Abstract

Abstract Background Sacubitril/Valsartan has been shown to improve symptoms and outcomes in patients with heart failure (HF) reduced ejection fraction in a single large randomised controlled trial. However, real-world data on its effect is limited. Purpose Our centre operates a dedicated HF clinic for the initiation and titration of Sacubitril/Valsartan in suitable patients. We report on patient tolerability and incidence of adverse effects. We also assessed change in New York Heart Association (NYHA) class and left ventricular ejection fraction (LVEF) post-treatment, as well as HF hospitalisation and mortality at 6 months. Methods We conducted a retrospective review of all patients seen in the clinic between January 2016 to January 2019. Patient demographics and pre-initiation treatments were recorded. We compared NYHA class and LVEF category as measured by echocardiography, at initiation and post-titration to the maximum tolerated dose. Data on HF admissions were obtained from electronic hospital records and mortality from a national database. Results A total of 179 patients were initiated on Sacubitril/Valsartan and included in the study. Mean age was 71 years (41–90), and 138 (77%) were male. Half of the patient cohort (89) had an ischaemic aetiology. Prior to initiation, all patients were established on an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Almost all were on a beta-blocker (99%) and mineralocorticoid receptor antagonist (98%). 56 patients (31%) had a Cardiac Resynchronisation Therapy (CRT) device and 31 (17%) had an Implantable Cardioverter-Defibrillator (ICD). Only 4 patients (2%) had to discontinue treatment completely due to an adverse reaction. Among them, 3 patients sustained an acute kidney injury (AKI) while 1 patient had increased breathlessness. 40 patients (22%) reported symptomatic hypotension which required dose reduction. 7 patients (4%) sustained an AKI. 2 patients reported a rash and 1 patient reported nausea. Figure 1 shows the change in NYHA class after establishment on Sacubitril/Valsartan. Data on change in LVEF post establishment of Sacubitril/Valsartan was available in 124 patients and is shown in figure 2. A total of 133 patients had completed titration of treatment by July 2018 and included in the analysis of 6-month outcome. 13 patients had one HF hospitalisation and all-cause mortality was 4.5% (6 patients). Only 1 patient had heart failure documented as the primary cause of death. Change in NYHA class and LVEF Conclusion In our cohort of well treated HF patients with reduced ejection fraction, 40% of patients experienced an improvement in NYHA class after establishment on Sacubitril/Valsartan while 35% of patients also experienced a significant improvement in LVEF. Treatment was well tolerated and the discontinuation rate was low when managed in a dedicated HF clinic focused on initiation of Sacubitril/Valsartan.

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