Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors.

BACKGROUND: Bleeding is one of the most frequent complications in patients undergoing transcatheter aortic valve replacement (TAVR). Importantly, major bleeding is associated with poor clinical outcomes after TAVR. However, large studies on bleeding complications in the contemporary TAVR population are limited. OBJECTIVES: The aim of this study was to assess the incidence, temporal trends, clinical outcomes, and predictors of bleeding in patients undergoing transfemoral TAVR. METHODS: The CENTER2 study is a pooled patient-level database from 10 clinical studies including patients who underwent TAVR between 2007 and 2022. RESULTS: A total of 23,562 patients underwent transfemoral TAVR. The mean age was 81.5 ± 6.7 years, and 56% were women. Major bleeding within the first 30 days was observed in 1,545 patients (6.6%). Minor bleeding was reported in 1,143 patients (4.7%). Rates of major bleeding decreased from 11.5% in 2007-2010 to 5.5% in 2019-2022 (Ptrend < 0.001). Dual antiplatelet therapy was associated with higher major bleeding rates compared with single antiplatelet therapy (12.2% vs 9.1%; OR: 1.40; 95% CI: 1.13-1.72; P = 0.002). Patients with major bleeding had increased mortality risk during the first 30 days (14.1% vs 4.3%; OR: 3.66; 95% CI: 3.11-4.31; P < 0.001) and during 1-year follow-up (27.8% vs 14.5%; HR: 1.50; 95% CI: 1.41-1.59; P < 0.001). Minor bleeding did not affect 1-year mortality risk (16.7% vs 14.5%; HR: 1.11; 95% CI: 0.93-1.32; P = 0.27). Predictors of major bleeding were female sex and peripheral vascular disease. CONCLUSIONS: Bleeding complications remain frequent and important in patients undergoing transfemoral TAVR. Increased mortality risk in major bleeding persists after the initial 30 days. (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves [CENTER]; NCT03588247).

Impacto del COVID-19 en pacientes con estenosis aórtica severa: análisis basado en inteligencia artificial / The impact of COVID-19 in patients with severe aortic stenosis: Artificial intelligence research

Introducción: La estenosis aórtica severa es una enfermedad mortal en caso de no ser intervenida. Este estudio pretende conocer el impacto de la pandemia por COVID-19 en la mortalidad de pacientes con estenosis severa durante la primera ola y compararlo con el mismo período del año anterior. Métodos: Se analizaron mediante software basado en inteligencia artificial todos los pacientes que acudieron al hospital en una región española durante la primera ola y en el año anterior, evaluándose la mortalidad comparada entre pacientes con estenosis aórtica severa con y sin COVID-19 durante la pandemia y la era pre-COVID. Se comparó la mortalidad en tres grupos diferentes. En cuanto al número de cirugías cardiacas, se observó una tendencia a la baja en los pacientes sin COVID-19 con respecto al mismo período del año anterior (p = 0,07), y un descenso significativo entre pacientes COVID-19 positivo y COVID-19 negativo. Resultados: Durante la primera ola, acudieron un 13,82% menos de pacientes. Un total de 1.112 tenían estenosis aórtica, de los cuales un 5,48% fueron COVID-19 positivo. La mortalidad fue mayor (p=0,01) en COVID-19 negativo durante la pandemia (4,37%) frente a los de la era pre-COVID-19 (2,57%); también lo fue en el grupo COVID-19 positivo (11,47%) frente a los COVID-19 negativo (4,37%) durante la primera ola (p=0,01). Se observó una tendencia a la disminución de cirugías (p=0,07) en los pacientes COVID-19 negativo durante la pandemia y disminuyeron significativamente en pacientes COVID-19 positivo, frente a los COVID-19 negativo (p=0,04). Conclusiones: El estudio reveló una disminución de los pacientes que acudieron al hospital y un exceso de mortalidad en pacientes con estenosis aórtica severa sin la infección durante la primera ola, frente al mismo período del año anterior; y también, en los pacientes COVID-19 positivo, frente a los COVID-19 negativo. (AU)

Introduction: Untreated, severe, symptomatic aortic stenosis is associated with an ominous diagnosis without intervention. This study aims to determine the impact of the COVID-19 pandemic on the mortality of patients with severe stenosis during the first wave and compare it with the same period last year. Methods: All patients who went to the hospitals in an Spanish region during the first wave, and in the same period of previous year, were analyzed using artificial intelligence-based software, evaluating the mortality of patients with severe aortic stenosis with and without COVID-19 during the pandemic and the pre-COVID era. Mortality of the 3 groups was compared. Regarding cardiac surgeries was a tendency to decrease (P=.07) in patients without COVID-19 between the pandemic and the previous period was observed. A significant decrease of surgeries between patients with COVID-19 and without COVID-19 was shown. Results: Data showed 13.82% less admitted patients during the first wave. A total of 1,112 of them had aortic stenosis and 5.48% were COVID-19 positive. Mortality was higher (P=.01), in COVID-19 negative during the pandemic (4.37%) versus those in the pre-COVID-19 era (2.57%); it was also in the COVID-19 positive group (11.47%), versus COVID-19 negative (4.37%) during the first wave (P=.01). Conclusions: The study revealed a decrease in patients who went to the hospital and an excess of mortality in patients with severe aortic stenosis without infection during the first wave, compared to the same period last year; and also, in COVID-19 positive patients versus COVID-19 negative. (AU)

The impact of COVID-19 in patients with severe aortic stenosis: Artificial intelligence research.

INTRODUCTION: Untreated, severe, symptomatic aortic stenosis is associated with an ominous diagnosis without intervention. This study aims to determine the impact of the COVID-19 pandemic on the mortality of patients with severe stenosis during the first wave and compare it with the same period last year. METHODS: All patients who went to the hospitals in a spanish region during the first wave, and in the same period of previous year, were analysed using Artificial Intelligence-based software, evaluating the mortality of patients with severe aortic stenosis with and without COVID-19 during the pandemic and the pre-COVID era. Mortality of the three groups were compared. Regarding cardiac surgeries was a tendency to decrease (p = .07) in patients without COVID-19 between the pandemic and the previous period was observed. A significant decrease of surgeries between patients with COVID-19 and without COVID-19 was shown. RESULTS: Data showed 13.82% less admitted patients during the first wave. 1112 of them, had aortic stenosis and 5.48% were COVID-19 positive. Mortality was higher (p = .01), in COVID-19 negative during the pandemic (4.37%) versus those in the pre-COVID19 era (2.57%); it was also in the COVID-19 positive group (11.47%), versus covid-19 negative (4.37%) during the first wave (p = .01). CONCLUSIONS: The study revealed a decrease in patients who went to the hospital and an excess of mortality in patients with severe AD without infection during the first wave, compared to the same period last year; and also, in COVID-19 positive patients versus COVID-19 negative.

[The impact of COVID-19 in patients with severe aortic stenosis: Artificial intelligence research]. / Impacto del COVID-19 en pacientes con estenosis aórtica severa: análisis basado en inteligencia artificial.

Introduction: Untreated, severe, symptomatic aortic stenosis is associated with an ominous diagnosis without intervention. This study aims to determine the impact of the COVID-19 pandemic on the mortality of patients with severe stenosis during the first wave and compare it with the same period last year. Methods: All patients who went to the hospitals in an Spanish region during the first wave, and in the same period of previous year, were analyzed using artificial intelligence-based software, evaluating the mortality of patients with severe aortic stenosis with and without COVID-19 during the pandemic and the pre-COVID era. Mortality of the 3 groups was compared. Regarding cardiac surgeries was a tendency to decrease (P = .07) in patients without COVID-19 between the pandemic and the previous period was observed. A significant decrease of surgeries between patients with COVID-19 and without COVID-19 was shown. Results: Data showed 13.82% less admitted patients during the first wave. A total of 1,112 of them had aortic stenosis and 5.48% were COVID-19 positive. Mortality was higher (P = .01), in COVID-19 negative during the pandemic (4.37%) versus those in the pre-COVID-19 era (2.57%); it was also in the COVID-19 positive group (11.47%), versus COVID-19 negative (4.37%) during the first wave (P = .01). Conclusions: The study revealed a decrease in patients who went to the hospital and an excess of mortality in patients with severe aortic stenosis without infection during the first wave, compared to the same period last year; and also, in COVID-19 positive patients versus COVID-19 negative.

Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra-annular device. The Spanish Allegra valve-in-valve (SAVIV) registry.

OBJECTIVES: The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device. BACKGROUND: Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. METHODS: All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1). RESULTS: After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. CONCLUSIONS: The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.

Modelo de intervención coronaria percutánea primaria en la Comunidad de Castilla-La Mancha / The primary percutaneous coronary intervention program in Castile-La Mancha

La cardiopatía isquémica, y en particular el infarto agudo de miocardio, es la primera causa de muerte en nuestro país y supera a las enfermedades tumorales. La intervención coronaria percutánea primaria, cuando está disponible, es el tratamiento de elección para los pacientes con infarto agudo de miocardio de menos de 12 h de evolución. La universalización del tratamiento de revascularización percutánea a todos los pacientes con infarto de miocardio implica la creación de redes bien organizadas. La participación de los profesionales y su coordinación con los responsables sanitarios locales es imprescindible. En este artículo se describe el protocolo del Código de Reperfusión en Castilla-La Mancha (CORECAM), que resume la iniciativa de Castilla-La Mancha para el abordaje de los pacientes con infarto agudo de miocardio (AU)

Coronary heart disease, and acute myocardial infarction in particular, is the primary cause of death in Spain, resulting in more deaths than cancer. Where available, primary percutaneous coronary intervention is the treatment of choice in the first 12 hours after an acute myocardial infarction. The universalization of percutaneous revascularization to all patients with myocardial infarctions necessitates the creation of well-organized networks. The participation of health-care professionals and coordination with local health-care authorities are essential. This article describes the CORECAM protocol of the primary percutaneous coronary intervention program in Castile-La Mancha, Spain, thereby providing a summary of the treatment initiative for patients with acute myocardial infarction (AU)

Clinical outcomes of dexamethasone-eluting stent implantation in ST-elevation acute myocardial infarction.

OBJECTIVES: The aim of our study was to evaluate the safety and midterm clinical results of dexamethasone-eluting stent (DexES) implantation in ST-segment elevation acute myocardial infarction (STEMI). BACKGROUND: Inflammation plays a pivotal role in both inestabilization of coronary atherosclerotic plaques and development of restenosis after stent placement. Antiinflammatory agents may attenuate those mechanisms and improve clinical outcomes. There is little information about clinical results of DexES and no data are available about their utilization during percutaneous coronary intervention (PCI) in STEMI. METHODS: Consecutive patients with STEMI that underwent primary or rescue PCI in our institution were treated with DexES. Clinical follow-up with routine realization of noninvasive test for detection of myocardial ischemia and coronariography if necessary, were performed. The objective of the study was to evaluate the rate of MACE (death, reinfarction, or target lesion revascularization) during midterm follow-up. RESULTS: The procedure was successful in 96.7% of cases. There were no in-hospital deaths or reinfarctions. One acute stent thrombosis occurred and no subacute thrombosis were observed. During a mean follow-up period of 384 days, cardiac-related death was 1.1%, there were no reinfarctions or late stent thrombosis and target lesion revascularization rate was 4.2%. CONCLUSION: We conclude that utilization of DexES for PCI in STEMI is safe and provides good midterm clinical outcomes.