Faculty Bibliography

OBJECTIVE:The impact of global coronal malalignment (GCM; C7 plumb line-midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors' primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes. METHODS:This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed. RESULTS:Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD-Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7-S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence-lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%-83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK). CONCLUSIONS:Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.

BACKGROUND:The Miller et al adult spinal deformity frailty index (ASD-FI) correlates with complication risk; however, its development was not rooted in clinical outcomes, and the 40 factors needed for its calculation limit the index's clinical utility. The present study aimed to develop a simplified, weighted frailty index for ASD patients METHODS: This study is a retrospective review of a single-center database. Component ASD-FI parameters contributing to overall ASD-FI score were assessed via Pearson correlation. Top significant, clinically relevant factors were regressed against ASD-FI score to generate the modified ASD-FI (mASD-FI). Component mASD-FI factors were regressed against incidence of medical complications, and factor weights were calculated from regression of these coefficients. Total mASD-FI score ranged from 0 to 21, and was calculated by summing weights of expressed parameters. Linear regression and published ASD-FI cutoffs generated corresponding mASD-FI frailty cutoffs: not frail (NF, <7), frail (7-12), severely frail (SF, >12). Analysis of variance assessed the relationship between frailty category and validated baseline measures of pain and disability at baseline. RESULTS:= .001). CONCLUSIONS:This study modifies an existing ASD frailty index and proposes a weighted, shorter mASD-FI. The mASD-FI relies less on patient-reported variables, and it weights component factors by their contribution to adverse outcomes. Because increasing mASD-FI score is associated with inferior clinical measures of pain and disability, the mASD-FI may serve as a valuable tool for preoperative risk assessment.

STUDY DESIGN/UNASSIGNED:Retrospective cohort study. OBJECTIVE/UNASSIGNED:This study aims to report the incidence, risk factors, and recovery rate of neurological complications (NC) in patients with adult cervical deformity (ACD) who underwent corrective surgery. METHODS/UNASSIGNED:ACD patients undergoing surgery from 2013 to 2015 were enrolled in a prospective, multicenter database. Patients were separated into 2 groups according to the presence of neurological complications (NC vs no-NC groups). The types, timing, recovery patterns, and interventions for NC were recorded. Patients' demographics, surgical details, radiographic parameters, and health-related quality of life (HRQOL) scores were compared. RESULTS/UNASSIGNED:106 patients were prospectively included. Average age was 60.8 years with a mean of 18.2 months follow-up. The overall incidence of NC was 18.9%; of these, 68.1% were major complications. Nerve root motor deficit was the most common complication, followed by radiculopathy, sensory deficit, and spinal cord injury. The proportion of complications occurring within 30 days of surgery was 54.5%. The recovery rate from neurological complication was high (90.9%), with most of the recoveries occurring within 6 months and continuing even after 12 months. Only 2 patients (1.9%) had continuous neurological complication. No demographic or preoperative radiographic risk factors could be identified, and anterior corpectomy and posterior foraminotomy were found to be performed less in the NC group. The final HRQOL outcome was not significantly different between the 2 groups. CONCLUSIONS/UNASSIGNED:Our data is valuable to surgeons and patients to better understand the neurological complications before performing or undergoing complex cervical deformity surgery.

OBJECTIVE:The shared decision-making (SDM) process provides an opportunity to answer frequently asked questions (FAQs). The authors aimed to present a concise list of answers to FAQs to aid in SDM for adult spinal deformity (ASD) surgery. METHODS:From a prospective, multicenter ASD database, patients enrolled between 2008 and 2016 who underwent fusions of 5 or more levels with a minimum 2-year follow-up were included. All deformity types were included to provide general applicability. The authors compiled a list of FAQs from patients undergoing ASD surgery and used a retrospective analysis to provide answers. All responses are reported as either the means or the proportions reaching the minimal clinically important difference at the 2-year follow-up interval. RESULTS:Of 689 patients with ASD who were eligible for 2-year follow-up, 521 (76%) had health-related quality-of-life scores available at the time of that follow-up. The mean age at the initial surgery was 58.2 years, and 78% of patients were female. The majority (73%) underwent surgery with a posterior-only approach. The mean number of fused levels was 12.2. Revision surgery accounted for 48% of patients. The authors answered 12 FAQs as follows:1. Will my pain improve? Back and leg pain will both be reduced by approximately 50%.2. Will my activity level improve? Approximately 65% of patients feel improvement in their activity level.3. Will I feel better about myself? More than 70% of patients feel improvement in their appearance.4. Is there a chance I will get worse? 4.1% feel worse at 2 years postoperatively.5. What is the likelihood I will have a complication? 67.8% will have a major or minor complication, with 47.8% having a major complication.6. Will I need another surgery? 25.0% will have a reoperation within 2 years.7. Will I regret having surgery? 6.5% would not choose the same treatment.8. Will I get a blood transfusion? 73.7% require a blood transfusion.9. How long will I stay in the hospital? You need to stay 8.1 days on average.10. Will I have to go to the ICU? 76.0% will have to go to the ICU.11. Will I be able to return to work? More than 70% will be working at 1 year postoperatively.12. Will I be taller after surgery? You will be 1.1 cm taller on average. CONCLUSIONS:The above list provides concise, practical answers to FAQs encountered in the SDM process while counseling patients for ASD surgery.

The aim of this study was to investigate the cost utility of treating non-frail versus frail or severely frail adult spinal deformity (ASD) patients. 79 surgical ASD patients >18 years with available frailty and ODI data at baseline and 2-years post-surgery (2Y) were included. Utility data was calculated using the ODI converted to the SF-6D. QALYs utilized a 3% discount rate to account for decline to life expectancy (LE). Costs were calculated using the PearlDiver database. ICER was compared between non-operative (non-op.) and operative (op.) NF and F/SF patients at 2Y and LE. When compared to non-operative ASD, the ICER was $447,943.96 vs. $313,211.01 for NF and F/SF at 2Y, and $68,311.35 vs. $47,764.61 for NF and F/SF at LE. Frail and severely frail patients had lower cost per QALY compared to not frail patients at 2Y and life expectancy, and had lower ICER values when compared to a non-operative cohort of ASD patients. While these results support operative correction of frail and severely frail patients, it is important to note that these patients are often at worse baseline disability, which is closely related to frailty scores, and have more opportunity to improve postoperatively. Furthermore, there may be a threshold of frailty that is not operable due to the risk of severe complications that is not captured by this analysis. While future research should investigate economic outcomes at extended follow up times, these findings support the cost effectiveness of ASD surgery at all frailty states.

BACKGROUND: Bone morphogenetic protein (BMP) and allograft containing mesenchymal stem cells (live cell) are popular biologic substitutes for iliac crest autograft used in transforaminal lumbar interbody fusion (TLIF). Use of these agents in the pathogenesis of postoperative radiculitis remains controversial. Recent studies have independently linked minimally invasive (MIS) TLIF with increased radiculitis risk compared to open TLIF. The purpose of this study was to assess the rate of postoperative radiculitis in open and MIS TLIF patients along with its relationship to concurrent biologic adjuvant use. METHODS: Patients ≥18 years undergoing single-level TLIF from June 2012 to December 2018 with minimum 1-year follow-up were included. Outcome measures were rate of radiculitis, intra- and postoperative complications, revision surgery; length of stay (LOS), and estimated blood loss (EBL). RESULTS:= .038, N = 336) compared to other combinations of surgical approach and biologic use. CONCLUSIONS: Neither the MIS approach nor BMP use is an independent risk factor for post-TLIF radiculitis. However, risk of radiculitis significantly increases when they are used in tandem. This should be considered when selecting biological adjuvants for MIS TLIF. LEVEL OF EVIDENCE/METHODS: 3.

STUDY DESIGN/UNASSIGNED:Cadaveric study. OBJECTIVE/UNASSIGNED:To evaluate accuracy, radiation exposure, and surgical time of a new robotic-assisted navigation (RAN) platform compared with freehand techniques in conventional open and percutaneous procedures. METHODS/UNASSIGNED:Ten board-certified surgeons inserted 16 pedicle screws at T10-L5 (n = 40 per technique) in 10 human cadaveric torsos. Pedicle screws were inserted with (1) conventional MIS technique (L2-L5, patient left pedicles), (2) MIS RAN (L2-L5, patient right pedicles), (3) conventional open technique (T10-L1, patient left pedicles), and (4) open RAN (T10-L1, patient right pedicles). Output included (1) operative time, (2) number of fluoroscopic images, and (3) screw accuracy. RESULTS/UNASSIGNED:= .650). CONCLUSION/UNASSIGNED:RAN significantly improved accuracy and decreased radiation exposure in comparison to freehand techniques in both conventional open and percutaneous surgical procedures in cadavers. RAN significantly increased setup time compared with both conventional procedures.

INTRODUCTION/BACKGROUND:Outcomes after anterior cervical diskectomy and fusion (ACDF) and cervical total disk arthroplasty (TDA) are satisfactory, but related morbidity and revision surgery rates are notable. This study sought to determine complication variations among ACDF, TDA, and combined ACDF-TDA as well as predictors of postoperative complications. METHODS:Patients undergoing 1- to 2-level ACDF and/or TDA with at least a 2-year follow-up from 2009 to 2011 were identified from the Statewide Planning and Research Cooperative System database. Patient demographics, hospital-related parameters, mortality, and postoperative outcomes were compared, and their predictors were identified using multivariate logistic regression. RESULTS:A total of 16,510 and 449 individuals underwent ACDF and cervical TDA, respectively, and 201 underwent ACDF-TDA. ACDF-TDA patients had the highest rates of cardiac complications and pulmonary embolism (PE) (P ≤ 0.006), whereas TDA patients had higher individual surgical and device/implant/internal fixation complications (P ≤ 0.025). ACDF-TDA patients experienced the lowest rate of revisions. Cervical TDA increased the odds of any surgical complications (OR = 2.5, P = 0.002), overall complications (OR = 1.57, P = 0.034), and revisions (OR = 2.29, P < 0.001). Deyo index predicted any medical/surgical complications (OR = 1.43 and 1.19, respectively). Female sex was associated with increased odds of readmission (OR 1.30, P < 0.001) but was protective against medical complications (OR = 0.81, P = 0.013). DISCUSSION/CONCLUSIONS:Combined ACDF-TDA procedures were not associated with increases in 2-year individual or overall complications, readmissions, or revisions. LEVEL OF EVIDENCE/METHODS:Level 3-Therapeutic study.

BACKGROUND CONTEXT/BACKGROUND:Considerable debate exists regarding the optimal surgical approach for adult spinal deformity (ASD). It remains unclear which approach, posterior-only or combined anterior-posterior (AP), is more cost-effective. Our goal is to determine the 2-year cost per quality-adjusted life year (QALY) for each approach. PURPOSE/OBJECTIVE:To compare the 2-year cost-effectiveness of surgical treatment for ASD between the posterior-only approach and combined AP approach. STUDY DESIGN/METHODS:Retrospective economic analysis of a prospective, multicenter database PATIENT SAMPLE: From a prospective, multicenter surgical database of ASD, patients undergoing 5 or more level fusions through a posterior-only or AP approach were identified and compared. METHODS:QALYs gained were determined using baseline, 1-year, and 2-year post-operative Short Form 6D. Cost was calculated from actual, direct hospital costs including any subsequent readmission or revision. Cost-effectiveness was determined using cost/QALY gained. RESULTS:The AP approach showed significantly higher index cost than the posterior-only approach ($84,329 vs $64,281). This margin decreased at 2-year follow-up with total costs of $89,824 and $73,904, respectively. QALYs gained at two years were similar with 0.21 and 0.17 in the posterior-only and the AP approaches, respectively. The cost/QALY at two years after surgery was significantly higher in the AP approach ($525,080) than in the posterior-only approach ($351,086). CONCLUSIONS:We assessed 2-year cost-effectiveness for the surgical treatment through posterior-only and AP approaches. The posterior-only approach is less expensive both for the index surgery and at 2-year follow-up. The QALY gained at 2-years was similar between the two approaches. Thus, posterior-only approach was more cost-effective than the AP approach under our study parameters. However, both approaches were not cost-effective at 2-year follow-up.

BACKGROUND CONTEXT: Neurologic complications following adult spinal deformity (ASD) are common and may play a role in the outcomes for our patients. Neurologic complications may include radiculopathy, sensory deficit or motor weakness. The impact that these specific complications have on HRQL is unknown. PURPOSE: Neurologic complications are common following ASD. Understanding their impact on Health-related quality of life (HRQL) measures is critical. STUDY DESIGN/SETTING: Retrospective cohort study of prospective ASD database. PATIENT SAMPLE: Retrospective cohort study, 733 patients. OUTCOME MEASURES: Neurologic complications, HRQL scores.
METHOD(S): ASD patients (>18yrs, scoliosis >=20degree, SVA >=5cm, PT >=25degree and/or TK >60degree). Inclusion criteria was HRQL at baseline (BL) and 1 year, and lower extremity motor score (LEMS) at BL, 6-week and 1-year ODI, SRS22r and SF36 were determined at BL and 1yr LEMS was calculated from 0-50, with 50 designated as normal motor function. Patients were divided into 4 groups: pLEMS (perfect, no deficit), dLEMS (new postop deficit that returned to normal at 1 year), iLEMS (deficit improved from abnormal baseline), and wLEMS (new postop deficit persistent at one year).
RESULT(S): A total of 733 patients were eligible, with 95 (12.96%) reporting neurologic complications (NC). Impact of any NC vs no complication at 1yr was significant for ODI (5.1), PCS (3.6) and SRSpain (0.2) at 1 year (p<0.001 all). For NC vs any other complication, there was still a decrease in ODI (3.9) and PCS (2.4) at 1 year (p<0.01). NC subtype: radiculopathy caused worse outcomes for (4.3) and SRS pain (0.3) (p<0.05), sensory deficit caused worse SRSmental (0.5) (p<0.05), but no HRQL change was detected for motor deficit at 1 year. PLEMS (456/733) had improvement in all HRQL, and these improvements were not different with or w/o NC, or non-NC. Compared to pLEMS w/o complication, dLEMS (62/733) and iLEMS (147/733) were statically similar, however wLEMS (68/733) had worse ODI (7.1), SRStotal (0.3), activity (0.3), mental (0.3), pain (0.3) (p<0.05 all).
CONCLUSION(S): Neurologic complications that occur following ASD have a significant effect on HRQLs. The magnitude of effect is driven by radiculopathy and by lower extremity motor score. LEMS scores that remain normal, return back to normal or improve have similar outcomes, while patients that have continued weakness remain statistically worse at 1 year. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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