Journal of the American College of Cardiology最新文献

{"title":"Effect of Time-Varying Exposure to School-Based Health Promotion on Adiposity in Childhood","authors":"Ying Fang, Changlin Zhai, Haihua Pan","doi":"10.1016/j.jacc.2024.08.084","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.084","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"211 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142793378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply: Considerations on the SI! Program for Elementary Schools Trial","authors":"Gloria Santos-Beneit, Rodrigo Fernández-Jiménez, Valentin Fuster","doi":"10.1016/j.jacc.2024.09.1241","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.09.1241","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"83 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142793379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Importance of Growing the Next Generation of Global Cardiovascular Leaders","authors":"Cathleen Biga, Wael Al Mahmeed","doi":"10.1016/j.jacc.2024.11.010","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.11.010","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"262 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142763236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In the Wake of OCEANIC-AF, Is Equipoise Regarding Factor XI Inhibition Still Afloat?","authors":"C. Michael Gibson","doi":"10.1016/j.jacc.2024.10.105","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.105","url":null,"abstract":"Although factor Xa inhibitors reduce intracranial hemorrhage vs vitamin K antagonists in atrial fibrillation (AF),<span><span>¹</span></span> concerns regarding nonintracranial bleeding have led to the development of factor XI/XIa inhibitors, which offer the promise of uncoupling pathologic thrombosis from normal hemostasis. Although phase 2 and 3 studies support the safety of factor XI/XIa inhibition in a variety of settings, the premature termination of OCEANIC-AF (Oral FXI(a) Inhibition Compared to Standard Therapy in Patients With Atrial Fibrillation) because of the inferior efficacy of asundexian compared to apixaban<span><span>²</span></span> has raised important questions. Is this a class effect? Is there still equipoise regarding the efficacy of factor XI/XIa inhibitors? To represent a therapeutic advance, the right drug must be administered at the right dose to the right subject. The results of OCEANIC-AF can be evaluated in the context of this drug development paradigm.","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"18 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142763235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital Health Technologies for Cardiometabolic Disease and Diabetes: A Perspective From the U.S. Food and Drug Administration","authors":"Haider J. Warraich, Bray Patrick-Lake, Anindita Saha, Leeda Rashid, Vinay Pai, Ali Abbasi, Matthew C. Diamond, Troy Tazbaz, Robert M. Califf","doi":"10.1016/j.jacc.2024.10.075","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.075","url":null,"abstract":"&lt;h2&gt;Section snippets&lt;/h2&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Overview of DHT Regulation&lt;/h2&gt;DHTs that meet the definition of a medical device are regulated by the FDA, which applies regulatory controls and marketing pathways based on the intended use and potential risk of the device (Figure 1). Devices are classified from Class 1 with the lowest risk (eg, a toothbrush, Digital Visual Acuity Test), Class 2 with intermediate risk (eg, CGMs, WellDoc’s Bluestar, a digital therapeutic for type 2 diabetics to help them manage their condition), to Class 3 with the highest risk (eg,&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Gaps in Evidence&lt;/h2&gt;A major limitation inhibiting widespread adoption of DHTs is the lack of evidence of a causal link between recommendations to use particular DHTs, actual use, and improved clinical outcomes in the population for whom the DHT is recommended. Although studies have shown that the detection of cardiometabolic disease by DHTs can be successfully validated relative to measures like blood glucose or hemoglobin A1c, it remains unclear whether their use makes a difference in the clinical status of those&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Gaps in Clinical Integration&lt;/h2&gt;Lack of integration can affect the effectiveness of DHTs, particularly in the postmarket phase. The tendency for each new “app” to exist as a standalone product or point solution without integration into a coherent base of technologies or unified applicably at the point of care creates an enormous barrier to uptake and leads to skepticism among clinicians, health systems, and payers. Many stand-alone DHTs may be unlikely to provide definitive diagnostic information or be comprehensive enough to&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Gaps in Patient Access and Retention&lt;/h2&gt;Cardiometabolic disease is disproportionately concentrated among people who face broad socioeconomic challenges. However, DHTs have greater uptake in groups with lower disease prevalence rates, exacerbating the “digital divide.” This digital divide is worsened by the poor evidence base leading to sparse insurance coverage, making these technologies accessible only to more affluent patients. Many disadvantaged groups can face additional barriers such as mistrust of institutionalized health care&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Developing a Value Proposition for DHTs&lt;/h2&gt;The prime deficiency of most DHTs is a lack of evidence showing their use leads to health benefits for patients, improved care management for clinicians, and economic value to payers. Careful testing and validation has been used for decades by manufacturers of drugs, devices, and biologics, resulting in great success for manufacturers, the health system, payers, and the public. This results in an ecosystem wherein manufacturers have incentive to innovate, and health systems, payers, and the&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;The Role of Clinicians and Health Systems&lt;/h2&gt;Clinicians can play critical roles in ensuring ","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"261 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142763247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic and Prognostic Performance of High-Sensitivity Cardiac Troponin T vs I","authors":"Luca Koechlin, Jasper Boeddinghaus, Dimitrios Doudesis, Pedro Lopez-Ayala, Tobias Zimmermann, Klara Rumora, Jeanne du Fay de Lavallaz, Ziwen Li, Kuan Ken Lee, Andrew R. Chapman, Karin Wildi, Danielle M. Gualandro, Muntadher Al Karam, Maria Rubini Giménez, Gabrielle Huré, Òscar Miró, Zoe Klein, Paolo Bima, Desiree Wussler, Michael Christ, Christian Mueller","doi":"10.1016/j.jacc.2024.10.076","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.076","url":null,"abstract":"<h2>Section snippets</h2><section><section><section><h2>Study design</h2>This was a secondary analysis of the APACE (Advantageous Predictors of Acute Coronary Syndromes Evaluation; <span><span>NCT00470587</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>) study.⁷ For this analysis, we excluded patients with ST-segment elevation MI, patients in whom the diagnosis remained unclear even after final adjudication and had at least 1 elevated concentration of hs-cTnT/I, and patients with missing hs-cTnT or hs-cTnI measurements at presentation. The study was performed according to the principles of the Declaration of Helsinki and</section></section></section><section><section><h2>Results</h2>Among 7,614 patients (median age: 61 years [Q1-Q3: 48.0-73.0 years]; 34% women), 18.3% had MI when using hs-cTnT for adjudication and 17.3% when using hs-cTnI for adjudication, respectively.</section></section><section><section><h2>Discussion</h2>In this large prospective, international, multicenter study with external validation, we directly compared the diagnostic and prognostic performance of hs-cTnT and hs-cTnI.The main findings of this study were that hs-cTnI had a slightly higher diagnostic accuracy for MI and that hs-cTnT had higher prognostic accuracy for all-cause and CV death. These findings are of interest to clinicians because both assays are currently considered equivalent in both indications. Their underlying</section></section><section><section><h2>Conclusions</h2>hs-cTnT and hs-cTnI differ in their diagnostic and prognostic performance.</section></section><section><section><h2>Funding Support and Author Disclosures</h2>The APACE study was supported by research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the University Hospital Basel, the University of Basel, Abbott, Beckman Coulter, Brahms, Idorsia, LSI Medience Corporation, Ortho Clinical Diagnostics, Quidel, Roche, Siemens, Singulex, and SpinChip Diagnostics. The BASEL VIII study was supported by research grants from the Swiss Heart Foundation, the KTI, the European Union, the University Hospital Basel, the</section></section><section><section><h2>Acknowledgments</h2>The authors are indebted to the patients who participated in the study and to the emergency department staff as well as the laboratory technicians of all participating sites for their most valuable efforts.</section></section>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"208 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142763238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamic Trends and Practice Patterns in Femoropopliteal Revascularization From 2016 Through 2023","authors":"Joseph M. Kim, Siling Li, Yang Song, Robert W. Yeh, Eric A. Secemsky","doi":"10.1016/j.jacc.2024.10.102","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.102","url":null,"abstract":"<h2>Section snippets</h2><section><section><section><h2>Data sources</h2>The study included all Medicare fee-for-service beneficiaries aged ≥66 years who underwent femoropopliteal revascularization by International Classification of Diseases–10th Revision codes between January 1, 2016, and December 31, 2023. Patient comorbidities were identified using the Chronic Conditions Warehouse data, and procedural data were identified using claims codes.</section><section><h2>Statistical analyses</h2>Trends of femoropopliteal artery revascularization procedures were examined by quarter year from January 1. 2016, to</section></section></section><section><section><h2>Results</h2>During the study period, the number of endovascular revascularization procedures declined 38.2%; the number of surgical revascularization procedures declined 59.7%. PTA was the primary device (27.72%) used for endovascular revascularization before the onset of the paclitaxel-coated device safety concern (years 2016-2018), followed closely by DCB (24.91%). After the paclitaxel safety concern, the use of DCBs declined to a nadir of 17.89% by 2019, with a proportional increase in the use of</section></section><section><section><h2>Discussion</h2>In this analysis of &gt;275,000 Medicare fee-for-service beneficiaries, we found a substantial decline in endovascular and surgical revascularizations. The paclitaxel safety concern sparked a rapid shift away from the use of paclitaxel-coated devices and toward the use of uncoated devices, particularly PTA. The use of DCBs has only recently regained some ground since its nadir in 2019, but their use remains remarkably low relative to PTA despite evidence supporting their superior efficacy and the</section></section><section><section><h2>Conclusions</h2>The onset of the paclitaxel safety concern is associated with a decrease in the use of drug-coated device use in femoropopliteal revascularization and is associated with increased mortality, exacerbated further after the onset of the COVID pandemic.</section></section><section><section><h2>Funding Support and Author Disclosures</h2>This research was sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) and supported by an educational grant from Abbott Vascular. The views presented here represent those of the authors and do not necessarily reflect the official views of SCAI or Abott Vascular. Dr Yeh has received research funding from Boston Scientific, Abbott, and Medtronic; and has been a consultant for Boston Scientific, Abbott, Medtronic, Edwards, CathWorks, and Shockwave. Dr Secemsky has</section></section>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"46 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142763192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Patient Behind the Doctor","authors":"Denisa Metani","doi":"10.1016/j.jacc.2024.10.073","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.073","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Funding Support and Author Disclosures</h2>The author has reported that she has no relationships relevant to the contents of this paper to disclose.</section></section>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"8 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142763222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Coming AI Revolution in Clinical Trials","authors":"Sneha S. Jain, Ashish Sarraju, Nigam H. Shah, Kevin A. Schulman, Euan A. Ashley, Robert A. Harrington, Kenneth W. Mahaffey","doi":"10.1016/j.jacc.2024.10.093","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.093","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Digital Strategy and Data Infrastructure</h2>Current systems for data storage and analysis are siloed, limiting the potential for AI to function efficiently across data networks. Without interoperable data systems, even the most advanced AI tools will struggle to deliver real impact. We need a unified data strategy—how we manage, integrate, and safeguard data across platforms—focused on a patient-centered data ecosystem that facilitates information flow across EHRs, health system applications, personal records, and clinical trial data</section></section><section><section><h2>Business Model Innovation</h2>Current clinical trial business models are designed around trial sites, not participants. They involve processes that are labor-intensive, duplicative, and burdened by high fixed costs for recruitment, site management, and data collection. Data are often collected redundantly, despite also being obtained for routine clinical care, with gaps in collection due to episodic follow-up instead of continuous monitoring. AI has the potential to streamline certain processes, shorten timelines, and lower</section></section><section><section><h2>Regulatory Modernization and AI Evaluation</h2>Regulatory bodies are crucial in ensuring the safety and efficacy of AI-augmented clinical trials, yet the current regulatory framework was not designed to accommodate the rapid advancements in AI technology or the unique risks of AI use in RCTs. Rather than relying on traditional linear approval pathways, regulators should embrace iterative approaches that incorporate regular feedback. Participants in RCTs that use AI tools for operations are a potentially vulnerable population in which there</section></section><section><section><h2>Funding Support and Author Disclosures</h2>Dr Jain has received consulting fees from Bristol Myers Squibb, ARTIS Ventures, and Broadview Ventures outside of the submitted work. Dr Sarraju holds stock in Medeloop. Dr Ashley is a founder of Personalis, DeepCell, and Svexa; is a founding advisor of Nuevocor; is a nonexecutive director at AstraZeneca; and has served as an advisor for SequenceBio, Novartis, Medical Excellence Capital, Foresite Capital, and Third Rock Ventures. Dr Harrington has served on the Board of Directors for the</section></section>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"35 1 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142763240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Management of Stable Angina","authors":"Iris A. de Koning MSc ,&nbsp;Tom Vromen MD, PhD ,&nbsp;Joyce M. Heutinck MD ,&nbsp;Hareld M.C. Kemps MD ,&nbsp;Dick H.J. Thijssen PhD","doi":"10.1016/j.jacc.2024.08.082","DOIUrl":"10.1016/j.jacc.2024.08.082","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 24","pages":"Pages e339-e340"},"PeriodicalIF":21.7,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142758569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}