Pub Date : 2025-10-03DOI: 10.1016/j.ahj.2025.107285
Tayyab Shah MD , Samantha Coratti BA , David Farraday BA , Laurie Norton MA, MBE , Charles Rareshide MS , Jingsan Zhu MS, MBA , Michael G. Levin MD , Sae-Hwan Park PhD , Scott M. Damrauer MD , Jay S. Giri MD, MHS , Neel P. Chokshi MD, MBA , Benjamin M. Jackson MD, MS , Mitesh S. Patel MD, MBA , Alexander C. Fanaroff MD, MHS
Directly contacting eligible participants with an offer to join a randomized clinical trial (RCT) is an efficient recruitment method, but the effect of different outreach strategies on enrollment fraction and completion of the trial protocol is uncertain. In a study within a trial (SWAT) of an RCT testing a physical activity intervention in patients with peripheral artery disease, eligible patients were randomized to receive an email with an invitation to join the study and a link to the trial’s online platform (“opt-in”) or to receive an email framing participation as part of the standard of care followed by telephone outreach from a study coordinator (“opt-out”). Among 5176 participants contacted by unsolicited email (3909 opt-in, 1267 opt-out), enrollment fraction was 1.0% in the opt-in arm (n = 39) versus 3.6% in the opt-out arm (n = 45) (OR 3.65, 95% CI 2.37-5.64); there were no significant differences between opt-in and opt-out participants in the rate of completion of trial protocol steps. This SWAT of recruitment strategies demonstrates the potential for opt-out framing and active outreach to increase enrollment fraction without compromising protocol completion in direct-to-participant RCTs.
{"title":"Effect of opt-in versus opt-out framing on trial recruitment: a study within a trial of the GAMEPAD randomized trial","authors":"Tayyab Shah MD , Samantha Coratti BA , David Farraday BA , Laurie Norton MA, MBE , Charles Rareshide MS , Jingsan Zhu MS, MBA , Michael G. Levin MD , Sae-Hwan Park PhD , Scott M. Damrauer MD , Jay S. Giri MD, MHS , Neel P. Chokshi MD, MBA , Benjamin M. Jackson MD, MS , Mitesh S. Patel MD, MBA , Alexander C. Fanaroff MD, MHS","doi":"10.1016/j.ahj.2025.107285","DOIUrl":"10.1016/j.ahj.2025.107285","url":null,"abstract":"<div><div>Directly contacting eligible participants with an offer to join a randomized clinical trial (RCT) is an efficient recruitment method, but the effect of different outreach strategies on enrollment fraction and completion of the trial protocol is uncertain. In a study within a trial (SWAT) of an RCT testing a physical activity intervention in patients with peripheral artery disease, eligible patients were randomized to receive an email with an invitation to join the study and a link to the trial’s online platform (“opt-in”) or to receive an email framing participation as part of the standard of care followed by telephone outreach from a study coordinator (“opt-out”). Among 5176 participants contacted by unsolicited email (3909 opt-in, 1267 opt-out), enrollment fraction was 1.0% in the opt-in arm (<em>n</em> = 39) versus 3.6% in the opt-out arm (<em>n</em> = 45) (OR 3.65, 95% CI 2.37-5.64); there were no significant differences between opt-in and opt-out participants in the rate of completion of trial protocol steps. This SWAT of recruitment strategies demonstrates the potential for opt-out framing and active outreach to increase enrollment fraction without compromising protocol completion in direct-to-participant RCTs.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107285"},"PeriodicalIF":3.5,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145231441","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}
Pub Date : 2025-10-02DOI: 10.1016/j.ahj.2025.107284
Ahmed Abdelaziz MD , Shrouk Ramadan MD , Mohammed Tarek Hasan MD , Muhammad Desouky MD , Karim Atta MBBS , Abdelrahman Hafez MD , Mahmoud Mohamed Shams MD , Ahmed Helmi MD , Rahma AbdElfattah Ibrahim MD , Ahmed Sobhy MD , Rehab Adel Diab MD , Fayed Mohamed Rzk MD , Ahmed Farid Gadelmawla MD , Ziad Mohsen Alenna MD , Mohamed Abdelaziz MD , Mohamed Nabil Hamouda MD , Noha Hammad MD , Daniel Lorenzatti MD , Carl J Lavie MD , Leandro Slipczuk MD, PhD , Gregg W Stone MD
Complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease reduces major adverse cardiac events (MACE) compared with incomplete revascularization, although whether survival is improved is uncertain. For this systematic review and meta-analysis, all randomized trials of complete vs incomplete revascularization in patients with acute MI without cardiogenic shock were identified from PubMed, Scopus, Web of Science, and Cochrane Library databases from inception to December 31, 2024. The primary and major secondary endpoints were MACE and all-cause mortality derived from reconstructed time-to-event individual-patient-data from published Kaplan-Meier curves. Additional outcomes included cardiovascular mortality, MI, and unplanned repeat revascularizations. Outcomes were expressed as hazard ratios with 95% confidence intervals. This study was registered with the PROSPERO (number, CRD42023415428). A total of 9 randomized trials with 9,658 patients (86.8% with STEMI) were identified among whom 4,671 (48.4%) patients had complete revascularization. Patients with complete revascularization had a lower 5-year risk of MACE (HR: 0.59, 95% CI: 0.54 to 0.66, P < .001) compared with incomplete revascularization. Complete revascularization was also associated with lower 5-year risks of all-cause mortality (HR: 0.64, 95% CI: 0.56 to 0.72, P < .001), cardiovascular mortality (HR: 0.82, 95% CI: 0.71 to 0.95, P = .008), MI (HR: 0.69, 95% CI: 0.55 to 0.87, P < .001), and unplanned repeat revascularizations (HR: 0.62, 95% CI: 0.54 to 0.71, P < .001). Complete revascularization results in lower risks of all-cause and cardiovascular mortality, MI, unplanned repeat revascularizations and MACE in patients with acute MI and multivessel disease. These results support current guidelines recommending CR in hemodynamically stable patients with STEMI, emphasizing that this approach may improve survival.
与不完全血运重建术相比，st段抬高型心肌梗死（STEMI）和多血管疾病患者的完全血运重建术可减少主要不良心脏事件（MACE），尽管生存率是否提高尚不确定。在这项系统评价和荟萃分析中，从PubMed、Scopus、Web of Science和Cochrane Library数据库中确定了从开始到2024年12月31日的急性心肌梗死无心源性休克患者的完全与不完全血运重建术的所有随机试验。主要终点和次要终点是MACE和全因死亡率，这些全因死亡率来自于已发表的Kaplan-Meier曲线中重构的个体患者数据。其他结果包括心血管死亡率、心肌梗死和计划外重复血运重建术。结果以95%置信区间的风险比表示。本研究已在PROSPERO注册（编号：CRD42023415428）。共有9项随机试验，9658例患者（86.8%）被确定为STEMI，其中4671例（48.4%）患者完全血运重建术。完全血运重建术患者发生MACE的5年风险较低(HR: 0.59, 95% CI: 0.54 ~ 0.66, p
{"title":"Complete revascularization in patients with acute myocardial infarction and multivessel disease: Pooled analysis of Kaplan-Meier-derived individual-patient-data","authors":"Ahmed Abdelaziz MD , Shrouk Ramadan MD , Mohammed Tarek Hasan MD , Muhammad Desouky MD , Karim Atta MBBS , Abdelrahman Hafez MD , Mahmoud Mohamed Shams MD , Ahmed Helmi MD , Rahma AbdElfattah Ibrahim MD , Ahmed Sobhy MD , Rehab Adel Diab MD , Fayed Mohamed Rzk MD , Ahmed Farid Gadelmawla MD , Ziad Mohsen Alenna MD , Mohamed Abdelaziz MD , Mohamed Nabil Hamouda MD , Noha Hammad MD , Daniel Lorenzatti MD , Carl J Lavie MD , Leandro Slipczuk MD, PhD , Gregg W Stone MD","doi":"10.1016/j.ahj.2025.107284","DOIUrl":"10.1016/j.ahj.2025.107284","url":null,"abstract":"<div><div>Complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease reduces major adverse cardiac events (MACE) compared with incomplete revascularization, although whether survival is improved is uncertain. For this systematic review and meta-analysis, all randomized trials of complete vs incomplete revascularization in patients with acute MI without cardiogenic shock were identified from PubMed, Scopus, Web of Science, and Cochrane Library databases from inception to December 31, 2024. The primary and major secondary endpoints were MACE and all-cause mortality derived from reconstructed time-to-event individual-patient-data from published Kaplan-Meier curves. Additional outcomes included cardiovascular mortality, MI, and unplanned repeat revascularizations. Outcomes were expressed as hazard ratios with 95% confidence intervals. This study was registered with the PROSPERO (number, CRD42023415428). A total of 9 randomized trials with 9,658 patients (86.8% with STEMI) were identified among whom 4,671 (48.4%) patients had complete revascularization. Patients with complete revascularization had a lower 5-year risk of MACE (HR: 0.59, 95% CI: 0.54 to 0.66, <em>P</em> < .001) compared with incomplete revascularization. Complete revascularization was also associated with lower 5-year risks of all-cause mortality (HR: 0.64, 95% CI: 0.56 to 0.72, <em>P</em> < .001), cardiovascular mortality (HR: 0.82, 95% CI: 0.71 to 0.95, <em>P</em> = .008), MI (HR: 0.69, 95% CI: 0.55 to 0.87, <em>P</em> < .001), and unplanned repeat revascularizations (HR: 0.62, 95% CI: 0.54 to 0.71, <em>P</em> < .001). Complete revascularization results in lower risks of all-cause and cardiovascular mortality, MI, unplanned repeat revascularizations and MACE in patients with acute MI and multivessel disease. These results support current guidelines recommending CR in hemodynamically stable patients with STEMI, emphasizing that this approach may improve survival.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107284"},"PeriodicalIF":3.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228615","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}
Pub Date : 2025-09-30DOI: 10.1016/j.ahj.2025.107283
Joseph Rossano MD , Charles Canter MD , Cordula Wolf MD , Nicholas Favatella PharmD , Jeffrey Lockman PhD , Shilpa Puli PhD , Atefeh Javidialsaadi PhD , Joshua Dyme MD , Christina Crevar MS , Seema Mital MD
Background
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. The efficacy and safety of mavacamten in pediatric patients with obstructive HCM has not been evaluated.
Methods
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.
Conclusions
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.
{"title":"Mavacamten in symptomatic adolescent patients with obstructive hypertrophic cardiomyopathy: design of the phase 3 SCOUT-HCM trial","authors":"Joseph Rossano MD , Charles Canter MD , Cordula Wolf MD , Nicholas Favatella PharmD , Jeffrey Lockman PhD , Shilpa Puli PhD , Atefeh Javidialsaadi PhD , Joshua Dyme MD , Christina Crevar MS , Seema Mital MD","doi":"10.1016/j.ahj.2025.107283","DOIUrl":"10.1016/j.ahj.2025.107283","url":null,"abstract":"<div><h3>Background</h3><div>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. The efficacy and safety of mavacamten in pediatric patients with obstructive HCM has not been evaluated.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov: NCT06253221</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 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}
Pub Date : 2025-09-25DOI: 10.1016/j.ahj.2025.09.014
Kevin D. Hill MD, MSCI , Jake Koerner MS , Hwanhee Hong PhD , Jennifer S. Li MD, MHS , Christoph Hornik MD, PhD , Prince J. Kannankeril MD, MSCI , Jeffrey P. Jacobs MD , H Scott Baldwin MD , Marshall L. Jacobs MD , Eric M. Graham MD , Brian Blasiole MD, PhD , David F. Vener MD , Adil S. Husain MD , S. Ram Kumar MD, PhD , Alexis Benscoter MD , Eric Wald MD , Tara Karamlou MD, MSc , Andrew H. Van Bergen MD , David Overman MD , Pirooz Eghtesady MD , Sean M. O’Brien PhD
Background
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 = .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.
Methods
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 noninformative 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.
Results
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.
Conclusion
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.
背景：在接受心脏手术的婴儿中，预防性类固醇常被用于减少体外循环的全身炎症反应。STRESS试验发现，随机分配给甲基强的松龙组（n=599）和安慰剂组（n=601）的婴儿出现较差结果的几率没有差异（校正优势比[OR]， 0.86； P=0.14）。然而，二次分析显示甲基强的松龙可能有益处。为了使用不同的概率方法进一步研究，我们使用贝叶斯分析重新分析了STRESS试验。方法：我们使用协变量调整的比例优势模型，采用最初的STRESS试验主要终点，死亡、移植、主要并发症和术后住院时间的排序组合。我们进行了马尔可夫链蒙特卡罗模拟来评估收益的概率（OR 1）。初步分析假设利与弊的概率为中性，先验信念强度较弱（几乎是非信息性先验分布）。为了说明效果的程度，我们计算了甲基强的松龙和安慰剂的预测死亡、移植或主要并发症的风险。敏感性分析评估悲观（5%-30%先验获益可能性）、中性和乐观（70%-95%）先验信念，并将控制先验信念的强度分为弱（30%方差）、中等（15%）和强（5%）。二次分析利用先前四次类固醇试验的数据得出经验先验。结果：甲泼尼龙获益的后验概率为92%，伤害的后验概率为8%。18.8%的受试者发生复合死亡或主要并发症，甲基强的松龙的绝对风险差为-2% （95% CI -3%, +1%）。9项敏感性分析中的每一项都显示甲基强的松龙组的获益概率大于危害概率，其中9项分析中有8项显示获益概率为80%以上，死亡、移植或主要并发症风险的绝对差异≥1%。从先前的类固醇试验中获得先验的二次分析结果与95%的后验获益概率一致。结论：我们使用一系列先验信念对STRESS试验进行贝叶斯再分析，证明与安慰剂相比，围手术期甲基强的松龙降低了接受体外循环的婴儿死亡或主要并发症的风险。这项更深入的分析扩展了STRESS试验提供的甲基强的松龙的初步临床评估。试验注册：Clinicaltrials.gov: NCT03229538 （https://clinicaltrials.gov/study/NCT03229538）。
{"title":"A Bayesian re-analysis of the STRESS trial","authors":"Kevin D. Hill MD, MSCI , Jake Koerner MS , Hwanhee Hong PhD , Jennifer S. Li MD, MHS , Christoph Hornik MD, PhD , Prince J. Kannankeril MD, MSCI , Jeffrey P. Jacobs MD , H Scott Baldwin MD , Marshall L. Jacobs MD , Eric M. Graham MD , Brian Blasiole MD, PhD , David F. Vener MD , Adil S. Husain MD , S. Ram Kumar MD, PhD , Alexis Benscoter MD , Eric Wald MD , Tara Karamlou MD, MSc , Andrew H. Van Bergen MD , David Overman MD , Pirooz Eghtesady MD , Sean M. O’Brien PhD","doi":"10.1016/j.ahj.2025.09.014","DOIUrl":"10.1016/j.ahj.2025.09.014","url":null,"abstract":"<div><h3>Background</h3><div>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; <em>P</em> = .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.</div></div><div><h3>Methods</h3><div>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 noninformative 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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Trial Registration</h3><div>Clinicaltrials.gov: NCT03229538 (<span><span>https://clinicaltrials.gov/study/NCT03229538</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107282"},"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}
Pub Date : 2025-09-24DOI: 10.1016/j.ahj.2025.08.004
Umaimah Naeem, Huda Abdul Qadir
{"title":"Letter to the editor: Loop and thiazide diuretics and outcomes in heart failure with preserved ejection fraction","authors":"Umaimah Naeem, Huda Abdul Qadir","doi":"10.1016/j.ahj.2025.08.004","DOIUrl":"10.1016/j.ahj.2025.08.004","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Page 213"},"PeriodicalIF":3.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257162","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}
Pub Date : 2025-09-24DOI: 10.1016/j.ahj.2025.08.003
Barna Szabó-Söderberg, Lars H. Lund PhD
{"title":"Response to letter by Naeem regarding article, “Loop and thiazide diuretics and outcomes in heart failure with preserved ejection fraction”","authors":"Barna Szabó-Söderberg, Lars H. Lund PhD","doi":"10.1016/j.ahj.2025.08.003","DOIUrl":"10.1016/j.ahj.2025.08.003","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 214-215"},"PeriodicalIF":3.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257114","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}
Pub Date : 2025-09-22DOI: 10.1016/j.ahj.2025.09.012
Sirtaz Adatya MD , Anika S. Naidu MD , Keane K. Lee MD , Andrew P. Ambrosy MD, MPH , Amir W. Axelrod MD , Howard H. Dinh MD , Eric Au MD , Ankeet S. Bhatt MD , Thida C. Tan MPH , Rishi V. Parikh MPH , Alan S. Go MD
Background
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 1 year of incident HFrEF using data available within electronic health records (EHR).
Methods
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 1 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 to 2022.
Results
Among 28,292 adults with incident HFrEF, 17.3% experienced WHF hospitalization and 15.1% all-cause death at 1 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.
Conclusion
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.
{"title":"Enhancing risk stratification for incident systolic heart failure through machine learning and natural language processing","authors":"Sirtaz Adatya MD , Anika S. Naidu MD , Keane K. Lee MD , Andrew P. Ambrosy MD, MPH , Amir W. Axelrod MD , Howard H. Dinh MD , Eric Au MD , Ankeet S. Bhatt MD , Thida C. Tan MPH , Rishi V. Parikh MPH , Alan S. Go MD","doi":"10.1016/j.ahj.2025.09.012","DOIUrl":"10.1016/j.ahj.2025.09.012","url":null,"abstract":"<div><h3>Background</h3><div>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 1 year of incident HFrEF using data available within electronic health records (EHR).</div></div><div><h3>Methods</h3><div>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 1 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 to 2022.</div></div><div><h3>Results</h3><div>Among 28,292 adults with incident HFrEF, 17.3% experienced WHF hospitalization and 15.1% all-cause death at 1 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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107280"},"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}
Pub Date : 2025-09-22DOI: 10.1016/j.ahj.2025.09.010
Rose Crowley Bmed, MD , Sonia Azzopardi RN , Annie Curtin RN , Georgia Rendell RN , Louise Segan MBBS , Jeremy William MBBS , Kenneth Cho MBBS , Nicholas D’Elia MBBS , Margareta Sutija PhD , Tommy Kende MBBS, PhD , David Chieng MBBS, PhD , Hariharan Sugumar MBBS, PhD , Aleksandr Voskoboinik MBBS, PhD , Sandeep Prabhu MBBS, PhD , Liang-Han Ling MBBS, PhD , Vaughan G Macefield BSc, PhD, DSc , Jonathan M Kalman MBBS, PhD , Peter M Kistler MBBS, PhD
Background
Lifestyle modification is a key pillar of atrial fibrillation (AF) management. Yoga has beneficial effects on cardiovascular health and has shown promise as an intervention in AF. However, randomized data are absent.
Objectives
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.
Methods
This is a randomized 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 randomized 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.
Conclusions
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 noninvasive, nonpharmacologic lifestyle strategy in the management of AF.
Trial Registration
The trial was preregistered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000264583).
{"title":"Yoga vs regular exercise for atrial fibrillation: Design of the yoga-AF randomized controlled trial","authors":"Rose Crowley Bmed, MD , Sonia Azzopardi RN , Annie Curtin RN , Georgia Rendell RN , Louise Segan MBBS , Jeremy William MBBS , Kenneth Cho MBBS , Nicholas D’Elia MBBS , Margareta Sutija PhD , Tommy Kende MBBS, PhD , David Chieng MBBS, PhD , Hariharan Sugumar MBBS, PhD , Aleksandr Voskoboinik MBBS, PhD , Sandeep Prabhu MBBS, PhD , Liang-Han Ling MBBS, PhD , Vaughan G Macefield BSc, PhD, DSc , Jonathan M Kalman MBBS, PhD , Peter M Kistler MBBS, PhD","doi":"10.1016/j.ahj.2025.09.010","DOIUrl":"10.1016/j.ahj.2025.09.010","url":null,"abstract":"<div><h3>Background</h3><div>Lifestyle modification is a key pillar of atrial fibrillation (AF) management. Yoga has beneficial effects on cardiovascular health and has shown promise as an intervention in AF. However, randomized data are absent.</div></div><div><h3>Objectives</h3><div>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.</div></div><div><h3>Methods</h3><div>This is a randomized 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 randomized 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.</div></div><div><h3>Conclusions</h3><div>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 noninvasive, nonpharmacologic lifestyle strategy in the management of AF.</div></div><div><h3>Trial Registration</h3><div>The trial was preregistered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000264583).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107278"},"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}
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.
Methods
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.
Results
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 classification III or IV, and 329 (41.8%) had systolic blood pressure (sBP) <100 mm Hg. 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 mm Hg, 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 = .01).
Conclusions
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.
{"title":"Vericiguat and hypotension in patients with heart failure and reduced ejection fraction: VERIFY-HF registry","authors":"Shingo Matsumoto MD, PhD , Takahito Nasu MD, PhD , Wataru Fujimoto MD, PhD , Nobuyuki Kagiyama MD, PhD , Yasuyuki Shiraishi MD, PhD , Shunsuke Ishii MD, PhD , Takeshi Ijichi MD, PhD , Gaku Nakazawa MD, PhD , Takanori Ikeda MD, PhD , Koshiro Kanaoka MD, PhD","doi":"10.1016/j.ahj.2025.09.013","DOIUrl":"10.1016/j.ahj.2025.09.013","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 classification III or IV, and 329 (41.8%) had systolic blood pressure (sBP) <100 mm Hg. 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 mm Hg, 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 (<em>P</em> = .01).</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107281"},"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}
Pub Date : 2025-09-18DOI: 10.1016/j.ahj.2025.09.011
Daijiro Tomii MD , Bashir Alaour MD, PhD , Dik Heg PhD , Taishi Okuno MD , Masaaki Nakase MD , Daryoush Samim MD , Fabien Praz MD , Jonas Lanz MD , Stefan Stortecky MD, MPH , David Reineke MD , Stephan Windecker MD , Thomas Pilgrim MD, MSc
Background
Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.
Objectives
To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.
Methods
Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.
Results
Among 1,345 patients with excessive cusp calcification undergoing TAVR, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, P = .030). SEV had a lower transprosthetic gradient (8.0 mmHg vs 11.2 mmHg, P < .001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs 58.1%, P = .008) and new permanent pacemaker implantation (22.6% vs 15.5%, P = .001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs 50.2%, P = .173).
Conclusions
In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.
Clinical Trial Registration
https://www.clinicaltrials.gov. NCT01368250.
背景：主动脉尖过度钙化增加经导管主动脉瓣置换术（TAVR）后围手术期并发症的风险。过度钙化患者的器械性能差异可能影响长期临床结果。目的：比较自扩式（SEV）和球囊可扩式（BEV）假体在TAVR中治疗牙尖钙化过度患者的围术期和远期疗效。方法：从2007年8月至2023年6月，采用CoreValve/Evolut SEV或SAPIEN BEV进行TAVR的严重主动脉瓣狭窄和主动脉瓣复合钙容量≥235 mm³（Hounsfield单位阈值850）的连续患者纳入前瞻性单中心登记。进行1:1倾向匹配分析，以解释各组之间的基线差异。结果：在1345例患者中，鉴定出271对配对。85%的患者手术成功，组间无差异。与SEV相比，BEV的环空破裂发生率更高（2.2% vs 0%, p=0.030）。结论：在接受TAVR的小叶过度钙化的患者中，BEV与SEV相比有更高的环破裂风险，但瓣旁反流的风险较低，永久性起搏器植入的风险较低。在5年的随访中，SEV和BEV的死亡率具有可比性。临床试验注册：https://www.Clinicaltrials: gov. NCT01368250。
{"title":"Self-expanding versus balloon-expandable transcatheter heart valves in patients with excessive aortic valve cusp calcification","authors":"Daijiro Tomii MD , Bashir Alaour MD, PhD , Dik Heg PhD , Taishi Okuno MD , Masaaki Nakase MD , Daryoush Samim MD , Fabien Praz MD , Jonas Lanz MD , Stefan Stortecky MD, MPH , David Reineke MD , Stephan Windecker MD , Thomas Pilgrim MD, MSc","doi":"10.1016/j.ahj.2025.09.011","DOIUrl":"10.1016/j.ahj.2025.09.011","url":null,"abstract":"<div><h3>Background</h3><div>Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.</div></div><div><h3>Objectives</h3><div>To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.</div></div><div><h3>Methods</h3><div>Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.</div></div><div><h3>Results</h3><div>Among 1,345 patients with excessive cusp calcification undergoing TAVR, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, <em>P</em> = .030). SEV had a lower transprosthetic gradient (8.0 mmHg vs 11.2 mmHg, <em>P</em> < .001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs 58.1%, <em>P</em> = .008) and new permanent pacemaker implantation (22.6% vs 15.5%, <em>P</em> = .001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs 50.2%, <em>P</em> = .173).</div></div><div><h3>Conclusions</h3><div>In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.</div></div><div><h3>Clinical Trial Registration</h3><div><span><span>https://www.clinicaltrials.gov</span><svg><path></path></svg></span>. NCT01368250.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107279"},"PeriodicalIF":3.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102609","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}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号