Transcatheter edge-to-edge repair for the management of secondary mitral regurgitation - CRT 2025 Beyond the Guidelines.

Secondary mitral regurgitation (SMR) remains a prevalent and challenging complication in patients with heart failure (HF), associated with poor prognosis despite optimal guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy. Current American and European guidelines recommend GDMT as first-line therapy, with transcatheter edge-to-edge repair (TEER) reserved for severe symptomatic SMR patients who remain refractory. However, both guidelines preceded the reporting of pivotal randomized controlled trials (RESHAPE-HF2, MATTERHORN, and EFFORT) and emerging evidence in new clinical scenarios.

Health Status Outcomes With Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in ISCHEMIA.

Background: In ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), an invasive strategy demonstrated better health status outcomes than a conservative strategy in patients with chronic coronary disease (CCD). Some previous studies have shown greater health status benefits with coronary artery bypass grafting (CABG) than percutaneous coronary intervention (PCI). Whether the health status benefits of invasive management in ISCHEMIA were driven primarily by participants treated with CABG is unknown.

Mechanistic Basis for Differential Effects of Interatrial Shunt Treatment in HFrEF vs HFpEF: The RELIEVE-HF trial.

Background: The RELIEVE-HF trial randomized 508 patients with heart failure (HF) to interatrial shunt-treatment vs placebo-procedure. Randomization was stratified into 2 patient groups with HF with reduced ejection fraction (HFrEF;LVEF≤40%) and HF with preserved EF (HFpEF;LVEF>40%). HF event rates (all-cause death, transplantation/LVAD, HF hospitalization/outpatient worsening) after shunt treatment during 2-year follow-up were directionally opposite: decreased by 51% in HFrEF, increased by 69% in HFpEF.

Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support.

Background: Cardiovascular and oncology trials increasingly require large sample sizes and long follow-up periods. Several approaches have been developed to optimize sample size including sample size re-estimation based on the promising zone approach. With time-to-event endpoints, methods traditionally used to test for treatment effects are based on proportional hazards assumptions, which may not always hold.

Analysis of inter-hospital transfer on clinical outcomes after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: A secondary analysis of the BRIGHT-4 trial.

Background: Previous studies evaluating the influence of inter-hospital transfer on mortality in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) reported conflicting results. The multicenter BRIGHT-4 trial demonstrated that bivalirudin plus a post-PCI high-dose infusion (1.75 mg/kg/h) reduced the 30-day primary endpoint of all-cause mortality or Bleeding Academic Research Consortium (BARC) types 3-5 bleeding compared with heparin monotherapy in STEMI patients.

Impact of Atrial Fibrillation in Patients With Severe Mitral Regurgitation Undergoing Transcatheter Edge-to-Edge Repair.

Background: Atrial fibrillation (AF) and mitral regurgitation (MR) are closely linked, and one may worsen the other. We investigated the impact of baseline AF in patients with MR undergoing transcatheter edge-to-edge repair.

Methods: One-hundred-fifty-six consecutive patients with symptomatic heart failure (HF) undergoing mitral valve transcatheter edge-to-edge repair for severe MR were studied.

Cardiovascular Research Technologies 2025: Beyond the Guidelines: DAPT selection and duration before and after PCI.

Dual antiplatelet therapy (DAPT) remains a cornerstone of secondary prevention in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). The balance between ischemic protection and bleeding risk has driven refinements in therapy duration. In 2025, the American College of Cardiology (ACC), American Heart Association (AHA), American College of Emergency Physicians (ACEP), National Association of EMS Physicians (NAEMSP), and the Society of Cardiovascular Angiography and Interventions (SCAI) released joint guidelines on the management of patients with ACS, with a particular emphasis on DAPT duration.

Comparative Prognosis by Stress ECG and Stress Imaging: Results From the ISCHEMIA Trial.

Background: Limited contemporary evidence exists on risk prediction by stress imaging and exercise electrocardiography (ECG) among patients with chronic coronary syndromes (CCS). Objectives From the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) study, prognosis was examined by core laboratory-defined stress imaging and exercise ECG findings in CCS patients.

Methods: A total of 5,179 patients (qualifying by stress nuclear imaging [n = 2,567], echocardiography [n = 1,085], cardiac magnetic resonance [CMR] [n = 257], and ECG [n = 1,270]) were randomized.

Early support in patients with St-segment elevation myocardial infarction complicated by shock. Design of exception from informed consent processes in recover iv trial.

Cardiogenic shock (CS) is a state of critical end-organ hypoperfusion due to reduced cardiac output. Patients with acute myocardial infarction-related cardiogenic shock (AMI-CS) have a survival to discharge of only 50%-60%. Mechanical circulatory support (MCS) devices are intended to support the failing heart and improve perfusion.

Impact of Baseline Anteroposterior Mitral Annular Dimensions on Clinical Outcomes after MitraClip for Secondary Mitral Regurgitation.

Background: In the randomized Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT; NCT01626079) trial, mitral transcatheter edge-to-edge repair (M-TEER) improved clinical outcomes in patients with severe secondary mitral regurgitation (MR). A prior post hoc analysis from the COAPT trial showed that increasing anteroposterior mitral annular diameter (APMAD) was the sole independent echocardiographic predictor of the composite endpoint of death or heart failure hospitalizations (HFH) at 2 years. Given the relationship between the mitral annulus and leaflets, we examined the association of baseline APMAD with long-term clinical outcomes.

Adding the patient perspective: the necessity of patient reported outcomes in cardiac surgery clinical trials.

Purpose Of Review: This review highlights the growing importance of patient reported outcomes (PROs) in cardiac surgery trials. Cardiac surgery trials have traditionally focused on cardiovascular events such as survival, stroke or myocardial infarction. However, as surgical outcomes have continued to improve, incorporating the patient's perspective through PROs has become increasingly critical.

Nonculprit Vulnerable Plaques and Prognosis in Myocardial Infarction With Versus Without ST-Segment Elevation: A PROSPECT II Substudy.

Background: Clinical guidelines recommend different revascularization strategies for nonculprit lesions in patients with ST-segment-elevation myocardial infarction (STEMI) versus non-STEMI (NSTEMI). Whether the prevalence of untreated high-risk vulnerable plaques differs in STEMI and NSTEMI and affects their outcomes is unknown.

Methods: In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree II), a multicenter, prospective natural history study, patients with recent myocardial infarction underwent 3-vessel coronary angiography with coregistered near-infrared spectroscopy and intravascular ultrasound after successful percutaneous coronary intervention of obstructive lesions from 2014 through 2017.

Expert perspectives on the intravascular imaging guidance of PCI, diagnosis and treatment - Beyond the Guidelines: Insights from the Cardiovascular Research Technologies 2025 meeting.

Advancements in percutaneous coronary intervention (PCI) technology and post-PCI patient management have led to improvements in clinical outcomes in coronary artery disease patients. At the forefront of these advancements is intravascular imaging - reduced risks of death, myocardial infarction, repeat revascularization, and stent thrombosis have been demonstrated with intravascular imaging-guided PCI compared with angiography guidance alone. The latest 2024 European Society of Cardiology chronic coronary syndrome guidelines and the 2025 American College of Cardiology/American Heart Association acute coronary syndrome guidelines provide a Class I recommendation for use of intravascular imaging in complex PCI.

Circulating protein biomarkers and their association with vulnerable plaque characteristics - a PROSPECT II substudy.

Background: In the PROSPECT-II study, near infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) was used to characterize atherosclerotic plaques in the coronary arteries. NIRS-derived lipid core burden index (LCBI) and IVUS-derived plaque burden (PB) were able to identify plaques strongly associated with adverse cardiovascular events.

Aim: Our aim was to identify biomarkers associated with LCBI or PB in the coronary arteries.

Long-Term Prognostic Impact of OCT-Derived High-Risk Plaque Features: Extended Follow-Up of the CLIMA Study.

Background: The long-term prognostic impact of presumed high-risk morphologic plaque features detected by intracoronary optical coherence tomographic (OCT) imaging remains largely unknown.

Objectives: The aim of this study was to assess the relationship between OCT plaque characteristics and cardiovascular outcomes throughout 5 years as part of the CLIMA (Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome) study.

Methods: In the multicenter, international, prospective CLIMA study, 1,003 patients underwent OCT evaluation of the untreated proximal left anterior descending coronary artery.

Optical coherence tomography- vs angiography-guided coronary stent implantation in calcified lesions: the ILUMIEN IV trial.

Background And Aims: The large-scale, randomized ILUMIEN IV trial was examined to determine whether procedural guidance with optical coherence tomography (OCT) during percutaneous coronary intervention (PCI) of angiographically calcified lesions improves outcomes.

Methods: Patients with a single PCI target lesion were included in the present analysis. The presence of none, mild, moderate or severe lesion calcification was determined by an angiographic core laboratory.

Forward Flow in Patients With Heart Failure and Functional Mitral Regurgitation: The COAPT Trial.

Background: Heart failure (HF) is characterized by a reduction in forward cardiac output (forward flow), potentially worsened by functional mitral regurgitation (FMR). The impact of reduced forward flow in HF patients with FMR is uncertain, and the outcomes of mitral transcatheter edge-to-edge repair (TEER) according to forward flow levels have not been described.

Methods: This study assessed the change in baseline flow in patients with HF and FMR enrolled in the COAPT trial randomized to TEER plus guideline-directed medical therapy (GDMT) compared with GDMT alone.

Preventive percutaneous coronary intervention for non-flow-limiting vulnerable atherosclerotic coronary plaques in diabetes: the PREVENT trial.

Background And Aims: The efficacy and safety of preventive percutaneous coronary intervention (PCI) for treating vulnerable plaques in diabetic patients remain unclear.

Methods: The PREVENT (Preventive Coronary Intervention on Stenosis with Functionally Insignificant Vulnerable Plaque) trial was a randomized clinical trial that compared preventive PCI plus optimal medical therapy with optimal medical therapy alone in patients with non-flow-limiting (fractional flow reserve >0.80) vulnerable plaques identified via intracoronary imaging.

Ticagrelor vs. clopidogrel in bivalirudin-treated patients with STEMI undergoing primary PCI: The BRIGHT-4 trial.

Background And Aims: The optimal antiplatelet agent regimen in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI) with bivalirudin anticoagulation is uncertain. This analysis sought to evaluate the safety and efficacy of ticagrelor compared with clopidogrel in patients with STEMI treated with PPCI with radial artery access and bivalirudin anticoagulation.

Methods: This post-hoc analysis compared bivalirudin plus ticagrelor with bivalirudin plus clopidogrel in 3009 BRIGHT-4 patients that were treated with PPCI.

Lipoprotein(a), Cholesterol, Triglyceride Levels, and Vulnerable Coronary Plaques: A PROSPECT II Substudy.

Background: Although lipoprotein(a) (Lp[a]) has been associated with acute myocardial infarction (MI), the relationship between Lp(a) and the presence of high-risk "vulnerable" coronary plaques has not been studied.

Objectives: The aim of this study was to investigate whether specific lipoproteins are associated with pancoronary plaque volume and lipid deposition vs the development of non-flow-limiting high-risk vulnerable plaques.

Methods: In PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) II, 3-vessel coronary artery imaging was performed with a combined near-infrared spectroscopy and intravascular ultrasound catheter after treatment of all flow-limiting lesions in patients with recent MI.

Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy.

Background: A novel optical coherence tomography (OCT)-based physiology assessment technique, virtual flow reserve (VFR), has been demonstrated to perform as a reliable surrogate for invasive physiology.

Objectives: The authors sought to examine the performance of post-percutaneous coronary intervention (PCI) VFR as a predictor of 2-year clinical outcomes independent from the OCT-based minimal stent area (MSA).

Methods: The ILUMIEN IV (Optical Coherence Tomography [OCT] Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI) trial prospectively recruited 2,487 patients with diabetes or high-risk coronary lesions randomizing to OCT- vs angiography-guided drug-eluting stent implantation.

Use of coronary artery bypass graft surgery and percutaneous coronary intervention and associated outcomes in the ISCHEMIA trial.

Background: In the ISCHEMIA Trial, 5,179 patients with stable coronary disease were randomized to initial invasive or conservative management.

Methods: PCI was recommended with a SYNTAX score 0 to 22 (low) and CABG with a SYNTAX score ≥33 (high). Either could be recommended for intermediate scores.