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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 育龄妇女高血压风险的社会决定因素(SAFE HEART)研究的设计与原理:美国心脏协会 "红色研究 "计划。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-09 DOI: 10.1016/j.ahj.2024.05.016

Background

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.

Methods

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.

Discussion

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.

背景:心血管健康知识(CVHL)和健康的社会决定因素(SDoH)在塑造心血管健康(CVH)结果方面发挥着相互关联的关键作用。然而,人们对心血管健康风险的认识却明显下降,从 2009 年 65% 的女性意识到心血管疾病(CVD)是导致女性死亡的主要原因,到 2019 年仅有 44% 的女性意识到这一点。美国心脏协会 "红色研究"(RGR)计划旨在开发一个开源、纵向、动态的登记册,帮助女性了解和参与研究,并学习心血管疾病的预防知识。我们建议利用这一平台,特别是在黑人和西班牙裔育龄妇女中,解决心血管疾病和慢性心血管疾病的差距,促进健康公平:本研究的主要目的是评估心血管健康素养(CVHL)、使用多元社会评分的 SDoH 以及高血压(HTN)发病风险增加的育龄妇女的心血管健康素养之间的横向联系。为此,我们将采用横断面研究设计,让已加入 RGR 注册表(注册表已注册)的妇女参与其中。为了增强队列的种族和民族/社会经济多样性,我们还将从巴尔的摩和华盛顿特区社区招募 300 名妇女参加 "育龄妇女高血压风险的社会决定因素(SAFE HEART)研究"。社区注册和注册妇女将接受基线社会表型分析,包括详细的 SDoH 问卷、CVH 指标评估和 CVHL 评估。次要目标是评估为期 4 个月的积极健康教育干预是否会导致 300 名社区登记妇女的 CVHL 发生变化:讨论:SAFE HEART 研究探讨了 CVHL、SDoH 和 CVH 之间的关联,重点关注少数民族群体和社会经济条件较差的育龄妇女,以及通过教育干预改善这些参数的能力。这些发现将为今后制定社区参与战略,解决育龄妇女的 CVHL 和 SDoH 问题提供参考。
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引用次数: 0
Information for Readers 读者信息
IF 4.8 2区 医学 Q1 Medicine Pub Date : 2024-06-08 DOI: 10.1016/S0002-8703(24)00134-0
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引用次数: 0
Prediction of 30‐day mortality after surgery for infective endocarditis using risk scores: Insights from a European multicenter comparative validation study 使用风险评分预测感染性心内膜炎术后 30 天的死亡率:欧洲多中心比较验证研究的启示。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-06 DOI: 10.1016/j.ahj.2024.05.021
Giuseppe Gatti MD , Antonio Fiore MD, PhD , Maria Ismail MD , Andriy Dralov MD , Wael Saade MD , Venera Costantino MSc , Giulia Barbati MStat , Pascal Lim MD, PhD , Raphael Lepeule MD, PhD , Ilaria Franzese MD , Alessandro Minati MD , Sandro Sponga MD, PhD , Enrico Fabris MD, PhD , Roberto Luzzati MD, PhD , Gianfranco Sinagra MD, PhD , Giuseppe Biondi-Zoccai MD, MStat , Giacomo Frati MD, PhD , Andrea Perrotti MD, PhD , Igor Vendramin MD, PhD , Enzo Mazzaro MD

Background

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).

Methods

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, Staphylococcus spp, 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.

Results

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, P = .01 or less). For a higher/lesser than 20% expected mortality, the agreement of prediction between APORTEI score and EuroSCORE II was 86%.

Conclusion

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.

背景:目前尚不清楚专为预测感染性心内膜炎(IE)心脏手术后早期死亡率而创建的风险评分是否优于欧洲心脏手术风险评估系统 II(EuroSCORE II):方法:对欧洲多中心系列确诊 IE 手术患者的围手术期数据和结果进行了回顾性研究。仅保留已知病原体且所有考虑变量均无缺失值的病例进行分析。比较验证了EuroSCORE II和五种特定的IE术后早期死亡率风险评分--(1) STS-IE(胸外科医师协会IE评分);(2) PALSUSE(人工瓣膜、年龄≥70岁、心内大面积破坏、葡萄球菌属、紧急手术、性别(女性)、EuroSCORE≥10);(3) ANCLA(贫血、纽约心脏协会 IV 级、危急状态、心内大面积损伤、胸主动脉手术); (4) AEPEI II(心内膜感染研究与预防协会 II);(5) APORTEI(Análisis de los factores PROnósticos en el Tratamiento quirúrgico de la Endocarditis Infeciosa)- 采用校准图和接收器工作特征曲线分析法。根据汉利-麦克尼尔法,对曲线下面积(AUC)进行了1:1比较。此外,还评估了 APORTEI 评分与 EuroSCORE II 预测术后 30 天死亡率的一致性:来自欧洲五所大学附属中心的 1012 名患者接受了 1036 例心脏手术,术后 30 天死亡率为 9.7%。所有IE特异性风险评分的校准结果均优于EuroSCORE II;AEPEI II和APORTEI评分表现最佳。尽管校准效果不佳,但EuroSCORE II在辨别每种特异性风险评分方面都胜出一筹(AUC,0.751 vs. 0.693或更低,p=0.01或更低)。对于高于/低于20%的预期死亡率,APORTEI评分和EuroSCORE II的预测一致率为86%:结论:EuroSCORE II 对 IE 术后 30 天死亡率的判别高于五种已建立的 IE 特异性风险评分。AEPEI II 和 APORTEI 评分的校准结果最好。
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引用次数: 0
The relative merits of using a high-sensitivity cardiac Troponin T assay compared to a nonhigh-sensitivity troponin T assay after noncardiac surgery 非心脏手术后使用高灵敏度心肌肌钙蛋白 T 检测法与非高灵敏度心肌肌钙蛋白 T 检测法的相对优势。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-06 DOI: 10.1016/j.ahj.2024.05.020
Flavia K. Borges MD, PhD , Daniel I. Sessler MD , Maria Tiboni MD , Ameen Patel MD , Yannick LeManach MD, PhD , Diane Heels-Ansdell BSc, MSc , Sadeesh Srinathan MD , Chew Yin Wang MBChB , Clara Chow MD, PhD , Emmanuelle Duceppe MD, PhD , Peter Kavsak BSc, PhD , Sandra N. Ofori MBBS, MSc , Shirley Pettit RN , Otavio Berwanger MD, PhD , Andrea Kurz MD , Alparslan Turan MD , Ana Claudia Tonelli MD, PhD , PJ Devereaux MD, PhD , VISION Study Investigators

Introduction

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.

Methods

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).

Results

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; P = .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 (P-value < .001).

Conclusions

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.

导言:非心脏手术后肌钙蛋白升高与 30 天死亡风险升高有关。在非心脏手术环境中使用第五代检测方法高敏肌钙蛋白 T(hsTnT)与第四代检测方法非高敏肌钙蛋白 T(non-hsTnT)的相对优势鲜为人知。我们的目的是确定 hsTnT 是否能识别出更多的高危患者,而如果采用非 hsTnT 测量,这些患者可能会被漏诊:VISION 研究纳入了 40,004 名接受术后肌钙蛋白测量的非心脏手术患者。其中,1806 名患者同时进行了第四代非 hsTnT 和第五代 hsTnT 的测量(4451 个配对结果)。我们比较了不同阈值的绝对浓度、时间和对预测 30 天主要心血管并发症(死亡、非致命性心脏骤停、冠状动脉血运重建和充血性心力衰竭的综合结果)的影响:根据制造商设定的 14 纳克/升阈值,有 580 例(32.1%)患者的术后 hsTnT 浓度高于阈值,而他们的非 hsTnT 浓度低于制造商设定的阈值。与 hsTnT 浓度低于制造商阈值的患者相比,这 580 名患者发生重大心血管事件的风险更高(OR 2.33;CI 95% 1.04-5.23;P=0.049)。在非心脏手术后出现心肌损伤的患者中,只有 54% 的患者能在术后 6-12 小时内被第四代非 hsTnT 检测方法检测到,而第五代 hsTnT 检测方法的检测率为 86%(P 值 结论):在术后头 3 天内,第 5 代 hsTnT 至少能发现三分之一的肌钙蛋白升高患者,而在这种情况下,如果使用已公布的阈值,第 4 代非 hsTnT 可能无法检测到肌钙蛋白升高。此外,第五代 hsTnT 发现肌钙蛋白升高患者的时间早于第四代非 hsTnT,这表明第五代 hsTnT 有可能改善术后风险分层。
{"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}
引用次数: 0
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 在冠状动脉疾病患者中使用西罗莫司洗脱铁生物可吸收支架与钴铬依维莫司洗脱支架:IRONMAN-II 试验的原理与设计。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-04 DOI: 10.1016/j.ahj.2024.05.019
Lei Song MD , Changdong Guan MSc , Mengyue Yu MD , Zhongwei Sun MSc , Guosheng Fu MD , Yong He MD , Shaobin Jia MD , Jiyan Chen MD , Feng Qi MD , Jie Bai MD , Wei li MD , Junbo Ge MD , Yaling Han MD , Runlin Gao MD

Background

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).

Methods

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).

Conclusion

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.

背景:之前的首次人体研究初步确定了新型薄支架铁生物可吸收支架(IBS)的安全性和有效性。目前的研究旨在直接比较 IBS 与当代金属药物洗脱支架(DES)的成像、生理疗效和临床结果:方法:来自中国 36 个中心的 518 名患者被随机分配接受 IBS(257 名)或金属 DES(261 名)治疗。该研究的主要终点是2年的节段内晚期管腔损失,主要次要终点是2年的定量血流比和光学相干断层扫描(OCT)测量的横截面平均血流面积(仅限于OCT亚组,每组25名患者):这将是首个研究新型薄支架 IBS 与当代金属 DES 相比的安全性和有效性的有效随机试验。研究结果将为今后此类研究和金属生物可吸收支架的应用提供宝贵的证据。
{"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}
引用次数: 0
Echocardiographic and clinical features of patients developing prosthesis‐patient mismatch after transcatheter aortic valve replacement: Insights from the Recovery-TAVR registry TAVR 术后假体与患者不匹配患者的超声心动图和临床特征:Recovery TAVR 登记的启示。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-03 DOI: 10.1016/j.ahj.2024.05.015
Francesco Bruno MD , Joao Matteo Rampone MD , Fabian Islas MD , Riccardo Gorla MD , Guglielmo Gallone MD , Francesco Melillo MD , Pier Pasquale Leone MD , Paolo Cimaglia MD , Maria Concetta Pastore MD , Anna Franzone MD , Federico Landra MD , Luca Scudeler MD , Pilar Jimenez-Quevedo MD , Tommaso Viva MD , Francesco Piroli MD , Renato Bragato MD , Michele Trichilo MD , Anna Degiovanni MD , Stefano Salizzoni MD , Federica Ilardi MD , Fabrizio D'Ascenzo MD

Background

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.

Methods

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.

Results

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, P = .33), aged 82 (IQR 79-85y) years vs 82 (IQR 78-86 P = .46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, P = .04); they had smaller left ventricular outflow tract (LVOT) diameter (20 mm, IQR 19-21 vs 20 mm, IQR 20-22, P = .02), reduced SVi (34.2 vs 38 mL/m2, P < .01) and transaortic flow rate (190.6 vs 211 mL/s, P < .01). At predischarge FU patients with PPM had more paravalvular aortic regurgitation (moderate-severe AR 15.8% vs 9.2%, P < .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, P = .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, P = .02)). No evidence of a significant impact of PPM on overall (P = .71) and CV (P = .70) mortality was observed. Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, P = .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, P < .001) and LVOT diameter (OR 0.79, 0.65-0.95, P = .01) had protective effect.

Conclusions

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

背景:假体与患者不匹配(PPM)对经导管主动脉瓣置换术(TAVR)术后主要终点的影响尚存争议,对心脏损伤进展的影响也鲜有研究。因此,我们的研究旨在评估中低手术风险患者 "真实世界 "队列中 PPM 的发生率和预测因素,及其对死亡率和心脏损伤的临床超声心动图进展的影响。方法:本分析纳入了来自 RECOVERY-TAVR 国际多中心观察登记处的 963 名在 2017 年至 2021 年期间接受 TAVR 手术的患者。对这些患者的多参数超声心动图数据进行了1年随访(FU)分析。根据最新的国际建议,采用 VARC-3 标准将临床和超声心动图特征按是否存在 PPM 和 PPM 的严重程度进行分层:结果:18%的患者在TAVR术后出现了PPM。结果:18%的患者在TAVR术后出现了PPM,其中7.7%的患者出现了严重的PPM。基线时,50.3% 的 PPM 患者为男性(与无 PPM 患者的 46.2% 相比,P=0.33),年龄为 82(IQR 79-85y)岁(与 82(IQR 78-86 相比,P=0.46)岁),55.6% 的患者植入了球囊扩张瓣膜(与无 PPM 患者的 46.8%,P=0.04);他们的左心室流出道(LVOT)直径较小(20 mm,IQR 19-21 vs 20 mm,IQR 20-22,P=0.02),SVi降低(34.2 vs 38 ml/m2,P结论:18%的TAVR患者观察到PPM。超声心动图评估显示了与PPM相关的早期心室适应性不良改变模式,这可能是心功能减退的前兆,与NYHA分级在1年内的显著恶化有关。这些发现强调了在接受TAVR手术的患者中预防任何级别的PPM的重要性,尤其是在高危人群中。
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引用次数: 0
Seattle proportional risk model in GISSI-HF: Estimated benefit of ICD in patients with EF less than 50% GISSI-HF 中的西雅图比例风险模型:EF 小于 50% 患者 ICD 的估计获益:EF <50 患者 ICD 的估计获益。
IF 4.8 2区 医学 Q1 Medicine Pub Date : 2024-05-31 DOI: 10.1016/j.ahj.2024.05.014
Lee B. Bockus MD PhD , Ramin Shadman MD , Jeanne E. Poole MD , Todd F. Dardas MD , Donata Lucci MS , Jennifer Meessen MSc , Roberto Latini MD , Aldo Maggioni MD , Wayne C. Levy MD

Background

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 <50%.

Methods

The SPRM was estimated in patients with EF ≤50% and in a logistic regression model comparing SCD with non-SCD.

Results

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, P < 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.

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 >50%, 47.8% may be eligible, including 30.2% with EF >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).

Conclusions

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.

背景:西雅图比例风险模型(SPRM)可估算出心力衰竭(HF)患者的心脏性猝死(SCD)比例,从而确定最有可能从植入式心律转复除颤器(ICD)治疗中获益的人(SCD估计比例≥50%的人)。GISSI-HF试验测试了鱼油和洛伐他汀在高血压患者中的应用。我们使用 SPRM 评估其在该队列中预测 EF≤50% 且 SPRM 预测的 SCD 比例≥50% 或方法的患者中 ICD 潜在获益的准确性:在 EF≤50% 的患者中以及在比较 SCD 与非 SCD 的逻辑回归模型中估算 SPRM:我们对6750名EF≤50%的患者进行了评估。共有 1,892 例全因死亡,其中包括 610 例 SCD。50%的EF≤35%患者和43%的EF36%至50%患者的SPRM≥50%。SPRM(OR:1.92,P<0.0001)准确预测了SCD与非SCD的风险,1年后SCD的估计比例为44%,而观察到的比例为41%。按照传统的 ICD 植入标准(EF ≤35%,NYHA II 级或 III 级),64.5% 的 GISSI-HF 患者符合条件,估计 ICD 的获益率为 0.81。SPRM >50%时,47.8%的患者可能符合条件,其中 30.2%的患者 EF >35%。EF≤35%且SPRM≥50%的GISSI-HF参与者估计ICD HR为0.64,与EF36%至50%且SPRM≥50%的患者相当(HR:0.65):SPRM可区分GISSI-HF患者中的SCD与非SCD,无论是EF≤35%的患者,还是EF36%至50%的患者。EF≤35%和EF36%-50%患者的ICD获益估计值相当,这支持使用比例风险模型为考虑接受一级预防ICD治疗的患者做出共同决策。
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引用次数: 0
Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial 重度 ASYmptomatic 主动脉瓣狭窄早期瓣膜置换术试验的原理和设计。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-30 DOI: 10.1016/j.ahj.2024.05.013
Carla Richardson BSc, MSc , Tom Gilbert BSc(Hons) , Saadia Aslam MB , Cassandra L. Brookes BSc, MSc , Anvesha Singh BM, PhD , David E. Newby BA, BSc, PhD, BM, DM, DSc , Marc R. Dweck BSc, MBChB, MRCP , Ralph A. H. Stewart MBChB, MD , Paul S. Myles MBBS, MPH, MD, DSc , Tom Briffa PhD , Joseph Selvanayagam MBBS(Hons) DPhil , Clara K. Chow MBBS, PhD , Gavin J. Murphy BSc, MBChB, MD , Enoch F. Akowuah MBChB(Hons), MD, MRCS , Joanne Lord BSc, MSc, PhD , Shaun Barber BSc, PhD , Ana Suazo Di Paola BSc, MSc , Gerry P. McCann BSc, MBChB, MD , Graham S. Hillis BMedBiol, MBChB, PhD

Background

Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (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’.

Methods

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 <50%, previous aortic valve replacement or life expectancy <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.

Results

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.

Conclusions

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.

背景:无症状重度主动脉瓣狭窄的主动脉瓣置换术尚存争议。重度无症状主动脉瓣狭窄早期瓣膜置换术(EASY-AS)试验旨在确定,与指南推荐的 "观察等待 "策略相比,早期主动脉瓣置换术是否能改善临床效果、生活质量和成本效益:在一项务实的国际开放式平行分组随机对照试验(NCT04204915)中,2844 名重度主动脉瓣狭窄患者将按 1:1 的比例随机接受早期(手术或经导管)主动脉瓣置换术,或仅在出现症状或左心室功能受损时接受主动脉瓣置换术。排除标准包括其他严重瓣膜疾病、计划中的心脏手术、射血分数结果:招募工作于 2020 年 3 月开始,目前在英国、澳大利亚、新西兰和塞尔维亚开放。2022 年 7 月达到可行性要求,主要阶段于 2022 年 10 月开始,其他国际中心正在筹备中:EASY-AS试验将确定对无症状的重度主动脉瓣狭窄患者实施早期主动脉瓣置换术的策略是否能降低心血管死亡率或心衰住院率,并改善其他重要预后。
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引用次数: 0
Overview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system 关于 TriClip 经导管三尖瓣修复系统的 2024 年 FDA 顾问小组会议概述。
IF 4.8 2区 医学 Q1 Medicine Pub Date : 2024-05-29 DOI: 10.1016/j.ahj.2024.05.011
Lior Lupu MD, MBA, Dan Haberman MD, Kalyan R. Chitturi DO, Jason P. Wermers MS, Itsik Ben-Dor MD, Ron Waksman MD

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.

三尖瓣反流(TR)是一种常见病,死亡率和发病率都很高。由于内科和外科治疗的有效性和安全性有限,治疗这种疾病的巨大需求尚未得到满足。因此,为这类患者提供更安全、更微创、更有效治疗方案的经皮设备市场正在不断扩大。2024 年 2 月 13 日,美国食品和药物管理局(FDA)召开循环系统器械小组会议,讨论 TriClip 经导管瓣膜修复系统(雅培,美国加利福尼亚州圣克拉拉市)的安全性和有效性。会议讨论了几个重要问题,包括 TRILUMINATE 关键性研究最新公布的数据、在批准器械时使用以患者为导向的结果,以及在批准突破性器械时有关培训要求和推广计划的讨论。在本手稿中,我们总结了赞助商和 FDA 提交的数据,并描述了会议期间的审议和讨论情况。
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引用次数: 0
Intramuscular versus enteral penicillin prophylaxis to prevent progression of rheumatic heart disease: Study protocol for a noninferiority randomized trial (the GOALIE trial) 肌肉注射与肠内注射青霉素预防风湿性心脏病进展:非劣效性随机试验(GOALIE 试验)研究方案
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-24 DOI: 10.1016/j.ahj.2024.05.012
Joselyn Rwebembera MMed , Emma Ndagire MMed , Natalie Carvalho PhD , Allison R. Webel PhD , Craig Sable MD , Emmy Okello PhD , Rachel Sarnacki MBA , Alison M. Spaziani MPH , Atukunda Mucunguzi Msc , Daniel Engelman PhD , Anneke Grobler PhD , Andrew Steer PhD , Andrea Beaton MD

Background

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.

Methods/Design

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.

Discussion

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.

Trial Registration

ClinicalTrials.gov: NCT05693545

背景风湿性心脏病(RHD)一直是导致中低收入国家年轻人死亡和发病的主要心血管疾病。使用青霉素进行二级抗生素预防(SAP)仍然是控制风湿性心脏病的基石,然而,治疗依从性不佳破坏了大多数二级预防计划。影响最佳SAP依从性的许多障碍是青霉素肌肉注射剂所特有的,而口服青霉素则有可能克服这些障碍。这项非劣效性试验比较了肌肉注射和口服青霉素 SAP 对预防轻度 RHD 在 2 年内恶化的疗效。方法/设计 肌肉注射与口服青霉素预防风湿性心脏病进展(GOALIE)试验将对通过超声心动图筛查确定患有轻度风湿性心脏病(根据世界心脏联盟2023年标准定义的A期或B期)的5至17岁乌干达儿童随机分组,采用苄星青霉素G(BPG组)和口服青霉素SAP(SAP组)、苄青霉素 G(BPG 组,每 28 天肌肉注射一次青霉素)或苯氧甲基青霉素(Pen V 组,每天口服两次青霉素),为期 2 年。由 3 位 RHD 专家和 2 位心脏病专家组成的超声心动图盲法评审小组将在入组时确定 RHD 的超声心动图分期,并将在研究结束时通过共识审查确定同样的分期。通过同伴支持小组和病例管理策略,为坚持治疗和保留研究提供支持。主要结果是 Pen V 治疗组与 BPG 治疗组相比,发展为更晚期 RHD 的儿童比例。次要结果是患者报告的结果(治疗接受度、满意度和与健康相关的生活质量)、成本,以及口服青霉素与肌肉注射青霉素预防治疗 RHD 的成本效益比较。总样本量为 1,004 名参与者,在考虑到 7% 的随访损失的情况下,以 4% 的差值计算,将有 90% 的力量证明非劣效性。该研究于 2023 年 10 月开始招募参与者,预计将于 2026 年 12 月进行最终的参与者随访。图表摘要(图 1)总结了超声心动图筛查、参试者注册和随访的流程。GOALIE 坚持认为,口服青霉素的劣势必须在当时得到证实,而且必须针对 RHD 严重程度进展这一最重要的近期临床结果。这项工作还考虑了其他可能影响口服预防的因素,并改变了可接受疗效的计算方法,包括患者报告的结果和成本:NCT05693545
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引用次数: 0
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American heart journal
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