Background:Atrial fibrillation (AF) clinical trials are essential for informing evidence-based care, yet many trials are discontinued or remain unpublished. This contributes to research inefficiency and reduced transparency. This study evaluated characteristics associated with discontinuation and non-publication of AF clinical trials registered on ClinicalTrials.gov. Methods:We performed a retrospective analysis of interventional AF trials registered between 1999 and 2025 on ClinicalTrials.gov. Trials were categorized as completed or discontinued, and as published or unpublished. Trial characteristics were extracted, and multivariable logistic regression was used to identify predictors of discontinuation and non-publication. Results:Among 538 AF trials, 423 trials (78.6 percent) were completed and 115 trials (21.4 percent) were discontinued. Only 153 trials (36.2 percent) were published. The estimated median time from primary completion to publication was 18.0 months (95% confidence interval, 14.0-21.0 months). Trials enrolling 100 participants or more had significantly lower odds of both discontinuation and non-publication. Multicenter trials showed higher odds of discontinuation but lower odds of non-publication. The other characteristics studied were not significant predictors. Conclusions:A substantial proportion of AF trials are discontinued or remain unpublished, revealing ongoing gaps in research transparency. Larger sample sizes support higher completion and publication rates, while a multicenter design increases discontinuation risk but improves dissemination. These findings underscore the need for strategies that strengthen trial feasibility and reporting practices.

Objective Different therapeutic modalities of peripheral artery disease (PAD) are associated with higher complication rates and worse outcomes in women specifically. Also, there are no published safety and effectiveness data of PAD outcomes by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness after treatment of PAD, either by surgical or endovascular approaches. Methods We analyzed adults with PAD in the National Inpatient Sample from 2009 to 2020 by using the International Classification of Diseases, Ninth/Tenth Revision codes. Outcomes included in-hospital mortality, major/minor amputations, length of stay, and inflation-adjusted costs. Comorbidities were assessed using the Elixhauser Index. Sex-based trends were evaluated overall and by revascularization type using survey-weighted linear and logistic regression with interaction terms for sex and year. Costs were derived from cost-to-charge ratios. Analyses were performed in Stata 16. Results Among 23.6 million PAD hospitalizations, women were significantly older (P < .001) and carried a greater comorbidity burden (P < .001). Despite this, their clinical presentation differed, with women experiencing higher in-hospital mortality (P < .001) but markedly lower rates of both major and minor amputations (both P < .001, respectively). After adjustment for age and comorbidities, women continued to show higher odds of in-hospital mortality following endovascular procedures (adjusted odds ratio [AOR] = 1.11; 95% confidence interval [CI]: 1.05-1.17; P < .001) and surgical revascularization (AOR = 1.19; 95% CI: 1.12-1.26; P < .001). In contrast, women had significantly lower odds of major (AOR = 0.78) and minor (AOR = 0.52) amputations after endovascular intervention, and lower odds of minor amputation after surgery (AOR = 0.64; all P < .001, respectively). Women also had a shorter adjusted length of stay after endovascular procedures (beta = -0.18; P < .001) but a longer stay after surgery (beta = +0.28; P < .001). Importantly, inflation-adjusted hospitalization costs were consistently lower for women after both endovascular (beta = -$1497; P < .001) and surgical revascularization (beta = -$423; P < .001). Conclusions In this contemporary nationwide analysis, women hospitalized with PAD experienced higher adjusted in-hospital mortality but lower rates of major and minor amputations compared with men. These findings emphasize the importance of sex-specific clinical strategies, ensuring equitable access to revascularization procedures and conducting further research to better understand the biological and systemic factors contributing to these disparities.

Background: The shorter time to hemostasis in patients who undergo transradial cardiac catheterization may reduce the complications, cause less pain, facilitate early discharge, and improve patient satisfaction. Objective: This trial aimed to evaluate if SoftSeal‐STF (Chitogen Inc., Plymouth, MN) with manual compression alone or in combination with a radial compression device (RCD) would reduce time to hemostasis compared to patients with RCD only (Vasc Band). Methods: We enrolled 300 patients in four arms, including SoftSeal‐STF with manual compression, Vasc Band (standard of care), SoftSeal‐STF with TR Band, and SoftSeal‐STF with EasyClik. This study was analyzed as an observational study due to modification in the design of a randomized trial. The primary outcome was time to hemostasis; the secondary outcomes were complications before discharge, a 3 day follow‐up, and a follow‐up office visit (30–45 days postprocedure). Results: The median time to hemostasis (interquartile range [IQR]) was significantly lower in the SoftSeal‐STF + TR Band group and the SoftSeal‐STF + EasyClik group than in the Vasc Band group (45 [40–69] minutes vs. 120 [120–124] minutes, p < 0.0001; 44 [40–58.5] minutes vs. 120 [120–124] minutes, p < 0.0001, respectively). The median time to hemostasis (IQR) was not different between SoftSeal‐STF + TR Band and SoftSeal‐STF + EasyClik (45 [40–69] minutes vs. 44 [40–58.5] minutes, p = 0.3). The median time to hemostasis (IQR) was lowest in the SoftSeal‐STF + manual compression group (19 [15–30] minutes), but these patients had more postoperative pain and bruising along with logistic issues within the catheterization lab. Conclusion: The SoftSeal‐STF + RCD is a safe and time‐efficient strategy in patients who undergo transradial cardiac catheterization. (Radial Artery Vascular Complication and Resource Utilization [RAVE]). Trial Registration: ClinicalTrials.gov identifier: NCT03522077

Real-world data on the effects of mavacamten on diastology and global longitudinal strain (GLS) in symptomatic patients with obstructive hypertrophic cardiomyopathy (oHCM) are limited. We share our experience with mavacamten over a 24-week period at an HCM Center of Excellence. Sixty-one adults with symptomatic oHCM who started on mavacamten between March 2023 and February 2024 were retrospectively identified. All patients had an electrocardiogram performed at each clinic visit, and 72-hour Holter monitoring was performed at 12- and 24-week visits. The mean age was 57.2 ± 14.5 years; 32 (51.6%) patients were female. Of the 61 patients, 45 completed a 24-week period and were the main subject of this study. After 6 months of treatment, the proportion of patients in Grade 1 diastolic dysfunction increased from 26.6% to 62.2%, p = 0.001, and the proportion in Grade 2 diastolic dysfunction decreased from 66.6% to 35.5%, p = 0.006; 26.7% (n = 12/45) of patients improved by 2 New York Heart Association functional classes and 46.7% (n = 21/45) by 1. GLS remained stable over time. At week 24, 35 of 45 patients (77.7%) had a left ventricular outflow tract gradient ≤30 mmHg. No arrhythmia burden or major side effects were reported. Left ventricular ejection fraction remained above 55% in all but 1 patient, who recovered within a month. In conclusion, our experience of significantly improved diastology and stable GLS after mavacamten treatment aligns with trial outcomes. Longitudinal investigations are needed to further assess the long-term impacts.

Background:Data are limited on outcomes of elective vs nonelective mitral transcatheter edge-to-edge repair (M-TEER). Methods:Using the National Inpatient Sample, all adult patients who had M-TEER from 2013-2020 were included in the study. Univariate and multivariate linear and logistic regression were used to evaluate outcomes. Results:Of 43,920 patients who underwent M-TEER, with a mean age (SE) of 77 (0.13) years, 46% were women. Of these, 23% were nonelective, and 77% were elective cases. Whites were more likely to have elective, and African Americans and Hispanics were more likely to have nonelective M-TEER. In-hospital mortality and resource utilization decreased over time in elective cases, but no significant change was seen in nonelective cases. Risk-adjusted odds of in-hospital mortality were higher in nonelective vs elective cases (adjusted odds ratio, 2.85; P < .001). Risk-adjusted length of stay was also higher in nonelective vs elective cases (adjusted beta-coefficient, 7.16; P < .001). Finally, the risk-adjusted inflation-adjusted cost was also higher in nonelective vs elective cases (adjusted beta-coefficient, 23,673; P < .001). Conclusions:Nonelective M-TEER is associated with poor outcomes. Hence, these patients should be treated in a timely fashion and should not be deferred if they meet the criteria for M-TEER. Rapid up-titration of guideline-directed medical therapy should be considered in patients with moderate to severe secondary mitral regurgitation to avoid an emergent need for transcatheter edge-to-edge repair and associated poor outcomes.

Background: The bicuspid aortic valve (BAV) is the most prevalent congenital heart defect and is frequently associated with aortopathy. The etiology of aortic dilation in BAV is multifactorial, involving both hemodynamic stress and intrinsic aortic wall abnormalities. While previous studies have proposed several mechanisms, the specific and valve-related predictors of aortopathy remain unclear. Research question: Which clinical and echocardiographic features independently predict the presence of aortopathy in patients with BAV? Goals: To identify the patient and value-related characteristics associated with aortopathy in a large, real-world BAV cohort using standardized imaging and statistical approaches. Approach: Between 2013 and 2017, across 33 echocardiography labs within a large U.S. health system, 1,227 patients diagnosed with BAV were retrospectively reviewed. BAV morphology, presence of raphe, calcification severity (grades 0-4), aortic regurgitation (AR), aortic stenosis (AS), age, sex, and body surface area (BSA) were collected. Aortopathy was defined based on measurements of the aorta at the sinus of Valsalva and mid-ascending portions, indexed to body surface area. Univariate analysis (Mann-Whitney U and Chi-square) identified candidate predictors. A multivariable logistic regression model was constructed to identify independent predictors of aortopathy. Multicollinearity was assessed using the variance inflation factor and tolerance. Results: Among 1,227 BAV patients, 755 (61.5%) had aortopathy. They were older (54.7 vs. 51.9 years, p=0.006), had higher BSA (2.09 vs. 2.00 m 2 , p<0.001), and were more often male (73.1% vs. 58.3%, p<0.001). Independent predictors of aortopathy included male sex, age, AR severity, and BAV Type 1 (vs. Types 2 and 3). Calcification was inversely associated. AS, BSA, and raphe were not significant predictors. The model demonstrated excellent calibration (Hosmer-Lemeshow p = 0.715). Conclusion: Clinical characteristics emerge to differentiate BAV patients with aortopathy. Although the relationships between aortopathy and BAV are complex, specific clinical and echocardiographic variables in this cohort, particularly BAV Type 1, age, Male sex, calcification, and AR severity, were independently associated with aortopathy. These findings support multifactorial pathogenesis of BAV-associated aortopathy and may inform future risk stratification and surveillance strategies.

BACKGROUND:Owing to the recognition of previously unknown pathogenic gene variants and reclassification of longer-known variants, gene distribution in patients with hypertrophic cardiomyopathy (HCM) is ever-changing. Conflicting data make the role of genotype in risk stratification unclear. METHODS:We evaluated genotype distribution and genotype-phenotype correlations in all adult patients with HCM seen at our HCM Center of Excellence from March 31, 2010, to April 30, 2023. We also evaluated a composite outcome, including all-cause mortality, stroke, implantable cardioverter-defibrillator placement, heart failure hospitalization, left ventricular assist device implantation, heart transplantation, septal myectomy, and alcohol septal ablation, based on genotype status. All-cause mortality was separately analyzed. RESULTS:Of 827 patients with HCM, genotyping was completed in 754 (91.2 %). We identified 202 (27 %) genotype-positive (Gen-P), 163 (22 %) variant of unknown significance (VUS), and 389 (51 %) genotype-negative (Gen-N) patients. Mean ages were 47, 57, and 58 years, respectively. The most common gene implicated was MYBPC3 (63 %). More patients were on optimal medical treatment after following up with our HCM center. Electrocardiographic, Holter, echocardiographic, and cardiac magnetic resonance imaging characteristics differed based on genotype status. The composite outcome was worse in Gen-P than Gen-N (HR 1.84, p<0.001). Although analysis of all-cause mortality showed survival was different for Gen-P and VUS patients than for Gen-N patients, this difference was not statistically significant. CONCLUSION:MYBPC3 was the most common gene implicated. Outcomes were worse in Gen-P patients. Centers of Excellence play an important role in the optimal medical management of patients with HCM.

Atrial fibrillation (AFib) is a common arrhythmia in patients with hypertrophic cardiomyopathy (HCM), associated with a high risk of embolic stroke regardless of CHA2DS2-VASc score. In-hospital outcomes of patients with HCM with AFib undergoing left atrial appendage occlusion (LAAO) are unknown. We used National Inpatient Sample (NIS) data from 2016 to 2019 for our analysis. Linear and logistic regression analyses were used to evaluate continuous and binary outcomes, respectively. Outcomes were adjusted for age, sex, and Elixhauser Comorbidity Index. We evaluated 60,607 hospitalized patients from 2016 to 2019 who underwent a LAAO procedure. Patients with HCM (n= 386) were younger than patients without HCM (60,221) (72 vs 76 years, p<0.01). Females made up 42% of both groups. The in-hospital mortality rate was 0.7% in the HCM group and 0.1% in the non-HCM group. HCM was associated with higher in-hospital mortality on both univariate (OR 6.87, CI 1.629 - 29.01, p=0.009) and multivariate analysis (adjusted OR 7, CI 1.64 - 30.29, p=0.009), as shown in Table 1. However, HCM was not independently associated with an increase in the length of stay (adjusted β=.0.009, CI -0.271 - 0.290, p=0.947) or total hospital cost (adjusted β=2154, CI -1100 - 5409, p=0.195). HCM is independently associated with an increased risk of in-hospital mortality in patients who undergo percutaneous LAAO. It is important to investigate the underlying factors for increased mortality in patients with HCM undergoing percutaneous LAAO.