Citations

Background: It is currently unknown whether patient engagement in adult congenital heart disease (CHD) care is influenced by social determinants of health (SDOH) such as race/ethnicity, education, and income. Adapting from the chronic care model, patient engagement, defined as the knowledge, skills, ability, and willingness to manage one’s health, can minimize lapses in care and improve CHD care outcomes. Methods: This cross-sectional study analyzes data from patients aged 18 and older with a self-reported diagnosis of CHD enrolled in a digital health research study called Empower My Congenital Heart. Patient engagement was measured using the Gothenburg Empowerment Scale (GES). We compared mean GES scores across demographic categories (race/ethnicity, education, and income), using independent samples t-tests or one-way ANOVA as appropriate. Additionally, we conducted a multivariate linear regression analysis to evaluate the impact of race/ethnicity, education, and income on GES scores, adjusting for age, gender, marital status, parental status, and employment status. Results: Of 323 adult CHD patients, the mean age was 45.6 ±15 years, 32.5% were males, 89.9% were non-Hispanic White, 29.7% had less than a Bachelor's degree, and 43.5% had less than $100,000 annual household income. The mean GES score was 61.8 ± 8, with significantly higher scores observed for non-Hispanic White identifying individuals (p=0.006) and those with a Bachelor's or higher level of education (p=0.005), while no difference across income levels (p = 0.394) (Figure 1). Linear regression analysis demonstrated that race and ethnicity remained significantly associated with GES scores (Table 1). Conclusions: Race/ethnicity and education level (in the bivariate analysis only), but not income, are the SDOH variables significantly associated with how empowered a CHD patient is in managing their health care. Future interventions that target enhancing patient engagement and self-management skills should take into consideration the influence of these demographic and social factors.

Background: Hypertension and systemic inflammation are independently associated with adverse cardiovascular outcomes. While hypertension is a known risk factor for left ventricular (LV) hypertrophy, the role of inflammation in LV structural changes remains unclear. It is also uncertain whether concomitant inflammation and hypertension ("inflammatory hypertension") exacerbate LV hypertrophy. Research Question: Is inflammatory hypertension associated with increased LV mass index (LVMI) compared to hypertension without inflammation? Methods: We analyzed baseline data from Black adults enrolled in the Genetic Epidemiology Network of Arteriopathy (GENOA) cohort in Jackson, Mississippi. Inflammation was defined by high sensitivity C-reactive protein (hsCRP) >3 mg/L, and hypertension as systolic blood pressure (SBP) >130 mmHg. Participants were classified into four groups: noninflammatory-normotensive (reference group), noninflammatory-hypertensive, inflammatory-normotensive, and inflammatory-hypertensive. The primary outcome was LVMI, assessed by echocardiography. Associations between groups and LVMI were evaluated using generalized estimating equations to account for familial clustering and adjusted for covariates including age, sex, education, smoking status, body mass index, number of antihypertensive medications, statin use, cholesterol, and diabetes. Results: Among 1,027 participants (mean age 64 ± 8.5 years; 71% women), baseline LVMI differed by inflammation-hypertension status. Compared with the LVMI in noninflammatory-normotensive cohort (n=108; 74.5 g/m 2 [70.4–78.6]), significantly higher LVMI was observed in noninflammatory-hypertensive (n=343; 83.6 g/m 2 [81.3–85.9], p<0.001) and inflammatory-hypertensive groups (n=497; 84.7 g/m 2 [82.8–86.7], p<0.001). There was no statistically significant difference between inflammatory-hypertensive and noninflammatory-hypertensive groups (84.7 vs 83.6 g/m 2 )(p=0.460). The inflammatory-normotensive cohort also did not differ from the reference group (74.9 g/m 2 [70.2–79.5], p=0.901). Secondary analyses using elevated IL-6 to define inflammation yielded similar findings ( Figure 1 ). Conclusion: In individuals with inflammatory hypertension, hypertension appears to be the primary driver of LV hypertrophy. Further studies in larger, diverse populations are needed to definitively evaluate the potential additive effect of inflammatory hypertension on LV remodeling.

Background: The comparable long-term benefits of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with multivessel disease remains limited in underrepresented populations, particularly in patients with multivessel coronary artery disease and heart failure with severely reduced left ventricular ejection fraction (LVEF <35%). Research Question: Among patients with HF and LVEF < 35% which revascularization strategy (CABG or PCI) provides superior long-term clinical outcomes? Methods: We conducted a systematic review and meta-analysis of observational studies involving patients with ischemic heart disease (IHD), HF and LVEF < 35% undergoing PCI or CABG with a minimum follow-up duration of five years. PubMed, Embase, and Cochrane databases were searched for studies published up to April 15, 2025. We computed hazard ratios (HR) from propensity score matched results. We used Cochrane Review Manager version 9.2.1 for statistical analysis. The primary endpoints of interest included all-cause mortality at 5 to 10 years, repeat revascularization, and all-cause mortality at 10 or more years. Results: We included 8 studies with 12,697 patients (6,187 PCI vs 6,510 CABG). Median follow-up duration ranged from 3.8 to 5.2 years, with the longest reported follow-up up to 13 years. The cumulative, propensity adjusted, incidence of all-cause mortality was significantly lower in the CABG group compared to PCI in 5 to 10 years of follow-up (HR 0.61; 95% CI 0.54-0.69; p<0.001) and ≥ 10 years (HR 0.63; 95% CI 0.53-0.74; p<0.001). Additionally, CABG was associated with a reduced need for repeat revascularization in the 5 to 10 year time frame, with a HR of 0.42 (95% CI 0.22-0.81; p=0.01). Conclusion: In this systematic review and meta-analysis of patients with IHD and an ejection fraction ≤ 35% undergoing revascularization, CABG was associated with a reduction in all-cause mortality at ≥ 5 and ≥ 10 years of follow-up, as compared to PCI.

Importance The prevalence of cardiovascular disease differs substantially across neighborhoods. However, few studies have examined the contribution of neighborhood-level structural racism to inequities in cardiovascular health. Objective To investigate the association between neighborhood-level manifestations of structural racism and the prevalence of cardiovascular clinical and behavioral risk factors and cardiovascular diseases. Design, Setting, and Participants This cross-sectional study consisted of 71 915 US census tracts. The Structural Racism Effect Index (SREI) was appended to the 2020 Centers for Disease Control and Prevention’s PLACES dataset. Race and ethnicity were self-reported and obtained from the 2019 American Community Survey 5-year estimates. Data analysis was conducted from June 2024 to October 2024. Exposure The SREI is a composite score of census tract measures within 9 domains affected by structural racism (built environment, criminal justice, education, employment, housing, income and poverty, social cohesion, transportation, and wealth). The SREI scores were categorized into distribution-based quintiles, where higher quintiles represented greater neighborhood structural racism. Main Outcomes and Measures Neighborhood-level prevalence of cardiovascular clinical (high blood pressure, high cholesterol, obesity, and diabetes) and behavioral (current cigarette smoking and no leisure-time physical activity) risk factors and cardiovascular disease (coronary heart disease and stroke). Multilevel-linear mixed models, adjusting for confounders, were used to estimate adjusted prevalence rate ratios (aPRR). Results Among 71 915 census tracts, neighborhoods in the highest quintiles of structural racism were more likely than neighborhoods in the lowest quintile to be in the southern region (quintile 1, 19.9% vs quintile 5, 56.8%). The proportion of the population that was Black was largest in neighborhoods in the highest quintile of structural racism (quintile 1, 2.2% vs quintile 5, 23.0%). After adjustment, compared with the lowest quintile of structural racism, the highest quintile had significantly higher prevalence rates of cardiovascular clinical risk factors, including high blood pressure (aPRR, 1.37; 95% CI, 1.37-1.38), obesity (aPRR, 1.40; 95% CI, 1.39-1.40), and diabetes (aPRR, 1.80; 95% CI, 1.79-1.81). Similarly, for cardiovascular behavioral risk factors, the highest quintile of structural racism had significantly higher prevalence rates of current cigarette smoking (aPRR, 1.84; 95% CI, 1.83-1.85) and no leisure-time physical activity (aPRR, 1.88; 95% CI, 1.87-1.89). Additionally, for cardiovascular diseases, the highest quintile of structural racism had higher prevalence rates of coronary heart disease (aPRR, 1.80; 95% CI, 1.79-1.82) and stroke (aPRR, 1.99; 95% CI, 1.98-2.00). Conclusions and Relevance In this cross-sectional study, structural racism was associated with inequities in neighborhood cardiovascular health, highlighting opportunities for place-based prevention efforts.

Background: Tremor in multiple sclerosis (MS) is often refractory to medications. Deep brain stimulation (DBS) may help, but possible side effects and disease exacerbation limit its use. Objectives: Evaluate outcomes of DBS for MS-associated tremor. Methods: Retrospective review of 18 patients with MS-associated tremor who underwent DBS, analyzing Expanded Disability Status Scale (EDSS) and Fahn–Tolosa–Marin (FTM) tremor scores. Results: Median age at surgery was 49.5 years (range, 28–75), with postoperative follow-up 2.5 years (range, 0–22). No relapses (0/18) or new lesions (0/8) occurred postoperatively. All had ventral intermediate nucleus leads; other targets were not used in programming. EDSS remained stable (median 6 to 6.25; p = 0.2). FTM scores improved (median 14.5 to 10, p = 0.008). Patients with EDSS 3.5–6 had variable outcomes ( p = 0.02). Conclusions: DBS is a potential treatment for severe MS tremor and did not provoke relapse. Targeting VIM alone may optimize tremor control and maintain magnetic resonance imaging (MRI) access.

Purpose: To compare stone clearance, stone-free status, and complications between patients undergoing ureteroscopy for renal stones using either Flexible and Navigable Ureteral Access Sheath (FANS) or the CVAC 2.0 system. Materials and Methods: A prospective study was completed on patients undergoing flexible ureteroscopy for renal stones at a single institution from March 2024 to December 2024. Subject demographics, intra-op data, volumetric and single-dimension stone clearance on non-contrast CT, and complications were compared. Stone-free rates (SFRs) using standardized cutoffs were compared. Pearson correlation analysis was performed to assess the relationship between preoperative stone volume and postoperative stone burden. Subanalysis was performed for patients with preoperative stone burden >1.5 cm. Results: A total of 123 cases (CVAC 2.0-36, FANS-87) were included, with 64 eligible for volumetric analysis. Preoperative stone volume was larger in the CVAC group vs FANS (1075 mm 3 vs 397 mm 3 ; p < 0.001). Absolute stone clearance was greater in the CVAC group (1016 mm 3 vs 392 mm 3 ; p < 0.001), whereas residual stone volume (4.1 mm 3 vs 15.0 mm 3 ; p = 0.55) and SFRs (90% vs 81%; p = 0.48) were similar. In individuals with >1.5 cm preoperative stone burden, relative stone clearance was greater with CVAC 2.0 (98.9% vs 95.1%; p = 0.026). Pearson correlation analysis revealed positive linear relationship between preoperative stone volume and residual stone volume for FANS, but not for CVAC 2.0. Conclusions: In this comparative study of FANS and CVAC 2.0, over 95% stone clearance was observed in both groups despite large initial stone burdens. In contrast to FANS, residual stone volumes with CVAC 2.0 did not increase significantly with increasing preoperative stone volumes.

Abstract eSource – particularly EHR-to-EDC – is an emerging paradigm in clinical research that enables automated transfer of electronic health record (EHR) data into electronic data capture (EDC) systems, with the potential to reduce site burden, improve data quality and accelerate oncology clinical trial workflows. However, widespread implementation remains limited due to technical, regulatory and operational barriers. To address these challenges, the European Institute for Innovation through Health Data (i~HD) launched the eSource Scale-Up Task Force in 2024. This multi-stakeholder initiative brings together leading oncology centres and pharmaceutical sponsors to establish a consensus-driven roadmap for eSource adoption. Central to this effort are three foundational resources: readiness criteria for early adopters, a performance indicator framework for monitoring success and an operational playbook to guide implementation. This article provides a structured overview of the Task Force’s objectives, collaborative model and outputs, with specific attention to its focus on interoperability, regulatory alignment and real-world validation. While initially developed for oncology, the Task Force’s framework is applicable across therapeutic areas characterized by data-intensive workflows.

ABSTRACT Background Recent data show increased ventricular tachycardia (VT) related mortality. We aimed to investigate the trends and disparities of VT‐related mortality according to cardiomyopathy subtypes. Methods Mortality and demographic data were obtained from the CDC Wide‐ranging Online Data for Epidemiologic Research database between 1999 and 2020. VT‐related mortality was defined as the underlying cause of death and ischemic cardiomyopathy (ICM) or nonischemic cardiomyopathy (NICM) as the contributing cause of death. The direct method of standardization was utilized to estimate age‐adjusted mortality rates (AAMRs). Temporal trends were evaluated using log‐linear regression models. Results A total of 15 888 deaths were related to both VT and ICM, and 16 777 were due to both VT and NICM. There was a significant increase in VT and ICM‐related mortality between 2006 and 2020 with an APC of +1.38% ( p < 0.05). Similarly, VT and NICM‐related mortality increased between 2008 and 2020 with an APC of +0.60% ( p < 0.05). ICM had a higher AAMR in males [6.23 (6.12–6.34)], Whites [3.49 (3.43–3.54)], Hispanics [2.11 (1.95–2.26)], and the Midwest region [3.73 (3.61–3.85)] compared to NICM. In contrast, NICM had a higher AAMR in females [1.57 (1.52–1.61)], Black or African Americans [5.02 (4.84–5.20)], and the South region [3.10 (3.03–3.18)]. p for all trend < 0.05. Conclusions Real‐world data show significant differences in VT‐related mortality according to cardiomyopathy subtypes with prominent sex, race, and regional disparities. Clinical and public health strategies are needed to address inequities and improve outcomes.

Introduction Male circumcision (MC) has been shown to decrease transmission of HIV and is a critical strategy to decrease its incidence in countries with high rates of heterosexually transmitted HIV. Early infant MC (EIMC), with single-use MC devices, could increase rates of MC in Sub-Saharan Africa. Our objective was to determine the safety, efficacy and satisfaction of ShangRing EIMC in resource-constrained environments. Methods Healthy male infants aged 1–60 days underwent ShangRing EIMC performed by non-physician clinicians in 14 sites in Kenya, Tanzania and Uganda. The primary outcomes were the safety and efficacy of ShangRing EIMC. Secondary outcomes were pain related to the procedure, wound healing and parental satisfaction. Male infants were assessed at discharge and on postoperative days 7 and 28 for wound healing and complications. This trial is registered with Clinical.Trials.gov, NCT03338699 , and is complete. Results From the 1697 participants enrolled from February to November 2020, 1691 (99.6%) underwent ShangRing EIMC. Median duration of the procedure was 10 min (IQR 6–13). The mean Neonatal Infant Pain Scale 20 min postprocedure was 0.3 (SD 0.8), indicating no pain. At the time of discharge, 1679 (99.0%) participants had a normal-appearing wound and 1574 (93.1%) demonstrated complete wound healing at 28 days. A total of 17 (1.0%) AEs were reported, most related to bleeding. A total of 1635 (99.1%) of parents were satisfied with the appearance of the circumcised penis at 28 days. Conclusion ShangRing EIMC is a simple and successful MC method that non-physician clinicians can perform safely, with low AE rate, satisfactory wound healing and high satisfaction rate among parents. This indicates that the ShangRing EIMC can be considered a long-term strategic approach to accelerate the scale-up of MC in Sub-Saharan Africa. Trial registration number NCT03338699 .

Importance Advances in Alzheimer disease (AD) have shifted research focus to earlier disease stages, necessitating more scalable approaches to identify cognitively unimpaired individuals with amyloid β (Aβ) pathology. Objective To assess the utility of plasma phosphorylated tau 217 (p-tau217) for classifying Aβ status in cognitively unimpaired individuals, both as a stand-alone test and in a 2-step approach where positive plasma results were confirmed using a second modality (Aβ positron emission tomography [PET] or cerebrospinal fluid [CSF]). Design, Setting, and Participants This cross-sectional cohort study used data collected between June 2009 and March 2024. We included 2916 cognitively unimpaired participants from 12 international independent observational cohorts in the US, Europe, Australia, and Canada with available plasma p-tau217 levels and CSF or PET Aβ biomarkers. Performance comparisons between mass spectrometry and immunoassay-based p-tau217 measurements were also performed (n = 964). Exposures Plasma p-tau217 levels measured by immunoassay. Main Outcome and Measures Aβ status, determined by CSF or Aβ PET biomarkers. Results Participants had a mean (SD) age of 66.9 (9.9) years; 971 (33.3%) were Aβ positive by either CSF or PET, 1667 (57.2%) were women, and 1108 (38.1%) carried at least 1 APOE ε4 allele. As a stand-alone test, plasma p-tau217 achieved a positive predictive value (PPV) of 79% (95% CI, 74-84) and an overall accuracy of 81% (95% CI, 80-82). In a 2-step workflow, the PPV and accuracy significantly increased to 91% (95% CI, 86-95). While this approach required screening of 677 individuals with plasma p-tau217 to identify 100 Aβ-positive individuals, compared to 536 participants when using PET alone, it reduced the need for PET testing to 124. Immunoassays demonstrated comparable PPVs to mass spectrometry (80% [95% CI, 74-86] vs 85% [95% CI, 81-90]; P = .12) but significantly lower overall accuracy (82% [95% CI, 79-84]% vs 88 [95% CI, 86-90]; P &amp;lt; .001) and true Aβ-positive detection rate (49% [95% CI, 43-55] vs 69% [95% CI, 64-75]; P &amp;lt; .001). Conclusions and Relevance The findings highlight the potential of plasma p-tau217 as a stand-alone test—or when used in a sequential 2-step approach alongside PET or CSF testing—as a cost-effective, scalable, and minimally burdensome strategy for identifying preclinical AD. Tailored screening workflows that incorporate p-tau217 can improve efficiency in participant selection for preclinical AD trials and, in the future, help guide access to disease-modifying treatments.