Large Unselected Population Research Articles

Effectiveness and safety of biosimilars in pediatric inflammatory bowel diseases: an observational longitudinal study on the French National Health Data System.

Data on biosimilar use in pediatric inflammatory bowel diseases (IBD) are scarce compared to the status of studies in adults, resulting in limitations in its treatment. We compared effectiveness and safety of biosimilars versus originators in this population. We used data from the French National Health Data System to identify children (less than 18years old at treatment initiation) initiating treatment with a biosimilar or the originator infliximab or adalimumab for Crohn's disease (CD) or ulcerative colitis (UC), from first biosimilar launch (January 2015 and October 2018, respectively) to 31 December 2022. Patients' follow-up went until 30 June 2023. We compared the risks of treatment failure and overnight hospitalization in biosimilar versus originator new users using inverseharzard ratio (HR) of probability of treatment weighted Cox regressions (IPTW). We included 5870 patients (infliximab: n = 3491; adalimumab: n = 2379) in the study. Biosimilars represented, respectively, 76.0% (n = 2652) and 29.0% (n = 691) of infliximab and adalimumab initiations. CD represented 70.9% (n = 2476) and 69.0% (n = 1642) of infliximab and adalimumab initiations. Biosimilar use was not associated with increased risks of treatment failure [IPTW HR (95% confidence interval,CI): infliximab 0.92 (0.78-1.09) in CD, 0.98 (0.76-1.27) in UC; adalimumab 0.98 (0.85-1.14) in CD, 1.01 (0.82-1.24) in UC]. Occurrence of all-cause hospitalization was not different between exposure groups [IPTW HR (95% CI): infliximab 0.96 (0.78-1.18); adalimumab 1.03 (0.80-1.33)]. No difference in occurrence of serious infections, mainly gastro-intestinal or dermatological, was found. We provide reassuring results on the use, effectiveness and safety of biosimilars in a large unselected pediatric population suffering from IBD.

Critical congenital heart disease: contemporary prenatal screening performance and outcomes in a multi-centre perinatology service

BackgroundPrenatal detection of critical congenital heart disease (CCHD) optimises perinatal decision-making and neonatal outcomes. The objective of this study was to determine the prenatal screening performance, care pathways and perinatal outcomes for prenatally and postnatally diagnosed cases of CCHD over a four-year period.Study designThis retrospective cohort study in a tertiary centre and its two affiliated secondary sites examined all cases of CCHD, including cases of pregnancy termination and in-utero fetal death, neonatal death and liveborn babies that underwent cardiac catheterization or surgery in the first six weeks of life. Prenatal and postnatal data were ascertained from the first trimester assessment for all patients diagnosed prenatally. Cases requiring intervention that were first identified in the postnatal period were included to determine prenatal detection rates. Follow-up for all cases of CCHD continued to one year of age.ResultsIn a consecutive cohort of 49,950 pregnancies in a 4-year period 01/2019 to 12/2022, a prenatal diagnosis of CCHD was made in 96 cases, yielding a prevalence of 1.9 per 1000 births. The prenatal detection for right duct-dependant heart pathology and congenital heart block was 100%, 85% for left duct-dependant pathology and 93% for transposition of the great arteries (TGA). In the prenatally diagnosed group, 37% of cases were complicated by extracardiac structural abnormalities, a genetic diagnosis or both. All cases of prenatal detection were identified in the context of routine anatomy screening rather than specialist Fetal Cardiac screening services. Almost half of all pregnancies complicated by CCHD did not undergo neonatal cardiac intervention, by virtue of parental choice determined either prenatally or after birth. An additional eight babies were diagnosed with CCHD in the neonatal period, such that the prenatal detection rate for CCHD was 92% (96/104, 95% CI = 84%-96%). Survival at 1-year for infants deemed suitable for CCHD surgery was 85%.ConclusionIn a large unselected population, optimal rates of prenatal detection of critical congenital heart disease can be achieved by a protocolised approach to mid-trimester fetal anatomy ultrasound, underpinned by a programme of sonographer education and training. The cardiac abnormalities most likely to evade prenatal detection are left-sided obstructive lesions.

1321-P: Screening for Liver Fibrosis in Diabetes—Assessing the Performance of Current Recommendations in a Large Unselected Population

American Diabetes Association’s Standard of Care 2023 recommended screening patients with T2D for significant liver fibrosis with FIB-4 and transient elastography (TE). However, the evidence supporting this approach is controversial. The aim of this study was to assess the use of FIB-4, and its correlation with TE, in an unselected population of patients with diabetes. Adult patients from NHANES 2017-2020 with complete data on FIB-4 and TE were included. Diabetes was defined based on FPG, A1c or prior history. Patients with secondary causes of liver steatosis were excluded. NAFLD was defined as a controlled attenuation parameter ≥274 dB/m, while clinically significant and advanced liver fibrosis were defined as TE ≥9.6 and ≥12 kPa, respectively. Among 1193 patients with diabetes (Age: 61 ± 13; BMI: 32.6 ± 7.3 kg/m2; A1c: 7.4 ± 1.7%), the prevalence of NAFLD, clinically significant liver fibrosis, and advanced fibrosis were 68%, 15% and 8%, respectively. These were significantly higher than in patients without diabetes even after stratifying for BMI (all p<0.001). Liver fibrosis worsened with increasing insulin resistance (HOMA-IR), but were not associated with A1c levels. FIB-4 performed poorly to predict significant or advanced liver fibrosis in diabetes (AUC: 0.59 [0.54-0.64] and AUC: 0.63 [0.56-0.69], respectively). Moreover, it performed numerically worse than plasma AST alone (AUC: 0.63, p=0.10 and AUC: 0.68, p=0.10, respectively). Among patients with significant and advanced fibrosis based on TE, FIB-4 was <1.30 (suggested cut-off for screening) in 51% and 47% of patients (i.e., false negatives), suggesting a significant disagreement between these tests. Patients with diabetes are at high risk of liver disease, and therefore, screening for liver fibrosis is warranted. However, our results suggest that current screening strategies based on FIB-4 and TE may not be adequate, as they may miss a significant number of patients with advanced fibrosis. Disclosure F.Bril: None. M.Gray: Advisory Panel; Takeda Pharmaceutical Co., Ltd., Theratechnologies, Consultant; Novo Nordisk.

Abstract 564: Genetic Basis Of Thoracic Aortic Aneurysms In A Large Unselected Clinical Population

Objectives: Thoracic aortic aneurysms (TAAs) are associated with protein coding variants in genes associated with Loeys-Dietz Syndrome (LDS), vascular Ehlers-Danlos Syndrome (VEDS) and ACTA2 . The purpose of this study was to estimate the prevalence of these variants, along with potential novel variants, in a large unselected clinical population. Methods: We analyzed exome sequence data from 174,452 participants. Rare variants (frequency <0.001) were annotated by functional consequence and classification as pathogenic or likely pathogenic (P/LP) in the ClinVar database. TAA diagnoses were determined by ICD-10 codes. Results: 2,670 (1.5%) individuals had a TAA diagnosis; mean age was 66.1 years, compared to 56.7 for the study population (p=0.014). 69% of TAA cases were male and 71% were smokers. There were 20 carriers of ClinVar P/LP variants in LDS genes (8 variants in 10 carriers for SMAD3 , 3 variants in 3 carriers for TGFB2 , 2 variants in 2 carriers for TGFBR1 , 3 variants in 5 carriers for TGFBR2); 5 had a diagnosis of TAA (2 for SMAD 3, 1 each for the others; ORs =16-65); the age of diagnosis was significantly lower than for non-carriers (p<0.0001). 11 P/LP carriers without a TAA diagnosis were <55 years old and could be at risk for TAA. There was 1 TAA case in 21 COL3A1 P/LP carriers and 0 cases in 10 COL1A1 P/LP carriers. We also identified LDS and VEDS variants that are classified as uncertain significance that could be reclassified as P/LP based on their association with early TAA (Table 1). ACTA2 P/LP variants were also strongly associated with TAA (OR=26; p<0.001). The prevalence of P/LP variants in these genes is 1/3,300 (1/1,350 if potential novel pathogenic variants are included). Conclusions: Our results provide estimates of the prevalence and penetrance of variants associated with TAA in a large unselected clinical population, reveal potential novel pathogenic variants, and support the use of genetic data to identify individuals with high disease risk.

Normative values of hand grip strength in a large unselected Chinese population: Evidence from the China National Health Survey.

Hand grip strength (HGS) is a powerful indicator of sarcopenia and other adverse health outcomes. Normative values for HGS for general Chinese people with a broad age spectrum are lacking. This study aims to establish normative values of HGS and explore the correlations between HGS and body composition among unselected people aged 8-80 in China. From 2012 to 2017, 39655 participants aged 8-80years in the China National Health Survey were included. Absolute HGS was measured using a Jamar dynamometer. The relative HGS was normalized by body mass index. Body composition indexes included body mass index, body fat percentage, muscle mass, fat mass index (FMI) and muscle mass index (MMI). Sex-specific smoothed centile tables for the P1 , P5 , P25 , P50 , P75 , P95 and P99 centiles of HGS and body composition were generated using lambda-mu-sigma method. The correlations between muscle strength and body composition were estimated by partial Spearman correlation analysis. The median values (25th and 75th percentile) of HGS in boys and girls (8-19years old) were 22 (14, 34) kg and 18 (12, 22) kg, respectively; in men and women aged 20-80 were 39 (33, 44) kg and 24 (20, 27) kg, respectively. Values of upper and lower HGS across ages had three periods: an increase to a peak in the 20s in men (with the 5th and 95th values of 30 and 55kg, respectively) and 30s in women (with the 5th and 95th values of 18 and 34kg, respectively), preservation through midlife (20s-40s), and then a decline after their 50s. The lowest HGS values in both sexes were in the 70- to 80-year-old group, with the 5th and 95th percentile values of 16 and 40kg in men, and 10 and 25kg in women. There were substantial sex differences in body composition in the life course (all P values <0.001). In ageing, the decrease of muscle strength was faster than that of muscle mass in both sexes. The correlations between muscle mass and HGS were most robust than other correlations, especially in women (0.68 vs. 0.50), children and adolescents. Our study established the age- and sex-specific percentile reference values for hand grip strength in an unselected Chinese population across a broad age-spectrum. The rich data can facilitate the practical appraisal of muscle strength and promote early prediction of sarcopenia and other impairments associated with neuromuscular disorders.

Genetic Basis of Thoracic Aortic Aneurysms in a Large Unselected Clinical Population

Genetic Basis of Thoracic Aortic Aneurysms in a Large Unselected Clinical Population

Diagnostic yield of an insertable cardiac monitor in a large patient population

Insertable cardiac monitors (ICMs) are increasingly used for cardiac rhythm diagnosis with expanding indications. Little has been reported about their use and efficacy. The study sought to evaluate the clinical utility of a novel ICM (Biotronik BIOMONITOR III) including the time to diagnosis in unselected patients with different ICM indications. Patients from 2 prospective clinical studies were included to determine the diagnostic yield of the ICM. The primary endpoint was time to clinical diagnosis per implant indication or to the first change in atrial fibrillation (AF) therapy. A total of 632 patients were included with a mean follow-up of 233 ± 168 days. Of 384 patients with (pre)syncope, 34.2% had a diagnosis at 1 year. The most frequent therapy was permanent pacemaker implantation. Of 133 patients with cryptogenic stroke, 16.6% had an AF diagnosis at 1 year, resulting in oral anticoagulation. Of 49 patients with an indication for AF monitoring, 41.0% had a relevant change in AF therapy based on ICM data at 1 year. Of 66 patients with other indications, 35.4% received a rhythm diagnosis at 1 year. Moreover, 6.5% of the cohort had additional diagnoses: 26 of 384 patients with syncope, 8 of 133 patients with cryptogenic stroke, and 7 of 49 patients with AF monitoring. In a large unselected patient population with heterogeneous ICM indications, the primary endpoint of rhythm diagnosis was achieved in ∼1 in 4, and additional clinically relevant findings was achieved in 6.5% of patients at short-term follow-up.

Real-world experience of abiraterone acetate plus prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: long-term results of the prospective ABItude study

BackgroundLimited real-world data exist on the effectiveness and safety of abiraterone acetate plus prednisone (abiraterone hereafter) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) naive to chemotherapy. Most of the few available studies had a retrospective design and included a small number of patients. In the interim analysis of the ABItude study, abiraterone showed good clinical effectiveness and safety profile in the chemotherapy-naive setting over a median follow-up of 18 months.Patients and methodsWe evaluated clinical and patient-reported outcomes (PROs) of chemotherapy-naive mCRPC patients treated with abiraterone as for clinical practice in the Italian, observational, prospective, multicentric ABItude study. mCRPC patients were enrolled at abiraterone start (February 2016-June 2017) and followed up for 3 years; clinical endpoints and PROs, including quality of life (QoL) and pain, were prospectively collected. Kaplan–Meier curves were estimated.ResultsOf the 481 patients enrolled, 454 were assessable for final study analyses. At abiraterone start, the median age was 77 years, with 58.6% elderly patients and 69% having at least one comorbidity (57.5% cardiovascular diseases). Visceral metastases were present in 8.4% of patients. Over a median follow-up of 24.8 months, median progression-free survival (any progression reported by the investigators), time to abiraterone discontinuation, and overall survival were, respectively, 17.3 months [95% confidence interval (CI) 14.1-19.4 months], 16.0 months (95% CI 13.1-18.2 months), and 37.3 months (95% CI 36.5 months-not estimable); 64.2% of patients achieved ≥50% reduction in prostate-specific antigen. QoL assessed by Functional Assessment of Cancer Therapy—Prostate, the European Quality of Life 5 Dimensions 3 Level, and European Quality of Life Visual Analog Scale remained stable during treatment. Median time to pain progression according to Brief Pain Inventory data was 31.1 months (95% CI 24.8 months-not estimable). Sixty-two patients (13.1%) had at least one adverse drug reaction (ADR) and 8 (1.7%) one serious ADR.ConclusionWith longer follow-up, abiraterone therapy remains safe, well tolerated, and active in a large unselected population.

Feasibility and Accuracy of the Automated Software for Dynamic Quantification of Left Ventricular and Atrial Volumes and Function in a Large Unselected Population.

We aimed to evaluate the feasibility and accuracy of machine learning-based automated dynamic quantification of left ventricular (LV) and left atrial (LA) volumes in an unselected population. We enrolled 600 unselected patients (12% in atrial fibrillation) clinically referred for transthoracic echocardiography (2DTTE), who also underwent 3D echocardiography (3DE) imaging. LV ejection fraction (EF), LV, and LA volumes were obtained from 2D images; 3D images were analyzed using dynamic heart model (DHM) software (Philips) resulting in LV and LA volume–time curves. A subgroup of 140 patients also underwent cardiac magnetic resonance (CMR) imaging. Average time of analysis, feasibility, and image quality were recorded, and results were compared between 2DTTE, DHM, and CMR. The use of DHM was feasible in 522/600 cases (87%). When feasible, the boundary position was considered accurate in 335/522 patients (64%), while major (n = 38) or minor (n = 149) border corrections were needed. The overall time required for DHM datasets was approximately 40 seconds. As expected, DHM LV volumes were larger than 2D ones (end-diastolic volume: 173 ± 64 vs. 142 ± 58 mL, respectively), while no differences were found for LV EF and LA volumes (EF: 55% ± 12 vs. 56% ± 14; LA volume 89 ± 36 vs. 89 ± 38 mL, respectively). The comparison between DHM and CMR values showed a high correlation for LV volumes (r = 0.70 and r = 0.82, p < 0.001 for end-diastolic and end-systolic volume, respectively) and an excellent correlation for EF (r = 0.82, p < 0.001) and LA volumes. The DHM software is feasible, accurate, and quick in a large series of unselected patients, including those with suboptimal 2D images or in atrial fibrillation.

Prenatal Testosterone Associates With Blood Pressure in Young Adults: A Prospective Cohort Study.

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Validation of Normal P-Wave Parameters in a Large Unselected Pediatric Population of North-Western Romania: Results of the CARDIOPED Project.

Aims Reference values of the P-wave on 12 lead electrocardiograms are lacking for children and adolescents in Eastern Europe. Hence, the present study is aimed at determining the standard values of the P-wave in children and adolescents based on ECG data from the CARDIOPED project, a large-scale general population of children who participated in a screening program in Transylvania, Romania. Methods and Results A total of 22,411 ECGs of participants aged 6 to 18 years old from a school-based ECG screening were obtained between February 2015 and December 2015 in Transylvania, Romania. Three pediatric cardiologists manually reviewed each ECG. P-wave duration, voltage, axis, and correlation with gender and age were analyzed. The mean P-wave duration was 88 ± 10.7 ms, with a maximum duration of 128 ms. P-wave showed a positive correlation with age but did not differ between sexes. There was a positive correlation between the P-wave duration and the heart rate, but not with the body max index. The mean P-wave axis was 40.4 ± 31.1, and the mean P-wave amplitude was 0.12 ± 0.03 mV. Conclusion In this study on many pediatric subjects, we have provided normal limits for the P-wave in Romanian children aged 6-18 years. Our findings are useful for creating interpretation guidelines for pediatric ECG.

Feasibility and accuracy of the automated software for dynamic quantification of left ventricular and atrial volumes and function in a large unselected population

Abstract Funding Acknowledgements Type of funding sources: None. Objective. Preliminary studies showed the accuracy of machine learning based automated dynamic quantification of left ventricular (LV) and left atrial (LA) volumes. We aimed to evaluate the feasibility and accuracy of machine learning based automated dynamic quantification of LV and LA volumes in an unselected population. Methods. We enrolled 600 unselected patients (12% in atrial fibrillation) clinically referred for transthoracic echocardiography (2DTTE), who also underwent 3D echocardiography (3DE) imaging. LV ejection fraction (EF), LV and LA volumes were obtained from 2D images; 3D images were analysed using Dynamic Heart Model (DHM) software (Philips) resulting in LV and LA volume-time curves. A subgroup of 140 patients underwent also cardiac magnetic resonance (CMR) imaging. Average time of analysis, feasibility, and image quality were recorded and results were compared between 2DTTE, DHM and CMR. Results. The use of DHM was feasible in 522/600 cases (87%). When feasible, the boundary position was considered accurate in 335/522 patients (64%), while major (n = 38) or minor (n = 149) borders corrections were needed. The overall time required for DHM datasets was approximately 40 seconds, resulting in physiologically appearing LV and LA volume–time curves in all cases. As expected, DHM LV volumes were larger than 2D ones (end-diastolic volume: 173 ± 64 vs 142 ± 58 mL, respectively), while no differences were found for LV EF and LA volumes (EF: 55%±12 vs 56%±14; LA volume 89 ± 36 vs 89 ± 38 mL, respectively). The comparison between DHM and CMR values showed a high correlation for LV volumes (r = 0.70 and r = 0.82, p &amp;lt; 0.001 for end-diastolic and end-systolic volume, respectively) and an excellent correlation for EF (r= 0.82, p &amp;lt; 0.001) and LA volumes. Conclusions. The DHM software is feasible, accurate and quick in a large series of unselected patients, including those with suboptimal 2D images or in atrial fibrillation. Table 1 DHM quality Adjustment Feasibility Good Suboptimal Minor Major Total of patients (n, %) 522/600 (87%) 327/522 (62%) 195/522 (28%) 149/522 (29%) 38/522 (6%) Normal subjects (n, %) 39/40 (97%) 23/39 (57%) 16/39 (40%) 9/39 (21%) 1/39 (3%) Atrial Fibrillation (n, %) 59/73 (81%)* 28/59 (47%) 31/59 (53%) 15/59 (25%) 6/59 (10%) Valvular disease (n, %) 271/312 (87%) 120/271 (%) 151/271 (%) 65/271 (24%) 16/271 (6%) Coronary artery disease (n, %) 47/58 (81%)* 26/47 (46%) 21/47 (37%) 16/47 (34%) 5/47 (11%) Miscellaneous (n, %) 24/25 (96%) 18/24 (75%) 6/24 (25%) 5/24 (21%) 3/24 (12%) Feasibility of DHM, image quality and need to adjustments in global population and in each subgroup. Abstract Figure 1

External validation of the Dutch prediction model for prehospital triage of trauma patients in South West region of England, United Kingdom.

This paper investigates the use of a major trauma prediction model in the UK setting. We demonstrate that application of this model could reduce the number of patients with major trauma being incorrectly sent to non-specialist hospitals. However, more research is needed to reduce over-triage and unnecessary transfer to Major Trauma Centres. To externally validate the Dutch prediction model for identifying major trauma in a large unselected prehospital population of injured patients in England. External validation using a retrospective cohort of injured patients who ambulance crews transported to hospitals. South West region of England. All patients ≥16 years with a suspected injury and transported by ambulance in the year from February 1, 2017. 1) Patients aged ≤15 years; 2) Non-ambulance attendance at hospital with injuries; 3) Death at the scene and; 4) Patients conveyed by helicopter. This study had a census sample of cases available to us over a one year period. Tested the accuracy of the prediction model in terms of discrimination, calibration, clinical usefulness, sensitivity and specificity and under- and over triage rates compared to usual triage practices in the South West region. Major trauma defined as an Injury Severity Score>15. A total of 68799 adult patients were included in the external validation cohort. The median age of patients was 72 (i.q.r. 46-84); 55.5% were female; and 524 (0.8%) had an Injury Severity Score>15. The model achieved good discrimination with a C-Statistic 0.75 (95% CI, 0.73 - 0.78). The maximal specificity of 50% and sensitivity of 83% suggests the model could improve undertriage rates at the expense of increased overtriage rates compared with routine trauma triage methods used in the South West, England. The Dutch prediction model for identifying major trauma could lower the undertriage rate to 17%, however it would increase the overtriage rate to 50% in this United Kingdom cohort. Further prospective research is needed to determine whether the model can be practically implemented by paramedics and is cost-effective.

Metabolic bone disease in patients with epilepsy and the use of antiepileptic drugs – Insight from a Danish cross-sectional study

Osteoporosis is a bone disorder defined by a decrease in bone mineral density (BMD) which can lead to an increased risk of fractures. Patients with epilepsy are more prone to having fractures. When accounting for seizure-related fractures, the epilepsy patient population still suffers from an increased risk of fractures. This can be attributed to adverse effects of antiepileptic drugs (AEDs). The aim of this study was to investigate the association between the use of AEDs and decreased BMD in a large unselected population of Danish patients with epilepsy. The study was a cross-sectional study based on data retrieved from 835 patients visiting an outpatient Epilepsy Clinic in Glostrup, Denmark, from January 1st 2006 - January 31st 2018. The data included results from DXA-scans and demographic information. Logistic regression models and other statistical analyses were performed. The results showed that the odds for having osteoporosis when taking EIAEDs were 2.2 (95 % CI: 1.2-3.8, P = 0.007) times higher than those taking NEIAEDs. Furthermore, the odds for having osteoporosis increased with duration of epilepsy (OR = 1.0, 95 % CI: 1.0 - 1.0, P = 0.001) and when the patients consume two AEDs compared to one AED (OR = 2.3, 95 % CI: 1.3-4.1, P < 0.001). Additionally, consuming three AEDs compared to one lead to a 2.3 times higher risk of having osteoporosis (95 % CI: 1.2-4.4, P = 0.01). When accounted for many riskfactors, EIAEDs, polytherapy with AEDs and duration of epilepsy are correlated with osteoporosis. There is a need for using these known riskfactors as guidelines in indentifying patients at increased risk of developing osteoporosis.

Four-year results of the AIDA trial: comparison of Absorb bioresorbable scaffold with Xience everolimus-eluting metallic stent in daily clinical practice

Abstract Aims Absorb bioresorbable scaffold (BRS) related events were noticed between 1 and 3 years – the approximate time of active scaffold bioresorption. This resulted in the recommendation for 3 year DAPT after Absorb BRS implantation. We aimed to evaluate the safety and efficacy of the Absorb BRS in comparison with Xience everolimus-eluting stent (EES) at 4 years follow-up in large unselected population. In addition, we aimed to assess the value of prolonged DAPT against scaffold thrombosis. Methods AIDA was an investigator-initiated, non-inferiority, multicenter, randomized, all-comers trial. Target vessel failure (a composite of cardiac death, target-vessel myocardial infarction and target-vessel revascularization) and device thrombosis at 4-year follow-up are the primary focus of this analysis. During the trial recommendation for DAPT was changed to up to 3-years post Absorb BVS implantation. Whether this adaption influenced the results after Absorb BVS will be assessed. Results Between August 2013 and December 2015, 1,845 patients were enrolled, of whom 924 were randomized to treatment with Absorb BRS and 921 to Xience EES. The baseline characteristics in the two study arms were well balanced. Of all patients, 18% had diabetes mellitus, more than 50% presented with ACS and the median SYNTAX score was 11. In the Absorb BRS arm, 97% of lesions were predilated and in 74% post-dilatation was performed. Four-year clinical outcomes are currently being adjudicated by an independent clinical event committee. The results will be available at EuroPCR 2020. Conclusions Absorb BRS is associated with higher rates of scaffold thrombosis throughout 3-year of follow-up. The performance of Absorb BRS beyond 3-years, in comparison with the Xience EES, in a large unselected population will be presented. (ClinicalTrials.gov Identifier: NCT01858077) Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Better outcome of exercise-related out-of-hospital cardiac arrest in men and in the young

Abstract Background Survival from out-of-hospital cardiac arrest (OHCA) is higher if the arrest occurs in relation to physical activity,however there is contradicting data on prognosis with regards to gender and age. The purpose of the study was to compare prognosis and circumstances of exercise-related OHCA in different age-groups as well as between genders in a large unselected population. Methods Observational data from exercise-related OHCA occurring outside of home reported to the Swedish Register of Cardiopulmonary Resuscitation (SRCR) from 2011 to 2014 and from 2016 to 2018 was analyzed. Comparing analyses were made for three different age-groups (0–35, 36–65 and &amp;gt;65 years) and for males versus females. Results A total number of 9607 cases of OHCA outside of home where resuscitation was attempted occurred during the study period, 635 (6.6%) were exercise-related. Mean age was similar between males and females (59.1 years in both groups). The 30-day survival rate was significantly higher among exercise-related OHCAs compared to non-exercise-related OHCAs (44.5% vs 18.8%, p&amp;lt;0.0001). The highest survival rate was observed in the age-group 0–35 years, compared to 36–65 years and &amp;gt;65 years respectively (59.6% vs 46.0% and 40.4% respectively, p=0.01). A sub-group analysis of victims aged 0–25 years (n=32) showed a survival rate of 68.8%. Exercise-related OHCA in women (9.1% of total) were bystander witnessed to a lower extent than in men (66.7% vs 79.6%, p=0.03). Both men and women received bystander CPR at the same extent but median time to CPR was 1min longer for women (2.0 vs 1.0 min, p=0.001). Women had lower rates of ventricular fibrillation as initial rhythm (43.4% vs 64.7%, p=0.003) and 30-day survival was lower among women (29.3% vs 46.0%, p=0.02). Conclusion Women seem to be protected from exercise-related OHCA but in case of occurrence the prognosis is actually worse compared to men. This may partly be explained by lower grade of bystander witnesses and longer time to CPR, but the results indicate the need for further studies on additional factors, such as variances in underlying disease pattern and exercise habits of women. In addition, this study presents an exceptionally high survival rate for exercise-related OHCA in the youngest age-groups, especially in victims 0–25 years of age which is a novel finding. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): The Swedish Heart-Lung Foundation, Laerdal Foundation

Impact of Influenza Vaccination on Mortality in the Oldest Old: A Propensity Score-Matched Cohort Study.

Influenza remains a major cause of illness and death in geriatric populations. While the influenza vaccine has successfully reduced morbidity and mortality, its effectiveness is suspected to decrease with age. The aim of this study was to assess the impact of influenza vaccination on all-cause mortality in very old ambulatory subjects. We conducted a prospective cohort study from 1 July 2016 to 31 June 2017 in a large unselected ambulatory population aged over 80 years. We compared all-cause mortality in vaccinated versus unvaccinated subjects after propensity-score matching, to control for age, sex and comorbidities. Among the 9149 patients included, with mean age 86 years, 4380 (47.9%) were vaccinated against influenza. In total, 5253 (57.4%) had at least one chronic disease. The most commonly vaccinated patients were those with chronic respiratory failure (76.3%) and the least commonly vaccinated were those suffering from Parkinson’s disease (28.5%). Overall, 2084 patients (22.8%) died during the study. After propensity score matching, the mortality was evaluated at 20.9% in the vaccinated group and 23.9% in the unvaccinated group (OR = 0.84 [0.75–0.93], p = 0.001). This decrease in mortality in the vaccinated group persisted whatever the age and Charlson Comorbidity index. In conclusion, nearly a half of this ambulatory elderly population received Influenza vaccine. After adjustment on comorbidities, influenza vaccination was associated with a significant decrease in all-cause mortality, even in the eldest multimorbid population. Improving immunization coverage in this frail older population is urgently needed.

1315-P: Application of Multiplex ECL Assay in Mass Screening for Presymptomatic Type 1 Diabetes

Islet autoantibody (IAb) assays for a general population screening should ideally be high-troughput, low-cost, and offer high-sensitivity and high positive predictive value in a low-risk population. The Autoimmunity Screening for Kids (ASK) study has compared the performance of the ’gold standard’ radiobinding assays (RBAs) and a multiplex electrochemiluminesence assay (ECL) in a large unselected pediatric population. Single IAb by RBA but negative by ECL have been previously shown to be low-affinity and of low predictive value for progression to clinical diabetes. From 2017-2019, ASK screened for IAbs 23,400 Colorado children ages 1-17 y. A high-throughput multiplex ECL assay combining IAbs to insulin, GAD and IA-2 in one single well was used in parallel with standard non-multiplex RBAs. At the initial screening with RBA, 3.0% (697/23400) of children were positive for at least one IAb, including 0.4% (98/23400) for multiple IAbs and 2.6% (599/23400) for a single IAb. Among children with ≥2 IAbs, ECL assay results were 89.8% congruent with RBA. In contrast, only 21.5% (129/599 p&amp;lt;0.0001) of children with single IAb by RBA were ECL positive (i.e., high-affinity). During a median follow-up of 0.5 y (range 0.1-2.5 y), 90% (98/109) of children with a single IAb by both RBA and ECL remained persistently positive and 9.2% of those progressed to ≥2 IAbs. In contrast, 74% (242/328, p=0.0003) of children with a single IAb by RBA but ECL negative remained persistently positive; only 1.8% (p=0.001) of those converted to ≥2 IAbs (half became ECL positive). ASK results suggest that applying the ECL assay as the confirmation test may help to remove nearly 80% of subjects with single IAb from further follow-up and monitoring, with little loss of sensitivity. Alternatively, the multiplex ECL could be used as the primary screening tool to leverage its high throughput and low cost, compared to RBAs. Disclosure X. Jia: None. L. He: None. D. Miao: None. K. Waugh: None. B.I. Frohnert: None. A. Steck: None. M. Rewers: None. L. Yu: None. C.R. Geno Rasmussen: None.

73: Maternal CMV screening in a large unselected population

73: Maternal CMV screening in a large unselected population

Hypertrophic Cardiomyopathy-Related Sudden Cardiac Death in Young People in Ontario.

Hypertrophic cardiomyopathy (HCM) is considered a leading cause of sudden cardiac death (SCD) in younger people. The incidence of HCM-related SCD and its relationship to exercise have not been well studied in large comprehensive studies outside of tertiary care settings. This study sought to estimate the incidence of HCM-related SCD and its association with exercise in a large unselected population. Using the Office of the Chief Coroner of Ontario database encompassing all deaths attended by the coroner, we identified all HCM-related SCDs in individuals 10 to 45 years of age between 2005 and 2016 (70 million person-years). Confirmation of HCM was based on typical macroscopic and microscopic features (definite HCM-related SCD). Sudden deaths with a prior clinical diagnosis of HCM but no autopsy were considered probable HCM-related SCDs. Cases with typical features but no myofiber disarray were considered possible HCM. The completeness of data was verified in a subset of patients in the Toronto area with the use of a registry of all emergency medical services-attended cardiac arrests, with an autopsy rate of 94%. To estimate the number of HCM-related aborted cardiac arrests and lives potentially saved by implantable cardioverter-defibrillators, all de novo implantations for secondary prevention and all implantations and appropriate shocks for primary prevention in patients with HCM 10 to 45 years of age, respectively, were identified with the use of a registry containing data on implantable cardioverter-defibrillator implantations from all implanting sites throughout Ontario. Forty-four, 3, and 6 cases of definite, probable, and possible HCM-related SCDs, respectively, were identified, corresponding to estimated annual incidence rates of 0.31 per 1000 HCM person-years (95% CI, 0.24-0.44) for definite HCM-related SCD, 0.33 per 1000 HCM person-years (95% CI, 0.34-0.62) for definite or probable HCM-related SCD, and 0.39 per 1000 HCM person-years (95% CI, 0.28-0.49) for definite, probable, or possible HCM-related SCD (estimated 140 740 HCM person-years of observation). The estimated annual incidence rate for HCM-related SCD plus aborted cardiac arrest and HCM-related life-threatening arrhythmia (SCD, aborted cardiac arrest, and appropriate implantable cardioverter-defibrillator shocks) was 0.84 per 1000 HCM person-years (95% CI, 0.70-1.0). The majority (70%) of SCDs occurred in previously undiagnosed individuals. Most SCDs occurred during rest (64.8%) or light activity (18.5%). The incidence of HCM-related SCD in the general population 10 to 45 years of age is substantially lower than previously reported, with most cases occurring in previously undiagnosed individuals. SCDs are infrequently related to exercise.