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

Circulation, Volume 150, Issue Suppl_1, Page A4146507-A4146507, November 12, 2024. Background:Atrial flutter (AFL) is a common supraventricular tachyarrhythmia characterized by a rapid and regular atrial rate. Although the global burden of atrial flutter on the general population has risen dramatically over the past four decades, the impact of sex on clinical outcomes for these patients is poorly characterized. This study aims to investigate sex disparities in clinical outcomes over recent years for patients admitted with atrial flutter.Methods:In this large scale, retrospective cohort study, adult patients who were admitted with AFL were analyzed from 2016 to 2021 using the National Readmissions Database. The study population was divided into male and female groups. Diagnoses were classified using the International Classification of Diseases, 10th edition codes. The primary outcome was 30-day readmissions. Secondary outcomes included inpatient mortality and length of stay.Results:A total of 132,027 patients with AFL meeting inclusion criteria were included in the study. Of these, 82,988 (62.9%) were male and 49,040 (37.1%) were female. The mean age was 63.0 ± 11.5 for males vs 67.2 ± 11.4 years for females. Readmissions were higher in females (10% vs 9%) than males. Cox regression analysis showed higher readmission events in females (HR: 1.07, 95% CI: 1.01-1.13, p < 0.010) when compared to males. Multivariate regression analysis for inpatient mortality and length of stay was higher for females than males (p < 0.01 for both).Conclusion:Women experienced higher readmission rates and had worse outcomes including inpatient mortality and higher length of stay compared to their male counterparts. These findings suggest that female patients may require closer monitoring and targeted intervention to improve these outcomes.

Circulation, Volume 150, Issue Suppl_1, Page A4139904-A4139904, November 12, 2024. Background:Atrial Fibrillation (AF) in patients with metabolic syndrome is a substantial health concern among older adults in the United States. This study investigated trends and disparities in AF mortality among older adults aged 65 and older with metabolic syndrome from 1999-2020.Methods:We used the Centers for Disease Control database for mortality statistics with an underlying cause of death of AF in metabolic syndrome (ICD code I48 for AF and scattered codes indicating metabolic syndrome i.e. E10-14, E66, E78, E88, I10) between the years 1999 – 2020. Age-adjusted mortality rates (AAMR) were calculated per 100,000 deaths. The AAMR were assessed by demographic variables, including race, geographic density, sex, age, and US Census Region. Temporal trends were evaluated using Joinpoint regression software. Average annual percent change (AAPC) was considered statistically significant if p < 0.05.Results:Between 1999 and 2020, AF in metabolic syndrome caused 944,960 deaths among U.S. adults aged 65+. Most deaths occurred in medical facilities (35.8%). The overall AAMR for AF in metabolic syndrome-related deaths rose from 36.6 in 1999 to 173.4 in 2020, with an AAPC of 6.48 (95% CI: 5.07 to 7.77, p < 0.000001). A significant increase was noted from 1999 to 2001 (APC: 26.58; 95% CI: 6.04 to 43.91, p < 0.000001), followed by a continued rise from 2001 to 2020 (APC: 4.56; 95% CI: 3.60 to 5.15, p = 0.012797). Older men had higher AAMRs than older women (116.0 vs 92.3). Among racial/ethnic groups, White population had the highest AAMRs (108.8) and AAPC (6.70; 95% CI: 5.23 to 7.95), followed by American Indians/Alaska Natives (81.7), Blacks (74.1), Hispanics (68.2), and Asians (61.6). AAMRs varied by state, from 61.1 in Nevada to 170.0 in Vermont. The Western region had the highest average AAMR (116.7). Nonmetropolitan areas had slightly higher AAMRs than metropolitan areas (113.0 vs. 99.9).Conclusion:The analysis reveals a dramatic fourfold increase in AF-related mortality within metabolic syndrome among older U.S. adults over two decades. This substantial rise in mortality rates underscores the urgent need for targeted interventions and strategies to address these trends. By addressing structural barriers to quality healthcare and health disparities, we can effectively counter this concerning trend and achieve positive outcomes for this vulnerable group.

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 A4146209-A4146209, November 12, 2024. Background:The management of recurrent pericarditis has evolved to include colchicine and novel anti-interleukin-1 agents, given the limited efficacy of traditional NSAIDs and corticosteroids. We conducted a pairwise and network meta-analysis to evaluate the efficacy and safety of colchicine and anti-IL-1 agents in recurrent pericarditis.Methods:We conducted a comprehensive search on various databases and registries, such as MEDLINE (via PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL), to retrieve relevant RCTs. We used STATA version 17 to perform meta-analyses under a random-effects model and applied the empirical Bayes (Paule and Mandel) variance estimator to dichotomous data. We performed a network meta-analysis with a placebo/standard therapy group as the comparator in MetaXL 5.3 using the Generalized Pairwise Modeling based on the Bucher method.Results:A total of 6 RCTs were included in the meta-analysis. The risk of pericarditis recurrence was significantly decreased by colchicine (RR 0.46, 95% CI 0.37-0.58) and anti-IL-1 agents (RR 0.13, 95% CI 0.03-0.54) compared to placebo or standard therapy. Colchicine significantly decreased the risk of treatment failure (RR 0.42, 95% CI 0.31-0.57) but did not have a significant impact on the risk of adverse events (RR 1.06, 95% CI 0.31-3.62). No significant risk of adverse events (RR 2.16, 95% CI 0.66-7.01) or serious adverse events (RR 1.01, 95% CI 0.23-4.41) was observed with anti-interleukin-1 agents. Colchicine was also associated with a decreased risk of pericarditis-related rehospitalization (RR 0.26, 95% CI 0.10-0.70). The network meta-analysis showed that anti-IL-1 agents (RR 0.13, 95% CI 0.05 to 0.30) were associated with a greater reduction in pericarditis recurrence than colchicine (RR 0.46, 95% CI 0.37 to 0.59). All anti-interleukin-1 agents significantly decreased the risk of pericarditis recurrence, with comparable efficacies among the different agents.Conclusion:Colchicine and anti-IL-1 agents significantly reduced the risk of pericarditis recurrence with the anti-IL-1 agents demonstrating greater efficacy. Further, high-powered, large-scale RCTs that directly compare various treatment options are needed to confirm or refute our findings.

Circulation, Volume 150, Issue Suppl_1, Page A4140381-A4140381, November 12, 2024. Introduction:Post-heart Transplant (HTx) ischemia-reperfusion injury (IRI) is associated with an increased risk of rejection and cardiac allograft vasculopathy (CAV). It has been suggested that induction therapy with anti-thymocyte globulin (ATG) may protect against immediate (in the first 30 days) IRI post-HTx. Additionally, ATG has been associated with reduced first-year coronary plaque progression as assessed by intravascular ultrasound (IVUS) among HTx recipients. Whether ATG can decrease first-year intimal thickening in patients experiencing IRI has not been investigated. Therefore, we aim to examine the clinical outcomes of patients who received ATG induction therapy and experienced immediate IRI post-HTx.Methods:Between 2010 and 2020, we assessed 241 patients undergoing HTx and were noted to have immediate post-HTx IRI on their endomyocardial biopsy. Patients were divided into those who received ATG (n=105) induction therapy vs. non-receivers (n=136). In our program, ATG is given to sensitized patients or those with baseline serum creatinine >2.0 mg/dL to delay the initiation of tacrolimus, which may introduce bias to this study. Endpoints included 1-year freedom from any treated rejection (ATR), acute cellular rejection (ACR, grade 2R or 3R), and antibody-mediated rejection (AMR, pAMR grade ≥1, 3-year survival, and 3-year freedom from non-fatal major adverse cardiac events (NF-MACE, including myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, and stroke). IVUS was performed at 4-8 weeks (baseline) and at 1 year post-HTx. Studied IVUS parameters included first-year average change in maximum initial thickness (MIT) and change in MIT ≥0.5mm.Results:Among patients with immediate post-HTx IRI, patients who received ATG induction therapy (57% were sensitized pre-HTx) remained at high immunological risk at 1 year with significantly lower freedom from ATR and AMR but had similar 3-year survival as compared to those who did not receive ATG (Table 1). No between-group differences were observed in the average 1-year change in MIT or the percentage of patients with ≥0.5mm change in MIT.Conclusion:Induction therapy with ATG did not appear to decrease first-year intimal thickening in patients experiencing IRI immediately post-HTx. Future studies are warranted to mitigate immunological complications and reduce coronary plaque progression in high-risk HTx patients.

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 A4143130-A4143130, November 12, 2024. Background:Chagas disease (CD), caused by Trypanosoma cruzi, leads to chronic Chagas cardiomyopathy, one of the deadliest and most debilitating cardiopathies. Benznidazole (BZN) is the medication of choice in Brazil, effective during the acute phase, but its efficacy during the chronic phase is unclear.Aims:To determine if BZN treatment reduces cardiac inflammation and fibrosis via magnetic resonance imaging (MRI) and its association with the circulating immune profile of CD patients.Methods:We collected cardiac images and plasma from a cohort of CD patients before and 6 months after BZN treatment. We performed: 1- MRI of left and right ventricle function and volumes, T1 (MAPA T1), T2 mapping (MAPA T2), and extracellular volume (ECV); 2- analysis of soluble factors including cytokines, chemokines, and growth factors using the Bio-48 Plex Human Cytokine Screening Panel kit. Changes in the variables MAPAT1, MAPAT2, and ECV were used to classify the improvement of CD patients undergoing BZN therapy. Patients with the greatest reductions in these variables post-therapy, compared to pre-therapy, were considered to have greater clinical improvement. Thus, patients were divided into two groups: greater clinical improvement (GCI; n=15) and smaller clinical improvement (SCI; n=15) (figure 1). Data were analyzed using GraphPad Prism 8 software with statistical significance set at p

Circulation, Volume 150, Issue Suppl_1, Page A4139928-A4139928, November 12, 2024. Background:Ketone body metabolism, known for its multifaceted effects, is gaining attention as a potential therapeutic target for cardiovascular diseases. However, the impact of ketone bodies on cardiac hypertrophy and Heart Failure with Preserved Ejection Fraction (HFpEF) remains unclear.Research Questions:To elucidate the effects of ketone bodies on cardiac hypertrophy.The aim of the present research is to investigate the impact of ketone bodies on cardiac hypertrophy induced by metabolic abnormalities using organ-specific ketone body synthesis-deficient mice.Methods:Obesity and hypertension were induced by a high-fat diet combined with NG-Nitro-L-arginine methyl ester hydrochloride (L-NAME) (Combined Stress), and the resultant cardiac hypertrophy and ketone body synthesis were evaluated. Subsequently, organ-specific knockout mice of HMG-CoA synthase 2 (Hmgcs2), a rate-limiting enzyme in ketone body synthesis, were subjected to Combined Stress to assess the impact on cardiac hypertrophy. To conduct a metabolism-focused analysis, cell type-specific nuclei were isolated and subjected to RNA sequencing (RNA-seq) and comprehensive metabolomics analysis. To evaluate the direct effects of ketone bodies, H9C2 cells, rat cardiac cells ,were treated with β-hydroxybutyrate, followed by analysis of oxygen consumption and metabolomics.Results:Combined Stress resulted in increased myocardial cross-sectional area and enhanced ketone body synthesis in the liver and heart. Hepatocyte-specific Hmgcs2 knockout mice (Hmgcs2ΔHep) subjected to Combined Stress exhibited exacerbated myocardial hypertrophy (cardiomyocyte cell size;Hmgcs2flox: 322.8 ± 88.3 μm2:Hmgcs2ΔHep: 444.0 ± 118.5 μm2; p < 0.0001). RNA-seq analysis revealed that the upregulation of glycolytic genes induced by Combined Stress did not occur inHmgcs2ΔHepmice, and a metabolic phenotype favoring fatty acid oxidation persisted. In the liver, hepatocyte destruction and increased serum fatty acid levels were observed. Additionally, H9C2 cells treated with β-hydroxybutyrate showed decreased fatty acid utilization and increased glucose utilization.Conclusion:In cardiac hypertrophy induced by obesity and hypertension, ketone body synthesis mitigates fatty acid overload and promotes glucose utilization, thereby exerting an anti-hypertrophic effect.

Circulation, Volume 150, Issue Suppl_1, Page A4132152-A4132152, November 12, 2024. Background:Hypertrophic cardiomyopathy (HCM) is associated with increased mortality mainly due to sudden cardiac arrest. However, it is not clear how HCM affects in-hospital mortality among patients hospitalized due to other cardiovascular conditions requiring intervention.Methods:National Inpatient Sample (NIS) database was queried from 2016 to 2020 to identify hospitalized patients with a diagnosis of HCM. Patients with HCM were stratified based on their concomitant cardiovascular conditions necessitating interventions.Results:Data pertinent to 278,995 admission cases with HCM was analyzed. Of this, 15,035 cases had concomitant non-ST elevation MI (NSTEMI), and 1,230 cases had ST-elevation MI (STEMI). Additionally, 15,100 cases were diagnosed with aortic valve diseases (AVD), 33,580 had concomitant mitral valve diseases (MVD), 5,580 cases had tricuspid valve diseases (TVD), and 16,815 cases had pulmonary valve diseases (PVD). Cardiovascular procedures were more common among HCM patients with concomitant STEMI (43.5%) followed by HCM patients with AVD (17.1%) and HCM patients with NSTEMI (16.9%). Stratification of mortality rate based on cardiovascular procedures and the underlying indication revealed CABG to have the highest mortality rate for HCM patients with STEMI (25%), followed by PCI for HCM patients with STEMI and HFrEF (12.5%). HCM patients with NSTEMI undergoing revascularization had higher mortality when PCI was performed for HFrEF cases and when CABG was performed for HFpEF cases. For HCM patients with AVD requiring repair or replacement, TAVR was superior to SAVR if performed in patients with HFpEF but was inferior among HFrEF subgroup in terms of in-hospital mortality. For subgroup of HCM patients with MVD, transcatheter replacement was associated with a lower mortality than surgical repair regardless of concomitant heart failure. Data was insufficient for HCM patients with concomitant TVD or PVD undergoing repair or replacement procedures.Conclusions:Among hospitalized patients with HCM, concomitant HFrEF but not HFpEF is associated with a significantly higher mortality rate regardless of the underlying cardiovascular conditions requiring revascularization or heart valvular repair. A more comprehensive preoperative risk assessment could delineate the ideal procedures for HCM patients with certain comorbidities and specific need.

Circulation, Volume 150, Issue Suppl_1, Page A4146462-A4146462, November 12, 2024. Background:Recurrent ventricular tachycardia (VT) is common in patients with ischemic heart disease (IHD), even with anti-arrhythmic drugs on board. While ICDs can abort VT episodes, ICD shocks can be painful. Ablation therapy can reduce the number of ICD shocks and interventions, but the optimal ablation technique is still uncertain.Purpose:We aim to review the clinical efficacy and safety of catheter ablation vs anti-arrhythmic drugs in patients with IHD.Methods:We conducted comprehensive searches across PubMed, CENTRAL, WOS, Scopus, and EMBASE until Feb 2024. Pooled data were reported using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, along with a 95% confidence interval (CI). This systematic review and meta-analysis was registered with PROSPERO ID: CRD42024551760.Results:We included seven RCTs with a total of 836 patients. Patients who underwent ablation had a lower risk of VT storm compared to those who received anti-arrhythmic drugs [RR: 0.65 with 95% CI (0.49, 0.87), P < 0.01), Compared to anti-arrhythmic drugs, the catheter ablation group also required less Appropriate ICD therapy [RR: 0.72 with 95% CI (0.57, 0.90), P < 0.01), and fewer ICD shocks [ RR: 0.64 with 95% CI (0.45, 0.93), P = 0.02). However, there was no significant difference in VT recurrence [RR: 0.91 with 95% CI (0.74, 1.14), P = 0.42), all-cause mortality [RR: 0.87 with 95% CI (0.65, 1.16), P = 0.34), or any adverse events [RR: 0.96 with 95% CI (0.50, 1.84), P = 0.91) between the two groups.Conclusion:Our meta-analysis showed that catheter ablation was associated with a reduction in VT storm, ICD therapy, and ICD shocks. However, when compared to anti-arrhythmic drugs, catheter ablation for VT in IHD patients did not appear to afford any significant survival advantage.

Circulation, Volume 150, Issue Suppl_1, Page A4146291-A4146291, November 12, 2024. Background:Circulatory diseases represent the primary cause of mortality in the US. Comprehending trends and potential disparities in the prevalence of circulatory conditions, such as angina pectoris (AP), myocardial infarction (MI), hypertension (HTN), and coronary heart disease (CHD), is essential for forming public health strategies.Aim:To investigate trends in the prevalence of circulatory conditions, including AP, MI, HTN, and CHD among US adults from 2019 to 2022.Methods:Prevalence percentages for all available circulatory diseases from the Centers for Disease Control and Prevention’s National Health Interview Survey (NHIS) database were retrieved for patients aged >18 years from 2019 to 2022. Annual Percentage Changes (APCs) along with their respective 95% CIs were calculated using regression analysis with Join point. The data was stratified by year, gender, age, race, nativity, veteran status, social vulnerability, employment status, metropolitan statistical area (MSA) status and census region.Results:Between 2019 and 2022, HTN was steadily the most prevalent, staying relatively constant at 27.0% (95% CI: 26.4, 27.7) in 2019 and 27.2% (95% CI: 26.5, 27.8) in 2022. Males consistently had higher prevalence than females with significant increases noted from 2019 to 2022 (APC: 1.0234). Black or African American had the highest prevalence (34.4% in 2022). The South (30.1% in 2022) and the West (22.5% in 2022) had respectively the highest and lowest rates. The second highest prevalence was seen in CHD increasing from 4.6% (95% CI: 4.3, 4.9) in 2019 to 4.9 (95% CI: 4.7, 5.2) in 2020. Males consistently exhibited a higher prevalence than females, with both genders showing significant increases in recent years (Male APC: 3.1448) (Female APC: 2.0165). For MI, a slight decrease was noted from 3.1% (95% CI:2.9, 3.4) in 2019 to 3.0% (95% CI:2.7, 3.2) in 2022. White individuals exhibited the highest prevalence (3.3% in 2022). AP had the lowest overall prevalence staying relatively consistent (1.7% in 2019 and 1.6% in 2022) (Figure 1).Conclusion:Significant trends (Figure 2) in most common circulatory diseases have been identified. Targeted interventions are imperative, particularly for high-risk demographics such as males, older adults, veterans, and unemployed individuals.

Circulation, Volume 150, Issue Suppl_1, Page A4143977-A4143977, November 12, 2024. Introduction:Chimeric Antigen Receptor T-cell therapy (CAR-T) has revolutionized the treatment of relapsed refractory multiple myeloma (RRMM) and lymphoma over the past decade. Our objective is to examine the incidence, patterns, and outcomes of cardiac events in patients with RRMM and lymphoma who are receiving CAR-T therapy, utilizing the FDA Adverse Event Reporting System (FAERS) database.Methods:We employed the FDA Adverse Event Reporting System (FAERS) database and the Medical Dictionary for Regulatory Activities (MEDRA) to conduct a retrospective post-marketing pharmacovigilance inquiry. We analyzed the incidence of cardiac events associated with six CAR-T products, namely Idecabtagene vicleucel, Cilitacabtagene autoleucel, Axicabtagene ciloleucel, Tisagenlecleucel, Lisocabtagene maraleucel, and Brexucabtagene autoleucel, since their FDA approval (accessed 05/01/2024). We assessed the cardiotoxicities such as coronary artery disease (CAD), myocardial infarction (MI), arrhythmia, heart failure, and hypotension.Results:A total of 12,949 adverse events, including Axicabtagene ciloleucel (n=6222, 48%), Brexucabtagene autoleucel (n=1127, 8.7%), Tisagenlecleucel (n=3290, 25.4%), Lisocabtagene maraleucel (n=463, 3.5%), Idecabtagene vicleucel (n=722, 5.5%), and Cilitacabtagene autoleucel (n=1125, 8.6%). Of those, 675 cases (5.2% of the total) that were related to cardiac events, regardless of their severity. The cardiotoxicity incidence was highest in Brexucabtagene autoleucel (n=85,7.5%), followed by Idecabtagene vicleucel (n=50,6.9%), Tisagenlecleucel (n=208,6.3%), Axicabtagene ciloleucel (n=278,4.5%), Lisocabtagene maraleucel (n=17,3.6%), and Ciltacabtagene autoleucel (n=37,3.2%).Cytokine release syndrome (CRS) is linked to nearly 440 cardiac events,accounting for 65% of all cardiac events.The most prevalent cardiotoxic event was Atrial Fibrillation (122), followed by the development of heart failure (113), Ventricular arrhythmia (108), hypotension (87), and Brady arrhythmia (41).The recipients of Brexucabtagene autoleucel had the highest mortality rate (n = 26,2.3%), followed by those receiving Tisagenlecleucel (n = 71,2.1%) and Lisocabtagene maraleucel (n = 10,2.1%).Conclusion:The cardiotoxic properties of CAR-T therapy can lead to fatal adverse events. Improving outcomes and preventing mortality in these populations can be achieved through timely monitoring.

Circulation, Volume 150, Issue Suppl_1, Page A4147545-A4147545, November 12, 2024. Introduction:Pulsed field ablation (PFA) is an adaptation of direct current ablation first used for catheter ablation in the 1980s. Expectations of a reduced risk profile led to the current resurgence in investment and interest in the technology as a potential alternative energy source for ablations to treat atrial fibrillation (AF). However, reports of adverse events, including new risks, are increasing.Research Question:How many adverse effects are reported with the use of newly available PFA systems?Aims:Quantify and describe the adverse events from PFA reported to date in the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.Methods:We searched the U.S. FDA’s MAUDE database for all reports filed with the code “QZI”, which is the product code for PFA systems created with the first FDA approvals in February 2024. All reports from inception through April 2024 (a total of 3 months) were included in this review. Per manufacturer presentation in May 2024, approximately 1000 cases utilizing PFA had been captured in a post-market registry of the predominant commercially used technology, but the exact number of cases can not be determined from MAUDE data.Results:A total of 217 adverse events were reported over the first 3 months of US approval, with 91 of these considered patient injuries. These injuries included 10 cases of cardiac tamponade, 7 reports of postoperative arrhythmia, 6 instances of device-related tissue entrapment, 5 cases of hemolysis with impaired renal function, 5 cases of stroke or TIA, including both embolic and hemorrhagic, 3 cases of intraoperative heart block, 2 coronary spasms, and 2 cases of intraoperative ST elevation.(Figure)Of the 91 reported patient safety events, 46 required hospitalization, 13 cases required temporary pacing, 11 required pericardiocentesis, 4 required dialysis, 4 required cardiothoracic surgery, and 2 required cardioversion.Conclusions:A number of adverse events have been reported to the MAUDE database in the first 3 months of FDA approval of PFA. The cardiac electrophysiology community should remain vigilant to ensure that the benefit-risk profile remains acceptable for patient safety.

Circulation, Volume 150, Issue Suppl_1, Page A4147674-A4147674, November 12, 2024. Background:Leadless pacemaker (LP) is a novel pacemaker offering an innovative approach to bradyarrhythmia treatment. Aveir LP and Micra LP are the two leadless pacing systems available in the United States. Aveir LP was approved by the Food and Drug Administration (FDA) in April 2022. Data regarding the adverse events (AE) following implantation of Aveir LP is scarce, largely limited to single centers, and no real-world comparative analyses were done previously.Methods:We queried the FDA Manufacturer and User Facility Device Experience (MAUDE) database between April 2022 and December 2023 to assess the safety and AE following implantation of Aveir LP. “AVIER” and “MICRA” were the key terms used to search the MAUDE database. The event types “death” and “injury” were included in our search to capture major clinical events related to the patient. Disproportionality analysis was performed using the reporting odds ratio (ROR) to compare the adverse events of Aveir LP with Micra LP. A signal to noise ratio was considered to be significant if the confidence interval (CI) did not cross the number “one”.Results:Our search resulted in 207 event reports for Aveir LP and 1969 event reports for Micra LP. Major device related adverse events with Aveir LP were capturing problem (33.8%) followed by dislodgement (16.9%), and sensing problem (7.2%). Most encountered device related AE with Micra LP were capturing problem (37.8%), pacing problem (11.5%), and sensing problem (9.3%). Frequencies of all the analyzed AE are shown in Figure 1. The reporting of pericardial effusion (ROR 2.84, 95% CI 2.18-3.71), and dislodgment (ROR 1.85, 95% CI 1.26-2.73) were significantly higher with Aveir, whereas cardiac arrest (ROR 0.18, 95% CI 0.04-0.74) was disproportionately lower. Overall, patient related AE were significantly higher (ROR 1.53, 95% CI 1.20-1.95) and device related events were significantly lower (ROR 0.65, 95% CI 0.51-0.83) with Aveir LP compared to Micra LP (Figure 2).Conclusion:This is the first real-world comparative analysis of two leadless pacing systems available in the United States. Our analysis showed that, when compared to Micra LP, the newer Aveir LP had lower device related events but higher patient related events, largely driven by pericardial effusion. These events could be attributed to the operator learning curve and long-term data are needed to further verify these findings.

Circulation, Volume 150, Issue Suppl_1, Page A4144666-A4144666, November 12, 2024. Background:There is limited data on the safety and efficacy of ventricular tachycardia (VT) ablation in patients with chronic kidney disease (CKD). We examined the outcomes of patients with CKD undergoing VT ablation in a nationally representative cohort of patients.Methods:The National Inpatient Sample Database (NIS) was analyzed from 2018 to 2021 to identify patients ≥18 years old with VT undergoing ablation. Patients with atrial fibrillation, atrial flutter, supraventricular tachycardia, or pre-excitation syndrome were excluded. Patients were divided into those with CKD and without CKD. A multivariable logistic regression model was utilized to assess the association of CKD with in-hospital mortality and outcomes after adjusting for confounders.Results:Our cohort included 1608 VT ablation procedures, of which 428 (27%) were performed on CKD patients. Mean age was 63 (±13) years, 318 (19%) were female, and 1194 (74%) were White. 1475 (92%) of the procedures were done at an urban teaching hospital, and 1240 (77%) at a private non-profit hospital. On multivariable analysis, CKD was associated with significantly higher odds of death (adjusted odds ration [aOR]: 3.43; 95% confidence interval [CI]: 1.79-6.5; p=0.0002), acute decompensated heart failure (aOR: 3.1; 95% CI 2.24-4.56; p