Predictors of serious, preventable, and costly medical complications in a population of adult spinal deformity patients.

BACKGROUND CONTEXT: In 2008, the Centers for Medicare and Medicaid Services (CMS) established a list of hospital-acquired conditions (HACs) with significant deleterious effects on both patients and providers. Adult spinal deformity (ASD) surgery is complex and highly invasive, and as such may result in significant morbidity including these HACs. PURPOSE: Identify predictors for developing the most common HACs among adult spinal deformity (ASD) patients undergoing corrective surgery. STUDY DESIGN/SETTING: Retrospective analysis. PATIENT SAMPLE: One thousand one hundred and seventy-one ASD patients. OUTCOME MEASURES: HACs, Health-Related Quality of Life scores(HRQLs), Reoperation, Integrated Health State (IHS) METHODS: ASD pts undergoing surgery (>18 years, scoliosis ≥20°, SVA ≥5 cm, PT ≥25° and/or TK >60°) with complete data at BL and up to 2 years post-op were included. Patients were stratified by presence of >1 HAC, defined as at least one superficial/deep SSI, UTI, DVT, or PE within a 30-day post-op window. Random forest analysis generated 5,000 Conditional Inference Trees to compute a variable importance table for top predictors of HACs. An area-under-the-curve (AUC) methodology compared normalized HRQL scores between groups to determine an IHS with 2-year follow-up. RESULTS: Total of 1,171 pts (59.8 years, 76.2%F, 28.1kg/m2) underwent corrective ASD surgery, with 1,053 pts in the non-HAC group and 118 in the HAC group. Of these pts, 25.4% had UTI, 15.4% DVT, 19.2% superficial SSI, 20.8% deep SSI, and 19.2% PE. HAC pts were on average older (63.5 vs 59.3, p=.004) and more often frail (51.3 vs 39.7%, p=.021) than non-HAC pts. Postop LOS and reoperation were most associated with HAC groups: [1] LOS >7 days [2] reoperation. Patient-related predictors of HACs were [3] age >50 yerr, [4] frailty, and [13] BMI >31. Procedure-related predictors of HACs were [5] operative-time >405 minutes, [6] levels fused >9, EBL >1450 mL, and [11] decompression. BL radiographic predictors were [7] PT >20°, [9] PI-LL>6°, [10] TL Cobb angle >15°, [12] SVA C7-S1 >29 mm. No differences were observed between groups with regards to IHS ODI (0.73 vs 0.74, p=.863), SRS (1.3 vs1.3, p=.374), NRS Back (0.6 vs 0.6, p=.158). HAC had higher rates of reoperation than non-HAC (0.08 vs 0.01, p=.066), and any HAC within 30-days of index was a significant predictor of reoperation (OR: 2.448 [1.94-3.09], p<.001). CONCLUSIONS: In a population of ASD patients, HACs were associated with length of stay, reoperation, age, and frailty. Radiographic parameters such as pelvic tilt >20°, PI-LL >6°, & SVA >29 mm also increased odds of HACs, and should raise postoperative awareness for HAC development.

Predictors of Superior Recovery Kinetics in Adult Cervical Deformity Correction: An Analysis Using a Novel Area Under the Curve Methodology.

STUDY DESIGN: Retrospective review of a prospective database. OBJECTIVE: The aim of this study was to identify demographic, surgical, and radiographic factors that predict superior recovery kinetics following cervical deformity (CD) corrective surgery. SUMMARY OF BACKGROUND DATA: Analyses of CD corrective surgery use area under the curve (AUC) to assess health-related quality of life (HRQL) metrics throughout recovery. METHODS: Outcome measures were baseline (BL) to 1-year (1Y) health-related quality of life (HRQL) (Neck Disability Index [NDI]). CD criteria were C2-7 Cobb angle >10°, coronal Cobb angle >10°, C2-C7 sagittal vertical axis (cSVA) >4 cm, TS-CL >10°, or chin-brow vertical angle >25°. AUC normalization divided BL and postoperative outcomes by BL. Normalized scores (y axis) were plotted against follow-up (x axis). AUC was calculated and divided by cumulative follow-up length to determine overall, time-adjusted recovery (Integrated Health State [IHS]). IHS NDI was stratified by quartile, uppermost 25% being "Superior" Recovery Kinetics (SRK) versus "Normal" Recovery Kinetics (NRK). BL demographic, clinical, and surgical information predicted SRK using generalized linear modeling. RESULTS: Ninety-eight patients included (62 ±â€Š10 years, 28 ±â€Š6 kg/m2, 65% females, Charlson Comorbidity Index: 0.95), 6% smokers, 31% smoking history. Surgical approach was: combined (33%), posterior (49%), anterior (18%). Posterior levels fused: 8.7, anterior: 3.6, estimated blood loss: 915.9ccs, operative time: 495 minutes. Ames BL classification: cSVA (53.2% minor deformity, 46.8% moderate), TS-CL (9.8% minor, 4.3% moderate, 85.9% marked), horizontal gaze (27.4% minor, 46.6% moderate, 26% marked). Relative to BL NDI (Mean: 47), normalized NDI decreased at 3 months (0.9 ±â€Š0.5, P = 0.260) and 1Y (0.78 ±â€Š0.41, P < 0.001). NDI IHS correlated with age (P = 0.011), sex (P = 0.042), anterior approach (P = 0.042), posterior approach (P = 0.042). Greater BL pelvic tilt (PT) (SRK: 25.6°, NRK: 17°, P = 0.002), pelvic incidence-lumbar lordosis (PI-LL) (SRK: 8.4°, NRK: -2.8°, P = 0.009), and anterior approach (SRK: 34.8%, NRK: 13.3%; P = 0.020) correlated with SRK. 69.4% met MCID for NDI (<Δ-15) and 63.3% met substantial clinical benefit for NDI (<Δ-10); 100% of SRK met both MCID and substantial clinical benefit. The predictive model for SRK included (AUC = 88.1%): BL visual analog scale (VAS) EuroQol five-dimensional descriptive system (EQ5D) (odds rario [OR] 0.96, 95% confidence interval [CI]: 0.92-0.99), BL swallow sleep score (OR: 1.04, 95% CI: 1.01-1.06), BL PT (OR: 1.12, 95% CI: 1.03-1.22), BL modified Japanese Orthopedic Association scale (mJOA) (OR: 1.5, 95% CI: 1.07-2.16), BL T4-T12, BL T10-L2, BL T12-S1, and BL L1-S1. CONCLUSION: Superior recovery kinetics following CD surgery was predicted with high accuracy using BL patient-reported (VAS EQ5D, swallow sleep, mJOA) and radiographic factors (PT, TK, T10-L2, T12-S1, L1-S1). Awareness of these factors can improve decision-making and reduce postoperative neck disability.Level of Evidence: 3.

Baseline Frailty Status Influences Recovery Patterns and Outcomes Following Alignment Correction of Cervical Deformity.

BACKGROUND: Frailty severity may be an important determinant for impaired recovery after cervical spine deformity (CD) corrective surgery. OBJECTIVE: To evaluate postop clinical recovery among CD patients between frailty states undergoing primary procedures. METHODS: Patients >18 yr old undergoing surgery for CD with health-related quality of life (HRQL) data at baseline, 3-mo, and 1-yr postoperative were identified. Patients were stratified by the modified CD frailty index scale from 0 to 1 (no frailty [NF] <0.3, mild/severe fraily [F] >0.3). Patients in NF and F groups were propensity score matched for TS-CL (T1 slope [TS] minus angle between the C2 inferior end plate and the C7 inferior end plate [CL]) to control for baseline deformity. Area under the curve was calculated for follow-up time intervals determining overall normalized, time-adjusted HRQL outcomes; Integrated Health State (IHS) was compared between NF and F groups. RESULTS: A total of 106 CD patients were included (61.7 yr, 66% F, 27.7 kg/m2)-by frailty group: 52.8% NF, 47.2% F. After propensity score matching for TS-CL (mean: 38.1°), 38 patients remained in each of the NF and F groups. IHS-adjusted HRQL outcomes from baseline to 1 yr showed a significant difference in Euro-Qol 5 Dimension scores (NF: 1.02, F: 1.07, P = .016). No significant differences were found in the IHS Neck Disability Index (NDI) and modified Japanese Orthopedic Association between frailty groups (P > .05). F patients had more postop major complications (31.3%) compared to the NF (8.9%), P = .004, though DJK occurrence and reoperation between the groups was not significant. CONCLUSION: While all groups exhibited improved postop disability and pain scores, frail patients experienced greater amount of improvement in overall health state compared to baseline disability. This signifies that with frailty severity, patients have more room for improvement postop compared to baseline quality of life.

The impact of postoperative neurologic complications on recovery kinetics in cervical deformity surgery.

OBJECTIVE: The objective of the study is to investigate which neurologic complications affect clinical outcomes the most following cervical deformity (CD) surgery. METHODS: CD patients (C2-C7 Cobb >10°, CL >10°, cSVA >4 cm or chin-brow vertical angle >25°) >18 years with follow-up surgical and health-related quality of life (HRQL) data were included. Descriptive analyses assessed demographics. Neurologic complications assessed were C5 motor deficit, central neurodeficit, nerve root motor deficits, nerve sensory deficits, radiculopathy, and spinal cord deficits. Neurologic complications were classified as major or minor, then: intraoperative, before discharge, before 30 days, before 90 days, and after 90 days. HRQL outcomes were assessed at 3 months, 6 months, and 1 year. Integrated health state (IHS) for the neck disability index (NDI), EQ5D, and modified Japanese Orthopaedic Association (mJOA) were assessed using all follow-up time points. A subanalysis assessed IHS outcomes for patients with 2Y follow-up. RESULTS: 153 operative CD patients were included. Baseline characteristics: 61 years old, 63% female, body mass index 29.7, operative time 531.6 ± 275.5, estimated blood loss 924.2 ± 729.5, 49% posterior approach, 18% anterior approach, 33% combined. 18% of patients experienced a total of 28 neurologic complications in the postoperative period (15 major). There were 7 radiculopathy, 6 motor deficits, 6 sensory deficits, 5 C5 motor deficits, 2 central neurodeficits, and 2 spinal cord deficits. 11.2% of patients experienced neurologic complications before 30 days (7 major) and 15% before 90 days (12 major). 12% of neurocomplication patients went on to have revision surgery within 6 months and 18% within 2 years. Neurologic complication patients had worse mJOA IHS scores at 1Y but no significant differences between NDI and EQ5D (0.003 vs. 0.873, 0.458). When assessing individual complications, central neurologic deficits and spinal cord deficit patients had the worst outcomes at 1Y (2.6 and 1.8 times worse NDI scores, P = 0.04, no improvement in EQ5D, 8% decrease in EQ5D). Patients with sensory deficits had the best NDI and EQ5D outcomes at 1Y (31% decrease in NDI, 8% increase in EQ5D). In a subanalysis, neurologic patients trended toward worse NDI and mJOA IHS outcomes (P = 0.263, 0.163). CONCLUSIONS: 18% of patients undergoing CD surgery experienced a neurologic complication, with 15% within 3 months. Patients who experienced any neurologic complication had worse mJOA recovery kinetics by 1 year and trended toward worse recovery at 2 years. Of the neurologic complications, central neurologic deficits and spinal cord deficits were the most detrimental.

Does Patient Frailty Status Influence Recovery Following Spinal Fusion for Adult Spinal Deformity?: An Analysis of Patients With 3-Year Follow-up.

STUDY DESIGN: Retrospective review of a prospective database. OBJECTIVE: The aim of this study was to evaluate postop clinical recovery among adult spinal deformity (ASD) patients between frailty states undergoing primary procedures SUMMARY OF BACKGROUND DATA.: Frailty severity may be an important determinant for impaired recovery after corrective surgery. METHODS: It included ASD patients with health-related quality of life (HRQLs) at baseline (BL), 1 year (1Y), and 3 years (3Y). Patients stratified by frailty by ASD-frailty index scale 0-1(no frailty: <0.3 [NF], mild: 0.3-0.5 [MF], severe: >0.5 [SF]). Demographics, alignment, and SRS-Schwab modifiers were assessed with χ/paired t tests to compare HRQLs: Scoliosis Research Society 22-question Questionnaire (SRS-22), Numeric Rating Scale (NRS) Back/Leg Pain, Oswestry Disability Index (ODI). Area-under-the-curve (AUC) method generated normalized HRQL scores at baseline (BL) and f/u intervals (1Y, 3Y). AUC was calculated for each f/u, and total area was divided by cumulative f/u, generating one number describing recovery (Integrated Health State [IHS]). RESULTS: A total of 191 patients were included (59 years, 80% females). Breakdown of patients by frailty status: 43.6% NF, 40.8% MF, 15.6% SF. SF patients were older (P = 0.003), >body mass index (P = 0.002). MF and SF were significantly (P < 0.001) more malaligned at BL: pelvic tilt (NF: 21.6°; MF: 27.3°; SF: 22.1°), pelvic incidence and lumbar lordosis (7.4°, 21.2°, 19.7°), sagittal vertical axis (31 mm, 87 mm, 82 mm). By SRS-Schwab, NF were mostly minor (40%), and MF and SF markedly deformed (64%, 57%). Frailty groups exhibited BL to 3Y improvement in SRS-22, ODI, NRS Back/Leg (P < 0.001). After HRQL normalization, SF had improvement in SRS-22 at year 1 and year 3 (P < 0.001), and NRS Back at 1Y. 3Y IHS showed a significant difference in SRS-22 (NF: 1.2 vs. MF: 1.32 vs. SF: 1.69, P < 0.001) and NRS Back Pain (NF: 0.52, MF: 0.66, SF: 0.6, P = 0.025) between frailty groups. SF had more complications (79%). SF/marked deformity had larger invasiveness score (112) compared to MF/moderate deformity (86.2). Controlling for baseline deformity and invasiveness, SF showed more improvement in SRS-22 IHS (NF: 1.21, MF: 1.32, SF: 1.66, P < 0.001). CONCLUSION: Although all frailty groups exhibited improved postop disability/pain scores, SF patients recovered better in SRS-22 and NRS Back. Despite SF patients having more complications and larger invasiveness scores, they had overall better patient-reported outcomes, signifying that with frailty severity, patients have more room for improvement postop compared to BL quality of life. LEVEL OF EVIDENCE: 3.

Recovery kinetics following spinal deformity correction: a comparison of isolated cervical, thoracolumbar, and combined deformity morphometries.

BACKGROUND CONTEXT: The postoperative recovery patterns of cervical deformity patients, thoracolumbar deformity patients, and patients with combined cervical and thoracolumbar deformities, all relative to one another, is not well understood. Clear objective benchmarks are needed to quantitatively define a "good" versus a "bad" postoperative recovery across multiple follow-up visits, varying deformity types, and guide expectations. PURPOSE: To objectively define and compare the complete 2-year postoperative recovery process among operative cervical only, thoracolumbar only, and combined deformity patients using area-under-the-curve (AUC) methodology. STUDY DESIGN/SETTING: Retrospective review of 2 prospective, multicenter adult cervical and spinal deformity databases. PATIENT SAMPLE: One hundred seventy spinal deformity patients. OUTCOME MEASURES: Common health-related quality of life (HRQOL) assessments across both databases included the EuroQol 5-Dimension Questionnaire and Numeric Rating Scale (NRS) back pain assessment. In order to compare disability improvements, the Neck Disability Index (NDI) and the Oswestry Disability Index (ODI) were merged into one outcome variable, the ODI-NDI. Both assessments are gauged on the same scale, with minimal question deviation. Sagittal Radiographic Alignment was also assessed at pre- and all postoperative time points. METHODS: Operative deformity patients >18 years old with baseline (BL) to 2-year HRQOLs were included. Patients were stratified by cervical only (C), thoracolumbar only (T), and combined deformities (CT). HRQOL and radiographic outcomes were compared within and between deformity groups. AUC normalization generated normalized HRQOL scores at BL and all follow-up intervals (6 weeks, 3 months, 1 year, and 2 year). Normalized scores were plotted against follow-up time interval. AUC was calculated for each follow-up interval, and total area was divided by cumulative follow-up length, determining overall, time-adjusted HRQOL recovery (Integrated Health State, IHS). Multiple linear regression models determined significant predictors of HRQOL discrepancies among deformity groups. RESULTS: One hundred seventy patients were included (27 C, 27 T, and 116 CT). Age, BMI, sex, smoking status, osteoporosis, depression, and BL HRQOL scores were similar among groups (p >. 05). T and CT patients had higher comorbidity severities (CCI: C 0.696, T 1.815, CT 1.699, p = .020). Posterior surgical approaches were most common (62.9%) followed by combined (28.8%) and anterior (6.5%). Standard HRQOL analysis found no significant differences among groups until 1-year follow-up, where C patients exhibited comparatively greater NRS back pain (4.88 vs. 3.65 vs. 3.28, p = .028). NRS Back pain differences between groups subsided by 2-years (p>.05). Despite C patients exhibiting significantly faster ODI-NDI minimal clinically important difference (MCID) achievement (33.3% vs. 0% vs. 23.0%, p < .001), all deformity groups exhibited similar ODI-NDI MCID achievement by 2-years (51.9% vs. 59.3% vs. 62.9%, p = 0.563). After HRQOL normalization, similar results were observed relative to the standard analysis (1-year NRS Back: C 1.17 vs. T 0.50 vs. CT 0.51, p < .001; 2-year NRS Back: 1.20 vs. 0.51 vs. 0.69, p = .060). C patients exhibited a worse NRS back normalized IHS (C 1.18 vs. T 0.58 vs. CT 0.63, p = .004), indicating C patients were in a greater state of postoperative back pain for a longer amount of time. Linear regression models determined postoperative distal junctional kyphosis (adjusted beta: 0.207, p = .039) and osteoporosis (adjusted beta: 0.269, p = .007) as the strongest predictors of a poor NRS back IHS (model summary: R2 = 0.177, p = .039). CONCLUSIONS: Despite C patients exhibiting a quicker rate of MCID disability (ODI-NDI) improvement, they exhibited a poorer overall recovery of back pain with worse NRS back scores compared with BL status and other deformity groups. Postoperative distal junctional kyphosis and osteoporosis were identified as primary drivers of a poor postoperative NRS back IHS. Utilization of the IHS, a single number adjusting for all postoperative HRQOL visits, in conjunction with predictive modelling may pose as an improved method of gauging the effect of surgical details and complications on a patient's entire recovery process.

Recovery Kinetics: Comparison of Patients Undergoing Primary or Revision Procedures for Adult Cervical Deformity Using a Novel Area Under the Curve Methodology.

BACKGROUND: Limited data are available to objectively define what constitutes a "good" versus a "bad" recovery for operative cervical deformity (CD) patients. Furthermore, the recovery patterns of primary versus revision procedures for CD is poorly understood. OBJECTIVE: To define and compare the recovery profiles of CD patients undergoing primary or revision procedures, utilizing a novel area-under-the-curve normalization methodology. METHODS: CD patients undergoing primary or revision surgery with baseline to 1-yr health-related quality of life (HRQL) scores were included. Clinical symptoms and HRQL were compared among groups (primary/revision). Normalized HRQL scores at baseline and follow-up intervals (3M, 6M, 1Y) were generated. Normalized HRQLs were plotted and area under the curve was calculated, generating one number describing overall recovery (Integrated Health State). Subanalysis identified recovery patterns through 2-yr follow-up. RESULTS: Eighty-three patients were included (45 primary, 38 revision). Age (61.3 vs 61.9), gender (F: 66.7% vs 63.2%), body mass index (27.7 vs 29.3), Charlson Comorbidity Index, frailty, and osteoporosis (20% vs 13.2%) were similar between groups (P > .05). Primary patients were more preoperatively neurologically symptomatic (55.6% vs 31.6%), less sagittally malaligned (cervical sagittal vertical axis [cSVA]: 32.6 vs 46.6; T1 slope: 28.8 vs 36.8), underwent more anterior-only approaches (28.9% vs 7.9%), and less posterior-only approaches (37.8% vs 60.5%), all P < .05. Combined approaches, decompressions, osteotomies, and construct length were similar between groups (P > .05). Revisions had longer op-times (438.0 vs 734.4 min, P = .008). Following surgery, complication rate was similar between groups (66.6% vs 65.8%, P = .569). Revision patients remained more malaligned (cSVA, TS-CL; P < .05) than primary patients until 1-yr follow-up (P > .05). Normalized HRQLs determined primary patients to exhibit less neck pain (numeric rating scale [NRS]) and myelopathy (modified Japanese Orthopaedic Association) symptoms through 1-yr follow-up compared to revision patients (P < .05). These differences subsided when following patients through 2 yr (P > .05). Despite similar 2-yr HRQL outcomes, revision patients exhibited worse neck pain (NRS) Integrated Health State recovery (P < .05). CONCLUSION: Despite both primary and revision patients exhibiting similar HRQL outcomes at final follow-up, revision patients were in a greater state of postoperative neck pain for a greater amount of time.