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Short term follows up for changes in anginal symptoms after receiving enhanced external counter pulsation in patients with 3vessels disease treated

medically versus percutaneous coronary intervention

Ali Yahya Abdullah Alsallami1, Ahmed Mohamad Mechi2, Khalid amber3

1Assistant professor in interventional cardiology, Iraq, University of Kufa, Medical College, Department of cardiology, Email: [email protected], Orcid: https://orcid.org/0000-0001-7653-9203

2M.B.Ch.B, Cardiology Fellow, Kufa University, College of Medicine, Najaf Center for Cardiac Surgery &

Interventional, Email: [email protected], https://orcid.org/0000-0003-4682-1392

3M.B.Ch.B; F.I.C.M.S (Medicine), Consultant cardiology, Head of AL NAJAF cardiac center, Email:

[email protected], https://orcid.org/0000-0002-4254-6525 Email: [email protected]

Abstract

Background: Refractory angina usually refers to as (equal or more than 3 months in duration) stable ischemic heart disease which cannot be regulated by a therapeutic treatment, surgical cardiac intervention, and where reversible cardiac ischemia has been stated to be the reason for the manifestation clinically. Aim: The efficacy of use enhanced external counter pulsation in treating refractory angina pectoris in those do PCI vs. medical alone and short-term outcome. Patient and method: 91 patients with refractory angina pectoris un respond to treatment and/or intervention or unfit for intervention or surgery have been enrolled in this study, for all ECG, echocardiography study done to assess LV and valvular function, Doppler study for lower limb artery to assess if there is peripheral vascular disease, abdominal ultrasound done to exclude the presence of aortic abdominal aneurysm, then if patient eligible for EECP inclusion criteria refer for EECP unit. After end of all session all patients assess improvement according to change in Canadian cardiovascular society grading CCS pre and post EECP and on follow up 6 month and 1 year. Result: Over 12 month’s period of the study, 91 persons were assessed including 32(35%) women and 59 (65%) men. The age range was 45 years to 80 years with the mean age range 61 years (SD ± 8.2). Most patients treated with 30 session with 1 hour per session on average of 26 (SD ± 7) session with response rate at end of sessions 88.7% where response mean improvement of symptom and according to (CCS) change per and post EECP. Conclusion: The main conclusions can be stated as follows:

(1) No befit from doing single vessel intervention in patient with 3 vessels disease in improving response to EECP or improving echocardiographic parameter.

(2) EECP appear as safe effective therapy in selective patient with refractory angina not respond to medical and unfit for intervention or surgery.

(3) Response to EECP in well selected patient persists for 1 year.

Keywords: enhanced external counter pulsation, adult coronary heart disease, interventional cardiology

Introduction

Refractory angina usually refers to as (equal or more than 3 months in duration) stable ischemic heart disease which cannot be regulated by a therapeutic treatment, surgical cardiac intervention, and where reversible cardiac ischemia has been stated to be the reason for the manifestation clinically [1]. External Enhanced Counter pulsation is non-invasive therapy include putting external compressive sleeves for the calves, upper and lower thighs followed by consecutively blowing up them with beginning them from distally to proximally with time of heart cycle.

Transforming an impact resemble to that produced from an intra-aortic balloon pump, the sleeves are blow nearby beginning of diastole to increase venous return furthermore coronary perfusion, and discharged in systole to diminish fundamental vascular opposition, improving cardiac workload and systemic perfusion. Therapy is done 1 to 2-hour sessions over a several weeks which approximate to 35 hours totally. The action mechanism by which counter pulsation has been exhibits to enhance the function of endothelium [5-7] to diminish vascular stiffness [4,8-9]

and to flow of friction reserve and collateral blood flow [10-11] as well as promotion of

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peripheral vascular extension caused by blood flow, and additionally influencing endothelial determined vasoactive factors by decreasing proinflammatory cytokines and induction turnover of nitric oxide [2-3,9].The Worldwide EECP tolerant Registry explored cardiac failure patients (who with ejection fraction equal or less than 35 percent) accompanied with refractory angina furthermore detected upgrades for angina population, decreasing nitroglycerin utilization and life quality later termination of therapy. These impacts were preserved in a considerable ratio of patients after following up for three years [10, 12-13]. However, there is a bulk of studies of EECP have examined its using of EECP in cases of stable angina instead of refractory angina and, due to the intervention nature, EECP is restricted by a sum of contraindications which may include coagulation disorders with an international normal ratio of more than 2.5, severe chronic obstructive lung disease, cardiac arrhythmias, venous disease, severe peripheral arterial disease [11]. However, EECP has been revealed reduction of hospitalization fees that will serve to encourage EECP adoption going forward [14]. Equivalent to the progresses in cardiovascular carefulness, there is a growing of patients’ amount, mainly individuals with progressive coronary artery sickness, carries extreme manifestations caused by angina pectoris that not respond for ideal therapeutic treatment [15]. The modern treatments for refractory angina include medications (such as Ivabradine and Ranolazine), noninvasive treatment compromise enhanced external counter pulsation (EECP) and extracorporeal shockwave cure, invasive therapy, neuro- modulation, and others [16-17]. As indicated nowadays scientific revisions, noninvasive EECP has been confirmed to be a hopeful therapy for angina relieve caused by firm coronary artery illnesses [18]. EECP method, a noninvasive and nonpharmacological outpatient management, has been accepted by the Food and Drug Administration (FDA) in United States in patients with unstable or stable angina pectoris, congestive cardiac failure, cardiogenic trauma and intense myocardial infarction [19]. Nowadays the EECP technique is utilized for angina patients unqualified for routine medical treatment who are not hopeful for further revascularization methods and those desired to suspend invasive therapy. A lot of trials have confirmed that EECP lessened symptoms of angina by protracted total occlusions [20-21], advanced satisfaction of life quality [21-22], improved exercise tolerance 21-24 and also increased the time to training provoked depression of ST-segment23-25 and to enhance perfusion of myocardium [23-24]. The instrument underlying the profit of EECP-derived is under assessment, which may be included the possible mechanisms include endothelial function enhancement, improvement of collateralization, atherosclerosis declining, and peripheral ‘‘training impacts’’ resemble for exercising [19]. The intense hemodynamic impact resulted shear pressure that may cause enhancement of production of powerful elements of vasodilatation which include nitric oxide and prostacyclin from endothelial cells [26]. Several studies approved that there was increased quantity of nitric oxide and reduction of the brain natriuretic peptide and serum enthelin-1 concentration following EECP treatment [24-26]. Sessa et al. [27] established that prolonged practicing of exercise stimulates synthesis of nitric oxide gene expression and production of coronary nitric oxide in model of dogs. This procedure may have been started following EECP with enriching their training tolerance. Masuda et al., exhibited an increment in both resting furthermore post practice perfusion which may be enhance indirectly through creation preexist collaterals or opening new ones by expanded trans myocardial stress gradients throughout EECP [28-29]. EECP-enhanced promotions in periphery of endothelial function furthermore rigidity of arteries should lead to an important decrease in left ventricular after load and thusly, a decrease in oxygen gas needing of myocardial tissue. We have achieved 2 revisions exploring whether these EECP-induced decreases in after load of left ventricle are definitely connected with

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perfection in keys of myocardial oxygen request in coronary artery disorders patients with manifestations of chronic cardiac ischemia [30].

Aim of study

The efficacy of use enhanced external counter pulsation in treating refractory angina pectoris in those do PCI vs. medical alone and short-term outcome

Patient and method

518 patients with refractory angina pectoris un respond to treatment and/or intervention or unfit for intervention or surgery have been selected to enter in this study, all these persons had been selected from those patients visit the cardiology consult department in Al-Najef cardiac center or from private clinic from the period January 2018 to December 2019, all patients how been selected to enter in this study undergo coronary angiography through femoral access and those with 3 vessels diseased patients where significant coronary stenosis (>70 %) in each vessel (opinion of two specialist) have been enrolled in this study and the patients divided in two group, first group those with 3 vessels disease and unfit for intervention or surgery, second group those with 3 vessels and can do percutaneous coronary intervention for one or two vessels then those patients do PCI reassess for ischemia symptom after 6 weeks and only patients with persistent ischemic symptomatic post PCI enrolled in this study where those improve symptom after PCI excluded from study, at the end only 91 patients were enrolled in this study including 48 patients in first group and 43 patients in second group ,both group refer to EECP after 8 week from coronary angiography. All patients treated according to guidelines and refer to EECP according to it, from all patients agree to enter in this research counsel have been taken. For all patient's data collected about age, sex, blood pressure, laboratory finding of glucose, renal function, complete blood count have been done. This patients includes 59 male and 32 female was involve in this prospective, randomized non-blind control trail, there age range from 45 to 80 year, symptomatic angina despite medication and/or intervention, for all ECG, echocardiography study done to assess LV and valvular function, Doppler study for lower limb artery to assess if there is peripheral vascular disease, abdominal ultrasound done to exclude the presence of aortic abdominal aneurysm, then if patient eligible for EECP inclusion criteria refer for EECP unit.

After end of all sessions all patients assess improvement according to change in Canadian cardiovascular society grading CCS pre and post EECP and do echocardiographic examination on follow up 6 month and 1 year, at follow up by clinical visit or telephone attachment, 31 patients miss contact and 3 patients die at period 2-8 months after end of session and 4 patients no tolerated session so stop prematurely and excluded from data analysis and only 53 patient complete 1 year follow up as seen in algorithm 1. In EECP unit we have 20 EECP device (Vasomedical, Inc., Westbury, New York) each one compose of an air compressor that attach to pneumatic cuffs and control by computer system, also each device have figure plethysmography for monitor systolic and diastolic pulse wave and transmitted to computer, the pneumatic cuff applied to lower limb and inflated sequentially during diastole with pressure 250-300 mmHg for few second by computer control which detect diastole by ECG or figure plethysmography monitor, each session duration 1 hour and most patient’s should complete 30 session if tolerated, before assessment for response and the need for extension of session.

Inclusion criteria

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Patient with refractory angina pectoris are not-responds to medication and/or intervention or unfit for intervention/surgery.

Exclusion criteria

1. Severe peripheral vascular diseased 2. Abdominal aortic aneurysm

3. Severe aortic regurgitation 4. Uncontrolled hypertension

5. Uncontrolled congestive heart failure

6. Within 2 week from angiography from femoral access 7. Thrombocytopenia and bleeding tendency

8. Deep vein thrombosis 9. Significant varicose vein

Statistical analysis

We use paired student t test and chi square test for both continuous variables and categorical variables, p value < 0.05 was regards as statistical significance. We use mean, with stander deviation to describe categorical variables and t test for continuous variables as blood pressure before and after intervention, calculations done by EXCEL Microsoft 2016 software.

Algorithm 1 patient selection for study and 1 year follow up

52patientsdo PCI 48 patients with 3VD unfit for intervention or surgery 518 patients with refractory angina coronary angiography

9 patients do PCI and improve symptom of

angina

43 patients do PCI and still have symptom of angina

91 patients do EECP Reassessment for angina symptom

From PCI group 18 loss of contact 2 die

From medical group 13 loss of contact 4 stop session early 1 die

23 patients do PCI and complete EECP with 1 year follow up

30 patients on medical therapy and complete EECP with 1 year follow up AFTER 1 YEAR FOLOW UP

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Results

Over 12 month’s period of the study, 91 persons were assessed including 32(35%) women and 59 (65%) men. The age range was 45 years to 80 years with the mean age range 61 years (SD ± 8.2), demographic data seen in table 1. Most patients treated with 30 session with 1 hour per session on average of 26 (SD ± 7) session with response rate at end of sessions 88.7% where response mean improvement of symptom and according to (CCS) change per and post EECP.

We found no deference between PCI group and angiography only group in responding to EECP or improvement on echocardiographic parameter as it is not statistically significant (p-value = 0.

87, p-value = 0.47) as seen in figure 1 and 2. The response to EECP was not statistically (p-value

= 0.185) affected by sex as seen in figure 3. The smoking not statistically (p-value = 0.67) affect the response of patients to EECP as seen in figure 4. The age appear as not statistically significant (p-value < 0.26) in response rate of patients to EECP as seen in figure 5.

Hypertension appear to be non-effluence in response patients to EECP as it not statistically significant (p-value = 0.4) as seen in figure 6. Surprisingly that diabetes observe as no influence in response to EECP as it not statistically significant (p-value = 0.12) as seen in figure 7.

Figure 1: Relation of PCI group and angiography only group in response to EECP, P-value = 0.

87

Figure 2: Relation of PCI group and angiography only group in response to echocardiography parameter, P-value = 0.4

0 5 10 15 20 25 30

respond not

Chart Title

pci angiography

0 5 10 15 20

respond in echocardiography

parameter

not

Chart Title

PCI angiography

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Figure 3: Sex and response to EECP, P-value = 0.185

Figure 4: Smoker response to EECP, P-value = 0.67

Figure 5 age and response to EECP, P-value < 0.26

RESPOND NOT RESPOND

FEMAL 6 2

MAL 41 4

0 5 10 15 20 25 30 35 40 45

FEMAL MAL

RESPOND NOT RESPOND

SMOKER 20 2

NON SMOKER 27 4

0 5 10 15 20 25 30

SMOKER NON SMOKER

RESPOND NOT RESPOND

<65 28 5

>65 19 1

0 5 10 15 20 25 30

<65 >65

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Figure 6 hypertension and response to EECP, P-value < 0.4

Figure 7 diabetic and response to EECP, P-value < 0.12 Table 1: Demographic data

Discussion

Most patients in this research have diffuse coronary disease confirmed by angiography some do intervention and other was beyond or unfit for it, so as they with refractory angina and unreasoned to medication they referred to EECP and in this research we found dramatic symptomatic response to this type of therapy specially that most patient was in CCS3 and CCS4.

0 5 10 15 20 25 30 35

RESPONS NOT REPONSE

hypertesion

response to EECP

0 5 10 15 20 25 30 35

respons not respons

dabetic

response to EECP

sex Male (59) Female(32)

age 45-80

No of session 26.1(SD ± 8.2) hypertension 36

diabetic 33

smoker 22

Do angiography 50

Do PCI 24

Respond to EECP 47

death 3

complicated session 4

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After the end of EECP sessions most patients improve in their symptom from CCS3 and CCS4 to CCS1 and CCS2 and this in concomitant with MUST-EECP [31]. Also we observe that this improvement in symptom persist in follow up till the end of year of follow up in majority of patients and this in concomitant with other research [32-34] and most patients with CCS4 get response that no patient in 1 year follow up enter this stage as most patients remain in CCS2 and to lesser extend in CCS3 [35], and that why we found dramatic improve in quality of life in our patients. Decrease in symptom (CCS) may appear without increment in myocardial perfusion, and the initial advantage of this therapy can related to secondary action comparable to those of physical rehabilitation [36]. The mode of action of persist long-term benefits are multi-factorial and include refinement in the endothelial function, angiogenesis, exercise training effect, and neurohormonal modulation [37-38]. The International EECP Patient Registry (IEPR) [39]

reported sustained improvement in angina and quality of life in the majority of patients over a 2- year period, an observational study has reported that the benefits may be sustained for 5 years [40]. In this research we found no deference in response for EECP and in echocardiographic parameter in those how do PCI or not after angiographic confirm 3 vessel disease. In our research we observe that diabetic and nondiabetic patients show significant refinement in symptom and quality of life with after EECP therapy as observe by other research [41-42].

Conclusion

1.No befit from doing single vessel intervention in patient with 3 vessels disease in improving response to EECP or improving echocardiographic parameter

2.EECP appear as safe effective therapy in selective patient with refractory angina not respond to medical and unfit for intervention or surgery.

3.Response to EECP in well selected patient persist for 1 year

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35. Lawson WE, Hui JC, Cohn PF. Long-term prognosis of patients with angina treated with enhanced external counter pulsation: fiveyears follow-up study. Clin Cardiol2000;23:254-258.

36. Pettersson T, Bondesson S, Cojocaru D, Ohlsson O, Wackenfors A, Edvinsson L. One- year follow-up of patients with refractory angina pectoris treated with enhanced external counter pulsation. BMC Cardiovasc Disord2006;6:28.

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38. Masuda D, Nohara R, Hirai T, Kataoka K, Chen LG, Hosokawa R, Inubushi M, Tadamura E, Fujita M, Sasayama S. Enhanced external counterpulsation improved myocardial perfusion and coronary flow reserve in patients with chronic stable angina; evaluation by(13)N- ammonia positron emission tomography. Eur Heart J 2001;22:1451-1458.

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41. Lawson WE, Hui JC, Cohn PF. Long-term prognosis of patients with angina treated with enhanced external counter pulsation: fiveyears follow-up study. Clin Cardiol2000;23:254-258.

42. Urano H, Ikeda H, Ueno T, Matsumoto T, et al. Enhanced External Counter pulsation Improves Exercise Tolerance, Reduces ExerciseInduced Myocardial Ischemia and Improves Left Ventricular Diastolic Filling in Patients With Coronary Artery Disease. J Am Coll Cardiol, 2001;

37(1):93-99.

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