Faculty Bibliography

BACKGROUND CONTEXT: Previous data have indicated that ASD can be a debilitating disease that impacts physical function to a similar degree as diabetes and heart disease. Correlation of specific deformity types to other disease states demonstrated that patients with severe sagittal malalignment reported similar disability as poorly functioning amputee patients. Little data exists comparing the impact of operative and nonoperative treatment on the disease state for ASD patients and correlating the change in physical function to comparable disease states. PURPOSE: Compare baseline and two year follow up SF-36v2 Health Survey (SF-36) scores of ASD patients treated operatively and nonoperatively to evaluate the ability of operative or nonoperative treatment to 1) restore ASD patients to normative physical function levels and 2) identify disease state correlates for different deformity types and the ability of treatment to improve health status. STUDY DESIGN/SETTING: Multicenter, prospective, consecutive case series. PATIENT SAMPLE: ASD patients (scoliosis >20degree, sagittal vertical axis (SVA) >5cm, pelvic tilt (PT) >25degree, and/or thoracic kyphosis (TK) >60degree), age>18 years. OUTCOME MEASURES: Short Form 36 Health Survey Standard Form Version 2 (SF-36). METHODS: Prospective analysis of consecutive ASD patients enrolled into a multicenter database. Inclusion criteria: no prior spine surgery, age>18years, ASD, and minimum 2-year follow-up. ASD evaluated according to: (1) type of scoliosis (thoracic, lumbar, thoracic and lumbar or none) and (2) severity of sagittal malalignment (sagittal vertical axis [SVA]). Patients divided into those treated operatively (OP) or nonoperatively (NON). Baseline and 2-year follow up SF-36 physical component (PCS) and mental component (MCS) scores calculated for each group and compared to US normative and disease-specific values. SF-36 reported as norm-based values (NBS) and minimal clinically important difference (MCID) values for PCS and MCS (3 NBS points). RESU!

BACKGROUND: Adult spinal deformity is a prevalent cause of pain and disability. Established measures of sagittal spinopelvic alignment such as sagittal vertical axis and pelvic tilt can be modified by postural compensation, including pelvic retroversion, knee flexion, and the use of assistive devices for standing. We introduce the T1 pelvic angle, a novel measure of sagittal alignment that simultaneously accounts for both spinal inclination and pelvic retroversion. The purpose of this study was to investigate the relationship of the T1 pelvic angle and other established sagittal alignment measures and to correlate these parameters with health-related quality-of-life measures. METHODS: This is a multicenter, prospective, cross-sectional analysis of consecutive patients with adult spinal deformity. Inclusion criteria were adult spinal deformity, an age of greater than eighteen years, and any of the following: scoliosis, a Cobb angle of >/=20 degrees , sagittal vertical axis of >/=5 cm, thoracic kyphosis of >/=60 degrees , and pelvic tilt of >/=25 degrees . Clinical measures of disability included the Oswestry Disability Index (ODI), Scoliosis Research Society (SRS)-22, and Short Form-36 (SF-36) questionnaires. RESULTS: Five hundred and fifty-nine consecutive patients with adult spinal deformity (mean age, 52.5 years) were enrolled. The T1 pelvic angle correlated with the sagittal vertical axis (r = 0.837), pelvic incidence minus lumbar lordosis (r = 0.889), and pelvic tilt (0.933). Categorizing the patients by increasing T1 pelvic angle (<10 degrees , 10 degrees to 20 degrees , 21 degrees to 30 degrees , and >30 degrees ) revealed a significant and progressive worsening in health-related quality of life (p < 0.001 for all). The T1 pelvic angle and sagittal vertical axis correlated with the ODI (0.435 and 0.455), SF-36 Physical Component Summary (-0.445 and -0.458), and SRS (-0.358 and -0.383) (p < 0.001 for all). Utilizing a linear regression analysis, a T1 pelvic angle of 20 degrees corresponded to a severe disability (an ODI of >40), and the meaningful change in T1 pelvic angle corresponding to one minimal clinically important difference was 4.1 degrees on the ODI. CONCLUSIONS: The T1 pelvic angle correlates with health-related quality of life in patients with adult spinal deformity. The T1 pelvic angle is related to both pelvic tilt and sagittal vertical axis; however, unlike sagittal vertical axis, it does not vary on the basis of the extent of pelvic retroversion or patient support in standing. Since the T1 pelvic angle is an angular and not a linear measure, it does not require calibration of the radiograph. Thus, the T1 pelvic angle measures sagittal deformity independent of many postural compensatory mechanisms, and it can be useful as a preoperative planning tool, with a target T1 pelvic angle of <14 degrees . LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

BACKGROUND CONTEXT: Lumbar interbody fusion (LIF) techniques have been used for years to treat a number of pathologies of the lower back. These procedures may use an anterior, posterior, or combined surgical approach. Each approach is associated with a unique set of complications, but the exact prevalence of complications associated with each approach remains unclear. PURPOSE: To investigate the rates of perioperative complications of anterior lumbar interbody fusion (ALIF), posterior/transforaminal lumbar interbody fusion (P/TLIF), and LIF with a combined anterior-posterior interbody fusion (APF). STUDY DESIGN/SETTING: Retrospective review of national data from a large administrative database. PATIENT SAMPLE: Patients undergoing ALIF, P/TLIF, or APF. OUTCOME MEASURES: Perioperative complications, length of stay (LOS), total costs, and mortality. METHODS: The Nationwide Inpatient Sample database was queried for patients undergoing ALIF, P/TLIF, or APF between 2001 and 2010 as identified via International Classification of Diseases, ninth revision codes. Univariate analyses were carried out comparing the three cohorts in terms of the outcomes of interest. Multivariate analysis for primary outcomes was carried out adjusting for overall comorbidity burden, race, gender, age, and length of fusion. National estimates of annual total number of procedures were calculated based on the provided discharge weights. Geographic distribution of the three cohorts was also investigated. RESULTS: An estimated total of 923,038 LIFs were performed between 2001 and 2010 in the United States. Posterior/transforaminal lumbar interbody fusions accounted for 79% to 86% of total LIFs between 2001 and 2010, ALIFs for 10% to 15%, and APF decreased from 10% in 2002 to less than 1% in 2010. On average, P/TLIF patients were oldest (54.55 years), followed by combined approach (47.23 years) and ALIF (46.94 years) patients (p<.0001). Anterior lumbar interbody fusion, P/TLIF, and combined surgical costs were $75,872, $65,894, and $92,249, respectively (p<.0001). Patients in the P/TLIF cohort had the greatest number of comorbidities, having the highest prevalence for 10 of 17 comorbidities investigated. Anterior-posterior interbody fusion group was associated with the greatest number of complications, having the highest incidence of 12 of the 16 complications investigated. CONCLUSIONS: These data help to define the perioperative risks for several LIF approaches. Comparison of outcomes showed that a combined approach is more expensive and associated with greater LOS, whereas ALIF is associated with the highest postoperative mortality. These trends should be taken into consideration during surgical planning to improve clinical outcomes.

STRUCTURED ABSTRACT: Study Design. Animal modelObjective. Determine whether Amicar and TXA inhibit spine fusion volumeSummary of Background Data. Amicar and TXA are antifibrinolytics used to reduce perioperative bleeding. Prior in vitro data showed that antifibrinolytics reduce osteoblast bone mineralization. This study tested whether antifibrinolytics Amicar and TXA inhibit spine fusion.Methods. Posterolateral L4-L6 fusion was performed in fifty mice, randomized into groups of ten, that received the following treatment before and after surgery: (1) Saline; (2) TXA 100mg/kg; (3) TXA 1000mg/kg; (4) Amicar 100 mg/kg; (5) Amicar 1000 mg/kg. High-resolution plane radiography was performed after 5 weeks and micro-CT was performed at the end of the 12-week study. Radiographs were graded using the Lenke scale. Micro-CT was used to quantify fusion mass bone volume. One-way analysis of variance (ANOVA) by ranks with Kruskal-Wallis testing was used to compare the radiographic scores. One-way ANOVA with least-significant differences (LSD) post-hoc testing was used to compare the micro-CT bone volume.Results. The average (+/- SD) bone volume/total volume (%) measured in the saline, TXA 100 mg/kg, TXA 1000 mg/kg, Amicar 100 mg/kg and Amicar 1000 mg/kg groups were 10.8+/-2.3, 9.7+/-2.2, 13.4+/-3.2, 15.5+/-5.2 and 17.9+/-3.5%, respectively. There was a significant difference in the Amicar 100 mg/kg (p < 0.05) and Amicar 1000 mg/kg (p < 0.001) groups compared to saline. There was greater bone volume in the Amicar groups compared to the TXA group (p < 0.001). There was more bone volume in the TXA 1000 mg/kg group compared to TXA 100 mg/kg (p < 0.05) but the bone volume in neither of the TXA groups was different to saline (p = 0.49). There were no between-group differences observed using plane radiographic scoring.Conclusions. Amicar significantly enhanced the fusion bone mass in a dose-dependent manner while TXA did not have a significant effect on fusion compared to saline control.These data are in contrast to prior in vitro data that antifibrinolytics inhibit osteoblast bone mineralization.

To achieve optimal results after fusion for adolescent idiopathic scoliosis (AIS), radiographic parameters must be aligned with motion and performance. The effects of fusion on balance are poorly understood. Center of mass (COM) excursion and instantaneous interaction with center of pressure (COP) provides information about patients' balancing ability during gait. This study investigates the interaction between COM and COP (COM-COP) in AIS patients before and one year after spine fusion and determines what radiographic goals predict restoration of harmonious COM-COP. This was a prospective study that investigated sixteen adolescents with AIS curvature >30 requiring surgical correction. Clinical outcomes measures, X-rays, and 3D motion-capture gait analysis were collected. Sagittal and coronal COM and COP offsets and inclination angles were calculated from positional data. COM excursion was calculated as peak COM displacement based on mediolateral and vertical deviation from a line fitted to the patient's path. Radiographic parameters were measured to determine variables predictive of change in COM excursion. Post-operatively, average COM peak displacement decreased (42.6 to 13.1mm, p=0.001) and COM peak vertical displacement remained unchanged (17.0 to 16.3mm, p=0.472). COM-COP inclination angles reduced in the coronal, but not sagittal plane. Coronal lower extremity peak inclination angles reduced (8.8 to 7.5 , p=0.025), correlating with C7 plumb-line offset (R=0.581, p=0.018). Thoracic Cobb, thoracic kyphosis, and C7 plumb-line were predictors of change in COM excursion. Mediolateral COM excursion post-surgery may reflect an attempt to reduce kinetic demands with improved spinal alignment. Although AIS correction has historically focused on the coronal plane, sagittal parameters may be more important for motion than previously theorized.

The choice among the many options of approach and adjunct techniques in planning a posterior lumbar fusion can be problematic. Debates remain as to whether solid fusion has an advantage over pseudarthrosis regarding long-term symptom deterioration and whether an instrumented or a noninstrumented approach will best serve clinically and/or cost effectively, particularly in elderly patients. Increased motion resulting in higher rates of nonunion and the use of nonsteroidal anti-inflammatory drugs have been studied in animal models and are presumed risk factors, despite the lack of clinical investigation. Smoking is a proven risk factor for pseudarthrosis in both animal models and level III clinical studies. Recent long-term studies and image/clinical assessment of lumbar fusions and pseudarthrosis show that, although imaging remains a key area of difficulty in assessment, including an instrumented approach and a well-selected biologic adjunct, as well as achieving a solid fusion, all carry important long-term clinical advantages in avoiding revision surgery for nonunion.

BACKGROUND: Animal spinal cord injury (SCI) models have proved invaluable in better understanding the mechanisms involved in traumatic SCI and evaluating the effectiveness of experimental therapeutic interventions. Over the past 25 years, substantial gains have been made in developing consistent, reproducible and reliable animal SCI models. STUDY DESIGN: Review. OBJECTIVE: The objective of this review was to consolidate current knowledge on SCI models and introduce newer paradigms that are currently being developed. RESULTS: SCI models are categorized based on the mechanism of injury into contusion, compression, distraction, dislocation, transection or chemical models. Contusion devices inflict a transient, acute injury to the spinal cord using a weight-drop technique, electromagnetic impactor or air pressure. Compression devices compress the cord at specific force and duration to cause SCI. Distraction SCI devices inflict graded injury by controlled stretching of the cord. Mechanical displacement of the vertebrae is utilized to produce dislocation-type SCI. Surgical transection of the cord, partial or complete, is particularly useful in regenerative medicine. Finally, chemically induced SCI replicates select components of the secondary injury cascade. Although rodents remain the most commonly used species and are best suited for preliminary SCI studies, large animal and nonhuman primate experiments better approximate human SCI. CONCLUSION: All SCI models aim to replicate SCI in humans as closely as possible. Given the recent improvements in commonly used models and development of newer paradigms, much progress is anticipated in the coming years.

BACKGROUND: Postoperative venous thromboembolic events (VTEs), which include pulmonary emboli and deep venous thromboses, are potentially preventable causes of death. The aim of this study was to investigate the patient and procedure-related risk factors for the occurrence of VTEs in patients undergoing spinal fusion.METHODS: We used ICD-9-CM (International Classification of Diseases, 9th Revision, Clinical Modification) procedure codes to identify patients in the Nationwide Inpatient Sample (NIS) database for 2001 through 2010 who were treated with spinal fusion. The occurrence of a symptomatic VTE was identified with use of ICD-9-CM diagnosis codes. Patient demographics, hospital characteristics, and comorbidities in the VTE and non-VTE groups were analyzed, and independent risk factors for VTE were identified.RESULTS: A total of 710,154 spinal fusion procedures were identified in the NIS from 2001 to 2010, and 3525 (0.50%) of these patients were recorded as having 3777 VTEs, consisting of 2038 deep venous thromboses (0.29%) and 1739 pulmonary emboli (0.24%). Patients with a VTE were older on average (57.63 years compared with 52.88 years for patients without a VTE) and more often male (VTE incidence, 0.58% compared with 0.42% for female) and black (VTE incidence, 0.78% compared with 0.47% for white). Postoperative VTE occurrence was associated with a longer hospital stay (18.0 compared with 3.94 days) and higher total hospital charges ($207,253 compared with $66,823). A number of comorbidities and procedure-related factors were identified as independent risk factors for VTE.CONCLUSIONS: We present a VTE Risk Index, based on the independent risk factors identified in this study, for the VTE following spinal fusion. In conjunction with current guidelines, this risk index can be used to guide clinical decision-making regarding VTE prophylaxis in patients undergoing spinal fusion.LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

BACKGROUND: Antifibrinolytics can reduce intraoperative blood loss. The primary aim of this study was to determine the efficacy of intraoperative tranexamic acid, epsilon-aminocaproic acid, and placebo at reducing perioperative blood loss and the transfusion rate in patients with adolescent idiopathic scoliosis undergoing posterior spinal arthrodesis. METHODS: This is a prospective, randomized, double-blind comparison of tranexamic acid, epsilon-aminocaproic acid, and placebo used intraoperatively in patients with adolescent idiopathic scoliosis. One hundred and twenty-five patients with adolescent idiopathic scoliosis were randomly assigned to the tranexamic acid, epsilon-aminocaproic acid, or control groups. Parameters recorded included estimated blood loss, hematocrit, blood product usage, drain output, and total blood losses. The primary outcomes were intraoperative blood loss and postoperative drainage. Secondary outcomes were transfusion requirements and hematocrit changes both intraoperatively and postoperatively. RESULTS: One hundred and twenty-five patients (ninety-seven female and twenty-eight male, with a mean age of fifteen years) were randomized to receive tranexamic acid (thirty-six patients), epsilon-aminocaproic acid (forty-two patients), or saline solution (forty-seven patients). The groups were similar at baseline, with one exception: the saline solution group had a higher estimated blood volume at baseline than the tranexamic acid group. Both tranexamic acid and epsilon-aminocaproic acid reduced the estimated blood loss per degree and estimated blood loss per pedicle screw. Epsilon-aminocaproic acid, but not tranexamic acid, reduced estimated blood loss and estimated blood loss per level. Tranexamic acid also reduced total blood losses compared with epsilon-aminocaproic acid or saline solution. In an analysis controlling for level, degree, and number of anchors, tranexamic acid reduced drain output and total blood losses. Tranexamic acid or epsilon-aminocaproic acid had a smaller decrease in hematocrit postoperatively. In an analysis controlling for the mean arterial pressure during surgical exposure, tranexamic acid reduced estimated blood loss and total blood losses. Overall, antifibrinolytics (tranexamic acid or epsilon-aminocaproic acid) reduced estimated blood loss, total blood losses, and the decline in hematocrit postoperatively compared with saline solution. There was no difference among the groups with respect to the transfusion rate, duration of surgery, levels fused, or pedicle screws placed. CONCLUSIONS: Tranexamic acid and epsilon-aminocaproic acid reduced operative blood loss but not transfusion rate. Tranexamic acid is more effective at reducing postoperative drainage and total blood losses compared with epsilon-aminocaproic acid. Maintenance of the mean arterial pressure at <75 mm Hg during surgical exposure appears to be critical for maximizing antifibrinolytic benefit. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

OBJECT: Incremental cost-effectiveness analysis is critical to the efficient allocation of health care resources; however, the incremental cost-effectiveness ratio (ICER) of surgical versus nonsurgical treatment for adult spinal deformity (ASD) has eluded the literature, due in part to inherent empirical difficulties when comparing surgical and nonsurgical patients. Using observed preoperative health-related quality of life (HRQOL) for patients who later underwent surgery, this study builds a statistical model to predict hypothetical quality-adjusted life years (QALYs) without surgical treatment. The analysis compares predicted QALYs to observed postoperative QALYs and forms the resulting ICER. METHODS: This was a single-center (Baylor Scoliosis Center) retrospective analysis of consecutive patients undergoing primary surgery for ASD. Total costs (expressed in 2010 dollars) incurred by the hospital for each episode of surgical care were collected from administrative data and QALYs were calculated from the 6-dimensional Short-Form Health Survey, each discounted at 3.5% per year. Regression analysis was used to predict hypothetical QALYs without surgery based on preoperative longitudinal data for 124 crossover surgical patients with similar diagnoses, baseline HRQOL, age, and sex compared with the surgical cohort. Results were projected through 10-year follow-up, and the cost-effectiveness acceptability curve (CEAC) was estimated using nonparametric bootstrap methods. RESULTS: Three-year follow-up was available for 120 (66%) of 181 eligible patients, who were predominantly female (89%) with average age of 50. With discounting, total costs averaged $125,407, including readmissions, with average QALYs of 1.93 at 3-year follow-up. Average QALYs without surgery were predicted to be 1.6 after 3 years. At 3- and 5-year follow-up, the ICER was $375,000 and $198,000, respectively. Projecting through 10-year follow-up, the ICER was $80,000. The 10-year CEAC revealed a 40% probability that the ICER was $80,000 or less, a 90% probability that the ICER was $90,000 or less, and a 100% probability that the ICER was less than $100,000. CONCLUSIONS: Based on the WHO's suggested upper threshold for cost-effectiveness (3 times per capita GDP, or $140,000 in 2010 dollars), the analysis reveals that surgical treatment for ASD is cost-effective after a 10-year period based on predicted deterioration in HRQOL without surgery. The ICER well exceeds the WHO threshold at earlier follow-up intervals, highlighting the importance of the durability of surgical treatment in assessing the value of surgical intervention. Due to the study's methodology, the results are dependent on the predicted deterioration in HRQOL without surgery. As such, the results may not extend to patients whose HRQOL would remain steady without surgery. Future research should therefore pursue a direct comparison of QALYs for surgical and nonsurgical patients to better understand the cost-effectiveness of surgery for the average ASD patient.