Browsing by Author "Kelly, Michael"

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    ItemOpen Access
    Adult Scoliosis Deformity Surgery: Comparison of Outcomes Between One Versus Two Attending Surgeons.
    (Spine, 2017-07) Gomez, Jaime A; Lafage, Virginie; Sciubba, Daniel M; Bess, Shay; Mundis, Gregory M; Liabaud, Barthelemy; Hanstein, Regina; Shaffrey, Christopher; Kelly, Michael; Ames, Christopher; Smith, Justin S; Passias, Peter G; Errico, Thomas; Schwab, Frank; International Spine Study Group

    Study design

    Retrospective review of prospectively collected data.

    Objective

    Assess outcomes of adult spinal deformity (ASD) surgery performed by one versus two attending surgeons.

    Summary of background data

    ASD centers have developed two attending teams to improve efficiency; their effects on complications and outcomes have not been reported.

    Methods

    Patients with ASD with five or more levels fused and more than 2-year follow-up were included. Estimated blood loss (EBL), length of stay (LOS), operating room (OR) time, complications, quality of life (Health Related Quality of Life), and x-rays were analyzed. Outcomes were compared between one-surgeon (1S) and two-surgeon (2S) centers. A deformity-matched cohort was analyzed.

    Results

    A total of 188 patients in 1S and 77 in 2S group were included. 2S group patients were older and had worse deformity based on the Scoliosis Research Society-Schwab classification (P < 0.05). There were no significant differences in levels fused (P = 0.57), LOS (8.7 vs 8.9 days), OR time (445.9 vs 453.2 min), or EBL (2008 vs 1898 cm; P > 0.05). 2S patients had more three-column osteotomies (3CO; P < 0.001) and used less bone morphogenetic protein 2 (BMP-2; 79.9% vs 15.6%; P < 0.001). The 2S group had fewer intraoperative complications (1.3% vs 11.1%; P = 0.006). Postoperative (6 wk to 2 yr) complications were more frequent in the 2S group (4.8% vs 15.6%; P < 0.002). After matching for deformity, there were no differences in (9.1 vs 10.1 days), OR time (467.8 vs 508.4 min), or EBL (3045 vs 2247 cm; P = 0.217). 2S group used less BMP-2 (20.6% vs 84.8%; P < 0.001), had fewer intraoperative complications (P = 0.015) but postoperative complications due to instrumentation failure/pseudarthrosis were more frequent (P < 0.01).

    Conclusion

    No significant differences were found in LOS, OR time, or EBL between the 1S and 2S groups, even when matching for severity of deformity. 2S group had less BMP-2 use, fewer intraoperative complications but more postoperative complications.

    Level of evidence

    2.
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    ItemOpen Access
    Artificial Intelligence Based Hierarchical Clustering of Patient Types and Intervention Categories in Adult Spinal Deformity Surgery: Towards a New Classification Scheme that Predicts Quality and Value.
    (Spine, 2019-07) Ames, Christopher P; Smith, Justin S; Pellisé, Ferran; Kelly, Michael; Alanay, Ahmet; Acaroğlu, Emre; Pérez-Grueso, Francisco Javier Sánchez; Kleinstück, Frank; Obeid, Ibrahim; Vila-Casademunt, Alba; Shaffrey, Christopher I; Burton, Douglas; Lafage, Virginie; Schwab, Frank; Shaffrey, Christopher I; Bess, Shay; Serra-Burriel, Miquel; European Spine Study Group, International Spine Study Group
    STUDY DESIGN:Retrospective review of prospectively-collected, multicenter adult spinal deformity (ASD) databases. OBJECTIVE:To apply artificial intelligence (AI)-based hierarchical clustering as a step toward a classification scheme that optimizes overall quality, value, and safety for ASD surgery. SUMMARY OF BACKGROUND DATA:Prior ASD classifications have focused on radiographic parameters associated with patient reported outcomes. Recent work suggests there are many other impactful preoperative data points. However, the ability to segregate patient patterns manually based on hundreds of data points is beyond practical application for surgeons. Unsupervised machine-based clustering of patient types alongside surgical options may simplify analysis of ASD patient types, procedures, and outcomes. METHODS:Two prospective cohorts were queried for surgical ASD patients with baseline, 1-year, and 2-year SRS-22/Oswestry Disability Index/SF-36v2 data. Two dendrograms were fitted, one with surgical features and one with patient characteristics. Both were built with Ward distances and optimized with the gap method. For each possible n patient cluster by m surgery, normalized 2-year improvement and major complication rates were computed. RESULTS:Five hundred-seventy patients were included. Three optimal patient types were identified: young with coronal plane deformity (YC, n = 195), older with prior spine surgeries (ORev, n = 157), and older without prior spine surgeries (OPrim, n = 218). Osteotomy type, instrumentation and interbody fusion were combined to define four surgical clusters. The intersection of patient-based and surgery-based clusters yielded 12 subgroups, with major complication rates ranging from 0% to 51.8% and 2-year normalized improvement ranging from -0.1% for SF36v2 MCS in cluster [1,3] to 100.2% for SRS self-image score in cluster [2,1]. CONCLUSION:Unsupervised hierarchical clustering can identify data patterns that may augment preoperative decision-making through construction of a 2-year risk-benefit grid. In addition to creating a novel AI-based ASD classification, pattern identification may facilitate treatment optimization by educating surgeons on which treatment patterns yield optimal improvement with lowest risk. LEVEL OF EVIDENCE:4.
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    ItemOpen Access
    Comparison of Best Versus Worst Clinical Outcomes for Adult Cervical Deformity Surgery
    (Global Spine Journal, 2019-05-01) Smith, Justin S; Shaffrey, Christopher I; Kim, Han Jo; Passias, Peter; Protopsaltis, Themistocles; Lafage, Renaud; Mundis, Gregory M; Klineberg, Eric; Lafage, Virginie; Schwab, Frank J; Scheer, Justin K; Kelly, Michael; Hamilton, D Kojo; Gupta, Munish; Deviren, Vedat; Hostin, Richard; Albert, Todd; Riew, K Daniel; Hart, Robert; Burton, Doug; Bess, Shay; Ames, Christopher P
    Study Design: Retrospective cohort study. Objective: Factors that predict outcomes for adult cervical spine deformity (ACSD) have not been well defined. To compare ACSD patients with best versus worst outcomes. Methods: This study was based on a prospective, multicenter observational ACSD cohort. Best versus worst outcomes were compared based on Neck Disability Index (NDI), Neck Pain Numeric Rating Scale (NP-NRS), and modified Japanese Orthopaedic Association (mJOA) scores. Results: Of 111 patients, 80 (72%) had minimum 1-year follow-up. For NDI, compared with best outcome patients (n = 28), worst outcome patients (n = 32) were more likely to have had a major complication (P =.004) and to have undergone a posterior-only procedure (P =.039), had greater Charlson Comorbidity Index (P =.009), and had worse postoperative C7-S1 sagittal vertical axis (SVA; P =.027). For NP-NRS, compared with best outcome patients (n = 26), worst outcome patients (n = 18) were younger (P =.045), had worse baseline NP-NRS (P =.034), and were more likely to have had a minor complication (P =.030). For the mJOA, compared with best outcome patients (n = 16), worst outcome patients (n = 18) were more likely to have had a major complication (P =.007) and to have a better baseline mJOA (P =.030). Multivariate models for NDI included posterior-only surgery (P =.006), major complication (P =.002), and postoperative C7-S1 SVA (P =.012); models for NP-NRS included baseline NP-NRS (P =.009), age (P =.017), and posterior-only surgery (P =.038); and models for mJOA included major complication (P =.008). Conclusions: Factors distinguishing best and worst ACSD surgery outcomes included patient, surgical, and radiographic factors. These findings suggest areas that may warrant greater awareness to optimize patient counseling and outcomes.
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    ItemOpen Access
    Cost-utility analysis of cervical deformity surgeries using 1-year outcome.
    (The spine journal : official journal of the North American Spine Society, 2018-09) Poorman, Gregory W; Passias, Peter G; Qureshi, Rabia; Hassanzadeh, Hamid; Horn, Samantha; Bortz, Cole; Segreto, Frank; Jain, Amit; Kelly, Michael; Hostin, Richard; Ames, Christopher; Smith, Justin; LaFage, Virginie; Burton, Douglas; Bess, Shay; Shaffrey, Chris; Schwab, Frank; Gupta, Munish

    Background context

    Cost-utility analysis, a special case of cost-effectiveness analysis, estimates the ratio between the cost of an intervention to the benefit it produces in number of quality-adjusted life years. Cervical deformity correction has not been evaluated in terms of cost-utility and in the context of value-based health care. Our objective, therefore, was to determine the cost-utility ratio of cervical deformity correction.

    Study design

    This is a retrospective review of a prospective, multicenter cervical deformity database. Patients with 1-year follow-up after surgical correction for cervical deformity were included. Cervical deformity was defined as the presence of at least one of the following: kyphosis (C2-C7 Cobb angle >10°), cervical scoliosis (coronal Cobb angle >10°), positive cervical sagittal malalignment (C2-C7 sagittal vertical axis >4 cm or T1-C6 >10°), or horizontal gaze impairment (chin-brow vertical angle >25°). Quality-adjusted life years were calculated by both EuroQol 5D (EQ5D) quality of life and Neck Disability Index (NDI) mapped to short form six dimensions (SF6D) index. Costs were assigned using Medicare 1-year average reimbursement for: 9+ level posterior fusions (PF), 4-8 level PF, 4-8 level PF with anterior fusion (AF), 2-3 level PF with AF, 4-8 level AF, and 4-8 level posterior refusion. Reoperations and deaths were added to cost and subtracted from utility, respectively. Quality-adjusted life year per dollar spent was calculated using standardized methodology at 1-year time point and subsequent time points relying on maintenance of 1-year utility.

    Results

    Eighty-four patients (average age: 61.2 years, 60% female, body mass index [BMI]: 30.1) were analyzed after cervical deformity correction (average levels fused: 7.2, osteotomy used: 50%). Costs associated with index procedures were 9+ level PF ($76,617), 4-8 level PF ($40,596), 4-8 level PF with AF ($67,098), 4-8 level AF ($31,392), and 4-8 level posterior refusion ($35,371). Average 1-year reimbursement of surgery was $55,097 at 1 year with eight revisions and three deaths accounted for. Cost per quality-adjusted life year (QALY) gained to 1-year follow-up was $646,958 by EQ5D and $477,316 by NDI SF6D. If 1-year benefit is sustained, upper threshold of cost-effectiveness is reached 3-4.5 years after intervention.

    Conclusions

    Medicare 1-year average reimbursement compared with 1-year QALYdescribed $646,958 by EQ5D and $477,316 by NDI SF6D. Cervical deformity surgeries reach accepted cost-effectiveness thresholds when benefit is sustained 3-4.5 years. Longer follow-up is needed for a more definitive cost-analysis, but these data are an important first step in justifying cost-utility ratio for cervical deformity correction.
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    ItemOpen Access
    Counseling Guidelines for Anticipated Postsurgical Improvements in Pain, Function, Mental Health, and Self-image for Different Types of Adult Spinal Deformity.
    (Spine, 2020-08) Line, Breton; Bess, Shay; Lafage, Virginie; Ames, Christopher; Burton, Douglas; Kim, Han Jo; Gupta, Munish; Hart, Robert; Klineberg, Eric; Kelly, Michael; Kebaish, Khaled; Hostin, Richard; Mundis, Gregory; Schwab, Frank; Shaffrey, Christopher; Smith, Justin S; International Spine Study Group
    STUDY DESIGN:Retrospective analysis of a multicenter prospective adult spinal deformity (ASD) database. OBJECTIVE:Quantify postoperative improvements in pain, function, mental health, and self-image for different ASD types. SUMMARY OF BACKGROUND DATA:Medical providers are commonly requested to counsel patients on anticipated improvements in specific health domains including pain, function, and self-image following surgery. ASD is a heterogeneous condition; therefore, health domain improvements may vary according to deformity type. Few studies have quantified outcomes for specific ASD types. METHODS:Surgically treated ASD patients (≥4 levels fused) prospectively enrolled into a multicenter database, minimum 2-year follow-up, were categorized into ASD types according to Scoliosis Research Society-Schwab ASD classification (THORACIC, LUMBAR, DOUBLE, SAGITTAL, MIXED). Demographic, radiographic, operative, and patient reported outcome measures (NRS back and leg pain, SRS-22r, SF-36) data were evaluated. Preoperative and last postoperative values for pain, physical and social function, mental health, and self-image were evaluated, improvements in each domain were quantified, and domain scores compared to generational normative values. Postoperative improvements were also calculated for three age cohorts (<45 yr, 45-65 yr, and >65 yr) within each deformity type. RESULTS:359 of 564 patients eligible for study (mean age 57.9 yr, mean scoliosis 43.4°, mean SVA 63.3 mm, mean 11.7 levels fused) had ≥2 yr follow-up. Domain improvements for the entire ASD population were 45.1% for back pain, 41.3% for leg pain, 27.1% for physical function, 35.9% for social function, 62.0% for self-image, and 22.6% for mental health (P < 0.05). LUMBAR, SAGITTAL, and MIXED had greatest improvements in pain and function, while THORACIC and DOUBLE had greatest improvements in self-image. Self-image was the most impacted preoperative domain and demonstrated the greatest postoperative improvement for all ASD types. CONCLUSION:ASD patients demonstrated quantifiable postoperative improvements in pain, self-image, physical and social function, and mental health; however, improvements differed between ASD types. Further research is needed to understand specific patient expectations for ASD treatment. LEVEL OF EVIDENCE:3.
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    ItemOpen Access
    Development of predictive models for all individual questions of SRS-22R after adult spinal deformity surgery: a step toward individualized medicine.
    (European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2019-09) Ames, Christopher P; Smith, Justin S; Pellisé, Ferran; Kelly, Michael; Gum, Jeffrey L; Alanay, Ahmet; Acaroğlu, Emre; Pérez-Grueso, Francisco Javier Sánchez; Kleinstück, Frank S; Obeid, Ibrahim; Vila-Casademunt, Alba; Shaffrey, Christopher I; Burton, Douglas C; Lafage, Virginie; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; Serra-Burriel, Miquel; European Spine Study Group; International Spine Study Group

    Purpose

    Health-related quality of life (HRQL) instruments are essential in value-driven health care, but patients often have more specific, personal priorities when seeking surgical care. The Scoliosis Research Society-22R (SRS-22R), an HRQL instrument for spinal deformity, provides summary scores spanning several health domains, but these may be difficult for patients to utilize in planning their specific care goals. Our objective was to create preoperative predictive models for responses to individual SRS-22R questions at 1 and 2 years after adult spinal deformity (ASD) surgery to facilitate precision surgical care.

    Methods

    Two prospective observational cohorts were queried for ASD patients with SRS-22R data at baseline and 1 and 2 years after surgery. In total, 150 covariates were used in training machine learning models, including demographics, surgical data and perioperative complications. Validation was accomplished via an 80%/20% data split for training and testing, respectively. Goodness of fit was measured using area under receiver operating characteristic (AUROC) curves.

    Results

    In total, 561 patients met inclusion criteria. The AUROC ranged from 56.5 to 86.9%, reflecting successful fits for most questions. SRS-22R questions regarding pain, disability and social and labor function were the most accurately predicted. Models were less sensitive to questions regarding general satisfaction, depression/anxiety and appearance.

    Conclusions

    To the best of our knowledge, this is the first study to explicitly model the prediction of individual answers to the SRS-22R questionnaire at 1 and 2 years after deformity surgery. The ability to predict individual question responses may prove useful in preoperative counseling in the age of individualized medicine. These slides can be retrieved under Electronic Supplementary Material.
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    ItemOpen Access
    Does Patient Frailty Status Influence Recovery Following Spinal Fusion for Adult Spinal Deformity?: An Analysis of Patients With 3-Year Follow-up.
    (Spine, 2020-04) Pierce, Katherine E; Passias, Peter G; Alas, Haddy; Brown, Avery E; Bortz, Cole A; Lafage, Renaud; Lafage, Virginie; Ames, Christopher; Burton, Douglas C; Hart, Robert; Hamilton, Kojo; Kelly, Michael; Hostin, Richard; Bess, Shay; Klineberg, Eric; Line, Breton; Shaffrey, Christopher; Mummaneni, Praveen; Smith, Justin S; Schwab, Frank A; International Spine Study Group (ISSG)

    Study design

    Retrospective review of a prospective database.

    Objective

    The aim of this study was to evaluate postop clinical recovery among adult spinal deformity (ASD) patients between frailty states undergoing primary procedures SUMMARY OF BACKGROUND DATA.: Frailty severity may be an important determinant for impaired recovery after corrective surgery.

    Methods

    It included ASD patients with health-related quality of life (HRQLs) at baseline (BL), 1 year (1Y), and 3 years (3Y). Patients stratified by frailty by ASD-frailty index scale 0-1(no frailty: <0.3 [NF], mild: 0.3-0.5 [MF], severe: >0.5 [SF]). Demographics, alignment, and SRS-Schwab modifiers were assessed with χ/paired t tests to compare HRQLs: Scoliosis Research Society 22-question Questionnaire (SRS-22), Numeric Rating Scale (NRS) Back/Leg Pain, Oswestry Disability Index (ODI). Area-under-the-curve (AUC) method generated normalized HRQL scores at baseline (BL) and f/u intervals (1Y, 3Y). AUC was calculated for each f/u, and total area was divided by cumulative f/u, generating one number describing recovery (Integrated Health State [IHS]).

    Results

    A total of 191 patients were included (59 years, 80% females). Breakdown of patients by frailty status: 43.6% NF, 40.8% MF, 15.6% SF. SF patients were older (P = 0.003), >body mass index (P = 0.002). MF and SF were significantly (P < 0.001) more malaligned at BL: pelvic tilt (NF: 21.6°; MF: 27.3°; SF: 22.1°), pelvic incidence and lumbar lordosis (7.4°, 21.2°, 19.7°), sagittal vertical axis (31 mm, 87 mm, 82 mm). By SRS-Schwab, NF were mostly minor (40%), and MF and SF markedly deformed (64%, 57%). Frailty groups exhibited BL to 3Y improvement in SRS-22, ODI, NRS Back/Leg (P < 0.001). After HRQL normalization, SF had improvement in SRS-22 at year 1 and year 3 (P < 0.001), and NRS Back at 1Y. 3Y IHS showed a significant difference in SRS-22 (NF: 1.2 vs. MF: 1.32 vs. SF: 1.69, P < 0.001) and NRS Back Pain (NF: 0.52, MF: 0.66, SF: 0.6, P = 0.025) between frailty groups. SF had more complications (79%). SF/marked deformity had larger invasiveness score (112) compared to MF/moderate deformity (86.2). Controlling for baseline deformity and invasiveness, SF showed more improvement in SRS-22 IHS (NF: 1.21, MF: 1.32, SF: 1.66, P < 0.001).

    Conclusion

    Although all frailty groups exhibited improved postop disability/pain scores, SF patients recovered better in SRS-22 and NRS Back. Despite SF patients having more complications and larger invasiveness scores, they had overall better patient-reported outcomes, signifying that with frailty severity, patients have more room for improvement postop compared to BL quality of life.

    Level of evidence

    3.
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    ItemOpen Access
    Effective Prevention of Proximal Junctional Failure in Adult Spinal Deformity Surgery Requires a Combination of Surgical Implant Prophylaxis and Avoidance of Sagittal Alignment Overcorrection.
    (Spine, 2020-02) Line, Breton G; Bess, Shay; Lafage, Renaud; Lafage, Virgine; Schwab, Frank; Ames, Christopher; Kim, Han Jo; Kelly, Michael; Gupta, Munish; Burton, Douglas; Hart, Robert; Klineberg, Eric; Kebaish, Khaled; Hostin, Richard; Mundis, Gregory; Eastlack, Robert; Shaffrey, Christopher; Smith, Justin S; International Spine Study Group

    Study design

    Propensity score matched analysis of a multi-center prospective adult spinal deformity (ASD) database.

    Objective

    Evaluate if surgical implant prophylaxis combined with avoidance of sagittal overcorrection more effectively prevents proximal junctional failure (PJF) than use of surgical implants alone.

    Summary of background data

    PJF is a severe form of proximal junctional kyphosis (PJK). Efforts to prevent PJF have focused on use of surgical implants. Less information exists on avoidance of overcorrection of age-adjusted sagittal alignment to prevent PJF.

    Methods

    Surgically treated ASD patients (age ≥18 yrs; ≥5 levels fused, ≥1 year follow-up) enrolled into a prospective multi-center ASD database were propensity score matched (PSM) to control for risk factors for PJF. Patients evaluated for use of surgical implants to prevent PJF (IMPLANT) versus no implant prophylaxis (NONE), and categorized by the type of implant used (CEMENT, HOOK, TETHER). Postoperative sagittal alignment was evaluated for overcorrection of age-adjusted sagittal alignment (OVER) versus within sagittal parameters (ALIGN). Incidence of PJF was evaluated at minimum 1 year postop.

    Results

    Six hundred twenty five of 834 eligible for study inclusion were evaluated. Following PSM to control for confounding variables, analysis demonstrated the incidence of PJF was lower for IMPLANT (n = 235; 10.6%) versus NONE (n = 390: 20.3%; P < 0.05). Use of transverse process hooks at the upper instrumented vertebra (HOOK; n = 115) had the lowest rate of PJF (7.0%) versus NONE (20.3%; P < 0.05). ALIGN (n = 246) had lower incidence of PJF than OVER (n = 379; 12.0% vs. 19.2%, respectively; P < 0.05). The combination of ALIGN-IMPLANT further reduced PJF rates (n = 81; 9.9%), while OVER-NONE had the highest rate of PJF (n = 225; 24.2%; P < 0.05).

    Conclusion

    Propensity score matched analysis of 625 ASD patients demonstrated use of surgical implants alone to prevent PJF was less effective than combining implants with avoidance of sagittal overcorrection. Patients that received no PJF implant prophylaxis and had sagittal overcorrection had the highest incidence of PJF.

    Level of evidence

    3.
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    ItemOpen Access
    Evolution in Surgical Approach, Complications, and Outcomes in an Adult Spinal Deformity Surgery Multicenter Study Group Patient Population.
    (Spine deformity, 2019-05) Daniels, Alan H; Reid, Daniel BC; Tran, Stacie Nguyen; Hart, Robert A; Klineberg, Eric O; Bess, Shay; Burton, Douglas; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Ames, Christopher P; Hamilton, D Kojo; LaFage, Virginie; Schwab, Frank; Eastlack, Robert; Akbarnia, Behrooz; Kim, Han Jo; Kelly, Michael; Passias, Peter G; Protopsaltis, Themistocles; Mundis, Gregory M; International Spine Study Group

    Study design

    Retrospective review of a prospectively collected multicenter database.

    Objectives

    To evaluate the evolution of surgical treatment strategies, complications, and patient-reported outcomes for adult spinal deformity (ASD) patients.

    Summary of background data

    ASD surgery is associated with high complication rates. Evolving treatment strategies may reduce these risks.

    Methods

    Adult patients undergoing ASD surgery from 2009 to 2016 were analyzed (n = 905). Preoperative and surgical parameters were compared across years. Subgroup analysis of 436 patients with minimum two-year follow-up was also performed.

    Results

    From 2009 to 2016, there was a significant increase in the mean preoperative age (52 to 63.1, p < .001), body mass index (26.3 to 32.2, p = .003), Charlson Comorbidity index (1.4 to 2.2, p < .001), rate of previous spine surgery (39.8% to 53.1%, p = .01), and baseline disability (visual analog scale [VAS] back and leg pain) scores (p < .01), Oswestry Disability Index, and 22-item Scoliosis Research Society Questionnaire scores (p < .001). Preoperative Schwab sagittal alignment modifiers and overall surgical invasiveness index were similar across time. Three-column osteotomy utilization decreased from 36% in 2011 to 16.7% in 2016. Lateral lumbar interbody fusion increased from 6.4% to 24.1% (p = .004), anterior lumbar interbody fusion decreased from 22.9% to 16.7% (p = .043), and transforaminal lumbar interbody fusion/posterior lumbar interbody fusion utilization remained similar (p = .448). Use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in 2012 was 84.6%, declined to 58% in 2013, and rebounded to 76.3% in 2016 (p = .006). Tranexamic acid use increased rapidly from 2009 to 2016 (13.3% to 48.6%, p < .001). Two-year follow-up sagittal vertical axis, pelvic tilt, pelvic incidence-lumbar lordosis, and maximum Cobb angles were similar across years. Intraoperative complications decreased from 33% in 2010 to 9.3% in 2016 (p < .001). Perioperative (<30 days, <90 days) complications peaked in 2010 (42.7%, 46%) and decreased by 2016 (24.1%, p < .001; 29.6%, p = .007). The overall complication rate decreased from 73.2% in 2008-2014 patients to 62.6% in 2015-2016 patients (p = .03). Two-year health-related quality of life outcomes did not significantly differ across the years (p > .05).

    Conclusions

    From 2009 to 2016, despite an increasingly elderly, medically compromised, and obese patient population, complication rates decreased. Evolving strategies may result in improved treatment of ASD patients.

    Level of evidence

    Level IV.
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    ItemOpen Access
    Impact of New Motor Deficit on HRQOL After Adult Spinal Deformity Surgery: Subanalysis From Scoli Risk 1 Prospective Study.
    (Spine, 2021-04) Saigal, Rajiv; Lau, Darryl; Berven, Sigurd H; Carreon, Leah; Dekutoski, Mark B; Kebaish, Khaled M; Qiu, Yong; Matsuyama, Yukihiro; Kelly, Michael; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Lewis, Stephen J; Cheung, Kenneth MC; Shaffrey, Christopher I; Fehlings, Michael G; Lenke, Lawrence G; Ames, Christopher P; AOSpine Knowledge Forum Deformity

    Study design

    International, multicenter, prospective, longitudinal observational cohort.

    Objective

    To assess how new motor deficits affect patient reported quality of life scores after adult deformity surgery.

    Summary of background data

    Adult spinal deformity surgery is associated with high morbidity, including risk of new postoperative motor deficit. It is unclear what effect new motor deficit has on Health-related Quality of Life scores (HRQOL) scores.

    Methods

    Adult spinal deformity patients were enrolled prospectively at 15 sites worldwide. Other inclusion criteria included major Cobb more than 80°, C7-L2 curve apex, and any patient undergoing three column osteotomy. American Spinal Injury Association (ASIA) scores and standard HRQOL scores were recorded pre-op, 6 weeks, 6 months, and 2 years.

    Results

    Two hundred seventy two complex adult spinal deformity (ASD) patients enrolled. HRQOL scores were worse for patients with lower extremity motor score (LEMS). Mean HRQOL changes at 6 weeks and 2 years compared with pre-op for patients with motor worsening were: ODI (+12.4 at 6 weeks and -4.7 at 2 years), SF-36v2 physical (-4.5 at 6 weeks and +2.3 at 2 years), SRS-22r (0.0 at 6 weeks and +0.4 at 2 years). Mean HRQOL changes for motor-neutral patients were: ODI (+0.6 at 6 weeks and -12.1 at 2 years), SF-36v2 physical (-1.6 at 6 weeks and +5.9 at 2 years), and SRS-22r (+0.4 at 6 weeks and +0.7 at 2 years). For patients with LEMS improvement, mean HRQOL changes were: ODI (-0.6 at 6 weeks and -16.3 at 2 years), SF-36v2 physical (+1.0 at 6 weeks and +7.0 at 2 years), and SRS-22r (+0.5 at 6 weeks and +0.9 at 2 years).

    Conclusion

    In the subgroup of deformity patients who developed a new motor deficit, total HRQOLs and HRQOL changes were negatively impacted. Patients with more than 2 points of LEMS worsening had the worst changes, but still showed overall HRQOL improvement at 6 months and 2 years compared with pre-op baseline.Level of Evidence: 3.
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    Patient and procedural risk factors for decline in lower-extremity motor scores following adult spinal deformity surgery.
    (Journal of neurosurgery. Spine, 2023-04) Mohanty, Sarthak; Hassan, Fthimnir M; Lenke, Lawrence G; Burton, Douglas; Daniels, Alan H; Gupta, Munish C; Kebaish, Khaled M; Kelly, Michael; Kim, Han Jo; Klineberg, Eric O; Passias, Peter G; Protopsaltis, Themistocles; Schwab, Frank; Shaffrey, Christopher I; Smith, Justin S; Line, Breton G; Lafage, Renaud; Lafage, Virginie; Bess, Shay

    Objective

    The purpose of this study was to discern factors that differentiate patients who experience postoperative lower-extremity motor function decline in the early postoperative period.

    Methods

    Adult spinal deformity (ASD) patients who were enrolled in a multicenter, observational, and prospectively collected study from 2018 to 2021 at 18 spinal deformity centers in North America were queried. Eligible participants met at least one of the following radiographic and/or procedural inclusion criteria: pelvic incidence minus lumbar lordosis (PI-LL) ≥ 25°, T1 pelvic angle (T1PA) ≥ 30°, sagittal vertical axis (SVA) ≥ 15 cm, thoracic scoliosis ≥ 70°, thoracolumbar scoliosis ≥ 50°, global coronal malalignment ≥ 7 cm, 3-column osteotomy, spinal fusion ≥ 12 levels, and/or age ≥ 65 years with ≥ 7 levels of instrumentation. Patients with an inflammatory or autoimmune disease and those who were incarcerated or pregnant were excluded, as were non-English speakers. Only patients with baseline and 6-week postoperative lower-extremity motor score (LEMS) were analyzed. Patient information, including demographic data, operative data, patient-reported outcomes, and radiographic parameters, were collected. Univariate and multivariable logistic regression models were built to quantify the degree to which a patient's postoperative LEMS decline was related to demographic and clinical characteristics.

    Results

    In total, 205 patients (mean age 61.5 years, mean total instrumented levels 12.6, 67.3% female, 54.2% primary cases, 79.5% with pelvic fixation) were evaluated. Of these 205 patients, 32 (15.5%) experienced LEMS decline in the perioperative period. These patients were older (p = 0.0014) and had greater BMI (p = 0.0176), higher frailty scores (p = 0.047), longer operating room times (p = 0.033), and greater estimated blood loss (p < 0.0001), and they were more frequently observed to have intraoperative neurophysiological monitoring (IONM) changes (p = 0.018). The deteriorated cohort had greater C7SVA at baseline (p = 0.0028) but were comparable in terms of all other radiographic parameters. No radiographic differences were seen between the groups at the 6-week visit; however, the deteriorated cohort experienced greater change in PI-LL (p < 0.0001), lumbar lordosis (p = 0.0461), C7SVA (p = 0.0004), and T1PA (p < 0.0001). Multivariate logistic regression demonstrated that the presence of IONM changes and each degree of negative change in T1PA conferred 3.71 (95% CI 1.01-13.42) and 1.09 (1.01-1.19) greater odds of postoperative LEMS deterioration, respectively.

    Conclusions

    In this study, 15.6% of ASD patients incurred LEMS decline in the perioperative period. The magnitude of change in global sagittal alignment, specifically T1PA, was the strongest independent predictor of LEMS decline, which has implications for surgical planning, patient counseling, and clinical research.
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    Postoperative Discharge to Acute Rehabilitation or Skilled Nursing Facility Compared to Home Does Not Reduce Hospital Readmissions, Return to Surgery or Improve Outcomes Following Adult Spine Deformity Surgery.
    (Spine, 2023-09) Bess, Shay; Line, Breton G; Nunley, Pierce; Ames, Christopher; Burton, Douglas; Mundis, Gregory; Eastlack, Robert; Hart, Robert; Gupta, Munish; Klineberg, Eric; Kim, Han Jo; Kelly, Michael; Hostin, Richard; Kebaish, Khaled; Lafage, Virgine; Lafage, Renaud; Schwab, Frank; Shaffrey, Christopher; Smith, Justin S; International Spine Study Group

    Study design

    Retrospective review of a prospective multi-center adult spinal deformity (ASD) study.

    Objective

    Evaluate 30-day readmissions, 90-day return to surgery, postoperative complications, and patient reported outcomes (PROs) for matched ASD patients receiving nonhome discharge (NON), including acute rehabilitation (REHAB) and skilled nursing facility (SNF), or home (HOME) discharge following ASD surgery.

    Summary of background data

    Postoperative disposition following ASD surgery frequently involves nonhome discharge. Little data exists for longer term outcomes for ASD patients receiving nonhome discharge versus patients discharged to home.

    Methods

    Surgically treated ASD patients prospectively enrolled into a multicenter study were assessed for NON or HOME disposition following hospital discharge. NON was further divided into REHAB or SNF. Propensity score matching (PSM) was used to match for patient age, frailty, spine deformity, levels fused and osteotomies performed at surgery. Thirty-day hospital readmissions, 90-day return to surgery, postoperative complications, 1-year and minimum 2-year postoperative PROs were evaluated.

    Results

    241 of 374 patients were eligible for study. NON patients were identified and matched to HOME patients. Following matching, 158 patients remained for evaluation; NON and HOME had similar preoperative age, frailty, spine deformity magnitude, surgery performed, and duration of hospital stay (P>0.05). Thirty-day readmissions, 90-day return to surgery, and postoperative complications were similar for NON versus HOME, and similar for REHAB (N=64) versus SNF (N=42) versus HOME (P>0.05). At 1-year and minimum 2-year follow up, HOME demonstrated similar to better PRO scores including ODI, SF-36 MCS and PCS, and SRS scores versus NON, REHAB and SNF (P<0.05).

    Conclusion

    Acute needs must be considered following ASD surgery, however matched analysis comparing 30-day hospital readmissions, 90-day return to surgery, postoperative complications and PROs demonstrated minimal benefit for NON, REHAB or SNF versus HOME at 1-year and 2-year follow up, questioning the risk and cost/benefits of routine use of nonhome discharge.

    Level of evidence

    I-IV: Level III; prognostic.
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    Prospective Multicenter Assessment of All-Cause Mortality Following Surgery for Adult Cervical Deformity.
    (Neurosurgery, 2018-12) Smith, Justin S; Shaffrey, Christopher I; Kim, Han Jo; Passias, Peter; Protopsaltis, Themistocles; Lafage, Renaud; Mundis, Gregory M; Klineberg, Eric; Lafage, Virginie; Schwab, Frank J; Scheer, Justin K; Miller, Emily; Kelly, Michael; Hamilton, D Kojo; Gupta, Munish; Deviren, Vedat; Hostin, Richard; Albert, Todd; Riew, K Daniel; Hart, Robert; Burton, Doug; Bess, Shay; Ames, Christopher P; International Spine Study Group
    BACKGROUND:Surgical treatments for adult cervical spinal deformity (ACSD) are often complex and have high complication rates. OBJECTIVE:To assess all-cause mortality following ACSD surgery. METHODS:ACSD patients presenting for surgical treatment were identified from a prospectively collected multicenter database. Clinical and surgical parameters and all-cause mortality were assessed. RESULTS:Of 123 ACSD patients, 120 (98%) had complete baseline data (mean age, 60.6 yr). The mean number of comorbidities per patient was 1.80, and 80% had at least 1 comorbidity. Surgical approaches included anterior only (15.8%), posterior only (50.0%), and combined anterior/posterior (34.2%). The mean number of vertebral levels fused was 8.0 (standard deviation [SD] = 4.5), and 23.3% had a 3-column osteotomy. Death was reported for 11 (9.2%) patients at a mean of 1.1 yr (SD = 0.76 yr; range = 7 d to 2 yr). Mean follow-up for living patients was 1.2 yr (SD = 0.64 yr). Causes of death included myocardial infarction (n = 2), pneumonia/cardiopulmonary failure (n = 2), sepsis (n = 1), obstructive sleep apnea/narcotics (n = 1), subsequently diagnosed amyotrophic lateral sclerosis (n = 1), burn injury related to home supplemental oxygen (n = 1), and unknown (n = 3). Deceased patients did not significantly differ from alive patients based on demographic, clinical, or surgical parameters assessed, except for a higher major complication rate (excluding mortality; 63.6% vs 22.0%, P = .006). CONCLUSION:All-cause mortality at a mean of 1.2 yr following surgery for ACSD was 9.2% in this prospective multicenter series. Causes of death were reflective of the overall high level of comorbidities. These findings may prove useful for treatment decision making and patient counseling in the context of the substantial impact of ACSD.
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    Quantifying the Contribution of Lower Limb Compensation to Upright Posture: What Happens if Adult Spinal Deformity Patients Do Not Compensate?
    (Spine, 2023-03) Lafage, Renaud; Duvvuri, Priya; Elysee, Jonathan; Diebo, Bassel; Bess, Shay; Burton, Douglas; Daniels, Alan; Gupta, Munish; Hostin, Richard; Kebaish, Khaled; Kelly, Michael; Kim, Han Jo; Klineberg, Eric; Lenke, Lawrence; Lewis, Stephen; Ames, Christopher; Passias, Peter; Protopsaltis, Themistocles; Shaffrey, Christopher; Smith, Justin S; Schwab, Frank; Lafage, Virginie; International Spine Study Group

    Study design

    This is a multicenter, prospective cohort study.

    Objective

    This study tests the hypothesis that elimination of lower limb compensation in patients with adult spinal deformity (ASD) will significantly increase the magnitude of sagittal malalignment.

    Summary of background data

    ASD affects a significant proportion of the elderly population, impairing functional sagittal alignment and inhibiting overall quality of life. To counteract these effects, patients with ASD use their spine, pelvis, and lower limbs to create a compensatory posture that allows for standing and mobility. However, the degree to which each of the hips, knees, and ankles contributes to these compensatory mechanisms has yet to be determined.

    Methods

    Patients undergoing corrective surgery for ASD were included if they met at least one of the following criteria: complex surgical procedure, geriatric deformity surgery, or severe radiographic deformity. Preoperative full-body x-rays were evaluated, and age and PI-adjusted normative values were used to model spine alignment based upon three positions: compensated (all lower extremity compensatory mechanisms maintained), partially compensated (removal of ankle dorsiflexion and knee flexion, with maintained hip extension), and uncompensated (ankle, knee, and hip compensation set to the age and PI norms).

    Results

    288 patients were included (mean age 60 y, 70.5% females). As the model transitioned from the compensated to uncompensated position, initial posterior translation of the pelvis decreased significantly to an anterior translation versus the ankle (P.Shift: 30 to -7.6 mm). This was associated with a decrease in pelvic retroversion (PT: 24.1 to 16.1), hip extension (SFA: 203 to 200), knee flexion (KA: 5.5 to-0.4), and ankle dorsiflexion (AA: 5.3 to 3.7). As a result, the anterior malalignment of the trunk significantly increased: SVA (65 to 120 mm) and G-SVA (C7-Ankle from 36 to 127 mm).

    Conclusion

    Removal of lower limbs compensation revealed an unsustainable truncal malalignment with two-fold greater SVA.
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    Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial.
    (JAMA network open, 2024-06) Fehlings, Michael G; Pedro, Karlo M; Alvi, Mohammed Ali; Badhiwala, Jetan H; Ahn, Henry; Farhadi, H Francis; Shaffrey, Christopher I; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M; Jacobs, W Bradley; Riew, K Daniel; Kelly, Michael; Brodke, Darrel S; Vaccaro, Alexander R; Hilibrand, Alan S; Wilson, Jason; Harrop, James S; Yoon, S Tim; Kim, Kee D; Fourney, Daryl R; Santaguida, Carlo; Massicotte, Eric M; Huang, Peng

    Importance

    The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery.

    Objective

    To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM.

    Design, setting, and participants

    This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023.

    Intervention

    Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery.

    Main outcomes and measures

    The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE).

    Results

    Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007).

    Conclusions and relevance

    In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.
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    Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.
    (The Lancet. Neurology, 2021-02) Fehlings, Michael G; Badhiwala, Jetan H; Ahn, Henry; Farhadi, H Francis; Shaffrey, Christopher I; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M; Jacobs, W Bradley; Riew, K Daniel; Kelly, Michael; Brodke, Darrel S; Vaccaro, Alexander R; Hilibrand, Alan S; Wilson, Jason; Harrop, James S; Yoon, S Tim; Kim, Kee D; Fourney, Daryl R; Santaguida, Carlo; Massicotte, Eric M; Kopjar, Branko

    Background

    Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy.

    Methods

    This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18-80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8-14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828.

    Findings

    From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference -0·38 points (-0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications.

    Interpretation

    In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study.

    Funding

    AOSpine North America.
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    Surgery for the Adolescent Idiopathic Scoliosis Patients After Skeletal Maturity: Early Versus Late Surgery.
    (Spine deformity, 2019-01) Lonner, Baron S; Ren, Yuan; Bess, Shay; Kelly, Michael; Kim, Han Jo; Yaszay, Burt; Lafage, Virginie; Marks, Michelle; Miyanji, Firoz; Shaffrey, Christopher I; Newton, Peter O

    Introduction

    Informed decision making for operative treatment of the skeletally mature adolescent idiopathic scoliosis (AIS) patient meeting surgical indications requires a discussion of differences in operative morbidity in adult scoliosis versus AIS. This study evaluated differences in operative data and outcomes between AIS and adult scoliosis patients based on an estimated natural history of curve progression.

    Methods

    Twenty-eight adult scoliosis patients (43.7 ± 15.8 years; 93% F) were 1:2 matched with 56 (Risser 4/5) AIS patients (15.7 ± 2.1 years) based on gender and curve type as vetted by 5 surgeons' consensus in committee. Curve progression of 0.3°/year for the first 10 years following skeletal maturity and a 0.5°/year thereafter was assumed to estimate curve progression from AIS to adulthood for the adult counterpart. Operative data, complications, and quality of life (Scoliosis Research Society [SRS-22r] questionnaire) measures were evaluated, with a minimum 2-year follow-up.

    Results

    Postoperative major Cobb and percentage correction were similar between adult versus AIS, whereas operative time, percentage estimated blood loss (EBL; % total blood volume), length of hospital stay (LOS), and total spine levels fused were greater for adult patients (p < .05). No difference was found in EBL, operative time, or LOS when normalized by levels fused. Ten (36%) adult scoliosis patients were fused to the pelvis compared with none in AIS (p < .0001). Major complication rate was higher for adult versus AIS (25% vs. 5.4%; p < .05). Preoperative SRS-22r scores were worse for adult patients; however, they demonstrated greater improvement in SRS-22r than the AIS cohort at final follow-up. A higher percentage of adult patients reached the MCID in self-image domain than the AIS patients (92.3% vs. 61.8%; p = .0040).

    Conclusion

    Treatment of the adult scoliosis patient who has undergone an estimated natural history of progression is characterized by greater levels fused, operative time, and higher complication rates than the AIS counterpart. Longer-term follow-up of AIS is needed to define the benefits of early intervention of relatively asymptomatic adolescent patients versus late treatment of symptomatic disease in the adult.
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    The health impact of adult cervical deformity in patients presenting for surgical treatment: Comparison to United States population norms and chronic disease states based on the EuroQuol-5 dimensions questionnaire
    (Clinical Neurosurgery, 2017-05-01) Smith, Justin S; Line, Breton; Bess, Shay; Shaffrey, Christopher I; Kim, Han Jo; Mundis, Gregory; Scheer, Justin K; Klineberg, Eric; O'Brien, Michael; Hostin, Richard; Gupta, Munish; Daniels, Alan; Kelly, Michael; Gum, Jeffrey L; Schwab, Frank J; Lafage, Virginie; Lafage, Renaud; Ailon, Tamir; Passias, Peter; Protopsaltis, Themistocles; Albert, Todd J; Riew, K Daniel; Hart, Robert; Burton, Doug; Deviren, Vedat; Ames, Christopher P; Group, International Spine Study
    BACKGROUND: Although adult cervical spine deformity (ACSD) is associated with pain and disability, its health impact has not been quantified in comparison to other chronic diseases. OBJECTIVE: To perform a comparative analysis of the health impact of symptomatic ACSD to US normative and chronic disease values using EQ-5D (EuroQuol-5 Dimensions questionnaire) scores. METHODS: ACSD patients presenting for surgical treatment were identified from a prospectively collected multicenter database. Baseline demographics and EQ-5D scores were collected and compared with US normative and disease state values. RESULTS: Of 121 ACSD patients, 115 (95%) completed the EQ-5D (60% women, mean age 61 years, previous spine surgery in 44%). Diagnoses included kyphosis with mid-cervical (63.4%), cervico-thoracic (23.5%), or thoracic (8.7%) apex and primary coronal deformity (4.3%). The mean ACSD EQ-5D index was 0.511 (standard definition = 0.224), which is 34% below the bottom 25th percentile (0.780) for similar age- and gender-matched US normative populations. Mean ACSD EQ-5D index values were worse than the bottom 25th percentile for several other disease states, including chronic ischemic heart disease (0.708), malignant breast cancer (0.708), and malignant prostate cancer (0.708). ACSD mean index values were comparable to the bottom 25th percentile values for blindness/low vision (0.543), emphysema (0.508), renal failure (0.506), and stroke (0.463). EQ-5D scores did not significantly differ based on cervical deformity type (P =.66). CONCLUSION: The health impact of symptomatic ACSD is substantial, with negative impact across all EQ-5D domains. The mean ACSD EQ-5D index was comparable to the bottom 25th percentile values for blindness/low vision, emphysema, renal failure, and stroke.
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    The Health Impact of Symptomatic Adult Spinal Deformity: Comparison of Deformity Types to United States Population Norms and Chronic Diseases.
    (Spine, 2016-02) Bess, Shay; Line, Breton; Fu, Kai-Ming; McCarthy, Ian; Lafage, Virgine; Schwab, Frank; Shaffrey, Christopher; Ames, Christopher; Akbarnia, Behrooz; Jo, Han; Kelly, Michael; Burton, Douglas; Hart, Robert; Klineberg, Eric; Kebaish, Khaled; Hostin, Richard; Mundis, Gregory; Mummaneni, Praveen; Smith, Justin S; International Spine Study Group
    A retrospective analysis of a prospective, multicenter database.The aim of this study was to evaluate the health impact of symptomatic adult spinal deformity (SASD) by comparing Standard Form Version 2 (SF-36) scores for SASD with United States normative and chronic disease values.Recent data have identified radiographic parameters correlating with poor health-related quality of life for SASD. Disability comparisons between SASD patients and patients with chronic diseases may provide further insight to the disease burden caused by SASD.Consecutive SASD patients, with no history of spine surgery, were enrolled into a multicenter database and evaluated for type and severity of spinal deformity. Baseline SF-36 physical component summary (PCS) and mental component summary (MCS) values for SASD patients were compared with reported U.S. normative and chronic disease SF-36 scores. SF-36 scores were reported as normative-based scores (NBS) and evaluated for minimally clinical important difference (MCID).Between 2008 and 2011, 497 SASD patients were prospectively enrolled and evaluated. Mean PCS for all SASD was lower than U.S. total population (ASD = 40.9; US = 50; P < 0.05). Generational decline in PCS for SASD patients with no other reported comorbidities was more rapid than U.S. norms (P < 0.05). PCS worsened with lumbar scoliosis and increasing sagittal vertical axis (SVA). PCS scores for patients with isolated thoracic scoliosis were similar to values reported by individuals with chronic back pain (45.5 vs 45.7, respectively; P > 0.05), whereas patients with lumbar scoliosis combined with severe sagittal malalignment (SVA >10 cm) demonstrated worse PCS scores than values reported by patients with limited use of arms and legs (24.7 vs 29.1, respectively; P < 0.05).SASD is a heterogeneous condition that, depending upon the type and severity of the deformity, can have a debilitating impact on health often exceeding the disability of more recognized chronic diseases. Health care providers must be aware of the types of SASD that correlate with disability to facilitate appropriate diagnosis, treatment, and research efforts.3.
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    Utilization of Predictive Modeling to Determine Episode of Care Costs and to Accurately Identify Catastrophic Cost Nonwarranty Outlier Patients in Adult Spinal Deformity Surgery: A Step Toward Bundled Payments and Risk Sharing.
    (Spine, 2020-03) Ames, Christopher P; Smith, Justin S; Gum, Jeffrey L; Kelly, Michael; Vila-Casademunt, Alba; Burton, Douglas C; Hostin, Richard; Yeramaneni, Samrat; Lafage, Virginie; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; Pellisé, Ferran; Serra-Burriel, Miquel; European Spine Study Group and International Spine Study Group

    Study design

    Retrospective review of prospectively-collected, multicenter adult spinal deformity (ASD) database.

    Objective

    The aim of this study was to evaluate the rate of patients who accrue catastrophic cost (CC) with ASD surgery utilizing direct, actual costs, and determine the feasibility of predicting these outliers.

    Summary of background data

    Cost outliers or surgeries resulting in CC are a major concern for ASD surgery as some question the sustainability of these surgical treatments.

    Methods

    Generalized linear regression models were used to explain the determinants of direct costs. Regression tree and random forest models were used to predict which patients would have CC (>$100,000).

    Results

    A total of 210 ASD patients were included (mean age of 59.3 years, 83% women). The mean index episode of care direct cost was $70,766 (SD = $24,422). By 90 days and 2 years following surgery, mean direct costs increased to $74,073 and $77,765, respectively. Within 90 days of the index surgery, 11 (5.2%) patients underwent 13 revisions procedures, and by 2 years, 26 (12.4%) patients had undergone 36 revision procedures. The CC threshold at the index surgery and 90-day and 2-year follow-up time points was exceeded by 11.9%, 14.8%, and 19.1% of patients, respectively. Top predictors of cost included number of levels fused, surgeon, surgical approach, interbody fusion (IBF), and length of hospital stay (LOS). At 90 days and 2 years, a total of 80.6% and 64.0% of variance in direct cost, respectively, was explained in the generalized linear regression models. Predictors of CC were number of fused levels, surgical approach, surgeon, IBF, and LOS.

    Conclusion

    The present study demonstrates that direct cost in ASD surgery can be accurately predicted. Collectively, these findings may not only prove useful for bundled care initiatives, but also may provide insight into means to reduce and better predict cost of ASD surgery outside of bundled payment plans.

    Level of evidence

    3.