Authors:

V V Gomez Leiva¹ , V E Ruiz Ruiz¹ , J L Fujigaki Zaldivar¹ , F Flores Puente¹ , J G Rodriguez Serrano¹ , L Campuzano Pineda¹ , E Gomez Alvarez¹ , J A Merino Rajme¹ , ¹National Medical Center 20 de Noviembre - Mexico City - Mexico ,

INTRODUCTION. In Mexico, heart failure (HF) has a prevalence of 1.6 million persons and annual incidence of 600,000 new cases. 

Sacubitril/Valsartan (S/V) has proved to be superior than conventional therapy decreasing the number of readmissions in the emergency room, days in the intensive care unit, total hospitalizations days, improve in quality of life and survival, echocardiography has shown improvement in the left ventricular ejection fraction (LVEF) and reverse remodeling achieved. 

PURPOSE. Compare the echocardiographic parameters, quality of life, institutional costs, tolerance and side effects in patients with heart failure with reduced ejection fraction before and after 3 months therapy with S/V. 

METHODS. Patients diagnosed with HF, LVEF =35%, persistence of symptoms and treated with conventional therapy were recruited to initiate S/V therapy. After written consent was obtain, echocardiographic parameters (LVEF, diastolic diameter, systolic diameter, diastolic function and pulmonary artery systolic pressure), quality of life: 6-minute walk test (6-MWT) and Kansas City cardiomyopathy questionnaire (KCCQ) and institutional cost were measured; follow-up was made at three months, with the same parameters. 

Data analysis was made with SPSS statistical program (v 24.0). Data is presented as means and standard deviations, frequencies and percentages. The distribution of variables was determined with the Shapiro-Wilk test; Wilcoxon and Friedman test were used. Statistically significant was taken at p <0.05. 

RESULTS. 25 patients were enrolled. Baseline characteristics: mean age 54 years (± 13.7), women 32%, non-ischemic 52%, 52% without pacemaker, 12% with implantable cardioverter defibrillator (ICD), 12% with cardiac resynchronization therapy (CRT) and 24% with ICD-CRT. 68% were non responders (59% ischemic), 20% responders (60% non-ischemic) and 12% super responders (all non-ischemic). 

Echocardiographic parameters exhibited the reverse remodeling achieved, improvement in the LVEF (26.1% ± 7.3 to 29.9 ± 8.5, p 0.02), diastolic diameter (61.2±9.5 to 60.4±7.2, p 0.57), systolic diameter LV (50.8±11.8 to 50.3±10.8, p 0.80), pulmonary artery systolic pressure (32.4±15.4 to 32.6±17.1, p 0.64), diastolic function (grade II to grade I or absence, p 0.23). Improvement in the 6-MWT (430.6±152.6 to 472.3±91, p 0.16), KCCQ (41.7±14.2 to 56.7±7 p 0.005). 

Hospitalized (4.7±10.2 to 0.2±1, p 0.02) and disabilities (8.8±22.9 to 0.1±0.8 p 0.08) days decreased, dose tolerance (100mg bid) was 80% with a decrease in side effects. Institutional cost for three months with triple therapy was US $54,547.74 and for S/V was US $ 9,659.45. 

CONCLUSION. The therapy with S/V for the treatment of patients with HF and LVEF =35% with persistence of symptoms shows an improvement in the quality of life by KQ, reverse left ventricular remodeling, further institutional saving was US $ 44,888.29 this could be related with a decrease in hospitalizations days.