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179. Correcting ASD patients to normative alignment results in no functional benefit but more PJK and PJF [Meeting Abstract]
Protopsaltis, T S; Soroceanu, A; Lafage, R; Kim, H J; Balouch, E; Norris, Z; Smith, J S; Daniels, A H; Klineberg, E O; Ames, C P; Hart, R A; Bess, S; Shaffrey, C I; Schwab, F J; Lenke, L G; Lafage, V; Gupta, M C; International, Spine Study Group
BACKGROUND CONTEXT: A previous study utilized normative alignment to determine overcorrections and predict mechanical complications in adult spinal deformity (ASD) surgery. Other studies have recommended alignment targets that optimize age-appropriate physical function. The difference in functional outcomes and mechanical complications between these prescribed alignment targets has not been explored. This study utilizes a component angle of the T1 pelvic angle (TPA) within the fusion to compare normative and age-pelvic incidence (PI) optimal alignment in terms of proximal junctional kyphosis (PJK), proximal junctional failure (PJF) and health related quality of life measures (HRQL). Using the component of TPA within the fusion, the T4-pelvic angle (T4PA), allows for the measurement spinopelvic alignment separate from that of the unfused thoracic spine and any PJK that may occur postoperatively. PURPOSE: To compare ASD patients corrected to normative alignment vs age-PI optimal alignment in terms of PJK/PJF and outcomes. STUDY DESIGN/SETTING: Retrospective analysis of a prospective multicenter ASD database and a database of asymptomatic subjects. PATIENT SAMPLE: This study included 1,916 ASD patients and 118 asymptomatic subjects for formula development; 288 ASD patients with 2-year X-ray and HRQL follow-up. OUTCOME MEASURES: SF36-PCS, ODI, SRS-22, NRS back/leg, PJK (change in UIV to UIV+2 >10degree), PJF (defined as severe PJK with change >21.6degree, or UIV olisthesis, or proximal junctional fracture).
METHOD(S): Baseline relationships between age, PI and T4PA, were analyzed in the ASD patients and compared to the asymptomatic subjects. Linear regression modeling was used to determine alignment based on PI and age in asymptomatic subjects (normative alignment), and in ASD patients, alignment corresponding to age-appropriate functional status (optimal alignment). ASD patients with UIV above T4 were grouped based on their corrections: normative vs optimal. Extreme over or under corrected patients were excluded (greater than or less than 2SD from mean postop T4PA). For each group, the rate of PJK and PJF were determined.
RESULT(S): In the multilinear regression analysis of the 119 asymptomatic subjects, T4PA correlated with age and PI, r=.713, p<.0001. 1916 ASD patients were included in the optimal formula development. In the 288 ASD patients included in the pre- to postop analysis (137 normative, 151 optimal), there was no difference in baseline alignment or HRQL between the groups. At 6 weeks, the normative aligned group had smaller T4PA (4.45 vs 14.1) and PI-LL (-7.24 vs 7.4), all p<.0001. Normative aligned patients had the higher PJK rate (40% vs 27.2%, p=.03) compared with optimal; and a higher PJF rate (17% vs 6.8%, p=.008). PJF patients had -1.2degreeof T4PA offset from normative alignment and -5.2degreeof offset from optimal alignment. By contrast, no PJF patients had 3.8degree of T4PA offset from normative alignment and -0.42degree of offset from optimal alignment. There was a trend toward worse 2-year SF36-PCS in patients who suffered PJF (37.7 vs 41.6, p=.09). Both the Normative and Optimal groups improved in outcomes from baseline to 2-year (p<.001) with no difference in 2-year HRQL.
CONCLUSION(S): Correcting ASD patients to normative alignment resulted in higher rates of PJK and PJF without improvements in HRQL. ASD patients should not be corrected to match the alignment of their asymptomatic unfused peers, rather they should be realigned optimally to match age-appropriate physical function. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002408
ISSN: 1529-9430
CID: 4971462
267. Establishing safety thresholds for surgical invasiveness based on frailty status in ASD surgery [Meeting Abstract]
Neuman, B J; Wang, K; McNeely, E; Klineberg, E O; Smith, J S; Bess, S; Lafage, V; Lafage, R; Gupta, M C; Schwab, F J; Passias, P G; Protopsaltis, T S; Gum, J L; Ames, C P; Shaffrey, C I; Kebaish, K M; International, Spine Study Group
BACKGROUND CONTEXT: Both frailty and surgical invasiveness are correlated with increased risk of complications following ASD surgery, yet there is no accepted risk-stratification system combining these factors. PURPOSE: The aim of this study is to ascertain data-driven categories defining the risk for 90-day complications following ASD surgery based on frailty and surgical invasiveness. STUDY DESIGN/SETTING: Retrospective review of a multicenter database. PATIENT SAMPLE: A total of 1,272 surgical ASD patients undergoing spinal fusions >=5 levels OUTCOME MEASURES: Ninety-day complication risk, 90-day complication rate, invasiveness thresholds for increased complications.
METHOD(S): Using a prospective, multicenter database, we identified 1,272 surgical ASD patients undergoing posterior spinal fusion of at least five levels. Patients were separated into three frailty groups based on the ASD-FI frailty index. Within each frailty group, stratum-specific likelihood ratio (SSLR) analyses were performed to define frailty-based surgical invasiveness cutoffs associated with increased risk for 90-day complications. Cutoffs generated through SSLR were confirmed with multivariable logistic regression analysis controlling for age, alignment, and ODI.
RESULT(S): Mean age was 60 +/- 14 years, 74% females. Of 1,272 surgical ASD patients, 319 (35%) were nonfrail (NF), 667 (52%) frail (F), and 286 (23%) severely frail (SF). Mean SI was 93 +/- 35. The mean complication rate was 35.4% for NF, 37% for F and 43.6% for SF. SSLR analysis of NF patients produced 2 complication categories: 33% complication rate for SI < 153 and 73% for SI >= 153. NF patients with SI >= 153 had 4.14x higher odds of complications than NF patients with SI <153 (p=0.04). SSLR analysis of F patients produced 3 complication categories: 26% complication rate for SI < 60, 42% for SI of 60 to 179, and 64% for SI >= 180. Relative to F patients with SI < 60, F patients with SI 60 to 179, and SI >= 180 had 2.4x and 6.7x higher odds of complications, respectively (p<0.01 for both). SSLR analysis of SF patients produced 2 complication categories: 35% complication rate for SI < 82 and 49% complication rate for SI >= 82. SF patients with SI >= 82 had 1.77x higher odds of complications than SF patients with SI < 82 (p=0.04).
CONCLUSION(S): Frailer groups were found to have lower SI cutoffs, indicating the less invasiveness surgeries can be performed on frail patients to minimize complication risk. This risk-stratification system is useful for counselling patients regarding their risk of complication. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002407
ISSN: 1529-9430
CID: 4971472
127. Durability and failure mechanisms of cervical deformity correction surgery [Meeting Abstract]
Balouch, E; Protopsaltis, T S; Norris, Z; Eastlack, R K; Smith, J S; Hamilton, D K; Daniels, A H; Klineberg, E O; Passias, P G; Hart, R A; Bess, S; Shaffrey, C I; Schwab, F J; Lafage, V; Ames, C P; International, Spine Study Group
BACKGROUND CONTEXT: Cervical deformity (CD) surgery can markedly improve patient quality of life. The longevity of CD correction and the mechanism of alignment deterioration are not well understood. PURPOSE: To investigate preoperative risk factors and failure mechanisms that erode CD corrections and the impact on functional outcomes. STUDY DESIGN/SETTING: Retrospective review of a prospective CD database. PATIENT SAMPLE: This study included 155 operative CD patients with baseline (BL) and 1-year follow-up. OUTCOME MEASURES: Alignment at baseline, 3 months, 6 months and 1 year: cervical sagittal vertical axis (cSVA), C2 Slope (C2S), T1 slope (T1S), C2-C7 lordosis (CL), T1S-CL mismatch (TS-CL), Neck Disability Index (NDI), Modified Japanese Orthopaedic Association score (mJOA).
Method(s): A retrospective review of a prospective database of operative CD patients was analyzed. Patients with baseline, 3-month, 6-month and 1-year cervical radiographs were included. Cervical sagittal vertical axis (cSVA) <4cm was used to categorize patients as well-aligned vs malaligned. Additionally, three subsets were defined as follows: (1) patients who were malaligned preoperatively (cSVA>=4) and remained well aligned at 1 year postoperatively; (2) patients who were well-aligned but experienced alignment deterioration (cSVA>=4cm) up to 1 year postop, and; (3) patients who never attained cSVA <4cm. These groups were compared in terms of demographic factors, surgical factors, baseline radiographic parameters and radiographic and surgical outcomes at baseline and 1 year, using t-tests and X2 tests for continuous and categorical variables, respectively.
Result(s): A total of 155 patients were included (mean age 61.41, 60.9% F). The entire cohort was analyzed at all time points for alignment using cSVA. Among 89 patients with X-rays at every time point, 30 patients (34%) maintained their good alignment correction at 1-year postop. Seventeen patients (19%) experienced alignment deterioration and 42 patients (46%) never reached cSVA <4cm at any time point. Four patients lost their correction at 3 months, 6 patients at 6 months and 8 patients were malaligned by 1 year. The never-aligned cohort was significantly older when compared to those who maintained alignment or those who deteriorated (65.9 vs 61.8 vs 58.8, p=0.038). Patients who never achieved good alignment and those who suffered deterioration had a significantly higher rate of DJK (42.9% vs 47.1% vs 3.3%, p=0.001). Other failure mechanisms in the deterioration group included loss of subjacent spinopelvic compensation and PJK. At baseline, patients with alignment deterioration had a smaller cSVA compared to those who maintained or never reached good alignment (40.5 vs 52.0 and 60.1mm, p=0.001), and less TK (-43.4 vs -55.9 vs -61.4, p=0.049). At 1-year postop, patients with deterioration had worsening of their mJOA score at 6 months compared to those who maintained or never reached proper alignment (2.50 vs 0.04 vs 1.20, p=0.032). There were no significant differences in smokers, BMI, frailty, osteoporosis, levels fused, UIV, LIV, EBL, operative time, rod diameter, rod material, utilization 3-column osteotomy, mean osteotomy grade, in construct (fused) loss of alignment or revision rate between the groups (all p>.05)
Conclusion(s): Cervical deformity correction surgery failed to achieve acceptable sagittal alignment in 46% of patients. In those with successful correction, 36% suffered alignment deterioration within 1 year. Distal junctional kyphosis was the most common failure mechanism leading to loss of correction. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002352
ISSN: 1529-9430
CID: 4971492
41. Robotic pedicle screw placement has a dynamic learning curve based on spine surgery invasiveness index [Meeting Abstract]
Ashayeri, K; O'Malley, N; Norris, Z; Mottole, N; Patel, H; Balouch, E; Buckland, A J; Protopsaltis, T S
BACKGROUND CONTEXT: Robot-guided lumbar instrumented fusion (RGLF) for accurate pedicle screw placement is increasingly popular. Learning curve (LC) has been reported to be short, but simple comparison of a set number of early to later cases may oversimplify the LC. This study offers an analysis of a single institution LC for RGLF as it relates to increasing case complexity as determined by Spine Surgical Invasive Index (SII) as described by Mirza, and advanced techniques. PURPOSE: To determine if RGLF is related to SII and is more dynamic than previously described. STUDY DESIGN/SETTING: Single-center retrospective cohort study. PATIENT SAMPLE: A total of 346 patients undergoing RGLF at a single institution from 2018 to 2021. OUTCOME MEASURES: Case complexity indicators (levels fused, SII, iliac fixation, single position surgery), radiation dose, procedure/operative time (PTime/OpTime), EBL, LOS, failed registration, robotic mechanical failures, perioperative complications and OR returns.
METHOD(S): All RGLFs at a single institution were included. Outcome measures indicating case complexity (levels fused, SII, iliac fixation, single position surgery) underwent regression analysis to determine risk factors for robot-related complications. Peaks in these characteristics over the course of 346 cases were identified. Outcomes including radiation dose, procedure/operative time (PTime/OpTime), EBL, LOS, failed registration, robotic mechanical failures, perioperative complications, and returns to OR were analyzed in stepwise fashion by each consecutive case using independent samples t-tests and chi-squared analyses as appropriate.
RESULT(S): A total of 346 RGLFs included. No significant changes in demographics over time. SII was an independent risk factor for robot registration and intraoperative mechanical failures on multivariate regression analysis (p<0.001). SII had significant peaks between 10 to 20 cases and 165 to 330 cases. The following outcomes were overcome during a first LC corresponding to an early SII peak: PTime (401.2+/-135.6 vs 361.4+/-99.7 min; p= 0.047), OpTime (326.0+/-129.4 vs 279.4+/-91.9 min; p= 0.034), robot mechanical failures (26.7% vs 10.1%; p=0.046), all postop complications (60.0% vs 29.2%; p=0.037), ileus (9.0% vs 3.3%; p=0.046), urinary complications (6.4% vs 1.9%; p=0.043). A later LC corresponding to a second SII peak saw significant changes in PTime per level (291.1+/-84.7 vs 259.5+/-108.5 min; p=0.017), OpTime per level (223.6+/-70.4 vs 200.9+/-90.7 min; p= 0.038), EBL (316.7+/-264.0 vs 247.4+/-204.6 mL; p=0.035), LOS (3.8+/-2.2 vs 2.7+/-1.1 days; p=0.001), all intraoperative complications (23.8% vs 13.2%; p=0.036), surgical site infections (2.54% vs 10.34%; p=0.022), robot registration failures (8.3% vs 2.1%; p=0.039), new neurological deficits (5.2% vs 0.0%; p=0.050), instrumentation failures (1.7% vs 3.7%; p =0.043), and returns to OR for pedicle screw revision (1.2% vs 8.9%; p=0.046) or for neurological deficit (3.9% vs 0.0%; p=0.050).
CONCLUSION(S): Two learning curves were observed that mirrored significant peaks in SII. The second, more significant, wave of complications was observed with increased surgical complexity. This suggests a longer, more dynamic learning curve than has been previously described. Avoiding surgeries with high SII at the beginning of RGLF experience may prevent early complications. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002348
ISSN: 1529-9430
CID: 4971502
139. Segmental lordosis restoration using ALIF vs TLIF in adults with flatback deformity [Meeting Abstract]
Buell, T; Shaffrey, C I; Bess, S; 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; Ames, C P; Smith, J S; International, Spine Study Group
BACKGROUND CONTEXT: Few studies investigate segmental lordosis restoration after long fusion with anterior (ALIF) vs transforaminal lumbar interbody fusion (TLIF) for adults with flatback deformity. PURPOSE: Our objective was to compare segmental lordosis restoration, health-related quality-of-life (HRQL), and complications associated with L4-S1 ALIF vs TLIF in operative treatment of flatback deformity. STUDY DESIGN/SETTING: Retrospective review of a prospectively collected multicenter consecutive case registry. PATIENT SAMPLE: Database enrollment required age >=18 years, scoliosis >=20degree, sagittal vertical axis (SVA) >=5cm, pelvic tilt >=25degree, or thoracic kyphosis >=60degree. OUTCOME MEASURES: Radiographic correction (including L4-S1 segmental lordosis), HRQL (Oswestry Disability Index [ODI], Short Form-36 [SF-36] scores, Scoliosis Research Society-22 [SRS-22r] scores), and complications.
Method(s): Prospective multicenter data were reviewed. Study inclusion required pelvic incidence to lumbar lordosis mismatch >=10degree (flatback), index ALIF vs TLIF at L4-L5 and/or L5-S1, and minimum 2-year follow-up. Cage details (height and lordosis) were also assessed.
Result(s): Of 222 consecutive patients, 157 (71%) achieved 2-year follow-up (age=63+/-10years, women=82%, ALIF=43%, TLIF=57%). Index operations had 12+/-3 posterior levels, iliac fixation=93%, and ALIF/TLIF at L4-L5 (66%) and L5-S1 (85%). ALIF vs TLIF cages were similar in height, but cage lordosis was greater for ALIF: L4-L5 (9degree+/-5degree vs 7degree+/-2degree, p=0.025) and L5-S1 (14degree+/-9degree vs 7degree+/-3degree, p<0.001). ALIF (vs TLIF) was associated with significantly more L4-S1 segmental lordosis at last follow-up (37degree+/-11degree vs 31degree+/-9degree, p<0.001) despite similar baseline measurement (32degree+/-15degree vs 31degree+/-14degree, p=0.705). Multiple regression demonstrated 1degree increase in L4-L5 ALIF cage lordosis led to 0.9degree increase in L4-L5 segmental lordosis (p=0.014), and 1degree increase in L5-S1 ALIF cage lordosis led to 0.5degree increase in L5-S1 segmental lordosis (p=0.005). For all patients, final alignment improved significantly (p<0.05): T12-S1 lordosis (25degree+/-17degree to 48degree+/-13degree), L4-S1 lordosis (32degree+/-14degree to 34degree+/-10degree),
EMBASE:2014002344
ISSN: 1529-9430
CID: 4971512
126. Proximal and distal reciprocal alignment changes following cervical deformity correction [Meeting Abstract]
Lafage, R; Smith, J S; Protopsaltis, T S; Klineberg, E O; Mundis, G M; Passias, P G; Elysee, J; Gupta, M C; Shaffrey, C I; Kim, H J; Bess, S; Schwab, F J; Lafage, V; Ames, C P; International, Spine Study Group
BACKGROUND CONTEXT: Hyperextension of C0-C2 is a painful compensatory mechanism used to maintain horizontal gaze that is analogous to high pelvic tilt to maintain upright posture. The magnitude and impact of relaxation of this hyperextension following CD correction are not well understood. PURPOSE: To investigate whether correction of cervical sagittal malalignment allows for relaxation of C0-C2 hyperextension and improved clinical outcome. STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: This study included 65 ACD patients with 1- or 2-year follow-up. OUTCOME MEASURES: Radiographic alignment, range of motion (ROM).
Method(s): CD patients undergoing surgery short of the occiput and the pelvis were included. In addition to the classic alignment parameters, ROM and reserve of extension were calculated across the C2-C7 and C0-C2 segments. After describing the cohort in terms of preoperative information, correlations and hierarchical stepwise regressions investigated the association between C2-C7 correction and change in C0-C2 reserve of extension while controlling for maintenance of horizontal gaze. Stratification by DELTAC2-C7 percentile was conducted followed by paired t-tests to investigate changes in TK, C0-C2 and reserve of extension within each percentile.
Result(s): Sixty-five patients were included (61.8yo+/-9.6, 68%F). At baseline, they presented with a cervical kyphotic alignment (C2-C7: -11.7degree+/-18.2; TS-CL: 38.6degree+/-18.6), a negative global alignment (SVA: -12mm+/-71), and hyperlordosis at C0-C2 (33.2degree+/-11.8). The ROM was 25.7degree+/-17.7 and 21.3degree+/-9.9 at C2-C7 and C0-C2, respectively, with an associated reserve of extension of ~9degree for each segment. Limited C0-C2 ROM and reserve of extension significantly correlated with the Neck Disability Index (r=-0.371 & -0.394) and with decreased general health (r=0.455 & 0.512) (all p<0.005) The mean number of levels treated was 7.0+/-3.1 (24.6% ACDF, 43.1% posterior), with 49.2% of the patients receiving an osteotomy, and 16.9% a 3CO. At 1 year, C2-C7 increased to 5.5degree+/-13.4, SVA became neutral (12mm+/-54), C0-C2 decreased to 27.7degree+/-11.7, and TK increased to -49.4+/-18.1 (all p <0.001). At C2-C7 ROM decreased significantly to 9.5degree+/-14.1, and increased to 27.6degree+/-8.1 at C0-C2 without change in reserve of extension. The horizontal gaze significantly improved (4.5+/-13.3 vs -0.5+/-9.3 p=0.003). Controlling horizontal gaze, change in C2-C7 lordosis significantly correlated with increased TK (r=-0.615, p<0.01), decreased C0-C2 (r=-0.686, p<0.001), and increased C0-C2 reserve of extension (r=0.414, p<0.015). Larger C0-C2 ROM and reserve of extension correlated with decreased in Neck Disability Index (r=-0.571 & -0.470 p<0.05). Stratification by DELTAC2-C7 percentile highlighted the reciprocal change above and below the fusion. Within the lowest percentile (DELTAC2-C7: 2degree+/-9.6), no significant difference was noticed between pre and 1 year, while within the highest percentile (DELTAC2-C7: -42.8+/-14.1), C0-C2 decreased (-9.7degree+/-10.5, p=0.001), TK kyphosis increased (14.3degree+/-7.5, p<0.001) and C0-C2 reserve of extension increased (5.8degree+/-6.4, p=0.026). Subanalysis on patients with available 2-year data (N=42) demonstrated similar trends.
Conclusion(s): Correction of cervical malalignment can significantly impact proximal (C0-C2) and distal (T2-T12) compensation. Restoration of a more natural alignment resulted in an increase of the reserve of extension between C0-C2 and was associated with improved clinical outcomes. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002343
ISSN: 1529-9430
CID: 4971522
206. Comparison of patient factors (frailty) vs surgical factors (invasiveness) for optimization of 2-year cost utility: We should focus on the patient factors [Meeting Abstract]
Gum, J L; Yeramaneni, S; Wang, K; Hostin, R A; Kebaish, K M; Neuman, B J; Jain, A; Kelly, M P; Burton, D C; Ames, C P; Shaffrey, C I; Klineberg, E O; Kim, H J; Protopsaltis, T S; Passias, P G; Mundis, G M; Eastlack, R K; Schwab, F J; Hart, R A; Gupta, M C; Daniels, A H; Smith, J S; Lafage, V; Line, B; Bess, S; International, Spine Study Group
BACKGROUND CONTEXT: Adult spinal deformity (ASD) surgery is costly and carries a high complication rate. It is therefore very important to optimize value (cost-per-QALY) or cost-utility in ASD surgery. To identify targets for improvement, we compared the influence of patient factors, measured by frailty, vs surgical factors, measured by surgical invasiveness (SI), on 2-year cost-utility. Patient frailty is an approximation of baseline patient health status, whereas SI represents extensiveness of the surgical intervention. Data comparing the relative importance of these aggregate measures on cost-utility are limited. Additionally, this analysis can serve to help identify the most impactful modifiable factors in the value equation. PURPOSE: The aim of this study was to assess whether frailty or SI is a more important determinant of 2-year cost-utility in ASD surgery. STUDY DESIGN/SETTING: Prospective, multicenter study. PATIENT SAMPLE: ASD patients with >4-level fusion and eligible for minimum 2-year follow-up were included. OUTCOME MEASURES: Two-year cost-per-QALY.
METHOD(S): Index and total episode of care (EOC; iEOC; tEOC) cost was calculated using Medicare's inpatient prospective payment system (IPPS) for MS-DRGs 453-460. All costs were adjusted for inflation to 2020 US dollar values. QALYs gained were calculated using baseline, 1-year, and 2-year SF-6D scores. A discount rate of 3% was assumed. Cost-per-QALY was determined by calculating total EOC per cumulative QALY at two years. Patients were categorized as not-frail (NF, <0.3), frail (F, 0.3<= to <0.5), and severely frail (SF, >0.5). SI was categorized as low-SI (SI<90) and high-SI (SI>90). A generalized linear model with gamma error distribution and log link was used to estimate the association between frailty and SI on cost-per-QALY. All analyses were controlled for gender and blood loss. Other variables commonly adjusted for (ie, age, levels fused) were intentionally not controlled for in this analysis to avoid collinearity with either frailty or SI.
RESULT(S): DRG data for index and revision surgery was available for 505/889 patients. Mean age was 62.5+12.4years, 76% were women, and 91% were Caucasian. Of the total patients,72% demonstrated positive gain in QALY at 2 years (0.12+0.09, p<0.001) compared to baseline. The mean iEOC was $72,717, tEOC was $86,066, and cost-per-QALY was $52,357. Eighty-nine patients had 114 (range 1-5) revisions (17.6%) compared to 416 without. The tEOC in revision group was $151,913 compared to $71,978 in the non-revision group with 2-year cost-per-QALY 98,262 compared to 42,537, respectively. On adjusted analysis, F and SF patients compared to NF patients had significantly higher cost-per-QALY (p<0.0001 for all comparisons) regardless of the surgical invasiveness. However, SI was not significantly associated with cost-per-QALY regardless of patient's frailty.
CONCLUSION(S): Increasing levels of frailty were associated with significantly and incrementally higher values of 2-year cost-per-QALY in both low and high SI groups. However, within each frailty group, the high and low SI groups had equivalent cost-per-QALY. Frailty appears to be a better determinant of 2-year cost-per-QALY compared to surgical invasiveness. Surgeons should place more importance on modifiable patient factors compared to surgical factors to improve or optimize 2-year cost-utility in ASD surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002329
ISSN: 1529-9430
CID: 4971532
124. Cervical deformity score: a composite alignment tool to optimize outcomes while mitigating complications [Meeting Abstract]
Elysee, J; Lafage, R; Smith, J S; Klineberg, E O; Passias, P G; Mundis, G M; Protopsaltis, T S; Gupta, M C; Shaffrey, C I; Kim, H J; Bess, S; Ames, C P; Schwab, F J; Lafage, V; International, Spine Study Group
BACKGROUND CONTEXT: Cervical alignment and cervical deformity surgery are complex topics. Recently, a score inspired by work on thoracolumbar alignment was developed for cervical alignment (cervical deformity score, CDS). While this score was designed to predict early mechanical failures, its association with patient reported outcomes (PROM) remains unclear. PURPOSE: Investigate the association between PROM, complications, and a newly described cervical deformity score. STUDY DESIGN/SETTING: Retrospective review of prospective multicenter database. PATIENT SAMPLE: A total of 102 adult cervical deformity (CD) patients with at least 1 year follow-up. OUTCOME MEASURES: NDI, neck pain, EQ5D, complication rates.
Method(s): CD patients with baseline and 1-year follow-up were included. Postoperative CDS was constructed using offset from age-adjusted values: SVA [(age -55)*2+25], T1 Slope [(age -55)/4 + 28.7], and TS minus CL [cst: between 26.5 and 14.5degree]. Points were assigned based on the offset from alignment targets and the CDS was the sum of the three individual scores. Association with patient-reported outcomes was investigated using Pearson's correlations. Comparison of CDS between patients with and without complication within 1-year was conducted. Logistical regression controlling for demographic and comorbidities was conducted to identify if CDS was an independent predictor of complications.
Result(s): A total of 102 patients met inclusion criteria (61.7yo+/-10, 66.7% F); 37.6% of them had a history of previous cervical surgery (16.7% previous ACDF, 11.7% previous posterior fusion). Preoperatively, they had elevated disability (NDI: 47.1+/-18.1), pain (NSR Neck: 6.6+/-2.5), myelopathy (mJOA: 13.6+/-2.7) and lower general health (EQ5D: 0.74+/-0.07). They also presented with an overall cervical kyphotic alignment (C2-C7: -6.3degree+/-20.9), a moderate cervical anterior alignment (cSVA: 39mm+/-20; TS-CL: 37.9degree+/-19.4) and a posterior global thoracolumbar alignment (SVA: -3mm+/-68). The median of number of levels fused was 7 [4-9], with 49% treated with a posterior approach and 30.4% with a combined approach; 83.2% received an osteotomy, 44.6% some posterior osteotomy, 16.8% grade 6 or 7. The mean operative time was 368min+/-208, median EBL was 525cc [200 1025], and LOS was 5 days [4 8]. At 1 year, patients improved significantly in terms of disability (NDI: 36.2+/-20.7, 60.8% reached MCID), pain (NSR: 4.1+/-2.9) and general health (EQ5D: 0.79+/-0.08) (all p<0.001). The cervical alignment significantly changed (C2-C7: 7.8+/-14.5m; cSVA: 34mm+/-15; TS-CL: 28.9degree+/-12.6 all p <0.002), with a 1-year CDS of 1.68+/-2.46 (prctl [0 3.25]). There was a significant association between increased CDS and increased disability (r=0.273), pain (r=0.336) and lower general health (r=-0.283). Patient with a lower disability level (NDI<20) had a significantly lower CDS (0.71+/-2.3 vs 2.16+/-2.4 p<0.004). Patients without any complications before 1 year had a lower CDS (0.78+/-2.33 vs 2.18+/-2.40 p=0.005), as did patients without major complications (1.36+/-2.27 vs 2.50+/-.78 p=0.037). Deeper analysis revealed significant differences in terms of CDS for patients experiencing cardiopulmonary, instrumentation and radiographic complications (p<0.05). Multivariate analysis, controlling for age and comorbidities, show 1-year CDS to be a significant predictor of complication (p=0.002, OR=1.409).
Conclusion(s): With better outcomes and lower complication rate, maintaining a proportionate alignment postoperatively can result in superior outcomes following CD surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002290
ISSN: 1529-9430
CID: 4971542
172. Matched analysis demonstrates fusion to upper thoracic spine does not improve correction or outcomes compared to thoracolumbar upper instrumented vertebra (UIV) for select adult spinal deformities [Meeting Abstract]
Bess, S; Line, B; Lafage, R; Ames, C P; Eastlack, R K; Mundis, G M; Lafage, V; Klineberg, E O; Gupta, M C; Kelly, M P; Passias, P G; Protopsaltis, T S; Burton, D C; Kebaish, K M; Kim, H J; Schwab, F J; Shaffrey, C I; Smith, J S; International, Spine Study Group
BACKGROUND CONTEXT: Few guidelines exist regarding appropriate upper instrumented vertebra (UIV) selection for adult spinal deformity (ASD) patients undergoing long fusion to the pelvis. Fusion to upper thoracic (UT) spine may provide greater deformity correction and reduce proximal junctional failure (PJF) rates compared to fusions terminating at the thoracolumbar (TL) spine. Previous reports comparing outcomes for UT vs TL UIV for ASD surgery are confounded by discrepant patient cohorts. PSM analyses can be used to reduce selection bias and mimic patient randomization. PURPOSE: Use a propensity score matched (PSM) analysis to compare surgical and hospital data, deformity correction, complication rates, and patient reported outcomes (PROs) for demographically and radiographically matched ASD patients receiving TL vs UT UIV. STUDY DESIGN/SETTING: PSM analysis of ASD patients prospectively enrolled into a multicenter study. PATIENT SAMPLE: Surgically treated ASD patients. OUTCOME MEASURES: Numeric rating scale (NRS) back and leg pain, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), Oswestry Disability Index (ODI), estimated blood loss, duration of hospital stay, postoperative complications, revision spine surgery, PJF.
Method(s): ASD patients prospectively enrolled into a multicenter study from 2009-2018 were classified according to SRS-Schwab ASD Types. Study inclusion; 1) surgery for lumbar (L), sagittal (S) or mixed (M) deformities, 2) fusion to pelvis, 3) >=5 levels fused, 4) >=2 year follow up. Study exclusion; double major or thoracic scoliosis, thoracic hyperkyphosis (>70degree). UIV cohorts formed based on bimodal UIV distribution (TL=L2-T8 vs UT=T6-T1). PSM matched TL and UT for preop demographics, scoliosis, PI-LL, TK, SVA, TPA and osteotomies. Postop deformity correction, complications, and PROs were compared for UT vs TL in L, M, S deformities.
Result(s): Of 699 eligible patients, 417 (L [n=70], S [n=166] and M [n=198]) were evaluated. UT and TL had similar preop age, frailty, spine deformity, follow up, osteotomies performed (p>0.05). UT had greater blood loss in L and M deformities, greater SICU admissions for L and S, longer hospital and greater revision surgery for implant failures for all deformities than TL (p<0.05). UT had fewer PJF for L deformities (p<0.05). Deformity correction and PROM improvement was similar UT vs TL for all cohorts at last follow up (p>0.05).
Conclusion(s): The theoretical benefits of UT fusion were not demonstrated for matched L, S and M patients receiving long fusion to the pelvis. UT had greater blood loss, hospital stay and revision surgery for implant failures than TL. For select deformities surgeons should consider TL UIV rather than UT; however, more research is needed to determine best outcomes for fusion levels for ASD. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002134
ISSN: 1529-9430
CID: 4971682
P85. Delayed staging during same hospitalization increases complication risk following adult spinal deformity surgery [Meeting Abstract]
Neuman, B J; Wang, K; McNeely, E; Klineberg, E O; Smith, J S; Bess, S; Lafage, V; Passias, P G; Protopsaltis, T S; Gum, J L; Ames, C P; Shaffrey, C I; Kebaish, K M; International, Spine Study Group
BACKGROUND CONTEXT: Since circumferential adult spinal deformity (ASD) surgery can lead to high surgical burden for the patient, surgeons may elect to stage these procedures during the same hospitalization. As a result, there is a trend toward planning same-hospitalization staged ASD surgeries by performing an anterior lumbar interbody fusion (ALIF) prior to a subsequent staged posterior fusion. PURPOSE: The aim of this study was to determine optimal timing for staging (early vs delayed) thoracolumbar ASD surgery within the same hospitalization. STUDY DESIGN/SETTING: Retrospective review of a multicenter database. PATIENT SAMPLE: A total of 158 surgical ASD patients undergoing anterior and staged posterior spinal fusion >=5 levels. OUTCOME MEASURES: Our outcome measures were 90-day complication rates, postoperative alignment, and 2-year ODI.
METHOD(S): Using a prospective, multicenter database, we identified 158 surgical ASD patients undergoing first an anterior surgery followed by a staged posterior spinal fusion >=5 levels during the same hospitalization. Stratum-specific likelihood ratio (SSLR) analysis was performed to calculate a cutoff point beyond which 90-day complications were increased. The cutoff generated through SSLR were confirmed with multivariable logistic regression analysis controlling for age, gender, levels fused for each stage, preoperative alignment, three-column osteotomy, and Charlson Comorbidity Index. The outcome measures were 90-day complication rates, postoperative alignment, and 2-year ODI. Multivariable analyses were performed with logistic, Poisson and linear regressions where appropriate.
RESULT(S): Utilization of staged procedures increased 4x from 2008-2019, and the mean staging interval was 3 days (range 1-8). On SSLR analysis, patients were divided into two staging categories based on complication risk: early (<6 days, range 1-5, N=139) versus delayed (>= 6 day, range 6-8, N=19). On bivariate analysis, the delayed group had higher 90-day complication rates (68.4% vs 32.4%, p=0.002) and longer operative times (638 min vs 739 min, p=0.020) relative to the early group. Adjusting for covariates on multivariable analysis, patients with delayed staging had significantly greater odds of 90-day complications (OR=7.57, p=0.006), and longer total operative time (beta=119, p=0.035). With respect to specific complications, delayed staging carries increased odds of infection compared to early staging (OR=11.8 p=0.031). There were no significant differences in postoperative alignment or 2-year ODI between the groups (p>0.05 for all).
CONCLUSION(S): Compared to early staging (< 6 days) of ALIF and subsequent staged posterior fusion, delayed staging (>= 6 days) is associated with greater odds of 90-day complications, particularly infection. With the growing trend toward staged ASD surgeries, efforts should be made to shorten the interval between ALIF and subsequent posterior fusion. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2014002155
ISSN: 1529-9430
CID: 4971652