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P80. Demographic differences and health impact of severe global sagittal, coronal, and mixed spinal deformity in symptomatic adults [Meeting Abstract]

Buell, T; Smith, J S; Shaffrey, C I; Kim, H J; Klineberg, E O; Lafage, V; Lafage, R; Protopsaltis, T S; Passias, P G; Mundis, G M; Eastlack, R K; Deviren, V; Kelly, M P; Daniels, A H; Gum, J L; Soroceanu, A; Hamilton, D K; Gupta, M C; Burton, D C; Hostin, R A; Kebaish, K M; Hart, R A; Schwab, F J; Bess, S; Ames, C P
BACKGROUND CONTEXT: Prior studies demonstrated that symptomatic adult spinal deformity (SASD) is a heterogeneous condition with varying degrees of negative health impact depending on the specific type and severity of deformity. Currently, there is some controversy regarding the subset of SASD with global coronal malalignment (GCM) and its associated health impact. Moreover, few reports have assessed the health impact of this global coronal parameter in comparison to other deformity types. A comparative study of deformity types with severe global malalignment (eg, severe GCM) may provide clinically relevant insights and identify potential differences in demographics and health impact. PURPOSE: To compare demographics and health impact of SASD patients with severe global malalignment (primary sagittal [SAG-only] vs primary coronal [COR-only] vs sagittal+coronal [MIX]). STUDY DESIGN/SETTING: Retrospective analysis of a prospective multicenter database. PATIENT SAMPLE: Enrollment required age >=18 yrs and one of the following: scoliosis >=20degree, sagittal vertical axis (SVA) >=5cm, pelvic tilt >=25degree, and/or thoracic kyphosis >=60degree. OUTCOME MEASURES: Short Form-36 (SF-36) PCS score.
METHOD(S): Consecutive SASD patients from a prospective multicenter database were evaluated for type and severity of global malalignment. Severe alignment thresholds included SVA >=10cm (SAG-only), GCM >=6cm (COR-only), or both SVA >=10cm and GCM >=6cm (MIX). SF-36 PCS scores were compared with U.S. normative values.
RESULT(S): Of 492 SASD patients that met threshold alignment criteria, 463 (94%) completed the SF-36 and were included (78% women, mean age 65 years, mean BMI 28.6 kg/m2, previous spine surgery in 65%). Deformity types were SAG-only (58%), COR-only (19%) and MIX (23%). COR-only had more women (94%, p<0.001), younger age (61 years, p=0.004), and lower BMI (26 kg/m2, p<0.001). Charlson Comorbity Index (CCI) scores and total number of comorbidities were comparable among the deformity types (p>0.05). All deformity types were 'frail' based on ASD-Frailty Index scores (SAG-only [3.9], COR-only [3.1], MIX [4.0]). Overall mean PCS was lower compared to similar age- and gender-matched U.S. normative values (29.0 vs 45.3, p<0.001). Mean PCS was significantly different between deformity types (p<0.001): SAG-only (28.5) vs COR-only (33.1) vs MIX (27.0). PCS offsets from normative population scores were significantly different between deformity types (p=0.001): SAG-only (-16.6) vs COR-only (-13.4) vs MIX (-18.2).
CONCLUSION(S): Demographic comparisons demonstrated significantly more women, younger age, and lower BMI in the COR-only deformity type. Severe global malalignment (SVA >=10cm and/or GCM >=6cm) had substantial debilitating impact on health, with MIX deformity type (i.e., severe global sagittal and coronal malalignment) experiencing the greatest health impact. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747201
ISSN: 1878-1632
CID: 4597612

209. Patient-specific cervical deformity corrections with consideration of associated risk: establishment of risk benefit thresholds for invasiveness based on deformity and frailty severity [Meeting Abstract]

Passias, P G; Pierce, K E; Lafage, R; Lafage, V; Klineberg, E O; Daniels, A H; Kebaish, K M; Protopsaltis, T S; Jr, R A H; Line, B; Hart, R A; Burton, D C; Bess, S; Schwab, F J; Shaffrey, C I; Smith, J S; Ames, C P; International, Spine Study Group
BACKGROUND CONTEXT: Cervical deformity (CD) severity has been linked to poor quality of life and severe neck pain. However, little is known of the relationship between surgical invasiveness accounting for cervical deformity severity and frailty status. PURPOSE: Investigate the outcomes of CD surgery by invasiveness, frailty status and baseline degree of deformity. STUDY DESIGN/SETTING: Retrospective cohort study. PATIENT SAMPLE: Ninety-six CD patients. OUTCOME MEASURES: HRQL measurements: NDI, EQ5D, mJOA.
METHOD(S): Inclusion criteria was defined as operative CD patients (C2-C7 Cobb>10degreeor CK>10degree, cSVA>4cm or CBVA>25degree) >18yr with follow up (1-year) radiographic and HRQL scores, NDI, mJOA and EQ5D. Patients were stratified by severity of deformity by TS-CL, categorized by the new-mJOA based modifiers: Low/Mod <45degree (Low-Mod); Severe >45degree(Sev). Frailty scores were calculated based upon the modified CD frailty index by Passias et. Al and categorized into severely frail (SF) >=0.5 and not SF (N-SF)<0.5. Patients were categorized by their frailty and deformity status (Low-Mod/N-SF; Low-Mod/SF; Sev/N-SF; Sev/SF). Logistic regression analysis assessed the relationship between increasing invasiveness and outcomes (DJK, complications). Within the significant frailty/deformity risk groups, decision tree analysis assessed thresholds for an invasiveness severity cut-off point, below which experiencing a reoperation, complication, DJK occurrence and poor mJOA were higher.
RESULT(S): Ninety-six CD patients met inclusion criteria (62.2+/-10.2 years, 66% female, 28.4+/-7.4 kg/m2). By approach: 19.8% anterior-only, 47.9% posterior-only, 32.3% combined (levels fused: 7.7+/-3.9). By deformity severity: 23.7% Low, 40.9% Moderate, 34.4% Severe, while frailty assessment placed 32.3% in N-SF and 67.7% SF. This categorized the patients into deformity/frailty groups as follows: 19.8% Low-Mod/N-SF(19), 13.5%(13) Sev/N-SF, 44.8%(43) Low-Mod/SF, 21.9%(21) Sev/SF. Logistic regression analysis found a significant relationship between increasing deformity severity and occurrence of severe postop DJK(1.053 [1.016-1.093], p= 0.005), complications(1.045 [1.012 - 1.080], p=0.007), revision by 1-year(1.059 [1.000-1.122], p= 0.049). Additionally, increasing invasiveness and occurrence of severe DJK (1.030 [1.007-1.054], p= 0.024) and revision (1.026 [1.008 - 1.044], p=0.005). Invasiveness increased with deformity and frailty severity: 53.6 Low-Mod/N-SF, 81.4 Sev/N-SF, 56.4 Low-Mod/SF, 79.8 Sev/SF; p=0.002. After defining a favorable outcome as no occurrence of severe DJK, no major complications and no revisions, and 1Y mJOA improvement (28.1%), invasiveness scores were compared within deformity/frailty groups between patients who met/did not meet the favorable outcome. For the NSF deformity groups, those with a favorable outcome had larger invasiveness scores (Low-Mod: 58.7 vs 48.5; Sev: 77.7 vs 89.6). For the SF deformity groups, the favorable outcome had significantly lower invasiveness scores for the Low-Mod deformity group (38.1 vs 62.9, p=0.008), while the Sev/SF deformity favorable outcome group remained larger (86.8 vs 79.4), though this was not significant. For the Low-Mod/SF group an invasiveness cutoff score of <48 where achieving a favorable outcome was 3x higher (3.08[1.2-7.9], p=0.019).
CONCLUSION(S): For SF patients, when deformity severity is low to moderate, surgeons may limit the invasiveness of their procedures in order to account for the patient's susceptibility to poor outcomes. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747231
ISSN: 1878-1632
CID: 4597562

190. Assessing the impact of surgical and patient factors on recovery kinetics after ASD surgery [Meeting Abstract]

Neuman, B J; Sachdev, R; McNeely, E; Klineberg, E O; Passias, P G; Protopsaltis, T S; Smith, J S; Ames, C P; Bess, S; Kebaish, K M
BACKGROUND CONTEXT: Although researchers have extensively studied factors predicting clinical outcomes at static time points, assessing rate of recovery after adult spinal deformity (ASD) surgery has largely been ignored. This study aims to address this gap in knowledge by evaluating the impact of frailty and invasiveness on recovery kinetics, using area-under-the-curve (AUC) methodology. PURPOSE: To assess the impact of patient specific and surgical factors on postoperative recovery kinetics. STUDY DESIGN/SETTING: Retrospective review of a prospective, multicenter database. PATIENT SAMPLE: A total of 320 patients were identified from a multicenter database who had minimum 2-year HRQOL follow-up, with preoperative, 6-week and 1-year data available. OUTCOME MEASURES: Our primary outcome measure was integrated health state (IHS) score, a marker of postoperative recovery.
METHOD(S): ASD patients with minimum 2-year follow-up were stratified by frailty and surgical invasiveness. Previously validated ASD-FI scores were used to separate non-frail (<.3) patients from those that there were frail (.3 to.5) and severely frail (>.5). Patients were also stratified by surgical inverness, using ASD-SR, into four quartiles, Q1: <65, Q2: 66-89, Q3: 90-119, Q4: >120. Patient demographics, BMI, CCI and surgical parameters were also collected. To assess recovery kinetics, SRS-22r and ODI scores at 6-weeks, 1-year and 2-year were normalized against preoperative values and graphed as a function of time. AUC was summed across all time points to generate a single IHS score. Multivariate linear regression was used with IHS scores as primary outcome variable.
RESULT(S): A total of 320 patients met the inclusion and exclusion criteria. The mean (SD) patient age was 58.6 (14.7) with 79% female. Overall, 139 were non-frail, 131 frail and 46 severely frail. On univariate analysis, frail and severely frail patients were noted to have worse baseline and 2-year HRQOL scores for SRS pain, activity and ODI; however, when comparing differences in HRQOL across this 2-year period, F and SF were noted to have greater improvements in both SRS and ODI (p<.05). On multivariate regression, frail and severely frail patients, compared to those non-frail, were found to have better IHS scores for ODI, SRS-22r pain, and SRS-22r activity, indicating more favorable recovery (p<.05). In particular, for SRS-22r activity, frail (adjusted beta: 0.37, p=<.01) and severely frail (adjusted beta: 0.74, p=<.01) patients were found to have higher IHS compared to their non-frail counterparts. Similarly, for SRS-22r pain, frail and severely frail patients showed improved recovery with higher IHS scores in comparison to non-frail patients. In contrast to frailty, operative variables, including surgical invasiveness and EBL, were insignificant predictors of IHS scores for either ODI or SRS-22r domains.
CONCLUSION(S): Our results suggest that patient-specific factors, namely frailty, play a larger role in predicting postoperative recovery kinetics, in comparison to surgical factors, which appear to have limited if any impact. Despite frail patients having lower preoperative and 2-year HRQOL scores, they were noted to have higher IHS scores SRS pain, activity, and ODI indicating more favorable recovery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747283
ISSN: 1878-1632
CID: 4597482

P74. Adult spinal deformity patients with metabolic syndrome have significantly higher costs [Meeting Abstract]

Passias, P G; Brown, A; Pierce, K E; Bortz, C; Alas, H; Hassanzadeh, H; Labaran, L; Protopsaltis, T S; Buckland, A J
BACKGROUND CONTEXT: Adult spinal deformity (ASD) correction involves complex, invasive procedures. However, it is unknown how metabolic syndrome affects the cost efficiency of ASD surgery. PURPOSE: Investigate the differences in ASD surgery cost for metabolic syndrome patients. STUDY DESIGN/SETTING: Retrospective review of a single center ASD database. PATIENT SAMPLE: A total of 557 ASD patients. OUTCOME MEASURES: Complications, revisions and costs.
METHOD(S): ASD patients (scoliosis >=20degree, SVA>=5cm, PT >=25degree, or TK >=60degree) >=18, undergoing >=4 level fusions were included. Descriptive analysis assessed mean baseline demographic, radiographic and surgical data were assessed. Patients diagnosed with: BMI >30, diabetes mellitus, and HTN were classified metabolic syndrome patients (MetS). Independent samples T-tests assessed baseline differences in SVA, PT, PI-LL, and levels fused between MetS and non-MetS patients. Total surgery costs for MetS and non-MetS ASD patients were compared. Costs were calculated using the PearlDiver database, which reflects both private insurance and Medicare reimbursement claims. Complications and comorbidities (CC) and major complications and comorbidities (MCC) were assessed according to CMS.gov manual definitions.
RESULT(S): A total of 557 patients met inclusion criteria. Baseline demographics and surgical details: age 60.8 +/- 13.2, 67.5% female, BMI 28.3 +/- 6.67, 6.2% anterior approach, 81.0% posterior approach, 12.8% combined approach, 10.4 +/- 3.9 levels fused, op time 423.5 +/- 166.4 minutes, EBL 2061.4 +/- 1631.5 cc, LOS 7.6 +/- 5.4 days. 11 MetS patients were included. There was no significant difference in BL SVA (54.2degree vs 70.3degree), PT (26.7degree vs 23.7degree), PI-LL (16.4degree vs 21.2degree), or levels fused between groups (10.5 vs 10.6) (all p>0.05). Twenty-seven percent of MetS patients experienced a CC or MCC, with 18% undergoing revisions within 90 days (vs 13.2% and 3.2% for non-MetS, p<0.05). The average costs of surgery for MetS patients was $68,004.06 vs $48,726.40 for non-MetS patients (p<0.05).
CONCLUSION(S): Metabolic syndrome is a growing concern among health care providers. In metabolic syndrome patients undergoing corrective adult spinal deformity surgery, the total costs of surgery was 28.4% higher for metabolic syndrome patients ($68,004.06 vs $48,726.40). Optimizing modifiable factors like diabetes or BMI in preoperative patients may have an impact on cost effectiveness. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747218
ISSN: 1878-1632
CID: 4597582

P48. Disparities in etiology, clinical presentation and determinants for distal junctional kyphosis based on timing of occurrence: are we treating two separate issues? [Meeting Abstract]

Pierce, K E; Passias, P G; Lafage, V; Lafage, R; Kim, H J; Daniels, A H; Eastlack, R K; Klineberg, E O; Line, B; Protopsaltis, T S; Burton, D C; Bess, S; Schwab, F J; Shaffrey, C I; Smith, J S; Ames, C P; International, Spine Study Group
BACKGROUND CONTEXT: Following cervical deformity (CD) corrective surgery, durability remains a challenge and distal junctional kyphosis (DJK) is an important risk for a surgeon to consider. DJK is the result from fixation failure, adjacent level fracture or spondylolisthesis. The timing of DJK onset has yet to be investigated. PURPOSE: To determine the timing of DJK development following CD corrective surgery. STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: A total of 139 CD patients. OUTCOME MEASURES: Early/Late DJK Development, Severe DJK, Symptomatic DJK.
METHOD(S): Included: surgical CD patients (C2-C7 Cobb>10degree, CL>10degree, cSVA>4cm, or CBVA>25degree) without preop DJK. DJK angle was defined as the change in kyphosis between lower-most instrumented vertebra (LIV) and LIV-2 from preop to postop (<-10). X2 analysis and post-hoc testing assessed annual and overall incidence of early (3M follow-u) and late (DJK development at 6M, 1Y, 2Y) DJK development among operative patients. Differences between early and late DJK (development after 3 months) were assessed. Pearson correlations determined significant variables associated with development of early versus late DJK. Severe DJK was defined as DJK angle <-20degree. DJK was considered symptomatic if associated with reoperation or the previously published thresholds of NDI>24 or mJOA<14. The natural progression of the disease was predicted with the use of a Kaplan-Meier survivorship analysis.
RESULT(S): A total of 139 patients without preop DJK were included (16 re-op) (61.8yrs, 62.3%F, 29.1kg/m2). Surgical characteristics: 20.1% anterior approach, 42.4% posterior, 36.7% combined (levels fused: 7.6). Incidence of DJK from 2013-2018: 23%. Early: 9.4%, late: 10.1% (6M delayed: 3.6%, 1Y delayed: 6.5%, 2Y delayed: 2.2%). No differences were observed between op and reop for development of early or late DJK at all f/u (p>0.050). Presence of upgoing plantar response at baseline neuro exam, C2-C7 angle, T1-C2 angle, CBVA and combined approach correlated with development of early DJK. For late DJK: history of tumor and pulmonary disease, pelvic incidence, T10-L2 angle, and L4 pelvic angle. Apex of the secondary driver was significantly lower in the Late group (mean early: T2/3; late: T10; p=0.023). 3M radiographically, Early DJK patients had greater TK (-57.9degree vs -40degree, p=0.024, while L4PA remained larger in the late DJK group (14.5degree, p=0.009). Between early and late groups, 41.7% of early DJK patients met criteria for severe DJK, while 0% of Late DJK patient were severe(p=0.010); symptomatic DJK between the two groups was not significant (p=0.941). Kaplan-Meier survivorship analysis determined patients within the cohort to have a 91.1% cumulative probability of maintaining non-DJK status by 3-month follow-up, 85.9% at 6-month, 80% at 1-year, and 77.0% by 2-year follow-up.
CONCLUSION(S): Patients undergoing CD corrective surgery have incidence of early and incidence of late DJK. While the majority of DJK development occurs within the first 6 months, late DJK occurs and differs in presentation and etiologic factors. Early DJK occurrence is more likely to be severe radiographically, associated with neurological decline, and is more strongly related to biomechanical factors such as use of a combined approach at the time of surgery. Contrarily, although equally likely to be symptomatic as reflected in loss of clinical gains from surgery, late DJK is more likely mild radiographically and associated with suboptimal cervical realignment and lack of addressing secondary drivers, likely related to negative compensatory mechanisms. Customized prophylactic approaches for both occurrences is mandated. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747175
ISSN: 1878-1632
CID: 4597702

275. Opioid use after adult spinal deformity surgery: propensity-matched comparison of Japanese vs amAmerican cohorts [Meeting Abstract]

Gum, J L; Carreon, L Y; Yagi, M; Hosogane, N; Watanabe, K; Smith, J S; Shaffrey, C I; Kim, H J; Klineberg, E O; Lafage, V; Lafage, R; Protopsaltis, T S; Passias, P G; Mundis, G M; Eastlack, R K; Kelly, M P; Daniels, A H; McNeely, E; Soroceanu, A; Hamilton, D K; Gupta, M C; Burton, D C; Hostin, R A; Kebaish, K M; Hart, R A; Schwab, F J; Bess, S; Ames, C P; International, Spine Study Group
BACKGROUND CONTEXT: Amidst a current US opioid epidemic, it is important to understand factors that contribute to long-term or sustained opioid use after elective spine surgery. Recent reports have reported up to 25% of opioid-naive patients are taking opioids at 2-year follow-up after adult spinal deformity (ASD) surgery. This suggests ASD surgery, or at least the postoperative course, could be a significant factor contributing to long-term or sustained opioid use. ln Asian countries, opioids are rarely prescribed for postoperative pain. Potentially, there is a significant cultural difference that can play a role in patient expectations in the postoperative period leading to long-term opioid use. PURPOSE: To compare long-term or sustained (2-years) opioid use after ASD surgery between American and Japanese Cohorts STUDY DESIGN/SETTING: Propensity-matched comparison of American and Japanese ASD patients PATIENT SAMPLE: Patients from two (United States vs Japanese) prospective, multicenter ASD databases were compared OUTCOME MEASURES: Baseline and 2-year opioid use and SRS-22 domains were compared METHODS: We propensity matched 127 JPN to 619 US ASD patients based on age, sex, BMI, 3-column osteotomy, pelvic fixation, number of levels fused and preoperative SVA. Pre-op and 2-year postoperative opioid use was determined using responses to SRS22R Q11 and grouped into 3 categories (none, weekly, or daily). We have previously validated the use of SRS22R Q11 as an accurate measure for opioid use by comparing to a prospective study specifically designed to study opioid use and postoperative outcomes in ASD.
RESULT(S): From each cohort, 34 cases were successfully matched, with no difference in baseline parameters, including baseline opioid use (p=0.095), between the cohorts. The relatively low numbers in each cohort arise from difficulty matching a lower BMI and lower baseline opioid use in the JPN cohort. At 2-years postop, 22 US (65%) vs 31 JPN (91%) reported no opioid use, 1 US (3%) vs 0 JPN (0%) reported weekly use, and 11 US (32%) vs 3 JPN (9%) reported daily use (p=0.009). There was no difference in 2-year SRS-22 Self-image and Mental Health between the two groups while US patients had better Satisfaction (4.29 vs 3.84, p=0.032) but lower Function scores (3.52 vs 3.90, p=0.029).
CONCLUSION(S): In propensity-matched ASD cohorts, 35% of US patients were still using opioids 2 years after surgery compared to 9% of JPN patients, with the most taking opioids daily. Further studies are needed to identify sources of this variability. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747272
ISSN: 1878-1632
CID: 4597492

170. Radiculitis: assessing the risk of biologic use in minimally invasive transforaminal lumbar interbody fusions [Meeting Abstract]

Stickley, C; Wang, E; Ayres, E W; Maglaras, C; Fischer, C R; Stieber, J R; Quirno, M; Protopsaltis, T S; Passias, P G; Buckland, A J
BACKGROUND CONTEXT: Recombinant human bone morphogenetic protein 2 (BMP) is increasingly utilized in minimally invasive (MIS) transforaminal lumbar interbody fusions (TLIF) in order to increase rate of fusion by promoting bone growth through the induction of osteoblast differentiation, awhile reducing morbidity related to iliac crest autograft. Despite these benefits, BMP use is still controversial due to its pro-inflammatory mechanism of action and potential to cause radiculitis. PURPOSE: To assess whether BMP is a risk factor for postoperative radiculitis in TLIF. STUDY DESIGN/SETTING: Single-center retrospective cohort study. PATIENT SAMPLE: A total of 397 TLIFs from June 2012 to December 2018. OUTCOME MEASURES: Perioperative clinical characteristics, post-operative risk of radiculitis and complication, and future reoperation rates.
METHOD(S): Patients >= 18 years-old undergoing elective single-level TLIFs from 2012 to 2018 were included. Outcome measures included perioperative clinical characteristics, postoperative risk of radiculitis and complication, and future reoperation rates. Radiculitis was defined the delayed onset of radicular symptoms postoperatively in patients whom had initial resolution of radicular symptoms immediately postoperatively, in the absence of persistent neurological compression on postoperative imaging. Statistical analyses included independent t-tests and chi-square analysis. Propensity score matching was utilized to control for demographic differences between the groups. Independent predictors for post-operative radiculitis were assessed by multivariate logistic regression. Significance set at p<0.05.
RESULT(S): A total of 397 cases were included in the study (59.33 +/- 13.49 mean age, 28.98 +/- 6.29 mean BMI, 52.90% female, 2.29 +/- 1.92 average Charleston comorbidity Index). There were 223 open procedures and 174 MIS. For the entire cohort, 238 cases utilized BMP and 159 did not, with 102 MIS pairing with BMP use. The MIS TLIFs had a higher percentage of BMP use than open TLIFs (58.6% vs 25.7%, p<0.001), lower estimated blood loss (212.28 +/- 193.79 mL vs 410.91 +/- 337.98 mL, p<0.001) higher fluoroscopy dosage (52.43 +/- 48.61mGy vs 16.77 +/- 27.84mGy, p<0.001), and a lower length of stay (3.20 +/- 2.55 days vs 4.11 +/- 2.52 days, p<0.001). There were no other differences in perioperative clinical characteristics. There was a significantly higher rate of postoperative radiculitis in the MIS TLIFs compared to open (12.6% vs 6.8%, p=0.046) and use of BMP compared to no BMP (13.2% vs 6.7%, p=0.029). There was a 15.7% radiculitis rate when MIS was paired with BMP use. There were no other notable differences in complication rates or rates of reoperation. Individually, MIS had a 12.6% radiculitis rate (p=0.046) and BMP use had a 13.2% rate (p=0.029). Propensity score match controlled for the significant difference in CCI between the MIS and open groups (N=168 each). Multivariate regression indicated that MIS (p=0.314) and BMP (p=0.109) were not independent predictors individually when controlling for age, gender, and BMI. When technique was paired with biologic use the regression revealed MIS + BMP is a risk factor of post-operative radiculitis (2.265(4.753-1.079), p=0.031).
CONCLUSION(S): While BMP and MIS technique were not independent risk factors for postoperative radiculitis, there is an increased risk of radiculitis when using BMP in MIS TLIF. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747262
ISSN: 1878-1632
CID: 4597512

P103. The modification of appropriateness criteria for a cervical deformity corrective surgery [Meeting Abstract]

Pierce, K E; Ahmad, W; Naessig, S; Vira, S N; Lafage, R; Lafage, V; Buckland, A J; Protopsaltis, T S; Diebo, B G; Passias, P G
BACKGROUND CONTEXT: The Scoliosis Research Society established appropriateness criteria for surgery for degenerative lumbar scoliosis (DLS) in order to improve and unify clinical decision making. Though utilized and validated in various cohorts, an appropriateness criteria has yet to be developed in a cervical deformity (CD) population. PURPOSE: To modify the DLS Appropriateness criteria to be utilized in a CD cohort. STUDY DESIGN/SETTING: Retrospective review of a single-surgeon CD database PATIENT SAMPLE: A total of 100 CD patients. OUTCOME MEASURES: Appropriateness criteria.
METHOD(S): CD patients>18yrs were included. Each patient was scored based upon the SRS-appropriateness criteria, comprised of clinical or radiographic characteristics and was modified for a cervical deformity cohort: (1) Severity of Symptoms [NDI], (2) Severity of Myelopathy[mJOA.], (3) Progression of Deformity, (4) Global Sagittal Malalignment [Schwab modifiers], (5) Severity of Risk Factors, (6) Degree of the T1S-CL curvature. For the category 'progression', radiographs were only available at one preoperative time point, and we were unable to include this in the total score. Based upon certain combinations of criteria, patients were stratified into Appropriate and Not Appropriate.
RESULT(S): A total of 100 patients were included (61yrs, 62% F, 29.5kg/m2). Assessment of the categories of Appropriateness of CD surgery: (1) Symptoms: 6% None to Mild, 94% Moderate to Severe; (2) Myelopathy: 16% None to Mild, 45% Moderate, 39% Severe; (3) All were grouped No Progression in the present study; (4) 19% demonstrated Global Malalignment (+/++Schwab), 81% did not; (5) Risk Factors: 27% had None to Mild, 63% Moderate, 10% Severe; (6) Curvature TS-CL demonstrated 88.6% of patients Severe (>20degree). Not Appropriate: None to Mild (NDI <28), with (1) None to Moderate myelopathy (mJOA >12) and Severe Risk Factors (2) None to Mild myelopathy (15-18) and No Progression or Imbalance (3) Moderate myelopathy (mJOA 12-15) and None to Moderate Risk Factors and no Progression, or imbalance and TSCL <25degree. Appropriate: Moderate to Severe Symptoms (NDI >=30), with (1) Severe myelopathy (mJOA<12) and Any Risk Factors (2) Moderate myelopathy and None to Moderate Risk Factors (3) Moderate myelopathy with Severe Risk Factors, Progression AND Imbalance (4) None to Mild myelopathy and None to Moderate Risk Factors and Progression OR imbalance (5) None to Mild myelopathy with None to Moderate Risk Factors and TSCL >25degree. In the present cohort, 94% were deemed Appropriate for surgery, 6% Not Appropriate. Less Appropriate patients demonstrated higher rates of postop dysphagia complications (17% vs 2%), met MCID for NDI less (0% vs 30.9%), and had more occurrences of DJK (16.7% vs 6.4%) by 2 years, p<0.05.
CONCLUSION(S): In light of the heterogeneity and uncertainty surrounding CD, this study developed CD appropriateness criteria, using established methodology, for surgeons to consider in the preoperative decision-making that correlate well with major postop occurrences. Application of the appropriateness criteria for CD may optimize patient selection and reduce the incidence of unwarranted surgery, although future validation is necessary. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747172
ISSN: 1878-1632
CID: 4597712

245. Predicting massive intraoperative blood loss in adult spinal deformity surgery [Meeting Abstract]

Soroceanu, A; Scheer, J K; Protopsaltis, T S; Gupta, M C; Passias, P G; Gum, J L; Smith, J S; Mundis, G M; Bess, S; Lafage, V; Ames, C P; Klineberg, E O; International, Spine Study Group
BACKGROUND CONTEXT: Due to inherent patient and surgical factors, some adult spinal deformity patients are at higher risk of larger blood loss. This is associated with increased risk of complications, coagulopathy, and higher requirements for blood component replacement intraoperatively. The medical team should be aware of expected blood loss in order to adequately plan patient monitoring and blood product requirements. PURPOSE: This study aims to develop and validate a model based on patient characteristics and surgical strategies to predict which patients undergoing adult spinal deformity surgery are at greater risk of massive intra-operative blood loss. STUDY DESIGN/SETTING: Retrospective analysis of a multicenter prospective database. PATIENT SAMPLE: Surgical ASD patients undergoing long fusions (>5 levels). OUTCOME MEASURES: Massive intraoperative blood loss (>7% of a patient's ideal body weight), ICU stay, complications.
METHOD(S): Surgical adult spinal deformity patients undergoing long fusions (> 5 levels) were analyzed. Massive blood loss was defined as an intraoperative blood loss over 7% of a patients' ideal body weight, in accordance to the anesthesia literature. The impact of mEBL on complications and ICU stay was assessed through multivariate poisson and logistic regression, adjusting for baseline patient demographics and magnitude of surgery. Multivariate logistic regression modeling was used to build a prediction model of mEBL. Potential predictors were identified using univariate analysis. The model was built using a combination of backward elimination and bootstrap selection. Model fit was assessed using the Hosmer-Lemeshow test and the ROC curve. Split sample internal cross-validation was performed.
RESULT(S): A total of 1,205 patients met inclusion criteria, and mEBL occurred in 7.8% (94/1205) of cases. In this cohort, mEBL was an independent risk factor for major complications (IRR 2.89, p=0.0001), and postoperative ICU stay (OR 4.68, p=0.001). Predictors of mEBL included: revision surgery (OR 1.66, p=0.05), performing a three-column osteotomy (OR 2.65, p=0.0001), number of levels fused (OR 1.19, p=0.0001), number of levels decompressed (OR 1.15, p=0.004), and number of LLIF interbodies (OR 0.69, p=0.066). The predictive model had a good discrimination (ROC curve 0.76), and good calibration (Hosmer-Lemeshow p=0.39), which held true when performing split-sample cross-validation.
CONCLUSION(S): We built and validated a model to predict massive intra operative blood loss in ASD surgery. In this model, baseline patient demographics and elements of the surgical strategy are used to predict which patients are at greater risk for massive blood loss. This tool would be of particular help to the anesthesia team, allowing to identify preoperatively which patients are at greater risk and plan intraoperative care and fluid management accordingly. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747464
ISSN: 1878-1632
CID: 4597152

P23. Does prior cervical fusion (CF) affect PJK rate and UIV level selection in thoracolumbar fusion surgery for adult spinal deformity (ASD)? [Meeting Abstract]

Mundis, G M; Lafage, R; Lafage, V; Eastlack, R K; Klineberg, E O; Passias, P G; Protopsaltis, T S; Soroceanu, A; Shaffrey, C I; Smith, J S; Bess, S; Kebaish, K M; Gupta, M C; Hostin, R A; Kelly, M P; Kim, H J; International, Spine Study Group
BACKGROUND CONTEXT: Many different risk factors for PJK have been identified in those having surgery for ASD. The presence of CF prior to thoracolumbar fusion as a risk factor in this patient population has not been investigated. PURPOSE: To investigate if prior cervical fusion would be a risk factor for PJK when upper thoracic UIV was selected. STUDY DESIGN/SETTING: Retrospective review of prospective multicenter database. PATIENT SAMPLE: Inclusion: age >18 and one of the following inclusion criteria was queried: PI-LL >10, PT >20, Max Cobb>10, SVA > 5 cm. OUTCOME MEASURES: Development of PJK; HRQOL include NRS back and leg, ODI, SRS-22, EQ5D METHODS: Inclusion: age >18 and one of the following inclusion criteria was queried: PI-LL >10, PT >20, Max Cobb>10, SVA > 5 cm. 1023 patients were identified and grouped as CF (prior CF; n=101) and NoCF (n=922). Patients with 5 or fewer levels of CF and those without further cervical spine surgery at final follow-up were included (cASD= 86; ASD= 910). After initial analysis propensity matching was performed controlling for: age, BMI, pre-op alignment (PI, PI-LL, TPA, SVA), change in alignment (PI-LL), and UIV/LIV.
RESULT(S): Among 996 patients the CF group was older (64 v 60; p<0.000), higher BMI (29.7 v 28; p<0.014), with equal gender distribution. PJK at 1 year was 34.9% (n=30) in CF and 34.7% (n=316) in NoCF. All patients included had a minimum of four segments unfused between CF and TL fusion. No differences were found between groups when stratifying by UIV (UT=upper thoracic; LT=Lower thoracic; L=lumbar). Radiographically CF had worse preop deformity (PI-LL 21.3 v 17.2; TPA 27.3 v 23.6; SVA 90.6 v 68.5; p<0.05), with no difference in postop alignment between groups. CF was more likely to have LT UIV (61.6% v 46%; p=0.045) and fusion to the ilium (93% v 81%; p=0.005). After propensity matching 79 patients were included in each group. CF had 68 patients with ACDF, 5 patients with PSF, and 6 patients with A/PSF. There was no difference in the rate of PJK (39.2 v 34.2%), PJK magnitude (13.4 v 13.7) or change in PJK angle (10.1 v 10.4). PJK rate and magnitude are not different by UT or LT as UIV.
CONCLUSION(S): The presence of CF is not associated with the development of PJK or PJK magnitude in this propensity matched cohort. All CF patients had a minimum of four segments unfused between the CF and the TL fusion which may act as a buffer and be protective of PJK. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747445
ISSN: 1878-1632
CID: 4597172