Transcript Chronic anxiety in ICD patients: A multi

CoRPS
Center of Research
on Psychology
in Somatic diseases
Lösungswege bei psychologischen Problemen für Patienten und ihre
Angehörigen: Leben met dem implantierten Cardioverter Defibrillator
Susanne S. Pedersen (PhD), Professor of Cardiac Psychology
CoRPS
Affiliations
• CoRPS - Center of Research on Psychology in
Somatic diseases, Tilburg University, the
Netherlands
• Thoraxcenter, Erasmus Medical Center,
Rotterdam, the Netherlands
• Department of Cardiology, Odense University
Hospital, Denmark
07/07/2015
2
CoRPS
Acknowledgements
THE NETHERLANDS
DENMARK
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Mathias Meine, MD, PhD (UMCU)
Pieter Doevendans, MD, PhD (UMCU)
Dominic AMJ Theuns, PhD (EMC)
Luc Jordaens, MD, PhD (EMC)
Ruud AM Erdman, PhD (EMC)
Ron T van Domburg, PhD (EMC)
Patrick Serruys, MD, PhD (EMC)
Agnes JQ Muskens-Heemskerk (EMC)
Berry Middel, PhD (UMCG)
Don Poldermans, MD, PhD (EMC)
Pim Cuijpers, PhD (VU)
GERMANY
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Karl-Heinz Ladwig, MD, PhD, Helmholtz Zentrum
München
Christoph Herrmann-Lingen, MD, PhD, University of
Göttingen
Martin Scherer, MD, PhD, University Clinic, Lübeck
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Jens Brock Johansen, MD, PhD, Aarhus University
Hospital
Peter T Mortensen, MD, Aarhus University Hospital
Mogens Lytken Larsen, MD, DSci, Odense
University Hospital
Lars Køber, MD, PhD, Copenhagen University
Hospital
Steen Pehrson, MD, Copenhagen University
Hospital
USA
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Samuel Sears, PhD, East Carolina University
Leo Pozuelo, MD, Cleveland Clinic
Matthew Burg, PhD, Yale University Section of
Cardiovascular Medicine
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
CoRPS
Rise in ICD implantations
2002
MADIT-II
2000
CRT-D
2004
SCD-HeFT
1997/8
Number of Worldwide ICD Implants Per Year
DC-ICD
COMPANION
90.000
1980
1989
800,000 heart patients
First Human
in
Europe and 1 mill in
Implant
1985
North America
have a
cardiovascular implantable
FDA
Approval of
electronic device
80.000
70.000
60.000
50.000
•Transvenous Leads
•Biphasic Waveform
ICDs
40.000
AVID
CASH
CIDS
1993
Smaller
Devices
1999
 MUSTT
1988
30.000
Tiered
Therapy
20.000
1996
 MADIT
10.000
0
1980
1985
1990
Crespo et al. Am J Med Sci 2005;329:238-46
1995
2000
2005
CoRPS Impact of ICD indication on patient-centered
outcomes
Table 1. Overview of studies on the impact of ICD indication on patient-centered outcomes
Authors
N
Study design
Follow-up
Questionnaire(s)
91
Cross-sectional
(3 to 60+ months
after ICD
implantation)
-
HADS
Groeneveld
14
et al.
120
Cross-sectional
(median = 2 yrs)
-
Pedersen, et
15
al.
154
Prospective
3 months
Euro-QoL ; SF-12 ; Health
1
Utilities Index-Mark 3 ;
2
FPAS ; Essential ICD QoL
2
Domains
1
SF-36
Pedersen, et
16
al.
176
Prospective
6 months
HADS
Sweeney et
17
al.
426
RCT
12 months
SF-36
Van den
18
Broek et al.
308
Prospective
2 months
STAI ; HAM-A
Van den
19
Broek et al.
165
Prospective
2 months
HCS ; ICDC ; HAM-A
Bilge et al.
13
Disease-specific
questionnaire used
No
Endpoint(s)
Yes
General and ICD-specific
QoL
No significant
impact
No
QoL
No significant
impact
1
No
Anxiety; depression
No significant
impact
1
No
QoL
No significant
impact
No
Anxiety
No significant
impact
Yes
Feelings of disability;
cardiopulmonary
symptoms; ICD concerns;
anxiety
No significant
impact
1
1
1
1
2
1
2
1
Anxiety; depression
Impact of
indication
No significant
impact
N = sample size; FPAS = Florida Patient Acceptance Survey; HADS = Hospital Anxiety and Depression Scale; HAM-A = Hamilton Rating Scale for Anxiety;
HCS = Health Complaints Scale; ICDC = ICD Concerns questionnaire: QoL = quality of life; RCT = randomized controlled trial; SF-12; Short Form Health
5
Survey 12; SF-36 = Short Form Health Survey 36; STAI = Spielberger State-Trait Anxiety Index
Pedersen, Sears, Burg, & van den Broek. PACE 2009;32:153-6
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
CoRPS
ICD shocks are physically painful
• “It’s like getting kicked in the chest by a big horse!”
• Rated a 6 on a 0-10 point pain scale
Ahmad et al. PACE 2000;23:934-8
General
belief
shocks
are
the
most
important
CoRPS
determinant of patient-centered outcomes
• “Most research has pointed to ICD shock as the
primary culprit if reductions in quality of life occur…”
• “Implantable cardioverter defibrillator (ICD) patients
potentially face significant psychological distress
because of their risk for life-threatening arrhythmias
and the occurrence of ICD shock...”
• “Those individuals who experience an ICD shock relate
greater levels of psychological distress, anxiety, anger,
and depression than those who do not...”
Sears et al. Circulation 2005;111:e380-2; Sears et al. PACE
2007;30:858-64; Raitt J Am Coll Cardiol 2008;51:1366-8
CoRPS Perhaps the relationship is more complex….
• “…the relationship between ICD shocks, appropriate or
inappropriate,and health-related quality of life is neither
simple nor linear… Other studies either have (2) or have not
(3) found an effect between number of shocks and adverse
psychologic effect.”
• “In MADIT II (Multicenter Automatic Defibrillator Trial II)…
mental health was not observed to change in patients
completing follow-up quality-of-life questionnaires, although
declines in physical health were noted for patients
experiencing appropriate shocks, likely due to worsening
congestive heart failure (9).”
Pedersen & van den Broek. J Am Coll Cardiol 2008 (Letter)
Daubert et al. J Am Coll Cardiol 2008 (Response)
CoRPS Clinical trials: Effect of shocks on quality of life
Trial
Recruitment
Fu mths Programming
Shock effect
Dose-response
Primary prevention
CABG-PATCH
1990-1996
6
Shock only
No
-
AMIOVIRT
1996-2000
12
ATP and shock?
No
-
SCD-HEFT
1997-2001
30
Shock only
Mixed
No
MADIT-II
1997-2001
36
Shock only
Mixed
No
DEFINITE
1998-2002
36 (63)
Shock only
Mixed
-
Secondary prevention
CIDS
1990-1997
12
ATP and shock
No
Yes
AVID
1993-1997
12
ATP and shock
Yes
Yes
07/07/2015Pedersen et al. (Viewpoint). PACE, In Press
12
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
CoRPS Impact of device advisories on patient-
centered outcomes
Table 1. Overview of studies on the impact of device advisories on patient-centered outcomes
Authors
Birnie et al.
(2009) (18)
Advisory
Class II advisory
(Medtronic)
N
86 advisory
patients;
Response rate
Patients 70.5%
Study
design
Time between
advisory and
assessment
> 24 months
Endpoint
Prospective;
14  4 month
follow-up
< 2 months*
Anxiety
Case-control
< 1 month
Distress
Case-control
<1 to >4 months
Distress ; QoL
Prospective,
case-control;
1-month
follow-up
1 to 3 months
Distress ;
2
uncertainty ;
confidence in
2
device
Case-control
7.6  1.6 months
Anxiety ;
1
depression ;
2
QoL
Case-control
Controls 70.1%
Impact of device advisory
Device
2
acceptance
No significant impact
94 controls
van den
Broek et al.
(2006) (13)
Class II advisory
(Medtronic)
33 advisory
patients
Cuculi et al.
(2006) (14)
Class I advisory
30 advisory
patients;
(Guidant)
90%
1
Increase in the number of
anxious patients from 6.1%
pre compared to 24.2% post
advisory
1
No significant impact; 3
distress measures were
significantly higher in the
controls
not mentioned
25 controls
Gibson et al.
(2008) (15)
Sneed et al.
(1994) (16)
Class I advisory:
13/31 (42%)
31 advisory
patients;
(Guidant)
50 controls
Class II advisory
31 advisory
patients;
(Guidant)
89%
100%
21 caregivers
Undavia et
al. (2008)
(17)
Class I advisory:
43/61 (70%)
61 advisory
patients;
(not mentioned)
43 controls
1
1
90%
2
2
1
QoL = Quality of life; Generic measure; Disease-specific measure; * conveyed via personal communication with the author
Pedersen et al. PACE 2009:32:1006-11
1
No significant
impact
Patient and caregiver
confidence decreased;
anxiety increased in
patients and confusion in
caregivers over time
No significant impact
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
CoRPS Extent of device acceptance among patients
• ICD is described as a lifesaver by the majority of
patients
• Majority of patients do
well, despite ICD shocks,
device advisories,
complications, and
expanding indications
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
ICD
therapy:
Psychological
sequelae
and
their
CoRPS
consequences
• Clinically significant anxiety and depression in a
subgroup of patients (20-30%)
• Psychological sequelae lead to:
• Who are these high-risk patients
decreased quality of life
– increased risk of arrhythmia
– poor prognosis
–
• Who are these high-risk patients?
Tung et al. J Am Coll Cardiol 2008;52:1111-21
Sears & Conti. Heart 2002:488-93
Shocks,
Type
D
and
anxiety
sensitivity
as
CoRPS
predictor of interviewer-rated anxiety
N = 308
Van den Broek et al, PACE 2008;31:850-857
Shocks,
Type
D
and
anxiety
sensitivity
as
CoRPS
predictor of self-reported anxiety*
N = 308
• No significant change in anxiety during
follow-up (p=.10), but significant time
by shocks effect (p=.003)
• Main effects for Type D (p<.0001) and
anxiety sensitivity (p=.0001), but not
shocks (p=.30)
*Assessed with STAI at baseline and 2 months
Adjusting for anxiety sensitivity, Type D, age, shocks,
gender, marital status, education, ICD indication, and
age (ANCOVA with repeated measures)
Van den Broek et al. PACE 2008;31:850-7
CoRPS Type D (distressed) personality
Pedersen & Denollet. Curr Cardiol Rev 2006;2:205-13
Denollet et al. Circulation Cardiovasc Qual Outcomes, In Press
Prevalence
of
anxiety
and
depression
in
CoRPS
patients stratified by Type D and shocks
80
70
60
N = 182
%
72
67
61
57
50
40
Type D - shocks
Type D - no shocks
Non Type D - shocks
Non Type D - no shocks
32
30
20
13
19
14
10
0
Anxiety
Depression
Pedersen et al. Psychosom Med 2004;66:714-9
CoRPS ICD concerns stratified by shocks
ICD Concerns - mean scores
• ICD concerns – concerns about the ICD firing,
e.g. “having no warning the ICD will fire”
14
p < 0.001
11.89 (8.57)
12
10
8
6.55 (6.99)
6
4
2
0
No shocks 1 shocks
Pedersen et al. Am Heart J 2005;149:664-9
N = 182
CoRPS
ICD concerns, shocks and distress*
• ICD concerns (OR=6.35; 95% CI: 2.84–14.20)
was an independent determinant of anxiety
• ICD concerns (OR=2.29; 95% CI: 1.06-4.96) were
also independently associated with depression
*adjusting for gender, age, marital status, time since
implantation, and shocks
Pedersen et al. Am Heart J 2005;149:664-9
CoRPS Correlates of anxiety and depression
Female gender
Age
Living with a spouse
Non-ischaemic etiology
Symptomatic CHF
Co-morbidity
ICD-related complications
ICD shocks
Years with ICD therapy
Current smoking
Amiodarone
Other antiarrhythmic medication
Psychotropic medication
Anxiety
[95% CI]
Depression
[95% CI]
2.38 [1.32-4.29]†
ns
ns
ns
5.15 [3.08-8.63]‡
ns
ns
2.21 [1.32-3.72]†
ns
ns
ns
ns
ns
ns
ns
ns
ns
6.82 [3.77-12.39]‡
ns
ns
2.00 [1.06-3.80]*
ns
ns
ns
ns
2.75 [1.40-5.40]†
* P < 0.05; † P < 0.01; ‡ P < 0.001
Johansen, Pedersen et al. Europace 2008:10:545-51
N = 610
CoRPS
Predictors of quality of life (8 months)
Age, LVEF
Psychological
variables*
Shocks
Total variance
General
health
21.2%
39.9%
3.5%
64.5%
Mental health
13.7%
27.4%
0.7%
41.8%
Physical
health
23.4%
24.1%
7.3%
54.8%
* Social support, optimism, depression, anxiety
07/07/2015Sears et al. Psychosomatics 2005;46:451-7
26
CoRPS Sex differences in distress: Mediating role of
somatosensory amplification
Examples: “I have a low tolerance for pain”; “I am often aware of various things
happening within my body”
Versteeg, Baumert, Pedersen, Ladwig et al. Health
Psychol 2010;29:477-83
CoRPS
Depression and time to first VT/VF
Adjusted analysis:
•HR: 3.2 – time to first shock
for VT/VF
•HR: 3.2 – all shocks for VT/VF
including recurrent episodes
Whang, Sears et al. J Am Coll Cardiol 2005;45:1090-5
CoRPS Distress and arrhythmia: Anxious Type D
patients and increased risk of VTs
N = 391
van den Broek, Denollet et al. J Am Coll Cardiol 2009;54:531-7
CoRPS
Posttraumatic stress symptoms and mortality
Ladwig
et al. Arch Gen Psychiatry 2008;65:1325-30
07/07/2015
30
CoRPS Clustering of Type D personality and high ICD
pre-implantation concerns and mortality
N = 371
2-year mortality (%)
HR: 3.65; 95%CI: 1.57-8.45; p = .003
20
18
16
14
12
10
8
6
18.2%
5.2%
4
2
0
Type D and concerns
Pedersen et al. Europace published ahead-of-print August 18, 2010
None or one risk marker
CoRPS Do we have the answer to the key question?
• Demographic: Female gender, age,
no partner
?
• Clinical: Shocks, diabetes, (worsening
of) heart failure
• Psychological: Type D personality,
clustering of psychosocial risk factors,
prior distress, poor social support
• Medication: Psychotropic,
amiodarone
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Clinical practice tips
CoRPS Prevalence of distress in ICD partners and
patients
N = 182
Prevalence (%)
p = .048
45
40
35
30
25
20
15
10
5
0
42
p = .901
31
28
29
Partners
Patients
Anxiety
Depression
Pedersen et al. Psychosom Med 2004;66:714-9
Prevalence
of
anxiety
and
depression
in
CoRPS
patients and partners stratified by gender
%
70
58
Prevalence
60
p = .99
50
40
40
30
N = 182
p = .040
29
Male patients
Female patients
39
27 29 26 29
Male partners
Female partners
20
10
0
Anxiety
Depression
Pedersen et al. Psychosom Med 2004;66:714-9
CoRPS ICD patient and partner distress: The role of Type D
personality
N = 196
Pedersen et al. PACE 2009;32:184-192
CoRPS Partner distress: The role of personality and clinical
factors related to the patient
Highest level of anxiety in partners:
• Secondary prevention indication (patient) AND shock (patient)
• Secondary prevention indication (patient) AND Type D
(partner)
Highest level of depression in partners:
• Patient secondary prevention indication AND partner Type D
Pedersen et al. PACE 2009;32:184-192
CoRPS
Poor social support in partners and patients
Perceived social support stratified by
CHF/ICD and patient/partner status
25
Mean scores
20
CHF patient
15
ICD patient
10
ICD partner
5
0
Friends
Family
Significant
other
Poor social support in ICD patients and
their partnersa
_____________________________________________
OR
[95% CI]
p
____________________________________________
ICD patient1
3.54
[2.05-6.11]
<0.001
ICD partner1
5.41
[2.61-11.23]
<0.001
Female gender
0.79
[0.45-1.38]
0.40
Age
1.00
[0.98-1.02]
0.87
2
Having no partner
1.97
[1.06-4.64]
0.03
Symptoms of anxiety
1.26
[0.71-2.22]
0.43
Symptoms of depression 1.41
[0.77-2.60]
0.27
Type D personality
2.24
[1.26-4.00]
0.006
____________________________________________________________
a Multivariable analysis (using a median split on the MSPSS)
1 Reference category: CHF patient
2 Coded as: 1 = Unmarried/having no partner; 0 = Married/having a partner
Pedersen
07/07/2015et al. Psychosomatics 2009;50:461-7
38
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
CoRPS How to break the vicious circle...
Structural heart disease
Electrical instability
ICD shock – the paradox
Autonomic imbalance
HR  HRV
Inflammation 
Distress
(Anxiety /
Depression)
Tachyarrhythmia /
shock
Safety?
Danger?
Increased perception,
dysfunctional appraisal,
maladaptive coping
Personality
Pre-existing distress
Social support
07/07/2015Braunschweig, Boriani, Bauer, Hatala, Herrmann-Lingen, Kauzner,
Pedersen, Pehrson et al. EHRA consensus paper, Submitted
40
CoRPS
WEBCARE
Pedersen et al. Trials 2009;10:120
CoRPS Objectives and study endpoints
OBJECTIVES
• To investigate whether the web-based intervention is
superior to usual care
STUDY ENDPOINTS
• Primary: Patient-centered outcomes (i.e., distress and
quality of life); health care utilization/cost-effectiveness
• Secondary: Ventricular arrhythmias; cortisol awakening
response
• Long-term: Mortality
CoRPS Participants
• N = 350 recruited from 3 centers in the Netherlands
• Inclusion criteria: 18-75 years, access to and ability to
use internet, speaking and understanding Dutch
• Exclusion criteria: Life expectancy < 1 year, history of
psychiatric illness other than affective/anxiety
disorders, on the waiting list for heart transplantation,
insufficient knowledge of the Dutch language
CoRPS Study design – randomized controlled trial
5-10 days post implantation:
completion of baseline
questionnaire
-T1
T0
Follow-up
Intervention
T1
T2
T3
14
26
52
Usual care
Weeks
0
Hospitalisation
for ICD
implantation
2
Randomisation
to intervention
or usual care
CoRPS Intervention – web application
CoRPS Intervention (fixed, 3-month duration)
COMPONENTS
TOPICS DEALT WITH
 Psycho-education about the ICD
 Emotional reactions to ICD
therapy
 Problem-solving skills
 Which aspects of ICD therapy
may lead to distress
 Cognitive restructuring
 Relaxation training
 How to deal with shocks
 Disease-specific issues and fears
 How to prevent the avoidance of
 Personalized feedback by a therapist
activities
via the computer
 Interpretation of bodily
symptoms
 How to cope with uncertainty
 Help-seeking behavior
 How to cope with stress
CoRPS Advantages of web-based approach
• Low-threshold accessibility
• Less stigma – no face-to-face meetings with
therapists
• Obtain treatment at any time and place, work at
own pace and review the material as often as
desired
• No extra hospital visits – being reminded less of
illness as the context of the intervention is
different
CoRPS
Overview
• ICD therapy from the patient’s perspective
Expanding indications
– ICD shocks
– Device advisories
– Overall adjustment
–
•
•
•
•
Prevalence and characteristics of high-risk patients
What about the partners?
WEBCARE – a web-based behavioral intervention
Take home message and clinical practice tips
CoRPS Take home message...
• The majority of ICD patients do well with an ICD
• A subgroup of ICD patients is at risk of psychological distress
and adverse health outcomes
• Shocks may be one determinant – do not forget the
psychological profile of the patient
• The partner is also important
• Changes in clinical variables, such as worsening of heart
failure and medication should be assessed
• Questionable whether new features to reduce ICD shocks
will alleviate distress in all patients
07/07/2015
49
CoRPS Tips for dealing with high-risk patients in
clinical practice
 Know who they are – screen for psychological
distress and monitor over time
 Establish a good rapport with patients and partners
 Look at body language and non-verbal cues
 Check if their medication and general treatment
can be optimized further
 Involve the partner – but also distress in partner
 Teach patients relaxation/breathing therapy
CoRPS
 Recommend that patients develop a “shock plan”
(may not work for all). Further information on
following Cardiology Patient Pages:
 Patients: Sears et al. Circulation 2005;111:e380-2
 Partners: Hazelton et al. Circulation 2009;120:e73-6
 Referral to mental health professional if available
CoRPS
Contact details
Professor Susanne S. Pedersen
CoRPS - Center of Research on Psychology in Somatic diseases, Tilburg
University, The Netherlands
www.tilburguniversity.nl/corps
Phone: + 31 (0) 13 466 2503
E-mail: [email protected]
Pedersen SS, Kupper N, Denollet J.
Psychological factors and heart disease
(Chapter 35). The ESC Textbook of
Cardiovascular Medicine, 2nd ed.
(Eds. J Camm, T Lüscher, P Serruys).
Oxford University Press 2009.