Vaccine-carditis study: Spanish multicenter registry of inflammatory heart disease after COVID-19 vaccination.

INTRODUCTION AND OBJECTIVES: Vaccines against SARS-CoV-2 have been a major scientific and medical achievement in the control of the COVID-19 pandemic. However, very infrequent cases of inflammatory heart disease have been described as adverse events, leading to uncertainty in the scientific community and in the general population. METHODS: The Vaccine-Carditis Registry has included all cases of myocarditis and pericarditis diagnosed within 30 days after COVID-19 vaccination since August 1, 2021 in 29 centers throughout the Spanish territory. The definitions of myocarditis (probable or confirmed) and pericarditis followed the consensus of the Centers for Disease Control and the Clinical Practice Guidelines of the European Society of Cardiology. A comprehensive analysis of clinical characteristics and 3-month evolution is presented. RESULTS: From August 1, 2021, to March 10, 2022, 139 cases of myocarditis or pericarditis were recorded (81.3% male, median age 28 years). Most cases were detected in the 1st week after administration of an mRNA vaccine, the majority after the second dose. The most common presentation was mixed inflammatory disease (myocarditis and pericarditis). 11% had left ventricular systolic dysfunction, 4% had right ventricular systolic dysfunction, and 21% had pericardial effusion. In cardiac magnetic resonance studies, left ventricular inferolateral involvement was the most frequent pattern (58%). More than 90% of cases had a benign clinical course. After a 3-month follow-up, the incidence of adverse events was 12.78% (1.44% mortality). CONCLUSIONS: In our setting, inflammatory heart disease after vaccination against SARS-CoV-2 predominantly affects young men in the 1st week after the second dose of RNA-m vaccine and presents a favorable clinical course in most cases.

Validation of the TRI-SCORE in patients undergoing surgery for isolated tricuspid regurgitation.

INTRODUCTION: Estimation of peri-procedural risk in patients with tricuspid regurgitation (TR) undergoing isolated tricuspid valve surgery (ITVS) is of paramount importance. The TRI-SCORE is a new surgical risk scale specifically developed for this purpose, which ranged from 0 to 12 points and included eight parameters: right-sided heart failure signs, daily dose of furosemide ≥125 mg, glomerular filtration rate <30 mL/min, elevated bilirubin (with a value of 2 points), age ≥70 years, New York Heart Association Class III-IV, left ventricular ejection fraction <60% and moderate/severe right ventricular dysfunction (with a value of 1 point). The objective of the study was to evaluate the performance of the TRI-SCORE in an independent cohort of patients undergoing ITVS. METHODS: A retrospective observational study was performed in four centres, including consecutive adult patients undergoing ITVS for TR between 2005 and 2022. The TRI-SCORE and the traditional risk scores used in cardiac surgery (Logistic EuroScore (Log-ES) and EuroScore-II (ES-II)) were applied for each patient, and discrimination and calibration of the three scores were evaluated in the entire cohort. RESULTS: A total of 252 patients were included. The mean age was 61.5±11.2 years, 164 (65.1%) patients were female, and TR mechanism was functional in 160 (63.5%) patients. The observed in-hospital mortality was 10.3%. The estimated mortality by the Log-ES, ES-II and TRI-SCORE was 8.7±7.3%, 4.7±5.3% and 11.0±16.6%, respectively. Patients with a TRI-SCORE ≤4 and >4 had an in-hospital mortality of 1.3% and 25.0%, p=0.001, respectively. The discriminatory capacity of the TRI-SCORE had a C-statistic of 0.87 (0.81-0.92), which was significantly higher than both the Log-ES (0.65 (0.54-0.75)) and ES-II (0.67 (0.58-0.79)), p=0.001 (for both comparisons). CONCLUSION: This external validation of the TRI-SCORE demonstrated good performance to predict in-hospital mortality in patients undergoing ITVS, which was significantly better than the Log-ES and ES-II, which underestimated the observed mortality. These results support the widespread use of this score as a clinical tool.

Comprehensive Assessment of Myocardial Ischemia Mechanisms in the Catheterization Laboratory: Design and Rationale of the Advanced Invasive Diagnosis Strategy for Patients with Stable Coronary Syndromes Undergoing Coronary ANGIOgraphy - the AID-ANGIO Study.

BACKGROUND: The diagnostic yield of invasive coronary angiography (ICA) to identify obstructive coronary artery disease in the context of chronic coronary syndromes (CCS) is very low. Furthermore, myocardial ischemia may have a non-obstructive origin, which cannot be detected by ICA. METHODS: AID-ANGIO is an observational, prospective, single-cohort, multicenter study, intended to evaluate the diagnostic yield of adopting a hierarchical strategy to assess obstructive and non-obstructive causes of myocardial ischemia in an all-comers population of patients with CCS at the time of ICA. The primary endpoint will investigate the additional diagnostic value of such strategy over angiography alone regarding the identification of ischemia-generating mechanisms. SUMMARY: An estimated sample of consecutive 260 patients with CCS referred by their clinicians to ICA, will be enrolled. In a stepwise manner, a conventional ICA will be performed as the initial diagnostic tool. Those patients with severe-grade stenosis will not undergo further assessment and an obstructive origin for myocardial ischemia will be assumed. Subsequently, the remainder with intermediate-grade stenosis will be assessed with pressure guidewires. Those with a negative result from physiological evaluation and those without epicardial coronary stenosis will be further studied for ischemia of non-obstructive origin, including microvascular dysfunction and vasomotor disorders. The study will be conducted in two steps. Firstly, ICA images will be displayed to patient's referring clinicians, who will be asked to identify the existent epicardial stenosis, their angiographic severity and probable physiological relevance, together with a tentative therapeutic approach. Then, the diagnostic algorithm will continue to be applied and, considering the whole gathered information, a definite therapeutic plan will be consensually established by the interventional cardiologist and patient's referring clinicians. CONCLUSION: The AID-ANGIO study will assess the additional diagnostic yield of a hierarchical strategy over ICA alone to identify ischemia-generating mechanisms in patients with CCS and its impact on therapeutic approach. Positive results of the study might support a streamlined invasive diagnostic process for patients with CCS.

Effects of intravenous lysine acetylsalicylate versus oral aspirin on platelet responsiveness in patients with ST-segment elevation myocardial infarction: the ECCLIPSE-STEMI trial.

Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. However, evidence is lacked about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to oral aspirin. Recently, we demonstrated in healthy volunteers that the administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin. Loading dose of LA achieves platelet inhibition faster, and with less variability than aspirin. However, there are no data of this issue in patients with an ST-segment elevation myocardial infarction (STEMI). This is a prospective, randomized, multicenter, open platelet function study conducted in STEMI patients. Subjects were randomly assigned to receive a loading dose (LD) of intravenous LA 450 mg plus oral ticagrelor 180 mg, or LD of aspirin 300 mg plus ticagrelor 180 mg orally. Platelet function was evaluated at baseline, 30 min, 1 h, 4 h and 24 h using multiple electrode aggregometry and vasodilator-stimulated phosphoprotein phosphorylation (VASP). The primary endpoint of the study is the inhibition of platelet aggregation (IPA) after arachidonic acid (AA) 0.5 mM at 30 min. Secondary endpoints were the IPA at 1, 4, and 24 h after AA, and non-AA pathways through the sequence (ADP and TRAP). A total of 32 STEMI patients were randomized (16 LA, 16 aspirin). The inhibition of platelet aggregation after AA 0.5 mM at 30 min was greater in subjects treated with LA compared with aspirin: 166 vs. 412 respectively (p = 0.001). This differential effect was observed at 1 h (p = 0.01), but not at 4 and 24 h. Subjects treated with LA presented less variability and faster inhibition of platelet aggregation wit AA compared with aspirin. The administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin on ticagrelor inhibited platelets in patients with STEMI. Loading dose of LA achieves an earlier platelet inhibition, and with less variability than aspirin.Trial Registration: Unique identifier: NCT02929888; URL: http://www.clinicaltrials.gov.

Post-infarct mitral insufficiency: when to resort to reparative surgery, when to the mitral clip.

Severe mitral insufficiency is a feared complication that develops in 10-12% of patients with myocardial infarction and ST elevation. It results from the rupture of the papillary muscle or is secondary to an acute remodelling of the left ventricle in its entirety or of the infarcted region. The mortality of patients with acute clinical onset reaches 50%. The ideal treatment of acute mitral insufficiency is controversial and still a source of debate. Most of these patients are at high surgical risk or inoperable; therefore, they are treated conservatively and have a poor prognosis. In these candidates, percutaneous treatment of insufficiency with percutaneous edge to edge can be considered an alternative.

Mitral and tricuspid valve disease: diagnosis and management. Consensus document of the Section on Valvular Heart Disease and the Cardiovascular Imaging, Clinical Cardiology, and Interventional Cardiology Associations of the Spanish Society of Cardiology.

The diagnosis and management of mitral and tricuspid valve disease have undergone major changes in the last few years. The expansion of transcatheter interventions and widespread use of new imaging techniques have altered the recommendations for the diagnosis and treatment of these diseases. Because of the exponential growth in the number of publications and clinical trials in this field, there is a strong need for continuous updating of local protocols. The recently published 2021 European Society of Cardiology guidelines for the management of valvular heart disease did not include some of the new data on these new therapies and, moreover, the number of mitral and tricuspid interventions varies widely across Europe. Therefore, all this information must be summarized to facilitate its use in each specific country. Consequently, we present the consensus document of the Section on Valvular Disease, Cardiovascular Imaging, Clinical Cardiology, and Interventional Cardiology Associations of the Spanish Society of Cardiology for the diagnosis and management of mitral and tricuspid valve disease.

Influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con reestenosis en el stent / Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis

Introducción y objetivos La neoateroesclerosis es una de las causas de la reestenosis en el stent (RS). Nuestro objetivo es evaluar la influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con RS. Métodos Se trata de un análisis conjunto de los subestudios de tomografía de coherencia óptica (OCT) de los RIBS IV y V, 2 ensayos clínicos aleatorizados y multicéntricos que comparan el tratamiento con un balón recubierto con paclitaxel frente al stent liberador de everolimus en pacientes con RS. La evaluación con OCT se realizó basalmente y a los 6-9 meses. La neoateroesclerosis se definió en la OCT basal como una neoíntima con contenido calcificado o lipídico. Se evaluaron los resultados angiográficos y por OCT a los 6-9 meses y la aparición de eventos adversos cardiovasculares mayores a los 3 años de seguimiento en pacientes con y sin neoateroesclerosis tratados con balón recubierto con paclitaxel o stent liberador de everolimus. Resultados Se estudió mediante OCT a 64 pacientes en el momento del procedimiento. Se documentó neoateroesclerosis en 23 lesiones (36%). El seguimiento angiográfico a los 6-9 meses no mostró diferencias entre los pacientes con y sin neoateroesclerosis en reestenosis (5 [24%] frente a 6 [15%]; p=0,49), diámetro luminal mínimo (1,79±0,7 frente a 1,94±0,6 mm; p=0,41) o pérdida tardía (0,33±0,7 frente a 0,15±0,5; p=0,34). El seguimiento con OCT confirmó la ausencia de diferencias en los parámetros cuantitativos y las características del tejido de recubrimiento entre los 2 grupos. A los 3 años de seguimiento, la incidencia de eventos fue de 3 (13%) frente a 5 (12%) en los grupos con y sin neoateroesclerosis respectivamente (HR=0,94; IC95%, 0,22-3,93; p=0,93). Conclusiones En este estudio con una pequeña muestra de pacientes aleatorizados a tratamiento con balón recubierto con paclitaxel o stent liberador de everolimus por RS, ... (AU)

Introduction and objectives Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. Methods This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. Results Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). Conclusions In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR. (AU)

The SADDEN DEATH Study: Results from a Pilot Study in Non-ICU COVID-19 Spanish Patients.

Introduction: The worldwide pandemic, coronavirus disease 2019 (COVID-19) is a novel infection with serious clinical manifestations, including death. Our aim is to describe the first non-ICU Spanish deceased series with COVID-19, comparing specifically between unexpected and expected deaths. Methods: In this single-centre study, all deceased inpatients with laboratory-confirmed COVID-19 who had died from March 4 to April 16, 2020 were consecutively included. Demographic, clinical, treatment, and laboratory data, were analyzed and compared between groups. Factors associated with unexpected death were identified by multivariable logistic regression methods. Results: In total, 324 deceased patients were included. Median age was 82 years (IQR 76-87); 55.9% males. The most common cardiovascular risk factors were hypertension (78.4%), hyperlipidemia (57.7%), and diabetes (34.3%). Other common comorbidities were chronic kidney disease (40.1%), chronic pulmonary disease (30.3%), active cancer (13%), and immunosuppression (13%). The Confusion, BUN, Respiratory Rate, Systolic BP and age ≥65 (CURB-65) score at admission was >2 in 40.7% of patients. During hospitalization, 77.8% of patients received antivirals, 43.3% systemic corticosteroids, and 22.2% full anticoagulation. The rate of bacterial co-infection was 5.5%, and 105 (32.4%) patients had an increased level of troponin I. The median time from initiation of therapy to death was 5 days (IQR 3.0-8.0). In 45 patients (13.9%), the death was exclusively attributed to COVID-19, and in 254 patients (78.4%), both COVID-19 and the clinical status before admission contributed to death. Progressive respiratory failure was the most frequent cause of death (92.0%). Twenty-five patients (7.7%) had an unexpected death. Factors independently associated with unexpected death were male sex, chronic kidney disease, insulin-treated diabetes, and functional independence. Conclusions: This case series provides in-depth characterization of hospitalized non-ICU COVID-19 patients who died in Madrid. Male sex, insulin-treated diabetes, chronic kidney disease, and independency for activities of daily living are predictors of unexpected death.

Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis.

INTRODUCTION AND OBJECTIVES: Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. METHODS: This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. RESULTS: Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). CONCLUSIONS: In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR.

Onda de lesión subepicárdica sin lesión coronaria obstructiva / Subepicardial ischemia without obstructive coronary disease

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Disfunción sinusal secundaria a intoxicación por carbamazepina / Sinus dysfunction due to carbamazepine intoxication

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Respuesta al ECG de abril de 2019 / Response to ECG, April 2019

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ECG de abril de 2019 / ECG, April 2019

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Sex differences in treatment and prognosis of acute coronary syndrome with interventional management.

OBJECTIVE: Female sex has been associated with differences in diagnostic and management of acute coronary syndrome (ACS). Our aim was to analyze sex differences in ACS with interventional management in a tertiary care hospital. METHODS: Patients with ACS admitted to a Spanish tertiary care referral center were included prospectively and consecutively. All patients included in the study underwent a coronary angiography. RESULTS: From the total cohort of 1214 patients, 290 (24%) were women. Women were older (71 ±â€¯12.8 vs 64 ±â€¯13.4 years, p < 0.001) and showed lower ischemic risk and higher hemorrhagic risk scores (GRACE 159 ±â€¯45 vs 171 ±â€¯42, p = 0.005; CRUSADE 41 ±â€¯19 vs 28 ±â€¯17, p < 0.001). There were no significant differences in time to coronary angiography and revascularization rates between sex groups. A lower proportion of women received high-potency antiplatelet agents (29% vs 41.3%, p = 0.004). In-hospital evolution and one-year mortality were similar between groups. CONCLUSIONS: In our population, there were no gender differences in management and prognosis of ACS. Differences in risk profile among groups could have an influence on antiplatelet therapy.