Factors Associated with the Maintenance of Cost-Effectiveness at 5 Years in Adult Spinal Deformity Corrective Surgery.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To evaluate factors associated with the long-term durability of cost-effectiveness (CE) in ASD patients. BACKGROUND: A substantial increase in costs associated with the surgical treatment for adult spinal deformity (ASD) has given precedence to scrutinize the value and utility it provides. METHODS: We included 327 operative ASD patients with 5-year (5 Y) follow-up. Published methods were used to determine costs based on CMS.gov definitions and were based on the average DRG reimbursement rates. Utility was calculated using quality-adjusted life-years (QALY) utilizing the Oswestry Disability Index (ODI) converted to Short-Form Six-Dimension (SF-6D), with a 3% discount applied for its decline with life expectancy. The CE threshold of $150,000 was used for primary analysis. RESULTS: Major and minor complication rates were 11% and 47% respectively, with 26% undergoing reoperation by 5 Y. The mean cost associated with surgery was $91,095±$47,003, with a utility gain of 0.091±0.086 at 1Y, QALY gained at 2 Y of 0.171±0.183, and at 5 Y of 0.42±0.43. The cost per QALY at 2 Y was $414,885, which decreased to $142,058 at 5 Y.With the threshold of $150,000 for CE, 19% met CE at 2 Y and 56% at 5 Y. In those in which revision was avoided, 87% met cumulative CE till life expectancy. Controlling analysis depicted higher baseline CCI and pelvic tilt (PT) to be the strongest predictors for not maintaining durable CE to 5 Y (CCI OR: 1.821 [1.159-2.862], P=0.009) (PT OR: 1.079 [1.007-1.155], P=0.030). CONCLUSIONS: Most patients achieved cost-effectiveness after four years postoperatively, with 56% meeting at five years postoperatively. When revision was avoided, 87% of patients met cumulative cost-effectiveness till life expectancy. Mechanical complications were predictive of failure to achieve cost-effectiveness at 2 Y, while comorbidity burden and medical complications were at 5 Y.

Development of a modified frailty index for adult spinal deformities independent of functional changes following surgical correction: a true baseline risk assessment tool.

PURPOSE: To develop a simplified, modified frailty index for adult spinal deformity (ASD) patients dependent on objective clinical factors. METHODS: ASD patients with baseline (BL) and 2-year (2Y) follow-up were included. Factors with the largest R2 value derived from multivariate forward stepwise regression were including in the modified ASD-FI (clin-ASD-FI). Factors included in the clin-ASD-FI were regressed against mortality, extended length of hospital stay (LOS, > 8 days), revisions, major complications and weights for the clin-ASD-FI were calculated via Beta/Sullivan. Total clin-ASD-FI score was created with a score from 0 to 1. Linear regression correlated clin-ASD-FI with ASD-FI scores and published cutoffs for the ASD-FI were used to create the new frailty cutoffs: not frail (NF: < 0.11), frail (F: 0.11-0.21) and severely frail (SF: > 0.21). Binary logistic regression assessed odds of complication or reop for frail patients. RESULTS: Five hundred thirty-one ASD patients (59.5 yrs, 79.5% F) were included. The final model had a R2 of 0.681, and significant factors were: < 18.5 or > 30 BMI (weight: 0.0625 out of 1), cardiac disease (0.125), disability employment status (0.3125), diabetes mellitus (0.0625), hypertension (0.0625), osteoporosis (0.125), blood clot (0.1875), and bowel incontinence (0.0625). These factors calculated the score from 0 to 1, with a mean cohort score of 0.13 ± 0.14. Breakdown by clin-ASD-FI score: 51.8% NF, 28.1% F, 20.2% SF. Increasing frailty severity was associated with longer LOS (NF: 7.0, F: 8.3, SF: 9.2 days; P < 0.001). Frailty independently predicted occurrence of any complication (OR: 9.357 [2.20-39.76], P = 0.002) and reop (OR: 2.79 [0.662-11.72], P = 0.162). CONCLUSIONS: Utilizing an existing ASD frailty index, we proposed a modified version eliminating the patient-reported components. This index is a true assessment of physiologic status, and represents a superior risk factor assessment compared to other tools for both primary and revision spinal deformity surgery as a result of its immutability with surgery, lack of subjectivity, and ease of use.

Cost Benefit of Implementation of Risk Stratification Models for Adult Spinal Deformity Surgery.

STUDY DESIGN/SETTING: Retrospective cohort study. OBJECTIVE: Assess the extent to which defined risk factors of adverse events are drivers of cost-utility in spinal deformity (ASD) surgery. METHODS: ASD patients with 2-year (2Y) data were included. Tertiles were used to define high degrees of frailty, sagittal deformity, blood loss, and surgical time. Cost was calculated using the Pearl Diver registry and cost-utility at 2Y was compared between cohorts based on the number of risk factors present. Statistically significant differences in cost-utility by number of baseline risk factors were determined using ANOVA, followed by a generalized linear model, adjusting for clinical site and surgeon, to assess the effects of increasing risk score on overall cost-utility. RESULTS: By 2 years, 31% experienced a major complication and 23% underwent reoperation. Patients with ≤2 risk factors had significantly less major complications. Patients with 2 risk factors improved the most from baseline to 2Y in ODI. Average cost increased by $8234 per risk factor (R2 = .981). Cost-per-QALY at 2Y increased by $122,650 per risk factor (R2 = .794). Adjusted generalized linear model demonstrated a significant trend between increasing risk score and increasing cost-utility (r2 = .408, P < .001). CONCLUSIONS: The number of defined patient-specific and surgical risk factors, especially those with greater than two, were associated with increased index surgical costs and diminished cost-utility. Efforts to optimize patient physiology and minimize surgical risk would likely reduce healthcare expenditures and improve the overall cost-utility profile for ASD interventions.Level of evidence: III.

Clinical and Economic Impact of Proximal Junctional Kyphosis on Pediatric and Adult Spinal Deformity Patients.

The common goal of pediatric and adult spinal reconstructive procedures is to minimize long-term risk of disability, pain, and mortality. A common complication that has proved particularly problematic in the adult spinal deformity population and that has been an area of increased research and clinical focus is proximal junctional kyphosis (PJK). The incidence of PJK ranges from 10%-40% based on criteria used to define the condition. Clinically, PJK complication is associated with increased pain, decreased self-image and Scoliosis Research Society scores, and severe neurological injuries affecting the patient's quality of life. Economically, direct costs of PJK complication-associated revision surgery ranges from $20,000 to $120,000, which places an enormous burden on patients, providers, and payers. To mitigate the risk of PJK occurrence postoperatively, it is paramount to develop consistent guidelines in defining and classifying PJK in addition to extensive preoperative planning and risk stratification that is patient specific. This article will provide an overview on the clinical and economic impact of PJK in pediatric and adult spine deformity patients with an emphasis on the role of patient factors and predictive analytics, challenges in developing a consistent PJK classification, and current treatment and prevention 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.

The Shape of the Fused Spine is Associated With Acute Proximal Junctional Kyphosis in Adult Spinal Deformity: An Assessment Based on Vertebral Pelvic Angles.

STUDY DESIGN: Retrospective review of prospective database. OBJECTIVES: Vertebral pelvic angles (VPAs) account for complexity in spine shape by assessing the relative position of each vertebra with regard to the pelvis. This study uses VPAs to investigate the shape of the fused spine after T10-pelvis fusion, in patients with adult spinal deformity (ASD), and then explores its association with proximal junctional kyphosis (PJK). METHODS: Included patients had radiographic evidence of ASD and underwent T10-pelvis realignment. VPAs were used to construct a virtual shape of the post-operative spine. VPA-predicted and actual shapes were then compared between patients with and without PJK. Logistic regression was used to identify components of the VPA-based model that were independent predictors of PJK occurrence and post-operative shape. RESULTS: 287 patients were included. VPA-predicted shape was representative of the true post-operative contour, with a mean point-to-point error of 1.6-2.9% of the T10-S1 spine length. At 6-weeks follow-up, 102 patients (35.5%) developed PJK. Comparison of the true post-operative shapes demonstrated that PJK patients had more posteriorly translated vertebrae from L3 to T7 (P < .001). Logistic regression demonstrated that L3PA (P = .047) and T11PA (P < .001) were the best independent predictors of PJK and were, in conjunction with pelvic incidence, sufficient to reproduce the actual spinal contour (error <3%). CONCLUSIONS: VPAs are reliable in reproducing the true, post-operative spine shape in patients undergoing T10-pelvis fusion for ASD. Because VPAs are independent of patient position, L3PA, T11PA, and PI measurements can be used for both pre- and intra-operative planning to ensure optimal alignment.

Improvements in Outcomes and Cost After Adult Spinal Deformity Corrective Surgery Between 2008 and 2019.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: To assess whether patient outcomes and cost-effectiveness of adult spinal deformity (ASD) surgery have improved over the past decade. BACKGROUND: Surgery for ASD is an effective intervention, but one that is also associated with large initial healthcare expenditures. Changes in the cost profile for ASD surgery over the last decade has not been evaluated previously. MATERIALS AND METHODS: ASD patients who received surgery between 2008 and 2019 were included. Analysis of covariance was used to establish estimated marginal means for outcome measures [complication rates, reoperations, health-related quality of life, total cost, utility gained, quality adjusted life years (QALYs), cost-efficiency (cost per QALY)] by year of initial surgery. Cost was calculated using the PearlDiver database and represented national averages of Medicare reimbursement for services within a 30-day window including length of stay and death differentiated by complication/comorbidity, revision, and surgical approach. Internal cost data was based on individual patient diagnosis-related group codes, limiting revisions to those within two years (2Y) of the initial surgery. Cost per QALY over the course of 2008-2019 were then calculated. RESULTS: There were 1236 patients included. There was an overall decrease in rates of any complication (0.78 vs . 0.61), any reoperation (0.25 vs . 0.10), and minor complication (0.54 vs . 0.37) between 2009 and 2018 (all P <0.05). National average 2Y cost decreased at an annual rate of $3194 ( R2 =0.6602), 2Y utility gained increased at an annual rate of 0.0041 ( R2 =0.57), 2Y QALYs gained increased annually by 0.008 ( R2 =0.57), and 2Y cost per QALY decreased per year by $39,953 ( R2 =0.6778). CONCLUSION: Between 2008 and 2019, rates of complications have decreased concurrently with improvements in patient reported outcomes, resulting in improved cost effectiveness according to national Medicare average and individual patient cost data. The value of ASD surgery has improved substantially over the course of the last decade.

Diagnosis-Related Group-Based Payments for Adult Spine Deformity Surgery Significantly Vary across Centers: Results from a Multicenter Prospective Cohort Study.

BACKGROUND: To investigate the variation in total episode-of-care (EOC) payment and quality-adjusted life-year (QALY) gain for complex adult spine deformity surgeries in the United States, adjusting for case type and surgeon preferences. METHODS: Patients aged >18 years with adult spine deformity with Medicare Severity-Diagnosis-Related Groups (DRGs) 453-460 and a minimum of 2 years of follow-up from index surgery were included. Index and total payments were calculated using Medicare's Inpatient Prospective Payment System. All costs were adjusted for inflation to 2020 U.S. dollar values. QALYs gained were calculated using baseline, 1-year, and 2-year Short-Form 6D scores. Mixed-effect models were used to estimate the proportion of variation in total EOC payment and QALY gain. RESULTS: A total of 330/543 patients from 6 sites were included. Mean age was 62.4 ± 11.9 years, 79% were women, and 92% were white. The mean index and total EOC payment were $77,302 and $93,182, respectively. Patients gained on average 0.15 QALY (P < 0.0001) 2 years after surgery. In unadjusted analysis, 39% of the variation in total EOC payment across the 6 centers was attributable to relative weight of DRG and base rate. Adjusting for patient and procedural factors increased the proportion of variation in total EOC payments across the centers to 56%. Less than 2% of the variation in QALY gain was observed across the 6 centers. CONCLUSIONS: Medicare-based payments for complex spine deformity fusions are primarily driven by relative weight of the DRG and the hospital's base rate. Patient and procedural factors are unaccounted for in the DRG-based payments made to the providers.

Failure in Adult Spinal Deformity Surgery: A Comprehensive Review of Current Rates, Mechanisms, and Prevention Strategies.

STUDY DESIGN: Literature review. OBJECTIVE: The aim of this review is to summarize recent literature on adult spinal deformity (ASD) treatment failure as well as prevention strategies for these failure modes. SUMMARY OF BACKGROUND DATA: There is substantial evidence that ASD surgery can provide significant clinical benefits to patients. The volume of ASD surgery is increasing, and significantly more complex procedures are being performed, especially in the aging population with multiple comorbidities. Although there is potential for significant improvements in pain and disability with ASD surgery, these procedures continue to be associated with major complications and even outright failure. METHODS: A systematic search of the PubMed database was performed for articles relevant to failure after ASD surgery. Institutional review board approval was not needed. RESULTS: Failure and the potential need for revision surgery generally fall into 1 of 4 well-defined phenotypes: clinical failure, radiographic failure, the need for reoperation, and lack of cost-effectiveness. Revision surgery rates remain relatively high, challenging the overall cost-effectiveness of these procedures. CONCLUSION: By consolidating the key evidence regarding failure, further research and innovation may be stimulated with the goal of significantly improving the safety and cost-effectiveness of ASD surgery.

Evolution of Adult Cervical Deformity Surgery Clinical and Radiographic Outcomes Based on a Multicenter Prospective Study: Are Behaviors and Outcomes Changing With Experience?

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Assess changes in outcomes and surgical approaches for adult cervical deformity surgery over time. SUMMARY OF BACKGROUND DATA: As the population ages and the prevalence of cervical deformity increases, corrective surgery has been increasingly seen as a viable treatment. Dramatic surgical advancements and expansion of knowledge on this procedure have transpired over the years, but the impact on cervical deformity surgery is unknown. MATERIALS AND METHODS: Adult cervical deformity patients (18 yrs and above) with complete baseline and up to the two-year health-related quality of life and radiographic data were included. Descriptive analysis included demographics, radiographic, and surgical details. Patients were grouped into early (2013-2014) and late (2015-2017) by date of surgery. Univariate and multivariable regression analyses were used to assess differences in surgical, radiographic, and clinical outcomes over time. RESULTS: A total of 119 cervical deformity patients met the inclusion criteria. Early group consisted of 72 patients, and late group consisted of 47. The late group had a higher Charlson Comorbidity Index (1.3 vs. 0.72), more cerebrovascular disease (6% vs. 0%, both P <0.05), and no difference in age, frailty, deformity, or cervical rigidity. Controlling for baseline deformity and age, late group underwent fewer three-column osteotomies [odds ratio (OR)=0.18, 95% confidence interval (CI): 0.06-0.76, P =0.014]. At the last follow-up, late group had less patients with: a moderate/high Ames horizontal modifier (71.7% vs. 88.2%), and overcorrection in pelvic tilt (4.3% vs. 18.1%, both P <0.05). Controlling for baseline deformity, age, levels fused, and three-column osteotomies, late group experienced fewer adverse events (OR=0.15, 95% CI: 0.28-0.8, P =0.03), and neurological complications (OR=0.1, 95% CI: 0.012-0.87, P =0.03). CONCLUSION: Despite a population with greater comorbidity and associated risk, outcomes remained consistent between early and later time periods, indicating general improvements in care. The later cohort demonstrated fewer three-column osteotomies, less suboptimal realignments, and concomitant reductions in adverse events and neurological complications. This may suggest a greater facility with less invasive techniques.

The Additional Economic Burden of Frailty in Adult Cervical Deformity Patients Undergoing Surgical Intervention.

SUMMARY OF BACKGROUND DATA: The influence of frailty on economic burden following corrective surgery for the adult cervical deformity (CD) is understudied and may provide valuable insights for preoperative planning. OBJECTIVE: To assess the influence of baseline frailty status on the economic burden of CD surgery. STUDY DESIGN: Retrospective cohort. MATERIALS AND METHODS: CD patients with frailty scores and baseline and two-year Neck Disability Index data were included. Frailty score was categorized patients by modified CD frailty index into not frail (NF) and frail (F). Analysis of covariance was used to estimate marginal means adjusting for age, sex, surgical approach, and baseline sacral slope, T1 slope minus cervical lordosis, C2-C7 angle, C2-C7 sagittal vertical axis. Costs were derived from PearlDiver registry data. Reimbursement consisted of a standardized estimate using regression analysis of Medicare payscales for services within a 30-day window including length of stay and death. This data is representative of the national average Medicare cost differentiated by complication/comorbidity outcome, surgical approach, and revision status. Cost per quality-adjusted life-year (QALY) at two years was calculated for NF and F patients. RESULTS: There were 126 patients included. There were 68 NF patients and 58 classified as F. Frailty groups did not differ by overall complications, instance of distal junctional kyphosis, or reoperations (all P >0.05). These groups had similar rates of radiographic and clinical improvement by two years. NF and F had similar overall cost ($36,731.03 vs. $37,356.75, P =0.793), resulting in equivocal costs per QALYs for both patients at two years ($90,113.79 vs. $80,866.66, P =0.097). CONCLUSION: F and NF patients experienced similar complication rates and upfront costs, with equivocal utility gained, leading to comparative cost-effectiveness with NF patients based on cost per QALYs at two years. Surgical correction for CD is an economical healthcare investment for F patients when accounting for anticipated utility gained and cost-effectiveness following the procedure. LEVEL OF EVIDENCE: III.

Operative treatment outcomes for adult cervical deformity: a prospective multicenter assessment with mean 3-year follow-up.

OBJECTIVE: Adult cervical deformity (ACD) has high complication rates due to surgical complexity and patient frailty. Very few studies have focused on longer-term outcomes of operative ACD treatment. The objective of this study was to assess minimum 2-year outcomes and complications of ACD surgery. METHODS: A multicenter, prospective observational study was performed at 13 centers across the United States to evaluate surgical outcomes for ACD. Demographics, complications, radiographic parameters, and patient-reported outcome measures (PROMs; Neck Disability Index, modified Japanese Orthopaedic Association, EuroQol-5D [EQ-5D], and numeric rating scale [NRS] for neck and back pain) were evaluated, and analyses focused on patients with ≥ 2-year follow-up. RESULTS: Of 169 patients with ACD who were eligible for the study, 102 (60.4%) had a minimum 2-year follow-up (mean 3.4 years, range 2-8.1 years). The mean age at surgery was 62 years (SD 11 years). Surgical approaches included anterior-only (22.8%), posterior-only (39.6%), and combined (37.6%). PROMs significantly improved from baseline to last follow-up, including Neck Disability Index (from 47.3 to 33.0) and modified Japanese Orthopaedic Association score (from 12.0 to 12.8; for patients with baseline score ≤ 14), neck pain NRS (from 6.8 to 3.8), back pain NRS (from 5.5 to 4.8), EQ-5D score (from 0.74 to 0.78), and EQ-5D visual analog scale score (from 59.5 to 66.6) (all p ≤ 0.04). More than half of the patients (n = 58, 56.9%) had at least one complication, with the most common complications including dysphagia, distal junctional kyphosis, instrumentation failure, and cardiopulmonary events. The patients who did not achieve 2-year follow-up (n = 67) were similar to study patients based on baseline demographics, comorbidities, and PROMs. Over the course of follow-up, 23 of the total 169 enrolled patients were reported to have died. Notably, these represent all-cause mortalities during the course of follow-up. CONCLUSIONS: This multicenter, prospective analysis demonstrates that operative treatment for ACD provides significant improvement of health-related quality of life at a mean 3.4-year follow-up, despite high complication rates and a high rate of all-cause mortality that is reflective of the overall frailty of this patient population. To the authors' knowledge, this study represents the largest and most comprehensive prospective effort to date designed to assess the intermediate-term outcomes and complications of operative treatment for ACD.

Outcomes of operative treatment for adult spinal deformity: a prospective multicenter assessment with mean 4-year follow-up.

OBJECTIVE: The current literature has primarily focused on the 2-year outcomes of operative adult spinal deformity (ASD) treatment. Longer term durability is important given the invasiveness, complications, and costs of these procedures. The aim of this study was to assess minimum 3-year outcomes and complications of ASD surgery. METHODS: Operatively treated ASD patients were assessed at baseline, follow-up, and through mailings. Patient-reported outcome measures (PROMs) included scores on the Oswestry Disability Index (ODI), Scoliosis Research Society-22r (SRS-22r) questionnaire, mental component summary (MCS) and physical component summary (PCS) of the SF-36, and numeric rating scale (NRS) for back and leg pain. Complications were classified as perioperative (≤ 90 days), delayed (90 days to 2 years), and long term (≥ 2 years). Analyses focused on patients with minimum 3-year follow-up. RESULTS: Of 569 patients, 427 (75%) with minimum 3-year follow-up (mean ± SD [range] 4.1 ± 1.1 [3.0-9.6] years) had a mean age of 60.8 years and 75% were women. Operative treatment included a posterior approach for 426 patients (99%), with a mean ± SD 12 ± 4 fusion levels. Anterior lumbar interbody fusion was performed in 35 (8%) patients, and 89 (21%) underwent 3-column osteotomy. All PROMs improved significantly from baseline to last follow-up, including scores on ODI (45.4 to 30.5), PCS (31.0 to 38.5), MCS (45.3 to 50.6), SRS-22r total (2.7 to 3.6), SRS-22r activity (2.8 to 3.5), SRS-22r pain (2.3 to 3.4), SRS-22r appearance (2.4 to 3.5), SRS-22r mental (3.4 to 3.7), SRS-22r satisfaction (2.7 to 4.1), NRS for back pain (7.1 to 3.8), and NRS for leg pain (4.8 to 3.0) (all p < 0.001). Degradations in some outcome measures were observed between the 2-year and last follow-up evaluations, but the magnitudes of these degradations were modest and arguably not clinically significant. Overall, 277 (65%) patients had at least 1 complication, including 185 (43%) perioperative, 118 (27%) delayed, and 56 (13%) long term. Notably, the 142 patients who did not achieve 3-year follow-up were similar to the study patients in terms of demographic characteristics, deformities, and baseline PROMs and had similar rates and types of complications. CONCLUSIONS: This prospective multicenter analysis demonstrated that operative ASD treatment provided significant improvement of health-related quality of life at minimum 3-year follow-up (mean 4.1 years), suggesting that the benefits of surgery for ASD remain durable at longer follow-up. These findings should prove useful for counseling, cost-effectiveness assessments, and efforts to improve the safety of care.

Surgeons' risk perception in ASD surgery: The value of objective risk assessment on decision making and patient counselling.

BACKGROUND: Surgeons often rely on their intuition, experience and published data for surgical decision making and informed consent. Literature provides average values that do not allow for individualized assessments. Accurate validated machine learning (ML) risk calculators for adult spinal deformity (ASD) patients, based on 10 year multicentric prospective data, are currently available. The objective of this study is to assess surgeon ASD risk perception and compare it to validated risk calculator estimates. METHODS: Nine ASD complete (demographics, HRQL, radiology, surgical plan) preoperative cases were distributed online to 100 surgeons from 22 countries. Surgeons were asked to determine the risk of major complications and reoperations at 72 h, 90 d and 2 years postop, using a 0-100% risk scale. The same preoperative parameters circulated to surgeons were used to obtain ML risk calculator estimates. Concordance between surgeons' responses was analyzed using intraclass correlation coefficients (ICC) (poor < 0.5/excellent > 0.85). Distance between surgeons' and risk calculator predictions was assessed using the mean index of agreement (MIA) (poor < 0.5/excellent > 0.85). RESULTS: Thirty-nine surgeons (74.4% with > 10 years' experience), from 12 countries answered the survey. Surgeons' risk perception concordance was very low and heterogeneous. ICC ranged from 0.104 (reintervention risk at 72 h) to 0.316 (reintervention risk at 2 years). Distance between calculator and surgeon prediction was very large. MIA ranged from 0.122 to 0.416. Surgeons tended to overestimate the risk of major complications and reintervention in the first 72 h and underestimated the same risks at 2 years postop. CONCLUSIONS: This study shows that expert surgeon ASD risk perception is heterogeneous and highly discordant. Available validated ML ASD risk calculators can enable surgeons to provide more accurate and objective prognosis to adjust patient expectations, in real time, at the point of care.

Opioid use prior to surgery is associated with worse preoperative and postoperative patient reported quality of life and decreased surgical cost effectiveness for symptomatic adult spine deformity; A matched cohort analysis.

BACKGROUND: Preoperative opioid is associated with poor postoperative outcomes for several surgical specialties, including neurosurgical, orthopedic, and general surgery. Patients with symptomatic adult spinal deformity (SASD) are among the highest patient populations reporting opioid use prior to surgery. Surgery for SASD has been demonstrated to improve patient reported quality of life, however, little medical economic data exists evaluating impact of preoperative opioid use upon surgical cost-effectiveness for SASD. The purpose of this study was to evaluate the impact that preoperative opioid use has upon SASD surgery including duration of intensive care unit (ICU) and hospital stay, postoperative complications, patient reported outcome measures (PROMs), and surgical cost-effectiveness using a propensity score matched analysis model. METHODS: Surgically treated SASD patients enrolled into a prospective multi-center SASD study were assessed for preoperative opioid use, and divided into two cohorts; preoperative opioid users (OPIOID) and preoperative opioid non-users (NON). Propensity score matching (PSM) was used to control for patient age, medical comorbidities, spine deformity type and magnitude, and surgical procedures for OPIOID vs NON. Preoperative and minimum 2-year postoperative PROMs, duration of ICU and hospital stay, postoperative complications, and opioid use at one and two years postoperative were compared for OPIOID vs NON. Preoperative, one year, and minimum two-year postoperative SF6D values were calculated, and one- and two-year postoperative QALYs were calculated using SF6D change from baseline. Hospital costs at the time of index surgery were calculated and cost/QALY compared at one and two years postop for OPIOID vs NON. RESULTS: 261/357 patients (mean follow-up 3.3 years) eligible for study were evaluated. Following the PSM control, OPIOID (n=97) had similar preoperative demographics, smoking and depression history, spine deformity magnitude, and surgery performed as NON (n=164; p>0.05). Preoperatively, OPIOID reported greater NRS back pain (7.7 vs 6.7) and leg pain (5.2 vs 3.9), worse ODI (50.8 vs 36.9), worse SF-36 PCS (28.8 vs 35.6), and worse SRS-22r self-image (2.3 vs 2.5) than NON, respectively (p<0.05). OPIOID had longer ICU (41.2 vs 21.4 hours) and hospital stay (10.6 vs 8.0 days) than NON, respectively (p<0.05). At last postoperative follow up, OPIOID reported greater NRS back pain (4.1 vs 2.3) and leg pain (2.9 vs 1.7), worse ODI (32.4 vs 19.4), worse SF-36 PCS (37.4 vs 47.0), worse SRS-22r self-image (3.5 vs 4.0), and lower SRS-22r treatment satisfaction score (2.5 vs 4.5) than NON, respectively (p<0.05). At last follow-up postoperative Cost/QALY was higher for OPIOID ($44,558.31) vs NON ($34,304.36; p<0.05). At last follow up OPIOID reported greater postoperative opioid usage than NON [41.2% vs. 12.9%, respectively; odds ratio =4.7 (95% CI=2.6-8.7; p<0.05)]. CONCLUSIONS: Prospective, multi-center, matched analysis demonstrated SASD patients using opioids prior to SASD surgery reported worse preoperative and postoperative quality of life, had longer ICU and hospital stay, had less cost effectiveness of SASD surgery. Preoperative opioid users also reported lower treatment satisfaction, and reported greater postoperative opioid use than non-users. These data should be used to council patients on the negative impact preoperative opioid use can have on SASD surgery.

Examination of the Economic Burden of Frailty in Patients With Adult Spinal Deformity Undergoing Surgical Intervention.

BACKGROUND: With increasing interest in cost optimization, costs of adult spinal deformity (ASD) surgery intersections with frailty merit investigation. OBJECTIVE: To investigate costs associated with ASD and frailty. METHODS: Patients with ASD (scoliosis ≥20°, sagittal vertical axis [SVA] ≥5 cm, pelvic tilt ≥ 25°, or thoracic kyphosis ≥ 60°) with baseline and 2-yr radiographic data were included. Patients were severely frail (SF), frail (F), or not frail (NF). Utility data were converted from Oswestry Disability Index to Short-Form Six-Dimension. Quality-adjusted life years (QALYs) used 3% rate for decline to life expectancy. Costs were calculated using PearlDiver. Loss of work costs were based on SRS-22rQ9 and US Bureau of Labor Statistics. Accounting for complications, length of stay, revisions, and death, cost per QALY at 2 yr and life expectancy were calculated. RESULTS: Five hundred ninety-two patients with ASD were included (59.8 ± 14.0 yr, 80% F, body mass index: 27.7 ± 6.0 kg/m2, Adult Spinal Deformity-Frailty Index: 3.3 ± 1.6, and Charlson Comorbidity Index: 1.8 ± 1.7). The average blood loss was 1569.3 mL, and the operative time was 376.6 min, with 63% undergoing osteotomy and 54% decompression. 69.3% had a posterior-only approach, 30% combined, and 0.7% anterior-only. 4.7% were SF, 22.3% F, and 73.0% NF. At baseline, 104 were unemployed losing $971.38 weekly. After 1 yr, 62 remained unemployed losing $50 508.64 yearly. With propensity score matching for baseline SVA, cost of ASD surgery at 2 yr for F/SF was greater than that for NF ($81 347 vs $69 722). Cost per QALY was higher for F/SF at 2 yr than that for NF ($436 473 vs $430 437). At life expectancy, cost per QALY differences became comparable ($58 965 vs $58 149). CONCLUSION: Despite greater initial cost, F and SF patients show greater improvement. Cost per QALY for NF and F patients becomes similar at life expectancy.

Reaching the medicare allowable threshold in adult spinal deformity surgery: multicenter cost analysis comparing actual direct hospital costs versus what the government will pay.

STUDY DESIGN: Retrospective multicenter cost analysis. OBJECTIVE: To (1) determine if index episode of care (iEOC) costs of Adult Spinal Deformity (ASD) surgeries are below the Medicare Allowable (MA) threshold, and (2) identify variables that can predict iEOC cases that are below MA. Previous studies have suggested that actual direct hospital cost of Adult Spinal Deformity (ASD) surgery is higher than Medicare Allowable (MA) rates, which has become the benchmark reimbursement target for hospital accounting systems. METHODS: From a prospective, multicenter ASD surgical database, patients undergoing long instrumented fusions (> 5 level) with cost data were identified. iEOC cost was calculated utilizing actual direct hospital cost. MA rates were calculated using hospital specific, year-appropriate CMS Inpatient Pricer Payment System. Recursive partitioning identified potentially modifiable variables that can predict iEOC cost < MA. RESULTS: Administrative direct cost data from 210 patients were obtained from 4 of 11 centers. Ninety-five (45%) patients had iEOC cost < MA. There was significant variation across the four centers in both iEOC cost ($56,788-$78,878, p < 0.0001) and reimbursement ($40,623-$91,351, p < 0.0001) across deformity-specific DRGs (453,454,456,457). Academic centers were more likely to have iEOC costs < MA (67.2% vs 8.9%, p < 0.0001). Recursive partitioning (r2 = 0.309) identified rhBMP-2 use of < 24 mg, sagittal plane deformity, a combined anterior/posterior approach, and an SF36-MCS < 39 as predictive for iEOC cost < MA. Performing an anterior/posterior approach reimburses between 14.7% and 121.1% more (2.2-fold) than posterior-only approach. This change in DRG allows iEOC cost to be more likely below the MA threshold. CONCLUSION: There is significant institutional (private vs academic) variation in ASD reimbursement. BMP use, deformity type, approach, and baseline mental health impact ASD surgery cost being below Medicare reimbursement. ASD surgeries with anterior/posterior approaches are in DRGs that can potentially reimburse 2.2-fold the posterior-only surgery, making it more likely to fall below the MA threshold. LEVEL OF EVIDENCE: III.

Assessment of Adult Spinal Deformity Complication Timing and Impact on 2-Year Outcomes Using a Comprehensive Adult Spinal Deformity Classification System.

STUDY DESIGN: Retrospective review of prospectively collected multicenter registry data. OBJECTIVE: To identify rates and timing of postoperative complications in adult spinal deformity (ASD) patients, the impact of complication type and timing on health related quality of life (HRQoL) outcomes, and the impact of complication timing on readmission and reoperation rates. Better understanding of complication timing and impact on HRQoL may improve patient selection, preoperative counseling, and postoperative complication surveillance. SUMMARY OF BACKGROUND DATA: ASD is common and associated with significant disability. Surgical correction is often pursued, but is associated with high complication rates. The International Spine Study Group, AO Spinal Deformity Forum, and European Spine Study Group have developed a new complication classification system for ASD (ISSG-AO spine complications classification system). METHODS: The ISSG-AO spine complications classification system was utilized to assess complications occurring over the 2-year postoperative time period amongst a multicenter, prospectively enrolled cohort of patients who underwent surgery for ASD. Kaplan-Meier survival curves were established for each complication type. Propensity score matching was performed to adjust for baseline disability and comorbidities. Associations between each complication type and HRQoL, and reoperation/readmission and complication timing, were assessed. RESULTS: Of 584 patients meeting inclusion criteria, cardiopulmonary, gastrointestinal, infection, early adverse events, and operative complications contributed to a rapid initial decrease in complication-free survival. Implant-related, radiographic, and neurologic complications substantially decreased long-term complication-free survival. Only radiographic and implant-related complications were significantly associated with worse 2-year HRQoL outcomes. Need for readmission and/or reoperation was most frequent among those experiencing complications after postoperative day 90. CONCLUSION: Surgeons should recognize that long-term complications have a substantial negative impact on HRQoL, and should carefully monitor for implant-related and radiographic complications over long-term follow-up.Level of Evidence: 4.

Risk-benefit assessment of major versus minor osteotomies for flexible and rigid cervical deformity correction.

INTRODUCTION: Osteotomies are commonly performed to correct sagittal malalignment in cervical deformity (CD). However, the risks and benefits of performing a major osteotomy for cervical deformity correction have been understudied. The objective of this retrospective cohort study was to investigate the risks and benefits of performing a major osteotomy for CD correction. METHODS: Patients stratified based on major osteotomy (MAJ) or minor (MIN). Independent t-tests and Chi-squared tests were used to assess differences between MAJ and MIN. A sub-analysis compared patients with flexible versus rigid CL. RESULTS: 137 CD patients were included (62 years, 65% F). 19.0% CD patients underwent a MAJ osteotomy. After propensity score matching for cSVA, 52 patients were included. About 19.0% CD patients underwent a MAJ osteotomy. MAJ patients had more minor complications (P = 0.045), despite similar surgical outcomes as MIN. At 3M, MAJ and MIN patients had similar NDI, mJOA, and EQ5D scores, however by 1 year, MAJ patients reached MCID for NDI less than MIN patients (P = 0.003). MAJ patients with rigid deformities had higher rates of complications (79% vs. 29%, P = 0.056) and were less likely to show improvement in NDI at 1 year (0.95 vs. 0.54, P = 0.027). Both groups had similar sagittal realignment at 1 year (all P > 0.05). CONCLUSIONS: Cervical deformity patients who underwent a major osteotomy had similar clinical outcomes at 3-months but worse outcomes at 1-year as compared to minor osteotomies, likely due to differences in baseline deformity. Patients with rigid deformities who underwent a major osteotomy had higher complication rates and worse clinical improvement despite similar realignment at 1 year.

Operative Treatment of Severe Scoliosis in Symptomatic Adults: Multicenter Assessment of Outcomes and Complications With Minimum 2-Year Follow-up.

BACKGROUND: Few reports focus on adults with severe scoliosis. OBJECTIVE: To report surgical outcomes and complications for adults with severe scoliosis. METHODS: A multicenter, retrospective review was performed on operatively treated adults with severe scoliosis (minimum coronal Cobb: thoracic [TH] ≥ 75°, thoracolumbar [TL] ≥ 50°, lumbar [L] ≥ 50°). RESULTS: Of 178 consecutive patients, 146 (82%; TH = 8, TL = 88, L = 50) achieved minimum 2-yr follow-up (mean age = 53.9 ± 13.2 yr, 92% women). Operative details included posterior-only (58%), 3-column osteotomy (14%), iliac fixation (72%), and mean posterior fusion = 13.2 ± 3.7 levels. Global coronal alignment (3.8 to 2.8 cm, P = .001) and maximum coronal Cobb improved significantly (P ≤.020): TH (84º to 57º; correction = 32%), TL (67º to 35º; correction = 48%), L (61º to 29º; correction = 53%). Sagittal alignment improved significantly (P < .001), most notably for L: C7-sagittal vertical axis 6.7 to 2.5 cm, pelvic incidence-lumbar lordosis mismatch 18º to 3º. Health-related quality-of-life (HRQL) improved significantly (P < .001), most notably for L: Oswestry Disability Index (44.4 ± 20.5 to 26.1 ± 18.3), Short Form-36 Physical Component Summary (30.2 ± 10.8 to 39.9 ± 9.8), and Scoliosis Research Society-22r Total (2.9 ± 0.7 to 3.8 ± 0.7). Minimal clinically important difference and substantial clinical benefit thresholds were achieved in 36% to 75% and 29% to 51%, respectively. Ninety-four (64%) patients had ≥1 complication (total = 191, 92 minor/99 major, most common = rod fracture [13.0%]). Fifty-seven reoperations were performed in 37 (25.3%) patients, with most common indications deep wound infection (11) and rod fracture (10). CONCLUSION: Although results demonstrated high rates of complications, operative treatment of adults with severe scoliosis was associated with significant improvements in mean HRQL outcome measures for the study cohort at minimum 2-yr follow-up.