Research Article - Interventional Cardiology (2021) Volume 13, Issue 1

Impact of Sacubitril/Valsartan on Patient Outcomes in Chronic Heart Failure

Corresponding Author:
Eyubova UA
Department of III Internal Diseases,
Azerbaijan Medical University;
Baku,
Azerbaijan,
E-mail: [email protected] mail.ru

Received date: December 14, 2020 Accepted date: December 28, 2020 Published date: January 04, 2021

Abstract

Background: Chronic Heart Failure (CHF) remains one of the most important problems in cardiology, despite the availability of various modern diagnostic methods and a number of advances in treatment. This is due to its widespread use, lowering the quality of life of patients, as well as high rates of recurrent decompensation and death. Despite the optimal use of modern treatments based on proven medical principles, the disease still has a high morbidity and mortality rate.

Aim: The aim of our study was to evaluate the conservative treatment which pathogenetic complementarity with the inclusion of a combination of sacubitril/valsartan in the treatment of patients with chronic heart failure with a comparison with device therapy of chronic heart failure.

Materials and Methods: The study included 64 patients over the age of 38 suffering from Chronic Heart Failure (CHF) (45 men, 19 women, 59.5 ± 0.9 years of age). Patients were divided into basic and control groups. 33 patients were included in the main group. In the main group, patients received sacubitril/valsartan twice daily in addition to the classic conservative treatment of CHF. The control group included 31 patients who underwent CRT surgery and classic conservative treatment without of sacubitril/valsartan. During the study, the clinical performance of patients before and after 6 months of treatment, the results of BNP tests, the results of a 6-minute walking test were compared.

Conclusion: Evaluation of the results of examinations of patients after 6 months revealed more positive changes in the indicators of the majority of patients in the main group (especially on functional class) than in 6 months ago.

Keywords

Chronic heart failure • Sacubitril /Valsartan combination • CRT

Background

In the treatment of patients with CHF, our main goal is to improve the clinical condition of patients, increase their functional capacity and quality of life, prevent re-hospitalization and, most importantly, reduce the number of deaths [1-3].

Chronic Heart Failure (CHF) remains one of the most important problems in cardiology, this is due to its widespread use, lowering the quality of life of patients, as well as high rates of recurrent decompensation and death. Despite the optimal use of modern treatments based on proven medical principles, the disease still has a high morbidity and mortality rate [4-9]. Many new drugs and devices are currently being used to treat patients with chronic heart failure [2].

Modern principles of existing pharmacological treatments are based on the pathogenetic concept of CHF, which develops as a result of long-term activation of the neurohumoral system. These include, first of all, renin-angiotensin-aldosterenone and sympathetic-adrenal systems, which are considered pathognomonic in patients with chronic heart failure with poor prognosis. Theoretically, the combined use of different groups of neurohumoral modulators may provide additional benefits in the treatment of patients with chronic heart failure as a result of a more complete blockade of neurohormones. The essence of such a concept is very simple, so the higher the level of different levels of neurohumoral regulation, the better the result [2]. In recent years, a new pharmacological drug has been used in the conservative treatment of patients with chronic heart failure with a reduced emission fraction. This pharmacological drug is a pharmacological agent that can provide simultaneous blockade of both the angiotensin system and neprilisyn. Recently, a number of studies have been conducted on this drug, and a series of studies are ongoing.

In addition to drug treatment, the device is widely used in modern therapies. Of these, resynchron heart therapy is the most widely used treatment in recent years in all countries of the world. In patients with moderate to severe heart failure, CRT treatment may improve quality of life in two-thirds of patients and prolong life in one-third [10]. However, not all patients receiving this treatment respond positively to the CRT method. A number of features can affect the course of the disease after this treatment and the mortality rate. For example, in patients with ischemic etiology, left ventricular function develops less positively after this treatment due to scar tissue of the myocardium. This reduces the likelihood of favorable remodeling during the use of CRT in such patients [3].

Materials and Methods

The study included 64 patients over the age of 38 who were treated at the Eurasia Hospital with a diagnosis of CHF. The diagnosis of CHF was confirmed on the basis of anamnesis, objective and instrumental examination methods.

Eligibility criteria

History of chronic heart failure; circulatory failure (functional class II-IV, NHYA); left ventricular ejection fraction <40%.

Exclusion criteria

Acute myocardial infarction; hypertrophic cardiomyopathy; congenital heart defects; Patients under 25 years of age; heart failure in oncology patients. According to the admission criteria, a total of 64 patients were included in the study, 45 men (70.3% ± 5.7%) and 19 women (29.7% ± 5.7%). The mean age of the patients was 59.5 ± 0.9. During the study, each patient in the main group was given a combination of sacubitril / valsartan twice a day for 6 months in addition to the conservative treatment received for CHF. CRT surgery was performed on patients in the control group. Demographic and clinical characteristics of the patients included in the study are given in Table 1. Thus, no statistically significant differences were obtained during the analysis of the indicators between of patients divided into two groups P>0.05.

                Characteristics Groups
I group (n=33) II group  (n=31)
Age   59.6 ± 1.3          59.5 ± 1.4
(38-70)  (39-73)
Male 25 20
        75.8% ± 7.5%                      64.5% ± 8.6%            
Female 8 11
        24.2% ± 7.5%                        35.5% ± 8.6%           
BMI 36.9 ± 0.5 35.9 ± 0.3
(31.6-43.6) (32.1-38.7)
Obesity
I grade 8 6
          24.2% ± 7.5%          19.4% ± 7.1%
II grade 18 25
         54.5% ± 8.7%          80.6% ± 7.1%
III grade 7 0
         21.2% ±7.1%   0.00%
Action
Activ 4 4
         12.1% ± 5.7%           12.9% ± 6.0%
Non-activ 29 27
          87.9% ± 5.7%                                     87.1% ± 6.0%
Smoking
Does not smoke 8 11
          24.2% ± 7.5%            35.5% ± 8.6%
A few 8 4
           24.2% ± 7.5%            12.9% ± 6.0%
A lot 17 16
          51.5% ± 8.7%                51.6% ± 9.0%
Diabetus mellitus 27 26
            81.8% ± 6.7%              83.9% ± 6.6%
Arterial hypertension 21 20
            63.6% ± 8.4%               64.5% ± 8.6%
Family
Mother 5 7
            15.2% ± 6.2%               22.6 ± 7.5%
Father 8 4
            24.2% ± 7.5%              12.9% ± 6.0%
Both 20 20
             60.6% ± 8.5%                64.5% ± 8.6%

Table 1: Demographic and clinical characteristics of patients.

Results

During the study, the clinical performance of patients before and 6 months after the start of treatment, the results of a 6-minute walking test were compared. Statistical analyzes included the Wilcoxon Signed Ranks Test (Tables 2 and 3) and the Mann-Whitney Test (Table 4), and the Pearson Chi-Square Tests (Table 5).

Ranks   n Mean rank Sum of ranks p
Shortness of breath a- Shortness of breath Negative ranks 30 15,50 465,00 0
Positive ranks 0 0,00 0,00  
Ties 3      
Total 33      
Heartbeat a – Heartbeat Negative ranks 28 14,50 406,00  
Positive ranks 0 0,00 0,00  
Ties 5      
Total 33      
Cough a–Cough Negative ranks 15 8,00 120,00 0
Positive ranks 0 0,00 0,00  
Ties 18      
Total 33      
Pulmonary auscultation a-pulmonary auscultation Negative ranks 33 17,00 561,00 0
Positive ranks 0 0,00 0,00  
Ties 0      
Total 33      
Edema in the legs a-edema in the legs Negative ranks 33 17,00 561,00 0
Positive ranks 0 0,00 0,00  
Ties 0      
Total 33      
Pulse fullness a - Pulse fullness Negative ranks 1 1,00 1,00 0.317
Positive ranks 0 0,00 0,00  
Ties 32      
Total 33      
Pulse rate a - Pulse rate Negative ranks 32 16,50 528,00 0
Positive ranks 0 0,00 0,00  
Ties 1      
Total 33      
SaO2 a–SaO2 Negative ranks 0 0,00 0,00 0
Positive ranks 33 17,00 561,00  
Ties 0      
Total 33      
Decompentation a-Decompentation Negative ranks 26 14,29 371,50 0
Positive ranks   6,50 6,50  
Ties 6      
Total 33      
6 min. walk test a-6 min. walk test Negative ranks 32 16,50 528,00 0
Positive ranks 0 0,00 0,00  
Ties 1      
Total 33      
FC a–FC   Ties 0at   0
  Total 33    
SPATs - SPAT Negative Ranks 21au 11,00  
Total 33      
SAH a–SAH Negative Ranks 21 11,00 231,00 0
Positive Ranks 0 0,00 0,00  
Ties 12      
Total 33      
DAH a–DAH Negative Ranks 21 11,00 231,00 0
Positive Ranks 0 0,00 0,00  
Ties 12      
Total 33      

Table 2: Wilcoxon Signed ranks testi–Group 1.

Ranksa   n Mean Rank Sum of Ranks p
Shortness of breath a-Shortness of breath Negative ranks 18 9,50 171,00 0
Positive ranks 0 0,00 0,00  
Ties 13      
Total 31      
Heartbeat a–Heartbeat Negative ranks 27 14,00 378,00 0
Positive ranks 0 0,00 0,00  
Ties 4      
Total 31      
Cough a-Cough Negative ranks 12 6,50 78,00 0.001
Positive ranks 0 0,00 0,00  
Ties 19      
Total 31      
pulmonary auscultation a-pulmonary auscultation Negative ranks 28 14,50 406,00 0
Positive ranks 0 0,00 0,00  
Ties 3      
Total 31      
edema in the legs a-edema in the legs Negative ranks 30 15,50 465,00 0
Positive ranks 0 0,00 0,00  
Ties 1      
Total 31      
Pulse fullness a-Pulse fullness Negative ranks 4 2,50 10,00 0.046
Positive ranks 0 0,00 0,00  
Ties 27      
Total 31      
Pulse rate a-Pulse rate Negative ranks 31 16,00 496,00 0
Positive ranks 0 0,00 0,00  
Ties 0      
Total 31      
SaO2  a–SaO2 Negative ranks 0 0,00 0,00 0
Positive ranks 31 16,00 496,00  
Ties 0      
Total 31      
Decompentation a-Decompentation Negative ranks 24 14,25 342,00 0
Positive ranks 2 4,50 9,00  
Ties 5      
Total 31      
6 min. walk test a-6 min. walk test Negative ranks 31 16,00 496,00 0
Positive ranks 0 0,00 0,00  
Ties 0      
Total 31      
FC a-FC Negative ranks 18 9,50 171,00 0
Positive ranks 0 0,00 0,00  
Ties 13      
Total 31      
SAH a–SAH Negative ranks 24 12,50 300,00 0
Positive ranks 0 0,00 0,00  
Ties 7      
Total 31      
DAH a–DAH Negative ranks 22 11,50 253,00 0
Positive ranks 0 0,00 0,00  
Ties 9      
Total 31      

Table 3: Wilcoxon Signed ranks testi–Group 2.

Ranks
Gr1   n Mean rank Sum of ranks
  Group 1 33    
  Group 2 31    
  Total 64    
Test Statisticsa        
  Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2-tailed)
Shortness of breath 5,03,000 10,64,000 -0,139 0,890
Shortness of breath a 3,80,000 9,41,000 -2,517 0,012
Heartbeat 4,49,500 9,45,500 -0,985 0,325
Heartbeat a 4,48,000 9,44,000 -1,042 0,298
Cough 4,87,000 10,48,000 -0,368 0,713
Cough a 3,91,500 9,52,500 -2,309 0,021
Pulmonary auscultation 4,07,000 9,03,000 -1,913 0,056
Pulmonary auscultation a 4,92,500 9,88,500 -0,376 0,707
Edema in the legs 4,75,500 10,36,500 -0,844 0,399
Edema in the legs a 2,74,000 8,35,000 -3,521 0,000
Pulse fullness 5,02,500 10,63,500 -0,155 0,877
Pulse fullness a 4,70,000 9,66,000 -0,800 0,424
Pulse rate 4,97,000 9,93,000 -0,195 0,845
Pulse rate a 4,90,000 9,86,000 -0,290 0,772
SaO2 4,08,000 9,69,000 -1,485 0,138
SaO2 a 4,55,500 9,51,500 -0,775 0,439
QRS 4,82,000 9,78,000 -0,447 0,655
Decompentation 4,46,500 10,07,500 -0,892 0,373
Decompentation a 4,99,500 10,60,500 -0,178 0,859
6 min. walk test 4,66,000 10,27,000 -1,315 0,189
6 min. walk test a 3,41,500 9,02,500 -3,105 0,002
FC 5,10,500 10,71,500 -0,021 0,983
FC a 3,49,500 9,10,500 -2,390 0,017
Initial compensation period 3,73,000 9,34,000 -1,958 0,050
SAH 4,75,500 10,36,500 -0,496 0,620
SAH a 5,06,000 10,67,000 -0,079 0,937
DAH 4,86,500 10,47,500 -0,360 0,718
DAH a 4,71,500 10,32,500 -0,564 0,573

Table 4: Mann-Whitney Test.

Ranks Significance
Shortness of breath Chi-square 0,020
Df 2
Sig. 0,990
Shortness of breath a Chi-square 8,165
Df 3
Sig. 0,043
Heartbeat Chi-square 4,478
Df 2
Sig. 0,107
Heartbeat a Chi-square 5,142
Df 2
Sig. 0,076
Cough Chi-square 5,379
Df 2
Sig. 0,068
Cough a Chi-square 5,531
Df 2
Sig. 0,063
Pulmonary auscultation Chi-square 3,718
df 1
Sig. 0,054
Pulmonary auscultation a Chi-square 3,541
df 2
Sig. 0,170
edema in the legs Chi-square 0,724
df 1
Sig. 0,395
Edema in the legs a Chi-square 16,263
df 3
Sig. 0,001
Pulse fullness Chi-square 0,024
df 1
Sig. 0,876
Pulse fullness a Chi-square 0,650
df 1
Sig. 0,420
6 min. walk test Chi-square 1,756
df 1
Sig. 0,185
6 min. walk test a Chi-square 13,706
df 2
Sig. 0,001
FC Chi-square 0,414
df 2
Sig. 0,813
FCa Chi-square 6,687
df 3
Sig. 0,083
Initial compensation period Chi-square 7,212
df 3
Sig. 0,065

Table 5: Pearson chi-square tests.

Discussion

As can be seen from the tables above, during the study, the pulse and blood pressure readings, anamnesis, physical examination results of all patients, as well as the results of the 6-minute walking test were examined in detail by statistical analysis. Both qualitative and quantitative tests were used in statistical analysis. During the Wilxson test, statistical accuracy was obtained in the results of other indicators 6 months later, except for pulse fulness in group 1. p<0.05 Calculation of pulse fullness results 6 months before and after did not give statistically accurate results (p= 0.317). There are also positive changes in the comparison of pre- and post-treatment outcomes of patients in group 2. Thus, statistically accurate results were obtained. That is, positive results were obtained from the treatments carried out separately in both groups. An intergroup analysis of patients’ results was performed with the Mann- Whitney Test. Although statistical accuracy was not obtained in all indicators during this analysis, statistical accuracy was obtained in some indicators (history of shortness of breath, cough complaints, 6-minute walking test) as shown in Table 3. The most important of these is the acivite of patients and functional class indicator. The intergroup 6 minutes’ walk test index gave a statistically accurate result (p=0.000). The intergroup functional class index gave a statistically accurate result (p=0.017). In the Pearson Chi-Square Test, a qualitative analysis, no statistical accuracy was obtained in most indicators, nor in the functional class (p=0.083).

Conclusion

OIn summary, a statistical analysis of the results of our study concluded that the addition of sacubitril/valsartan complex to the treatment of patients had a better effect on the reduction of complaints in the anamnesis of patients, activity of patients and functional class performance than other treatments.

References