Abstract 4141889: Shifting trends and study characteristics associated with randomization, blinding, and data monitoring committee oversight of cardiovascular trials: analysis of ClinicalTrials.gov listings from 2000 to 2023

Circulation, Volume 150, Issue Suppl_1, Page A4141889-A4141889, November 12, 2024. Background:In response to concerns regarding insufficient transparency and selective reporting, the International Committee of Medical Journal Editors (ICMJE) issued a statement in 2004 mandating the registration of all clinical trials in a publicly accessible repository. Its impact on the trend of cardiovascular (CV) trial has not been comprehensively examined. The relationship between trial characteristics and designs aimed at enhancing methodological rigor and scientific validity, such as the implementation of randomization, blinding, and a data monitoring committee (DMC), remains unclear.Methods:The analysis included studies that: (1) were registered in ClinicalTrials.gov between 2000 and 2023; (2) involved ≥1 intervention; and (3) investigated ≥1 CV condition. Interrupted time-series analysis was performed to assess the impact of the ICMJE policy on the annual trend of trial registration. Multivariable logistic regression was conducted to assess the association between study characteristics and randomization, blinding, or DMC oversight.Results:A total of 38,262 CV trials were identified from 473,593 records. Prior to the implementation of ICMJE policy, the number of new CV trials increased by 10.9 (95% confidence interval [CI]: 1.5 to 20.3) every year. Following the implementation, the ascending trend intensified significantly (p

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Novembre 2024

Abstract 4139724: Heart Transplant in Geriatric Population from 2000 to 2023: UNOS Database Study

Circulation, Volume 150, Issue Suppl_1, Page A4139724-A4139724, November 12, 2024. Background:Advancements in heart transplant has expanded boundaries to greater range of patients to receive transplant. Despite concerns of increased morbidity and mortality, data from previous studies showed selected patients 70 years or older who underwent heart transplant had similar morbidity and mortality compared to younger patients. With growing population age and increase in technology, transplant candidacy is expanded to selected robust geriatric patients.Objective(s):Determine change in the number of transplant cases and the percent from total yearly cardiac transplant in geriatric populationMethod:Heart transplant recipients of all ages from 2000 to 2023 were identified in the United Network for Organ Sharing (UNOS) database and stratified into different age groups. Primary outcomes of interest included number of heart transplant cases and percentage from total yearly transplant.Results:In total, we identified 66,079 heart transplant recipients from 2000 to 2023. Among these patients, 9,964 (12.40%) were patients aged 65 above and 28,554 (45.50%) were 50-64 years old (figure 1A). There was an overall increase in the number of heart transplants from 2000 to 2023, 2,199 to 4,545 cases per year, respectively. There was an increase in the number of heart transplants in the geriatric population from 216 to 841 (figure 1B). From 2000 to 2013, there was an increase in the percent of transplant recipients in patients 65 years and older from 9.80% to 17.60%, after which remained stable (figure 1C). There was a relative decrease in proportion of patients 50-64 years from 2000 to 2014, from 51.10% to 42.80%, respectively. The number of cardiac transplants among 50-64 year old group from 2000 to 2008 decreased from 1,123 to 920 then increased again by 2014.Conclusion:There has been a significant increase in the total number of heart transplants from 2000 to 2023. Currently, heart transplants in geriatric population consist of a significant portion of total heart transplants close to 1 of 5 transplants that occur per year (18% to 19%). This number has grown from 9.80% (2000) to 18.50% (2023) among all heart transplants per year.

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Novembre 2024

Abstract 4143554: Ventricular Support Use and Mortality Rates in Cardiogenic Shock Between 2018-2023: A Report from the Northern New England Cardiovascular Disease Study Group

Circulation, Volume 150, Issue Suppl_1, Page A4143554-A4143554, November 12, 2024. Background:Despite advances in ventricular support devices, increasing awareness and multiple national initiatives to improve survival, mortality from cardiogenic shock remains high. Previous observational studies have shown decreased mortality rates with intra-aortic balloon pump usage over Impella. Relationship between support device use and overall survival in patients with cardiogenic shock remains an area of further investigation.Aims:Our objective was to examine the temporal trends in the mortality and ventricular support in patients with cardiogenic shock undergoing PCI in Northern New England from 2018-2023.Methods:The NNE registry was queried to identify patients presenting for PCI who manifest cardiogenic shock between 2018 and 2023. Shock was defined by the NCDR definition including sustained hypotension requiring inopressor use. Demographics, procedural data, mortality and intraprocedural ventricular support device use was collected. Standard statistical methods were used to calculate outcomes and statistical significance.Results:A total of 842 patients were identified who presented with shock. Overall, in-hospital mortality was 30.9%, and varied from 27.72% in 2018 to 38.3% in 2021 during the height of the COVID-19 pandemic (Figure 1). Mechanical support use remained flat, with an average use of 56% of all cases (Figure 2). The distribution of intra-aortic balloon pumps and Impella devices changed, with Impella use increasing from around 41% in 2018 to 44% by the end of the study in 2023, and intra-aortic balloon pump usage declining from 55% in 2018 to 49% by 2023 (Figure 3). Data was limited to perform a correlation analysis between type of mechanical support device and mortality rates.Conclusions:Despite using ventricular support in nearly 60% of cases, in-hospital mortality for cardiogenic shock remains around 30%. Our data reveals a trend towards higher Impella usage with declining intra-aortic balloon pump usage, interestingly with no change in mortality. This warrants further research to better understand how to optimize care for patients presenting with cardiogenic shock.

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Novembre 2024

Abstract 4123308: Trends in Gestational Diabetes Mellitus By US State, 2019 -2023

Circulation, Volume 150, Issue Suppl_1, Page A4123308-A4123308, November 12, 2024. Introduction/ Background:Gestational diabetes mellitus (GDM) is one of the most frequent adverse pregnancy outcomes and increases the risk of lifetime cardiometabolic disease. Given known geographic disparities in maternal morbidity and mortality in the US, we examined state-level prevalence and trends in GDM from 2019-2023.Methods:We conducted a serial, cross-sectional analysis of maternal health data recorded on birth certificates from all livebirths in the US using the National Center for Health Statistics Natality Files. We included pregnant individuals aged 15-44 years who gave birth from 2019-2023, had a singleton, live birth, and did not have pre-pregnancy diabetes. We calculated the age-standardized prevalence and average-annual percent change (AAPC) in GDM from 2019-2023, overall, by U.S. census region (Northeast, Midwest, South, and West), and in each US state and the District of Columbia (DC).Results:Of the 17,432,486 individuals with live births between 2019 and 2023, overall prevalence of GDM per 100 live births (95% confidence interval) was 6.9 (6.9, 6.9) in 2019 and 8.0 (8.0, 8.1) in 2023 (AAPC 3.2 [-1.7, 8.5]). There was significant geographic variation in overall prevalence of GDM by US region and state (Figure 1). In 2023, prevalence was higher in the Midwest (8.8 [8.7, 8.9]) and Western states (8.6, [8.5,8.6]) compared with the Southern (7.3, [7.3, 7.4]) and Northeastern states (8.1, [8.0,8.2]), ranging from 5.5 (4.9,6.0) in DC to 13.0 (12.2,13.8) in Alaska. Prevalence was higher in 2023 compared with 2019 in all US regions and states and DC, except Alaska, Connecticut, Idaho, Maine, New Jersey, and Wyoming. Prevalence increased most rapidly in the Western US states (AAPC 4.2%/year [0.1, 8.4]) with the greatest change observed in Montana from 5.1 (4.7, 5.6) in 2019 to 8.0 (7.5, 8.5) in 2023 (AAPC 10.3%/year [5.6, 15.3]).Conclusions:GDM prevalence increased significantly from 2019-2023 with substantial heterogeneity by US region and state. More localized state-level analysis with context-specific polices that address factors associated with geographic differences in GDM are needed to promote maternal cardiometabolic health equity in the US.

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Novembre 2024

Abstract 4140549: Association of Liver Stiffness measured by Transient Elastography with All-Cause Mortality in Heart Failure patients: Trinetx Database 2015-2023

Circulation, Volume 150, Issue Suppl_1, Page A4140549-A4140549, November 12, 2024. Introduction:Persistently elevated filling pressure leading to central venous congestion is associated with poor prognosis. This central venous congestion stimulates connective tissue hyperplasia causing tissue fibrosis and stiffness of the liver. However, risk stratification involving hepatic fibrosis in heart failure is limited.Research Question:Is liver stiffness associated with higher mortality in heart failure?Aims:To utilize liver stiffness measured by transient elastography as an imaging phenotype in HF risk stratification and prevention.Methods:De-identified data from 285 HF patients without pre-existing liver disease/cirrhosis, with liver stiffness measured (kPa) by transient elastography from 2015-2023 were extracted from TriNetX, a real-time, electronic, federated data network of 34 healthcare organizations. Liver stiffness was further classified as high and low with 8kPa as a cut-off. Comparisons employed the chi-square or Fisher’s exact test for categorical variables and the student’s t-test or Mann-Whitney-Wilcoxon test, as appropriate. Multivariable Cox proportional hazards models were applied to evaluate the association with mortality and readmissions in 30 days.Results:The mean age of the cohort is 65±11 years. The majority were women (57.9%). Participants were followed for a median of 3.8 (1.52-6.67) years; 83 out of 285 patients died. Multivariable analysis showed that 1 SD increase in liver stiffness was associated with increased mortality (HR 1.13, 95% CI 1.05-1.21; p

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Novembre 2024

Abstract 4145362: Sex Differences in Mortality Following ST-Elevation Myocardial Infarction between 2019-2023 : Insights from the Northern New England Cardiovascular Disease Study Group

Circulation, Volume 150, Issue Suppl_1, Page A4145362-A4145362, November 12, 2024. Background:Women have historically had higher mortality following STEMI than men. The difference in mortality is in part related to higher bleeding rates in women when compated to men. Little is known about the mortality differences in women versus men in the current era of radial first and other bleeding avoidance stategie for PCI.Methods:We queried in the NNE database to identofy all PCI cases between 2019 and 2023. From the dataset, patients who underwent PCI for an indication of STEMI were identified, and demographic as well as procedural variables were collected. Patients with shock prior to PCI were excluded. In-hosptial outcomes were assessed including bleeding and need for transfusion. Mortality was obtained from discharge vital status. Standard statisical methods were used to assess significance of differences, using STATA for calculations.Results:A total of 22,681 pateints were identified who underwent PCI between 2019 and 2023. Of these, 4,356 (19.2%) underwent PCI for STEMI and did not have shock. Of the patients with STEMI, 3,198 (73.4%) were men and 1,158 (26.6%) were women. When compared with men, women tended to be older, have smaller BSA, and similar BMI. Procedurally, the percent radial cases and IIBIIIA receptor inhibitor use were similar between men and women. In-hospital mortalty was 3.3% for women and 1.7% for men (p

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Novembre 2024

Abstract 4144337: Temporal Trends of Permanent Pacemaker Implantation With Transcatheter Aortic Valve Replacement in the United States 2016 – 2023

Circulation, Volume 150, Issue Suppl_1, Page A4144337-A4144337, November 12, 2024. Background:Permanent pacemaker implantation (PPMI) after transcatheter aortic valve replacement (TAVR) is associated with adverse outcomes and cost. Whether the incidence and timing of PPMI has changed with the advent of newer device iterations and implantation techniques is unknown.Methods:This contemporary analysis queried the Vizient Database to identify patients who underwent TAVR from January 2016 to November 2023. The primary outcome was the trend of PPMI within 30 days of TAVR (i.e., during index admission, or readmission for PPMI within 30 days) over the study years. Linear trend test was used for trend analyses.Results:Of 253,100 TAVR patients, 24,797 (9.8%) received a PPMI within 30 days. Compared to the non-PPMI group, patients in the PPMI group were of similar age, but were more likely male and White, and had a higher burden of comorbidities. Over the study period, the rate of 30-day post-TAVR PPMI ranged from a low of 13.6% in 2017 to a high of 16.6% in 2023, with an overall increase in trend (p=0.04). With respect to timing of PPMI, the rate of PPMI during index TAVR admission remained similar (p=0.19), while the rate of 30-day readmission for PPMI increased (p

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Novembre 2024

Abstract 4144032: Decadal Trends in Heart Failure Prevalence (2013-2023) Among Women of Childbearing Age with Prior Adverse Pregnancy Outcomes: Insights from a Population-Based Study

Circulation, Volume 150, Issue Suppl_1, Page A4144032-A4144032, November 12, 2024. Background:Heart failure (HF) represents a critical public health concern, especially among women of childbearing age, where its prevalence has been steadily increasing over recent years. Women with prior adverse pregnancy outcomes, such as hypertensive disorders of pregnancy, gestational diabetes mellitus, or preterm birth, face an elevated risk of developing heart failure later in life.Methods:This study investigated heart failure prevalence and trends over the period 2013 to 2023, leveraging data from 64 healthcare organizations within the TriNetX global health research network within the US Collaborative Network. The cohort consisted of 979,178 females aged 15-60 who had maternal care-related encounters and were diagnosed with specific conditions indicative of adverse pregnancy outcomes. These conditions included hypertensive disorders of pregnancy, gestational diabetes mellitus, placenta previa, intrauterine growth restriction, or macrosomia. Prevalence rates were calculated annually and stratified by age and race. The analysis encompassed January 1, 2013, to December 31, 2023, with a one-day lookback period.Results:Across the decade from 2013 to 2023, there was a notable surge in heart failure prevalence, escalating from 0.39% to 1.26%, corresponding to an average annual increase of approximately 12.38%. When examining racial disparities, Asians exhibited the lowest prevalence rates, initiating at 0.236% in 2013 and ascending to 0.673% in 2023, with an average annual increase of roughly 10.1%. Of note, the Black or African American cohort manifested the highest prevalence rates in both 2013 (0.708%) and 2023 (2.35%), with an average annual increase of approximately 12.77%. Within the 45-49 years age group, prevalence surged from 1.69% to 2.57%, signifying an average annual rise of about 4.36%, highlighting the escalating burden of heart failure among middle-aged adults.Conclusions:This study illuminates a concerning surge in heart failure prevalence over the past decade, revealing alarming rises across age and racial demographics. Particularly noteworthy is the heightened impact on younger individuals and certain minority groups, notably Black or African American patients.

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Novembre 2024

Abstract 4145545: Mortality and Ventricular Support Use in Cardiogenic Shock between 2018-2023: A Report from the Northern New England Cardiovascular Disease Study Group

Circulation, Volume 150, Issue Suppl_1, Page A4145545-A4145545, November 12, 2024. Background:Mortality from cardiogenic shock remains high, despite increasing awareness and multiple national initiatives to improve survival. Little is known about the relationship between support device use and overall survival in patients with cardiogenic shock. We sought to examine the temporal trends in mortality and ventricular support in patients with cardiogenic shock undergoing PCI in Northern New England.Methods:The NNE registry was queried to identify patients presenting for PCI who manifest cardiogenic shock between 2018 and 2023. Shock was defined by the NCDR definition including sustained hypotension requiring ionopressor use. Demographics, procedural data, mortality and intraprocedural ventricular support device use was collected. Standard statistical methods were used to calculate outcomes and statistical significance.Results:At total of 842 patients were identified who presented with shock. Overall in-hospital mortality was 30.9%, and varied from 27.4% in 2018 to 38.3% in 2021 during the height of the COVID-19 pandemic (Image 1). Mechanical support use remained flat, with an average use of 57% of all cases (Image 2). The distribution of intra-aortic balloon pumps and Impella devices changed, with Impella use increasing from around 41% in 2018 to 44%and IABP use decreasing from 55% to around 49% by the end of the study in 2023 (Image 3). There was no correlation between survival and type of mechanical support device used.Conclusions:Despite using ventricular support in nearly 60% of cases, in-hospital mortality for cardiogenic shock remains high at around 30%. A trend towards less IABP use and higher Impella use has not changed overall mortality. More study is needed to better understand how to optimize care for patients presenting with cardiogenic shock.

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Novembre 2024