Safety and Feasibility of Robot-Assisted Percutaneous Coronary Intervention Using the AVIAR 2.0 System: A Prospective, Multi-Center, Single-Arm, Open, Investigator-Initiated, Post-Approval Clinical Trial.

Background And Objectives: Traditional manual percutaneous coronary intervention (PCI) exposes operators to significant radiation and physical stress. The recently developed Advanced Vascular Intervention Assist Robot (AVIAR) 2.0 system in South Korea aimed to overcome these issues by evaluating its safety and feasibility in a clinical setting.

Quantitative Coronary Angiography Guidance for Drug-Eluting Stent Implantation: A Narrative Review.

Background: Percutaneous coronary intervention (PCI) using drug-eluting stents is an established strategy for the treatment of significant obstructive coronary artery disease. Evidence supports that intravascular imaging-guided PCI offers advantages over conventional angiography-guided PCI, though its use is limited, likely due to high costs. Angiography-guided PCI relies on visual estimation, leading to inter- and intra-observer variability and suboptimal outcomes.

Long-term impacts of complete revascularization on clinical outcomes in patients with coronary chronic total occlusion.

The impact of complete revascularization (CR), achieved through the recanalization of coronary chronic total occlusions (CTOs), on long-term patient outcomes remains uncertain. To evaluate this in patients who achieved CR after CTO-PCI with those who did not due to deferred CTO-PCI, the Asan Medical Center Registry was reviewed to identify coronary artery disease (CAD) patients with CTOs treated between January 2003 and December 2018. Patients were included with single-vessel disease with CTO and with multivessel disease who had undergone revascularization for non-CTO lesions.

Clinical impact of deep learning-derived intravascular ultrasound characteristics in patients with deferred coronary artery.

Prognostic markers for long-term outcomes are lacking in patients with deferred (nonculprit) coronary artery lesions. This study aimed to identify the morphological criteria for predicting adverse outcomes and validate their clinical impact. Using deep learning models, we extracted geometrical parameters and maximal attenuation (or calcium) burden index (ABI-max or CBI-max) from the intravascular ultrasound (IVUS) images of nonculprit vessels in 1115 patients.

Patent Foramen Ovale Closure in Older Patients With Stroke: Patient Selection for Trial Feasibility.

Background And Objectives: Whether patent foramen ovale (PFO) closure benefits older patients with PFO and cryptogenic stroke is unknown because randomized controlled trials (RCTs) have predominantly enrolled patients younger than 60 years of age. Our objective was to estimate anticipated effects of PFO closure in older patients to predict the numbers needed to plan an RCT.

Methods: Effectiveness estimates are derived from major observational studies (Risk of Paradoxical Embolism [RoPE] Study and Oxford Vascular Study, together referred to as the "RoPE-Ox" database) and all 6 major RCTs (Systematic, Collaborative, PFO Closure Evaluation [SCOPE] Consortium).

Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation: A Randomized Clinical Trial.

Importance: Although intravascular ultrasonography (IVUS) guidance promotes favorable outcomes after percutaneous coronary intervention (PCI), many catheterization laboratories worldwide lack access.

Objective: To investigate whether systematic implementation of quantitative coronary angiography (QCA) to assist angiography-guided PCI could be an alternative strategy to IVUS guidance during stent implantation.

Design, Setting, And Participants: This randomized, open-label, noninferiority clinical trial enrolled adults (aged ≥18 years) with chronic or acute coronary syndrome and angiographically confirmed native coronary artery stenosis requiring PCI.

Age- and Sex-Specific Disparities in Outcomes After Ticagrelor Versus Clopidogrel in East Asian Patients.

It is unknown whether there are age- and gender-related differences in the safety and efficacy of potent P2Y12 inhibitors in East Asian populations with a different bleeding or ischemic propensity. Using data from the TICAKOREA (Ticagrelor Versus Clopidogrel in Asian/Korean Patients with ACS Intended for Invasive Management) trial comparing ticagrelor versus clopidogrel for 800 Korean patients with acute coronary syndrome, the safety and efficacy outcomes were compared according to age (<75 vs ≥75 years) and gender (men vs women). The primary bleeding end point was clinically significant bleeding, and the primary ischemic end point was a major adverse cardiovascular event (MACE) at 12 months.

Early left atrial venting versus conventional treatment for left ventricular decompression during venoarterial extracorporeal membrane oxygenation support: The EVOLVE-ECMO randomized clinical trial.

Aims: Few studies have reported data on the optimal timing of left ventricular (LV) unloading during venoarterial extracorporeal membrane oxygenation (VA-ECMO) for cardiac arrest or shock. This study evaluated the feasibility of an early LV unloading strategy compared with a conventional strategy in VA-ECMO.

Methods And Results: Between December 2018 and August 2022, 60 patients at two institutions were randomized in a 1:1 ratio to receive early (n = 30) or conventional (n = 30) LV unloading strategies.

Validation of Academic Research Consortium for High Bleeding Risk Definition in East-Asian Patients.

Background: Clinical applicability of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in East-Asian patients receiving potent antiplatelet therapy for acute coronary syndromes (ACS) is still undetermined.

Objectives: The purpose of this study was to validate the ARC definition for HBR in East-Asian patients with ACS for invasive management.

Methods: We analyzed data from the TICAKOREA (Ticagrelor Versus Clopidogrel in Asian/Korean Patients With ACS Intended for Invasive Management) trial and randomly assigned 800 Korean ACS subjects to receive, in a 1:1 ratio, ticagrelor or clopidogrel.

Selective ensemble methods for deep learning segmentation of major vessels in invasive coronary angiography.

Background: Invasive coronary angiography (ICA) is a primary imaging modality that visualizes the lumen area of coronary arteries for diagnosis and interventional guidance. In the current practice of quantitative coronary analysis (QCA), semi-automatic segmentation tools require labor-intensive and time-consuming manual correction, limiting their application in the catheterization room.

Purpose: This study aims to propose rank-based selective ensemble methods that improve the segmentation performance and reduce morphological errors that limit fully automated quantification of coronary artery using deep-learning segmentation of ICA.

Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomized, controlled PREVENT trial.

Background: Acute coronary syndromes are commonly caused by the rupture of vulnerable plaque, which often appear angiographically not severe. Although pharmacologic management is considered standard therapy for stabilizing plaque vulnerability, the potential role of preventive local treatment for vulnerable plaque has not yet been determined. The PREVENT trial was designed to compare preventive percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) with OMT alone in patients with functionally nonsignificant high-risk vulnerable plaques.

Machine Learning-Based prediction of Post-Treatment ambulatory blood pressure in patients with hypertension.

Pre-treatment prediction of individual blood pressure (BP) response to anti-hypertensive medication is important to determine the specific regimen for promptly and safely achieving a target BP. This study aimed to develop supervised machine learning (ML) models for predicting patient-specific treatment effects using 24-hour ambulatory BP monitoring (ABPM) data..

Effect of rosuvastatin 20 mg versus rosuvastatin 5 mg plus ezetimibe on statin side-effects in elderly patients with atherosclerotic cardiovascular disease: Rationale and design of a randomized, controlled SaveSAMS trial.

Background: Current guidelines recommend that patients with established atherosclerotic cardiovascular disease (ASCVD) use high-intensity statin therapy to lower low-density lipoprotein (LDL)-cholesterol levels by at least 50%, irrespective of age. However, in real-world practice, there is reluctance to maintain statin use in response to side-effects, particularly statin-associated muscle symptoms (SAMS). Moreover, no randomized trial has been conducted on the safety of statin therapy in elderly patients.

Impact of Complete or Incomplete Revascularization for Left Main Coronary Disease: The Extended PRECOMBAT Study.

Background: Whether complete revascularization (CR) or incomplete revascularization (IR) may affect long-term outcomes after PCI) and coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease is unclear.

Objectives: The authors sought to assess the impact of CR or IR on 10-year outcomes after PCI or CABG for LMCA disease.

Methods: In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) 10-year extended study, the authors evaluated the effect of PCI and CABG on long-term outcomes according to completeness of revascularization.

Myocardial Scar and Revascularization on Mortality in Ischemic Cardiomyopathy (from the Late Gadolinium Enhancement Cardiac Magnetic Resonance Study).

Myocardial viability test to guide revascularization remains uncertain in patients with ischemic cardiomyopathy. We evaluated the different impacts of revascularization on cardiac mortality according to the extent of myocardial scar assessed by cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE) in patients with ischemic cardiomyopathy. A total of 404 consecutive patients with significant coronary artery disease and an ejection fraction ≤35% were assessed by LGE-CMR before revascularization.

Use of Recanalized Vessels for Diabetic Foot Reconstruction: Pushing the Boundaries of Reconstruction in a Vasculopathic Lower Extremity.

Background: Free flap after lower extremity revascularization may enable limb salvage in defects after critical limb ischemia. This study examined the outcomes of reconstruction of ischemic diabetic foot according to the severity of the vessel occlusion and assessed whether recanalized vessels may serve as a reliable recipient vessel.

Methods: A total of 62 patients who underwent diabetic foot reconstruction with free flaps after successful percutaneous transluminal angioplasty (PTA) from February of 2010 to February of 2016 were identified and divided into three groups: group 1, nonoccluded vessels as recipient ( n = 11); group 2, recanalized artery after PTA for partially occluded artery ( n = 30); and group 3, recanalized artery after PTA for completely occluded artery ( n = 21).

Ten-year prognostic value of coronary CT angiography in asymptomatic patients with type 2 diabetes.

Introduction And Objectives: The United Kingdom Prospective Diabetes Study (UKPDS) risk score has limited value for predicting coronary artery disease (CAD) events. We investigated the additive value of coronary computed tomography angiography (CCTA) on top of the UKPDS risk score in predicting 10-year adverse cardiac events in asymptomatic patients with type 2 diabetes.

Methods: We evaluated 589 asymptomatic diabetic patients without a history of CAD who underwent CCTA.

A Novel Device for Tricuspid Regurgitation Reduction Featuring 3-Dimensional Leaflet and Atraumatic Anchor: Pivot-TR System.

A new device called the Pivot-TR system was designed to treat tricuspid regurgitation with a novel spacer crossing the valve vertically. Its unique atraumatic anchoring system composed of both the elephant long nose and the inferior vena cava spiral anchor, in addition to the relatively easy implantation mechanism, enabled easy retrieval of the system later on. The system showed promising feasibility and safety results in this swine-based animal experiment, which should encourage human translation study.