1. Increased Patient Device Concerns But Not General Anxiety in Patients with a Secondary Indication for the ICD Susanne S. Pedersen, Professor of Cardiac Psychology

2. Affiliations 1.Department of Medical Psychology and Neuropsychology, Center of Research on Psychology in Somatic diseases (CoRPS), Tilburg University, the Netherlands 2.Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands 3.Department of Cardiology, Odense University Hospital, Denmark

3. Background The implantable cardioverter defibrillator (ICD) is superior to anti-arrhythmic drugs for the prevention of sudden cardiac death Established treatment both as primary and secondary prophylaxis → expansion of indications Concerns of clinicians and patients about the impact of the ICD on patient-centered outcomes, particularly as primary prophylaxis treatment ACC/AHA/ESC Guidelines. Circulation 2006;114:e385-e484

4. Patients with a primary indication for the ICD differ from secondary indication patients: –may fail to understand why they need the device (e.g. if survived several years post MI) –fears of device malfunction, advisory, and complications, incl. inappropriate shocks Conviction of cardiologists: –Primary indication has been described as “one of the more confusing and poorly understood consultations cardiologists perform” Zimetbaum. JAMA 2007; 297:1909–1916 Pedersen, Sears, Burg, van den Broek. PACE 2009;32:153-156

5. Viewpoint – indication and patient- centered outcomes Pedersen, Sears, Burg, van den Broek. PACE 2009;32:153-156

6. Objective To examine the influence of indication (primary versus secondary) on disease- specific and general anxiety

7. Methods: Patient sample Consecutive cohort (N = 312) of patients implanted with an ICD between August 2003 to December 2008 at the Erasmus Medical Center, Rotterdam, the Netherlands Derived from the ongoing Mood and personality as precipitants of arrhythmia in patients with an Implantable cardioverter Defibrillator: A prospective Study (MIDAS)

8. Methods: Procedure Patients completed a set of standardized questionnaires at three time points: –Baseline (one day prior to ICD implantation) –10 days post implantation –3 months post implantation

9. Methods: Measures Demographic and clinical: Information derived from medical records and purpose- designed questions in the questionnaire Number of ICD therapies (ATPs and ICD shocks) were obtained by means of device interrogation Psychological: The 8-item ICD Patient Concerns questionnaire (e.g. “I am worried about not having any warning that my ICD will fire”) The 20-item State-Trait Anxiety Inventory (state measure) (e.g. “I feel nervous”)

10. Results: Sample characteristics Secondary indication: = 37.5% (117/312) Mean age = 57.7 ± 12.3 Men = 80.1% (250/312) Heart failure = 38.1% (119/312) Ischemic etiology = 59.3% (185/312) ICD shock (appropriate and/or inappropriate) during 3-month follow-up = 6.1% (19/312)

11. Results: Mean scores on patient ICD concerns Main effect: p<.001; all comparisons at all time points (all ps<.001) Time effect: p<.001 Time by indication: p<.27 ICDC score range: 0-32 ANOVA with repeated measures

12. Results: Mean scores on general anxiety Main effect: p<.13 Time effect: p<.001 Time by indication: p=.87 STAI score range: 20-80 ANOVA with repeated measures

13. Results: Indication and ICD concerns (adjusted)* PredictorF-testP Secondary indication9.574.002 Age3.989.047 Sex.254.62 Atrial fibrillation.011.92 Ischemic etiology4.154.042 Heart failure.144.71 Shock during follow-up6.485.011 * ANCOVA with repeated measures

14. Results: Shock and ICD concerns No shock during follow-upShock during follow-up Primary ----- Secondary -----

15. Conclusions Patients with an ICD due to secondary prophylaxis experienced more device concerns than primary prophylaxis patients No differences between groups on general anxiety Patients receiving a shock during follow-up, irrespective of indication, reported more ICD concerns

16. Conclusions Generic measures of anxiety may not be sufficiently sensitive to measure the impact of indication on patient-centered outcomes Monitor ICD patients from the time of implantation for distress – use of a disease- specific measure Intervene if symptoms do not abate – consequences for risk of future therapies and mortality Van den Broek, Denollet et al. JACC 2009;54:531-37 Pedersen, Theuns, Jordaens et al. Submitted

17. WEBCARE

18. Acknowledgements Collaborators: Dominic AMJ Theuns, PhD (EMC) Luc Jordaens, MD, PhD (EMC) Agnes JQ Muskens-Heemskerk (EMC) Ruud AM Erdman, PhD (EMC) Funding to Dr. SS Pedersen: VENI grant (451-05-001) from the Netherlands Organisation for Scientific Research (NWO) VIDI grant (91710393) from the Netherlands Organisation for Health Research and Development (ZonMw)