Risultati per: Analisi sull’uso dei farmaci anti-osteoporotici in sette database europei

Circulation, Volume 150, Issue Suppl_1, Page A4139239-A4139239, November 12, 2024. Objective:Identification of individuals with reduced or preserved ejection fraction heart failure (HFrEF/HFpEF) within claims data is typically based on ICD-10-CM diagnosis codes that use systolic and diastolic HF (SHF/DHF) nomenclature. The objective of this study was to assess the performance characteristics of using ICD-10-CM diagnostic codes from claims data for HFrEF and HFpEF classification relative to a reference standard using EF results or clinician documentation within an integrated claims/EMR database.Methods:EMR data from the Healthcare Integrated Research Database (HIRD®) were searched to identify patients with EF assessment between 01/01/2016 and 01/31/2023. HFrEF was defined as EF ≤ 40% or documented reduced EF, while HFpEF was defined as EF ≥ 50% or documented preserved/normal EF. The most recent EF assessment date or EMR entry date (if EF assessment date not available) was set as the index date. Claims submitted from 7 days to 6 months post index date were then reviewed to identify SHF and DHF diagnoses as well as comorbid conditions. Analyses were performed to determine sensitivity, specificity, and positive/negative predictive values (PPV/NPV), accuracy and F1 scores of the claims-based algorithm, with a sensitivity analysis performed using the subset of patients with a known EF assessment date available.Results:A total of 45,272 patients had EF assessment in the EMR data with either a SHF or DHF diagnoses in the claims data. Mean (SD) age was 71.7 (12.7) years, 51.2% were male. The most common comorbidities of interest included hypertension (89.5%), dyslipidemia (71.9%), atrial fibrillation (45.9%), type 2 diabetes (43.7%), and chronic kidney disease (39.6%). Counts by heart failure classification and algorithm performance characteristics are in Table 1. Sensitivity analyses for those with known EF assessment dates showed similar results.Conclusions:Overall performance of the claims-based algorithm was good to very good, although EF data integrated with claims data can improve HF classification. Future claims-based algorithm development could also incorporate treatments and comorbidities to improve performance.

Circulation, Volume 150, Issue Suppl_1, Page A4139942-A4139942, November 12, 2024. Background:Thromboembolic events in atrial fibrillation (AF) patients represent a significant health concern among older adults in the United States. This study investigates trends and demographic disparities in mortality rates due to thromboembolic events in AF patients aged 65 and older from 1999 to 2020.Methods:Utilizing the CDC WONDER database from 1999-2020, this retrospective analysis focused on ICD code I48 for AF and related stroke codes (I26, I63, I74, and I82). Age-adjusted mortality rates (AAMRs) per 100,000 persons were calculated, and trends were assessed using Average Annual Percentage Change (AAPC) and Annual Percent Change (APC). Data were stratified by year, sex, race/ethnicity, and geographical regions.Results:Between 1999 and 2020, thromboembolic events in AF accounted for 422,525 deaths among adults aged 65+ in the U.S., primarily occurring in medical facilities (45.0%). The overall AAMR for thromboembolic events in AF-related deaths increased from 47.3 in 1999 to 49.1 in 2020, with an AAPC of -0.15 (95% CI: -0.37 to 0.07, p = 0.169). A significant decline occurred from 1999 to 2006 (APC: -1.45; 95% CI: -3.22 to -0.63, p < 0.000001), followed by a mild rise from 2006 to 2020 (APC: 0.50; 95% CI: 0.25 to 0.88, p = 0.013). Older women exhibited higher AAMRs compared to older men (women: 46.4; men: 43.5). Among racial/ethnic groups, White patients had the highest AAMRs (48.7), followed by Black population (33.5), American Indians (30.1), Asians (28.8), and Hispanics (27.3). All racial groups saw significant increases in AAMRs except Asian population, who experienced a slight decrease. The highest AAPC was observed in Blacks (1.46; 95% CI: 0.94 to 1.84, p < 0.000001). AAMRs varied by state, ranging from 29.2 in Nevada to 83.9 in Vermont. The Western region had the highest average AAMR (52.0). Nonmetropolitan areas had higher AAMRs than metropolitan areas (51.6 vs. 44.4).Conclusion:This analysis reveals stable yet slightly increasing mortality rates for thromboembolic events in AF among older adults in the U.S. over the past two decades, highlighting ongoing public health concerns. Addressing disparities and improving healthcare access for vulnerable populations are crucial to reducing these mortality rates and improving health outcomes.

Circulation, Volume 150, Issue Suppl_1, Page A4141585-A4141585, November 12, 2024. Introduction/Background:Despite increasing awareness of lipoprotein(a) [Lp(a)] as an independent, genetically determined, causal risk driver of atherosclerotic cardiovascular disease (ASCVD), Lp(a) screening occurs infrequently, and nationwide, comprehensive data characterizing the risk of elevated Lp(a) are lacking.Aims:To evaluate the association of Lp(a) level with cardiovascular disease (CVD) events in individuals with and without pre-existing ASCVD using real-world data from the Family Heart DatabaseTM.Methods:Observational, retrospective cohort study using longitudinal data in over 324 million individuals from 2012-2021. Selection criteria included individuals ≥18 years with ≥1 Lp(a) test measured in nmol/L during May 1, 2013 to December 31, 2020, and ≥1 medical claim pre- and post-index date (date of earliest Lp[a] test). Lp(a) levels were categorized by percentile (80th). Elevated Lp(a) was defined as >80thpercentile ( >140 nmol/L). Multivariable Cox Proportional Hazards model analyses compared a group with Lp(a)

Circulation, Volume 150, Issue Suppl_1, Page A4146295-A4146295, November 12, 2024. Background:Previous studies have highlighted the impact of sex differences on the outcomes of patients admitted for ST-elevation myocardial infarction (STEMI). However, there is limited evidence as to whether there is a difference in the outcomes between females and male STEMI patients who have a concomitant diagnosis of chronic kidney disease (CKD) and end-stage renal disease (ESRD).Research Question:Does sex affect the outcomes for STEMI patients with concomitant CKD and ESRD?Methods:This is a retrospective population-based cohort study that uses the National Inpatient Sample database. CKD patients in the United States hospitalized for STEMI were identified using the International Classification of Diseases, Ninth and Tenth Revision (ICD-9 and 10) codes. Inclusion criteria were adult patients who were hospitalized from 2012 to 2020. A subset of patients with ESRD were also identified. Multivariate regression analysis was performed, with the model adjusted for age and comorbidities. The primary outcome of interest was in-hospital mortality. Secondary outcomes evaluated included ischemic stroke, major bleeding complications, pressor requirement, permanent pacemaker implantation, percutaneous coronary intervention, coronary artery bypass grafting, surgery, pericardiocentesis, mechanical circulatory support, and mechanical ventilation.Results:A total of 1,283,255 STEMI patients without CKD, 158,715 STEMI patients with CKD, and 22,690 STEMI patients with ESRD were identified and analyzed. Among patients with STEMI and CKD, females demonstrated higher in-hospital mortality compared to male counterparts (16.7% vs 12.7%, aOR=1.13, 95% CI: 1.05-1.21, p

Circulation, Volume 150, Issue Suppl_1, Page A4147863-A4147863, November 12, 2024. Background:Ischemic heart disease (IHD) affects over 120 million people and is the leading cause of death globally. Our study aims to assess the trends in IHD-related mortality in the regions of the Americas.Research Questions/Hypothesis:Has IHD-related mortality decreased from 2000 to 2019 in all regions of the Americas?Aims:Analyze differences in IHD-related mortality in different regions of the Americas.Methods:We analyzed the Pan American Health Organization (PAHO) database for IHD-related mortality rates in 2000, 2010, and 2019. The age-standardized mortality rates per 100,000 population were extracted, and trends were analyzed by gender and region.Results:The IHD-related mortality was consistently higher in males as compared to females in the last 2 decades. The mortality rate decreased in males in all regions from 2000 to 2019 apart from the Mexico, Central America and Latin Caribbean region where it increased from 115.12 in 2000 to 119.50 in 2019.The greatest decrease in IHD-related mortality in males was seen in the North America region from 164.49 in 2000 to 93.73 in 2019. This opposite trend was seen in females where mortality decreased in all regions from 2000 to 2019.Conclusion:The sociodemographic and temporal trends highlighted by this study need to be further investigated, and targeted policy measures are required to reduce the disparities in IHD-related mortality.

Circulation, Volume 150, Issue Suppl_1, Page A4147547-A4147547, November 12, 2024. Background:Paroxysmal atrial fibrillation (PAF) is an intermittent irregular arrhythmia that terminates within seven days. Prior studies have shown that females with atrial fibrillation are at increased risk of mortality and readmissions compared to men. Given the dramatic rise in PAF diagnoses over the past several years, the impact of sex on clinical outcomes in this patient population requires further analysis. This study aims to investigate sex-based disparities in clinical outcomes over recent years for patients with PAF.Methods:In this large scale, retrospective cohort study, patients who were admitted with PAF were analyzed from 2016 to 2020 using the National Readmissions Database. The study population was divided into male and female groups. Diagnoses were classified according to the International Classification of Diseases Tenth (ICD-10) Revision codes. The primary outcome was 30-day readmissions. Secondary outcomes included inpatient mortality and length of stay.Results:During the study period, a total of 548,617 patients with PAF meeting inclusion criteria were admitted. Of this population, 55.3% were female (n = 303,412) and 44.7% (n =245,205) were male. The mean age was 73.7 ± 11.9 years for females and 65.7± 13.6 years for males. After adjusting for baseline characteristics, female sex was associated with a higher 30-day readmission rate (HR: 1.06, CI: 1.03-1.09, p < 0.001). Multivariate regression analysis for inpatient mortality and length of stay was higher for females than males (p < 0.01 for both).Conclusion:Female patients experienced worse overall outcomes compared to male patients with higher readmission rates, inpatient mortality, and longer length of stay. These data suggest that targeted intervention for females may be required to improve these outcomes.

Circulation, Volume 150, Issue Suppl_1, Page A4124307-A4124307, November 12, 2024. Background:Obesity is considered a significant risk factor for numerous cardiovascular conditions due to its effects on cardiac structure and function. The prevalence of atrial fibrillation (AF) is elevated among patients with obesity due to the dysregulation of several mechanisms. Weight loss has been shown to reverse cardiac remodeling, leading to a lower recurrence of AF despite the better prognosis in obese patients described as the obesity paradox.Methods:We utilized the National Inpatient Sample 2016-2019 to extract patients ≥18 years of age admitted with AF as the primary diagnosis based on ICD 10 codes. We performed univariate and multivariate regression analysis for known coronary risk factors. We divided patients based on their body mass index (BMI), and our primary outcomes were determining the odds of electrical cardioversion (ECV) and cardiac ablation (CA) due to AF.Results:The analysis included 1,625,809 weighted patients. Patients include underweight (6.66%), normal BMI (4.03), overweight (6.51%), obesity class I (20.65%), obesity class II (21.45%), and obesity class III (40.7).After multivariate regression analysis, patients with obesity class I, II, or III had higher odds of ECV, irrespectively of coronary risk factors (OR 1.3, 95% CI 1.25-1.37, OR 1.3, 95% CI 1.32-1.43, OR 1.3, 95% CI1.29-1.38, respectively, with statistically significant P values). However, underweight or normal BMI patients had fewer odds of ECV (OR 0.5 95%CI 0.49-0.61 and OR 0.6 95%CI 0.58-0.74, respectively, with P values

Circulation, Volume 150, Issue Suppl_1, Page A4115235-A4115235, November 12, 2024. Intro:The AHA endorses screening youth athletes to identify risk for sudden cardiac arrest (SCA). Rates of SCA can be predicted by social determinants of health (SDOH) such as education level and proportion of Black residents in ZIP Code. The Child Opportunity Index (COI) quantifies neighborhood factors that influence health and development. The link between COI and youth cardiac screening findings and outcomes remains unclear.Hypothesis:Cardiac screening data will differ significantly by COI.Aims:To identify differences in cardiac screening data in children of varying COI.Methods:The HeartBytes Database, including sports exams, self-reported physical activity (PA), and zip codes from Simon’s Heart screenings was augmented with COI index zip code data. Chi-squared and logistic regression were used to analyze demographics, cardiac risk factors, and screening results.Data:Screening data of 11,431 youth athletes (median age 14.3 (IQR = 3), BMI 20.6 (4.8), 53.7% male, 70.6% White) was analyzed. The majority of children had very high overall COI (Figure 1). Hypertension, hyperlipidemia, Kawasaki disease, and heart infection were similar across COI levels (p > 0.05). Levels of physical activity varied significantly across levels of overall COI, with the highest levels reported in the lowest COI group (50.4% with >10 hours PA/week) (Chi-Squared; p = 0.007). Positive screening rates varied significantly by level of COI (p = 0.013) (Figure 2). The overall level of education, health environment, and socioeconomic COI did not predict positive screening outcomes in logistic regression analysis (all p >0.05).Conclusion:Prevalence of cardiac risk factors did not vary significantly across COI levels, however, positive screening rates were highest in moderate and very low COI levels. Simon’s Heart engaged communities across the COI spectrum; however, a majority of children had high or very high COI. Further efforts are needed to expand access to underserved populations of lower COI.

Circulation, Volume 150, Issue Suppl_1, Page A4140013-A4140013, November 12, 2024. Background:Prior research has noted disparities in sleep duration among demographic groups and those with cardiometabolic disorders. However, these are mostly based on self-reported data. The NIH All of Us Fitbit database offers a new method for objective and reliable sleep assessment.Goals:The study aimed to objectively assess sleep duration using the All of Us Fitbit database across various demographic variables and cardiometabolic disorders.Methods:All of Us participants with at least one year of Fitbit data were identified. Fitbit’s “minutes asleep” parameter was extracted daily over the first year of Fitbit use and averaged. The average total minutes asleep (TMA) was compared across self-reported age, sex and race groups. For those individuals who also shared their electronic health record (EHR) data, TMA was compared between those with and without hypertension, diabetes, and sleep apnea. T-test and ANOVA were used for comparisons.Results:The first year of Fitbit data for 13,039 participants (51 [16]* years, 69% female, 82% White) was analyzed, with sleep information available for 330 [104] days (90% complete data). TMA decreased with age, with the 18-44, 45-64, and 65+ groups averaging 366 [64], 348 [72], and 339 [85] minutes respectively (p

Circulation, Volume 150, Issue Suppl_1, Page A4129709-A4129709, November 12, 2024. Background:The current unmet needs for aspirin usage in atherosclerosis lie in its short half-life and narrow indication for anti-platelet effects. Daily aspirin intake is mandatory, and the anti-inflammatory effects of aspirin for atherosclerosis have not successfully translated to clinical practice. Nanoparticles remain in circulation for 2-3 days, with a large portion being cleared by splenic monocytes, which are known to inherently target inflamed sites.Hypothesis:By altering the pharmacokinetics of aspirin through loading into nanoparticles, aspirin-nanoparticles can exert prolonged anti-platelet effects and target atherosclerosis sites via monocyte carriers for anti-inflammatory effects, resulting in dual therapies.Methods:Splenic monocytes were loaded with aspirin-liposomes and co-cultured with endothelial cells or platelets to examine the interactions between them using high-resolution time-series microscopy. Prolonged anti-platelet effects and targeted anti-inflammatory effects of aspirin were validated in intact mice and hindlimb ischemia models, respectively. Furthermore, the dual therapies of aspirin-liposomes were validated in an atherosclerotic mouse model created by partial carotid ligation and a western diet in apoE gene knock-out mice.Results:When splenic monocytes were loaded with aspirin-liposomes, they emitted extracellular vesicles (EVs) loaded with aspirin towards endothelial cells or platelets. As inflamed cells upregulate caveolin expression, they uptake an increased amount of transferred EVs compared to non-inflamed cells. Additionally, aspirin-liposomes showed prolonged circulation time and increased splenic accumulation compared to aspirin itself, resulting in prolonged anti-platelet effects ( >7 days) and targeted anti-inflammatory effects at inflamed sites. Compared to the daily oral aspirin group in the atherosclerosis model, the weekly intravenous aspirin-liposome group showed superior therapeutic effects, including attenuated systemic and local inflammation and patent lumen in atherosclerotic sites.Conclusion:Aspirin-nanoparticles can exert prolonged anti-platelet effects combined with targeted anti-inflammatory effects, resulting in superior therapeutic effects on atherosclerosis.

Circulation, Volume 150, Issue Suppl_1, Page ASu703-ASu703, November 12, 2024. Introduction:Out of hospital cardiac arrest (OHCA) is a leading cause of death in the United States, with upwards of 360,000 OHCAs annually. Receiving bystander cardiopulmonary resuscitation (CPR) almost doubles an individual’s odds of survival compared to those who don’t receive bystander CPR. Unfortunately, in the US, bystander application of CPR only occurs in 40% of OHCA. Improving the rate of bystander CPR and AED use will improve survival rates for OHCA.Minoritized populations experience worse outcomes from OHCA. Compared to non-Hispanic whites, they are less likely to survive to hospital discharge. A cross-sectional study of witnessed OHCA patients found that Black and Hispanic patients had lower rates of bystander CPR. Less is known about disparities in care for Asian American persons who experience OHCA. Studies using the Resuscitation Outcomes Consortium Epidemiologic Registry (ROC) and the Cardiac Arrest Registry to Enhance Survival (CARES) have concluded discrepant results, with ROC finding that Asian Americans were less likely to receive bystander CPR and CARES finding that they were just as likely to receive bystander CPR compared to non-Hispanic Whites. To that end, we sought to evaluate the association between bystander CPR and Asian race after witnessed OHCA.Objective:To evaluate the association between race/ethnicity and the odds of receiving bystander cardiopulmonary resuscitation (bCPR) after witnessed out-of-hospital cardiac arrest (OHCA).Methods:Data were obtained from the National Emergency Medical Services Information System (NEMSIS) database for adults (≥18 years) with a witnessed non-traumatic OHCA in the year 2022. Patients were separated into two groups: Non-Hispanic White and Asians. The primary outcome was the odds of receiving bCPR. Exclusions included traumatic etiology, do-not-resuscitate orders, and arrests witnessed by healthcare providers. Pearson’s chi-square test was used to test significance.Results:A total of 73,215 witnessed OHCA activations were included in this study. Overall, bystander CPR rates were lower for the Asian group (59.8%) compared to the Non-Hispanic White group (65.0%). Pearson’s chi-square test showed a statistically significant difference between the bCPR rates of the Asian group and Non-Hispanic White group, with a p-value of less than 0.001.Conclusion:Racial/ethnic disparities exist for Asian individuals in the odds of receiving bCPR after a witnessed non-traumatic OHCA.

Circulation, Volume 150, Issue Suppl_1, Page A4141689-A4141689, November 12, 2024. Background:Female patients referred for coronary artery bypass grafting (CABG) are generally older and have more comorbidities than their male counterparts. Although higher perioperative mortality among female patients has been reported, there is a lack of large-scale, real-life data on this outcome and its trend.Aim:To study the mortality rate among female patients undergoing CABG from 2015-2020 and compare it with that of their male counterparts.Methods:The National Inpatient Sample from January 2015 to December 2020 was utilized to identify the study population using the International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification. The primary outcome was the overall in-hospital mortality of CABG based on sex, and the secondary outcome was the mortality trend between the groups.Results:We evaluated 929,759 patients who underwent CABG, of whom 230,000 (24.3%) were female. The female patient group was slightly older than the male patient group (66.4 vs 65.4 years, P

Circulation, Volume 150, Issue Suppl_1, Page A4141628-A4141628, November 12, 2024. Introduction:Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of mortality worldwide. Lipid-lowering therapies (LLTs) are a key element to reduce the risk of recurrence of ASCVD events. However, despite concordant guidelines, LLTs are often underused in real-life setting.Research questions:The aim of this study is to describe the use of LLTs and its impact on morbi-mortality in the year following a first ASCVD event.Methods:This retrospective study used the national health data system (SNDS), collecting health insurance claims and hospital discharge data from 99% of the French population. Incident cases in 2021 were identified, corresponding to all adults with a first ASCVD event, based on ICD-10 hospital coding. ASCVD includes coronary artery disease [myocardial infarction, unstable angina or coronary revascularization], cerebrovascular events [ischemic stroke, carotid revascularization] and peripheral artery disease (PAD) requiring artery revascularization. In patients discharged alive from the index event, longitudinal analyses were performed at 1-year from discharge to describe LLT use, occurrence of major ASCVD events and all-cause mortality.Results:In 2021, 195,211 newly diagnosed ASCVD cases were identified among 43,1M adults (mean age: 70.3 (±13.7) yo; 62% of male). The first ASCVD event was myocardial infarction (N=51,614) or ischemic stroke (N=52,865) in 53.5% of incident cases. The remaining 46.5% corresponded mostly to coronary revascularization procedures (N=83,910), followed by PAD (N=26,925). In-hospital mortality was 5.5% (N=10,673). In patients analyzed at 1 year (N=180,875), 16.9% did not receive any LLT. This value rose to 26.7% among patients who had no received LLT prior to the ASCVD event. After a myocardial infarction, patients were more likely to receive LLT (91.9%) compared to after an ischemic stroke (72.9%) or revascularization for PAD (68.0%). Finally, 1-year all-cause mortality was higher in non-LLT compared to LLT patients (20.9% vs 4.0%). Additional data on the recurrence of ASCVD events as a function of LLT use are currently being analyzed and will be presented at the congress.Conclusion:Contrary to recommendations, the underuse of LLTs after a first ASCVD event remains very high, particularly after a stroke. This is associated with a significantly higher mortality at 1 year, justifying the need to reinforce implementation of the guidelines in real life for a better management of residual lipid risk.

Circulation, Volume 150, Issue Suppl_1, Page A4144617-A4144617, November 12, 2024. Introduction:Over the past two decades, treatment advances for atrial fibrillation (AF) and stroke have improved overall survival (OS). However, a significant proportion of the population still faces high mortality, suggesting an uneven distribution of improvements. This study analyzes mortality after stroke in older adults with AF in the United States (US), highlighting disparities and trends.Method:A retrospective analysis was conducted using the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database, extracting data through ICD-10 code I48, I63.1, I63.2, I63.4, I63.5, I63.8, I63.9, I64, I69.4, to find stroke-related deaths among people diagnosed with AF, aged ≥65 years old from 1999 to 2019. We examined demographic disparities in mortality rates by age, gender, race, geographic region, rural/urban classification, and place of death. Results were reported as age-adjusted mortality rates (AAMR) with 95% confidence intervals (CI). Joinpoint regression assessed trend changes and average annual percentage change (AAPC).Results:Between 1999 and 2019, 398,571 individuals aged 65 and older died from AF and stroke in the US, with an AAMR of 45.6 per 100,000 (95% CI: 45.5-45.8). The AAMR declined from 47.0 in 1999 to 45.7 in 2019. Mortality rates showed disparities: females had a higher AAMR than males (46.4 vs. 43.4), non-Hispanics higher than Hispanics (46.7 vs. 27.9), and Whites higher than Blacks (48.5 vs. 32.8). The West was the most affected region (53.9), while the Northeast was the least affected (42.1). State variations were most pronounced in Vermont and Oregon (84.9 and 78.6) and lowest in Louisiana and Nevada (28.3 and 27.0). Rural areas had higher AAMR than urban areas (51.1 vs. 44.4). Most deaths occurred in inpatient settings (39.3%), followed by nursing homes (32.6%). The age group 85 years and older accounted for the majority of deaths (56.5%).Conclusions:Overall mortality due to stroke and AF has decreased, yet disparities persist. Focused action is needed to mitigate these deaths. Expanding access to healthcare in rural areas and promoting stroke prevention programs are vital for improving survival rates.

Circulation, Volume 150, Issue Suppl_1, Page A4147077-A4147077, November 12, 2024. Background:Tricuspid regurgitation (TR) worsens heart failure symptoms and perpetuates right ventricular failure (RVF). Given the limited efficacy of medicines and high risk of surgical mortality, percutaneous therapeutic options are gaining importance. The TRILUMINATE study reported an 86% reduction in TR severity and 4% mortality rate using Triclip G4 tricuspid transcatheter edge-to-edge repair (T-TEER) system with improvement in health status. Triclip subsequently gained FDA approval for TR on April 2, 2024.Objective:To evaluate reported device and patient related adverse events during early experience with Triclip system for T-TEER.Methods:The events reported for Triclip since it gained FDA approval were extracted from the FDA MAUDE database. Previously published reports, duplicates and events before FDA approval were excluded. Grades of TR at baseline and after T-TEER associated with single leaflet device attachment (SLDA) were compared using Wilcoxon rank sum test.Results:After excluding 14 reports, 45 were included, dating from 04/02/24 to 05/31/24. Of these, 31 (67.4%) featured patient complications, with SLDA being the most frequent (n=24, 53%).(Figure-1) Cause of SLDA was reported in 8 reports.(Figure-2) SLDA led to regression of TR to pre-procedure levels in 10 patients and Polymorphic VT in one patient. Other patient issues included damage to leaflets (n=7, 15.6%) which necessitated surgery in one case and prompted consideration of the same in another. There were 4 reports of clip entrapment in the chordae. Device-related issues included 3 cases of leaks in the steerable guide catheter affecting its ability to hold the column, knotting on the lock line, difficulties with positioning the second clip above the valve, clip reopening beyond the expected 5°, clip opening while locked but staying closed post-deployment, delays in clip delivery, and challengers in guiding catheter positioning. No acute deaths were reported in the MAUDE database within 2 months of device approval.Conclusion:Our research findings summarize the reported adverse events during the early period following FDA approval of Triclip G4 T-TEER system. This provides valuable insights into common failure modes and complications, offering guidance on their optimal utilization. Multiple adverse events can be noted soon after approval of the Triclip, underscoring the importance of good initial training and proctoring.

Circulation, Volume 150, Issue Suppl_1, Page A4135095-A4135095, November 12, 2024. Background:While anticoagulation is crucial for atrial fibrillation (AF) patients to prevent ischemic events, those with thrombocytopenia have a potential increased risk of bleeding. This study examines the outcomes of hospitalized AF patients with thrombocytopenia.Methods:The National Inpatient Sample (NIS) from 2016-2020 was analyzed to identify adult patients with AF and thrombocytopenia (using the proper ICD-10 codes). Multivariate logistic and regression analyses were performed after adjusting for multiple patient and hospital confounders to compare outcomes between patients with and without thrombocytopenia. The primary outcome was all-cause inpatient mortality. Secondary outcomes included major bleeding (defined as gastrointestinal, intracranial, pulmonary, or unspecified bleeding), hypovolemic shock, packed red blood cell (pRBC) transfusion, ischemic stroke, length of stay (LOS), and total charges.Results:Among 2,016,244 AF admissions, 75,545 patients (3.75%) had thrombocytopenia. Thrombocytopenia was associated with increased inpatient mortality (adjusted odds ratio [aOR] 2.47, 95% CI 2.21-2.77, p < 0.001). Thrombocytopenia was also associated with increased risk of major bleeding (aOR 1.99, 95% CI 1.8-2.19, p < 0.001), hypovolemic shock (aOR 3.11, 95% CI 2.29-4.24, p < 0.001), pRBC transfusion (aOR 3.07, 95% CI 2.8-3.37, p < 0.001). There was no significant difference in ischemic stroke risk (aOR 0.67, 95% CI 0.37-1.21, p < 0.19) but thrombocytopenia was associated with longer LOS (aMD 1.5 days, 95% CI 1.41-1.59, p < 0.001) and higher total charges (aMD $16,508, 95% CI 14,805-18,211, p < 0.001).Conclusions:Thrombocytopenia in hospitalized AF patients is associated with increased mortality, bleeding risk, and healthcare costs, with no clear impact on ischemic stroke. These findings highlight the need for careful risk-benefit assessment and individualized management strategies for this vulnerable patient population.