Mitral regurgitation is the most common valve disease worldwide. Despite its wide success in inoperable or high-risk surgical patients, transcatheter edge-to-edge repair remains limited by some anatomic features and the non-negligible rate of significant residual regurgitation. Transcatheter mitral valve replacement has emerged as a viable alternative that promises to overcome these issues, but its development has been progressing slowly. This review aims to provide a comprehensive overview of the current state of transcatheter mitral valve replacement, including patient selection, procedural techniques, and currently available outcomes.
Transcatheter structural heart interventions, including aortic, mitral and tricuspid valve replacement or repair, and patent foramen ovale, atrial septal defect, and left atrial appendage closure, have dramatically expanded over the past two decades, providing substantial improvements in both clinical outcomes and quality of life. These interventions are performed in a high-risk patient population, which is at risk for both thrombotic and bleeding complications. The introduction of prosthetic devices into the arterial or venous circulation under heterogeneous hemodynamic conditions inevitably increases the risk for thrombotic events and thromboembolic complications. Consequently, the selection of antithrombotic therapy (AT) regimen and its duration is complex and should be tailored to each patient’s risk profile, balancing the expected risk and benefits. This state-of-the-art review critically examines the thrombotic risks inherent to transcatheter structural heart interventions, synthesizes available evidence and current guidelines recommendations on antithrombotic management, and defines persisting gaps in knowledge while discussing the most relevant ongoing clinical trials.
Background: Diabetes accelerates atherosclerosis and restenosis and impairs vascular healing, complicating percutaneous coronary intervention (PCI). Drug-coated balloons (DCBs) deliver antiproliferative therapy without a permanent scaffold, but their comparative mid-term performance in diabetic patients relative to non-diabetic patients is incompletely defined. Methods: We analysed a large all-comers cohort of consecutive patients who underwent a DCB-based PCI between 2018 and 2022, stratified by diabetes status. The primary endpoint was a composite of cardiac death, target vessel revascularisation (TVR) and target vessel myocardial infarction. Cumulative incidence was estimated by Kaplan–Meier analysis, and predictors were assessed by Cox regression. Results: Among 853 patients (304 diabetic, 549 non-diabetic), diabetic patients had more comorbidities and more frequent in-stent restenosis (52.3% vs. 41.8%). Over a median follow-up of 376 days, the two-year incidence of the composite endpoint was higher among diabetic patients (21.3% vs. 10.6%, p = 0.007), as was target lesion revascularisation (TLR; 13.6% vs. 5.5%, p = 0.004). Diabetes independently predicted the composite endpoint (adjusted hazard ratio: 1.87; 95% CI: 1.10–3.17) and TLR (adjusted HR: 2.33; 95% CI: 1.18–4.62), whereas DCB type and procedural variables did not. Conclusions: In an all-comers DCB-PCI population, diabetes was independently associated with higher rates of mid-term major adverse cardiovascular events and target lesion revascularisation, while device and procedural variables did not drive outcomes, underscoring the importance of systemic risk management in regard to diabetic patients.