Financial Disclosures

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1 Samuel Sears, Ph.D. Nationally recognized expert in the care of ICD patients. Published over 150 research articles in the medicine literature. Completing 23rd year of collaborations in academic medicine and psychology. Regularly appears in National PBS TV series, Second Opinion. Founded ICD Coach to produce first ICD patient mobile phone app 2013 O. Max Gardner Award Winner-Highest Honor in UNC System

2 Samuel F. Sears, Ph.D. Financial Disclosures Founder, President ICD Coach and QOL Apps, Inc Research Grants: Funds to East Carolina University Medtronic, Inc. ZOLL Medical Consultant: Funds to East Carolina University Medtronic, Inc. Speaking Honoraria Medtronic: Zoll Medical St. Jude Medical, Inc. Boston Scientific

3 BEYOND THE DEVICE: Comprehensive Care for ICD Patients Samuel F. Sears, PhD East Carolina University Professor, Department of Psychology Department of Cardiovascular Sciences East Carolina Heart Institute Brody School of Medicine Greenville, NC

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5 ICDs save lives. Psych. distress = 25-33% of pts.

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7 Learning Objectives To review evidence for key psychosocial issues in ICD pts To provide some talking points for common patient challenges

8 GOALS: CLINIC PERSPECTIVE: Prevent premature death Reduce symptoms Maximize functional capacity Optimize QOL Produce happy, satisfied patients and families

9 ICD PATIENT CHALLENGES: COPE WITH CARDIAC CONDITION(S) COPE WITH ICD RESUME ACTIVITY & QOL

10 Coping with CHF vs. CA vs. COPD How hard is it to cope with CHF? Steinhauser, et al., Sept 2011, J of Pain and Sx Mgmt Compared CHF, COPD, & Stage IV CA (breast, prostate, colon or lung CA): All illnesses were comparable on QOL Functional Status: CHF & COPD worst Anxiety CHF Worst Depression- CHF & COPD Worst CHF threats are less predictable?

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12 GOAL: PATIENT PERSPECTIVE The purposes of my CV Care-ICD: Prevent premature death Produce feeling of security Achieve QOL

13 Maslow s Hierarchy of Human Needs Self-actualization Self-esteem Social Acceptance Security Survival

14 Simplified ICD Patient Needs Pursue Achievement of QOL Produce a Feeling of Security Prevent Premature Death

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16 ICD Patient Distress Type of Distress Percent of ICD Patients Depression 18-41% Posttraumatic stress disorder (PTSD) 20% General Anxiety 13-38% Shock Anxiety 15-44% Avoidance of Activity 33-84% Poor Understanding -ICD 60-80%

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18 QOL Intervention Model Psych. Support & Psych Hx Adverse Events (Recall; Shocks Catastrophic Thinking Avoidance Behavior Fear/Anxiety QOL & Function Hypervigilance Sears & Conti, 2002, 2003

19 Continuum of ICD Shock Response Shock Continuum Sears & Conti, 2002, HEART No shocks Cumulative Shocks Anxiety Spectrum ICD Storms Normalized Fear Shock Phobias (e.g. exertion) Generalized Anxiety PTSD Thoughts and Behaviors The ICD keeps me safe during exertion The ICD is my reason for not exerting There is very little that I am safe to do with my ICD The ICD does not keep me safe

20 Shocks rated as a 6 on 1-10 scale More Painful?: Shock Pain Inappropriate shocks more painful than appropriate shocks. (Median pain = 9 vs. 4 ) Only predictor of turn off ICD considerations (Marcus, Chan, & Redberg, 2010)

21 What is important to CHF pts? Top rated anxieties ICD pts Fear of Exercise Fear of Heart Beating Fast Perini, Kutyifa, Veazie, Daubert, Moss, 2017) AHJ Top rated probs for CHF pts Dyspnea 44% Physical capacity 18% Exhaustion -mental activities 13% Fear due to HF 13% Pisa, Eichmann, Hupfer, 2015

22 ICD Patient Research Summary Distress is common and risks identified. Most patients can tolerate a shock. 2 or more trigger shock anxiety 5 or more shocks trigger global anxiety. Inappropriate shocks are rated more painful and pts can give up on ICD. Shock anxiety occurs with or w/o shock.

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24 Activity Avoidance ADULTS: Approx % of ICD pts avoid exertion (Lemon 2004) CHILDREN: Approx. 84.5% of kids with ICDs avoid activity (Sears et al., 2012)

25 Exercise /Activity Research Kronish et al, 2017; JACC Recent AMI Evidence Wristwatch accelerometers in 330 ACS pts studied Only 16% of post MI patients achieved Guideline Level of exercise post MI by week 5 Cited Fear of Exercise and 35% depressed Pandey, et al., 2017 JACC: EP Recent ICD Meta-Analysis ICD pys benefit with improved Cardiac Fitness Decreased shocks in the EXERCISE group

26 1)What is the average amount of activity in ICD patients? 2) What are the effects of ICD shocks?

27 Mean Activity Levels Baseline Activity Level = 22.5 hours over 7 days ATP Shock Total Baseline Posttherapy 22.4 (0.05 to 61.3) 22.1 (0.13 to 70.3) 23.5 (0.93 to 58.2) 22.5 (0.05 to 61.3) 20.7 (0.02 to 60.9) 21.3 (0.02 to 70.3)

28 Results

29 JACC EP ) Does activity change when AF starts? 2) Does it matter in mortality?

30 Daily Activity (minutes) Prior Week Week 1 Week 2 Week 3 Week 4 Baseline week vs. 4 weeks after AF onset (8%, 11%, 14%, and 17% decrease, p<0.001). JACC EP 2016

31 Does it matter in mortality? JACC EP 2016 At 4 year f/u, mortality was 20.6% vs. 8.6% in matched controls.

32 Exercise & ICD Pts: ALTITUDE Study 2015 (Kramer, Mitchell, Monteiro, Jones, Reynolds, JAHA) Remote monitored ICD patients N= 98, 437 followed for 2.2 years on activity Average activity = 107 minutes +/- 66 (less than 2 hours a day) Survival: 4 years later Most vs. least active still alive (90% vs. 50%) 44% greater risk of death in least active

33 Studied N= 2,770 patients with ICDs F/u over 22 ± 9 months. Repeated Measures: Activity = Accelerometer Shock Anxiety EuroQol 5-D 1) Does ICD shock reduce activity in international sample? Yes, For how long? 2) What about anxiety and QOL? Sears, Rosman, et al., 2018 Heart Rhythm

34 Learning Objectives To review evidence for key psychosocial issues in ICD pts To provide some talking points for common patient challenges

35 PATIENT PAGES: Circulation ICD Shock ICD Spouse Coping ICD & Sexual Health Recall AF Trauma CHF Plan Kids and ICDs 2014 Cardiac Dz and Sex 2014 ARVD Kids Heart Smart

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37 Clinical Strategies Shock Plan Supportive Communication Activity Plan Screen and Refer

38 Shock Plan

39 Shock Planning 2: PREPARING FOR SHOCK EVENT SYMPTOMS ACTION ICD shock ICD shock Feel fine immediately Chest pains/pressure, shortness of breath, rapid heart action, feel dizzy, confused or unwell Call cardiologist to discuss the event and arrange appropriate follow-up Seek medical attention immediately 2 or more shocks within 24 hrs Feel fine or ill Seek medical attention immediately

40 PACE, 2015

41 Supportive Communication

42 A shift from VICTIM to SURVIVOR reduces stress. SURVIVORSHIP: An active mental approach to cope Emphasizes the positive and the future, rather than the past VICTIMHOOD: Supportive Communication A passive process that emphasizes loss and limitations Emphasizes how no one else can understand their experience

43 Shock: Clinic Talk SHOCKED PATIENT PROTECTION: The ICD provides you with a constant guard against your risk. EMPATHY: Shocks can shake your confidence in your safety and future. PLAN: We have reduced your risk of future shocks via our changes. RETURN TO LIFE: What activities do you want to get back to soon?

44 Activity Plan

45 Activity Plan Disengagement = Disease. Research: Activity is safe but rare!

46 Meta-Analysis: Activity in ICD Pts Examined 6 RCTs in ICD pts: Pandey et al., 2017 JACC: EP (EFFICACY AND SAFETY OF EXERCISE) Typical Exercise group: 8-12 weeks of exercise Pooled Analysis: RESULTS: ICD Patients in Exercise vs. Usual Care ICD patients benefit with improved Cardiac Fitness Decreased chance of shock in the EXERCISE group Cardiac rehab by exclusion only!

47 Activity and QOL: Clinic talk Quality of life requires knowing and doing what you enjoy. ACTIVITY: What activities do you enjoy? (alive and well) REWARDS: What do you like about that? BARRIERS SAFETY: Do you have any concerns about returning to it? REASSURANCE AND PERMISSION: I encourage you to return to those! What s the plan?

48 Screen and Refer

49 Screen and Refer: Clinic Talk Living with Cardiac Problems can be stressful. I would like to refer you to someone with expertise in helping patients successfully manage it. High FEAR: Excessive Fear of Shocks Avoidance Behaviors Psychological Activity Restrictions High STRESS: Evidence of Psychological Distress Suicidal history or ideation High life change, or loss High UTILIZER: Low QOL:

50 QOL is an ACHIEVEMENT, not an ENTITLEMENT.