Download Randomized trial of Rotational Atherectomy Versus Balloon

PROFORMA FOR REGISTRATION OF SUBJECT FOR DESSERTION
SUBMITTED BY:
MS SONAL SHARMA.
1st yr. M. Sc. (Nursing)
MEDICAL SURGICAL NURSING
2012-2014 BATCH
SARVODAYA COLLEGE OF NURSING
0
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
PROFORMA FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
1.
NAME OF THE CANDIDATE AND
ADDRESS
2.
NAME OF THE INSTITUTION
3.
COURSE OF THE STUDY AND SUBJECT
4.
DATE OF ADMISSION OF COURSE
5.
TITLE OF THE TOPIC
6.
BRIEF RESUME OF THE INTENDED
WORK
6.0 Introduction
Enclosed
6.1 Need for the study
Enclosed
6.1.1 Statement of the problem
Enclosed
6.2 Review of related literature
Enclosed
6.3 Objectives of the study
Enclosed
6.3.1 Operational definitions
Enclosed
6.3.2 Assumptions
Enclosed
6.3.3 Hypothesis
Enclosed
6.3.4 Sampling Criteria
Enclosed
(Inclusion and Exclusion criteria)
6.3.5 Delimitations
Enclosed
MATERIALS AND METHODS
7.1. Sources of data: The data will be collected from the students who are studying for 2nd
7.
MS. SONAL SHARMA
IST YEAR MSC NURSING
SARVODAYA COLLEGE OF NURSING.
AGRAHARA DASARAHALLI ,MAGADI
MAIN ROAD ,BANGALORE
SARVODAYA COLEGE OF NURSING
IST YEAR MSC NURSING
Medical Surgical Nursing.
11 -06-2012
“A Study to assess the effectiveness
of structured teaching programme on
knowledge regarding newer modalities of
Angioplasty among students at selected
schools of nursing, Bangalore.”
and 3rd year General Nursing and Midwifery course (GNM) in selected schools of
nursing at Bangalore.
7.2.Method of data collection: Self Administered questionnaire
7.3 Does the study require any investigations or interventions to be conducted on the patients or
other humans or animals? No
7.4. Has ethical clearance been obtained from your institution? Yes
8
LIST OF REFERENCES
Enclosed
1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1.
NAME OF THE CANDIDATE AND
Ms SONAL SHARMA.
IST YEAR MSC NURSING
ADDRESS
SARVODAYA COLLEGE OF NURSING.
MAGADI
MAIN
ROAD
AGRAHARA
DASARAHALLI ,BANGALORE
2.
NAME OF THE INSTITUTION
SARVODAYA COLLEGE OF NURSING
3.
COURSE OF THE STUDY AND
IST YEAR MSC NURSING
SUBJECT
MEDICAL SURGICAL NURSING
4.
DATE OF ADMISSION OF COURSE
5.
TITLE OF THE TOPIC
11-06-2012
“A Study to assess the effectiveness of
structured teaching programme on
knowledge regarding newer modalities of
Angioplasty among students at selected
schools of nursing, Bangalore.”
2
BRIEF RESUME OF INTENTED WORK
6.0 INTRODUCTION
"The devil has put a penalty on all things we enjoy in life. Either we suffer in health
or we suffer in soul or we get fat."
Albert Eisntein
Health is related deeply to life-style. Ideal health will however, always
remains a mirage, because everything in our life is subject to change. Health may be
described as a potentiality—the ability of an individual or a social group to modify
himself or itself continually, in the face of changing conditions of life not only, in order
to function better in the present but also to prepare for the future.1
The heart is a muscular organ, that is about the size of owns fist. It pumps
blood around body and beats approximately 70 times a minute. After the blood leaves
the right side of the heart, it goes to lungs where it picks up oxygen. The oxygen-rich
blood returns to heart and is then pumped to the organs of body through a network of
arteries. The blood returns to heart through veins before being pumped back to lungs
again. This process is called circulation. The heart gets its own supply of blood from a
network of blood vessels on the surface of heart, called coronary arteries.2
Cardiovascular disease refers to any disease that affects the cardiovascular
system, principally cardiac disease, vascular diseases of the brain and kidney, and
peripheral arterial disease. The causes of cardiovascular disease are diverse
but atherosclerosis and hypertension are the most common. Over time, the walls of
arteries can become furred up with fatty deposits, This process is known as
atherosclerosis and the fatty deposits are called atheroma. Coronary arteries become
3
narrow due to a build-up of atheroma, the blood supply to heart will be restricted. This
can cause angina (chest pains).If a coronary artery becomes completely blocked, it can
cause myocardial infarction (Heart attack).3
Cardiovascular diseases remain the biggest cause of deaths worldwide,
though over the last two decades, cardiovascular mortality rates have declined in many
high-income countries. At the same time, cardiovascular deaths and disease have
increased at a fast rate in low- and middle-income countries. Coronary heart disease
(CHD) is the UK's biggest killer, around one in five men and one in seven women die
from the disease. CHD causes around 94,000 deaths in the UK each year. In the UK,
there are an estimated 2.6 million people living with the condition and angina affects 2
million people. CHD affects more men than women, and with age it increases.(2,3)
Percutaneous coronary intervention (PCI), commonly known as coronary
angioplasty or Percuteneous Transluminal coronary angioplasty(PTCA), is a nonsurgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart
found in coronary heart disease. These stenotic segments are due to the build up of
cholesterol-laden plaques that form due to atherosclerosis. angioplasty is a relatively new
procedure introduced in the late 1970's by Andreas Gruentzig. During PCI, a cardiologist
feeds a deflated balloon or other device on a catheter from the inguinal femoral artery or
radial artery up through blood vessels until they reach the site of blockage in the heart.
X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is
inflated to open the artery, allowing blood to flow. A stent is often placed at the site of
blockage to permanently open the artery. This allows more blood and oxygen to be
delivered to the heart muscle. When successful, PTCA can relieve chest pain of angina,
improve the prognosis of patients with unstable angina, and minimize or stop a heart
4
attack without having the patient undergo open heart coronary artery bypass graft
(CABG) surgery.4
Various new technical devices are available for effective angioplasty.
These include the use of the excimer laser for photo ablation of plaque (blockage) and
rotational atherectomy (use of a high-speed diamond-encrusted drill) for mechanical
ablation of plaque with or without stent. Both are very effective for complicated disease
conditions of arteries.
Laser angioplasty is similar to balloon angioplasty, but instead of a balloon
tipped catheter, one with a laser at the tip is used. The laser is guided to the blockage,
then used to destroy the plaque layer by layer vaporising it into gaseous partical. This
technique utilizing a laser coupled to a catheter which is used in the dilatation of
occluded blood vessels. This includes laser thermal angioplasty where the laser
energy heats up a metal tip, and direct laser angioplasty where the laser energy
directly ablates the occlusion. One form of the latter approach uses an excimer laser
which creates microscopically precise cuts without thermal injury. Current evidence
on the safety and efficacy of percutaneous laser coronary angioplasty is adequate to
support the use of this procedure in carefully selected patients for whom
conventional angioplasty would otherwise be technically difficult. Percutaneous laser
coronary angioplasty has been used for CAD with severe stenosis or atherosclerotic
occlusion, when standard techniques for recannalisation are unlikely to succeed or
have failed. . This procedure is often used with adjunctive balloon angioplasty and
followed by angiography to document the results (5, 6)
5
Percutaneous transluminal coronary rotational atherectomy (PTCRA) is
one of the newer cardiac interventional devices introduced to relieve the burden of
coronary artery stenoses by myocardial revascularisation and was devised to improve
upon existing percutaneous coronary revascularization procedures. High-speed rotational
atherectomy was introduced in the early 1980s by David Auth. Percutaneous
transluminal coronary rotational atherectomy (PTCRA) is a similar technique to
coronary angioplasty. However, rather than using a balloon and a stent to expand the
artery, a small diamond cutter is first used to remove the fatty deposit that is blocking the
artery It is usually used when the coronary artery has a high level of calcium in it.
Calcium makes the artery very hard and can prevent balloons or stents expanding
properly to relieve the narrowing. Once the small diamond cutter has been used, the
artery is then treated with balloons and stents as normal.7
Rotational atherectomy works by debulking plaque and calcified lesions into
small particles (approximately 5 micrometers) which pass into the capillary circulation,
where they are thought to be scavenged by the reticuloendothelial system. The device
itself consists of a brass burr coated with diamond chips measuring 30 to 120 mcm in
diameter. Available in various sizes from 1.25 to 2.50 mm, the burr is selected to match
the diameter of the vessel being treated. The burr is welded to a drive shaft. On rotation,
the burr selectively removes hard tissue, soft tissue being deflected by the elastic recoil
of normal segments of vessel. The device was developed in the late 1980s Ritchie
1987; Ahn 1988; Hansen 1988a; Hansen 1988b and first used in humans shortly
thereafter Erbel 1989a; Erbel 1989b;Fourrier 1989.
Following local anesthesia, sheaths are inserted into the femoral artery
and vein. An appropriately shaped, large lumen guiding catheter with side-holes is
6
positioned in the ostium of the coronary artery. If the lesion to be treated is located in the
right coronary or a dominant left circumflex coronary artery, a temporary pacing
electrode is positioned in the right ventricular apex. Under fluoroscopy, the steerable
guidewire is advanced through the stenosis and directed into the distal part of the
coronary artery. The device is then advanced along the guidewire and placed just above
the stenosis. If resistance is encountered, shown by a fall in rotational speed (as
measured in revolutions per minute), the tip is withdrawn slightly and then advanced
again in order to maintain the high speed rotation Ramsdale 1997.3
NEED FOR THE STUDY
Coronary heart disease (CHD) is the single largest cause of death in the
developed countries and is one of the leading causes of disease burden in developing
countries. In 2001 there were 7.3 million deaths due to CHD worldwide. Three-fourths
of global deaths due to CHD occurred in the low- and middle-income countries.(2)
Cardiovascular disease (CVD) currently accounts for nearly half of noncommunicable
diseases (NCDs). NCDs have overtaken communicable diseases as the world's major
disease burden, with CVD remaining the leading global cause of death, accounting for
17.3 million deaths per year, a number that is expected to grow to >23.6 million by
2030.8
Cardiovascular diseases are major causes of mortality and disease in the
Indian subcontinent, causing more than 25% of deaths. It has been predicted that these
diseases will increase rapidly in India and this country within the next 15 years.
Coronary heart disease and stroke have increased in both urban and rural areas. The
anticipated rise in CVD mortality, based solely on demographic shifts of population age
7
profile, is staggering. It has been projected, for example, that mortality attributable to
“circulatory system diseases” in India would rise by 103% in men and by 90% in women
during the period 1985 to 2015.21 By 2015, these diseases are expected to account for
34% of all male deaths and 32% of all female deaths in India.9
Angioplasty having some advantage over traditional practices .It is successful
in getting rid of chest pain and in preventing a heart attack or death. It is an easier
procedure, Recovery is much shorter and less painful, requiring a one- or two-day
hospital stay, compared to a stay for a week or more for bypass surgery. Some hospitals
are now performing angioplasty on low-risk patients in the morning and sending them
home the same day. Angioplasty can be performed under local anaesthesia, as opposed
to general anaesthesia, which is needed for bypass surgery. There are more risks
associated with general anesthesia.The chest do not need to be opened, an advantage that
substantially reduces pain, recovery time, and scarring. There is no need to use a heartlung machine; this type of machine makes bypass surgery easier to do but increases the
possibility of stroke.10
Failure to cross a chronic total occlusion with a guide wire accounts for 80% of
unsuccessful procedures. This limitation is extremely important because all currently
available devices require initial crossing of the occlusion with a guide wire. Preliminary
data suggest that several rotational, laser, and ultrasound devices maybe capable of
recanalizing 30-50% occlusions resistant to PTCA guide wires. Treatment options for
patients with CAD with severe stenosis or occlusion include thrombolysis, percutaneous
balloon angioplasty, stent placement, percutaneous cutting balloon or coronary artery
bypass grafting. Very often, over time what initially is deposited as relatively soft,
cholesterol-rich atheromatous material hardens into a calcified atherosclerotic plaque.
8
Such atheromas restrict the flow of blood, and therefore often are referred to as stenotic
lesions or stenoses, the blocking material being referred to as stenotic material Rotational
angioplasty procedures are a common technique for removing such stenotic material.
Such procedures are used most frequently to commence the opening of calcified lesions
in coronary arteries. Often the rotational angioplasty procedure is not used alone, but is
followed by a balloon angioplasty procedure. This, in turn, may frequently be followed by
placement of a stent to assist in keeping the artery open. Rotational angioplasty devices
were utilized in removing the excessive scar tissue from the stents and, thereby were
useful in restoring the patency of the arteries. Percutaneous laser coronary angioplasty has
been used for CAD with sever stenosis or atherosclerotic occlusion, when standard
techniques for recannalisation are unlikely to succeed or have failed.(11 ,12)
A study was conducted to make comparison
either excimer laser or
rotational atherectomy can improve the initial angiographic and clinical outcomes
compared with balloon angioplasty alone, 685 patients with symptomatic coronary
disease warranting elective percutaneous revascularization for a complex lesion were
randomly assigned to balloon angioplasty (n=222), excimer laser angioplasty (n=232), or
rotational atherectomy (n=231) results showed patients who underwent rotational
atherectomy had a higher rate of procedural success than those who underwent excimer
laser angioplasty or conventional balloon angioplasty (89% versus 77% and
80%, P=.0019), but no difference was observed in major in-hospital complications
(3.2% versus 4.3% versus 3.1%, P=.71). At the 6-month follow-up, revascularization of
the original target lesion was performed more frequently in the rotational atherectomy
group (42.4%) and the excimer laser group (46.0%) than in the angioplasty group
9
(31.9%, P=.013) Procedural success of rotational atherectomy is superior to balloon
angioplasty.13
A study was conducted on the mechanisms and clinical results of excimer
laser coronary angioplasty (ELCA) versus rotational atherectomy (RA), both followed
by adjunct PTCA; 119 patients (158 ISR lesions) were treated with ELCA+PTCA and
130 patients (161 ISR lesions) were treated with RA+PTCA. Quantitative coronary
angiographic and planar intravascular ultrasound (IVUS) measurements were performed
routinely. In additi on, volumetric IVUS analysis to compare the mechanisms of lumen
enlargement was performed in 28 patients with 30 lesions (16 ELCA+PTCA, 14
RA+PTCA).Despite certain differences in the mechanisms of lumen enlargement, both
ELCA+PTCA and RA+PTCA can be used to treat diffuse ISR with similar clinical
results.14
A study conducted on the limitations of balloon angioplasty stimulated
the development of alternative revascularization approaches such as laser angioplasty.
PTCA is best suited for the treatment of discrete atherosclerotic stenoses, with lower
success rates and more difficult application in patients with diffuse atherosclerotic
disease or total occlusions . In contrast to balloon angioplasty where the plaque material
is compressed or displaced, laser angioplasty ablates the plaque material . This bulk
removal of plaque material could improve acute procedural success rates, decrease
complication rates, treat "untreatable" lesions, and decrease restenosis rates. Because
laser energy can vaporize atherosclerotic plaque, there may be no requirement for a
preexisting channel, and therefore laser angioplasty may have a high success rate for the
10
treatment of coronary occlusions. This applicability for the treatment of diffuse
atherosclerotic disease would offer treatment opportunities currently unavailable with
conventional bypass surgery or angioplasty. 15
An experimental study was conducted to assess the learning needs of the nursing
students on the care of patient with heart failure. An online interactive heartfailure
module was developed and integrated into a medical-surgical nursing course to
assist students in learning how to care for patients with heartfailure. The purpose of this
study was to examine whether the integration of an online heart failure module improved
baccalaureate nursing student’s knowledge on self-management of heart failure. Among
235 students, significant improvement of heart failure of knowledge on self-management
of heart failure was observed. Students had problems mastering knowledge of weight
monitoring, use of nonsteroidal anti-inflammatory drugs, symptoms to report to
physicians, and potassium-based salt substitutes. These findings were similar to four
studies examining nurses' knowledge of heart failure. Students and nurses have difficulty
mastering similar heart failure education concepts. An additional strategy, such as
simulated or case scenarios, needs to be developed to help nurses and nursing
students master all key concepts of heart failure self-management.16
So the above studies show that, In future India will host half of the
cases of CVD in world. mortality and morbidity rates are very high due to incidences
and prevalence of cardiovascular diseases .For reducing the incidences of mortality and
morbidity due to CVD the health care perssonel must have the knowledge regarding
advanced care and newer modalities of treatment of cardiovascular diseases With the
newer modalities like rotational and laser angioplasty it becomes more effective and
11
successful, because these techniques enhance the approach of angioplasty in complex
coronary disease. So it is necessary to impart the knowledge regarding these newer
modalities among nursing students to improve the quality of nursing care rendered by
them in future.
6.2 REVIEW OF LITERATURE
A review of literature on the research topic makes research familiar with
the existing studies & provides information which to base knowledge, it creates accurate
picture of the foundation.
The literature for present study is organized under the following headings:
LITERATURE RELATED TO,
1. INCIDENCE AND PREVELANCE OF CARDIO VASCULAR DISEASE
2. LITERATURE RELATED TO NEWER MODALITIES OF ANGIOPLASTY
(ROTATIONAL ANGIOPLASTY AND LASER ANGIOPLASTY)
3. LITERATURE RELATED TO
STUDENTS KNOWLEDGE REGARDING
NEWER MODALITIES OF ANGIOPLASTY
1. INCIDENCE & PREVELENCE OF CARDIO VASCULAR
DISEASE
There is a wide disparity in prevalence and cardiovascular
disease mortality in different Indian state.
A study was conducted to determine
significance of various nutritional factors and other lifestyle variables in explaining this
difference in cardiovascular disease mortality we performed an analysis. In 1998 the
12
annual death rate
for
India
was
840/100,000
population.
Cardiovascular
diseases contribute to 27% of these deaths and its crude mortality rate was 227/100,000.
Major differences in cardiovascular disease mortality rates in different Indian states were
reported varying from 75-100 in sub-Himalayan states of Nagaland, Meghalaya,
Himachal Pradesh and Sikkim to a high of 360-430 in Andhra Pradesh, Tamil Nadu,
Punjab and Goa. There was a significant positive correlation of cardiovascular
disease mortality with prevalence of obesity (R=0.37) and dietary consumption of fats
(R=0.67), milk and its products (R=0.27) and sugars (R=0.51) and negative correlation
with green leafy vegetable intake(R=-0.42)17
In an international cooperative study on the epidemiology of coronary heart
disease teams examined 12, 770 men 40 to 59 years old in Finland, Greece, Italy, Japan,
the Netherlands, the United States and Jugoslavia, who were re-examined 5 years later.
In the United States of a total of 125 deaths during the 5 years 62 were due to coronary
heart disease, in Finland 38 of 111, in the Netherlands 16 of 50, and in all other groups
only about 1 in 8. Within countries there were no significant differences in incidence of
the disorder between regions except in rural Finland where the east had significantly
more than the west. There was a tendency for incidence to be related to the prevalence of
hypertension, serum cholesterol values and saturated fatty acids in the diet.18
The Framingham Heart Study indicates that the incidence of congestive heart
failure increases with age and is higher in men than in women. Hypertension and
coronary heart disease are the two most common conditions predating its onset. Diabetes
mellitus and electrocardiographic left ventricular hypertrophy are also associated with an
increased risk of heart failure. During the 1980s, the annual age-adjusted incidence of
13
congestive heart failure among persons aged ≥ 45 years was 7.2 cases/1,000 in men and
4.7 cases/1,000 in women, whereas the age-adjusted prevalence of overt heart failure
was 24/1,000 in men and 25/1,000 in women. Despite improved treatments for ischemic
heart disease and hypertension, the age-adjusted incidence of heart failure has declined
by only 11%/calendar decade in men and by 17%/calendar decade in women during a
40-year period of observation. In addition. Congestive heart failure remains highly lethal,
with a median survival time of 1.7 years in men and 3.2 years in women and a 5-year
survival rate of 25% in men and 38% in women.19
A prospective study on Relationship of plasma insulin levels to the
incidence of myocardial infarction and coronary heart disease mortality in a middle-aged
population shows that The possible role of plasma insulin levels as a risk factor of
coronary heart disease has been studied in a population of 7246 non diabetic, working
men, aged 43–54 years, initially free from heart disease, and followed for 63 months on
average. 128 new coronary heart disease events (non fatal myocardial infarction and
coronary related deaths) were detected during this period. The annual risk is analysed by
a multivariate model including age, serum cholesterol and triglycerides, blood pressure,
smoking, obesity, plasma glucose and insulin fasting and 2 hours after a 75 g oral
glucose load. It is shown that the fasting plasma insulin level and the fasting insulinglucose ratio are positively associated with risk independent of the other factors. The
same variables, 2 hours after the glucose load are also positively associated with risk but
their contributions are not significant in the multivariate analysis. It is concluded that
high insulin levels may constitute an independent risk factor for coronary heart disease
complications in middle aged non diabetic .20
14
A study to investigate the levels of prevalence of cardiovascular disease and
management of major cardiovascular risk factors in two villages in rural Andhra Pradesh,
India. A cross-sectional survey was done by selecting a random sample stratified by age
and gender from each village using census lists compiled in 2002. For each individual,
trained study staff administered a Telugu-translation of a structured questionnaire,
performed a brief physical examination and collected a fasting venous blood sample.
Weighted estimates of mean (or percentages with) risk factor levels in the population
were calculated and are reported with confidence intervals unless otherwise specified.
Results: Data was collected from 345 adults aged 20 to 90. The average household size
was 4.2 and the mean combined household income was about Indian Rupees 25,454
(US$580) per year. The mean systolic blood pressure was 116 (114-117) mm Hg,
diastolic blood pressure 73 (114-120) mm Hg, total cholesterol 4.6 (4.5-4.7) mmol/L,
HDL-cholesterol 0.8 (0.8-0.9) mmol/L, LDL-cholesterol 3.2 (3.1-3.3) mmol/ L and
triglyceride 1.3 (1.2-1.4) mmol/L. The prevalence of current smoking was 19.9% (15.424.4%), hypertension 20.3% (16.2-24.4%), diabetes 3.7% (1.8-5.5%), overweight 16.9%
(12.3-21.5%) and obesity 4.4% (1.9-6.8%). A medical diagnosis of cardiovascular
disease (previous heart attack, stroke or angina) was reported by 2.5% (1.1-3.9%) and a
further 1.1% (0.1-2.1%) had angina by the 'Rose' classification. The possibility of
increasing cardiovascular risk factors and prevalence of vascular disease in areas of rural
India represent a public health concern. Larger and repeated epidemiological studies
focusing on chronic diseases are required to inform treatment and prevention strategies
suitable for use in these areas and other resource poor settings.21
15
2.LITERATURE
RELATED
TO
NEWER
MODALITIES
OF
ANGIOPLASTY (rotational angioplasty and laser angio plasty)
A preliminary report was published on Percutaneous coronary rotational
angioplasty trial on humans, the trial was attempted on 12 patients. The procedure was
performed with a flexible rotating shaft with an abrasive tip, varying in diameter from
1.25 to 3.5 mm, tracking along a central guide wire. Among the 12 patients (mean age 58
years), 4 had a stenosis in the left anterior descending coronary artery and 8 a stenosis in
the right coronary artery. After the guide wire crossed the stenosis, the abrasive tip was
slowly advanced and several passes across the stenosis were made. The residual stenosis
was measured with computerized automatic quantitative coronary angiography. Success
was defined as a reduction of percent stenosis by >20%. If residual stenosis remained
significant (>50%), the procedure was completed by balloon dilation. The device could
not be inserted in 2 of the 12 patients.Five of the 10 patients underwent rotational
angioplasty alone, and 5 had the procedure completed by balloon dilation. The stenosis
was significantly enlarged from 0.56 ± 0.31 mm to 1.26 ± 0.28 mm. The outline of the
vessel appeared smooth and regular.There were no complications related to the
procedure and all patients were free of symptoms when discharged 2 to 3 days after the
procedure. Thus, coronary rotational angioplasty is a simple and safe procedure allowing
marked dilation of the narrowed segment. However, long-term follow-up is required for
further evaluation22
A study was conducted, in the study sequential intravascular ultrasound
imaging was used before intervention, after rotational atherectomy and after adjunct
16
balloon angioplasty to characterize the mechanisms of lumen enlargement after each.
Forty-eight lesions in 46 patients were treated with rotational atherectomy followed by
adjunct balloon angioplasty in 44. Quantitative coronary arteriographic and intravascular
ultrasound measurements of the target lesion were made before intervention, after
rotational atherectomy and after balloon angioplasty Sequential intravascular ultrasound
imaging shows that high speed rotational atherectomy causes lumen enlargement by
selective ablation of hard, especially calcific, atherosclerotic plaque with little tissue
disruption and rare arterial expansion. Adjunct balloon angioplasty further increased
lumen area by a combination of arterial dissection and arterial expansion, especially of
compliant, noncalcified plaque elements.23
This study was performed to determine the relation of patient characteristics,
stenosis morphology, and operator technique to procedural outcome to gain insight into
which patients might be best treated with this device. Four hundred stenoses from 316
patients randomly selected from the initial Rotablator experience at three major referral
institutions were analyzed.. Procedural success was achieved in 89.8% of stenoses , and
major ischemic complications (death, 0.3%; non-Q-wave myocardial infarction,
occurred in 8.9% of patients. The procedural outcome of rotational atherectomy is
highly correlated with stenosis morphology and location and sex of the patient. After
stratification for these parameters, overall outcome with the Rotablator appears to be
similar to that with balloon angioplasty and other competing techniques.24
17
A study conducted for a systematic overview (meta-analysis) of randomized
trials of balloon angioplasty versus coronary atherectomy, laser angioplasty, or cutting
balloon atherotomy to evaluate the effects of plaque modification during percutaneous
coronary intervention. Sixteen trials (9,222 patients) constitute the randomized
controlled experience with atherectomy, laser, or atherotomy versus balloon angioplasty
with or without coronary stenting. Each trial tested the hypothesis that ablative therapy
would result in better clinical or angiographic results than balloon dilation
alone. mechanical approaches involving plaque ablation or sectioning have not been
associated with improved clinical outcomes or lower restenosis in randomized trials.
New innovations in tissue ablation should be identified before any new large clinical
trials are launched. The solution to the problem of restenosis in native coronary arteries
will likely come not from mechanical removal of atheromatous plaque, but from
vascular brachytherapy or molecular interventions such as drug-eluting stents that alter
vascular biology .25
3.
LITERATURE
KNOWLEDGE
RELATED
REGARDING
TO
NURSING
NEWER
STUDENTS
MODALITIES
OF
ANGIOPLASTY
Excelsior College, partnered with the Commission on Graduates of Foreign
Nursing Schools conducted a study that assessed self-perceptions of nursing knowledge
and
the
clinical
needs
of
international
nurses.
The Clinical
Competency
Survey developed for this study was used to measure perceived proficiency in activities
related to safe and effective nursing practice. These included conducting physical
18
assessments, planning nursing care, administering medications, performing treatments,
managing specific disease conditions, and using technology. Analyses indicate that
international nurses perceived themselves to be less proficient in cardiac assessment and
interventions and the use of technology and more proficient in wound and skin
management and general physical assessments26
A survey on trends in smoking, diet, physical exercise, and attitudes
toward
health
in
European
university
students,
was
carried
out
of
university students from 13 European countries (Belgium, England, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, The Netherlands, Poland, Portugal, and Spain)
in 1990 (4,701 men, 5,729 women) and repeated in 2000 (4,604 men, 5,732 women).
smoking, exercise, fruit and fat intake, beliefs in the importance of behaviors for health,
and awareness of the influence of behaviors on heart disease risk were assessed in
study.The differences in health behaviors, beliefs, and risk awareness between the two
surveys were disappointing in this educated sector of young adult Europeans. The
association between changes in beliefs and prevalence of behavior emphasizes the
importance of enhancing positive attitudes to healthier lifestyles.27
A retrospective study on educational programme on Patients' and nurses' knowledge of
cardiac-related symptoms and cardiac misconceptions. The goal was to educate
both nurses and patients about the American Heart Association's Get-With-the-Guidelines
Program for Coronary Artery Disease. The educational strategies were successful,
and data revealed an increase in nursing knowledge of core measures. After a two-phase
study, the program was eventually rolled out hospital-wide. The study results show
19
that nurses' compliance with and knowledge of the AHA core measures increased as a
direct result of the study.28
6.2.1STATEMENT OF THE PROBLEM
“A study to assess the effectiveness of Structured teaching programme on
knowledge regarding newer modalities of Angioplasty among students at Selected
Schools of Nursing, Bangalore. ’’
6.3. OBJECTIVES OF THE STUDY
1. To assess the knowledge regarding newer modalities of angioplasty among students
before and after structured teaching programme.
2. To evaluate the effectiveness of structured teaching programme on knowledge
regarding newer modalities of angioplasty among students.
3. To determine the association between post test knowledge on newer modalities of
angioplasty among students and selected demographic variable.
6.3.1OPERATIONAL DEFINITONS
1. EFFECTIVENESS: Refers to the extent to which the structured teaching
programme has helped in gaining knowledge on newer modalities of angioplasty
such as rotational and laser angioplasty after administering structured teaching
programme among students assessed by response to structured knowledge
questionnaire.
2.
STRUCTURED TEACHING PROGRAMME: Refers to systematic planned
group instructions designed to provide information on anatomy and physiology of
cardio vascular system, definition, indications, contraindications, procedure, pre and post
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procedural nursing care of newer modalities of angioplasty by lecture cum discussion
method for 45 minutes using AV aids such as LCD projector, flash cards and charts.
3. NEWER MODALITIES OF ANGIOPLASTY: refers to newly developed
techniques of angioplasty, which are used for reopening of narrowed or blocked arteries
in the heart (coronary arteries) without major surgery such as Rotational angioplasty and
laser angioplasty.
4. STUDENTS: Refers to students who are studying for 2nd and 3rd year General
Nursing and Midwifery course (G.N.M ) in selected school of nursing at Bangalore
5. SELECTED SCHOOLS OF NURSING :Sarvodaya Schools of nursing, Bangalore.
6.3.2 ASSUMPTION:
It is assumed that students may have some knowledge regarding newer modalities of
angioplasty.
6.3.3 HYPOTHESES:
H1 – There is a significant improvement in knowledge regarding newer modalities of
angioplasty.
H2 – There is significant association between knowledge scores and selected sociodemographic variables.
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6.3.4 SAMPLING CRITERIA:
Inclusion Criteria
Students who are :
1. willing to participate in study.
2. available at the time of data collection.
Exclusion Criteria
Students who are:
1. Already diagonosed with cardio vascular disease.
6.3.5 DELIMITATION
1. Study is delimited to 4 weeks
7. MATERIALS AND METHODS
7.1 SOURCE OF DATA:
Data will be collected from students who are studying for 2nd and 3rd year General
Nursing and Midwifery course (GNM) in selected schools of nursing at Bangalore.
METHOD OF DATA COLLECTION:
o Research Approach
: Evaluative approach
o Research Design
: Quasi experimental Design
o Setting
: Sarvodaya Schools of Nursing at Bangalore
o Population
: All students in selected schools
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: Students studying for 2nd and 3rd year
o Sample
General nursing and Midwifery course
(GNM) in selected schools of nursing
at Bangalore.
o Sample size
: 60 (sixty)
o Sampling technique
: Simple Random Sampling
o Method of Data Collection
: Self Administered Questionnaire
o Tool for data collection
: Structured Knowledge Questionnaire
o Method of analysis
: The researcher will use descriptive and
Inferential statistics and present in the
form of tables ,graphs and diagrams.
Demographic variables will be analyzed by frequency and percentage distribution.
The level of the knowledge will be analyzed by mean and standard deviation. The
effectiveness of structured teaching programme will be analyzed by paired ‘t’ test.
The association between demographic variables and knowledge regarding newer
modalities of angioplasty will be analyzed by using Chi-Square test.
o Duration of the study
: 4 weeks
o Research variable
Dependent variable
:
Knowledge of students regarding newer
modalities of angioplasty
Independent variable
: Structured teaching programme on newer
modalities of angioplasty.
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Demographic variables
: age, religion, type of family, gender, previous
education, present placement
o Projected outcome
: The study will be successful in improving the
knowledge of students regarding newer modalities of angioplasty which will help them
to upgrade their knowledge and improve the quality of nursing care rendered by them
professionally.
Does the study require any investigation or interventions to be conducted on
patients or other human or animals?
- NO.
Has ethical clearance been obtained from institution?
Yes . Ethical clearance is enclosed with this.
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LIST OF REFERENCES
1. Health is wealth from Wikipedia. The free Encyclopedia Available from
http://en.wikipedia.org/wiki/healthiswealth
2. Coronary Heart disease . from NHS choices
www.nhs.uk/condition/coronary/heart/disease/pages/introduction.aspx
3. Percutaneous transluminal coronary rotational atherectomy for lesions of
coronary arteries May- 2002
http://www.msac.gov.au/internet/msac/publishing.nsf/Content/ Report.pdf
4. Percutaneous coronary intervention from Wikipedia, the free encyclopedia
available from
http://en.wikipedia.org/wiki/percutaneous_coronary_intervention#cite_notereview2010-3
5. Different types of angioplasty . from ehealthMD
www.ehealthmd.com/content/different-types-angioplasty#axzz2HyZwqxea
25
6. Percutaneous laser coronary angioplasty, from NHS National Institute for Health and
Clinical Excellence , issue date January-2011
www.nice.org.uk/guidance/IPG378/publicinfo
7. Percutaneous transluminal rotational atherectomy for coronary artery disease The Cochrane Library - Villanueva - Wiley Online Library
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003334/pdf
8. International cardiovascular disease statistics
http://bellevuecollege.edu/artshum/materials/inter/Spring04/SizeMatters/internat
CardioDisSTATsp04.pdf
9. Cardiovascular diseases in India , International Heart Protection Summit
September 2011 pdf .
www.deloitte.com/in
10.
What are the advantages of angioplasty over bypass surgery?
From ehealthMD :
http://ehealthmd.com/content/what-are-advantagesangioplasty-over-bypass surgery#ixzz2I41K8Swc
26
11.
Shturman, LeonidProudnikov, Dmitrii UrjevichFilippov, Aleksi Filippovich
Rotational angioplasty device with abrasive crown from Patent 7507245 issued
on March 24, 2009.
http://www.patentstorm.us/patents/7507245/description.html
12.
International procedure overview of percutaneous laser coronary angioplasty,
Available from URL:http//.www.nice.org.uk/nicemedia/ live/
12804/50606/50606.pdf
13.
Nicolaus Reifart, , Michel Vandormael, , Mladen Krajcar, ; et al
Articles: Randomized Comparison of Angioplasty of Complex Coronary
Lesions at a Single Center Excimer Laser, Rotational Atherectomy, and Balloon
Angioplasty Comparison (ERBAC) Study
http://circ.ahajournals.org/content/96/1/91.short
14.
Roxana Mehran, ; George Dangas; Gary S. Mintz, . et al
Treatment of In-Stent Restenosis With Excimer Laser Coronary Angioplasty
Versus Rotational Atherectomy
http://circ.ahajournals.org/content/101/21/2484.short
15.
Deckelbaum LI. Coronary Laser Angioplasty 1994;14(2):101-10.
www.ncbi.nihgov/pubmed/8183044
27
16.
Yehle KS,Chanq K.The Integretion ofan online module on student learning.
http://journals.lww.com/cinjournal/Fulltext/publishahead/The_Integration_of_an_Online_
Module_on_Student.99864.aspx
17.
Gupta . R , Mishra.A , Rastogi.P et al. – 2011 Corolation of regional cardio
Vascular disease modality in india with life styles and nutritional factors.
international journal of cardiology,2006,108(3):291-300
www.europepmc.org/abstract/MED/15978684
18. International Cooperative Study on Cardiovascular Epidemiology
http://onlinelibrary.wiley.com/doi/10.1111/j.1753-4887.1970.tb06161.x/abstract
19.
Kalon K.L. Ho, Joan L. Pinsky, William B. Kannel
The epidemiology of heart failure: The Framingham Study
http://www.sciencedirect.com/science/article/pii/073510979390455A
20.
P. Ducimetiere, E. Eschwege, L. Papoz, et al Relationship of plasma insulin levels
to the incidence of myocardial infarction and coronary heart disease mortality in a
middle-aged population
http://link.springer.com/article/10.1007%2fbf00275270
28
21.
Chow clara , cardona magnolia , krishnam raju. et al Cardiovascular disease
and risk factors among adults in rural India- : the Andhra Pradesh Rural Health
Initiative
http://cat.inist.fr/?aModele=affichen&cpsidt=18573595
22.
Jean L. Fourrier, Michel E. Bertrand, David C. Auth, et al
Percutaneous coronary rotational angioplasty in humans: Preliminary report
From: Journal of the American College of Cardiology
Volume 14, Issue 5, 1 November 1989, Pages 1278–1282
http://www.sciencedirect.com/science/article/pii/0735109789904282
23.
Julie A. Kovach, Gary S. Mintz, , Augusto D. Pichard, et al
Sequential intravascular ultrasound of the mechanisms of rotational atherectomy and
adjunct balloon angioplasty. From: Journal of the American College of Cardiology
Volume 22, Issue 4, October 1993, Pages 1024–1032
http://www.sciencedirect.com/science/article/pii/073510979390412T
24.
Samin K Sharma, , Annapoorna Kini,, Roxana Mehran,
Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for
Diffuse in stent Restenosis
http://www.sciencedirect.com/science/article/pii/S0002870303005933
29
25.
John A. Bittl; Derek P. Chew; Eric J. Topol,
Clinical Research: Interventional Cardiology | March 2004
Meta-Analysis of randomized trials of percutaneous transluminal coronary
Angioplasty versus atherectomy, cutting balloon atherotomy, or laser angioplasty
http://content.onlinejacc.org/article.aspx?articleid=1135455
26.
Patricia A. Edwards, Catherine R. Davis, Internationally educated nurses perceptions
Of their clinical competence, The journal of continuing education in nursing ,November2006- vol-37 issue 6: 265-269
http://www.healio.com/journals/JCEN/%7B454DD4A8-4CB2-46C5-8E610812D7C2888%7D/Internationally-Educated-Nurses_perceptions-of-their-Clinical
-Competence
27.
Steptoe A, Wardle J, Cui W, Bellisle F, et al
Trends in smoking, diet, physical exercise, and attitudes toward health in
European university students from 13 countries, 1990-2000.
http://europepmc.org/abstract/MED/12200093
28.
Andrew J. Newens, Elaine McColl, Senga Bond,et al.
Patients' and nurses' knowledge of cardiac-related symptoms and cardiac
misconceptions
http://www.sciencedirect.com/science/article/pii/S014795639680029X
30
Signature of the candidate
:
Remarks of the guide
:
Name and Designation (in block letters)
:
Guide
:
Signature
:
Head of Department
:
Signature
:
Remarks of chairman / principal
:
Signature
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