1. CoRPS Center of Research on Psychology in Somatic diseases E-health for implantable cardioverter defibrillator patients to improve secondary prevention: New kid on the block for a selected few? 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, Denmark Phone: + 31 (0) 13 466 2503 E-mail: s.s.pedersen@uvt.nl www.tilburguniversity.nl/corps

3. CoRPS Project participants CoRPS Susanne S. Pedersen (PI; PhD) Johan Denollet (PhD) Mirela Habibovic (MSc; PhD candidate) Free University, Amsterdam Pim Cuijpers (PhD) Amphia Hospital, Breda Marco Alings (MD, PhD) Canisius Hospital, Nijmegen Leon Bouwels (MD, PhD) Catharina Hospital, Eindhoven Pepijn van der Voort (MD) Erasmus Medical Center, Rotterdam Luc Jordaens (MD, PhD) Dominic Theuns (PhD) Onze Lieve Vrouwe Gasthuis, Amsterdam Jean Paul Herrman (MD, PhD) Vlietland Hospital, Schiedam Suzanne Valk (MD) STIN (Stichting ICD dragers Nederland) Peter Zaadstra (Projectadvisor) Funding ZonMw/Dutch Heart Foundation (grant no. 300020002) and ZonMW (VIDI grant 91710393) to Dr. SS Pedersen

4. CoRPS Background Objectives - WEBCARE Methods – WEBCARE Preliminary results – WEBCARE Pros and cons of e-health in ICD patients

5. CoRPS Background Objectives - WEBCARE Methods – WEBCARE Preliminary results – WEBCARE Pros and cons of e-health in ICD patients

6. CoRPS ICD units per million inhabitants 2009 Eucomed data (based on reports from major manufacturers) 800,000 heart patients in Europe and 1 mill in North America have a cardiovascular implantable electronic device

7. 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 “It’s like getting kicked in the chest by a big horse!” TRANSVENOUS ICD: Leads in or on the heart

8. CoRPS Epstein, J Am Coll Cardiol 2008;52:1122-7 ICD therapy: Benefits and side effects

9. CoRPS Complications (lead fractures, dislodgement, and infection) Shocks that are inappropriate   mortality risk ? Potential malfunctioning, as notified with a device recall Significant anxiety and depression in 20-30% of patients Patient´s psychological reaction to the device may increase the risk of arrhythmias Tung et al. J Am Coll Cardiol 2008;52:1111-21 Pedersen et al. Pacing Clin Electrophyiol 2009;32:1006-11 Risk that patients will refuse this potentially life-saving treatment ICD therapy: Benefits and side effects

10. CoRPS

11. Prevalence of anxiety and depression in patients stratified by Type D and shocks Pedersen et al. Psychosom Med 2004;66:714-719 % (N = 182)

12. CoRPS Whang, Sears et al. J Am Coll Cardiol 2005;45:1090-5 Distress (depression) and arrhythmias Adjusted analysis: HR: 3.2 – time to first shock for VT/VF HR: 3.2 – all shocks for VT/VF including recurrent episodes

13. CoRPS Posttraumatic stress symptoms and mortality Ladwig et al. Arch Gen Psychiatry 2008;65:1325-30 N = 147

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

15. CoRPS ICD shock - the paradox Danger? Shock Safety? Braunschweig, Boriani,... Pedersen et al., Europace 2010;12:1673-90

16. CoRPS N = 12-246; 15 trials AuthorsN (design)Duration Crössman et al. (2011)119 (RCT)6 Dunbar et al. (2009)246 (RCT)12 mths Irvine et al. (2011)193 (RCT)12 mths Kuhl et al. (2009)30 (RCT)1 mth Lewin et al. (2009)192 (RCT)6 mths Sears et al. (2007)30 (RCT)4 mths BENEFITS Pedersen et al. Pacing Clin Electrophysiol 2007;30:1546-1554 Salmoraga-Blotcher et al. BMC Cardiovasc Disorders 2009;9:56 Psychological intervention trials in ICD patients

17. CoRPS Background Objectives - WEBCARE Methods – WEBCARE Preliminary results – WEBCARE Pros and cons of e-health in ICD patients

18. CoRPS Primary: To investigate whether the web-based intervention is superior to usual care in terms of reducing anxiety, depression, and ICD concerns as well as improving ICD acceptance and QoL To investigate the cost-effectiveness of the web-based intervention and whether the web-based intervention is associated with reduced health-care utilization OBJECTIVES

19. CoRPS Secondary: To examine whether psychological (i.e., Type D personality and positive affect) and clinical factors (i.e., cardiac resynchronization therapy (CRT)) moderate the effect of the intervention, with a view to developing risk profiles of patients who are less likely to benefit from the intervention Explorative: To explore whether the web-based intervention influences physiological parameters (i.e., ventricular arrhythmias and the cortisol awakening response (CAR))

20. CoRPS Background Objectives - WEBCARE Methods – WEBCARE Preliminary results – WEBCARE Pros and cons of e-health in ICD patients

21. CoRPS Consecutive first-time ICD patients recruited from: ₋Amphia Hospital, Breda ₋Canisius Hospital, Nijmegen ₋Catharina Hospital, Eindhoven ₋Erasmus Medical Center, Rotterdam ₋Onze Lieve Vrouwe Gasthuis, Amsterdam ₋Vlietland Hospital, Schiedam Patient population 350 patients

22. CoRPS Patients implanted with an ICD 18-75 years of age Speaking and understanding Dutch With access to and ability to use the internet Providing written informed consent Inclusion criteria

23. CoRPS A life expectancy less than 1 year A history of psychiatric illness other than affective/anxiety disorders On the waiting list for heart transplantation With insufficient knowledge of the Dutch language Exclusion criteria

24. CoRPS Study design

25. CoRPS Patient reported measures ConstructQuestionnaire AnxietyGAD-7Generalized Anxiety Disorder Scale FSASFlorida Shock Anxiety Scale STAI-SStait-Trait Anxiety Inventory PDSPosttraumatic Stress Disorder Scale Depressive symptomsHADSHospital Anxiety and Depression Scale PHQ-9Patient Health Questionnaire Quality of lifeSF-12Short Form Health Survey 12 EQ-5DEuroQol 5D MLWHFQMinnesota Living With Heart Failure Questionnaire ICD concernsICDCICD Patient Concerns Questionnaire ICD acceptanceFPASFlorida Patient Acceptance Survey Health care utilization and cost- effectiveness TiC-PTrimbos/iMTA questionnaire for Costs associated with Psychiatric Illness Type D personalityDS14Type D Scale ExpectationsEXPPatient expectations about the ICD treatment OptimismLOTLife Orientation Test

26. CoRPS Salivary cortisol, using the Salivette, assessed at 3 out of the 4 time points (i.e., T0 = 5 to 10 days after ICD implantation; T1 = 14 weeks post-implantation; T3 = 52 weeks post-implantation) Four samples will be taken at each time point and on the consecutive day, that is (a) when waking up, (b) ½ hour later, (c) 11.00 a.m., and (d) 3.00 p.m. Physiological measures

27. CoRPS Clinical: ICD indication, etiology, LVEF, CRT, co- morbidity, type of ICD therapy (ATP vs. shock; appropriate vs. inappropriate), QRS-complex, cardiac medication, etc. Demographic: Sex, age, marital status, education, working status Other: Smoking status, participation in cardiac rehabilitation since ICD implantation, the use of psychotropic medication, help-seeking from a psychologist/psychiatrist Other measures

28. CoRPS Primary: Anxiety; depression; ICD concerns; ICD acceptance; quality of life; health care utilization; cost- effectiveness of the intervention Secondary: Ventricular arrhythmias; cortisol awakening response Long-term: Mortality Study endpoints

29. CoRPS Intervention – web application

30. CoRPS Intervention (fixed, 3-month duration) COMPONENTS  Psycho-education about the ICD  Problem-solving skills  Cognitive restructuring  Relaxation training  Personalized feedback by a therapist via the computer TOPICS DEALT WITH  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

31. CoRPS WEBCARE Pedersen et al. Trials 2009;10:120

32. CoRPS Background Objectives - WEBCARE Methods – WEBCARE Preliminary results – WEBCARE Pros and cons of e-health in ICD patients

33. CoRPS Patient inclusion (total) – status 50% ↓

34. CoRPS Patient inclusion stratified by center

35. CoRPS Intervention completion rate

36. CoRPS Reason for initial refusal of participation: Too much work No interest in participating in a study Participating in other studies Reason for quitting prematurely: Too confronting / too personal Too time consuming / too much work Have a lot of other things to deal with Feeling fine, no need for extra support Reasons for refusal and quitting prematurely

37. CoRPS Background Objectives - WEBCARE Methods – WEBCARE Preliminary results – WEBCARE Pros and cons of e-health in ICD patients

38. CoRPS E-health in ICD patients for a selected few 50% of patients are excluded  reasons: o Lack of internet o Age > 75 years o Language 59% response rate  reasons: o Inclusion at participating centers needs to be optimized o Other study participation (competing with clinical studies) o Timing of intervention (too soon) o Including patients irrrespective of distress (no screening) o Type of intervention (patient preferences) o Too work intensive o Too confronting

39. CoRPS 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 material as often as desired No extra hospital visits – reminded less of illness as the context of the intervention is different Advantages of web-based approach

40. CoRPS Clinical and societal relevance Immediate applicability in health care Identification of high-risk patients  screening Personalized care  optimization of clinical management of device patients Reduced health-care utilization Increased cost-effectiveness

41. CoRPS E-health may fit some but not all ICD patients

42. CoRPS Research group Center of Research on Psychology in Somatic diseases, Tilburg University, The Netherlands Susanne S. Pedersen (PhD) Professor of Cardiac Psychology

43. CoRPS Living in a Device World: Focus on Recent Challenges and Tools to Improve Clinical Care for Patients with an Implantable Cardioverter Defibrillator Device Conference, 3-4 November 2011, Tilburg, the Netherlands Themes OVERCOMING THE SHOCK OF THE ICD ICD REGISTRIES AND THE INCLUSION OF THE PATIENT PERSPECTIVE DEACTIVATION OF THE ICD AND END OF LIFE ISSUES NEGLECTED SUBGROUPS CRT SELECTION AND RESPONSE THE DO’S AND DON’TS OF PATIENT COMMUNICATION SEXUALITY IN ICD PATIENTS BEHAVIORAL INTERVENTIONS LOOKING INTO THE FUTURE Selection of invited faculty Nico Blom (MD, PhD), Leiden University Medical Center, NL Matthew Burg (PhD), Yale School of Medicine, USA Dorothy Frizelle (PhD), University of Hull, UK Jens Brock Johansen, (MD, PhD), Odense University Hospital, DK Karl-Heinz Ladwig (MD, PhD), Helmholtz Institute, Munich, GE Trudie Lobban, The Arryhthmia Alliance, UK Mathias Meine (MD, PhD), University Medical Center Utrecht, NL Susanne S. Pedersen (PhD), CoRPS, Tilburg University, NL Samuel Sears (PhD), East Carolina University, USA Steen Pehrson (MD, PhD), Copenhagen University Hospital, DK Dominic Theuns (PhD), Erasmus Medical Center Rotterdam, NL More information available on: www.tilburguniversity.edu/device2011