American heart journal最新文献

{"title":"Ventricular-arterial coupling is associated with clinical outcomes in patients with systemic right ventricle","authors":"Giulia Pasqualin MD ,&nbsp;Amrit Misra MD ,&nbsp;Kimberlee Gauvreau ScD ,&nbsp;Stephen P. Sanders MD ,&nbsp;Akshay S. Desai MD ,&nbsp;Alex Alexander PA-C ,&nbsp;Ashwin Prakash MD ,&nbsp;Michael M. Givertz MD ,&nbsp;Anne Marie Valente MD","doi":"10.1016/j.ahj.2025.02.013","DOIUrl":"10.1016/j.ahj.2025.02.013","url":null,"abstract":"<div><h3>Background</h3><div>Adults with transposition of the great arteries (TGA) and systemic right ventricle (SRV) are at risk for heart failure (HF) and decreased survival. Ventricular-arterial coupling (VAC) quantifies the interaction between myocardial contractile function and the load imposed by the arterial circulation and may be valuable in identifying subclinical SRV dysfunction. The purpose of our study is to determine the association of VAC with adverse clinical outcomes in adults with TGA and SRV.</div></div><div><h3>Methods</h3><div>A single center, retrospective cohort study of subjects ≥16 years of age with TGA and SRV who underwent a cardiac magnetic resonance (CMR) examination. VAC was calculated as the ratio between CMR-derived SRV end-systolic volume and stroke volume. Cox proportional hazards regression analysis was performed to assess the association of VAC with clinical outcomes.</div></div><div><h3>Results</h3><div>One hundred sixty-seven subjects (mean age 32 ± 10 years, 59% males) were evaluated. VAC predicted the composite outcome of death, cardiac arrest and HF hospitalizations (hazard ratio (HR) 2.09; 95% CI, 1.12-3.92, <em>P</em> = .02), as well as other cardiovascular hospitalizations including device implantation and percutaneous or surgical structural intervention (HR 1.65, 95% CI, 1.09-2.49, <em>P</em> = .02) after adjustment for age, sex, and the presence of significant tricuspid regurgitation.</div></div><div><h3>Conclusions</h3><div>VAC is associated with major clinical adverse outcomes in patients with TGA and SRV, and may improve risk stratification of this complex population.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 29-38"},"PeriodicalIF":3.7,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472063","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":"Implementing depression treatment for cardiac populations in rapidly changing contexts: Design of the hybrid effectiveness-implementation IHEART DEPCARE trial","authors":"Andrea T. Duran PhD ,&nbsp;Jennifer Mizhquiri Barbecho MPH ,&nbsp;Kaitlin Shaw MPH ,&nbsp;Siqin Ye MD, MS ,&nbsp;Nohora Ospina BA ,&nbsp;Samantha Simantiris BA ,&nbsp;Joseph E. Schwartz PhD ,&nbsp;Nathalie Moise MD, MS","doi":"10.1016/j.ahj.2025.02.009","DOIUrl":"10.1016/j.ahj.2025.02.009","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Rationale&lt;/h3&gt;&lt;div&gt;Few coronary heart disease (CHD) patients engage in &lt;em&gt;evidence-based depression treatments&lt;/em&gt; (ie, antidepressants, therapy, exercise). We present the protocol and analysis plan for a hybrid type II effectiveness-implementation trial evaluating the impact of a theory-informed, multilevel &lt;em&gt;implementation strategy&lt;/em&gt; centered around an electronic shared decision making (eSDM)/patient activation tool.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Design&lt;/h3&gt;&lt;div&gt;The IHEART DEPCARE Trial uses a pre-post single group, open label design with 4 sites (each with a cluster of cardiology clinics and a cluster of primary care clinics, 8 clusters in total) introduced to the multilevel strategy (ie, single arm) in random order with patients (a pre-implementation cohort and nonoverlapping post-implementation cohort) nested within clinicians, nested within clusters. All primary care and cardiology clinicians at participating clinics are included. The patient sample includes English- and Spanish-speaking CHD patients ≥21 years of age with screen-detected elevated depressive symptoms (ie, Patient Health Questionnaire-9 score ≥10) and a scheduled visit during the relevant time period. In the pre-implementation period, CHD patients receive usual care. At the start of each implementation period, a site's behavioral health providers (BHPs) and clinic administrators are invited to problem solving meetings; patients receive an eSDM and patient activation tool that includes psychoeducation, patient activation, and treatment selection support; and clinicians/BHPs receive a summary report of patients’ preferences &lt;em&gt;(implementation strategy)&lt;/em&gt;. During pre- and post-implementation periods, patients are assessed at baseline and 6 months for depressive symptoms, depression treatment intensification, health-related quality of life years, and (at baseline only) patient activation and decisional conflict. The primary effectiveness outcome is change in depressive symptoms from baseline to follow-up during the post-implementation period compared to pre-implementation period. Key trial design changes, relative to our initial pre-COVID-19 trial protocol, include transition from a stepped wedge design to a single pre- post design randomized to strategy timing, reduction of exclusion criteria, options to bypass clinicians for direct BHP referrals (vs reliance on referrals) and addressing multiplicity in our statistical analysis plan. The trial was launched in April 2019 and is estimated to conclude by July 2025.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Discussion&lt;/h3&gt;&lt;div&gt;The IHEART DEPCARE Trial is the first hybrid type II effectiveness-implementation trial to examine the effect of a brief, theory-informed eSDM and patient activation tool strategy on depression treatment uptake and symptoms in CHD patients. Our protocol advances the field of implementation science by incorporating a multilevel (vs single-level) implementation strategy to address depression, highlighting unique challenges ","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 52-65"},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466843","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":"Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial","authors":"Jeffrey M. Ashburner PhD, MPH ,&nbsp;Reinier W.P. Tack MD ,&nbsp;Shaan Khurshid MD, MPH ,&nbsp;Ashby C. Turner MD ,&nbsp;Steven J. Atlas MD, MPH ,&nbsp;Daniel E. Singer MD ,&nbsp;Patrick T. Ellinor MD, PhD ,&nbsp;Emelia J. Benjamin MD, ScM ,&nbsp;Ludovic Trinquart PhD ,&nbsp;Steven A. Lubitz MD, MPH ,&nbsp;Christopher D. Anderson MD, MMSc","doi":"10.1016/j.ahj.2025.02.010","DOIUrl":"10.1016/j.ahj.2025.02.010","url":null,"abstract":"<div><h3>Background</h3><div>Detection of undiagnosed atrial fibrillation (AF) after ischemic stroke through extended cardiac monitoring is important for preventing recurrent stroke. We evaluated whether a tool that displays clinically predicted AF risk to clinicians caring for stroke patients was associated with the use of extended cardiac monitoring.</div></div><div><h3>Methods</h3><div>We prospectively included hospitalized ischemic stroke patients without known AF in a preintervention (October 2018 - June 2019) and intervention period (March 11, 2021 - March 10, 2022). The intervention consisted of an electronic health record (EHR)-based best-practice advisory (BPA) alert which calculated and displayed 5-year risk of AF. We used a multivariable Fine and Gray model to test for an interaction between predicted AF risk and period (preintervention vs intervention) with regards to incidence of extended cardiac monitoring. We compared the incidence of extended cardiac monitoring within 6-months of discharge between periods, stratified by BPA completion.</div></div><div><h3>Results</h3><div>We included 805 patients: 493 in the preintervention cohort and 312 in the intervention cohort. In the intervention cohort, the BPA was completed for 180 (58%) patients. The association between predicted clinical risk of AF and incidence of 6-month extended cardiac monitoring was not different by time period (interaction HR = 1.00 [95% Confidence Interval (CI) 0.98; 1.02]). The intervention period was associated with an increased cumulative incidence of cardiac monitoring (adjusted HR = 1.32 [95% CI 1.03-1.69]).</div></div><div><h3>Conclusions</h3><div>An embedded EHR tool displaying predicted AF risk in a poststroke setting had limited clinician engagement and predicted risk was not associated with the use of extended cardiac monitoring.</div></div><div><h3>Clinical Trial Registration</h3><div>NCT04637087</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 57-66"},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466758","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":"Lipoprotein(a) immunoassays and their associations with coronary artery calcification and aortic valve calcification","authors":"Maarten J.G. Leening MD, PhD, FESC ,&nbsp;Ching F. Khan MD, MSc ,&nbsp;Fang Zhu MPH, PhD ,&nbsp;Sunny S. Singh MD, PhD ,&nbsp;Maryam Kavousi MD, PhD, FESC ,&nbsp;Eric J.G. Sijbrands MD PhD ,&nbsp;Yolanda B. de Rijke PhD ,&nbsp;Daniel Bos MD, PhD","doi":"10.1016/j.ahj.2025.02.008","DOIUrl":"10.1016/j.ahj.2025.02.008","url":null,"abstract":"<div><h3>Background</h3><div>Lp(a) causes atherosclerosis and degenerative aortic valve disease, but concerns have risen that mass-based assays may beaffected by isoform sizes and provide inaccurate estimates of Lp(a) exposure.</div></div><div><h3>Methods</h3><div>We compared contemporary immunoturbidimetric assays reporting either mass-based (Randox) or molar-based (Roche) using data from 5,129 unselected participants from the prospective population-based Rotterdam Study cohort. We studied the association of both Lp(a) measurements with the burden of coronary artery calcium (CAC) and aortic valve calcification (AVC) in a random subset of participants who underwent cardiac CT.</div></div><div><h3>Results</h3><div>There was a near perfect linear correlation between Lp(a) concentrations from both immunoassays (R² 98.8%) with most pronounced differences apparent only at very high Lp(a) concentrations. Lp(a) concentrations were related with natural logtransformed Agatston scores (Randox standardized linear β 0.1003, <em>P</em> = 5.6·10⁻⁸; Roche standardized linear β 0.1004, <em>P</em> = 5.4·10⁻⁸). Lp(a) concentrations were strongly but similarly related to natural log-transformed AVC Agatston scores (Randox standardized linear β 0.1525, <em>P</em> = 9.2·10⁻¹⁶; Roche standardized linear β 0.1539, <em>P</em> = 4.8·10⁻¹⁶).</div></div><div><h3>Conclusion</h3><div>We demonstrate that these immunoassays provide interchangeable Lp(a) measurements, and that associations with CAC and AVC were near-identical. This provides opportunities to directly compare findings from research done with either immunoassay.</div></div><div><h3>Trial Registration</h3><div>The Rotterdam Study has been entered in the Netherlands National Trial Register and the WHO International Clinical Trials Registry Platform under shared catalog number NTR6831.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 42-46"},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial","authors":"Maria Barca-Hernando MD, PhD ,&nbsp;Sonia Otalora-Valderrama MD, PhD ,&nbsp;Juan Jose Lopez-Nuñez MD, PhD ,&nbsp;Jose Portillo-Sanchez MD, PhD ,&nbsp;Javier Pagan-Escribano MD, PhD ,&nbsp;Patricia Lopez-Miguel MD ,&nbsp;Isabelle Mahe MD, PhD ,&nbsp;Elisabeth Mena-Muñoz MD ,&nbsp;Ines Jou-Segovia MD ,&nbsp;Egidio Imbalzano MD ,&nbsp;Paloma Agudo-de Blas MD, PhD ,&nbsp;Alicia Lorenzo-Hernandez MD, PhD ,&nbsp;Carmen Diaz-Pedroche MD, PhD ,&nbsp;Jesus Aibar-Gallizo MD, PhD ,&nbsp;Gloria de la Red-Bellvis MD ,&nbsp;Fatima del Molino-Sanz MD ,&nbsp;Cristina Amado-Fernandez MD ,&nbsp;Jose Luis Fernandez-Reyes MD ,&nbsp;Aurora Villalobos-Sanchez MD, PhD ,&nbsp;Juan Bosco Lopez-Saez MD, PhD ,&nbsp;Luis Jara-Palomares MD, PhD","doi":"10.1016/j.ahj.2025.02.004","DOIUrl":"10.1016/j.ahj.2025.02.004","url":null,"abstract":"<div><h3>Background</h3><div>Unprovoked venous thromboembolism (VTE) is considered when no clear major provoking factor for VTE is identified. Although the 1-year risk of diagnosing new cancer in these patients can be as high as 5%, the benefits of extensive screening remain uncertain. It is possible that in a risk-enriched population of patients, screening yields benefit. Recently, the RIETE score, a composite score including sex, age, chronic pulmonary disease, anemia, platelet count and previous VTE, was found to improve risk prediction for identification of occult cancer in patients with unprovoked VTE. As for screening tests, whole body 18F-fluorodeoxyglucose Positron Emission/Computed Tomography (18F-FDG PET/CT) is a promising and sensitive tool for occult cancer screening.</div></div><div><h3>Methods</h3><div>This manuscript summarizes the rationale and design of 2 prospective studies in patients with unprovoked symptomatic VTE: (1) ValRIETE is an international, multicenter, prospective, adaptative, cohort study that plans to include 1,550 patients; the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. This study will enable the external validation of the RIETE score, with several ancillary aims related to additional clinical and biomarker predictors. Recruitment began in December 2022. (2) SOME-RIETE is an open-label, randomized, multicenter clinical trial that plans to enroll 650 patients with a RIETE score ≥3 to compare limited screening with limited screening plus whole body 18F-FDG PET/CT. The primary outcome is cancer diagnosis within 3 months after VTE event. Secondary outcomes include cancer diagnosis and mortality at 12 months.</div></div><div><h3>Conclusions</h3><div>This study provides clinically meaningful data on and the utility of extended screening of cancer by 18F-FDG PET/CT.</div></div><div><h3>Study Registration</h3><div>VaLRIETE study: ethics committee of the Virgen del Rocio University Hospital, Sevilla (Spain). <span><span>https://www.juntadeandalucia.es/salud/portaldeetica/xhtml/inicio/inicio.iface</span><svg><path></path></svg></span> (1687-N-22).</div></div><div><h3>Trial Registration</h3><div><em>SOME-RIETE:</em> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT03937583).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 81-93"},"PeriodicalIF":3.7,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456673","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":"Patient characteristics, presentation, causal microorganisms, and overall mortality in the NatIonal Danish endocarditis stUdieS (NIDUS) registry","authors":"Katra Hadji-Turdeghal MD ,&nbsp;Peter Laursen Graversen MD ,&nbsp;Jacob Eifer Møller MDDMSc ,&nbsp;Niels Eske Bruun MDDMSc ,&nbsp;Jonas A. Povlsen MDPh.D. ,&nbsp;Claus Moser MDPh.D ,&nbsp;Morten Smerup MDPh.D. ,&nbsp;Peter Søgaard MDDMSc ,&nbsp;Hanne Sortsøe Jensen MDPh.D ,&nbsp;Peter Godsk Jørgensen MD ,&nbsp;Andreas Dalsgaard Jensen MD ,&nbsp;Jeppe K. Petersen MDPhD ,&nbsp;Eva Havers-Borgersen MD ,&nbsp;Jannik Helweg-Larsen MDPh.D. ,&nbsp;Daniel Faurholt-Jepsen MDPh.D. ,&nbsp;Henning Bundgaard MDDMSc ,&nbsp;Kasper Iversen MDDMSc ,&nbsp;Lauge Østergaard MDPhD. ,&nbsp;Lars Køber MDDMSc ,&nbsp;Emil L. Fosbøl MDPhD.","doi":"10.1016/j.ahj.2025.02.006","DOIUrl":"10.1016/j.ahj.2025.02.006","url":null,"abstract":"<div><h3>Background</h3><div>Most knowledge on infective endocarditis (IE) comes from large IE cohorts that include patients from tertiary hospitals, leading to referral bias and retrospective population-based studies. This highlights the need for a more detailed characterization of IE in unselected patient cohorts.</div></div><div><h3>Methods</h3><div>In the National Danish Endocarditis Studies (NIDUS) registry, all hospitalizations in Denmark from 2016 to 2021 with an IE diagnosis were reviewed and validated using electronic medical records (EMR) by healthcare professionals under the supervision of IE experts. Episodes meeting the European Society of Cardiology 2015 modified diagnostic criteria for possible or definite IE were included.</div></div><div><h3>Results</h3><div>We screened 4390 unique patients, of whom 3557 (81%) were included in the NIDUS registry. Of the 3557 unique patients, 2832 (79.6%) were classified as definite IE and 725 (20.4%) as possible IE. The age was 73.7 years, and most patients were men (68.3%). In total, 689 (19.4%) underwent surgery during hospitalization. The most frequent comorbidities were diabetes (23.7%), heart failure (18.7%), and chronic kidney disease (17.4%). Most patients presented with fever (61.1%), followed by dyspnea (33.0%) and myalgias (27.0%). Sepsis was found in 828 (23.3%) patients, while 378 (10.6%) had signs of embolization at admission. Positive blood cultures were identified in 3191 (89.7%) patients, and the most frequent microbiological etiology was <em>Staphylococcus aureus</em> (31.9%). The in-hospital mortality was 17.3%, and the 1-year mortality rate was 31.3%.</div></div><div><h3>Conclusion</h3><div>The NatIonal Danish endocarditis studies (NIDUS) registry provides comprehensive, granular, and nationwide data on a cohort of patients with infective endocarditis, revealing that when selection is not restricted to tertiary hospitals or voluntary registries, some important differences emerge. Patients with IE are on average older, have a similar burden of comorbidities, and less often undergo surgery. Minimizing selection bias with the use of a national registry provides a clearer picture of IE as it occurs in real-world clinical settings.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 119-132"},"PeriodicalIF":3.7,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design, rationale, and characterization of the mobile health based occupational cardiovascular risk intervention study (mHealth-OPEN study)","authors":"Yixin Tian PhD ,&nbsp;Xin Wang MD ,&nbsp;Zhen Hu PhD ,&nbsp;Xue Yu MS ,&nbsp;Min Shao MS ,&nbsp;Chuanxi Zhang MS ,&nbsp;Dedi Zhang MS ,&nbsp;Wenping Shan MS ,&nbsp;Chenye Chang MS ,&nbsp;Chenda Zhang MS ,&nbsp;Yuxuan Nie MS ,&nbsp;Congyi Zheng PhD ,&nbsp;Xue Cao PhD ,&nbsp;Xuyan Pei PhD ,&nbsp;Yujie Zhang MS ,&nbsp;Nuerguli Tuerdi MS ,&nbsp;Zengwu Wang PhD","doi":"10.1016/j.ahj.2025.02.005","DOIUrl":"10.1016/j.ahj.2025.02.005","url":null,"abstract":"<div><h3>Background</h3><div>The substantial workforce and suboptimal cardiovascular health highlights the urgent need for workplace interventions. This ongoing cluster-randomized trial aims to evaluate the effectiveness, feasibility, and acceptability of a mobile health (mHealth) based comprehensive intervention program to improve cardiovascular health among employees.</div></div><div><h3>Methods and results</h3><div>We conducted a 1-year, 2-arm, parallel-group, cluster-randomized controlled multicenter trial involving 10,000 participants (aged 18-65, including 1,600 participants with high cardiovascular risk) across 20 workplaces. Workplaces were randomly assigned in a 1:1 ratio to either the intervention or control group. We established a mHealth based multifaceted cardiovascular risk management system that enables intelligent management. The intervention groups received a mHealth-based management with primary prevention inventions for all participants and additional cardiovascular risk interventions for participants with high cardiovascular risk via the system. The control groups received usual care. Primary outcomes included percentage changes in hypertension, diabetes, and dyslipidemia control rates among participants with high cardiovascular risk, and percentage changes in the rate of regular physical activity among all the participants, from baseline to 12-month follow-up. Secondary outcomes included changes in blood pressure, glucose, lipid, treatment adherence, behavioral factors, questionnaire scores, and incidence of major cardiovascular events. By now, baseline recruitment has been completed, with comparable characteristics between management and control groups.</div></div><div><h3>Conclusions</h3><div>This rigorous designed mHealth-based workplace intervention demonstrates potential for nationwide implementation, offering cardiovascular benefits for employees.</div></div><div><h3>Clinical trial registration</h3><div><span><span>www.chictr.org.cn</span><svg><path></path></svg></span>. Identifier: ChiCTR2200066196.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 32-41"},"PeriodicalIF":3.7,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmaco-invasive strategy and dosing of tenecteplase in STEMI patients 60 to <75 years: An inter-trial comparison of the STREAM-1 and STREAM-2 trials","authors":"Kevin R. Bainey MD, MSc ,&nbsp;Robert C. Welsh MD ,&nbsp;Yinggan Zheng MA, MEd ,&nbsp;Alexandra Arias-Mendoza MD ,&nbsp;Arsen D. Ristić MD, PhD ,&nbsp;Oleg V. Averkov MD, PhD ,&nbsp;Yves Lambert MD ,&nbsp;Tracy Temple BScN, RN ,&nbsp;Eric Ly BHK ,&nbsp;Kris Bogaerts PhD ,&nbsp;Peter Sinnaeve MD, PhD ,&nbsp;Cynthia M. Westerhout PhD ,&nbsp;Frans Van de Werf MD, PhD ,&nbsp;Paul W. Armstrong MD ,&nbsp;STREAM-2 Investigators","doi":"10.1016/j.ahj.2025.02.002","DOIUrl":"10.1016/j.ahj.2025.02.002","url":null,"abstract":"<div><h3>Background</h3><div>Previous studies indicate a safety risk with full-dose TNK in elderly patients. In a study of patients ≥60 years STREAM-2 (STrategic Reperfusion Early After Myocardial infarction-2), a pharmaco-invasive (PI) strategy with half-dose TNK was similar (in efficacy and safety) to primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) patients presenting &lt;3 hours. While no treatment difference ± 75 years was observed, the role of this half-dose PI strategy in patients &lt;75 years is unknown. In this comparison of STEAM-1 and -2, we analyzed PI strategies with full-dose (STREAM-1) versus half-dose TNK (STREAM-2) to evaluate their relative efficacy and safety in this younger STEMI cohort.</div></div><div><h3>Methods</h3><div>We evaluated patients 60 to &lt;75 years from STREAM-1 and STREAM-2 receiving PI treatment versus PPCI for their resolution of ST-elevation after fibrinolysis and angiography, primary efficacy composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, and safety events.</div></div><div><h3>Results</h3><div>Among 1103 patients, 327 received a full-dose PI strategy (STREAM-1), 289 a half-dose PI strategy (STREAM-2) and 487 PPCI (338 in STREAM-1; 149 in STREAM-2). Half- compared to full-dose TNK resulted in similar proportions of patients achieving ST resolution ≥50% (71.2% vs 68.7%, <em>P = .</em>519): their ICH risks were 2.1% vs 1.5%, <em>P = .</em>605 respectively). Following angiography, PI patients had nominally better ST resolution ≥50% compared to their PPCI counterpart (STREAM-1: 87.7% vs. 83.2%, <em>P = .</em>120; STREAM-2: 88.2% vs. 81.0%, <em>P = .</em>048) with similar primary composite outcome at 30 days (STREAM-1: 14.4% vs. 16.3%, 0.90 [0.62, 1.31]; STREAM-2: 9.0% vs 8.1%, 1.29 [0.64, 2.61]). Major (non-ICH) bleeding markedly declined in STREAM-2 compared to STREAM-1 in both treatment groups (STREAM-1: 7.1% vs. 6.0%; STREAM-2: 0.3% vs. 0.7%).</div></div><div><h3>Conclusions</h3><div>In STEMI patients 60 to &lt;75 years presenting within 3 hours of symptoms, half-dose PI treatment appears as efficacious as a full-dose PI strategy with a low systemic bleeding risk. Half-dose PI treatment deserves consideration when timely PPCI is not attainable in this important STEMI sub-group.</div></div><div><h3>Clinicaltrials.gov registration numbers</h3><div>NCT00623623, NCT02777580.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 20-31"},"PeriodicalIF":3.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424556","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":"Transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis aged 70 years or younger: A NOTION-2 substudy","authors":"Troels Højsgaard Jørgensen MD, PhD ,&nbsp;Hans Gustav Hørsted Thyregod MD, PhD ,&nbsp;Mikko Savontaus MD, PhD ,&nbsp;Öjvind Bleie MD, PhD ,&nbsp;Evald H Christiansen MD, PhD ,&nbsp;Matti Niemela MD, PhD ,&nbsp;Oskar Angerås MD, PhD ,&nbsp;Ingibjörg J. Gudmundsdóttir MD, DM ,&nbsp;Mika Laine MD, PhD ,&nbsp;Andreas Rück MD, PhD ,&nbsp;Bernard Prendergast MD, DMSc ,&nbsp;Martin Leon MD, PhD ,&nbsp;Lars Søndergaard MD, DMSc ,&nbsp;Ole De Backer MD, PhD ,&nbsp;NOTION-2 investigators","doi":"10.1016/j.ahj.2025.02.003","DOIUrl":"10.1016/j.ahj.2025.02.003","url":null,"abstract":"<div><div>This NOTION-2 sub-study revealed distinct outcomes for transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in low surgical risk patients aged ≤ 70 years with a tricuspid or bicuspid aortic valve stenosis (AS). One year after intervention, the risk of death, stroke or rehospitalization in patients with tricuspid AS was similar after TAVR when compared to SAVR (absolute risk difference: −2.0%; 95% confidence interval (CI): −11.8% to 7.7%) Conversely, in patients with bicuspid AS, TAVR was associated with a significantly higher risk of adverse outcomes (absolute risk difference: 13.8%; 95% CI: 1.2% to 26.3%). These analyses are exploratory, but highlight the importance of tailoring the intervention to the patient's clinical risk profile, life expectancy, native aortic valve morphology and the anticipated risks associated with TAVR or SAVR.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 67-70"},"PeriodicalIF":3.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective randomized single-blind multicenter study to assess the safety and effectiveness of the SELUTION SLR 014 drug eluting balloon in the treatment of subjects with in-stent restenosis: Rationale and design","authors":"Donald E. Cutlip MD ,&nbsp;Roxana Mehran MD ,&nbsp;Gheorghe Doros PhD ,&nbsp;Vladimir Kaplinskiy MD ,&nbsp;Jane Lee PhD ,&nbsp;Luke Zheng BS ,&nbsp;Milan Kausik MD ,&nbsp;Eric Osborn MD, PhD ,&nbsp;Ron Waksman MD","doi":"10.1016/j.ahj.2025.02.001","DOIUrl":"10.1016/j.ahj.2025.02.001","url":null,"abstract":"<div><h3>Background</h3><div>Repeat drug-eluting stenting is superior to balloon angioplasty for prevention of recurrent in-stent restenosis (ISR), but carries a potential disadvantage of multiple layers of stent. The safety and effectiveness of a sirolimus drug-eluting balloon as an alternative has not been assessed.</div></div><div><h3>Study Design and Methods</h3><div>The SELUTION4ISR trial is a prospective, multicenter, single-blinded, randomized, controlled trial. A total of 418 subjects with bare metal or drug-eluting stent (DES) ISR with up to 2 previous stent procedures at the target lesion, lesion length &lt;26 mm and reference diameter ≥2.0 mm - ≤4.5 mm will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB (SLR DEB) or standard of care (SOC), which includes either repeat DES or balloon angioplasty without drug coating. A subset of subjects will undergo planned angiographic and optical coherence tomography follow-up. The primary endpoint will be target lesion failure, defined as cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months follow-up. The study will sequentially assess noninferiority of the SLR DEB to SOC in the overall cohort, followed by noninferiority then superiority of the SLR DEB to DES in the cohort with only 1 previous stent at the target lesion.</div></div><div><h3>Trial Registration</h3><div>The trial is registered at Clinicaltrials.gov (NCT04280029).</div></div><div><h3>Current Status</h3><div>The trial completed enrollment in July 2024.</div></div><div><h3>Conclusion</h3><div>The SELUTION4ISR study will evaluate the safety and effectiveness of SLR DEB in a prospective, randomized, international, multicenter trial for treatment of coronary ISR.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 11-19"},"PeriodicalIF":3.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424559","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}