BACKGROUND AND AIMS:Recent trials have challenged the guideline recommendation of beta-blockers for post-myocardial infarction (MI) patients without reduced left ventricular ejection fraction (LVEF). Whether these recent findings apply equally to women and men remains unknown. METHODS:Using data from REBOOT (tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion), the largest randomized trial evaluating the effect of beta-blockers after acute MI with LVEF > 40%, a pre-specified sex-specific subgroup analysis was performed. A total of 8438 out of the 8505 randomized patients comprised the intention-to-treat population. RESULTS:Among 8438 patients, 1627 were women, who were older, had more comorbidities, and received fewer guideline-based therapies than men. Over a median follow-up of 3.7 years, women had overall higher rates of the primary composite outcome (death, MI, or heart failure hospitalization) than men. The incidence rate of the primary endpoint in women was 30.4 and 21.0/1000 patient-years in the beta-blocker group and no beta-blocker group, respectively (hazard ratio 1.45, 95% confidence interval 1.04-2.03). No significant differences were observed in men (hazard ratio .94, 95% confidence interval .79-1.13; P for interaction = .026). The excess risk in women was mainly driven by increased mortality and was most evident among those with preserved LVEF (P for interaction = .030) and those receiving higher beta-blocker doses (P for interaction = .045). CONCLUSIONS:In the REBOOT trial of MI patients managed according to contemporary standards, beta-blocker therapy was associated with evidence of harm in women-particularly those with preserved LVEF and receiving higher doses-an effect not observed in men.

Growth differentiation factor 15 (GDF15) is a stress-responsive cytokine strongly associated with aging, multimorbidity, and cardiovascular disease. Although prior studies have established its prognostic value in high-risk populations, its role in the general population remains less defined. The aim of this study was to determine if there is an association between plasma GDF15 levels, heart disease and mortality in a representative population-based cohort. We analyzed 1532 participants (mean age 55 years; 54.6% women) with available baseline plasma GDF15 concentrations. Participants were stratified according to an optimal cutoff of 1081 pg/mL, derived from ROC curve analysis for mortality. Associations with prevalent heart disease were assessed using multivariable logistic regression models adjusted for cardiovascular risk factors and NT-proBNP. Mortality was analyzed using Cox proportional hazards models, with model performance evaluated by C-index and time-dependent ROC curves. Individuals with GDF15 > 1081 pg/mL were older and exhibited a more adverse cardiometabolic profile with higher prevalence of comorbidities. Elevated GDF15 was independently associated with ischemic cardiomyopathy (OR 3.34, 95% CI: 1.38-8.11), particularly in men (OR 4.26, 95% CI: 1.40-12.96), but not in women. No independent associations were observed with arrhythmias, valvulopathy, or heart failure after adjustment for NT-proBNP. During a median follow-up of 6.2 years, 51 deaths occurred. Elevated GDF15 independently predicted all-cause mortality (HR 2.47, 95% CI: 1.19-5.13), though the effect was attenuated after adjustment for NT-proBNP. GDF15 improved model discrimination (ΔC-index = +0.01; LRT p = 0.011) and showed robust time-dependent predictive ability, with AUCs of 0.76, 0.82, and 0.85 at 2, 4, and 6 years, respectively. In this population-based cohort, elevated GDF15 identified individuals with an adverse health profile, was independently associated with ischemic cardiomyopathy in men, and predicted mortality. Although its incremental predictive value over NT-proBNP was modest, GDF15 could provide complementary biological information and may enhance multimarker strategies for cardiovascular risk stratification in the general population.

AIMS:Current guidelines recommend beta-blocker therapy after myocardial infarction (MI) regardless of left ventricular ejection fraction (LVEF). However, recent trials question their benefit in patients with preserved LVEF. No study has yet compared beta-blocker effects during the acute coronary syndrome (ACS) phase (≤1 year post-MI) vs. the chronic coronary syndrome (CCS) phase (>1 year). METHODS AND RESULTS:In this pre-specified landmark analysis of the REBOOT trial, we evaluated the effect of beta-blocker therapy on outcomes in two post-MI phases: the ACS period (first year; cohort 1, n = 8438) and the CCS period (>1 year, event-free patients with follow-up; cohort 2, n = 7783). The primary endpoint was all-cause death, nonfatal reinfarction, or heart failure hospitalization; secondary endpoints included individual and additional cardiovascular events. Among 623 primary outcome events, 238 occurred in the first year (28.9/1000 patient-years) and 385 thereafter (19.3/1000 patient-years). Secondary prevention use was generally high, but patients with early events had lower prescription rates than those with late events or no events. Beta-blockers were not associated with lower risk of the primary or component outcomes in either phase. A nonsignificant trend towards benefit of beta-blockers appeared during the first year in patients with mildly reduced LVEF (41-49%), whereas in the CCS phase, higher beta-blocker doses were associated with worse outcomes. CONCLUSION:In invasively treated MI patients with LVEF >40%, beta-blockers did not reduce adverse outcomes in either the ACS or CCS phases. These findings challenge their routine use in this population and support reconsidering current guidelines. Long-term beta-blocker users after MI may be candidates for deprescription.

INTRODUCTION AND OBJECTIVES:Recent trials have questioned the clinical benefit of beta-blockers in post-myocardial infarction (MI) patients with preserved left ventricular ejection fraction (LVEF). However, differences in pathophysiology and risk profile between MI with and without ST-segment elevation (STEMI and NSTEMI) may influence the effect of beta-blockers. METHODS:In this prespecified subgroup analysis of the REBOOT trial, which randomized invasively managed MI patients with LVEF> 40% to beta-blockers or control, we evaluated differences in long-term effects of the intervention between STEMI (n=4296) and NSTEMI (n=4142). The primary endpoint was a composite of all-cause death, reinfarction, or heart failure hospitalization over a median follow-up of 3.7 years. RESULTS:The primary endpoint and its components occurred more frequently in NSTEMI than in STEMI. A significant interaction between MI type and beta-blocker allocation was observed (P=.027). Among STEMI patients, beta-blockers were associated with a higher incidence of the primary endpoint (HR, 1.27; 95%CI, 1.00-1.62), whereas NSTEMI patients assigned to beta-blockers showed no effect (HR, 0.89; 95%CI, 0.72-1.10). Notably, NSTEMI patients with mildly reduced LVEF (40% to 50%) on beta-blockers experienced significantly fewer events than controls. CONCLUSIONS:The absence of clear clinical benefit from beta-blockers in invasively managed MI patients with preserved LVEF was consistent across STEMI and NSTEMI. The observed interaction by infarct type is exploratory and should not be interpreted as definitive evidence of harm associated with beta-blocker therapy in patients with STEMI and preserved LVEF. NSTEMI patients with mildly reduced LVEF may benefit from beta-blockers, warranting further investigation. (ClinicalTrials.gov: NCT03596385).

BACKGROUND:Modern therapeutic strategies have reduced mortality after a ST-segment elevation acute myocardial infarction (STEMI). However, up-to-date information on the incidence and prognostic impact of arrhythmias following this event is lacking. OBJECTIVES:This study sought to evaluate the incidence and clinical impact of ambulatory arrhythmias detected by an implantable cardiac monitor (ICM) using Bluetooth connectivity and remote monitoring after STEMI. METHODS:The TeVeO study was a multicenter, prospective study of patients who survived STEMI with reduced left ventricular ejection fraction (LVEF). Patients underwent continuous electrocardiographic monitoring using an ICM after discharge. Indication for implantable cardioverter-defibrillator (ICD) placement for primary prevention was evaluated at 6 months. RESULTS:A total of 3,565 patients were hospitalized for STEMI and subsequently discharged from our institutions. Of these, 636 had an LVEF ≤40% on day 4 or later. After application of the inclusion and exclusion criteria, 224 patients (35%) were enrolled (median LVEF: 35%). After a median follow-up time of 3.1 years, the mortality rate was 3.7 per 100 patient-years. No cases of sudden arrhythmic death were observed. At 6 months, an ICD was implanted in 25 (11%) patients (23 for primary prevention, 2 for secondary prevention). During follow-up, 119 patients (53%) experienced at least 1 ambulatory arrhythmia: 39 (17%) atrial fibrillation (AF), 35 (16%) nonsustained ventricular tachycardia, 33 (15%) sinus pauses >3 seconds, 14 (6%) second-or third-degree atrioventricular block, and 5 (2.2%) sustained monomorphic ventricular tachycardia/appropriate ICD therapy. The incidence rate of nonsustained ventricular tachycardia was 5.4 and for sustained monomorphic ventricular tachycardia/appropriate ICD therapy 0.9 per 100 patient-years. Only AF was independently associated with increased mortality (adjusted HR = 2.5; P = 0.04). CONCLUSIONS:The incidence and burden of ventricular arrhythmias were lower than expected. AF was associated with an increased mortality.

Background Atherosclerosis may start early in life, progressing silently for decades before clinical presentation of atherosclerotic cardiovascular disease (ASCVD) occur. Current preventive strategies rely on only five risk factors (age, sex, cholesterol levels, blood pressure, and smoking), and the available risk scores do not include young adults (< 40 years old). Importantly, the risk scores do not account for the presence of the actual disease, atherosclerosis, resulting in lower precision at the individual level. The aims of Phase 1 of the REACT initiative are to determine the prevalence of silent atherosclerosis across the lifespan and to identify its sex- and age-specific predictors using both contemporary and more advanced methods such as multi-territory vascular imaging and multi-omics profiling. Methods This prospective cohort study is enrolling 16,000 representative adults (18–70 years, women-to-men ratio 1:1) from Denmark and Spain, without a history of ASCVD. The presence and burden of silent atherosclerosis is assessed by 3D vascular ultrasound of the carotid and femoral arteries, and by computed tomography angiography of the coronary, carotid, and femoral arteries. Microvascular status is assessed by retina imaging. Risk factor assessment for silent atherosclerosis includes traditional factors supplemented with detailed questionnaires, physical examinations, blood and urine analyses, as well as multi-omics profiling. Conclusion By providing a detailed understanding of the predictors and age- and sex stratified prevalence of silent atherosclerosis across multiple vascular territories, phase 1 of the REACT project will inform and advance future personalized ASCVD prevention strategies.

BACKGROUND:Atherosclerosis may begin in early adulthood and remain clinically silent for decades before cardiovascular disease manifests. Although silent atherosclerosis is associated with cardiovascular events and death independent of traditional cardiovascular disease risk factors, its age- and sex-specific prevalence, vascular territory distribution, and plaque volume across adult life remain incompletely defined. METHODS:We conducted a prospective cohort study in Denmark and Spain. Adults 18 to 70 years of age without known atherosclerotic cardiovascular disease were enrolled in five prespecified age strata that included balanced numbers of women and men. Silent atherosclerosis was assessed at baseline with three-dimensional vascular ultrasonography of the carotid and femoral arteries and with coronary computed tomographic angiography. RESULTS:A total of 16,808 adults were enrolled in the study. The mean (±SD) age of the participants was 45±12 years, and 51.4% were women. Silent atherosclerosis was present in 57.1% of the participants (95% confidence interval, 56.3 to 58.0). In the youngest age stratum (18 to 29 years), atherosclerosis was present in 8.7% of the men and 6.7% of the women; prevalence increased with age, with a later, steeper midlife rise among women. Among participants in the younger age strata, atherosclerosis was most often peripheral and confined to a single vascular territory; with increasing age, plaque volume increased exponentially and the prevalence of multiarterial involvement became more frequent. Isolated coronary-artery atherosclerosis was uncommon in every age stratum (≤9.3% of men and ≤5.0% of women). CONCLUSIONS:This study of silent atherosclerosis showed that the disease was detectable in early adulthood, with age- and sex-associated increases in prevalence across arterial territories and marked increases in plaque volume. (Funded by the Novo Nordisk Foundation; REACT ClinicalTrials.gov number, NCT06692127.).

Medical imaging research platforms must support complex data management, heterogeneous collaboration models, and the growing use of Artificial Intelligence (AI) methods, often across institutional boundaries. Designing systems that can adapt to evolving research requirements without extensive redevelopment remains a challenge in healthcare informatics. This paper presents D-AI-COM, a modular medical imaging platform for DICOM management and AI-assisted analysis, designed to support adaptable research workflows. D-AI-COM is grounded in practical experience extending a previously developed platform, where attempts to incorporate multi-institutional collaboration, automated data ingestion, and containerized AI execution revealed architectural limitations. We describe the architecture of D-AI-COM together with the design rationale underlying its main components, including fine-grained permission control, self-describing AI algorithms, event-driven automation, and unified management of imaging and structured clinical data. To demonstrate how these design decisions are operationalized, we present representative research workflows drawn from common medical imaging scenarios. By documenting the lessons learned during its design, this work contributes insights for building adaptable, research-oriented medical imaging platforms.

Introducción y objetivos Ensayos recientes han cuestionado el beneficio clínico de los bloqueadores beta en pacientes tras un infarto agudo de miocardio (IAM) con fracción de eyección del ventrículo izquierdo (FEVI) conservada. Las diferencias en la fisiopatología y el perfil de riesgo entre un IAM con y sin elevación del ST (IAMCEST e IAMSEST) podrían influir en su efecto. Métodos En este análisis de subgrupos preespecificado del ensayo REBOOT, en el que se aleatorizó a pacientes con IAM tratados de forma invasiva y con una FEVI> 40% a recibir bloqueadores beta o tratamiento de control, se evaluó las diferencias en los efectos a largo plazo de la intervención entre los pacientes con IAMCEST (n=4.296) y los pacientes con IAMSEST (n=4.142). El objetivo principal primario fue un compuesto de muerte por cualquier causa, reinfarto u hospitalización por insuficiencia cardiaca durante un seguimiento mediano de 3,7 años. Resultados El objetivo principal y sus componentes se dieron más frecuentemente en el IAMSEST que en el IAMCEST. Se observó una interacción significativa entre el tipo de IAM y la asignación a bloqueadores beta (p = 0,027). En el IAMCEST, los bloqueadores beta se asociaron con una mayor incidencia del objetivo principal (HR=1,27; IC95%, 1,00-1,62), mientras que, en el IAMSEST, no se dieron diferencias (HR=0,89; IC95%, 0,72-1,10). Pacientes con IAMSEST y FEVI intermedia (40-50%) tratados con bloqueadores beta presentaron significativamente menos episodios que los controles. Conclusiones La ausencia de beneficio de los bloqueadores beta en el IAM tratados invasivamente con FEVI conservada es consistente en IAMCEST e IAMSEST. La interacción observada por tipo de infarto es exploratoria y no debe interpretarse como una señal definitiva de daño asociado al uso de bloqueadores beta en el IAMCEST. Pacientes con IAMSEST y FEVI parecen beneficiarse de bloqueadores beta, pero se requiere de investigación adicional en estudios adecuados. (ClinicalTrials.gov: NCT03596385)

BACKGROUND:Current guideline recommendations for the use of beta-blockers after myocardial infarction without reduced ejection fraction are based on trials conducted before routine reperfusion, invasive care, complete revascularization, and contemporary pharmacologic therapies became standard practice. METHODS:We conducted an open-label, randomized trial in Spain and Italy to evaluate the effect of beta-blocker therapy, as compared with no beta-blocker therapy, in patients with acute myocardial infarction (with or without ST-segment elevation) and a left ventricular ejection fraction above 40%. The primary outcome was a composite of death from any cause, reinfarction, or hospitalization for heart failure. RESULTS:In total, 4243 patients were randomly assigned to receive beta-blocker therapy and 4262 to receive no beta-blocker therapy; after exclusions, 8438 patients were included in the main analysis. During a median follow-up of 3.7 years, a primary-outcome event occurred in 316 patients (22.5 events per 1000 patient-years) in the beta-blocker group and in 307 patients (21.7 events per 1000 patient-years) in the no-beta-blocker group (hazard ratio, 1.04; 95% confidence interval [CI], 0.89 to 1.22; P = 0.63). Death from any cause occurred in 161 patients and 153 patients, respectively (11.2 vs. 10.5 events per 1000 patient-years; hazard ratio, 1.06; 95% CI, 0.85 to 1.33); reinfarction in 143 patients and 143 patients (10.2 vs. 10.1 events per 1000 patient-years; hazard ratio, 1.01; 95% CI, 0.80 to 1.27); and hospitalization for heart failure in 39 patients and 44 patients (2.7 vs. 3.0 events per 1000 patient-years; hazard ratio, 0.89; 95% CI, 0.58 to 1.38). No apparent between-group differences in safety outcomes were noted. CONCLUSIONS:Among patients discharged after invasive care for a myocardial infarction with a left ventricular ejection fraction above 40%, beta-blocker therapy appeared to have no effect on the incidence of death from any cause, reinfarction, or hospitalization for heart failure. (Funded by Centro Nacional de Investigaciones Cardiovasculares Carlos III and others; ClinicalTrials.gov number, NCT03596385; EudraCT number, 2017-002485-40.).

BACKGROUND:Current guidelines recommend beta blockers after myocardial infarction (MI) regardless of left ventricular ejection fraction (LVEF), aiming to reduce reinfarction and ventricular arrhythmias. However, recent trials have challenged this practice in patients without reduced LVEF. Whether beta blocker withdrawal in these patients increases short-term or recurrent ischaemic events remains uncertain. AIMS:We aimed to evaluate the short-term ischaemic safety of beta blocker withholding or withdrawal at hospital discharge in patients with MI and LVEF >40% and to determine the effect of beta blocker therapy on a broad composite ischaemic endpoint. METHODS:This is a post hoc analysis of the REBOOT trial, in which patients with MI and LVEF >40% were randomised to beta blocker therapy or no beta blocker at discharge. The incidence of short-term (3-month) and recurrent ischaemic events (a composite of cardiac death, reinfarction, sustained ventricular tachycardia/fibrillation, resuscitated cardiac arrest, or unplanned revascularisation) was assessed overall and according to prior beta blocker use. RESULTS:From the 8,438 patients in the intention-to-treat population of the trial, information regarding beta blocker history was available for 8,401. Of these, 12.1% were on chronic beta blocker therapy before MI. Overall, withholding or withdrawing beta blockers was not associated with increased short-term ischaemic risk (hazard ratio [HR] 1.13, 95% confidence interval [CI]: 0.74-1.72). Over a median follow-up of 3.7 years, there were no differences in recurrent ischaemic events between groups (HR 0.98, 95% CI: 0.82-1.16), nor significant interactions with prior beta blocker therapy. In patients who were on a beta blocker before the index MI, randomisation to no beta blocker (withdrawal) was not associated with an increased risk of ischaemic events during trial follow-up (composite ischaemic endpoint HR 0.93, 95% CI: 0.64-1.34). CONCLUSIONS:In patients with MI and LVEF >40%, beta blocker withholding or withdrawal at discharge was not associated with increased short-term or recurrent ischaemic events, supporting the safety of this strategy in contemporary clinical practice.

Treatment of heart failure and reduced ejection fraction (HFrEF) using angiotensin receptor-neprilysin inhibitor demonstrates beneficial effects on cardiac remodeling (CR). We assessed the impact of sacubitril/valsartan on the concentrations of HF biomarkers in relation to parameters of CR using imaging techniques in patients with HFrEF. In a prospective single-center open-label study, 68 patients with symptomatic HFrEF were treated with sacubitril/valsartan and followed-up every three months for 12 months. Soluble suppression of tumorigenicity 2 (sST2), N-terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity cardiac troponin I (hs-cTnI) were measured in blood samples. Additionally, echocardiography and cardiac magnetic resonance imaging (cMRI) were performed to assess heart structural and functional changes. Following treatment initiation, follow-up visits revealed an improved NYHA functional class in these patients, alongside significant decreases in all circulating biomarkers, increases in left ventricular ejection fraction (LVEF), and reductions in volume- and diameter-related LV parameters. Sustained gradual decreases in sST2 concentrations over time correlated with NT-proBNP concentrations (rho=+0.26, P < 0.001). Both biomarkers were inversely correlated with LVEF, and positively correlated with volume- and diameter-related LV parameters from echocardiography and cMRI. However, NT-proBNP concentrations exhibited stronger correlations with these LV parameters and were associated with the number of LV segments showing fibrosis, unlike sST2. Sacubitril/valsartan treatment in HFrEF leads to reduced sST2 and NT-proBNP concentrations with distinct decreasing curves, which are linked to reverse CR through LV-related parameters. In contrast to sST2, NT-proBNP is also associated with fibrosis, suggesting that both biomarkers unveil distinct mechanisms during CR in patients treated with sacubitril/valsartan.

Introduction Updated primary prevention strategies are needed for post-infarction sudden cardiac death (SCD) based on implantable cardioverter-defibrillator (ICD). Current recommendations, based on left ventricular systolic function and functional class, may be obsolete because they are derived from ancient studies that do not incorporate the potential benefit of either current comprehensive treatment of ischaemic heart disease or modern device programming. Among patients with post-infarction left ventricular dysfunction, modern implantable cardiac monitoring devices (ICM) allow a unique opportunity to determine in real-time the burden of non-sustained ventricular tachycardias and their relationship to the subsequent occurrence of sustained or symptomatic events.Methods and analysis Approximately 200 patients with left ventricular ejection fraction (LVEF) equal to or less than 40% after acute myocardial infarction will be included in the study. They will be implanted with a Confirm RX, an ICM with real-time remote connection via a smartphone. At 6 months, LVEF and functional status will be re-evaluated and cardiac morpho-functional characterisation will be performed by MRI. At this time, and following current European guidelines, patients with an indication will receive an ICD; the others will continue to be monitored using an ICM for a minimum of 2 years. Patients are expected to be followed up for 4 years after the index event. More than 20 000 remote transmissions are expected to be analysed. The study will focus on the relationship between the detection of non-sustained ventricular tachycardias by ICMs (defined as at least 8 R-R intervals at 160 beats per minute) and the subsequent occurrence of symptomatic arrhythmic events. An advanced statistical analysis will be performed using machine and deep learning techniques to determine the clinical variables, those that are derived from monitoring and imaging tests and related to mid-term prognosis.Ethics and dissemination The study was approved by the Ethical Committee of the University Hospital of Salamanca (protocol number PI 2019 03 246) on 30 April 2020. Each patient will be informed about the study in both oral and written form by a physician and will be included in the study after written consent is obtained.For the first time, a study will provide real-time information on the arrhythmic burden of patients with post-infarction ventricular dysfunction and its prognostic implications in the medium term. Several publications in scientific journals are planned.Trial registration number NCT04765943.

Background Oral anticoagulation (OAC) use increases the risk of intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF) and CHA2DS2-VASc ≥2. Left atrial appendage occlusion (LAAO) is an alternative to OAC, however data about its use in patients with prior ICH is scarce and the timing of its performance is controversial. Furthermore, the long-term outcomes in this group of patients have not been described previously. Objective To evaluate the safety and efficacy of LAAO in patients with non-valvular AF and prior ICH (CHA2DS2-VASc ≥2) and to determine adequate timing of its performance. Methods This is a multicenter retrospective registry that included 128 patients, whose indication for this procedure was ICH. Patients were divided into two groups: early occlusion (n=31; 24.2%), in which the procedure was performed before 90 days had elapsed after the bleeding, and late occlusion (n=97; 75.8%), after 90 days. Results Global procedural success was of 97% (124/128). Procedure-related complications occurred in 4 patients (3.15%): 2 cardiac tamponade, 1 device embolization and 1 transient ischemic attack during hospitalization. There was a significant reduction in the ischemic and bleeding rates compared to expected based on CHA2DS2-VASc and HASBLED scores (93.9% and 89.9% respectively) after a mean follow-up of 73.9±34.1 months. There were no significant differences neither in baseline characteristics between the early and late occlusion groups nor in the procedural success or complications rates. Furthermore, no statistically significant differences were found in mortality, ischemic events, or hemorrhage between the early and late occlusion group. Conclusions Left atrial appendage occlusion is an effective and safe treatment alternative to reduce the risk of ischemic stroke in selected patients with atrial fibrillation and prior intracranial hemorrhage. In this study, we did not find differences regarding safety and efficacy in early closure compared with late closure. Further studies are needed to support early closure to reduce the complications associated with oral anticoagulation withdrawal.

Background and Objectives: Degenerative aortic stenosis has become the most common primary valve lesion referred for intervention, with thousands of transcatheter aortic valve implantation (TAVI) procedures being performed annually. To date, there are no quantitative tools capable of evaluating patient experience adapted to percutaneous procedures of this nature. The goal of this study is to propose and validate the VALVEX questionnaire as the reference tool to assess patient experience throughout the TAVI process and to identify areas for improvement in healthcare. Methods: This was a cross-sectional observational study with a 30-day follow-up that included consecutive patients > 18 years of age undergoing elective TAVI in two Spanish hospitals. A multidisciplinary panel including patients was constituted to design, refine, and pilot the VALVEX questionnaire. During its completion 30 days after the procedure, the dimensions assessed were the care provided before, during, and after TAVI, as well as the facilities and overall patient satisfaction. Reliability, validity, and feasibility were analysed during the validation phase. Results: A total of 335 patients were enrolled and filled out the VALVEX questionnaire (mean age 81.1 ± 5 years, 52% female). Evaluation of feasibility showed a mean completion time of 7.8 ± 2.3 min, with a 2.1% rate of unanswered questions. Cronbach's alpha index was 0.912, with high internal reliability measurements for all the assessed dimensions. An intraclass correlation coefficient (ICC) of 0.851 was determined as an indicator of stability. The Delphi panel achieved a consensus of over 85% in clarity, coherence, relevance, and sufficiency. Conclusions: We have successfully validated the VALVEX questionnaire as the first quantitative tool specifically designed to measure and evaluate patient experience throughout the TAVI procedure and recovery. This questionnaire is a valid, reliable, simple, and easy-to-use resource that could be used as a reference tool to assess patient experience for TAVI or other percutaneous cardiac interventions.