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  • By Author: Lafage, Virginie x
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Justin S. Smith, Thomas J. Buell, Christopher I. Shaffrey, Han Jo Kim, Eric Klineberg, Themistocles Protopsaltis, Peter Passias, Gregory M. Mundis Jr., Robert Eastlack, Vedat Deviren, Michael P. Kelly, Alan H. Daniels, Jeffrey L. Gum, Alex Soroceanu, Munish Gupta, Doug Burton, Richard Hostin, Robert Hart, Virginie Lafage, Renaud Lafage, Frank J. Schwab, Shay Bess and Christopher P. Ames

OBJECTIVE

Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically.

METHODS

A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30–90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2–7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°.

RESULTS

Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively).

CONCLUSIONS

This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.

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Alex Soroceanu, Justin S. Smith, Darryl Lau, Michael P. Kelly, Peter G. Passias, Themistocles S. Protopsaltis, Jeffrey L. Gum, Virginie Lafage, Han-Jo Kim, Justin K. Scheer, Munish Gupta, Gregory M. Mundis Jr., Eric O. Klineberg, Douglas Burton, Shay Bess, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

It is being increasingly recognized that adult cervical deformity (ACD) is correlated with significant pain, myelopathy, and disability, and that patients who undergo deformity correction gain significant benefit. However, there are no defined thresholds of minimum clinically important difference (MCID) in Neck Disability Index (NDI) and modified Japanese Orthopaedic Association (mJOA) scores.

METHODS

Patients of interest were consecutive patients with ACD who underwent cervical deformity correction. ACD was defined as C2–7 sagittal Cobb angle ≥ 10° (kyphosis), C2–7 coronal Cobb angle ≥ 10° (cervical scoliosis), C2–7 sagittal vertical axis ≥ 4 cm, and/or chin-brow vertical angle ≥ 25°. Data were obtained from a consecutive cohort of patients from a multiinstitutional prospective database maintained across 13 sites. Distribution-based MCID, anchor-based MCID, and minimally detectable measurement difference (MDMD) were calculated.

RESULTS

A total of 73 patients met inclusion criteria and had sufficient 1-year follow-up. In the cohort, 42 patients (57.5%) were female. The mean age at the time of surgery was 62.23 years, and average body mass index was 29.28. The mean preoperative NDI was 46.49 and mJOA was 13.17. There was significant improvement in NDI at 1 year (46.49 vs 37.04; p = 0.0001). There was no significant difference in preoperative and 1-year mJOA (13.17 vs 13.7; p = 0.12). Using multiple techniques to yield MCID thresholds specific to the ACD population, the authors obtained values of 5.42 to 7.48 for the NDI, and 1.00 to 1.39 for the mJOA. The MDMD was 6.4 for the NDI, and 1.8 for the mJOA. Therefore, based on their results, the authors recommend using an MCID threshold of 1.8 for the mJOA, and 7.0 for the NDI in patients with ACD.

CONCLUSIONS

The ACD-specific MCID thresholds for NDI and mJOA are similar to the reported MCID following surgery for degenerative cervical disease. Additional studies are needed to verify these findings. Nonetheless, the findings here will be useful for future studies evaluating the success of surgery for patients with ACD undergoing deformity correction.

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Michael Y. Wang, Stacie Tran, G. Damian Brusko, Robert Eastlack, Paul Park, Pierce D. Nunley, Adam S. Kanter, Juan S. Uribe, Neel Anand, David O. Okonkwo, Khoi D. Than, Christopher I. Shaffrey, Virginie Lafage, Gregory M. Mundis Jr., Praveen V. Mummaneni and the MIS-ISSG Group

OBJECTIVE

The past decade has seen major advances in techniques for treating more complex spinal disorders using minimally invasive surgery (MIS). While appealing from the standpoint of patient perioperative outcomes, a major impediment to adoption has been the significant learning curve in utilizing MIS techniques.

METHODS

Data were retrospectively analyzed from a multicenter series of adult spinal deformity surgeries treated at eight tertiary spine care centers in the period from 2008 to 2015. All patients had undergone a less invasive or hybrid approach for a deformity correction satisfying the following inclusion criteria at baseline: coronal Cobb angle ≥ 20°, sagittal vertical axis (SVA) > 5 cm, or pelvic tilt > 20°. Analyzed data included baseline demographic details, severity of deformity, surgical metrics, clinical outcomes (numeric rating scale [NRS] score and Oswestry Disability Index [ODI]), radiographic outcomes, and complications. A minimum follow-up of 2 years was required for study inclusion.

RESULTS

Across the 8-year study period, among 222 patients, there was a trend toward treating increasingly morbid patients, with the mean age increasing from 50.7 to 62.4 years (p = 0.013) and the BMI increasing from 25.5 to 31.4 kg/m2 (p = 0.12). There was no statistical difference in the severity of coronal and sagittal deformity treated over the study period. With regard to radiographic changes following surgery, there was an increasing emphasis on sagittal correction and, conversely, less coronal correction. There was no statistically significant difference in clinical outcomes over the 8-year period, and meaningful improvements were seen in all years (ODI range of improvement: 15.0–26.9). Neither were there statistically significant differences in major complications; however, minor complications were seen less often as the surgeons gained experience (p = 0.064). Operative time was decreased on average by 47% over the 8-year period.

Trends in surgical practice were seen as well. Total fusion construct length was unchanged until the last year when there was a marked decrease in conjunction with a decrease in interbody levels treated (p = 0.004) while obtaining a higher degree of sagittal correction, suggesting more selective but powerful interbody reduction methods as reflected by an increase in the lateral and anterior column resection techniques being utilized.

CONCLUSIONS

The use of minimally invasive methods for adult spinal deformity surgery has evolved over the past decade. Experienced surgeons are treating older and more morbid patients with similar outcomes. A reliance on selective, more powerful interbody approaches is increasing as well.

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Blake N. Staub, Renaud Lafage, Han Jo Kim, Christopher I. Shaffrey, Gregory M. Mundis Jr., Richard Hostin, Douglas Burton, Lawrence Lenke, Munish C. Gupta, Christopher Ames, Eric Klineberg, Shay Bess, Frank Schwab, Virginie Lafage and the International Spine Study Group

OBJECTIVE

Numerous studies have attempted to delineate the normative value for T1S−CL (T1 slope minus cervical lordosis) as a marker for both cervical deformity and a goal for correction similar to how PI-LL (pelvic incidence–lumbar lordosis) mismatch informs decision making in thoracolumbar adult spinal deformity (ASD). The goal of this study was to define the relationship between T1 slope (T1S) and cervical lordosis (CL).

METHODS

This is a retrospective review of a prospective database. Surgical ASD cases were initially analyzed. Analysis across the sagittal parameters was performed. Linear regression analysis based on T1S was used to provide a clinically applicable equation to predict CL. Findings were validated using the postoperative alignment of the ASD patients. Further validation was then performed using a second, normative database. The range of normal alignment associated with horizontal gaze was derived from a multilinear regression on data from asymptomatic patients.

RESULTS

A total of 103 patients (mean age 54.7 years) were included. Analysis revealed a strong correlation between T1S and C0–7 lordosis (r = 0.886), C2–7 lordosis (r = 0.815), and C0–2 lordosis (r = 0.732). There was no significant correlation between T1S and T1S−CL. Linear regression analysis revealed that T1S−CL assumed a constant value of 16.5° (R2 = 0.664, standard error 2°). These findings were validated on the postoperative imaging (mean absolute error [MAE] 5.9°). The equation was then applied to the normative database (MAE 6.7° controlling for McGregor slope [MGS] between −5° and 15°). A multilinear regression between C2–7, T1S, and MGS demonstrated a range of T1S−CL between 14.5° and 26.5° was necessary to maintain horizontal gaze.

CONCLUSIONS

Normative CL can be predicted via the formula CL = T1S − 16.5° ± 2°. This implies a threshold of deformity and aids in providing a goal for surgical correction. Just as pelvic incidence (PI) can be used to determine the ideal LL, T1S can be used to predict ideal CL. This formula also implies that a kyphotic cervical alignment is to be expected for individuals with a T1S < 16.5°.

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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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David B. Bumpass, Lawrence G. Lenke, Jeffrey L. Gum, Christopher I. Shaffrey, Justin S. Smith, Christopher P. Ames, Shay Bess, Brian J. Neuman, Eric Klineberg, Gregory M. Mundis Jr., Frank Schwab, Virginie Lafage, Han Jo Kim, Douglas C. Burton, Khaled M. Kebaish, Richard Hostin, Renaud Lafage, Michael P. Kelly and for the International Spine Study Group

OBJECTIVE

Adolescent spine deformity studies have shown that male patients require longer surgery and have greater estimated blood loss (EBL) and complications compared with female patients. No studies exist to support this relationship in adult spinal deformity (ASD). The purpose of this study was to investigate associations between sex and complications, deformity correction, and health-related quality of life (HRQOL) in patients with ASD. It was hypothesized that male ASD patients would have greater EBL, longer surgery, and more complications than female ASD patients.

METHODS

A multicenter ASD cohort was retrospectively queried for patients who underwent primary posterior-only instrumented fusions with a minimum of 5 levels fused. The minimum follow-up was 2 years. Primary outcomes were EBL, operative time, intra-, peri-, and postoperative complications, radiographic correction, and HRQOL outcomes (Oswestry Disability Index, SF-36, and Scoliosis Research Society-22r Questionnaire). Poisson multivariate regression was used to control for age, comorbidities, and levels fused.

RESULTS

Ninety male and 319 female patients met the inclusion criteria. Male patients had significantly greater mean EBL (2373 ml vs 1829 ml, p = 0.01). The mean operative time, transfusion requirements, and final radiographic measurements did not differ between sexes. Similarly, changes in HRQOL showed no significant differences. Finally, there were no sex differences in the incidence of complications (total, major, or minor) at any time point after controlling for age, body mass index, comorbidities, and levels fused.

CONCLUSIONS

Despite higher EBL, male ASD patients did not experience more complications or require less deformity correction at the 2-year follow-up. HRQOL scores similarly showed no sex differences. These findings differ from adolescent deformity studies, and surgeons can counsel patients that sex is unlikely to influence the outcomes and complication rates of primary all-posterior ASD surgery.

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Emmanuelle Ferrero, Barthelemy Liabaud, Jensen K. Henry, Christopher P. Ames, Khaled Kebaish, Gregory M. Mundis, Richard Hostin, Munish C. Gupta, Oheneba Boachie-Adjei, Justin S. Smith, Robert A. Hart, Ibrahim Obeid, Bassel G. Diebo, Frank J. Schwab and Virginie Lafage

OBJECTIVE

Three-column osteotomy (3CO) is a demanding technique that is performed to correct sagittal spinal malalignment. However, the impact of the 3CO level on pelvic or truncal sagittal correction remains unclear. In this study, the authors assessed the impact of 3CO level and postoperative apex of lumbar lordosis on sagittal alignment correction, complications, and revisions.

METHODS

In this retrospective study of a multicenter spinal deformity database, radiographic data were analyzed at baseline and at 1- and 2-year follow-up to quantify spinopelvic alignment, apex of lordosis, and resection angle. The impact of 3CO level and apex level of lumbar lordosis on the sagittal correction was assessed. Logistic regression analyses were performed, controlling for cofounders, to investigate the effects of 3CO level and apex level on intraoperative and postoperative complications as well as on the need for subsequent revision surgery.

RESULTS

A total of 468 patients were included (mean age 60.8 years, mean body mass index 28.1 kg/m2); 70% of patients were female. The average 3CO resection angle was 25.1° and did not significantly differ with regard to 3CO level. There were no significant correlations between the 3CO level and amount of sagittal vertical axis or pelvic tilt correction. The postoperative apex level significantly correlated with greater correction of pelvic tilt (2° per more caudal level, R = −0.2, p = 0.006). Lower-level 3CO significantly correlated with revisions for pseudarthrosis (OR = 3.88, p = 0.001) and postoperative motor deficits (OR = 2.02, p = 0.026).

CONCLUSIONS

In this study, a more caudal lumbar 3CO level did not lead to greater sagittal vertical axis correction. The postoperative apex of lumbar lordosis significantly impacted pelvic tilt. 3CO levels that were more caudal were associated with more postoperative motor deficits and revisions.

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Justin S. Smith, Christopher I. Shaffrey, Eric Klineberg, Virginie Lafage, Frank Schwab, Renaud Lafage, Han Jo Kim, Richard Hostin, Gregory M. Mundis Jr., Munish Gupta, Barthelemy Liabaud, Justin K. Scheer, Bassel G. Diebo, Themistocles S. Protopsaltis, Michael P. Kelly, Vedat Deviren, Robert Hart, Doug Burton, Shay Bess and Christopher P. Ames

OBJECTIVE

Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database.

METHODS

This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators.

RESULTS

Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33%) patients had 1–11 reoperations (total of 44 reoperations). The most common indications for reoperation were rod breakage (n = 14), deep wound infection (n = 15), and PJK (n = 6). The 24 patients who did not achieve 2-year follow-up had a mean of 0.85 years of follow-up, and the types of early and delayed complications encountered in these 24 patients were comparable to those encountered in the patients that achieved 2-year follow-up.

CONCLUSIONS

Among 82 ASD patients treated with 3CO, 64 (78.0%) had at least 1 early or delayed complication (57 minor, 85 major). The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.

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Justin K. Scheer, Justin S. Smith, Frank Schwab, Virginie Lafage, Christopher I. Shaffrey, Shay Bess, Alan H. Daniels, Robert A. Hart, Themistocles S. Protopsaltis, Gregory M. Mundis Jr., Daniel M. Sciubba, Tamir Ailon, Douglas C. Burton, Eric Klineberg, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

The operative management of patients with adult spinal deformity (ASD) has a high complication rate and it remains unknown whether baseline patient characteristics and surgical variables can predict early complications (intraoperative and perioperative [within 6 weeks]). The development of an accurate preoperative predictive model can aid in patient counseling, shared decision making, and improved surgical planning. The purpose of this study was to develop a model based on baseline demographic, radiographic, and surgical factors that can predict if patients will sustain an intraoperative or perioperative major complication.

METHODS

This study was a retrospective analysis of a prospective, multicenter ASD database. The inclusion criteria were age ≥ 18 years and the presence of ASD. In total, 45 variables were used in the initial training of the model including demographic data, comorbidities, modifiable surgical variables, baseline health-related quality of life, and coronal and sagittal radiographic parameters. Patients were grouped as either having at least 1 major intraoperative or perioperative complication (COMP group) or not (NOCOMP group). An ensemble of decision trees was constructed utilizing the C5.0 algorithm with 5 different bootstrapped models. Internal validation was accomplished via a 70/30 data split for training and testing each model, respectively. Overall accuracy, the area under the receiver operating characteristic (AUROC) curve, and predictor importance were calculated.

RESULTS

Five hundred fifty-seven patients were included: 409 (73.4%) in the NOCOMP group, and 148 (26.6%) in the COMP group. The overall model accuracy was 87.6% correct with an AUROC curve of 0.89 indicating a very good model fit. Twenty variables were determined to be the top predictors (importance ≥ 0.90 as determined by the model) and included (in decreasing importance): age, leg pain, Oswestry Disability Index, number of decompression levels, number of interbody fusion levels, Physical Component Summary of the SF-36, Scoliosis Research Society (SRS)–Schwab coronal curve type, Charlson Comorbidity Index, SRS activity, T-1 pelvic angle, American Society of Anesthesiologists grade, presence of osteoporosis, pelvic tilt, sagittal vertical axis, primary versus revision surgery, SRS pain, SRS total, use of bone morphogenetic protein, use of iliac crest graft, and pelvic incidence–lumbar lordosis mismatch.

CONCLUSIONS

A successful model (87% accuracy, 0.89 AUROC curve) was built predicting major intraoperative or perioperative complications following ASD surgery. This model can provide the foundation toward improved education and point-of-care decision making for patients undergoing ASD surgery.