Pastore Maria Concetta, Mandoli Giulia Elena, Giannoni Alberto, Benfari Giovanni, Dini Frank Lloyd, Pugliese Nicola Riccardo, Taddei Claudia, Correale Michele, Brunetti Natale Daniele, Carluccio Erberto, Mengoni Anna, Guaricci Andrea Igoren, Piscitelli Laura, Citro Rodolfo, Ciccarelli Michele, Novo Giuseppina, Corrado Egle, Pasquini Annalisa, Loria Valentina, Degiovanni Anna, Patti Giuseppe, Santoro Ciro, Moderato Luca, Malagoli Alessandro, Emdin Michele, Cameli Matteo, Rosa Gianmarco, Magnesa Michele, Mazzeo Pietro, De Carli Giuseppe, Bellino Michele, Iuliano Giuseppe, Casciano Ofelia, Binno Simone, Canepa Marco, Tondi Stefano, Cicoira Mariantonietta, Mega Simona
Department of Medical Biotechnologies, Division of Cardiology, University of Siena, 53100, Siena, Italy.
Cardiology and Cardiovascular Medicine Department, Fondazione Toscana G. Monasterio, Via Giuseppe Moruzzi, 1, 56124 Pisa, Italy.
Eur Heart J Open. 2021 Dec 21;2(1):oeab046. doi: 10.1093/ehjopen/oeab046. eCollection 2022 Jan.
This sub-study deriving from a multicentre Italian register [Deformation Imaging by Strain in Chronic Heart Failure Over Sacubitril-Valsartan: A Multicenter Echocardiographic Registry (DISCOVER)-ARNI] investigated whether sacubitril/valsartan in addition to optimal medical therapy (OMT) could reduce the rate of implantable cardioverter-defibrillator (ICD) indications for primary prevention in heart failure with reduced ejection fraction (HFrEF) according to European guidelines indications, and its potential predictors.
In this observational study, consecutive patients with HFrEF eligible for sacubitril/valsartan from 13 Italian centres were included. Lack of follow-up or speckle tracking data represented exclusion criteria. Demographic, clinical, biochemical, and echocardiographic data were collected at baseline and after 6 months from sacubitril/valsartan initiation. Of 351 patients, 225 (64%) were ICD carriers and 126 (36%) were not ICD carriers (of whom 13 had no indication) at baseline. After 6 months of sacubitril/valsartan, among 113 non-ICD carriers despite having baseline left ventricular (LV) ejection fraction (EF) ≤ 35% and New York Heart Association (NYHA) class = II-III, 69 (60%) did not show ICD indications; 44 (40%) still fulfilled ICD criteria. Age, atrial fibrillation, mitral regurgitation > moderate, left atrial volume index (LAVi), and LV global longitudinal strain (GLS) significantly varied between the groups. With receiver operating characteristic curves, age ≥ 75 years, LAVi ≥ 42 mL/m and LV GLS ≥-8.3% were associated with ICD indications persistence (area under the curve = 0.65, 0.68, 0.68, respectively). With univariate and multivariate analysis, only LV GLS emerged as significant predictor of ICD indications at follow-up in different predictive models.
Sacubitril/valsartan may provide early improvement of NYHA class and LVEF, reducing the possible number of implanted ICD for primary prevention in HFrEF. Baseline reduced LV GLS was a strong marker of ICD indication despite OMT. Early therapy with sacubitril/valsartan may save infective/haemorrhagic risks and unnecessary costs deriving from ICDs.
本项亚研究源自一项意大利多中心注册研究[沙库巴曲缬沙坦在慢性心力衰竭中的应变变形成像:一项多中心超声心动图注册研究(DISCOVER)-ARNI],旨在探讨在优化药物治疗(OMT)基础上加用沙库巴曲缬沙坦是否能根据欧洲指南适应证降低射血分数降低的心力衰竭(HFrEF)患者一级预防植入式心脏复律除颤器(ICD)的指征发生率及其潜在预测因素。
在这项观察性研究中,纳入了来自13个意大利中心符合使用沙库巴曲缬沙坦条件的连续HFrEF患者。缺乏随访或斑点追踪数据为排除标准。在基线时以及开始使用沙库巴曲缬沙坦6个月后收集人口统计学、临床、生化和超声心动图数据。在351例患者中,225例(64%)在基线时为ICD携带者,126例(36%)不是ICD携带者(其中13例无指征)。在使用沙库巴曲缬沙坦6个月后,在113例尽管基线左心室(LV)射血分数(EF)≤35%且纽约心脏协会(NYHA)分级为II-III级但不是ICD携带者的患者中,69例(60%)未出现ICD指征;44例(40%)仍符合ICD标准。两组之间年龄、心房颤动、中度以上二尖瓣反流、左心房容积指数(LAVi)和左心室整体纵向应变(GLS)有显著差异。通过受试者工作特征曲线分析,年龄≥75岁、LAVi≥42 mL/m²和左心室GLS≥-8.3%与ICD指征持续存在相关(曲线下面积分别为0.65、0.68、0.68)。通过单因素和多因素分析,在不同的预测模型中,仅左心室GLS在随访时成为ICD指征的显著预测因素。
沙库巴曲缬沙坦可使NYHA分级和左心室射血分数早期改善,减少HFrEF患者一级预防中可能植入ICD的数量。尽管接受了OMT,但基线时左心室GLS降低是ICD指征的有力标志。沙库巴曲缬沙坦早期治疗可避免ICD带来的感染/出血风险和不必要的费用。