6 years, 52% female, 30.7 ± 7kg/m2. By approach, 14.3% of patients underwent procedures by anterior approach, 56% posterior, and 30% had combined approaches. Average anterior levels fused: 3.6, posterior: 4.8, and mean total number of levels fused: 4.5. Mean operative time for the cohort was 902.5 minutes with an average estimated blood loss of 830 ccs. The mean BL neck disability index (NDI) score was 56.5 and a mJOA of 12.81. While BL NDI score correlated with gender (P = 0.050), it did not correlate with BL global or cervical radiographic factors. An increased NDI score at 1Y postoperatively correlated with BL body mass index (P = 0.026). A decreased NDI score was associated with 1Y T12-S1 angle (P = 0.009) and 1Y T10 L2 angle (P = 0.013). Overall, BL mJOA score correlated with the BL radiographic factors of T1 slope (P = 0.005), cervical lordosis (P = 0.001), C2-T3 (P = 0.008), C2 sacral slope (P = 0.050), SVA (P = 0.010), and CL Apex (P = 0.043), as well as gender (P = 0.050). Linear regression modeling for the prior independent variables found a significance of P = 0.046 and an R2 of 0.367. Year 1 mJOA scores correlated with 1Y values for maximum kyphosis (P = 0.043) and TS-CL (P = 0.010). At 1Y, a smaller mJOA score correlated with BL S1 sacral slope (P = 0.014), pelvic incidence (P = 0.009), L1-S1 (P = 0.012), T12-S1 (P = 0.008). The linear regression model for those 4 variables demonstrated an R2 of 0.169 and a P = 0.005. An increased mJOA score correlated with PI-LL difference at 1Y (P = 0.012), L1-S1 difference (P = 0.036), T12-S1 difference (0.006), maximum lordosis (P = 0.026), T9-PA difference (P = 0.010), and difference of T4-PA (P = 0.008). Conclusions: While the impact of preoperative sagittal and cervical parameters on mJOA was strong, the BL radiographic factors did not impact NDI scores. PostOp HRQL was significantly associated with sagittal parameters for mJOA (both worsening and improvement) and NDI scores (improvement). When cervical surgery has been indicated, radiographic alignment is important for postoperative HRQL.

Prioritization of realignment associated with superior clinical outcomes for surgical cervical deformity patients.

BACKGROUND: To optimize quality of life in patients with cervical deformity (CD), there may be alignment targets to be prioritized. OBJECTIVE: To prioritize the cervical parameter targets for alignment. METHODS: Included: CD patients (C2-C7 Cobb >10°°, C2-C7 lordosis [CL] >10°°, cSVA > 4 cm, or chin-brow vertical angle >25°°) with full baseline (BL) and 1-year (1Y) radiographic parameters and Neck Disability Index (NDI) scores; patients with cervical (C) or cervicothoracic (CT) Primary Driver Ames type. Patients with BL Ames classified as low CD for both parameters of cSVA (<4 cm) and T1 slope minus CL (TS-CL) (<15°°) were excluded. Patients assessed: Meeting Minimal Clinically Important Difference (MCID) for NDI (<-15 ΔNDI). Ratios of correction were found for regional parameters categorized by Primary Ames Driver (C or CT). Decision tree analysis assessed cut-offs for differences associated with meeting NDI MCID at 1Y. RESULTS: Seventy-seven CD patients (62.1 years, 64%F, 28.8 kg/m2). 41.6% met MCID for NDI. A backward linear regression model including radiographic differences as predictors from BL to 1Y for meeting MCID for NDI demonstrated an R 2= 0.820 (P = 0.032) included TS-CL, cSVA, MGS, C2SS, C2-T3 angle, C2-T3 sagittal vertical axis (SVA), CL. By primary Ames driver, 67.5% of patients were C, and 32.5% CT. Ratios of change in predictors for MCID NDI patients for C and CT were not significant between the two groups (P > 0.050). Decision tree analysis determined cut-offs for radiographic change, prioritizing in the following order: ≥42.5° C2-T3 angle, >35.4° CL, <-31.76° C2 slope, <-11.57 mm cSVA, <-2.16° MGS, >-30.8 mm C2-T3 SVA, and ≤-33.6° TS-CL. CONCLUSIONS: Certain ratios of correction of cervical parameters contribute to improving neck disability. Prioritizing these radiographic alignment parameters may help optimize patient-reported outcomes for patients undergoing CD surgery.

Prioritization of Realignment Associated With Superior Clinical Outcomes for Cervical Deformity Patients.

OBJECTIVE: To prioritize the cervical parameter targets for alignment. METHODS: Included: cervical deformity (CD) patients (C2-7 Cobb angle > 10°, cervical lordosis > 10°, cervical sagittal vertical axis [cSVA] > 4 cm, or chin-brow vertical angle > 25°) with full baseline (BL) and 1-year (1Y) radiographic parameters and Neck Disability Index (NDI) scores; patients with cervical [C] or cervicothoracic [CT] Primary Driver Ames type. Patients with BL Ames classified as low CD for both parameters of cSVA ( < 4 cm) and T1 slope minus cervical lordosis (TS-CL) ( < 15°) were excluded. Patients assessed: meeting minimum clinically important differences (MCID) for NDI ( < -15 ΔNDI). Ratios of correction were found for regional parameters categorized by primary Ames driver (C or CT). Decision tree analysis assessed cutoffs for differences associated with meeting NDI MCID at 1Y. RESULTS: Seventy-seven CD patients (mean age, 62.1 years; 64% female; body mass index, 28.8 kg/m2). Forty-one point six percent of patients met MCID for NDI. A backwards linear regression model including radiographic differences as predictors from BL to 1Y for meeting MCID for NDI demonstrated an R2 of 0.820 (p = 0.032) included TS-CL, cSVA, McGregor's slope (MGS), C2 sacral slope, C2-T3 angle, C2-T3 SVA, cervical lordosis. By primary Ames driver, 67.5% of patients were C, and 32.5% CT. Ratios of change in predictors for MCID NDI patients for C and CT were not significant between the 2 groups (p > 0.050). Decision tree analysis determined cutoffs for radiographic change, prioritizing in the following order: ≥ 42.5° C2-T3 angle, > 35.4° cervical lordosis, < -31.76° C2 slope, < -11.57-mm cSVA, < -2.16° MGS, > -30.8-mm C2-T3 SVA, and ≤ -33.6° TS-CL. CONCLUSION: Certain ratios of correction of cervical parameters contribute to improving neck disability. Prioritizing these radiographic alignment parameters may help optimize patient-reported outcomes for patients undergoing CD surgery.

Redefining cervical spine deformity classification through novel cutoffs: An assessment of the relationship between radiographic parameters and functional neurological outcomes.

PURPOSE: The aim is to investigate the relationship between cervical parameters and the modified Japanese Orthopedic Association scale (mJOA). MATERIALS AND METHODS: Surgical adult cervical deformity (CD) patients were included in this retrospective analysis. After determining data followed a parametric distribution through the Shapiro-Wilk Normality (P = 0.15, P > 0.05), Pearson correlations were run for radiographic parameters and mJOA. For significant correlations, logistic regressions were performed to determine a threshold of radiographic measures for which the correlation with mJOA scores was most significant. mJOA score of 14 and <12 reported cut-off values for moderate (M) and severe (S) disability. New modifiers were compared to an existing classification using Spearman's rho and logistic regression analyses to predict outcomes up to 2 years. RESULTS: A total of 123 CD patients were included (60.5 years, 65%F, 29.1 kg/m2). For significant baseline factors from Pearson correlations, the following thresholds were predicted: MGS (M:-12 to-9° and 0°-19°, P = 0.020; S: >19° and <-12°, χ2= 4.291, P = 0.036), TS-CL (M: 26°to 45°, P = 0.201; S: >45°, χ2= 7.8, P = 0.005), CL (M:-21° to 3°, χ2= 8.947, P = 0.004; S: <-21°, χ2= 9.3, P = 0.009), C2-T3 (M: -35° to -25°, χ2= 5.485, P = 0.046; S: <-35°, χ2= 4.1, P = 0.041), C2 Slope (M: 33° to 49°, P = 0.122; S: >49°, χ2= 5.7, P = 0.008), and Frailty (Mild: 0.18-0.27, P = 0.129; Severe: >0.27, P = 0.002). Compared to existing Ames- International Spine Study Group classification, the novel thresholds demonstrated significant predictive value for reoperation and mortality up to 2 years. CONCLUSIONS: Collectively, these radiographic values can be utilized in refining existing classifications and developing collective understanding of severity and surgical targets in corrective surgery for adult CD.

Improvement in some Ames-ISSG cervical deformity classification modifier grades may correlate with clinical improvement.

This retrospective cohort study describes adult cervical deformity(ACD) patients with Ames-ACD classification at baseline(BL) and 1-year post-operatively and assesses the relationship of improvement in Ames modifiers with clinical outcomes. Patients ≥ 18yrs with BL and post-op(1-year) radiographs were included. Patients were categorized with Ames classification by primary deformity descriptors (C = cervical; CT = cervicothoracic junction; T = thoracic; S = coronal) and alignment/myelopathy modifiers(C2-C7 Sagittal Vertical Axis[cSVA], T1 Slope-Cervical Lordosis[TS-CL], Horizontal Gaze[Horiz], mJOA). Univariate analysis evaluated demographics, clinical intervention, and Ames deformity descriptor. Patients were evaluated for radiographic improvement by Ames classification and reaching Minimal Clinically Important Differences(MCID) for mJOA, Neck Disability Index(NDI), and EuroQuol-5D(EQ5D). A total of 73 patients were categorized: C = 41(56.2%), CT = 18(24.7%), T = 9(12.3%), S = 5(6.8%). By Ames modifier 1-year improvement, 13(17.8%) improved in mJOA, 26(35.6%) in cSVA grade, 19(26.0%) in Horiz, and 15(20.5%) in TS-CL. The overall proportion of patients without severe Ames modifier grades at 1-year was as follows: 100% cSVA, 27.4% TS-CL, 67.1% Horiz, 69.9% mJOA. 1-year post-operatively, severe myelopathy(mJOA = 3) prevalence differed between Ames-ACD descriptors (C = 26.3%, CT = 15.4%, T = 0.0%, S = 0.0%, p = 0.033). Improvement in mJOA modifier correlated with reaching 1-year NDI MCID in the overall cohort (r = 0.354,p = 0.002). For C descriptors, cSVA improvement correlated with reaching 1-year NDI MCID (r = 0.387,p = 0.016). Improvement in more than one radiographic Ames modifier correlated with reaching 1-year mJOA MCID (r = 0.344,p = 0.003) and with reaching more than one MCID for mJOA, NDI, and EQ-5D (r = 0.272,p = 0.020). In conclusion, improvements in radiographic Ames modifier grades correlated with improvement in 1-year postoperative clinical outcomes. Although limited in scope, this analysis suggests the Ames-ACD classification may describe cervical deformity patients' alignment and outcomes at 1-year.

Predictors of Superior Recovery Kinetics in Adult Cervical Deformity Correction: An Analysis Using a Novel Area Under the Curve Methodology.

STUDY DESIGN: Retrospective review of a prospective database. OBJECTIVE: The aim of this study was to identify demographic, surgical, and radiographic factors that predict superior recovery kinetics following cervical deformity (CD) corrective surgery. SUMMARY OF BACKGROUND DATA: Analyses of CD corrective surgery use area under the curve (AUC) to assess health-related quality of life (HRQL) metrics throughout recovery. METHODS: Outcome measures were baseline (BL) to 1-year (1Y) health-related quality of life (HRQL) (Neck Disability Index [NDI]). CD criteria were C2-7 Cobb angle >10°, coronal Cobb angle >10°, C2-C7 sagittal vertical axis (cSVA) >4 cm, TS-CL >10°, or chin-brow vertical angle >25°. AUC normalization divided BL and postoperative outcomes by BL. Normalized scores (y axis) were plotted against follow-up (x axis). AUC was calculated and divided by cumulative follow-up length to determine overall, time-adjusted recovery (Integrated Health State [IHS]). IHS NDI was stratified by quartile, uppermost 25% being "Superior" Recovery Kinetics (SRK) versus "Normal" Recovery Kinetics (NRK). BL demographic, clinical, and surgical information predicted SRK using generalized linear modeling. RESULTS: Ninety-eight patients included (62 ±â€Š10 years, 28 ±â€Š6 kg/m2, 65% females, Charlson Comorbidity Index: 0.95), 6% smokers, 31% smoking history. Surgical approach was: combined (33%), posterior (49%), anterior (18%). Posterior levels fused: 8.7, anterior: 3.6, estimated blood loss: 915.9ccs, operative time: 495 minutes. Ames BL classification: cSVA (53.2% minor deformity, 46.8% moderate), TS-CL (9.8% minor, 4.3% moderate, 85.9% marked), horizontal gaze (27.4% minor, 46.6% moderate, 26% marked). Relative to BL NDI (Mean: 47), normalized NDI decreased at 3 months (0.9 ±â€Š0.5, P = 0.260) and 1Y (0.78 ±â€Š0.41, P < 0.001). NDI IHS correlated with age (P = 0.011), sex (P = 0.042), anterior approach (P = 0.042), posterior approach (P = 0.042). Greater BL pelvic tilt (PT) (SRK: 25.6°, NRK: 17°, P = 0.002), pelvic incidence-lumbar lordosis (PI-LL) (SRK: 8.4°, NRK: -2.8°, P = 0.009), and anterior approach (SRK: 34.8%, NRK: 13.3%; P = 0.020) correlated with SRK. 69.4% met MCID for NDI (<Δ-15) and 63.3% met substantial clinical benefit for NDI (<Δ-10); 100% of SRK met both MCID and substantial clinical benefit. The predictive model for SRK included (AUC = 88.1%): BL visual analog scale (VAS) EuroQol five-dimensional descriptive system (EQ5D) (odds rario [OR] 0.96, 95% confidence interval [CI]: 0.92-0.99), BL swallow sleep score (OR: 1.04, 95% CI: 1.01-1.06), BL PT (OR: 1.12, 95% CI: 1.03-1.22), BL modified Japanese Orthopedic Association scale (mJOA) (OR: 1.5, 95% CI: 1.07-2.16), BL T4-T12, BL T10-L2, BL T12-S1, and BL L1-S1. CONCLUSION: Superior recovery kinetics following CD surgery was predicted with high accuracy using BL patient-reported (VAS EQ5D, swallow sleep, mJOA) and radiographic factors (PT, TK, T10-L2, T12-S1, L1-S1). Awareness of these factors can improve decision-making and reduce postoperative neck disability.Level of Evidence: 3.

The impact of postoperative neurologic complications on recovery kinetics in cervical deformity surgery.

OBJECTIVE: The objective of the study is to investigate which neurologic complications affect clinical outcomes the most following cervical deformity (CD) surgery. METHODS: CD patients (C2-C7 Cobb >10°, CL >10°, cSVA >4 cm or chin-brow vertical angle >25°) >18 years with follow-up surgical and health-related quality of life (HRQL) data were included. Descriptive analyses assessed demographics. Neurologic complications assessed were C5 motor deficit, central neurodeficit, nerve root motor deficits, nerve sensory deficits, radiculopathy, and spinal cord deficits. Neurologic complications were classified as major or minor, then: intraoperative, before discharge, before 30 days, before 90 days, and after 90 days. HRQL outcomes were assessed at 3 months, 6 months, and 1 year. Integrated health state (IHS) for the neck disability index (NDI), EQ5D, and modified Japanese Orthopaedic Association (mJOA) were assessed using all follow-up time points. A subanalysis assessed IHS outcomes for patients with 2Y follow-up. RESULTS: 153 operative CD patients were included. Baseline characteristics: 61 years old, 63% female, body mass index 29.7, operative time 531.6 ± 275.5, estimated blood loss 924.2 ± 729.5, 49% posterior approach, 18% anterior approach, 33% combined. 18% of patients experienced a total of 28 neurologic complications in the postoperative period (15 major). There were 7 radiculopathy, 6 motor deficits, 6 sensory deficits, 5 C5 motor deficits, 2 central neurodeficits, and 2 spinal cord deficits. 11.2% of patients experienced neurologic complications before 30 days (7 major) and 15% before 90 days (12 major). 12% of neurocomplication patients went on to have revision surgery within 6 months and 18% within 2 years. Neurologic complication patients had worse mJOA IHS scores at 1Y but no significant differences between NDI and EQ5D (0.003 vs. 0.873, 0.458). When assessing individual complications, central neurologic deficits and spinal cord deficit patients had the worst outcomes at 1Y (2.6 and 1.8 times worse NDI scores, P = 0.04, no improvement in EQ5D, 8% decrease in EQ5D). Patients with sensory deficits had the best NDI and EQ5D outcomes at 1Y (31% decrease in NDI, 8% increase in EQ5D). In a subanalysis, neurologic patients trended toward worse NDI and mJOA IHS outcomes (P = 0.263, 0.163). CONCLUSIONS: 18% of patients undergoing CD surgery experienced a neurologic complication, with 15% within 3 months. Patients who experienced any neurologic complication had worse mJOA recovery kinetics by 1 year and trended toward worse recovery at 2 years. Of the neurologic complications, central neurologic deficits and spinal cord deficits were the most detrimental.

A cost benefit analysis of increasing surgical technology in lumbar spine fusion.

BACKGROUND CONTEXT: Numerous advances have been made in the field of spine fusion, such as minimally invasive (MIS) or robotic-assisted spine surgery. However, it is unknown how these advances have impacted the cost of care. PURPOSE: Compare the economic outcomes of lumbar spine fusion between open, MIS, and robot-assisted surgery patients. STUDY DESIGN/SETTING: Retrospective review of a single center spine surgery database. PATIENT SAMPLE: Three hundred sixty propensity matched patients. OUTCOME MEASURES: Costs, EuroQol-5D (EQ5D), cost per quality adjusted life years (QALY). METHODS: Inclusion criteria: surgical patients >18 years undergoing lumbar fusion surgery. Patients were categorized into 3 groups based on procedure type: open, MIS, or robotic. Open patients undergoing poster spinal fusion were considered as the control group. MIS patients included those undergoing transforaminal or lateral lumbar interbody fusion with percutaneous screws. Robotic patients were those undergoing robot-assisted fusion. Propensity score matching was performed between all groups for the number of levels fused. Costs were calculated using the PearlDiver database, which reflects both private insurance and Medicare reimbursement claims for ICD-9 codes. For robotic cases, costs were reflective of operational fees and initial purchase cost. Complications and comorbidities and major complications and comorbidities were assessed according to CMS.gov manual definitions. QALYs and cost per QALY were calculated using a 3% discount rate to account for residual decline to life expectancy (78.7 years). Costs per QALY were calculated for both 1 year and life expectancy, assuming no loss of benefit. A 10,000 trial Monte Carlo simulation with probabilistic sensitivity analysis (PSA) assessed our model parameters and costs. RESULTS: Three hundred sixty propensity matched patients (120 open, 120 MIS, 120 robotic) met inclusion criteria. Descriptive statistics for the cohort were: age 58.8±13.5, 50% women, BMI 29.4±6.3, operative time 294.4±119.0, LOS 4.56±3.31 days, estimated blood loss 515.9±670.0 cc, and 2.3±2.2 average levels fused. Rates of post-op complications were significantly higher in robotic cases versus open and MIS (43% vs. 21% and 22% for open and MIS, p<.05). However, revision rates were comparable between all groups (3% open, 3% MIS, 5% robotic, p>.05). After factoring in complications, revisions, and purchasing and operating fees, the costs of robotic cases was significantly higher than both open and MIS surgery ($60,047.01 vs. $42,538.98 open and $41,471.21 MIS). In a subanalysis of 42 patients with baseline (BL) and 1Y EQ5D data, the cost per QALY at 1Y for open, MIS, and robot-assisted cases was $296,624.48, $115,911.69, and $592,734.30. If utility gained was sustained to life expectancy, the cost per QALY was $14,905.75, $5,824.71, $29,785.64 for open, MIS, and robot-assisted cases. Results of the PSA were consistent with MIS surgery having the most incremental cost effectiveness when compared to open and robotic surgery. CONCLUSIONS: Numerous advances have been made in the field of spine surgery, however, there has been limited discussion of the effect these advances have on economic outcomes. When matched for levels fused, robot-assisted surgery patients had significantly higher rates of complications and 30% higher costs of surgery compared to minimally invasive and open spine surgery patients. While 1 year economic outcomes were not optimal for robotic surgery cases, the projected costs per QALYs at life expectancy were well below established acceptable thresholds. The above findings may be reflective of an educational learning curve and emerging surgical technologies undergoing progressive refinement.

Pelvic Incidence Affects Age-adjusted Alignment Outcomes in a Population of Adult Spinal Deformity.

STUDY DESIGN: A single-center retrospective cohort study. OBJECTIVE: The objective of this study was to assess the effects of patient height and pelvic incidence (PI) on age-adjusted alignment outcomes of surgical adult spinal deformity (ASD) patients. SUMMARY OF BACKGROUND DATA: Patient height and PI have yet to be evaluated for their individual effects on achieving age-adjusted alignment targets. METHODS: Surgical ASD patients were grouped by percentile (low: <25th; normative: 25th-75th; high: >75th) for height and PI. Correction groups were generated at postoperative follow-up for actual alignment compared with age-adjusted ideal values for pelvic tilt (PT), pelvic incidence minus lumbar lordosis mismatch (PI-LL), and sagittal vertical axis, and PI-adjusted ideal alignment values for sacral slope (SS), as derived from clinically relevant formulas. Means comparison tests assessed differences in rates of matching ideal alignment (±10 y threshold for age-adjusted targets; -7 to 5 degrees measured minus ideal for SS) across height and PI groups. RESULTS: Breakdown of all included 198 patients by PI group: low (25%, 38±11 degrees), normative (50%, 57±5 degrees), high (25%, 75±7 degrees). Breakdown of patient height groups: low (25%, 1.52±0.04 m), normative (50% 1.64±0.05 m), and high (25%, 1.79±0.06 m). Overall, 29% of patients met postoperative age-adjusted alignment targets for PT, 23% for PI-LL, and 25% for sagittal vertical axis. Overall, 26% of patients met PI-adjusted SS alignment. There were no differences across patient height groups in rates of achieving adjusted alignment target (all P>0.05). Patients with high PI reached age-adjusted ideal alignment for PT at a lower rate (16%) than patients with normative (33%) or low PI (33%, P=0.056). Of patients that matched at least 1 ideal alignment target, those with high PI showed inferior preoperative to postoperative changes in EuroQol 5-dimension questionnaire as compared with normative and low PI patients (P=0.015). CONCLUSIONS: Patients with high PI reached ideal postoperative age-adjusted PT alignment at a lower rate than patients with normative and low PI. Height had no impact on postoperative age-adjusted alignment outcomes. Current postoperative ideal alignment targets may warrant an adjustment to account for PI.

A cost utility analysis of treating different adult spinal deformity frailty states.

The aim of this study was to investigate the cost utility of treating non-frail versus frail or severely frail adult spinal deformity (ASD) patients. 79 surgical ASD patients >18 years with available frailty and ODI data at baseline and 2-years post-surgery (2Y) were included. Utility data was calculated using the ODI converted to the SF-6D. QALYs utilized a 3% discount rate to account for decline to life expectancy (LE). Costs were calculated using the PearlDiver database. ICER was compared between non-operative (non-op.) and operative (op.) NF and F/SF patients at 2Y and LE. When compared to non-operative ASD, the ICER was $447,943.96 vs. $313,211.01 for NF and F/SF at 2Y, and $68,311.35 vs. $47,764.61 for NF and F/SF at LE. Frail and severely frail patients had lower cost per QALY compared to not frail patients at 2Y and life expectancy, and had lower ICER values when compared to a non-operative cohort of ASD patients. While these results support operative correction of frail and severely frail patients, it is important to note that these patients are often at worse baseline disability, which is closely related to frailty scores, and have more opportunity to improve postoperatively. Furthermore, there may be a threshold of frailty that is not operable due to the risk of severe complications that is not captured by this analysis. While future research should investigate economic outcomes at extended follow up times, these findings support the cost effectiveness of ASD surgery at all frailty states.

Readmission in elective spine surgery: Will short stays be beneficial to patients.

There has been limited discussion as to whether spine surgery patients are benefiting from shorter in-patient hospital stays or if they are incurring higher rates of readmission and complications secondary to shortened length of stays. Included in this study were 237,446 spine patients >18yrs and excluding infection. Patients with Clavien Grade 5 complications in 2015 had the lowest mean time to readmission after initial surgery in all years at 12.44 ± 9.03 days. Pearson bivariate correlations between LOS ≤ 1 day and decreasing days to readmission was the strongest in 2016.). Logistic regression analysis found that LOS ≤ 1 day showed an overall increase in the odds of hospital readmission from 2012 to 2016 (2.29 [2.00-2.63], 2.33 [2.08-2.61], 2.35 [2.11-2.61], 2.27 [2.06-2.49], 2.33 [2.14-2.54], all p < 0.001).

ODI Cannot Account for All Variation in PROMIS Scores in Patients With Thoracolumbar Disorders.

STUDY DESIGN: Retrospective review of single institution. OBJECTIVE: To assess the relationship between Patient-Reported Outcomes Measurement Information System (PROMIS) and Oswestry Disability Index (ODI) scores in thoracolumbar patients. METHODS: Included: Patients ≥18 years with a thoracolumbar spine condition (spinal stenosis, disc herniation, low back pain, disc degeneration, spondylolysis). Bivariate correlations assessed the linear relationships between ODI and PROMIS (Physical Function, Pain Intensity, and Pain Interference). Correlation cutoffs assessed patients with high and low correlation between ODI and PROMIS. Linear regression predicted the relationship of ODI to PROMIS. RESULTS: A total of 206 patients (age 53.7 ± 16.6 years, 49.5% female) were included. ODI correlated with PROMIS Physical Function (r = -0.763, P < .001), Pain Interference (r = 0.800, P < .001), and Pain Intensity (r = 0.706, P < .001). ODI strongly predicted PROMIS for Physical Function (R 2 = 0.58, P < .001), Pain Intensity (R 2 = 0.50, P < .001), and Pain Interference (R 2 = 0.64, P < .001); however, there is variability in PROMIS that ODI cannot account for. ODI questions about sitting and sleeping were weakly correlated across the 3 PROMIS domains. Linear regression showed overall ODI score as accounting for 58.3% (R 2 = 0.583) of the variance in PROMIS Physical Function, 63.9% (R 2 = 0.639) of the variance in Pain Interference score, and 49.9% (R 2 = 0.499) of the variance in Pain Intensity score. CONCLUSIONS: There is a large amount of variability with PROMIS that cannot be accounted for with ODI. ODI questions regarding walking, social life, and lifting ability correlate strongly with PROMIS while sitting, standing, and sleeping do not. These results reinforce the utility of PROMIS as a valid assessment for low back disability, while indicating the need for further evaluation of the factors responsible for variation between PROMIS and ODI.

Probability of severe frailty development among operative and nonoperative adult spinal deformity patients: an actuarial survivorship analysis over a 3-year period.

BACKGROUND: Little is known of how frailty, a dynamic measure of physiological age, progresses relative to age or disability status. Operative treatment of adult spinal deformity (ASD) may play a role in frailty remediation and maintenance. PURPOSE: Compare frailty status, severe frailty development, and factors influencing severe frailty development among ASD patients undergoing operative or nonoperative treatment. DESIGN: Retrospective review with maximum follow-up of 3 years. SETTING: Prospective, multicenter, ASD database. PARTICIPANTS: Patients were consecutively enrolled from 13 participating centers. INCLUSION CRITERIA: ≥18 years undergoing either operative or nonoperative treatment for ASD, exclusion criteria: spinal deformity of neuromuscular etiology, presence of active infection, or malignancy. The mean age of the participants analyzed were 54.9 for the operative cohort and 55.0 for the nonoperative cohort. OUTCOMES MEASURES: Frailty status, severe frailty development, and factors influencing severe frailty development. METHODS: ASD patients (coronal scoliosis ≥20°, sagittal vertical axis (SVA) ≥5 cm, Pelvic Tilt (PT) ≥25°, or thoracic kyphosis ≥60°) >18 y/o, with Base Line (BL) frailty scores were included. Frailty was scored from 0 to 1 (not frail: <0.3, frail 0.3-0.5, severe frailty >0.5) through the use of ASD-frailty index (FI) which has been validated using the International Spine Study Group (ISSG) ASD database, European Spine Study Group ASD database, and the Scoli-RISK-1 Patient Database. The ISSG is funded through research grants from DePuy Synthes and individual donations and supported the current work. Operative (Op) and Nonoperative (Non-Op) patients were propensity matched. T-tests compared frailty among treatment groups and BL, 1, 2, and ≥3 years. An actuarial Kaplan-Meier survivorship analysis with log-rank (Mantel-Cox) test, adjusting for patients lost to follow-up, determined probability of severe frailty development. Multivariate Cox Regressions gauged the effect of sagittal malalignment, patient and surgical details on severe frailty development. RESULTS: The analysis includes 472 patients (236 Op, 236 Non-Op) selected by propensity score matching from a cohort of 1,172. Demographics and comorbidities were similar between groups (p>.05). Op exhibited decreased frailty at all follow-up intervals compared with BL (BL: 0.22 vs Y1: 0.18; Y2: 0.16; Y3: 0.15, all p<.001). Non-Op displayed similar frailty from BL to 2Y follow up, and increased frailty at 3Y follow up (0.23 vs 0.25, p=.014). Compared with Non-Op, Op had lower frailty at 1Y (0.18 vs 0.24), 2Y (0.16 vs 0.23), and 3Y (0.15 vs 0.25; all p<.001). Cumulative probability of maintaining nonsevere frailty was (Op: 97.7%, Non-Op: 94.5%) at 1Y, (Op: 95.1%, Non-Op: 90.4%) at 2Y, and (Op: 95.1%, Non-Op: 89.1%) at ≥3Y, (p=.018). Among all patients, baseline depression (hazard ratio: 2.688[1.172-6.167], p=.020), Numeric Rating Scale (NRS) back pain scores (HR: 1.247[1.012-1.537], p=.039), and nonoperative treatment (HR: 2.785[1.167-6.659], p=.021) predicted severe frailty development with having a HR>1.0 and p value<.05. Among operative patients, 6-week postoperative residual SVA malalignment (SRS-Schwab SVA+modifier) (HR: 15.034[1.922-116.940], p=.010) predicted severe frailty development indicated by having a HR>1.0 and p value <.05. CONCLUSIONS: Non-Op patients were more likely to develop severe frailty, and at a quicker rate. Baseline depression, increased NRS back pain scores, nonoperative treatment, and postoperative sagittal malalignment at 6-week follow-up significantly predicted severe frailty development. Operative intervention and postoperative sagittal balance appear to play significant roles in frailty remediation and maintenance in ASD patients. Frailty is one factor, in a multifactorial conservation, that may be considered when determining operative or nonoperative values for ASD patients. Operating before the onset of severe frailty, may result in a lower complication risk and better long-term clinical outcomes.

Bariatric Surgery Population at Significantly Increased Risk of Spinal Disorders and Surgical Intervention Compared With Morbidly Obese Patients.

INTRODUCTION: Obesity is associated with acceleration of musculoskeletal degenerative diseases and functional impairment secondary to spinal disorders. Bariatric surgery (BS) is an increasingly common treatment for severe obesity but can affect bone and mineral metabolism. The effect of BS on degenerative spinal disorders is yet to be fully described. The aim of our study was to analyze changes in bariatric patients' risk for spinal degenerative diseases and spinal surgery. METHODS: Retrospective analysis of the prospectively collected New York State Inpatient Database (NYSID) years (2004-2013) using patient linkage codes. The incidence of degenerative spinal diagnoses and spinal surgery was queried using International Classification of Diseases, Ninth Revision (ICD)-9 codes for morbidly obese patients (ICD-9 278.01) with and without a history of BS. The incidence of degenerative spinal diagnoses and spinal surgery was determined using χ tests for independence. Logistic testing controlled for age, sex, and comorbidity burden. RESULTS: A total of 18,176 patients were identified in the NYSID database with a history of BS and 146,252 patients were identified as morbidly obese without a history of BS. BS patients have a significantly higher rate of spinal diagnoses than morbidly obese patients without BS (19.3% vs. 8.1%, P<0.001). Bariatric patients were more likely to have spinal diagnoses and procedures than nonbariatric obese patients (P<0.001). This was mostly observed in lumbar spinal stenosis (5.0%), cervical disk herniation (3.3%), lumbar disk degeneration (3.4%), lumbar spondylolisthesis (2.9%), lumbar spondylosis (1.9%), and cervical spondylosis with myelopathy (2.0%). Spine procedure rates are higher for bariatric patients than nonbariatric overall (25.6% vs. 2.3, P<0.001) and for fusions and decompressions (P<0.001). When controlling for age, sex, and comorbidities (and diagnosis rate with regards to procedure rates), these results persist, with BS patients having a higher likelihood of spinal diagnoses and procedures. In addition, bariatric patients had a lower comorbidity burden than morbidly obese patients without a history of BS. CONCLUSIONS: Morbidly obese BS patients have a dramatically higher incidence of spinal diagnoses and procedures, relative to morbidly obese patients without BS. Further study is necessary to determine if there is a pathophysiological mechanism underlying this higher risk of spinal disease and intervention in bariatric patients, and the effect of BS on these rates following treatment. LEVEL OF EVIDENCE: Level III.

A Simpler, Modified Frailty Index Weighted by Complication Occurrence Correlates to Pain and Disability for Adult Spinal Deformity Patients.

BACKGROUND: The Miller et al adult spinal deformity frailty index (ASD-FI) correlates with complication risk; however, its development was not rooted in clinical outcomes, and the 40 factors needed for its calculation limit the index's clinical utility. The present study aimed to develop a simplified, weighted frailty index for ASD patients METHODS: This study is a retrospective review of a single-center database. Component ASD-FI parameters contributing to overall ASD-FI score were assessed via Pearson correlation. Top significant, clinically relevant factors were regressed against ASD-FI score to generate the modified ASD-FI (mASD-FI). Component mASD-FI factors were regressed against incidence of medical complications, and factor weights were calculated from regression of these coefficients. Total mASD-FI score ranged from 0 to 21, and was calculated by summing weights of expressed parameters. Linear regression and published ASD-FI cutoffs generated corresponding mASD-FI frailty cutoffs: not frail (NF, <7), frail (7-12), severely frail (SF, >12). Analysis of variance assessed the relationship between frailty category and validated baseline measures of pain and disability at baseline. RESULTS: The study included 50 ASD patients. Eight factors were included in the mASD-FI. Overall mean mASD-FI score was 5.7 ± 5.2. Combined, factors comprising the mASD-FI showed a trend of predicting the incidence of medical complications (Nagelkerke R 2 = 0.558; Cox & Snell R 2 = 0.399; P = .065). Breakdown by frailty category is NF (70%), frail (12%), and SF (18%). Increasing frailty category was associated with significant impairments in measures of pain and disability: Oswestry Disability Index (NF: 23.4; frail: 45.0; SF: 49.3; P < .001), SRS-22r (NF: 3.5; frail: 2.6; SF: 2.4; P = .001), Pain Catastrophizing Scale (NF: 41.9; frail: 32.4; SF: 27.6; P < .001), and NRS Leg Pain (NF: 2.3; frail: 7.2; SF: 5.6; P = .001). CONCLUSIONS: This study modifies an existing ASD frailty index and proposes a weighted, shorter mASD-FI. The mASD-FI relies less on patient-reported variables, and it weights component factors by their contribution to adverse outcomes. Because increasing mASD-FI score is associated with inferior clinical measures of pain and disability, the mASD-FI may serve as a valuable tool for preoperative risk assessment.

Development of a Novel Cervical Deformity Surgical Invasiveness Index.

STUDY DESIGN: Retrospective review. OBJECTIVE: The aim of this study was to develop a novel surgical invasiveness index for cervical deformity (CD) surgery that incorporates CD-specific parameters. SUMMARY OF BACKGROUND DATA: There has been a surgical invasiveness index for general spine surgery and adult spinal deformity, but a CD index has not been developed. METHODS: CD was defined as at least one of the following: C2-C7 Cobb >10°, cervical lordosis (CL) >10°, cervical sagittal vertical axis (cSVA) >4 cm, chin brow vertical angle >25°. Consensus from experienced spine and neurosurgeons selected weightings for each variable that went into the invasiveness index. Binary logistic regression predicted high operative time (>338 minutes), estimated blood loss (EBL) (>600 mL), or length of stay (LOS) >5 days) based on the median values of operative time, EBL, and LOS. Multivariable regression modeling was utilized to construct a final model incorporating the strongest combination of factors to predict operative time, LOS, and EBL. RESULTS: Eighty-five CD patients were included (61 years, 66% females). The variables in the newly developed CD invasiveness index with their corresponding weightings were: history of previous cervical surgery (3), anterior cervical discectomy and fusion (2/level), corpectomy (4/level), levels fused (1/level), implants (1/level), posterior decompression (2/level), Smith-Peterson osteotomy (2/level), three-column osteotomy (8/level), fusion to upper cervical spine (2), absolute change in T1 slope minus cervical lordosis, cSVA, T4-T12 thoracic kyphosis (TK), and sagittal vertical axis (SVA) from baseline to 1-year. The newly developed CD-specific invasiveness index strongly predicted long LOS (R = 0.310, P < 0.001), high EBL (R = 0.170, P = 0.011), and extended operative time (R = 0.207, P = 0.031). A second analysis used multivariable regression modeling to determine which combination of factors in the newly developed index were the strongest determinants of operative time, LOS, and EBL. The final predictive model included: number of corpectomies, levels fused, decompression, combined approach, and absolute changes in SVA, cSVA, and TK. This model predicted EBL (R = 0.26), operative time (R = 0.12), and LOS (R = 0.13). CONCLUSION: Extended LOS, operative time, and high blood loss were strongly predicted by the newly developed CD invasiveness index, incorporating surgical factors and radiographic parameters clinically relevant for patients undergoing CD corrective surgery. LEVEL OF EVIDENCE: 4.

Durability of Satisfactory Functional Outcomes Following Surgical Adult Spinal Deformity Correction: A 3-Year Survivorship Analysis.

BACKGROUND: Despite reports showing positive long-term functional outcomes following adult spinal deformity (ASD)-corrective surgery, it is unclear which factors affect the durability of these outcomes. OBJECTIVE: To assess durability of functional gains following ASD-corrective surgery; determine predictors for postoperative loss of functionality. METHODS: Surgical ASD patients > 18 yr with 3-yr Oswestry Disability Index (ODI) follow-up, and 1-yr postoperative (1Y) ODI scores reaching substantial clinical benefit (SCB) threshold (SCB < 31.3 points). Patients were grouped: those sustaining ODI at SCB threshold beyond 1Y (sustained functionality) and those not (functional decline). Kaplan-Meier survival analysis determined postoperative durability of functionality. Multivariate Cox regression assessed the relationship between patient/surgical factors and functional decline, accounting for age, sex, and levels fused. RESULTS: All 166 included patients showed baseline to 1Y functional improvement (mean ODI: 35.3 ± 16.5-13.6 ± 9.2, P < .001). Durability of satisfactory functional outcomes following the 1Y postoperative interval was 88.6% at 2-yr postoperative, and 71.1% at 3-yr postoperative (3Y). Those sustaining functionality after 1Y had lower baseline C2-S1 sagittal vertical axis (SVA) and T1 slope (both P < .05), and lower 1Y thoracic kyphosis (P = .035). From 1Y to 3Y, patients who sustained functionality showed smaller changes in alignment: pelvic incidence minus lumbar lordosis, SVA, T1 slope minus cervical lordosis, and C2-C7 SVA (all P < .05). Those sustaining functionality beyond 1Y were also younger, less frail at 1Y, and had lower rates of baseline osteoporosis, hypertension, and lung disease (all P < .05). Lung disease (Hazard Ratio:4.8 [1.4-16.4]), 1Y frailty (HR:1.4 [1.1-1.9]), and posterior approach (HR:2.6 [1.2-5.8]) were associated with more rapid decline. CONCLUSION: Seventy-one percent of ASD patients maintained satisfactory functional outcomes by 3Y. Of those who failed to sustain functionality, the largest functional decline occurred 3-yr postoperatively. Frailty, preoperative comorbidities, and surgical approach affected durability of functional gains following surgery.