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Peter G. Passias, Haddy Alas, Sara Naessig, Han Jo Kim, Renaud Lafage, Christopher Ames, Eric Klineberg, Katherine Pierce, Waleed Ahmad, Douglas Burton, Bassel Diebo, Shay Bess, D. Kojo Hamilton, Munish Gupta, Paul Park, Breton Line, Christopher I. Shaffrey, Justin S. Smith, Frank Schwab, Virginie Lafage, and the International Spine Study Group

OBJECTIVE

The goal of this study was to assess the conversion rate from baseline cervical alignment to postoperative cervical deformity (CD) and the corresponding proximal junctional kyphosis (PJK) rate in patients undergoing thoracolumbar adult spinal deformity (ASD) surgery.

METHODS

The operative records of patients with ASD with complete radiographic data beginning at baseline up to 3 years were included. Patients with no baseline CD were postoperatively stratified by Ames CD criteria (T1 slope–cervical lordosis mismatch [TS-CL] > 20°, cervical sagittal vertical axis [cSVA] > 40 mm), where CD was defined as fulfilling one or more of the Ames criteria. Severe CD was defined as TS-CL > 30° or cSVA > 60 mm. Follow-up intervals were established after ASD surgery, with 6 weeks postoperatively defined as early; 6 weeks–1 year as intermediate; 1–2 years as late; and 2–3 years as long-term. Descriptive analyses and McNemar tests identified the CD conversion rate, PJK rate (< −10° change in uppermost instrumented vertebra and the superior endplate of the vertebra 2 levels superior to the uppermost instrumented vertebra), and specific alignment parameters that converted.

RESULTS

Two hundred sixty-six patients who underwent ASD surgery (mean age 59.7 years, 77.4% female) met the inclusion criteria; 103 of these converted postoperatively, and the remaining 163 did not meet conversion criteria. Thirty-eight patients converted to CD early, 26 converted at the intermediate time point, 29 converted late, and 10 converted in the long-term. At conversion, the early group had the highest mean TS-CL at 25.4° ± 8.5° and the highest mean cSVA at 33.6 mm—both higher than any other conversion group. The long-term group had the highest mean C2–7 angle at 19.7° and the highest rate of PJK compared to other groups (p = 0.180). The early group had the highest rate of conversion to severe CD, with 9 of 38 patients having severe TS-CL and only 1 patient per group converting to severe cSVA. Seven patients progressed from having only malaligned TS-CL at baseline (with normal cSVA) to CD with both malaligned TS-CL and cSVA by 6 weeks. Conversely, only 2 patients progressed from malaligned cSVA to both malaligned cSVA and TS-CL. By 1 year, the former number increased from 7 to 26 patients, and the latter increased from 2 to 20 patients. The revision rate was highest in the intermediate group at 48.0%, versus the early group at 19.2%, late group at 27.3%, and long-term group at 20% (p = 0.128). A higher pelvic incidence–lumbar lordosis mismatch, lower thoracic kyphosis, and a higher thoracic kyphosis apex immediately postoperatively significantly predicted earlier rather than later conversion (all p < 0.05). Baseline lumbar lordosis, pelvic tilt, and sacral slope were not significant predictors.

CONCLUSIONS

Patients with ASD with normative cervical alignment who converted to CD after thoracolumbar surgery had varying radiographic findings based on timing of conversion. Although the highest number of patients converted within 6 weeks postoperatively, patients who converted in the late or long-term follow-up intervals had higher rates of concurrent PJK and greater radiographic progression.

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Themistocles S. Protopsaltis, Nicholas Stekas, Justin S. Smith, Alexandra Soroceanu, Renaud Lafage, Alan H. Daniels, Han Jo Kim, Peter G. Passias, Gregory M. Mundis Jr., Eric O. Klineberg, D. Kojo Hamilton, Munish Gupta, Virginie Lafage, Robert A. Hart, Frank Schwab, Douglas C. Burton, Shay Bess, Christopher I. Shaffrey, and Christopher P. Ames

OBJECTIVE

Cervical deformity (CD) patients have severe disability and poor health status. However, little is known about how patients with rigid CD compare with those with flexible CD. The main objectives of this study were to 1) assess whether patients with rigid CD have worse baseline alignment and therefore require more aggressive surgical corrections and 2) determine whether patients with rigid CD have similar postoperative outcomes as those with flexible CD.

METHODS

This is a retrospective review of a prospective, multicenter CD database. Rigid CD was defined as cervical lordosis (CL) change < 10° between flexion and extension radiographs, and flexible CD was defined as a CL change ≥ 10°. Patients with rigid CD were compared with those with flexible CD in terms of cervical alignment and health-related quality of life (HRQOL) at baseline and at multiple postoperative time points. The patients were also compared in terms of surgical and intraoperative factors such as operative time, blood loss, and number of levels fused.

RESULTS

A total of 127 patients met inclusion criteria (32 with rigid and 95 with flexible CD, 63.4% of whom were females; mean age 60.8 years; mean BMI 27.4); 47.2% of cases were revisions. Rigid CD was associated with worse preoperative alignment in terms of T1 slope minus CL, T1 slope, C2–7 sagittal vertical axis (cSVA), and C2 slope (C2S; all p < 0.05). Postoperatively, patients with rigid CD had an increased mean C2S (29.1° vs 22.2°) at 3 months and increased cSVA (47.1 mm vs 37.5 mm) at 1 year (p < 0.05) compared with those with flexible CD. Patients with rigid CD had more posterior levels fused (9.5 vs 6.3), fewer anterior levels fused (1 vs 2.0), greater blood loss (1036.7 mL vs 698.5 mL), more 3-column osteotomies (40.6% vs 12.6%), greater total osteotomy grade (6.5 vs 4.5), and mean osteotomy grade per level (3.3 vs 2.1) (p < 0.05 for all). There were no significant differences in baseline HRQOL scores, the rate of distal junctional kyphosis, or major/minor complications between patients with rigid and flexible CD. Both rigid and flexible CD patients reported significant improvements from baseline to 1 year according to the numeric rating scale for the neck (−2.4 and −2.7, respectively), Neck Disability Index (−8.4 and −13.3, respectively), modified Japanese Orthopaedic Association score (0.1 and 0.6), and EQ-5D (0.01 and 0.05) (p < 0.05). However, HRQOL changes from baseline to 1 year did not differ between rigid and flexible CD patients.

CONCLUSIONS

Patients with rigid CD have worse baseline cervical malalignment compared with those with flexible CD but do not significantly differ in terms of baseline disability. Rigid CD was associated with more invasive surgery and more aggressive corrections, resulting in increased operative time and blood loss. Despite more extensive surgeries, rigid CD patients had equivalent improvements in HRQOL compared with flexible CD patients. This study quantifies the importance of analyzing flexion-extension images, creating a prognostic tool for surgeons planning CD correction, and counseling patients who are considering CD surgery.

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Thomas J. Buell, Justin S. Smith, Christopher I. Shaffrey, Han Jo Kim, Eric O. Klineberg, Virginie Lafage, Renaud Lafage, Themistocles S. Protopsaltis, Peter G. Passias, Gregory M. Mundis Jr., Robert K. Eastlack, Vedat Deviren, Michael P. Kelly, Alan H. Daniels, Jeffrey L. Gum, Alex Soroceanu, D. Kojo Hamilton, Munish C. Gupta, Douglas C. Burton, Richard A. Hostin, Khaled M. Kebaish, Robert A. Hart, Frank J. Schwab, Shay Bess, Christopher P. Ames, and the International Spine Study Group (ISSG)

OBJECTIVE

The impact of global coronal malalignment (GCM; C7 plumb line–midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors’ primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes.

METHODS

This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed.

RESULTS

Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD–Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7–S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence–lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%–83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK).

CONCLUSIONS

Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.

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Alan H. Daniels, Daniel B. C. Reid, Wesley M. Durand, D. Kojo Hamilton, Peter G. Passias, Han Jo Kim, Themistocles S. Protopsaltis, Virginie Lafage, Justin S. Smith, Christopher I. Shaffrey, Munish Gupta, Eric Klineberg, Frank Schwab, Douglas Burton, Shay Bess, Christopher P. Ames, Robert A. Hart, and the International Spine Study Group

OBJECTIVE

Optimal patient selection for upper-thoracic (UT) versus lower-thoracic (LT) fusion during adult spinal deformity (ASD) correction is challenging. Radiographic and clinical outcomes following UT versus LT fusion remain incompletely understood. The purposes of this study were: 1) to evaluate demographic, radiographic, and surgical characteristics associated with choice of UT versus LT fusion endpoint; and 2) to evaluate differences in radiographic, clinical, and health-related quality of life (HRQOL) outcomes following UT versus LT fusion for ASD.

METHODS

Retrospective review of a prospectively collected multicenter ASD database was performed. Patients with ASD who underwent fusion from the sacrum/ilium to the LT (T9–L1) or UT (T1–6) spine were compared for demographic, radiographic, and surgical characteristics. Outcomes including proximal junctional kyphosis (PJK), reoperation, rod fracture, pseudarthrosis, overall complications, 2-year change in alignment parameters, and 2-year HRQOL metrics (Lumbar Stiffness Disability Index, Scoliosis Research Society-22r questionnaire, Oswestry Disability Index) were compared after controlling for confounding factors via multivariate analysis.

RESULTS

Three hundred three patients (169 LT, 134 UT) were evaluated. Independent predictors of UT fusion included greater thoracic kyphosis (odds ratio [OR] 0.97 per degree, p = 0.0098), greater coronal Cobb angle (OR 1.06 per degree, p < 0.0001), and performance of a 3-column osteotomy (3-CO; OR 2.39, p = 0.0351). While associated with longer operative times (ratio 1.13, p < 0.0001) and greater estimated blood loss (ratio 1.31, p = 0.0018), UT fusions resulted in greater sagittal vertical axis improvement (−59.5 vs −41.0 mm, p = 0.0035) and lower PJK rates (OR 0.49, p = 0.0457). No significant differences in postoperative HRQOL measures, reoperation, or overall complication rates were detected between groups (all p > 0.1).

CONCLUSIONS

Greater deformity and need for 3-CO increased the likelihood of UT fusion. Despite longer operative times and greater blood loss, UT fusions resulted in better sagittal correction and lower 2-year PJK rates following surgery for ASD. While continued surveillance is necessary, this information may inform patient counseling and surgical decision-making.

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Nitin Agarwal, Federico Angriman, Ezequiel Goldschmidt, James Zhou, Adam S. Kanter, David O. Okonkwo, Peter G. Passias, Themistocles Protopsaltis, Virginie Lafage, Renaud Lafage, Frank Schwab, Shay Bess, Christopher Ames, Justin S. Smith, Christopher I. Shaffrey, Douglas Burton, D. Kojo Hamilton, and the International Spine Study Group

OBJECTIVE

Obesity, a condition that is increasing in prevalence in the United States, has previously been associated with poorer outcomes following deformity surgery, including higher rates of perioperative complications such as deep and superficial infections. To date, however, no study has examined the relationship between preoperative BMI and outcomes of deformity surgery as measured by spine parameters such as the sagittal vertical axis (SVA), as well as health-related quality of life (HRQoL) measures such as the Oswestry Disability Index (ODI) and Scoliosis Research Society–22 patient questionnaire (SRS-22). To this end, the authors sought to clarify the relationship between BMI and postoperative change in SVA as well as HRQoL outcomes.

METHODS

The authors performed a retrospective review of a prospectively managed multicenter adult spinal deformity database collected and maintained by the International Spine Study Group (ISSG) between 2009 and 2014. The primary independent variable considered was preoperative BMI. The primary outcome was the change in SVA at 1 year after deformity surgery. Postoperative ODI and SRS-22 outcome measures were evaluated as secondary outcomes. Generalized linear models were used to model the primary and secondary outcomes at 1 year as a function of BMI at baseline, while adjusting for potential measured confounders.

RESULTS

Increasing BMI (compared to BMI < 18) was not associated with change of SVA at 1 year postsurgery. However, BMIs in the obese range of 30 to 34.9 kg/m2, compared to BMI < 18 at baseline, were associated with poorer outcomes as measured by the SRS-22 score (estimated change −0.47, 95% CI −0.93 to −0.01, p = 0.04). While BMIs > 30 appeared to be associated with poorer outcomes as determined by the ODI, this correlation did not reach statistical significance.

CONCLUSIONS

Baseline BMI did not affect the achievable SVA at 1 year postsurgery. Further studies should evaluate whether even in the absence of a change in SVA, baseline BMIs in the obese range are associated with worsened HRQoL outcomes after spinal surgery.

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Justin K. Scheer, Taemin Oh, Justin S. Smith, Christopher I. Shaffrey, Alan H. Daniels, Daniel M. Sciubba, D. Kojo Hamilton, Themistocles S. Protopsaltis, Peter G. Passias, Robert A. Hart, Douglas C. Burton, Shay Bess, Renaud Lafage, Virginie Lafage, Frank Schwab, Eric O. Klineberg, Christopher P. Ames, and the International Spine Study Group

OBJECTIVE

Pseudarthrosis can occur following adult spinal deformity (ASD) surgery and can lead to instrumentation failure, recurrent pain, and ultimately revision surgery. In addition, it is one of the most expensive complications of ASD surgery. Risk factors contributing to pseudarthrosis in ASD have been described; however, a preoperative model predicting the development of pseudarthrosis does not exist. The goal of this study was to create a preoperative predictive model for pseudarthrosis based on demographic, radiographic, and surgical factors.

METHODS

A retrospective review of a prospectively maintained, multicenter ASD database was conducted. Study inclusion criteria consisted of adult patients (age ≥ 18 years) with spinal deformity and surgery for the ASD. From among 82 variables assessed, 21 were used for model building after applying collinearity testing, redundancy, and univariable predictor importance ≥ 0.90. Variables included demographic data along with comorbidities, modifiable surgical variables, baseline coronal and sagittal radiographic parameters, and baseline scores for health-related quality of life measures. Patients groups were determined according to their Lenke radiographic fusion type at the 2-year follow-up: bilateral or unilateral fusion (union) or pseudarthrosis (nonunion). A decision tree was constructed, and internal validation was accomplished via bootstrapped training and testing data sets. Accuracy and the area under the receiver operating characteristic curve (AUC) were calculated to evaluate the model.

RESULTS

A total of 336 patients were included in the study (nonunion: 105, union: 231). The model was 91.3% accurate with an AUC of 0.94. From 82 initial variables, the top 21 covered a wide range of areas including preoperative alignment, comorbidities, patient demographics, and surgical use of graft material.

CONCLUSIONS

A model for predicting the development of pseudarthrosis at the 2-year follow-up was successfully created. This model is the first of its kind for complex predictive analytics in the development of pseudarthrosis for patients with ASD undergoing surgical correction and can aid in clinical decision-making for potential preventative strategies.

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Micheal Raad, Brian J. Neuman, Amit Jain, Hamid Hassanzadeh, Peter G. Passias, Eric Klineberg, Gregory M. Mundis Jr., Themistocles S. Protopsaltis, Emily K. Miller, Justin S. Smith, Virginie Lafage, D. Kojo Hamilton, Shay Bess, Khaled M. Kebaish, Daniel M. Sciubba, and the International Spine Study Group

OBJECTIVE

Given the recent shift in health care toward quality reporting requirements and a greater emphasis on a cost-quality approach, patient stratification with respect to long-term outcomes and the use of health care resources is of increasing value. Stratification tools may be effective if they are simple and evidence based. The authors hypothesize that preoperative patient-reported activity levels might independently predict postoperative outcomes in patients with adult spinal deformity.

METHODS

This is a retrospective cohort. A total of 575 patients in a prospective adult spinal deformity surgical database were identified with complete data regarding the preoperative level of activity. Answers to question 5 of the Scoliosis Research Society-22r Patient Questionnaire (SRS-22r) were used to stratify patients into active and inactive groups. Outcomes were length of hospital stay (LOS), level of activity, and reaching the minimum clinically important difference (MCID) for SRS-22r domains and the Physical Component Summary (PCS) of the SF-36 at 2 years postoperatively. The 2 groups were compared with respect to several potential confounders. Covariates with p < 0.1 were controlled for. The impact of activity on LOS was assessed using multivariate negative binomial regression analysis. Multivariate logistic regression models additionally controlling for the respective baseline health-related quality of life (HRQOL) scores were used to assess the association between preoperative activity levels and reaching the MCID at 2 years postoperatively.

RESULTS

A total of 420 (73%) of the 575 patients who met the inclusion criteria had complete data at 2 years postoperatively. The inactive group was more likely to be significantly older, have a higher Charlson Comorbidity Index, worse baseline radiographic deformity, and greater correction of most radiographic parameters. After controlling for possible confounders, the active group had a significantly shorter LOS (incidence risk ratio 0.91, p = 0.043). After adding respective baseline HRQOL scores to the models, active patients were significantly more likely to reach the MCID for the SRS-22r pain domain (OR 1.72, p = 0.026) and PCS (OR 1.94, p = 0.013). Active patients were also significantly more likely to be active at 2 years postoperatively on multivariate analysis (OR 8.94, p < 0.001).

CONCLUSIONS

The authors’ results show that patients who belong to the inactive group are likely to have a longer LOS and lower odds of reaching the MCID in HRQOL or being active at 2 years postoperatively. Inquiring about patients’ preoperative activity levels might be a reliable and simple stratification tool in terms of long- and short-term outcomes in ASD patients.

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Amit Jain, Hamid Hassanzadeh, Varun Puvanesarajah, Eric O. Klineberg, Daniel M. Sciubba, Michael P. Kelly, D. Kojo Hamilton, Virginie Lafage, Aaron J. Buckland, Peter G. Passias, Themistocles S. Protopsaltis, Renaud Lafage, Justin S. Smith, Christopher I. Shaffrey, Khaled M. Kebaish, and the International Spine Study Group

OBJECTIVE

Using 2 complication-reporting methods, the authors investigated the incidence of major medical complications and mortality in elderly patients after surgery for adult spinal deformity (ASD) during a 2-year follow-up period.

METHODS

The authors queried a multicenter, prospective, surgeon-maintained database (SMD) to identify patients 65 years or older who underwent surgical correction of ASD from 2008 through 2014 and had a minimum 2 years of follow-up (n = 153). They also queried a Centers for Medicare & Medicaid Services claims database (MCD) for patients 65 years or older who underwent fusion of 8 or more vertebral levels from 2005 through 2012 (n = 3366). They calculated cumulative rates of the following complications during the first 6 weeks after surgery: cerebrovascular accident, congestive heart failure, deep venous thrombosis, myocardial infarction, pneumonia, and pulmonary embolism. Significance was set at p < 0.05.

RESULTS

During the perioperative period, rates of major medical complications were 5.9% for pneumonia, 4.1% for deep venous thrombosis, 3.2% for pulmonary embolism, 2.1% for cerebrovascular accident, 1.8% for myocardial infarction, and 1.0% for congestive heart failure. Mortality rates were 0.9% at 6 weeks and 1.8% at 2 years. When comparing the SMD with the MCD, there were no significant differences in the perioperative rates of major medical complications except pneumonia. Furthermore, there were no significant intergroup differences in the mortality rates at 6 weeks or 2 years. The SMD provided greater detail with respect to deformity characteristics and surgical variables than the MCD.

CONCLUSIONS

The incidence of most major medical complications in the elderly after surgery for ASD was similar between the SMD and the MCD and ranged from 1% for congestive heart failure to 5.9% for pneumonia. These complications data can be valuable for preoperative patient counseling and informed consent.