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  • By Author: Lafage, Virginie x
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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.

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Peter G. Passias, Bassel G. Diebo, Bryan J. Marascalchi, Cyrus M. Jalai, Samantha R. Horn, Peter L. Zhou, Karen Paltoo, Olivia J. Bono, Nancy Worley, Gregory W. Poorman, Vincent Challier, Anant Dixit, Carl Paulino and Virginie Lafage

OBJECTIVE

It is becoming increasingly necessary for surgeons to provide evidence supporting cost-effectiveness of surgical treatment for cervical spine pathology. Anticipating surgical risk is critical in accurately evaluating the risk/benefit balance of such treatment. Determining the risk and cost-effectiveness of surgery, complications, revision procedures, and mortality rates are the most significant limitations. The purpose of this study was to determine independent risk factors for medical complications (MCs), surgical complications (SCs), revisions, and mortality rates following surgery for patients with cervical spine pathology. The most relevant risk factors were used to structure an index that will help quantify risk and anticipate failure for such procedures.

METHODS

The authors of this study performed a retrospective review of the National Inpatient Sample (NIS) database for patients treated surgically for cervical spine pathology between 2001 and 2010. Multivariate models were performed to calculate the odds ratio (OR) of the independent risk factors that led to MCs and repeated for SCs, revisions, and mortality. The models controlled for age (< and > 65 years old), sex, race, revision status (except for revision analysis), surgical approach, number of levels fused/re-fused (2–3, 4–8, ≥ 9), and osteotomy utilization. ORs were weighted based on their predictive category: 2 times for revision surgery predictors and 4 times for mortality predictors. Fifty points were distributed among the predictors based on their cumulative OR to establish a risk index.

RESULTS

Discharges for 362,989 patients with cervical spine pathology were identified. The mean age was 52.65 years, and 49.47% of patients were women. Independent risk factors included medical comorbidities, surgical parameters, and demographic factors. Medical comorbidities included the following: pulmonary circulation disorder, coagulopathy, metastatic cancer, renal failure, congestive heart failure, alcohol abuse, neurological disorder, nonmetastatic cancer, liver disease, rheumatoid arthritis/collagen vascular diseases, and chronic blood loss/anemia. Surgical parameters included posterior approach to fusion/re-fusion, ≥ 9 levels fused/re-fused, corpectomy, 4–8 levels fused/re-fused, and osteotomy; demographic variables included age ≥ 65 years. These factors increased the risk of at least 1 of MC, SC, revision, or mortality (risk of death). A total of 50 points were distributed among the factors based on the cumulative risk ratio of every factor in proportion to the total risk ratios.

CONCLUSIONS

This study proposed an index to quantify the potential risk of morbidity and mortality prior to surgical intervention for patients with cervical spine pathology. This index may be useful for surgeons in patient counseling efforts as well as for health insurance companies and future socioeconomics studies in assessing surgical risks and benefits for patients undergoing surgical treatment of the cervical spine.

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Justin K. Scheer, Peter G. Passias, Alexandra M. Sorocean, Anthony J. Boniello, Gregory M. Mundis Jr., Eric Klineberg, Han Jo Kim, Themistocles S. Protopsaltis, Munish Gupta, Shay Bess, Christopher I. Shaffrey, Frank Schwab, Virginie Lafage, Justin S. Smith, Christopher P. Ames and The International Spine Study Group

OBJECT

A high prevalence of cervical deformity (CD) has been identified among adult patients with thoracolumbar spinal deformity undergoing surgical treatment. The clinical impact of this is uncertain. This study aimed to quantify the differences in patient-reported outcomes among patients with adult spinal deformity (ASD) based on presence of CD prior to treatment.

METHODS

A retrospective review was conducted of a multicenter prospective database of patients with ASD who underwent surgical treatment with 2-year follow-up. Patients were grouped by the presence of preoperative CD: 1) cervical positive sagittal malalignment (CPSM) C2–7 sagittal vertical axis ≥ 4 cm; 2) cervical kyphosis (CK) C2–7 angle > 0; 3) CPSM and CK (BOTH); and 4) no baseline CD (NONE). Health-related quality of life (HRQOL) scores included the Physical Component Summary and Mental Component Summary (PCS and MCS) scores of the 36-Item Short Form Health Survey (SF-36), Oswestry Disability Index (ODI), Scoliosis Research Society-22 questionnaire (SRS-22), and minimum clinically important difference (MCID) of these scores at 2 years. Standard radiographic measurements were conducted for cervical, thoracic, and thoracolumbar parameters.

RESULTS

One hundred eighty-two patients were included in this study: CPSM, 45; CK, 37; BOTH, 16; and NONE, 84. Patients with preoperative CD and those without had similar baseline thoracolumbar radiographic measurements and similar correction rates at 2 years. Patients with and without preoperative CD had similar baseline HRQOL and on average both groups experienced some HRQOL improvement. However, those with preoperative CPSM had significantly worse postoperative ODI, PCS, SRS-22 Activity, SRS-22 Appearance, SRS-22 Pain, SRS-22 Satisfaction, and SRS-22 Total score, and were less likely to meet MCID for ODI, PCS, SRS-22 Activity, and SRS-22 Pain scores with the following ORs and 95% CIs: ODI 0.19 (0.07–0.58), PCS 0.17 (0.06–0.47), SRS-22 Activity 0.23 (0.09–0.62), SRS-22 Pain 0.20 (0.08–0.53), and SRS-22 Appearance 0.34 (0.12–0.94). Preoperative CK did not have an effect on outcomes. Interestingly, despite correction of the thoracolumbar deformity, 53.3% and 51.4% of patients had persistent CPSM and persistent CK, respectively.

CONCLUSIONS

Patients with thoracolumbar deformity without preoperative CD are likely to have greater improvements in HRQOL after surgery than patients with concomitant preoperative CD. Cervical positive sagittal alignment in adult patients with thoracolumbar deformity is strongly associated with inferior outcomes and failure to reach MCID at 2-year follow-up despite having similar baseline HRQOL to patients without CD. This was the first study to assess the impact of concomitant preoperative cervical malalignment in adult patients with thoracolumbar deformity. These results can help surgeons educate patients at risk for inferior outcomes and direct future research to identify an etiology and improve patient outcomes. Investigation into the etiology of the baseline cervical malalignment may be warranted in patients who present with thoracolumbar deformity.

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Taemin Oh, Justin K. Scheer, Robert Eastlack, Justin S. Smith, Virginie Lafage, Themistocles S. Protopsaltis, Eric Klineberg, Peter G. Passias, Vedat Deviren, Richard Hostin, Munish Gupta, Shay Bess, Frank Schwab, Christopher I. Shaffrey and Christopher P. Ames

OBJECT

Alignment changes in the cervical spine that occur following surgical correction for thoracic deformity remain poorly understood. The purpose of this study was to evaluate such changes in a cohort of adults with thoracic deformity treated surgically.

METHODS

The authors conducted a multicenter retrospective analysis of consecutive patients with thoracic deformity. Inclusion criteria for this study were as follows: corrective osteotomy for thoracic deformity, upper-most instrumented vertebra (UIV) between T-1 and T-4, lower-most instrumented vertebra (LIV) at or above L-5 (LIV ≥ L-5) or at the ilium (LIV-ilium), and a minimum radiographic follow-up of 2 years. Sagittal radiographic parameters were assessed preoperatively as well as at 3 months and 2 years postoperatively, including the C-7 sagittal vertical axis (SVA), C2–7 cervical lordosis (CL), C2–7 SVA, T-1 slope (T1S), T1S minus CL (T1S-CL), T2–12 thoracic kyphosis (TK), apical TK, lumbar lordosis (LL), pelvic incidence (PI), PI-LL, pelvic tilt (PT), and sacral slope (SS).

RESULTS

Fifty-seven patients with a mean age of 49.1 ± 14.6 years met the study inclusion criteria. The preoperative prevalence of increased CL (CL > 15°) was 48.9%. Both 3-month and 2-year apical TK improved from baseline (p < 0.05, statistically significant). At the 2-year follow-up, only the C2–7 SVA increased significantly from baseline (p = 0.01), whereas LL decreased from baseline (p < 0.01). The prevalence of increased CL was 35.3% at 3 months and 47.8% at 2 years, which did not represent a significant change. Postoperative cervical alignment changes were not significantly different from preoperative values regardless of the LIV (LIV ≥ L-5 or LIV-ilium, p > 0.05 for both). In a subset of patients with a maximum TK ≥ 60° (35 patients) and 3-column osteotomy (38 patients), no significant postoperative cervical changes were seen.

CONCLUSION

Increased CL is common in adult spinal deformity patients with thoracic deformities and, unlike after lumbar corrective surgery, does not appear to normalize after thoracic corrective surgery. Cervical sagittal malalignment (C2–7 SVA) also increases postoperatively. Surgeons should be aware that spontaneous cervical alignment normalization might not occur following thoracic deformity correction.