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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.
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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
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.
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EMBASE:2007747179
ISSN: 1878-1632
CID: 4597682
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
P11. How much lumbar lordosis does a patient need to reach their age-adjusted alignment target? A formulated approach predicting successful surgical outcomes [Meeting Abstract]
McCarthy, M H; Lafage, R; Smith, J S; Bess, S; Protopsaltis, T S; Ames, C P; Klineberg, E O; Kim, H J; Shaffrey, C I; Burton, D C; Mundis, G M; Gupta, M C; Schwab, F J; Lafage, V; International, Spine Study Group
BACKGROUND CONTEXT: Age-adjusted alignment targets for adult spinal deformity (ASD) patients have the potential to reduce the incidence of PJK while ensuring optimal HRQL. Previous studies demonstrated the interplay between lumbar lordosis (LL) and thoracic kyphosis (TK) and their relationship with pelvic morphology as measured by the plevic incidence (PI). In clinical practice, reaching this ideal alignment remains challenging as the relationship between lordosis and kyphosis is not clearly elucidated. PURPOSE: This study aimed at developing a pragmatic formula on how much lumbar lordosis is needed based on the patient age, PI and exiting thoracic kyphosis. STUDY DESIGN/SETTING: Multicenter retrospective review of a prospective database. PATIENT SAMPLE: A total of 347 adult spinal deformity patients reaching age-adjusted alignment at 1-year post surgery. OUTCOME MEASURES: Sagittal alignment and internal validation of predictive formula.
METHOD(S): Surgical ASD patients reaching an age-adjusted ideal alignment at one year were identified. Multilinear regressions analysis was used to identify the relationship between regional curvatures (LL &TK) permitting to reach a given global alignment (TPA) based on pelvic incidence.
RESULT(S): The 347 patients included (60 years old, 72% female, BMI 29+/-6.2) had a significant improvement in all sagittal parameters from pre-op to 1Y (p<0.001 except PI). Multilinear regression predicting L1-S1 based on TK, TPA and PI demonstrated excellent results (R2=0.85). Similar results were found when regressions were conducted for each TPA percentile group (R2 ranging from 0.83 to 0.87). Simplification of the coefficients of prediction led to the following equation: LL = PI + 0.3
EMBASE:2007747490
ISSN: 1878-1632
CID: 4597082
239. Comparison of single-position robot-assisted surgery vs conventional minimally invasive surgery following LLIF: an in vitro assessment [Meeting Abstract]
Protopsaltis, T S; Larson, J J; Frisch, R F; Huntsman, K T; Lansford, T J; Brady, R L; Maulucci, C; Hayward, G; Harris, J; Gonzalez, J; Bucklen, B
BACKGROUND CONTEXT: Lateral lumbar interbody fusion (LLIF) provides indirect decompression of the neural elements while minimizing the potential vascular complications associated with anterior lumbar interbody fusion (ALIF). Posterior fixation may be applied through various techniques such as conventional minimally invasive surgery (CMIS), requiring the patient to be repositioned prone to provide access to both pedicles. Conversely, robot-assisted navigation (RAN) of pedicle screws can be utilized from a single position without flipping the patient. RAN is theorized to reduce patient surgical time, radiation, and blood loss due to positioning and workflow effects. PURPOSE: To evaluate the effect of robot-assisted navigation in comparison to CMIS methods in terms of surgical time, radiation exposure, and pedicle screw accuracy. STUDY DESIGN/SETTING: Cadaveric study. PATIENT SAMPLE: N/A OUTCOME MEASURES: N/A METHODS: Twelve unembalmed human torsos were implanted with 2-level static LLIF cages, followed by posterior bilateral pedicle screw fixation using either CMIS (n=6) or RAN (n=6). Preoperative computed tomography (CT) RAN workflow utilized CT scans of the specimen taken offsite and transferred to the robotic system during setup. Screw planning was performed using these CT scans, and then was merged with intraoperative fluoroscopy. Surgical times, surgeon radiation exposure, and screw accuracy were measured. Patient flip time from a consecutive patient series was included.
RESULT(S): Significant differences in surgical times and radiation dosages were found between groups. Surgical time for preoperative RAN and CMIS was 64.7 min+/-4.1 min and 123.0 min+/-13.7 min, respectively. Time per screw for RAN and CMIS workflows was 2.7+/-0.6 min and 4.3+/-1.3 min, respectively. RAN was significantly different for total operative time and time per screw in comparison to CMIS (p<0.05). Radiation dosages and times were separated into interbody and posterior fixation procedures separately, and sorted by imaging workflow. RAN and CMIS radiation dosages during posterior fixation were 0.4+/-0.2 rad and 2.7+/-1.6, respectively (p<0.05). Screw accuracy was as follows: CMIS resulted in 4 breaches (11% breach rate), while RAN resulted in a single breach (3% breach rate).
CONCLUSION(S): Significant differences were found in both surgical time and radiation exposure between CMIS and RAN, with RAN resulting in shorter surgical times and less radiation exposure to the surgeon than CMIS. Consideration should be given to single-position LLIF procedures that utilize RAN to instrument the spine with bilateral pedicle screws. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747244
ISSN: 1878-1632
CID: 4597522
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
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
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.
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EMBASE:2007747218
ISSN: 1878-1632
CID: 4597582
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