American heart journal最新文献

{"title":"Win Ratio Analyses Using a Modified Hierarchical Composite Outcome: Insights from PARAGLIDE-HF.","authors":"Satoshi Shoji, Derek D Cyr, Adrian F Hernandez, Eric J Velazquez, Jonathan H Ward, Kristin M Williamson, Samiha Sarwat, Randall C Starling, Akshay S Desai, Shelley Zieroth, Scott D Solomon, Robert J Mentz","doi":"10.1016/j.ahj.2024.10.020","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.020","url":null,"abstract":"<p><strong>Background: </strong>The win ratio (WR) is an emerging alternative for reporting composite outcomes, prioritizing clinically significant events such as mortality while incorporating surrogate measures. However, its benefits should be weighed against limitations, particularly the influence of lower hierarchical outcomes. This secondary analysis of the PARAGLIDE-HF trial performed a WR sensitivity analysis using a modified hierarchical composite outcome to assess the utility of WR sensitivity analysis and the efficacy of sacubitril/valsartan versus valsartan.</p><p><strong>Methods: </strong>PARAGLIDE-HF compared sacubitril/valsartan with valsartan in heart failure (HF) patients with ejection fraction >40% (N=466). A hierarchical outcome in the primary analysis included cardiovascular death, HF hospitalizations, urgent HF visits, and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP), with a 25% decrease considered a win. In the pre-specified subgroup with ejection fraction ≤60% (N=357), sacubitril/valsartan showed a treatment effect on the hierarchical outcome (WR, 1.46; 95% CI, 1.08-1.97). Sensitivity analyses for this subgroup included: 1) excluding NT-proBNP change, 2) substituting the 25% proportion change of NT-proBNP with 10% or 50%, and 3) including renal outcomes within the hierarchical outcome. In addition to the WR, the win odds (WO), in which 50% of the ties are allocated to both the numerator and denominator of the WR-a potentially more suitable modification of the WR that accounts for the presence of ties-were presented.</p><p><strong>Results: </strong>Excluding NT-proBNP (WR, 1.49; 95% CI, 1.00-2.22; WO, 1.12; 95% CI, 1.00-1.26), adjusting the NT-proBNP threshold from 25% to 10% or 50% (WR, 1.41; 95% CI, 1.06-1.89; WO, 1.27; 95% CI, 1.04-1.56 for 10%; and WR, 1.54; 95% CI, 1.11-2.12; WO, 1.25; 95% CI, 1.06-1.48 for 50%), and incorporating renal outcomes (WR, 1.44; 95% CI, 1.07-1.94; WO, 1.28; 95% CI, 1.05-1.56) consistently favored sacubitril/valsartan.</p><p><strong>Conclusions: </strong>Multiple WR sensitivity analyses support a consistent treatment benefit of sacubitril/valsartan versus valsartan in patients with ejection fraction >40% to 60%. Future studies could consider prespecifying WR sensitivity analysis for comprehensive assessment of treatment effects.</p><p><strong>Trial registration: </strong>PARAGLIDE-HF; ClinicalTrials.gov ID, NCT03988634 (https://clinicaltrials.gov/study/NCT03988634).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590079","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 Randomized Controlled Trial of Gamification to Increase Physical Activity Among Black and Hispanic Breast and Prostate Cancer Survivors: Rationale and Design of the ALLSTAR Clinical Trial.","authors":"Alexander C Fanaroff, Jennifer A Orr, Chinyere Anucha, Emily Kim, Charles Rareshide, Meagan Echevarria, Stephanie Rodarte, Mareen Kassabian, Elina Balasian, Bonnie Ky, Kevin G M Volpp, Saro Armenian","doi":"10.1016/j.ahj.2024.10.021","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.021","url":null,"abstract":"<p><strong>Background: </strong>Survivors of breast and prostate cancer, especially those that are Black and/or Hispanic, are at high risk for cardiovascular events. Physical activity can reduce the risk of cardiovascular events in cancer survivors, but Black and Hispanic people are less likely to engage in routine physical activity. Concepts from behavioral economics have been used to design scalable, low-touch, gamification interventions that increase physical activity in individuals at high risk for cardiovascular events, but the effectiveness of these strategies in Black and Hispanic survivors of breast and prostate cancer is uncertain.</p><p><strong>Study design and objectives: </strong>ALLSTAR (NCT05176756) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of a gamification intervention informed by behavioral economic concepts to increase daily physical activity in Black and Hispanic breast and prostate cancer survivors who received cardiotoxic therapies and have additional risk factors for cardiovascular disease. Patients were either referred by their cancer care team or identified by electronic health record searches; contacted by letter, email, text message and/or phone; and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 1500-3000 steps from baseline, and are randomized 1:1 to control or gamification. Interventions continue for 6 months, with follow-up for an additional 3 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 150 participants, with a primary endpoint of change from baseline in daily steps over the 6-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 3-month post-intervention follow-up period, change in moderate to vigorous physical activity over the intervention and follow-up periods, and change in patient-reported measures of physical function, fatigue, and overall quality of life.</p><p><strong>Conclusions: </strong>ALLSTAR is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification is superior to control in increasing physical activity in Black and Hispanic breast and prostate cancer survivors. Its results will have important implications for strategies to promote physical activity in survivors of breast and prostate cancer, specifically among minority populations.</p><p><strong>Clinical trial registration: </strong>clinicaltrials.gov; https://clinicaltrials.gov/study/NCT05176756.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590061","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":"TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery: the TRACS trial: TAVI in centers without on-site cardiac surgery.","authors":"Gianmarco Iannopollo, Marta Cocco, Alessandro Leone, Salvatore Saccà, Domenico Mangino, Andrea Picchi, Matteo Rocco Reccia, Massimo Fineschi, Emanuele Meliga, Andrea Audo, Giampiero Nobile, Carlo Tumscitz, Carlo Penzo, Francesco Saia, Andrea Rubboli, Carolina Moretti, Luigi Vignali, Giampaolo Niccoli, Paolo Cimaglia, Andrea Rognoni, Daniela Aschieri, Daniele Iaccarino, Filippo Ottani, Caterina Cavazza, Ferdinando Varbella, Gioel Gabrio Secco, Leonardo Bolognese, Ugo Limbruno, Vincenzo Guiducci, Gianluca Campo, Gianni Casella","doi":"10.1016/j.ahj.2024.10.019","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.019","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic valve implantation (TAVI) has emerged as an effective and safe treatment for patients with symptomatic aortic stenosis. The indication to TAVI should be agreed upon by a Heart Team, and the procedure should be performed in centers with on-site cardiac surgery. However, TAVI complications requiring emergent cardiac surgery (ECS) have become very rare. Concurrently, access disparities and prolonged waiting times are pressing issues due to increasing clinical demand of TAVI. Many solutions have been proposed and one of them is the possibility of performing TAVI in centers without on-site cardiac surgery.</p><p><strong>Methods and design: </strong>The TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery (TRACS) trial is a prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients with symptomatic severe aortic stenosis and deemed inoperable, at high surgical risk, or presenting with at least one clinical factor compromising the benefit/risk ratio for ECS, will be randomized to undergo TAVI either in centers with or without on-site cardiac surgery. The primary endpoint will be the composite occurrence of all-cause death, stroke, and hospital readmission for cardiovascular causes at one year. The safety endpoint will include death attributable to periprocedural complications actionable by ECS. The study aims to enroll 566 patients.</p><p><strong>Implications: </strong>The TRACS trial aims to address critical gaps in knowledge regarding the safety and efficacy of TAVI procedures performed in centers without on-site cardiac surgery, potentially improving access and outcomes for high-risk patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05751577.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590076","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 DEFIANCE Study: A Randomized Controlled Trial of Mechanical Thrombectomy Versus Anticoagulation Alone for Iliofemoral Deep Vein Thrombosis.","authors":"Steven D Abramowitz, Xhorlina Marko, Donna D'Souza, Sonya Noor, Keith Pereira, Mitchell J Silver, Stuart P Rosenberg, Craig D Markovitz, Thomas Tu, Ido Weinberg, Stephen Black","doi":"10.1016/j.ahj.2024.10.016","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.016","url":null,"abstract":"<p><strong>Background: </strong>Deep vein thrombosis (DVT) is a common medical condition that is associated with clinically significant sequelae, including postthrombotic syndrome (PTS). Anticoagulation alone remains the guideline-recommended treatment for many patients with iliofemoral DVT. Recent technological advances have led to an increase in the use of mechanical thrombectomy for DVT, but mechanical thrombectomy-based procedures have not yet been compared with standard-of-care anticoagulation therapy in randomized studies.</p><p><strong>Methods: </strong>The DEFIANCE study (ClinicalTrials.gov: NCT05701917) is an international and actively enrolling randomized controlled trial (RCT) in lower extremity DVT assessing an interventional strategy that includes mechanical thrombectomy with the ClotTriever System (Inari Medical, Irvine, CA) versus anticoagulation alone. Approximately 300 patients with unilateral iliofemoral DVT and symptom duration ≤12 weeks will be randomized 1:1. Study conduct includes an independent core laboratory for duplex ultrasound assessment, an independent medical monitor for safety adjudication, and evaluation of PTS severity on the Villalta scale using best clinical practices. The primary endpoint is a composite outcome structured as a hierarchal win ratio of 1) the occurrence of treatment failure or therapy escalation as adjudicated by the medical monitor, with failure defined as amputation or gangrene of the target leg or venous thromboembolism-related mortality, and 2) the assessment of PTS severity at the 6-month follow-up visit. In addition to being a component of the primary endpoint, the severity of PTS at 6 months is also evaluated as a stand-alone secondary endpoint. An additional secondary endpoint is a composite of outcomes at the 10-day visit and is structured as a hierarchal win ratio of 1) vessel compressibility on duplex ultrasound, 2) patient-reported pain, and 3) improvement of edema. The safety endpoints are access site complications requiring endovascular or surgical repair and the occurrence through the 30-day visit of mortality, major bleeding, or new symptomatic pulmonary embolism.</p><p><strong>Conclusions: </strong>DEFIANCE will be the first RCT to evaluate a mechanical thrombectomy-based interventional approach versus anticoagulation therapy alone for DVT. The results will inform the treatment of patients with iliofemoral DVT and the prevention of PTS-associated morbidity.</p><p><strong>Trial registration: </strong>DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis (DEFIANCE), ClinicalTrials.gov: NCT05701917, URL: https://clinicaltrials.gov/study/NCT05701917?cond=Deep%20Vein%20Thrombosis&term=defiance&rank=1.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567818","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":"Use of E-Cigarette, Traditional Cigarettes, and C-Reactive Protein: The Cross Cohort Collaboration.","authors":"Zhiqi Yao, Erfan Tasdighi, Zeina A Dardari, John Erhabor, Kunal K Jha, Ngozi Osuji, Tanuja Rajan, Ellen Boakye, Carlos J Rodriguez, Joao A C Lima, Suzanne Judd, Theodore Feldman, Jonathan A Fialkow, Vasan S Ramachandran, Omar El Shahawy, Emelia J Benjamin, Aruni Bhatnagar, Andrew P DeFilippis, Khurram Nasir, Michael J Blaha","doi":"10.1016/j.ahj.2024.10.012","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.012","url":null,"abstract":"<p><p>This cross-sectional study included 18,797 participants from six longitudinal cohorts (CARDIA, FHS Gen III, HCHS/SOL, MESA, MiHeart, and REGARDS). 5,806 of them were with high-sensitivity C-reactive protein (hs-CRP) measurements. We found that among exclusive electronic cigarette (EC) use was associated with significantly lower high-sensitivity C-reactive protein (hs-CRP) levels compared to exclusive combustible cigarette use, suggesting a potentially lower inflammatory burden. hs-CRP levels in dual users and former smokers currently using EC were comparable to those observed in exclusive cigarette smokers. In contrast, individuals who exclusively used ECs showed no significant difference in hs-CRP levels compared to never smokers. These findings have important implications for tobacco regulation, public health, and clinical practice, highlighting the need for continued monitoring of EC-related health impacts.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493165","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 multicentric randomized EVAOLD trial: evaluation of a strategy guided by imaging versus routine invasive strategy in elderly patients with ischemia.","authors":"Gilles Barone-Rochette, Gerald Vanzetto, Nicolas Danchin, Philippe Gabriel Steg, Olivier Hanon, Clemence Charlon, Sandra David-Tchouda, Gaetan Gavazzi, Tabassome Simon, Jean-Luc Bosson","doi":"10.1016/j.ahj.2024.10.013","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.013","url":null,"abstract":"<p><strong>Background: </strong>The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain.</p><p><strong>Study design: </strong>EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥ 80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be non-inferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, non-fatal myocardial infarction, non-fatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show non-inferiority with 80% power. Non-inferiority based on exponential survival curves will be declared if the upper limit of the one-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a non-inferiority margin of 7% in absolute difference and an event rate of 40% in the INV group.</p><p><strong>Conclusion: </strong>EVAOLD is a nationwide, prospective, open-label trial testing the non-inferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients.</p><p><strong>Clinicaltrials: </strong>gov Identifier: NCT03289728.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493164","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 Randomized Embedded Multifactorial Adaptive Platform for Extra Corporeal Membrane Oxygenation (REMAP ECMO) - Design and Rationale of the Left Ventricular Unloading trial domain.","authors":"Myrthe P J van Steenwijk, Joost van Rosmalen, Carlos V Elzo Kraemer, Dirk W Donker, Jeannine A J M Hermens, Adriaan O Kraaijeveld, Jacinta J Maas, Sakir Akin, Leon J Montenij, Alexander P J Vlaar, Walter M van den Bergh, Annemieke Oude Lansink-Hartgring, Jesse de Metz, Niek Voesten, Eric Boersma, Erik Scholten, Albertus Beishuizen, Chris P H Lexis, Harlinde Peperstraete, Simon Schiettekatte, Roberto Lorusso, Diederik A M P J Gommers, Dick Tibboel, Rudolf A de Boer, Nicolas M D A Van Mieghem, Christiaan L Meuwese","doi":"10.1016/j.ahj.2024.10.010","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.010","url":null,"abstract":"<p><strong>Background: </strong>The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a \"Randomized Embedded Multifactorial Adaptive Platform (REMAP)\" in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP).</p><p><strong>Methods: </strong>REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is \"successful weaning from ECMO\" being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until one year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered.</p><p><strong>Conclusion: </strong>This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05913622.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493162","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":"Brief report: U.S. trends in use of colchicine by cardiologists and other specialties, 2018 to 2024.","authors":"Michael Khorsandi, Omar Mhaimeed, Omar Dzaye, Erfan Tasdighi, G Caleb Alexander, Michael J Blaha","doi":"10.1016/j.ahj.2024.10.011","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.011","url":null,"abstract":"<p><p>Colchicine has emerged as an effective agent for reducing ASCVD based on recent large cardiovascular outcome trials and exerts its benefit through targeting inflammation. In light of the robust body of data and FDA approval of low-dose colchicine for ASCVD prevention, this paper aimed to use the National Prescription Audie to quantify the volume and trends of colchicine prescriptions dispensed rough U.S. retail pharmacies between March 2018 and February 2024. Despite a 6% increase in total monthly prescriptions since 2020, driven primarily by cardiologists, this specialty still represents only 2.8-4% of the national monthly totals with small absolute numbers (i.e. estimated ∼4000 incremental prescriptions/month since 2020), suggesting limited cardiologist adoption of colchicine for ASCVD prevention despite favorable clinical trial data.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493163","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":"Fontan circulation and systemic disease - a retrospective cohort analysis over 35 years of follow-up.","authors":"Gruschen R Veldtman, Ali Abualsaud, Sarah Cohen, Maria Victoria Ordonez, Liming Guo, Chao Li, Aihua Liu, Jasmine Grewal, Michelle Gurvitz, Judith Therrien, Ariane Marelli","doi":"10.1016/j.ahj.2024.10.008","DOIUrl":"10.1016/j.ahj.2024.10.008","url":null,"abstract":"<p><strong>Background: </strong>The Fontan operation provides lifesaving palliation for individuals with single ventricle (SV) physiology. Given recent concerns of systemic disease (SD) for patients with a Fontan circulation, we sought to (1) quantify the increase in SD incidence associated with the Fontan circulation; (2) identify the risk factor of SD; (3) assess the association between SD and mortality in patients with a Fontan circulation.</p><p><strong>Methods: </strong>A matched retrospective cohort study design was adopted. From the Quebec Congenital Heart Disease (CHD) Database with up to 35 years of follow-up, patients who survived at least 30 days after the Fontan operation were identified. For each Fontan patient, patients with isolated ventricular septal defect (VSD) with the same sex and age were identified and 20 of them were randomly selected to form the control group. The presence of SD was defined as at least 1 hospitalization due to extra-cardiac complications including liver, respiratory, gastrointestinal or renal disease. Time-to-event analysis including Kaplan-Meier curve analysis and Cox proportional hazard models were conducted to assess the cumulative risk of SD, risk factors of SD, and the association between SD and 10-year mortality.</p><p><strong>Results: </strong>A total of 533 patients with Fontan circulation were identified and matched with 10,280 VSD patients. The cumulative probabilities of SD at 10- and 35-years follow-up were 59.02% and 89.66% in patients with a Fontan circulation, 4 to 7 times of the probabilities in VSD patients (8.68% and 23.34%, respectively; LogRank tests P < .0001). In Fontan patients, cardiovascular complications were associated with a 4.1-fold (95% CI: 3.52-4.88) higher risk of developing SD. Multisystem disease (>1 extra-cardiac organ affected) disease was associated with a 3.38-fold (95%CI: 1.73-6.60) increase in 10-year mortality risk when comparing to the absence of SD.</p><p><strong>Conclusions: </strong>This population-based study demonstrated that patients with a Fontan circulation had increased risk of SD, which in turn led to higher risk of mortality. These findings underscore the need for more systematic surveillance of cardiac and systemic disease for patients after Fontan operation.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456289","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":"Design and Rationale of a Pragmatic Randomized Clinical Trial of Early Dronedarone versus Usual Care to Change and Improve Outcomes in Persons with First-Detected Atrial Fibrillation - The CHANGE AFIB Study.","authors":"Sean D Pokorney, Hayley Nemeth, Karen Chiswell, Christine Albert, Nadine Allyn, Rosalia Blanco, Javed Butler, Hugh Calkins, Mitchell S V Elkind, Gregg C Fonarow, John M Fontaine, David S Frankel, Gregory J Fermann, Rex Gale, Matthew Kalscheur, Paulus Kirchhof, Andrew Koren, Joseph B Miller, Jason Rashkin, Andrea M Russo, Christine Rutan, Benjamin Steinberg, Jonathan P Piccini","doi":"10.1016/j.ahj.2024.10.001","DOIUrl":"https://doi.org/10.1016/j.ahj.2024.10.001","url":null,"abstract":"<p><strong>Background: </strong>While there are several completed clinical trials that address treatment strategies in patients with symptomatic and recurrent atrial fibrillation (AF), there are no randomized clinical trials that address first-line rhythm control of new-onset AF. Recent data suggest that early initiation of rhythm control within 1 year can improve outcomes.</p><p><strong>Methods: </strong>In this open-label pragmatic clinical trial nested within the Get With The Guidelines Atrial Fibrillation registry, approximately 3,000 patients with first-detected AF will be enrolled at approximately 200 sites. Participants will be randomized (1:1) to treatment with dronedarone in addition to usual care versus usual care alone. The primary endpoint will be time to first cardiovascular (CV) hospitalization or death from any cause through 12 months from randomization. Secondary endpoints will include a WIN ratio (all-cause death, ischemic stroke or systemic embolism, heart failure hospitalization, acute coronary hospitalization), CV hospitalization, and all-cause mortality. Patient reported outcomes will be analyzed based on change in Atrial Fibrillation Effect on Quality of Life (AFEQT) and change in Mayo AF-Specific Symptom Inventory (MAFSI) from baseline to 12 months.</p><p><strong>Conclusion: </strong>CHANGE AFIB will determine if treatment with dronedarone in addition to usual care is superior to usual care alone for the prevention of CV hospitalization or death from any cause in patients with first-detected AF. The trial will also determine whether initiation of rhythm control at the time of first-detected AF affects CV events or improves patient reported outcomes.</p><p><strong>Clinicaltrials: </strong>GOV #: - NCT05130268.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456287","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}