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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.
Copyright
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.
Copyright
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.
Copyright
EMBASE:2007747244
ISSN: 1878-1632
CID: 4597522

4. At what point should the thoracolumbar region be addressed in patients undergoing corrective cervical deformity surgery? [Meeting Abstract]

Passias, P G; Pierce, K E; Lafage, V; Lafage, R; Klineberg, E O; Diebo, B G; Protopsaltis, T S; Hamilton, D K; Vira, S N; 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: Thoracolumbar malalignment is often seen in patients presenting with cervical deformities. For operative cervical deformity (CD) patients, it is unknown whether certain thoracolumbar parameters play a large role in poor outcomes (complications, distal junctional kyphosis, reoperation) and whether addressment of such parameters is warranted. PURPOSE: To investigate the impact of cervical to thoracolumbar ratios on poor outcomes in CD corrective surgery. STUDY DESIGN/SETTING: Retrospective cohort study. PATIENT SAMPLE: 110 CD patients. OUTCOME MEASURES: Radiographic parameters: regionally and globally; complications; distal junctional kyphosis (DJK); reoperations; health-related quality-of-life (HRQLs): NDI, EQ5D, mJOA.
METHOD(S): Included: surgical CD pts (C2-C7 Cobb >10degree, CL>10degree, cSVA >4cm, or CBVA >25degree) with full baseline and 1-year data. Patients were assessed for ratios of preop cervical and global parameters including: C2 slope/T1 slope, TS-CL/PI-LL, cSVA/SVA. Deformity classification ratios of cervical (Ames-ISSG) to spinopelvic (SRS-Schwab) were investigated: cSVA modifier/SVA modifier, TS-CL modifier/PI-LL modifier. Cervical to thoracic ratios included C2-C7 lordosis/T4-T12 kyphosis. Correlations assessed the relationship between ratios and poor outcome (major complication, reoperation, HRQL decline or failure to meet MCID). Decision tree analysis through multiple iterations of multivariate regressions assessed cut-offs for ratios for acquiring suboptimal outcomes.
RESULT(S): A total of 110 cervical deformity patients were included in the present analysis (61.5+/-9.9 years, 66% female, 28.8+/-7.5 kg/m2). By approach, 18.2% underwent anterior-only procedures, 46.4% posterior, and 35.4% combined. Average levels fused: 7.7+/-3.7 levels (anterior: 3.5, posterior: 8.5). The average preoperative radiographic ratios assessed included a C2 slope/T1 slope 1.56, TS-CL/PI-LL of 11.1, cSVA/SVA of 5.4, CL/TK of 0.26. Ames-ISSG and SRS-Schwab modifier ratios of cSVA/SVA 0.1 and TS-CL/PI-LL of 0.35. Pearson correlations demonstrated a significant relationship between major complications and the baseline TS-CL/PI-LL with a cutoff of >12.72 (p=0.034), >0.482 Ames TS-CL/Schwab PI-LL modifiers (p=0.019), and the CL/TK ratios (>0.814, p=0.050). Reoperation had a significant correlation with the TS-CL/PI-LL (>5.819, p=0.009) and the cSVA/SVA (>3.79, p=0.002) ratios. Postoperative DJK had a correlation with the C2 slope/T1 slope (>1.59, p=0.017) and CL/TK (>0.692, p=0.0629) ratios. Not meeting MCID for NDI correlated with the CL/TK ratio (>1.402, p=0.016) and not meeting MCID for EQ5D correlated with the Ames TS-CL/Schwab PI-LL (>0.564, p=0.010).
CONCLUSION(S): Consideration of the ratio of distal regional to global alignment is a critical determinant of outcomes in cervical deformity corrective surgery. Several key ratios of cervical to global alignment were found to correlate with the occurrence of suboptimal realignment parameters, or poor clinical outcomes. A larger cervical lordosis to thoracic kyphosis was most representative of this risk, which predicted a complication, DJK, and not meeting MCID for NDI. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747208
ISSN: 1878-1632
CID: 4597602

296. Residual coronal malalignment results in less improvement in pain and disability after ASD surgery [Meeting Abstract]

Jain, A; McNeely, E; Neuman, B J; Gum, J L; Bess, S; Hostin, R A; Lafage, V; Yeramaneni, S; Klineberg, E O; Lafage, R; Gupta, M C; Smith, J S; Burton, D C; Passias, P G; Protopsaltis, T S; Kebaish, K M; International, Spine Study Group
BACKGROUND CONTEXT: Prior literature has demonstrated that correction of sagittal plane deformity in adult patients has resulted in improvements in health-related quality of life (HRQOL) outcomes. In the absence of sagittal plane pathology, the effects of coronal malalignment under-correction in patients with spinal deformity have not been fully investigated. PURPOSE: To evaluate the impact of coronal malalignment correction on HRQOL outcomes in adult spinal deformity. STUDY DESIGN/SETTING: Retrospective review of a multicenter database. PATIENT SAMPLE: A total of 522 ASD patients had preoperative coronal malalignment greater than 40 mm. We excluded anyone who had SVA greater than 50 mm in order to control for patients without severe sagittal deformities. OUTCOME MEASURES: Our outcome measures included Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS), and several other SF-36 and SRS-22r health domains scores.
METHOD(S): Using a prospective, multicenter database, we identified 1560 surgical patients. Of these, 522 patients had preoperative coronal malalignment greater than 40 mm. We excluded anyone who had SVA greater than 50 mm in order to control for patients who only had coronal plane deformity. We only included patients undergoing primary surgery. We then compared 2-year post HRQOL outcomes in patients that had their coronal malalignment corrected (CVA < 40mm) vs not.
RESULT(S): Mean age of patients was 54 +/- 15 years, 91% females. 79 patients were identified with only a coronal plane deformity undergoing a primary ASD surgery. Of these, 38 (48%) were under-corrected and 41 (52%) had their coronal alignment corrected to <40mm. Compared to the corrected group, the uncorrected group had a higher ODI (26.0+/- 2.9 vs 14.7+/- 2.5; p=0.002) and lower SRS-22r Activity (3.6+/- 0.14 vs 4.2+/- 0.11; p=002), SRS-22r Appearance (3.3+/- 0.16 vs 3.9+/- 0.12, p=.001), SRS-22r total (3.6+/- 0.12 vs 4.1+/- 0.11, p=.004), SF-36 Physical Component Summary (40.8+/- 1.3 vs 46.8+/- 1.6; p=.005), SF-36 Physical Function (40.5+/- 1.7 vs 46.0+/- 1.5, p=.01), SF-36 Bodily Pain (41.7+/- 1.6 vs 47.8+/- 1.5, p=.006), SF-36 General Health (47.2+/- 1.8 vs 52.2+/- 1.4, p=.03), SF-36 Social Functioning (45.9+/- 2.1 vs 51.7+/- 1.4, p=.03), SF-36 Mental Health (48.9+/- 1.9 vs 54.2+/- 1.8, p=.048) 2 years following index surgery.
CONCLUSION(S): Patients with coronal malalignment and little sagittal plane deformity experience worse improvement in pain and disability, with under-correction of their coronal plane deformity. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747516
ISSN: 1878-1632
CID: 4597042

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

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.
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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