American heart journal最新文献

{"title":"Design and rationale of the social determinants of the risk of hypertension in women of reproductive age (SAFE HEART) study: An American Heart Association research goes red initiative","authors":"","doi":"10.1016/j.ahj.2024.05.016","DOIUrl":"10.1016/j.ahj.2024.05.016","url":null,"abstract":"<div><h3>Background</h3><p>Cardiovascular health literacy (CVHL) and social determinants of health (SDoH) play interconnected and critical roles in shaping cardiovascular health (CVH) outcomes. However, awareness of CVH risk has declined markedly, from 65% of women being aware that cardiovascular disease (CVD) is the leading cause of death for women in 2009 to just 44% being aware in 2019. The American Heart Association Research Goes Red (RGR) initiative seeks to develop an open-source, longitudinal, dynamic registry that will help women to be aware of and participate in research studies, and to learn about CVD prevention. We proposed to leverage this platform, particularly among Black and Hispanic women of reproductive age, to address CVHL gaps and advance health equity.</p></div><div><h3>Methods</h3><p>The primary objective of the study is to evaluate the cross-sectional association of CVHL, SDoH using a polysocial score, and CVH in women of reproductive age at increased risk of developing hypertension (HTN). To achieve this we will use a cross-sectional study design, that engages women already enrolled in the RGR registry (registry-enrolled). To enhance the racial and ethnic/social economic diversity of the cohort, we will additionally enroll 300 women from the Baltimore and Washington D.C. community into the Social Determinants of the Risk of Hypertension in Women of Reproductive Age (SAFE HEART) Study. Community-enrolled and registry-enrolled women will undergo baseline social phenotyping including detailed SDoH questionnaire, CVH metrics assessment, and CVHL assessment. The secondary objective is to assess whether a 4-month active health education intervention will result in a change in CVHL in the 300 community-enrolled women.</p></div><div><h3>Discussion</h3><p>The SAFE HEART study examines the association between CVHL, SDoH, and CVH, with a focus on racial and ethnic minority groups and socioeconomically disadvantaged women of reproductive age, and the ability to improve these parameters by an educational intervention. These findings will inform the future development of community-engaged strategies that address CVHL and SDoH among women of reproductive age.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001388/pdfft?md5=d9c70cd853b434b9279b581c05de4835&pid=1-s2.0-S0002870324001388-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141305203","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":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(24)00134-0","DOIUrl":"https://doi.org/10.1016/S0002-8703(24)00134-0","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141294441","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":"Prediction of 30‐day mortality after surgery for infective endocarditis using risk scores: Insights from a European multicenter comparative validation study","authors":"Giuseppe Gatti MD ,&nbsp;Antonio Fiore MD, PhD ,&nbsp;Maria Ismail MD ,&nbsp;Andriy Dralov MD ,&nbsp;Wael Saade MD ,&nbsp;Venera Costantino MSc ,&nbsp;Giulia Barbati MStat ,&nbsp;Pascal Lim MD, PhD ,&nbsp;Raphael Lepeule MD, PhD ,&nbsp;Ilaria Franzese MD ,&nbsp;Alessandro Minati MD ,&nbsp;Sandro Sponga MD, PhD ,&nbsp;Enrico Fabris MD, PhD ,&nbsp;Roberto Luzzati MD, PhD ,&nbsp;Gianfranco Sinagra MD, PhD ,&nbsp;Giuseppe Biondi-Zoccai MD, MStat ,&nbsp;Giacomo Frati MD, PhD ,&nbsp;Andrea Perrotti MD, PhD ,&nbsp;Igor Vendramin MD, PhD ,&nbsp;Enzo Mazzaro MD","doi":"10.1016/j.ahj.2024.05.021","DOIUrl":"10.1016/j.ahj.2024.05.021","url":null,"abstract":"<div><h3>Background</h3><p>It remains unclear today whether risk scores created specifically to predict early mortality after cardiac operations for infective endocarditis (IE) outperform or not the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II).</p></div><div><h3>Methods</h3><p>Perioperative data and outcomes from a European multicenter series of patients undergoing surgery for definite IE were retrospectively reviewed. Only the cases with known pathogen and without missing values for all considered variables were retained for analyses. A comparative validation of EuroSCORE II and 5 specific risk scores for early mortality after surgery for IE—(1) STS-IE (Society of Thoracic Surgeons for IE); (2) PALSUSE (Prosthetic valve, Age ≥70, Large intracardiac destruction, <em>Staphylococcus spp</em>, Urgent surgery, Sex (female), EuroSCORE ≥10); (3) ANCLA (Anemia, New York Heart Association class IV, Critical state, Large intracardiac destruction, surgery on thoracic Aorta); (4) AEPEI II (Association pour l’Étude et la Prévention de l'Endocardite Infectieuse II); (5) APORTEI (Análisis de los factores PROnósticos en el Tratamiento quirúrgico de la Endocarditis Infecciosa)—was carried out using calibration plot and receiver-operating characteristic curve analysis. Areas under the curve (AUCs) were compared 1:1 according to the Hanley–McNeil's method. The agreement between APORTEI score and EuroSCORE II of the 30-day mortality prediction after surgery was also appraised.</p></div><div><h3>Results</h3><p>A total of 1,012 patients from 5 European university-affiliated centers underwent 1,036 cardiac operations, with a 30-day mortality after surgery of 9.7%. All IE-specific risk scores considered achieved better results than EuroSCORE II in terms of calibration; AEPEI II and APORTEI score showed the best performances. Despite poor calibration, EuroSCORE II overcame in discrimination every specific risk score (AUC, 0.751 vs 0.693 or less, <em>P</em> = .01 or less). For a higher/lesser than 20% expected mortality, the agreement of prediction between APORTEI score and EuroSCORE II was 86%.</p></div><div><h3>Conclusion</h3><p>EuroSCORE II discrimination for 30-day mortality after surgery for IE was higher than 5 established IE-specific risk scores. AEPEI II and APORTEI score showed the best results in terms of calibration.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141287659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The relative merits of using a high-sensitivity cardiac Troponin T assay compared to a nonhigh-sensitivity troponin T assay after noncardiac surgery","authors":"Flavia K. Borges MD, PhD ,&nbsp;Daniel I. Sessler MD ,&nbsp;Maria Tiboni MD ,&nbsp;Ameen Patel MD ,&nbsp;Yannick LeManach MD, PhD ,&nbsp;Diane Heels-Ansdell BSc, MSc ,&nbsp;Sadeesh Srinathan MD ,&nbsp;Chew Yin Wang MBChB ,&nbsp;Clara Chow MD, PhD ,&nbsp;Emmanuelle Duceppe MD, PhD ,&nbsp;Peter Kavsak BSc, PhD ,&nbsp;Sandra N. Ofori MBBS, MSc ,&nbsp;Shirley Pettit RN ,&nbsp;Otavio Berwanger MD, PhD ,&nbsp;Andrea Kurz MD ,&nbsp;Alparslan Turan MD ,&nbsp;Ana Claudia Tonelli MD, PhD ,&nbsp;PJ Devereaux MD, PhD ,&nbsp;VISION Study Investigators","doi":"10.1016/j.ahj.2024.05.020","DOIUrl":"10.1016/j.ahj.2024.05.020","url":null,"abstract":"<div><h3>Introduction</h3><p>Troponin elevation after noncardiac surgery is associated with an elevated risk of 30-day mortality. Little is known about relative merit of using a high-sensitivity Troponin T (hsTnT), the fifth-generation assay, vs the nonhigh sensitivity Troponin T (non-hsTnT), the fourth-generation assay, in the noncardiac surgery setting. We aimed to identify whether hsTnT can identify additional patients at risk that would have gone undetected with non-hsTnT measurement.</p></div><div><h3>Methods</h3><p>The VISION Study included 40,004 noncardiac surgery patients with postoperative troponin measurements. Among them, 1,806 patients had both fourth-generation non-hsTnT and fifth-generation hsTnT concomitant measurements (4,451 paired results). We compared the absolute concentrations, the timing, and the impact of different thresholds on predicting 30-day major cardiovascular complications (composite of death, nonfatal cardiac arrest, coronary revascularization, and congestive heart failure).</p></div><div><h3>Results</h3><p>Based on the manufacturers’ threshold of 14 ng/L, 580 (32.1%) patients had postoperative hsTnT concentrations greater than the threshold, while their non-hsTnT concentrations were below the manufacturer's threshold. These 580 patients had higher risk of major cardiovascular events (OR 2.33; CI 95% 1.04-5.23; <em>P</em> = .049) than patients with hsTnT concentrations below the manufacturer threshold. Among patients with myocardial injury after noncardiac surgery, only 50% would be detected by the fourth-generation non-hsTnT assay at 6 to 12 hours postoperative as compared to 85% with the fifth-generation hsTnT assay (<em>P</em>-value &lt; .001).</p></div><div><h3>Conclusions</h3><p>Within the first 3 postoperative days, fifth-generation hsTnT identified at least 1 in 3 patients with troponin elevation that would have gone undetected by fourth-generation non-hsTnT using published thresholds in this setting. Furthermore, fifth-generation hsTnT identified patients with an elevation earlier than fourth-generation non-hsTnT, indicating potential to improve postoperative risk stratification.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293020","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":"Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial","authors":"Lei Song MD ,&nbsp;Changdong Guan MSc ,&nbsp;Mengyue Yu MD ,&nbsp;Zhongwei Sun MSc ,&nbsp;Guosheng Fu MD ,&nbsp;Yong He MD ,&nbsp;Shaobin Jia MD ,&nbsp;Jiyan Chen MD ,&nbsp;Feng Qi MD ,&nbsp;Jie Bai MD ,&nbsp;Wei li MD ,&nbsp;Junbo Ge MD ,&nbsp;Yaling Han MD ,&nbsp;Runlin Gao MD","doi":"10.1016/j.ahj.2024.05.019","DOIUrl":"10.1016/j.ahj.2024.05.019","url":null,"abstract":"<div><h3>Background</h3><p>The previous first-in-human study established the preliminary safety and effectiveness of the novel thin-strut iron bioresorbable scaffold (IBS). The current study aims to directly compare the imaging and physiological efficacy, and clinical outcomes of IBS with contemporary metallic drug-eluting stents (DES).</p></div><div><h3>Methods</h3><p>A total of 518 patients were randomly allocated to treatment with IBS (257 patients) or metallic DES (261 patients) from 36 centers in China. The study is powered to test noninferiority of the IBS compared with the metallic everolimus-eluting stent in terms of the primary endpoint of in-segment late lumen loss at 2 years, and major secondary endpoints including 2-year quantitative flow ratio and cross-sectional mean flow area measured by optical coherence tomography (OCT) (limited to the OCT subgroup, 25 patients in each group).</p></div><div><h3>Conclusion</h3><p>This will be the first powered randomized trial investigating the safety and efficacy of the novel thin-strut IBS compared to a contemporary metallic DES. The findings will provide valuable evidence for future research of this kind and the application of metallic bioresorbable scaffolds.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141260260","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":"Echocardiographic and clinical features of patients developing prosthesis‐patient mismatch after transcatheter aortic valve replacement: Insights from the Recovery-TAVR registry","authors":"Francesco Bruno MD ,&nbsp;Joao Matteo Rampone MD ,&nbsp;Fabian Islas MD ,&nbsp;Riccardo Gorla MD ,&nbsp;Guglielmo Gallone MD ,&nbsp;Francesco Melillo MD ,&nbsp;Pier Pasquale Leone MD ,&nbsp;Paolo Cimaglia MD ,&nbsp;Maria Concetta Pastore MD ,&nbsp;Anna Franzone MD ,&nbsp;Federico Landra MD ,&nbsp;Luca Scudeler MD ,&nbsp;Pilar Jimenez-Quevedo MD ,&nbsp;Tommaso Viva MD ,&nbsp;Francesco Piroli MD ,&nbsp;Renato Bragato MD ,&nbsp;Michele Trichilo MD ,&nbsp;Anna Degiovanni MD ,&nbsp;Stefano Salizzoni MD ,&nbsp;Federica Ilardi MD ,&nbsp;Fabrizio D'Ascenzo MD","doi":"10.1016/j.ahj.2024.05.015","DOIUrl":"10.1016/j.ahj.2024.05.015","url":null,"abstract":"<div><h3>Background</h3><p>The impact of prosthesis-patient mismatch (PPM) on major endpoints after transcatheter aortic valve replacement (TAVR) is controversial and the effects on progression of heart damage are poorly investigated. Therefore, our study aims to evaluate the prevalence and predictors of PPM in a “real world” cohort of patients at intermediate and low surgical risk, its impact on mortality and the clinical-echocardiographic progression of heart damage.</p></div><div><h3>Methods</h3><p>963 patients who underwent TAVR procedure between 2017 and 2021, from the RECOVERY-TAVR international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data of these patients were analyzed at 1-year follow-up (FU). Clinical and echocardiographic features were stratified by presence of PPM and PPM severity, as per the most current international recommendations, using VARC-3 criteria.</p></div><div><h3>Results</h3><p>18% of patients developed post-TAVR. PPM, and 7.7% of the whole cohort had severe PPM. At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, <em>P</em> = .33), aged 82 (IQR 79-85y) years vs 82 (IQR 78-86 <em>P</em> = .46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, <em>P</em> = .04); they had smaller left ventricular outflow tract (LVOT) diameter (20 mm, IQR 19-21 vs 20 mm, IQR 20-22, <em>P</em> = .02), reduced SVi (34.2 vs 38 mL/m², <em>P</em> &lt; .01) and transaortic flow rate (190.6 vs 211 mL/s, <em>P</em> &lt; .01). At predischarge FU patients with PPM had more paravalvular aortic regurgitation (moderate-severe AR 15.8% vs 9.2%, <em>P</em> &lt; .01). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in end-systolic diameter (33 mm vs 28 mm, <em>P</em> = .03) and a significant increase in left ventricle end systolic indexed volume in those with moderate and severe PPM (52 IQR 42-64 and 52, IQR 41-64 vs 44 IQR 35-59 in those without, <em>P</em> = .02)). No evidence of a significant impact of PPM on overall (<em>P</em> = .71) and CV (<em>P</em> = .70) mortality was observed. Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, <em>P</em> = .03). Prosthesis size≤23 mm (OR 11.6, 1.68-80.1) was an independent predictor of PPM, while SVi (OR 0.87, 0.83-0.91, <em>P</em> &lt; .001) and LVOT diameter (OR 0.79, 0.65-0.95, <em>P</em> = .01) had protective effect.</p></div><div><h3>Conclusions</h3><p>PPM was observed in 18% of patients undergoing TAVR. Echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations, possibly precursor to a reduction in cardiac function, associated with a significant deterioration in NYHA class at 1 year. These findings emphasize the importance of prevention of PPM of any grade in patients undergoing TAVR p","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141260232","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":"Seattle proportional risk model in GISSI-HF: Estimated benefit of ICD in patients with EF less than 50%","authors":"Lee B. Bockus MD PhD ,&nbsp;Ramin Shadman MD ,&nbsp;Jeanne E. Poole MD ,&nbsp;Todd F. Dardas MD ,&nbsp;Donata Lucci MS ,&nbsp;Jennifer Meessen MSc ,&nbsp;Roberto Latini MD ,&nbsp;Aldo Maggioni MD ,&nbsp;Wayne C. Levy MD","doi":"10.1016/j.ahj.2024.05.014","DOIUrl":"10.1016/j.ahj.2024.05.014","url":null,"abstract":"<div><h3>Background</h3><p>The Seattle Proportional Risk Model (SPRM) estimates the proportion of sudden cardiac death (SCD) in heart failure (HF) patients, identifying those most likely to benefit from implantable cardioverter-defibrillator (ICD) therapy (those with ≥50% estimated proportion of SCD). The GISSI-HF trial tested fish oil and rosuvastatin in HF patients. We used the SPRM to evaluate its accuracy in this cohort in predicting potential ICD benefit in patients with EF ≤50% and an SPRM-predicted proportion of SCD either ≥50% or &lt;50%.</p></div><div><h3>Methods</h3><p>The SPRM was estimated in patients with EF ≤50% and in a logistic regression model comparing SCD with non-SCD.</p></div><div><h3>Results</h3><p>We evaluated 6,750 patients with EF ≤50%. There were 1,892 all-cause deaths, including 610 SCDs. Fifty percent of EF ≤35% patients and 43% with EF 36% to 50% had an SPRM of ≥50%. The SPRM (OR: 1.92, <em>P</em> &lt; 0.0001) accurately predicted the risk of SCD vs non-SCD with an estimated proportion of SCD of 44% vs the observed proportion of 41% at 1 year.</p><p>By traditional criteria for ICD implantation (EF ≤35%, NYHA class II or III), 64.5% of GISSI-HF patients would be eligible, with an estimated ICD benefit of 0.81. By SPRM &gt;50%, 47.8% may be eligible, including 30.2% with EF &gt;35%. GISSI-HF participants with EF ≤35% with SPRM ≥50% had an estimated ICD HR of 0.64, comparable to patients with EF 36% to 50% with SPRM ≥50% (HR: 0.65).</p></div><div><h3>Conclusions</h3><p>The SPRM discriminated SCD vs non-SCD in GISSI-HF, both in patients with EF ≤35% and with EF 36% to 50%. The comparable estimated ICD benefit in patients with EF ≤35% and EF 36% to 50% supports the use of a proportional risk model for shared decision making with patients being considered for primary prevention ICD therapy.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141199213","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":"Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial","authors":"Carla Richardson BSc, MSc ,&nbsp;Tom Gilbert BSc(Hons) ,&nbsp;Saadia Aslam MB ,&nbsp;Cassandra L. Brookes BSc, MSc ,&nbsp;Anvesha Singh BM, PhD ,&nbsp;David E. Newby BA, BSc, PhD, BM, DM, DSc ,&nbsp;Marc R. Dweck BSc, MBChB, MRCP ,&nbsp;Ralph A. H． Stewart MBChB, MD ,&nbsp;Paul S. Myles MBBS, MPH, MD, DSc ,&nbsp;Tom Briffa PhD ,&nbsp;Joseph Selvanayagam MBBS(Hons) DPhil ,&nbsp;Clara K. Chow MBBS, PhD ,&nbsp;Gavin J. Murphy BSc, MBChB, MD ,&nbsp;Enoch F. Akowuah MBChB(Hons), MD, MRCS ,&nbsp;Joanne Lord BSc, MSc, PhD ,&nbsp;Shaun Barber BSc, PhD ,&nbsp;Ana Suazo Di Paola BSc, MSc ,&nbsp;Gerry P. McCann BSc, MBChB, MD ,&nbsp;Graham S. Hillis BMedBiol, MBChB, PhD","doi":"10.1016/j.ahj.2024.05.013","DOIUrl":"10.1016/j.ahj.2024.05.013","url":null,"abstract":"<div><h3>Background</h3><p>Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The <u>E</u>arly valve replacement in severe <u>ASY</u>mptomatic <u>A</u>ortic <u>S</u>tenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of ‘watchful waiting’.</p></div><div><h3>Methods</h3><p>In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction &lt;50%, previous aortic valve replacement or life expectancy &lt;2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life.</p></div><div><h3>Results</h3><p>Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up.</p></div><div><h3>Conclusions</h3><p>The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001285/pdfft?md5=dfce1202fcab2521c060ba9c3c7fc07b&pid=1-s2.0-S0002870324001285-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141183642","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":"Overview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system","authors":"Lior Lupu MD, MBA,&nbsp;Dan Haberman MD,&nbsp;Kalyan R. Chitturi DO,&nbsp;Jason P. Wermers MS,&nbsp;Itsik Ben-Dor MD,&nbsp;Ron Waksman MD","doi":"10.1016/j.ahj.2024.05.011","DOIUrl":"10.1016/j.ahj.2024.05.011","url":null,"abstract":"<div><p>Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178970","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":"Intramuscular versus enteral penicillin prophylaxis to prevent progression of rheumatic heart disease: Study protocol for a noninferiority randomized trial (the GOALIE trial)","authors":"Joselyn Rwebembera MMed ,&nbsp;Emma Ndagire MMed ,&nbsp;Natalie Carvalho PhD ,&nbsp;Allison R. Webel PhD ,&nbsp;Craig Sable MD ,&nbsp;Emmy Okello PhD ,&nbsp;Rachel Sarnacki MBA ,&nbsp;Alison M. Spaziani MPH ,&nbsp;Atukunda Mucunguzi Msc ,&nbsp;Daniel Engelman PhD ,&nbsp;Anneke Grobler PhD ,&nbsp;Andrew Steer PhD ,&nbsp;Andrea Beaton MD","doi":"10.1016/j.ahj.2024.05.012","DOIUrl":"10.1016/j.ahj.2024.05.012","url":null,"abstract":"<div><h3>Background</h3><p>Rheumatic Heart Disease (RHD) persists as a major cardiovascular driver of mortality and morbidity among young people in low-and middle-income countries. Secondary antibiotic prophylaxis (SAP) with penicillin remains the cornerstone of RHD control, however, suboptimal treatment adherence undermines most secondary prevention programs. Many of the barriers to optimal SAP adherence are specific to the intramuscular form of penicillin and may potentially be overcome by use of oral penicillin. This noninferiority trial is comparing the efficacy of intramuscular to oral penicillin SAP to prevent progression of mild RHD at 2 years.</p></div><div><h3>Methods/Design</h3><p>The Intramuscular vs Enteral Penicillin Prophylaxis to Prevent Progression of Rheumatic Heart Disease (GOALIE) trial is randomizing Ugandan children aged 5 to 17 years identified by echocardiographic screening with mild RHD (Stage A or B as defined by 2023 World Heart Federation criteria) to Benzathine Benzyl Penicillin G (BPG arm, every-28-day intramuscular penicillin) or Phenoxymethyl Penicillin (Pen V arm, twice daily oral penicillin) for a period of 2 years. A blinded echocardiography adjudication panel of 3 RHD experts and 2 cardiologists is determining the echocardiographic stage of RHD at enrollment and will do the same at study completion by consensus review. Treatment adherence and study retention are supported through peer support groups and case management strategies. The primary outcome is the proportion of children in the Pen V arm who progress to more advanced RHD compared to those in the BPG arm. Secondary outcomes are patient-reported outcomes (treatment acceptance, satisfaction, and health related quality of life), costs, and cost-effectiveness of oral compared to intramuscular penicillin prophylaxis for RHD. A total sample size of 1,004 participants will provide 90% power to demonstrate noninferiority using a margin of 4% with allowance for 7% loss to follow-up. Participant enrollment commenced in October 2023 and final participant follow-up is expected in December 2026. The graphical abstract (Fig. 1) summarizes the flow of echocardiographic screening, participant enrollment and follow-up.</p></div><div><h3>Discussion</h3><p>The GOALIE trial is critical in global efforts to refine a pragmatic approach to secondary prevention for RHD control. GOALIE insists that the inferiority of oral penicillin be proven contemporarily and against the most important near-term clinical outcome of progression of RHD severity. This work also considers other factors that could influence the adoption of oral prophylaxis and change the calculus for acceptable efficacy including patient-reported outcomes and costs.</p></div><div><h3>Trial Registration</h3><p>ClinicalTrials.gov: NCT05693545</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001273/pdfft?md5=82e9678fae7f1411d6728a94ffbcde20&pid=1-s2.0-S0002870324001273-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141136736","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}