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.

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.

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.

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.

Increasing Cost Efficiency in Adult Spinal Deformity Surgery: Identifying Predictors of Lower Total Costs.

STUDY DESIGN: Retrospective study of a prospective multicenter database. OBJECTIVE: The purpose of this study was to identify predictors of lower total surgery costs at 3 years for adult spinal deformity (ASD) patients. SUMMARY OF BACKGROUND DATA: ASD surgery involves complex deformity correction. METHODS: Inclusion criteria: surgical ASD (scoliosis ≥20°, sagittal vertical axis [SVA] ≥5 cm, pelvic tilt ≥25°, or thoracic kyphosis ≥60°) patients >18 years. Total costs for surgery were calculated using the PearlDiver database. Cost per quality-adjusted life year was assessed. A Conditional Variable Importance Table used nonreplacement sampling set of 20,000 Conditional Inference trees to identify top factors associated with lower cost surgery for low (LSVA), moderate (MSVA), and high (HSVA) SRS Schwab SVA grades. RESULTS: Three hundred sixtee of 322 ASD patients met inclusion criteria. At 3-year follow up, the potential cost of ASD surgery ranged from $57,606.88 to $116,312.54. The average costs of surgery at 3 years was found to be $72,947.87, with no significant difference in costs between deformity groups (P > 0.05). There were 152 LSVA patients, 53 MSVA patients, and 111 HSVA patients. For all patients, the top predictors of lower costs were frailty scores <0.19, baseline (BL) SRS Activity >1.5, BL Oswestry Disability Index <50 (all P < 0.05). For LSVA patients, no history of osteoporosis, SRS Activity scores >1.5, age <64, were the top predictors of lower costs (all P < 0.05). Among MSVA patients, ASD invasiveness scores <94.16, no past history of cancer, and frailty scores <0.3 trended toward lower total costs (P = 0.071, P = 0.210). For HSVA, no history of smoking and body mass index <27.8 trended toward lower costs (both P = 0.060). CONCLUSION: ASD surgery has the potential for improved cost efficiency, as costs ranged from $57,606.88 to $116,312.54. Predictors of lower costs included higher BL SRS activity, decreased frailty, and not having depression. Additionally, predictors of lower costs were identified for different BL deformity profiles, allowing for the optimization of cost efficiency for all patients.Level of Evidence: 3.

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.

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.

Multicenter assessment of outcomes and complications associated with transforaminal versus anterior lumbar interbody fusion for fractional curve correction.

OBJECTIVE: Few studies have compared fractional curve correction after long fusion between transforaminal lumbar interbody fusion (TLIF) and anterior lumbar interbody fusion (ALIF) for adult symptomatic thoracolumbar/lumbar scoliosis (ASLS). The objective of this study was to compare fractional correction, health-related quality of life (HRQL), and complications associated with L4-S1 TLIF versus those of ALIF as an operative treatment of ASLS. METHODS: The authors retrospectively analyzed a prospective multicenter adult spinal deformity database. Inclusion required a fractional curve ≥ 10°, a thoracolumbar/lumbar curve ≥ 30°, index TLIF or ALIF performed at L4-5 and/or L5-S1, and a minimum 2-year follow-up. TLIF and ALIF patients were propensity matched according to the number and type of interbody fusion at L4-S1. RESULTS: Of 135 potentially eligible consecutive patients, 106 (78.5%) achieved the minimum 2-year follow-up (mean ± SD age 60.6 ± 9.3 years, 85% women, 44.3% underwent TLIF, and 55.7% underwent ALIF). Index operations had mean ± SD 12.2 ± 3.6 posterior levels, 86.6% of patients underwent iliac fixation, 67.0% underwent TLIF/ALIF at L4-5, and 84.0% underwent TLIF/ALIF at L5-S1. Compared with TLIF patients, ALIF patients had greater cage height (10.9 ± 2.1 mm for TLIF patients vs 14.5 ± 3.0 mm for ALIF patients, p = 0.001) and lordosis (6.3° ± 1.6° for TLIF patients vs 17.0° ± 9.9° for ALIF patients, p = 0.001) and longer operative duration (6.7 ± 1.5 hours for TLIF patients vs 8.9 ± 2.5 hours for ALIF patients, p < 0.001). In all patients, final alignment improved significantly in terms of the fractional curve (20.2° ± 7.0° to 6.9° ± 5.2°), maximum coronal Cobb angle (55.0° ± 14.8° to 23.9° ± 14.3°), C7 sagittal vertical axis (5.1 ± 6.2 cm to 2.3 ± 5.4 cm), pelvic tilt (24.6° ± 8.1° to 22.7° ± 9.5°), and lumbar lordosis (32.3° ± 18.8° to 51.4° ± 14.1°) (all p < 0.05). Matched analysis demonstrated comparable fractional correction (-13.6° ± 6.7° for TLIF patients vs -13.6° ± 8.1° for ALIF patients, p = 0.982). In all patients, final HRQL improved significantly in terms of Oswestry Disability Index (ODI) score (42.4 ± 16.3 to 24.2 ± 19.9), physical component summary (PCS) score of the 36-item Short-Form Health Survey (32.6 ± 9.3 to 41.3 ± 11.7), and Scoliosis Research Society-22r score (2.9 ± 0.6 to 3.7 ± 0.7) (all p < 0.05). Matched analysis demonstrated worse ODI (30.9 ± 21.1 for TLIF patients vs 17.9 ± 17.1 for ALIF patients, p = 0.017) and PCS (38.3 ± 12.0 for TLIF patients vs 45.3 ± 10.1 for ALIF patients, p = 0.020) scores for TLIF patients at the last follow-up (despite no differences in these parameters at baseline). The rates of total complications were similar (76.6% for TLIF patients vs 71.2% for ALIF patients, p = 0.530), but significantly more TLIF patients had rod fracture (28.6% of TLIF patients vs 7.1% of ALIF patients, p = 0.036). Multiple regression analysis demonstrated that a 1-mm increase in L4-5 TLIF cage height led to a 2.2° reduction in L4 coronal tilt (p = 0.011), and a 1° increase in L5-S1 ALIF cage lordosis led to a 0.4° increase in L5-S1 segmental lordosis (p = 0.045). CONCLUSIONS: Operative treatment of ASLS with L4-S1 TLIF versus ALIF demonstrated comparable mean fractional curve correction (66.7% vs 64.8%), despite use of significantly larger, more lordotic ALIF cages. TLIF cage height had a significant impact on leveling L4 coronal tilt, whereas ALIF cage lordosis had a significant impact on restoration of lumbosacral lordosis. The advantages of TLIF may include reduced operative duration and hospitalization; however, associated HRQL was inferior and more rod fractures were detected in the TLIF patients included in this study.

Predictors of serious, preventable, and costly medical complications in a population of adult spinal deformity patients.

BACKGROUND CONTEXT: In 2008, the Centers for Medicare and Medicaid Services (CMS) established a list of hospital-acquired conditions (HACs) with significant deleterious effects on both patients and providers. Adult spinal deformity (ASD) surgery is complex and highly invasive, and as such may result in significant morbidity including these HACs. PURPOSE: Identify predictors for developing the most common HACs among adult spinal deformity (ASD) patients undergoing corrective surgery. STUDY DESIGN/SETTING: Retrospective analysis. PATIENT SAMPLE: One thousand one hundred and seventy-one ASD patients. OUTCOME MEASURES: HACs, Health-Related Quality of Life scores(HRQLs), Reoperation, Integrated Health State (IHS) METHODS: ASD pts undergoing surgery (>18 years, scoliosis ≥20°, SVA ≥5 cm, PT ≥25° and/or TK >60°) with complete data at BL and up to 2 years post-op were included. Patients were stratified by presence of >1 HAC, defined as at least one superficial/deep SSI, UTI, DVT, or PE within a 30-day post-op window. Random forest analysis generated 5,000 Conditional Inference Trees to compute a variable importance table for top predictors of HACs. An area-under-the-curve (AUC) methodology compared normalized HRQL scores between groups to determine an IHS with 2-year follow-up. RESULTS: Total of 1,171 pts (59.8 years, 76.2%F, 28.1kg/m2) underwent corrective ASD surgery, with 1,053 pts in the non-HAC group and 118 in the HAC group. Of these pts, 25.4% had UTI, 15.4% DVT, 19.2% superficial SSI, 20.8% deep SSI, and 19.2% PE. HAC pts were on average older (63.5 vs 59.3, p=.004) and more often frail (51.3 vs 39.7%, p=.021) than non-HAC pts. Postop LOS and reoperation were most associated with HAC groups: [1] LOS >7 days [2] reoperation. Patient-related predictors of HACs were [3] age >50 yerr, [4] frailty, and [13] BMI >31. Procedure-related predictors of HACs were [5] operative-time >405 minutes, [6] levels fused >9, EBL >1450 mL, and [11] decompression. BL radiographic predictors were [7] PT >20°, [9] PI-LL>6°, [10] TL Cobb angle >15°, [12] SVA C7-S1 >29 mm. No differences were observed between groups with regards to IHS ODI (0.73 vs 0.74, p=.863), SRS (1.3 vs1.3, p=.374), NRS Back (0.6 vs 0.6, p=.158). HAC had higher rates of reoperation than non-HAC (0.08 vs 0.01, p=.066), and any HAC within 30-days of index was a significant predictor of reoperation (OR: 2.448 [1.94-3.09], p<.001). CONCLUSIONS: In a population of ASD patients, HACs were associated with length of stay, reoperation, age, and frailty. Radiographic parameters such as pelvic tilt >20°, PI-LL >6°, & SVA >29 mm also increased odds of HACs, and should raise postoperative awareness for HAC development.

Multicenter assessment of surgical outcomes in adult spinal deformity patients with severe global coronal malalignment: determination of target coronal realignment threshold.

OBJECTIVE: The impact of global coronal malalignment (GCM; C7 plumb line-midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors' primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes. METHODS: This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed. RESULTS: Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD-Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7-S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence-lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%-83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK). CONCLUSIONS: Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.

Prospective multicenter assessment of complication rates associated with adult cervical deformity surgery in 133 patients with minimum 1-year follow-up.

OBJECTIVE: Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically. METHODS: A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30-90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2-7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°. RESULTS: Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively). CONCLUSIONS: This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.

Cost-effectiveness of surgical treatment of adult spinal deformity: comparison of posterior-only versus anteroposterior approach.

BACKGROUND CONTEXT: Considerable debate exists regarding the optimal surgical approach for adult spinal deformity (ASD). It remains unclear which approach, posterior-only or combined anterior-posterior (AP), is more cost-effective. Our goal is to determine the 2-year cost per quality-adjusted life year (QALY) for each approach. PURPOSE: To compare the 2-year cost-effectiveness of surgical treatment for ASD between the posterior-only approach and combined AP approach. STUDY DESIGN: Retrospective economic analysis of a prospective, multicenter database PATIENT SAMPLE: From a prospective, multicenter surgical database of ASD, patients undergoing five or more level fusions through a posterior-only or AP approach were identified and compared. METHODS: QALYs gained were determined using baseline, 1-year, and 2-year postoperative Short Form 6D. Cost was calculated from actual, direct hospital costs including any subsequent readmission or revision. Cost-effectiveness was determined using cost/QALY gained. RESULTS: The AP approach showed significantly higher index cost than the posterior-only approach ($84,329 vs. $64,281). This margin decreased at 2-year follow-up with total costs of $89,824 and $73,904, respectively. QALYs gained at 2 years were similar with 0.21 and 0.17 in the posterior-only and the AP approaches, respectively. The cost/QALY at 2 years after surgery was significantly higher in the AP approach ($525,080) than in the posterior-only approach ($351,086). CONCLUSIONS: We assessed 2-year cost-effectiveness for the surgical treatment through posterior-only and AP approaches. The posterior-only approach is less expensive both for the index surgery and at 2-year follow-up. The QALY gained at 2-years was similar between the two approaches. Thus, posterior-only approach was more cost-effective than the AP approach under our study parameters. However, both approaches were not cost-effective at 2-year follow-up.

Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.

STUDY DESIGN: Economic modeling of data from a multicenter, prospective registry. OBJECTIVE: The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery. SUMMARY OF BACKGROUND DATA: ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis. METHODS: Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05). RESULTS: BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ±â€Š$6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ±â€Š$17,000) than for patients without pseudarthrosis ($61,000 ±â€Š$25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients. CONCLUSION: BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research. LEVEL OF EVIDENCE: 2.