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97. Complications following adult spinal deformity impact length of stay and are driven by intervention severity and can be predicted using a weighted score [Meeting Abstract]

Klineberg, E O; Lafage, R; Lafage, V; Smith, J S; Shaffrey, C I; Mundis, G M; Kim, H J; Gupta, M C; Ames, C P; Passias, P G; Protopsaltis, T S; Burton, D C; Schwab, F J; Bess, S; International, Spine Study Group
BACKGROUND CONTEXT: Complications occur commonly following adult spinal deformity surgery. Length of stay may be influenced by the type of surgical intervention, and/or by postoperative complication and the intervention required to treat that complication. PURPOSE: To understand the impact of complications and their intervention severity on the incremental increase in length of stay. STUDY DESIGN/SETTING: Retrospective cohort study of prospective ASD database. PATIENT SAMPLE: The study included 1418 adult spinal deformity patients. OUTCOME MEASURES: Neurologic complications, HRQL scores.
METHOD(S): ASD patients (>18yrs, scoliosis >=20degree, SVA >=5cm, PT >=25degree and/or TK >60degree). Complications were classified based on complication type, and intervention severity (grade 0, no intervention, Grade 1 minimal intervention (medication change, etc), Grade 2 moderate (cardioversion, chest tube, etc), grade 3 major intervention (return to OR).
RESULT(S): Of the 1418 patients included, 901 had at least one complication event, with 568 with a complication before discharge. Three hundred and six had an event that required a reoperation and 275 were readmitted for their event. When determining LOS, a baseline was established that was influenced by the type of surgery and placed into three groups based on osteotomy (O) and interbody use (I); Group 1 (n408): 0% O, 75% I, LOS=7.9, Group 2 (n374): 100% O, 0% I, LOS=11.9, Group 3 (n595) 100% O and I, LOS=11.2. Having a complication event prior to discharge led to an increase of 1-4 days for each group (p<0.01). This was true for every complication, regardless of type, but was worse for renal and pneumonia. The increase in LOS was most driven by the intervention required. No intervention had an LOS of 6.9, Grade 1 +1.2 days, Grade 2, +1.8 days, Grade 3 +2.5 days. Using the sum of a weighted intervention score (SUM=1*#grade1 + 2*#grade2 + 3*#grade3), we can even more accurately predict the incremental increase in LOS. This occurs until a weighted score of 7 which accurately predicts an increase of 7.5 days.
CONCLUSION(S): Length of stay following ASD is predicted by the type of surgical intervention, and postoperative complication profile. Additional days are most predicted by the type of complication and by intervention severity. A weighted intervention score can predict the additional LOS and is useful to help understand the impact of complications. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747183
ISSN: 1878-1632
CID: 4597662

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

167. Validation of the ACS-NSQIP risk index in a prospective, multicenter adult spinal deformity database [Meeting Abstract]

Pierce, K E; Passias, P G; Lafage, V; Lafage, R; Mundis, G M; Uribe, J S; Kim, H J; Protopsaltis, T S; Daniels, A H; Hart, R A; Burton, D C; Shaffrey, C I; Schwab, F J; Ames, C P; Smith, J S; Bess, S; Klineberg, E O; Group, I S S
BACKGROUND CONTEXT: Adult spinal deformity (ASD) corrective surgery is often associated with high rates of adverse outcomes during the recovery course. With the growth of predictive analytics in the medical field, it is important to utilize the developing machine-learning resources to consider the risks associated with major operations. PURPOSE: To assess the validity of the ACS-NSQIP risk index for postop complications and mortality in a prospective multicenter ASD database. STUDY DESIGN/SETTING: Retrospective cohort study of a prospective multicenter ASD database PATIENT SAMPLE: A total of 1,281 ASD patients. OUTCOME MEASURES: Predictive performance of the ACS-NSQIP calculator in an ASD database.
METHOD(S): Patients>18yrs undergoing surgery for ASD (scoliosis>=20degree, SVA>=5cm, PT>=25degree or TK>=60degree). Calculated perioperative complication risk averages via the ACS-NSQIP surgical calculator with CPT codes were compared with 30-day complication rates in the ASD database. Outcomes assessed (as defined by NSQIP): serious complication, any complication, pneumonia, cardiac complication, SSI, UTI, VTE, renal failure, return to OR, death, sepsis and length of hospital stay. Predictive performance of the calculator was analyzed by Brier score (sum of squared differences between the binary outcome and the predicted risk). It ranges from 0 to a maximum Brier score [(mean observed outcome)*(1-[mean observed outcome])]. Values closer to 0 are suggestive of better predictive performance (>0.05 considered poor). Length of stay was assessed with a Bland-Altman plot, observed LOS on the x-axis and the difference between the observed and predicted LOS on the y-axis. Performance of the calculator for serious/any complications for surgeries indicated as 'Risk significantly higher than estimate' was assessed by comparing means of patients who were in the top quartile for their ISSG-invasiveness scores.
RESULT(S): A total of 1,281 ASD patients (60.2 yrs, 73.5% F, 28 kg/m2) were included. A total of 49.4% of procedures involved decompression and 100% involved fusion, with a mean number of levels fused of 10.98. The means for individual patient characteristics that coincide with the variables entered into the online risk calculator interface are as follows: functional status through baseline ODI scores (Independent [0-40]: 35.6%, Partially Dependent [41-80]: 61.8%, Totally Dependent [81+]: 2.6%), 0% emergent cases, ASA Class (I: 5.6%, II: 46.8%, III: 41.7%, IV: 1.4%, V: 0%), 11.9% disseminated cancer, 9.1% diabetes mellitus, 36.5% use of hypertensive medications, 10.8% CHF, 5.9% current smoker, 5.2% COPD, and 4.4% acute renal failure. Predictive of any 30-day postoperative complications ranged from 2.8-18.5% across CPT codes, where the actual rate in the cohort was 9.0%, and demonstrated good predictive performance via Brier Score (0.00064516, Max: 0.00819), as well as pneumonia, SSI, UTI, VTE, renal failure, death and sepsis (Brier Max: 0-0.01458096). Serious and cardiac complications, as well as return to OR were poorly predicted via the NSQIP risk index (Brier Max > 0.05). Mean difference between observed and predicted LOS was 4.276 days with a 95% confidence interval of 9.484 - -0.932. When indicated for significantly high risk, the calculator poorly predicted overall and serious complications (Brier Max >0.1).
CONCLUSION(S): While the ACS-NSQIP risk index had acceptable predictive performance in regards to the occurrence of overall post-operative complications, notable exceptions were detected. Specifically, deficiencies in assessing serious complications, cardiac complication and return to OR were seen, and performance was noted to diminish with procedures of greater invasiveness. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747151
ISSN: 1878-1632
CID: 4597752

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

233. Development of risk stratification predictive models for cervical deformity surgery [Meeting Abstract]

Passias, P G; Ahmad, W; Oh, C; Lafage, V; Lafage, R; Hamilton, D K; Protopsaltis, T S; Klineberg, E O; Gum, J L; 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: As the field of corrective cervical deformity (CD) surgery progresses, surgeons continue to take on more challenging cases. In order to minimize suboptimal postoperative outcomes it is important to develop a tool that allows for proper preoperative risk stratification. PURPOSE: Develop individualized predictive models for identification of risk-factors that lead to the development of major complications, revisions, and unplanned reoperation. STUDY DESIGN/SETTING: Retrospective cohort study of a prospective adult cervical deformity database. PATIENT SAMPLE: A total of 105 CD patients. OUTCOME MEASURES: Major complications (prolonged hospitalization, invasive intervention, prolonged or permanent morbidity, death within 1 year[1Y]), unplanned revision or reoperation after CD surgery within 1Y, HRQOL (NDI, mJOA, EQ5D).
METHOD(S): CD patients (cervical kyphosis >10degree, coronal scoliosis >10degree, cSVA >4cm, TS-CL >10degree, or CBVA >25degree) >=18 years old with complete baseline (BL), 1Y HRQoL and radiographic data. Patients were stratified into two groups based on their outcome from surgery: revision (Rev) and major complication (MC). Descriptive analysis identified cohort demographics, radiographic parameters and surgical details. Univariate analysis of preoperative and surgical factors was conducted to determine associations with any of the two outcomes. Stepwise logistic regressions identified surgical, radiographic, and HRQL factors that were associated with Rev or MC. Decision tree analysis established cut-offs for predictive variables.
RESULT(S): A total of 105 CD patients were included (61.6yrs, 67%F, BMI: 28.4kg/m2, CCI: 0.96+/-1.3). Surgical details: 7.6+/- 3.7 levels fused; mean EBL of 816 mL. By surgical approach, 45.71% had a posterior approach, 35.24% combined approach, and 19.05% anterior approach. Radiographically at baseline, patients presented with: PT: 18.9+/- 11.3; PI: 53.0+/-11.2; PI-LL: -0.45+/-17.2; SVA: -4.3+/-66.8, TS-CL: 37.9 +/-20.2; cSVA: 38.4+/-19.9. Postoperatively, 20 patients experienced a MC and 17 patients underwent a subsequent rev. instrumentation location (LIV: 1.1[1.0-1.3] and UIV: 1.5[1.1-2.1]) was significantly associated with undergoing a rev after index surgery (all p<0.05). The development of a postoperative MC was significantly associated with BL radiographic pelvic parameters (all <0.05). Predictive modeling incorporating preoperative and surgical factors identified development of a Rev to include: UIV>C3, LIV>T3, C2-T3 SVA<46.7degree, C2-C7 SVA>57.6degree, CTPA>7.8degree, and C2S<60.4 (AUC:0.80). For developing a MC, a model consisting of preoperative and surgical factors included BL EQ5D-VAS<30, TS-CL>59.2degree, C2-C7 SVA > 69.1degree, C2-T3 SVA < 18.6, Apex C2-C7 SVA >4.25, surgical invasiveness and posterior osteotomies (AUC:0.83).
CONCLUSION(S): Major adverse events were not uncommon following adult cervical deformity correction. Risk stratification models were developed to predict with high accuracy the occurrence of these common significant postoperative events. Revisions were predicted with an accuracy of 80% using a predominance of radiographic variables, while the occurrence of other major complications was also predicted with high reliability utilizing additional baseline HRQoL data and surgical factors. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747211
ISSN: 1878-1632
CID: 4597592

P70. A combined anterior-posterior approach in select cervical deformity corrections has potential for superior cost effectiveness driven by outcomes [Meeting Abstract]

Pierce, K E; Passias, P G; Lafage, R; Lafage, V; Mundis, G M; Eastlack, R K; Kelly, M P; Protopsaltis, T S; Carreon, L Y; Line, B; Hart, R A; Burton, D C; Bess, S; Schwab, F J; Shaffrey, C I; Smith, J S; Ames, C P
BACKGROUND CONTEXT: The choice of surgical approach in CD surgery is often dictated by surgeon preference and experience. This choice could significantly impact the costs and outcomes of an operation, therefore the approaches should be analyzed in order to determine the optimal approach from a cost-utility perspective. The cost utility of different surgical approaches in cervical deformity (CD) has not been investigated in the literature. PURPOSE: Investigate the cost utility of differing approaches in operative CD patients. STUDY DESIGN/SETTING: Retrospective review of a prospective multicenter cervical deformity database. PATIENT SAMPLE: A total of 105 CD patients. OUTCOME MEASURES: Costs, EuroQol-5D (EQ-5D), Quality adjusted life years (QALYs), Cost per quality adjusted life years.
METHOD(S): Included CD patients (C2-C7 Cobb>10degreeor CK>10degree, cSVA>4cm or CBVA>25degree) >18yr with follow-up (1-year) surgical and health related quality of life scores. Costs were calculated using the PearlDiver database, which reflects both private insurance and Medicare reimbursement claims. QALYs and cost per QALY were calculated using a 3% discount rate to account for residual decline to life expectancy (78.7 years). After accounting for complications, LOS, revisions, and death, cost per QALY at 1Y and life expectancy [LE] were calculated for surgical approach (anterior-only, posterior-only [excluding PSO and VCR to account for differences in instrumentation], combined). In a subanalysis, approach groups were propensity-score matched for TS-CL to account for baseline (BL) deformity.
RESULT(S): A total of 105 CD patients met inclusion criteria (61.9 yrs, 63% female, 28.6kg/m2, CCI: 0.97). By approach, 21.9% underwent anterior only, 37.1% posterior only and 41% combined approaches. Average number of levels fused was 6.9, with a mean EBL of 948 ml and total operative time of 544.2 minutes. Mean EQ5D at BL was 0.74+/-0.07 and at 1Y was 0.79+/-0.08 (a difference of 0.05+/-0.08). Average difference in EQ5D from BL to 1Y was significant (p=0.002) across approach: 0.093 anterior-only, 0.021 posterior-only, 0.044 combined. 13% (3) of anterior-only patients underwent a revision, 10.3% (4) of posterior and 13.9% (6) of combined approaches. The average costs per surgery for CD patients at 1-year undergoing surgery by anterior approach was $27,640.75, $38,499.44 posterior-only, and $36,553.41 combined approach (p>0.05).The cost per QALY was higher for posterior-only patients at 1-year ($948,946.81) compared to anterior-only ($152,616.65) and combined ($424,110.14), p<0.001. If the utility gained was sustained to life expectancy, the cost per QALY for the anterior-only group was $21,665.87, posterior-only was $134,715.06 and combined approach was $60,207.82., p<0.001. After PSM for TS-CL, 15 patients remained in each group. The cost per QALY remained higher for posterior-only patients at 1-year and LE (both p<0.050).
CONCLUSION(S): After accounting for comorbidities, complications, revisions, and death, all surgical approaches showed improvement in postoperative EQ5D scores, however posterior approach demonstrated overall lower cost effectiveness. CD patients who underwent anterior-only approach had the lowest average costs for CD corrective surgery, as well as the lowest cost per QALY (best cost-effectiveness) compared to posterior and combined approaches. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747179
ISSN: 1878-1632
CID: 4597682

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.
Copyright
EMBASE:2007747464
ISSN: 1878-1632
CID: 4597152

282. Establishment of an individualized distal junctional kyphosis risk index taking into account radiographic and surgical components [Meeting Abstract]

Passias, P G; Naessig, S; Pierce, K E; Lafage, R; Lafage, V; Eastlack, R K; Daniels, A H; Protopsaltis, T S; Klineberg, E O; Mundis, G M; 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: Distal junctional kyphosis (DJK) is a radiographic finding identified after patients undergo instrumented spinal fusions which can lead to decreased mobility in the affected spinal segments. There is a lack of consensus of the true etiology of DJK, since it is multifactorial in nature. PURPOSE: Develop a novel risk index specific to each patient to minimize postoperative DJK occurrence using distal construct and surgical factors STUDY DESIGN/SETTING: Retrospective review of a single-center comprehensive CD database PATIENT SAMPLE: A total of 110 CD patients (pts) OUTCOME MEASURES: DJK, Health Related Quality of Life, Reoperation, Minimal Clinically Important Difference (MCID) EQ5D.
METHOD(S): CD pts with BL and at least 1Y radiographic parameters were included. A patient-specific DJK score was created through use of unstandardized Beta weights of a multivariate regression model predicting DJK (end of fusion construct to the 2nd distal vertebra change in this angle by <-10degree from BL to postop). The equation consisted of distal construct factors [A) BL-3M inclination angle, B) BL inflection point, C) LIV angle,] and surgical factors [D) combined approach, E) TS-CL, F) PT, G) C2-C7, H) T4-T12, I) osteoporosis]. A BL model was created as a reference that included all of the above factors not including (C2-C7 and T4-T12). Correlations with 2Y outcomes was identified with use of this BL reference score.
RESULT(S): A total of 110 CD pts included (61yrs, 66.4%F, 28.8kg/m2). Of these, 31.8% pts developed DJK (16.1% 3M, 11.4% 6M, 62.9% 1Y). At BL DJK pts were more frail, had more combined approaches, and had more anterior approaches (all p<0.05). Multivariate model regression analysis identified individualized scores through creation of a DJK equation: 1.15+ 0.04 (Inclination) -2.3 (Preinflection) + 0.04 (LIV angle) + 0.78 (combine approach) + 0.09 (TS-CL) + 0.02 (PT) + 0.11 (C2-C7) + 0.02 (T4-T12) + 0.12 (osteoporosis). This equation (min: 0007 and a max: 95.3) has an 86.3% accuracy of predicting DJK. Having a score>81 predicted DJK with an accuracy of 89.3%. The BL reference equation, (-1.3+0.002 [BL inclination score]-1.3 [BL inclination C6 to T1]-0.05 [BL LIV angle] +1.4 [combined approach] + 0.01 [BL PT]-0.023 [osteoporosis]), correlated with 2Y outcomes of NSR-back percentage(p=0.003), reoperation(p=0.04) and MCID for EQ5D(p=0.04).
CONCLUSION(S): This study created a newly proposed risk index that focuses heavily on distal construct and surgical factors. Having a DJK score >81 was associated with an increase in risk of DJK. The reference models created were identified to correlate with 2-year outcomes of NSR-back percentage, reoperation rates and minimal clinically importance difference for EQ5D. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747420
ISSN: 1878-1632
CID: 4597212

135. Multicenter prospective assessment of outcomes and complications associated with adult spinal deformity surgery in 62 patients with severe global coronal malalignment [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; International, Spine Study Group
BACKGROUND CONTEXT: Substantial adult spinal deformity (ASD) research has focused on sagittal plane radiological assessment and emphasized the importance of sagittal correction on patient-reported outcomes. It seems less attention has been given to evaluation of ASD in the coronal plane. However, recent ASD studies have demonstrated baseline global coronal malalignment (GCM; substantial displacement of the C7 coronal plumb line from midsacrum) in up to 35% of patients. Moreover, GCM can worsen postoperatively or may occur as an iatrogenic complication in previously balanced patients. Collectively, this may suggest that the associated clinical impact of GCM on ASD surgical outcomes has been underestimated. Currently, few reports focus on surgical outcomes in ASD patients with GCM. PURPOSE: Our objective was to assess treatment outcomes and complication rates associated with ASD surgery in the subset of patients with severe GCM. STUDY DESIGN/SETTING: Retrospective review of a prospectively collected multicenter consecutive case registry. PATIENT SAMPLE: Enrollment required: age >=18 years, scoliosis >=20degree, sagittal vertical axis (SVA) >=5cm, pelvic tilt >=25degree, and/or thoracic kyphosis >=60degree. OUTCOME MEASURES: Radiographic correction (both standard coronal and sagittal spinopelvic deformity measurements) and health-related quality of life (HRQL) outcomes, which included Oswestry Disability Index (ODI), Short Form-36 (SF-36) scores, Scoliosis Research Society-22 (SRS-22) scores, and back/leg pain numerical rating scale (NRS) scores.
METHOD(S): Surgically treated ASD patients with severe GCM (coronal C7PL-midsacral offset magnitude >=1 SD above the mean) were identified. Baseline and follow-up radiographic and HRQL outcomes were analyzed. Percentages of patients achieving minimal clinically important difference (MCID) and substantial clinical benefit (SCB) were assessed. Demographic, frailty, surgical, and complications data were collected. The primary focus for analysis was on patients who reached minimum 2-year follow-up.
RESULT(S): Of 691 potentially eligible operative patients (mean GCM = 4+/-3 cm), 80 met criteria for severe GCM >= 7cm. Of these 80 patients, 62 (78%, mean age 64 years, 81% women) had minimum 2-year follow-up. Baseline frailty score was 3.9+/-1.5 (indicating patients were frail) and 48% had prior spine fusion. Surgical data included: posterior-only (58%), mean fusion 13 levels, sacroiliac fixation (97%), and three-column osteotomy (36%). Postoperative biplane alignment improved significantly (p<0.001): GCM 11 to 4 cm, lumbar Cobb 30degree to 11degree, C7-S1 SVA 13 to 4 cm, and PI-LL 31degree to 5degree. Overall HRQL improved significantly (p<=0.003): ODI 51 to 37, SF-36 PCS 29 to 37, SRS-22r 2.6 to 3.5, and back/leg pain NRS 7 to 4 and 5 to 3, respectively. Thresholds for MCID/SCB were met in 43-83% of patients. A total of 89 complications were reported (34 minor/55 major), and 45 (73%) patients had >=1 complication (most commonly rod fracture [19%] and PJK [18%]). There were 34 reoperations in 22 (36%) patients (most common indications rod fracture/PJK). The 18 patients who did not achieve 2-year follow-up had a mean of 0.63 years follow-up, and the types of complications encountered in these 18 patients were comparable to those encountered in patients with 2-year follow-up.
CONCLUSION(S): ASD surgery for patients with severe GCM is associated with significant improvements in biplane alignment and HRQL outcome measures despite high complication rates. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747472
ISSN: 1878-1632
CID: 4597132