BACKGROUND:Transcatheter aortic valve implantation (TAVI) is increasingly performed in younger and lower-risk patients. Since many of these patients will outlive their transcatheter heart valve (THV), redo-TAVI procedures are expected to rise in number. Yet, real-world evidence on the procedural safety and efficacy of redo-TAVI remains limited. AIMS:We aimed to evaluate the 30-day procedural and clinical outcomes of redo-TAVI using the balloon-expandable SAPIEN 3 platform. METHODS:The ReTAVI registry is a prospective, international study enrolling consecutive patients with a failed aortic THV undergoing redo-TAVI with a balloon-expandable SAPIEN 3 THV. Data were collected across 59 international centres. All imaging was centrally analysed, and major clinical events were adjudicated by an independent committee. RESULTS:â¨A total of 143 patients (median age 84 years; 40.6% female; median Society of Thoracic Surgeons risk score 7.0%) were enrolled. The predominant failing THVs were balloon-expandable SAPIEN 3 (30.1%), self-expanding CoreValve/Evolut (53.1%), and ACURATE (14.0%) platforms. The most common failure mode was isolated regurgitation (48.6%), followed by stenosis (35.2%) and a mixed pathology (16.2%). The replacement valve was successfully implanted in 95.1% of patients, with a 30-day mortality rate of 3.5%. The 30-day stroke and pacemaker implantation rates were 0.7% and 6.3%, respectively. Redo-TAVI significantly improved valve haemodynamics, with mean gradients decreasing overall (Δ=-12.0 mmHg), and a more pronounced reduction in stenotic failures (Δ=-29.0 mmHg). Coronary obstruction was observed in 1.4% of cases. CONCLUSIONS:Redo-TAVI with a balloon-expandable SAPIEN 3 THV platform is a safe and effective reintervention strategy across diverse failed THV types, when guided by the Heart Team, standardised procedural planning, and comprehensive imaging. CLINICALTRIALS:gov: NCT05601453.

Adequate PFO sizing is critical to prevent device embolization. When endovascular retrieval is necessary, the use of a long sheath 2- to 5-F sizes larger than the original introducer is recommended.

Increasingly, transcatheter options are available for the treatment of valvular heart disease. The role of the Clinical Valve Coordinator is ideally positioned to improve access to care, quality of outcomes and patient experiences, and contribute to the efficient cardiac programmes and the growing number of heart valve centres. International societies and guidelines recommend the inclusion of the Clinical Valve Coordinator in multidisciplinary Heart Teams to support patients, contribute unique expertise to team-based care, and help programmes expand access to care. The role of the Clinical Valve Coordinator is unevenly adopted in Europe. In this context, we outline a comprehensive framework of the competencies and professional development aligned with the needs of patients with aortic, mitral and tricuspid disease, discuss requirements for infrastructure and successful organisational integration in valvular heart disease teams and programmes, and propose preliminary indicators to measure role impact and address the current gap in evidence to guide role development across diverse regions. The Clinical Valve Coordinator plays a vital role as a central member of the multidisciplinary team to support the care requirements of people with complex valvular heart disease in the rapidly evolving clinical context of treatment options and management strategies. The document provides a roadmap for the development, implementation and evaluation of a pan-European initiative to improve the delivery of valvular heart disease services and optimise the experience of care of patients and their family.

BACKGROUND:Up-titration of guideline-directed medical therapy (GDMT) is known to enhance left ventricular function in heart failure (HF) with reduced ejection fraction. However, data regarding its effect on right ventricular (RV) function remain sparse. We aimed to assess the impact of GDMT up-titration on the RV, especially RV to pulmonary artery coupling, and its prognostic value in these patients. METHODS:All consecutive patients (n=291) with left ventricular ejection fraction <50% followed for GDMT up-titration in a dedicated HF clinic in a tertiary center from January 2019 to June 2022 with an echocardiography at baseline (before up-titration) and at follow-up (end of up-titration) were included. RESULTS:The median age is 65 (55-74) years; 24% are female. Ischemic cardiomyopathy was the main cause of HF (47%), and left ventricular ejection fraction was 30% (22%-34%). After 2 years, 49 patients (17%) reached the primary end point (all-cause death or hospitalization for acute HF). RV size and function significantly improved after GDMT up-titration (all, P<0.001), including RV to pulmonary artery coupling assessed by tricuspid annular plane systolic excursion/systolic pulmonary artery pressure (0.62 versus 0.81 mm/mm Hg; P<0.001). Tricuspid annular plane systolic excursion/systolic pulmonary artery pressure <0.65 mm/mm Hg at follow-up remained associated with the primary end point after adjustment with comorbidities (hazard ratio, 5.9 [95% CI, 2.8-12.1]; P<0.001), clinical and biological severity (hazard ratio, 6.4 [95% CI, 2.4-17.8]; P<0.001), and echocardiography (hazard ratio, 3.6 [95% CI, 1.6-8.4]; P=0.002). In addition, tricuspid annular plane systolic excursion/systolic pulmonary artery pressure was associated with an incremental prognostic value (C-index improvement, P<0.01), over and above prognostic factors, including left ventricular ejection fraction. CONCLUSIONS:This study highlights the independent and incremental prognostic value of tricuspid annular plane systolic excursion/systolic pulmonary artery pressure in HF with reduced ejection fraction during GDMT up-titration, suggesting to also consider RV to pulmonary artery coupling with echocardiography as a treatment goal.

Aims Despite procedural success, certain patients fail to derive clinical benefit from transcatheter aortic valve implantation (TAVI). In a nationwide TAVI registry, we assessed the proportion of patients experiencing either a deterioration in quality of life (QoL) or death 1 year after TAVI, and the factors associated with these outcomes. Methods and results This prospective substudy of the FRANCE TAVI registry included patients enrolled between 2018 and 2019 who completed the EuroQoL-5-dimension-5-level (EQ-5D-5L) questionnaire at baseline and 1 year. Among the 3159 patients (median age 83 years), EQ-5D-5L visual analogue scale increased significantly from 60 (IQR 50-70) at baseline to 70 (IQR 50-80) at follow-up (P < 0.001). However, 459 patients (14.5%) experienced a deterioration in QoL, and 596 (18.9%) died within 1 year. According to a multivariable logistic model, factors significantly associated with poor outcome were frailty [OR 1.40, 95% confidence interval (CI) (1.08-1.83)], diabetes [OR 1.41, 95% CI (1.06-1.88)], chronic pulmonary disease [OR 1.55, 95% CI (1.09-2.20)], critical pre-operative status [OR 0.42, 95% CI (0.21-0.83)], left ventricular ejection fraction [OR 1.01, 95% CI (1.00-1.02)], mean aortic gradient at discharge [OR 0.97, 95% CI (0.95-1.00)], need for pacemaker implantation [OR 1.51, 95% CI (1.10-2.06)], anticoagulation therapy at discharge [OR 1.65, 95% CI (1.23-2.22)], and time to discharge [OR 1.04, 95% CI (1.01-1.07)]. Conclusion Although TAVI improved overall QoL, 14.5% of patients experienced a deterioration in QoL and 18.9% died within 1 year. Predictors included baseline comorbidities and post-procedural factors (anticoagulation at discharge and time to discharge), which are largely unpredictable.

Abstract Background Calcific aortic valve disease (CAVD) is the most common valvular heart disease in developed countries, yet no pharmacological therapy is available to slow or halt its progression. CAVD is driven by progressive calcification of aortic valve leaflets, in which myeloid cells play a central role. While macrophages have been implicated in CAVD pathogenesis, the contribution of their precursors, monocytes, remains poorly understood. We hypothesized that circulating monocytes acquire a pro-calcific and pro-inflammatory phenotype contributing to valve remodelling and CAVD progression. Methods We profiled circulating CD14 + monocytes from healthy volunteers (Vol), patients with CAVD, and without CAVD (NCAVD). Peripheral blood mononuclear cells (PBMCs) were isolated, and monocyte subpopulations were phenotyped by flow cytometry. Transcriptome profiling by RNA sequencing identified disease-associated gene signatures, which were validated by RT-qPCR. The CD14 + monocyte secretome was analysed using multiplex assays. Functional ability of CAVD-derived CD14 + monocytes to induce myofibroblastic transdifferentiation (MT) and osteoblastic differentiation (OD) of human valvular interstitial cells (VICS) was evaluated by immunocytochemistry and quantitative o-cresolphthalein complexone assays. Results In PBMCs, CAVD monocytes displayed a subpopulation shift, with an increased proportion of CD14⁺⁺CD16⁻ classical monocytes and a reduced CD14⁺CD16⁺⁺ non-classical monocyte levels. In CD14 + monocytes, transcriptomic analysis revealed upregulation of inflammation-related ( PDK4 ) and calcification-related ( ATP2B1 ) genes, alongside downregulation of immunomodulatory genes ( DDR1 , IKBKE ). Secretome analysis showed reduced production of immunomodulatory and anti-osteoblastogenic cytokines (IL-4, CCL3) while promoting gene expression of factors promoting MT and OD in VICS. These alterations were associated with a marked monocyte-induced increase in αSMA and OPN expression in VICS and a two-fold increase in calcification. Conclusion We demonstrate for the first time that circulating monocytes from patients with CAVD exhibit enhanced pro-inflammatory and pro-calcific properties that may contribute to CAVD progression. Additionally, we identify dysregulated gene sets within these monocytes that represent potential novel therapeutic targets for CAVD.

BACKGROUND:Transcatheter aortic valve implantation (TAVI) has become widely used to treat symptomatic patients with aortic stenosis (AS), but increasing demand has led to treatment delays, which are associated with increased morbi-mortality. AIMS:To reduce time to treatment in patients awaiting a TAVI, we constructed a multi-component intervention which includes (1) a paper- and internet-based component aimed at improving AS and TAVI knowledge and (2) an organizational component aimed at TAVI centres to improve scheduling of examinations and procedures. Their effectiveness, cost-effectiveness and implementation were evaluated in a cluster randomized controlled trial (cRCT). METHODS:The cRCT (NCT_05237804) used a factorial design to evaluate the two components of the intervention, alone and together. The cluster was the TAVI centre. As patients may be referred to TAVI centres by regional hospitals, participating regional hospitals were included in the cluster of their referral TAVI centre. Clusters were allocated to one of four treatment groups after stratification on annual number of TAVI procedures, presence of a coordinating nurse and participation of a regional hospital. Patients aged ≥18 years with symptomatic AS and a TAVI indication were included in the study. The expected sample size was 798 patients. The primary outcome is the percentage of patients treated within 2 months of the TAVI indication. Secondary outcomes are time to treatment, mortality, quality of life, knowledge regarding TAVI and AS, medication compliance and incremental cost-effectiveness ratios. Implementation measures include dose, fidelity, adaptations, reached population, satisfaction and acceptability. TRIAL STATUS:Overall, 828 patients have been enrolled. Data had not been analysed at the time the protocol was submitted.

BACKGROUND:Transcatheter tricuspid valve replacement (TTVR) is increasingly performed to treat patients with severe or greater symptomatic tricuspid regurgitation (TR) at high risk for surgery. However, patients with large tricuspid annuli are not eligible for most TTVR systems. AIMS:This study aimed to report intraprocedural and 30-day clinical success rates for patients undergoing TTVR with the 55-70 mm LuX-Valve Plus system in the European TRINITY study cohort. METHODS:The co-primary endpoints were intraprocedural and 30-day clinical success, as defined by the Tricuspid Valve Academic Research Consortium criteria. Clinical and echocardiographic outcomes were reported. RESULTS:Enrolled patients (n=114) had a mean age of 77.8±5.8 years and a high Society of Thoracic Surgeons risk score of 9.9±6.0%. Intraprocedural success was 95.6%, with no cases of intraprocedural mortality or stroke. Two patients (1.8%) required cardiac surgery within the first 24 hours. At 30 days, 7 patients (6.1%) required a pacemaker implantation. Thirty-day clinical success was 91.2%, with residual severe TR being the primary reason for failure. In 93.7% of patients, residual TR was moderate or less. The mean Kansas City Cardiomyopathy Questionnaire score improved from 57.3±20.7 points to 71.0±23.5 points (p<0.001), and the proportion of patients with New York Heart Association Class III-IV symptoms reduced from 57.1% at baseline to 20.9% at 30 days (p<0.001). CONCLUSIONS:TTVR with the LuX-Valve Plus system to treat patients with severe or greater symptomatic TR and a large tricuspid annulus was associated with high intraprocedural and 30-day clinical success rates, significant TR reduction and functional improvement, and low permanent pacemaker implantation rates.

Background: A high burden of right ventricular pacing (RVP) increases the risk of hospitalization because of heart failure. Data on predictive factors for high burden of RVP in patients with permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) are limited. Objective: This study aimed to identify predictors of high RVP burden in patients with current indications for PPI after TAVR. Methods: We included consecutive patients who underwent PPI after TAVR between 2013 and 2023 at our institution. Dual-chamber pacemakers were programmed with an algorithm favoring spontaneous atrioventricular (AV) conduction. High burden of RVP was defined as a pacing percentage of > 20% (> 20% ventricular pacing [VP]) at 3- to 12-month follow-up. Results: Among 193 patients included, 92 (47.7%) had > 20% VP at 3- to 12-month follow-up. Male gender (odds ratio [OR] 2.48, 95% confidence interval [CI] 1.31–4.67), permanent atrial fibrillation (OR 2.49, 95% CI 1.01–6.15), and high-degree AV block as the indication for PPI (OR 5.05, 95% CI 2.32–11.0) were independent predictors of > 20% VP. A H2AS risk score predicting > 20% VP was derived, including high-degree AV block (2 points), permanent atrial fibrillation (1 point), and male sex (1 point). A score of ≥ 3 identified a 68% prevalence of > 20% VP. Over a median follow-up of 27.7 months, > 20% VP was associated with a higher risk of all-cause mortality or heart failure hospitalization (hazard ratio 2.03, 95% CI 1.09–3.81, P = .03). Conclusion: A high RVP burden of > 20% can be anticipated using a readily available pre-PPI risk assessment. The H2AS risk score may assist clinicians in determining the most appropriate VP strategy for patients after TAVR with an indication for PPI.

Background In a context of extending transcatheter aortic valve replacement (TAVR) to patients with a longer life expectancy, it is important to better document the incidence and outcomes of reintervention. Objectives The authors sought to evaluate the incidence, predictive factors, and long-term outcomes of surgical (explant TAVR) or transcatheter (redo TAVR) reintervention after TAVR. Methods Patients who had a TAVR between 2010 and 2022 recorded in the FRANCE 2 and FRANCE TAVI registries were included in the analysis. Cumulative incidence of early (≤1 year) and late (>1 year) reintervention was assessed using the Kalbfleisch and Prentice method to account for all-cause death as a competing risk. Patients who had reintervention for infective endocarditis were excluded. Long-term mortality was evaluated using Kaplan-Meier analysis. Results Among 72,850 patients included, the cumulative incidence of overall reintervention at 8 years was 1.7% including 591 patients who had redo TAVR and 111 patients who required explant TAVR with a low incidence of Bentall intervention. Reintervention occurred mostly early in 62.1% of cases and was more frequent in patients who had a mean aortic gradient >20 mm Hg immediately after index TAVR. Age and mean aortic gradient before TAVR and mean aortic gradient >20 mm Hg, aortic regurgitation ≥ grade 2, and percutaneous coronary intervention after TAVR were predictive of reintervention. Six-year mortality was high but was similar in patients who had early and late reintervention (76.2% vs 64.0%; P = 0.77). Conclusions Reintervention after TAVR remains rare and was mostly performed early after the procedure and by redo TAVR. Further studies are warranted, particularly in younger patients with longer life expectancy.

Background: Transcatheter aortic valve implantation (TAVI) treatment pathways can be supported by a dedicated clinical valve coordinator (CVC), enhancing their efficiency. We aimed to evaluate the impact of a CVC in managing the treatment pathway of patients undergoing TAVI across Europe before and after implementing 8 Benchmark best practices. Methods: The BENCHMARK registry (ClinicalTrials NCT04579445) was a multicenter international study of patients with severe symptomatic aortic stenosis undergoing TAVI with balloon-expandable valves across 28 European centers. Primary outcomes were hospital and intensive care length of stay (LoS). The secondary outcome was 30-day patient safety. Results: Of 2323 patients, 1262 were treated at centers without a pre-existing CVC and 1061 at centers with a pre-existing CVC; propensity matching resulted in 891 matched pairs. The total procedural time was significantly reduced in both groups (p < 0.001) after implementing Benchmark best practices. Hospital LoS was lower before Benchmark when a CVC was present and was significantly shorter in both groups following implementation (p < 0.001), as was the critical care LoS (p < 0.001). The presence of a CVC did not affect safety outcomes but was associated with a reduced risk of major vascular bleeding when combined with Benchmark best practices. Patient satisfaction was higher in centers with a pre-existing CVC (p < 0.001). Conclusions: The addition of a CVC to the multidisciplinary team and their sustained contributions to processes of care align with the implementation of Benchmark practices, significantly decrease the health service requirements of TAVI patients, and are associated with improved patient-reported experiences.