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Matthew J. McGirt, Mohamad Bydon, Kristin R. Archer, Clinton J. Devin, Silky Chotai, Scott L. Parker, Hui Nian, Frank E. Harrell Jr., Theodore Speroff, Robert S. Dittus, Sharon E. Philips, Christopher I. Shaffrey, Kevin T. Foley and Anthony L. Asher

OBJECTIVE

Quality and outcomes registry platforms lie at the center of many emerging evidence-driven reform models. Specifically, clinical registry data are progressively informing health care decision-making. In this analysis, the authors used data from a national prospective outcomes registry (the Quality Outcomes Database) to develop a predictive model for 12-month postoperative pain, disability, and quality of life (QOL) in patients undergoing elective lumbar spine surgery.

METHODS

Included in this analysis were 7618 patients who had completed 12 months of follow-up. The authors prospectively assessed baseline and 12-month patient-reported outcomes (PROs) via telephone interviews. The PROs assessed were those ascertained using the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for back pain (BP) and leg pain (LP). Variables analyzed for the predictive model included age, gender, body mass index, race, education level, history of prior surgery, smoking status, comorbid conditions, American Society of Anesthesiologists (ASA) score, symptom duration, indication for surgery, number of levels surgically treated, history of fusion surgery, surgical approach, receipt of workers’ compensation, liability insurance, insurance status, and ambulatory ability. To create a predictive model, each 12-month PRO was treated as an ordinal dependent variable and a separate proportional-odds ordinal logistic regression model was fitted for each PRO.

RESULTS

There was a significant improvement in all PROs (p < 0.0001) at 12 months following lumbar spine surgery. The most important predictors of overall disability, QOL, and pain outcomes following lumbar spine surgery were employment status, baseline NRS-BP scores, psychological distress, baseline ODI scores, level of education, workers’ compensation status, symptom duration, race, baseline NRS-LP scores, ASA score, age, predominant symptom, smoking status, and insurance status. The prediction discrimination of the 4 separate novel predictive models was good, with a c-index of 0.69 for ODI, 0.69 for EQ-5D, 0.67 for NRS-BP, and 0.64 for NRS-LP (i.e., good concordance between predicted outcomes and observed outcomes).

CONCLUSIONS

This study found that preoperative patient-specific factors derived from a prospective national outcomes registry significantly influence PRO measures of treatment effectiveness at 12 months after lumbar surgery. Novel predictive models constructed with these data hold the potential to improve surgical effectiveness and the overall value of spine surgery by optimizing patient selection and identifying important modifiable factors before a surgery even takes place. Furthermore, these models can advance patient-focused care when used as shared decision-making tools during preoperative patient counseling.

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Anthony L. Asher, Clinton J. Devin, Kristin R. Archer, Silky Chotai, Scott L. Parker, Mohamad Bydon, Hui Nian, Frank E. Harrell Jr., Theodore Speroff, Robert S. Dittus, Sharon E. Philips, Christopher I. Shaffrey, Kevin T. Foley and Matthew J. McGirt

OBJECTIVE

Current costs associated with spine care are unsustainable. Productivity loss and time away from work for patients who were once gainfully employed contributes greatly to the financial burden experienced by individuals and, more broadly, society. Therefore, it is vital to identify the factors associated with return to work (RTW) after lumbar spine surgery. In this analysis, the authors used data from a national prospective outcomes registry to create a predictive model of patients’ ability to RTW after undergoing lumbar spine surgery for degenerative spine disease.

METHODS

Data from 4694 patients who underwent elective spine surgery for degenerative lumbar disease, who had been employed preoperatively, and who had completed a 3-month follow-up evaluation, were entered into a prospective, multicenter registry. Patient-reported outcomes—Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain (BP) and leg pain (LP), and EQ-5D scores—were recorded at baseline and at 3 months postoperatively. The time to RTW was defined as the period between operation and date of returning to work. A multivariable Cox proportional hazards regression model, including an array of preoperative factors, was fitted for RTW. The model performance was measured using the concordance index (c-index).

RESULTS

Eighty-two percent of patients (n = 3855) returned to work within 3 months postoperatively. The risk-adjusted predictors of a lower likelihood of RTW were being preoperatively employed but not working at the time of presentation, manual labor as an occupation, worker’s compensation, liability insurance for disability, higher preoperative ODI score, higher preoperative NRS-BP score, and demographic factors such as female sex, African American race, history of diabetes, and higher American Society of Anesthesiologists score. The likelihood of a RTW within 3 months was higher in patients with higher education level than in those with less than high school–level education. The c-index of the model’s performance was 0.71.

CONCLUSIONS

This study presents a novel predictive model for the probability of returning to work after lumbar spine surgery. Spine care providers can use this model to educate patients and encourage them in shared decision-making regarding the RTW outcome. This evidence-based decision support will result in better communication between patients and clinicians and improve postoperative recovery expectations, which will ultimately increase the likelihood of a positive RTW trajectory.

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

OBJECTIVE

Lumbar spondylolisthesis is a degenerative condition that can be surgically treated with either open or minimally invasive decompression and instrumented fusion. Minimally invasive surgery (MIS) approaches may shorten recovery, reduce blood loss, and minimize soft-tissue damage with resultant reduced postoperative pain and disability.

METHODS

The authors queried the national, multicenter Quality Outcomes Database (QOD) registry for patients undergoing posterior lumbar fusion between July 2014 and December 2015 for Grade I degenerative spondylolisthesis. The authors recorded baseline and 12-month patient-reported outcomes (PROs), including Oswestry Disability Index (ODI), EQ-5D, numeric rating scale (NRS)–back pain (NRS-BP), NRS–leg pain (NRS-LP), and satisfaction (North American Spine Society satisfaction questionnaire). Multivariable regression models were fitted for hospital length of stay (LOS), 12-month PROs, and 90-day return to work, after adjusting for an array of preoperative and surgical variables.

RESULTS

A total of 345 patients (open surgery, n = 254; MIS, n = 91) from 11 participating sites were identified in the QOD. The follow-up rate at 12 months was 84% (83.5% [open surgery]; 85% [MIS]). Overall, baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts. Two hundred fifty seven patients underwent 1-level fusion (open surgery, n = 181; MIS, n = 76), and 88 patients underwent 2-level fusion (open surgery, n = 73; MIS, n = 15). Patients in both groups reported significant improvement in all primary outcomes (all p < 0.001). MIS was associated with a significantly lower mean intraoperative estimated blood loss and slightly longer operative times in both 1- and 2-level fusion subgroups. Although the LOS was shorter for MIS 1-level cases, this was not significantly different. No difference was detected with regard to the 12-month PROs between the 1-level MIS versus the 1-level open surgical groups. However, change in functional outcome scores for patients undergoing 2-level fusion was notably larger in the MIS cohort for ODI (−27 vs −16, p = 0.1), EQ-5D (0.27 vs 0.15, p = 0.08), and NRS-BP (−3.5 vs −2.7, p = 0.41); statistical significance was shown only for changes in NRS-LP scores (−4.9 vs −2.8, p = 0.02). On risk-adjusted analysis for 1-level fusion, open versus minimally invasive approach was not significant for 12-month PROs, LOS, and 90-day return to work.

CONCLUSIONS

Significant improvement was found in terms of all functional outcomes in patients undergoing open or MIS fusion for lumbar spondylolisthesis. No difference was detected between the 2 techniques for 1-level fusion in terms of patient-reported outcomes, LOS, and 90-day return to work. However, patients undergoing 2-level MIS fusion reported significantly better improvement in NRS-LP at 12 months than patients undergoing 2-level open surgery. Longer follow-up is needed to provide further insight into the comparative effectiveness of the 2 procedures.

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Charles H. Crawford III, Leah Y. Carreon, Mohamad Bydon, Anthony L. Asher and Steven D. Glassman

OBJECTIVE

Patient satisfaction is a commonly used metric in the current health care environment. While factors that affect patient satisfaction following spine surgery are complex, the authors of this study hypothesized that specific diagnostic groups of patients are more likely to be satisfied after spine surgery and that this is reflected in patient-reported outcome measures. The purpose of this study was to determine if the preoperative diagnosis—disc herniation, stenosis, spondylolisthesis, adjacent segment degeneration, or mechanical disc collapse—would impact patient satisfaction following surgery.

METHODS

Patients enrolled in the Quality Outcomes Database, formerly known as the National Neurosurgery Quality and Outcomes Database (N2QOD), completed patient-reported outcome measures, including the Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back pain (NRS-BP) and leg pain (NRS-LP) preoperatively and 1-year postoperatively. Patients were stratified by diagnosis and by their response to the satisfaction question: 1) surgery met my expectations; 2) I did not improve as much as I hoped, but I would undergo the same operation for the same results; 3) surgery helped, but I would not undergo the same operation for the same results; or 4) I am the same or worse as compared with before surgery.

RESULTS

A greater proportion of patients with primary disc herniation or spondylolisthesis reported that surgery met expectations (66% and 67%, respectively), followed by recurrent disc herniation and stenosis (59% and 60%, respectively). A smaller proportion of patients who underwent surgery for adjacent segment degeneration or mechanical disc collapse had their expectations met (48% and 41%, respectively). The percentage of patients that would undergo the same surgery again, by diagnostic group, was as follows: disc herniation 88%, recurrent disc herniation 79%, spondylolisthesis 86%, stenosis 82%, adjacent segment disease 75%, and mechanical collapse 73%. Regardless of diagnosis, mean improvement and ultimate 1-year postoperative ODI, NRS-BP, and NRS-LP reflected patient satisfaction.

CONCLUSIONS

Preoperative diagnosis was predictive of patient satisfaction following spine surgery. The mean change in and 1-year ODI, NRS-BP, and NRS-LP reflected patient satisfaction regardless of preoperative diagnosis.

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Meghan E. Murphy, Hannah Gilder, Patrick R. Maloney, Brandon A. McCutcheon, Lorenzo Rinaldo, Daniel Shepherd, Panagiotis Kerezoudis, Daniel S. Ubl, Cynthia S. Crowson, William E. Krauss, Elizabeth B. Habermann and Mohamad Bydon

OBJECTIVE

With improving medical therapies for chronic conditions, elderly patients increasingly present as candidates for operative intervention for degenerative diseases of the spine. To date, there is a paucity of studies examining complications in lumbar decompression, without fusion, that include patients older than 80 years. Using a multicenter national database, the authors of this study evaluated lumbar decompression in the elderly, including octogenarians, to evaluate for associations between age and patient outcomes.

METHODS

The 2011–2013 American College of Surgeons' National Surgical Quality Improvement Program data set was queried for patients 65 years and older with diagnosis and procedure codes inclusive of degenerative spine disease and lumbar decompression without fusion. Morbidity and mortality within the 30-day postoperative period were the primary outcomes. Secondary outcomes of interest included unplanned readmission within 30 days or discharge to a nonhome facility. Outcomes and operative characteristics were compared using chi-square tests, Kruskal-Wallis tests, and multivariable logistic regression models.

RESULTS

A total of 8744 patients were identified; of these patients 4573 (52.30%) were 65 years and older. Elderly patients were stratified into 3 age categories: 85 years or older (n = 314), 75–84 years (n = 1663), and 65–74 years (n = 2596). Univariate analysis showed that, compared with age younger than 65 years, increased age was associated with the number of levels (≥ 3), readmissions within 30 days, nonhome discharge, any complication, length of stay, and blood transfusion (all p < 0.001). On multivariable analysis and with younger than 65 years as the reference, increased age was associated with any minor complication (p < 0.001; ≥ 85 years: OR 3.47, 95% CI 1.69–7.13; 75–84 years: OR 2.34, 95% CI 1.45–3.78; and 65–74 years: OR 1.44, 95% CI 0.94–2.20), as well as discharge location other than home (p < 0.001; ≥ 85 years: OR 13.59, 95% CI 9.47–19.49; 75–84 years: OR 5.64, 95% CI 4.33–7.34; and 65–74 years: OR 2.61, 95% CI 2.05–3.32).

CONCLUSIONS

The authors' high-powered, multicenter analysis of lumbar decompression without fusion in the elderly, specifically including patients older than 80 years, demonstrates that increased age is associated with more extensive operations, resulting in longer hospital stays, increased rates of nonhome discharge, and minor complications.

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Lorenzo Rinaldo, Brandon A. McCutcheon, Meghan E. Murphy, Daniel L. Shepherd, Patrick R. Maloney, Panagiotis Kerezoudis, Mohamad Bydon and Giuseppe Lanzino

OBJECTIVE

The mechanism by which greater institutional case volume translates into improved outcomes after surgical clipping of unruptured intracranial aneurysms (UIAs) is not well established. The authors thus aimed to assess the effect of case volume on the rate of various types of complications after clipping of UIAs.

METHODS

Using information on the outcomes of inpatient admissions for surgical clipping of UIAs collected within a national database, the relationship of institutional case volume to the incidence of different types of complications after clipping was investigated. Complications were subdivided into different categories, which included all complications, ischemic stroke, intracerebral hemorrhage, medical complications, infectious complications, complications related to anesthesia, and wound complications. The relationship of case volume to different types of complications was assessed using linear regression analysis. The relationships between case volume and overall complication and stroke rates were fit with both linear and quadratic equations. The numerical cutoff for institutional case volume above and below which the authors found the greatest differences in mean overall complication and stroke rate was determined using classification and regression tree (CART) analysis.

RESULTS

Between October 2012 and September 2015, 125 health care institutions reported patient outcomes from a total of 6040 cases of clipping of UIAs. On linear regression analysis, increasing case volume was negatively correlated to both overall complications (r2 = 0.046, p = 0.0234) and stroke (r2 = 0.029, p = 0.0557) rate, although the relationship of case volume to the complication (r2 = 0.092) and stroke (r2 = 0.067) rate was better fit with a quadratic equation. On CART analysis, the cutoff for the case number that yielded the greatest difference in overall complications and stroke rate between higher- or lower-volume centers was 6 cases/year and 3 cases/year, respectively.

CONCLUSIONS

Although the authors confirm that increasing case volume is associated with reduced complications after clipping of UIAs, their results suggest that the relationship between case volume and complications is not necessarily linear. Moreover, these results indicate that the effect of case volume on outcome is most evident between very-low-volume centers relative to centers with a medium-to-high volume.

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Lorenzo Rinaldo, Brandon A. McCutcheon, Meghan E. Murphy, Mohamad Bydon, Alejandro A. Rabinstein and Giuseppe Lanzino

OBJECTIVE

Hypoplasia of the A1 segment of the anterior cerebral artery is frequently observed in patients with anterior communicating artery (ACoA) aneurysms. The effect of this anatomical variant on ACoA aneurysm morphology is not well understood.

METHODS

Digital subtraction angiography images were reviewed for 204 patients presenting to the authors' institution with either a ruptured or an unruptured ACoA aneurysm. The ratio of the width of the larger A1 segment to the smaller A1 segment was calculated. Patients with an A1 ratio greater than 2 were categorized as having A1 segment hypoplasia. The relationship of A1 segment hypoplasia to both patient and aneurysm characteristics was then assessed.

RESULTS

Of 204 patients that presented with an ACoA aneurysm, 34 (16.7%) were found to have a hypoplastic A1. Patients with A1 segment hypoplasia were less likely to have a history of smoking (44.1% vs 62.9%, p = 0.0410). ACoA aneurysms occurring in the setting of a hypoplastic A1 were also found to have a larger maximum diameter (mean 7.7 vs 6.0 mm, p = 0.0084). When considered as a continuous variable, increasing A1 ratio was associated with decreasing aneurysm dome-to-neck ratio (p = 0.0289). There was no significant difference in the prevalence of A1 segment hypoplasia between ruptured and unruptured aneurysms (18.9% vs 10.7%; p = 0.1605).

CONCLUSIONS

Our results suggest that a hypoplastic A1 may affect the morphology of ACoA aneurysms. In addition, the relative lack of traditional risk factors for aneurysm formation in patients with A1 segment hypoplasia argues for the importance of hemodynamic factors in the formation of ACoA aneurysms in this anatomical setting.