A comparative cohort study of surgical approaches for adult spinal deformity at a minimum 2-year follow-up.

STUDY DESIGN: This study was a retrospective multi-center comparative cohort study. MATERIALS AND METHODS: A retrospective institutional database of operative adult spinal deformity patients was utilized. All fusions > 5 vertebral levels and including the sacrum/pelvis were eligible for inclusion. Revisions, 3 column osteotomies, and patients with < 2-year clinical follow-up were excluded. Patients were separated into 3 groups based on surgical approach: 1) posterior spinal fusion without interbody (PSF), 2) PSF with interbody (PSF-IB), and 3) anteroposterior (AP) fusion (anterior lumbar interbody fusion or lateral lumbar interbody fusion with posterior screw fixation). Intraoperative, radiographic, and clinical outcomes, as well as complications, were compared between groups with ANOVA and χ2 tests. RESULTS: One-hundred and thirty-eight patients were included for study (PSF, n = 37; PSF-IB, n = 44; AP, n = 57). Intraoperatively, estimated blood loss was similar between groups (p = 0.171). However, the AP group had longer operative times (547.5 min) compared to PSF (385.1) and PSF-IB (370.7) (p < 0.001). Additionally, fusion length was shorter in PSF-IB (11.4) compared to AP (13.6) and PSF (12.9) (p = 0.004). There were no differences between the groups in terms of change in alignment from preoperative to 2 years postoperative. There were no differences in clinical outcomes. While postoperative complications were largely similar between groups, operative complications were higher in the AP group (31.6%) compared to the PSF (5.4%) and PSF-IB (9.1) groups (p < 0.001). CONCLUSION: While there were differences in intraoperative outcomes (operative time and fusion length), there were no differences in postoperative clinical or radiographic outcomes. AP fusion was associated with a higher rate of operative complications.

Predicting 30-day mortality after surgery for metastatic disease of the spine: the H2-FAILS score.

PURPOSE: Scoring systems for metastatic spine disease focus on predicting long- to medium-term mortality or a combination of perioperative morbidity and mortality. However, accurate prediction of perioperative mortality alone may be the most important factor when considering surgical intervention. We aimed to develop and evaluate a new tool, the H2-FAILS score, to predict 30-day mortality after surgery for metastatic spine disease. METHODS: Using the National Surgical Quality Improvement Program database, we identified 1195 adults who underwent surgery for metastatic spine disease from 2010 to 2018. Incidence of 30-day mortality was 8.7% (n = 104). Independent predictors of 30-day mortality were used to derive the H2-FAILS score. H2-FAILS is an acronym for: Heart failure (2 points), Functional dependence, Albumin deficiency, International normalized ratio elevation, Leukocytosis, and Smoking (1 point each). Discrimination was assessed using area under the receiver operating characteristic curve (AUC). The H2-FAILS score was compared with the American Society of Anesthesiologists Physical Status Classification (ASA Class), the 5-item modified Frailty Index (mFI-5), and the New England Spinal Metastasis Score (NESMS). Internal validation was performed using bootstrapping. Alpha = 0.05. RESULTS: Predicted 30-day mortality was 1.8% for an H2-FAILS score of 0 and 78% for a score of 6. AUC of the H2-FAILS was 0.77 (95% confidence interval: 0.72-0.81), which was higher than the mFI-5 (AUC 0.58, p < 0.001), ASA Class (AUC 0.63, p < 0.001), and NESMS (AUC 0.70, p = 0.004). Internal validation showed an optimism-corrected AUC of 0.76. CONCLUSIONS: The H2-FAILS score accurately predicts 30-day mortality after surgery for spinal metastasis. LEVEL OF EVIDENCE: Prognostic level III.

Distal junctional kyphosis in adult cervical deformity patients: where does it occur?

PURPOSE: To evaluate the impact of the lowest instrumented vertebra (LIV) on Distal Junctional kyphosis (DJK) incidence in adult cervical deformity (ACD) surgery. METHODS: Prospectively collected data from ACD patients undergoing posterior or anterior-posterior reconstruction at 13 US sites was reviewed up to 2-years postoperatively (n = 140). Data was stratified into five groups by level of LIV: C6-C7, T1-T2, T3-Apex, Apex-T10, and T11-L2. DJK was defined as a kyphotic increase > 10° in Cobb angle from LIV to LIV-1. Analysis included DJK-free survival, covariate-controlled cox regression, and DJK incidence at 1-year follow-up. RESULTS: 25/27 cases of DJK developed within 1-year post-op. In patients with a minimum follow-up of 1-year (n = 102), the incidence of DJK by level of LIV was: C6-7 (3/12, 25.00%), T1-T2 (3/29, 10.34%), T3-Apex (7/41, 17.07%), Apex-T10 (8/11, 72.73%), and T11-L2 (4/8, 50.00%) (p < 0.001). DJK incidence was significantly lower in the T1-T2 LIV group (adjusted residual = -2.13), and significantly higher in the Apex-T10 LIV group (adjusted residual = 3.91). In covariate-controlled regression using the T11-L2 LIV group as reference, LIV selected at the T1-T2 level (HR = 0.054, p = 0.008) or T3-Apex level (HR = 0.081, p = 0.010) was associated with significantly lower risk of DJK. However, there was no difference in DJK risk when LIV was selected at the C6-C7 level (HR = 0.239, p = 0.214). CONCLUSION: DJK risk is lower when the LIV is at the upper thoracic segment than the lower cervical segment. DJK incidence is highest with LIV level in the lower thoracic or thoracolumbar junction.

Sacral-Alar-Iliac (SAI) Fixation in Children With Spine Deformity: Minimum 10-Year Follow-Up.

INTRODUCTION: Sacral-alar-iliac (SAI) screws are utilized to achieve pelvic fixation in spine deformity patients. The primary purpose of this study is to investigate the long-term outcomes of pediatric patients with scoliosis treated with posterior spinal fusion and SAI fixation at 10-year clinical and radiographic follow-up. METHODS: We reviewed the clinical and radiographic records of patients aged 18 years or below treated for scoliosis with posterior spinal fusion using SAI fixation. Pelvic obliquity and the major coronal curve were determined at the preoperative visit and 6-week, 1-year, 5-year, and 10-year postoperative visits. SAI screw-specific data collected included screw dimensions, rate of screw revision, pain at the SAI screw sites, presence of lucency >2 mm around the screw, screw loosening or breaking, and deep surgical site infections. RESULTS: Ninety-seven of 151 patients (75%) were included. The average age at index surgery was 13.5±3.1 years, and the most common diagnosis was cerebral palsy (67%). The mean duration of follow-up was 11±3 years. The mean pelvic obliquity measured 20±8.0 degrees preoperatively, and 8.7±4.0 degrees at the 10-year follow-up. There were no significant difference in pelvic obliquity when comparing the 10-year follow-up visit with the 6-week postoperative follow-up. Average screw dimensions were 8.4×68.8 mm. By the 10-year follow-up, 4 patients (4%) had at least 1 SAI screw-related complication. Of these patients, 2 (2%) had pain at 1 SAI screw, 4 (4%) had lucency around the screw, and 3 (3%) had broken or loose screws. Two (2%) required SAI screw revision because of late deep wound infection, and underwent exchange with a longer screw. There were no intrapelvic protrusions, vascular, or neurological complications. CONCLUSIONS: SAI screws are a safe and effective method for pelvic fixation in children with spinal deformity. The outcomes at ≥10 years are satisfactory, with low rates of long-term complications and excellent postoperative correction and subsequent maintenance of coronal curvature and pelvic obliquity over time. LEVEL OF EVIDENCE: Level IV.

Recurrence of proximal junctional kyphosis after revision surgery for symptomatic proximal junctional kyphosis in patients with adult spinal deformity: incidence, risk factors, and outcomes.

PURPOSE: Although proximal junctional kyphosis (PJK) is common after long spinal fusion, the outcomes of revision surgery for symptomatic PJK are unclear. Our aim was to assess the outcomes of revision surgery for symptomatic PJK in patients with adult spinal deformity and elucidate the incidence and risk factors for recurrent PJK (rePJK). METHODS: We evaluated standing radiographs and health-related quality of life (HRQOL) in patients who underwent revision surgery for symptomatic PJK with at least 2-year follow-up. Patients were assigned to the non-rePJK or rePJK group according to PJK recurrence. RESULTS: Thirty-nine consecutive patients (mean age, 63 ± 11 years; 24 women) met the inclusion criteria. RePJK occurred in 12 patients (31%). There were significant differences in the following parameters between groups (non-rePJK vs. rePJK): initial proximal junctional sagittal Cobb angle (PJA) (26.6° vs. 35.6°), thoracic kyphosis (TK) (38.6° vs. 52.8°), and sagittal vertical axis (SVA) (9.3 vs. 15.9 cm), and pre- to postoperative SVA decrease (6.1 vs. 12.2 cm). Significant risk factors for rePJK were initial PJA > 40°, preoperative TK > 60°, preoperative SVA > 10.0 cm, correction of TK > 15°, and correction of SVA > 5.0 cm. HRQOL scores improved significantly; however, postoperative SRS-22r activity scores were significantly worse in the rePJK group vs the non-rePJK group. CONCLUSION: The incidence of rePJK was 31%. Risk factors for rePJK were large initial PJA, high preoperative TK and SVA, and greater correction of TK and SVA. HRQOL did not differ significantly between patients with vs without rePJK, except immediate postoperative SRS-22r activity scores. LEVEL OF EVIDENCE: III.

The Scoli-RISK 1 results of lower extremity motor function 5 years after complex adult spinal deformity surgery.

INTRODUCTION: Neurologic complications after complex adult spinal deformity (ASD) surgery are important, yet outcomes are heterogeneously reported, and long-term follow-up of actual lower extremity motor function is unknown. OBJECTIVE: To prospectively evaluate lower extremity motor function scores (LEMS) before and at 5 years after surgical correction of complex ASD. DESIGN: Retrospective analysis of a prospective, multicenter, international observational study. METHODS: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers around the world. Inclusion criteria were Cobb angle of > 80°, corrective osteotomy for congenital or revision deformity and/or 3-column osteotomy. Among patients with 5-year follow-up, comparisons of LEMS to baseline and within each follow-up period were made via documented neurologic exams on each patient. RESULTS: Seventy-seven (28.3%) patients had 5-year follow-up. Among these 77 patients with 5-year follow-up, rates of postoperative LEMS deterioration were: 14.3% hospital discharge, 10.7% at 6 weeks, 6.5% at 6 months, 9.5% at 2 years and 9.3% at 5 years postoperative. During the 2-5 year window, while mean LEMS did not change significantly (-0.5, p = 0.442), eight (11.1%) patients deteriorated (of which 3 were ≥ 4 motor points), and six (8.3%) patients improved (of which 2 were ≥ 4 points). Of the 14 neurologic complications, four (28.6%) were surgery-related, three of which required reoperation. While mean LEMS were not impacted in patients with a major surgery-related complication, mean LEMS were significantly lower in patients with neurologic surgery-related complications at discharge (p = 0.041) and 6 months (p = 0.008) between the two groups as well as the change from baseline to 5 years (p = 0.041). CONCLUSIONS: In 77 patients undergoing complex ASD surgery with 5-year follow-up, while mean LEMS did not change from 2 to 5 years, subtle neurologic changes occurred in approximately 1 in 5 patients (11.1% deteriorated; 8.3% improved). Major surgery-related complication did not result in decreased LEMS; however, those with neurologic surgery-related complications continued to have decreased lower extremity motor function at 5 years postoperative. These results underscore the importance of long-term follow-up to 5 years, using individual motor scores rather than group averages, and comparing outcomes to both baseline and last follow-up.

Artificial intelligence clustering of adult spinal deformity sagittal plane morphology predicts surgical characteristics, alignment, and outcomes.

PURPOSE: AI algorithms have shown promise in medical image analysis. Previous studies of ASD clusters have analyzed alignment metrics-this study sought to complement these efforts by analyzing images of sagittal anatomical spinopelvic landmarks. We hypothesized that an AI algorithm would cluster preoperative lateral radiographs into groups with distinct morphology. METHODS: This was a retrospective review of a multicenter, prospectively collected database of adult spinal deformity. A total of 915 patients with adult spinal deformity and preoperative lateral radiographs were included. A 2 × 3, self-organizing map-a form of artificial neural network frequently employed in unsupervised classification tasks-was developed. The mean spine shape was plotted for each of the six clusters. Alignment, surgical characteristics, and outcomes were compared. RESULTS: Qualitatively, clusters C and D exhibited only mild sagittal plane deformity. Clusters B, E, and F, however, exhibited marked positive sagittal balance and loss of lumbar lordosis. Cluster A had mixed characteristics, likely representing compensated deformity. Patients in clusters B, E, and F disproportionately underwent 3-CO. PJK and PJF were particularly prevalent among clusters A and E. Among clusters B and F, patients who experienced PJK had significantly greater positive sagittal balance than those who did not. CONCLUSIONS: This study clustered preoperative lateral radiographs of ASD patients into groups with highly distinct overall spinal morphology and association with sagittal alignment parameters, baseline HRQOL, and surgical characteristics. The relationship between SVA and PJK differed by cluster. This study represents significant progress toward incorporation of computer vision into clinically relevant classification systems in adult spinal deformity. LEVEL OF EVIDENCE IV: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation.

BACKGROUND: The Global Alignment and Proportion (GAP) score, based on pelvic incidence-based proportional parameters, was recently developed to predict mechanical complications after surgery for spinal deformities in adults. However, this score has not been validated in an independent external dataset. QUESTIONS/PURPOSES: After adult spinal deformity surgery, is a higher GAP score associated with (1) an increased risk of mechanical complications, defined as rod fractures, implant-related complications, proximal or distal junctional kyphosis or failure; (2) a higher likelihood of undergoing revision surgery to treat a mechanical complication; and (3) is a lower (more proportioned) GAP score category associated with better validated outcomes scores using the Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22) and the Short Form-36 questionnaires? METHODS: A total of 272 patients who had undergone corrective surgeries for complex spinal deformities were enrolled in the Scoli-RISK-1 prospective trial. Patients were included in this secondary analysis if they fulfilled the original inclusion criteria by Yilgor et al. From the original 272 patients, 14% (39) did not satisfy the radiographic inclusion criteria, the GAP score could not be calculated in 14% (37), and 24% (64) did not have radiographic assessment at postoperative 2 years, leaving 59% (159) for analysis in this review of data from the original trial. A total of 159 patients were included in this study,with a mean age of 58 ± 14 years at the time of surgery. Most patients were female (72%, 115 of 159), the mean number of levels involved in surgery was 12 ± 4, and three-column osteotomy was performed in 76% (120 of 159) of patients. The GAP score was calculated using parameters from early postoperative radiographs (between 3 and 12 weeks) including pelvic incidence, sacral slope, lumbar lordosis, lower arc lordosis and global tilt, which were independently obtained from a computer software based on centralized patient radiographs. The GAP score was categorized as proportional (scores of 0 to 2), moderately disproportional (scores of 3 to 6), or severely disproportional (scores higher than 7 to 13). Receiver operating characteristic area under curve (AUC) was used to assess associations between GAP score and risk of mechanical complications and risk of revision surgery. An AUC of 0.5 to 0.7 was classified as "no or low associative power", 0.7 to 0.9 as "moderate" and greater than 0.9 as "high". We analyzed differences in validated outcome scores between the GAP categories using Wilcoxon rank sum test. RESULTS: At a minimum of 2 years' follow-up, a higher GAP score was not associated with increased risks of mechanical complications (AUC = 0.60 [95% CI 0.50 to 0.70]). A higher GAP score was not associated with a higher likelihood of undergoing a revision surgery to treat a mechanical complication (AUC = 0.66 [95% 0.53 to 0.78]). However, a moderately disproportioned GAP score category was associated with better SF-36 physical component summary score (36 ± 10 versus 40 ± 11; p = 0.047), better SF-36 mental component summary score (46 ± 13 versus 51 ± 12; p = 0.01), better SRS-22 total score (3.4 ± 0.8 versus 3.7 ± 0.7, p = 0.02) and better ODI score (35 ± 21 versus 25 ± 20; p = 0.003) than severely disproportioned GAP score category. CONCLUSION: Based on the findings of this external validation study, we found that alignment targets based on the GAP score alone were not associated with increased risks of mechanical complications and mechanical revisions in patients with complex adult spinal disorders. Parameters not included in the original GAP score needed to be considered to reduce the likelihood of mechanical complications. LEVEL OF EVIDENCE: Level III, diagnostic study.

Clinical results and functional outcomes after three-column osteotomy at L5 or the sacrum in adult spinal deformity.

PURPOSE: Three-column osteotomies at L5 or the sacrum (LS3COs) are technically challenging, yet they may be needed to treat lumbosacral kyphotic deformities. We investigated radiographic and clinical outcomes after LS3CO. METHODS: We analyzed 25 consecutive patients (mean age 56 years) who underwent LS3CO with minimum 2-year follow-up. Standing radiographs and health-related quality-of-life scores were evaluated. A new radiographic parameter ["lumbosacral angle" (LSA)] was introduced to evaluate sagittal alignment distal to the S1 segment. RESULTS: From preoperatively to the final follow-up, significant improvements occurred in lumbar lordosis (from - 34° to - 49°), LSA (from 0.5° to 22°), and sagittal vertical axis (SVA) (from 18 to 7.3 cm) (all, p < .01). Mean Scoliosis Research Society (SRS)-22r scores in activity, pain, self-image, and satisfaction (p < .05), and Oswestry Disability Index scores (p < .01) also improved significantly. Patients with SVA ≥ 5 cm at the final follow-up experienced less improvement in SRS-22r satisfaction scores than those with SVA < 5 cm. Patients with LSA < 20° at the final follow-up had significantly lower SRS-22r activity scores than those with LSA ≥ 20° (p = .014). Two patients had transient neurologic deficits, and 11 patients underwent revision for proximal junctional kyphosis (5), pseudarthrosis (3), junctional stenosis (2), or neurologic deficit (1). CONCLUSIONS: LS3CO produced radiographic and clinical improvements. However, patients who remained sagittally imbalanced had less improvement in SRS-22r satisfaction score than those whose sagittal imbalance was corrected, and patients who maintained kyphotic deformity in the lumbosacral spine had lower SRS-22r activity scores than those whose lumbosacral kyphosis was corrected. These slides can be retrieved under Electronic Supplementary Material.

The impact of patient blood management on blood utilization and clinical outcomes in complex spine surgery.

BACKGROUND: Patient blood management (PBM) is especially applicable in major spine surgery, during which bleeding and transfusion are common. What remains unclear in this setting is the overall impact of bundled PBM measures on transfusion requirements and clinical outcomes. We compared these outcomes before and after implementing a PBM program. STUDY DESIGN AND METHODS: We conducted a retrospective review of 928 adult complex spine surgery patients performed by a single surgeon between January 2009 and June 2016. Although PBM measures were phased in over time, tranexamic acid (TXA) administration became standard protocol in July 2013, which defined our pre- and post-PBM periods. Transfusion rates for all blood components before and after PBM implementation were compared, as were morbid event rates and mortality. RESULTS: Baseline characteristics were similar before and after PBM. Before PBM, the mean number of units/patient decreased for red blood cells (RBCs; by 19.5%; p = 0.0057) and plasma (by 33%; p = 0.0008), but not for platelets (p = 0.15). After risk adjustment by multivariable analyses, the composite outcome of morbidity or mortality showed a nonsignificant trend toward improvement after PBM (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.39-1.01; p = 0.055), and the risk of thrombotic events was unchanged (OR, 1.12; 95% CI, 0.42-2.58; p = 0.80). CONCLUSION: In complex spine surgery, a multifaceted PBM program that includes TXA can be advantageous by reducing transfusion requirements without changing clinical outcomes.

Non-neurologic adverse events after complex adult spinal deformity surgery: results from the prospective, multicenter Scoli-RISK-1 study.

PURPOSE: Accurate information regarding the expected complications of complex adult spinal deformity (ASD) is important for shared decision making and informed consent. The purpose of the present study was to investigate the rate and types of non-neurologic adverse events after complex ASD surgeries, and to identify risk factors that affect their occurrence. METHODS: The details and occurrence of all non-neurologic adverse events were reviewed in a prospective cohort of 272 patients after complex ASD surgical correction in a mulitcentre database of the Scoli-RISK-1 study with a planned follow-up of 2 years. Logistic regression analyses were used to identify potential risk factors for non-neurologic adverse events. RESULTS: Of the 272 patients, 184 experienced a total of 515 non-neurologic adverse events for an incidence of 67.6%. 121 (44.5%) patients suffered from more than one adverse event. The most frequent non-neurologic adverse events were surgically related (27.6%), of which implant failure and dural tear were most common. In the unadjusted analyses, significant factors for non-neurologic adverse events were age, previous spine surgery performed, number of documented non-neurologic comorbidities and ASA grade. On multivariable logistic regression analysis, previous spine surgery was the only independent risk factor for non-neurologic adverse events. CONCLUSIONS: The incidence of non-neurologic adverse events for patients undergoing corrective surgeries for ASD was 67.6%. Previous spinal surgery was the only independent risk factor predicting the occurrence of non-neurologic adverse events. These findings complement the earlier report of neurologic complications after ASD surgeries from the Scoli-RISK-1 study. These slides can be retrieved under Electronic Supplementary Material.

External validation of the adult spinal deformity (ASD) frailty index (ASD-FI).

PURPOSE: To assess the ability of the recently developed adult spinal deformity frailty index (ASD-FI) to predict odds of perioperative complications, odds of reoperation, and length of hospital stay after adult spinal deformity (ASD) surgery using a database other than the one used to create the index. METHODS: We used the ASD-FI to calculate frailty scores for 266 ASD patients who had minimum postoperative follow-up of 2 years in the European Spine Study Group (ESSG) database. Patients were enrolled from 2012 through 2013. Using ASD-FI scores, we categorized patients as not frail (NF) (< 0.3 points), frail (0.3-0.5 points), or severely frail (SF) (> 0.5 points). Multivariable logistic regression, adjusted for preoperative and surgical factors such as operative time and blood loss, was performed to determine the relationship between ASD-FI category and odds of major complications, odds of reoperation, and length of hospital stay. RESULTS: We categorized 135 patients (51%) as NF, 90 patients (34%) as frail, and 41 patients (15%) as SF. Overall mean ASD-FI score was 0.29 (range 0-0.8). The adjusted odds of experiencing a major intraoperative or postoperative complication (OR 4.5, 95% CI 2.0-10) or having a reoperation (OR 3.9, 95% CI 1.7-8.9) were higher for SF patients compared with NF patients. Mean hospital stay was 2.1 times longer (95% CI 1.8-2.4) for SF patients compared with NF patients. CONCLUSIONS: Greater patient frailty, as measured by the ASD-FI, is associated with longer hospital stays and greater odds of major complications and reoperation. These slides can be retrieved under Electronic Supplementary Material.

An assessment of frailty as a tool for risk stratification in adult spinal deformity surgery.

OBJECTIVE The goal of this study was to analyze the value of an adult spinal deformity frailty index (ASD-FI) in preoperative risk stratification. Preoperative risk assessment is imperative before procedures known to have high complication rates, such as ASD surgery. Frailty has been associated with risk of complications in trauma surgery, and preoperative frailty assessments could improve the accuracy of risk stratification by providing a comprehensive analysis of patient factors that contribute to an increased risk of complications. METHODS Using 40 variables, the authors calculated frailty scores with a validated method for 417 patients (enrolled between 2010 and 2014) with a minimum 2-year follow-up in an ASD database. On the basis of these scores, the authors categorized patients as not frail (NF) (< 0.3 points), frail (0.3-0.5 points), or severely frail (SF) (> 0.5 points). The correlation between frailty category and incidence of complications was analyzed. RESULTS The overall mean ASD-FI score was 0.33 (range 0.0-0.8). Compared with NF patients (n = 183), frail patients (n = 158) and SF patients (n = 109) had longer mean hospital stays (1.2 and 1.6 times longer, respectively; p < 0.001). The adjusted odds of experiencing a major intraoperative or postoperative complication were higher for frail patients (OR 2.8) and SF patients ( 4.1) compared with NF patients (p < 0.01). For frail and SF patients, respectively, the adjusted odds of developing proximal junctional kyphosis (OR 2.8 and 3.1) were higher than those for NF patients. The SF patients had higher odds of developing pseudarthrosis (OR 13.0), deep wound infection (OR 8.0), and wound dehiscence (OR 13.4) than NF patients (p < 0.05), and they had 2.1 times greater odds of reoperation (p < 0.05). CONCLUSIONS Greater patient frailty, as measured by the ASD-FI, was associated with worse outcome in many common quality and value metrics, including greater risk of major complications, proximal junctional kyphosis, pseudarthrosis, deep wound infection, wound dehiscence, reoperation, and longer hospital stay.

Male sex may not be associated with worse outcomes in primary all-posterior adult spinal deformity surgery: a multicenter analysis.

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.

2,3-Diphosphoglycerate Concentrations in Autologous Salvaged Versus Stored Red Blood Cells and in Surgical Patients After Transfusion.

BACKGROUND: Stored red blood cells (RBCs) are deficient in 2,3-diphosphoglycerate (2,3-DPG), but it is unclear how autologous salvaged blood (ASB) compares with stored blood and how rapidly 2,3-DPG levels return to normal after transfusion. Therefore, we compared levels of 2,3-DPG in stored versus ASB RBCs and in patients' blood after transfusion. METHODS: Twenty-four patients undergoing multilevel spine fusion surgery were enrolled. We measured 2,3-DPG and the oxyhemoglobin dissociation curve (P50) in samples taken from the ASB and stored blood bags before transfusion and in blood samples drawn from patients before and after transfusion. RESULTS: The mean storage duration for stored RBCs was 24 ± 8 days. Compared with fresh RBCs, stored RBCs had decreased 2,3-DPG levels (by approximately 90%; P < 0.0001) and a decreased P50 (by approximately 30%; P < 0.0001). However, ASB RBCs did not exhibit these changes. The mean 2,3-DPG concentration decreased by approximately 20% (P < 0.05) in postoperative blood sampled from patients who received 1 to 3 stored RBC units and by approximately 30% (P < 0.01) in those who received ≥4 stored RBC units. 2,3-DPG was unchanged in patients who received no stored blood or ASB alone. After surgery, 2,3-DPG levels recovered gradually over 3 postoperative days in patients who received stored RBCs. CONCLUSIONS: Stored RBCs, but not ASB RBCs, have decreased levels of 2,3-DPG and a left-shift in the oxyhemoglobin dissociation curve. Postoperatively, 2,3-DPG levels remain below preoperative baseline levels for up to 3 postoperative days in patients who receive stored RBCs but are unchanged in those who receive only ASB RBCs.

Analysis of an unexplored group of sagittal deformity patients: low pelvic tilt despite positive sagittal malalignment.

PURPOSE: In adult spinal deformity (ASD), patients increase pelvic tilt (PT) to maintain standing alignment. Previously, ASD patients with low PT and high disability were described. This study investigates this unusual population in terms of demographic, radiographic, and clinical features after three-column osteotomy (3CO). METHODS: In this multicenter retrospective study, ASD patients underwent single lumbar 3CO. Since PT is proportional to pelvic incidence (PI), the low PT group (LowPT) was defined as having a baseline (BL) PT/PI <25th percentile. HRQOL and full spine x-rays were analyzed at BL and 1 year. LowPT patients were compared to those with high PT/PI (HighPT) in a matched range of T1 pelvic angle. RESULTS: LowPT group had PT/PI <0.4 (n = 31). High disability was reported at baseline for both groups with significant improvement postoperatively, but without difference between groups. LowPT had significantly smaller lack lumbar lordosis but larger SVA, T1 spinopelvic inclination. Postoperatively, there were improvements in all sagittal modifiers except PT in LowPT. 33 % of LowPT had an increase in PT (>5°) postoperatively. This subset had more deformity at baseline, achieving good T1SPi postoperative correction but without achieving the SRS-Schwab target SVA at 1 year. CONCLUSION: LowPT group had high levels of disability. After 3CO surgery, low PT patients experience only partial improvements in sagittal vertical axis (SVA) and 33 % of the group increased their PT. Further work is necessary to determine optimal realignment approaches for this unusual set of patients. It is unclear if neuromuscular pathology plays a role in the setting of high SVA without pelvic retroversion.

Patients with spinal deformity over the age of 75: a retrospective analysis of operative versus non-operative management.

PURPOSE: The goal of the present study was to compare the outcomes of operative and non-operative patients with adult spinal deformity (ASD) over 75 years of age. METHODS: A retrospective review of a multicenter prospective adult spinal deformity database was conducted examining patients with ASD over the age of 75 years. Demographics, comorbidities, operation-related variables, complications, radiographs, and Health-related quality of life (HRQOL) measures collected included Oswestry Disability Index, Short Form-36, and Scoliosis Research Society-22 preoperatively, and at 1 and 2 years later. Minimum clinically important difference (MCID) was calculated and also compared. RESULTS: 27 patients (12 operative, 15 non-operative) were studied. There were no significant differences (p > 0.05) between operative and non-operative patients for age, body mass-index, and comorbidities, but operative patients had worse baseline HRQOL than non-operative patients. Operative patients had a significant improvement in radiographic parameters in 2-year HRQOL, whereas non-operative patients did not (p > 0.05). Operative patients were significantly more likely to reach MCID (range 41.7-81.8 vs. 0-33.3 %, p < 0.05). In the surgical group, 9 (75 %) patients had at least 1 complication (24 total complications). CONCLUSIONS: In the largest series to date comparing operative and non-operative management of adult spinal deformity in elderly patients greater than 75 years of age, reconstructive surgery provides significant improvements in pain and disability over a 2-year period. Furthermore, operative patients were more likely to reach MCID than non-operative patients. When counseling elderly patients with ASD, such data may be helpful in the decision-making process regarding treatment.

Three-column osteotomies of the lower cervical and upper thoracic spine: comparison of early outcomes, radiographic parameters, and peri-operative complications in 48 patients.

PURPOSE: To evaluate and compare early radiographic and clinical outcomes of lower cervical and upper thoracic three-column osteotomies (3CO) for cervicothoracic kyphosis correction. METHODS: Patients who underwent 3CO at the cervicothoracic junction at two institutions were retrospectively reviewed. Patients were divided into two groups: lower cervical osteotomy (LCO) and upper thoracic osteotomy (UTO: T1-T5). Operative data, radiographic alignment, peri-operative complications, and clinical outcomes were compared between the groups. RESULTS: Forty-eight patients [male: 24; female: 24; average age 61 years (range 18-92 years); mean follow-up: 22 months] met inclusion criteria. A total of 24 pedicle subtraction osteotomies and 24 vertebral column resections were performed. Compared to UTO, LCO operative time was significantly shorter, average ICU and hospital stays were significantly longer, and the average pre-operative cervical sagittal vertical axis (SVA) and kyphosis were significantly greater (p < 0.05). For both groups, there was significant improvement in cervical SVA, cervical lordosis, segmental angle, Neck Disability Index (NDI), SRS Activity, and pain visual analog score (p < 0.05). Reoperation rates were similar between the groups (LCO: 33.3 %; UTO: 18 %, p = 0.28). Significantly, more patients required tracheostomy/gastrostomy tubes after LCO (3 vs. 0 in the UTO group, p = 0.03). CONCLUSIONS: Three-column posterior osteotomies at the cervicothoracic junction restored regional sagittal alignment and improved quality of life in this series of patients with rigid cervicothoracic deformity, albeit with high complication rates. Lower cervical osteotomies provided greater cervical SVA correction and were shorter operations, although they were associated with more complications and longer hospital and ICU stays compared to upper thoracic osteotomies.

Maintenance of radiographic correction at 2 years following lumbar pedicle subtraction osteotomy is superior with upper thoracic compared with thoracolumbar junction upper instrumented vertebra.

PURPOSE: The goal of this study was to characterize the spino-pelvic realignment and the maintenance of that realignment by the upper-most instrumented vertebra (UIV) for adult deformity spinal (ASD) patients treated with lumbar pedicle subtraction osteotomy (PSO). METHODS: ASD patients were divided by UIV, classified as upper thoracic (UT: T1-T6) or Thoracolumbar (TL: T9-L1). Complications were recorded and radiographic parameters included thoracic kyphosis (TK, T2-T12), lumbar lordosis (LL, L1-S1), sagittal vertical axis (SVA), pelvic tilt, and the mismatch between pelvic incidence and LL. Patients were also classified by the Scoliosis Research Society (SRS)-Schwab modifier grades. Changes in radiographic parameters and SRS-Schwab grades were evaluated between the two groups. Additional analyses were performed on patients with pre-operative SVA ≥ 15 cm. RESULTS: 165 patients were included (UT: 81 and TL: 84); 124 women, 41 men, with average age 59.9 ± 11.1 years (range 25-81). UT had a lower percentage of patients above the radiographic thresholds for disability than TL. UT had a significantly higher percentage of patients that improved in SRS-Schwab global alignment grade than the TL group at 2 years. Within the patients with pre-operative SVA ≥ 15 cm, TL developed significantly increased SVA and had a significantly higher percentage of patients above the SVA threshold at 3 months, and 1 and 2 years than UT. CONCLUSIONS: Patients undergoing a single-level PSO for ASD who have fixation extending to the UT region (T1-T6) are more likely to maintain sagittal spino-pelvic alignment, lower overall revision rates and revision rate for proximal junctional kyphosis than those with fixation terminating in the TL region (T9-L1).

Complications and intercenter variability of three-column osteotomies for spinal deformity surgery: a retrospective review of 423 patients.

OBJECT: Three-column resection osteotomies (3COs) are commonly performed for sagittal deformity but have high rates of reported complications. Authors of this study aimed to examine the incidence of and intercenter variability in major intraoperative complications (IOCs), major postoperative complications (POCs) up to 6 weeks postsurgery, and overall complications (that is, both IOCs and POCs). They also aimed to investigate the incidence of and intercenter variability in blood loss during 3CO procedures. METHODS: The incidence of IOCs, POCs, and overall complications associated with 3COs were retrospectively determined for the study population and for each of 8 participating surgical centers. The incidence of major blood loss (MBL) over 4 L and the percentage of total blood volume lost were also determined for the study population and each surgical center. Complication rates and blood loss were compared between patients with one and those with two osteotomies, as well as between patients with one thoracic osteotomy (ThO) and those with one lumbar or sacral osteotomy (LSO). Risk factors for developing complications were determined. RESULTS: Retrospective review of prospectively acquired data for 423 consecutive patients who had undergone 3CO at 8 surgical centers was performed. The incidence of major IOCs, POCs, and overall complications was 7%, 39%, and 42%, respectively, for the study population overall. The most common IOC was spinal cord deficit (2.6%) and the most common POC was unplanned return to the operating room (19.4%). Patients with two osteotomies had more POCs (56% vs 38%, p = 0.04) than the patients with one osteotomy. Those with ThO had more IOCs (16% vs 6%, p = 0.03), POCs (58% vs 34%, p < 0.01), and overall complications (67% vs 37%, p < 0.01) than the patients with LSO. There was significant variation in the incidence of IOCs, POCs, and overall complications among the 8 sites (p < 0.01). The incidence of MBL was 24% for the study population, which varied significantly between sites (p < 0.01). Patients with MBL had a higher risk of IOCs, POCs, and overall complications (OR 2.15, 1.76, and 2.01, respectively). The average percentage of total blood volume lost was 55% for the study population, which also varied among sites (p < 0.01). CONCLUSIONS: Given the complexity of 3COs for spinal deformity, it is important for spine surgeons to understand the risk factors and complication rates associated with these procedures. In this study, the overall incidence of major complications following 3CO procedures was 42%. Risks for developing complications included an older age (> 60 years), two osteotomies, ThO, and MBL.