Tricuspid regurgitation is a prevalent disease associated with high morbidity and mortality, with few treatment options. The aim of the TRILUMINATE trial is to evaluate the safety and effectiveness ...of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation.
The TRILUMINATE trial is a prospective, multicentre, single-arm study in 21 sites in Europe and the USA. Patients with moderate or greater triscuspid regurgitation, New York Heart Association class II or higher, and who were adequately treated per applicable standards were eligible for enrolment. Patients were excluded if they had systolic pulmonary artery pressure of more than 60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. Tricuspid regurgitation was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was a reduction in tricuspid regurgitation severity by at least one grade at 30 days post procedure, with a performance goal of 35%, analysed in all patients who had an attempted tricuspid valve repair procedure upon femoral vein puncture. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups. The trial has completed enrolment and follow-up is ongoing; it is registered with ClinicalTrials.gov, number NCT03227757.
Between Aug 1, 2017, and Nov 29, 2018, 85 patients (mean age 77·8 years SD 7·9; 56 66% women) were enrolled and underwent successful TriClip implantation. Tricuspid regurgitation severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97·5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p<0·0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, five (6%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p<0·0001). Single leaflet attachment occurred in five (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolisations, or strokes occurred. At 6 months, all-cause mortality had occurred in four (5%) of 84 patients.
The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure.
Abbott.
Tricuspid regurgitation (TR) is a frequent disease with a progressive increase in mortality as disease severity increases. Transcatheter therapies for treatment of TR may offer a safe and effective ...alternative to surgery in this high-risk population.
The purpose of this report was to study the 1-year outcomes with the TriClip transcatheter tricuspid valve repair system, including repair durability, clinical benefit and safety.
The TRILUMINATE trial (n = 85) is an international, prospective, single arm, multicenter study investigating safety and performance of the TriClip Tricuspid Valve Repair System in patients with moderate or greater TR. Echocardiographic assessment was performed by a core laboratory.
At 1 year, TR was reduced to moderate or less in 71% of subjects compared with 8% at baseline (p < 0.0001). Patients experienced significant clinical improvements in New York Heart Association (NYHA) functional class I/II (31% to 83%, p < 0.0001), 6-minute walk test (272.3 ± 15.6 to 303.2 ± 15.6 meters, p = 0.0023) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (improvement of 20 ± 2.61 points, p < 0.0001). Significant reverse right ventricular remodeling was observed in terms of size and function. The overall major adverse event rate and all-cause mortality were both 7.1% at 1 year.
Transcatheter tricuspid valve repair using the TriClip device was found to be safe and effective in patients with moderate or greater TR. The repair itself was durable at reducing TR at 1 year and was associated with a sustained and marked clinical benefit with low mortality after 1 year in a fragile population that was at high surgical risk. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR; NCT03227757)
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Classification of left ventricular diastolic function (LVDF) by echocardiography is controversial. The aim of this study was to evaluate the impact of the last 2016 recommendations for LVDF ...evaluation on brain natriuretic peptide (BNP) levels, proportion of final heart failure (HF) diagnosis, and cardiovascular outcomes.
Outpatients with first consultation at a one-stop HF clinic (2009-2014) were screened. The initial visit included echocardiography with LVDF evaluation and determination of BNP level. HF diagnosis was confirmed or ruled out at the end of the visit. Cardiovascular events during follow-up were recorded. LVDF classification was originally performed with the 2009 recommendations and reevaluated using the 2016 recommendations.
A total of 157 patients (mean age 73.24 ± 10.3 years; 70.1% women) were included. Originally (2009 recommendations), most of the patients were classified with grade I diastolic dysfunction (DD; 67.5%). After the reanalysis using the 2016 recommendations, 49% were reclassified with normal LVDF. These subjects showed lower BNP levels (40.8 pg/mL) and a lower proportion of HF diagnosis (9.6%). Another part of the initial grade I DD group (31.1%) was reclassified with indeterminate LVDF; they had intermediate BNP levels, proportion of HF, and rate of cardiovascular events. Lower reclassification rates were observed in the other groups of DD. Kaplan-Meier survival curves showed significantly better prognostic stratification after the reclassification (P = .539 vs P = .003).
Current recommendations for the evaluation of LVDF by echocardiography resulted in more accurate classification of patients, according to their BNP levels, HF diagnosis, and cardiovascular outcomes, especially for those patients previously classified with grade I DD.
Objectives This study sought to evaluate the efficacy of enalapril and carvedilol to prevent chemotherapy-induced left ventricular systolic dysfunction (LVSD) in patients with hematological ...malignancies. Background Current chemotherapy may induce LVSD. Angiotensin-converting enzyme inhibitors and beta-blockers prevent LVSD in animal models of anthracycline-induced cardiomyopathy. Methods In this randomized, controlled study, 90 patients with recently diagnosed acute leukemia (n = 36) or patients with malignant hemopathies undergoing autologous hematopoietic stem cell transplantation (HSCT) (n = 54) and without LVSD were randomly assigned to a group receiving enalapril and carvedilol (n = 45) or to a control group (n = 45). Echocardiographic and cardiac magnetic resonance (CMR) imaging studies were performed before and at 6 months after randomization. The primary efficacy endpoint was the absolute change from baseline in LV ejection fraction (LVEF). Results The mean age of patients was 50 ± 13 years old, and 43% were women. At 6 months, LVEF did not change in the intervention group but significantly decreased in controls, resulting in a −3.1% absolute difference by echocardiography (p = 0.035) and −3.4% (p = 0.09) in the 59 patients who underwent CMR. The corresponding absolute difference (95% confidence interval CI) in LVEF was −6.38% (95% CI: −11.9 to −0.9) in patients with acute leukemia and −1.0% (95% CI: −4.5 to 2.5) in patients undergoing autologous HSCT (p = 0.08 for interaction between treatment effect and disease category). Compared to controls, patients in the intervention group had a lower incidence of the combined event of death or heart failure (6.7% vs. 22%, p = 0.036) and of death, heart failure, or a final LVEF <45% (6.7% vs. 24.4%, p = 0.02). Conclusions Combined treatment with enalapril and carvedilol may prevent LVSD in patients with malignant hemopathies treated with intensive chemotherapy. The clinical relevance of this strategy should be confirmed in larger studies. (Prevention of Left Ventricular Dysfunction During Chemotherapy OVERCOME; NCT01110824 )
The role of high-intensity exercise and other emerging risk factors in lone atrial fibrillation (Ln-AF) epidemiology is still under debate. The aim of this study was to analyse the contribution of ...each of the emerging risk factors and the impact of physical activity dose in patients with Ln-AF.
Patients with Ln-AF and age- and sex-matched healthy controls were included in a 2:1 prospective case-control study. We obtained clinical and anthropometric data transthoracic echocardiography, lifetime physical activity questionnaire, 24-h ambulatory blood pressure monitoring, Berlin questionnaire score, and, in patients at high risk for obstructive sleep apnoea (OSA) syndrome, a polysomnography. A total of 115 cases and 57 controls were enrolled. Conditional logistic regression analysis associated height odds ratio (OR) 1.06 1.01-1.11, waist circumference (OR 1.06 1.02-1.11), OSA (OR 5.04 1.44-17.45), and 2000 or more hours of cumulative high-intensity endurance training to a higher AF risk. Our data indicated a U-shaped association between the extent of high-intensity training and AF risk. The risk of AF increased with an accumulated lifetime endurance sport activity ≥ 2,000 h compared with sedentary individuals (OR 3.88 1.55-9.73). Nevertheless, a history of <2000 h of high-intensity training protected against AF when compared with sedentary individuals (OR 0.38 0.12-0.98).
A history of ≥ 2,000 h of vigorous endurance training, tall stature, abdominal obesity, and OSA are frequently encountered as risk factors in patients with Ln-AF. Fewer than 2000 total hours of high-intensity endurance training associates with reduced Ln-AF risk.
The creative economy has been recognized as key in urban development and planning, which the UNESCO Creative Cities Network (UCCN) consolidates. While benefiting from the label, the tourism sector ...also plays a fundamental role in the creative strategy. This paper explores how intangible heritage and creative industries can work as a tourism asset for creative cities and thus participate in their development. An NVivo thematic content analysis of all the tourism-related actions listed in the UCCN reports was performed to identify what types of cultural tourism products and actions are linked to the creative cities and to understand how they relate to their UNESCO creative fields to detect gaps and potentials. Tourism activity represents 17% of the total actions listed in the creative cities’ reports, mostly concentrated in the Crafts & Folk Art field. The empirical results highlight tendencies that can be applied and adapted to future destinations with intangible assets on their territory and that want to work with the creative industries. Thus, this paper unveils an underexplored potential of synergies between two important economic and creative activities.
Las enfermedades valvulares están sufriendo un aumento global en su prevalencia debido principalmente a su etiología degenerativa y al incremento de la esperanza de vida en la población general.
La ...insuficiencia mitral (IM) moderada y severa grava el pronóstico de los pacientes independientemente del mecanismo responsable y de la función sistólica del ventrículo izquierdo. Un mayor índice de sospecha clínica y la auscultación cardíaca rutinaria seguidas de ecocardiografía son herramientas clave para un diagnóstico precoz, incluso entre paciente asintomáticos.
La cirugía mitral es el principal tratamiento de la IM. En los últimos años se han desarrollado procedimientos percutáneos como la reparación transcatéter borde a borde que permiten tratar a un mayor espectro de pacientes. Pese a la elevada mortalidad de los pacientes con IM significativa no tratada, la realidad es que la IM es una entidad claramente infratratada.
Existen puntos de mejora a lo largo del flujo que sigue el paciente con IM. Concienciar a la población, mejorar el diagnóstico precoz y buscar siempre el mejor tratamiento son estrategias que pueden conducir a una optimización del manejo de los pacientes con IM.
The prevalence of heart valve disease is progressively increasing mainly due to its degenerative etiology and the increase in expectancy of life in the general population.
Moderate and severe mitral regurgitation (MI) worsen patients’ prognosis regardless of the mechanism responsible and the left ventricle systolic function. A higher index of clinical suspicion and routine cardiac auscultation followed by echocardiography are key tools for early diagnosis, even among asymptomatic patients.
Mitral surgery is the main treatment for MI. In the last years, percutaneous procedures such as edge-to-edge transcatheter repair have been developed to treat a wider spectrum of patients. Despite the high mortality of patients with significant untreated MI, the reality is that MI is a clearly undertreated entity.
There are points of improvement along the flow followed by the patient with MI. Raising awareness among the population, improving early diagnosis and always seeking the best treatment are strategies that can lead to optimizing the management of patients with MI.
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