1. CoRPS Center of Research on Psychology in Somatic diseases Patients with an ICD Susanne S. Pedersen, Professor of Cardiac Psychology

2. CoRPS Affiliations Prof.dr. Susanne S. Pedersen 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 & Institute of Psychology, Southern University of Denmark, Denmark E-mail: s.s.pedersen@uvt.nl www.tilburguniversity.nl/corps

3. CoRPS Overview Epidemiology and challenges of ICD therapy Prevalence of distress in ICD patients Which patients are at risk of distress? Why bother about distress in ICD patients? What to do about distress in ICD patients? Take home message

4. CoRPS Overview Epidemiology and challenges of ICD therapy Prevalence of distress in ICD patients Which patients are at risk of distress? Why bother about distress in ICD patients? What to do about distress in ICD patients? Take home message

5. CoRPS The implantable cardioverter defibrillator (ICD) Ahmad et al. PACE 2000;23:931-3 Crespo et al. Am J Med Sci 2005;329:238-46 Used as primary and secondary prevention of sudden cardiac death ICD is superior to anti-arrhythmic drugs in saving lives The ICD can shock with up to 700-800 volts TRANSVENOUS ICD: Leads in or on the heart

6. CoRPS Number of Worldwide ICD Implants Per Year  First Human Implant  FDA Approval of ICDs Transvenous Leads Biphasic Waveform  Smaller Devices  DC-ICD  AVID  CASH  CIDS  MUSTT  CRT-D 1980 1985 1989 1993 1996 1997/8 1999 2000 2002 1988  MADIT  MADIT-II 2004 SCD-HeFT  COMPANION  Tiered Therapy 800,000 heart patients in Europe and 1 mill in North America have a cardiovascular implantable electronic device Rise in ICD implantations Crespo et al. Am J Med Sci 2005;329:238-46

7. CoRPS ICD therapy: Challenges to patients ICD shock Fractured leads Home monitoring New hardware Symptomatic heart failure Expanding indications Primary Secondary Device advisories

8. CoRPS Patient’s personality and pre-implantation psychological functioning Let’s not forget....

9. CoRPS Focus on patient-centered outcomes

10. CoRPS Institute of Medicine, USA A NEW HEALTH SYSTEM FOR THE 21ST CENTURY Guidelines set out to provide consistent, high-quality medical care to all people: Safe, effective, timely, equitable, efficient and patient- centered…. The Institute of Medicine. Washington DC: National Academy Press 2001 Matlock. Circulation (Editorial TRUST trial) 2010;122:319-21 Big brother is watching you: What do patients think about ICD home monitoring? “To move the care of patients with ICDs, and the entire field of cardiology for that matter, into the next strata of quality, the field must become more patient-centered. Patients’ perspectives, goals, and values should guide all medical trials, guidelines, and decisions.”

11. CoRPS Overview Epidemiology and challenges of ICD therapy Prevalence of distress in ICD patients Which patients are at risk of distress? Why bother about distress in ICD patients? What to do about distress in ICD patients? Take home message

12. CoRPS Prevalence of distress in ICD patients Versteeg et al. Int J Cardiol 2011;146:438-9; Pedersen et al. Int J Cardiol 2011;147:420-3; von Känel et al. J Affect Disord 2011;131:344-52 Subset of patients: 1 in 4 (25%) Depression: 11% to 28% Anxiety: 11% to 26% Posttraumatic stress ≈ 12% Chronic anxiety ≈ 50%

13. CoRPS Stability of psychological functioning Baseline ICD concerns (n=328) Normal levels (Score 0-12) Increased levels (Score ≥ 13) 12-month ICD concerns Normal levels (Score 0-12) 63.7% [49.0-81.4]21.3% [13.2-32.5] Increased levels (Score ≥ 13) 5.8% [2.0-12.8]9.1% [4.1-17.2] Baseline anxiety symptoms (n=332) Normal levels (Score 0-7) Probable clinical levels (Score ≥ 8) 12-month anxiety symptoms Normal levels (Score 0-7) 70.2% [54.7-88.7]14.2% [7.7-23.8] Probable clinical levels (Score ≥ 8) 5.7% [2.0-12.7]9.9% [4.7-18.3] Baseline depressive symptoms (n=332) Normal levels (Score 0-7) Probable clinical levels (Score ≥ 8) 12-month depressive symptoms Normal levels (Score 0-7) 69.0% [53.6-87.3]10.2% [4.9-18.7] Probable clinical levels (Score ≥ 8) 8.1% [3.5-15.9]12.7% [6.6-21.9] Majority of patients (i.e., 72% to 81%) preserved pre implantation level of psychological functioning 12 months post implantation Around 10% to 21% of patients crossed over from high to low levels of distress Around 5% to 8% changed from low to high levels of distress Pedersen, Jordaens, Theuns et al. Int J Cardiol 2011;In Press

14. CoRPS Overview Epidemiology and challenges of ICD therapy Prevalence of distress in ICD patients Which patients are at risk of distress? Why bother about distress in ICD patients? What to do about distress in ICD patients? Take home message

15. CoRPS ICD shocks

16. CoRPS General belief – ICD shock explains all distress in ICD patients “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. Pacing Clin Electrophysiol 2007;30:858-64; Raitt J Am Coll Cardiol 2008;51:1366-8

17. CoRPS Clinical trials: Effect of shocks on quality of life TrialRecruitmentFU mthsProgrammingShock effectDose-response Primary prevention CABG-PATCH1990-1996 6Shock only No - AMIOVIRT1996-200012ATP and shock?No- SCD-HEFT1997-200130Shock onlyMixedNo MADIT-II1997-200136Shock only MixedNo DEFINITE1998-200236 (63)Shock onlyMixed- Secondary prevention CIDS1990-199712ATP and shockNo Yes AVID1993-199712ATP and shockYes Yes Mixed evidence Pedersen et al. Pacing Clin Electrophysiol 2010;33:1430-6

18. CoRPS Irvine et al. Am Heart J 2002;144:282-9 CIDS trial: Impact of ICD shocks on mental health at 12 months Dose-response relationship

19. CoRPS Piotrowicz et al. Eur Heart J 2007;28:601-7 MADIT II trial: Impact of ICD shocks on PCS and MCS during 12-month follow-up N = 390 No dose-response relationship

20. CoRPS What would the predictive value of shocks be if clinical trials studying QoL as the endpoint had also included other competitive factors (e.g. psychological)?

21. CoRPS Sears et al. Psychosomatics 2005;46:451-7 Predictors of quality of life (8 months) * Social support, optimism, depression, anxiety Age, LVEFPsychological variables* ShocksTotal variance General health 21.2%39.9%3.5%64.5% Mental health13.7%27.4%0.7%41.8% Physical health 23.4%24.1%7.3%54.8%

22. CoRPS Intra-individual changes in psychological functioning between pre implantation and 12 months stratified by ICD shock* * A positive mean score change indicates improvement in psychological functioning Explained variance in changes: ICD concerns: 5.1% Anxiety: 3.1% Depression: 3.5% Pedersen, Jordaens, Theuns et al. Int J Cardiol 2011;In Press N = 308

23. CoRPS Predictors of mean score changes in psychological functioning during follow-up ICD concernsAnxietyDepression β*[95% CI]pβ*[95% CI]pβ*[95% CI]p Male gender-.01[-2.02 – 1.56].80.07[-.29 – 1.50].19.03[-.58 – 1.05].57 Age-.04[-.04 –.09].45.11[.001 –.07].04 # -.007[-.03 –.03].90 Primary prevention indication.12[.20 – 3.73].03 #.16[.37 – 2.16].006 †.12[-.02 – 1.61].06 NYHA class III-IV-.05[-2.32 –.82].35-.05[-1.19 –.40].33-.03[-.95 –.51].56 LVEF ≤35%-.09[-3.93 –.22].08-.15[-2.54 – -.41].007 † -.10[-1.79 –.13].09 Atrial fibrillation.005[-1.71 – 1.53].92-.12[-1.78 – -.14].02 # -.008[-.81 –.69].88 Diabetes mellitus-.09[-3.82 –.16].07-.03[-1.33 –.68].52-.07[-1.55 –.27].17 Type D personality-.10[-3.45 – -.05].04 # -.17[-2.36 – -.49].003 † -.20[-2.37 – -.66].001 † Beta-blockers-.03[-2.40 – 1.23].53-.005[-.96 –.87].93.01[-.76 –.91].86 Psychotropic medication-.03[-2.38 – 1.42].62-.06[-1.55 –.38].23.02[-.71 – 1.04].72 Shock during follow-up-.19[-6.14 – -1.91]<.001 ‡ -.16[-2.75 – -.60].002 † -.18[-2.63 – -.66].001 † Baseline psychological functioning.57[.45 –.64]<.001 ‡.54[.40 –.61]<.001 ‡.51[.30 –.48]<.001 ‡ Shock: ↑ ICD concerns, Anxiety, Depression Type D: ↑ ICD concerns, Anxiety, Depression Primary prevention: ↓ ICD concerns, Anxiety Older age: ↓ Anxiety LVEF ≤35%: ↑ Anxiety AF: ↑ Anxiety Baseline psych: ↓ ICD concerns, Anxiety, Depression Pedersen, Jordaens, Theuns et al. Int J Cardiol 2011;In Press

24. CoRPS Sears et al. Pacing Clin Electrophysiol 2010;33:1437-41 Ahmad et al. Pacing Clin Electrophysiol 2000;23:931-3 It is physically painful (6 on a 0-10 point pain scale) “It’s like getting kicked in the chest by a big horse!” Shock viewpoint and counter viewpoint ICD shock Critical event to some patients, but variability in impact…

25. CoRPS Pedersen et al. Pacing Clin Electrophysiol 2010;33:1430-6 Given that programming of the ICD is changing, leading to fewer shocks and improved quality of life, it may be timely to also examine the influence of other determinants (e.g. heart failure progression and personality) of patient-reported outcomes... Shock viewpoint and counter viewpoint

26. CoRPS Symptomatic heart failure

27. CoRPS Correlates of anxiety and depression Johansen, Pedersen et al. Europace 2008;10:545-51 AnxietyDepressionOR [95% CI] Female gender 2.38 [1.32-4.29]† ns Age ns ns Living with a spouse ns ns Non-ischaemic etiology ns ns Symptomatic CHF 5.15 [3.08-8.63]‡ 6.82 [3.77-12.39]‡ Co-morbidity ns ns ICD-related complications ns ns ICD shocks 2.21 [1.32-3.72]† 2.00 [1.06-3.80]* Years with ICD therapy ns ns Current smoking ns ns Amiodaronens ns Other antiarrhythmic medication ns ns Psychotropic medication ns 2.75 [1.40-5.40]† * P < 0.05; † P < 0.01; ‡ P < 0.001 N = 610

28. CoRPS Predictors of persistent depression Pedersen et al. Am J Cardiol 2011;108:69-74 HR: 2.60 [95% CI: 2.44-1.71] HR: 8.30 [95% CI: 4.42-15.58] HR: 2.09 [95% CI: 1.01-4.29] HR: 1.92 [95% CI: 1.05-3.52] HR: 2.47 [95% CI: 1.36-4.48] HR: 2.29 [95% CI: 1.26-4.15] 14% (52/386)

29. CoRPS SF-36 Physical Component Summary SF-36 Mental Component Summary Habibovic, Pelle, Versteeg... & Pedersen. Europace In Press N = 435 ICD = 188 HF = 208 ICD/HF = 39 Perhaps the relationship is more complex – the ICD or underlying disease….

30. CoRPS Type D personality

31. CoRPS Type D (distressed personality) Pedersen & Schiffer. Herzschrittmacherther Elektrophysiol 2011;22:181-8 Denollet et al. Circ Cardiovasc Qual Outcomes 2010;3:546-57

32. CoRPS Prevalence of anxiety and depression in patients stratified by Type D and shocks Pedersen, Jordaens, Theuns et al. Psychosom Med 2004;66:714-9 % N = 182

33. CoRPS Pedersen, Jordaens,Theuns et al. Am J Cardiol 2011;108:69-74 Persistent depression 3 months post implantation 8.30 [4.42-15.58] 2.60 [1.44-1.71] 2.47 [1.36-4.48] 2.29 [1.26-4.15] 2.09 [1.01-4.29] 1.92 [1.05-3.52] 14% (52/386) Odds Ratios [95% CI] N = 386

34. CoRPS Overview Epidemiology and challenges of ICD therapy Prevalence of distress in ICD patients Which patients are at risk of distress? Why bother about distress in ICD patients? What to do about distress in ICD patients? Take home message

35. CoRPS Whang, Sears et al. J Am Coll Cardiol 2005;45:1090-5 Depression and ventricular tachyarrhythmias Adjusted analysis: HR: 3.2 – time to first shock for VT/VF HR: 3.2 – all shocks for VT/VF including recurrent episodes

36. CoRPS Posttraumatic stress symptoms and mortality Ladwig et al. Arch Gen Psychiatry 2008;65:1325-30 N = 147 HR: 3.45 (95%CI: 1.57-7.60; p =.003)

37. CoRPS Pedersen, Erdman et al. Europace 2010;12:1446-52 Type D personality and high ICD pre- implantation concerns and mortality N = 371 HR: 3.65 (95%CI: 1.57-8.45; p =.003) 18.2% 5.2%

38. CoRPS Review Expert medical devices 2012

39. CoRPS Overview Epidemiology and challenges of ICD therapy Prevalence of distress in ICD patients Which patients are at risk of distress? Why bother about distress in ICD patients? What to do about distress in ICD patients? Take home message

40. CoRPS How to break the vicious cycle? Shock Braunschweig, Boriani,... Pedersen et al., Europace 2010;12:1673-90 Stressed out… Me ???!!

41. CoRPS 1. Screen and monitor

42. CoRPS Braunschweig, Boriani,.... Pedersen et al. Europace 2010;12:1673-90

43. CoRPS Pedersen, Theuns, Jordaens et al. Am Heart J 2005;149;664-9 ICD Patient Concerns questionnaire We want to know what things worry you about living with your ICD. It is important that you answer every question. Don’t spend too long thinking about your answers. For each question please circle one number. Please don’t leave any out. 0 = Not at all 1 = A little bit 2 = Somewhat 3 = Quite a lot 4 = Very much so I AM WORRIED ABOUT...... 1.My ICD firing01234 2.Doing activities/hobbies that may cause my ICD to fire01234 3.Time spent thinking about my ICD firing01234 4.Working too hard/overdoing things causing my ICD to fire01234 5.Having no warning my ICD will fire01234 6.The symptoms/pain associated with my ICD firing01234 7.Not being able to prevent my ICD from firing01234 8.Getting too stressed in case my ICD fires01234

44. CoRPS 2. Psychological and behavioral intervention

45. CoRPS Pedersen, van den Broek, & Sears. PACE 2007;30:1546-54 Intervention in ICD patients

46. CoRPS More new studies added... AuthorsN (design)FU-periodOutcome Dunbar246 (RCT)12 mths  anxiety;  depression;  health care consumption and disability days Kuhl30 (RCT)1 mthno change in knowledge perception Lewin 192 (RCT)6 mths  anxiety;  depression;  admissions;  QoL Sears30 (RCT)4 mths  anxiety;  cortisol  depression in 1-day workshop group BENEFITS Dunbar et al. PACE 2009;32:1259-71; Kuhl et al. J Cardiovasc Nursing 2009;24:225-31; Lewin et al. Heart 2009;95:63-9; Sears et al. PACE 2007;30:858-64

47. CoRPS How to break the vicious cycle? Cardiac psychology has something to offer to patients Reduce catastrophic thinking Alleviate symptoms of anxiety and depression Improve quality of life Effect on survival?

48. CoRPS E-health the future? Pedersen et al. Trials 2009;10:120

49. CoRPS Intervention – web application

50. CoRPS Intervention (fixed, 3-month duration) COMPONENTSTOPICS DEALT WITH  Psycho-education about the ICD  Problem-solving skills  Cognitive restructuring  Relaxation training  Personalized feedback by a therapist via the computer  Emotional reactions to ICD therapy  Which aspects of ICD therapy may lead to distress  How to deal with shocks  Disease-specific issues and fears  How to prevent the avoidance of activities  Interpretation of bodily symptoms  How to cope with uncertainty  Help-seeking behavior  How to cope with stress

51. CoRPS “One size fits some but not all”

52. CoRPS

53. 3. Clinical practice tips

54. CoRPS General measures Establish trustful relationship… o with patients and partners o with mental health expert inside or outside the team Listen to patients and leave room for questions and emotions Look at patient’s body language Regularly explore beliefs, health resources and distress (both pre-existing and newly developed) Sears et al. Stress and Health 2008;24:239-48 Braunschweig, Boriani,.... Pedersen et al. Europace 2010;12:1673-90

55. CoRPS General measures Offer quick help if shocks and / or distress occur Ask for subjective effects of shock… o Sensory and emotional perception o Interpretation o Behavioral consequences o Encourage resumption of activities asap Explore patient needs for more information and support Provide reassurance Sears et al. Stress and Health 2008;24:239-48 Braunschweig, Boriani,.... Pedersen et al. Europace 2010;12:1673-90

56. CoRPS ICD specific education o How the device works, triggers of shocks, how to respond to shocks (e.g. shock plan [Sears et al. Circulation 2005;211:e380-2] ) o Everyday functioning (e.g. occupational limitations, physical and sexual activity, driving) Multidisciplinary cardiac rehabilitation o “One size does not fit all” o Demonstrate safety of customized exertion via cardiac rehabilitation approaches Sears et al. Stress and Health 2008;24:239-48 Braunschweig, Boriani,.... Pedersen et al. Europace 2010;12:1673-90 Specific measures

57. CoRPS Relaxation and stress management o Assist patients in reducing arousal via progressive muscle relaxation and diaphragmatic breathing Cognitive restructuring (CBT) o Teach patients to value the ICD as a source of protection rather than a threat to their well-being o Encourage activity planning and exposure-based exercises to teach patients to engage in activities they have reduced or avoided due to the device Sears et al. Stress and Health 2008;24:239-48 Braunschweig, Boriani,.... Pedersen et al. Europace 2010;12:1673-90 Specific measures

58. CoRPS Social support o Provide patients with social support via nursing contact, patient calls and support groups Referral to a mental health professional Prescription of pharmacotherapy (e.g. SSRIs and anxiolytics) Sears et al. Stress and Health 2008;24:239-48 Braunschweig, Boriani,.... Pedersen et al. Europace 2010;12:1673-90 Specific measures

59. CoRPS Tips how to reduce distress post-shock...

60. CoRPS Overview Epidemiology and challenges of ICD therapy Prevalence of distress in ICD patients Which patients are at risk of distress? Why bother about distress in ICD patients? What to do about distress in ICD patients? Take home message

61. CoRPS Take home message A subset (25%-33%) are at risk of psychological morbidity Psychological factors are independent predictors of prognosis despite state-of-the-art treatment Information on psychological risk and health status are not standardarly assessed nor available as a proxy from patient medical records Screen and monitor – we need to know who they are Multi-factorial CR/psychosocial/behavioral interventions targeted to the individual most likely to be successful