Am. Heart J. [JOURNAL]
Sun
200 papers
Immune checkpoint inhibitor-induced myocarditis and outcomes after re-exposure.
Khan MS, Rashid AM, Hanif M … +5 more , Asad ZUA, Khalid S, Kelly RJ, Paulson AS, DiMaio JM
Am Heart J · 2026 Aug · PMID 41932492 · Publisher ↗
BACKGROUND: Immune checkpoint inhibitors (ICI) can cause myocarditis, leaving physicians uncertain regarding the safety of restarting ICIs after recovery. This study aims to measure real-world incidence of ICI-induced my...
BACKGROUND: Immune checkpoint inhibitors (ICI) can cause myocarditis, leaving physicians uncertain regarding the safety of restarting ICIs after recovery. This study aims to measure real-world incidence of ICI-induced myocarditis and whether re-exposure to ICI after myocarditis impacts all-cause mortality. METHODS: Adult patients with cancer treated with ICIs were identified from TriNetX network, and outcomes were compared between patients re-exposed to ICI and those who were not. RESULTS: Among 195,578 patients receiving ICIs, 0.6% (n=1,214) developed myocarditis. Myocarditis was associated with increased all-cause mortality (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.25-1.66). Among those with myocarditis, 13.8% (n=168) were re-exposed to ICIs; re-exposure was associated with lower all-cause mortality (HR, 0.50; 95% CI, 0.35-0.73). CONCLUSIONS: ICI-induced myocarditis increases mortality, while re-exposure may improve survival in selected patients.
Optimal antiplatelet strategy in patients with advanced chronic kidney disease undergoing drug-eluting stent implantation: Design and rationale of the randomized ADAPT-CKD trial.
Jin IT, Lee SH, Yun KH … +21 more , Kim W, Shin S, Jang JY, Cho DK, Cha JJ, Kang TS, Lee JH, Cho YK, Heo JH, Ahn SG, Lee J, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS
Am Heart J · 2026 Aug · PMID 41932491 · Publisher ↗
BACKGROUND: Although shortened dual antiplatelet therapy (DAPT) strategies have demonstrated favorable outcomes in the general percutaneous coronary intervention (PCI) population, patients with advanced chronic kidney di...
BACKGROUND: Although shortened dual antiplatelet therapy (DAPT) strategies have demonstrated favorable outcomes in the general percutaneous coronary intervention (PCI) population, patients with advanced chronic kidney disease (CKD) have been underrepresented in randomized clinical trials. The optimal duration of DAPT after PCI remains uncertain in patients with CKD, who are at increased risk for both ischemic and bleeding events. METHODS: The ADAPT-CKD trial is an investigator-initiated, multicenter, open-label, randomized, superiority study designed to compare an abbreviated vs a standard DAPT strategy in patients with advanced CKD undergoing PCI with contemporary drug-eluting stents. A total of 900 patients with an estimated glomerular filtration rate <45 mL/min/1.73 m² will be randomly assigned in a 1:1 ratio to abbreviated DAPT (<3 months of DAPT after PCI) or standard DAPT (≥6 months). The primary endpoint is net adverse clinical events at 1 year, defined as a composite of all-cause death, myocardial infarction, stent thrombosis, stroke, or major bleeding according to the Bleeding Academic Research Consortium criteria. The primary hypothesis is that abbreviated DAPT is superior to standard DAPT in reducing net adverse clinical events at 1 year after randomization. CONCLUSIONS: The ADAPT-CKD trial will provide randomized evidence on the efficacy and safety of an abbreviated DAPT strategy compared with a standard DAPT strategy in patients with advanced CKD undergoing PCI. The results are expected to inform clinical decision-making regarding optimal antiplatelet therapy in this high-risk population. CLINICAL TRIAL REGISTRATION: https://www. CLINICALTRIALS: gov. Unique identifier: NCT04708587.
Patient characteristics and prognostic importance of dialysis in IE-A nationwide study.
Petersen JK, Østergaard L, Graversen PL … +14 more , Hadji-Turdeghal K, Stahl A, Alhakak A, Møller JE, Bruun NE, Povlsen JA, Moser C, Smerup M, Helweg-Larsen J, Faurholt-Jepsen D, Bundgaard H, Iversen K, Køber L, Fosbøl E
Am Heart J · 2026 Aug · PMID 41921587 · Publisher ↗
BACKGROUND: Acute kidney injury (AKI) requiring dialysis is a serious complication of infective endocarditis (IE), yet detailed data on risk factors and outcomes are limited. METHODS: Using the nationwide NIDUS registry,...
BACKGROUND: Acute kidney injury (AKI) requiring dialysis is a serious complication of infective endocarditis (IE), yet detailed data on risk factors and outcomes are limited. METHODS: Using the nationwide NIDUS registry, we identified all dialysis-naive patients hospitalized with first-time left-sided IE in Denmark from 2016 to 2021. Patients were grouped by whether they developed dialysis-requiring AKI. Factors associated with dialysis were assessed with multivariable logistic regression. In-hospital and post-discharge mortality were evaluated using Kaplan-Meier methods and multivariable Cox models. RESULTS: Among 2,738 patients with left-sided IE, 203 (7%) received dialysis for AKI (70% male; median age 70 years) and 2,535 (93%) did not (66% male; median age 75 years). Those requiring dialysis had greater comorbidity, and more frequently underwent valvular surgery (57.0% vs 19.8%, P< .01), with two-thirds initiating dialysis postoperatively. Independent factors associated with initiation of dialysis included chronic kidney disease, diabetes, liver disease, sepsis, valvular surgery, and infection with Staphylococcus aureus or Enterococcus species. In-hospital mortality was substantially higher among patients requiring dialysis (37.9 vs 16.5%; HR 1.86, 95% CI 1.39-2.50). In-hospital mortality was higher with dialysis (37.9% vs 16.5%; HR 1.86, 95% CI 1.39-2.50). Among survivors, associated mortality was higher within 3 months (12.0% vs 9.0%; HR 2.35, 95% CI 1.30-4.27) but similar from 3 to 12 months (6.3% vs 11.3%; HR 0.89, 95% CI: 0.41-1.93). CONCLUSION: Patients initiating dialysis during IE had an increased burden of traditional risk factors for AKI-with valve surgery representing the strongest associated risk factor for initiating dialysis. Patients initiating dialysis during IE had a markedly higher in-hospital mortality. Among survivors, higher associated mortality was confined to the early post-discharge period and diminished after 3 months.
Design and rationale of the EMPagliflozin after Aortic Valve Replacement (EMPAVR) study: A randomized clinical trial.
Sørensen LM, Reinert MS, Raja AA … +13 more , de Backer O, Bieliauskas G, Schou M, Jensen J, Møller ELR, Linde JJ, Kofoed KF, Kühl JT, Procida K, Petersen JK, Havers-Borgersen E, Køber L, Fosbøl E
Am Heart J · 2026 Jul · PMID 41903746 · Publisher ↗
INTRODUCTION: Left ventricular (LV) hypertrophy and dysfunction secondary to aortic stenosis (AS) are key components of the disease's underlying pathophysiology. Previous trials suggest that up to 1/3 of patients do not...
INTRODUCTION: Left ventricular (LV) hypertrophy and dysfunction secondary to aortic stenosis (AS) are key components of the disease's underlying pathophysiology. Previous trials suggest that up to 1/3 of patients do not benefit symptomatically after aortic valve replacement (AVR), which could be explained by insufficient LV remodeling. Sodium‒glucose cotransporter-2 (SGLT2) inhibitors are effective in heart failure (HF) and have been shown to improve LV remodeling (change in LV mass). METHODS: The EMPAVR study is an investigator-initiated, randomized, placebo-controlled, and double-blinded trial comparing the effect of empagliflozin to placebo in patients with severe and symptomatic AS undergoing transcatheter aortic valve implantation (TAVI). The primary outcome for the EMPAVR trial is the difference in LV mass indexed to body surface area (measured by cardiac CT) from pre-AVR to 6 months post-AVR. Patients are randomized in a 1:1 ratio to 180 days of treatment. DISCUSSION: To the best of our knowledge, the EMPAVR study is the first placebo-controlled trial investigating the effects of SGLT2 inhibition in patients following TAVI because of AS. The EMPAVR study has the potential to pave the way for treatment of the LV in valvular heart disease and may help patients worldwide and expand our understanding of aortic stenosis. TRIAL REGISTRATION: The EMPAVR study was registered in December 2024 (Clinical Trial Registration number: NCT06171802) before enrollment of the first patient. All patients will provide oral and written informed consent. The EMPAVR study is approved by the Regional Committee on Health Research Ethics and the Danish Medicines Agency.
Design and rationale of the Impella®-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients.
Goldstein DJ, Reichenspurner H, Vorovich E … +7 more , Teuteberg J, Ramzy D, Lobdell KW, Parks RJ, May A, Aggarwal S, Soltesz EG
Am Heart J · 2026 Jul · PMID 41895564 · Publisher ↗
BACKGROUND: Cardiac surgery patients with severe preoperative left ventricular (LV) dysfunction are at high risk for poor postoperative outcomes including prolonged ventilation, renal failure and post-cardiotomy cardioge...
BACKGROUND: Cardiac surgery patients with severe preoperative left ventricular (LV) dysfunction are at high risk for poor postoperative outcomes including prolonged ventilation, renal failure and post-cardiotomy cardiogenic shock (PCCS). Mortality and morbidity remain high for patients who develop PCCS, thus mandating the availability of more effective prophylactic and treatment options. METHODS: The Impella®-Protected Cardiac Surgery Trial (IMPACT) is a prospective, multicenter, single-arm pilot study assessing Impella 5.5® use prior to weaning from cardiopulmonary bypass in high-risk cardiac surgery patients. Key inclusion criteria are a baseline LV ejection fraction ≤25% or ≤35% with significant mitral regurgitation and planned mitral valve replacement or repair (MVR), and undergoing planned, on-pump isolated coronary artery bypass grafting, MVR, aortic valve replacement, or a combination of these with or without tricuspid valve replacement. The primary effectiveness endpoint is the rate of PCCF at hospital discharge. The primary safety endpoint is the composite of all-cause mortality, stroke and new requirement for renal replacement therapy evaluated through 90 days post-operation. Additional secondary endpoints include hospital and ICU lengths of stay, vasoactive-inotropic score, duration of mechanical ventilation and cardiovascular mortality. A concurrent registry will aim to collect data on patients not approached for study enrollment or who do not meet all inclusion and exclusion criteria. CONCLUSIONS: IMPACT results will provide data on trial and technique feasibility, patient selection criteria and aid in informing future trial designs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05529654, https://clinicaltrials.gov/study/NCT05529654.
Design and rationale of the prospective, randomized, controlled trial to assess the management of moderate aortic stenosis by clinical surveillance or transcatheter aortic valve replacement: The PROGRESS Trial.
Généreux P, Makkar RR, Bax JJ … +7 more , Pibarot P, Lindman BR, Prince H, Park B, Cohen DJ, Mack MJ, Leon MB
Am Heart J · 2026 Jul · PMID 41895563 · Publisher ↗
BACKGROUND: For patients with moderate aortic stenosis (AS), current US guidelines recommend clinical surveillance every 1 to 2 years. However, moderate AS has been associated with increased morbidity and mortality in mu...
BACKGROUND: For patients with moderate aortic stenosis (AS), current US guidelines recommend clinical surveillance every 1 to 2 years. However, moderate AS has been associated with increased morbidity and mortality in multiple observational studies, suggesting a possible role for earlier treatment with transcatheter aortic valve replacement (TAVR). To date, no large, randomized trial has examined whether an early intervention with TAVR will improve outcomes among these patients. STUDY DESIGN AND OBJECTIVES: The PROGRESS trial is a prospective, open-label, randomized, controlled, multicenter trial that includes up to 750 patients with moderate AS and at-risk features randomized 1:1 to either clinical surveillance or transfemoral TAVR with the SAPIEN 3/SAPIEN 3 Ultra/SAPIEN 3 Ultra RESILIA transcatheter heart valve (Edwards Lifesciences, Irvine, CA). Patients are stratified by site, left ventricular ejection fraction, and peak jet velocity. The primary effectiveness endpoint is the composite of death or heart failure event with or without hospitalization at 2 years. The primary safety endpoint (evaluated in the TAVR arm only) is a composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complications, or valve dysfunction requiring reintervention at 30 days. Patients will be followed annually through 10 years. CONCLUSIONS: The PROGRESS trial is the first large, randomized trial assessing the role of early intervention among patients with moderate AS with at-risk features compared to clinical surveillance. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04889872.
Enhancing invasive coronary function testing: Multivessel assessment of coronary microvascular dysfunction in patients with angina and no obstructive coronary artery disease (ANOCA).
Tzoumas A, Tapp DN, Ashokprabhu N … +15 more , Schmidt CW, Kaur S, Carnesi J, Hanycz C, Lakhia E, Davis JT, Wilson K, Baker A, Almanzar A, Zhang J, Mahbub E, Rai S, Mohan A, Quesada O, Henry TD
Am Heart J · 2026 Jul · PMID 41871679 · Publisher ↗
BACKGROUND: Invasive coronary function testing (ICFT) is the gold standard for diagnosing coronary microvascular dysfunction (CMD) and is predominantly performed in the left anterior descending coronary artery (LAD). How...
BACKGROUND: Invasive coronary function testing (ICFT) is the gold standard for diagnosing coronary microvascular dysfunction (CMD) and is predominantly performed in the left anterior descending coronary artery (LAD). However, it is unclear whether multivessel testing has additional diagnostic yield. METHODS: We analyzed a prospective registry of 231 patients with angina and no obstructive coronary artery disease (ANOCA) who underwent consecutive ICFT using the Doppler method in both the proximal LAD and the left circumflex (LCx) arteries for assessment of coronary flow reserve (CFR). RESULTS: 231 ANOCA patients with a median age of 59 (49,67) years were included in this analysis. ICFT with multivessel CFR assessment that included the LCx in addition to the LAD identified an additional 10% of patients with CMD (CFR ≤ 2.5) that would have been missed by LAD assessment only. Patients with multivessel CMD had statistically significant lower CFR in the LAD (1.9 vs 2.7, P < .001) and the LCx (1.9 vs 2.4, P < .001) compared to patients with single vessel CMD. CONCLUSION: Among ANOCA patients ICFT with multivessel CFR assessment identified an additional 10% of patients with CMD only seen in the LCx. Future studies are needed to elucidate the role of multivessel CMD assessment in the management of patients with ANOCA.
Attaining LDL-cholesterol target post major coronary event: Care gap, associated factors and clinical outcomes.
Iribarren C, Lu M, Go AS … +3 more , Rana JS, Ngai K, Rogers AM
Am Heart J · 2026 Jul · PMID 41871678 · Publisher ↗
BACKGROUND: Despite evidence supporting low-density lipoprotein cholesterol (LDL-C) reduction below 70 mg/dL after a major acute coronary event (MACE), many patients fail to reach this target. METHODS: Retrospective coho...
BACKGROUND: Despite evidence supporting low-density lipoprotein cholesterol (LDL-C) reduction below 70 mg/dL after a major acute coronary event (MACE), many patients fail to reach this target. METHODS: Retrospective cohort study (baseline 2012-2022) with follow-up through 12/31/2024 (median follow-up: 5.1 years). Participants were 47,416 adults with nonfatal myocardial infarction and/or coronary revascularization discharged on lipid-lowering therapy. Main exposures were LDL-C levels within 1-year postevent and annually for 10 years. Outcomes were incident ASCVD events (myocardial infarction, revascularization, ischemic stroke, CHD death) and composite CVD events (ASCVD, heart failure, peripheral vascular disease, CVD death). RESULTS: The cohort's mean (SD) age was 66 (12) years; 72% were male, and 58% white. In year 1, 12% lacked LDL-C testing; this rose from 44% in year 2% to 64% in year 10. Target LDL-C attainment was 67% in year 1 and 57% to 60% in years 2 to 10. Women and African American patients had lower target attainment. There was a clear upward trend of improved target control over time (58% in 2012, 77% in 2022). Comorbidities, cardiac rehabilitation participation, and adherence to lipid lowering therapy were associated with improved LDL-C control. Achieving LDL-C <70 mg/dL was associated with lower risk of ASCVD (HR 0.79, 95% CI: 0.77-0.82) and composite CVD (HR 0.84, 95% CI: 0.82-0.87); both P < .001. Numbers needed to treat (NNT) to prevent one ASCVD or composite CVD event were 19.7 and 26.3, respectively. CONCLUSIONS: Significant gaps exist in LDL-C monitoring and treatment goal attainment post-MACE. Notable disparities by sex and race/ethnicity were observed. Failure to meet LDL-C targets was associated with a significant increase in ASCVD and CVD risk.
Outcomes of implantable cardioverter-defibrillator implantation in adults with congenitally corrected transposition of great arteries.
Egbe AC, Kholeif Z, Madhavan M … +2 more , Deshmukh AJ, DeSimone CV
Am Heart J · 2026 Jul · PMID 41871677 · Publisher ↗
BACKGROUND: Ventricular arrhythmias and sudden cardiac death (SCD) are common in adults with congenitally corrected transposition of great arteries (cc-TGA). The purpose of this study was to describe the outcomes after i...
BACKGROUND: Ventricular arrhythmias and sudden cardiac death (SCD) are common in adults with congenitally corrected transposition of great arteries (cc-TGA). The purpose of this study was to describe the outcomes after implantable cardioverter-defibrillator (ICD) implantation in adults with cc-TGA. METHOD: Retrospective cohort study of adults with cc-TGA who underwent ICD implantation at Mayo Clinic (2003-2024). Indications for ICD implantation were classified as primary versus secondary prevention. Study outcomes were appropriate and inappropriate ICD shocks. Exploratory outcomes were device-related complications and mortality. RESULTS: Of 278 patients, 87 (31%) underwent ICD implantation (age 45±15 years, 59% males; primary prevention [N = 67, 77%], secondary prevention [N = 20, 23%]). Overall, 14 (16%) patients received appropriate ICD shock. The annual incidence of appropriate ICD shock was 3.7% per year and was lower in the primary versus secondary prevention groups (1.9% versus 8.2% per year, P = .006). Overall, 11 (13%) patients received inappropriate ICD shock, yielding annual incidence of 3.5% per year. This was similar between the 2 groups. Apart from ICD implantation for secondary prevention, none of the conventional risk factors were associated with an appropriate ICD shock. All-cause mortality was high (31%) among the cohort, but none of the patients experienced SCD. CONCLUSIONS: We observed a high rate of appropriate ICD shock, especially in the secondary prevention group. However, risk stratification of ICD implantation for primary prevention remains challenging. The absence of SCD (despite a high prevalence of all-cause mortality) suggest that ICD implantation may provide a survival benefit.
Comparative validation of risk scores for in-hospital complications following chronic total occlusion percutaneous coronary intervention.
Poletti E, Thotakura S, Kearney KE … +5 more , Lombardi WL, Hamilton DE, Gurm HS, Brilakis ES, Azzalini L
Am Heart J · 2026 Jul · PMID 41864398 · Publisher ↗
BACKGROUND: Chronic total occlusion percutaneous coronary intervention (CTO-PCI) is a high-risk procedure where reliable risk prediction is essential. We compared the performance of 2 risk models (Blue Cross Blue Shield...
BACKGROUND: Chronic total occlusion percutaneous coronary intervention (CTO-PCI) is a high-risk procedure where reliable risk prediction is essential. We compared the performance of 2 risk models (Blue Cross Blue Shield of Michigan Cardiovascular Consortium [BMC2] and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS-CTO]) for the prediction of in-hospital outcomes after CTO-PCI. METHODS: We retrospectively analysed 1,157 CTO-PCI procedures performed at a single tertiary center between 2019 and 2023. Primary endpoint was in-hospital mortality. Discrimination was assessed with the area under the curve (AUC) method and calibration with calibration plots. Model accuracy was further quantified by the Brier score. RESULTS: Major adverse cardiac and cerebrovascular events (MACCE) occurred in 3.0% (n = 35), and mortality in 1.0% (n = 11). The BMC2 score outperformed PROGRESS-CTO for mortality prediction (AUC 0.96 vs 0.71; P < .001). BMC2 achieved excellent prediction for acute kidney injury (AUC 0.93), dialysis (0.91), and stroke (0.84), while PROGRESS-CTO provided moderate accuracy for periprocedural myocardial infarction, pericardiocentesis (both AUC 0.71), coronary perforation (AUC 0.72) and MACCE (AUC 0.62). Calibration plots indicated better calibration for the PROGRESS-CTO model, while both models showed low overall prediction error (Brier score). CONCLUSIONS: In CTO-PCI, BMC2 offers superior performance for in-hospital mortality prediction. Their complementary features suggest BMC2 as a powerful, data-demanding, and patient-focused tool, while PROGRESS-CTO as an easy-to-calculate, procedure-oriented model.
Assessment of the gradient gap after TAVR with balloon and self-expandable valves: Analysis of a large patient cohort.
Arow Z, Oliva O, Seyeddi SS … +8 more , Bonfils L, Lepage L, Hussein-Aro R, Vaknin-Assa H, Assali A, De Biase C, Tchetche D, Dumonteil N
Am Heart J · 2026 Jul · PMID 41856449 · Publisher ↗
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a key treatment for severe aortic stenosis (AS). Several studies have consistently shown discrepancies between transvalvular gradients measured by transthoraci...
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a key treatment for severe aortic stenosis (AS). Several studies have consistently shown discrepancies between transvalvular gradients measured by transthoracic echocardiography (TTE) and those obtained invasively. The aim of this study was to evaluate this discrepancy in a large patient cohort and determine whether it is associated with clinical outcomes. METHODS: This study included patients with severe AS who underwent TAVR using either balloon-expandable (BEVs) or self-expanding valves (SEVs). The primary endpoint was the magnitude of discrepancy between peak transvalvular gradients measured by TTE and invasive hemodynamic assessment. Secondary endpoints included the association of this gradient difference with in-hospital, 30-day, and 1-year mortality. In addition, multivariable linear regression analysis was performed to identify independent predictors of gradient discrepancy. RESULTS: A total of 1,798 TAVR patients were included: 799 received BEVs and 999 received SEVs. Postprocedural mean peak gradients by echocardiography were significantly higher in the BEV group (20 ± 8 mmHg) than in the SEV group (15 ± 7 mmHg; P < .001). Invasive mean peak gradients were lower overall, at 5.9 ± 4 mmHg for BEVs and 5.3 ± 3.8 mmHg for SEVs (P = .001). The mean difference between echocardiographic and invasive measurements was significantly greater in the BEV group (14 ± 8 mmHg) compared to the SEV group (10 ± 7 mmHg; P < .001). There were no statistically significant differences in mortality between the BEV and SEV groups. Additionally, female sex, hypertension, preserved left ventricular function, small valve size, and small aortic annulus were all linked to greater differences between echocardiographic and invasive gradients. CONCLUSION: echocardiographic gradients after TAVR consistently overestimate invasive values, especially with balloon-expandable valves, but without impacting short or mid-term mortality.
Evolution of endoscopic mitral valve surgery over a 11-year period at a high-volume center.
Pausch J, Bhadra OD, Weimann J … +7 more , Hua X, Alassar Y, Girdauskas E, Schaefer A, Pecha S, Reichenspurner H, Conradi L
Am Heart J · 2026 Jul · PMID 41856448 · Publisher ↗
BACKGROUND: Endoscopic mitral valve surgery (MVS) has evolved at specialized centers aiming to reduce surgical trauma and improve recovery. The aim of this study was to monitor the evolution and temporal changes of endos...
BACKGROUND: Endoscopic mitral valve surgery (MVS) has evolved at specialized centers aiming to reduce surgical trauma and improve recovery. The aim of this study was to monitor the evolution and temporal changes of endoscopic MVS at our institution. METHODS: Between 2012 and 2022, a total of 1.037 consecutive patients underwent endoscopic MVS and were categorized into an initial- (2012-2017; n = 487) and a late-group (2018-2022; n = 550). Data was retrospectively analyzed. RESULTS: Patient age increased during the study period from 56.0 (47.0-64.2) to 61.0 (55.0-68.0) years (p trend = 0.0275). The prevalence of coronary artery disease (9.3% vs 17.1%; P < .001) and endocarditis (2.1% vs 6.0%; P = .0026) differed between groups. Median STS PROM score increased from 0.3 (0.3-0.5) to 0.4 (0.3-0.9) (p trend < 0.001). MV repair was performed in 92.7%. Concomitant procedures, eg, closure of left atrial appendage (21.0%), atrial ablation (19.2%) or tricuspid valve repair (6.7%) increased significantly over time (p trend < 0.01). Nevertheless, median bypass and cross-clamp times decreased (p trend < 0.001). Median postoperative ventilation time was 5.0 (3.3-7.0) hours and decreased during the study-period (p trend < 0.001). Length of intensive care unit and in-hospital stay were 2.0 (1.0-3.0) and 7.0 (6.0-9.0)days, respectively. At 30 days, overall mortality was 0.6% excluding patients with endocarditis. After 5 years re-operation rate was 2.5% and overall survival was 94.0%. During a maximum follow up of 11.2 years, reoperation rate was 5.0%, whereas overall survival was 88.5%. CONCLUSIONS: In the present analysis, evolution of endoscopic MVS from isolated procedures in young, low-risk patients with simple MV pathology to combined procedures in older patients with complex MV disease, was demonstrated. Despite increasing surgical risk, complexity of MV disease as well as an increasing rate of concomitant procedures, perioperative outcome remained favorable over time, resulting in promising mid- to long-term results.
American Heart Association cardiovascular health metrics and cancer outcomes: A systematic review and meta-analysis.
Torres J, Navarro S, Gao H … +5 more , Xiong T, Wehner MR, Hawk ET, Leeper NJ, Nead KT
Am Heart J · 2026 Jul · PMID 41856447 · Publisher ↗
BACKGROUND: Cardiovascular disease and cancer have numerous shared risk factors. Our objective is to determine whether American Heart Association (AHA) cardiovascular health (CVH) metrics are associated with cancer outco...
BACKGROUND: Cardiovascular disease and cancer have numerous shared risk factors. Our objective is to determine whether American Heart Association (AHA) cardiovascular health (CVH) metrics are associated with cancer outcomes. METHODS: We searched PubMed and Scopus (inception to July 15, 2025). We included cohort studies examining the association of AHA CVH metrics with cancer risk and cancer mortality. We conducted meta-analyses to generate summary risk ratios (RRs), hazard ratios (HRs), and standard errors for outcomes with at least 3 contributing studies reporting associations with low (worse), moderate, and high (best) CVH score groups. We utilized meta regression to examine dose-response relationships of CVH score groups. RESULTS: Our systematic review included 26 studies. Moderate (RR, 0.85; 95% CI, 0.79-0.91, P < .001) and high (RR, 0.72; 95% CI, 0.64-0.81, P < .001) CVH scores were associated with decreased overall cancer risk with evidence of a dose-response effect for more favorable groups (coefficient, -0.09; standard error [SE], 0.02; P < .001). High CVH scores were associated with statistically significantly decreased risk of breast (RR, 0.72; 95% CI, 0.58-0.90), colorectal (RR, 0.65, 95% CI, 0.57-0.74), and lung cancer (RR, 0.34; 95% CI, 0.16-0.70). We found evidence for lower cancer mortality in the moderate (HR, 0.64; 95% CI, 0.61-0.68, P < .001) and high (HR, 0.47; 95% CI, 0.41-0.53, P < .001) CVH score groups. Meta regression demonstrated a dose-response effect on all cancer mortality (coefficient, -0.33; SE, 0.05; P < .001). CONCLUSIONS: We provide evidence for a dose response association of better CVH scores with decreased cancer incidence and cancer mortality. Optimizing CVH may improve cancer outcomes.
Trial event rate assumption and noninferiority margin in comparative trials of aortic valve replacement.
Dimagli A, Redfors B, Gaudino M
Am Heart J · 2026 Jul · PMID 41856446 · Publisher ↗
This letter evaluates whether overestimation of control event rates and the use of absolute noninferiority margins influenced conclusions of randomized trials comparing transcatheter and surgical aortic valve replacement...
This letter evaluates whether overestimation of control event rates and the use of absolute noninferiority margins influenced conclusions of randomized trials comparing transcatheter and surgical aortic valve replacement. By reanalyzing published noninferiority trials using observed event rates and corresponding relative margins, we assessed the robustness of trial conclusions to alternative margin specifications. Our findings inform interpretation of noninferiority evidence underlying contemporary clinical decision-making in aortic valve replacement.
Physical rehabilitation for older patients with acute HFpEF (REHAB-HFpEF) trial: Design and rationale.
Pastva AM, Reeves GR, Whellan DJ … +10 more , Mentz RJ, Chen H, Bertoni AG, Duncan PW, Espeland MA, Reed SD, Nelson MB, O'Connor CM, Kitzman DW, REHAB-HFpEF Trial Investigators
Am Heart J · 2026 Jul · PMID 41812966 · Full text
RATIONALE: Older patients hospitalized for acute decompensated heart failure with preserved ejection fraction (HFpEF) experience persistently poor outcomes, including physical disability, cognitive impairment, depression...
RATIONALE: Older patients hospitalized for acute decompensated heart failure with preserved ejection fraction (HFpEF) experience persistently poor outcomes, including physical disability, cognitive impairment, depression, impaired health-related quality of life (HRQOL), rehospitalizations, loss of independence, and mortality. In our previous phase 2 REHAB-HF trial, an innovative physical rehabilitation intervention, delivered across three phases-inpatient, 12-week outpatient, and 3-month home-based maintenance-produced large improvements in physical function and HRQOL, with signals of reduced clinical events among patients with acute HFpEF. These findings provide a compelling rationale for a definitive, event-powered trial to evaluate clinical outcomes. HYPOTHESIS: Targeting physical frailty and multisystem functional impairments using the REHAB-HF intervention-a transitional, tailored, structured, and progressive multidomain rehabilitation program focused on balance, mobility, strength, and endurance-will reduce clinical events in older, predominantly frail patients hospitalized for acute HFpEF. DESIGN: REHAB-HFpEF is a multicenter, randomized, single-blind, attention-controlled phase 3 trial across 22 U.S. health system centers, enrolling 880 patients aged ≥60 years hospitalized for acute HFpEF. The primary endpoint is combined all-cause rehospitalizations and mortality at 6 months. Key secondary endpoints include major mobility disability (defined as inability to walk ≥160 meters on the 6-minute walk test) and HRQOL measured by the Kansas City Cardiomyopathy Questionnaire. Healthcare costs will also be assessed. CONCLUSIONS: REHAB-HFpEF is designed to address care gaps for frail older adults with acute HFpEF, who currently lack an evidence-based rehabilitation pathway. If successful in meeting endpoints, this trial could establish a scalable rehabilitation intervention that improves recovery, reduces adverse events, and lowers healthcare costs. Findings may shift HF management paradigms, inform guidelines, and influence national coverage policy for this growing, high-risk population. CURRENT STATUS: Enrollment ongoing, 478 of 880 (66%) as of 24Feb2027. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT05525663, https://clinicaltrials.gov/study/NCT05525663?term=NCT05525663&rank=1.
Impact of total stent length on long-term outcomes with different newer-generation drug-eluting stent designs in ST-segment elevation myocardial infarction: A subgroup analysis from the BIOSTEMI ES randomized trial.
Iglesias JF, Roffi M, Heg D … +11 more , Muller O, Kurz DJ, Haegeli L, Rigger J, Kaiser C, Girod G, Cook S, Bossard M, Losdat S, Windecker S, Pilgrim T
Am Heart J · 2026 Jul · PMID 41812965 · Publisher ↗
BACKGROUND: Longer total stent length (TSL) increases the risk of target lesion failure (TLF) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention with...
BACKGROUND: Longer total stent length (TSL) increases the risk of target lesion failure (TLF) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention with second-generation drug-eluting stents (DES). We aimed to assess the long-term impact of TSL on patient- and stent-related outcomes in STEMI patients treated with different newer-generation DES designs. METHODS: We performed a post hoc subgroup analysis of the BIOSTEMI Extended Survival randomized trial (NCT05484310). Patients undergoing primary percutaneous coronary intervention for STEMI were randomized to ultrathin-strut biodegradable-polymer sirolimus-eluting stents (BP-SES) or thin-strut durable-polymer everolimus-eluting stents (DP-EES) and categorized according to TSL implanted at the culprit site (≤40 vs >40 mm). The device-oriented composite endpoint (TLF) was the composite of cardiac death, target-vessel myocardial reinfarction, or clinically indicated target lesion revascularization, and the patient-oriented composite endpoint was the composite of all-cause death, any myocardial reinfarction, any revascularization, or any stroke, at 5 years. RESULTS: A total of 1,686 STEMI patients were included (mean age, 62.4 years; female, 23%; mean TSL, 33.8 mm), of whom 423 (25%) were treated with TSL >40 mm. At 5 years, TSL >40 mm was associated with a significantly higher risk of patient-oriented composite endpoint compared with TSL ≤40 mm (31.7% vs 27.4%; hazard ratio [HR], 1.30; 95% confidence interval [CI], 1.03-1.64; P = .029), whereas no difference was observed in TLF. However, there was a significant interaction between DES type and TSL for TLF at 5 years. Among patients with TSL >40 mm, BP-SES were associated with a lower risk of TLF compared with DP-EES (7.3% vs 17.1%; HR, 0.39; 95% CI, 0.21-0.74; P = .004; P for interaction = .032), a difference primarily driven by a lower rate of target vessel myocardial reinfarction. No significant differences between BP-SES and DP-EES were observed in patients with TSL ≤40 mm. After adjustment for multivessel treatment, increasing TSL with DP-EES, but not BP-SES, was independently associated with a higher risk of TLF (adjusted HR per 5-mm increase, 1.07; 95% CI, 1.02-1.11; P = .003). CONCLUSION: In STEMI patients treated with contemporary DES, TSL >40 mm was associated with an increased risk of patient-oriented, but not device-related, adverse outcomes at 5 years. Among patients requiring TSL >40 mm, ultrathin-strut BP-SES significantly reduced the risk of TLF compared with DP-EES, whereas no between-DES differences were observed in patients treated with TSL ≤40 mm. TRIAL REGISTRATION: The BIOSTEMI ES trial is registered at ClinicalTrials.gov (NCT05484310).
Design and rationale of the clinical trial to obtain the highest efficacy of dual antiplatelet therapy after carotid artery stenting in high bleeding risk patients (CHET): A multicenter, randomized, open-label, superiority trial.
Kim HJ, Song TJ, Park MS … +26 more , Baek JH, Kim YW, Eun MY, Woo HG, Jeong D, Park H, Jung JM, Kim JY, Kim BJ, Kim YD, Park HK, Choi KH, Kim JG, Cho HJ, Joon An S, Lee SY, Lee SJ, Lee SJ, Lee J, Yoo J, Shin DW, Kang HG, Seo JH, Bang OY, Seo WK, CHET Investigators
Am Heart J · 2026 Jul · PMID 41802529 · Publisher ↗
RATIONALE: Abbreviated dual antiplatelet therapy (DAPT) strategies effective in percutaneous coronary intervention among patients with high bleeding risk (HBR) may not be applicable to carotid artery stenting (CAS) owing...
RATIONALE: Abbreviated dual antiplatelet therapy (DAPT) strategies effective in percutaneous coronary intervention among patients with high bleeding risk (HBR) may not be applicable to carotid artery stenting (CAS) owing to anatomical and procedural differences. PRIMARY HYPOTHESIS: Among patients with HBR undergoing CAS, abbreviated DAPT followed by SAPT will reduce clinically significant bleeding compared to prolonged DAPT, while maintaining noninferiority in net clinical outcomes, including ischemic and major bleeding events. DESIGN: CHET trial is a multicenter, randomized, open-label, superiority trial in HBR patients undergoing CAS. Assuming a 38% relative reduction in bleeding (10.4%-6.45%), 1,524 participants (762 per group) provide 80% power with a two-sided alpha of 0.05; the final target is 1,556 (778 per group), allowing 2% dropout. Key HBR criteria include age ≥75 years, ischemic stroke within 6 months, renal insufficiency, anemia, and thrombocytopenia. All patients will receive aspirin and clopidogrel for 30 days after CAS (enrichment period). Event-free patients on day 30 were randomized 1:1 to receive SAPT (aspirin 100 mg daily or clopidogrel 75 mg daily, at the treating physician's discretion) or continued DAPT for 11 months. The primary safety endpoint is clinically significant bleeding (BARC 2, 3, or 5) from day 30 to 12 months post-CAS. The secondary efficacy endpoint is a composite of nonfatal stroke, nonfatal myocardial infarction, cardiovascular death, and major bleeding (BARC 3 or 5). ENROLLMENT DATES AND CURRENT STATUS: CHET began enrollment on July 15, 2024. As of February 5, 2026, the trial is currently enrolling, with 328 participants enrolled. Enrollment is expected to be completed by November 2029, and follow-up by December 2030. CONCLUSIONS: CHET trial is the first randomized controlled trial to define optimal DAPT duration in HBR patients after CAS. TRIAL REGISTRATION: www. CLINICALTRIALS: gov (NCT06276374).
Adults with repaired systemic biventricular congenital heart disease with a systemic left ventricle and heart failure with reduce ejection fraction.
Ellabbad M, Kholeif Z, Ammash NM … +4 more , Dunlay SM, Jokhadar M, Majdalany D, Egbe AC
Am Heart J · 2026 Jul · PMID 41802528 · Publisher ↗
BACKGROUND: Results of observational studies assessing clinical benefits of guideline-directed medical therapy (GDMT) for heart failure (HF) in adults with congenital heart disease are conflicting. This is because these...
BACKGROUND: Results of observational studies assessing clinical benefits of guideline-directed medical therapy (GDMT) for heart failure (HF) in adults with congenital heart disease are conflicting. This is because these studies were based on a heterogenous population and lacked standardized criteria for assessing adequacy of HF therapy across studies. The current study addressed these limitations by studying the effect of GDMT (using a standardized GDMT score) in adults with repaired systemic biventricular congenital heart disease, systemic left ventricle, and HF with reduced ejection fraction. METHODS: HF with reduced ejection fraction was defined as stage B/C HF and systemic left ventricular EF < 50%. GDMT score was assessed at baseline encounter (baseline GDMT score) and 1-year follow-up. GDMT uptitration was calculated as defined as ∆GDMT (∆=delta or change in) score from baseline. Cox regression was used to assess the relationship between HF therapy (baseline and ∆GDMT score) and outcomes (HF hospitalization and mortality). RESULTS: Of 778 patients, baseline and ∆GDMT scores were 2 (1, 3) and 0.56 (0.49, 0.62), respectively. Of 778, only 258 (33%) had GDMT uptitration (∆GDMT score >0). Higher use of GDMT at baseline (adjusted hazard ratio [HR] per 1 point increase in GDMT score 0.83, 95% confidence interval [CI] 0.74, 0.92, P < .001), and increased use of GDMT over time (adjusted HR for 1 point increase in ∆GDMT score HR 0.71, 95% CI 0.62, 0.82, P < .001) were associated with lower risk of HF hospitalization. Higher baseline GDMT score (adjusted HR 0.87, 95% CI 0.76, 0.98, P = .01), and ∆GDMT score (adjusted HR 0.84, 95% CI 0.72, 0.86, P = .002) were also associated with lower mortality. CONCLUSIONS: GDMT use at baseline, and GDMT uptitration were associated with improved outcomes and suggest a dose-dependent relationship between use of GDMT and risk of adverse outcomes. Furthermore, 67% of patients did not receive GDMT uptitration, suggesting suboptimal therapy and opportunities for improvement.
A pilot randomized clinical trial of gamification to increase medication adherence.
Fanaroff AC, Clark K, Reid-Bey L … +4 more , Rareshide C, Zhu J, Norton L, Volpp KG
Am Heart J · 2026 Jul · PMID 41802527 · Full text
INTRODUCTION: Medication nonadherence is a key contributor to poor control of cardiovascular risk factors, but most interventions shown to increase adherence are labor-intensive and have not been implemented widely. Gami...
INTRODUCTION: Medication nonadherence is a key contributor to poor control of cardiovascular risk factors, but most interventions shown to increase adherence are labor-intensive and have not been implemented widely. Gamification interventions informed by behavioral economic theory increase physical activity with minimal cost and personnel requirements. We tested the feasibility of a gamification intervention to increase medication adherence among patients at risk of cardiovascular disease with a history of medication nonadherence. METHODS: Patients seen in a single primary care clinic who were prescribed 1 or 2 antihypertensive medications and a statin and had a recent history of nonadherence were identified and offered enrollment in a pilot randomized controlled trial. Patients were enrolled on the Penn Way to Health platform, provided with a validated home blood pressure cuff, and randomized to attention control or gamification. Attention control patients received daily text messages asking if they took their antihypertensive medication and statin, and biweekly text messages asking them to check and report their blood pressure. Gamification participants received the same text messages, and were also enrolled in a game in which they were provided with 90 points per week and lost 10 points each day they did not report taking their antihypertensive medications or statin and each time they did not report a blood pressure when requested. Each week, participants with 70 points or more moved up a level; those with less than 70 points moved down a level. The intervention continued for 14 weeks, followed by a 4-week post-intervention follow-up period. The trial's primary outcome was self-reported adherence. RESULTS: A total of 622 patients were eligible for the study and were contacted by study staff; ultimately 43 (of a planned 84) were enrolled and randomized to gamification (n = 21) or control (n = 22). Mean (SD) age was 65 (7.2), 20 (46.5%) were women, and 25 (58.1%) were Black. Over the 18-week study period, there was no significant difference between arms in adherence to antihypertensive medications (79.6% [gamification] vs. 78.6% [control]; difference between arms, 1.4%, 95% CI -1.2 to 3.9%) or statins (80.4% [gamification] vs. 78.6% [control]; difference between arms, 1.8%, 95% CI -2.2 to 5.9%). There were no differences in self-reported adherence between arms over the post-intervention follow-up period, and similarly no differences between arms in medication adherence by SureScripts data, systolic blood pressure, or low-density lipoprotein cholesterol. CONCLUSIONS: In this pilot randomized controlled trial, we found that a behaviorally-designed gamification intervention did not increase adherence to antihypertensive medications and statins compared with attention control. Challenges with recruiting patients with a history of poor adherence and lack of tools for automated, inexpensive, unobtrusive measurement of daily medication-taking behavior are key limitations to the deployment of gamification to increase medication adherence. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov; unique identifier: NCT05326386.
Empagliflozin and functional aerobic capacity in individuals with increased risk of heart failure: The Empire Prevent Cardiac trial.
Larsen JH, Andersen CF, Jessen MM … +10 more , Hansen MC, Omar M, Jensen J, Antonsen L, Forman JL, Højlund K, Poulsen MK, Brønd JC, Schou M, Møller JE
Am Heart J · 2026 Mar · PMID 41802526 · Publisher ↗
BACKGROUND: Higher maximal oxygen consumption (VO₂ max) is associated with lower risk of developing heart failure (HF). Empagliflozin improves VO max in HF with reduced ejection fraction, but the effect on VO max in indi...
BACKGROUND: Higher maximal oxygen consumption (VO₂ max) is associated with lower risk of developing heart failure (HF). Empagliflozin improves VO max in HF with reduced ejection fraction, but the effect on VO max in individuals at risk of HF remain unknown. OBJECTIVE: This study aimed to evaluate the effect of 180 days treatment with empagliflozin compared to placebo on VO max, daily physical activity level, and quality of life (QoL) in individuals with overweight or obesity and risk of HF. METHOD: This investigator-initiated, double-blinded, randomized, placebo-controlled, multicenter trial included elderly individuals with body mass index >28 kg/m and at least one additional risk factor for HF, including hypertension, ischemic heart disease, stroke, or chronic kidney disease. Individuals with HF or type 2 diabetes mellitus were excluded. The primary endpoint was the mean difference in change of VO max. The secondary outcome was objectively measured physical activity level. QoL was an explorative outcome. RESULTS: Among 191 randomized individuals (94 empagliflozin, 97 placebo), 89% had hypertension and 66% ischemic heart disease. At baseline, 69% were male, median age was 68 years, median body mass index 31.9 kg/m², mean left ventricular ejection fraction 65 ± 9%, and mean VO₂ max 18.1 ± 4.3 mL/min/kg. Empagliflozin did not change VO max with an estimated treatment difference of -0.2 mL/min/kg (97.5% confidence interval -1.2 to 0.8), adjusted P = 1.00. No significant treatment differences were observed for neither daily physical activity nor QoL. CONCLUSIONS: Empagliflozin did not affect VO max, physical activity level, or QoL in elderly individuals with overweight or obesity and risk of HF.
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