Patient population and data collection
Data of 259 patients who underwent CVS due to organic heart disease, and who were admitted to our Hospital, with CHF from January 2018 to December 2020, we collected. The patients were divided into Group A (172 cases) and Group B (87 cases) based on whether the patients were treated with sacubitril/valsartan regularly.
Inclusion criteria
1. CVS due to organic valvular disease, and none of the patients were treated with sacubitril/valsartan before surgery.
2. Meeting the relevant diagnostic criteria for CHF according to the ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2016[20].
The NYHA cardiac function classification was between grade II and IV, including 36 cases of grade II, 201 cases of grade III, and 22 cases of grade IV, and LVEF between 25 and 50%.
Exclusion criteria
1. Coronary heart disease with organic valvular disease requiring revascularization, severe arrhythmia, acute heart failure, and cardiogenic shock.
2. Contraindication to the drug used in this study.
3. Liver or kidney disease or accompanied by other serious systemic diseases.
4. After surgical treatment, there were still serious organic valvular lesions that require surgical treatment, or artificial valve disorders or valve aging.
After admission, all patients were treated with digitalgia, β-blockers, diuretics, and other drugs for conventional anti-heart failure as per their clinical conditions. After discharge, they continued with the original treatment plan, and were followed-up regularly for half a year. The patients in Group A were treated with sacubitril/valsartan (25 mg/time, starting with oral administration twice a day and gradually increasing to 200 mg/time depending on the follow-up) (Entresto, Approval number: H20170363, Novartis Pharma Schweiz AG, Specifications: 100 mg (sacubitril 49 mg/valsartan 51 mg)) in addition to conventional treatment. The patients in Group B were treated with conventional anti-heart failure therapy only. The duration of treatment and follow-up was 6 months. Prior-treatment clinical characteristics, post-treatment data, mortality, and follow-up data of the two groups were analyzed(Table 1, 2, 3). This study was approved by the ethics committee of Union Hospital of Fujian Medical University, and conformed to the Declaration of Helsinki. And this retrospective review of patient data did not require written informed consent from participants in accordance with national guidelines.
Outcome measures
A comparative evaluation was conducted on the clinical treatment effect of the two groups according to NYHA classification. Effectiveness was defined as an NYHA cardiac function grade improved by 1 grade or above. An invalid outcome was defined as no significant change or decrease in NYHA cardiac function.
Effective rate = Effectiveness/total quantity*(100%).
NYHA Cardiac function grade, SBP, DBP, resting heart rate, hypertension, diabetes mellitus, coronary heart disease and atrial fibrillation were recorded prior to and post- treatment in both groups. The time from the CVS and the morning fasting venous blood samples were taken to measure and compare the NT-proBNP, serum creatinine, alanine aminotransferase, aspartate aminotransferase, potassium ion, sodium ion, hemoglobin, hematocrit and blood glucose. Echocardiography was performed in the two groups, and a comparative analysis was performed on the changes of cardiac function indicators in the two groups, including LVEF, LVEDD, LVESD, left atrial size, and cardiac output. During the treatment, adverse drug reactions, hospitalization time, readmission times due to cardiac insufficiency and acute heart failure cases were observed in the two groups.
Statistical analysis
All statistical analyses were performed using SPSS version 19.0 (SPSS, Inc., Chicago, IL, USA). Data types included measurement, enumeration, and grade data. Distributed variables were presented as mean ± standard deviation(SD), or median and inter-quartile range. Categorical variables were presented as numbers and percentages(n, %). Comparisons of measurements were performed with t-test or the Mann– Whitney test, where appropriate.