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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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Rafael De la Garza Ramos, Jonathan Nakhla, Daniel M. Sciubba and Reza Yassari

OBJECTIVE

In a meta-analysis, the authors sought to compare outcomes after iliac screw (IS) versus S2 alar-iliac (S2AI) screw fixation in adult patients.

METHODS

A PubMed/MEDLINE database search was performed for studies comparing IS and S2AI screw fixation techniques in adults. Levels of evidence were assigned based on the North American Spine Society guidelines. Three outcomes were examined: 1) revision surgery rate secondary to mechanical failure or wound complications, 2) surgical site infection rate, and 3) screw prominence/pain. Data were pooled and outcomes compared between techniques. Absolute risk reductions (ARRs) were also calculated for outcome measures.

RESULTS

Five retrospective cohort studies (all level III evidence) were included in our analysis. A total of 323 adult patients were included—147 in the IS group (45.5%) and 176 in the S2AI group (54.5%). Overall, revision surgery due to mechanical failure or wound complications was needed in 66 of 323 patients (revision surgery rate 20.4%)—27.9% in the IS group and 14.2% in the S2AI group (13.7% ARR; p < 0.001). Four studies reported wound infections among 278 total patients, with an infection rate of 12.6% (35/278)—25.4% in the IS group and 2.6% in the S2AI group (22.8% ARR; p < 0.001). Three studies examined development of screw prominence/pain; combined, these studies reported screw prominence/pain in 21 of 215 cases (9.8%)—18.1% in the IS group and 1.8% in the S2AI group (16.3% ARR; p < 0.001).

CONCLUSIONS

S2AI screw fixation in adults has a significantly lower mechanical failure and complication rate than IS fixation based on the current best available evidence.

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Micheal Raad, Jay S. Reidler, Mostafa H. El Dafrawy, Raj M. Amin, Amit Jain, Brian J. Neuman, Lee H. Riley III, Daniel M. Sciubba, Khaled M. Kebaish and Richard L. Skolasky

OBJECTIVE

It is important to identify differences in the treatment of common diseases over time and across geographic regions. Several studies have reported increased use of arthrodesis to treat lumbar spinal stenosis (LSS). The purpose of this study was to investigate geographic variations in the treatment of LSS by US region.

METHODS

The authors reviewed inpatient and outpatient medical claims from 2010 to 2014 using the MarketScan Commercial Claims and Encounters database (Truven Health Analytics), which includes data on commercially insured members younger than 65 years. ICD-9 code 724.02 was used to identify patients aged ≥ 40 and < 65 years who underwent surgery for “spinal stenosis of the lumbar region” and for whom LSS was the only principal diagnosis. The primary outcome was the performance of spinal arthrodesis as part of the procedure. Geographic regions were based on patient residence and defined according to the US Census Bureau as the Northeast, Midwest, South, and West.

RESULTS

Rates of arthrodesis, as opposed to decompression alone, varied significantly by region, from 48% in the South, to 42% in the Midwest, 36% in the Northeast, and 31% in the West. After controlling for patient age, sex, and Charlson Comorbidity Index values, the differences remained significant. Compared with patients in the Northeast, those in the South (OR 1.6, 95% CI 1.50–1.75) and Midwest (OR 1.3, 95% CI 1.18–1.41) were significantly more likely to undergo spinal arthrodesis. On multivariate analysis, patients in the West were significantly less likely to have a prolonged hospital stay (> 3 days) than those in the Northeast (OR 0.84, 95% CI 0.75–0.94). Compared with the rate in the Northeast, the rates of discharge to a skilled nursing facility were lower in the South (OR 0.41, 95% CI 0.31–0.55) and West (OR 0.72, 95% CI 0.53–0.98). The 30-day readmission rate was significantly lower in the West (OR 0.81, 95% CI 0.65–0.98) than in the Northeast and similar between the other regions. Mean payments were significantly higher in the Midwest (mean difference $5503, 95% CI $4279–$6762), South (mean difference $6187, 95% CI $5041–$7332), and West (mean difference $7732, 95% CI $6384–$9080) than in the Northeast.

CONCLUSIONS

The use of spinal arthrodesis, as well as surgical outcomes and payments for the treatment of LSS, varies significantly by US region. This highlights the importance of developing national recommendations for the treatment of LSS.

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Seba Ramhmdani, Marc Comair, Camilo A. Molina, Daniel M. Sciubba and Ali Bydon

Interspinous process devices (IPDs) have been developed as less-invasive alternatives to spinal fusion with the goal of decompressing the spinal canal and preserving segmental motion. IPD implantation is proposed to treat symptoms of lumbar spinal stenosis that improve during flexion. Recent indications of IPD include lumbar facet joint syndrome, which is seen in patients with mainly low-back pain. Long-term outcomes in this subset of patients are largely unknown. The authors present a previously unreported complication of coflex (IPD) placement: the development of a large compressive lumbar synovial cyst. A 64-year-old woman underwent IPD implantation (coflex) at L4–5 at an outside hospital for low-back pain that occasionally radiates to the right leg. Postoperatively, her back and right leg pain persisted and worsened. MRI was repeated and showed a new, large synovial cyst at the previously treated level, severely compressing the patient’s cauda equina. Four months later, she underwent removal of the interspinous process implant, bilateral laminectomy, facetectomy, synovial cyst resection, interbody fusion, and stabilization. At the 3-month follow-up, she reported significant back pain improvement with some residual leg pain. This case suggests that facet arthrosis may not be an appropriate indication for placement of coflex.

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Micheal Raad, Callum J. Donaldson, Mostafa H. El Dafrawy, Daniel M. Sciubba, Lee H. Riley III, Brian J. Neuman, Khaled M. Kebaish and Richard L. Skolasky

OBJECTIVE

Recommendations for the surgical treatment of isolated lumbar spinal stenosis (LSS) (i.e., in the absence of concomitant scoliosis or spondylolisthesis) are unclear. The aims of this study were to investigate trends in the surgical treatment of isolated LSS in US adults and determine implications for outcomes.

METHODS

The authors analyzed inpatient and outpatient claims from the Truven Health Analytics MarketScan Commercial Claims and Encounters Database for 20,279 patients aged 40–64 years who underwent surgery for LSS between 2010 and 2014. Only patients with continuous 12-month insurance coverage after surgery were included. The rates of decompression with arthrodesis versus decompression only and of simple (1- or 2-level, single-approach) versus complex (> 2-level or combined-approach) arthrodesis were analyzed by year and geographic region. These trends were further analyzed with respect to complications, length of hospital stay, payments made to the hospital, and patient discharge status. Statistical significance was set at p < 0.05.

RESULTS

The proportion of patients who underwent decompression with arthrodesis compared with decompression only increased significantly and linearly from 2010 to 2014 (OR 1.08; 95% CI 1.06–1.10). Arthrodesis was more likely to be complex rather than simple with each subsequent year (OR 1.4; 95% CI 1.33–1.49). This trend was accompanied by an increased likelihood of postoperative complications (OR 1.11; 95% CI 1.02–1.21), higher costs (payments increased by a mean of US$1633 per year; 95% CI 1327–1939), and greater likelihood of being discharged to a skilled nursing facility as opposed to home (OR 1.11; 95% CI 1.03–1.20). The South and Midwest regions of the US had the highest proportions of patients undergoing arthrodesis (48% and 42%, respectively). The mean length of hospital stay did not change significantly (p = 0.324).

CONCLUSIONS

From 2010 to 2014, the proportion of adults undergoing decompression with arthrodesis versus decompression only for the treatment of LSS increased, especially in the South and Midwest regions of the US. A greater proportion of these fusions were complex and were associated with more complications, higher costs, and a greater likelihood of being discharged to a skilled nursing facility.

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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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Hannah M. Carl, A. Karim Ahmed, Nancy Abu-Bonsrah, Rafael De la Garza Ramos, Eric W. Sankey, Zachary Pennington, Ali Bydon, Timothy F. Witham, Jean-Paul Wolinsky, Ziya L. Gokaslan, Justin M. Sacks, C. Rory Goodwin and Daniel M. Sciubba

OBJECTIVE

Resection of metastatic spine tumors can improve patients’ quality of life by addressing pain or neurological compromise. However, resections are often complicated by wound dehiscence, infection, instrumentation failures, and the need for reoperation. Moreover, when reoperations are needed, the most common indication is surgical site infection and wound breakdown. In turn, wound reoperations increase morbidity as well as the length and cost of hospitalization. The aim of this study was to examine perioperative risk factors associated with increased rate of wound reoperations after metastatic spine tumor resection.

METHODS

A retrospective study of patients at a single institution who underwent metastatic spine tumor resection between 2003 and 2013 was conducted. Factors with a p value < 0.200 in a univariate analysis were included in the multivariate model.

RESULTS

A total of 159 patients were included in this study. Karnofsky Performance Scale score > 70, smoking status, hypertension, thromboembolic events, hyperlipidemia, increasing number of vertebral levels, and posterior approach were included in the multivariate analysis. Thromboembolic events (95% CI 1.19–48.5, p = 0.032) and number of levels involved were independently associated with increased wound reoperation rates in the multivariate model. For each additional spinal level involved, the risk for wound reoperations increased by 21% (95% CI 1.03–1.43, p = 0.018).

CONCLUSIONS

Although wound complications and subsequent reoperations are potential risks for all patients with metastatic spine tumor, due to adjuvant radiotherapy and other medical comorbidities, this study identified patients with thromboembolic events or those requiring a larger incision as being at the highest risk. Measures intended to decrease the occurrence of perioperative venous thromboembolism and to improve wound care, especially for long incisions, may decrease wound-related revision surgeries in this vulnerable group of patients.

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Taylor E. Purvis, C. Rory Goodwin, Camilo A. Molina, Steven M. Frank and Daniel M. Sciubba

OBJECTIVE

The aim of this study was to characterize the association between percentage change in hemoglobin (ΔHb)—i.e., the difference between preoperative Hb and in-hospital nadir Hb concentration—and perioperative adverse events among spine surgery patients.

METHODS

Patients who underwent spine surgery at the authors’ institution between December 4, 2008, and June 26, 2015, were eligible for this retrospective study. Patients who underwent the following procedures were included: atlantoaxial fusion, subaxial anterior cervical fusion, subaxial posterior cervical fusion, anterior lumbar fusion, posterior lumbar fusion, lateral lumbar fusion, excision of intervertebral disc, and excision of spinal cord lesion. Data on intraoperative transfusion were obtained from an automated, prospectively collected, anesthesia data management system. Data on postoperative hospital transfusions were obtained through an Internet-based intelligence portal. Percentage ΔHb was defined as: ([preoperative Hb − nadir Hb]/preoperative Hb) × 100. Clinical outcomes included in-hospital morbidity and length of stay associated with percentage ΔHb.

RESULTS

A total of 3949 patients who underwent spine surgery were identified. Of these, 1204 patients (30.5%) received at least 1 unit of packed red blood cells. The median nadir Hb level was 10.6 g/dl (interquartile range 8.7–12.4 g/dl), yielding a mean percentage ΔHb of 23.6% (SD 15.4%). Perioperative complications occurred in 234 patients (5.9%) and were more common in patients with a larger percentage ΔHb (p = 0.017). Hospital-related infection, which occurred in 60 patients (1.5%), was also more common in patients with greater percentage ΔHb (p = 0.001).

CONCLUSIONS

Percentage ΔHb is independently associated with a higher risk of developing any perioperative complication and hospital-related infection. The authors’ results suggest that percentage ΔHb may be a useful measure for identifying patients at risk for adverse perioperative events.

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Emily K. Miller, Brian J. Neuman, Amit Jain, Alan H. Daniels, Tamir Ailon, Daniel M. Sciubba, Khaled M. Kebaish, Virginie Lafage, Justin K. Scheer, Justin S. Smith, Shay Bess, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

The goal of this study was to analyze the value of an adult spinal deformity frailty index (ASD-FI) in preoperative risk stratification. Preoperative risk assessment is imperative before procedures known to have high complication rates, such as ASD surgery. Frailty has been associated with risk of complications in trauma surgery, and preoperative frailty assessments could improve the accuracy of risk stratification by providing a comprehensive analysis of patient factors that contribute to an increased risk of complications.

METHODS

Using 40 variables, the authors calculated frailty scores with a validated method for 417 patients (enrolled between 2010 and 2014) with a minimum 2-year follow-up in an ASD database. On the basis of these scores, the authors categorized patients as not frail (NF) (< 0.3 points), frail (0.3–0.5 points), or severely frail (SF) (> 0.5 points). The correlation between frailty category and incidence of complications was analyzed.

RESULTS

The overall mean ASD-FI score was 0.33 (range 0.0–0.8). Compared with NF patients (n = 183), frail patients (n = 158) and SF patients (n = 109) had longer mean hospital stays (1.2 and 1.6 times longer, respectively; p < 0.001). The adjusted odds of experiencing a major intraoperative or postoperative complication were higher for frail patients (OR 2.8) and SF patients ( 4.1) compared with NF patients (p < 0.01). For frail and SF patients, respectively, the adjusted odds of developing proximal junctional kyphosis (OR 2.8 and 3.1) were higher than those for NF patients. The SF patients had higher odds of developing pseudarthrosis (OR 13.0), deep wound infection (OR 8.0), and wound dehiscence (OR 13.4) than NF patients (p < 0.05), and they had 2.1 times greater odds of reoperation (p < 0.05).

CONCLUSIONS

Greater patient frailty, as measured by the ASD-FI, was associated with worse outcome in many common quality and value metrics, including greater risk of major complications, proximal junctional kyphosis, pseudarthrosis, deep wound infection, wound dehiscence, reoperation, and longer hospital stay.

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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.