Abstract
Sacubitril/Valsartan (S/V) is indicated in stable, symptomatic HFrEF as an alternate to an ACEI or ARB. Initiation of S/V requires planning and care coordination with relatively low rates of utilization despite a Class I-BR recommendation. Starting S/V early after a hospitalization for HF may increase utilization.
A retrospective chart review of HF patients who were initiated on S/V either in-hospital or within 7 days after hospitalization for decompensated HF was conducted. Patients had to have all of the following at the time of S/V initiation: HFrEF with EF ≤ 40%; serum K+ ≥ 4.0 ≤ 5.0; serum creatinine ≤ 1.5 mg/dl; and a systolic BP ≥ 110 mmHg. Clinical outcomes of the patients were evaluated and descriptive statistics were used to analyze the data.
A total of 27 patients who met the inclusion criteria were evaluated. S/V was initiated in-hospital in 8 patients and outpatient in 19 patients. Baseline characteristics were mean age 71 ± 7 years, 74% men, 93% white, NYHA FC class III 85% and class IV 15%, and mean EF 29% ± 4%. Twenty patients were on an ACEI and 7 were on an ARB. All patients were on a beta-blocker and 18 were on an aldosterone receptor antagonist. Twelve (44%) patients tolerated S/V at last follow-up (5 months). Fifteen (56%) patients discontinued S/V therapy during the first month of treatment. S/V was discontinued for hypotension in 7 patients and hypotension with acute kidney injury (AKI) in 8 patients. AKI was most likely secondary to pre-renal azotemia with 6 of the 8 patients with BUN/creatinine ratios > 20:1. Hypotension and AKI resolved in all patients upon discontinuation of S/V. There were no significant differences between patients continuing versus patients discontinuing S/V other than location of S/V initiation. Only 2 of 8 (25%) patients initiated in hospital continued S/V therapy while 10 of 19 (53%) outpatients continued therapy. However, there was no difference in the number of days from hospitalization to start of S/V therapy between those tolerating (10.3 ± 2.0 days) and not tolerating S/V therapy (9.7 ± 1.9 days).
Early initiation of S/V may lead to greater utilization of this Class I recommended therapy, but our data suggests early initiation after HF decompensation is not tolerated in a majority of HF patients. Hypotension and AKI are the primary reasons for intolerance.