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212. Operative treatment of adult spinal deformity patients with severe scoliosis: retrospective review of a prospectively collected multicenter series with minimum 2-year follow up [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: Prior studies have demonstrated potential benefits of adult spinal deformity (ASD) surgery, but less outcomes data exist for operative ASD patients with severe scoliotic curves (thoracic [TH] curve >=75degree, thoracolumbar [TL] curve >=50degree, or lumbar [LL] curve >=50degree). Also, the surgical complication profile is less clear for this subset of patients with severe scoliotic deformity and warrants focused investigation. PURPOSE: The objective of the current study was to assess treatment outcomes and complication rates associated with ASD surgery in patients with severe scoliosis. STUDY DESIGN/SETTING: Retrospective review of a prospectively collected multicenter consecutive case registry PATIENT SAMPLE: Enrollment required: age >=18 yrs, scoliosis >=20degree, sagittal vertical axis (SVA) >=5cm, pelvic tilt >=25degree, and/or thoracic kyphosis >=60degree. OUTCOME MEASURES: 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, and Scoliosis Research Society-22 (SRS-22) scores.
METHOD(S): Using a prospective multicenter database, we identified surgically treated ASD patients with severe scoliosis (TH Cobb >=75degree or TL/LL Cobb >=50degree) and minimum 2-yr follow-up. Demographic data, surgical characteristics, radiographic alignment measurements, HRQL outcomes and associated complications were analyzed.
RESULT(S): Of 178 patients, 146 (82%, mean age 54 yrs, 92% women, 88 TL, 50 LL, 8 TH) had minimum 2-yr follow-up (mean=3.1 yrs). Almost 30% had prior spine fusion, 6% were active or past smokers, 16% had osteoporosis and 77% had at least 1 comorbidity. Surgical details included: posterior-only (58%) or anterior-posterior approach (42%), SPO (65%), 3CO (14%), TLIF (23%), ALIF (37%), sacropelvic fixation (76%), upper thoracic UIV (64%) and mean posterior fusion length of 13.2 levels. Postoperative coronal alignment improved significantly for all patients (global coronal alignment 3.8 to 2.8 cm, p< 0.001; TH Cobb 38degree to 24degree, p<0.001; TL Cobb 61degree to 30degree, p<0.001; LL Cobb 50degree to 24degree, p<0.001; Fractional Cobb 20degree to 7degree, p<0.001). Overall sagittal alignment also improved significantly (p<0.05), most notably for severe lumbar curves (C7-S1 SVA 6.7 to 2.5 cm, p<0.001; PI-LL 18degreeto 3degree, p<0.001). Overall HRQL improved significantly, including ODI (39 to 26, p<0.001), SF-36 PCS (35 to 41, p<0.001) and SRS-22r (2.9 to 3.8, p<0.001). A total of 191 complications were reported (92 minor/99 major), and 94 (64%) patients had at least one complication. The most common complications included dural tear (12%), pleural effusion (12%), rod fracture (11%), radiculopathy (8%) and proximal junctional kyphosis (7%). 34 reoperations were performed in 27 (18%) patients, with most common indications of rod fracture/pseudarthrosis (8), deep wound infection (6) and neurological deficit (5).
CONCLUSION(S): Surgery for severe adult scoliosis is associated with significant improvement in radiographic alignment and HRQL measures. Although associated complication rates are high, these appear to be comparable to reports of less severe scoliosis. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747121
ISSN: 1878-1632
CID: 4597792

10. Pelvic nonresponders, postoperative cervical malalignment, and proximal junctional kyphosis following treatment of adult spinal deformity: influence of realignment strategies on occurrence [Meeting Abstract]

Passias, P G; Pierce, K E; Lafage, V; Lafage, R; Protopsaltis, T S; Diebo, B G; Kebaish, K M; Ames, C P; Smith, J S; Shaffrey, C I; Burton, D C; Kelly, M P; Hart, R A; Bess, S; Schwab, F J; Gupta, M C; International, Spine Study Group
BACKGROUND CONTEXT: For surgical adult spinal deformity (ASD) patients, determining optimal restoration of alignment and spinal shape is an active area of research. Complex corrective measures taken are in ASD. Incidence of specific alignment outcomes has yet to be investigated in each of the complex realignment ideals. PURPOSE: Assess alignment outcomes (pelvic nonresponse [PNR], PJK, postop cervical deformity [CD]) following ASD-corrective surgery in the context of correction relative to various alignment schemas. STUDY DESIGN/SETTING: Retrospective cohort study of prospective ASD database. PATIENT SAMPLE: A total of 468 ASD patients. OUTCOME MEASURES: PNR, PJK, postop CD.
METHOD(S): ASD patients with preop, 6-week postop (6W), and 2-year postop (2Y) radiographic data included. PNR: 10-year mismatch (undercorrection; unimproved) from a patient's age-adjusted PT at 6W and maintained at 2Y. Pelvic responder (PR): PT +/-10 match age-adjusted goals. Patients were stratified by incremental additions of corrective alignment schemas: (a) improvement in Schwab SVA, (b) matching age-adjusted PI-LL, (c) match postop "ideal" and "theoretical" Roussouly, (d) improvement in proportionality spinal score at 6W. PNR, PJK, and CD development by 2Y were compared within groups, as well as simultaneous improvement/match of the suggested corrective measures (exclusively). In a subanalysis, patients were stratified by severity of baseline PT, low (<20degree), moderate (20-30degree), and severe (>30degree) to determine which alignment schema is necessary to achieve less PNR, PJK and postop CD.
RESULT(S): A total of 468 patients (56.3 yrs, 76.5% F; 25.6% PNR, 40.6% PR) met inclusion criteria. Rates of postop PJK (PNR:49.2% vs PR:59.5%) and CD (18.3% vs 25.8%) were significantly less in the PNR group, p<0.05. Sole improvement in Schwab SVA (73.2%) did not impact PNR, PJK or CD (p>0.050). Undercorrected age-adjusted PI-LL presented with more PNR (60.1%), whereas overcorrected had increased PJK (68.2%), p<0.001. Matching Roussouly at 6W decreased PNR (17.8% vs mismatch:42.3%, p=0.002). 6W proportional spine, had lower rates of PNR (19.7%, severely disproportioned: 58.8%, p<0.001), with postop moderately disproportioned GAP with highest rates of PJK (p=0.010). Incremental addition of alignment schemas was assessed for effect on malalignment outcomes. Schwab and age-adjusted use (20.9%) had less incidence of PNR (28.6% vs 38.7%) than just Schwab. Addition of the Roussouly (18.3%) presented with less PNR (20% vs 30.4%) and PJK (38.5% vs 60.3%) than only Schwab & age-adjusted. Lastly, addition of proportion (16.7%) had 0% occurrence of PNR and CD. Stratifying by baseline PT severity, the low group demonstrated the least incidence of PNR (7.7%) and CD (10.3%) and PJK (41.3%) when matching theoretical Roussouly at 6W (all p<0.050). This remained the same for moderate PT for PNR and PJK, except Schwab improvement decreased postop CD occurrence (21.2%, p=0.049). Severe PT assessment determined PNR (20%), PJK (37.5%) and CD (19.4%) were the lowest with improvement of proportion at 6W (p<0.050).
CONCLUSION(S): Following ASD corrective surgery, 25.6% of patients showed residual pelvic malalignment, qualifying as pelvic nonresponders. Use of complex realignment schemas (SRS-Schwab, age-adjusted, Roussouly shape, GAP) decreased rates of pelvic nonresponse, PJK and postop cervical deformity development. Severe (>30degree) baseline pelvic tilt requires particular emphasis of proportionality in addition to other realignment ideals. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747485
ISSN: 1878-1632
CID: 4597092

191. Multiple revision surgeries are associated with reduced patient satisfaction in adult spinal deformity [Meeting Abstract]

Durand, W M; Daniels, A H; Lafage, R; Passias, P G; Kim, H J; Protopsaltis, T S; Lafage, V; Smith, J S; Shaffrey, C I; Gupta, M C; Klineberg, E O; Schwab, F J; Gum, J L; Mundis, G M; Eastlack, R K; Kebaish, K M; Soroceanu, A; Jr, R A H; Burton, D C; Bess, S; Ames, C P; Hart, R A; Hamilton, D K; International, Spine Study Group
BACKGROUND CONTEXT: Revision surgery is often necessary for adult spinal deformity (ASD) patients. Satisfaction with management is an important component of HRQOL. PURPOSE: We hypothesized that patients who underwent multiple revision surgeries following adult spinal deformity correction would exhibit lower satisfaction scores. STUDY DESIGN/SETTING: Retrospective cohort study of a prospectively collected multicenter database of ASD patients. PATIENT SAMPLE: A total of 668 patients undergoing ASD surgery and eligible for minimum 2-year follow-up were included. OUTCOME MEASURES: SRS-22r satisfaction score.
METHOD(S): Visits were stratified by occurrence prior to the index surgery (period 0), after the index surgery only (period 1) (ie, never underwent revision or had not yet undergone revision), after first revision only (period 2), and after second revision only (period 3). Patients were further stratified by prior spine surgery before their index surgery. SRS-22r satisfaction scores were evaluated at all periods using multiple linear regression adjusting for age, gender, and CCI.
RESULT(S): In total, 46.6% had prior spine surgery before their index surgery. The overall revision rate was 21.3%. among patients with no spine surgery prior to the index surgery, satisfaction increased from period 0 to 1 (2.8 to 4.3, p<0.0001), decreased after one revision from period 1 to 2 (4.3 to 3.9, p=0.0004), and decreased after a second revision from period 2 to 3 (3.9 to 3.3, p=0.0437). Among patients with spine surgery prior to the index procedure, satisfaction increased from period 0 to 1 (2.8 to 4.2, p<0.0001), and decreased from period 1 to 2 (4.2 to 3.8, p=0.0011). No differences in follow-up time from last surgery were observed between visits in periods 1, 2, and 3 (all p>0.3). among patients with multiple revisions, 40% experienced rod fracture, 40% PJK, and 33% pseudarthrosis.
CONCLUSION(S): ASD patients exhibit decreased satisfaction with subsequent revision. Among patients undergoing primary surgery in our database, this effect is additive for multiple revisions. These results have important implications for surgeons, patients, insurers, hospital administrators, and policymakers. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747137
ISSN: 1878-1632
CID: 4597772

127. Preoperative optimization of modifiable frailty factors reduces risk of hospital acquired conditions in elective surgical spine patients [Meeting Abstract]

Pierce, K E; Naessig, S; Ahmad, W; Segreto, F A; Vira, S N; Maglaras, C; O'Connell, B K; Paulino, C B; Bell, J; Hassanzadeh, H; Lafage, R; Lafage, V; Raman, T; Protopsaltis, T S; Buckland, A J; Diebo, B G; Passias, P G
BACKGROUND CONTEXT: Hospital acquired conditions (HACs) were established in the Affordable Care Act, and are defined as reasonably preventable complications that are nonreimbursable. In high risk patient populations for HACs, such as frail surgical spine patients, preoperative evaluation should consider modifiable factors. PURPOSE: To identify if optimizing the modifiable factors in the frailty index reduce the risk of developing HACs in population of surgical spine patients. STUDY DESIGN/SETTING: Retrospective cohort study. PATIENT SAMPLE: This study included 196,523 elective spine surgery patients in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP). OUTCOME MEASURES: Modifiable patient frailty factors: hypertension and diabetes mellitus; rates of HACs, superficial or deep surgical site infection (SSI), deep venous thromboembolism (VTE) and urinary tract infection (UTI), across frailty scores.
METHOD(S): Patients >18 years who underwent elective spine surgery were identified in ACS-NSQIP database from 2005-2016. HACs identified: SSI, VTE, and UTI. Patient frailty was assessed utilizing the modified NSQIP 5-factor frailty index. The modified frailty score (mFI-5) is assessed on a scale between 0 and 1 (no frailty [NF] <0.3, mild frailty [MF] 0.3-0.5, severe frailty [SF] >0.5). Descriptive analysis quantified rates of patient characteristics, operative details, and HAC prevalence. Stepwise linear regression models determined significant predictors of baseline frailty using controllable patient factors. HACs were compared between 'optimized' and 'non-optimized' frailty status in the cohort. Level of significance was set to P<0.05.
RESULT(S): A total of 196,523 patients (57+/-14.2 years, 30.4 kg/m2, 48%F) met inclusion criteria. Overall, 5,720 (2.9%) of patients developed an HAC, the most common was an SSI (1.3%), followed by UTI (1.1%). When stratified by the mFI-5 frailty severity groups at baseline, 83.6% of patients were categorized NF, 15.1% MF and 1.3% SF. Within the frailty severity groups, prevalence of overall HACs increased significantly (NF: 2.64%, MF: 4.17%, 5.93%, p<0.001). Rates of all individual postoperative HACs assessed also increased with greater baseline frailty severity: SSI (NF: 1.14%, MF: 1.93%, SF: 2.39%, p<0.001), UTI (NF: 0.91%, MF: 1.66%, SF: 2.85%, p<0.001), VTE (NF: 0.68%, MF: 0.80%, SF: 1.16%, p=0.002). Stepwise linear regression models determined that diabetes mellitus (beta = 0.493) and hypertension (beta = 0.679) were the most significant predictors for increased baseline frailty by way of the mFI-5 NSQIP index (Final model: R2= 0.897). Of total patients, 47.2% had the optimal modifiable frailty factors (no history of diabetes or hypertension). The optimal frailty patients had significantly less overall incidence of SSI (2.03% vs 2.5%, p<0.001), UTI (0.65% vs 1.4%, p<0.001), DVT (0.56% vs 0.84%, p<0.001), and any overall HAC (2.18% vs 3.56%, p<0.001).
CONCLUSION(S): Stepwise linear regression models determined that hypertension and diabetes account for 89.7% of variance in baseline mFI-5 score. Patients with these optimal controllable factors had reduced incidence of all hospital acquired conditions. In order to optimize hospital resources and treatment outcomes, physicians and patients should be aware of the modifiable factors that contribute to a patient's frailty that can ultimately impact acquiring HACs. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747148
ISSN: 1878-1632
CID: 4597762

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

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.
Copyright
EMBASE:2007747172
ISSN: 1878-1632
CID: 4597712

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

217. Outcomes of surgical treatment for patients with mild scoliosis and age appropriate sagittal alignment with minimum 2-year follow up [Meeting Abstract]

Scheer, J K; Smith, J S; Passias, P G; Kim, H J; Bess, S; Protopsaltis, T S; Burton, D C; Klineberg, E O; Lafage, V; Schwab, F J; Shaffrey, C I; Gupta, M C; Ames, C P; International, Spine Study Group
BACKGROUND CONTEXT: Operative treatment of adult spinal deformity (ASD) can be very challenging with high complication rates. Despite these challenges it's well established that pts benefit from such treatment. However, the surgical outcomes for pts with mild scoliosis and age appropriate sagittal alignment have not been reported. PURPOSE: To determine if patients (pts) with mild scoliosis and age appropriate sagittal alignment have favorable outcomes following surgical correction. STUDY DESIGN/SETTING: Retrospective review of a prospective, multicenter ASD database. PATIENT SAMPLE: ASD patients: operative pts age>=18, and all preoperartive pelvic tilt (PT), mismatch between pelvic incidence and lumbar lordosis (PI-LL), and C7 sagittal vertical axis (SVA) within established age adjusted parameters with minimum 2-year follow up. A subanalysis for pts with max coronal cobb angle 10-30degree (mild scoli) was done. OUTCOME MEASURES: Health-related quality of life (HRQOL) scores: Oswestry Disability Index (ODI), Short form-36(SF36), Scoliosis Research Society (SRS22), back/leg pain numerical rating scale (NRS) and minimum clinically important difference (MCID)/substantial clinical benefit (SCB). Radiographic values: max coronal cobb angle, coronal C7 plumb line, PT, PI-LL, thoracic kyphosis (TK), SVA. Demographic, frailty, surgical and complications data were collected.
METHOD(S): Two-year and baseline HRQOL/radiographic data were compared.
RESULT(S): A total of 103 pts were included from 667 operative patients (89.3% female, avg age 59.8+/-13.1yrs). Of the 103 pts, 29 (28.2%) had max preop coronal cobb angle 10-30degree. Two-year max coronal cobb angle and C7 coronal plumb were significantly improved compared to baseline (p<0.001 for both the overall cohort and mild scoli). All 2yr HRQOL measures were significantly improved compared to baseline(p<0.001) for both groups. 33.3-81.5%% of mild scoli pts met either MCID/SCB for all HRQOL. In mild scoli pts, 62.1% had min one complication, 27.6% had a major complication with 24.1% requiring a revision.
CONCLUSION(S): Pts with mild scoliosis and sagittal alignment within age appropriate parameters benefit from surgical correction at 2 years postop both radiographically and clinically including 81.5% meeting MCID for SRS pain despite having high complication rates. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747419
ISSN: 1878-1632
CID: 4597222

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

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.
Copyright
EMBASE:2007747420
ISSN: 1878-1632
CID: 4597212