Johnson Francis, MBBS, MD, DM, FCSI
*, Beena Johnson, MBBS,
DCH, MD, FIACAM
†, Michael Niehaus MD
‡
*Associate Professor of Cardiology, Medical College
Calicut, Kerala, India.
†Consultant in Psychological Medicine, Baby Memorial
Hospital, Calicut, Kerala, India.
‡Professor of Cardiology, Dept. of Cardiology and
Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625
Hannover, Germany.
Address for
correspondence: Dr. Johnson Francis, MBBS, MD, DM, FCSI,
Pulikkottil, Thondayad, Chevarambalam P.O., Calicut -17, Kerala, India.
PIN: 673 017. E-mail: francisj@calicutmedicalcollege.ac.in
Abstract
Background:
The implantable cardioverter defibrillator (ICD) is a life saving
device for individuals with life threatening ventricular arrhythmias.
There is no doubt that it is a cost effective therapy in various
congenital and acquired arrhythmogenic disorders. Nevertheless, shock
delivery may be painful and frightening which causes psychological
distress and deterioration of perceived quality of life.
Methods:
A systematic meta-analysis on studies reporting quality of life in
patients implanted with ICDs was done using professional databases.
Related articles and references of the relevant articles were also
searched for suitable studies.
Results: Thirty
studies with a total of 3412 patients on implantable defibrillators
were identified. Five of them were large randomised studies with a
total of 1680 patients, while 25 were non-randomised studies. Medical
Outcome Study 36-item Short Form health survey (SF - 36) was the most
common instrument used for assessment of quality of life. Only one of
the 5 major randomised trial reported worsening of quality of life
after implantation of a defibrillator. In the subgroup of patients
receiving shocks, three out of the five trials reported worsening of
quality of life.
Summary:
Most of the randomised studies showed either neutral or better quality
of life in patients on implantable defibrillators. In the subset of
patients receiving shocks, worsening of quality of life was found in
most randomised studies. Therefore, activation of antitachycardia
pacing should be performed in every ICD-patient in order to miminze
painful shocks and consequent deterioration of quality of life.
Key Words: Implantable
defibrillator; meta analysis; quality of life
Introduction
Implantable cardioverter - defibrillators (ICD) have proven their value
as life saving devices
1-3.
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. Systematic attempts at evaluation of
QOL in ICD recipients have been there over the past decade. This paper
aims at a comprehensive analysis of the literature on QOL in ICD
recipients.
Methods
A
systematic accumulation of available data on QOL in patients with ICDs.
PubMed searches were conducted using the search words implantable
defibrillator, ICD, quality of life and QOL. The retrieved results were
checked to identify relevant studies. Further studies were sought by
searching for the related articles and the references of the retrieved
article. Reports of major ICD trials were screened for data on quality
of life.
Results
Thirty studies
on patients with ICDs reported data on QOL (
Table 1)
4-33. Of the total 4653 patients in
these 30 studies, 3412 had ICDs implanted. The earliest study in 1993
reported on 57 patients
4.
The largest available data is from the PainFREE Rx II trial with 634
patients on ICD
33. The next
largest study was the Antiarrhythmics Versus Implantable Defibrillators
(AVID) trial with 416 patients on ICD with an equal number on
amiodarone for comparison
23.
22 studies had 50 or more patients on ICD while only seven had over
hundred patients on ICD. Fourteen studies were published in the last
decade while sixteen were in the current decade. Twelve studies used
Medical Outcome Study 36-item Short Form health survey (SF - 36) for
assessment of quality of life.
Table
1: ICD Studies reporting Quality of Life Data
Instruments for Assessment of QOL
SF
- 36 was the most common instrument used for QOL assessment across the
studies. It comprises of a 36-item short-form questionnaire constructed
to survey health status in the Medical Outcomes Study
33. SF -
36 is a generic instrument and not disease specific. There are eight
multi-item scales, four each for physical and mental health assessment.
The physical scales are: 1) Physical functioning, 2) Role physical, 3)
Bodily pain and 4) General health. The scales for assessing mental
health are: 1) Vitality, 2) Social functioning, 3) Role emotional and
4) Mental health.
Various other
scales have also been used in the studies, like Ferrans and Powers
Quality of Life Index
7,18,30, Quality-of-life Profile for the
Chronically Ill
13, Quality
of Life Index: Cardiac Version
1
and specifically developed quality of life questionnaire for ICD
patients
10. The latter two
can be considered as disease specific measurements of QOL.
Major Randomized Trials
Of the
thirty studies available, five were large randomized trials (
Table 2) with 1680 patients on ICD
altogether. Three of them were primary prevention trials
17,27,33
while two of them were secondary prevention trials
21,23. One primary
prevention trial reported worsening of QOL after ICD while another
reported neutral results and the third and most recent one reported
improvement in QOL. This disparity was present among the secondary
prevention trials as well, where one reported improvement while another
reported worsening of QOL. Disparity was less between the trials in
those patients receiving ICD shocks. Three trials reported worsening of
QOL while one each reported neutral and better QOL in patients
receiving shocks.
Table
2: Randomized ICD Trials Reporting Quality of Life
Summary of QOL Data from Major
Randomized Trials
A] Primary
Prevention Trials
1. CABG Patch Trial
Patients with
impaired left ventricular function and positive signal averaged
electrocardiogram undergoing CABG were randomly assigned to ICD versus
no antiarrhythmic treatment in the CABG Patch trial
17. All ICD-patients were implanted with
patch electrodes during thoracotomy for CABG application. SF-36 was
used to evaluate the QOL in 490 (68%) of the 719 patients available at
6 month follow up. Of these, 262 patients had ICD while 228 were
controls. Patients in the ICD group had lower levels of psychological
well being than the control group, especially those who experienced
shock delivery of the ICD. The study was terminated when statistical
analysis suggested that there was no significant difference in the
primary outcome of total mortality. The lack of effect of ICDs in
reducing mortality has been attributed to better survival in patients
who have undergone revascularisation by CABG.
2. AMIOVIRT Trial
Amiodarone
versus implantable cardioverter-defibrillator (AMIOVIRT) trial included
one hundred three patients with non-ischemic dilated cardiomyopathy
(NIDCM), left ventricular ejection fraction < or = 0.35, and
asymptomatic non sustained ventricular tachycardia (NSVT)
27. They were randomized to receive
either amiodarone or an ICD. The authors described no statistically
significant survival advantage after one year or three years. QOL was
also similar in both treatment groups. This trial was also neutral
towards change of QOL in those receiving ICD shocks. Quality of Well
Being Schedule and the State Trait Anxiety Inventory were the
instruments used for assessment in this study.
3. PainFREE Rx II Trial
Pacing Fast
Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial
was the largest trial reporting data on QOL as well as the latest
33. This trial compared the safety and
utility of empirical anti-tachycardia pacing (ATP) with shocks for fast
ventricular tachycardia in patients receiving ICD. Of 634 ICD patients
313 were randomized to empirical ATP while 321 patients received shocks
as the initial therapy of spontaneous fast ventricular tachycardia. ATP
was effective in 229 of 284 episodes in the ATP arm. QOL was measured
with the SF-36 and found to be improved in patients with fast
ventricular tachycardia in both arms but even more in the ATP arm. Of
the 131 patients with fast ventricular tachycardia, 98 completed SF-36
both at baseline and at 1 year. The ATP arm had significant improvement
in 5 subscales - physical functioning, role physical, bodily pain,
social functioning and role emotional, while the shock arm had
improvement in only bodily pain score. None of the subscale
measurements were significantly reduced at 1 year in either arm.
B] Secondary
Prevention Trials
1. The Canadian
Implantable Defibrillator Study (CIDS)
CIDS
21 compared antiarrhythmic therapy versus
ICD in patients resuscitated from cardiac arrest, and those with
sustained ventricular tachycardia with syncope or ventricular
tachycardia of more than 150 beats per minute with near syncope and
left ventricular ejection fraction < or = 0.35 or syncope with
inducible ventricular tachycardia.
The total
mortality was lower in the ICD group, but the difference did not reach
statistical significance. (P=0.09). QOL evaluation was done as a
secondary endpoint in the study with the Rand Corporation's 38-item
Mental Health Inventory (MHI) and the Nottingham Health Profile (NHP)
for 317 English-speaking participants. Perceived QOL was found to
be improved more in the ICD group. Significant improvement from
baseline to the 6- and 12-month follow-up assessment was seen for 7 of
the 10 variables assessed. Quality of life did not improve in those
patients who received > or =5 shocks from their device. Still they
were comparable to the antiarrhythmic group in QOL. There was no
difference between those who received no shock and those who received
1-4 shocks from their ICD. None of the quality-of-life variables
improved with time in the antiarrhythmic therapy group.
2. The Antiarrhythmics Versus
Implantable Defibrillator (AVID) Trial
AVID Trial
1 compared antiarrhythmic drug therapy
with ICD in survivors of cardiac arrest and those with sustained
ventricular tachycardia with syncope, or hemodynamically unstable
sustained ventricular tachycardia with ejection fraction < or = 40%.
The study was prematurely terminated when a statistically significant
reduction in mortality was demonstrated in the ICD group. Perceived QOL
was evaluated as a secondary endpoint using SF-36 and Quality of Life
Index: Cardiac Version. Of the 800 eligible patients with a 1-year
survival, 416 patients were in the ICD group and 384 patients in the
antiarrhythmic group. Perceived QOL related was low in both groups,
related to adverse symptoms of the particular therapy. The occurrence
of one or more shocks was associated with significant reduction in QOL
in the ICD group.
Data from non-randomised studies
Of the 30 studies evaluated in
this report, 25 were non-randomised (
Table
3). Sixteen of these trials had 50 or more patients on ICD. Five
of these trials reported improvement in QOL in ICD patients while 6
reported neutral results and five reported worsening of QOL. IICD
implantation did not worsen QOL in recipients.
Table
3: Quality of Life in Major Non Randomised Studies
The earliest
study which reported QOL data from ICD patients was by Luderitz et al
4. Fifty-five of their 57 patients stated
that it was worth having an ICD implanted. This study also documented
that patients receiving more than 5 shocks had a higher anxiety level.
The latest of the non-randomised studies was by Sears et al
32. They noted that patients with high
positive health expectations and high optimism reported better mental
health and social functioning at follow-up assessment. These two
factors may be targeted in future studies to improve QOL in ICD
recipients.
The largest of
the non-randomised studies actually reported on dual chamber
defibrillators for restoration of sinus rhythm in atrial
tachyarrhythmias. This study by Newman et al
25
had 267 patients implanted with DDD ICD. A total of 150 patients
completed SF-36 evaluation. Significant improvement was noted in
role-physical, physical functioning, vitality, mental health and social
functioning scales. No deterioration of QOL was noted in those who
received shocks.
In the next
largest non-randomized study by Kamphuis et al
22
133 patients were on ICD and 35 on other modalities of treatment. No
significant difference in QOL was noted between the two groups.
Physical function, mental health and social function improved with time
in both treatment groups. In contrast, Stankoweit et al
15 who studied 132 patients on ICD noted
reduced well being in 61% of them.
Conclusion
Distressing
aspects of ICD shocks are lack of warning, multiple shocks, and
progressively increased sensations with multiple shocks. Three of the
major randomised studies reported worsening of QOL in those patients
receiving ICD shocks, especially when patients were receiving
five or more shocks. Despite the AMIOVIRT Trial
27
did not find any difference in the QOL between those receiving ICD
shocks, the main issue regarding quality of life is the occurrence of
shocks. The PainFREE Rx II Trial
33
demonstrates very clearly that QOL can be improved by programming of
antitachycardia pacing even in patients with fast VTs. This trial also
documented the efficacy of antitachycardia pacing.
With regard to
a potential deterioration of perceived QOL caused by delivery of ICD
shocks for fast VTs, we would recommend to program ATP attempts in all
ICD patients regardless of the cycle length of the index arrhythmia.
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