Ongoing large randomized clinical trials on complex percutaneous coronary interventions:Intravascular imaging-guided trials

.tabletop{ vertical-align: top; } ABSTRACT Percutaneous coronary intervention of complex coronary artery disease remains challenging and is still associated with suboptimal cardiovascular outcomes. Over the years, different strategies and technologies have been developed to improve these results. Particularly, the development and evolution of intravascular imaging modalities to guide the procedure have improved lesion assessment and preparation, and stent optimization. However, whether these advantages are beneficial in this particular setting is still under discussion. In this article we intend to briefly summarize previous imaging-guided trials and give an outline on the ongoing large trials that are being conducted on imaging-guided interventions in complex coronary disease

Oropharyngeal Colostrum Positively Modulates the Inflammatory Response in Preterm Neonates

During the first days of life, premature infants have physiological difficulties swallowing, thereby missing out on the benefits of breastfeeding. The aim of this study is to assess the effects of oropharyngeal mother’s milk administration in the inflammatory signaling of extremely premature infants. Neonates (n = 100) (<32 week’s gestation and/or <1500 g) were divided into two groups: mother’s milk group (n = 48), receiving 0.2 mL of oropharyngeal mother’s milk every 4 h for the first 15 days of life, and a control group (n = 52), not receiving oropharyngeal mother’s milk. Serum concentrations of interleukin (IL) IL-6, IL-8, IL-10, IL-1ra, tumor necrosis factor alpha (TNF-a), and interferón gamma (IFN- y) were assessed at 1, 3, 15, and 30 days of postnatal life. Maternal and neonatal outcomes were collected. The rate of common neonatal morbidities in both groups was similar. The mother’s milk group achieved full enteral feeding earlier, and showed a decrease in Il-6 on days 15 and 30, in IL-8 on day 30, and in TNF-a and INF- y on day 15, as well as an increase in IL-1ra on days 3 and 15 and in IL-10 on day 30. Oropharyngeal mother’s milk administration for 15 days decreases the pro-inflammatory state of preterm neonates and provides full enteral nutrition earlier, which could have a positive influence on the development of the immune system and inflammatory response, thereby positively influencing other developmental outcomes

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF \u3c 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded

Coronary microvascular dysfunction in takotsubo syndrome assessed by angiography-derived index of microcirculatory resistance: a pressure-wire-free tool

Background: Coronary microvascular dysfunction (CMD) has been proposed as a key mechanism in Takotsubo syndrome (TTS). The non-hyperaemic angiography-derived index of microcirculatory resistance (NH-IMRangio) has been validated as a pressure-wire-free tool for the assessment of coronary microvasculature. We aimed to study the presence of CMD in TTS patients and its association with levels of cardiac biomarkers and systolic dysfunction patterns. Methods: We recruited 181 consecutive patients admitted for TTS who underwent cardiac angiography at a tertiary center from January 2014 to January 2021. CMD was defined as an NH-IMRangio ≥ 25. Plasma levels of NT-proBNP, high-sensitive cardiac troponin T (hs-cTnT) and the left ventricular ejection fraction (LVEF) by echocardiography were measured at admission. Results: Mean age was 75.3 years, 83% were women and median LVEF was 45%. All patients presented CMD (NH-IMRangio ≥ 25) in at least one epicardial coronary artery. The left anterior descending artery (LAD) showed higher median NH-IMRangio values than left circumflex (LCx) and right coronary arteries (RCA) (44.6 vs. 31.3 vs. 36.1, respectively; p < 0.001). NH-IMRangio values differed among ventricular contractility patterns in the LAD and RCA (p = 0.0152 and 0.0189, respectively) with the highest values in the mid-ventricular + apical and mid-ventricular + basal patterns. NT-proBNP levels, but not high-sensitive cardiac troponin T (hs-cTnT), were correlated with both the degree and the extent of CMD in patients with TTS. Lower LVEF was also associated with higher NH-IMRangio values. Conclusions: CMD is highly prevalent in patients admitted for TTS and is associated with both a higher degree of systolic dysfunction and higher BNP levels, but not troponin

Prevalencia e implicaciones pronósticas de los trastornos del sueño en la insuficiencia cardíaca crónica

Objetivos: Evaluar la prevalencia e implicaciones pronosticas de los trastornos del sueño en pacientes con insuficiencia cardíaca crónica atendidos en una unidad de Insuficiencia Cardiaca hospitalaria. Métodos: Se realizó un estudio observacional, descriptivo y prospectivo. Ámbito: Unidad de Insuficiencia Cardíaca del Hospital de la Santa Creu i Sant Pau. Participantes: Pacientes atendidos por primera vez en la Unidad entre abril del 2014 y noviembre del 2014. Variables: Se realizó una evaluación de los trastornos del sueño mediante el cuestionario 'Insomnia Severity Index ' (8,9) modificado. Se obtuvieron datos sociodemográficos, clínicos y farmacológicos de la historia clínica del paciente. Se evaluó la aparición de eventos adversos en el seguimiento ( hospitalización por insuficiencia cardíaca y/o muerte de causa cardiovascular). Análisis: Las variables cualitativas se describieron en forma de porcentajes y las cuantitativas en forma de media y desviaciones estándares. Resultados: La muestra total fue de 68 pacientes con una media de edad de 68 ± 12 años; un 59% de los pacientes fueron varones. La etiología de la Insuficiencia Cardiaca fue en un 37% de causa no isquémica, en un 40% de causa isquémica, en el 10% valvular y en un 13% de otras etiologías. Los trastornos del sueño estaban presentes en el 48.5% del total de la muestra (33 pacientes). Los pacientes con trastornos del sueño presentaron mayor incidencia de efectos adversos cardiovasculares en el seguimiento (21% vs 0%; p< 0.05). Conclusiones: La prevalencia de los trastornos del sueño es alta en pacientes con insuficiencia cardiaca y se asocia a un peor pronóstico clínico

Prevalencia e implicaciones pronósticas de los trastornos del sueño en la insuficiencia cardíaca crónica

Objetivos: Evaluar la prevalencia e implicaciones pronosticas de los trastornos del sueño en pacientes con insuficiencia cardíaca crónica atendidos en una unidad de Insuficiencia Cardiaca hospitalaria. Métodos: Se realizó un estudio observacional, descriptivo y prospectivo. Ámbito: Unidad de Insuficiencia Cardíaca del Hospital de la Santa Creu i Sant Pau. Participantes: Pacientes atendidos por primera vez en la Unidad entre abril del 2014 y noviembre del 2014. Variables: Se realizó una evaluación de los trastornos del sueño mediante el cuestionario 'Insomnia Severity Index ' (8,9) modificado. Se obtuvieron datos sociodemográficos, clínicos y farmacológicos de la historia clínica del paciente. Se evaluó la aparición de eventos adversos en el seguimiento ( hospitalización por insuficiencia cardíaca y/o muerte de causa cardiovascular). Análisis: Las variables cualitativas se describieron en forma de porcentajes y las cuantitativas en forma de media y desviaciones estándares. Resultados: La muestra total fue de 68 pacientes con una media de edad de 68 ± 12 años; un 59% de los pacientes fueron varones. La etiología de la Insuficiencia Cardiaca fue en un 37% de causa no isquémica, en un 40% de causa isquémica, en el 10% valvular y en un 13% de otras etiologías. Los trastornos del sueño estaban presentes en el 48.5% del total de la muestra (33 pacientes). Los pacientes con trastornos del sueño presentaron mayor incidencia de efectos adversos cardiovasculares en el seguimiento (21% vs 0%; p< 0.05). Conclusiones: La prevalencia de los trastornos del sueño es alta en pacientes con insuficiencia cardiaca y se asocia a un peor pronóstico clínico

Impact of Baseline Anemia in Patients Undergoing Transcatheter Aortic Valve Replacement: A Prognostic Systematic Review and Meta-Analysis

Transcatheter aortic valve replacement (TAVR) is currently the treatment of choice for patients aged ≥75 years with severe aortic stenosis. Preoperative anemia is present in a large proportion of patients and may increase the risk of post-procedural complications. The purpose of this prognostic systematic review was to analyze the impact of baseline anemia on short- and mid-term outcomes following TAVR. A computerized search was performed on PubMed and Web of Science databases for studies published between January 2013 and December 2022. Primary outcomes were 30-day need for transfusion, acute renal failure, 30-day and mid-term mortality, and readmission during the first year post-TAVR. Data were analyzed via random effects model using inverse variance method with 95% confidence intervals. Eleven observational studies met our eligibility criteria and included a total of 12,588 patients. The prevalence of baseline anemia ranged between 39% and 72%, with no relevant sex differences. Patients with preprocedural anemia received more blood transfusions [OR: 2.95 (2.13–4.09)]), and exhibited increased rates of acute kidney injury [OR:1.74 (1.45–2.10)], short-term mortality [OR: 1.47 (1.07–2.01], and mid-term [OR: 1.89 (1.58–2.25)] mortality following TAVR compared with those without anemia. Baseline anemia determined an increased risk for blood transfusion, acute kidney injury, and short/mid-term mortality among TAVR recipients

Human vs. machine vs. core lab for the assessment of coronary atherosclerosis with lumen and vessel contour segmentation with intravascular ultrasound

A machine learning (ML) algorithm for automatic segmentation of intravascular ultrasound was previously validated. It has the potential to improve efficiency, accuracy and precision of coronary vessel segmentation compared to manual segmentation by interventional cardiology experts. The aim of this study is to compare the performance of human readers to the machine and against the readings from a Core Laboratory. This is a post-hoc, cross-sectional analysis of the IBIS-4 study. Forty frames were randomly selected and analyzed by 10 readers of varying expertise two separate times, 1 week apart. Their measurements of lumen, vessel, plaque areas, and plaque burden were performed in an offline software. Among humans, the intra-observer variability was not statistically significant. For the total 80 frames, inter-observer variability between human readers, the ML algorithm and Core Laboratory for lumen area, vessel area, plaque area and plaque burden were not statistically different. For lumen area, however, relative differences between the human readers and the Core Lab ranged from 0.26 to 12.61%. For vessel area, they ranged from 1.25 to 9.54%. Efficiency between the ML algorithm and the readers differed notably. Humans spent 47 min on average to complete the analyses, while the ML algorithm took on average less than 1 min. The overall lumen, vessel and plaque means analyzed by humans and the proposed ML algorithm are similar to those of the Core Lab. Machines, however, are more time efficient. It is warranted to consider use of the ML algorithm in clinical practice.Fil: Bass, Ronald D.. University Of Georgetown; Estados UnidosFil: Garcia Garcia, Hector M.. MedStar Washington Hospital Center; Estados UnidosFil: Sanz Sánchez, Jorge. Hospital Universitari i Politecnic La Fe; España. Centro de Investigación en Red en Bioingeniería; EspañaFil: Ziemer, Paulo G. P.. National Laboratory for Scientific Computing; BrasilFil: Bulant, Carlos Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tandil; ArgentinaFil: Kuku, Kayode K.. MedStar Washington Hospital Center; Estados UnidosFil: Kahsay, Yirga A.. MedStar Washington Hospital Center; Estados UnidosFil: Beyene, Solomon. MedStar Washington Hospital Center; Estados UnidosFil: Melaku, Gebremedhin. MedStar Washington Hospital Center; Estados UnidosFil: Otsuka, Tatsuhiko. University of Bern; SuizaFil: Choi, JooHee. University Of Georgetown; Estados UnidosFil: Fernández Peregrina, Estefanía. MedStar Washington Hospital Center; Estados UnidosFil: Erdogan, Emrah. Barts Health NHS Trust; Reino UnidoFil: Gonzalo, Nieves. Hospital Universitario Clínico San Carlos; EspañaFil: Bourantas, Christos V.. Barts Health NHS Trust; Reino Unido. Queen Mary University of London; Reino UnidoFil: Blanco, Pablo Javier. National Laboratory for Scientific Computing; BrasilFil: Räber, Lorenz. University of Bern; Suiz

Use of MitraClip for mitral valve repair in patients with acute mitral regurgitation following acute myocardial infarction: Effect of cardiogenic shock on outcomes (IREMMI Registry)

Objectives To assess outcomes in patients with acute mitral regurgitation (MR) following acute myocardial infarction (AMI) who received percutaneous mitral valve repair (PMVR) with the MitraClip device and to compare outcomes of patients who developed cardiogenic shock (CS) to those who did not (non-CS).Background Acute MR after AMI may lead to CS and is associated with high mortality.Methods This registry analyzed patients with MR after AMI who were treated with MitraClip at 18 centers within eight countries between January 2016 and February 2020. Patients were stratified into CS and non-CS groups. Primary outcomes were mortality and rehospitalization due to heart failure. Secondary outcomes were acute procedural success, functional improvement, and MR reduction. Multivariable Cox regression analysis evaluated association of CS with clinical outcomes.Results Among 93 patients analyzed (age 70.3 +/- 10.2 years), 50 patients (53.8%) experienced CS before PMVR. Mortality at 30 days (10% CS vs. 2.3% non-CS; p = .212) did not differ between groups. After median follow-up of 7 months (IQR 2.5-17 months), the combined event mortality/re-hospitalization was similar (28% CS vs. 25.6% non-CS; p = .793). Likewise, immediate procedural success (90% CS vs. 93% non-CS; p = .793) and need for reintervention (CS 6% vs. non-CS 2.3%, p = .621) or re-admission due to HF (CS 13% vs. NCS 23%, p = .253) at 3 months did not differ. CS was not independently associated with the combined end-point (hazard ratio 1.1; 95% CI, 0.3-4.6; p = .889).Conclusions Patients found to have significant MR during their index hospitalization for AMI had similar clinical outcomes with PMVR whether they presented in or out of cardiogenic shock, provided initial hemodynamic stabilization was first achieved before PMVR

Prognostic Role of TAPSE to PASP Ratio in Patients Undergoing MitraClip Procedure.

Transcatheter mitral valve repair (TMVR) is an effective therapy for high-risk patients with severe mitral regurgitation (MR) but heart failure (HF) readmissions and death remain substantial on mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in HF. In this study, we aimed to assess the prognostic value of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) ratio as a non-invasive measure of RV-to-PA coupling in patients undergoing TMVR with MitraClip (Abbott, CA, USA). Multicentre registry including 228 consecutive patients that underwent successful TMVR with MitraClip. The sample was divided in two groups according to TAPSE/PASP median value: 0.35. The primary combined endpoint encompassed HF readmissions and all-cause mortality. Mean age was 72.5 ± 11.5 years and 154 (67.5%) patients were male. HF readmissions and all-cause mortality were more frequent in patients with TAPSE/PASP ≤ 0.35: Log-Rank 8.844, p = 0.003. On Cox regression, TAPSE/PASP emerged as a prognostic predictor of the primary combined endpoint, together with STS-Score. TAPSE/PASP was a better prognostic predictor than either TAPSE or PASP separately. TAPSE/PASP ratio appears as a novel prognostic predictor in patients undergoing MitraClip implantation that might improve risk stratification and candidate selection