American heart journal最新文献

{"title":"Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics.","authors":"Cian P McCarthy, Christie M Ballantyne, Ron Blankstein, Matthew J Budoff, Marc Ditmarsch, C Michael Gibson, John J P Kastelein, Ann Marie Navar, Stephen J Nicholls, Kausik K Ray, Cheerag Shirodaria, Michelle C Williams, James L Januzzi","doi":"10.1016/j.ahj.2025.07.012","DOIUrl":"10.1016/j.ahj.2025.07.012","url":null,"abstract":"<p><strong>Background: </strong>Obicetrapib is a potent, selective cholesteryl ester transfer protein (CETP) inhibitor that significantly lowers low-density lipoprotein cholesterol (LDL-C). Additive reductions in LDL-C occur when obicetrapib is combined with ezetimibe. The impact of obicetrapib and ezetimibe fixed-dose combination (FDC) on coronary plaque burden is unknown. Favorable changes in noncalcified coronary atherosclerotic plaque volume (NCPV) may indicate a potential beneficial effect on atherosclerotic cardiovascular disease (ASCVD) events.</p><p><strong>Methods: </strong>REMBRANDT is a placebo-controlled, double-blind, randomized trial designed to assess the efficacy of obicetrapib and ezetimibe FDC on coronary plaque burden. Individuals aged 45 years or older with ASCVD (imaging evidence of vascular disease or clinically manifested ASCVD) and an LDL-C of ≥70 mg/dL despite maximally tolerated lipid-modifying therapy are eligible to participate. Eligible participants (N = 300) will be randomized in a 1:1 ratio to obicetrapib 10 mg and ezetimibe 10 mg FDC once daily or placebo tablet once daily. The primary efficacy outcome of REMBRANDT is percent change in total NCPV from baseline to 18 months as assessed by coronary computed tomographic angiography (CCTA). Secondary endpoints include absolute change in total NCPV, percent and absolute change in NCPV in the most diseased coronary segment, percent change in LDL-C, and change in perivascular fat attenuation index from baseline to 18 months.</p><p><strong>Conclusion: </strong>The REMBRANDT trial will determine whether the favorable effects of obicetrapib and ezetimibe FDC on LDL-C translate to a reduction in coronary plaque burden as a potential mechanism for ASCVD risk reduction.</p><p><strong>Clinical trial registration: </strong>NCT06305559.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"325-338"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144666899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incremental cost of complications after TAVR and SAVR in contemporary clinical practice.","authors":"James E Harvey, Michael Ryan, Candace Gunnarsson, Soumya Chikermane, Suzanne J Baron","doi":"10.1016/j.ahj.2025.07.001","DOIUrl":"10.1016/j.ahj.2025.07.001","url":null,"abstract":"<p><strong>Background: </strong>Prior studies have demonstrated that peri-procedural complications are associated with increased healthcare costs after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). Given the technological and procedural advances that have occurred in the management of aortic valve disease over the last decade, this study aims to understand the incremental cost of specific complications after SAVR and TAVR in contemporary practice.</p><p><strong>Methods: </strong>Using the Medicare 100% standard analytic file, we identified all beneficiaries receiving SAVR or TAVR in the United States during fiscal year 2021. Specific complications were identified via ICD-10 codes. Multivariable analyses were performed to estimate the incremental cost and length of stay (LOS) for each complication. Attributable costs were calculated by adjusting the incremental cost of each complication for its incidence.</p><p><strong>Results: </strong>The cost of an uncomplicated TAVR index hospitalization was $46,257 with LOS 2.2 days, while an uncomplicated SAVR cost $58,488 with LOS 8.1 days. The presence of any complication increased costs and LOS for TAVR ($66,601; 5.9 days) and SAVR ($88,900; 13.4 days). Prolonged ventilation was associated with the highest incremental cost for TAVR ($55,742), while pacemaker implantation had the highest attributable cost ($1,270). Prolonged ventilation accounted for the highest incremental ($69,728) and attributable ($2,580) cost associated with SAVR.</p><p><strong>Conclusion: </strong>This study provides contemporary data on the incremental costs of specific peri-procedural complications associated with TAVR and SAVR. These findings can be used to develop targeted interventions to optimize healthcare resource utilization in patients undergoing aortic valve replacement.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"278-287"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Active Monitoring for AtriaL FIbrillation (AMALFI): Rationale, protocol, and pilot for a pragmatic, randomized, controlled trial of remote screening for asymptomatic atrial fibrillation.","authors":"Rohan Wijesurendra, Guilherme Pessoa-Amorim, Georgina Buck, Charlie Harper, Richard Bulbulia, Nicholas R Jones, Christine A'Court, Rijo Kurien, Karen Taylor, Barbara Casadei, Louise Bowman","doi":"10.1016/j.ahj.2025.07.004","DOIUrl":"10.1016/j.ahj.2025.07.004","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;Screening for asymptomatic atrial fibrillation (AF) might reduce cardioembolic strokes and screening for asymptomatic AF is recommended by some international guidelines. However, any impact of AF screening on clinical outcomes depends on a sustained increase in AF detection and anticoagulation use over time than would have occurred with routine care alone, highlighting the importance of long-term studies to generate the evidence needed to justify establishing formal screening programs. AMALFI aims to establish the long-term efficacy and cost-effectiveness of remote screening for asymptomatic AF in older individuals at increased risk of stroke using a noninvasive 14-day continuous ECG monitoring patch in UK primary care. This paper describes the study protocol and baseline characteristics of included participants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;AMALFI (ISCRTN 15544176) recruited individuals aged ≥65 years with CHA&lt;sub&gt;2&lt;/sub&gt;DS&lt;sub&gt;2&lt;/sub&gt;-VASc score ≥3 (men) or ≥4 (women) with no previous diagnosis of AF/atrial flutter from 27 UK primary care practices. Participants were randomized to ECG monitoring (Zio XT, iRhythm Technologies; intervention) or usual care (control). Those allocated to ECG monitoring were sent and returned the patch by mail. After wear, participants returned the patch to the device manufacturer where ECG data were analyzed via a deep-learned AI algorithm and confirmed by qualified cardiographic technicians. A final report was sent to study investigators, and those indicating AF or other arrhythmias considered by the study team to be clinically actionable were communicated to general practitioners (GPs) immediately by secure email. Additionally, GPs were notified by mail of the presence or absence of AF episodes ≥30 seconds, and of the burden of AF for each of their participants who wore a patch. The letter included signposting to relevant guidelines and findings were managed at the GP's discretion. Participants allocated to the control group were not required to undertake any action. The primary study outcome is the rate of new AF detection at 2.5 years, with secondary outcomes including time spent with a known AF diagnosis at 5 years of follow-up, and analyses of these outcomes by predefined age and sex subgroups. Exploratory outcomes will assess randomized assessments of time to AF detection within 2.5 and 5 years after randomization, time spent with a known AF diagnosis up to 2.5 years from randomization, and anticoagulation exposure within 2.5 and 5 years after randomization. Other exploratory long-term assessments include randomized comparisons of numbers and proportions of hospitalizations (total and cardiovascular), ischemic stroke, major bleed, and death (all-cause and cardiovascular) in both groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Between 2019 and 2022, AMALFI randomized 5,040 people in England to screening versus usual care using mail-based invitations. Participant mean age was 77 ± 6 y","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"310-324"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144666898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Defining diastolic dysfunction post-Fontan: Threshold, risk factors, and associations with outcomes.","authors":"Tarek Alsaied, Runjia Li, Haley Grant, Mary D Schiff, Yu Li, Adam B Christopher, Jacqueline Kreutzer, Bryan H Goldstein, Jonathan H Soslow, Yue-Hin Loke, Mark A Fogel, Timothy C Slesnick, Rajesh Krishnamurthy, Vivek Muthurangu, Adam L Dorfman, Christopher Lam, Justin D Weigand, Joshua D Robinson, Laura J Olivieri, Rahul H Rathod","doi":"10.1016/j.ahj.2025.07.007","DOIUrl":"10.1016/j.ahj.2025.07.007","url":null,"abstract":"<p><strong>Background: </strong>Following the Fontan procedure, patients with single ventricle physiology are at high risk of diastolic dysfunction (DD) and elevated end-diastolic pressure (EDP).</p><p><strong>Objective: </strong>This study aims to determine (1) the optimal EDP threshold correlated with adverse outcomes post-Fontan and (2) the clinical and imaging predictors of DD.</p><p><strong>Methods: </strong>The study included patients from the Fontan Outcome Registry using CMR Examinations (FORCE) who underwent cardiac catheterization and cardiac magnetic resonance (CMR) within a 2-year window. The composite outcome was defined as all-cause mortality, sustained atrial or ventricular arrhythmia, plastic bronchitis, protein-losing enteropathy, or listing for transplantation. The EDP cutoff was determined using the lowest Brier score from Cox proportional hazard models.</p><p><strong>Results: </strong>The study included 861 patients (mean age 16.4 ± 9.3 years). Mean EDP was 9.0 ± 3.5 mm Hg, with DD defined at an optimal EDP threshold >13 mm Hg. Patients were followed for a median of 3.6 years after catheterization. By univariable analysis patients with DD were more likely to have Fontan associated liver disease (40% vs 29%, P = .03) and kidney disease (19% vs 6%, P < .001). In multivariable analyses, DD was associated with the composite outcome (HR 3.37, 95% CI: 2.03-5.59, P < .001). Ninety-seven patients (11.3%) had DD. Multivariable analysis demonstrated that older age at catheterization, greater body mass index (BMI), nonleft ventricular morphology, and higher ventricular end-diastolic volume (EDV) were associated with DD.</p><p><strong>Conclusion: </strong>DD, defined as an EDP >13 mm Hg, is linked to over 3-fold higher risk of adverse outcomes. Risk factors for DD include older age, higher BMI, nonleft ventricular morphology, and larger EDV. The presence of risk factors may warrant screening catheterization to identify DD and modify care accordingly.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"288-296"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial.","authors":"Niekbachsh Mohammadnia, Lucas T W Vestjens, Neil J Craig, Jan G P Tijssen, Remco J J Knol, Sergiy V Lazarenko, Mariëlle G J Duffels, Jeroen Jaspers Focks, Martin E W Hemels, Iris Oving, Hanke J Schalkx, John W Eikelboom, Aysun Cetinyurek-Yavuz, Erik H J G Aarntzen, Damini Dey, Piotr J Slomka, Robin Nijveldt, Niels P Riksen, Niels van Royen, Michael C Honigberg, Marc R Dweck, Jan H Cornel, Saloua El Messaoudi","doi":"10.1016/j.ahj.2025.07.010","DOIUrl":"10.1016/j.ahj.2025.07.010","url":null,"abstract":"<p><strong>Background: </strong>Aortic valve stenosis (AS) is one of the most common valvular heart diseases worldwide. Its prevalence increases with age and is expected to rise further as the population ages. Untreated severe AS carries a 2-year mortality rate exceeding 50%. Furthermore, surveillance and management of AS impose a significant burden on healthcare systems. Therefore, effective pharmacological strategies are urgently needed to slow or halt the progression of AS.</p><p><strong>Rationale and design: </strong>Inflammation plays a central role in the pathogenesis of both atherosclerosis and AS. Anti-inflammatory therapy with low-dose colchicine reduces cardiovascular events in patients with coronary artery disease, but its efficacy has not been tested in AS. Colchicine and Inflammation in Aortic Stenosis (CHIANTI) is an investigator-initiated, placebo-controlled, double-blind, multicenter, randomized trial involving 150 patients with moderate AS. After confirming tolerance during a two-week run-in phase, eligible participants underwent coronary computed tomography (CT) angiography, ¹⁸F-sodium fluoride (¹⁸F-NaF) positron emission tomography (PET)-CT, and echocardiography. Thereafter, participants were randomized 1:1 to colchicine 0.5 mg once daily or a matching placebo. All baseline imaging is repeated after 24 months. The primary endpoint is the change in aortic valve calcium score on CT. Secondary endpoints are (1) the change in aortic valve ¹⁸F-NaF uptake on PET-CT and corrected for target-to-background ratio, and (2) the change in peak aortic jet velocity on echocardiography.</p><p><strong>Conclusion: </strong>The CHIANTI trial evaluates whether anti-inflammatory therapy with low-dose colchicine can slow or halt the progression of moderate AS. If successful, it would offer the first effective pharmacological treatment for AS.</p><p><strong>Trial registration: </strong>Registered on ClinicalTrials.gov (https://clinicaltrials.gov/), ID: NCT05162742.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"297-309"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mavacamten in symptomatic adolescent patients with obstructive hypertrophic cardiomyopathy: design of the phase 3 SCOUT-HCM trial.","authors":"Joseph Rossano, Charles Canter, Cordula Wolf, Nicholas Favatella, Jeffrey Lockman, Shilpa Puli, Atefeh Javidialsaadi, Joshua Dyme, Christina Crevar, Seema Mital","doi":"10.1016/j.ahj.2025.107283","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.107283","url":null,"abstract":"<p><strong>Background: </strong>Mavacamten, a first-in-class cardiac myosin inhibitor, is approved internationally for the treatment of symptomatic adult patients with obstructive hypertrophic cardiomyopathy (HCM) and has been shown to improve cardiac function and symptoms in adult patients across multiple phase 3 trials. Efficacy and safety of mavacamten in pediatric patients with obstructive HCM has not been evaluated.</p><p><strong>Methods: </strong>SCOUT-HCM is a phase 3, randomized, placebo-controlled, double-blind, parallel-group, multicenter, international study in symptomatic adolescent patients (12 years to < 18 years old) with obstructive HCM. The aim of the study is to assess the efficacy, safety, and pharmacokinetics of mavacamten in this population. Participants will be randomized 1:1 to mavacamten or placebo for 28 weeks, followed by a 28-week active-treatment period (when patients randomized to placebo will cross over to mavacamten) and an open-label long-term extension period for ≤ 144 weeks. Participants will initiate mavacamten at a dosage of 2.5 mg/day or 5 mg/day; dose titration will be based on echocardiographic assessment of Valsalva left ventricular (LV) outflow tract (LVOT) gradient and LV ejection fraction. The primary endpoint is change from baseline to week 28 in Valsalva LVOT gradient. Secondary endpoints include efficacy parameters of resting and post-exercise LVOT gradients, peak oxygen consumption, symptoms, and health status, plus safety and pharmacokinetic parameters.</p><p><strong>Conclusions: </strong>SCOUT-HCM is the first clinical trial to evaluate a cardiac myosin inhibitor in adolescent patients with obstructive HCM. SCOUT-HCM will assess the utility of mavacamten in this patient population with an unmet clinical need. Trial registration ClinicalTrials.gov: NCT06253221.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107283"},"PeriodicalIF":3.5,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145211409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Bayesian Re-analysis of the STRESS Trial.","authors":"Kevin D Hill, Jake Koerner, Hwanhee Hong, Jennifer S Li, Christoph Hornik, Prince J Kannankeril, Jeffrey P Jacobs, H Scott Baldwin, Marshall L Jacobs, Eric M Graham, Brian Blasiole, David F Vener, Adil S Husain, S Ram Kumar, Alexis Benscoter, Eric Wald, Tara Karamlou, Andrew H Van Bergen, David Overman, Pirooz Eghtesady, Ryan Butts, John S Kim, John P Scott, Brett R Anderson, Michael F Swartz, Sean M O'Brien","doi":"10.1016/j.ahj.2025.09.014","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.09.014","url":null,"abstract":"<p><strong>Background: </strong>Prophylactic steroids are often used to reduce the systemic inflammatory response to cardiopulmonary bypass in infants undergoing heart surgery. The STRESS trial found that the odds of a worse outcome did not differ between infants randomized to methylprednisolone (n=599) versus placebo (n=601) (adjusted odds ratio [OR], 0.86; P=0.14). However, secondary analyses showed possible benefits with methylprednisolone. To investigate further using a different probabilistic approach, we re-analyzed the STRESS trial using Bayesian analytics.</p><p><strong>Methods: </strong>We used a covariate-adjusted proportional odds model using the original STRESS trial primary endpoint, a ranked composite of death, transplant, major complication and post-op length of stay. We performed Markov Chain Monte Carlo simulations to assess the probability of benefit (OR <1) versus harm (OR >1). Primary analysis assumed a neutral probability of benefit versus harm with weak prior belief strength (nearly non-informative prior distribution). To illustrate magnitude of effect, we calculated predicted risk of death, transplant or major complications for methylprednisolone and placebo. Sensitivity analyses evaluated pessimistic (5%-30% prior likelihood of benefit), neutral and optimistic (70%-95%) prior beliefs, and controlled strength of prior belief as weak (30% variance), moderate (15%) and strong (5%). A secondary analysis derived empirical priors using data from four previous steroid trials.</p><p><strong>Results: </strong>The posterior probability of any benefit from methylprednisolone was 92% and probability of harm was 8%. Composite death or major complication occurred in 18.8% of subjects with an absolute risk difference of -2% (95% CI -3%, +1%) for methylprednisolone. Each of 9 sensitivity analyses demonstrated greater probability of benefit than harm in the methylprednisolone group with 8 of 9 demonstrating >80% probability of benefit and ≥1% absolute difference in risk of death, transplant or major complications. In secondary analysis deriving priors from previous steroid trials, results were consistent with a 95% posterior probability of benefit.</p><p><strong>Conclusion: </strong>Our Bayesian re-analysis of the STRESS trial, using a range of prior beliefs, demonstrated a high probability that perioperative methylprednisolone reduces the risk of death or major complications in infants undergoing cardiopulmonary bypass compared with placebo. This more in-depth analysis expands the initial clinical evaluation of methylprednisolone provided by the STRESS trial.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: NCT03229538 (https://clinicaltrials.gov/study/NCT03229538).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145181833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing Risk Stratification for Incident Systolic Heart Failure through Machine Learning and Natural Language Processing.","authors":"Sirtaz Adatya, Anika S Naidu, Keane K Lee, Andrew P Ambrosy, Amir W Axelrod, Howard H Dinh, Eric Au, Ankeet S Bhatt, Thida C Tan, Rishi V Parikh, Alan S Go","doi":"10.1016/j.ahj.2025.09.012","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.09.012","url":null,"abstract":"<p><strong>Background: </strong>Clinical guidelines advocate use of validated risk models in patients experiencing heart failure with reduced ejection fraction (HFrEF) to inform prognosis and assist with management. We developed models for worsening HF (WHF) hospitalizations and death within one year of incident HFrEF using data available within electronic health records (EHR).</p><p><strong>Methods: </strong>Adults with incident HFrEF were identified from 2013 to 2022 within an integrated healthcare delivery system. We developed decision tree-based models to estimate risks of WHF hospitalization and death within one year of the incident HFrEF date. WHF hospitalizations were ascertained using validated natural language processing algorithms. We evaluated the models using cross-validation and measured final performance (i.e., model discrimination using area under the curve [AUC] and model calibration using the Brier score and calibration plots) on a contemporary hold-out test set of patients from 2021-2022.</p><p><strong>Results: </strong>Among 28,292 adults with incident HFrEF, 17.3% experienced WHF hospitalization and 15.1% all-cause death at one year of follow-up. We observed an AUC of 0.698 (95% CI: 0.682-0.714) for WHF hospitalization and 0.849 (95% CI: 0.836-0.861) for death and calibrated with a wide range of predicted risks. In comparison, a claims-based risk score displayed an AUC of 0.577 (95% CI: 0.570-0.606) for WHF hospitalization and a smaller dynamic range. Of patients classified as high risk for WHF hospitalization, only 12.0% were receiving full guideline-directed medical therapy at 6 months after HFrEF diagnosis.</p><p><strong>Conclusion: </strong>Risk models derived using EHR-based data elements can predict both 1-year WHF hospitalization and all-cause mortality in adults with incident HFrEF more accurately than claims-based approaches. These models can be used to improve population management and better target personalized strategies of care.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Yoga vs Regular Exercise for Atrial Fibrillation: Design of the Yoga-AF Randomized Controlled Trial.","authors":"Rose Crowley, Sonia Azzopardi, Annie Curtin, Georgia Rendell, Louise Segan, Jeremy William, Kenneth Cho, Nicholas D'Elia, Margareta Sutija, Tommy Kende, David Chieng, Hariharan Sugumar, Aleksandr Voskoboinik, Sandeep Prabhu, Liang-Han Ling, Vaughan G Macefield, Jonathan M Kalman, Peter M Kistler","doi":"10.1016/j.ahj.2025.09.010","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.09.010","url":null,"abstract":"<p><strong>Background: </strong>Lifestyle modification is a key pillar of AF management. Yoga has beneficial effects on cardiovascular health and has shown promise as an intervention in AF. However, randomised data are absent.</p><p><strong>Objectives: </strong>To determine the effect of regular yoga on AF episodes and AF burden in people with paroxysmal or persistent AF over a 12-month period.</p><p><strong>Methods: </strong>This is a randomised control trial of a yoga program in addition to standard care, compared to standard care alone in people with paroxysmal or persistent AF undergoing a rhythm control management strategy. 222 participants will be randomised 1:1 to the yoga intervention or control. Yoga will be conducted in studio and online with a target of at least 3 classes/week. Controls will be instructed to exercise for at least 150 minutes/week. Rhythm monitoring will be with implantable loop recorder, or ECG capable smartwatch with AF detection and twice daily ECGs. Autonomic metrics will be assessed in the laboratory by HRV, blood pressure variability and direct recordings of muscle sympathetic nerve activity. Following a 3-month training period, the dual primary endpoints of AF recurrence (time to recurrence, as defined by any sustained atrial tachyarrhythmia lasting > 1 hour) and AF burden will be determined at 12 months.</p><p><strong>Conclusions: </strong>This study aims to determine the impact of yoga on AF recurrence and burden in people with paroxysmal and persistent AF. Yoga may provide an effective non-invasive, non-pharmacologic lifestyle strategy in the management of AF.</p><p><strong>Trial registration: </strong>The trial was pre-registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000264583).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vericiguat and hypotension in patients with heart failure and reduced ejection fraction: VERIFY-HF registry.","authors":"Shingo Matsumoto, Takahito Nasu, Wataru Fujimoto, Nobuyuki Kagiyama, Yasuyuki Shiraishi, Shunsuke Ishii, Takeshi Ijichi, Gaku Nakazawa, Takanori Ikeda, Koshiro Kanaoka","doi":"10.1016/j.ahj.2025.09.013","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.09.013","url":null,"abstract":"<p><strong>Background: </strong>Real-world characteristics and outcomes in patients with heart failure (HF) and reduced ejection fraction (HFrEF) treated with vericiguat remain unclear. We investigated patient characteristics, hypotension-the most relevant clinical event-, and outcomes after initiating vericiguat in patients with HFrEF.</p><p><strong>Methods: </strong>In this nationwide, multicentre retrospective study involving 22 hospitals in Japan, we examined symptomatic or asymptomatic hypotension and drug discontinuation within 90 days after initiation of vericiguat in patients with left ventricular ejection fraction <45%. The association between hypotension and HF outcomes was also examined.</p><p><strong>Results: </strong>Among the 799 patients with HFrEF, the mean age was 69.6 years, and 218 (27.3%) were female. Of them, 316 (39.5%) had New York Heart Association (NYHA) classification III or IV, and 329 (41.8%) had systolic blood pressure (sBP) <100 mmHg. Hypotension was observed in 25.3% of patients within 90 days, with asymptomatic hypotension being the most common (17.9%). By contrast, drug discontinuation related to hypotension was less frequent (4.4%). After adjustment, sBP <100 mmHg, low body mass index, and in-hospital vericiguat initiation were associated with the incidence of hypotension within 90 days. Patients who experienced hypotension had a greater risk of cardiovascular death or HF hospitalization than those who did not (P=0.01).</p><p><strong>Conclusions: </strong>Although hypotension was relatively common soon after starting vericiguat, they were not often associated with drug discontinuation. Patients experiencing hypotension had a greater risk of HF outcomes, but this would be primarily associated with their vulnerability, given the infrequent discontinuation.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}