RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

1 / NAME AND ADDRESS OF THE CANDIDATE / Ms. KALAICHELVI. A
ACHARYA COLLEGE OF NURSING,
CHOLANAGAR, R. T. NAGAR POST, BANGALORE
2 / NAME OF THE INSTITUTION / ACHARYA COLLEGE OF NURSING, CHOLANAGAR,
R.T.NAGAR POST,BANGALORE 32.
3 / COURSE OF THE STUDY AND SUBJECT / M.Sc NURSING 1st YEAR
MEDICAL SURGICAL NURSING
4 / DATE OF ADMISSION TO COURSE / 26/10/2009
5 / STATEMENT OF THE PROBLEM / A STUDY TO EVALUATE THE EFFECTIVENESS OF STRUCTURED TEACHING PROGRAMME ON KNOWLEDGE REGARDING CARE OF PATIENT WITH AN IMPLANTED CRDIAC DEVICE AMONG STAFF NURSES WORKING IN SELECTED HOSPITALS, BANGALORE.

6. A BRIEF RESUME OF THE INTENDED WORK

“The intuitive mind is a sacred gift and the rational mind is a faithful servant”

-Albert Einstein.

INTRODUCTION

Globally, cardiovascular disease is the number one cause of death and in 2005 cardiovascular disease was responsible for approximately thirty percent of deaths worldwide. Cardiovascular disease is a broad term that encompasses such varied illnesses as coronary artery disease, peripheral arterial disease, cerebrovascular disease, rhythmic disorders, rheumatic heart disease, congenital heart disease, and congestive heart failure1.

Cardiac disease in India has quadrupled in the last 40 years and WHO estimated that by 2020 close to 60 percent of cardiac patients worldwide will be Indian. The established risk factors of cardiovascular disease include lack of exercise, poor diet, and smoking. Thecardiovascular crisis is glaringly evident in developing countries, and especially inIndia. While India is still trying to shake off diseases rooted in poverty, both their urban and rural areas are experiencing a mounting epidemic of cardiovascular disease2.

Cardiologists blame drop in age of heart disease affecting Indians to faulty food intake (including excessive consumption of milk products and junk food), sedentary lifestyle and stress. Genetic disposition of Indians has also been identified as a prime cause for early onset of cardiac problems. “Heart disease manifested almost a decade earlier in Indians than in other ethnic groups, thus contributing to the excessive long-term morbidity and higher cost of treatment3.

More than 80 million people worldwide have some form of cardiovascular diseases, as estimated by the American Heart Association. Sudden cardiac death accounts for 300,000 deaths in the US each year. Atrial fibrillation affects 10 million people worldwide4.

Prevalence of Congestive Heart Failure in India was 18.8 million Indians (1.76% of population), the Incidence rate was 1.57 million per year (0.15%). More than 1 million patients with heart failure are now eligible to receive device therapy. Prevalence of Congestive Heart Failure in the US was 4.8 million Americans (1.76% of population). In which 2% of age 40-59, 5% of age 60-69, 10% of age over 70. The Incidence rate was 432 thousand per year (0.15%)5.

As health professionals, our practice is constantly becoming more complex and diverse. We are also engulfed in technology in the pursuit of improving quality of life for our patients. Why? The answer is sudden cardiac arrests (SCA), also referred as sudden cardiac death. About 325,000 SCA occur annually in the United States, of which 163,221 SCA take place out-of-hospitals. An unusual rapid heart rate of unknown cause comes and goes, even when at rest. The result is a malfunction in the heart’s electrical system that leads to ventricular tachycardia and ventricular fibrillation, the immediate cause of SCA6.

It was estimated that 75% of SCA had a previous heart attack. Roughly 330,000 CHD deaths take place out-of-hospital annually. CHD is also the leading cause of death in women. Bradyarrhythmias account for approximately 20-30% of all SCA6.

Cardiovascular disease, now the leadingcause of death, strikes Indians early and kills many in theirproductive mid-life years. Deaths due to CVD, in the age groupof 35 to 64 years, resulted in 9.2 million potentially productiveyears of life being lost in 2000 and are expected to rise to aloss of 17.9 million years in 20307.

As per reports, the overall sales in the global market for cardiovascular devices in 2008 amounted to USDollar 76.7 billion, while the projected sales for 2010 are an estimated USDollar 86.4 billion. At a compound annual growth rate of 2.8 percent, year 2015 will witness sales of cardiovascular devices to be valued at a phenomenal USDollar 97.3 billion. Cardiac rhythm management and cardiovascular monitoring and diagnostic devices represent high growth opportunities for the overall cardiovascular devices market. The treatment and diagnosis of cardiovascular diseases have and will provide the requisite impetus for undisputed growth of the overall cardiovascular devices segment4.

Treatment of the cardiac diseases depends on the severity of the symptoms which the patient have. Drug therapy such as beta blockers, diuretics, digoxin will be prescribed for commencing stage of heart disease. Devices are often used in patients with heart failure to prolong life. Sudden cardiac death is caused by an abrupt arrhythmia that results in lack of blood flow to the brain and can result in death. This condition can be treated with an implantable cardiac defibrillator that will deliver a shock to the heart when it recognizes such a rhythm and shock the heart back into normal rhythm. Another device that has been recently used to treat heart failure is called a biventricular pacemaker. This is a device that is used in patients that have a bundle branch block. These devices have been shown to improve quality of life, exercise tolerance and mortality. Cardiac transplantation is done in patients with severe end stage heart failure8.

Patients with implanted cardiac devices constitute a growing segment of the contemporary healthcare practice. According to the American Heart Association, morethan 170,000 pacemakers and 30,000 implantable cardioverter-defibrillators (ICDs)are implanted in the United States each year9.

Since there were released the results of the Multicenter Automatic Defibrillator Implementation Trials (MADIT I and II), which found ICD treatment is superior to drug therapy for the treatment of ventricular arrhythmias, the number of implantations of ICDs has quadrupled 10,11.

In fact, pacemakers with biventricular pacing capability, some of them combined with ICD function, are now being implanted for New York Heart Association Class III and IV heart failure patients aiming to improve their quality of life and increase their life expectancy 12.

A recent study which pooled data from three trials of 1,080 patients found that cardiac resynchronization (biventricular pacemaker-based therapy) decreased the risk of death from progressive heart failure (often sudden death from lethal arrhythmias) or cardiac transplantation compared to the control group by 59%. 13

Similarly, recent data from the registry of the European Heart Rhythm Associationhave shown that, despite the fact that ICDs are underused in Europe; device implantation rate exhibits an increased trend in most European countries over the last few years 14.

A recent report in the premier medical journal, 60 percent of the world’s heart patients will be in India. The majority of these patients will suffer from cardiac arrhythmias, heart failure and coronary artery diseases. Implantable cardiac devices such as pacemakers, de-fibrillators, cardiac therapy devices and coronary stents play a major role in the treatment of these life-threatening conditions15.

The process of implanting these cardiac devices is complex and requires highly specialized and technically skilled practitioners., Medtronic has a mobile unitlaunched in 2004, which travels all over the United States, training health professionals. It has, so far, trained over 8,500 physicians, nurses and other health professionals via its mobile training unit.15

Division ofCardiology, Italy shows the statistical data of implantable cardiac devices. In which Implantable cardioverter-defibrillator implantation had done for 4692 patients in 2005 (44.2%), 5938 patients in 2006 (52.2%), 7324 patients in 2007 (55.7%). Single-chamber ICDs were implanted in 30.9, 31.0, and 28.5% of patients, dual chamber ICDs in 31.9, 31.5, and 31.7%, and biventricular ICDs in 37.2, 37.5, and 39.8%, respectively. The ICD implantation rate in Italy increased significantly in the period 2005-07. The registry showed a significant increase in prophylactic and biventricular ICD use, reflecting a favorable adherence to trials and guidelines in the clinical practice 16.

Taking care of such a rapidly growing patient population constitutes a challenge for all health care providers working in a cardiology ward, operating room or primary care practice. Nurses among them have a unique role by being the most appropriate persons to provide in-hospital and long term health care, education and psychological support to these patients 17.

6.1. NEED FOR THE STUDY

Cardiac diseases such as Ischemic heart disease, mainly heart attacks and coronary artery disease are the leading cause of mortality in the world, accounting for 7.1 million deaths in 2001. More than 80 per cent of these were in developing countries18.

India will carry 60 per cent of the world’s heart disease burden, nearly four times more than its share of the global population, according to a study. Adding to the burden is a higher incidence of the types of heart disease resulting in serious illness and mortality, and the fact that these conditions strike at an earlier age, says the study. Death rates are especially high among the country’s poorest residents, unable to get to hospital quickly in an emergency, or to afford routine treatments and surgery18.

Epidemiologists in India and international agencies have been sounding an alarmon the rapidly rising burdens of CVD for the past 15 years.They reported prevalence of coronary heart disease in adultsurveys has risen 4-fold over the last 40 years (to a presentlevel of around 10%), and even in rural areas the prevalencehas doubled over the past 30 years (to a present level of around4%). Cardiovascular disease is now the leading cause of death,accounting for 29% of all deaths in 2005. A verbal autopsy study conducted in 45 villages of a southernstate, the findings revealed that 32% of all deaths were due toCVD, outranking infectious diseases, which were responsiblefor 13%7.

Heart rhythm disorder comprises of fast heart rhythm known as tachycardia and slow heart rhythm known as bradycardia. In USA, more than 300,000 sudden cardiac deaths occur every year. In India with 1 billion populations, the incidence of cardiac disease especially coronary artery disease is very high. The sudden cardiac death in India is estimated to be much higher due to increased prevalence of coronary artery disease19.

Therefore there is an urgent need for specialty clinics to identify and treat these patients. Asian heart institute is fully equipped to treat the cardiac rhythm disorder, which is the predominant cause for sudden cardiac deaths. 19

The WHO estimates that, over the next10 years, India will lose 237 billion USDollars due to heart disease,stroke, and diabetes. The union budget presented by the Finance Minister of India,allocated 4 million U.S. dollars to aNational Program for the Prevention and Control of Diabetes,Cardiovascular Diseases, and Stroke.If these looming threats of escalating epidemics of diabetesand CVD are neglected, the adverse effects on development arelikely to be unaffordable for a country that is now on the fasttrack for economic development and aspires to be a major economicpower in the 21st century7.

Implanted cardiovascular devices represents a growing market within the medical technology and equipment segment because of continual increase in the number if people suffering from cardiovascular diseases and conditions. In addition, leading vendors worldwide are focusing more on research and development activities in this domain leading to development of exciting technologically advanced devices and techniques for treatment of cardiovascular diseases and conditions. This will not only guarantee strong revenue growth for the vendors developing these technologies, but also provide enhanced value to the patients as well as the cardiologists4.

The use of medical devices, such as cardiac pacemakers,prosthetic heart valves and vascular prostheses, has becomea routine treatment procedure in cardiovascular medicine. Unfortunately,bacterial infections of these devices are a serious and sometimeslife-threatening for the patient, necessitating explanation.Despite implementing different prophylactic strategies to avoidcontamination of the device, infections do occur20.

A study was conducted on hazards of Patients with active implantable cardiac devices and systems, the result showed due to mismanagement of the device about 41% are at risk of injury, and it could cause tissue damage resulting in severe injury or death. They concluded that health professionals especially nurse should be educated under in-service education program about management of patient with implanted cardiac devices21.

A recent study report of serious injury resulting from implanted cardiac defibrillators, Canada issued a Notice to Hospitals entitled "Important safety information regarding patients with implanted devices and implanted systems with leads". It warned about the risks of tissue overheating, serious injury and death in this group of patients. It suggested that all health professionals should be educated about care of patient with implanted cardiac devices 21.

A recent study report of rising rate of cardiac device infection, US reveals the infection rates vary between 2% and 8%. Treatment typically involves the removal of all implanted hardware, in addition to long-term antibiotic therapy. They concluded that beyond the highly specialized role of a pacemaker nurse, any nurse working in a primary health care setting should be familiar with at least some general aspects of the implanted cardiac device patients follow up care and provide counseling to this patient population 17.

Staff nurses’ play a major role in hospital and long-term care will ensure an uneventful procedure and a safe discharge as well as early detection of device malfunction and late complications. Education of the patient will prevent any self or environmental interactions which can adversely affect proper device function and will increase his or her adherence to the follow-up treatment. Finally, by providing psychosocial and emotional support the nursing staff can address the immediate concerns of the patient and help him or her cope successfully with the new life situation. Continuing education is extremely important for nurses counseling patients with implanted devices in order to play their role successfully as the continuous link to the multidisciplinary team of professionals that guide the oftentimes forgotten humanistic care of these patients 17.

All these above mentioned factors have urged the researcher to assess and educate the staff nurses knowledge about care of patient with implanted cardiac devices for patient wellbeing by using intervention based measures.

6.2 REVIEW OF LITERATURE

This chapter deals with the review of literature. Related literatures were reviewed to gain insight into the problem selected. The literature found useful has been presented in this chapter.

The results of studies conducted in various aspects on implanted cardiac device are presented below:

6.2.1. Review of literature related to prevalence of cardiac diseases

6.2.2. Review of literature related to implanted cardiac device and its management

6.2.3 Review of literature related to knowledge of staff nurses on care of patient with an implanted cardiac device

6.2.4. Review of literature related to effectiveness of structured teaching programme regarding care of patient with implanted cardiac device among the staff nurses.

6.2.1. Review of literature related to prevalence of cardiac diseases

A random survey was performed on prevalence of cardiac diseases in India. The result showed that by 2010 there will be close to 100 million heart patients in India. Now it is 30 million. They concluded that Cardiac diseases have nearly doubled in India, an alarming fact, considering that it has almost halved in Europe and the USA22.

A study was conducted on prevalence rates of cardio vascular disease in India. The result showed that the Challenge of Cardiovascular Disease 13.5% in India about 50 percent of related deaths occur among people younger than 70. They concluded that, the prevalence rates among younger adults (age group of 40 years and above) are also likely to increase 23.

A study was conducted on prevalence of heart attack in India. A survey performed in hospitals. The result showed that there are about 12% of people pertaining for heart attack, about 2000 implantable cardiac device procedures performed every year. They concluded that every year there are so many people complaining with cardiac diseases in which 80% of them are poor people 24.

6.2.2. Review of literature related to implanted cardiac device and its management

A study was conducted on a follow-up of patients with implantable cardioverter defibrillators in United States.Population of this study involves 381 patients who received an implantable cardioverter defibrillator were followed for up to 9 years. The result showed that the device was effective in preventing sudden cardiac death with survival rates of 97% at 3 years and 94% at 5 years. Complication rates were low. They concluded that implantable cardioverter defibrillators are effective for managementof serious ventricular dysrhythmias and also minimizing the mortality rates 25.

A study was conducted on Quality of life in patients with an implantable cardioverter-defibrillator in Delhi. The sample of the study was 80 patients by convenience sampling method.Questionnaire was given to assess the quality of life to all selected patients. The result showed that there is significant increase in quality of life of patient with implantable defibrillators up to 5 years. They concluded that implantable cardiac devices plays major role of increasing patient well being 26.

A comparative study was conducted on malfunctions of patient with implantable cardiac devices and patient with drug therapy for the treatment of congestive heart failure, rhythmic disorders in New York. Totally 738 patients were selected by simple random sampling method to assess the malfunctions over the period of 5 years by assessment tool and questionnaire. The result showed that Compared with medications (21%) for similar medical problems, these devices (38%) had efficacy and malfunction (complication) rates that are much better. They concluded that implanted cardiac devices are very effective in management of cardiac diseases 27.

6.2.3 Review of literature related to knowledge of staff nurses on care of patient with an implanted cardiac device

A survey was designed using a purposive sample of 152 nurses from cardiology areas in four large teaching hospitals and a 28-point postal questionnaire to explore knowledge of the device and its impact. The result showed that Knowledge of the device and its effects appeared poorly understood by all nurses, irrespective of additional qualifications, length of time since qualifying or area of work. They concluded that most subjects were not confident in their abilities to prepare patients for implant or life at home after implant and Lack of understanding may impair preparation of patients for implantation of or for living with an implantable cardioverter defibrillator28.