Assess the acceptance and quality of Life of Patients
with Implantable Cardioverter Defibrillator (ICD) in selected
OPD’s of a Tertiary Care Hospital, Kochi
Vaisakh G.1*, Arun
Kumar S.K.2
1II Year M Sc
Nursing Student, CVTS Nursing, Amrita College of Nursing, AIMS, Kochi
2Lecturer,
Department of Community Health Nursing, Amrita College of Nursing, AIMS, Kochi
*Corresponding Author’s Email: vaisakhg143@gmail.com
ABSTRACT:
A descriptive study was conducted to assess the
acceptance of patients to Implantable Cardioverter Defibrillator (ICD),
determine the quality of life of patients with ICD and find out the association
between selected demographic variables. Quality-of-life outcomes with the ICD
may be directly related to coping successfully with ICD shocks. Little is known
about the acceptance and the quality of life of patients with ICD. This study
was conducted among 40 subjects, selected using non-probability convenient
sampling technique and data were collected using questionnaires including the
Florida Patient Acceptance Survey (FPAS) and SF-36 as a measure of quality of
life (QOL). Overall patient acceptance of the ICD was moderate, with FPAS
acceptance score of 51.9 ± 10.8 on the
0-to-100 point scale. The FPAS subscale mean scores indicated that the
group was very positive (83.4) about the benefits of having the device and had
few body image concerns (13.7), moderate device-related distress (41.1), and
moderate return to function scores (53.1). The mean SF-36 v2 indicated worst
quality of life (QOL) scores in the physical component (PCS) (44.2 ± 8.8), and
worst QOL scores in the mental component (MCS) (47.3 ± 14.2). Better QOL was observed in vitality of mental
component with mean score 50.6. Whereas worst QOL was observed in all the
physical domains which includes physical functioning, role functioning, bodily
pain and general health with mean score of 42.3, 43.5, 45.6 and 46.2
respectively. In the mental domains worst QOL was observed in social
functioning, role emotional and mental health with mean score of 45.8, 40.8 and
48.5. Demographic data show that
majority 30 (75%) of subjects were above 60 years and 36 (90%) were males.
There were no significant association exist between demographic variables and
mental and physical components of quality of life scores. The study concluded
that majority of the subjects had moderate to high device acceptance and
quality of life of the subjects were borderline to worst. This may be because
majority of the subjects 75% were above 60 years of age. Monitoring as well as
therapeutic interventions are needed to improve acceptance and QOL of patients
with ICD.
KEYWORDS: Implantable cardioverter
defibrillator, ICD, quality of life, acceptance, cardiac assist device.
INTRODUCTION:
The Implantable Cardioverter
Defibrillator (ICD) has undergone a remarkable transformation over the past
years. Modern ICD devices provides detailed information about the morphology
and rates of arrhythmias and store electrocardiographic signals before, during
and after therapy. Nowadays ICDs are extensively used as primary prevention of
sudden death in high-risk subjects and secondary prevention of sudden cardiac
death (SCD).1
The ICD automatically detects an abnormal heartbeat
and will deliver small rapid pacing impulses or an electric shock to the heart
to restore a normal heart rhythm. During the first year after implantation, the
chances of receiving at least one ICD shock can range from one third to one
half of all ICD recipients.2 Quality of life outcomes with the ICD
may be directly related to coping successfully with ICD shocks. Although most
people are able to tolerate a shock to some extent, the experience of shock is
discomforting and can prompt feelings of anxiety, depression, or fear.3
A study conducted by Habibovic
M et al. to evaluate whether anxiety is predictive of ventricular arrhythmias
or mortality in patients with an implantable cardioverter
defibrillator. The result reveals that
within the first year after ICD implantation, 19% of patients experienced a
ventricular arrhythmia, and 4% died. Anxiety was associated with an increased
risk of ventricular arrhythmias and mortality after one year of ICD
implantation, independent of demographic and clinical covariates.4
ICD have proven their value as life saving devices. As
the number of patients implanted with these devices rises world-wide, concerns
about the quality of the life prolonged by the ICDs become more and more
relevant. Patients on ICD are prone for deterioration of quality of life (QOL)
due to worsening of the pre-existing cardiac disorder as they survive longer
with the support of the device. Unexpected and often painful shocks can either
be perceived as instances of life regained or as potential threats to survival
by different patients.5
ICD implantation involves psychosocial adjustments for
both patients and relatives.6 Quality of life after implantation is
reported to remain unchanged or to improve, little is known about effect of
having an ICD and how patients perceive their quality of life. Negative
emotions are associated with the unpredictability and frequency of ICD shock,
and depressed mood, anger, anxiety and uncertainty are common feelings reported
by patients with an ICD.7
However there can be difference in sample
characteristics and co-morbidities in patients from different parts of the
world, so that it is essential to have data regarding the level of acceptance
and quality of life of patients with ICD in Indian scenario. Carlsson E Olsson SB, Hertervig E
studied on the role of the nurse in enhancing quality of life in patients with
an implantable cardioverter-defibrillator. The goals
included seeing how well they accepted their situation after the operation when
they had ongoing support of the nurse, in comparison to a control group who
received conventional patient education by the physician. The result revealed
that there is significant improvement after ICD implantation in study group
than control group.6
MATERIALS AND
METHODS:
The Florida Patient Acceptance Survey (FPAS) measures
device patient acceptance using 18 items rated on a 5-point Likert
scale from 0 (strongly disagree) to 5 (strongly agree), with a high score
indicating more acceptance.8 Four subscale scores can be derived
from the patient responses, including: (i) return to
function (ii) device-related distress (iii) positive appraisal and (iv) body
image concerns. The remaining three items are filler items. A composite score
referring to total patient acceptance is also possible. Total FPAS score and
return-to-function and positive appraisal scores are positively correlated with
device acceptance, i.e. a lower score reflects poorer device acceptance; in
contrast, device-related distress and body image concern subscores
are negatively correlated with device acceptance, i.e. a higher score means
lesser device acceptance.9
Quality of life of patients with implantable cardioverter defibrillator was assessed by SF-36v2 which is
a standardized questionnaire developed by Quality metric cooperated agency in
USA. The license to use the tool was obtained from the Director of consulting
agency. A standardized Malayalam version was also obtained from the agency.
SF-36v2 yields an eight scale profile of functional health and wellbeing scores
as well as psychometrically based physical and mental summary measures. Each
scale is directly transformed into a 0-100 scale on the assumption that each
question carries equal weight. Scoring of the tool was done with the
help of SF-36v2 health outcome scoring software provided by the agency, which
was based on norm based scoring with an average mean of 50 and standard
deviation of 10. This makes it possible to meaningfully compare scores for 8
scale profile and the physical and mental summary measures. The eight scale
profile are vitality, physical functioning, bodily pain, general health
perceptions, physical role functioning, emotional role functioning, social role
functioning, mental health. Scores obtained were grouped into two categories
that is better quality of life (QOL) and worst QOL.10
After obtaining ethical clearance, 40 subjects who met
the sample selection criteria were selected by non-probability convenient
sampling technique. The data collection time was from 8am to 2pm. Data were
collected from cardiology OPD for a period of four months from November 2014 to
February 2015. On an average the researcher could collect data from two to
eight patients per week. During the follow up visit the patients has to undergo
ICD interrogation prior to consultation, hence data was collected by researcher
during the time of waiting for interrogation in the OPD. The subject’s
participation was ensured only after obtaining the informed consent and
explaining the purpose of the study. Sociodemographic data was collected by
interviewing. Followed by this, Tool II and Tool III were administered to the
participants which included FPAS and SF 36v2 questionnaire. The subjects took
minimum half an hour to complete the questionnaire. Anonymity and
confidentiality of the data were maintained. Majority of the subjects reported
well to the questionnaire and the researcher did not encounter difficulties
during the time of data collection. Data analysis was done using descriptive
and inferential statistics. The sample characteristics were described using
frequency and percentage. Bar diagrams were used to illustrate acceptance and
QOL scores. Association between QOL and demographic variables was assessed
using Fishers exact test.
RESULTS:
Table 1: Sample
characteristics based on demographic variables
|
Sl No |
Variables |
Frequency (f) |
percentage (%) |
|
1. |
Age |
|
|
|
|
a) <39 years |
2 |
5 |
|
|
b) 40-49 years |
3 |
7.5 |
|
|
c) 50-59 years |
5 |
12.5 |
|
|
d) Greater than 60 years |
30 |
75 |
|
2. |
Gender |
|
|
|
|
a) Male |
36 |
90 |
|
|
b) Female |
4 |
10 |
|
3. |
Marital status |
|
|
|
|
a) Married |
38 |
95 |
|
|
b) Widow |
2 |
5 |
|
4. |
Educational status |
|
|
|
|
a) Primary education |
3 |
7.5 |
|
|
b) Secondary education |
15 |
37.5 |
|
|
c) Higher secondary |
5 |
12.5 |
|
|
d) Diploma |
2 |
5.0 |
|
|
e) Graduate |
10 |
25.0 |
|
|
f) Post Graduate |
5 |
12.5 |
|
5. |
Occupation |
|
|
|
|
a) Employed |
15 |
37.5 |
|
|
b) Unemployed |
5 |
12.5 |
|
|
c) Retired |
20 |
50.0 |
|
6. |
Monthly Income |
|
|
|
|
a) <5000 |
10 |
25.0 |
|
|
b) 5001-10000 |
6 |
15.0 |
|
|
c) 10001-15000 |
7 |
17.5 |
|
|
d) >15000 |
17 |
42.5 |
Among the 40 subjects majority 30
(75%) of subjects were above 60 years and 36 (90%) were males. Majority 38 (95%)
of the subjects were married. Regarding educational status, 15 (37.5%) were
with secondary education followed by (25%) graduates and 5 (12.5%)
postgraduates. Majority 20 (50%) of subjects were retired employees, (15%)
37.5% were employed and 12.5% were unemployed. There were 17 (42.5%) subjects
with >15000 Rs and 10 (25%) with <5000 Rs of monthly income.
Distribution of subjects based on
device acceptance
Figure 1: Diagram representing acceptance to implantable cardioverter defibrillator
Figure 4 depicts the Overall
patient acceptance of the ICD was moderate, with FPAS acceptance score of 51.9
± 10.8 on the 0-to-100 point scale. The FPAS subscale mean scores indicated
that the group was very positive about the benefits of having the device
(m=83.4) and had few body image concerns (m= 13.7), moderate device-related
distress (m= 41.1), and moderate return to function scores (m= 53.1).
Figure 2: Bar diagram representing distribution of
subjects based on quality of life.
From the above figure it is
evident that regarding physical component summary only 30% of subjects shown
better quality of life and 70% shown worst quality of life. Regarding mental
component summary 45% of subjects shown better quality of life and 55% shown
worst quality of life.
Figure 3: Multiple bar diagram representing quality of
life based on physical components.
Figure 2 presents that among the subjects only 17.5%
experienced better quality of life and 82.5% experienced worst quality of life
related to physical functioning. There were
42.5% subjects experienced better quality of life related to role
functioning. This figure also depicts
regarding bodily pain which shows that 42.5% experienced better quality of life
and 57.5% experienced worst quality of life.
Regarding the general health of subjects 40% experienced better quality
of life and 60% experienced worst quality of life.
Figure 4: Multiple
bar diagram showing quality of life based on mental component.
Figure 3 illustrates that half of the
subjects experienced better quality of life in vitality, social functioning and
mental health domain. Regarding role emotional, only 40% subjects experienced
better quality of life.
Table 2: Distribution of quality of life scores based
on physical and mental component domains.
|
Sl No |
Quality of life domains |
Range |
Overall QOL mean score |
Standard Deviation |
||
|
Minim |
Maxim |
(R) |
||||
|
1. |
Physical Component Summary |
22.7 |
60.65 |
37.95 |
44.2 |
8.8 |
|
a)
|
Physical functioning |
21.18 |
57.54 |
36.36 |
42.3 |
8.7 |
|
b)
|
Role Functioning |
21.23 |
57.16 |
35.93 |
43.5 |
13.6 |
|
c)
|
Bodily pain |
21.68 |
62.00 |
40.32 |
45.6 |
13.3 |
|
d)
|
General Health |
28.46 |
66.50 |
38.04 |
46.2 |
11.6 |
|
2. |
Mental component Summary |
17.03 |
66.41 |
49.38 |
47.3 |
14.2 |
|
a)
|
Vitality |
25.86 |
70.42 |
44.56 |
50.6 |
12.3 |
|
b)
|
Social Functioning |
17.23 |
57.34 |
40.11 |
45.8 |
13.1 |
|
c)
|
Role emotional |
14.39 |
56.17 |
41.78 |
40.8 |
15.1 |
|
d)
|
Mental Health |
19.48 |
63.95 |
44.47 |
48.5 |
13.6 |
Table 3: Association between physical
component of quality of life and selected demographic variables
|
Sl No |
Variables |
Physical Component Summary |
p-value |
|||
|
Worst QOL |
Better QOL |
|||||
|
f |
% |
f |
% |
|||
|
1 |
Age |
|
|
|
|
|
|
|
a) Less than 60 years |
9 |
90 |
1 |
10 |
0.296 |
|
|
b) 60 years and above |
19 |
63.3 |
11 |
36.7 |
|
|
2. |
Gender |
|
|
|
|
|
|
|
a) Male |
25 |
69.4 |
11 |
30.6 |
1.000 |
|
|
b) Female |
3 |
75 |
1 |
25 |
|
|
3. |
Marital status |
|
|
|
|
|
|
|
a) Married |
27 |
71.1 |
11 |
28.9 |
0.515 |
|
|
b) Widow |
1 |
50 |
1 |
50 |
|
|
4. |
Educational status |
|
|
|
|
|
|
|
a) Upto higher
secondary |
18 |
78.3 |
5 |
21.7 |
0.296 |
|
|
b) Diplomate
or above |
10 |
58.8 |
7 |
41.2 |
|
|
4. |
Occupation |
|
|
|
|
|
|
|
a) Employed |
11 |
73. |
4 |
26.7 |
1.000 |
|
|
b) Unemployed or retired |
17 |
684 |
8 |
32 |
|
|
5. |
Monthly Income |
|
|
|
|
|
|
|
a)
<5000 |
7 |
70 |
3 |
30 |
0.958 |
|
|
b)
5001-10000 |
5 |
83.3 |
1 |
16.7 |
|
|
|
c)
10001-15000 |
5 |
71.4 |
2 |
28.6 |
|
|
|
d)
>15000 |
11 |
64.7 |
6 |
35.3 |
|
Table 3 shows that the association between
physical component of quality of life and selected demographic variables like
age, gender, marital status, educational status, occupation and monthly income
were not statistically significant at 0.05 level.
Table 4: Association between mental
component of quality of life and selected demographic variables
|
Sl No |
Variables |
Mental component summary |
p-value |
|||
|
Worst QOL |
Better QOL |
|||||
|
f |
% |
f |
% |
|||
|
1 |
Age |
|
|
|
|
|
|
|
a) Less than 60 years |
7 |
70 |
3 |
30 |
0.464 |
|
|
b) 60 years and above |
15 |
50 |
15 |
50 |
|
|
2. |
Gender |
|
|
|
|
|
|
|
a)
Male |
20 |
55.6 |
16 |
44.4 |
1.000 |
|
|
b) Female |
2 |
50 |
2 |
50 |
|
|
3. |
Marital status |
|
|
|
|
|
|
|
a) Married |
21 |
55.3 |
17 |
44.7 |
1.000 |
|
|
b) Widow |
1 |
50 |
1 |
50 |
|
|
4. |
Educational status |
|
|
|
|
|
|
|
a) Upto higher
secondary |
13 |
56.5 |
10 |
43.5 |
1.000 |
|
|
b) Diplomate
or above |
9 |
52.9 |
8 |
47.1 |
|
|
4. |
Occupation |
|
|
|
|
|
|
|
a)
Employed |
8 |
53.3 |
7 |
46.7 |
1.000 |
|
|
b) Unemployed or retired |
14 |
56 |
11 |
44 |
|
|
5. |
Monthly Income |
|
|
|
|
|
|
|
a)
<5000 |
7 |
70 |
3 |
30 |
0.575 |
|
|
b)
5001-10000 |
2 |
33.3 |
4 |
66.7 |
|
|
|
c)
10001-15000 |
4 |
57.1 |
3 |
42.9 |
|
|
|
d)
>15000 |
9 |
52.1 |
8 |
47.1 |
|
Table 4 depicts that no significant
association exist between the demographic variables and mental component score
at 0.05 level.
DISCUSSION:
Overall patient acceptance of ICD was
moderate, with FPAS acceptance score of 51.9 ± 10.8 on the 0-to-100 point
scale. Subscale mean scores of FPAS
indicated that the group was very positive about the benefits of having the
device (m=83.4) and had few body image concerns (m= 13.7), moderate
device-related distress (m= 41.1), and moderate return to function scores (m=
53.1).
Moderate acceptance score might be because,
the majority (75%) of the subjects were above 60 years of age. Device related
distress and return to role function were moderate, it might be due to
recurrent shocks and functional limitations due to the underlying disease
condition. High score in positivity
about benefits of having the device and low score in body image concern which
indicates that Positivity towards use of ICD was good despite moderate device
related distress was present. From these all findings it can be concluded that
benefits are more than distress in users of ICD.
Findings of the present study is supported
by a similar study conducted by Wilson MH et al. to assess disease specific
quality of life-patient acceptance: racial and gender differences in patients
with implantable cardioverter defibrillators. Results
revealed that overall patient acceptance of the ICD was high, with an average
FPAS acceptance score of 80.9. The FPAS subscale scores indicated that the
group was very positive about the benefits of having the device (mean, 90.3)
and had few body image concerns (mean, 10.6), low device-related distress
(mean, 15.6), and moderate return to function scores (mean, 63.0). These findings are similar to the
observations made by present study.11
Better quality of life was observed in
vitality of mental component with mean score 50.6. Whereas worst quality of
life was observed in all the physical domains which includes physical
functioning, role functioning, bodily pain and general health with mean score
of 42.3, 43.5, 45.6 and 46.2 respectively. The overall quality of life mean
score of physical component summary was 44.2 which indicates worst quality of
life. In the mental domains worst quality of life was observed in social
functioning, role emotional and mental health with mean score of 45.8, 40.8 and
48.5. The overall quality of life score of mental component summary was 47.3
which indicates worst quality of life.
A similar study conducted by Kimberly A, Udlis. to assess the impact of technology dependency on
device acceptance and quality of life in persons with implantable cardioverter defibrillators. Mean age was 68 ± 13 and 74%
were males. The mean SF-12 indicated lower QOL scores in the physical component
(PCS) (38.9 ± 11.1), and moderate QOL scores in the mental component (MCS)
(50.9 ± 10.2).10 The QOL life score of above study and present study
are similar but worst QOL was observed in mental component summary in present
study. This difference in QOL might be because of the varied sample
characteristics among the subjects of Indian population and West Indies.12
In the present study association was calculated
between physical component and mental component of quality of life with
selected demographic variables. There is no significant association (p>0.05)
between physical component and mental component of quality of life with any of
the demographic variables. This may be because of direct relationship of number
of shocks or underlying disease condition with quality of life.
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Received on 05.09.2015 Modified on 22.09.2015
Accepted on 28.09.2015 © A&V Publication all right reserved
Int. J. Adv. Nur. Management 3(4): Oct. - Dec. 2015; Page 303-308
DOI: 10.5958/2454-2652.2015.00022.0