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The aim of the present cross-sectional stndy identical to the final version just publisbed by
was to assess major dimensions of psychological Siegrist et al.^^ The PLC also allows comparisons
adjustment and quality-of-life in ICD patients hy with other groups of cardiac patients. Tbe seven
means of well-validated instruments, and to com- suhscales of the profile are "general performance,"
pare these results to those ohtained in a compara- "social capacity," "positive mood," "negative
hle group of patients with coronary artery disease mood," "psychological capacity," "socioemo-
who were not treated with an ICD. In addition, we tional well-being," and "cardiac symptom load."
examined ICD-specific attitudes and causes of dis- On the first six scales, high scores represent high
tress. Finally, it was our intention to descrihe the quality-of-life, whereas on the cardiac symptom
associations among typical ICD related problems, scale, high scores mean a high symptom load.
psychological adjustment, and quality-of-life. For all patients, detailed medical data were
available from their patient records.
Methods All findings were entered into a database sys-
tem on a personal computer. Statistical proce-
Seventy consecutive ICD patients who at- dures were performed by means of the SPSS/PC
tended a university hospital's cardiology outpa- software package. Comparisons of group means
tient clinic for a routine ICD checkup were asked were performed with Stndent's f-tests for inde-
to complete a set of questionnaires during their pendent samples. The Chi-square was used for
visit. This set included a numher of unstandard- comparing frequencies of nominal data. Correla-
ized items dealing with patients' attitudes toward tions of psychological scores with duration of ICD
the ICD, its possihle effects on daily life, and the therapy were computed as Pearson's r. The rela-
patients' coping strategies. Items were scaled from tive effects of sbock frequency and psychological
0 ("not at all/never") to 3 ("very much/very of- adjustment on quality-of-life scores were exam-
ten"]. They were included hecause until now ined by means of an analysis of variance using the
there has been no well-validated instrument for ANOVA procedure with PLC scores as dependent
assessing ICD-specific prohlems and the answers variahles.
might help to understand differences in quality- Additional comparisons were made using data
of-llfe. Psychological distress was assessed hy from a group of 112 male patients with advanced
means of the German version of the Hospital Anx- coronary three-vessel disease, hut without ICDs,
iety and Depression Scale [HADS-D). This short, who bad completed tbe HADS-D and PLC at a mean
standardized self-assessment questionnaire was
specifically designed for the detection of mood
disorders in the physically ill.^^ Its psychometric
properties are well documented, and a consider- Table I.
able number of studies have shown the usefulness Basic Characteristics of iCD and CAD Patients
of the scale in English or German-speaking cardiac
patients,^^"^"^ including patients with ICD.'^ These ICD CAD
studies also allowed the comparison of the scores Patients Patients
of our IGD patients with those of other patient (n = 63) (n = 112)
groups. In general, high scores on the anxiety and
depression suhscales represent high degrees of Sex
psychological distress with a cutoff point of > 10 Male 79% 100%
Female 21% 0%
for clinically relevant mood disorders.
Mean age (years) 61 ± 13 61 ± 7
Quality-of-life was measured hy means of the Married 78% 90%
Quality-of-Life Profile for the Chronically 111 Retired 88% 78%
(PLC). This standardized German self-assessment Cardiac diagnosis
questionnaire had also heen validated in cardiac Coronary artery disease 68% 100%
patients.^'' A more recent factor analysis in a larger Dilated cardiomyopathy 18% 0%
Other 14% 0%
patient group led to a slightly modified version,^^
Ejection fraction 36% ± 16% 55% ± 17%
wbich was used in the present study and is almost
Results
Sixty-three (90.0%) of the 70 patients com-
pleted the questionnaires. Their basal characteris-
tics are also shown in Tahle 1. About 80% of the
patients were men; two-thirds had coronary artery
disease, the other third had dilated cardiomy-
opathies or other diagnoses. Most patients had a
reduced ejection fraction. More than half of the
patients had survived a cardiac arrest {Tahle II).
The mean time interval since tbe ICD implanta- Figure 1. Quality-of-life in implantahle cardioverter
tion was 1.4 years; during this time, the patients defibrillator (ICD) patients versus coronary artery dis-
had received up to 56 ICD shocks with slight ease (CAD) patients without ICD. PLC mean scores and
differences between objective ICD memory and standard deviations by group. White bar ^ ICD (n = 63);
patients' self-reports. While 58.8% had received black bar - CAD (n = 112). All group comparisons: P >
second-generation ICDs, 41.2% carried third-gen- 0.05.
eration devices. Of tbe latter, 50% had had at least
one episode of antitachycardia pacing (ATP).
None of the patients bad experienced serious ICD Significant anxiety was found in 12.7%, de-
related complications such as infected or dislo- pression in 9.6%, and at least one ahnormal score
cated leads. The only subjective complications re- on tbe HADS-D in 17.5% of the patients. Fourteen
ported hy the patients were transient pain at the and nine-tentbs percent wisbed special psycbo-
site of the ICD (1 patient), syncope [1 patient), and logical support, and 34.8% indicated they would
psychological maladaptation. like to meet other ICD patients for discussing ICD
related problems.
The comparison of quality-of-life scores on
the PLC showed no significant differences be-
Table II. tween IGD patients and the group of CAD patients
Additional Characteristics of ICD Patients without ICD (Figure 1). This included similar lev-
els of cardiac symptom load experienced hy both
Survivors of sudden death 36 (57%) groups. Mean HADS-D depression scores were
Days since iCD 510 ± 408 similar in hoth groups (5.2 ± 3.8 vs 5.8 ± 3.8; P =
implantation (54-173-460-720-1690)* NS). HADS-D anxiety scores were, however, sig-
ICD generation nificantly lower in ICD patients (5.0 ± 3.7 vs 6.9 ±
Second 37 (59%) 3.7; P < 0.01). Because these comparisons might
Third 26(41%) have been influenced by the existing group, dif-
Number of ICD shocks ferences in gender distribution, cardiac diagnosis,
Selt-report 4.0 ± 8.3 (0-56)
or ejection fraction variahles were tested for a pos-
ICD memory 5.3 ± 9.6 (0-47)
sihle association with PLC and HADS-D scores hy
* values represent mini mum-first quartile-median-third quartile- Student's /-test, one-dimensional analysis of vari-
maximum. ance, or Pearson correlation, respectively. These
%HADS-D>10
Discussion
The treatment with automatic ICDs is an ef-
fective strategy for managing life-threatening ven-
tricular arrhythmias. Early reports have suggested
some side effects of this therapy on psychological
very much
adjustment.^~^ Consequently, it had to be asked if
not at all
these effects also affected patients' overall quality-
Figure 5. Positive experiences and attitudes by HADS-
D scores. Mean values of ICD specific items. —•— = to-
tal group: —•— = HADS-D normal (n = 52); —A—
HADS-D abnormal (n = 11}; + = P < 0.05; x - P <
0.01; O - P< 0.001.
M' •
• *
X
i>
tempted to also measure quality-of-life, they did
not use any instrument with previously tested va-
lidity or reliability to do so. Thus, this study does
not answer the question as to what was really mea-
sured and how the effects of ICD therapy on the ill-
defined "quality-of-life" were mediated. It cannot
be excluded that the observed effects were arti-
facts of low retest reliability, We admit that there
X is no gold standard for measuring quality-of-life.
y -h However, there are a couple of well-validated
-1-
multidimensional scales with defined subscales
for assessing physical, social, and psychological
+
aspects of quality-of-life.^^-^^ These instruments
allow comparisons with other patient groups as
well as meaningful longitudinal assessments.
The present study is the first one to use the
very much PLC, one such instrument, in a group of ICD pa-
tients. Besides the psychological dimension,
Figure 7. Negative experiences and attitudes by HADS- which had already been assessed in previous stud-
D scores: Mean values of ICD specific items. —•— - to- ies, the PLC gives scaled scores for social and
tal group: —•— - HADS-D normal (n ^ 52); —A— = physical functioning and well-being, resulting in a
HADS-D abnormal (n = 11); + = P < 0.05; x - P <
comprehensive description of quality-of-life. In-
0.01; -O - P < 0.001.
cluding an additional number of ICD specific
items is in accordance with a modular approach at
measuring quality-of-life,^" and allows linkage of
overall quality-of-life to the specific effects of ICD
of-life. Some authors^'^*^" subsequently addressed therapy. Since there are no standardized instru-
this subject, but their studies had some importaut ments for assessing ICD related attitudes and ex-
limitations; the investigation by Schohl et al.^" ret- periences, it was necessary to use unstandardized
rospectively studied patients' attitudes toward items derived from literature and clinical practice
ICD therapy by means of a simple questionnaire for this part of the study in order to create hy-
derived from clinical practice. Despite some inter- potheses ahout how ICD-specific problems were
esting findings regarding patients'attitudes, this correlated with psychological adjustment.
study failed to include any standardized measures Our results indicate that for the majority of
that could allow comparisons with other patient patients ICD therapy does not reduce quality-of-
groups. Anxiety and quality-of-life were retro- life or psychological functioning. This finding is
spectively requested by single items of unknown in accordance with recent research from other au-
validity and reliability at an unknown time thors.^•'''^*' The comparison with CAD patients
postimplantation. Thus, it is unclear what the au- without ICDs shows no significant differences in
thors really measured because the patients' an- PLC scores, including cardiac symptom load. Al-
swers might have been subject to response bias. though there were some clinical differences be-
A second group of investigators^"^ prospec- tween the two groups (gender distribution, cardiac
tively examined anxiety in ICD recipients by diagnosis, ejection fraction), none of them was sig-
means of the well-established State Trait Anxiety nificantly associated with PLC scores. Thus, with
Inventory (STAI). It is not surprising that these au- respect to the PLC, the differences in basic charac-
thors found a decrease of state anxiety after ICD teristics do not appear to be relevant for this com-
parisou. It can also be stated that both patient with negative attitudes towards several aspects of
groups experienced similar levels of cardiac ICD therapy, although it is not known if mood dis-
symptoms. Mean anxiety scores of the ICD pa- turbance was the result of lower ICD acceptance,
tients were even lower than those of the CAD pa- or rather, a cause of higher problem reporting.
tients without ICDs. This cannot be explained by Although shock frequency also influenced
the higher proportion of women in the ICD group, some dimensions of quality-of-life, it could be
because women generally score higher on the shown that these effects were secondary to its ef-
HADS-D than men. The moderately lower propor- fects on anxiety and depression. Thus, one can say
tion of married ICD patients and their higher rate that psychological maladjustment, which is
of retirement might be suspected to increase but mainly caused by frequent ICD shocks, mediates a
not decrease mean anxiety scores.^^ While the decrease in overall quality-of-life. This conclusion
CAD group had advanced coronary disease (all pa- entails two treatment options.
tients had suffered at least one myocardial infarc- First, anxious or depressed patients, who can
tion and 80% bad undergone invasive therapies), easily be identified by means of simple self-report
but only slightly reduced ventricular function, the questionnaires such as the HADS(-D}, might be
ICD patients had a lower degree of coronary considered for special psychotherapeutic support.
pathology and revascularization, but a consider- Although there is no definite evidence from large
ably worse ejection fraction. However, a previous controlled trials, first results suggest a beneficial
study of a large group of 3,705 heart patients has effect of psychosocial interventions, especially
revealed that all of these cardiac findings are only support groups'^'^^'^^ on patients' psychological
minimally related to anxiety and depression,^"^ adaptation. This is in accordance with findings
and there is no evidence that differences in sever- from several controlled trials in CAD patients,
ity of disease may account for the observed differ- who, as a consequence of psychological counsel-
ences in mean anxiety between CAD and ICD ing, showed significant decreases of anxiety and
groups. Instead, lower anxiety in the present ICD depression,^^ and even significant reductions in
group may be the result of a feeling of security total and cardiovascular mortality.^^ Ahout 15%
granted by the ICD. The patients, a large number of of all ICD patients might need special care. This
whom had already survived a sudden death, ap- was the percentage of abnormal findings on the
parently appreciated the effective protection HADS-D as well as of patients who explicitly
against malignant arrhythmias. This is also re- wished psychological help. A considerably higher
flected in high overall treatment satisfaction,'^-^" percentage (35%) of patients wished to meet other
although most patients experience some problems ICD patients and talk about their ICD related prob-
with the ICD. lems. They could be offered a support group pro-
With increasing numbers of ICD shocks, how- gram, although it still remains to be documented if
ever, there was a dramatic increase in the number its probable effect on psychological function-
15.21,22
of patients with anxiety and depression, with pre- mg also improves overall quality-of-life.
dominating fears of recurrent shocks, which are Second, efforts should be made at reducing
experienced as very painful and upsetting. These ICD shock frequency by avoiding inadequate
fears can lead to an anxious avoidance of physical shocks and taking advantage of modern ICDs' ATP
and social activities and produce a feeling of ICD capahilities, which may terminate up to 90% of all
dependence.^ While some other authors already tachyarrhythmias^^ and can be expected to im-
described the influence of ICD therapy and fre- prove patients' quality-of-life.''
quent discharges on patients'anxiety,*'"" the above One limitation of the present study is its
mentioned problems with measuring quality-of- cross-sectional design and the variable time since
life precluded a reliable statement about how this ICD implantation. The latter showed no relevant
increase in anxiety affected overall quality-of-life. effect on HADS-D or PLC scores. The cross-sec-
Our results now indicate that ICD therapy primar- tional design appears adequate for answering the
ily affects emotional adjustment. Frequent shocks principal questions for which the study was un-
make patients more anxious and depressed. In ad- dertaken: it documents important associations of
dition, these mood disturhances are associated quality-of-life with central aspects of ICD therapy.
It would certainly not make much sense to com- shock frequency, nor did it examine the associa-
pare the quality-of-life of hospitalized patients tion of quality-of-life with ICD-specific problems.
awaiting ICD implantation with postoperative Thus, as the authors admit, the changes of quality-
qnality-of-life under daily living conditions. Nev- of-life they observed are difficult to interpret. In
ertheless, some longitudinal effects might require addition, that study is limited by the small num-
a prospective study design. For example, no defi- ber of patients (< 20) who completed the postim-
nite answer can be given to the question if psy- plant questionnaires. Prospective, detailed stud-
chological maladjustment in patients with fre- ies in larger patient groups are therefore desirable
quent ICD shocks was entirely a consequence of for a full understanding of the effects of ICD ther-
the experienced shocks or if patients with psycho- apy on quality-of-life and the way in which they
logical problems of other origin might also have a are mediated.
higher risk of arrhythmias and consequently re- We contend that in this field of highest techni-
ceive more shocks. This question can only be an- cal standards the level of psychological instru-
swered by prospective studies taking advantage of ments used in most studies, so far, is rather low and
the ICDs' capability of permanently recording ar- their suitability for the purposes of the investiga-
rhythmic events. tions is rarely well documented. Since there are
Such future investigations of psychological several established multidimensional quality-of-
well-being and quality-of-life in ICD patients life questionnaires, it does not seem acceptable to
should, in our opinion, be conducted in a prospec- reduce this complex phenomenon to a few unvali-
tive manner and use only adequate, well-validated dated yes/no questions. The present study, as well
assessment tools. Recently, after completion of as the one by May et al..^'' may provide an example
our study. May and coworkers^^ published a first of suitable and psychometrically sound instru-
prospective study using the Sickness Impact Pro- ments that are well accepted hy the patients. They
file, which may be considered an adequate tool for disprove the opinion'" that standardized instru-
use in ICD patients. These authors found a tempo- ments will not be applicable in ICD patients. In par-
rary worsening of quality-of-life 6 months after ticular, the HADS-D is available in many languages
ICD implantation, which is in contrast to our and may be considered a current standard for as-
cross-sectional data. That study did not control for sessing anxiety and depression in heart patients.
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