European Heart Journal - Cardiovascular Imaging最新文献

Aims: Several factors, including device design, annulus size, and sizing strategies, influence transcatheter heart valve (THV) haemodynamic outcomes in patients with aortic stenosis (AS). This sub-study evaluates early (30-day) echocardiographic outcomes of the Myval, Sapien, and Evolut THV series, focusing on haemodynamic performance and valve durability.

Methods and results: The LANDMARK trial is a prospective, randomised, multicentre, open-label, non-inferiority trial comparing 384 patients implanted with Myval THV series to 384 receiving Sapien and Evolut THV series. Haemodynamic assessments followed Valve Academic Research Consortium-3 recommendations. At 30-day, haemodynamic device success rates were 85.9%, 77.8, and 85.4% for Myval, Sapien, and Evolut THV series, respectively (PMyval-Sapien = 0.03 and PMyval-Evolut = 0.98). Significant improvements in peak aortic flow velocity, pressure gradients, effective orifice area (EOA), Doppler velocity index (DVI), and cardiac indices were observed across all groups, except for unchanged left ventricular ejection fraction. Moderate prosthesis-patient mismatch (PPM) was less frequent with Myval THV series(11.3%) vs. Sapien THV series(21.8%), but higher than Evolut THV series (5.3%) (PMyval-Sapien = 0.0024, PMyval-Evolut = 0.0396), while severe PPM showed no significant differences (4.2% vs. 6.3% vs. 1.8%; PMyval-Sapien = 0.394, PMyval-Evolut = 0.2438). Rates of ≥ moderate paravalvular leak (PVL) were lower in Myval (3.5%), and Sapien (1.7%) compared with Evolut THV series (8.3%) (PMyval-Sapien = 0.3769, PMyval-Evolut = 0.0336). Myval THV series required minimal oversizing compared with Evolut THV series (P < 0.0001).

Conclusion: The Myval THV series demonstrates short-term haemodynamic performance comparable to Evolut THV series and superior to Sapien THV series. Including intermediate sizes minimizes oversizing, underscoring its potential as an alternative for TAVI patients. Long-term follow-up is necessary to confirm these findings.

Clinical trial registration: ClinicalTrials.gov: NCT04275726, EudraCT number 2020-000,137-40.

Valvular heart disease represents a significant global health burden, with an estimated prevalence of 2.5% in high-income countries and projected increases due to population ageing. Randomized controlled trials in valvular heart disease have undergone substantial evolution, shifting from mortality-focused endpoints toward comprehensive assessments integrating imaging parameters and patient-centered outcomes. Cardiovascular imaging modalities, including echocardiography, cardiac computed tomography, and cardiac magnetic resonance, have become pivotal in trial design, patient selection, and endpoint definition. Recent landmark trials in aortic stenosis, including EARLY-TAVR and EVOLVED, have challenged traditional symptom-based intervention thresholds by incorporating imaging biomarkers of subclinical myocardial dysfunction and cardiac damage staging. In aortic regurgitation, the paucity of randomized controlled trials evidence contrasts with emerging transcatheter technologies, highlighting critical knowledge gaps. Mitral regurgitation trials have demonstrated the importance of patient phenotyping, with divergent outcomes between COAPT and MITRA-FR emphasizing the role of imaging in optimal patient selection. The recent TRILUMINATE and TRISCEND trials have transformed tricuspid regurgitation management through transcatheter interventions, prioritizing quality-of-life improvements alongside traditional clinical endpoints. Future directions include standardization of imaging protocols across modalities, development of artificial intelligence-enhanced analysis, and integration of multiparametric biomarkers for personalized risk stratification. The paradigm shift toward imaging-guided, patient-centered trial design represents a fundamental reimagining of therapeutic success in valvular heart disease, moving beyond procedural outcomes toward comprehensive assessment of clinical benefit and improved patient care.

Doppler-echocardiography is the primary imaging modality for the evaluation and follow-up of valvular heart devices. This article highlights the unique pitfalls associated with these devices, including imaging challenges and flow dynamics, which often push echocardiography to its limits. The use of a multi-modality imaging approach including cardiac computed tomography (CT) and magnetic resonance, and positron emission tomography-CT is recommended to confirm the diagnosis of prosthetic valve dysfunction (PVD), quantify its severity and determine its mechanism and aetiology. Thus, the distinction between non-structural and structural PVD is important to make by assessing: (i) the morphology and mobility of the valve leaflets; (ii) the changes in valve haemodynamic parameters during echocardiographic follow-up. Algorithms are also proposed to assess the presence and severity of residual valve regurgitation and iatrogenic stenosis following mitral or tricuspid transcatheter edge-to-edge repair. This article aims to enhance the understanding of imaging challenges and to propose solutions for clinicians managing patients with valvular heart disease devices.

Aims: Mixed aortic valve disease poses unique haemodynamic challenges. This study compared the clinical outcomes of concomitant moderate aortic stenosis (AS) and moderate aortic regurgitation to isolated AS.

Methods and results: We analysed a multicentre cohort of valvular heart disease between 2008 and 2022 at three tertiary centres. The entire cohort was divided into three groups: moderate AS accompanied by moderate aortic regurgitation (moderate ASR), isolated severe AS, and isolated moderate AS. The primary outcome was a composite of cardiac death and hospitalization for heart failure. The final analysis included 4395 patients (median age: 76 years, 50.8% male), comprising 224 patients with moderate ASR, 1996 with severe AS, and 2175 with moderate AS. Over a median follow-up of 3.4 years, aortic valve replacement (AVR) rates were 11.1, 57.2, and 7.8 per 100 person-years in the moderate ASR, severe AS, and moderate AS groups, respectively (P < 0.001). Patients with moderate ASR had a significantly higher risk of the primary outcome compared with moderate AS [adjusted hazard ratio (aHR) 1.49; 95% confidence interval (CI) 1.15-1.92; P = 0.002] and a risk comparable to severe AS (aHR 1.28; 95% CI 1.00-1.64; P = 0.052). These results remained consistent even when AVR was included as a time-varying covariate. Older age, male sex, renal dysfunction, and lower left ventricular ejection fraction were independent predictors of the primary outcome in patients with moderate ASR.

Conclusion: Moderate ASR should not be considered a benign condition, as it is associated with poor clinical outcomes comparable to those of severe AS.