LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

EVALUATION OF FACTORS THAT INFLUENCE THE EFFECTIVENESS OF

REHABILITATION OF PATIENTS WHO PERFORMED RADIOFREUENCY

ABLATION

A Thesis

By

Nasser M. Abou Zaid

MEDICAL ACADEMY

FACULTY OF MEDICINE

DEPARTMENT OF REHABILITATION

Supervisor:

Ass. Prof. DR. JURATE SAMENIENE

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1. SANTRAUKA

Tyrimą atliko 6-ojo kurso medicinos fakulteto studentė Nasser Abou Zaid.

Pavadinimas: Pacientų,kuriems atlikta radiodažnuminė abliacija, veiksnių įtakojančių reabilitacijos

efektyvumą vertinimas.

Tyrimo tikslas: Įvertinti veiksnius, įtakojančius pacientų,kuriems atlikta radiodažnuminė abliacija,

pirmojo reabilitacijos etapo efektyvumą.

Uždaviniai:

1. Nustatyti lyties, amžiaus, ritmo sutrikimų, sisteminių ligų, ligos pradžios laiko įtaką pacientų radiodažnuminės abliacijos rezultatams

2. Nustatyti pacientų po radiodažnuminės abliacijos riziką fiziniam treniravimu, kuri įtakoja pirmojo reabilitacijos etapo efektyvumą

Metodai: duomenys buvo renkami iš kardiologijos klinikų ligos istorijų. Išanalizavome 40 pacientų ligos

istorijas Iš jų 47,5 proc. moterų ir 52,5 proc. vyrų. Tiriamųjų amžiaus vidurkis 60,8 metų Visiems pravestas aritmijų gydymo planas, neatsižvelgiant į jų kilmę (supraventrikulinė ar skilvelnė). Visi pacientams atliktas elektrofiziologinis ištyrimas ir radiodažnuminė abliacija. Analizavome šiuos ligos istorijos duomenis: lytį, amžių, hospitalizacijos priežastiss, širdies ir sisteminių ligų anamnezę, aritmijų atsiradimo laiką, EKG, elektrofiziologinio ir echokardiografinio tyrimo rezultatus bei RDA rezultatus. Duomenų apdorojimui buvo panaudota Chi-kvadrato statistinė analizė.

Rezultatai ir išvados: Nustatėme,kad gerą RDA rezultatą apsprendė jaunas pacientų vyrų amžius, ilgas

aritmijos periodas, nedidelis širdies nepakankamumo laipsnis pagal NŠA bei aritmijos pobūdis supraventrikulinė tachikardija. Pirmojo reabilitacijos etapo efektyvumas priklauso nuo nustatytos rizikos fiziniam treniravimui. Analizuojant duomenis nustatėme, kad kuo tiriamieji buvo jaunesni ir turėjo mažiau sisteminių ligų tuo jų buvo geresnė funkcinė būklė ir mažesnė rizika fiziniam treniravimui.

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2. SUMMARY

The research was done by 6th course medicine faculty student Nasser Abou Zaid.

Title: Evaluation of Factors That Influence the Effectiveness of Rehabilitation of Patients Who Performed

Radiofrequency Ablation.

Aim of the study: The aim of the study is to evaluate the factors that influence the effectiveness of first

stage of rehabilitation for patients who performed radiofrequency ablation.

Objectives: 1. To determine the influence of gender, age, rhythm disorders, systemic diseases, time of the

onset of the disease, on the outcome of RFA

2. To determine the risk of training of patient after RFA that influence the effectiveness of first stage of rehabilitation program.

Methods: Data were collected from cases histories from cardiology clinics. A 40 cases history has been

reviewed for patients who performed RFA (Mage 60.8 years, Female 47.5% and male 52.5%) as a

treatment plan for Arrhythmias regardless the origin of it (supraventricular or ventricular). All of them went through electrophysiological examination. The data collected from cases histories are: gender, age, hospitalization cause, anamnesis of cardiac and systemic diseases, time of onset of the diseases, ECG, electrophysiology and echocardiography results and result of RFA. Chi-square statistical analysis was used.

Results and conclusions: Young patients, males, long period of arrhythmia, low NYHA classification

value and patients with supraventricular tachycardia had better outcomes. The effectiveness of first stage of rehabilitation depends on risk of training of the patient. Risk is low when the patients are younger and have less systemic diseases.

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3. ACKNOLEDGEMENTS

Many thanks for Ass. Prof. Dr. Jurate Sameniene for helping me and lightening my way to do this research, as well as for the residents and the nurses in Cardiology and Rehabilitation Departments for their help.

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4. CONFLICTS OF INTEREST

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5. ETHICS COMIITTEE APPROVAL

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6. ABBREVIATIONS

IHD: Ischemic Heart Disease b/m: beat per minute

AIVR: Accelerated Idioventricular Rhythm RFA: radiofrequency Ablation

LV: Left Ventricular Failure

WPW: Wolff-Parkinson-White Syndrome ASD: Atrial Septal Defect

AF: Atrial Fibrillation AFL: Atrial Flutter

MI: Myocardial Infarction UAP: Unstable Angina Pectoris HR: Heart Rate

Premature Ventricular Complexes: PVC MET: metabolic equivalent

EF: Ejection Fraction HT: Hypertension

WPW: Wolf-Parkinson-White NYHA: New York Heart Association AHA: American Heart Association SVT: Supraventricular Tachycardia

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7. TERMS

Case History: a record of the patient’s medical history (patient’s personal information, complaints, drug

usage, illnesses, previous surgeries, diagnosis, prescriptions, etc.) kept by doctor or hospital.

Metabolic Unit or Metabolic Equivalence (MET) – is the ratio of metabolic rate to the ratio of resting

rate, in which we can estimate and classify the amount of energy of patient physical activity.

One MET = 𝐾𝑐𝑎𝑙

ℎ∗𝐾𝑔 , 0.9 MET is when the patient sleeping, 1 – 1.5 MET is during rest position, 1.6 – 2.9

MET for low intensity, 3 – 5.9 MET for moderate intensity, ≥ 6 MET for high intensity [26].

Ejection Fraction (EF) – impaired hemodynamic features of the heart, where less blood pumped from

heart due to left heart failure. Thus leads to pulmonary hypertension and later to right heart failure. Most common patients susceptible to decreased EF are elderly women, especially those with Hypertension (HT), obesity, inflammation, cardiac defect, and heart microvasculature dysfunction [27].

Functional capacity – is a test that uses instruments to help us to measure physical ability of the patient.

This test is done for many reasons, it helps in developing effective treatment program, it is very important in making a rehabilitation program and checking its efficacy. It is also needed to know if the patient is able to work or when he is able to work after injury [30].

New York Heart Association (NYHA) classification – was founded in 1928, it helps doctors to provide

quick assessment of the patients status with heart failure in daily clinical exercises. It consists of I, II, III and IV classes as shown in the table [28].

American Heart Association (AHA) Method for Risk Selection – an extensive method used to

determine stratification of training the patients. This method uses risk factors, exercise testing, and the symptoms of present heart disease. It has four classes A, B, C and D [31].

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8. INTRODUCTION

As the number of patients with heart rhythm disturbances increases, the number of Radiofrequency ablation (RFA) procedures increase, RFA is a treatment for all arrhythmias forms (Ventricular and Supraventricular Tachycardia); a treatment with RFA has shown better results in prevention of disability, restore of function and distress relieving in arrhythmic patients. This operation is an Electrophysiological operation [5], usually done by making an isolation of pulmonary vein by method called ‘wide antral circumferential ablation’ [6].

It has been shown that for more than six months after the operation, they were emotionally, and physically better, but they should also do a routine examination and investigation for their health to detect early any impairment [4]. Rehabilitation and increase physical capacity after RFA is very important to improve patients’ quality of life [18].

Results showed that patients with long-term arrhythmia, DM, COPD, heart or valvular defect and NYHA classification are at low chance for good results. However, predictors such as gender, age, duration of rhythm disorder, hypertension, low ejection fraction, antiarrhythmic drug therapy, paroxysmal or chronic atrial fibrillation and past cardiac surgery have been the direct cause of sudden death [9].

To study more the factors that influence the outcome of RFA, we reviewed cases histories for patients who performed RFA no matter what the cause is and started first stage of rehabilitation program. We estimated factors such as gender, age, cardiac and systemic diseases, time of onset of the arrhythmia, ECG, echocardiography and electrophysiology results and NYHA classification. This made it possible to evaluate the factors that influence the outcome of RFA and compare these factors with results after RFA (succeeded or not succeeded). In addition, it helps us to determine the training groups (low risk, intermediate risk and high-risk training) for next rehabilitation stage according to factors such as NYHA classification, Ejection Fraction, and symptoms during first rehabilitation program. In other word, the better we choose these groups the better effectiveness we will get.

The aim of this study is to evaluate the factors that influence the effectiveness of rehabilitation of patients who performed RFA.

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9. AIM AND OBJECTIVES

Aim of the study: The aim of the study is to evaluate the factors that influence the effectiveness of first

stage of rehabilitation for patients who performed radiofrequency ablation.

Objectives: 1. To determine the influence of gender, age, rhythm disorders, systemic diseases, time of the

onset of the disease, on the outcome of RFA

2. To determine the risk of training of patient after RFA that influence the effectiveness of first stage of rehabilitation program.

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10. LITERATURE REVIEW

10.1 Ischemic Heart Disease

IHD is when blood flow and O2 supply to an area of myocardium decrease. Atherosclerosis of Coronary

artery is the most common cause of ischemia of myocardium, where the region supplied by the atherosclerotic coronary artery will have less blood and oxygen supply. The most common cause of death, disability and endured economic cost of illness is IHD. It is a common and serious disease in United States, where more than 13 million have IHD, more than 6 million of them presented with angina pectoris and the rest with Myocardial infarction (MI) [1].

According to the Hygiene Institute of Health Information Center, the Cardiovascular System in Lithuania causes death more than half of all other illnesses and incidence of Rhythm and Conduction disorders in 2014was about 108,000 of the population of Lithuania [10].

IHD risk factors are type II DM, obesity, and insulin resistance [1]. Clinical signs depend on severity of Atherosclerosis whether it affects the hemodynamics of coronary artery or no. IHD is presented in a variety of clinical manifestations: MI, angina pectoris, arrhythmias, acute coronary heart disease, conduction abnormalities or heart failure [11]. Postmortem studies show that atherosclerosis in coronary artery begins before age 20 and is prevalent among people who were asymptomatic. These patients may not show any clinical manifestation of myocardial ischemia, it can be detected only by exercise stress test or coronary angiography where we can find macroscopic scars due to MI in an area affected by occlusion of coronary artery, which supply this area. In other word, IHD can be symptomatic or asymptomatic. Myocardial ischemia can cause a syndrome called Angina Pectoris. This syndrome affects mostly males (more than 70% of patients with angina pectoris) most of them under 50 years old. It is well known that females are usually presented with atypical symptoms of angina pectoris [1]. Patients are usually presented with chest pain, dyspnea [12], beneath the sternum with clenched fist (Levine’s sign), then radiates to shoulders or both arms [1].

Unstable angina pectoris is (UAP) is another acute coronary artery caused by thrombosis or atherosclerotic plaque rupture. The onset of UAP is due to thrombosis in 10 to 80% of the patients, in this case an urgent percutaneous coronary intervention is needed. This will prevent exacerbation of the UAP to MI [13]. UAP is characterized by unpleasant sensations or pain in chest; on ECG, we see ST elevation and / or T wave inversion [1].

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MI occur when the coronary artery is totally or subtotally occluded due to thrombus or atherosclerotic plaque erosion [14]. In Europe 1/6 males and 1/7 females with MI will die because of it [15]. It can be with ST elevation or without. MI leads to myocardium necrosis, therefore an increased in cardiac biomarkers will increase [14]. Major complications that occur after MI are arrhythmia, pericardium rupture, or septal rupture [11].

10.2 Rhythm Disorders

Tachyarrhythmias is a form of tachycardia that have reentrant circuits or myocardial foci. Tachycardia is when Heart Rate (HR) is more than 100 b/m [2]. In USA, 600,000 people die because of heart failure and 50% of cardiac problems patients die suddenly because of arrhythmia [16]. Symptoms of Tachyarrhythmias may include: dizziness, dyspnea, increased HR, palpitations, fainting or even sudden death. Most commonly diagnosed by ECG or 24-hour Holter monitor. Tachycardia is originated from 2 abnormalities: problem in impulse propagation and/or formation of the impulse. Causes of arrhythmia are mainly divided into two categories: supraventricular (sinus tachycardia, atrial fibrillation and flutter, AV nodal tachycardia, WPW syndrome) and ventricular (ventricular premature complexes, AIVR, ventricular tachycardia, dilated or hypertrophic LV).Other causes: drugs (digoxin toxicity, flecainide), genetic predisposition (long and short QT syndromes) and IHD [2].

Atrial fibrillation is the most common clinical manifestation of arrhythmia; it affects 2.3 million of US citizens and 4.5 million in European Union. The onset of AF in patients aged 75 years is 5% and for patient aged 85 is 15%. It can start with other clinical manifestation of arrhythmia as atrial flutter (AFL) [17]. Ventricles respond irregularly to AF, where HR can reach 200 b/m [2].

AFL is a very fast atrium activity 260-300 b/m, with slower response of ventricles (2.1) [2]. In Lithuania, the onset of AFL in young people is 0.2% and in patients above 65 years is 0.9%. Male/female ratio is (2.5/1) [10].

Premature Ventricular Complex (PVC) is a form of ventricular arrhythmia, originates from Purkinje fibers results in wide QRS complex duration. It happens typically when getting old and in case of heart defect [2].

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10.3 RFA as Treatment for Arrhythmia

Disturbed heart rhythm can be treated pharmacologically and non-pharmacologically. It shows that treatment for arrhythmia pharmacologically has limited effect or in most of the cases is ineffective, it may cause proarrhythmia or drug toxicity, while non-pharmacological therapy such as RFA, implantable cardioverter defibrillator has more effect and success rate to treat arrhythmia [19]. When the procedure starts an electrophysiological study made before ablation to determine the location and mechanism of arrhythmia, then the doctor burns the cardiac tissue that causes arrhythmia. Therefore, no more electrical activity will be generated from this area and heart rate will be restored. Patients can go home next day if there were no complications. RFA has showed good results in treating arrhythmia and making patient’s life better no matter what the cause of arrhythmia is [4]. It should be done in experienced centers, because not all cardiac centers are able to perform it [3]. In case of rhythm disorder recurrence, the procedure need to be performed again, this can happen in 40% of the cases [21]. Some complications can happen after the procedure at very low rate (3.5%) [22] such as recurrent arrhythmia, hypercoagulability. Women are at high risk in complication more than men [8], and sudden death. They took in consideration long time monitoring for patients with Chronic Obstructive Pulmonary Disease (COPD), Diabetes Mellitus (DM), valvular heart disease or significant ventricular arrhythmia because they are at higher risk for complications and for failure of RFA [9].

After RFA the patient can be discharged next day, they will be advised to take anticoagulative drugs (low molecular weight heparin and warfarin) to avoid complications related coagulation. They should take in consideration that INR should be more than two. The patient also should continue taking the anti-arrhythmic drugs that were taken before the procedure for 8-12 weeks after RFA. A routine checking after the procedure in less than 3 months to check if there is recurrence of arrhythmia. Others complications after RFA could be: phrenic nerve palsy, deep vein thrombosis, atrioesophageal fistula, embolus that may lead to stroke or transient ischemic disease, pericardial effusion, pulmonary vein thrombosis or even death [22]. The successfulness of RFA with good results in case of atrial fibrillation is 70 – 75% after one single procedure, this rate increase till 85 – 90% after the second RFA procedures due to relapsed arrhythmia [36].

10.4 Rehabilitation of cardiovascular patients after RFA

Previously, medicine was consisting of diagnosis, treatment and prophylaxis. This was enough for patients with acute illnesses, but for chronic diseases, the efficacy was less and social functions of the patients was

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disturbed. This led to increase using of rehabilitation therapy and restore lost functions (physically and emotionally). Rehabilitation as a term was first used in 1946 by congress in Washington. It is the final treatment stage. Rehabilitation is different from country to another depending on economy, cultures, and health care system traditions and insurance [24].

Cardiac rehabilitation is indicated for patients who has cardiac diseases as secondary prevention. It includes patient education about cardiovascular risk factors reduction, stress management and physical activity. It is recommended by the international guidelines to increase quality of life and decrease morbidity and mortality [34].

Fig. 1 - Core components of cardiac rehabilitation.

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At the present time, cardiovascular rehabilitation is widely used and more organized. Therefore, the effectiveness of rehabilitation increased among individuals with valvular or congenital heart disease, chronic heart failure and coronary artery disease patients. According to European Association of Cardiovascular Prevention and Rehabilitation, it is recommended when the patients start cardiovascular rehabilitation, the exercise training and physical activity should be formulated according to intensity, frequency, safety during exercise, time and type of physical activity and volume (duration X intensity) [33].

It is recommended by the European Society of Cardiology to start cardiac rehabilitation after RFA, because it is very important to improve mental health and psychological problems, decrease hospital stay or admission and exercise capacity more than 38% according to some studies. Thus, leads to improve outcome of the procedure, quality of life of the patient, make him more productive in his society and reduce the costs of healthcare. Usually patients who have AF have low quality of life and after RFA and some of them are afraid to start the rehabilitation program. Rehabilitation consists of patients’ education, physical exercises and psychological support. Patients with pericarditis and heart defect takes longer in rehabilitation program due to complexities of the diseases, they need more psychoeducation and longer hospitalization [23].

10.5 Cardiac Rehabilitation in Lithuania

In Lithuania, the rehabilitation physical training such as activities, massage, breathing exercises with presence of psychological education. This psychophysical education can change muscles tone, increase active attention, self-control, develop of willingness and proper reaction to stimuli [24]. Cardiac Rehabilitation in Lithuania has three stages. First stage starts in in-patient department and lasts for 3-5 days. During this stage, the patient will undergo some basic physical training and prepare him for the next stage, where he will be determined in which training group will be, this selection happen according to Ejection Fraction, NYHA classification, and workload in metabolic equivalent (MET). Patients will be monitored according to vital signs (heart rate, respiratory rate, oxygen saturation, and blood pressure), ECG, and general appearance. Second stage will be in department of rehabilitation sanatorium or outpatient rehabilitation. The participants in this stage are the patient and his family and rehabilitation team consist of exercise specialist, doctors, mental health specialists, nurses, dietitians, physical and occupational therapists. Here the rehabilitation program goals will be determined. The patients will start exercise training in which they will determine the symptoms-limited exercise training before rehabilitation

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program starts, they will be monitored according to vital signs, and determine what limits the patients training like comorbidities. The physicians then will make an exercise prescription for the patients, which include duration (e.g. 20-40 min), intensity (50-80%), frequency (e.g. 2-6 days per week), modalities (e.g. treadmill, climbing stair), and progression. During this stage and recovery period, increasing of physical activity may cause rapid fatigue and insomnia. Therefore, the patient may experience anxiety, depression, negative attitude to physical activity and alexithymia. For these reasons, the patient as well as his family member should know the cause of heart problem and its course, risk factors of it and the need to change life style, the purpose of rehabilitation program, drugs usage and their side effects, diet change, increase physical activity and symptoms that may occur during physical effort. The third stage will be at home and the participants in this stage are the patient, his family and the family medicine doctor. During this recovery period, the patient will live and change his life style according to rehabilitation program and doctor prescriptions. The patient should visit family medicine clinic regularly to check his recovery progression and to do routine laboratory test or radiologic imaging. Also, during this period, the patient will be more socially active and get family and friends encouragement [25].

10.6 Risk of training of the patient

A safe physical training increase quality of life, aerobic capacity and cardiac function of the cardiovascular patients. If these exercises were done regularly it also improve psychological status, decrease risk factors of cardiovascular diseases, decrease mortality and sudden death rate, positively influence the outcome of surgery. It is very important to describe the nature and effects of training for the patients. To do that it is first recommended to evaluate the level of risk of training to avoid any cardiac risk stratification which may become critical and to target the appropriate patient for the appropriate rehabilitation program. To determine the risk of training of the patient we must first evaluate functional and clinical status of the patient beginning from physical and clinical history, laboratory and other tests. Then the patients are classified as low, moderate or high risk for training. Different criteria are used to evaluate the risk such as American College of Sports Medicine (ACSM), American Heart Association (AHA), American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and others. Every protocol uses different criteria such as Ejection Fraction, symptoms of metabolic, cardiovascular, respiratory diseases and Functional capacity using the metabolic equivalent (MET). For example if the protocol is using symptoms and ejection fraction the risk will increase when there is more symptoms and low ejection fraction value [31].

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11. RESEARCH METHODOLOGY AND METHODS

Research Planning

This research was conducted at Rehabilitation clinics at Lithuanian University of Health Sciences (LUHS) Hospital. The study was started after getting approval from bioethics committee at (LUHS) and approval from the director for public health, research and studies of the LUHS Hospital to get access on the hospital’s archives and patient’s cases histories. We used cases histories of the patients to get information about medical history and test results. The Confidentiality and personal data of the patient was treated carefully.

The objects of the study

Objects of the study are patients of LUHS Hospital rehabilitation clinics who suffered from cardiac rhythm disorders and who performed RFA as treatment for it. The patients performed RFA in 2017 and started first stage of rehabilitation in in-patient rehabilitation clinics during the study.

The objects selection

The selection of objects was based on patients who performed RFA due to heart rhythm disorders and started first stage rehabilitation in in-patients department of rehabilitation in LUHS Hospital. A population of 40 patients were selected (21 male (52.5%) and 19 Female (47.5%), Mage 60.8 years). One of them was

with Wolf-Parkinson-White (WPW) syndrome. All of the patients performed Electrophysiological investigations.

Research Methods

The data were collected from cases histories of the patients. The information needed from cases histories are the following: gender, age, hospitalization cause, cardiac diseases, the time when arrhythmia started for the first time, systemic diseases, ECG abnormalities, electrophysiology results, echocardiography results and the results of RFA (successful, not successful).

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We divided the patients according to the result of RFA into two categories: 1. successful results are patients who performed RFA and arrhythmia disappeared. 2. Unsuccessful results are patients who performed RFA and arrhythmia remained.

The first step we should do is to use this information to be able to classify the patients according to NYHA classification guidelines in order to determine patient’s ability to do physical activity in present of cardiac disease. The selection of patients according to NYHA classification is explained in table 1.

Table 1 - The New York Heart Association Classification system

[29] Claire Raphael, Cathy Briscoe, Justin Davies, Zachary Ian Whinnett, Charlotte Manisty, Richard Sutton, Jamil Mayet, and Darrel P Francis. Limitations of the New York Heart Association functional classification system and self‐reported walking distances in chronic heart failure. Heart. 2007 Apr; 93(4): 476–482.

We also divided the patients according to AHA guidelines which is useful to determine the risk of training of the patient in the second stage of rehabilitation in outpatient rehabilitation center. The selection of patients to which training group they belong is briefly explained in the following tables 2 and 3.

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Table 2 – The AHA criteria for risk stratification (Class A and B).

Class A

This classification includes:

• A1: Children, adolescents, men < 45 years old, and women < 55 years old who have no symptoms or known presence of heart disease or major coronary risk factors.

• A2: Men ≥ 45 years old and women ≥ 55 years old who have no symptoms or known presence of heart disease and with < 2 major cardiovascular risk factors.

• A3: Men ≥ 45 years old and women ≥ 55 years old who have no symptoms or known presence of heart disease and with ≥ 2 major cardiovascular risk factors.

Class B

This classification includes individuals with any of the following diagnoses:

• B1: CAD (MI, CABG, PTCA, angina pectoris, abnormal exercise test, and abnormal coronary angiograms) whose condition is stable and who have the clinical characteristics outlined below. • B2: Valvular heart disease, excluding severe valvular stenosis or regurgitation with the clinical

characteristics outlined below.

• B3: Congenital heart disease; risk stratification for patients with congenital heart disease should be guided by the 27th_{Bethesda Conference recommendations*.}

• B4: Cardiomyopathy: EF < 30%; includes stable patients with heart failure with clinical characteristics as outlined below, excluding hypertrophic cardiomyopathy or recent myocarditis. B5: Exercise test abnormalities that do not meet any of the high-risk criteria outlined in class C below.

Clinical characteristics (must include all of the following)

Clinical characteristics according to additional tests. They should check all the clinical features present.

1. New York Heart Association class 1 or 2 2. Exercise capacity ≤ 6 METs

3. No evidence of congestive heart failure

4. No evidence of myocardial ischemia or angina at rest or on the exercise test at or below 6 METs 5. Appropriate rise in systolic blood pressure during exercise

6. Absence of sustained or nonsustained ventricular tachycardia at rest or with exercise 7. Ability to satisfactorily self-monitor intensity of activity

[32] Anne Kastelianne França da Silva, Marianne Penachini da Costa de Rezende Barbosa, Aline Fernanda Barbosa Bernardo, Franciele Marques Vanderlei, Francis Lopes Pacagnelli, Luiz Carlos Marques Vanderlei. Cardiac risk stratification in cardiac rehabilitation programs: a review of protocols. Rev Bras Cir Cardiovasc vol.29 no.2 São José do Rio Preto Apr./June 2014

Class A represent Healthy people who have no symptoms or presence of cardiac disease and have two or less cardiovascular risk factors.

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Class B represent low risk people who have work load ≥ 6 METs, No symptoms, EF≥50%

Table 3 - The AHA criteria for risk stratification (Class C and D).

Class C

This classification includes individuals with any of the following diagnoses: • C1: CAD with the clinical characteristics outlined below.

• C2: Valvular heart disease, excluding severe valvular stenosis or regurgitation with the clinical characteristics outlined below.

• C3: Congenital heart disease; risk stratification for patients with congenital heart disease should be guided by the 27th_{Bethesda Conference recommendations.}

• C4: Cardiomyopathy: EF 30%; includes stable patients with heart failure with the clinical characteristics outlined below, excluding hypertrophic cardiomyopathy or recent myocarditis. • C5: Complex ventricular arrhythmias not well controlled.

Clinical characteristics (any of the following): 1. NYHA class 3 or 4.

2. Exercise test results

• Exercise capacity 6 of METs

• Angina or ischemic ST depression at a workload of 6 METs

• Fall in systolic blood pressure below resting levels during exercise • Nonsustained ventricular tachycardia with exercise

3. Previous episode of primary cardiac arrest (ie, cardiac arrest that did not occur in the presence of an acute myocardial infarction or during a cardiac procedure).

4. A medical problem that the physician believes may be life- threatening.

Class D

This classification includes individuals with any of the following: • D1: Unstable ischemia.

• D2: Severe and symptomatic valvular stenosis or regurgitation.

• D3: Congenital heart disease; criteria for risk that would prohibit exercise conditioning in patients with congenital heart disease should be guided by the 27th_{Bethesda Conference recommendations.}

• D4: Heart failure that is not compensated. • D5: Uncontrolled arrhythmias.

• D6: Other medical conditions that could be aggravated by exercise.

[32] Anne Kastelianne França da Silva, Marianne Penachini da Costa de Rezende Barbosa, Aline Fernanda Barbosa Bernardo, Franciele Marques Vanderlei, Francis Lopes Pacagnelli, Luiz Carlos Marques Vanderlei. Cardiac risk stratification in cardiac rehabilitation programs: a review of protocols. Rev Bras Cir Cardiovasc vol.29 no.2 São José do Rio Preto Apr./June 2014

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Class C represents moderate risk people who have work load ≤ 6METs, ST elevation ≥ 2mm, EF-35-45%, Angina with moderate or intense exercise, History of congestive heart failure, NYHA II.

Class D represents high risk people who have not compensated heart failure, NYHA III, IV, ischemia at low level of exercises, uncontrolled arrhythmia, EF ≤ 35%.

Methods of Data Analysis

The data of the research were analyzed by the Statistical Package for Social Sciences (SPSS) version 24. Chi-square statistical analysis was used. Data were presented in bivariate tables and analyzed as percentages. Significant results were Considered if P value < 0.05.

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12. RESULTS AND THEIR DISCUSSION

12.1 - To determine the influence of gender, age, rhythm disorders, systemic diseases, time of the onset of the disease on the outcome of RFA:

We divided our patients into 2 groups according to age groups, group 1 are people  59 years old and group 2 are people > 59 years old. From all over population, 72,5% had successful RFA results while only 27,5 had unsuccessful results. For patients with successful results, 44,8% are in group 1 and 55,2% are in group 2. For patients with unsuccessful results only 18,2% are in group 1 and 81,8% are in group 2. In age group 1, 86.6% had successful results and 13.4% had unsuccessful results. While in age group 2, 64% had successful results and 36% had unsuccessful results (Table 4).

Table 4 – results of RFA according to age groups

Age groups

group 1 group 2 Total N Row N % N Row N % N Row N % Results of

RFA

successful 13 44,8 16 55,2 29 100 unsuccessful 2 18,2 9 81,8 11 100

2_{=2,42, p=0,12}

From these results, we conclude that patients who are  59 years old had better outcome after RFA and more successful results compared with the patients who are > 59 years old.

For patients with successful results, 44,8% were female and 55,2% were male. While for unsuccessful results, 54,5% were female and 45,5% were male. In female patients, 68,4% had successful results and 31,6% had unsuccessful results. In males patients, 76,1% had successful results and 23.9% had unsuccessful results (Table 5).

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Table 5 – results of RFA according to gender

gender female male N Row N % N Row N % Results of RFA successful 13 44,8% 16 55,2% unsuccessful 6 54,5% 5 45,5% 2_{=0.3, p=0,58}

According to these results, we can see that male patients had better outcome and results compared with the female patients where the rate of success was lesser.

Based on study was done in Italian centers about the influence of age and gender on complications of RFA, it was found that elderly (> 60 years old) patients and females has the higher risk of post procedural complications. If the age > 80 years old, incidence of complications was higher. In females, incidence of complications was 2 times higher than in men, this may be due to higher levels of anti-coagulations and small vessels and body size [35]. Therefore, this study confirms our results.

Patients were divided into 2 groups according to their systemic diseases. Group 1 are patients who have hypertension and dyslipidemia, while group 2 are patients who have hypertension, dyslipidemia and other systemic diseases (diabetes mellitus, metabolic syndrome, obesity, renal failure, COPD, hypothyroidism and pneumonia). Patients who had successful results were 72,2% and they belong to group 1, in group 2 only 27,6% had successful results. On the other hand, patients who had unsuccessful results were 81,8% in group 1 and 18,2% were in group 2 (Table 6).

Table 6 – results of RFA according to systemic diseases

Systemic diseases group Group 1 Group2

Count Row N % Count Row N % Results of

RFA

Successful 21 72,4% 8 27,6% unsuccessful 9 81,8% 2 18,2%

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We conclude that, there is not too much effect of systemic diseases on the outcome of RFA.

Patients were separated into 3 groups according to duration since arrhythmia started until they performed RFA. In group 1 are patients who had arrhythmia for less than 1 year, in group 2 are patients who had arrhythmia for less than 2 years and in group 3, for 3 years and more. For patients with successful results, 24,1% were in group 1, 31,0% were in group 2 and 44,8% were in group 3. While for those who had unsuccessful results, 45,5% were in group 1, 18,2% were in group 2 and 36,4% were in group 3 (Table 7).

Table 7 – results of RFA according to duration of arrhythmia

Duration of Arrhythmia

Group 1 Group 2 Group 3 Count Row N% Count Row N% Count Row N % Results of

RFA

Successful 7 24,1% 9 31,0% 13 44,8% unsuccessful 5 45,5% 2 18,2% 4 36,4%

2_{=1,82, p=0,4}

We can see that patients who had arrhythmia for 1 year and less had more unsuccessful results compared with the other 2 groups and those who had arrhythmia for 3 years and more had more successful results. We analyzed whether patients’ heart insufficiency influences the effectiveness of the RFA or no. Group 1 represents patients who are determined for NYHA classification I, group 2 represents those with NYHA classification II and group 3 for those with NYHA classification III. Patients with successful results, 6,9% of them were in group 1, 62,1% in group 2 and 31,0% in group 3 while, for patients with unsuccessful results, 9,1% were in group 2 and the rest in group 3 (Table 8).

Table 8 – results of RFA according to NYHA classification

NYHA classification

Group 1 Group 2 Group 3 count Row N% count Row N% count Row N% Results of

RFA

Successful 2 6,9% 18 62,1% 9 31,0% unsuccessful 0 0,0% 1 9,1% 10 90,9%

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According to these results we conclude that patients with heart insufficiency who are determined with higher NYHA classification value are at higher risk to have unsuccessful RFA outcome compared to patients who are determined with lower NYHA classification value, where they were at low risk to have unsuccessful RFA outcome.

We divided patients according to the Rhythm Disorders they are suffering from, for group 1 are patients with atrial fibrillation, for group 2 are patients with ventricular extrasystole and group 3 with supraventricular tachycardia. In patients with successful results 89,3% are in group 1 and only 10,7% in group 3. For those with unsuccessful results 63,6% are in group 1, 18,2% are in group 2 and 18,2% in group 3 (Table 9).

Table 9 – results of RFA according to Rhythm Disorders

Rhythm Disorders

Group 1 Group 2 Group 3 count Row N% count Row N% Count Row N% Results of

RFA

Successful 25 89,3% 0 0,0% 3 10,7% Unsuccessful 7 63,6% 2 18,2% 2 18,2%

2_{=6,06, p=0,048}

We can conclude that patients who had ventricular extrasystole had no successful outcome. Patients who had atrial fibrillation had more unsuccessful and successful results this may be due to the huge number of patients who performed RFA due to atrial fibrillation and for those with supraventricular tachycardia, it seems that there is no effect on the outcome of RFA.

According to study was done about predictors of sudden death and bad outcome after RFA they found that direct predictors for sudden death and bad outcome in patients with AF after AV node ablation and permanent pacing are NYHA functional class (≥II), COPD, aortic stenosis, aortic regurgitation, mitral stenosis, DM while, indirect predictors for sudden death and bad outcome was ablation time, cardiac surgery, duration of AF, low left ventricular ejection fraction, cycle length or duration of AF, antiarrhythmic drug therapy, hypertension, Q-Tc interval, , diagnosis of paroxysmal or chronic AF, cardiac diseases and bundle branch block [9]. This study confirms our results except in systemic diseases we found that it has no effect on RFA outcome, but we conclude that patients which are determined with higher NYHA classification value are at higher risk for unsuccessful RFA outcome.

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12.2 To determine the risk of training of patient after RFA that influence the effectiveness of first stage of rehabilitation program:

We studied the risk of training of the patient according to age groups. Group 1 represents patients  59 years while group 2 represents patients > 59 years old. 100% of patients with mild risk training was from group 1. For moderate risk, 40% were from group 1 and 60% from group 2. In severe risk training, 27,8% were from group 1 and 72,2% were from group 2 (Table 10).

Table 10 – results of risk of training of the patients according to age group

Age group

Group 1 Group 2

Count Row N% Count Row N% risk of training of the patients Mild 2 100,0% 0 0,0% Moderate 8 40,0% 12 60,0% Severe 5 27,8% 13 72,2% 2_{=4,11, p=0,12}

Here we can conclude that the risk of training of the patients who are  59 years old is less than patient who are > 59 years old.

We analyzed the risk of training of the patients according to systemic diseases. Here Group 1 represents patients with hypertension and dyslipidemia, while Group 2 are patients with hypertension, dyslipidemia and other systemic diseases. 100% of the patients in mild training group are in group 1. For moderate training group, 77,8% were in group 1 and 22,2% were from group 2, while for severe training group, 70% were from group 1 and 30% were from group 2. Here we can see that patients with hypertension and dyslipidemia alone have mild to high risk of training of the patients while for patients with hypertension, dyslipidemia and other systemic diseases have moderate to high risk of training of the patients (Table 11).

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Table 11 – results of risk of training of the patients according to systemic diseases

Systemic diseases

Group 1 Group 2

Count Row N% Count Row N% risk of training of the patients Mild 2 100,0% 0 0,0% Moderate 14 70,0% 6 30,0% Severe 14 77,8% 4 22,2% 2_{=1,007, p=0,64}

We conclude that the more systemic diseases the patient have the higher risk of training of the patient will be.

We studied the risk of training of the patients according to duration of arrhythmia. Group 1 represents patients who had arrhythmia for less than 1 year, while Group 2 those who had it for less than 2 years and Group 3 patients who had arrhythmia for 3 years and more. In mild risk of training 50,0% were in Group 1 and the other in group 3. For moderate risk training 30,0% were in group1, 35,5% in group 2 and the rest in group 3 while for high risk training 27,8% were in group 1, 22,2% in group 2 and 50,0% in group 3

(Table 12).

Table 12 – results of risk of training of the patients according to duration of arrhythmia

Duration of Arrhythmia

Group 1 Group 2 Group 3 Count Row N% Count Row N% Count Row N% risk of training of the patients Mild 1 50,0% 0 0,0% 1 50,0% Moderate 6 30,0% 7 35,0% 7 35,0% Severe 5 27,8% 4 22,2% 9 50,0% 2_{=1,96, p=0,74}

We see that patients with AF, ventricular extrasystole and SVT in mild and moderate risk of training were almost in equal distribution. Patients with the most higher risk of training were with SVT.

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A safe physical training increase quality of life, aerobic capacity and cardiac function of the cardiovascular patients. If these exercises were done regularly it also improve psychological status, decrease risk factors of cardiovascular diseases, decrease mortality and sudden death rate, positively influence the outcome of surgery. To do that it is first recommended to evaluate the level of risk of training to avoid any cardiac risk stratification which may become critical. Different protocols are used to determine the risk of training [31]. In this study with used the AHA protocol to evaluate the risk. We found that when patient is younger  59 years and has less cardiovascular symptoms or systemic diseases (such as COPD which can limit the physical training and may be critical) the risk of training was low. We also studied the risk of training according to arrhythmia disorders, we found that in SVT patients was the highest risk of training therefore more monitoring and carful rehabilitation program selection are required.

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13. CONCLUSIONS

1. Young patients, males, long period of arrhythmia, low NYHA classification value and patients with supraventricular tachycardia had better outcomes compared with old patients, females, short period of arrhythmia, high NYHA classification value and patients with atrial fibrillation and ventricular extrasystole. Systemic diseases such as COPD, DM, hypertension have no influence on RFA outcome. 2. The effectiveness of first stage of rehabilitation depends on risk of training of the patient. Risk is low when the patients are younger and have less systemic diseases. The risk will increase if the patients are older, has SVT as a rhythm disorder.

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15. ACCESSORIES

Here is the list of information that we took from cases history: 1- Age:   59 years  > 59 years 2- Gender:  Male  Female 3- Systemic Diseases:  Hypertension  COPD  DM  Dyslipidemia  Other: ………. 4- Duration of Arrhythmia:  < 1 year  < 2 years

 3 years and more.

5- NYHA Classification Value:  I  II  III. 6- Rhythm Disorders:  Atrial Fibrillation  Ventricular Extrasystole  Supraventricular Tachycardia.

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7- To determine the risk of training of the patients we needed:  EF Percentage

 Symptoms in Presence of Heart Diseases  Severity of IHD

LITHUANIAN UNIVERSITY OF HEALTH SCIENCES