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Background: Systematic revascularization of asymptomatic coronary artery stenosis before transcatheter aortic valve replacement (TAVR) is controversial. Purpose: The purpose of this study was to evaluate the feasibility and safety of functional evaluation of coronary artery disease (CAD) followed by selective ischemia-guided percutaneous coronary revascularization following TAVR. Methods: This prospective, bi-centric, single-arm, open-label trial included all patients with severe aortic stenosis (AS) eligible for TAVR and with significant CAD defined as ≥1 coronary stenosis ≥ 70%. Patients with left main stenosis ≥ 50%, proximal left anterior descending artery (LAD) stenosis ≥ 90% or > class 2 Canadian Classification Society (CCS) angina were excluded. Myocardial ischemia was evaluated by stress cardiac imaging one month after TAVR. The primary endpoint was a composite of all-cause death, stroke, major bleeding (Bleeding Academic Research Consotium ≥ 3), major vascular complication (Valve Academic Research Consortium 3 criteria), acute coronary syndrome (ACS) and hospitalization for cardiac causes within 6 months of receiving TAVR. Results: Between June 2020 and June 2022, 64 patients were included in this study. The mean age was 84 ± 5.2 years. CAD mostly involved LAD (n = 27, 42%) with frequent multivessel disease (n = 30, 47%) and calcified lesions (n = 39, 61%). Stress cardiac imaging could be achieved in 70% (n = 46) of the patients, while 30% (n = 18) did not attend the stress test. Significant myocardial ischemia was observed in only three patients (4.5%). At 6-month follow-up, fifteen patients (23%) reached the primary endpoint, including death in six patients (9%), stroke in three patients (5%) and major bleeding in three patients (5%). ACS was observed in only two patients (3%) but both had severe coronary stenosis (≥90%) and did not refer for stress imaging for personal reasons. Hospital readmission (n = 27, 41%) was mostly related to non-cardiac causes (n = 17, 27%). Conclusions: In patients with asymptomatic CAD scheduled to undergo TAVR, a selective ischemia-guided coronary revascularization after TAVR seems to be safe, with a very low rate of ACS and few cases of myocardial ischemia requiring revascularization, despite low adherence to medical follow-up in this elderly population. This strategy could be evaluated in a randomized study.
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BACKGROUND: Sacubitril/valsartan has been demonstrated to significantly improve left ventricular performance and remodelling in patients with heart failure. However, its effects on the right ventricle in patients with chronic heart failure and sleep-disordered breathing (SDB) have not been studied. AIM: To investigate the impact of sacubitril/valsartan treatment on right ventricular function in patients with SDB. METHODS: This was a subanalysis of an observational prospective multicentre study involving 101 patients. At inclusion, patients were evaluated by echocardiography and nocturnal ventilatory polygraphy, which allowed patients to be divided into three groups: "central-SDB"; "obstructive-SDB"; and "no-SDB". RESULTS: After 3 months of sacubitril/valsartan therapy, a positive impact on right ventricular function was observed. In the general population, tricuspid annular plane systolic excursion increased by +1.32±4.74mm (P=0.024) and systolic pulmonary artery pressure decreased by -3.1±10.91mmHg (P=0.048). The central-SDB group experienced the greatest echocardiographic improvement, with a significant increase in tricuspid annular plane systolic excursion of +2.1±4.9mm (P=0.045) and a significant reduction in systolic pulmonary artery pressure of -8.4±9.7mmHg (P=0.001). CONCLUSIONS: Sacubitril/valsartan improved right ventricular function in patients with heart failure and SDB after only 3 months of treatment. The greatest improvement in right ventricular function was observed in the central-SDB group.
Asunto(s)
Aminobutiratos , Compuestos de Bifenilo , Combinación de Medicamentos , Insuficiencia Cardíaca , Recuperación de la Función , Valsartán , Función Ventricular Derecha , Humanos , Valsartán/uso terapéutico , Masculino , Femenino , Aminobutiratos/uso terapéutico , Aminobutiratos/efectos adversos , Función Ventricular Derecha/efectos de los fármacos , Estudios Prospectivos , Persona de Mediana Edad , Resultado del Tratamiento , Anciano , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/diagnóstico , Factores de Tiempo , Apnea Central del Sueño/fisiopatología , Apnea Central del Sueño/diagnóstico , Apnea Central del Sueño/tratamiento farmacológico , Bloqueadores del Receptor Tipo 1 de Angiotensina II/uso terapéutico , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Tetrazoles/uso terapéutico , Tetrazoles/efectos adversos , Inhibidores de Proteasas/uso terapéutico , Inhibidores de Proteasas/efectos adversos , Polisomnografía , Neprilisina/antagonistas & inhibidores , Enfermedad CrónicaRESUMEN
BACKGROUND: The PRADO-IC (Programme de Retour à Domicile après une Insuffisance Cardiaque) is a transition care program designed to improve the coordination of care between hospital and home that was generalized in France in 2014. The PRADO-IC consists of an administrative assistant who visits patients during hospitalization to schedule follow-up visits. The aim of the present study was to evaluate the PRADO-IC program based on the hypotheses provided by health authorities. METHODS AND RESULTS: The PRADOC study is a multicenter, controlled, randomized, open-label, mixed-method trial of the transition program PRADO-IC versus usual management in patients hospitalized with heart failure (standard of care group; NCT03396081). A total of 404 patients were recruited between April 2018 and May 2021. The mean patient age was 75 years (±12 years) in both groups. The 2 groups were well balanced regarding severity indices. At discharge, patients homogeneously received the recommended drugs. There was no difference between groups regarding hospitalizations for acute heart failure at 1 year, with 24.60% in the standard of care group and 25.40% in the PRADO-IC group during the year following the index hospitalization (hazard ratio, 1.04 [95% CI, 0.69-1.56]; P=0.85) or cardiovascular mortality (hazard ratio, 0.67 [95% CI, 0.34-1.31]; P=0.24). CONCLUSIONS: The PRADO-IC has not significantly improved clinical outcomes, though a trend toward reduced cardiovascular mortality is evident. These results will help in understanding how transitional care programs remain to be integrated in pathways of current patients, including telemonitoring, and to better tailor individualized approaches. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03396081.