American heart journal最新文献

{"title":"Characterizing High-Risk Enrollment Criteria and Impact on Clinical Outcomes in a Large Randomized Clinical Trial: Insights From the TWILIGHT Trial.","authors":"Philippe Gabriel Steg, Johny Nicolas, Usman Baber, Samantha Sartori, Zhongjie Zhang, Yihan Feng, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, George Dangas, Dariusz Dudek, Javier Escaned, C Michael Gibson, Ya-Ling Han, Kurt Huber, Adnan Kastrati, Upendra Kaul, Steven O Marx, Ran Kornowski, Vijay Kunadian, Birgit Vogel, Angelo Oliva, Shamir R Mehta, David Moliterno, Gennaro Sardella, Mitchell Krucoff, Richard A Shlofmitz, Samin Sharma, Stuart Pocock, Roxana Mehran","doi":"10.1016/j.ahj.2025.01.016","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.016","url":null,"abstract":"<p><strong>Background: </strong>The TWILIGHT trial showed that, among high-risk patients who underwent percutaneous coronary intervention (PCI) and were event-free at 3 months, ticagrelor monotherapy versus ticagrelor plus aspirin reduced bleeding without increasing ischemic events.</p><p><strong>Methods: </strong>This post-hoc analysis describes the risk profiles and outcomes of patients enrolled in the TWILIGHT trial. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, and the key secondary outcome was a composite of death, myocardial infarction, or stroke within one year after randomization.</p><p><strong>Results: </strong>The proportion of patients (n=7,119) fulfilling ≤3, 4, 5, or ≥6 risk factors was 21.5%, 32.7%, 27.4%, and 18.4%, respectively. Troponin-positive acute coronary syndrome (ACS) was the most prevalent clinical criterion (64.9%), and multivessel disease (MVD) was the most prevalent angiographic criterion (66.5%). The most frequent intersection of criteria was the combination of troponin-positive ACS, atherosclerotic vascular disease, MVD, left main or proximal anterior descending lesion, and stent length >30 mm. A stepwise increase in ischemic but not in bleeding risk was noted with an increasing number of high-risk criteria. Compared with ticagrelor plus aspirin, ticagrelor monotherapy reduced bleeding regardless of the number of risk factors (≤3-RF: 3.5% vs. 5.8%, HR 0.59, 95% CI [0.38-0.93]; 4-RF: 3.7% vs. 6.4%, HR 0.57, 95% CI [0.37-0.86]; 5-RF: 3.8% vs. 8.6%, HR 0.44, 95% CI [0.29-0.66]; ≥6-RF: 5.3% vs. 7.9%, HR 0.65, 95% CI [0.44-0.96]; p-interaction=0.56) without significantly increasing the ischemic risk (≤3-RF: 1.6% vs. 2.1%, HR 0.75, 95% CI [0.38-1.50]; 4-RF: 3.5% vs. 2.2%, HR 1.58, 95% CI [0.91-2.75]; 5-RF: 4.1% vs. 5.0%, HR 0.80, 95% CI [0.51-1.24]; ≥6-RF: 6.7% vs. 6.9%, HR 0.98, 95% CI [0.67-1.43]; p-interaction=0.22).</p><p><strong>Conclusions: </strong>In the TWILIGHT trial, the high-risk features correlated more strongly with ischemic than with bleeding risk. Nonetheless, the benefits of ticagrelor compared with ticagrelor plus aspirin were consistent, irrespective of the number of high-risk features. These findings are only applicable to patients who are event-free at 3 months after PCI.</p><p><strong>Clinical trial registration: </strong>The trial was registered with ClinicalTrials.gov, NCT02270242.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073161","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":"Study protocol for the Healthy Family Program on population blood pressure: a multicenter, parallel group, cluster randomized, controlled trial in rural China.","authors":"Yangyang Tang, Chao Jiang, Jiakun Guo, Yueyuan Li, Chi Wang, Shuk Han Chu, Zhiyan Wang, Yanfang Wu, Chang Hua, Yanmei Lu, Shuai Zhang, Yanna Song, Rong Han, Jianzeng Dong, Changsheng Ma, Jun Cai, Craig S Anderson, Xin Du","doi":"10.1016/j.ahj.2025.01.014","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.014","url":null,"abstract":"<p><strong>Background: </strong>We aim to determine the effectiveness of a community-based, health instructor led, multifaceted family intervention, as compared with usual care, on blood pressure (BP) management among Chinese rural residents, with or without hypertension.</p><p><strong>Methods/design: </strong>The Healthy Family Program is a cluster randomized controlled trial being undertaken in 80 villages (each with approximately 100 residents) with a target to enroll a total of 8000 older adults (aged 40-80 years). Villages were randomly assigned in a 1:1 ratio to either an intervention group to receive multifaceted strategies or a control group to continue with usual standard of care. The main components of the multifaceted intervention strategies include: 1) Establishing a BP management team led by family health instructors, with team members including family leaders and village doctors, and 2) Implementing an intervention that focused on six areas: education for a healthy lifestyle, free provision of sodium substitute, weight management, physical exercise, BP monitoring, and appropriate antihypertensive treatment for individuals with hypertension. The primary outcome is change in systolic BP from baseline to 6 months in all participants, reported as the absolute difference between intervention and control groups. After the 6-month intervention, support from the study coordination center and the distribution of low-sodium salt will be withdrawn, and all participants will be followed up until 12 months. As of December 31, 2024, 24 villages in the intervention group have completed the 6-month intervention.</p><p><strong>Conclusion: </strong>The Healthy Family Program will provide critically important data on the effectiveness of a novel BP management strategy in rural China.</p><p><strong>Trial registration: </strong>The study is registered at ClinicalTrials.gov (NCT06427096).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063337","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":"How the COAPT trial affected the selection of patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair: insights from the GIOTTO Registry.","authors":"Cesare Baldi, Marco Di Maio, Luca Esposito, Michele Bellino, Angelo Silverio, Marianna Adamo, Antonio Popolo Rubbio, Francesco De Felice, Arturo Giordano, Carmelo Grasso, Paolo Denti, Cosmo Godino, Federico De Marco, Fausto Castriota, Ida Monteforte, Annalisa Mongiardo, Anna Sonia Petronio, Gabriele Crimi, Emmanuel Villa, Antonio L Bartorelli, Rodolfo Citro, Gennaro Galasso, Giuseppe Tarantini, Corrado Tamburino, Francesco Bedogni","doi":"10.1016/j.ahj.2025.01.013","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.013","url":null,"abstract":"<p><strong>Background: </strong>The impact of the COAPT results on clinical practice has not yet been investigated in large real-world cohort study. The aim of the study is to evaluate the potential impact of the COAPT trial by analyzing the temporal trends of baseline characteristics and outcome of secondary mitral regurgitation (SMR) patients undergoing MitraClip (MC) included in the GIOTTO registry.</p><p><strong>Methods: </strong>The study population was divided into two groups, considering the enrolment before or after the COAPT publication. Temporal trend analyses were performed to evaluate the changes in baseline patients' characteristics and clinical outcome over time, and whether the COAPT publication influenced these changes. The outcome measure was the composite of hospitalization for heart failure (HF) and all-cause death at 1 year.</p><p><strong>Results: </strong>The analysis included 1184 consecutive SMR patients treated with MC at 19 Italian centres between January 2016 and March 2020, 809 (68.3%) in the pre-COAPT group and 375 (31.7%) in the post-COAPT group. Temporal trend analyses showed a decreasing trend for New York Heart Association (NYHA) class (p=0.003), hemoglobin (p=0.014), and a significant upward trend for left ventricular ejection fraction (p<0.001) and peripheral arterial disease (PAD, p=0.046). The publication of the COAPT trial impacted only on NYHA trend. Non-significant differences in the composite outcome were observed between groups (p = 0.086).</p><p><strong>Conclusions: </strong>The selection process of SMR patients undergoing MC changed over time, with a significant impact of the COAPT publication mainly on the trend of NYHA class. At 1-year, patients in the post-COAPT group showed a non-significant reduction in the incidence of hospitalization for HF and all-cause death.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063332","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":"Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell Combo^TM stent vs. Biolimus eluting absorbable polymer coated BioMatrix Alpha^TM stent in patients undergoing percutaneous coronary intervention. Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) XI trial: SORT-OUT XI Trial Design.","authors":"Ashkan Eftekhari, Evald Høj Christiansen, Jens Flensted Lassen, Bent Raungaard, Lars Jakobsen, Lisette Okkels Jensen","doi":"10.1016/j.ahj.2025.01.012","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.012","url":null,"abstract":"<p><strong>Rationale: </strong>The biodegradable polymer BioMatrix Alpha™ stent contains biolimus A9 drug which is sirolimus derivative increase in lipophicity. The biodegradable polymer sirolimus eluting Combo™ stent is a dual-therapy sirolimus-eluting and CD34+ antobody coated stent capturing endothelial progenitor cells (EPCs).</p><p><strong>Hypothesis: </strong>The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 BioMatrix Alpha ™ stent is noninferior to the biodegradable polymer sirolimus eluting Combo™ stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI).</p><p><strong>Methods: </strong>The SORT OUT XI study was a randomized, multicenter, single blinded, all-comer, 2-arm, noninferiority trial comparing the biodegradable polymer biolimus A9 BioMatrix Alpha™ stent to the biodegradable polymer sirolimus eluting Combo™ stent in three Danish University Hospitals in Western Denmark. The composite primary endpoint was target lesion failure (TLF) within 12 months. TLF was defined as composite of cardiac death, myocardial infarction not related to other than index lesion or target lesion revascularization. Clinically driven event detection was used and no planned follow up was performed. With a sample size of 1,564 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority with a predetermined noninferiority margin of 2.1%.</p><p><strong>Results: </strong>The trial ran from August 14, 2019 to March 19, 2023. A total of 3141 patients were enrolled and randomized 1:1 to Combo™ stent (n=1,573) and BioMatrix Alpha™ stent (n=1,568). Conclusion The SORT OUT XI trial will assess if the biolimus A9 eluting BioMAtrix Alpha™ stent is noninferior to the dual-therapy Combo™ stent with respect to target lesion failure. (ClinicalTrials.gov NCT03952273).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051377","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":"Baseline NT-proBNP Non-Response Score and Health Status Measures in Assessing Treatment Responses in Heart Failure with Reduced Ejection Fraction.","authors":"Thanat Chaikijurajai, Horng H Chen, W H Wilson Tang","doi":"10.1016/j.ahj.2025.01.011","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.011","url":null,"abstract":"<p><strong>Background: </strong>We aim to validate NT-proBNP nonresponse score (NNRS) previously derived from the PROTECT and BATTLESCARRED studies in comparison with standard health status measures in predicting natriuretic peptide responses in patients with heart failure with reduced ejection fraction.</p><p><strong>Methods: </strong>Data on the GUIDE-IT trial were used to derive the NNRS based on 4 predictors including baseline NT-proBNP, heart rate, NYHA functional class, and history of atrial fibrillation. The discriminative capacity of the NNRS and health status measures for having NT-proBNP >1,000 pg/mL at 12 months was assessed and compared with baseline or follow-up health status measures including Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), Duke Activity Status Index (DASI), and 6-minute walk distance. Multivariable logistic regression analysis was used to determine the predictive value of the score and health status measures greater than the median values for NT-proBNP response with adjustment for age, sex, body mass index, comorbidities, baseline creatinine and NT-proBNP levels.</p><p><strong>Results: </strong>Among 877 patients, 252 (28.7%) patients had NT-proBNP >1,000 pg/mL at 12 months. The discriminative capacity of the NT-proBNP non-response score was 0.72 (95% CI 0.67-0.77). After adjusting for covariates, only NNRS (P=.044) and KCCQ-OSS (P=.002) remained predictive for NT-proBNP non-response at 12 months.</p><p><strong>Conclusion: </strong>NT-proBNP non-response score and KCCQ-OSS was associated with persistently elevated NT-proBNP 12 months independently of baseline NT-proBNP levels.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051375","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 Prevail Global Trial Program Evaluating the Prevail Drug-Coated Balloon in Patients with In-stent Restenosis and De Novo Small Vessel Disease.","authors":"David E Kandzari, Azeem Latib, Darren Mylotte, Ziad A Ali, Azfar Zaman, Sandeep Brar, Maria Parke, Bruno Scheller","doi":"10.1016/j.ahj.2025.01.010","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.010","url":null,"abstract":"<p><strong>Background and rationale: </strong>In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) de novo lesions in small vessels.</p><p><strong>Trial design: </strong>Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (Agent^TM, Boston Scientific Corporation, Natick MA), and (2) patients with de novo small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025.</p><p><strong>Conclusions: </strong>The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions.</p><p><strong>Trial registration: </strong>Prevail Global, NCT06535854, is registered at https://clinicaltrials.gov/study/NCT06535854.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035976","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":"Higher levels of glucose within the normal range and cardiovascular risk: A landscape beyond diabetes and prediabetes","authors":"Moein Ebrahimi MD ,&nbsp;Gregg C. Fonarow MD","doi":"10.1016/j.ahj.2025.01.008","DOIUrl":"10.1016/j.ahj.2025.01.008","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 1-4"},"PeriodicalIF":3.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035975","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":"Evolving operator practices reduced patient radiation dose in interventional cardiology: Trends in a single center","authors":"Stephen Balter PhD ,&nbsp;Jeffrey Moses MD ,&nbsp;Kais Hyasat MBBS ,&nbsp;Michael Collins MD ,&nbsp;Ajay Kirtane MD ,&nbsp;Margaret McEntegart MD, PhD ,&nbsp;Leroy E Rabbani MD ,&nbsp;Gasmelseed Y Ahmed MD, PhD","doi":"10.1016/j.ahj.2025.01.007","DOIUrl":"10.1016/j.ahj.2025.01.007","url":null,"abstract":"<div><h3>Background</h3><div>This retrospective study addresses the role of operator and fluoroscopy equipment in reducing patient radiation exposure in the Cath lab.</div></div><div><h3>Methods</h3><div>Data from 99,400 procedures performed in our institution between 2007 and 2019 were reviewed. Dosimetric parameters included reference point air kerma (K_a,r), Kerma Area Product (P_KA), fluoroscopic time, and contrast volume. Results are characterized by their 50th and 99th percentiles. Data from a subset of fluoroscopes that were in continuous use and a subset of operators who used the same “continuous” fluoroscope in every year of the study were also analyzed.</div></div><div><h3>Results</h3><div>For all procedures, median K_a,r declined by 63%, from 1.5 to 0.5Gy; 99th percentiles declined by 44%, from 8.6 to 4.8Gy. For the 3 “continuous fluoroscopes” median K_a,r declined by 60% from 1.6 to 0.6Gy; 99th percentile by 52% from 9.1 to 4.4Gy. The all-procedure median contrast volume declined by 53%, from 150 to 70ml; 99th percentile by 42% from 600 to 350ml. The all-procedure median fluoroscopy time declined by 2%; the 99th percentile increased by 32%. In the continuous subset, median fluoroscopy time declined by 20%; 99th percentile increased by 5%. For the operator's subset, the median K_a,r declined by 43% (<em>P</em> = .0362); the 99th percentile decreased by 22% (<em>P</em> = .0481). Substantial radiation dose procedures decreased from 7% to 0.8% of the procedure volume.</div></div><div><h3>Conclusions</h3><div>There was a significant reduction in patient radiation (K_a,r and P_KA) and contrast volume during the study period driven by systematic and operator practice changes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 5-16"},"PeriodicalIF":3.7,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998798","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":"Incidence and outcomes of prosthetic valve endocarditis in adults with congenital heart disease","authors":"Andrea R. Hsu BS ,&nbsp;Snigdha Karnakoti MBBS ,&nbsp;Ahmed T. Abdelhalim MBBS ,&nbsp;William R. Miranda MD ,&nbsp;Heidi M. Connolly MD ,&nbsp;Joseph A. Dearani MD ,&nbsp;Daniel C. DeSimone MD ,&nbsp;Alexander C. Egbe MD, MPH","doi":"10.1016/j.ahj.2025.01.005","DOIUrl":"10.1016/j.ahj.2025.01.005","url":null,"abstract":"<div><h3>Background</h3><div>Patients with congenital heart disease (CHD) often require prosthetic valve implantation, increasing their lifetime risk of developing prosthetic valve endocarditis (PVE). The purpose of this study was to determine the incidence, risk factors, and outcomes of PVE in adults with CHD.</div></div><div><h3>Method</h3><div>Retrospective cohort study of adults with CHD and prior prosthetic valve implantation (2003-2023). Patients diagnosed with PVE were designated as the PVE group, while the patients without PVE were designated as the reference group.</div></div><div><h3>Results</h3><div>Of 9161 patients, 3150 (34%) had prosthetic valves. Among the patients with prosthetic valve, 86 (2.7%) developed PVE, yielding an incidence of 5.2 (95% confidence interval [CI] 4.8-1-5.6) events per 1000 patient-years. Of the 86 patients with PVE, the average age at the time of PVE diagnosis was 35 ± 9 years, the average interval between prosthetic valve implantation and PVE was 91 ± 27 months, and mean duration of follow-up with11.6 ± 4.9 years. The risk factors for PVE were male sex, younger age, type 2 diabetes, multiple prosthetic valves, and Melody bioprosthetic valve implantation. PVE was associated with more than a 2-fold increase in all-cause mortality (adjusted hazard ratio 2.21, 95% CI 1.33-3.68, <em>P</em> = .002), after adjustment for demographic/anatomic indices, and comorbidities. Of 86 patients with PVE, 21 (24%) died during follow-up. The 30-day, 1-year, and 5-year mortality after diagnosis of PVE was 1.6%, 12% and 15%, respectively. Of 86 patients, 39 (45%) developed 47 PVE-related complications (perivalvular abscess[(<em>n</em> = 21], and septic emboli [<em>n</em> = 26]). PVE-related complications were associated with all-cause mortality.</div></div><div><h3>Conclusions</h3><div>PVE was common in CHD patients with prosthetic valves and was associated with all-cause mortality. These findings highlight the prognostic implications of prosthetic valve implantation in patients with CHD, and the need for new criteria for risk stratification in order to improve outcomes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 125-133"},"PeriodicalIF":3.7,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998799","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":"Individualized transfusion decisions to minimize adverse cardiovascular outcomes in patients with acute myocardial infarction and anemia","authors":"Gerard T. Portela PhD ,&nbsp;Gregory Ducrocq MD ,&nbsp;Marnie Bertolet PhD ,&nbsp;John H. Alexander MD, MHS ,&nbsp;Shaun G. Goodman MD ,&nbsp;Simone Glynn MD, MPH, MSc ,&nbsp;Jordan B. Strom MD, MSc ,&nbsp;Sonja A. Swanson ScD ,&nbsp;Gilles Lemesle MD ,&nbsp;Sunil V. Rao MD ,&nbsp;Meechai Tessalee MD ,&nbsp;Tamar S. Polonsky MD, MSCI ,&nbsp;Michael Goldfarb MD, MSc ,&nbsp;Jay H. Traverse MD, ME ,&nbsp;Lynne Uhl MD ,&nbsp;Brandon M. Herbert MPH, PhD ,&nbsp;Johanne Silvain MD, PhD ,&nbsp;Jeffrey L. Carson MD ,&nbsp;Maria M. Brooks PhD ,&nbsp;MINT Trial Investigators","doi":"10.1016/j.ahj.2025.01.009","DOIUrl":"10.1016/j.ahj.2025.01.009","url":null,"abstract":"<div><h3>Background</h3><div>Risk-benefit tradeoffs between restrictive versus liberal red blood cell transfusion strategies may vary across individuals. This exploratory analysis aimed to derive and evaluate individualized treatment effects of defined transfusion strategies in patients with acute MI and anemia with the goal of minimizing adverse cardiovascular outcomes.</div></div><div><h3>Methods</h3><div>This study analyzed 3,447 (98.4%) patients randomized in the MINT (Myocardial Ischemia and Transfusion) trial between April 2017 to April 2023. Outcomes for this analysis included 30-day death or recurrent MI, death, and major adverse cardiovascular events (MACE, a composite of death, MI, stroke, and ischemia-driven unscheduled revascularization). Machine learning methods were used to identify baseline patient characteristics that informed the individualized treatment effect of a restrictive versus liberal transfusion strategy for each patient. The expected population risk of an outcome under a scenario in which patients received their optimal treatment, as indicated by the individualized treatment effect, was contrasted with expected risks for universally applying a restrictive strategy or a liberal strategy to all patients.</div></div><div><h3>Results</h3><div>Baseline characteristics did not inform individualized treatment effects on 30-day death and death or MI, suggesting minimal heterogeneity in treatment effect on these outcomes. An algorithm for estimating the individualized treatment effect on 30-day MACE included 12 baseline factors. If all patients received the optimal treatment as indicated by their estimated individualized treatment effect, the predicted risk of 30-day MACE in the sample population was 15.2% (95% CI 14.2%-16.2%). This corresponded to 4.0 (difference: −4.0%, 95% CI −5.8, −2.1) and 2.3 (difference: −2.3%, 95% CI −3.7, −0.9) percentage point risk reductions compared to applying a restrictive or liberal strategy to everyone respectively.</div></div><div><h3>Conclusions</h3><div>The MINT trial average treatment effect, favoring a liberal strategy, may be optimal to minimize risk of 30-day death and death or MI for acute MI patients with anemia represented in the MINT sample as no individualized treatment effects were estimated on these outcomes. However, individualized transfusion strategy decisions have potential to reduce risk of 30-day MACE. External validation of the MACE algorithm is required before clinical use.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov, NCT02981407, <span><span>https://clinicaltrials.gov/study/NCT02981407</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 146-155"},"PeriodicalIF":3.7,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998800","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}