RESUMEN Introducción y objetivos: La trombectomía manual (TM) en la intervención coronaria percutánea primaria (ICPp) intenta reducir la carga trombótica. Este estudio evalúa los resultados y los factores predictores de éxito de la TM. Métodos: El registro Hunted es un estudio de cohortes retrospectivo, unicéntrico, de pacientes tratados con TM en ICPp utilizan- do el catéter Hunter, desde julio de 2020 hasta febrero de 2022. El éxito de la TM se definió como una disminución angiográfica a grado ≤ 2 en la escala Thrombolysis in Myocardial Infarction (TIMI), con seguimiento clínico de eventos cardiovasculares adversos mayores. Resultados: De los 750 pacientes con infarto agudo de miocardio tratados con ICPp, en 401 (53%) se realizó TM. Los pacientes tratados tenían una edad media de 62 años y el 80% eran varones. La TM fue efectiva en 327 (81,55%) pacientes. Los predictores de TM efectiva fueron un mayor diámetro del vaso (p < 0,001), una alta carga de trombo (TIMI ≥ 4; p < 0,001) y un vaso diferente de la circunfleja (p < 0,001). Se presentaron complicaciones relacionadas con el dispositivo en 17 pacientes (4,3%). En el seguimiento, el 8,98% presentaron eventos mayores a 1 año y el 9,97% a 2 años. Conclusiones: En los pacientes con infarto de miocardio con elevación del segmento ST sometidos a ICPp, la estrategia de TM con catéter Hunter, en casos seleccionados con alta carga trombótica (escala TIMI ≥ 4), otros vasos que no fueran la circunfleja y diámetros > 2,5 mm, es una técnica eficaz y segura con una baja tasa de complicaciones.

Background There are limited prediction models of long-term mortality for patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Against this background, we aimed to derive and validate a predictive model for long-term mortality in patients with STEMI undergoing PCI.Methods A total of 23 086 patients from a STEMI network were included in the derivation cohort. Using time-to-event regression analysis, predictors of long-term mortality were identified and used to develop a score ranging from 0 to 206 points, with a score directly proportional to the probability of mortality. The predictive performance of this score was then validated in patients from the EXAMINATION-EXTEND study (n=1498) and Coronary Artery diSease Tracking registry (n=1112). An outcome-based cut-point optimisation analysis was performed to determine the best cut-off value in the derivation and validation cohorts.Results The prediction model for long-term mortality in STEMI (PREDICT-STEMI) score comprised seven variables: age, diabetes mellitus, previous myocardial infarction, previous ischaemic stroke/transient ischaemic attack, haemodynamic status, three-vessel disease and mechanical circulatory support. The score showed a Concordance index for long-term mortality of 0.81 (95% CI 0.80 to 0.81) in the derivation and 0.81 (95% CI 0.78 to 0.84) and 0.84 (95% CI 0.81 to 0.87) in the validation cohorts, respectively. The optimal prediction model cut-off was 60 points; compared with those with a low score, patients with a high score had a sixfold increased risk of long-term mortality in both the derivation and validation cohorts.Conclusions The PREDICT-STEMI score is a simple tool for predicting long-term mortality and facilitating early risk stratification and inform clinical decision-making.

Background. Despite technological innovations and improvements in stents and devices, sex-related discrepancies are still reported in the outcomes after ST-segment elevation myocardial infarction (STEMI), depending on biological and sex-specific pathophysiological differences, which have not been completely understood. The aim of the present study was to provide real-world data on the prognostic role of sex among patients with STEMI, enclosed into a recent up-to-date international registry. Methods. The ISACS-STEMI COVID-19 is a large-scale retrospective registry, including STEMI patients treated with mechanical reperfusion between 1 March and 30 June, 2019 and 2020. Patients, treated in 109 centers across Europe, Latin America, Southeast Asia, and North Africa, were grouped according to sex. Primary endpoint: In-hospital mortality; secondary endpoints: Time delay, 30-day mortality, and postprocedural Thrombolysis In Myocardial Infarction (TIMI) 3 flow. Results. We included 16,083 patients, 24.3% females (54.3% hospitalized in 2019, 45.7% in 2020). Women with STEMI were older, more often diabetic and hypertensive (p < 0.001), with a higher prevalence of hypercholesterolemia (p = 0.02), longer ischemia time (p = 0.01), ambulance referral (p = 0.03) and cardiogenic shock at presentation (p = 0.05), but less frequently smokers, with a previous cardiovascular event (p < 0.001) or anterior STEMI (p = 0.03) as compared to males. Preprocedural TIMI 0 flow, multivessel disease, need for thrombectomy (p < 0.001 and p = 0.001, respectively), use of Glycoprotein IIbIIIa inhibitors or cangrelor, radial access and implantation of drug-eluting stents (p < 0.001, p < 0.001 and p = 0.001, respectively) were also more common in men. Impaired postprocedural epicardial reperfusion (TIMI flow 0-2) was observed more frequently in females as compared to males (10% vs. 7.2%; adjusted OR [95% CI] = 1.30 [1.13-1.49], p = 0.01). In-hospital mortality was 5.8%, significantly higher among women (8.3% vs. 5%, p < 0.001, adjusted HR [95% CI] = 1.26 [1.06-1.5], p = 0.01). Similar data were observed for 30-day mortality (10.3% vs. 6.2%, p < 0.001, adjusted HR [95% CI] = 1.22 [1.06-1.38], p = 0.007). Conclusions. Among STEMI patients being treated with the most updated standard of care for primary percutaneous coronary intervention, female sex is still associated with higher complexity and impaired prognosis, displaying suboptimal epicardial reperfusion and increased in-hospital and 30-day mortality.

Introduction and objectives:Manual thrombectomy (MT) during primary percutaneous coronary intervention (PCI) aims to reduce thrombus burden. Our study evaluates the outcomes and predictors of successful MT. Methods:The Hunted registry is a retrospective, single-center cohort study including patients who underwent MT during PCI using the Hunter catheter from July 2020 through February 2022. MT success was defined as an angiographic reduction to a Thrombolysis in Myocardial Infarction (TIMI) thrombus grade of ≤ 2, with clinical follow-up for major adverse cardiovascular events. Results:Among 750 patients with acute myocardial infarction who underwent PCI, 401 (53%) received MT. The mean age of treated patients was 62 years (80% men). MT was effective in 327 patients (81.55%). Predictors of successful MT included larger vessel diameter (P < .001), high thrombus burden (TIMI grade ≥ 4 flow; P < .001), and non-circumflex target vessels (P < .001). Device-related complications occurred in 17 patients (4.3%). At follow-up, major adverse events occurred in 8.98% of patients at 1 year and in 9.97% at 2 years. Conclusions:In patients with ST-segment elevation myocardial infarction undergoing PCI, MT with the Hunter catheter in selected cases with high thrombus burden (TIMI grade ≥ 4 flow), non-circumflex target vessels, and vessel diameters > 2.5 mm, is a safe and effective technique with a low rate of complications.

BACKGROUND:Several scores have been developed to facilitate risk stratification and early discharge following primary angioplasty, particularly the Zwolle Risk Score (ZRS). However, validation in large-sized studies is still lacking. Therefore, the aim of the current study was to validate the use of the ZRS in a contemporary global population, including patients who were treated during the SARS-CoV-2 pandemic and enrolled in a large intercontinental observational study. METHODS:The ISACS-STEMI COVID-19 is a large-scale retrospective multicenter registry involving primary PCI centers from Europe, Latin America, South-East Asia, and NorthAfrica, including patients treated from March 1st until June 30th, in 2019 and 2020]. ZRS was calculated for each patient. The patients were additionally categorized according to the following values of the ZRS [≤3; 4-6; 7-9; ≥10]. Our study outcomes were in-hospital and 30-day mortality. The discriminatory capacity of the ZRS was assessed by the area under the ROC curve [c statistic] as an index of model performance. RESULTS:Our population is represented by 16084 STEMI patients undergoing mechanical reperfusion enrolled in 109 centers. The score showed a very good performance in the predicting mortality both in-hospital [AUC=0.83 [0.82-0.85], p<0.0001] and at 30- day follow-up [AUC=0.82 [0.81-0.84, p<0.0001]. The results were confirmed when the ZRS was separately applied to patients treated in 2019 and 2020, with good stability across time. ZRS was able to identify a large cohort [n=10672, 66.3%] of low-risk patients [score ≤3] with a very low mortality rate at 2 days [1%] and between 3 and 10 days [0.7%], with a very good negative predictive value for in-hospital [98.3%] and 30-day mortality [97.7%], with similar results in 2019 and 2020. CONCLUSION:This study is the first to demonstrate the good prognostic performance of the ZRS in a large-scale contemporary global multicenter validation set. Similar results were obtained both in the pre-pandemic and the COVID-19 era. ZRS ≤3 identified a very low-risk population that could be discharged early, even during the COVID-19 pandemic, with expected advantages in the availability of hospital beds and nursing staff, costs of medical care, and in-hospital risk of contagion.

INTRODUCTION:Despite the large use of renin-angiotensin system inhibitors (RASI) in STSegment Elevation Myocardial Infarction (STEMI) patients, few data have been reported on the prognostic impact of chronic RASI at admission in patients suffering from STEMI, especially during the COVID-19 pandemic. Therefore, the current study investigated the prognostic impact of chronic RASI at admission in patients suffering from STEMI, including both SARS-CoV-2 positive and negative individuals, enrolled before and during the COVID-19 pandemic. METHODS:We included STEMI patients who received primary percutaneous coronary intervention (PPCI) and were enrolled in the ISACS-STEMI COVID-19 registry. In the present sub-analysis, patients were allocated according to chronic RASI therapy at admission. The primary study endpoint was the occurrence of in-hospital mortality. Secondary endpoints were postprocedural TIMI 3 flow and mortality at 1 month. RESULTS:The overall population was 15,693 patients, including 6,213 patients pretreated with RASI. Several differences in baseline characteristics were observed between the two groups. No difference was observed in the prevalence of SARS-CoV-2 infection. After correction for all baseline confounders, including procedural features, chronic pretreatment with RASI was independently associated with improved postprocedural TIMI 3 flow (OR [95% CI] = 1.14 [1.03-1.35], p = 0.042), lower in-hospital mortality (adjusted OR [95% CI] = 0.64 [0.54-0.75], p < 0.001), and lower 30-day mortality (adjusted OR [95% CI] = 0.62 [0.53-0.73], p < 0.001). CONCLUSION:This is the largest study investigating the prognostic impact and benefits of chronic RASI pre-treatment in STEMI patients undergoing PPCI, including those treated during the COVID19 pandemic. We found that chronic RASI treatment at hospital admission was associated with significant improvement in reperfusion and reduction in mortality, without any negative effect in SARS-CoV-2 positive patients. Results should be interpreted considering the retrospective, nonrandomized nature of the study.

Patients with severe aortic stenosis (AS) and small aortic annulus pose diagnostic and therapeutic challenges. To investigate the frequency of discordant grading of severe AS in patients with a small aortic annulus and to evaluate the outcomes after transcatheter aortic valve implantation (TAVI). Patients with severe AS, an aortic annulus diameter of < 21 mm on echocardiography, a mean annulus diameter of < 23 mm, and an area ≤ 4.3 cm2 on cardiac computed tomography, who underwent TAVI, were retrospectively analyzed. The frequency of low-gradient severe AS was assessed. Patients were followed up for the occurrence of the composite endpoint of all-cause mortality, rehospitalizations for heart failure, non-fatal myocardial infarction, and non-fatal stroke. Among 230 patients with severe AS and a small aortic annulus (age 82 ± 6 years, 85

Introduction y objectives: Tako-tsubo syndrome (TTS) is a cardiac condition that mimics acute coronary syndrome, characterized by transient left ventricular dysfunction in the absence of culprit coronary artery stenosis. Although its etiology remains unknown, reversible microvascular dysfunction secondary to an adrenergic surge is thought to play a role. Treatment is empirical, although most patients receive beta-blockers (BB) in clinical practice. The Beta-blockers in Tako-tsubo Syndrome study (beta-Tako), is an academic, multicenter, pragmatic, prospective randomized open-label trial with blinded endpoint evaluation that aims to assess the efficacy and safety of BB in patients with TTS. Methods: The diagnosis of TTS will be confirmed by invasive coronary angiography and serial echocardiographic assessments. Two hundred patients with TTS will be randomized (1:1) to BB (n = 100) or no BB (n = 100). BB with alpha or nitric oxide release activity will be used in the treatment arm. Results: The primary efficacy endpoint is the comparison of the wall motion score index by echocardiography at 7 days, analyzed by an independent core laboratory. Changes in left ventricular ejection fraction and global longitudinal strain will also be evaluated. A composite clinical endpoint (death, stroke, admission for recurrent TTS, acute coronary syndrome, heart failure, or atrial fibrillation) at 1 year will be assessed by an independent clinical events committee. Several predefined substudies will be conducted to examine clinical, imaging, biomarker, pharmacogenetic, inflammatory, messenger ribonucleic acids, and quality-of-life parameters. Conclusions: The beta-Tako trial will generate robust scientific evidence to address unmet clinical needs and inform clinical and treatment decisions in this uniquely challenging clinical entity. The study has been registered (EU-CT number: 2023-510213-25-01, ClinicalTrials.gov Identifier, NCT06509074. (c) 2024 Sociedad Espa & ntilde;ola de Cardiolog & iacute;a. Published by Elsevier Espa & ntilde;a, S.L.U. All rights are reserved, including those for text and data mining, AI training, and similar technologies.

Introducción y objetivos: En los supervivientes de cáncer, la insuficiencia mitral (IM) puede deberse a cardiotoxicidad o coexistir incidentalmente dada la alta prevalencia de ambas afecciones. Se evaluó la eficacia y seguridad de la reparación mitral percutánea de borde a borde (M-TEER) en este contexto.Métodos: Estudio observacional, retrospectivo, multicéntrico, del registro español de M-TEER. Los pacientes con y sin antecedente oncológico se emparejaron 1:1 mediante puntuación de propensión. El objetivo principal incluyó la mortalidad total u hospitalización por insuficiencia cardiaca a medio plazo. Los objetivos secundarios fueron el grado de IM residual y la clase de la New York Heart Association al año.Resultados: De 1.237 pacientes (73  ±  11 años, 34% mujeres), 164 (13,3%) presentaban antecedente oncológico. La puntuación de propensión resultó en 163 pares. Los cánceres más frecuentes fueron de mama (20,9%), leucemia/linfoma (19,6%), de próstata (12,9%) y colorrectal (12,3%). La mediana de tiempo entre el cáncer y la M-TEER fue de 7 [RIC, 3-17] años. La IM se atribuyó a cardiotoxicidad en el 38,7% de los casos. El tipo de IM se asoció con localización del cáncer, antraciclinas y radioterapia en hemitórax izquierdo (p <  0,001). Tras un seguimiento de 24 (11-43) meses, el objetivo principal se dio en 80 (49,1%) supervivientes y en 69 (42,3%) controles (HR = 1,23; IC95%, 0,89-1,70; p  = 0,202). Al año, el grado de IM residual y la clase de la New York Heart Association fueron similares entre los grupos. Entre los supervivientes de cáncer, los predictores adversos fueron: hemopatías malignas, radioterapia mediastínica, diabetes, anemia y EuroSCORE II.Conclusiones: El antecedente de cáncer no impactó en la mortalidad a medio plazo, las hospitalizaciones por insuficiencia cardiaca, o los resultados funcionales y ecocardiográficos al año tras la M-TEER.

INTRODUCTION AND OBJECTIVES:Among cancer survivors, mitral regurgitation (MR) may reflect therapy-related cardiotoxicity or incidental coexistence given the high prevalence of both conditions. We evaluated the efficacy and safety of mitral transcatheter edge-to-edge repair (M-TEER) in this setting. METHODS:We conducted a retrospective, multicenter observational study using the Spanish M-TEER registry. Patients with and without prior cancer diagnosis were matched 1:1 using propensity score matching. The primary endpoint was a composite of all-cause mortality or unplanned heart failure hospitalization at mid-term follow-up. Secondary endpoints were residual MR grade and New York Heart Association functional class at 1 year. RESULTS:Of 1237 patients (73 ± 11 years, 34% female), 164 (13.3%) had a prior cancer diagnosis. Propensity score matching yielded 163 pairs. The most common malignancies were breast (20.9%), leukemia/lymphoma (19.6%), prostate (12.9%), and colorectal (12.3%). The median [interquartile range] time from cancer diagnosis to M-TEER was 7 [3-17] years. MR was attributable to cardiotoxicity in 38.7%. MR type was associated with cancer location, anthracycline exposure, and left-sided chest radiotherapy (P < .001). After a median follow-up of 24 [11-43] months, the primary endpoint occurred in 80 (49.1%) cancer survivors and 69 (42.3%) controls (HR, 1.23; 95%CI, 0.89-1.70; P = .202). At 1-year, residual MR grade and New York Heart Association class were similar between groups. Among cancer survivors, independent predictors of worse outcomes included hematologic malignancy, mediastinal radiotherapy, diabetes mellitus, anemia, and EuroSCORE II. CONCLUSIONS:A prior cancer diagnosis did not impact mid-term mortality, heart failure hospitalizations, or 1-year functional and echocardiographic outcomes after M-TEER.

Introducción y objetivos: El síndrome de tako-tsubo (STT) es una entidad cardiaca que simula un síndrome coronario agudo, caracterizada por una disfunción ventricular izquierda transitoria en ausencia de lesiones coronarias culpables. Su etiología es desconocida, pero se postula una disfunción microvascular reversible secundaria a una tormenta catecolaminérgica. El tratamiento es empírico, pero en la práctica clínica la mayoría de los pacientes reciben bloqueadores beta (BB). El estudio sobre bloqueadores beta en el STT (β-Tako) es un estudio académico, pragmático, prospectivo, multicéntrico, aleatorizado y abierto con evaluación ciega de acontecimientos, que pretende conocer la eficacia y seguridad de los BB en pacientes con STT.Métodos: El diagnóstico de STT se confirmará por coronariografía invasiva y estudios ecocardiográficos seriados. Se aleatorizarán 200 pacientes con STT (1:1) a BB (n = 100) o no BB (n = 100). Se utilizarán BB con actividad alfa o liberadora de óxido nítrico.Resultados: El objetivo primario de eficacia del estudio es la comparación del índice de puntuación del movimiento parietal por ecocardiografía a los 7 días, analizado en un laboratorio central independiente. También se estudiarán los cambios en la fracción de eyección y en la deformación longitudinal global. Un comité clínico independiente analizará el objetivo clínico combinado (muerte, accidente cerebrovascular, o reingreso por STT recurrente, síndrome coronario agudo, insuficiencia cardiaca o fibrilación auricular) a un año. Se realizarán diversos subestudios predefinidos (clínicos, imagen, biomarcadores, farmacogenéticos, inflamación, ácido ribonucleico mensajero y de calidad de vida).Conclusiones: El estudio β-Tako generará una valiosa evidencia científica sobre aspectos no conocidos del STT, y permitirá guiar las decisiones de abordaje clínico y tratamiento en esta compleja entidad clínica.Estudio registrado en EU-CT número: 2023-510213-25-01, identificador de ClinicalTrials.gov: NCT06509074.

BACKGROUND:Pre-existing mitral prosthesis raises technical challenges for transcatheter aortic valve replacement (TAVR) but has been scarcely studied. In this work we sought to compare outcomes of patients with previous surgical mitral valve prostheses undergoing TAVR with balloon-expandable valve (BEV) or self-expanding valve (SEV) systems. METHODS:Patients from the Spanish TAVR registry with pre-existing surgical mitral prostheses were included in this investigation. The primary endpoints were Valve Academic Research Consortium-3 technical and device success, with analysis according to valve type. Transcatheter heart valve (THV) embolization, mitral valve impingement, THV performance, and pacemaker findings were also assessed. RESULTS:A total of 243 patients were included (37% BEVs, 63% SEVs). Overall technical success was 95.9%. Thirty-day device success was higher in BEV patients (94.4% vs 85.0%, P = 0.036), mainly driven by fewer incidences of moderate residual aortic regurgitation (0% vs 5.9%, P = 0.028) and THV embolization (0% vs 3.9%, P = 0.087). BEV recipients exhibited higher mean transvalvular gradients (10.5 vs 8.1 mm Hg, P = 0.002) and lower rates of permanent pacemaker implantation (5.6% vs 15.7%, P = 0.023). There were no differences in mortality, bleeding, or readmission at 30 days. In the multivariate analysis, a mitroaortic distance of ≤ 7 mm and lack of transesophageal echocardiography guidance were associated with increased device failure. CONCLUSIONS:In patients with pre-existing MV prostheses, TAVR was safe and effective regardless of the THV type. Nevertheless, the use of BEVs resulted in an increased rate of device success, driven by lesser THV embolization and residual aortic regurgitation.

BACKGROUND:Hypertension is the most prevalent cardiovascular risk factor, with several detrimental effects on the cardiovascular system. Contrasting results have been reported so far on its prognostic role in patients admitted for ST-segment elevation myocardial infarction (STEMI). Therefore, we investigated the impact of hypertension on short-term mortality in a large multicenter contemporary registry of STEMI patients, including patients treated during COVID-19 pandemic. METHODS:The ISACS-STEMI COVID-19 was a retrospective registry that included STEMI patients treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 in 109 high-volume primary PCI centers from 4 continents. We collected data on baseline, clinical and procedural characteristics, in-hospital outcome and 30-day mortality. For this analysis patients were grouped according to history of hypertension at admission. RESULTS:A total of 16083 patients were assessed, including 8813 (54.8%) with history of hypertension. These patients were more often elderly, with a worse cardiovascular risk profile, but were less frequently active smoker. Some procedural differences were observed between the two groups, including lower rate of thrombectomy and use of glycoprotein IIb/IIIa inhibitors or cangrelor but more extensive coronary disease in patients with hypertension. Between patients with and without hypertension, there was no significant difference in SARS-CoV-2 positivity. Hypertensive patients had a significantly higher in-hospital and 30-day mortality, similarly observed in both pre-COVID-19 and COVID-19 era, and confirmed after adjustment for main baseline differences and propensity score (in-hospital mortality: adjusted odds ratio (OR) [95% confidence interval (CI)] =1.673 [1.389-2.014], P  < 0.001; 30-day mortality: adjusted hazard ratio (HR) [95% CI] = 1.418 [1.230-1.636], P  < 0.001). CONCLUSION:This is one of the largest and contemporary study assessing the impact of hypertension in STEMI patients undergoing primary angioplasty, including also the COVID-19 pandemic period. Hypertension was independently associated with significantly higher rates of in-hospital and 30-day mortality.

BACKGROUND:Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES:The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS:The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. RESULTS:A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). CONCLUSIONS:Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).

Background Acute coronary syndrome (ACS), specifically ST-segment elevation myocardial infarction is a major cause of morbidity and mortality throughout Europe. Diagnosis in the acute setting is mainly based on clinical symptoms and physician's interpretation of an electrocardiogram (ECG), which may be subject to errors. ST-segment elevation is the leading criteria to activate urgent reperfusion therapy, but a clear ST-elevation pattern might not be present in patients with coronary occlusion and ST-segment elevation might be seen in patients with normal coronary arteries. Methods The ASSIST project is a retrospective observational study aiming to improve the ECG-assisted assessment of ACS patients in the acute setting by incorporating an artificial intelligence platform, Willem™ to analyze 12‑lead ECGs. Our aim is to improve diagnostic accuracy and reduce treatment delays. ECG and clinical data collected during this study will enable the optimization and validation of Willem™. A retrospective multicenter study will collect ECG, clinical, and coronary angiography data from 10,309 patients. The primary outcome is the performance of this tool in the correct identification of acute myocardial infarction with coronary artery occlusion. Model performance will be evaluated internally with patients recruited in this retrospective study while external validation will be performed in a second stage. Conclusion ASSIST will provide key data to optimize Willem™ platform to detect myocardial infarction based on ECG-assessment alone. Our hypothesis is that such a diagnostic approach may reduce time delays, enhance diagnostic accuracy, and improve clinical outcomes.

BACKGROUND:Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. AIMS:This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. METHODS:A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. RESULTS:A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. CONCLUSION:The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

AbstractAimsIn low‐risk patients with severe aortic stenosis (AS), sutureless surgical aortic valve replacement (SU‐SAVR) may be an alternative to transcatheter aortic valve implantation (TAVI). The risk of heart failure hospitalization (HFH) after aortic valve replacement (AVR) in this population is incompletely characterized. This study aims to investigate the incidence, predictors, and outcomes of HFH in patients undergoing SU‐SAVR versus TAVI.Methods and resultsPatients referred for AVR between 2013 and 2020 at two centres were consecutively included. The decision for SU‐SAVR or TAVI was determined by a multidisciplinary Heart Team. Cox regression and competing risk analysis were conducted to assess adverse events. Of 594 patients (mean age 77.5 ± 6.4, 59.8% male), 424 underwent SU‐SAVR, while 170 underwent TAVI. Following a mean follow‐up of 34.1 ± 23.1 months, HFH occurred in 112 (27.8%) SU‐SAVR patients and in 8 (4.8%) TAVI patients (P < 0.001). The SU‐SAVR cohort exhibited higher all‐cause mortality (138 [32.5%] patients compared with 30 [17.6%] in the TAVI cohort [P < 0.001]). These differences remained significant after sensitivity analyses with 1:1 propensity score matching for baseline variables. SU‐SAVR with HFH was associated with increased all‐cause mortality (61.6% vs. 23.1%, P < 0.001). Independent associates of HFH in SU‐SAVR patients included diabetes, atrial fibrillation, chronic obstructive pulmonary disease, lower glomerular filtration rate and lower left ventricular ejection fraction. SU‐SAVR patients with HFH had a 12‐month LVEF of 59.4 ± 12.7.ConclusionsIn low‐risk AS, SU‐SAVR is associated with a higher risk of HFH and all‐cause mortality compared to TAVI. In patients with severe AS candidate to SU‐SAVR or TAVI, TAVI may be the preferred intervention.