Philippe Généreux

Background: Mitral valve transcatheter edge‐to‐edge repair can be more challenging in noncentral regions of the valve and in anterior or bileaflet lesions. We assess effect of implant location and leaflet lesion location on safety and effectiveness of PASCAL Precision system in degenerative mitral regurgitation (MR). Methods: Mitral valve transcatheter edge‐to‐edge repair outcomes in patients with degenerative MR treated with PASCAL Precision system (September 2022–October 2024), from the US STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry, were analyzed by implant location (A2P2/non‐A2P2) and leaflet lesion location (anterior/posterior/bileaflet). Procedural, clinical, and echocardiographic outcomes to 30 days were assessed. Results: At 30 days, both A2P2 (n=1526) and non‐A2P2 (n=299) groups had low event rates (cardiovascular mortality: 1.1% versus 1.0%, mitral valve reintervention: 0.4% versus 0.0% and single leaflet device attachment: 0.5% versus 0.3%; all P >0.05) and demonstrated significant MR reduction ( P 0.05), and demonstrated significant MR reduction ( P P =0.459) (MR ≤2+: 94.1%, 93.1%, and 94.5%; MR ≤1+: 79.0%, 69.2%, and 72.4%). All groups experienced significant improvement in Kansas City Cardiomyopathy Questionnaire Overall Summary scores (∆21.4, ∆18.8, ∆12.0 points; P =0.087). Conclusion: In real‐world patients with degenerative mitral regurgitation, treatment with the PASCAL Precision system was associated with favorable safety and effectiveness at 30 days, regardless of implant location or leaflet lesion location.

BACKGROUND: Aortic stenosis (AS) and mitral regurgitation (MR) frequently co-occur, complicating diagnosis and treatment. We examined current US treatment trends and patient outcomes among patients with severe AS and at least moderate MR. METHODS: We analyzed data from 2 992 362 patients (aged ≥18 years) undergoing 5 245 904 echocardiograms at 43 US institutions (Egnite Database; Egnite, Aliso Viejo, CA, with permissions) to identify a cohort of patients with severe AS and moderate or greater MR. The primary end point was 2-year all-cause mortality, assessed via Kaplan-Meier analysis. For patients undergoing transcatheter aortic valve replacement (TAVR) alone, MR severity changes from baseline to 45 days post-TAVR were visualized using Sankey diagrams. RESULTS: The cohort included 36 402 patients (mean age, 78.2 years; 54.6% male), of whom 52.0% were untreated, 36.5% underwent TAVR alone, and 11.5% underwent surgery or other transcatheter interventions. Two-year mortality for untreated patients was 36.8% (95% CI, 35.6%–38.0%) for AS with less than moderate MR, 57.3% (95% CI, 54.0%–60.6%) for AS with moderate MR, and 65.5% (95% CI, 60.9%–70.1%) for AS with moderate-to-severe or severe MR (log-rank P P <0.001). Among patients undergoing TAVR alone with follow-up MR data, 77.5% demonstrated improvement in MR. CONCLUSIONS: Patients with concurrent MR and AS exhibit substantially higher mortality yet have high rates of undertreatment throughout the duration of follow-up. TAVR alone significantly improves MR in most patients.

Aims: Asymptomatic severe aortic stenosis (aSAS) is associated with morbidity, with mortality increasing once symptoms develop. Benefits of early aortic valve replacement (AVR) over clinical surveillance (CS) with delayed AVR upon symptom onset have been demonstrated, and it is now recommended from the latest European Guidelines if procedural risk is low (Class IIa, Level A). The aim of this study is to estimate the economic impact of transcatheter aortic valve implantation (TAVI) for the treatment of aSAS. Methods and results: A cost-utility analysis compared TAVI using the SAPIEN 3/SAPIEN 3 Ultra valve vs. CS in patients with aSAS across nine European countries. A lifetime Markov model captured peri-procedural and long-term outcomes across three health states: alive and well, stroke, and death. Inputs were derived from the EARLY TAVR trial (NCT03042104) and literature sources. Clinical event rates were estimated via parametric survival analysis. Transcatheter aortic valve implantation treatment for patients with aSAS was modelled to be the economically dominant strategy for treating aSAS across all nine European healthcare systems, with cost-effectiveness probabilities ranging from 97.3% (UK) to 99.9% (Belgium). Incremental results per person included cost savings from −£1788 (UK) to −CHF15 802 (Switzerland), quality-adjusted life years gains of 0.18 (Germany, UK) to 0.23 (Switzerland), and life-year gains of 0.12 (UK) to 0.17 (Belgium). Annual discounting of upfront TAVI costs vs. delayed AVR costs drove results. Conclusion: For patients with aSAS, early intervention with TAVI is estimated to deliver greater health benefits and reduce costs compared with CS. These findings support policies promoting early detection and timely intervention before symptom onset.

BACKGROUND: The EARLY TAVR trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus a CS strategy by age is unknown. METHODS: The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composite or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65–69 years, absolute risk reduction, 13%; P =0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P =0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75–79 years, 5.9%; 70–74 years, 5.1%; 65–69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P =0.73). Approximately one-third of younger patients (65–69 years) in the CS arm presented with acute valve syndrome at the time of conversion, and the frequency tended to increase with age ( P =0.06). CONCLUSIONS: In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03042104.

Purpose of Review: Structural heart disease (SHD) encompasses diseases involving the heart valves, chambers, walls, and muscles. Current diagnostic methods have limited accessibility and predictive value. This review aims to present recent advances in artificial intelligence (AI)-guided tools in the screening of SHD and valvular heart disease (VHD), and to present challenges and opportunities for their use in clinical practice. Recent Findings: AI-guided models trained on ECGs, chest X-rays, and coronary artery calcium scans have a high accuracy in the diagnosis of SHD, heart failure, low left ventricular ejection fraction, and VHD. Some of these models can highlight the signals that influence their predictions, improving explainability. Summary: The use of AI in screening for SHD and VHD could lead to earlier diagnosis, enhanced accuracy, and better accessibility. However, outcome data on earlier diagnosis using these tools is required before broad deployment.

BACKGROUND: Heart failure (HF) remains a significant burden following transcatheter aortic valve replacement, adversely impacting survival and quality of life. Identification of patients who may benefit from closer monitoring or adjunctive medical therapy to reduce the risk of HF is an unmet need. The objective of this study was to develop and internally validate a clinical prediction model to determine the 1-year risk of HF hospitalization or death after transcatheter aortic valve replacement. METHODS: Using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we analyzed patients who underwent successful transcatheter aortic valve replacement for aortic stenosis and survived to discharge between 2016 and 2019. Covariates were selected based on expert opinion and prior literature. A hierarchical cumulative odds regression model was used to predict a composite outcome of (1) all-cause death, (2) ≥2 HF readmissions, or (3) 1 HF readmission at 1 year. RESULTS: Among 78 384 patients (median age, 82 years; 45.6% female), 17.4% experienced the composite outcome, including death (10.9%), ≥2 HF readmissions (1.6%), and 1 HF readmission (4.9%). The model demonstrated good discrimination (C statistic, 0.753 derivation and 0.747 validation) and excellent calibration. Among 1-year survivors, performance in predicting HF readmission as an isolated outcome was similar (C statistic, 0.753). A simplified model, including the top 12 variables from the full model, maintained comparable performance (C statistics, 0.74–0.75). CONCLUSIONS: This prediction model effectively stratifies post-transcatheter aortic valve replacement patients by risk of death or HF readmission, supporting its use to guide clinical surveillance and clinical trial enrollment for adjunctive medical therapies aimed at mitigating this risk.

BACKGROUND: The treatment of calcified coronary lesions requires optimal lesion preparation to achieve a larger minimal stent area (MSA), the strongest predictor of long-term outcomes. The comparative mechanisms of action of calcium-modifying therapies have not been well defined. METHODS: In a prospective, multicenter ECLIPSE trial (Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy Versus Conventional Angioplasty Technique Before Implantation of Drug-Eluting Stents), 2005 patients with severely calcified lesions were randomized to vessel preparation with orbital atherectomy (OA) versus balloon angioplasty (BA) before drug-eluting stent implantation. The primary end point of the optical coherence tomography (OCT) substudy was the MSA at the site of maximal calcification; MSA across the entire stent was also assessed. RESULTS: Postprocedural OCT images were available in 286 lesions in 276 patients treated with OA and 292 lesions in 279 patients treated with BA. By angiographic core laboratory analysis, 567 (98.1%) of lesions were severely calcified. By postprocedural OCT, the maximal calcium arc, maximal calcium thickness, and total calcium length measured 204° (149°–268°), 0.85 mm (°0.69–1.03°), and 22.0 (16.0–31.0) mm. Compared with BA, calcium modification was greater in the OA group (greater number, total length, and maximal depth of calcium fractures), especially in lesions with thicker calcium. Nonetheless, the MSA at the site of maximal calcification was large in both groups and not different (median [interquartile range], 7.44 [6.03–8.94] mm ² versus 7.05 [5.78–8.66] mm ² ; P =0.08). Similar results were observed for the MSA across the entire stent (5.86 [4.60–7.38] mm ² versus 5.57 [4.50–6.97] mm ² ; P =0.10). Among patients in the OCT substudy, 1-year target-vessel failure rates were low and not different between the groups (7.8% with OA and 6.6% with BA, P =0.61). CONCLUSIONS: In lesions that are severely calcified by angiography, the extent of calcification by OCT was highly variable. Despite greater calcium modification after OA, the acute MSA and 1-year target-vessel failure rates were not different between OA and BA. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03108456.