Pub Date : 2025-12-03DOI: 10.1016/j.ahj.2025.09.001
Niloufar Dadashpour MD, Majid Golestanieraghi MD
{"title":"Letter to the Editor regarding “Association between vasopressin administration and mortality in patients with cardiogenic shock”","authors":"Niloufar Dadashpour MD, Majid Golestanieraghi MD","doi":"10.1016/j.ahj.2025.09.001","DOIUrl":"10.1016/j.ahj.2025.09.001","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107269"},"PeriodicalIF":3.5,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681379","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 : 2025-12-01Epub Date: 2025-07-17DOI: 10.1016/j.ahj.2025.07.012
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
Background: 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.
Methods: 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.
Conclusion: 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.
{"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}
Pub Date : 2025-12-01Epub Date: 2025-07-12DOI: 10.1016/j.ahj.2025.07.001
James E Harvey, Michael Ryan, Candace Gunnarsson, Soumya Chikermane, Suzanne J Baron
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
{"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}
Pub Date : 2025-12-01Epub Date: 2025-07-10DOI: 10.1016/j.ahj.2025.07.007
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
Background: Following the Fontan procedure, patients with single ventricle physiology are at high risk of diastolic dysfunction (DD) and elevated end-diastolic pressure (EDP).
Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
背景：在Fontan手术后，单心室生理的患者发生舒张功能障碍（DD）和舒张末期压（EDP）升高的风险很高。目的：本研究旨在确定(1)与Fontan术后不良结果相关的最佳EDP阈值和(2)dd的临床和影像学预测因素。方法：研究纳入了使用CMR检查（FORCE）的Fontan预后登记的患者，这些患者在两年的窗口内接受了心导管插管和心脏磁共振（CMR）。综合结局定义为全因死亡率、持续性房性或室性心律失常、可塑性支气管炎、蛋白质丧失性肠病或移植清单。EDP临界值采用Cox比例风险模型的最低Brier评分确定。结果：纳入861例患者，平均年龄16.4±9.3岁。平均EDP为9.0±3.5 mm Hg， DD定义为最佳EDP阈值bbb13 mm Hg。置管后患者的中位随访时间为3.6年。通过单变量分析，DD患者更有可能患有丰坦相关的肝脏疾病（40% vs 29%, p=0.03）和肾脏疾病（19% vs 6%, p）。结论：DD，定义为EDP bb0 13 mm Hg，与不良结局风险增加三倍以上相关。DD的危险因素包括年龄较大、BMI较高、非左心室形态和较大的EDV。危险因素的存在可能需要进行导管筛查，以确定DD并相应地修改护理。
{"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}
Pub Date : 2025-12-01Epub Date: 2025-07-12DOI: 10.1016/j.ahj.2025.07.010
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
Background: 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.
Rationale and design: 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.
Conclusion: 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.
Trial registration: Registered on ClinicalTrials.gov (https://clinicaltrials.gov/), ID: NCT05162742.
{"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, <sup>18</sup>F-sodium fluoride (<sup>18</sup>F-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 <sup>18</sup>F-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}
Pub Date : 2025-12-01Epub Date: 2025-07-16DOI: 10.1016/j.ahj.2025.07.004
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
<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>AMALFI (ISCRTN 15544176) recruited individuals aged ≥65 years with CHA<sub>2</sub>DS<sub>2</sub>-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.</p><p><strong>Results: </strong>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
{"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":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>AMALFI (ISCRTN 15544176) recruited individuals aged ≥65 years with CHA<sub>2</sub>DS<sub>2</sub>-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.</p><p><strong>Results: </strong>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}
Pub Date : 2025-11-27DOI: 10.1016/j.ahj.2025.107313
Jiachen Shan MD , Jie Gao MD , Yuye Chen MD , Hongwen Ji MD
Background
Postoperative bleeding is a major concern in cardiac surgery, often leading to significant transfusion requirements. Despite this high transfusion demand, the use of postoperative autologous blood transfusion (PABT) remains underexplored.
Methods and Results
This large-scale, single-blind randomized controlled trial with a 30-day follow-up enrolls patients undergoing elective on- or off-pump coronary artery bypass grafting. Patients with shed mediastinal blood volumes over 500 mL within the first 6 hours postoperatively are randomly assigned 1:1 to either the PABT group or the standard care group. The PABT group receives postoperative autotransfusion and additional allogeneic RBC transfusions if needed, while the standard care group receives allogeneic RBC transfusions only when clinically necessary, without postoperative autotransfusion. The primary efficacy endpoint is the postoperative allogeneic RBC transfusion volume, defined as the cumulative amount transfused from the day of surgery to discharge. Secondary efficacy endpoints include postoperative allogeneic RBC and non-RBC transfusion rates, perioperative hematologic recovery, drainage volume, mechanical ventilation duration, ICU and hospital length of stay. The primary safety endpoint is the incidence of a composite of postoperative infections (pneumonia, bloodstream infections, and surgical site infections). Secondary safety endpoints include a composite of other postoperative complications (renal dysfunction, myocardial infarction, stroke, deep vein thrombosis, and all-cause mortality), individual components of these composites, and 30-day mortality and morbidity. The estimated sample size is 1,232 participants. Patient recruitment is planned from January 2026 to December 2029 and is currently in the preparatory phase. The study is registered at the Chinese Clinical Trial Registry (ChiCTR2500103269, https://www.chictr.org.cn/) and was registered on May 27, 2025.
Conclusions
The study is designed to identify the efficacy and safety of PABT after cardiac surgery. We hypothesize that PABT has superior efficacy and noninferior safety to the standard care.
{"title":"Efficacy and safety of postoperative autologous blood transfusion in cardiac surgery (RESCUE): Rationale, design, and study protocol of a multicenter randomized controlled trial","authors":"Jiachen Shan MD , Jie Gao MD , Yuye Chen MD , Hongwen Ji MD","doi":"10.1016/j.ahj.2025.107313","DOIUrl":"10.1016/j.ahj.2025.107313","url":null,"abstract":"<div><h3>Background</h3><div>Postoperative bleeding is a major concern in cardiac surgery, often leading to significant transfusion requirements. Despite this high transfusion demand, the use of postoperative autologous blood transfusion (PABT) remains underexplored.</div></div><div><h3>Methods and Results</h3><div>This large-scale, single-blind randomized controlled trial with a 30-day follow-up enrolls patients undergoing elective on- or off-pump coronary artery bypass grafting. Patients with shed mediastinal blood volumes over 500 mL within the first 6 hours postoperatively are randomly assigned 1:1 to either the PABT group or the standard care group. The PABT group receives postoperative autotransfusion and additional allogeneic RBC transfusions if needed, while the standard care group receives allogeneic RBC transfusions only when clinically necessary, without postoperative autotransfusion. The primary efficacy endpoint is the postoperative allogeneic RBC transfusion volume, defined as the cumulative amount transfused from the day of surgery to discharge. Secondary efficacy endpoints include postoperative allogeneic RBC and non-RBC transfusion rates, perioperative hematologic recovery, drainage volume, mechanical ventilation duration, ICU and hospital length of stay. The primary safety endpoint is the incidence of a composite of postoperative infections (pneumonia, bloodstream infections, and surgical site infections). Secondary safety endpoints include a composite of other postoperative complications (renal dysfunction, myocardial infarction, stroke, deep vein thrombosis, and all-cause mortality), individual components of these composites, and 30-day mortality and morbidity. The estimated sample size is 1,232 participants. Patient recruitment is planned from January 2026 to December 2029 and is currently in the preparatory phase. The study is registered at the Chinese Clinical Trial Registry (ChiCTR2500103269, <span><span>https://www.chictr.org.cn/</span><svg><path></path></svg></span>) and was registered on May 27, 2025.</div></div><div><h3>Conclusions</h3><div>The study is designed to identify the efficacy and safety of PABT after cardiac surgery. We hypothesize that PABT has superior efficacy and noninferior safety to the standard care.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107313"},"PeriodicalIF":3.5,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145627670","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 : 2025-11-24DOI: 10.1016/j.ahj.2025.107311
Shanmukh Sai Pavan Lingamsetty MD , Ravi Venkata Sai Krishna Medarametla MD , Kesar Prajapati MD , Sahas Reddy Jitta MD , Mohamed Doma MD , Harshith Thyagaturu MD , Mangesh Kritya MD , Jaswanth Jasti MD , Mohan Chandra Vinay Bharadwaj Gudiwada MD , Chenna Reddy Tera MD , Tirumala Nischal Jasty MD , Pradeep Kumar Devarakonda MD , Vikramaditya Reddy Samala Venkata MD , Mir B Basir DO , Michael S Megaly MD, MSc , Amir Lotfi MD , Andrew M Goldsweig MD, MS
Background
Supersaturated oxygen (SSO₂) therapy is an emerging intervention to minimize myocardial damage and improve outcomes in patients with ST-segment elevation myocardial infarction (STEMI). This meta-analysis evaluated the efficacy of SSO₂ therapy to reduce infarct size and microvascular obstruction (MVO).
Methods
PubMed, Embase, and Cochrane databases were systematically searched for studies comparing percutaneous coronary intervention (PCI) plus SSO2 to PCI alone for STEMI. Outcomes of interest included infarct size, MVO, and subsequent major adverse cardiovascular events (MACE), all-cause mortality, re-infarction, and target vessel revascularization (TVR). Mean differences (MD) with 95% confidence intervals (CIs) were calculated using random-effects models.
Results
Six studies (n = 1660) were included with 548 patients (33%) receiving SSO₂ therapy. Pooled analysis showed that PCI plus SSO₂ significantly reduced infarct size (MD −4.31; 95% CI −6.70 to −1.92; P < .01) and MVO (SMD −0.72; 95% CI −1.11 to −0.34; P < .01) compared with PCI alone. MACE, all-cause mortality, re-infarction, and TVR were comparable between the groups.
Conclusion
SSO₂ therapy significantly reduced infarct size and MVO in patients undergoing PCI for STEMI.
{"title":"Effects of supersaturated oxygen therapy on infarct size and microvascular obstruction following myocardial infarction: A systematic review and meta-analysis","authors":"Shanmukh Sai Pavan Lingamsetty MD , Ravi Venkata Sai Krishna Medarametla MD , Kesar Prajapati MD , Sahas Reddy Jitta MD , Mohamed Doma MD , Harshith Thyagaturu MD , Mangesh Kritya MD , Jaswanth Jasti MD , Mohan Chandra Vinay Bharadwaj Gudiwada MD , Chenna Reddy Tera MD , Tirumala Nischal Jasty MD , Pradeep Kumar Devarakonda MD , Vikramaditya Reddy Samala Venkata MD , Mir B Basir DO , Michael S Megaly MD, MSc , Amir Lotfi MD , Andrew M Goldsweig MD, MS","doi":"10.1016/j.ahj.2025.107311","DOIUrl":"10.1016/j.ahj.2025.107311","url":null,"abstract":"<div><h3>Background</h3><div>Supersaturated oxygen (SSO₂) therapy is an emerging intervention to minimize myocardial damage and improve outcomes in patients with ST-segment elevation myocardial infarction (STEMI). This meta-analysis evaluated the efficacy of SSO₂ therapy to reduce infarct size and microvascular obstruction (MVO).</div></div><div><h3>Methods</h3><div>PubMed, Embase, and Cochrane databases were systematically searched for studies comparing percutaneous coronary intervention (PCI) plus SSO<sub>2</sub> to PCI alone for STEMI. Outcomes of interest included infarct size, MVO, and subsequent major adverse cardiovascular events (MACE), all-cause mortality, re-infarction, and target vessel revascularization (TVR). Mean differences (MD) with 95% confidence intervals (CIs) were calculated using random-effects models.</div></div><div><h3>Results</h3><div>Six studies (<em>n</em> = 1660) were included with 548 patients (33%) receiving SSO₂ therapy. Pooled analysis showed that PCI plus SSO₂ significantly reduced infarct size (MD −4.31; 95% CI −6.70 to −1.92; <em>P</em> < .01) and MVO (SMD −0.72; 95% CI −1.11 to −0.34; <em>P</em> < .01) compared with PCI alone. MACE, all-cause mortality, re-infarction, and TVR were comparable between the groups.</div></div><div><h3>Conclusion</h3><div>SSO₂ therapy significantly reduced infarct size and MVO in patients undergoing PCI for STEMI.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107311"},"PeriodicalIF":3.5,"publicationDate":"2025-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145627652","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}
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