Citations

Study Design. Secondary analysis of a large administrative database. Objective. The objectives of this study are to: 1) identify the incidence and cause of 90-day readmissions following primary elective lumbar spine surgery, 2) offer insight into potential risk factors that contribute to these readmissions, and 3) quantify the cost associated with these readmissions. Summary of Background Data. As bundled-payment models for the reimbursement of surgical services become more popular in spine, the focus is shifting toward long-term patient outcomes in the context of 90-day episodes of care. With limited data available on national 90-day readmission statistics available, we hope to provide evidence that will aid in the development of more cost-effective perioperative care models. Methods. Using ICD-9 coding, we identified all patients 18 years of age and older in the 2014 Nationwide Readmissions Database (NRD) who underwent an elective, inpatient, primary lumbar spine surgery. Using multivariate logistic regression, we identified independent predictors of 90-day readmission while controlling for a multitude of confounding variables and completed a comparative cost analysis. Results. We identified 169,788 patients who underwent a primary lumbar spine procedure. In total 4268 (2.5%) were readmitted within 90 days. There was no difference in comorbidity burden between cohorts (readmitted vs. not readmitted) as quantified by the Elixhauser Comorbidity index. Independent predictors of increased odds of 90-day readmission were: anemia, uncomplicated diabetes and diabetes with chronic complications, surgical wound disruption and acute myocardial infarction at the time of the index admission, self-pay status, and an anterior surgical approach. Implant complications were identified as the primary related cause of readmission. These readmissions were associated with a significant cost increase. Conclusion. There are clearly identifiable risk factors that increase the odds of hospital readmission within 90 days of primary lumbar spine surgery. An overall 90-day readmission rate of 2.5%, while relatively low, carries significantly increased cost to both the patient and hospital. Level of Evidence: 3

Abstract NKAP is a multifunctional nuclear protein that associates with the histone deacetylase HDAC3. Although both NKAP and HDAC3 are critical for hematopoietic stem cell (HSC) maintenance and survival, it was not known whether these two proteins work together. To assess the importance of their association in vivo, serial truncation and alanine scanning was performed on NKAP to identify the minimal binding site for HDAC3. Mutation of either Y352 or F347 to alanine abrogated the association of NKAP with HDAC3, but did not alter NKAP localization or expression. Using a linked conditional deletion/re-expression system in vivo, we demonstrated that re-expression of the Y352A NKAP mutant failed to restore HSC maintenance and survival in mice when endogenous NKAP expression was eliminated using Mx1-cre and poly-IC, whereas re-expression of wild type NKAP maintained the HSC pool. However, Y352A NKAP did restore proliferation in murine embryonic fibroblasts when endogenous NKAP expression was eliminated using ER-cre and tamoxifen. Therefore, Y352 in NKAP is critical for association with HDAC3 and for HSC maintenance and survival but is not important for proliferation of murine embryonic fibroblasts, demonstrating that NKAP functions in different complexes in different cell types.

AbstractShape memory polymer (SMP) foam‐coated coils (FCCs) are new embolic coils coated with porous SMP designed to expand for increased volume filling and enhanced healing after implantation. The purpose of this study was to compare chronic aneurysm healing after treatment with SMP FCCs to bare platinum coil (BPC) controls in the rabbit elastase aneurysm model. BPCs or SMP FCCs were implanted in rabbit elastase‐induced aneurysms for follow‐up at 30 days (n = 10), 90 days (n = 5), and 180 days (n = 12 for BPCs; n = 14 for SMP FCCs). Aneurysm occlusion and histologic healing, including a qualitative healing score, neointima thickness, collagen deposition, and inflammation were compared between the two groups. The mean neointima thickness was significantly greater in groups treated with SMP FCCs for all three time points. Histologic healing scores and collagen deposition quantification suggested that aneurysms treated with SMP FCCs experience more complete healing of the dome by 90 days, but the differences were not statistically significant. More progressive occlusion and recanalization were observed in aneurysms treated with SMP FCCs, but neither difference was statistically significant. Additionally, the SMP foam used in the FCCs was found to degrade faster in the rabbit elastase model than expected based on previous studies in a porcine sidewall aneurysm model. This study suggests that SMP FCCs can promote neointima formation along the aneurysm neck, and may lead to more complete healing of the dome and neck. These findings indicate potential benefits of this device for aneurysm occlusion procedures. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B:2466–2475, 2019.

AbstractBackgroundWe reviewed the disease control and complications of the treatment of sacrococcygeal chordoma from four tertiary cancer centers with emphasis on the effects of radiotherapy in surgically treated patients.MethodsA total of 193 patients with primary sacrococcygeal chordoma from 1990 to 2015 were reviewed. There were 124 males, with a mean age of 59 ± 15 years and a mean follow‐up of 7 ± 4 years. Eighty‐nine patients received radiotherapy with a mean total dose of 61.8 ± 10.9 Gy.ResultsThe 10‐year disease‐free and disease‐specific survival was 58% and 72%, respectively. Radiation was not associated with local recurrence (hazard ratio [HR], 1.13; 95% confidence interval [CI], 0.59‐2.17; P = 0.71), metastases (HR, 0.93; 95% CI, 0.45‐1.91; P = 0.85) or disease‐specific survival (HR, 0.96; 95% CI, 0.46‐2.00; P = 0.91). Higher doses (≥70 Gy; HR, 0.52; 95% CI, 0.20‐1.32; P = 0.17) may be associated with reduced local recurrence. Radiotherapy was associated with wound complications (HR, 2.76; 95% CI, 1.64‐4.82;, P < 0.001) and sacral stress fractures (HR, 4.73; 95% CI, 1.88‐14.38; P < 0.001).ConclusionsIn this multicenter review, radiotherapy was not associated with tumor outcome but associated with complications. The routine use of radiotherapy with en‐bloc resection of sacrococcygeal chordomas should be reconsidered in favor of a selective, individualized approach with a radiation dose of ≥70 Gy.

408 Background: Standard of care for CCA/GBC is C-G therapy. MAbs (ATZ, pembrolizumab) targeting PD-L1 show promise in treating CCA/GBC. Hyaluronan (HA), which may impede drug and immune cell access, is high (67%) in CCA/GBC tumors. PEGPH20 enzymatically degrades HA. HALO 110-101 (NCT03267940) evaluates safety and activity of PEG-C-G-ATZ or PEG-C-G versus C-G in CCA/GBC pts. Methods: This study comprises two parts. In Run-In (RI) six pts were enrolled in PEG-C-G arm, then six pts in PEG-C-G-ATZ arm. Eight additional pts may be enrolled for tolerability. In Expansion (EX), up to 50 pts will be enrolled for efficacy. Treatment (Tx) cycle is 21 days (d). PEGPH20 dose is 3 μg/kg on d1, eight and 15 and ATZ dose is 1200 mg (one–three hours after PEGPH20) on d1 (PEG-C-G-ATZ only). C-G is dosed at 25 mg/m2 C and 1000 mg/m2 G on d2 and nine. In C-G arm (EX only), C-G is dosed on d1 and 8. Primary endpoints are ORR (RECIST v1.1), AEs (NCI CTCAE v4.03), laboratory/safety (RI only); secondary endpoints are PK; DOR, DCR, PFS; OS, OS by PD-L1 expression; ORR and DOR (imRECIST). Results: Eighteen pts have been enrolled (nine in each arm). The mean (SD) age is 57 (12.2) yrs in PEG-C-G and 69 (8.8) yrs in PEG-C-G-ATZ. 56% were men. All pts experienced ≥ 1 AE. The most common AEs are nausea, fatigue (50% each); decreased appetite (44%); anemia, constipation (39% each); thrombocytopenia, oedema peripheral, AST increased, myalgia (33% each). To date, there has been one dose-limiting toxicity (febrile neutropenia) in the PEG-C-G arm. There have been no deaths due to AEs. Conclusions: The overall safety profile of PEGPH20 + C + G ± ATZ is acceptable and consistent with safety observed for the individual components. There were no DLTs resulting in a dose reduction of PEGPH20, which is being dosed at 3 μg/kg in the EX phase. Clinical trial information: NCT03267940. [Table: see text]

Background: Lumbar spine injuries in National Collegiate Athletic Association (NCAA) athletes have not been well studied. Purpose: To describe the epidemiology of lumbar spine injuries in NCAA athletes during the 2009/2010 through 2013/2014 academic years utilizing the NCAA Injury Surveillance Program (ISP). Study Design: Descriptive epidemiology study. Methods: A voluntary convenience sample of NCAA varsity teams from 25 sports was examined. Mechanism of injury, injury recurrence, and time lost from sport were recorded. Injury rates were calculated as the number of injuries divided by the total number of athlete-exposures (AEs). AEs were defined as any student participation in 1 NCAA-sanctioned practice or competition. Injury rate ratios and injury proportion ratios were calculated to compare the rates within and between sports by event type, season, patient sex, mechanism, injury recurrence, and time lost from sport. Comparisons between sexes were made utilizing data that had both male and female samples. Results: An estimated 50,834 lumbar spine injuries were identified. The overall rate of injuries was 2.88 per 10,000 AEs. The rate of injuries was 2.60 per 10,000 AEs in men compared with 2.89 per 10,000 AEs in women for sex-comparable sports. Women were 1.11 times more likely than men to suffer a lumbar spine injury. Women's gymnastics (8.02 injuries per 10,000 AEs) and women's tennis (5.73 injuries per 10,000 AEs) had the highest rates of lumbar spine injuries. Athletes were 1.6 and 2.4 times more likely to sustain a lumbar spine injury during the preseason than the regular season or postseason, respectively. Noncontact was the most common mechanism of injury (45%). Injury recurrence was most common in men’s outdoor track (43%). Most injuries resulted in less than 24 hours of time loss from event participation (64%). Conclusion: The rate of lumbar spine injuries was high in NCAA athletes, and injuries commonly recurred (20.73%). In general, women were more likely to sustain a lumbar spine injury compared with men. Higher injury rates occurred during competition and via a noncontact mechanism of injury. In addition to prevention programs, reconditioning programs should be considered to prevent these injuries.