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.

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.

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.

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: Recombinant human bone morphogenetic protein 2 (BMP) is increasingly utilized in minimally invasive (MIS) transforaminal lumbar interbody fusions (TLIF) in order to increase rate of fusion by promoting bone growth through the induction of osteoblast differentiation, awhile reducing morbidity related to iliac crest autograft. Despite these benefits, BMP use is still controversial due to its pro-inflammatory mechanism of action and potential to cause radiculitis. PURPOSE: To assess whether BMP is a risk factor for postoperative radiculitis in TLIF. STUDY DESIGN/SETTING: Single-center retrospective cohort study. PATIENT SAMPLE: A total of 397 TLIFs from June 2012 to December 2018. OUTCOME MEASURES: Perioperative clinical characteristics, post-operative risk of radiculitis and complication, and future reoperation rates.
METHOD(S): Patients >= 18 years-old undergoing elective single-level TLIFs from 2012 to 2018 were included. Outcome measures included perioperative clinical characteristics, postoperative risk of radiculitis and complication, and future reoperation rates. Radiculitis was defined the delayed onset of radicular symptoms postoperatively in patients whom had initial resolution of radicular symptoms immediately postoperatively, in the absence of persistent neurological compression on postoperative imaging. Statistical analyses included independent t-tests and chi-square analysis. Propensity score matching was utilized to control for demographic differences between the groups. Independent predictors for post-operative radiculitis were assessed by multivariate logistic regression. Significance set at p<0.05.
RESULT(S): A total of 397 cases were included in the study (59.33 +/- 13.49 mean age, 28.98 +/- 6.29 mean BMI, 52.90% female, 2.29 +/- 1.92 average Charleston comorbidity Index). There were 223 open procedures and 174 MIS. For the entire cohort, 238 cases utilized BMP and 159 did not, with 102 MIS pairing with BMP use. The MIS TLIFs had a higher percentage of BMP use than open TLIFs (58.6% vs 25.7%, p<0.001), lower estimated blood loss (212.28 +/- 193.79 mL vs 410.91 +/- 337.98 mL, p<0.001) higher fluoroscopy dosage (52.43 +/- 48.61mGy vs 16.77 +/- 27.84mGy, p<0.001), and a lower length of stay (3.20 +/- 2.55 days vs 4.11 +/- 2.52 days, p<0.001). There were no other differences in perioperative clinical characteristics. There was a significantly higher rate of postoperative radiculitis in the MIS TLIFs compared to open (12.6% vs 6.8%, p=0.046) and use of BMP compared to no BMP (13.2% vs 6.7%, p=0.029). There was a 15.7% radiculitis rate when MIS was paired with BMP use. There were no other notable differences in complication rates or rates of reoperation. Individually, MIS had a 12.6% radiculitis rate (p=0.046) and BMP use had a 13.2% rate (p=0.029). Propensity score match controlled for the significant difference in CCI between the MIS and open groups (N=168 each). Multivariate regression indicated that MIS (p=0.314) and BMP (p=0.109) were not independent predictors individually when controlling for age, gender, and BMI. When technique was paired with biologic use the regression revealed MIS + BMP is a risk factor of post-operative radiculitis (2.265(4.753-1.079), p=0.031).
CONCLUSION(S): While BMP and MIS technique were not independent risk factors for postoperative radiculitis, there is an increased risk of radiculitis when using BMP in MIS TLIF. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: For surgical adult spinal deformity (ASD) patients, determining optimal restoration of alignment and spinal shape is an active area of research. Complex corrective measures taken are in ASD. Incidence of specific alignment outcomes has yet to be investigated in each of the complex realignment ideals. PURPOSE: Assess alignment outcomes (pelvic nonresponse [PNR], PJK, postop cervical deformity [CD]) following ASD-corrective surgery in the context of correction relative to various alignment schemas. STUDY DESIGN/SETTING: Retrospective cohort study of prospective ASD database. PATIENT SAMPLE: A total of 468 ASD patients. OUTCOME MEASURES: PNR, PJK, postop CD.
METHOD(S): ASD patients with preop, 6-week postop (6W), and 2-year postop (2Y) radiographic data included. PNR: 10-year mismatch (undercorrection; unimproved) from a patient's age-adjusted PT at 6W and maintained at 2Y. Pelvic responder (PR): PT +/-10 match age-adjusted goals. Patients were stratified by incremental additions of corrective alignment schemas: (a) improvement in Schwab SVA, (b) matching age-adjusted PI-LL, (c) match postop "ideal" and "theoretical" Roussouly, (d) improvement in proportionality spinal score at 6W. PNR, PJK, and CD development by 2Y were compared within groups, as well as simultaneous improvement/match of the suggested corrective measures (exclusively). In a subanalysis, patients were stratified by severity of baseline PT, low (<20degree), moderate (20-30degree), and severe (>30degree) to determine which alignment schema is necessary to achieve less PNR, PJK and postop CD.
RESULT(S): A total of 468 patients (56.3 yrs, 76.5% F; 25.6% PNR, 40.6% PR) met inclusion criteria. Rates of postop PJK (PNR:49.2% vs PR:59.5%) and CD (18.3% vs 25.8%) were significantly less in the PNR group, p<0.05. Sole improvement in Schwab SVA (73.2%) did not impact PNR, PJK or CD (p>0.050). Undercorrected age-adjusted PI-LL presented with more PNR (60.1%), whereas overcorrected had increased PJK (68.2%), p<0.001. Matching Roussouly at 6W decreased PNR (17.8% vs mismatch:42.3%, p=0.002). 6W proportional spine, had lower rates of PNR (19.7%, severely disproportioned: 58.8%, p<0.001), with postop moderately disproportioned GAP with highest rates of PJK (p=0.010). Incremental addition of alignment schemas was assessed for effect on malalignment outcomes. Schwab and age-adjusted use (20.9%) had less incidence of PNR (28.6% vs 38.7%) than just Schwab. Addition of the Roussouly (18.3%) presented with less PNR (20% vs 30.4%) and PJK (38.5% vs 60.3%) than only Schwab & age-adjusted. Lastly, addition of proportion (16.7%) had 0% occurrence of PNR and CD. Stratifying by baseline PT severity, the low group demonstrated the least incidence of PNR (7.7%) and CD (10.3%) and PJK (41.3%) when matching theoretical Roussouly at 6W (all p<0.050). This remained the same for moderate PT for PNR and PJK, except Schwab improvement decreased postop CD occurrence (21.2%, p=0.049). Severe PT assessment determined PNR (20%), PJK (37.5%) and CD (19.4%) were the lowest with improvement of proportion at 6W (p<0.050).
CONCLUSION(S): Following ASD corrective surgery, 25.6% of patients showed residual pelvic malalignment, qualifying as pelvic nonresponders. Use of complex realignment schemas (SRS-Schwab, age-adjusted, Roussouly shape, GAP) decreased rates of pelvic nonresponse, PJK and postop cervical deformity development. Severe (>30degree) baseline pelvic tilt requires particular emphasis of proportionality in addition to other realignment ideals. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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