1-year Visit Research Articles

Enhancing robotic precision in medial UKA: Image-based robot-assisted system had higher accuracy in implant positioning than imageless robot-assisted system across 292 knees.

The objective of this study was to compare the degree of accuracy in implant positioning and limb alignment offered by two robot-assisted (RA) systems: an image-based robot-assisted (IBRA) versus an imageless robot-assisted (ILRA) system for the treatment of medial knee osteoarthritis with unicompartmental knee arthroplasty (UKA). This retrospective radiographic study included medial UKAs performed between 2011 and 2023. Radiographic measurements taken preoperatively and at 1-year postoperative control visit focusing on hip-knee-ankle angle (HKA), posterior tibial slope (PTS), tibial component coronal alignment relative to Cartier's angle and restoration of proper joint line (JL) height were analyzed. Outliers for postoperative measurements were defined as follows: HKA <175° or >180°, PTS <2° or >8°, >3° or <-3° alterations in Cartier's angle and ±2 mm changes in the height of the joint line. The final sample consisted of 292 medial UKAs: 95 (32.5%) with an IBRA system and 197 (67.5%) with an ILRA system. Implant positioning and limb alignment were more accurate in the group of patients treated with IBRA, HKA (77.9% vs. 67.5%, p = 0.07), PTS (93.7% vs. 82.7%, p = 0.01), restoration of tibial varus relative to Cartier's angle (87.4% vs. 65%, p < 0.001) and restoration of JL height (81.1% vs. 69.5%, p = 0.04). Medial UKA surgery using an IBRA system was associated with a higher degree of accuracy in implant positioning and postoperative limb alignment as compared to an ILRA system. This is a valuable contribution to help communicate the advantages of using this surgical technique and improve its reproducibility. Level III, Retrospective cohort study.

Predictors of Persistent Limp Following Proximal Femoral Varus Osteotomy for Perthes Disease.

One of the most popular containment procedures for Legg-Calvé-Perthes disease (LCPD) is proximal femur varus osteotomy (PFO). While generally successful in achieving containment, PFO can cause limb length discrepancy, abductor weakness, and (of most concern for families) a persistent limp. While many studies have focused on radiographic outcomes following containment surgery, none have analyzed predictors of this persistent limp. The aim of this study was to determine clinical, radiographic, and surgical risk factors for persistent limp 2 years after PFO in children with LCPD. A retrospective review of a prospectively collected multicenter database was conducted for patients aged 6 to 11 years at disease onset with unilateral early-stage LCPD (Waldenström I) who underwent PFO. Limp status (no, mild, and severe), age, BMI, and pain scores were obtained at initial presentation, 3-month, and 2-year postoperative visits. Preoperative and follow-up radiographs were used to measure traditional morphologic hip metrics including acetabular index (AI), lateral center-edge angle (LCEA), and femoral neck-shaft angle (NSA). Univariate analysis as well as multivariate logistic regression models were used to analyze factors associated with mild and severe limp at the 2-year visit. A total of 95 patients met the inclusion criteria, and of these 50 patients underwent concomitant greater trochanter apophysiodesis (GTA) at the time of PFO. At the 2-year visit, there were 38 patients (40%) with a mild or severe limp. Multivariate logistic regression revealed no significant radiographic factors associated with a persistent limp. However, lower 2-year BMI and undergoing GTA were associated with decreased rates of persistent limp regardless of age ( P <0.05). When stratifying by age of disease onset, apophysiodesis appeared to be protective against any severity of limp in patients aged 6 to 8 years old ( P = 0.03), but not in patients 8 years or older ( P = 0.49). Persistent limp following PFO is a frustrating problem that was seen in 40% of patients at 2 years. However, lower follow-up BMI and performing a greater trochanter apophysiodesis, particularly in patients younger than 8 years of age, correlated with a lower risk of postoperative limp.

Long-Term Follow-Up of the LEAP Study: Early Versus Delayed Levodopa in Early Parkinson's Disease.

The Levodopa in EArly Parkinson's disease study showed no effect of earlier versus later levodopa initiation on Parkinson's disease (PD) progression over 80 weeks. We now report the effects over 5 years. The Levodopa in EArly Parkinson's disease study randomly assigned patients to levodopa/carbidopa 300/75 mg daily for 80 weeks (early start) or to placebo for 40 weeks followed by levodopa/carbidopa 300/75 mg daily for 40 weeks (delayed start). Follow-up visits were performed 3 and 5 years after baseline. We assessed the between-group differences in terms of square root transformed total Unified Parkinson's Disease Rating Scale score at 3 and 5 years with linear regression. We compared the prevalence of dyskinesia, prevalence of wearing off, and the levodopa equivalent daily dose. A total of 321 patients completed the 5-year visit. The adjusted square root transformed total Unified Parkinson's Disease Rating Scale did not differ between treatment groups at 3 (estimated difference, 0.17; standard error, 0.13; P = 0.18) and 5 years (estimated difference, 0.24; standard error, 0.13; P = 0.07). At 5 years, 46 of 160 patients in the early-start group and 62 of 161 patients in the delayed-start group experienced dyskinesia (P = 0.06). The prevalence of wearing off and the levodopa equivalent daily dose were not significantly different between groups. We did not find a difference in disease progression or in prevalence of motor complications between patients with early PD starting treatment with a low dose of levodopa 40 weeks earlier versus 40 weeks later over the subsequent 5 years. © 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Complications and outcomes after three-column osteotomy: a 5-year follow-up

BACKGROUNDThree-column spinal osteotomies (3-CO) are powerful techniques used to correct spinal deformity. These surgeries are associated with an elevated risk of complications. While outcomes have been reported in the literature with 2 years follow-up, longer-term outcomes of three-column osteotomies remain understudied. OBJECTIVESThis study aims to examine patient reported outcomes and complications for three-column osteotomies at 5 years. STUDY DESIGNRetrospective review of a prospectively collected spinal deformity cases database. PATIENT SAMPLEAll consecutive adult patients at a single spine surgery center treated with either a pedicle subtraction osteotomy (PSO) or vertebral column resection (VCR) for spinal deformity, and with a minimum 5-year follow-up were included. OUTCOME MEASURESVisual-analog scale (VAS) for back pain score (0 to 10), Oswestry Disability Index (ODI) score (0 to 100), number of complications, revision rate, sagittal balance, lumbar lordosis at preoperative and at 5-year visit. METHODSData was extracted from a prospectively collected spinal deformity surgery database continuously updated since 2002 with data from operative reports, patients’ medical visit notes and patients’ self-reported VAS and ODI questionnaires completed at each office visit. Radiographic measurements were performed on standing full-length spine radiographs taken at preop and 5-year visits. Descriptive statistics, comparison of means and proportions among groups, and a logistic regression analysis were conducted using the statistical software package SPSS version 28. Statistical significance was set at p<.05. RESULTSOf 127 consecutive adult patients with minimum of 5-year follow-up undergoing a 3-CO posterior spinal surgery for spinal deformity were identified and included in the study, 79 (62%) were treated with PSO, and 48 (38%) with VCR. Both PSO and VCR groups demonstrated significant improvements in VAS (PSO preop: 6.7, 5-year: 4.6, p<.001; VCR preop: 7.1, 5-year: 5.2, p<.001), and ODI (PSO preop: 52.9, 5-year: 45.4, p<.001; VCR preop: 57.5, 5-year 43.0, p<.001) that were maintained at 5 years. Major and minor complications occurring within 5 years were not statistically different between the PSO and VCR groups (major: 59.5% vs 56.3%, p=.85; minor: 45.6% vs 37.5%, p=.46). The rate of revision surgery within 5 years was 39.4% overall. Of the fifty patients requiring revision, 37.5% were for nonunion, 27.1% instrumentation failure, 14.6% proximal junctional kyphosis (PJK), 12.5% vertebral fracture, 6.3% motor weakness, and 2.1% infection. Improvements in lumbar lordosis were maintained at 5 years in both the PSO (29.9° vs 47.2°, p<.001) and VCR (34.6° vs 48.5°, p<.001) groups while sagittal balance maintained significant improvement in the VCR group (9.5 cm vs 6.3 cm, p=.008) but not the PSO (11.4 cm vs 9.3 cm, p=.065). CONCLUSIONPatients undergoing three-column osteotomies had a major complication rate of 57.5% and a minor complication rate of 42.5% after 5 years. Improvements in lumbar lordosis were maintained at 5-year follow-up, but sagittal balance was only maintained in the VCR group. Despite these radiographic findings, both VCR and PSO groups maintained significant clinical improvements in both VAS and ODI scores at 5-year follow up.

Application of Oxygen Saturation Test after Replantation of Avulsed Immature Permanent Teeth: A Prospective Observational Study

IntroductionThe evaluation of pulp status is crucial for avulsed immature permanent teeth after replantation. In addition to commonly used clinical and radiographic examinations providing clinical evidence, the oxygen saturation test may offer valuable assistance. The aim of this study was to analyze the efficacy of a pulse oximeter in evaluating pulp status in avulsed and replanted immature permanent teeth. MethodsA prospective observational study was performed including 51 avulsed and replanted immature permanent teeth. Routine clinical and radiographic examinations were performed and used as the basis for the diagnosis of pulp status during the 1-year follow-up period. Meanwhile, the oxygen saturation values of these teeth were recorded using a modified pulse oximeter at each visit. ResultsSeven teeth completed pulp revascularization (success group), whereas 44 teeth failed to revascularize (failure group). Abnormal clinical and/or radiographic manifestations in the failure group were observed at an average period of 42.7 days, which was too late because a high incidence of inflammatory root resorption (43.18%) had occurred. For oxygen saturation tests, teeth in the success group showed an immediate postreplantation oxygen value of 70.71 ± 3.35, then an upward trend starting from the 2-week postreplantation visit, and a significantly increased final value of 81.86 ± 2.34 at the 1-year visit. In contrast, no increase trend was found for teeth in the failure group because abnormal clinical and/or radiographic manifestations emerged. ConclusionsThe oxygen saturation test is a reliable diagnostic method to evaluate pulp status of avulsed teeth as early as 2 weeks after replantation.

Data-driven Stochastic Model for Quantifying the Interplay Between Amyloid-beta and Calcium Levels in Alzheimer's Disease.

The abnormal aggregation of extracellular amyloid- in senile plaques resulting in calcium dyshomeostasis is one of the primary symptoms of Alzheimer's disease (AD). Significant research efforts have been devoted in the past to better understand the underlying molecular mechanisms driving deposition and dysregulation. Importantly, synaptic impairments, neuronal loss, and cognitive failure in AD patients are all related to the buildup of intraneuronal accumulation. Moreover, increasing evidence show a feed-forward loop between and levels, i.e. disrupts neuronal levels, which in turn affects the formation of . To better understand this interaction, we report a novel stochastic model where we analyze the positive feedback loop between and using ADNI data. A good therapeutic treatment plan for AD requires precise predictions. Stochastic models offer an appropriate framework for modelling AD since AD studies are observational in nature and involve regular patient visits. The etiology of AD may be described as a multi-state disease process using the approximate Bayesian computation method. So, utilizing ADNI data from 2-year visits for AD patients, we employ this method to investigate the interplay between and levels at various disease development phases. Incorporating the ADNI data in our physics-based Bayesian model, we discovered that a sufficiently large disruption in either metabolism or intracellular homeostasis causes the relative growth rate in both and , which corresponds to the development of AD. The imbalance of ions causes disorders by directly or indirectly affecting a variety of cellular and subcellular processes, and the altered homeostasis may worsen the abnormalities of ion transportation and deposition. This suggests that altering the balance or the balance between and by chelating them may be able to reduce disorders associated with AD and open up new research possibilities for AD therapy.

PRESERFLO™ Microshunt: 1-Year Results of a 25-Gauge vs. 27-Gauge Needle Tract.

Background: The purpose of this study was to evaluate the effectiveness and safety of the PreserFlo™ microshunt (PMS) using a 25-Gauge vs. 27-Gauge needle tract. Methods: This is a prospective postoperative examination of 60 glaucoma eyes that received a PMS. The main outcome measures were intraocular pressure (IOP), glaucoma drug score (GDS), Kaplan-Meier success rates, complications, and secondary intervention rates. Two subgroups were formed for data comparison: 27-Gauge (27G), and 25-Gauge (25G). Success was defined as IOP < 18 mmHg together with ≥20% IOP reduction with medication allowed (qualified success = QS18) or not (full success = FS18). Results: IOP and GDS were reduced from baseline to the 1-year study visit as follows: All eyes from 23.4 ± 8.6 mmHg (3.1 ± 0.9) to 15.1 ± 5.9 mmHg (0.8 ± 1.1); 25G from 24.2 ± 7.3 mmHg (3.0 ± 0.8) to 12.7 ± 2.7 mmHg (0.5 ± 0.8); and 27G from 23.1 ± 9.2 mmHg (3.1 ± 1.0) to 16.2 ± 6.7 mmHg (0.9 ± 1.2). IOP at one year was lower in the 25G group compared to the 27G group (p = 0.035). Bleb needling was required in eight (13.3%) eyes and open bleb revisions in three (5.0%). Transient hypotony occurred in 21% and choroidal effusion in 8% of all eyes. Choroidal effusions were more frequent in the 25G group (21%) compared to the 27G group (2%, p = 0.031). One-year success rates were significantly higher in the 25G group compared to the 27G group for both QS18 (25G: 67.9% vs. 27G: 35.7%, p = 0.002) and FS18 (25G: 63.6% vs. 27G: 29.2%, p = 0.007). Conclusions: The PreserFlo microshunt is an effective and safe glaucoma surgery with a low rate of bleb revisions or needlings. We show that the 25G needle tract might be more efficient for IOP control at the cost of increased IOP-related complications compared to 27G.

Stratifying Disease Progression in Patients With Cardiac ATTR Amyloidosis

BackgroundTransthyretin cardiac amyloidosis (ATTR-CA) is a progressive cardiomyopathy. The clinical course varies among individuals and there are no established measures to assess disease progression. ObjectivesThe goal of this study was to assess the prognostic importance of an increase in N-terminal pro–B-type natriuretic peptide (NT-proBNP) and outpatient diuretic intensification (ODI) as markers of disease progression in a large cohort of patients with ATTR-CA. MethodsWe evaluated landmark survival analysis based on worsening of NT-proBNP and requirement for ODI between time of diagnosis and a 1-year visit, and subsequent mortality in 2,275 patients with ATTR-CA from 7 specialist centers. The variables were developed in the National Amyloidosis Centre (NAC) cohort (n = 1,598) and validated in the external cohort from the remaining centers (n = 677). ResultsBetween baseline and 1-year visits, 551 (34.5%) NAC patients and 204 (30.1%) patients in the external validation cohort experienced NT-proBNP progression (NT-proBNP increase >700 ng/L and >30%), which was associated with mortality (NAC cohort: HR: 1.82; 95% CI: 1.57-2.10; P < 0.001; validation cohort: HR: 1.75; 95% CI: 1.32-2.33; P < 0.001). At 1 year, 451 (28.2%) NAC patients and 301 (44.5%) patients in the external validation cohort experienced ODI, which was associated with mortality (NAC cohort: HR: 1.88; 95% CI: 1.62-2.18; P < 0.001; validation cohort: HR: 2.05; 95% CI: 1.53-2.74; P < 0.001). When compared with patients with a stable NT-proBNP and stable diuretic dose, a higher risk of mortality was observed in those experiencing either NT-proBNP progression or ODI (NAC cohort: HR: 1.93; 95% CI: 1.65-2.27; P < 0.001; validation cohort: HR: 1.94; 95% CI: 1.36-2.77; P < 0.001), and those experiencing both NT-proBNP progression and ODI (NAC cohort: HR: 2.98; 95% CI: 2.42-3.67; P < 0.001; validation cohort: HR: 3.23; 95% CI: 2.17-4.79; P < 0.001). ConclusionsNT-proBNP progression and ODI are frequent and consistently associated with an increased risk of mortality. Combining both variables produces a simple, universally applicable model that detects disease progression in ATTR-CA.

Abstract 6088: Predicting the risk of any-type cancer in asymptomatic adults using noninvasive glycosaminoglycan profiling

Abstract Background: Early detection of cancers through screening can reduce mortality. However, screening excludes individuals not considered at an increased risk of developing cancer, as determined by age, sex, or tobacco use. No molecular biomarker is routinely used to predict risk. Here, we investigated urine glycosaminoglycan profiles (GAGomes) as noninvasive biomarkers for any-cancer risk prediction. Methods: In this population-based case-control study, we included adults aged over 18 years from the Lifelines Cohort Study, Netherlands who were presumed healthy at baseline. All cases who self-reported any-type cancer or died by the 5-year study visit were confirmed in the Dutch Cancer Registry and matched 1:3 to randomly selected controls (1:1 for the interim analysis). We first developed a logistic regression reference model, including age, sex, and clinical variables to predict any-type cancer. Next, we added urine GAGomes (as a single aggregate score) to the model and assessed model improvement using the likelihood ratio test. We categorized the output of the saturated model (clinical variables plus urine GAGome score) into four groups based on bespoke specificity cut-offs: low-, moderate-, intermediate-, and high-risk. We estimated odds-ratios (ORs) for their association with any-type cancer compared to the moderate-risk group, as well as their sensitivity across subsets. Using the so-estimated OR in the high-risk group, we calculated the minimum pre-test 5-year absolute risk needed to reclassify an adult into a post-test 5-year absolute risk &amp;gt;3.00%. Results: In the interim analysis, we included 2054 adults (median age = 51 years, 57% females). Of them, 924 were diagnosed with any-type cancer over a 6 year-follow-up period (median time to diagnosis = 1.4 years). Urine GAGomes were found to be independent risk factors when added to the reference model, explaining 27% of the variance (Nagelkerke R2 = 0.26 vs. 0.21, p &amp;lt; 0.0001). The ORs in the low-, intermediate-, and high-risk groups were 0.05 (95% CI: 0.02-0.13 p &amp;lt; 0.0001), 5.31 (95% CI: 3.84-7.48, p &amp;lt; 0.0001) and 27.6 (95% CI: 14.3 - 51.6, p &amp;lt; 0.0001), respectively. The high-risk group detected +80% more cancers than the reference model at the same specificity (99.29%), particularly in situ and stage I (+204% and +64%) and among those aged 50-69 (+247%). Adults with a pre-test 5-year absolute risk &amp;gt; 0.25% returning a high-risk group would be reclassified to a post-test 5-year absolute risk &amp;gt; 3.00% for any-type cancer. Conclusion: Implementing urine GAGomes as a strategy for risk-stratified targeted screening could identify adults with increased risk of any-type cancer who are currently excluded from screening. Citation Format: Francesco Gatto. Predicting the risk of any-type cancer in asymptomatic adults using noninvasive glycosaminoglycan profiling [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 6088.

Abstract P495: Gut Microbiome and Plasma Metabolome Signatures Are Associated With Systemic Inflammation in Children

Introduction: Gut microbiota and microbial metabolites are hypothesized to influence health via systemic inflammation, but pediatric studies are lacking. We investigated associations of gut microbiota and plasma metabolome with inflammation in children aged 5-7. Hypothesis: Children with greater abundances of pro-inflammatory microbial taxa and metabolites have more systemic inflammation. Methods: We analyzed cross-sectional data from the community-based Gen3G cohort (Quebec), including children with 3 inflammation measures (IMs; plasminogen activator inhibitor 1, monocyte chemoattractant protein 1, tumor necrosis factor α), untargeted plasma metabolome (Metabolon platform) and gut microbiota (stool 16S rRNA sequencing) data at the 5-year visit. We log-transformed and standardized each IM, averaging them as an inflammation score (InfSc). We pareto-scaled log-transformed metabolites, imputing missing values as half the minimum detected. We selected 76 known bacterial metabolites a priori . We excluded metabolites detected in &lt;50% of samples and microbial amplicon sequence variants (ASVs) in &lt;10% of the samples or with &lt;0.1% overall proportion. We examined associations of ASVs and metabolites with IMs and InfSc using ANCOM-BC2 and linear regression, respectively, after multivariable adjustment (see Figure legend). FDR p-values &lt;0.05 were considered significant. Results: A total of 320 children (mean age 63±4 months, 47% female, 95% white) had IMs and metabolome data, and 146 had microbiota data. Of 335 ASVs tested, 59 were associated with InfSc and 154 with any IM (10 strongest associations in Figure A ). Of the 1038 total metabolites and 76 bacterial metabolites tested, 53 and 5 metabolites, respectively, were associated with InfSc and 80 and 10, respectively, with any IM (10 bacterial metabolites in Figure B ). Conclusions: Microbial ASVs and metabolites, including pro-inflammatory ones (e.g., P. succinatutens, lactate, kynurenine), were associated with systemic inflammation in 5yo children.

Improvements in lung function following vitamin C supplementation to pregnant smokers are associated with buccal DNA methylation at 5 years of age

BackgroundWe previously reported in the “Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function” randomized clinical trial (RCT) that vitamin C (500 mg/day) supplementation to pregnant smokers is associated with improved respiratory outcomes that persist through 5 years of age. The objective of this study was to assess whether buccal cell DNA methylation (DNAm), as a surrogate for airway epithelium, is associated with vitamin C supplementation, improved lung function, and decreased occurrence of wheeze.MethodsWe conducted epigenome-wide association studies (EWAS) using Infinium MethylationEPIC arrays and buccal DNAm from 158 subjects (80 placebo; 78 vitamin C) with pulmonary function testing (PFT) performed at the 5-year visit. EWAS were performed on (1) vitamin C treatment, (2) forced expiratory flow between 25 and 75% of expired volume (FEF25–75), and (3) offspring wheeze. Models were adjusted for sex, race, study site, gestational age at randomization (≤ OR > 18 weeks), proportion of epithelial cells, and latent covariates in addition to child length at PFT in EWAS for FEF25–75. We considered FDR p < 0.05 as genome-wide significant and nominal p < 0.001 as candidates for downstream analyses. Buccal DNAm measured in a subset of subjects at birth and near 1 year of age was used to determine whether DNAm signatures originated in utero, or emerged with age.ResultsVitamin C treatment was associated with 457 FDR significant (q < 0.05) differentially methylated CpGs (DMCs; 236 hypermethylated; 221 hypomethylated) and 53 differentially methylated regions (DMRs; 26 hyper; 27 hypo) at 5 years of age. FEF25–75 was associated with one FDR significant DMC (cg05814800), 1,468 candidate DMCs (p < 0.001), and 44 DMRs. Current wheeze was associated with 0 FDR-DMCs, 782 candidate DMCs, and 19 DMRs (p < 0.001). In 365/457 vitamin C FDR significant DMCs at 5 years of age, there was no significant interaction between time and treatment.ConclusionsVitamin C supplementation to pregnant smokers is associated with buccal DNA methylation in offspring at 5 years of age, and most methylation signatures appear to be persistent from the prenatal period. Buccal methylation at 5 years was also associated with current lung function and occurrence of wheeze, and these functionally associated loci are enriched for vitamin C associated loci.Clinical trial registration ClinicalTrials.gov, NCT01723696 and NCT03203603.

The Effect of Acute Knee Injuries and Related Knee Surgery on Serum Levels of Pro- and Anti-inflammatory Lipid Mediators and Their Associations With Knee Symptoms

Background: Despite an acute knee injury being a major risk factor for osteoarthritis, the factors that initiate and maintain this risk of longer-term knee symptoms are poorly understood. Bioactive lipids derived from omega-3 and -6 polyunsaturated fatty acids have key roles in the regulation of the inflammatory response and have been linked to joint damage and osteoarthritis pain in translational models. Hypothesis: There would be associations between systemic levels of bioactive lipids and knee symptoms longitudinally after an acute knee injury and related knee surgery. Study Design: Controlled laboratory study. Methods: This study analyzed a subset of young, active adults who had sustained an acute knee injury (recruited via a surgical care pathway) and healthy age- and sex-matched controls. Surgery, if performed, was conducted after the baseline serum sample was taken and before the 3-month and 2-year visits. Liquid chromatography–tandem mass spectrometry of 41 bioactive lipids was carried out in sera of (1) 47 injured participants (median age, 28 years) collected at baseline (median, 24 days after injury), 3 months, and 2 years, along with the Knee injury and Osteoarthritis Outcome Score, and (2) age- and sex-matched controls. Results: Levels of the omega-3 polyunsaturated fatty acids eicosapentaenoic acid (P≤ .0001) and docosahexaenoic acid (P≤ .0001) and the pro-resolving lipid mediators 17– and 14–hydroxydocosahexaenoic acid, and 18-hydroxyeicosapentaenoic acid were all significantly greater at baseline in injured participants compared with the later time points and also higher than in healthy controls (P = .0019 and P≤ .0001, respectively). Levels of pro-inflammatory prostaglandins E2 and D2, leukotriene B4, and thromboxane B2 were significantly lower at baseline compared with the later time points. Higher levels of 8,9–, 11,12–, and 14,15–dihydroxyeicosatrienoic acid (DHET) were cross-sectionally associated with more severe knee pain/symptoms according to the Knee injury and Osteoarthritis Outcome Score at 2 years (P = .0004, R2 = 0.251; P = .0002, R2 = 0.278; and P = .0012, R2 = 0.214, respectively). Conclusion: The profile of pro-resolving versus pro-inflammatory lipids at baseline suggests an initial activation of pro-resolution pathways, followed by the later activation of pro-inflammatory pathways. Clinical Relevance: In this largely surgically managed cohort, the association of soluble epoxide hydrolase metabolites, the DHETs, with more severe knee symptoms at 2 years provides a rationale for further investigation into the role of this pathway in persisting knee symptoms in this population, including potential therapeutic strategies.

Complication Rates Following Adult Spinal Deformity Surgery: Evaluation of the Category of Complication and Chronology.

Provide benchmarks for the rates of complications by type and timing. Prospective multicenter database. Complication rates following adult spinal deformity (ASD) surgery have been previously reported. However, the interplay between timing and complication type warrants further analysis. The data for this study were sourced from a prospective, multicenter ASD database. The date and type of complication were collected and classified into three severity groups (minor, major, and major leading to reoperation). Only complications occurring before the two-year visit were retained for analysis. Of the 1260 patients eligible for two-year follow-up, 997 (79.1%) achieved two-year follow-up. The overall complication rate was 67.4% (N=672). 247 patients (24.8%) experienced at least one complication on the day of surgery (including intraoperatively), 359 (36.0%) between postoperative day 1 and six weeks postoperatively, 271 (27.2%) between six weeks and one-year postoperatively, and finally 162 (16.3%) between one year and two years postoperatively. Using Kaplan-Meier survival analysis, the rate of remaining complication-free was estimated at different time points for different severities and types of complications. Stratification by type of complication demonstrated that most of the medical complications occurred within the first 60 days. Surgical complications presented over two distinct timeframes. Operative complications, incision-related complications, and infections occurred early (within 60d), while implant-related and radiographic complications occurred at a constant rate over the two-year follow-up period. Neurological complications had the highest occurrence within the first 60 days but continued to increase up to the two-year visit. Only one-third of ASD patients remained complication-free by two years, and 2 of 10 patients had a complication requiring a reoperation or revision. An estimation of the timing and type of complications associated with surgical treatment may prove useful for more meaningful patient counseling and aid in assessing the cost-effectiveness of treatment. 3.

One-year results for myopia control of orthokeratology with different back optic zone diameters: a randomized trial using a novel multispectral-based topographer.

To present the 1-year results of a prospective cohort study investigating the efficacy, potential mechanism, and safety of orthokeratology (ortho-k) with different back optic zone diameters (BOZD) for myopia control in children. This randomized clinical study was performed between Dec. 2020 and Dec. 2021. Participants were randomly assigned to three groups wearing ortho-k: 5 mm BOZD (5-MM group), 5.5 mm BOZD (5.5-MM group), and 6 mm BOZD (6-MM group). The 1-year data were recorded, including axial length, relative peripheral refraction (RPR, measured by multispectral refractive topography, MRT), and visual quality. The contrast sensitivity (CS) was evaluated by CSV-1000 instrument with spatial frequencies of 3, 6, 12, and 18 cycles/degree (c/d); the corneal higher-order aberrations (HOAs) were measured by iTrace aberration analyzer. The one-way ANOVA was performed to assess the differences between the three groups. The correlation between the change in AL and RPR was calculated by Pearson's correlation coefficient. The 1-year results of 20, 21, and 21 subjects in the 5-MM, 5.5-MM, and 6-MM groups, respectively, were presented. There were no statistical differences in baseline age, sex, or ocular parameters between the three groups (all P>0.05). At the 1-year visit, the 5-MM group had lower axial elongation than the 6-MM group (0.07±0.09 vs 0.18±0.11 mm, P=0.001). The 5-MM group had more myopic total RPR (TRPR, P=0.014), with RPR in the 15°-30° (RPR 15-30, P=0.015), 30°-45° (RPR 30-45, P=0.011), temporal (RPR-T, P=0.008), and nasal area (RPR-N, P<0.001) than the 6-MM group. RPR 15-30 in the 5.5-MM group was more myopic than that in the 6-MM group (P=0.002), and RPR-N in the 5-MM group was more myopic than that in the 5.5-MM group (P<0.001). There were positive correlations between the axial elongation and the change in TRPR (r=0.756, P<0.001), RPR 15-30 (r=0.364, P=0.004), RPR 30-45 (r=0.306, P=0.016), and RPR-N (r=0.253, P=0.047). The CS decreased at 3 c/d (P<0.001), and the corneal HOAs increased in the 5-MM group (P=0.030). Ortho-k with 5 mm BOZD can control myopia progression more effectively. The mechanism may be associated with greater myopic shifts in RPR.

One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis

BackgroundMechanical thrombectomy is a promising treatment option for deep vein thrombosis; however, long-term data are lacking. Here, we report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy with the ClotTriever System (Inari Medical). MethodsThe CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL). ResultsIn CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL. ConclusionsOne-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.

Study within a trial 119: The effectiveness of a thank you card to improve trial follow up; a randomised study within a trial

Background With attrition common in randomised trials, strategies are needed to minimise this. Many retention strategies include ‘thanks’ elements however there is currently no evidence of the effectiveness of a ‘thank you’ intervention separate to other trial activity or information. This Study Within A Trial (SWAT) sought to assess if a thank you card increases completion of the host trial primary outcome. Methods A two arm SWAT, using a 1:1 (intervention:control) allocation ratio, embedded within the DISC trial. The primary outcome was the difference in retention rate at 1 year post-treatment. Secondary outcomes were outcome data completeness, cost, and retention at 2 years post-treatment. Analyses were conducted using logistic regression adjusting for SWAT and host trial allocation. Results A total of 358 participants were randomised and included in the SWAT analyses. Completion of the 1-year outcome visit was 89.7% ( n = 157) in the intervention group and 90.2% (165) in the control group (adjusted odds ratio (OR) 0.95, 95% CI 0.48 to 1.90, p = .89). There was no evidence of a difference in completeness of key outcome data (adjusted OR 1.84, 95% CI 0.71 to 4.73, p = .20) or retention at 2 years post treatment (adjusted OR 1.13, 95% CI 0.59 to 2.17, p = .72). Conclusion It remains unclear if thank you cards increased the rate of primary outcome follow-up completion within the DISC trial. However, as the first evaluation of a distinct ‘thank you’ intervention for improving retention rates, further replications are required to determine effectiveness, ideally in populations other than older, male, Caucasians.

Optical Coherence Tomography Parameters and Optimal Cut-off Values for Predicting Visual Prognosis in Ethambutol-Induced Optic Neuropathy.

The objective of this study was to evaluate the prognostic value of optical coherence tomography (OCT) parameters in patients with ethambutol-induced optic neuropathy (EON) and establish their optimal cut-off values for predicting visual acuity outcomes. A retrospective cross-sectional study was conducted on 64 eyes of 32 patients with EON who underwent OCT. Peripapillary retinal nerve fiber layer (pRNFL) and macular ganglion cell-inner plexiform layer (mGCIPL) thickness were measured using Cirrus high-definition OCT (HD-OCT) within 3 months after EON diagnosis. Visual acuity of patients was recorded and analyzed at the first visit, the 1-year visit, and the latest visit. Prognostic capacities of OCT parameters for visual prognosis were evaluated and their optimal cut-off values for predicting final visual acuity were established. Increased pRNFL thickness was significantly associated with better visual acuity at 1 year postdiagnosis and the latest visit. A significant association was established between increased pRNFL thickness and a higher rate of recovery to visual acuity >20/25 at 1 year postdiagnosis. Receiver-operating characteristic curves identified ideal cut-off values for OCT parameters as follows: pRNFL thickness of 83 μm (sensitivity 100%, specificity 48.3%) and mGCIPL thickness of 74 μm (sensitivity 100%, specificity 83.3%) for visual acuity >20/25 at 1 year, mGCIPL thickness of 61 μm (sensitivity 85.7%, specificity 71.4%) for visual acuity >20/40 at 1 year, with corresponding AUCs exceeding 0.7. Both pRNFL and mGCIPL thickness possess potential values for predicting visual outcomes in patients with EON. Future research should continue to explore the utility of OCT parameters in EON prognosis.

Patient-Centered Positive Factors Influencing Glycemic Control in Adolescents with Type 1 Diabetes Mellitus in China: A Cross-Sectional and Longitudinal Study.

This study aimed to explore the stable longitudinalpatient-centered self-protectivefactors of glycosylated hemoglobin (HbA1c) in adolescents with type 1 diabetesmellitus(T1DM). We used both cross-sectional and longitudinal datasets at the Diabetes Education Center and National Endocrine and Metabolism Centre of a university hospital in China from April 2020 to July 2022. Participants were assessed using the Adolescent Diabetic Behavior Rating Scale (DBRS), Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen). HbA1c and other clinical variables were obtained from the medical record at the same time. 266 adolescents (131 male, age 14.1±3.9 years) completed the cross-sectional assessments and 131 (62 male, age 14.6±3.3 years) participated in a follow-up at a 1-year visit interval. Logistic regression analysis of cross-sectional data of 266 cases showed that there were significant positive effects between pump treatment (β=0.090, OR 2.460, P=0.005), DBRS scores (β=2.593, OR 13.366, P=0.002) and the meeting of standard HbA1c (<7.5%, 58 mmol/mol). Disease duration (β=-0.071, OR 0.932, P=0.033) was negatively correlated with it. The longitudinal multivariate generalized estimation equation model showed that DBRS scores (β=3.165, OR 23.681, P=0.009) and DSTAR-Teen scores (β=0.050, OR 1.051, P=0.012) had a positive influence on the meeting of standard HbA1c over one year time of 131 cases. Self-care and resilience had higher cross-temporal stability in influencing glycemic control over time. To reach a better glycemic control and improve long-term health outcomes, attention should be paid to the detection and enhancement of these patient-centered promoters.

Five-year outcomes of coarctoplasty with stent in the paediatric population, results from a retrospective single-centre cohort with centrally-adjudicated outcomes

Abstract Background Stenting is being increasingly used as a therapeutic option for coarctation of aorta (CoA) in paediatric patients. Although the short and mid-term outcomes are well-documented, data on long-term results are scant. Purpose The current study aimed to determine the long-term safety and efficacy of aortic coarctation stenting via centrally-adjudicated outcomes. Methods The present study is a retrospective cohort conducted at a large tertiary cardiovascular centre. All patients aged up to 15 years who had undergone de novo stenting for CoA between 2006 and 2017 were recruited. Both immediate and 5-year outcomes were investigated. Immediate outcomes, including procedural and in-hospital, were retrieved from electronic medical records, re-analysed, and finally adjudicated by the clinical event committee (CEC). The rates of five-year recoarctation, stent fracture, aneurysmal/pseudoaneurysmal formation, and all-cause mortality were reported as the main long-term outcomes. The first three mentioned outcomes were adjudicated only in patients with available predefined appropriate imaging follow-up tests (Figure 1). Patients who had available recorded 5-year clinical visits and those who answered the phone interview were evaluated for the 5-year mortality. Results A total of 274 patients (98 [35.8%] were female with median [interquartile range] age of 9 [6-12] years) who underwent de novo coarctoplasty with stent were included. Procedural success was achieved in 251 (91.6%) of the patients. Immediate complications were observed in a total of 24 (8.75%) as follows: There were 1 (0.3%) stent migration, 3 (1.1%) small, non-expanding non-flow-limiting aortic wall injuries, and 2 (0.7%) ischemic strokes. Also, there were 18 (6.6%) major vascular access complications, the most common of which was acute limb ischemia in 8 (2.9%) patients, followed by 5 (1.8%) pseudoaneurysms, 3 (1.1%) retroperitoneal haemorrhages, 1 (0.3%) arteriovenous fistula, and 1 (0.3%) large hematoma. A total of 4 (1.4%) in-hospital mortality occurred. The 5-year cumulative incidence of stent fracture, recoarctation of the aorta, and aneurysm/pseudoaneurysm of the aorta were 17/100 (17%), 73/154 (48%), and 8/101 (7.92%), respectively. Five-year all-cause mortality occurred in 4/251 (1.6%) (Table 1). Conclusion In our study, coarctoplasty with stent was safe and effective in the paediatric population during long-term follow-up. Developmental changes in childhood resulting in stent-size mismatch are suggested as a potential aetiology for a high re-intervention rate. Of note, re-intervention was safe and effective.Figure 1Table 1

53 REM Sleep Behavior Disorder in Parkinson’s Disease : Longitudinal Effects on Brain Lateralization

Objective:Laterality of motor symptom onset in Parkinson’s disease (PD) is well-known and under-appreciated. It is still unclear though if this laterality might have an influence on other symptoms. Specifically, REM sleep behavior disorder has been shown to be a factor that has a high probability to be lined to PD. In this study we analyzed the longitudinal effect of REM symptomatology on brain lateralization in PD.Participants and Methods:We used the baseline and 3-year visit data of 116 participants (67 without REM (PD-non-REM), 49 with REM (PD-REM)) aged 37-81 years from the Parkinson’s Progression Markers Initiative (PPMI) dataset. Statistical 3T MRI data (cortical thicknesses, areas, foldings of cortical Desikan atlas and volumes of subcortical regions) were obtained via FreeSurfer 7.1.1. Lateralization was computed using the formula: (left-right)/(lef +right). Mixed ANOVAs were performed on each region of interest.Results:Our findings showed an increased right asymmetry of the paracentral lobule area and of the pars orbitalis area and volume in PD-REM. There was a reduced right asymmetry of the parietal inferior volume at baseline in PD-REM, whereas REM symptomatology had a stable effect at the 3 years visit. At baseline, there was an increased left asymmetry of the thickness of the caudal anterior cingulate, pars orbitalis and pars triangularis regions in PD-REM. After 3 years, there was an increased right asymmetry in those regions. The precentral, frontal superior and transversal temporal gyri showed inverse results: an increased right asymmetry of the thickness at baseline and an increased left asymmetry after 3 years. Finally, REM symptomatology is associated with more significant increases of the left asymmetry of the frontal superior gyrus volume and of the right asymmetry of the supramarginal gyrus volume after 3 years than at baseline.Conclusions:These results provide evidence of the modulating effect of the disease progression on the relationship between REM symptoms and brain lateralization in PD.