Browsing by Author "Hart, Robert A"
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Item Open Access A Comprehensive Review of Complication Rates After Surgery for Adult Deformity: A Reference for Informed Consent.(Spine deformity, 2015-11) Sciubba, Daniel M; Yurter, Alp; Smith, Justin S; Kelly, Michael P; Scheer, Justin K; Goodwin, C Rory; Lafage, Virginie; Hart, Robert A; Bess, Shay; Kebaish, Khaled; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher P; International Spine Study Group (ISSG)Objective
An up-to-date review of recent literatures and a comprehensive reference for informed consent specific to ASD complications is lacking. The goal of the present study was to determine current complication rates after ASD surgery, in order to provide a reference for informed consent as well as to determine differences between three-column and non-three-column osteotomy procedures to aid in shared decision making.Methods
A review of the literature was conducted using the PubMed database. Randomized controlled trials, nonrandomized trials, cohort studies, case-control studies, and case series providing postoperative complications published in 2000 or later were included. Complication rates were recorded and calculated for perioperative (both major and minor) and long-term complication rates. Postoperative outcomes were all stratified by surgical procedure (ie, three-column osteotomy and non-three-column osteotomy).Results
Ninety-three articles were ultimately eligible for analysis. The data of 11,692 patients were extracted; there were 3,646 complications, mean age at surgery was 53.3 years (range: 25-77 years), mean follow-up was 3.49 years (range: 6 weeks-9.7 years), estimated blood loss was 2,161 mL (range: 717-7,034 mL), and the overall mean complication rate was 55%. Specifically, major perioperative complications occurred at a mean rate of 18.5%, minor perioperative complications occurred at a mean rate of 15.7%, and long-term complications occurred at a mean rate of 20.5%. Furthermore, three-column osteotomy resulted in a higher overall complication rate and estimated blood loss than non-three-column osteotomy.Conclusions
A review of recent literatures providing complication rates for ASD surgery was performed, providing the most up-to-date incidence of early and late complications. Providers may use such data in helping to counsel patients of the literature-supported complication rates of such procedures despite the planned benefits, thus obtaining a more thorough informed consent.Item Open Access A Multicenter Study of the Presentation, Treatment, and Outcomes of Cervical Dural Tears.(Global spine journal, 2017-04) O'Neill, Kevin R; Fehlings, Michael G; Mroz, Thomas E; Smith, Zachary A; Hsu, Wellington K; Kanter, Adam S; Steinmetz, Michael P; Arnold, Paul M; Mummaneni, Praveen V; Chou, Dean; Nassr, Ahmad; Qureshi, Sheeraz A; Cho, Samuel K; Baird, Evan O; Smith, Justin S; Shaffrey, Christopher; Tannoury, Chadi A; Tannoury, Tony; Gokaslan, Ziya L; Gum, Jeffrey L; Hart, Robert A; Isaacs, Robert E; Sasso, Rick C; Bumpass, David B; Bydon, Mohamad; Corriveau, Mark; De Giacomo, Anthony F; Derakhshan, Adeeb; Jobse, Bruce C; Lubelski, Daniel; Lee, Sungho; Massicotte, Eric M; Pace, Jonathan R; Smith, Gabriel A; Than, Khoi D; Riew, K DanielStudy design
Retrospective multicenter case series study.Objective
Because cervical dural tears are rare, most surgeons have limited experience with this complication. A multicenter study was performed to better understand the presentation, treatment, and outcomes following cervical dural tears.Methods
Multiple surgeons from 23 institutions retrospectively identified 21 rare complications that occurred between 2005 and 2011, including unintentional cervical dural tears. Demographic data and surgical history were obtained. Clinical outcomes following surgery were assessed, and any reoperations were recorded. Neck Disability Index (NDI), modified Japanese Orthopaedic Association (mJOA), Nurick classification (NuC), and Short-Form 36 (SF36) scores were recorded at baseline and final follow-up at certain centers. All data were collected, collated, and analyzed by a private research organization.Results
There were 109 cases of cervical dural tears among 18 463 surgeries performed. In 101 cases (93%) there was no clinical sequelae following successful dural tear repair. There were statistical improvements (P < .05) in mJOA and NuC scores, but not NDI or SF36 scores. No specific baseline or operative factors were found to be associated with the occurrence of dural tears. In most cases, no further postoperative treatments of the dural tear were required, while there were 13 patients (12%) that required subsequent treatment of cerebrospinal fluid drainage. Analysis of those requiring further treatments did not identify an optimum treatment strategy for cervical dural tears.Conclusions
In this multicenter study, we report our findings on the largest reported series (n = 109) of cervical dural tears. In a vast majority of cases, no subsequent interventions were required and no clinical sequelae were observed.Item Open Access Adult Spinal Deformity Knowledge in Orthopedic Spine Surgeons: Impact of Fellowship Training, Experience, and Practice Characteristics.(Spine deformity, 2018-01) Grabel, Zachary J; Hart, Robert A; Clark, Aaron J; Park, Sara Heejung; Shaffrey, Christopher I; Scheer, Justin K; Smith, Justin S; Kelly, Michael P; DePasse, J Mason; Gupta, Munish C; Ames, Christopher P; Daniels, Alan HSTUDY DESIGN:Survey study. OBJECTIVE:The purpose of this paper was to assess the level of adult spine deformity (ASD) knowledge among orthopedic spine surgeons and identify areas for improvement in spine surgery training. SUMMARY OF BACKGROUND DATA:ASD is increasingly encountered in spine surgery practice. While ASD knowledge among neurosurgeons has been evaluated, ASD knowledge among orthopedic spine surgeons has not previously been reported. METHODS:A survey of orthopedic spine surgeon members of North American Spine Society (NASS) was conducted to assess level of spine surgery training, practice experience, and spinal deformity knowledge base. The survey used was previously completed by a group of neurologic surgeons with published results. The survey used 11 questions developed and agreed upon by experienced spinal deformity surgeons. RESULTS:Complete responses were received from 413 orthopedic spine surgeons. The overall correct-answer rate was 69.0%. Surgeons in practice for less than 10 years had a higher correct-answer rate compared to those who have practiced for 10 years or more (74% vs. 67%; p = .000003). Surgeons with 75% or more of their practice dedicated to spine had a higher overall correct rate compared to surgeons whose practice is less than 75% spine (71% vs. 63%; p = .000029). Completion of spine fellowship was associated with a higher overall correct-answer rate compared to respondents who did not complete a spine fellowship (71% vs. 59%; p < .00001). CONCLUSIONS:Completion of spine fellowship and having a dedicated spine surgery practice were significantly associated with improved performance on this ASD knowledge survey. Unlike neurosurgeons, orthopedic spine surgeons who have practiced for less than 10 years performed better than those who have practiced for more than 10 years. Ongoing emphasis on spine deformity education should be emphasized to improve adult spinal deformity knowledge base.Item Open Access Adult Spinal Deformity Patients Recall Fewer Than 50% of the Risks Discussed in the Informed Consent Process Preoperatively and the Recall Rate Worsens Significantly in the Postoperative Period.(Spine, 2015-07) Saigal, Rajiv; Clark, Aaron J; Scheer, Justin K; Smith, Justin S; Bess, Shay; Mummaneni, Praveen V; McCarthy, Ian M; Hart, Robert A; Kebaish, Khaled M; Klineberg, Eric O; Deviren, Vedat; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher PStudy design
Recall of the informed consent process in patients undergoing adult spinal deformity surgery and their family members was investigated prospectively.Objective
To quantify the percentage recall of the most common complications discussed during the informed consent process in adult spinal deformity surgery, assess for differences between patients and family members, and correlate with mental status.Summary of background data
Given high rates of complications in adult spinal deformity surgery, it is critical to shared decision making that patients are adequately informed about risks and are able to recall preoperative discussion of possible complications to mitigate medical legal risk.Methods
Patients undergoing adult spinal deformity surgery underwent an augmented informed consent process involving both verbal and video explanations. Recall of the 11 most common complications was scored. Mental status was assessed with the mini-mental status examination-brief version. Patients subjectively scored the informed consent process and video. After surgery, the recall test and mini-mental status examination-brief version were readministered at 5 additional time points: hospital discharge, 6 to 8 weeks, 3 months, 6 months, and 1 year postoperatively. Family members were assessed at the first 3 time points for comparison.Results
Fifty-six patients enrolled. Despite ranking the consent process as important (median overall score: 10/10; video score: 9/10), median patient recall was only 45% immediately after discussion and video re-enforcement and subsequently declined to 18% at 6 to 8 weeks and 1 year postoperatively. Median family recall trended higher at 55% immediately and 36% at 6 to 8 weeks postoperatively. The perception of the severity of complications significantly differs between patient and surgeon. Mental status scores showed a transient, significant decrease from preoperation to discharge but were significantly higher at 1 year.Conclusion
Despite being well-informed in an optimized informed consent process, patients cannot recall most surgical risks discussed and recall declines over time. Significant progress remains to improve informed consent retention.Level of evidence
3.Item Open Access Adult Spinal Deformity Surgery Is Associated with Increased Productivity and Decreased Absenteeism From Work and School.(Spine, 2022-02) Durand, Wesley M; Babu, Jacob M; Hamilton, David K; Passias, Peter G; Kim, Han Jo; Protopsaltis, Themistocles; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Kelly, Michael P; Klineberg, Eric O; Schwab, Frank; Gum, Jeffrey L; Mundis, Gregory; Eastlack, Robert; Kebaish, Khaled; Soroceanu, Alex; Hostin, Richard A; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; Daniels, Alan H; International Spine Study Group (ISSG)Study design
Retrospective cohort study.Objective
We hypothesized that adult spinal deformity (ASD) surgery would be associated with improved work- and school-related productivity, as well as decreased rates of absenteeism.Summary of background data
ASD patients experience markedly decreased health-related quality of life along many dimensions.Methods
Only patients eligible for 2-year follow-up were included, and those with a history of previous spinal fusion were excluded. The primary outcome measures in this study were Scoliosis Research Society-22r score (SRS-22r) questions 9 and 17. A repeated measures mixed linear regression was used to analyze responses over time among patients managed operatively (OP) versus nonoperatively (NON-OP).Results
In total, 1188 patients were analyzed. 66.6% were managed operatively. At baseline, the mean percentage of activity at work/school was 56.4% (standard deviation [SD] 35.4%), and the mean days off from work/school over the past 90 days was 1.6 (SD 1.8). Patients undergoing ASD surgery exhibited an 18.1% absolute increase in work/school productivity at 2-year follow-up versus baseline (P < 0.0001), while no significant change was observed for the nonoperative cohort (P > 0.5). Similarly, the OP cohort experienced 1.1 fewer absent days over the past 90 days at 2 years versus baseline (P < 0.0001), while the NON-OP cohort showed no such difference (P > 0.3). These differences were largely preserved after stratifying by baseline employment status, age group, sagittal vertical axis (SVA), pelvic incidence minus lumbar lordosis (PI-LL), and deformity curve type.Conclusion
ASD patients managed operatively exhibited an average increase in work/school productivity of 18.1% and decreased absenteeism of 1.1 per 90 days at 2-year follow-up, while patients managed nonoperatively did not exhibit change from baseline. Given the age distribution of patients in this study, these findings should be interpreted as pertaining primarily to obligations at work or within the home. Further study of the direct and indirect economic benefits of ASD surgery to patients is warranted.Level of Evidence: 3.Item Open Access After 9 Years of 3-Column Osteotomies, Are We Doing Better? Performance Curve Analysis of 573 Surgeries With 2-Year Follow-up.(Neurosurgery, 2018-07) Diebo, Bassel G; Lafage, Virginie; Varghese, Jeffrey J; Gupta, Munish; Kim, Han Jo; Ames, Christopher; Kebaish, Khaled; Shaffrey, Christopher; Hostin, Richard; Obeid, Ibrahim; Burton, Doug; Hart, Robert A; Lafage, Renaud; Schwab, Frank J; International Spine Study Group (ISSG) of Denver, ColoradoBackground
In spinal deformity treatment, the increased utilization of 3-column (3CO) osteotomies reflects greater comfort and better training among surgeons. This study aims to evaluate the longitudinal performance and adverse events (complications or revisions) for a multicenter group following a decade of 3CO.Objective
To investigate if performance of 3CO surgeries improves with years of practice.Methods
Patients who underwent 3CO for spinal deformity with intra/postoperative and revision data collected up to 2 yr were included. Patients were chronologically divided into 4 even groups. Demographics, baseline deformity/correction, and surgical metrics were compared using Student t-test. Postoperative and revision rates were compared using Chi-square analysis.Results
Five hundred seventy-three patients were stratified into: G1 (n = 143, 2004-2008), G2 (n = 142, 2008-2009), G3 (n = 144, 2009-2010), G4 (n = 144 2010-2013). The most recent patients were more disabled by Oswestry disability index (G4 = 49.2 vs G1 = 38.3, P = .001), and received a larger osteotomy resection (G4 = 26° vs G1 = 20°, P = .011) than the earliest group. There was a decrease in revision rate (45%, 35%, 33%, 30%, P = .039), notably in revisions for pseudarthrosis (16.7% G1 vs 6.9% G4, P = .007). Major complication rates also decreased (57%, 50%, 46%, 39%, P = .023) as did excessive blood loss (>4 L, 27.2 vs 16.7%, P = .023) and bladder/bowel deficit (4.2% vs 0.7% P = .002). Successful outcomes (no complications or revision) significantly increased (P = .001).Conclusion
Over 9 yr, 3COs are being performed on an increasingly disabled population while gaining a greater correction at the osteotomy site. Revisions and complication rate decreased while success rate improved during the 2-yr follow-up period.Item Open Access Analysis of Successful Versus Failed Radiographic Outcomes After Cervical Deformity Surgery.(Spine, 2018-07) Protopsaltis, Themistocles S; Ramchandran, Subaraman; Hamilton, D Kojo; Sciubba, Daniel; Passias, Peter G; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Hart, Robert A; Gupta, Munish; Burton, Douglas; Bess, Shay; Shaffrey, Christopher; Ames, Christopher P; International Spine Study Group (ISSG)Study design
Prospective multicenter cohort study with consecutive enrollment.Objective
To evaluate preoperative alignment and surgical factors associated with suboptimal early postoperative radiographic outcomes after surgery for cervical deformity.Summary of background data
Recent studies have demonstrated correlation between cervical sagittal alignment and patient-reported outcomes. Few studies have explored cervical deformity correction prospectively, and the factors that result in successful versus failed cervical alignment corrections remain unclear.Methods
Patients with adult cervical deformity (ACD) included with either cervical kyphosis more than 10°, C2-C7 sagittal vertical axis (cSVA) of more than 4 cm, or chin-brow vertical angle of more than 25°. Patients were categorized into failed outcomes group if cSVA of more than 4 cm or T1 slope and cervical lordosis (TS-CL) of more than 20° at 6 months postoperatively.Results
A total of 71 patients with ACD (mean age 62 yr, 56% women, 41% revisions) were included. Fourty-five had primary cervical deformities and 26 at the cervico-thoracic junction. Thirty-three (46.4%) had failed radiographic outcomes by cSVA and 46 (64.7%) by TS-CL. Failure to restore cSVA was associated with worse preoperative C2 pelvic tilt angle (CPT: 64.4° vs. 47.8°, P = 0.01), worse postoperative C2 slope (35.0° vs. 23.8°, P = 0.004), TS-CL (35.2° vs. 24.9°, P = 0.01), CPT (47.9° vs. 28.2°, P < 0.001), "+" Schwab modifiers (P = 0.007), revision surgery (P = 0.05), and failure to address the secondary, thoracolumbar driver of the deformity (P = 0.02). Failure to correct TS-CL was associated with worse preoperative cervical kyphosis (10.4° vs. -2.1°, P = 0.03), CPT (52.6° vs. 39.1°, P = 0.04), worse postoperative C2 slope (30.2° vs. 13.3°, P < 0.001), cervical lordosis (-3.6° vs. -15.1°, P = 0.01), and CPT (37.7° vs. 24.0°, P < 0.001). Multivariate analysis revealed postoperative distal junctional kyphosis associated with suboptimal outcomes by cSVA (odds ratio 0.06, confidence interval 0.01-0.4, P = 0.004) and TS-CL (odds ratio 0.15, confidence interval 0.02-0.97, P = 0.05).Conclusion
Factors associated with failure to correct the cSVA included revision surgery, worse preoperative CPT, and concurrent thoracolumbar deformity. Failure to correct the TS-CL mismatch was associated with worse preoperative cervical kyphosis and CPT. Occurrence of early postoperative distal junctional kyphosis significantly affects postoperative radiographic outcomes.Level of evidence
3.Item Open Access Are insufficient corrections a major factor in distal junctional kyphosis? A simulated analysis of cervical deformity correction using in-construct measurements.(Journal of neurosurgery. Spine, 2024-05) Ani, Fares; Sissman, Ethan; Woo, Dainn; Soroceanu, Alex; Mundis, Gregory; Eastlack, Robert K; Smith, Justin S; Hamilton, D Kojo; Kim, Han Jo; Daniels, Alan H; Klineberg, Eric O; Neuman, Brian; Sciubba, Daniel M; Gupta, Munish C; Kebaish, Khaled M; Passias, Peter G; Hart, Robert A; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank J; Lafage, Virginie; Ames, Christopher P; Protopsaltis, Themistocles SObjective
The present study utilized recently developed in-construct measurements in simulations of cervical deformity surgery in order to assess undercorrection and predict distal junctional kyphosis (DJK).Methods
A retrospective review of a database of operative cervical deformity patients was analyzed for severe DJK and mild DJK. C2-lower instrumented vertebra (LIV) sagittal angle (SA) was measured postoperatively, and the correction was simulated in the preoperative radiograph in order to match the C2-LIV by using the planning software. Linear regression analysis that used C2 pelvic angle (CPA) and pelvic tilt (PT) determined the simulated PT that matched the virtual CPA. Linear regression analysis was used to determine the C2-T1 SA, C2-T4 SA, and C2-T10 SA that corresponded to DJK of 20° and cervical sagittal vertical axis (cSVA) of 40 mm.Results
Sixty-nine cervical deformity patients were included. Severe and mild DJK occurred in 11 (16%) and 22 (32%) patients, respectively; 3 (4%) required DJK revision. Simulated corrections demonstrated that severe and mild DJK patients had worse alignment compared to non-DJK patients in terms of cSVA (42.5 mm vs 33.0 mm vs 23.4 mm, p < 0.001) and C2-LIV SVA (68.9 mm vs 57.3 mm vs 36.8 mm, p < 0.001). Linear regression revealed the relationships between in-construct measures (C2-T1 SA, C2-T4 SA, and C2-T10 SA), cSVA, and change in DJK (all R > 0.57, p < 0.001). A cSVA of 40 mm corresponded to C2-T4 SA of 10.4° and C2-T10 SA of 28.0°. A DJK angle change of 10° corresponded to C2-T4 SA of 5.8° and C2-T10 SA of 20.1°.Conclusions
Simulated cervical deformity corrections demonstrated that severe DJK patients have insufficient corrections compared to patients without DJK. In-construct measures assess sagittal alignment within the fusion separate from DJK and subjacent compensation. They can be useful as intraoperative tools to gauge the adequacy of cervical deformity correction.Item Open Access Are We Focused on the Wrong Early Postoperative Quality Metrics? Optimal Realignment Outweighs Perioperative Risk in Adult Spinal Deformity Surgery.(Journal of clinical medicine, 2023-08) Passias, Peter G; Williamson, Tyler K; Mir, Jamshaid M; Smith, Justin S; Lafage, Virginie; Lafage, Renaud; Line, Breton; Daniels, Alan H; Gum, Jeffrey L; Schoenfeld, Andrew J; Hamilton, David Kojo; Soroceanu, Alex; Scheer, Justin K; Eastlack, Robert; Mundis, Gregory M; Diebo, Bassel; Kebaish, Khaled M; Hostin, Richard A; Gupta, Munish C; Kim, Han Jo; Klineberg, Eric O; Ames, Christopher P; Hart, Robert A; Burton, Douglas C; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; On Behalf Of The International Spine Study GroupBackground
While reimbursement is centered on 90-day outcomes, many patients may still achieve optimal, long-term outcomes following adult spinal deformity (ASD) surgery despite transient short-term complications.Objective
Compare long-term clinical success and cost-utility between patients achieving optimal realignment and suboptimally aligned peers.Study design/setting
Retrospective cohort study of a prospectively collected multicenter database.Methods
ASD patients with two-year (2Y) data included. Groups were propensity score matched (PSM) for age, frailty, body mass index (BMI), Charlson Comorbidity Index (CCI), and baseline deformity. Optimal radiographic criteria are defined as meeting low deformity in all three (Scoliosis Research Society) SRS-Schwab parameters or being proportioned in Global Alignment and Proportionality (GAP). Cost-per-QALY was calculated for each time point. Multivariable logistic regression analysis and ANCOVA (analysis of covariance) adjusting for baseline disability and deformity (pelvic incidence (PI), pelvic incidence minus lumbar lordosis (PI-LL)) were used to determine the significance of surgical details, complications, clinical outcomes, and cost-utility.Results
A total of 930 patients were considered. Following PSM, 253 "optimal" (O) and 253 "not optimal" (NO) patients were assessed. The O group underwent more invasive procedures and had more levels fused. Analysis of complications by two years showed that the O group suffered less overall major (38% vs. 52%, p = 0.021) and major mechanical complications (12% vs. 22%, p = 0.002), and less reoperations (23% vs. 33%, p = 0.008). Adjusted analysis revealed O patients more often met MCID (minimal clinically important difference) in SF-36 PCS, SRS-22 Pain, and Appearance. Cost-utility-adjusted analysis determined that the O group generated better cost-utility by one year and maintained lower overall cost and costs per QALY (both p < 0.001) at two years.Conclusions
Fewer late complications (mechanical and reoperations) are seen in optimally aligned patients, leading to better long-term cost-utility overall. Therefore, the current focus on avoiding short-term complications may be counterproductive, as achieving optimal surgical correction is critical for long-term success.Item Open Access Artificial intelligence clustering of adult spinal deformity sagittal plane morphology predicts surgical characteristics, alignment, and outcomes.(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, 2021-08) Durand, Wesley M; Lafage, Renaud; Hamilton, D Kojo; Passias, Peter G; Kim, Han Jo; Protopsaltis, Themistocles; Lafage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Kelly, Michael P; Klineberg, Eric O; Schwab, Frank; Gum, Jeffrey L; Mundis, Gregory; Eastlack, Robert; Kebaish, Khaled; Soroceanu, Alex; Hostin, Richard A; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; Daniels, Alan H; International Spine Study Group (ISSG)Purpose
AI algorithms have shown promise in medical image analysis. Previous studies of ASD clusters have analyzed alignment metrics-this study sought to complement these efforts by analyzing images of sagittal anatomical spinopelvic landmarks. We hypothesized that an AI algorithm would cluster preoperative lateral radiographs into groups with distinct morphology.Methods
This was a retrospective review of a multicenter, prospectively collected database of adult spinal deformity. A total of 915 patients with adult spinal deformity and preoperative lateral radiographs were included. A 2 × 3, self-organizing map-a form of artificial neural network frequently employed in unsupervised classification tasks-was developed. The mean spine shape was plotted for each of the six clusters. Alignment, surgical characteristics, and outcomes were compared.Results
Qualitatively, clusters C and D exhibited only mild sagittal plane deformity. Clusters B, E, and F, however, exhibited marked positive sagittal balance and loss of lumbar lordosis. Cluster A had mixed characteristics, likely representing compensated deformity. Patients in clusters B, E, and F disproportionately underwent 3-CO. PJK and PJF were particularly prevalent among clusters A and E. Among clusters B and F, patients who experienced PJK had significantly greater positive sagittal balance than those who did not.Conclusions
This study clustered preoperative lateral radiographs of ASD patients into groups with highly distinct overall spinal morphology and association with sagittal alignment parameters, baseline HRQOL, and surgical characteristics. The relationship between SVA and PJK differed by cluster. This study represents significant progress toward incorporation of computer vision into clinically relevant classification systems in adult spinal deformity.Level of evidence iv
Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.Item Open Access Assessment of Adult Spinal Deformity Complication Timing and Impact on 2-Year Outcomes Using a Comprehensive Adult Spinal Deformity Classification System.(Spine, 2022-03) Wick, Joseph B; Le, Hai V; Lafage, Renaud; Gupta, Munish C; Hart, Robert A; Mundis, Gregory M; Bess, Shay; Burton, Douglas C; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank J; Passias, Peter G; Protopsaltis, Themistocles S; Lafage, Virginie; Klineberg, Eric O; International Spine Study GroupStudy design
Retrospective review of prospectively collected multicenter registry data.Objective
To identify rates and timing of postoperative complications in adult spinal deformity (ASD) patients, the impact of complication type and timing on health related quality of life (HRQoL) outcomes, and the impact of complication timing on readmission and reoperation rates. Better understanding of complication timing and impact on HRQoL may improve patient selection, preoperative counseling, and postoperative complication surveillance.Summary of background data
ASD is common and associated with significant disability. Surgical correction is often pursued, but is associated with high complication rates. The International Spine Study Group, AO Spinal Deformity Forum, and European Spine Study Group have developed a new complication classification system for ASD (ISSG-AO spine complications classification system).Methods
The ISSG-AO spine complications classification system was utilized to assess complications occurring over the 2-year postoperative time period amongst a multicenter, prospectively enrolled cohort of patients who underwent surgery for ASD. Kaplan-Meier survival curves were established for each complication type. Propensity score matching was performed to adjust for baseline disability and comorbidities. Associations between each complication type and HRQoL, and reoperation/readmission and complication timing, were assessed.Results
Of 584 patients meeting inclusion criteria, cardiopulmonary, gastrointestinal, infection, early adverse events, and operative complications contributed to a rapid initial decrease in complication-free survival. Implant-related, radiographic, and neurologic complications substantially decreased long-term complication-free survival. Only radiographic and implant-related complications were significantly associated with worse 2-year HRQoL outcomes. Need for readmission and/or reoperation was most frequent among those experiencing complications after postoperative day 90.Conclusion
Surgeons should recognize that long-term complications have a substantial negative impact on HRQoL, and should carefully monitor for implant-related and radiographic complications over long-term follow-up.Level of Evidence: 4.Item Open Access Assessment of Patient Outcomes and Proximal Junctional Failure Rate of Adult Spinal Deformity Patients Undergoing Caudal Extension of Previous Spinal Fusion.(World neurosurgery, 2020-04-16) Daniels, Alan H; Reid, Daniel BC; Durand, Wesley M; Line, Breton; Passias, Peter; Kim, Han Jo; Protopsaltis, Themistocles; LaFage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Klineberg, Eric; Schwab, Frank; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; International Spine Study GroupOBJECT:This case series examined patients undergoing caudal extension of prior fusion without alteration of the prior UIV to assess patient outcomes and rates of PJK/PJF. METHODS:Patients eligible for 2-year minimum follow-up undergoing caudal extension of prior fusion with unchanged UIVs were identified. These patients were evaluated for PJK/PJF, and patient reported outcomes were recorded. RESULTS:In total, 40 patients were included. Mean follow-up duration was 2.2 years (SD 0.3). Patients in this cohort had poor preoperative sagittal alignment (PI-LL 26.7°, TPA 29.0°, SVA 93.4mm) and achieved substantial sagittal correction (ΔSVA -62.2mm, ΔPI-LL -19.8°, ΔTPA -11.1°) following caudal extension surgery. At final follow-up, there was a 0% rate of PJF among patients undergoing caudal extension of previous fusion without creation of a new UIV, but 27.5% of patients experienced PJK. Patients experienced significant improvement in both ODI and SRS-22r total score at 2-years post-operatively (p<0.05). In total, 7.5% (n=3) of patients underwent further revision, at an average of 1.1 years (SD 0.54) after the surgery with unaltered UIV. All three of these patients underwent revision for rod fracture with no revisions for PJK/PJF. CONCLUSIONS:Patients undergoing caudal extension of previous fusions for sagittal alignment correction have high rates of clinical success, low revision surgery rates, and very low rates of PJF. Minimizing repetitive tissue trauma at the UIV may result in decreased PJF risk, as the PJF rate in this cohort of unaltered UIV patients is below historical PJF rates of patients undergoing sagittal balance correction.Item Open Access Calibration of a comprehensive predictive model for the development of proximal junctional kyphosis and failure in adult spinal deformity patients with consideration of contemporary goals and techniques.(Journal of neurosurgery. Spine, 2023-06) Tretiakov, Peter S; Lafage, Renaud; Smith, Justin S; Line, Breton G; Diebo, Bassel G; Daniels, Alan H; Gum, Jeffrey; Protopsaltis, Themistocles; Hamilton, D Kojo; Soroceanu, Alex; Scheer, Justin K; Eastlack, Robert K; Mundis, Gregory; Nunley, Pierce D; Klineberg, Eric O; Kebaish, Khaled; Lewis, Stephen; Lenke, Lawrence; Hostin, Richard; Gupta, Munish C; Ames, Christopher P; Hart, Robert A; Burton, Douglas; Shaffrey, Christopher I; Schwab, Frank; Bess, Shay; Kim, Han Jo; Lafage, Virginie; Passias, Peter GObjective
The objective of this study was to calibrate an updated predictive model incorporating novel clinical, radiographic, and prophylactic measures to assess the risk of proximal junctional kyphosis (PJK) and failure (PJF).Methods
Operative patients with adult spinal deformity (ASD) and baseline and 2-year postoperative data were included. PJK was defined as ≥ 10° in sagittal Cobb angle between the inferior uppermost instrumented vertebra (UIV) endplate and superior endplate of the UIV + 2 vertebrae. PJF was radiographically defined as a proximal junctional sagittal Cobb angle ≥ 15° with the presence of structural failure and/or mechanical instability, or PJK with reoperation. Backstep conditional binary supervised learning models assessed baseline demographic, clinical, and surgical information to predict the occurrence of PJK and PJF. Internal cross validation of the model was performed via a 70%/30% cohort split. Conditional inference tree analysis determined thresholds at an alpha level of 0.05.Results
Seven hundred seventy-nine patients with ASD (mean 59.87 ± 14.24 years, 78% female, mean BMI 27.78 ± 6.02 kg/m2, mean Charlson Comorbidity Index 1.74 ± 1.71) were included. PJK developed in 50.2% of patients, and 10.5% developed PJF by their last recorded visit. The six most significant demographic, radiographic, surgical, and postoperative predictors of PJK/PJF were baseline age ≥ 74 years, baseline sagittal age-adjusted score (SAAS) T1 pelvic angle modifier > 1, baseline SAAS pelvic tilt modifier > 0, levels fused > 10, nonuse of prophylaxis measures, and 6-week SAAS pelvic incidence minus lumbar lordosis modifier > 1 (all p < 0.015). Overall, the model was deemed significant (p < 0.001), and internally validated receiver operating characteristic analysis returned an area under the curve of 0.923, indicating robust model fit.Conclusions
PJK and PJF remain critical concerns in ASD surgery, and efforts to reduce the occurrence of PJK and PJF have resulted in the development of novel prophylactic techniques and enhanced clinical and radiographic selection criteria. This study demonstrates a validated model incorporating such techniques that may allow for the prediction of clinically significant PJK and PJF, and thus assist in optimizing patient selection, enhancing intraoperative decision making, and reducing postoperative complications in ASD surgery.Item Open Access Changes in health-related quality of life measures associated with degree of proximal junctional kyphosis.(Spine deformity, 2023-05) Passias, Peter G; Frangella, Nicholas J; Williamson, Tyler K; Moattari, Kevin A; Lafage, Renaud; Lafage, Virginie; Smith, Justin S; Kebaish, Khaled M; Burton, Douglas C; Hart, Robert A; Ames, Christopher P; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank J; International Spine Study GroupPurpose
To explore the changes in health-related quality of life parameters observed in patients experiencing varying degrees of proximal junctional kyphosis following corrective adult spinal deformity fusions.Methods
Inclusion: adult spinal deformity patients > 18 y/o, undergoing spinal fusion. PJK: ≥ 10° measure of the sagittal Cobb angle between the inferior endplate of the UIV and the superior endplate of the UIV + 2. Severe PJK: > 28° PJK. Mild PJK: ≥ 10oand ≤ 28°. ANOVA, followed by ANCOVA, compared the change in HRQoLs between time points (BL, 1Y, 2Y) among PJK groups. Correlation-related change in PJK and change in HRQoL for mild and severe groups.Results
969 patients (age: 64.5 y/o,75% F, posterior levels fused:12.3) were studied. 59% no PJK, 32% mild PJK, 9% severe PJK. No differences in HRQoLs were seen between no PJK and PJK groups at baseline, one year, and 2 years. Adjusted analysis revealed Severe PJK patients improved less in SRS-22 Satisfaction (NoPJK: 1.6, MildPJK: 1.6, SeverePJK: 1.0; p = 0.022) scores at 2 years. Linear regression analysis only found clinical improvement in SRS-22 Satisfaction to correlate with the change of the PJK angle by 2 years (R = 0.176, P = 0.008). No other HRQoL metric correlated with either the incidence of PJK or the change in the PJK angle by one or 2 years.Conclusions
These results maintain that patients presenting with and without proximal junctional kyphosis report similar health-related qualities of life following corrective adult spinal deformity surgery, and SRS-22 Satisfaction may be a clinical correlate to the degree of PJK. Rather than proving proximal junctional kyphosis to have a minimal clinical impact overall on HRQoL metrics, these data suggest that future analysis of this phenomenon requires different assessments.Level of evidence
Level of evidence: III.Item Open Access Comparison of best versus worst clinical outcomes for adult spinal deformity surgery: a retrospective review of a prospectively collected, multicenter database with 2-year follow-up.(Journal of neurosurgery. Spine, 2015-09) Smith, Justin S; Shaffrey, Christopher I; Lafage, Virginie; Schwab, Frank; Scheer, Justin K; Protopsaltis, Themistocles; Klineberg, Eric; Gupta, Munish; Hostin, Richard; Fu, Kai-Ming G; Mundis, Gregory M; Kim, Han Jo; Deviren, Vedat; Soroceanu, Alex; Hart, Robert A; Burton, Douglas C; Bess, Shay; Ames, Christopher P; International Spine Study GroupObject
Although recent studies suggest that average clinical outcomes are improved following surgery for selected adult spinal deformity (ASD) patients, these outcomes span a broad range. Few studies have specifically addressed factors that may predict favorable clinical outcomes. The objective of this study was to compare patients with ASD with best versus worst clinical outcomes following surgical treatment to identify distinguishing factors that may prove useful for patient counseling and optimization of clinical outcomes.Methods
This is a retrospective review of a prospectively collected, multicenter, database of consecutively enrolled patients with ASD who were treated operatively. Inclusion criteria were age > 18 years and ASD. For patients with a minimum of 2-year follow-up, those with best versus worst outcomes were compared separately based on Scoliosis Research Society-22 (SRS-22) and Oswestry Disability Index (ODI) scores. Only patients with a baseline SRS-22 ≤ 3.5 or ODI ≥ 30 were included to minimize ceiling/floor effects. Best and worst outcomes were defined for SRS-22 (≥ 4.5 and ≤ 2.5, respectively) and ODI (≤ 15 and ≥ 50, respectively).Results
Of 257 patients who met the inclusion criteria, 227 (88%) had complete baseline and 2-year follow-up SRS-22 and ODI outcomes scores and radiographic imaging and were analyzed in the present study. Of these 227 patients, 187 had baseline SRS-22 scores ≤ 3.5, and 162 had baseline ODI scores ≥ 30. Forthe SRS-22, best and worst outcomes criteria were met at follow-up for 25 and 27 patients, respectively. For the ODI, best and worst outcomes criteria were met at follow-up for 43 and 51 patients, respectively. With respect to the SRS-22, compared with best outcome patients, those with worst outcomes had higher baseline SRS-22 scores (p < 0.0001), higher prevalence of baseline depression (p < 0.001), more comorbidities (p = 0.012), greater prevalence of prior surgery (p = 0.007), a higher complication rate (p = 0.012), and worse baseline deformity (sagittal vertical axis [SVA], p = 0.045; pelvic incidence [PI] and lumbar lordosis [LL] mismatch, p = 0.034). The best-fit multivariate model for SRS-22 included baseline SRS-22 (p = 0.033), baseline depression (p = 0.012), and complications (p = 0.030). With respect to the ODI, compared with best outcome patients, those with worst outcomes had greater baseline ODI scores (p < 0.001), greater baseline body mass index (BMI; p = 0.002), higher prevalence of baseline depression (p < 0.028), greater baseline SVA (p = 0.016), a higher complication rate (p = 0.02), and greater 2-year SVA (p < 0.001) and PI-LL mismatch (p = 0.042). The best-fit multivariate model for ODI included baseline ODI score (p < 0.001), 2-year SVA (p = 0.014) and baseline BMI (p = 0.037). Age did not distinguish best versus worst outcomes for SRS-22 or ODI (p > 0.1).Conclusions
Few studies have specifically addressed factors that distinguish between the best versus worst clinical outcomes for ASD surgery. In this study, baseline and perioperative factors distinguishing between the best and worst outcomes for ASD surgery included several patient factors (baseline depression, BMI, comorbidities, and disability), as well as residual deformity (SVA), and occurrence of complications. These findings suggest factors that may warrant greater awareness among clinicians to achieve optimal surgical outcomes for patients with ASD.Item Open Access Comparison of patient and surgeon perceptions of adverse events after adult spinal deformity surgery.(Spine, 2013-04) Hart, Robert A; Cabalo, Adam; Bess, Shay; Akbarnia, Behrooz A; Boachie-Adjei, Oheneba; Burton, Douglas; Cunningham, Matthew E; Gupta, Munish; Hostin, Richard; Kebaish, Khaled; Klineberg, Eric; Mundis, Gregory; Shaffrey, Christopher; Smith, Justin S; Wood, Kirkham; International Spine Study GroupStudy design
Survey based on complication scenarios.Objective
To assess and compare perceived potential impacts of various perioperative adverse events by both surgeons and patients.Summary of background data
Incidence of adverse events after adult spinal deformity surgery remains substantial. Patient-centered outcomes tools measuring the impact of these events have not been developed. An important first step is to assess the perceptions of surgeons and patients regarding the impact of these events on surgical outcome and quality of life.Methods
Descriptions of 22 potential adverse events of surgery (heart attack, stroke, spinal cord injury, nerve root injury, cauda equina injury, blindness, dural tear, blood transfusion, deep vein thrombosis, pulmonary embolism, superficial infection, deep infection, lung failure, urinary tract infection, nonunion, adjacent segment disease, persistent deformity, implant failure, death, renal failure, gastrointestinal complications, and sexual dysfunction) were presented to 14 spinal surgeons and 16 adult patients with spinal deformity. Impact scores were assigned to each complication on the basis of perceptions of overall severity, satisfaction with surgery, and effect on quality of life. Impact scores were compared between surgeons and patients with a Wilcoxon/Kruskal-Wallis test.Results
Mean impact scores varied from 0.9 (blood transfusion) to 10.0 (death) among surgeons and 2.3 (urinary tract infection) to 9.2 (stroke) among patients. Patients' scores were consistently higher (P < 0.05) than surgeons in all 3 categories for 6 potential adverse events: stroke, lung failure, heart attack, pulmonary embolism, dural tear, and blood transfusion. Three additional complications (renal failure, non-union, and deep vein thrombosis) were rated higher in 1 or 2 categories by patients.Conclusion
There was substantial variation in how both surgeons and patients perceived impacts of various adverse events after spine surgery. Patients generally perceived the impact of adverse events to be greater than surgeons. Patient-centered descriptions of adverse events would provide a more complete description of surgical outcomes.Item Open Access Comparison of Structural Disease Burden to Health-related Quality of Life Scores in 264 Adult Spinal Deformity Patients With 2-Year Follow-up: Novel Insights into Drivers of Disability.(Clinical spine surgery, 2017-03) Bakhsheshian, Joshua; Scheer, Justin K; Gum, Jeffrey L; Horner, Lance; Hostin, Richard; Lafage, Virginie; Bess, Shay; Protopsaltis, Themistocles S; Burton, Douglas C; Keefe, Malla; Hart, Robert A; Mundis, Gregory M; Shaffrey, Christopher I; Schwab, Frank; Smith, Justin S; Ames, Christopher P; International Spine Study Group (ISSG)Study design
This is a review of a prospective multicenter database.Objective
To investigate the relationship between preoperative disability and sagittal deformity in patients with high Oswestry Disability Index (ODI) and no sagittal malalignment, or low ODI and high sagittal malalignment.Summary of background data
The relationship between ODI and sagittal malalignment varies between each adult spinal deformity (ASD) patient.Methods
A prospective multicenter database of 365 patients with ASD undergoing surgical reconstruction was analyzed. Inclusion criteria entailed: age 18 years or above and the presence of spinal deformity as defined by a coronal Cobb angle≥20 degrees, sagittal vertical axis (SVA)≥5 cm, pelvic tilt (PT) angle≥25 degrees, or thoracic kyphosis≥60 degrees. Radiographic and health-related quality of life (HRQOL) variables were examined and compared, preoperatively and at 2-year postoperative follow-up. Group 1 (low disability high sagittal-LDHS) consisted of ODI<40 and SVA≥5 cm or PT≥25 degrees or pelvic incidence-lumbar lordosis≥11 degrees and group 2 (high disability low sagittal-HDLS) consisted of ODI>40 and SVA<5 cm and PT<25 degrees and pelvic incidence-lumbar lordosis<11 degrees.Results
Of 264 patients with follow-up, 58 (22.0%) patients were included in LDHS and 30 (11.4%) were included in HDLS. Both groups had similar demographics and preoperative coronal angles. HDLS had worse baseline HRQOL for all measures (P<0.05) except leg and back pain. HDLS had a higher rate of self-reported leg weakness, arthritis, depression and neurological disorder. Both groups had similar 2-year improvements in HRQOL (P>0.05), except only HDLS had a significant Scoliosis Research Society Mental improvement and a significantly higher rate of reaching minimal clinically important differences in Scoliosis Research Society Mental scores (P<0.05).Conclusions
There is an association of worse baseline HRQOL measures, weakness, arthritis, and mental disease in HDLS. Furthermore, HDLS patients demonstrated similar improvements to LDHS. However, HDLS had greater improvements in the mental domains, perhaps indicating the responsiveness of the mental disability to surgical treatment.Level of evidence
Level III.Item Open Access Complication rates of three common spine procedures and rates of thromboembolism following spine surgery based on 108,419 procedures: a report from the Scoliosis Research Society Morbidity and Mortality Committee.(Spine, 2010-11) Smith, Justin S; Fu, Kai-Ming G; Polly, David W; Sansur, Charles A; Berven, Sigurd H; Broadstone, Paul A; Choma, Theodore J; Goytan, Michael J; Noordeen, Hilali H; Knapp, Dennis Raymond; Hart, Robert A; Donaldson, William F; Perra, Joseph H; Boachie-Adjei, Oheneba; Shaffrey, Christopher IStudy design
Retrospective review of a prospectively collected database.Objective
The Scoliosis Research Society (SRS) collects morbidity and mortality (M and M) data from its members. Our objectives were to assess complication rates for 3 common spine procedures, compare these results with prior literature as a means of validating the database, and to assess rates of pulmonary embolism (PE) and deep venous thrombosis (DVT) in all cases reported to the SRS over 4 years.Summary of background data
Few modern series document complication rates of spinal surgery as routinely practiced across academic and community settings. Those available are typically based on relatively low numbers of procedures or confined to single-surgeon experiences.Methods
The SRS M and M database was queried for lumbar microdiscectomy (LD), anterior cervical discectomy and fusion (ACDF), and lumbar stenosis decompression (LSD) cases from 2004 to 2007. Revisions were excluded. The database was also queried for occurrence of clinically evident PE and DVT in all cases from 2004 to 2007.Results
A total of 9692 LDs, 6735 ACDFs, and 10,329 LSDs were identified, with overall complication rates of 3.6%, 2.4%, and 7.0%, respectively. These rates are comparable to previously published smaller series. For assessment of PE and DVT, 108,419 cases were identified and rates were calculated per 1000 cases based on diagnosis, age group, and implant use. Overall rates of PE, death due to PE, and DVT were 1.38, 0.34, and 1.18, respectively. Among 82,082 adults, the rate of PE ranged from 0.47 for LD to 12.4 for metastatic tumor. Similar variations were noted for DVT and deaths due to PE.Conclusion
Overall major complication rates for LD, ACDF, and LSD based on the SRS M and M database are comparable to those in previously reported smaller series, supporting the validity of this database for study of other less common spinal disorders. In addition, our data provide general benchmarks of clinically evident PE and DVT rates as a basis for ongoing efforts to improve care.Item Open Access Comprehensive study of back and leg pain improvements after adult spinal deformity surgery: analysis of 421 patients with 2-year follow-up and of the impact of the surgery on treatment satisfaction.(Journal of neurosurgery. Spine, 2015-05) Scheer, Justin K; Smith, Justin S; Clark, Aaron J; Lafage, Virginie; Kim, Han Jo; Rolston, John D; Eastlack, Robert; Hart, Robert A; Protopsaltis, Themistocles S; Kelly, Michael P; Kebaish, Khaled; Gupta, Munish; Klineberg, Eric; Hostin, Richard; Shaffrey, Christopher I; Schwab, Frank; Ames, Christopher P; International Spine Study GroupOBJECT Back and leg pain are the primary outcomes of adult spinal deformity (ASD) and predict patients' seeking of surgical management. The authors sought to characterize changes in back and leg pain after operative or nonoperative management of ASD. Outcomes were assessed according to pain severity, type of surgical procedure, Scoliosis Research Society (SRS)-Schwab spine deformity class, and patient satisfaction. METHODS This study retrospectively reviewed data in a prospective multicenter database of ASD patients. Inclusion criteria were the following: age > 18 years and presence of spinal deformity as defined by a scoliosis Cobb angle ≥ 20°, sagittal vertical axis length ≥ 5 cm, pelvic tilt angle ≥ 25°, or thoracic kyphosis angle ≥ 60°. Patients were grouped into nonoperated and operated subcohorts and by the type of surgical procedure, spine SRS-Schwab deformity class, preoperative pain severity, and patient satisfaction. Numerical rating scale (NRS) scores of back and leg pain, Oswestry Disability Index (ODI) scores, physical component summary (PCS) scores of the 36-Item Short Form Health Survey, minimum clinically important differences (MCIDs), and substantial clinical benefits (SCBs) were assessed. RESULTS Patients in whom ASD had been operatively managed were 6 times more likely to have an improvement in back pain and 3 times more likely to have an improvement in leg pain than patients in whom ASD had been nonoperatively managed. Patients whose ASD had been managed nonoperatively were more likely to have their back or leg pain remain the same or worsen. The incidence of postoperative leg pain was 37.0% at 6 weeks postoperatively and 33.3% at the 2-year follow-up (FU). At the 2-year FU, among patients with any preoperative back or leg pain, 24.3% and 37.8% were free of back and leg pain, respectively, and among patients with severe (NRS scores of 7-10) preoperative back or leg pain, 21.0% and 32.8% were free of back and leg pain, respectively. Decompression resulted in more patients having an improvement in leg pain and their pain scores reaching MCID. Although osteotomies improved back pain, they were associated with a higher incidence of leg pain. Patients whose spine had an SRS-Schwab coronal curve Type N deformity (sagittal malalignment only) were least likely to report improvements in back pain. Patients with a Type L deformity were most likely to report improved back or leg pain and to have reductions in pain severity scores reaching MCID and SCB. Patients with a Type D deformity were least likely to report improved leg pain and were more likely to experience a worsening of leg pain. Preoperative pain severity affected pain improvement over 2 years because patients who had higher preoperative pain severity experienced larger improvements, and their changes in pain severity were more likely to reach MCID/SCB than for those reporting lower preoperative pain. Reductions in back pain contributed to improvements in ODI and PCS scores and to patient satisfaction more than reductions in leg pain did. CONCLUSIONS The authors' results provide a valuable reference for counseling patients preoperatively about what improvements or worsening in back or leg pain they may experience after surgical intervention for ASD.Item Open Access Cost Benefit of Implementation of Risk Stratification Models for Adult Spinal Deformity Surgery.(Global Spine J, 2023-12-11) Passias, Peter G; Williamson, Tyler K; Kummer, Nicholas A; Pellisé, Ferran; Lafage, Virginie; Lafage, Renaud; Serra-Burriel, Miguel; Smith, Justin S; Line, Breton; Vira, Shaleen; Gum, Jeffrey L; Haddad, Sleiman; Sánchez Pérez-Grueso, Francisco Javier; Schoenfeld, Andrew J; Daniels, Alan H; Chou, Dean; Klineberg, Eric O; Gupta, Munish C; Kebaish, Khaled M; Kelly, Michael P; Hart, Robert A; Burton, Douglas C; Kleinstück, Frank; Obeid, Ibrahim; Shaffrey, Christopher I; Alanay, Ahmet; Ames, Christopher P; Schwab, Frank J; Hostin, Richard A; Bess, Shay; International Spine Study GroupSTUDY 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.