American heart journal最新文献

{"title":"DAPAgliflozin for renal protection in heart transplant recipients. Rationale and design of the randomized controlled DAPARHT trial","authors":"Stine Holmen MD ,&nbsp;Olivier Manintveld MD, PhD ,&nbsp;Kevin Damman MD, PhD ,&nbsp;Oscar Braun MD, PhD ,&nbsp;Ida Haugen Löfman MD, PhD ,&nbsp;Mariusz Szymanski MD, PhD ,&nbsp;Håvard Ravnestad MD ,&nbsp;Einar Gude MD, PhD ,&nbsp;Elisabeth Bjørkelund RN ,&nbsp;Arne K. Andreassen MD, PhD ,&nbsp;Lars Gullestad MD, PhD ,&nbsp;Kaspar Broch MD, PhD","doi":"10.1016/j.ahj.2025.08.010","DOIUrl":"10.1016/j.ahj.2025.08.010","url":null,"abstract":"<div><h3>Background and aims</h3><div>Heart transplantation is the preferred treatment for selected patients with end stage heart failure. Kidney function often declines after heart transplantation. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) slow the decline in eGFR in different populations. However, the effect of SGLT2i on kidney function in heart transplant recipients is unknown.</div></div><div><h3>Methods</h3><div>The Dapagliflozin for Renal protection in Heart Transplant recipients (DAPARHT) trial is an investigator initiated, double blind, randomized, placebo-controlled trial designed to assess dapagliflozin’s effect on kidney function in heart transplant recipients. Adults heart transplanted at least one year prior to randomization are eligible. Exclusion criteria include an estimated glomerular filtration rate (eGFR) &lt;25 mL/min/1.73 m², diabetes type I, and contraindication to study medication. Four hundred and thirty patients will be randomized 1:1 to receive 12 months blinded treatment with dapagliflozin 10 mg o.d. or placebo, followed by 24-months open-label treatment. The primary endpoint is the chronic slope of the eGFR from two weeks to 12 months after starting randomized treatment. The open-label phase evaluates dapagliflozin’s long-term effects on kidney function, clinical outcomes, safety, and tolerability. Enrolment began in June 2022. As of December 18, 2024, 300 patients were enrolled. The mean baseline creatinine was 104 ± 28 µmol/L with corresponding eGFR of 66 ± 22 mL/min/1.73 m². Estimated last patient visit is in September, 2028.</div></div><div><h3>Conclusion</h3><div>The DAPARHT trial will test whether dapagliflozin improves eGFR slope compared to placebo during one year of follow-up, providing the first randomized evidence of the efficacy of SGLT2i in heart transplant recipients.</div></div><div><h3>Trial Registration</h3><div>Dapagliflozin for Renal protection in Heart Transplant recipients (DAPARHT), NCT05321706, clinicaltrials.gov.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 128-135"},"PeriodicalIF":3.5,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939461","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":"Neonatal outcomes of pregnancy in women with congenital heart disease","authors":"Sarah A. Goldstein MD ,&nbsp;Lindsay A. Edwards MD ,&nbsp;Ester K. Nilles PhD ,&nbsp;Karen Chiswell PhD ,&nbsp;Alfred D’Ottavio II BSE, BEE ,&nbsp;Matthew R. Reeder PhD, MPH ,&nbsp;Kathleen Wood MD ,&nbsp;Neeta Sethi MD ,&nbsp;Cheryl L. Raskind-Hood MD, MPH ,&nbsp;Wendy M. Book MD ,&nbsp;Marcia L. Feldkamp PhD, PA, MSPH ,&nbsp;Jennifer S. Li MD, MHS ,&nbsp;Lorenzo D. Botto MD","doi":"10.1016/j.ahj.2025.08.009","DOIUrl":"10.1016/j.ahj.2025.08.009","url":null,"abstract":"<div><h3>Background</h3><div>Infants born to women with congenital heart disease (CHD) are at increased risk for adverse outcomes compared with the general population. There are few large, contemporary studies examining the relationship between CHD severity, maternal risk factors and neonatal outcomes.</div></div><div><h3>Methods</h3><div>Data on women with CHD who had a live birth from 2011 through 2014 in geographic areas in Georgia, North Carolina and Utah were analyzed. Maternal CHD was identified from clinical and administrative data collected for the CDC Lifespan CHD surveillance project. CHD was categorized as severe and non-severe (shunt, valve or shunt+valve lesions). Linked birth certificates provided information on neonatal outcomes and neonatal, maternal and pregnancy characteristics. Neonatal outcomes included preterm delivery (&lt;37 weeks), low birth weight (&lt;2,500 grams), small for gestational age (SGA), neonatal intensive care unit (NICU) admission, a composite of any adverse outcome (one or more of preterm delivery, SGA or NICU admission), and CHD. Neonatal outcomes were summarized using descriptive statistics. Differences by maternal CHD severity were assessed using Wilcoxon rank-sum and Chi-square tests for continuous and categorical variables, respectively. The association of maternal and pregnancy characteristics (race, pregestational diabetes (PGDM), hypertensive disorders of pregnancy (HDP), prior preterm birth, non-singleton pregnancy, maternal age, previous living live birth and CHD severity) with neonatal outcomes were assessed using logistic regression fit using generalized estimating equations clustered on mother and adjusted for mother’s age, birth year and geographical location of delivery.</div></div><div><h3>Results</h3><div>Of the 2,411 liveborn infants born to 1,982 women with CHD (34% with severe CHD), 19% were preterm, 18% were of low birth weight, 14% were SGA and 4.2% were diagnosed with CHD. Of the included infants, 25% required NICU and 40% experienced the composite adverse outcome. Infants born to mothers with severe CHD (vs non-severe) were more likely to experience the composite adverse outcome (aOR 2.1 [1.8, 2.5]) and CHD recurrence (aOR 17.1 [9.3, 31.5]). In a multivariable analysis, severe CHD (vs non-severe, aOR 2.2 [1.8, 2.7]), Black race (vs White, aOR 1.8 [1.4, 2.3]), PGDM (aOR 2.5 [1.3, 5.0]), hypertensive disorder of pregnancy (aOR 2.1 [1.5, 3.1]), prior preterm birth (aOR 2.0 [1.3, 3.1]), and non-singleton pregnancy (aOR 6.7 [3.8, 11.6]) were associated with increased risk of the composite adverse outcome.</div></div><div><h3>Conclusions</h3><div>Nearly half of infants born to women with CHD experienced the adverse composite neonatal outcome, with the highest risk among those born to women with severe CHD. In addition to CHD severity, risk factors for adverse neonatal outcomes among women with CHD included black race, hypertensive disorders of pregnancy, PGDM, prior preterm birth and non-si","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 101-110"},"PeriodicalIF":3.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939550","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":"Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry","authors":"Han-Su Park MD ,&nbsp;Chong Hyun Suh ,&nbsp;Jung-Min Ahn MD ,&nbsp;Do-Yoon Kang MD ,&nbsp;Soo-Yeon Ahn MD ,&nbsp;Sung-Bong Wee MD ,&nbsp;Seung-Han Lee MD ,&nbsp;Kyeong-Won Seo MD ,&nbsp;Min-Ju Kim MSc ,&nbsp;Seung-Jung Park MD ,&nbsp;Duk-Woo Park MD","doi":"10.1016/j.ahj.2025.08.006","DOIUrl":"10.1016/j.ahj.2025.08.006","url":null,"abstract":"<div><h3>Background</h3><div>Cerebral embolization is a common complication following transcatheter aortic valve replacement (TAVR). Cerebral embolic protection (CEP) devices have the potential to reduce embolic burden to the cerebral circulation; however, their effectiveness in real-world patients at high risk of stroke remains insufficiently studied.</div></div><div><h3>Methods</h3><div>As part of imaging study of the prospective Sentinel registry (NCT 05217888), we evaluated the effect of CEP on new cerebral embolism as determined by brain magnetic resonance imaging (MRI) in patients undergoing transfemoral TAVR who were considered at high risk for stroke. The primary endpoint was the number and volume of new cerebral lesions on brain MRI at postprocedure (2 to 7 days) compared to baseline in protected brain territories. The control group consists of enrolled patients in the ADAPT-TAVR trial (NCT03284827), in which TAVR was performed without the use of a CEP device.</div></div><div><h3>Results</h3><div>A total of 219 patients was included (49 in the SENTINEL registry and 170 patients in the ADAPT-TAVR trial). For the primary endpoint, the number and volume of new cerebral lesions was significantly lower in the CEP group than in the control group: the median no. of lesions; 1 (interquartile range [IQR], 1 to 2) vs 6 (IQR, 3 to 10), respectively; difference, -4 [IQR, -6 to -3]; <em>P</em> &lt; .001, and the median volume of lesions; 113.5 mm³ (IQR, 42.4-206.9) vs 283.5 mm³ (IQR, 129.7-682.4), respectively; difference, -145.9 [IQR, -296.7 to -67.1]; <em>P</em> &lt; .001). Strokes at 30 days occurred in 1 patient (2.0%) in the CEP group and 2 patients (1.2%) in the control group (<em>P</em> = .64).</div></div><div><h3>Conclusions</h3><div>Among patients who are at high risk for stroke undergoing TAVR, the use of CEP was associated with a significant reduction of new cerebral embolism in protected brain territories. Because the study was underpowered to detect clinically relevant events, the results cannot be considered clinically directive.</div></div><div><h3>Clinical Trail Registration</h3><div><span><span>http://ClinicalTrials.gov</span><svg><path></path></svg></span> (Identifier: NCT05217888).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 44-52"},"PeriodicalIF":3.5,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858807","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":"Distal versus conventional transradial artery access for coronary catheterization in patients with STEMI (DR-STEMI): Rationale and design of an international, multicenter, randomized trial","authors":"Grigorios Tsigkas MD, PhD ,&nbsp;Aikaterini Trigka-Vasilakopoulou MD ,&nbsp;Anastasios Apostolos MD, MSc ,&nbsp;Michael Papafaklis MD, PhD ,&nbsp;Giuseppe Colletti MD ,&nbsp;Antonio Mugnolo MD ,&nbsp;Zoltán Ruzsa MD ,&nbsp;Claudiu Ungureanu MD ,&nbsp;Dimitrios Nikas MD, PhD ,&nbsp;Panagiotis Xaplanteris MD, PhD ,&nbsp;Gabriele L Gasparini MD, PhD ,&nbsp;Alessandro Sciahbasi MD ,&nbsp;Ioannis Tsiafoutis MD ,&nbsp;Leonidas E. Poulimenos MD ,&nbsp;Matthaios Didagelos MD, PhD ,&nbsp;Loukas Pappas MD ,&nbsp;Pavlos Stougiannos MD ,&nbsp;Michalis Hamilos MD, PhD ,&nbsp;Antonios Ziakas MD, PhD ,&nbsp;Filippos Timpilis MD ,&nbsp;Periklis Davlouros MD, PhD","doi":"10.1016/j.ahj.2025.08.007","DOIUrl":"10.1016/j.ahj.2025.08.007","url":null,"abstract":"<div><h3>Rationale</h3><div>Transradial access (TRA) constitutes the cornerstone for cardiac catheterization and is recommended by <del>the</del> multiple recent guidelines, irrespective of clinical presentation. The existing literature has evaluated distal transradial access (dTRA), as a feasible and safe approach in patients with chronic and acute coronary syndrome, excluding although patients presenting with ST- elevation myocardial infraction (STEMI).</div></div><div><h3>Primary hypothesis</h3><div>The current randomized clinical trial compares dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri‑ and postprocedural characteristics.</div></div><div><h3>Design</h3><div>DR-STEMI is a prospective, open label, European, multicenter randomized-control trial which will include 554 patients (277 patients in each treatment arm). Patients with STEMI, will be screened on an all-comers basis for study inclusion and exclusion criteria, and those eligible will be allocated randomly (1:1), to dTRA versus TRA approach. The primary hypothesis of the study is that dTRA is noninferior to conventional TRA regarding the required time between the puncture of the radial artery and wire crossing of the infarct-related artery (i.e., needle-to-wire time).</div></div><div><h3>Current status</h3><div>Enrollment for the DR-STEMI trial began in May 2024, and as of April 15th^, 2025, 309 patients have been enrolled in the study. Recruitment is expected to continue for approximately 12 months.</div></div><div><h3>Trial registration</h3><div><span><span>clinicaltrials.gov</span><svg><path></path></svg></span>: NCT05605288</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 73-80"},"PeriodicalIF":3.5,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858806","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":"Beta-blocker side-effects in clinical practice: A nationwide approach","authors":"Peter Vibe Rasmussen MD, PhD ,&nbsp;Jarl Emanuel Strange MD, PhD ,&nbsp;Sebastian Kinnberg Nielsen MD ,&nbsp;Rasmus Borup Hansen MBSc ,&nbsp;Gunnar H. Gislason MD, PhD ,&nbsp;Morten Lamberts MD, PhD ,&nbsp;Morten Lock Hansen MD, PhD ,&nbsp;Anders Holt MD, PhD","doi":"10.1016/j.ahj.2025.08.005","DOIUrl":"10.1016/j.ahj.2025.08.005","url":null,"abstract":"<div><h3>Background</h3><div>Concerns regarding side-effects of beta-blockers (BBs) are frequent but data regarding the incidence of side-effects are conflicting and real-world data are sparse. Hence, we aimed to investigate the absolute and relative risks of BB side-effects in clinical practice.</div></div><div><h3>Methods</h3><div>Using Danish nationwide registers, we included Danish hypertensive patients initiating antihypertensive treatment with a BB or calcium-channel blocker (CCB). We computed crude as well as standardized 1-year risks and adjusted risk ratios of BB side-effects (depression, anxiety/insomnia, gastrointestinal side-effects, erectile dysfunction, and dizziness/fainting) compared with CCB treatment.</div></div><div><h3>Results</h3><div>We included 64,722 patients initiating treatment with a BB and 181,880 patients initiating treatment with a CCB. In patients initiated on BB, the standardized 1-year risk of any outcome, erectile dysfunction exempt, was 13.7% (95% CI: 13.4%-13.9%). The 1-year risk of specific BB side-effects was the highest for anxiety/insomnia (6.2%, 95% CI: 6.0%-6.3%), gastrointestinal side-effects (4.6%, 95% CI: 4.4%-4.7%), and erectile dysfunction (4.7%, 95% CI: 4.5%-4.9%).</div><div>The risk of side-effects was consistently increased when comparing BB treatment with CCBs including depression (Risk Ratio [RR] 1.48, 95% CI 1.41-1.55), anxiety/insomnia (RR 1.53, 95% CI 1.47-1.59), gastrointestinal side-effects (1.31, 95% CI 1.25-1.36), and dizziness/fainting (RR 1.50, 95% CI 1.38-1.61), but not erectile dysfunction (RR 0.91, 95% CI, 0.85-0.96).</div></div><div><h3>Conclusions</h3><div>In a large nationwide cohort, the incidence of BB side-effects was clinically relevant and consistently increased compared with CCBs with the exception of erectile dysfunction, which carried similar risks for both treatments.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 111-120"},"PeriodicalIF":3.5,"publicationDate":"2025-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144833781","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":"Understanding gaps in guideline-recommended adult congenital heart disease care: Data from 12 US health care centers","authors":"Joseph Bayne MD ,&nbsp;Rong Duan MS ,&nbsp;Lindsey Rudov MPH ,&nbsp;Rittal Mehta MS ,&nbsp;Ruth Phillippi MS ,&nbsp;Mark Roeder BA ,&nbsp;Sneha Saraf MS ,&nbsp;Jamie L. Jackson PhD ,&nbsp;Matthew Lewis MD ,&nbsp;Arwa Saidi MD ,&nbsp;Ronald Kanter MD ,&nbsp;Satinder Sandhu MD ,&nbsp;Thomas Young MD ,&nbsp;Roni Jacobsen MD ,&nbsp;Emily Ruckdeschel MD ,&nbsp;Adam Lubert MD ,&nbsp;Harsimran Singh MD ,&nbsp;Ali Zaidi MD ,&nbsp;Dan G. Halpern MD ,&nbsp;Scott Leezer BS ,&nbsp;Anushree Agarwal MD MAS","doi":"10.1016/j.ahj.2025.08.002","DOIUrl":"10.1016/j.ahj.2025.08.002","url":null,"abstract":"<div><h3>Background</h3><div>Guidelines recommend lifelong care with adult congenital heart disease (ACHD) specialists for adults with congenital heart disease (CHD). However, such gaps in visits at specialized ACHD centers have not been well-characterized from diverse US settings.</div></div><div><h3>Methods</h3><div>This retrospective study analyzed data from 12 centers in the national Patient-Centered Clinical Research Network. CHD conditions were classified using International Classification of Disease codes and a hierarchical algorithm. ACHD specialists were identified by investigators and encounter volumes. Data from the ‘Pre-COVID’ (2015-2019) and ‘COVID’ (2020-2022) periods were analyzed separately. Main outcome measures were: 1) Gaps in any ACHD specialist visit and recommended testing throughout the study period. 2) Gaps in recommended ACHD follow-up care.</div></div><div><h3>Results</h3><div>During pre-COVID (<em>N</em> = 18,934) and COVID (<em>N</em> = 22,453) periods, between 55.3%-55.8% were males, 27.2%-31.0% were 40+ years, 18.2%-19.6% had severe CHD, and 52.7%-55.0% had CHD physiologic class B-D conditions. Between 47.0%-54.5% had gaps in specialist visit and 13.0%-24.6% had gaps in all the testing. Patients with gaps in specialist visits were 6.33-9.44 times more likely to have gaps in testing. Gaps were more common among patients with moderate (adjusted odds ratio [AOR]: 2.61) and simple (AOR: 2.84) CHD, those aged 40+ (AOR: 1.53) and nonphysiologic class conditions (AOR 1.51). In both periods, 64.1%-71.5% of patients had gaps in follow-up care.</div></div><div><h3>Conclusions</h3><div>Three-quarters of adults with CHD experienced gaps in specialized ACHD care while receiving services at high volume comprehensive tertiary health centers. To address these gaps, interventions such as fostering physician collaboration within tertiary centers might be needed, and targeted to patients with less severe CHD, nonphysiologic class conditions, and those aged 40+ years.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 53-62"},"PeriodicalIF":3.5,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811523","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":"Medicare coverage gap status, adherence to oral anticoagulation, and stroke rates in patients with atrial fibrillation","authors":"Josephine Harrington MD ,&nbsp;Rohin K. Reddy MBBS ,&nbsp;Anthony Carnicelli MD ,&nbsp;Lauren Wilson PhD ,&nbsp;Renato D. Lopes MD, MHS, PhD ,&nbsp;Bernard J. Gersh MB, ChB, DPhil ,&nbsp;Lesley H. Curtis PhD ,&nbsp;Sean D. Pokorney MD, MBA ,&nbsp;Chiara Melloni MD ,&nbsp;Emily C. O’Brien PhD ,&nbsp;Christopher B. Granger MD","doi":"10.1016/j.ahj.2025.07.072","DOIUrl":"10.1016/j.ahj.2025.07.072","url":null,"abstract":"<div><h3>Background</h3><div>Prior to 2025, Medicare Part D included a coverage gap during which beneficiaries were responsible for substantially higher portions of medication costs. The impact of this on oral anticoagulant (OAC) prescription fills and subsequent stroke in patients with atrial fibrillation (AF) is not known.</div></div><div><h3>Methods</h3><div>Using Centers for Medicare and Medicaid Services claims data from 2016 to 2018, we evaluated OAC prescription fills in patients with AF by assessing their proportion of days covered on OAC before, during, and after their coverage gap. Hazard of stroke was assessed for patients who entered the coverage gap before entering, while in, and after exiting, the gap.</div></div><div><h3>Results</h3><div>Patients who entered the coverage gap had a 16% decrease in median proportion of days covered from pregap (0.92 [interquartile range 0.80, 0.97]) to in-gap (0.76 [0.41, 0.98]). Proportion of days covered continued to drop for patients who entered and then left the coverage gap, despite regaining coverage (pregap: 0.95 [0.85, 0.98]; in-gap: 0.88 [0.55, 0.97]; postgap: 0.70 [0.00, 1.00]). Patients who entered the gap were at significantly higher risk for stroke while in the gap (HR 2.21, 95% CI 1.91-2.54) and during the combined in-gap and postgap periods (HR 3.13, 95% CI 2.71-3.62).</div></div><div><h3>Conclusions</h3><div>OAC use decreased upon entering the coverage gap and was associated with an increased stroke risk, that persisted for the rest of the calendar year. Health policy decisions regarding Medicare can have unintended adverse public health consequences, highlighting the importance of assessing the impact of such policy changes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 63-72"},"PeriodicalIF":3.5,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803267","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":"PRevention of sudden cardiac death aFter myocardial infarction by defibrillator implantation: Design and rationale of the PROFID EHRA randomized clinical trial","authors":"Nikolaos Dagres MD ,&nbsp;Chris P Gale PhD ,&nbsp;Ramesh Nadarajah PhD ,&nbsp;Serge Boveda PhD ,&nbsp;Jose Luis Merino PhD ,&nbsp;Jens Cosedis Nielsen PhD ,&nbsp;Paulus Kirchhof MD ,&nbsp;Valentina Kutyifa PhD ,&nbsp;Miloš Táborský PhD ,&nbsp;Holger Thiele MD ,&nbsp;Jan G.P. Tijssen PhD ,&nbsp;Atul Verma MD ,&nbsp;Tom De Potter MD ,&nbsp;Frieder Braunschweig PhD ,&nbsp;Béla Merkely PhD ,&nbsp;Philipp Sommer MD ,&nbsp;Kevin Vernooy PhD ,&nbsp;Mahmoud Suleiman MD ,&nbsp;Helmut Pürerfellner MD ,&nbsp;Gerhard Hindricks PhD","doi":"10.1016/j.ahj.2025.07.071","DOIUrl":"10.1016/j.ahj.2025.07.071","url":null,"abstract":"<div><h3>Background</h3><div>Randomized clinical trials from over 20 years ago demonstrated that an implantable cardioverter defibrillator (ICD) improved survival for patients with severely reduced left ventricular ejection fraction (LVEF) after myocardial infarction (MI) compared with optimal medical therapy (OMT) alone. Since then advances in therapy have led to the reduction in the incidence of sudden cardiac death (SCD) in this population, whilst complication rates from ICD implantation are still substantial.</div></div><div><h3>Objectives</h3><div>To determine whether OMT without ICD implantation is not inferior to OMT with ICD implantation with respect to all-cause mortality.</div></div><div><h3>Design</h3><div>The PROFID EHRA trial is an investigator-driven, prospective, parallel-group, randomized, open-label, blinded outcome assessment (PROBE), multi-center, noninferiority trial without dedicated investigational medical device (Proof of Strategy Trial) with 2 groups with 1:1 randomization. PROFID-EHRA will recruit approximately 3,595 patients with documented history of MI at least 3 months prior, LVEF ≤35%, on OMT for at least 3 months, and with New York Heart Association class II or III, who will be randomized to OMT or OMT plus ICD, to collect 374 first primary outcome events within a median observation period of around 28 months from about 180 clinical sites in an estimated 13 countries. The primary outcome is time from randomization to the occurrence of all-cause death. Secondary outcomes include time from randomization to death from cardiovascular causes, to SCD, to first hospital readmission for cardiovascular causes after date of randomization, the average length of hospital stay during follow-up, and quality of life trajectories.</div></div><div><h3>Clinical Trial</h3><div>Trials.gov NCT05665608</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 37-43"},"PeriodicalIF":3.5,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798012","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":"A pragmatic individually randomized trial to evaluate the effectiveness of high-dose vs standard-dose influenza vaccine in older adults: Rationale and design of the DANFLU-2 trial.","authors":"Niklas Dyrby Johansen, Daniel Modin, Matthew M Loiacono, Rebecca C Harris, Marine Dufournet, Carsten Schade Larsen, Lykke Larsen, Lothar Wiese, Michael Dalager-Pedersen, Brian L Claggett, Kristoffer Grundtvig Skaarup, Filip Søskov Davidovski, Scott D Solomon, Martin J Landray, Gunnar H Gislason, Lars Køber, Pradeesh Sivapalan, Cyril Jean-Marie Martel, Jens Ulrik Stæhr Jensen, Tor Biering-Sørensen","doi":"10.1016/j.ahj.2025.07.069","DOIUrl":"10.1016/j.ahj.2025.07.069","url":null,"abstract":"<p><strong>Background: </strong>The high-dose inactivated influenza vaccine (HD-IIV) has been shown to reduce the incidence of influenza infection compared with standard-dose inactivated influenza vaccine (SD-IIV); however, its effectiveness in preventing severe respiratory and cardiovascular outcomes in the older general population has not yet been assessed in a fully powered individually randomized trial.</p><p><strong>Methods: </strong>DANFLU-2 is an ongoing pragmatic, registry-based, open-label, active-controlled, individually randomized trial conducted in Denmark during the 2022/2023, 2023/2024, and 2024/2025 influenza seasons. Utilizing innovative electronic recruitment strategies and an online informed consent process, the trial has enrolled 332,438 older adults ≥65 years; enrollment was completed in October 2024. Participants were randomly allocated in a 1:1 ratio to either HD-IIV or SD-IIV. Baseline, endpoint, and safety data are primarily obtained from the nationwide Danish administrative health registries. The primary endpoint is hospitalization for influenza or pneumonia with the trial also powered to assess the first secondary endpoint of hospitalization for any cardio-respiratory disease. The additional secondary endpoints of all-cause hospitalization and mortality will be tested hierarchically. Key ancillary analyses include cost-effectiveness and health care resource consumption assessments as well as a home self-swab sub-cohort.</p><p><strong>Discussion: </strong>DANFLU-2 is the largest individually randomized influenza vaccine trial ever conducted and will provide critical, high-quality evidence on the effectiveness of HD-IIV against cardio-respiratory hospitalizations and mortality in the older general population.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: NCT05517174, registered August 24, 2022, https://clinicaltrials.gov/study/NCT05517174.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764384","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 low-risk TAVR trials—A critical appraisal of the current landscape","authors":"Troels Højsgaard Jørgensen MD, PhD ,&nbsp;Hans Gustav Hørsted Thyregod MD, PhD ,&nbsp;Stefan Blankenberg MD, PhD ,&nbsp;Martin Leon MD ,&nbsp;Lars Sondergaard MD, DMSc ,&nbsp;Bernard Prendergast MD, PhD ,&nbsp;Ole De Backer MD, PhD","doi":"10.1016/j.ahj.2025.07.070","DOIUrl":"10.1016/j.ahj.2025.07.070","url":null,"abstract":"<div><div>The low-risk TAVR vs SAVR RCTs - PARTNER-3, Evolut Low-Risk, DEDICATE, and NOTION-2 - demonstrate that TAVR is at least as effective as SAVR in terms of early mortality and disabling stroke, although outcomes varied across studies. The excellent outcomes observed in the PARTNER-3 trial reflect the highly selected patient population, while the NOTION-2 trial highlights the challenges posed by anatomical variations, such as bicuspid aortic valves (AV). These findings highlight the importance of a personalized approach guided by a multidisciplinary Heart Team, taking into account both clinical and anatomical aspects when choosing between TAVR and SAVR.</div><div>Trial registration number: ClinicalTrials.gov NCT02825134.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 10-13"},"PeriodicalIF":3.5,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144758902","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}