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189. A data-driven approach to assessment of sagittal alignment: defining the spinopelvic ratio's impact on clinical outcomes in adult spinal deformity patients [Meeting Abstract]

Durand, W; Daniels, A H; Hamilton, D K; Passias, P G; Kim, H J; Protopsaltis, T S; Lafage, V; Lafage, R; Smith, J S; Shaffrey, C I; Gupta, M C; Klineberg, E O; Schwab, F J; Burton, D C; Bess, S; Ames, C P; Hart, R A
BACKGROUND CONTEXT: Analysis of interactions spinal alignment metrics may uncover novel and powerful alignment parameters, similar to pelvic incidence minus lumbar lordosis (PI-LL). PURPOSE: This study utilized a data driven approach to hypothesis generation by testing all possible division interactions between a set of spinal alignment parameters. TPA divided by PI (TPA/PI) was identified and subsequently characterized. STUDY DESIGN/SETTING: Retrospective analysis of a multicenter, prospectively-defined, consecutive cohort of ASD patients. PATIENT SAMPLE: A total of 1,439 patients with baseline ODI were included for hypothesis generation; 666 patients had 2-year postoperative follow-up and were included for validation. OUTCOME MEASURES: The primary outcome measure was Oswestry Disability Index (ODI).
METHOD(S): All possible combinations of division interactions between baseline metrics were assessed with linear regression against baseline ODI. Further analyses also utilized linear regression.
RESULT(S): From 247 raw alignment metrics, 32,398 division interactions were considered in hypothesis generation. Low-cervical and high-thoracic pelvic angles divided by pelvic incidence accounted for 7 of the top 10 most significant interactions. Conceptually, the TPA/PI is a measure of the relative alignment of the line connecting T1 to the femoral head and the line perpendicular to the sacral end plate. Among the validation cohort, the mean TPA/PI was 0.41 (SD 0.24) at baseline and 0.30 at 2 years postoperatively (SD 0.18). Higher TPA/PI was linearly associated with worse ODI at baseline (beta 28.7 for TPA/PI 1 vs 0, p<0.0001), 1 year (beta 16.5, p<0.0001), and 2 years (beta 20.0, p<0.0001). Further, the change in ODI at 2 years from baseline was linearly associated with the change in TPA/PI (beta 9.5, p=0.0172). The optimal statistical cutpoints for TPA/PI discriminating patients based on ODI were 0.21 and 0.41, labeled as 0 (<0.21), + (0.21-0.41), and ++ (>=0.41). At baseline, patients in the 0 group exhibited lower ODI as compared to patients in the + (41.8 vs 32.0, p<0.0001) and ++ (50.7 vs 32.0, p<0.0001) groups. The R-squared for regression of ODI against categorical TPA/PI alone (0.154) was directionally higher than that for the Schwab modifiers (SVA: 0.138, PI-LL 0.111, PT 0.057).
CONCLUSION(S): This study utilized a data-driven approach for hypothesis generation and identified TPA/PI, the spinopelvic ratio (SPR), as a promising measure of sagittal spinal alignment among ASD patients. This value is strongly associated with the Schwab modifier classification system. Patients with SPR >=0.21 exhibited inferior HRQOL. The SPR classification accounted for a directionally greater proportion of variance in ODI as compared to the three Schwab modifiers. These results highlight the interaction between global sagittal alignment and adequate pelvic structural support. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002167615
ISSN: 1878-1632
CID: 4051882

175. Intraoperative alignment goals for severe cervical deformity to achieve optimal improvements in health-related quality of life measures [Meeting Abstract]

Virk, S; Passias, P G; Lafage, R; Klineberg, E O; Mundis, G M; Protopsaltis, T S; Shaffrey, C I; Bess, S; Kim, H J; Ames, C P; Schwab, F J; Smith, J S; Lafage, V
BACKGROUND CONTEXT: Patients with severe cervical deformity (CD) often have profound deficits in numerous activities of daily living. Association between health status and postoperative radiographic goals is difficult to quantify. PURPOSE: Investigate the radiographic characteristics of patients who achieved optimal HRQOLs following surgery for CD. STUDY DESIGN/SETTING: Retrospective review of prospective CD database. PATIENT SAMPLE: Forty adult CD patients (C2-C7 Cobb>10degree, CL>10degree, cSVA>4cm, or CBVA>25degree). OUTCOME MEASURES: Health-related-quality of life (HRQL) scores, radiographic alignment.
METHOD(S): Surgical patients with severe CD were isolated based upon a previously presented combination of preop cSVA, T1 slope, maximum focal kyphosis in extension, C2 slope in extension, and number of kyphotic levels in extension. Those with available preop and 1-year postop HRQL data were included. Based on previous study, patients were grouped into 3 distinct patterns of CD: focal deformity (FD), flatneck (FN=large TS-CL and lack of compensation), or cervicothoracic (CT). Postoperative outcomes were defined as "good" if a patient had >2 of the 3 following criteria (1) NDI <20 or meeting MCID, (2) mild myelopathy (mJOA>=13), 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, HRQL scores, and alignment, via chi-squared or student's t-tests.
RESULT(S): Overall, 83/153 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 as follows: 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 = 0.03). In the FN cohort, patients who went on to have "good" outcomes presented with worse horizontal gaze (McGregor slope 21degree vs 6degree, p=0.061) and cSVA (72 mm vs 60 mm, p=0.030). "Good" outcome FN patients showed significantly greater postop correction of horizontal gaze (-25degree vs -5degree, p = 0.031). In the CT cohort, patients with "good" outcomes had superior global alignment both pre- (SVA: -17 mm vs 108 mm, p <0.001) and postoperatively (50 mm vs 145 mm, p=0.001). CT patients with "good" outcomes also had better postop cervical alignment (cSVA 35 mm vs 49 mm, p=0.030), and less kyphotic segments during extension (p=0.011). 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 (-2degree vs 5degree, p=0.030). 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>0.050).
CONCLUSION(S): The results of this study highlight intraoperative goals for three distinct sagittal morphotypes of severe CD: cervicothoracic, flat neck, and focal deformity. Distinct deformity specific intraoperative goals include obtaining proper sagittal global/cervical alignment for cervicothoracic patients, correcting maximal focal kyphosis in focal deformity patients, and correcting horizontal gaze for flat neck patients. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002167607
ISSN: 1878-1632
CID: 4051902

137. Surgical overcorrection relative to ideal spinopelvic alignment reduces rates of pelvic nonresponse for severely malaligned adult spinal deformity patients [Meeting Abstract]

Passias, P G; Bortz, C; Alas, H; Brown, A; Pierce, K E; Varlotta, C; Manning, J H; Ayres, E W; Abotsi, E J; Wang, E; Woo, D; Vasquez-Montes, D; Moawad, M A; Maglaras, C; Diebo, B G; Raman, T; Protopsaltis, T S; Buckland, A J; Gerling, M C; Schwab, F J; Lafage, R; Lafage, V
BACKGROUND CONTEXT: Persistent lumbopelvic malalignment following ASD-corrective surgery may impair quality of life and result in persistent pathologic compensation in the lower extremities. Patient-specific age- and BMI-adjusted alignment targets have been proposed to improve alignment outcomes; however, it is unclear whether reaching these postop targets reduces rates of pelvic nonresponse following surgery. PURPOSE: Assess the relationship between pelvic nonresponse to ASD-corrective surgery and persistent lower-extremity compensation. STUDY DESIGN/SETTING: Single center retrospective review. PATIENT SAMPLE: Fifty-eight ASD patients. OUTCOME MEASURES: Sagittal alignment.
METHOD(S): Included: surgical ASD patients with full-spine X-ray imaging at pre- and early postop follow-up (<1Y). Patients were grouped by postop improvement in PT, per SRS-Schwab Classification: those who did not improve (pelvic nonresponders, PNR), and those that did improve (pelvic responders, PR). Groups were propensity score matched for preop PT, and assessed for differences in demographics, surgical factors, and alignment (sagittal spinal and lower extremity) with means comparison tests. Rates of persistent postop lower extremity compensation (defined as no improvement in lower extremity alignment) were compared between groups. Subanalysis assessed the relationship between reaching postop age- and BMI-specific alignment targets and rates of pelvic nonresponse.
RESULT(S): Following propensity score matching, PNR (N=29) and PR (N=29) patients did not differ in age, sex, BMI or preop sagittal spinal alignment (all p>0.05); however, PNR patients presented with less knee flexion (9degree vs 14degree, p=0.043). Groups did not differ in levels fused (10.8 vs 10.8, p=0.974) or osteotomy (93% vs 92%, p=0.902). Postop, PNR patients had inferior lumbopelvic alignment in PT (30degree vs 17degree), PI-LL (17degree vs 3degree), and greater global malalignment for TPA (27degree vs 15degree, all p<0.001). For PNR patients, these changes in alignment were accompanied by greater compensatory anterior hip extension (53mm vs 31mm, p=0.021). PNR patients also showed greater pre- to postop increases in sacrofemoral angle (2degree vs -5degree), and smaller decreases in hip extension (-24mm vs -64mm), pelvic femoral angle (-1.4degree vs -3.8degree), and global sagittal angle (-3.5degree vs -8degree, all p<0.005), indicating persistent lower extremity compensation. PNR patients had higher rates of persistent postop lower extremity compensation for sacrofemoral angle (68% vs 25%), ankle flexion (64% vs 33%), and pelvic shift (28% vs 4%, all p<0.034). PNR and PR groups did not differ in rates of reaching age- and BMI specific ideal postop alignment for PT, SVA, TPA, or PI-LL (all p>0.05). For patients with severe preop SVA deformity, overcorrection relative to ideal postop PT targets was associated with lower rates of pelvic non-response (under: 12%, match: 18%, over: 71%, p<0.001). Lower rates of nonresponse were observed for patients with severe preop PT deformity overcorrected relative to ideal postop PI-LL (under: 0%, match: 30%, over: 70%, p=0.016).
CONCLUSION(S): Pelvic nonresponders following ASD-corrective surgery had higher rates of persistent compensatory action in the lower extremities. Patients with severe preop PT deformity who were surgically overcorrected with respect to ideal PI-LL had lower rates of postop pelvic nonresponse, indicating that for severely malalignmed patients, existing alignment targets may need to be adjusted to optimize alignment outcomes. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002167606
ISSN: 1878-1632
CID: 4051912

38. Prioritization of realignment associated with superior clinical outcomes for surgical cervical deformity patients [Meeting Abstract]

Pierce, K E; Passias, P G; Lafage, R; Chou, D; Burton, D C; Line, B; Klineberg, E O; Hart, R A; Gum, J L; Daniels, A H; Sciubba, D M; Hamilton, K; Bess, S; Protopsaltis, T S; Shaffrey, C I; Schwab, F J; Scheer, J K; Smith, J S; Lafage, V; Ames, C P; International, Spine Study Group
BACKGROUND CONTEXT: Many patients are unable to undergo a major cervical deformity corrective surgery due to deformity severity, age, comorbidities, and overall frailty status. In order to optimize quality of life in patients with cervical deformity, there may be alignment targets to be prioritized. PURPOSE: To prioritize the cervical parameter targets for alignment. STUDY DESIGN/SETTING: Retrospective review of a multicenter prospective cervical deformity database. PATIENT SAMPLE: Seventy-seven patients undergoing cervical deformity (CD) corrective surgery. OUTCOME MEASURES: Cervical regional alignment parameters: cervical sagittal vertical axis(cSVA), cervical lordosis(CL), T1 Slope minus CL(TS-CL), chin brow vertical angle(CBVA), McGregor's slope(MGS), C2-T3 plumb line(C2-T3 SVA), C2-T3 angle, C2 Slope. Health-related quality of life measures: NDI.
METHOD(S): Included:CD patients (C2-C7 Cobb>10degree, CL>10degree, cSVA>4cm, or CBVA>25degree) with full baseline (BL) and 1-year (1Y) radiographic parameters and NDI scores; patients with cervical or cervicothoracic Primary Driver Ames type. Patients with BL Ames classified as low CD for both parameters of cSVA(<4cm) and TS-CL(<15degree) were excluded. Patients assessed: Meeting MCID for NDI(<-15 DELTANDI). Ratios of correction were found for regional parameters (cSVA, CL, T1 Slope, TS-CL, CBVA, MGS, C2-T3 SVA, C2-T3 angle, C2 Slope) categorized by Primary Ames Driver (cervical[C] or cervicothoracic[CT]). Decision tree analysis assessed cut-offs for differences associated with meeting NDI MCID at 1Y.
RESULT(S): Seventy-seven CD patients included (62.1yrs, 64%F, 28.8kg/m2). Average CCI: 0.94, 7% current smokers. By approach, anterior: 19.4%, posterior: 41.6%, combined approach: 39%. Mean anterior levels fused: 3.5, posterior: 8.3, total: 7.5. Average op time: 553.1min; mean EBL: 1128.1ccs. 41.6% met MCID for NDI. A backwards linear regression model including radiographic differences as predictors from BL to 1 year for meeting MCID for NDI demonstrated an R2 of 0.820 (p=0.032) included TS-CL, cSVA, MGS, C2SS, C2-T3 angle, C2-T3 SVA, CL. By primary Ames driver, 67.5% of patients were categorized as C, and 32.5% as CT. Ratios of change in predictors for MCID NDI patients (BL -1Y) for C driver patients: 260.8% MGS, 140.3% CL, 121.2% C2-T3 angle, 49.6% C2 slope, 41.1% cSVA, 20.5% TS-CL, 3.1%C2-T3 SVA. While correction in CT driver patients included: 168.7% CL, 93% MGS, 70.8% C2-T3 angle, 31.1% cSVA, 27.5% C2 slope, 24.9% TS-CL, 13.7% C2-T3 SVA. The ratios were not significant between the two groups(p>0.050). Decision tree analysis determined cut-offs for radiographic change, prioritizing in the following order (based upon ordinal regression values): a correction <=42.5degreeC2-T3 angle (OR: 5.667[1.074-29.891], p=0.041), <35.4degreeCL (OR:4.636[0.857-25.071], p=0.075), >-31.76degreeC2 slope (OR: 3.2 [0.852-12.026], p=0.085), >-11.57mm cSVA (OR: 3.185[1.137-8.917], p=0.027), >-2.16degree MGS (OR: 2.724[0.971-7.636], p=0.057).
CONCLUSION(S): Certain ratios of correction of cervical parameters contribute to improving neck disability. Specific cut-offs of radiographic differences from baseline to 1 year were found prioritizing C2-T3 angle, followed by cervical lordosis, C2 slope, C2-C7 plumb line, and McGregor's slope, all strongly associated with meeting the minimal clinically important difference for the neck disability index score. Prioritizing these radiographic alignment parameters will optimize patient-reported outcomes for patients undergoing cervical deformity surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002165030
ISSN: 1878-1632
CID: 4051942

21. Machine learning models to predict operative vs nonoperative management of adult spinal deformity patients [Meeting Abstract]

Durand, W; Daniels, A H; Hamilton, D K; Passias, P G; Mundis, G M; Kebaish, K M; Kim, H J; Protopsaltis, T S; Lafage, V; Smith, J S; Shaffrey, C I; Gupta, M C; Klineberg, E O; Schwab, F J; Kelly, M P; Burton, D C; Bess, S; Ames, C P; Hart, R A; International, Spine Study Group
BACKGROUND CONTEXT: Adult spinal deformity (ASD) patients exhibit complex and highly variable pathology. The decision to manage patients operatively is subjective and varies based on training and experience. Machine learning algorithms have shown promise in supporting clinical decision-making. PURPOSE: We sought to develop models capable of accurately discriminating between patients receiving operative vs nonoperative treatment based only on baseline radiographic and clinical data at enrollment. STUDY DESIGN/SETTING: Retrospective analysis of a multicenter, prospectively-defined, consecutive cohort of ASD patients. PATIENT SAMPLE: A total of 1,503 patients were included in this study, divided in a 70:30 split for training and testing. OUTCOME MEASURES: Patients receiving operative treatment were defined as those undergoing surgery up to 1 year after their baseline visit.
METHOD(S): Potential predictors included available demographics, past medical history, HRQoL, and premeasured radiographic parameters from AP and lateral films. Variables with >10% missing data were discarded, and the remainder underwent median imputation. In total, 321 potential predictors were included. Random forest, elastic net regression, and support vector machines (SVMs) with radial and linear kernels were trained. Model performance was evaluated by area under the receiver operating characteristic curve (AUC).
RESULT(S): Of the patients, 69.0% (n=727) and 69.1% (n=311) in the training and testing sets received operative management, respectively. Upon evaluation with the testing dataset, performance for SVM linear (AUC=0.910), elastic net (0.913), and SVM radial (0.914) models was excellent, and the random forest model performed very well (0.830). In our SVM radial model, HRQoL metrics were particularly important for making predictions; the top 3 most important variables were SRS appearance, SRS total, and ODI.
CONCLUSION(S): This study developed models exhibiting excellent discrimination (AUC>0.9) between patients receiving operative vs nonoperative management, based solely on baseline enrollment values. HRQoL metrics were strongest in making these predictions. Future investigations may evaluate the implementation of such models for decision support in the clinical setting. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002165019
ISSN: 1878-1632
CID: 4051962

33. Comparison of bone morphogenetic protein and allogeneic stem cells in lateral interbody lumbar fusion [Meeting Abstract]

Lord, E L; Manning, J H; Wang, E; Vasquez-Montes, D; Jain, D; Protopsaltis, T S; Fischer, C R; Buckland, A J; Goldstein, J A; Passias, P G; Kim, Y H; Bendo, J A
BACKGROUND CONTEXT: Lateral interbody fusion (LLIF) is often performed with biologic adjuvants to promote fusion. Commercially available bone allograft containing allogeneic stem cells (ASC) and bone morphogenetic protein-2 (BMP) are designed to promote fusion while avoiding the morbidity of iliac crest autograft; however, no study to date has directly compared the two in LLIF. The ASC studied is Osteocel Pro (NuVasive, Inc). PURPOSE: This non-industry funded study compares fusion rate, complications, and costs between LLIF with BMP and ASC. STUDY DESIGN/SETTING: Single center retrospective comparative study. PATIENT SAMPLE: Patients with 1-3 lumbar levels treated with LLIF. OUTCOME MEASURES: Outcomes measures are fusion at 1 year postoperative, complication rates, length of stay, and costs.
METHOD(S): A retrospective chart review was conducted to identify patients treated with LLIF and ASC or BMP from February 2012 through September 2017. Patients were included who had from 1-3 lumbar levels treated with LLIF and at least 1 year of radiographic follow up. Interbody fusion was assessed on lumbar X-ray images using a validated scale.
RESULT(S): A total of 94 patients were included representing 162 levels fused. Of these, 74 patients and 133 levels were treated with BMP; 20 patients and 29 levels were treated with ASC. Comparing patients treated with BMP or ASC, there were no differences in age [61.6 vs 60.4, p=0.7], BMI [29.8 vs 28.3, p=0.3], gender [60.8% vs 55.0% female], smoking status [12.2% vs 10.0%, p=1], diabetes [28.4% vs 15.0%, p=0.2], Charleston Comorbidity Index [4.3 vs 3.5, p=0.2], revision status [47.3% vs 45.0%, p=0.9], intraoperative complications [4.1% vs 5.0%, p=1], postoperative complications [37.8% vs 30.0%, p=0.5], or blood loss [881 vs 528ml, p=0.2]. More levels were fused in the BMP group (1.8 vs 1.45, p=0.04) and the BMP group tended toward a longer length of stay [4.8 vs 3.8 days, p=0.06]. There was a nonsignificant trend toward a higher fusion rate with BMP vs ASC[98.5% vs 93.1%, p=0.1]. The average amount of rhBMP used per level was 2.0 cc compared to 5.9 cc of ASC. There was no difference in the cost of the BMP per level compared with ASC [4.45% vs 4.80%, p=0.33], but the BMP group tended toward a higher cost of total care [103.5% vs 87.6%, p=0.1].
CONCLUSION(S): ASC and BMP are both acceptable adjuvants in LLIF that demonstrate comparable fusion rates at 1 year with comparable cost in the setting of similar groups of patients. The radiographic fusion rate seen in our study compares to previous reports in the literature using ASC. Cost considerations are becoming ever more cogent in spine surgery; the results of this study can inform decision making regarding which biologic adjuvant to use in lumbar interbody fusion. FDA DEVICE/DRUG STATUS: Osteocel (Approved for this indication), rhBMP (Infuse) (Not approved for this indication)
Copyright
EMBASE:2002164963
ISSN: 1878-1632
CID: 4052002

54. Preoperative MRI predictors of health related quality of life improvement after microscopic lumbar discectomy [Meeting Abstract]

Varlotta, C; Vasquez-Montes, D; Manning, J H; Ayres, E W; Wang, E; Woo, D; Alas, H; Brown, A; Kim, Y H; Spivak, J M; Bendo, J A; Protopsaltis, T S; Stieber, J R; Buckland, A J
BACKGROUND CONTEXT: Lumbar herniated nucleus pulposus (HNP) is a common spinal pathology often treated by microscopic lumbar discectomy (MLD), though prior reports have not demonstrated which preoperative MRI factors may contribute to significant clinical improvement after MLD. PURPOSE: To analyze the MRI characteristics in patients with HNP that predict meaningful clinical improvement in Health Related Quality of Life scores (HRQL) after MLD. STUDY DESIGN/SETTING: Retrospective clinical and radiological study of patients undergoing MLD for HNP at a single institution over a two year period of time. PATIENT SAMPLE: Eighty-eight patients receiving MLD treatment for HNP. OUTCOME MEASURES: Cephalocaudal canal migration; canal & HNP anterior-posterior (AP) lengths and ratio; canal & HNP axial areas and ratio; hemi-canal & hemi-HNP axial areas and ratio; disc appearance (black, grey or mixed), baseline (BL) and 3-month (3M) postoperative HRQL scores.
METHOD(S): Patients >18 years old who received MLD for HNP with BL and 3M HRQL scores of PROMIS (Physical Function, Pain Interference, and Pain Intensity), ODI, VAS Back, and VAS Leg scores were included. HNP and spinal canal measurements of cephalocaudal migration, AP length, area, hemi-area, and disc appearance were performed using T2 axial and sagittal MRI. HNP measurements were divided by corresponding canal measurements to calculate AP, Area, and Hemi-Area ratios. Using known minimal clinically importance differences (MCID) for each DELTAHRQoL score, patients were separated into two groups based on whether they reached MCID (+) or did not reach MCID (-). The MCID for Pain Intensity was calculated using a decision tree. A linear regression illustrated correlations between PROMIS vs ODI and VAS Back/Leg scores. Independent t-tests and chi-square tests were utilized to investigate significant differences in HNP measurements between the (+) and (-) MCID groups.
RESULT(S): Eighty-eight MLD patients were included (age=44.6+/-14.9, 38.6% female). Pain Interference and pain intensity were strongly correlated with ODI and VAS Back/Leg (R>=.505), and physical function was significantly correlated with ODI and VAS Back/Leg (R=-.349) (all p<.01). The strongest MRI predictors of meeting HRQL MCID were grey disc appearance, HNP area (>116.6 mm2), hemi-HNP Area (>84.6 mm2), and Hemi-Area Ratio (>51.8%); (+) patients were 2.7 times more likely to have a grey HNP than (-) patients in 5 out of 6 HRQL score comparisons (p<.025). Also, (+) patients had larger HNP areas than (-) patients had in 5 out of 6 HRQoL score comparisons (116.6 mm2 +/- 46.4 vs 90.0 mm2 +/- 43.2, p<.04), and had larger hemi-HNP areas than (-) patients had in 4 out of 6 HRQL score comparisons (84.6 mm2 +/- 38.8 vs 66.3 mm2 +/- 29.7, p<.04). (+) patients had a greater hemi-area ratio than (-) patients had in 4 out of 6 HRQL score comparisons (51.8% +/- 14.7 vs 43.9% +/- 14.9, p<.05).
CONCLUSION(S): Patients who met MCID after MLD had larger HNP areas by 26.6 mm2 and larger hemi-HNP areas by 18.3 mm2 than those who did not meet MCID. These patients were also 2.7x more likely to have a grey HNP compared to patients who did not meet MCID. When accounting for HNP area relative to canal area, patients who met MCID had a 7.9% greater Hemi-HNP canal occupation than patients who did not meet MCID. The results of this study suggest that preoperative MRI parameters can be useful in predicting patient reported improvement after MLD. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002164952
ISSN: 1878-1632
CID: 4052012

49. Increasing surgical invasiveness relative to frailty status in cervical deformity surgery: a risk benefit analysis [Meeting Abstract]

Passias, P G; Brown, A; Diebo, B G; Lafage, R; Lafage, V; Burton, D C; Ames, C P; Mundis, G M; Protopsaltis, T S; Hart, R A; Neuman, B J; Line, B; Bess, S; Soroceanu, A; Shaffrey, C I; Klineberg, E O; Smith, J S; Schwab, F J; International, Spine Study Group
BACKGROUND CONTEXT: The Adult Spinal Deformity Invasiveness Index incorporates deformity-specific components to assess the magnitude of correction. It's unknown how invasiveness relates to outcomes in each frailty state. PURPOSE: Investigate the relationship between increasing invasiveness and outcomes in ASD surgery in each frailty states. STUDY DESIGN/SETTING: Retrospective review of prospective, consecutively enrolled multicenter ASD database. PATIENT SAMPLE: A total of 195 ASD patients with baseline demographic and surgical details. OUTCOME MEASURES: Invasiveness, frailty, minimal clinically important differences (MCID) for the Oswestry Disability Index, SF-36 Physical Component Scores, and Scoliosis Research Society Scores.
METHOD(S): ASD patients (scoliosis >=20degree, SVA >=5cm, PT >=25degree, or TK >=60degree) with baseline frailty and invasiveness scores. Invasiveness index included; posterior: decompression (1), fusion (2), instrumentation (1), osteotomies: 3-coloumn (14), Ponte (1), interbody fusion; anterior lumbar (8), transforaminal/posterior lumbar (2), iliac fixation (2), revision surgery (3). Invasiveness scores were calculated within different frailty states (not frail, NF, <0.3), frail (F, 0.3-0.5), severely frail (SF, >0.5). Logistic regression analysis assessed the relationship between increasing invasiveness and major complications or reoperations and meeting MCID for any of the measured HRQLs at 3 years. Decision tree analysis assessed thresholds for an invasiveness risk benefit cutoff point, above which experiencing complications or reoperations and not reaching MCID were higher. Significance was set to p<0.05.
RESULT(S): One hundred ninety-five of 322 patients met inclusion criteria. Baseline demographic info: age 59.9 +/- 14.4, 75% female, BMI 27.8 +/- 6.2, CCI 1.7 +/- 1.7. Baseline surgical info: 61% osteotomy, 52% decompression, 11.0 +/- 4.1 levels fused. There were 98 NF, 65 F, and 30 SF patients. For the entire cohort, binary regression analysis found a significant relationship between increasing invasiveness and experiencing a major complication or reoperation (1.01 [1.00-1.02], p=0.01). Within each frailty subgroup, the results were 1.01 ([1.00-1.03], p=0.05) for NF, 1.01 ([1.01-1.02], p<0.001) for F, and 1.01 ([1.00-1.01], p=0.02) for SF. When defining no major complications or reoperation and meeting MCID in any HRQL at 3 years as a favorable outcome, decision tree analysis established an invasiveness risk benefit cutoff of 63.9. Patients below this threshold were 1.8 [1.38-2.35] (p<0.001) times more likely to not have a major complication/reoperation and meet MCID at 3 years. Invasiveness above this point was a negative predictor (0.55 [0.401-0.754], p<0.001). When factoring in frailty, for NF patients the risk benefit cutoff was 79.3 (2.11 [1.39-3.20] (p<0.001), 111 for F (2.62 [1.70-4.06] (p<0.001), and 53.3 for SF (2.35 [0.78-7.13] (p=0.13).
CONCLUSION(S): Increasing invasiveness is associated with increased odds of major complications and reoperations. A risk/benefit cutoff for decreasing major complications/reoperations and meeting MCID was found to be 79.3 for NF patients, 111 for F patients, and 53.3 for SF patients. Above these thresholds, increasing invasiveness is associated with increasing the risk of major complications or reoperations and not meeting MCID at 3 years. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002164951
ISSN: 1878-1632
CID: 4052022

71. High preoperative T1 slope is a marker for global sagittal malalignment [Meeting Abstract]

Ayres, E W; Woo, D; Vasquez-Montes, D; Brown, A; Alas, H; Abotsi, E J; Varlotta, C; Bortz, C; Wang, E; Pierce, K E; Smith, M; Kim, Y H; Buckland, A J; Protopsaltis, T S
BACKGROUND CONTEXT: T1 slope (T1S) is a parameter typically discussed in the context of cervical deformity and is correlated with health-related quality of life outcomes. Although prior research has suggested that T1S is related to global alignment, a definition for "high" T1S has not been established. Most patients undergoing cervical surgery do not receive full spine imaging. Therefore, it would be beneficial to have a parameter obtained from cervical radiographs that is associated with thoracolumbar malalignment. PURPOSE: To define a threshold for T1S that is associated with thoracolumbar malalignment STUDY DESIGN/SETTING: Retrospective review of a prospective adult spinal deformity(ASD) database PATIENT SAMPLE: A total of 226 preoperative ASD patients. OUTCOME MEASURES: Baseline sagittal alignment: T1S, thoracic kyphosis(TK), C7 sagittal vertical axis (SVA), T1 pelvic angle (TPA), pelvic tilt (PT), pelvic incidence-lumbar lordosis mismatch (PI-LL).
METHOD(S): A database of preoperative ASD patients was analyzed. Patients without preoperative full-spine images were excluded. Measures obtained from standing lateral radiographs included: T1S, TK, SVA, TPA, PT, and PI-LL. T1S was correlated to each of these parameters. Decision tree analysis was then used to determine the T1S corresponding to published thresholds for high TK (40degree), SVA (40mm), TPA (25degree), and PT (25.degree). Alignment between high and normal T1S patients was compared via t-tests and chi-square tests.
RESULT(S): A total of 226 preoperative ASD patients were included (mean 58+/-16y 62% F). At baseline, 30% had high TK, 54% had high SVA, 46% had high TPA, and 46% had high PT. Larger T1S was significantly correlated with greater SVA (R=.365) TPA (R=.302), TK (R=.606), and PT (R=.230)(all p<.001). Decision tree analysis yielded a threshold of 30degree for high T1S, which 50% of patients had. Compared to patients with T1S<30degree, those with T1S>30degree had higher TK (41.5degree vs 25.8degree), SVA (78.7mm vs 33.7mm), TPA (27.6degree vs 18.3degree), and PT (26.3degree vs 20.8degree), and PI-LL (18.2degree vs 11.7degree)(all p<0.05). Seventy-nine percent of patients with high T1S had high TK (T1S<30= 13%), 69% had high SVA (T1S<30=38%), 66% had high TPA (T1S<30= 37%), 60% had PT>25degree (T1S<30= 42%), and 47% had PI-LL>20degree (T1S<30= 34%) (all p<.05). T1S was not associated with PI.
CONCLUSION(S): Similar to previous studies higher T1S was associated with worse global alignment. T1S was most strongly associated with TK. A T1S=30degree corresponds to thresholds for high TK, SVA, TPA, and PT. Therefore, surgeons should consider obtaining full-spine radiographs if a T1S>30degree is present on cervical imaging. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002164943
ISSN: 1878-1632
CID: 4052032

P142. Management of coronal malalignment in the setting of fractional curve correction [Meeting Abstract]

Wang, E; Varlotta, C; Abotsi, E J; Manning, J H; Woo, D; Ayres, E W; Egers, M; Vasquez-Montes, D; Passias, P G; Protopsaltis, T S; Errico, T J; Buckland, A J
BACKGROUND CONTEXT: Sagittal malalignment has been discussed extensively in adult spinal deformity (ASD) literature, while coronal malalignment (CM) and fractional curve (FC) have received less attention. As a result, little guidance currently exists for surgical indications in managing CM, despite it being a relatively common occurrence that can considerably impact patient wellbeing. Patients with CM significantly affected by FC are at particular risk for continued CM postoperatively, along with its complications. PURPOSE: Assess types of approach to fusion of the fractional curve in ASD surgery and their relation to coronal alignment and sagittal alignment. STUDY DESIGN/SETTING: Retrospective review at single institution. PATIENT SAMPLE: A total of 82 ASD patients undergoing primary spinal fusion of 4 or more levels to sacrum or pelvis. OUTCOME MEASURES: Baseline (BL), 1-year (Y1) postoperatively and BL-Y1 difference (DELTABL-Y1) in magnitudes of FC, coronal alignment (CA) and sagittal alignment (SA) parameters: pelvic incidence-LL (PI-LL), cervical sagittal vertical axis (cSVA), T1 pelvic angle (TPA).
METHOD(S): Patients >=18 years old undergoing primary >=4-level fusion to sacrum/pelvis between October 2011 and January 2018 with minimum 6-month follow-up included. Chart review performed for operative dates and details and patient follow-up information. Coronal and sagittal parameters measured using deformity measuring software program. FC measured as segmental angle between L4 and S1. CA measured as distance between C7 plumb line and central sacral vertical line. CA>=20mm designated as CM, per guidelines in literature. Chi-squared test used to compare percentages and ANOVA used to compare means, with significance set at p<0.05.
RESULT(S): A total of 82 patients studied (68.3%F, age 62.6+/-13.3, BMI 28.1+/-6.6, Charlson comorbidity index 0.80+/-1.16). Nine patients (10.98%) had anterior-posterior fusion (AP), 41 (50%) posterior-only fusion with interbody device (PIB), 32 (39.02%) PSF without interbody (PSF). Twenty-three patients (28.04%) had FC>=15degree at BL, 7 (8.54%) at Y1. Forty-one patients (50%) had CM at BL, 35 (42.68%) at Y1. AP fusion patients had least levels fused (6.4 AP, 11.4 PIB, 11.8 PSF, p<0.001). No difference in revision by approach (55.56% AP, 24.39% PIB, 28.13% PSF, p=0.179). Approach type was not associated with different BL, Y1 or DELTABL-Y1 alignment parameters for FC, CA or SA. Mean FC 9.89degree at BL, 6.91degree at Y1 and DELTABL-Y1 difference 5.77degree, no difference between approach groups (p=0.361, 0.127, 0.550, respectively). Mean value for CA 33.62mm at BL, 21.15mm at Y1 and DELTABL-Y1 difference 23.23mm, no difference between approach groups (p=0.087, 0.153, 0.206, respectively). Mean PI-LL 25.21degree at BL, 11.1degree at Y1 and DELTABL-Y1 difference -13.7degree, no difference between approach groups (p=0.503, 0.600, 0.356, respectively). Mean cSVA 27.53degree at BL, 28.85degree at Y1 and DELTABL-Y1 difference 1.29degree, no difference between approach groups (p=0.364, 0.099, 0.141, respectively). Mean TPA 28.37degree at BL, 21.12degree at Y1 and DELTABL-Y1 difference -6.63degree, no difference between approach groups (p=0.066, 0.248, 0.138, respectively).
CONCLUSION(S): Fusion to the sacrum/pelvis improves sagittal alignment, fractional curve and coronal alignment in most patients. However, while fractional curve and sagittal alignment are better corrected, coronal malalignment, particularly more severe malalignment at baseline, tends to persist postoperatively. Type of approach and use of interbody device does not appear to significantly impact these results. This should be considered in preoperative planning for patients with coronal deformity. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002164089
ISSN: 1878-1632
CID: 4052062