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Andrew K. Chan, Erica F. Bisson, Mohamad Bydon, Steven D. Glassman, Kevin T. Foley, Eric A. Potts, Christopher I. Shaffrey, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Michael Y. Wang, Kai-Ming Fu, Jonathan R. Slotkin, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Silky Chotai, Anthony M. DiGiorgio, Regis W. Haid and Praveen V. Mummaneni

OBJECTIVE

The AANS launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data to measure the safety and quality of spine surgery. Registry data offer “real-world” insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.

METHODS

Data from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol–5 Dimensions health survey (EQ-5D) results.

RESULTS

A total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β −4.79, 95% CI −9.28 to −0.31; p = 0.04).

CONCLUSIONS

Surgery for grade 1 lumbar spondylolisthesis—regardless of treatment strategy—was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.

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Zachary G. Ries, Steven D. Glassman, Ivan Vasilyev, Leanne Metcalfe and Leah Y. Carreon

OBJECTIVE

Diagnostic workup for lumbar degenerative disc disease (DDD) includes imaging such as radiography, MRI, and/or CT myelography. If a patient has unsuccessful nonoperative treatment, the surgeon must then decide if obtaining updated images prior to surgery is warranted. The purpose of this study was to investigate whether the timing of preoperative neuroimaging altered clinical outcome, as reflected by the subsequent rate of revision surgery, in patients with degenerative lumbar spinal pathology.

METHODS

From the Health Care Service Corporation administrative claims database, adult patients (minimum age 55 years old) with lumbar DDD who underwent surgery including posterior lumbar decompression with and without fusion (1–2 levels) and at least 5 years of continuous coverage after the index surgery were identified. The chi-square test was used to determine differences in revision rates stratified by timing of each imaging procedure relative to the index procedure (< 6 months, 6–12 months, 12–24 months, or > 24 months).

RESULTS

Of 28,676 cases identified, 5128 (18%) had revision surgery within 5 years. The timing of preoperative MRI or plain radiography was not associated with revision surgery. Among the entire cohort, there was a lower incidence of revision surgery in patients who had a CT myelogram within 1 year prior to the index surgery (p = 0.017). This observation was strongest in patients undergoing decompression only (p = 0.002), but not significant in patients undergoing fusion (p = 0.845).

CONCLUSIONS

Routine reimaging prior to surgery, simply because the existing MRI is 6–12 months old, may not be beneficial, at least as reflected in subsequent revision rates. The study also suggests that there may be a subset of patients for whom preoperative CT myelography reduces revision rates. This topic has important financial implications and deserves further study in a more granular data set.

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Mladen Djurasovic, Katlyn E. McGraw, Kelly Bratcher, Charles H. Crawford III, John R. Dimar II, Rolando M. Puno, Steven D. Glassman, R. Kirk Owens II and Leah Y. Carreon

OBJECTIVE

The goal of this study was to determine efficacy and cost-effectiveness of Cell Saver in 2- and 3-level lumbar decompression and fusion.

METHODS

Patients seen at a tertiary care spine center who were undergoing a posterior 2- or 3-level lumbar decompression and fusion were randomized to have Cell Saver used during their surgery (CS group, n = 48) or not used (No Cell Saver [NCS] group, n = 47). Data regarding preoperative and postoperative hemoglobin and hematocrit, estimated blood loss, volume of Cell Saver blood reinfused, number of units and volume of allogeneic blood transfused intraoperatively and postoperatively, complications, and costs were collected. Costs associated with Cell Saver use were calculated based on units of allogeneic blood transfusions averted.

RESULTS

Demographics and surgical parameters were similar in both groups. The mean estimated blood loss was similar in both groups: 612 ml in the CS group and 742 ml in the NCS group. There were 53 U of allogeneic blood transfused in 29 patients in the NCS group at a total blood product cost of $67,688; and 38 U of allogeneic blood transfused in 16 patients in the CS group at a total blood cost of $113,162, resulting in a cost of $3031 per allogeneic blood transfusion averted using Cell Saver.

CONCLUSIONS

Cell Saver use produced lower rates of allogeneic transfusion but was found to be more expensive than using only allogeneic blood for 2- and 3-level lumbar degenerative fusions. This increased cost may be reasonable to patients who perceive that the risks associated with allogeneic transfusions are unacceptable.

CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III.

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Joshua T. Bunch, Steven D. Glassman, Howard R. Underwood, Leanne N. Metcalfe, Stephen Ondra, Ivan Vasilyev and Leah Y. Carreon

OBJECTIVE

Full-length (36-inch) standing spine radiographs are commonly used by spine surgeons to evaluate patients with lumbar degenerative scoliosis (LDS). Despite this practice, the impact of these images on preoperative decision making and the rate of revision surgery has not been analyzed. The purpose of this study is to determine if preoperative full-length standing spine radiographs improve surgical decision making by decreasing the rate of revision surgery in patients with LDS.

METHODS

From the Health Care Service Corporation administrative claims database, the authors identified patients 50–80 years of age with LDS who had undergone surgery including posterior lumbar decompression and fusion over 2–6 levels and with at least 5 years of continuous coverage after the index surgery. Patients were stratified into the following groups, according to the preoperative imaging studies performed within 6 months before their index surgery: lumbar spine MRI studies only, lumbar spine MRI studies and standard lumbar spine radiographs, CT myelograms, and full-length standing spine radiographs. Survival analysis was performed with the occurrence of a revision within 5 years of the index surgery as the outcome of interest.

RESULTS

A total of 411 patients were included in the study after applying the inclusion and exclusion criteria. Revision surgery within 5 years after the index procedure was most frequent in the patients with preoperative MRI only (41.8%), followed by the patients with a CT myelogram (30.4%) and those with MRI and standard radiographs (24.8%). The lowest revision rate was seen among those with long-cassette standing radiographs (11.1%). Patients whose preoperative evaluation included full-length standing radiographs (OR 0.353, p = 0.034) and MRI studies plus radiographs (OR 0.650, p = 0.022) were less likely to require revision surgery at 5 years after the index procedure.

CONCLUSIONS

An assessment of standing alignment using full-length (36-inch) standing radiographs may be beneficial in reducing the risk of revision surgery in patients with lumbar scoliosis. This observation was not limited to patients with large curves or substantial deformity.

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Anthony L. Asher, Panagiotis Kerezoudis, Praveen V. Mummaneni, Erica F. Bisson, Steven D. Glassman, Kevin T. Foley, Jonathan R. Slotkin, Eric A. Potts, Mark E. Shaffrey, Christopher I. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Kai-Ming Fu, Clinton J. Devin, Kristin R. Archer, Silky Chotai, Andrew K. Chan, Michael S. Virk and Mohamad Bydon

OBJECTIVE

Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis.

METHODS

The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen’s effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO.

RESULTS

A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3–26.5 points for ODI, 0.04–0.3 points for EQ-5D, 0.6–4.5 points for NRS-LP, and 0.5–4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort.

CONCLUSIONS

The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.

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Andrew K. Chan, Erica F. Bisson, Mohamad Bydon, Steven D. Glassman, Kevin T. Foley, Eric A. Potts, Christopher I. Shaffrey, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Kai-Ming Fu, Jonathan R. Slotkin, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Silky Chotai, Anthony M. DiGiorgio, Alvin Y. Chan, Regis W. Haid and Praveen V. Mummaneni

OBJECTIVE

The American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data, to measure the safety and quality of neurosurgical procedures, including spinal surgery. Differing results from recent randomized controlled trials have established a need to clarify the groups that would most benefit from surgery for degenerative lumbar spondylolisthesis. In the present study, the authors compared patients who were the most and the least satisfied following surgery for degenerative lumbar spondylolisthesis.

METHODS

This was a retrospective analysis of a prospective, national longitudinal registry including patients who had undergone surgery for grade 1 degenerative lumbar spondylolisthesis. The most and least satisfied patients were identified based on an answer of “1” and “4,” respectively, on the North American Spine Society (NASS) Satisfaction Questionnaire 12 months postoperatively. Baseline demographics, clinical variables, surgical parameters, and outcomes were collected. Patient-reported outcome measures, including the Numeric Rating Scale (NRS) for back pain, NRS for leg pain, Oswestry Disability Index (ODI), and EQ-5D (the EuroQol health survey), were administered at baseline and 3 and 12 months after treatment.

RESULTS

Four hundred seventy-seven patients underwent surgery for grade 1 degenerative lumbar spondylolisthesis in the period from July 2014 through December 2015. Two hundred fifty-five patients (53.5%) were the most satisfied and 26 (5.5%) were the least satisfied. Compared with the most satisfied patients, the least satisfied ones more often had coronary artery disease (CAD; 26.9% vs 12.2%, p = 0.04) and had higher body mass indices (32.9 ± 6.5 vs 30.0 ± 6.0 kg/m2, p = 0.02). In the multivariate analysis, female sex (OR 2.9, p = 0.02) was associated with the most satisfaction. Notably, the American Society of Anesthesiologists (ASA) class, smoking, psychiatric comorbidity, and employment status were not significantly associated with satisfaction. Although there were no significant differences at baseline, the most satisfied patients had significantly lower NRS back and leg pain and ODI scores and a greater EQ-5D score at 3 and 12 months postoperatively (p < 0.001 for all).

CONCLUSIONS

This study revealed that some patient factors differ between those who report the most and those who report the least satisfaction after surgery for degenerative lumbar spondylolisthesis. Patients reporting the least satisfaction tended to have CAD or were obese. Female sex was associated with the most satisfaction when adjusting for potential covariates. These findings highlight several key factors that could aid in setting expectations for outcomes following surgery for degenerative lumbar spondylolisthesis.

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Anthony L. Asher, Clinton J. Devin, Brandon McCutcheon, Silky Chotai, Kristin R. Archer, Hui Nian, Frank E. Harrell Jr., Matthew McGirt, Praveen V. Mummaneni, Christopher I. Shaffrey, Kevin Foley, Steven D. Glassman and Mohamad Bydon

OBJECTIVE

In this analysis the authors compare the characteristics of smokers to nonsmokers using demographic, socioeconomic, and comorbidity variables. They also investigate which of these characteristics are most strongly associated with smoking status. Finally, the authors investigate whether the association between known patient risk factors and disability outcome is differentially modified by patient smoking status for those who have undergone surgery for lumbar degeneration.

METHODS

A total of 7547 patients undergoing degenerative lumbar surgery were entered into a prospective multicenter registry (Quality Outcomes Database [QOD]). A retrospective analysis of the prospectively collected data was conducted. Patients were dichotomized as smokers (current smokers) and nonsmokers. Multivariable logistic regression analysis fitted for patient smoking status and subsequent measurement of variable importance was performed to identify the strongest patient characteristics associated with smoking status. Multivariable linear regression models fitted for 12-month Oswestry Disability Index (ODI) scores in subsets of smokers and nonsmokers was performed to investigate whether differential effects of risk factors by smoking status might be present.

RESULTS

In total, 18% (n = 1365) of patients were smokers and 82% (n = 6182) were nonsmokers. In a multivariable logistic regression analysis, the factors significantly associated with patients’ smoking status were sex (p < 0.0001), age (p < 0.0001), body mass index (p < 0.0001), educational status (p < 0.0001), insurance status (p < 0.001), and employment/occupation (p = 0.0024). Patients with diabetes had lowers odds of being a smoker (p = 0.0008), while patients with coronary artery disease had greater odds of being a smoker (p = 0.044). Patients’ propensity for smoking was also significantly associated with higher American Society of Anesthesiologists (ASA) class (p < 0.0001), anterior-alone surgical approach (p = 0.018), greater number of levels (p = 0.0246), decompression only (p = 0.0001), and higher baseline ODI score (p < 0.0001). In a multivariable proportional odds logistic regression model, the adjusted odds ratio of risk factors and direction of improvement in 12-month ODI scores remained similar between the subsets of smokers and nonsmokers.

CONCLUSIONS

Using a large, national, multiinstitutional registry, the authors described the profile of patients who undergo lumbar spine surgery and its association with their smoking status. Compared with nonsmokers, smokers were younger, male, nondiabetic, nonobese patients presenting with leg pain more so than back pain, with higher ASA classes, higher disability, less education, more likely to be unemployed, and with Medicaid/uninsured insurance status. Smoking status did not affect the association between these risk factors and 12-month ODI outcome, suggesting that interventions for modifiable risk factors are equally efficacious between smokers and nonsmokers.

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Borys V. Gvozdyev, Leah Y. Carreon, Christopher M. Graves, Stephanie A. Riley, Katlyn E. McGraw, R. Joseph Head, John R. Dimar II and Steven D. Glassman

OBJECTIVE

Patient-reported outcomes (PROs) such as the Oswestry Disability Index (ODI) and EuroQol-5D (EQ-5D) are widely used to evaluate treatment outcomes following spine surgery for degenerative conditions. The goal of this study was to use the Charlson Comorbidity Index (CCMI) as a measure of general health status, for comparison with standard PROs.

METHODS

The authors examined serial CCMI scores, complications, and PROs in 371 patients treated surgically for degenerative lumbar spine conditions who were enrolled in the Quality and Outcomes Database from a single center. The cohort included 152 males (41%) with a mean age of 58.7 years. Patients with no, minor, or major complications were compared at baseline and at 1 year postoperatively.

RESULTS

Minor complications were observed in 177 patients (48%), and major complications in 34 (9%). There were no significant differences in preoperative ODI, EQ-5D, or CCMI among the 3 groups. At 1 year, there was a significantly greater deterioration in CCMI in the major complication group (1.03) compared with the minor (0.66) and no complication groups (0.44, p < 0.006), but no significant difference in ODI or EQ-5D.

CONCLUSIONS

Despite equivalent improvements in PROs, patients with major complications actually had greater deterioration in their general health status, as evidenced by worse CCMI scores. Because CCMI is predictive of medical and surgical risk, patients who sustained a major complication now carry a greater likelihood of adverse outcomes with future interventions, including subsequent spine surgery. Although PRO scores are a key metric, they fail to adequately reflect the potential long-term impact of major perioperative complications.

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Rishi K. Wadhwa, Junichi Ohya, Todd D. Vogel, Leah Y. Carreon, Anthony L. Asher, John J. Knightly, Christopher I. Shaffrey, Steven D. Glassman and Praveen V. Mummaneni

OBJECTIVE

The aim of this paper was to use a prospective, longitudinal, multicenter outcome registry of patients undergoing surgery for lumbar degenerative disease in order to assess the incidence and factors associated with 30-day reoperation and 90-day readmission.

METHODS

Prospectively collected data from 9853 patients from the Quality and Outcomes Database (QOD; formerly known as the N2QOD [National Neurosurgery Quality and Outcomes Database]) lumbar spine registry were retrospectively analyzed. Multivariate binomial regression analysis was performed to identify factors associated with 30-day reoperation and 90-day readmission after surgery for lumbar degenerative disease. A subgroup analysis of Medicare patients stratified by age (< 65 and ≥ 65 years old) was also performed. Continuous variables were compared using unpaired t-tests, and proportions were compared using Fisher’s exact test.

RESULTS

There was a 2% reoperation rate within 30 days. Multivariate analysis revealed prolonged operative time during the index case as the only independent factor associated with 30-day reoperation. Other factors such as preoperative diagnosis, body mass index (BMI), American Society of Anesthesiologists (ASA) class, diabetes, and use of spinal implants were not associated with reoperations within 30 days. Medicare patients < 65 years had a 30-day reoperation rate of 3.7%, whereas those ≥ 65 years had a 30-day reoperation rate of 2.2% (p = 0.026). Medicare beneficiaries younger than 65 years undergoing reoperation within 30 days were more likely to be women (p = 0.009), have a higher BMI (p = 0.008), and have higher rates of depression (p < 0.0001). The 90-day readmission rate was 6.3%. Multivariate analysis demonstrated that higher ASA class (OR 1.46 per class, 95% CI 1.25–1.70) and history of depression (OR 1.27, 95% CI 1.04–1.54) were factors associated with 90-day readmission. Medicare beneficiaries had a higher rate of 90-day readmissions compared with those who had private insurance (OR 1.43, 95% CI 1.17–1.76). Medicare patients < 65 years of age were more likely to be readmitted within 90 days after their index surgery compared with those ≥ 65 years (10.8% vs 7.7%, p = 0.017). Medicare patients < 65 years of age had a significantly higher BMI (p = 0.001) and higher rates of depression (p < 0.0001).

CONCLUSIONS

In this analysis of a large prospective, multicenter registry of patients undergoing lumbar degenerative surgery, multivariate analysis revealed that prolonged operative time was associated with 30-day reoperation. The authors found that factors associated with 90-day readmission included higher ASA class and a history of depression. The 90-day readmission rates were higher for Medicare beneficiaries than for those who had private insurance. Medicare patients < 65 years of age were more likely to undergo reoperation within 30 days and to be readmitted within 90 days after their index surgery.