Browsing by Author "Pellisé, Ferran"

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    ItemOpen Access
    An Analysis of the Incidence and Outcomes of Major Versus Minor Neurological Decline After Complex Adult Spinal Deformity Surgery: A Subanalysis of Scoli-RISK-1 Study.
    (Spine, 2018-07) Kato, So; Fehlings, Michael G; Lewis, Stephen J; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah Y; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Berven, Sigurd H

    Study design

    A subanalysis from a prospective, multicenter, international cohort study in 15 sites (Scoli-RISK-1).

    Objective

    To report detailed information regarding the severity of neurological decline related to complex adult spine deformity (ASD) surgery and to examine outcomes based on severity.

    Summary of background data

    Postoperative neurological decline after ASD surgeries can occur due to nerve root(s) or spinal cord dysfunction. The impact of decline and the pattern of recovery may be related to the anatomic location and the severity of the injury.

    Methods

    An investigation of 272 prospectively enrolled complex ASD surgical patients with neurological status measured by American Spinal Injury Association Lower Extremity Motor Scores (LEMS) was undertaken. Postoperative neurological decline was categorized into "major" (≥5 points loss) versus "minor" (<5 points loss) deficits. Timing and extent of recovery in LEMS were investigated for each group.

    Results

    Among the 265 patients with LEMS available at discharge, 61 patients (23%) had neurological decline, with 20 (33%) experiencing major decline. Of note, 90% of the patients with major decline had deficits in three or more myotomes. Full recovery was seen in 24% at 6 weeks and increased to 65% at 6 months. However, 34% continued to experience some neurological decline at 24 months, with 6% demonstrating no improvement. Of 41 patients (67%) with minor decline, 73% had deficits in one or two myotomes. Full recovery was seen in 49% at 6 weeks and increased to 70% at 6 months. Of note, 26% had persistence of some neurological deficit at 24 months, with 18% demonstrating no recovery.

    Conclusion

    In patients undergoing complex ASD correction, a rate of postoperative neurological decline of 23% was noted with 33% of these being "major." Although most patients showed substantial recovery by 6 months, approximately one-third continued to experience neurological dysfunction.

    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
    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 Group
    STUDY DESIGN/SETTING: Retrospective cohort study. OBJECTIVE: Assess the extent to which defined risk factors of adverse events are drivers of cost-utility in spinal deformity (ASD) surgery. METHODS: ASD patients with 2-year (2Y) data were included. Tertiles were used to define high degrees of frailty, sagittal deformity, blood loss, and surgical time. Cost was calculated using the Pearl Diver registry and cost-utility at 2Y was compared between cohorts based on the number of risk factors present. Statistically significant differences in cost-utility by number of baseline risk factors were determined using ANOVA, followed by a generalized linear model, adjusting for clinical site and surgeon, to assess the effects of increasing risk score on overall cost-utility. RESULTS: By 2 years, 31% experienced a major complication and 23% underwent reoperation. Patients with ≤2 risk factors had significantly less major complications. Patients with 2 risk factors improved the most from baseline to 2Y in ODI. Average cost increased by $8234 per risk factor (R2 = .981). Cost-per-QALY at 2Y increased by $122,650 per risk factor (R2 = .794). Adjusted generalized linear model demonstrated a significant trend between increasing risk score and increasing cost-utility (r2 = .408, P < .001). CONCLUSIONS: The number of defined patient-specific and surgical risk factors, especially those with greater than two, were associated with increased index surgical costs and diminished cost-utility. Efforts to optimize patient physiology and minimize surgical risk would likely reduce healthcare expenditures and improve the overall cost-utility profile for ASD interventions.Level of evidence: III.
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    Development and validation of risk stratification models for adult spinal deformity surgery.
    (Journal of neurosurgery. Spine, 2019-06) Pellisé, Ferran; Serra-Burriel, Miquel; Smith, Justin S; Haddad, Sleiman; Kelly, Michael P; Vila-Casademunt, Alba; Sánchez Pérez-Grueso, Francisco Javier; Bess, Shay; Gum, Jeffrey L; Burton, Douglas C; Acaroğlu, Emre; Kleinstück, Frank; Lafage, Virginie; Obeid, Ibrahim; Schwab, Frank; Shaffrey, Christopher I; Alanay, Ahmet; Ames, Christopher; International Spine Study Group; European Spine Study Group
    OBJECTIVE:Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO). METHODS:Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis. RESULTS:The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%-75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs. CONCLUSIONS:The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.
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    ItemOpen Access
    Development of Deployable Predictive Models for Minimal Clinically Important Difference Achievement Across the Commonly Used Health-related Quality of Life Instruments in Adult Spinal Deformity Surgery.
    (Spine, 2019-08) Ames, Christopher P; Smith, Justin S; Pellisé, Ferran; Kelly, Michael P; Gum, Jeffrey L; Alanay, Ahmet; Acaroğlu, Emre; Pérez-Grueso, Francisco Javier Sánchez; Kleinstück, Frank S; Obeid, Ibrahim; Vila-Casademunt, Alba; Burton, Douglas C; Lafage, Virginie; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; Serra-Burriel, Miquel; European Spine Study Group, International Spine Study Group

    Study design

    Retrospective analysis of prospectively-collected, multicenter adult spinal deformity (ASD) databases.

    Objective

    To predict the likelihood of reaching minimum clinically important differences in patient-reported outcomes after ASD surgery.

    Summary of background data

    ASD surgeries are costly procedures that do not always provide the desired benefit. In some series only 50% of patients achieve minimum clinically important differences in patient-reported outcomes (PROs). Predictive modeling may be useful in shared-decision making and surgical planning processes. The goal of this study was to model the probability of achieving minimum clinically important differences change in PROs at 1 and 2 years after surgery.

    Methods

    Two prospective observational ASD cohorts were queried. Patients with Scoliosis Research Society-22, Oswestry Disability Index , and Short Form-36 data at preoperative baseline and at 1 and 2 years after surgery were included. Seventy-five variables were used in the training of the models including demographics, baseline PROs, and modifiable surgical parameters. Eight predictive algorithms were trained at four-time horizons: preoperative or postoperative baseline to 1 year and preoperative or postoperative baseline to 2 years. External validation was accomplished via an 80%/20% random split. Five-fold cross validation within the training sample was performed. Precision was measured as the mean average error (MAE) and R values.

    Results

    Five hundred seventy patients were included in the analysis. Models with the lowest MAE were selected; R values ranged from 20% to 45% and MAE ranged from 8% to 15% depending upon the predicted outcome. Patients with worse preoperative baseline PROs achieved the greatest mean improvements. Surgeon and site were not important components of the models, explaining little variance in the predicted 1- and 2-year PROs.

    Conclusion

    We present an accurate and consistent way of predicting the probability for achieving clinically relevant improvement after ASD surgery in the largest-to-date prospective operative multicenter cohort with 2-year follow-up. This study has significant clinical implications for shared decision making, surgical planning, and postoperative counseling.

    Level of evidence

    4.
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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
    External validation of the adult spinal deformity (ASD) frailty index (ASD-FI)
    (European Spine Journal, 2018-09-01) Miller, Emily K; Vila-Casademunt, Alba; Neuman, Brian J; Sciubba, Daniel M; Kebaish, Khaled M; Smith, Justin S; Alanay, Ahmet; Acaroglu, Emre R; Kleinstück, Frank; Obeid, Ibrahim; Sánchez Pérez-Grueso, Francisco Javier; Carreon, Leah Y; Schwab, Frank J; Bess, Shay; Scheer, Justin K; Lafage, Virginie; Shaffrey, Christopher I; Pellisé, Ferran; Ames, Christopher P; European Spine Study Group; International Spine Study Group
    © 2018, Springer-Verlag GmbH Germany, part of Springer Nature. Purpose: To assess the ability of the recently developed adult spinal deformity frailty index (ASD-FI) to predict odds of perioperative complications, odds of reoperation, and length of hospital stay after adult spinal deformity (ASD) surgery using a database other than the one used to create the index. Methods: We used the ASD-FI to calculate frailty scores for 266 ASD patients who had minimum postoperative follow-up of 2 years in the European Spine Study Group (ESSG) database. Patients were enrolled from 2012 through 2013. Using ASD-FI scores, we categorized patients as not frail (NF) (< 0.3 points), frail (0.3–0.5 points), or severely frail (SF) (> 0.5 points). Multivariable logistic regression, adjusted for preoperative and surgical factors such as operative time and blood loss, was performed to determine the relationship between ASD-FI category and odds of major complications, odds of reoperation, and length of hospital stay. Results: We categorized 135 patients (51%) as NF, 90 patients (34%) as frail, and 41 patients (15%) as SF. Overall mean ASD-FI score was 0.29 (range 0–0.8). The adjusted odds of experiencing a major intraoperative or postoperative complication (OR 4.5, 95% CI 2.0–10) or having a reoperation (OR 3.9, 95% CI 1.7–8.9) were higher for SF patients compared with NF patients. Mean hospital stay was 2.1 times longer (95% CI 1.8–2.4) for SF patients compared with NF patients. Conclusions: Greater patient frailty, as measured by the ASD-FI, is associated with longer hospital stays and greater odds of major complications and reoperation. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.].
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    ItemOpen Access
    External Validation of the Adult Spinal Deformity (ASD) Frailty Index (ASD-FI) in the Scoli-RISK-1 Patient Database.
    (Spine, 2018-10) Miller, Emily K; Lenke, Lawrence G; Neuman, Brian J; Sciubba, Daniel M; Kebaish, Khaled M; Smith, Justin S; Qiu, Yong; Dahl, Benny T; Pellisé, Ferran; Matsuyama, Yukihiro; Carreon, Leah Y; Fehlings, Michael G; Cheung, Kenneth M; Lewis, Stephen; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Mehdian, Hossein; Bess, Shay; Shaffrey, Christopher I; Ames, Christopher P; AOSpine Knowledge Forum Deformity, the International Spine Study Group

    Study design

    Analysis of a prospective multicenter database.

    Objective

    To assess the ability of the recently created Adult Spinal Deformity (ASD) Frailty Index (ASD-FI) to predict odds of major complications and length of hospital stay for patients who had more severe preoperative deformity and underwent more invasive ASD surgery compared with patients in the database used to create the index.

    Summary of background data

    Accurate preoperative estimates of risk are necessary given the high complication rates currently associated with ASD surgery.

    Methods

    Patients were enrolled by participating institutions in Europe, Asia, and North America from 2009 to 2011. ASD-FI scores were used to classify 267 patients as not frail (NF) (<0.3), frail (0.3-0. 5), or severely frail (SF) (>0.5). Multivariable logistic regression, adjusted for preoperative and surgical covariates such as operative time and blood loss, was performed to determine the relationship between ASD-FI category and incidence of major complications, overall incidence of complications, and length of hospital stay.

    Results

    The mean ASD-FI score was 0.3 (range, 0-0.7). We categorized 105 patients as NF, 103 as frail, and 59 as SF. The adjusted odds of developing a major complication were higher for SF patients (odds ratio = 4.4; 95% CI 2.0, 9.9) compared with NF patients. After adjusting for covariates, length of hospital stay for SF patients increased by 19% (95% CI 1.4%, 39%) compared with NF patients. The odds of developing a major complication or having increased length of stay were similar between frail and NF patients.

    Conclusion

    Greater patient frailty, as measured by the ASD-FI, is associated with a longer hospital stay and greater risk of major complications among patients who have severe preoperative deformity and undergo invasive surgical procedures.

    Level of evidence

    2.
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    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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    Lower Extremity Motor Function Following Complex Adult Spinal Deformity Surgery: Two-Year Follow-up in the Scoli-RISK-1 Prospective, Multicenter, International Study.
    (The Journal of bone and joint surgery. American volume, 2018-04) Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; AO Spine International and SRS Scoli-RISK-1 Study Group
    BACKGROUND:The reported neurologic complication rate following surgery for complex adult spinal deformity (ASD) is variable due to several factors. Most series have been retrospective with heterogeneous patient populations and use of nonuniform neurologic assessments. The aim of this study was to prospectively document lower extremity motor function by means of the American Spinal Injury Association (ASIA) lower extremity motor score (LEMS) before and through 2 years after surgical correction of complex ASD. METHODS:The Scoli-RISK-1 study enrolled 272 patients with ASD, from 15 centers, who had undergone primary or revision surgery for a major Cobb angle of ≥80°, corrective osteotomy for congenital spinal deformity or as a revision procedure for any type of deformity, and/or a complex 3-column osteotomy. RESULTS:One of 272 patients lacked preoperative data and was excluded from the analysis, and 62 (22.9%) of the remaining 271 patients, who were included, lacked a 2-year postoperative assessment. Patients with no preoperative motor impairment (normal LEMS group; n = 203) had a small but significant decline from the mean preoperative LEMS value (50) to that at 2 years postoperatively (49.66 [95% confidence interval = 49.46 to 49.85]; p = 0.002). Patients who did have a motor deficit preoperatively (n = 68; mean LEMS, 43.79) had significant LEMS improvement at 6 months (47.21, p < 0.001) and 2 years (46.12, p = 0.003) postoperatively. The overall percentage of patients (in both groups combined) who had a postoperative LEMS decline, compared with the preoperative value, was 23.0% at discharge, 17.1% at 6 weeks, 9.9% at 6 months, and 10.0% at 2 years. CONCLUSIONS:The percentage of patients who had a LEMS decline (compared with the preoperative score) after undergoing complex spinal reconstructive surgery for ASD was 23.0% at discharge, which improved to 10.0% at 2 years postoperatively. These rates are higher than previously reported, which we concluded was due to the prospective, strict nature of the LEMS testing of patients with these challenging deformities. LEVEL OF EVIDENCE:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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    Non-neurologic adverse events after complex adult spinal deformity surgery: results from the prospective, multicenter Scoli-RISK-1 study.
    (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, 2019-01) Kwan, Kenny Yat Hong; Bow, Cora; Samartzis, Dino; Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Cheung, Kenneth Man Chee

    Purpose

    Accurate information regarding the expected complications of complex adult spinal deformity (ASD) is important for shared decision making and informed consent. The purpose of the present study was to investigate the rate and types of non-neurologic adverse events after complex ASD surgeries, and to identify risk factors that affect their occurrence.

    Methods

    The details and occurrence of all non-neurologic adverse events were reviewed in a prospective cohort of 272 patients after complex ASD surgical correction in a mulitcentre database of the Scoli-RISK-1 study with a planned follow-up of 2 years. Logistic regression analyses were used to identify potential risk factors for non-neurologic adverse events.

    Results

    Of the 272 patients, 184 experienced a total of 515 non-neurologic adverse events for an incidence of 67.6%. 121 (44.5%) patients suffered from more than one adverse event. The most frequent non-neurologic adverse events were surgically related (27.6%), of which implant failure and dural tear were most common. In the unadjusted analyses, significant factors for non-neurologic adverse events were age, previous spine surgery performed, number of documented non-neurologic comorbidities and ASA grade. On multivariable logistic regression analysis, previous spine surgery was the only independent risk factor for non-neurologic adverse events.

    Conclusions

    The incidence of non-neurologic adverse events for patients undergoing corrective surgeries for ASD was 67.6%. Previous spinal surgery was the only independent risk factor predicting the occurrence of non-neurologic adverse events. These findings complement the earlier report of neurologic complications after ASD surgeries from the Scoli-RISK-1 study. These slides can be retrieved under Electronic Supplementary Material.
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    Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.
    (Global spine journal, 2024-06) Sardi, Juan P; Smith, Justin S; Gum, Jeffrey L; Rocos, Brett; Charalampidis, Anastasios; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Qiu, Yong; Matsuyama, Yukihiro; Pellisé, Ferran; Polly, David W; Sembrano, Jonathan N; Dahl, Benny T; Kelly, Michael P; de Kleuver, Marinus; Spruit, Maarten; Alanay, Ahmet; Berven, Sigurd H; Lewis, Stephen J; AO Spine Knowledge Forum Deformity
    Prospective multicenter database post-hoc analysis. Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.
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    Patient-Reported Outcomes After Complex Adult Spinal Deformity Surgery: 5-Year Results of the Scoli-Risk-1 Study.
    (Global spine journal, 2022-10) Zuckerman, Scott L; Cerpa, Meghan; Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Kelly, Michael P; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kabeaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Smith, Justin S; AO Spine Knowledge Forum Deformity and SRS Scoli-RISK-1 Study Group

    Study design

    Prospective cohort.

    Objective

    To prospectively evaluate PROs up to 5-years after complex ASD surgery.

    Methods

    The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures.

    Results

    Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, P < 0.001), SF36-PCS (31.5 vs. 38.8, P < 0.001), SF36-MCS (44.9 vs. 49.1, P = 0.009), SRS-22-total (2.78 vs. 3.61, P < 0.001), NRS-back pain (5.70 vs. 2.95, P < 0.001) and NRS leg pain (3.64 vs. 2.62, P = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values (P > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without.

    Conclusions

    After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.
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    ItemOpen Access
    Predictors of Health-Related Quality-of-Life After Complex Adult Spinal Deformity Surgery: A Scoli-RISK-1 Secondary Analysis.
    (Spine deformity, 2017-03) Carreon, Leah Y; Glassman, Steven D; Shaffrey, Christopher I; Fehlings, Michael G; Dahl, Benny; Ames, Christopher P; Matsuyama, Yukihiro; Qiu, Yong; Mehdian, Hossein; Cheung, Kenneth MC; Schwab, Frank J; Pellisé, Ferran; Kebaish, Khaled M; Lenke, Lawrence G

    Study design

    Longitudinal cohort.

    Objectives

    To identify variables that predict 2-year Short Form-36 Physical Composite Summary Score (SF-36PCS) and the Scoliosis Research Society-22R (SRS22-R) Total score after surgery for complex adult spinal deformity.

    Summary of background data

    Increasingly, treatment effectiveness is assessed by the extent to which the procedure improves a patient's health-related quality of life (HRQOL). This is especially true in patients with complex adult spinal deformity.

    Methods

    The data set from the Scoli-Risk-1 study was queried for patients with complete 2-year SF-36 and SRS-22R. Regression analysis was performed to determine predictors of 2-year SF-36PCS and SRS-22R Total scores. Factors included were sex, age, smoking status, body mass index, American Society of Anesthesiologists (ASA) grade, Lower Extremity Motor Score improvement, indication for surgery, preoperative and 2-year maximum coronal Cobb angles, number of prior spine surgeries, number of three-column osteotomies, number of surgical levels, number of surgical stages, lowest instrumented level, presence and type of neurologic complication, and number of reported serious adverse events.

    Results

    Of 272 cases enrolled, 206 (76%) cases were included in this analysis, 143 (69%) females, and mean age of 57.69 years. Factors that were significantly associated with of 2-year SF-36PCS were age (p < .001), ASA grade (p < .001), maximum preoperative Cobb angle (p = .007), number of three-column osteotomies (p = .049) and type of neurologic complication (p = .068). Factors predictive of 2-year SRS-22R Total scores were maximum preoperative Cobb angle (p = .001) and the number of serious adverse events (p = .071).

    Conclusions

    Factors predictive of lower 2-year HRQOLs after surgery for complex adult spinal deformity were older age, higher ASA grade, larger preoperative Cobb angle, larger numbers of three-column osteotomies, and the occurrence of both neurologic and nonneurologic complications. Most of these factors are beyond the control of surgeons. Still, surgeons should medically optimize a patient prior to surgery to minimize the risk of complications and offer the best chance of improving a patient's quality of life.

    Level of evidence

    Level II. Prospective cohort.
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    ItemOpen Access
    Quality metrics in adult spinal deformity surgery over the last decade: a combined analysis of the largest prospective multicenter data sets.
    (Journal of neurosurgery. Spine, 2021-10) Pellisé, Ferran; Serra-Burriel, Miquel; Vila-Casademunt, Alba; Gum, Jeffrey L; Obeid, Ibrahim; Smith, Justin S; Kleinstück, Frank S; Bess, Shay; Pizones, Javier; Lafage, Virginie; Pérez-Grueso, Francisco Javier S; Schwab, Frank J; Burton, Douglas C; Klineberg, Eric O; Shaffrey, Christopher I; Alanay, Ahmet; Ames, Christopher P; International Spine Study Group (ISSG) and European Spine Study Group (ESSG)

    Objective

    The reported rate of complications and cost of adult spinal deformity (ASD) surgery, associated with an exponential increase in the number of surgeries, cause alarm among healthcare payers and providers worldwide. The authors conjointly analyzed the largest prospective available ASD data sets to define trends in quality-of-care indicators (complications, reinterventions, and health-related quality of life [HRQOL] outcomes) since 2010.

    Methods

    This is an observational prospective longitudinal cohort study. Patients underwent surgery between January 2010 and December 2016, with > 2 years of follow-up data. Demographic, surgical, radiological, and HRQOL (i.e., Oswestry Disability Index, SF-36, Scoliosis Research Society-22r) data obtained preoperatively and at 3, 6, 12, and 24 months after surgery were evaluated. Trends and changes in indicators were analyzed using local regression (i.e., locally estimated scatterplot smoothing [LOESS]) and adjusted odds ratio (OR).

    Results

    Of the 2286 patients included in the 2 registries, 1520 underwent surgery between 2010 and 2016. A total of 1151 (75.7%) patients who were treated surgically at 23 centers in 5 countries met inclusion criteria. Patient recruitment increased progressively (2010-2011 vs 2015-2016: OR 1.64, p < 0.01), whereas baseline clinical characteristics (age, American Society of Anesthesiologists class, HRQOL scores, sagittal deformity) did not change. Since 2010 there has been a sustained reduction in major and minor postoperative complications observed at 90 days (major: OR 0.59; minor: OR 0.65; p < 0.01); at 1 year (major: OR 0.52; minor: 0.75; p < 0.01); and at 2 years of follow-up (major: OR 0.4; minor: 0.80; p < 0.01) as well as in the 2-year reintervention rate (OR 0.41, p < 0.01). Simultaneously, there has been a slight improvement in the correction of sagittal deformity (i.e., pelvic incidence-lumbar lordosis mismatch: OR 1.11, p = 0.19) and a greater gain in quality of life (i.e., Oswestry Disability Index 26% vs 40%, p = 0.02; Scoliosis Research Society-22r, self-image domain OR 1.16, p = 0.13), and these are associated with a progressive reduction of surgical aggressiveness (number of fused segments: OR 0.81, p < 0.01; percent pelvic fixation: OR 0.66, p < 0.01; percent 3-column osteotomies: OR 0.63, p < 0.01).

    Conclusions

    The best available data show a robust global improvement in quality metrics in ASD surgery over the last decade. Surgical complications and reoperations have been reduced by half, while improvement in disability increased and correction rates were maintained, in patients with similar baseline characteristics.
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    ItemOpen Access
    Spinal cord injury in high-risk complex adult spinal deformity surgery: review of incidence and outcomes from the Scoli-RISK-1 study
    (Spinal Cord Series and Cases, 2024) Jiang, Fan; Joshi, Hetshree; Badhiwala, Jetan H; Wilson, Jamie RF; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah Y; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Berven, Sigurd H; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Lewis, Stephen J; Fehlings, Michael G
    Abstract Study design Clinical case series. Objective To describe the cause, treatment and outcome of 6 cases of perioperative spinal cord injury (SCI) in high-risk adult deformity surgery. Setting Adult spinal deformity patients were enrolled in the multi-center Scoli-RISK-1 cohort study. Methods A total of 272 patients who underwent complex adult deformity surgery were enrolled in the prospective, multi-center Scoli-RISK-1 cohort study. Clinical follow up data were available up to a maximum of 2 years after index surgery. Cases of perioperative SCI were identified and an extensive case review was performed. Results Six individuals with SCI were identified from the Scoli-RISK-1 database (2.2%). Two cases occurred intraoperatively and four cases occurred postoperatively. The first case was an incomplete SCI due to a direct intraoperative insult and was treated postoperatively with Riluzole. The second SCI case was caused by a compression injury due to overcorrection of the deformity. Three cases of incomplete SCI occurred; one case of postoperative hematoma, one case of proximal junctional kyphosis (PJK) and one case of adjacent segment disc herniation. All cases of post-operative incomplete SCI were managed with revision decompression and resulted in excellent clinical recovery. One case of incomplete SCI resulted from infection and PJK. The patient’s treatment was complicated by a delay in revision and the patient suffered persistent neurological deficits up to six weeks following the onset of SCI. Conclusion Despite the low incidence in high-risk adult deformity surgeries, perioperative SCI can result in devastating consequences. Thus, appropriate postoperative care, follow up and timely management of SCI are essential.
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    ItemUnknown
    Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS).
    (The spine journal : official journal of the North American Spine Society, 2021-11) Nielsen, Christopher J; Lewis, Stephen J; Oitment, Colby; Martin, Allan R; Lenke, Lawrence G; Qiu, Yong; Cheung, Kenneth Mc; de Kleuver, Marinus; Polly, David W; Shaffrey, Christopher I; Smith, Justin S; Spruit, Maarten; Alanay, Ahmet; Matsuyama, Yukihiro; Jentzsch, Thorsten; Rienmuller, Anna; Shear-Yashuv, Hananel; Pellisé, Ferran; Kelly, Michael P; Sembrano, Jonathan N; Dahl, Benny T; Berven, Sigurd H; Forum Deformity, Ao Spine Knowledge

    Background context

    Patients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements.

    Purpose

    The purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery.

    Study design

    Prospective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLE: Patients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity.

    Outcome measures

    Oswestry Disability Index (ODI) METHODS: : Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10-<20%) or no change (within 10%).

    Results

    Two-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling.

    Conclusions

    In this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group.
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    ItemOpen Access
    Surgeons' risk perception in ASD surgery: The value of objective risk assessment on decision making and patient counselling.
    (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, 2022-05) Pellisé, Ferran; Vila-Casademunt, Alba; Núñez-Pereira, Susana; Haddad, Sleiman; Smith, Justin S; Kelly, Michael P; Alanay, Ahmet; Shaffrey, Christopher; Pizones, Javier; Yilgor, Çaglar; Obeid, Ibrahim; Burton, Douglas; Kleinstück, Frank; Fekete, Tamas; Bess, Shay; Gupta, Munish; Loibl, Markus; Klineberg, Eric O; Sánchez Pérez-Grueso, Francisco J; Serra-Burriel, Miquel; Ames, Christopher P; European Spine Study Group, International Spine Study Group

    Background

    Surgeons often rely on their intuition, experience and published data for surgical decision making and informed consent. Literature provides average values that do not allow for individualized assessments. Accurate validated machine learning (ML) risk calculators for adult spinal deformity (ASD) patients, based on 10 year multicentric prospective data, are currently available. The objective of this study is to assess surgeon ASD risk perception and compare it to validated risk calculator estimates.

    Methods

    Nine ASD complete (demographics, HRQL, radiology, surgical plan) preoperative cases were distributed online to 100 surgeons from 22 countries. Surgeons were asked to determine the risk of major complications and reoperations at 72 h, 90 d and 2 years postop, using a 0-100% risk scale. The same preoperative parameters circulated to surgeons were used to obtain ML risk calculator estimates. Concordance between surgeons' responses was analyzed using intraclass correlation coefficients (ICC) (poor < 0.5/excellent > 0.85). Distance between surgeons' and risk calculator predictions was assessed using the mean index of agreement (MIA) (poor < 0.5/excellent > 0.85).

    Results

    Thirty-nine surgeons (74.4% with > 10 years' experience), from 12 countries answered the survey. Surgeons' risk perception concordance was very low and heterogeneous. ICC ranged from 0.104 (reintervention risk at 72 h) to 0.316 (reintervention risk at 2 years). Distance between calculator and surgeon prediction was very large. MIA ranged from 0.122 to 0.416. Surgeons tended to overestimate the risk of major complications and reintervention in the first 72 h and underestimated the same risks at 2 years postop.

    Conclusions

    This study shows that expert surgeon ASD risk perception is heterogeneous and highly discordant. Available validated ML ASD risk calculators can enable surgeons to provide more accurate and objective prognosis to adjust patient expectations, in real time, at the point of care.
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    ItemOpen Access
    The Effect of Tobacco Smoking on Adverse Events Following Adult Complex Deformity Surgery: Analysis of 270 Patients From the Prospective, Multicenter Scoli-RISK-1 Study.
    (Spine, 2020-01) Wilson, Jamie RF; Jiang, Fan; Badhiwala, Jetan H; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Dahl, Benny T; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Lenke, Lawrence G; Fehlings, Michael G

    Study design

    Post-hoc analysis of a prospective, multicenter cohort study.

    Objective

    To analyze the impact of smoking on rates of postoperative adverse events (AEs) in patients undergoing high-risk adult spine deformity surgery.

    Summary of background data

    Smoking is a known predictor of medical complications after adult deformity surgery, but the effect on complications, implant failure and other AEs has not been adequately described in prospective studies.

    Methods

    Twenty-six patients with a history of current smoking were identified out of the 272 patients enrolled in the SCOLI-RISK-1 study who underwent complex adult spinal deformity surgery at 15 centers, with 2-year follow-up. The outcomes and incidence of AEs in these patients were compared to the nonsmoking cohort (n = 244) using univariate analysis, with additional multivariate regression to adjust for the effect of patient demographics, complexity of surgery, and other confounders.

    Results

    The number of levels and complexity of surgery in both cohorts were comparable. In the univariate analysis, the rates of implant failure were almost double (odds ratio 2.28 [0.75-6.18]) in smoking group (n = 7; 26.9%)) that observed in the nonsmoking group (n = 34; 13.9%), but this was not statistically significant (P = 0.088). Surgery-related excessive bleeding (>4 L) was significantly higher in the smoking group (n = 5 vs. n = 9; 19.2% vs. 3.7%; OR 6.22[1.48 - 22.75]; P = 0.006). Wound infection rates and respiratory complications were similar in both groups. In the multivariate analysis, the smoking group demonstrated a higher incidence of any surgery-related AEs over 2 years (n = 13 vs. n = 95; 50.0% vs. 38.9%; OR 2.12 [0.88-5.09]) (P = 0.094).

    Conclusion

    In this secondary analysis of patients from the SCOLI-RISK-1 study, a history of smoking significantly increased the risk of excessive intraoperative bleeding and nonsignificantly increased the rate of implant failure or surgery-related AEs over 2 years. The authors therefore advocate a smoking cessation program in patients undergoing complex adult spine deformity surgery.

    Level of evidence

    2.
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    ItemOpen Access
    The Scoli-RISK 1 results of lower extremity motor function 5 years after complex adult spinal deformity surgery.
    (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, 2021-11) Lenke, Lawrence G; Zuckerman, Scott L; Cerpa, Meghan; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Kelly, Michael P; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Smith, Justin S; AO Spine Knowledge Forum Deformity and SRS Scoli-RISK-1 Study Group

    Introduction

    Neurologic complications after complex adult spinal deformity (ASD) surgery are important, yet outcomes are heterogeneously reported, and long-term follow-up of actual lower extremity motor function is unknown.

    Objective

    To prospectively evaluate lower extremity motor function scores (LEMS) before and at 5 years after surgical correction of complex ASD.

    Design

    Retrospective analysis of a prospective, multicenter, international observational study.

    Methods

    The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers around the world. Inclusion criteria were Cobb angle of > 80°, corrective osteotomy for congenital or revision deformity and/or 3-column osteotomy. Among patients with 5-year follow-up, comparisons of LEMS to baseline and within each follow-up period were made via documented neurologic exams on each patient.

    Results

    Seventy-seven (28.3%) patients had 5-year follow-up. Among these 77 patients with 5-year follow-up, rates of postoperative LEMS deterioration were: 14.3% hospital discharge, 10.7% at 6 weeks, 6.5% at 6 months, 9.5% at 2 years and 9.3% at 5 years postoperative. During the 2-5 year window, while mean LEMS did not change significantly (-0.5, p = 0.442), eight (11.1%) patients deteriorated (of which 3 were ≥ 4 motor points), and six (8.3%) patients improved (of which 2 were ≥ 4 points). Of the 14 neurologic complications, four (28.6%) were surgery-related, three of which required reoperation. While mean LEMS were not impacted in patients with a major surgery-related complication, mean LEMS were significantly lower in patients with neurologic surgery-related complications at discharge (p = 0.041) and 6 months (p = 0.008) between the two groups as well as the change from baseline to 5 years (p = 0.041).

    Conclusions

    In 77 patients undergoing complex ASD surgery with 5-year follow-up, while mean LEMS did not change from 2 to 5 years, subtle neurologic changes occurred in approximately 1 in 5 patients (11.1% deteriorated; 8.3% improved). Major surgery-related complication did not result in decreased LEMS; however, those with neurologic surgery-related complications continued to have decreased lower extremity motor function at 5 years postoperative. These results underscore the importance of long-term follow-up to 5 years, using individual motor scores rather than group averages, and comparing outcomes to both baseline and last follow-up.