Dattilo Giuseppe, Laterra Giulia, Licordari Roberto, Parisi Francesca, Pistelli Lorenzo, Colarusso Luigi, Zappia Luca, Vaccaro Vittoria, Demurtas Elisabetta, Allegra Marta, Crea Pasquale, Di Bella Gianluca, Signorelli Salvatore Santo, Aspromonte Nadia, Imbalzano Egidio, Correale Michele
Section of Cardiology, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, 98122 Messina, Italy.
Department of Clinical and Experimental Medicine, Policlinic University Hospital of Messina, 98122 Messina, Italy.
J Clin Med. 2023 Sep 28;12(19):6247. doi: 10.3390/jcm12196247.
Heart failure (HF) is a progressive condition with an increasing prevalence, and the scientific evidence of heart failure with reduced ejection fraction (HFrEF) reports a 6% rate of 1-year mortality in stable patients, whereas, in recently hospitalized patients, the 1-year mortality rates exceed 20%. The Sacubitril/Valsartan (S/V), the first angiotensin receptor neprilysin inhibitor (ARNI), significantly reduced both HF hospitalization and cardiovascular mortality.
to evaluate the effect of S/V in a follow-up period of 5 years from the beginning of the therapy. We compared the one-year outcomes of S/V use with those obtained after 5 years of therapy, monitoring the long-term effects in a real-world population with HFrEF.
Seventy consecutive patients with HFrEF and eligible for ARNI, according to PARADIGM-HF criteria, were enrolled. All patients had an overall follow-up of 60 months, during which time they underwent standard transthoracic echocardiography (TTE) with Global Longitudinal Strain (GLS) evaluation, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Six Minutes Walking Test (6MWT), and blood tests (NT-pro-BNP and BNP, renal function tests).
NTproBNP values were reduced significantly among the three time-points ( < 0.001). Among echocardiographic parameters, left ventricle end-diastolic volume (LV EDV) and E/e' significantly were reduced at the first evaluation (12 months), while left ventricle end-systolic volume (LV ESV) decreased during all follow-ups ( < 0.001). LV EF ( < 0.001) and GLS ( < 0.001) significantly increased at both evaluations. The 6MWT ( < 0.001) and KCCQ scores ( < 0.001) increased significantly in the first 12 months and remained stable along the other time-points. NYHA class showed an increase in class 1 subjects and a decrease in class 3 subjects during follow-up. NTproBNP, BNP, 6MWT, and KCCQ scores showed a significant change in the first 12 months, while LVEF, GLS, and ESV changed during all evaluations.
We verified that the improvements obtained after one year of therapy had not reached a plateau phase but continued to improve and were statistically significant at 5 years. Although our data should be confirmed in larger and multicentre studies, we can state that the utilization of Sacubitril/Valsartan has catalysed substantial transformations in the prognostic landscape of chronic HFrEF, yielding profound clinical implications.
心力衰竭（HF）是一种患病率不断上升的进行性疾病，射血分数降低的心力衰竭（HFrEF）的科学证据表明，稳定患者的1年死亡率为6%，而最近住院的患者1年死亡率超过20%。沙库巴曲缬沙坦（S/V）是首个血管紧张素受体脑啡肽酶抑制剂（ARNI），可显著降低HF住院率和心血管死亡率。
评估从治疗开始起5年随访期内S/V的效果。我们将S/V使用1年的结果与治疗5年后获得的结果进行比较，监测HFrEF真实世界人群中的长期效果。
根据PARADIGM-HF标准，连续纳入70例符合ARNI治疗条件的HFrEF患者。所有患者的总随访时间为60个月，在此期间，他们接受了标准经胸超声心动图（TTE）检查，并进行了整体纵向应变（GLS）评估、堪萨斯城心肌病问卷（KCCQ）、六分钟步行试验（6MWT）以及血液检查（NT-pro-BNP和BNP、肾功能检查）。
NTproBNP值在三个时间点之间显著降低（<0.001）。在超声心动图参数中，左心室舒张末期容积（LV EDV）和E/e'在首次评估（12个月）时显著降低，而左心室收缩末期容积（LV ESV）在所有随访期间均降低（<0.001）。两次评估时LV EF（<0.001）和GLS（<0.001）均显著增加。6MWT（<0.001）和KCCQ评分（<0.001）在最初12个月内显著增加，并在其他时间点保持稳定。随访期间，纽约心脏协会（NYHA）分级显示1级患者增加，3级患者减少。NTproBNP、BNP、6MWT和KCCQ评分在最初12个月有显著变化，而LVEF、GLS和ESV在所有评估中均有变化。
我们证实，治疗1年后获得的改善并未达到平台期，而是持续改善，且在5年时具有统计学意义。尽管我们的数据应在更大规模的多中心研究中得到证实，但我们可以说，沙库巴曲缬沙坦的使用已在慢性HFrEF的预后格局中引发了重大转变，具有深远的临床意义。
