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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 24/05/2017 2 CoRPS Acknowledgements THE NETHERLANDS DENMARK • • • • • • • • • • • • 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 • • • Karl-Heinz Ladwig, MD, PhD, Helmholtz Zentrum München Christoph Herrmann-Lingen, MD, PhD, University of Göttingen Martin Scherer, MD, PhD, University Clinic, Lübeck • • • • 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 • • • 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 24/05/2017Pedersen 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 24/05/2017Sears 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 24/05/2017 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 24/05/2017et 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 24/05/2017Braunschweig, 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 24/05/2017 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.