High-Dose TXA Is Associated with Less Blood Loss Than Low-Dose TXA without Increased Complications in Patients with Complex Adult Spinal Deformity.

BACKGROUND: Tranexamic acid (TXA) is commonly utilized to reduce blood loss in adult spinal deformity (ASD) surgery. Despite its widespread use, there is a lack of consensus regarding the optimal dosing regimen. The aim of this study was to assess differences in blood loss and complications between high, medium, and low-dose TXA regimens among patients undergoing surgery for complex ASD. METHODS: A multicenter database was retrospectively analyzed to identify 265 patients with complex ASD. Patients were separated into 3 groups by TXA regimen: (1) low dose (<20-mg/kg loading dose with ≤2-mg/kg/hr maintenance dose), (2) medium dose (20 to 50-mg/kg loading dose with 2 to 5-mg/kg/hr maintenance dose), and (3) high dose (>50-mg/kg loading dose with ≥5-mg/kg/hr maintenance dose). The measured outcomes included blood loss, complications, and red blood cell (RBC) units transfused intraoperatively and perioperatively. The multivariable analysis controlled for TXA dosing regimen, levels fused, operating room time, preoperative hemoglobin, 3-column osteotomy, and posterior interbody fusion. RESULTS: The cohort was predominantly White (91.3%) and female (69.1%) and had a mean age of 61.6 years. Of the 265 patients, 54 (20.4%) received low-dose, 131 (49.4%) received medium-dose, and 80 (30.2%) received high-dose TXA. The median blood loss was 1,200 mL (interquartile range [IQR], 750 to 2,000). The median RBC units transfused intraoperatively was 1.0 (IQR, 0.0 to 2.0), and the median RBC units transfused perioperatively was 2.0 (IQR, 1.0 to 4.0). Compared with the high-dose group, the low-dose group had increased blood loss (by 513.0 mL; p = 0.022) as well as increased RBC units transfused intraoperatively (by 0.6 units; p < 0.001) and perioperatively (by 0.3 units; p = 0.024). The medium-dose group had increased blood loss (by 491.8 mL; p = 0.006) as well as increased RBC units transfused intraoperatively (by 0.7 units; p < 0.001) and perioperatively (by 0.5 units; p < 0.001) compared with the high-dose group. CONCLUSIONS: Patients with ASD who received high-dose intraoperative TXA had fewer RBC transfusions intraoperatively, fewer RBC transfusions perioperatively, and less blood loss than those who received low or medium-dose TXA, with no differences in the rates of seizure or thromboembolic complications. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Predictive Analytics for Determining Extended Operative Time in Corrective Adult Spinal Deformity Surgery.

BACKGROUND: More sophisticated surgical techniques for correcting adult spinal deformity (ASD) have increased operative times, adding to physiologic stress on patients and increased complication incidence. This study aims to determine factors associated with operative time using a statistical learning algorithm. METHODS: Retrospective review of a prospective multicenter database containing 837 patients undergoing long spinal fusions for ASD. Conditional inference decision trees identified factors associated with skin-to-skin operative time and cutoff points at which factors have a global effect. A conditional variable-importance table was constructed based on a nonreplacement sampling set of 2000 conditional inference trees. Means comparison for the top 15 variables at their respective significant cutoffs indicated effect sizes. RESULTS: Included: 544 surgical ASD patients (mean age: 58.0 years; fusion length 11.3 levels; operative time: 378 minutes). The strongest predictor for operative time was institution/surgeon. Center/surgeons, grouped by decision tree hierarchy, a and b were, on average, 2 hours faster than center/surgeons c-f, who were 43 minutes faster than centers g-j, all P < 0.001. The next most important predictors were, in order, approach (combined vs posterior increases time by 139 minutes, P < 0.001), levels fused (<4 vs 5-9 increased time by 68 minutes, P < 0.050; 5-9 vs < 10 increased time by 47 minutes, P < 0.001), age (age <50 years increases time by 57 minutes, P < 0.001), and patient frailty (score <1.54 increases time by 65 minutes, P < 0.001). Surgical techniques, such as three-column osteotomies (35 minutes), interbody device (45 minutes), and decompression (48 minutes), also increased operative time. Both minor and major complications correlated with <66 minutes of increased operative time. Increased operative time also correlated with increased hospital length of stay (LOS), increased estimated intraoperative blood loss (EBL), and inferior 2-year Oswestry Disability Index (ODI) scores. CONCLUSIONS: Procedure location and specific surgeon are the most important factors determining operative time, accounting for operative time increases <2 hours. Surgical approach and number of levels fused were also associated with longer operative times, respectively. Extended operative time correlated with longer LOS, higher EBL, and inferior 2-y ODI outcomes. CLINICAL RELEVANCE: We further identified the poor outcomes associated with extended operative time during surgical correction of ASD, and attributed the useful predictors of time spent in the operating room, including site, surgeon, surgical approach, and the number of levels fused.

Are the Arbeitsgemeinschaft Für Osteosynthesefragen (AO) Principles for Long Bone Fractures Applicable to 3-Column Osteotomy to Reduce Rod Fracture Rates?

OBJECTIVE: The aim was to determine whether applying Arbeitsgemeinschaft für Osteosynthesefragen (AO) principles for external fixation of long bone fracture to patients with a 3-column osteotomy (3CO) would be associated with reduced rod fracture (RF) rates. SUMMARY OF BACKGROUND DATA: AO dictate principles to follow when fixating long bone fractures: (1) decrease bone-rod distance; (2) increase the number of connecting rods; (3) increase the diameter of rods; (4) increase the working length of screws; (5) use multiaxial fixation. We hypothesized that applying these principles to patients undergoing a 3CO reduces the rate of RF. METHODS: Patients were categorized as having RF versus no rod fracture (non-RF). Details on location and type of instrumentation were collected. Dedicated software was used to calculate the distance between osteotomy site and adjacent pedicle screws, angle between screws and the distance between the osteotomy site and rod. Classic sagittal spinopelvic parameters were evaluated. RESULTS: The study included 170 patients (34=RF, 136=non-RF). There was no difference in age (P=0.224), sagittal vertical axis correction (P=0.287), or lumbar lordosis correction (P=0.36). There was no difference in number of screws cephalad (P=0.62) or caudal (P=0.31) to 3CO site. There was a lower rate of RF for patients with >2 rods versus 2 rods (P<0.001). Patients with multiplanar rod fixation had a lower rod fracture rate (P=0.01). For patients with only 2 rods (N=68), the non-RF cohort had adjacent screws that trended to have less angulation to each other (P=0.06) and adjacent screws that had a larger working length (P=0.03). CONCLUSIONS: A portion of AO principles can be applied to 3CO to reduce RF rates. Placing more rods around a 3CO site, placing rods in multiple planes, and placing adjacent screws with a larger working length around the 3CO site is associated with lower RF rates.

Adult Spinal Deformity Surgery Is Associated with Increased Productivity and Decreased Absenteeism From Work and School.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: We hypothesized that adult spinal deformity (ASD) surgery would be associated with improved work- and school-related productivity, as well as decreased rates of absenteeism. SUMMARY OF BACKGROUND DATA: ASD patients experience markedly decreased health-related quality of life along many dimensions. METHODS: Only patients eligible for 2-year follow-up were included, and those with a history of previous spinal fusion were excluded. The primary outcome measures in this study were Scoliosis Research Society-22r score (SRS-22r) questions 9 and 17. A repeated measures mixed linear regression was used to analyze responses over time among patients managed operatively (OP) versus nonoperatively (NON-OP). RESULTS: In total, 1188 patients were analyzed. 66.6% were managed operatively. At baseline, the mean percentage of activity at work/school was 56.4% (standard deviation [SD] 35.4%), and the mean days off from work/school over the past 90 days was 1.6 (SD 1.8). Patients undergoing ASD surgery exhibited an 18.1% absolute increase in work/school productivity at 2-year follow-up versus baseline (P < 0.0001), while no significant change was observed for the nonoperative cohort (P > 0.5). Similarly, the OP cohort experienced 1.1 fewer absent days over the past 90 days at 2 years versus baseline (P < 0.0001), while the NON-OP cohort showed no such difference (P > 0.3). These differences were largely preserved after stratifying by baseline employment status, age group, sagittal vertical axis (SVA), pelvic incidence minus lumbar lordosis (PI-LL), and deformity curve type. CONCLUSION: ASD patients managed operatively exhibited an average increase in work/school productivity of 18.1% and decreased absenteeism of 1.1 per 90 days at 2-year follow-up, while patients managed nonoperatively did not exhibit change from baseline. Given the age distribution of patients in this study, these findings should be interpreted as pertaining primarily to obligations at work or within the home. Further study of the direct and indirect economic benefits of ASD surgery to patients is warranted.Level of Evidence: 3.

Examination of Adult Spinal Deformity Patients Undergoing Surgery with Implanted Spinal Cord Stimulators and Intrathecal Pumps.

STUDY DESIGN: Retrospective cohort study of a prospectively collected multi-center database of adult spinal deformity (ASD) patients. OBJECTIVE: We hypothesized that patients undergoing ASD surgery with and without previous spinal cord stimulators (SCS)/ intrathecal medication pumps (ITP) would exhibit increased complication rates but comparable improvement in health-related quality of life. SUMMARY OF BACKGROUND DATA: ASD patients sometimes seek pain management with SCS or ITP before spinal deformity correction. Few studies have examined outcomes in this patient population. METHODS: Patients undergoing ASD surgery and eligible for 2-year follow-up were included. Preoperative radiographs were reviewed for the presence of SCS/ITP. Outcomes included complications, Oswestry Disability Index (ODI), Short Form-36 Mental Component Score, and SRS-22r. Propensity score matching was utilized. RESULTS: In total, of 1034 eligible ASD patients, a propensity score-matched cohort of 60 patients (30 with SCS/ITP, 30 controls) was developed. SCS/ITP were removed intraoperatively in most patients (56.7%, n = 17). The overall complication rate was 80.0% versus 76.7% for SCS/ITP versus control (P > 0.2), with similarly nonsignificant differences for intraoperative and infection complications (all P > 0.2). ODI was significantly higher among patients with SCS/ITP at baseline (59.2 vs. 47.6, P = 0.0057) and at 2-year follow-up (44.4 vs. 27.7, P = 0.0295). The magnitude of improvement, however, did not significantly differ (P = 0.45). Similar results were observed for SRS-22r pain domain. Satisfaction did not differ between groups at either baseline or follow-up (P > 0.2). No significant difference was observed in the proportion of patients with SCS/ITP versus control reaching minimal clinically important difference in ODI (47.6% vs. 60.9%, P = 0.38). Narcotic usage was more common among patients with SCS/ITP at both baseline and follow-up (P < 0.05). CONCLUSION: ASD patients undergoing surgery with SCS/ITP exhibited worse preoperative and postoperative ODI and SRS-22r pain domain; however, the mean improvement in outcome scores was not significantly different from patients without stimulators or pumps. No significant differences in complications were observed between patients with versus without SCS/ITP.Level of Evidence: 3.

A Comparison of Three Different Positioning Techniques on Surgical Corrections and Postoperative Alignment in Cervical Spinal Deformity (CD) Surgery.

STUDY DESIGN: Retrospective review of a prospective multicenter cervical deformity database. OBJECTIVE: To examine the differences in sagittal alignment correction between three positioning methods in cervical spinal deformity surgery (CD). SUMMARY OF BACKGROUND DATA: Surgical correction for CD is technically demanding and various techniques are utilized to achieve sagittal alignment objectives. The effect of different patient positioning techniques on sagittal alignment correction following CD remains unknown. METHODS: Patients with sagittal deformity who underwent a posterior approach (with and without anterior approach) with an upper instrumented vertebra of C6 or above. Patients with Grade 5, 6, or 7 osteotomies were excluded. Positioning groups were Mayfield skull clamp, bivector traction, and halo ring. Preoperative lower surgical sagittal curve (C2-C7), C2-C7 sagittal vertical axis (cSVA), cervical scoliosis, T1 slope minus cervical lordosis (TS-CL), T1 slope (T1S), chin-brow vertebral angle (CBVA), C2-T3 curve, and C2-T3 SVA was assessed and compared with postoperative radiographs. Segmental changes were analyzed using the Fergusson method. RESULTS: Eighty patients (58% female) with a mean age of 60.6 ±â€Š10.5 years (range, 31-83) were included. The mean postoperative C2-C7 lordosis was 7.8°â€Š±â€Š14 and C2-C7 SVA was 34.1 mm ±â€Š15. There were overall significant changes in cervical alignment across the entire cohort, with improvements in T1 slope (P < 0.001), C2-C7 (P < 0.001), TS-CL (P < 0.001), and cSVA (P = 0.006). There were no differences postoperatively of any radiographic parameter between positioning groups (P > 0.05). The majority of segmental lordotic correction was achieved at C4-5-6 (mean 6.9°â€Š±â€Š11). Additionally, patients who had bivector traction applied had had significantly more segmental correction at C7-T1-T2 compared with Mayfield and halo traction (4.2° vs. 0.3° vs. -1.7° respectively, P < 0.027). CONCLUSION: Postoperative cervical sagittal correction or alignment was not affected by patient position. The majority of segmental correction occurred at C4-5-6 across all positioning methods, while bivector traction had the largest corrective ability at the cervicothoracic junction.Level of Evidence: 4.

Prospective multicenter assessment of complication rates associated with adult cervical deformity surgery in 133 patients with minimum 1-year follow-up.

OBJECTIVE: Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically. METHODS: A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30-90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2-7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°. RESULTS: Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively). CONCLUSIONS: This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.

Artificial Intelligence Models Predict Operative Versus Nonoperative Management of Patients with Adult Spinal Deformity with 86% Accuracy.

OBJECTIVE: Patients with ASD show complex and highly variable disease. The decision to manage patients operatively is largely subjective and varies based on surgeon training and experience. We sought to develop models capable of accurately discriminating between patients receiving operative versus nonoperative treatment based only on baseline radiographic and clinical data at enrollment. METHODS: This study was a retrospective analysis of a multicenter consecutive cohort of patients with ASD. A total of 1503 patients were included, divided in a 70:30 split for training and testing. Patients receiving operative treatment were defined as those undergoing surgery up to 1 year after their baseline visit. Potential predictors included available demographics, past medical history, patient-reported outcome measures, and premeasured radiographic parameters from anteroposterior and lateral films. In total, 321 potential predictors were included. Random forest, elastic net regression, logistic regression, and support vector machines (SVMs) with radial and linear kernels were trained. RESULTS: Of patients in the training and testing sets, 69.0% (n = 727) and 69.1% (n = 311), respectively, received operative management. On evaluation with the testing dataset, performance for SVM linear (area under the curve =0.910), elastic net (0.913), and SVM radial (0.914) models was excellent, and the logistic regression (0.896) and random forest (0.830) models performed very well for predicting operative management of patients with ASD. The SVM linear model showed 86% accuracy. CONCLUSIONS: This study developed models showing excellent discrimination (area under the curve >0.9) between patients receiving operative versus nonoperative management, based solely on baseline study enrollment values. Future investigations may evaluate the implementation of such models for decision support in the clinical setting.

Assessment of Patient Outcomes and Proximal Junctional Failure Rate of Patients with Adult Spinal Deformity Undergoing Caudal Extension of Previous Spinal Fusion.

OBJECTIVE: This case series examined patients undergoing caudal extension of prior fusion without alteration of the prior upper instrumented vertebra (UIV) to assess patient outcomes and rates of proximal junctional kyphosis (PJK)/proximal junctional failure (PJF). METHODS: Patients eligible for 2-year minimum follow-up undergoing caudal extension of prior fusion with unchanged UIVs were identified. These patients were evaluated for PJK/PJF, and patient reported outcomes were recorded. RESULTS: In total, 40 patients were included. Mean follow-up duration was 2.2 ± 0.3 years. Patients in this cohort had poor preoperative sagittal alignment (pelvic incidence minus lumbar lordosis [PI-LL] 26.7°, T1 pelvic angle [TPA] 29.0°, sagittal vertical axis [SVA] 93.4 mm) and achieved substantial sagittal correction (ΔSVA -62.2 mm, ΔPI-LL -19.8°, ΔTPA -11.1°) after caudal extension surgery. At final follow-up, there was a 0% rate of PJF among patients undergoing caudal extension of previous fusion without creation of a new UIV, but 27.5% of patients experienced PJK. Patients experienced significant improvement in both the Oswestry Disability Index and Scoliosis Research Society-22r total score at 2 years postoperatively (P < 0.05). In total, 7.5% (n = 3) of patients underwent further revision, at an average of 1.1 ± 0.54 years after the surgery with unaltered UIV. All 3 of these patients underwent revision for rod fracture with no revisions for PJK/PJF. CONCLUSIONS: Patients undergoing caudal extension of previous fusions for sagittal alignment correction have high rates of clinical success, low revision surgery rates, and very low rates of PJF. Minimizing repetitive tissue trauma at the UIV may result in decreased PJF risk because the PJF rate in this cohort of patients with unaltered UIV is below historical PJF rates of patients undergoing sagittal balance correction.

Sexual Dysfunction Secondary to Lumbar Stiffness in Adult Spinal Deformity Patients Before and After Long-Segment Spinal Fusion.

OBJECTIVE: Sexual function is an important factor contributing to quality of life. Adult spinal deformity (ASD) patients may have sexual limitations due to lumbar spinal stiffness that may be affected by long-segment fusion. METHODS: This study utilized a multicenter, prospectively defined, consecutive cohort of ASD patients. The primary outcome in this study was the Lumbar Stiffness Disability Index (LSDI) question 10: "Choose the statement that best describes the effect of low back stiffness on your ability to engage in sexual intercourse". RESULTS: In total, 368 patients were included in this study, including 76 men and 292 women, of which 80.7% (n = 293) underwent 9 or more level fusion and 74.4% (n = 270) had pelvic fixation. Baseline LSDI sexual function scores averaged 1.7 (SD 1.3), which improved to 1.3 (SD 1.2) at 2-year follow-up (P = 0.0008). After adjusting for confounding factors, worse LSDI sexual function score was strongly associated with worse Oswestry Disability Index, Scoliosis Research Society-22r total, and SF-36 Physical Component Summary and Mental Component Summary scores at both baseline and 2-year follow-up (p<0.05 for all comparisons). Predictors of poorer baseline sexual function included older age, increased SVA, and increased back pain (p<0.05 for all comparisons). Predictors of improvement in sexual function at 2-year follow-up included sagittal vertical axis improvement (P = 0.0032) and decreased postoperative back pain (P < 0.0001). CONCLUSIONS: This study found that sexual dysfunction scores due to lumbar stiffness significantly improved after surgery for ASD. Additionally, lumbar stiffness-related sexual dysfunction is strongly related to overall outcome measured by Oswestry Disability Index and Scoliosis Research Society-22r total score, highlighting the importance of sexual health on overall outcome in ASD patients.

Intraoperative alignment goals for distinctive sagittal morphotypes of severe cervical deformity to achieve optimal improvements in health-related quality of life measures.

BACKGROUND CONTEXT: Patients with severe cervical deformity (CD) often have profound deficits in numerous activities of daily living. The association between health status and postoperative radiographic goals is difficult to quantify. PURPOSE: We aimed to investigate the radiographic characteristics of patients who achieved optimal health related quality of life scores following surgery for CD. STUDY DESIGN: We performed a retrospective review of a prospectively collected database of patients with spinal deformity. PATIENT SAMPLE: One hundred and fifty-three patients with cervical deformity OUTCOME MEASURES: Common health-related quality of life scores (HRQOLs) measurements were taken for patients treated operatively for cervical deformity including neck disability index (NDI), modified Japanese Orthopaedic Association scale (mJOA) for myelopathy and numeric rating scale for neck pain (NRS-neck), METHODS: Surgical patients with severe CD were isolated based upon a previously presented discriminant analysis which outlined a combination of preoperative cervical sagittal vertical axis (cSVA), T1 slope, maximum focal kyphosis in extension, C2 slope in extension, and number of kyphotic levels in extension. Those with available preoperative and 1-year postoperative HRQL data were included. Based on a previous study, patients were grouped into three distinct sagittal morphotypes of CD: focal deformity (FD), flat neck (FN = large TS-CL and lack of compensation), or cervicothoracic (CT). Postoperative outcomes were defined as "good" if a patient had ≥2 of the three following criteria (1) NDI <20 or meeting MCID, (2) mild myelopathy (mJOA≥14), and (3) NRS-Neck ≤5 or improved by ≥2 points from baseline. Within each distinct deformity group, patients with good outcomes were compared to those with poor outcomes (ie, not meeting the criteria for good) for differences in demographics, HRQOL scores, and alignment, via Chi-squared or student's t tests. RESULTS: Overall, 83 of 153 patients met the criteria of severe CD and 40 patients had complete 1-year follow-up of clinical/radiographic data. Patient breakdown by deformity pattern was: CT (N=13), FN (N=17), and FD (N=17), with 7 patients meeting criteria for both FD and FN deformities. Within the FD cohort, maximal focal kyphosis (ie, kyphosis at one level) was better corrected in patients with a "good" outcome (p=.03). In the FN cohort, patients with "good" outcomes presented preoperatively with worse horizontal gaze (McGregor Slope 21° vs. 6°, p=.061) and cSVA (72 mm vs. 60 mm, p=.030). "Good" outcome FN patients showed significantly greater postop correction of horizontal gaze (-25° vs. -5°, p=.031). In the CT cohort, patients with "good" outcomes had superior global alignment both pre- (SVA: -17 mm vs. 108 mm, p<.001) and postoperatively (50 mm vs. 145 mm, p=.001). CT patients with "good" outcomes also had better postop cervical alignment (cSVA 35 mm vs. 49 mm, p=.030), and less kyphotic segments during extension (p=.011). In the FD cohort, there were no differences between "good" and "poor" outcomes patients in preoperative alignment; however, "good" outcome patients showed superior changes in postoperative focal kyphosis (-2° vs. 5°, p=.030). Within all three deformity pattern categories, there were no differences between "good" and "poor" outcome patients with respect to demographics or surgical parameters (levels fused, surgical approach, decompression, osteotomy, all p>.050). CONCLUSIONS: The results of this study show each CD patient's unique deformity must be carefully examined in order to determine the appropriate alignment goals to achieve optimal HRQOLs. In particular, the recognition of the sagittal morphotype can help assist surgeons to aim for specific alignment goals for CT, FN and FD. Distinct deformity specific intra-operative goals include obtaining proper sagittal global/cervical alignment for cervicothoracic patients, correcting maximal focal kyphosis in focal deformity patients, and correcting horizontal gaze for flatneck patients.

Younger Patients Are Differentially Affected by Stiffness-Related Disability Following Adult Spinal Deformity Surgery.

OBJECTIVE: The Lumbar Stiffness Disability Index (LSDI) assesses impact of lumbar stiffness on activities of daily living. We hypothesized that patients <60 years old would perceive greater lumbar stiffness-related functional limitation following fusion for adult spinal deformity. METHODS: Patients completed the LSDI and Scoliosis Research Society 22 Questionnaire, Revised (SRS-22r) preoperatively and at 2 years postoperatively. The primary independent variable was patient age <60 versus ≥60. Multivariable regression analyses were used. RESULTS: Analysis included 267 patients. Patients <60 years old (51.3%) and ≥60 years old (48.7%) were evenly represented. In bivariable analysis, patients age <60 exhibited lower LSDI at baseline versus patients age ≥60 (25.7 vs. 35.5, ß -9.8, P < 0.0001), but a directionally smaller difference at 2 years (26.4 vs. 32.3, ß -5.8, P = 0.0147). LSDI was associated with lower SRS-22r total score among both age groups at baseline and 2 years (all P < 0.0001); the association was stronger among patients age <60 versus ≥60 at 2 years. LSDI was associated with SRS-22r satisfaction scores at 2 years among patients age <60 (P < 0.0001), but not patients age ≥60 (P = 0.2250). The difference in SRS-22r satisfaction per unit LSDI between patients <60 years old and ≥60 years old was significant (P = 0.0021). CONCLUSIONS: Among patients with adult spinal deformity managed operatively, higher LSDI was associated with inferior SRS-22r total score and satisfaction at 2 years postoperatively. The association between increased LSDI and worse patient-reported outcome measures was greater among patients age <60 versus ≥60. Preoperative counseling is needed for patients age <60 undergoing adult spinal deformity surgery regarding effects that lumbar stiffness may have on postoperative function and satisfaction.

Comparison of Best Versus Worst Clinical Outcomes for Adult Cervical Deformity Surgery.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Factors that predict outcomes for adult cervical spine deformity (ACSD) have not been well defined. To compare ACSD patients with best versus worst outcomes. METHODS: This study was based on a prospective, multicenter observational ACSD cohort. Best versus worst outcomes were compared based on Neck Disability Index (NDI), Neck Pain Numeric Rating Scale (NP-NRS), and modified Japanese Orthopaedic Association (mJOA) scores. RESULTS: Of 111 patients, 80 (72%) had minimum 1-year follow-up. For NDI, compared with best outcome patients (n = 28), worst outcome patients (n = 32) were more likely to have had a major complication (P = .004) and to have undergone a posterior-only procedure (P = .039), had greater Charlson Comorbidity Index (P = .009), and had worse postoperative C7-S1 sagittal vertical axis (SVA; P = .027). For NP-NRS, compared with best outcome patients (n = 26), worst outcome patients (n = 18) were younger (P = .045), had worse baseline NP-NRS (P = .034), and were more likely to have had a minor complication (P = .030). For the mJOA, compared with best outcome patients (n = 16), worst outcome patients (n = 18) were more likely to have had a major complication (P = .007) and to have a better baseline mJOA (P = .030). Multivariate models for NDI included posterior-only surgery (P = .006), major complication (P = .002), and postoperative C7-S1 SVA (P = .012); models for NP-NRS included baseline NP-NRS (P = .009), age (P = .017), and posterior-only surgery (P = .038); and models for mJOA included major complication (P = .008). CONCLUSIONS: Factors distinguishing best and worst ACSD surgery outcomes included patient, surgical, and radiographic factors. These findings suggest areas that may warrant greater awareness to optimize patient counseling and outcomes.

Rod Fracture After Apparently Solid Radiographic Fusion in Adult Spinal Deformity Patients.

BACKGROUND: Rod fracture occurs with delayed fusion or pseudarthrosis after adult spinal deformity (ASD) surgery. Rod fracture after apparent radiographic fusion has not been previously investigated. METHODS: Patients with ASD in a multicenter database were assessed for radiographic fusion by a committee of 3 spinal deformity surgeons. Fusions were rated as bilaterally fused (A), unilaterally fused (B), partially fused (C), or not fused (D). Patients with grade A or B fusion and 2-year follow-up were included. Patients with radiographic fusion were evaluated for subsequent rod fracture. Adjusted analyses were conducted with multiple logistic regression, using backwards-variable selection to a threshold of P < 0.2, to assess for associated factors. RESULTS: Of 402 patients with radiographically apparent solid fusion, 9.5% (38) subsequently suffered a broken rod. On multivariate analysis, greater rates of rod fracture were seen among patients of age group 60-69 years (vs. 18-49), body mass index 30-34 and 35+ (vs. <25), stainless-steel rods (vs. titanium), patients with rods ≤5.5 mm (vs. 6.35 mm), and patients with Charlson score 0 (vs. 3+). Of the 38 patients with rod fractures, 18 (47.4%) presented with worsened pain, and 8 (21.1%) required revision at minimum 2-year follow-up. CONCLUSIONS: Rod fracture occurred in 9.5% of patients with apparently solid radiographic fusion after ASD surgery. Advanced age, obesity, small diameter rods (5.5 mm), osteotomy, and lower comorbidity burden were significantly associated with rod fracture. Nearly one-half of these patients noted worsening pain, and 21.1% required revision surgery. Instrumentation failure may occur and may be symptomatic even in the setting of apparent fusion on plain radiographs.

Center variation in episode-of-care costs for adult spinal deformity surgery: results from a prospective, multicenter database.

BACKGROUND CONTEXT: Adult spinal deformity (ASD) surgery is associated with significant resource utilization, costing more than $958 million in charges for Medicare patients and more than $1.7 billion in charges for managed care population in the last decade. Given the recent move toward bundled payment models, it is important to understand the various care components a patient receives over the course of a defined clinical episode, its associated cost, and the proportion of cost for each component toward the bundled payment. PURPOSE: To examine the degree and determinants of variation in inpatient episode-of-care (EOC) cost, resource utilization, and patient-reported outcomes for patients undergoing ASD surgery across four spine deformity centers in the United States. STUDY DESIGN/SETTING: Retrospective analysis of prospective, multicenter database. PATIENT SAMPLE: Consecutive patients enrolled in an ASD database from four spinal deformity centers. OUTCOME MEASURES: Total in-patient EOC costs and Short Form (SF)-6D. METHODS: The study used a multicenter database of 210 consecutively enrolled operative patients from 2008 to 2013 at four participating centers in the United States. Demographic, surgical, and direct cost data, expressed in 2013 dollars, for the entire inpatient EOC were obtained from administrative databases from the respective hospitals. Mixed models and multivariable linear regression were used to evaluate the impact of center on total costs adjusting for patient characteristics, length of stay (LOS), and surgical factors. RESULTS: A total of 126 patients with complete baseline and 2-year follow-up data were included. The percentages of patients from each center were 36.5%, 7.1%, 24.6%, and 31.7%. Overall, the mean patient age was 58.4±12.6 years, 86% were women, and 94% were Caucasian. The proportion of total cost variation explained by the center at which the patient was treated was 17%. After adjusting for patient, LOS, and surgical factors the cost variation reduced to 4%. In multivariable analysis, each additional level fused increased total cost variation by $2,500, whereas recombinant human bone morphogenetic protein-2 (BMP) use and posterior-only surgical approach lowered total EOC costs by $10,500 and $9,400, respectively. No significant difference was observed in 2-year quality-adjusted life year across centers. CONCLUSIONS: Total EOC costs for ASD surgery varied significantly by center. Levels fused, BMP use, and surgical approach were the primary drivers of cost variation across centers. Differences in resource utilization had no impact on 2-year quality-adjusted life year improvement across centers.

Prospective Multicenter Assessment of All-Cause Mortality Following Surgery for Adult Cervical Deformity.

BACKGROUND: Surgical treatments for adult cervical spinal deformity (ACSD) are often complex and have high complication rates. OBJECTIVE: To assess all-cause mortality following ACSD surgery. METHODS: ACSD patients presenting for surgical treatment were identified from a prospectively collected multicenter database. Clinical and surgical parameters and all-cause mortality were assessed. RESULTS: Of 123 ACSD patients, 120 (98%) had complete baseline data (mean age, 60.6 yr). The mean number of comorbidities per patient was 1.80, and 80% had at least 1 comorbidity. Surgical approaches included anterior only (15.8%), posterior only (50.0%), and combined anterior/posterior (34.2%). The mean number of vertebral levels fused was 8.0 (standard deviation [SD] = 4.5), and 23.3% had a 3-column osteotomy. Death was reported for 11 (9.2%) patients at a mean of 1.1 yr (SD = 0.76 yr; range = 7 d to 2 yr). Mean follow-up for living patients was 1.2 yr (SD = 0.64 yr). Causes of death included myocardial infarction (n = 2), pneumonia/cardiopulmonary failure (n = 2), sepsis (n = 1), obstructive sleep apnea/narcotics (n = 1), subsequently diagnosed amyotrophic lateral sclerosis (n = 1), burn injury related to home supplemental oxygen (n = 1), and unknown (n = 3). Deceased patients did not significantly differ from alive patients based on demographic, clinical, or surgical parameters assessed, except for a higher major complication rate (excluding mortality; 63.6% vs 22.0%, P = .006). CONCLUSION: All-cause mortality at a mean of 1.2 yr following surgery for ACSD was 9.2% in this prospective multicenter series. Causes of death were reflective of the overall high level of comorbidities. These findings may prove useful for treatment decision making and patient counseling in the context of the substantial impact of ACSD.

The Health Impact of Adult Cervical Deformity in Patients Presenting for Surgical Treatment: Comparison to United States Population Norms and Chronic Disease States Based on the EuroQuol-5 Dimensions Questionnaire.

BACKGROUND: Although adult cervical spine deformity (ACSD) is associated with pain and disability, its health impact has not been quantified in comparison to other chronic diseases. OBJECTIVE: To perform a comparative analysis of the health impact of symptomatic ACSD to US normative and chronic disease values using EQ-5D (EuroQuol-5 Dimensions questionnaire) scores. METHODS: ACSD patients presenting for surgical treatment were identified from a prospectively collected multicenter database. Baseline demographics and EQ-5D scores were collected and compared with US normative and disease state values. RESULTS: Of 121 ACSD patients, 115 (95%) completed the EQ-5D (60% women, mean age 61 years, previous spine surgery in 44%). Diagnoses included kyphosis with mid-cervical (63.4%), cervico-thoracic (23.5%), or thoracic (8.7%) apex and primary coronal deformity (4.3%). The mean ACSD EQ-5D index was 0.511 (standard definition = 0.224), which is 34% below the bottom 25th percentile (0.780) for similar age- and gender-matched US normative populations. Mean ACSD EQ-5D index values were worse than the bottom 25th percentile for several other disease states, including chronic ischemic heart disease (0.708), malignant breast cancer (0.708), and malignant prostate cancer (0.708). ACSD mean index values were comparable to the bottom 25th percentile values for blindness/low vision (0.543), emphysema (0.508), renal failure (0.506), and stroke (0.463). EQ-5D scores did not significantly differ based on cervical deformity type ( P = .66). CONCLUSION: The health impact of symptomatic ACSD is substantial, with negative impact across all EQ-5D domains. The mean ACSD EQ-5D index was comparable to the bottom 25th percentile values for blindness/low vision, emphysema, renal failure, and stroke.

Age-Adjusted Alignment Goals Have the Potential to Reduce PJK.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To explore proximal junctional kyphosis (PJK) as a function of age-adjusted surgical correction goals. SUMMARY OF BACKGROUND DATA: Recent adult spinal deformity (ASD) studies show that alignment targets are age-specific. Despite recognizing age and malalignment as PJK risk factors, no study has assessed the age-specific effects of alignment on PJK. METHODS: ASD patients with fusions to the pelvis were included and stratified into three groups: young adults (YA <40 years old), middle aged (MA: 40-65 years old), and the elderly (ED >65 years old). Analysis of variance compared the groups with respect to 1-year postoperative alignments and 1-year offsets from age-specific alignment targets. RESULTS: A total of 679 patients were enrolled (mean age = 61 years old, 77% female, body mass index = 28.1). At 1 year postoperatively, there was a significant decrease in pelvic tilt (PT; 29-23°), spinopelvic mismatch (pelvic incidence [PI]-lumbar lordosis [LL]) (28-5°), and sagittal vertical axis (SVA; 110-37 mm); overall incidence of PJK was 45.1%. Stratification by age (YA, n = 28; MA, n = 389; ED, n = 262) revealed an increase in PJK incidence with age: YA = 17.9%, MA = 43.8%, and ED = 50.2% (P < 0.001). PJK patients had smaller postoperative PI-LL mismatches (ED 0.8° vs. 9.8°, MA 3.1° vs. 7.3°) than non-PJK patients, without any significant differences in PT or SVA. Analysis of the postoperative offsets from age-specific norms revealed that PJK patients in the two older subgroups and in the study cohort as a whole were overcorrected as compared to non-PJK patients (PI-LL offset-all: -5.2° vs. 2.8°, MA: -1° vs. +4°, ED: -11° vs. -2°; SVA offset-all: -10 mm vs. 7 mm, MA: -3 mm vs. 10 mm, ED: -18 mm vs. -6 mm). The correlation coefficients between PJK angles and the offsets from age-adjusted objective were small (0.320 for PI-LL, 0.114 for PT, and 0.136 for SVA). CONCLUSION: Overall, this study suggests that PJK patients were overcorrected when compared to age-adjusted alignment goals. Certainly, elderly patients are subject to independent risk factors for PJK, making the prevention of PJK complex. However, individualized optimization of surgical alignment can improve outcomes. This emphasizes the need for surgeons to incorporate age-specific alignment targets into the standard preoperative planning process. LEVEL OF EVIDENCE: 3.

Complication rates associated with 3-column osteotomy in 82 adult spinal deformity patients: retrospective review of a prospectively collected multicenter consecutive series with 2-year follow-up.

OBJECTIVE Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database. METHODS This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators. RESULTS Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33%) patients had 1-11 reoperations (total of 44 reoperations). The most common indications for reoperation were rod breakage (n = 14), deep wound infection (n = 15), and PJK (n = 6). The 24 patients who did not achieve 2-year follow-up had a mean of 0.85 years of follow-up, and the types of early and delayed complications encountered in these 24 patients were comparable to those encountered in the patients that achieved 2-year follow-up. CONCLUSIONS Among 82 ASD patients treated with 3CO, 64 (78.0%) had at least 1 early or delayed complication (57 minor, 85 major). The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.

Outcomes of Operative and Nonoperative Treatment for Adult Spinal Deformity: A Prospective, Multicenter, Propensity-Matched Cohort Assessment With Minimum 2-Year Follow-up.

BACKGROUND: High-quality studies that compare operative and nonoperative treatment for adult spinal deformity (ASD) are needed. OBJECTIVE: To compare outcomes of operative and nonoperative treatment for ASD. METHODS: This is a multicenter, prospective analysis of consecutive ASD patients opting for operative or nonoperative care. Inclusion criteria were age >18 years and ASD. Operative and nonoperative patients were propensity matched with the baseline Oswestry Disability Index, Scoliosis Research Society-22r, thoracolumbar/lumbar Cobb angle, pelvic incidence-to-lumbar lordosis mismatch (PI-LL), and leg pain score. Analyses were confined to patients with a minimum of 2 years of follow-up. RESULTS: Two hundred eighty-six operative and 403 nonoperative patients met the criteria, with mean ages of 53 and 55 years, 2-year follow-up rates of 86% and 55%, and mean follow-up of 24.7 and 24.8 months, respectively. At baseline, operative patients had significantly worse health-related quality of life (HRQOL) based on all measures assessed (P < .001) and had worse deformity based on pelvic tilt, pelvic incidence-to-lumbar lordosis mismatch, and sagittal vertical axis (P ≤ .002). At the minimum 2-year follow-up, all HRQOL measures assessed significantly improved for operative patients (P < .001), but none improved significantly for nonoperative patients except for modest improvements in the Scoliosis Research Society-22r pain (P = .04) and satisfaction (P < .001) domains. On the basis of matched operative-nonoperative cohorts (97 in each group), operative patients had significantly better HRQOL at follow-up for all measures assessed (P < .001), except Short Form-36 mental component score (P = .06). At the minimum 2-year follow-up, 71.5% of operative patients had ≥1 complications. CONCLUSION: Operative treatment for ASD can provide significant improvement of HRQOL at a minimum 2-year follow-up. In contrast, nonoperative treatment on average maintains presenting levels of pain and disability. ABBREVIATIONS: ASD, adult spinal deformityHRQOL, health-related quality of lifeLL, lumbar lordosisMCID, minimal clinically important differenceNRS, numeric rating scaleODI, Oswestry Disability IndexPI, pelvic incidenceSF-36, Short Form-36SRS-22r, Scoliosis Research Society-22rSVA, sagittal vertical axis.