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.

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.

A Novel Junctional Tether Weave Technique for Adult Spinal Deformity: 2-Dimensional Operative Video.

Proximal junctional kyphosis (PJK) is a common problem after multilevel spine instrumentation for adult spinal deformity. Various anti-PJK techniques such as junctional tethers for ligamentous augmentation have been proposed. We present an operative video demonstrating technical nuances of junctional tether "weave" application. A 70-yr-old male with prior L2-S1 instrumented fusion presented with worsening back pain and posture. Imaging demonstrated pathological loss of lumbar lordosis (flat back deformity), proximal junctional failure, and pseudarthrosis. The patient had severe global and segmental sagittal malalignment, with sagittal vertical axis (SVA, C7-plumbline) measuring 22.3 cm, pelvic incidence (PI) 55°, lumbar lordosis (LL) 8° in kyphosis, pelvic tilt (PT) 30°, and thoracic kyphosis (TK) 6°. The patient gave informed consent for surgery and use of imaging for medical publication. Briefly, surgery first involved re-instrumentation with bilateral pedicle screws from T10 to S1. After right-sided iliac screw fixation (left-sided iliac screw fixation was not performed due to extensive prior iliac crest bone graft harvesting), we then completed a L2-3 Smith-Petersen osteotomy, extended L4 pedicle subtraction osteotomy, and L3-4 interbody arthrodesis with a 12° lordotic cage (9 × 14 × 40 mm). Cobalt Chromium rods were placed spanning the instrumentation bilaterally, and accessory supplemental rods spanning the PSO were attached. An anti-PJK junctional tether "weave" was then implemented using 4.5 mm polyethylene tape (Mersilene tape [Ethicon, Somerville, New Jersey]). Postoperative imaging demonstrated improved alignment (SVA 2.8 cm, PI 55°, LL 53°, PT 25°, TK 45°) and no significant neurological complications occurred during convalescence or at 6 mo postop.

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.

Cell Saver for Adult Spinal Deformity Surgery Reduces Cost.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: To determine if the use of cell saver reduces overall blood costs in adult spinal deformity (ASD) surgery. SUMMARY OF BACKGROUND DATA: Recent studies have questioned the clinical value of cell saver during spine procedures. METHODS: ASD patients enrolled in a prospective, multicenter surgical database who had complete preoperative and surgical data were identified. Patients were stratified into (1) cell saver available during surgery, but no intraoperative autologous infusion (No Infusion group), or (2) cell saver available and received autologous infusion (Infusion group). RESULTS: There were 427 patients in the Infusion group and 153 in the No infusion group. Patients in both groups had similar demographics. Mean autologous infusion volume was 698 mL. The Infusion group had a higher percentage of EBL relative to the estimated blood volume (42.2%) than the No Infusion group (19.6%, p < .000). Allogeneic transfusion was more common in the Infusion group (255/427, 60%) than the No Infusion group (67/153, 44%, p = .001). The number of allogeneic blood units transfused was also higher in the Infusion group (2.4) than the No Infusion group (1.7, p = .009). Total blood costs ranged from $396 to $2,146 in the No Infusion group and from $1,262 to $5,088 in the Infusion group. If the cost of cell saver blood was transformed into costs of allogeneic blood, total blood costs for the Infusion group would range from $840 to $5,418. Thus, cell saver use yielded a mean cost savings ranging from $330 to $422 (allogeneic blood averted). Linear regression showed that after an EBL of 614 mL, cell saver becomes cost-efficient. CONCLUSION: Compared to transfusing allogeneic blood, cell saver autologous infusion did not reduce the proportion or the volume of allogeneic transfusion for patients undergoing surgery for adult spinal deformity. The use of cell saver becomes cost-efficient above an EBL of 614 mL, producing a cost savings of $330 to $422. LEVEL OF EVIDENCE: Level III.

Effectiveness of preoperative autologous blood donation for protection against allogeneic blood exposure in adult spinal deformity surgeries: a propensity-matched cohort analysis.

OBJECTIVE: The goal of this study was to examine the effectiveness of preoperative autologous blood donation (PABD) in adult spinal deformity (ASD) surgery. METHODS: Patients undergoing single-stay ASD reconstructions were identified in a multicenter database. Patients were divided into groups according to PABD (either PABD or NoPABD). Propensity weighting was used to create matched cohorts of PABD and NoPABD patients. Allogeneic (ALLO) exposure, autologous (AUTO) wastage (unused AUTO), and complication rates were compared between groups. RESULTS: Four hundred twenty-eight patients were identified as meeting eligibility criteria. Sixty patients were treated with PABD, of whom 50 were matched to 50 patients who were not treated with PABD (NoPABD). Nearly one-third of patients in the PABD group (18/60, 30%) did not receive any autologous transfusion and donated blood was wasted. In 6 of these cases (6/60, 10%), patients received ALLO blood transfusions without AUTO. In 9 cases (9/60, 15%), patients received ALLO and AUTO blood transfusions. Overall rates of transfusion of any type were similar between groups (PABD 70% [42/60], NoPABD 75% [275/368], p = 0.438). Major and minor in-hospital complications were similar between groups (Major PABD 10% [6/60], NoPABD 12% [43/368], p = 0.537; Minor PABD 30% [18/60], NoPABD 24% [87/368], p = 0.499). When controlling for potential confounders, PABD patients were more likely to receive some transfusion (OR 15.1, 95% CI 2.1-106.7). No relationship between PABD and ALLO blood exposure was observed, however, refuting the concept that PABD is protective against ALLO blood exposure. In the matched cohorts, PABD patients were more likely to sustain a major perioperative cardiac complication (PABD 8/50 [16%], NoPABD 1/50 [2%], p = 0.046). No differences in rates of infection or wound-healing complications were observed between cohorts. CONCLUSIONS: Preoperative autologous blood donation was associated with a higher probability of perioperative transfusions of any type in patients with ASD. No protective effect of PABD against ALLO blood exposure was observed, and no risk of perioperative infectious complications was observed in patients exposed to ALLO blood only. The benefit of PABD in patients with ASD remains undefined.

Recovery following adult spinal deformity surgery: the effect of complications and reoperation in 149 patients with 2-year follow-up.

PURPOSE: To identify the effect of complications and reoperation on the recovery process following adult spinal deformity (ASD) surgery by examining health-related quality of life (HRQOL) measures over time via an integrated health state analysis (IHS). METHODS: A retrospective review of a multicenter, prospective ASD database was conducted. Complication number, type, and need for reoperation (REOP) or not (NOREOP) were recorded. Patients were stratified as having no complication (NOCOMP), any complication (COMP), only minor complications (MINOR) and any major complications (MAJOR). HRQOL measures included Oswestry Disability Index (ODI), Short Form-36 (SF-36), and Scoliosis Research Society-22 (SRS22) at baseline, 6 weeks, 1 and 2 years postoperatively. All HRQOL scores were normalized to each patient's baseline scores and an IHS was then calculated. RESULTS: 149 patients were included. COMP, MINOR, and MAJOR had significantly lower normalized SRS mental scores at 1 and 2 years than NOCOMP (p < 0.05). REOP had significantly worse normalized 1 and 2 year mental component score (MCS), SRS mental, and total score than NOCOMP (p < 0.05). COMP, MINOR, and MAJOR all had significantly lower SRS mental IHSs than NOCOMP (p < 0.05). REOP had significantly lower IHSs for MCS and SRS satisfaction than NOREOP (p < 0.05). REOP had a significantly lower MCS and SRS mental IHS than NOCOMP (p < 0.05). CONCLUSION: An IHS analysis suggests there was a significantly protracted mental recovery phase associated with patients that had at least one complication, as well as either a minor and major complication. The addition of a reoperation also adversely affected the mental recovery as well as overall satisfaction.

Postoperative Recovery After Adult Spinal Deformity Surgery: Comparative Analysis of Age in 149 Patients During 2-year Follow-up.

STUDY DESIGN: Retrospective review of a multicenter, prospective adult spinal deformity (ASD) database. OBJECTIVE: We hypothesized that increased age and increased preoperative disability would negatively impact both the length of time needed to achieve maximal recovery and the amount of functional improvement achieved. In order to gauge the recovery process, a normalization process was used to calculate an integrated health state (IHS) during the 2-year postoperative period. SUMMARY OF BACKGROUND DATA: Elderly patients with ASD generally have worse baseline health-related quality of life (HRQOL) measures than younger patients. Current methods of reporting outcomes are limited, perhaps diminishing the health impact of the entire postoperative recovery experience. METHODS: Inclusion criteria included 18 or more years and ASD. Patient groups: young (≤45 yr), middle (46-64), elderly (≥65) as well as by baseline Oswestry Disability Index (ODI) scores: MILD (0-30), MEDIUM (31-49), and HIGH (≥50). Collected HRQOL measures included ODI, Short Form-36(PCS/MCS), and Scoliosis Research Society-22 (SRS22) at baseline, 6 weeks, 1, and 2-year postoperative. All HRQOL measures were normalized to each patient's baseline scores. A 2-year IHS was calculated for each individual patient and the means were compared between groups. RESULTS: 149 patients were included (≤45:32, 46-64:67, ≥65:50). All groups significantly improved in all HRQOL at 2-year compared with baseline (P < 0.05) except for MCS, ODI, and SRS activity for the 45 or less group (P > 0.05). Normalized IHS HRQOL for young patients was worse than elderly for ODI, PCS, MCS, SRS activity, pain and total during the 2-year recovery period from index surgery. The MILD ODI group had significantly worse 2-year IHS values than the HIGH group for all HRQOL measured (P < 0.05) except SRS appearance and satisfaction (P > 0.05). CONCLUSION: Contrary to our hypothesis, an IHS analysis suggested that the recovery process was significantly better for elderly patients than young patients and better for patients with high baseline disability. LEVEL OF EVIDENCE: 3.

The costs and benefits of nonoperative management for adult scoliosis.

STUDY DESIGN: A prospective cohort of adult scoliosis patients treated nonoperatively had a minimum of 2-year follow-up during which time data were collected on the type and quantity of nonoperative treatment used. OBJECTIVE: To quantify the use, cost, and effectiveness of nonoperative treatment for adult scoliosis. SUMMARY OF BACKGROUND DATA: A 2007 systematic review of nonsurgical treatment in adult scoliosis revealed minimal data, and concluded that evidence for nonoperative care was lacking. METHODS: Duration of use and frequency of visits were collected for 8 specific treatment methods: medication, physical therapy, exercise, injections/blocks, chiropractic care, pain management, bracing, and bed rest. Costs for each intervention were determined using the Medicare Fee schedule. Outcome measures were the SRS-22, SF-12, and ODI. Analysis was performed for the entire group, and for subsets of high (ODI, >40), mid (ODI = 21-40) and low (ODI,