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John C. Andrefsky, Jeffrey I. Frank and Douglas Chyatte

Object. This study was conducted to delineate the ciliospinal reflex (CSR), which is defined as pupillary dilation caused by a noxious stimulus to the face or head. The authors anecdotally observed that patients in a pentobarbital coma have a CSR that can mimic pathological conditions. A pentobarbital coma obscures the results of the neurological examination in patients with potentially life-threatening cerebral edema; pupil size and reactivity are the only readily monitored signs. Any condition that incorrectly suggests evolving intracranial pathological processes can lead to unnecessary clinical actions.

Methods. The authors evaluated six consecutive patients in the neurointensive care unit in whom a pentobarbital coma had been induced, documenting the presence and duration of the CSR. The CSR was always bilateral and symmetrical, manifesting as enlarged (6–8 mm), seemingly nonreactive pupils continuing from 1 to 6 minutes and was usually seen after routine nursing maneuvers. The pupils appeared nonreactive to short flashes of direct light but did react if longer flashes were used.

Conclusions. Recognition of the CSR can potentially lead to reduction of unnecessary transportation and complicating medical interventions in critically neurologically ill patients in whom a pentobarbital coma has been induced.

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Roberto C. Heros

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Shay Bess, Jeffrey E. Harris, Alexander W. L. Turner, Virginie LaFage, Justin S. Smith, Christopher I. Shaffrey, Frank J. Schwab and Regis W. Haid Jr.

OBJECTIVE

Proximal junctional kyphosis (PJK) remains problematic following multilevel instrumented spine surgery. Previous biomechanical studies indicate that providing less rigid fixation at the cranial aspect of a long posterior instrumented construct, via transition rods or hooks at the upper instrumented vertebra (UIV), may provide a gradual transition to normal motion and prevent PJK. The purpose of this study was to evaluate the ability of posterior anchored polyethylene tethers to distribute proximal motion segment stiffness in long instrumented spine constructs.

METHODS

A finite element model of a T7–L5 spine segment was created to evaluate range of motion (ROM), intradiscal pressure, pedicle screw loads, and forces in the posterior ligament complex within and adjacent to the proximal terminus of an instrumented spine construct. Six models were tested: 1) intact spine; 2) bilateral, segmental pedicle screws (PS) at all levels from T-11 through L-5; 3) bilateral pedicle screws from T-12 to L-5 and transverse process hooks (TPH) at T-11 (the UIV); 4) pedicle screws from T-11 to L5 and 1-level tethers from T-10 to T-11 (TE-UIV+1); 5) pedicle screws from T-11 to L-5 and 2-level tethers from T-9 to T-11 (TE-UIV+2); and 6) pedicle screws and 3-level tethers from T-8 to T-11 (TE-UIV+3).

RESULTS

Proximal-segment range of motion (ROM) for the PS construct increased from 16% at UIV−1 to 91% at UIV. Proximal-segment ROM for the TPH construct increased from 27% at UIV−1 to 92% at UIV. Posterior tether constructs distributed ROM at the UIV and cranial adjacent segments most effectively; ROM for TE-UIV+1 was 14% of the intact model at UIV−1, 76% at UIV, and 98% at UIV+1. ROM for TE-UIV+2 was 10% at UIV−1, 51% at UIV, 69% at UIV+1, and 97% at UIV+2. ROM for TE-UIV+3 was 7% at UIV−1, 33% at UIV, 45% at UIV+1, and 64% at UIV+2. Proximal segment intradiscal pressures, pedicle screw loads, and ligament forces in the posterior ligament complex were progressively reduced with increasing number of posterior tethers used.

CONCLUSIONS

Finite element analysis of long instrumented spine constructs demonstrated that posterior tethers created a more gradual transition in ROM and adjacent-segment stress from the instrumented to the noninstrumented spine compared with all PS and TPH constructs. Posterior tethers may limit the biomechanical risk factor for PJK; however, further clinical research is needed to evaluate clinical efficacy.

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David S. Rosen, R. Loch Macdonald, Dezheng Huo, Fernando D. Goldenberg, Roberta L. Novakovic, Jeffrey I. Frank and Axel J. Rosengart

Object

In this study the authors analyzed the relationship of intraventricular hemorrhage (IVH) to in-hospital complications and clinical outcome in a large population of patients with aneurysmal subarachnoid hemorrhage (SAH).

Methods

Data from 3539 patients with aneurysmal SAH were evaluated, and these data were obtained from four prospective, randomized, double-blind, placebo-controlled trials of tirilazad that had been conducted between 1991 and 1997. Clinical characteristics, in-hospital complications, and outcome at 3 months post-SAH (Glasgow Outcome Scale score) were analyzed with regard to the presence or absence of IVH.

Results

Patients with SAH and IVH differ in demographic and admission characteristics from those with SAH but without IVH and are more likely to suffer in-hospital complications and a worse outcome at 3 months post-SAH.

Conclusions

The presence of IVH in patients with SAH has an important predictive value with regard to these aspects.

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Axel J. Rosengart, Dezheng Huo, Jocelyn Tolentino, Roberta L. Novakovic, Jeffrey I. Frank, Fernando D. Goldenberg and R. Loch Macdonald

Object

Prophylactic use of antiepileptic drugs (AEDs) in patients admitted with aneurysmal subarachnoid hemorrhage (SAH) is common practice; however, the impact of this treatment strategy on in-hospital complications and outcome has not been systematically studied. The goal in this study was twofold: first, to describe the prescribing pattern for AEDs in an international study population; and second, to delineate the impact of AEDs on in-hospital complications and outcome in patients with SAH.

Methods

The authors examined data collected in 3552 patients with SAH who were entered into four prospective, randomized, double-blind, placebo-controlled trials conducted in 162 neurosurgical centers and 21 countries between 1991 and 1997. The prevalence of AED use was assessed by study country and center. The impact of AEDs on in-hospital complications and outcome was evaluated using conditional logistic regressions comparing treated and untreated patients within the same study center.

Results

Antiepileptic drugs were used in 65.1% of patients and the prescribing pattern was mainly dependent on the treating physicians: the prevalence of AED use varied dramatically across study country and center (intraclass correlation coefficients 0.22 and 0.66, respectively [p < 0.001]). Other predictors included younger age, worse neurological grade, and lower systolic blood pressure on admission. After adjustment, patients treated with AEDs had odds ratios of 1.56 (95% confidence interval [CI] 1.16–2.10; p = 0.003) for worse outcome based on the Glasgow Outcome Scale; 1.87 (95% CI 1.43–2.44; p < 0.001) for cerebral vasospasm; 1.61 (95% CI 1.25–2.06; p < 0.001) for neurological deterioration; 1.33 (95% CI 1.01–1.74; p = 0.04) for cerebral infarction; and 1.36 (95% CI 1.03–1.80; p = 0.03) for elevated temperature during hospitalization.

Conclusions

Prophylactic AED treatment in patients with aneurysmal SAH is common, follows an arbitrary prescribing pattern, and is associated with increased in-hospital complications and worse outcome.

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David Rosen, Roberta Novakovic, Fernando D. Goldenberg, Dezheng Huo, Maria E. Baldwin, Jeffrey I. Frank, Axel J. Rosengart and R. Loch Macdonald

Object

Few studies have focused on the impact of racial differences in demographics, clinical characteristics, acute complications, and outcomes of patients with aneurysmal subarachnoid hemorrhage (SAH). The purpose of this study was to examine this issue.

Methods

The authors evaluated prospectively collected data on 1711 adult patients with aneurysmal SAH who were entered into two randomized, double-blind, placebo-controlled trials conducted at neurosurgical centers in North America between 1991 and 1997. Admission characteristics, treatment modalities, in-hospital complications, and 3-month outcomes assessed by application of the Glasgow Outcome Scale were compared using the chi-square test, a t-test, the Wilcoxon rank-sum test, and multiple logistic regressions based on a significance level of 0.05 in 241 African-American, 1342 Caucasian, and 128 other racial minority patients.

Caucasian patients were significantly older than patients of other races (p < 0.0001). African-American patients more frequently had a history of hypertension (p < 0.0001) and an elevated blood pressure at the time of admission (p < 0.0001). African-Americans and other racial minorities were more likely to have internal carotid artery aneurysms and Caucasians were more likely to have posterior circulation aneurysms (p = 0.0002). Rates of in-hospital complications were not significantly different except that pulmonary edema occurred more commonly in Caucasians (p = 0.036). After an adjustment was made for significant admission characteristics, the 3-month outcome was not significantly different among the races.

Conclusions

Race was not found to be a prognostic factor for outcome after aneurysmal SAH. The higher SAH mortality rate previously observed in African-American patients is likely a result of a higher incidence of SAH in this group. These findings highlight the importance of primary prevention programs aimed at modifying risk factors for SAH.

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Joshua Bakhsheshian, Justin K. Scheer, Jeffrey L. Gum, Richard Hostin, Virginie Lafage, Shay Bess, Themistocles S. Protopsaltis, Douglas C. Burton, Malla Kate Keefe, Robert A. Hart, Gregory M. Mundis Jr., Christopher I. Shaffrey, Frank Schwab, Justin S. Smith, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

Mental disease burden can have a significant impact on levels of disability and health-related quality of life (HRQOL) measures. Therefore, the authors investigated the significance of mental health status in adults with spinal deformity and poor physical function.

METHODS

A retrospective analysis of a prospective multicenter database of 365 adult spinal deformity (ASD) patients who had undergone surgical treatment was performed. Health-related QOL variables were examined preoperatively and at the 2-year postoperative follow-up. Patients were grouped by their 36-Item Short Form Health Survey mental component summary (MCS) and physical component summary (PCS) scores. Both groups had PCS scores ≤ 25th percentile for matched norms; however, the low mental health (LMH) group consisted of patients with an MCS score ≤ 25th percentile, and the high mental health (HMH) group included patients with an MCS score ≥ 75th percentile.

RESULTS

Of the 264 patients (72.3%) with a 2-year follow-up, 104 (28.5%) met the inclusion criteria for LMH and 40 patients (11.0%) met those for HMH. The LMH group had a significantly higher overall rate of comorbidities, specifically leg weakness, depression, hypertension, and self-reported neurological and psychiatric disease processes, and were more likely to be unemployed as compared with the HMH group (p < 0.05 for all). The 2 groups had similar 2-year postoperative improvements in HRQOL (p > 0.05) except for the greater improvements in the MCS and the Scoliosis Research Society-22r questionnaire (SRS-22r) mental domain (p < 0.05) in the LMH group and greater improvements in PCS and SRS-22r satisfaction and back pain domains (p < 0.05) in the HMH group. The LMH group had a higher rate of reaching a minimal clinically important difference (MCID) on the SRS-22r mental domain (p < 0.01), and the HMH group had a higher rate of reaching an MCID on the PCS and SRS-22r activity domain (p < 0.05). On multivariable logistic regression, having LMH was a significant independent predictor of failure to reach an MCID on the PCS (p < 0.05). At the 2-year postoperative follow-up, 14 LMH patients (15.1%) were categorized as HMH. Two LMH patients (2.2%), and 3 HMH patients (7.7%) transitioned to a PCS score ≥ 75th percentile for age- and sex-matched US norms (p < 0.01).

CONCLUSIONS

While patients with poor mental and physical health, according to their MCS and PCS scores, have higher medical comorbidity and unemployment rates, they still demonstrate significant improvements in HRQOL measurements postoperatively. Both LMH and HMH patient groups demonstrated similar improvements in most HRQOL domains, except that the LMH patients had difficulties in obtaining improvements in the PCS domain.

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Taemin Oh, Justin K. Scheer, Justin S. Smith, Richard Hostin, Chessie Robinson, Jeffrey L. Gum, Frank Schwab, Robert A. Hart, Virginie Lafage, Douglas C. Burton, Shay Bess, Themistocles Protopsaltis, Eric O. Klineberg, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Patients with adult spinal deformity (ASD) experience significant quality of life improvements after surgery. Treatment, however, is expensive and complication rates are high. Predictive analytics has the potential to use many variables to make accurate predictions in large data sets. A validated minimum clinically important difference (MCID) model has the potential to assist in patient selection, thereby improving outcomes and, potentially, cost-effectiveness.

METHODS

The present study was a retrospective analysis of a multiinstitutional database of patients with ASD. Inclusion criteria were as follows: age ≥ 18 years, radiographic evidence of ASD, 2-year follow-up, and preoperative Oswestry Disability Index (ODI) > 15. Forty-six variables were used for model training: demographic data, radiographic parameters, surgical variables, and results on the health-related quality of life questionnaire. Patients were grouped as reaching a 2-year ODI MCID (+MCID) or not (−MCID). An ensemble of 5 different bootstrapped decision trees was constructed using the C5.0 algorithm. Internal validation was performed via 70:30 data split for training/testing. Model accuracy and area under the curve (AUC) were calculated. The mean quality-adjusted life years (QALYs) and QALYs gained at 2 years were calculated and discounted at 3.5% per year. The QALYs were compared between patients in the +MCID and –MCID groups.

RESULTS

A total of 234 patients met inclusion criteria (+MCID 129, −MCID 105). Sixty-nine patients (29.5%) were included for model testing. Predicted versus actual results were 50 versus 40 for +MCID and 19 versus 29 for −MCID (i.e., 10 patients were misclassified). Model accuracy was 85.5%, with 0.96 AUC. Predicted results showed that patients in the +MCID group had significantly greater 2-year mean QALYs (p = 0.0057) and QALYs gained (p = 0.0002).

CONCLUSIONS

A successful model with 85.5% accuracy and 0.96 AUC was constructed to predict which patients would reach ODI MCID. The patients in the +MCID group had significantly higher mean 2-year QALYs and QALYs gained. This study provides proof of concept for using predictive modeling techniques to optimize patient selection in complex spine surgery.

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Ferran Pellisé, Miquel Serra-Burriel, Justin S. Smith, Sleiman Haddad, Michael P. Kelly, Alba Vila-Casademunt, Francisco Javier Sánchez Pérez-Grueso, Shay Bess, Jeffrey L. Gum, Douglas C. Burton, Emre Acaroğlu, Frank Kleinstück, Virginie Lafage, Ibrahim Obeid, Frank Schwab, Christopher I. Shaffrey, Ahmet Alanay, Christopher Ames, the International Spine Study Group and the European Spine Study Group

OBJECTIVE

Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO).

METHODS

Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis.

RESULTS

The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%–75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs.

CONCLUSIONS

The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.

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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.