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The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.

The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

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Page 1: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

The Psychology of the ICD Patient

This presentation is provided for general educational purposes only and should not be considered the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.

Page 2: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Objectives

• Describe relevant psychological research • Identify patients at risk for potential stress• Promote the ICD as a positive step towards a healthier,

safer lifestyle• Provide patients with coping strategies, such as shock

plans• Discuss benefits of reducing inappropriate shocks • Improve patient education procedures• Address possible family struggles• Explore relevant clinical research data

Page 3: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

ICD Patient Circle of Influence

Patient

Health

Professionals

Family &

Friends

Device

Company

Personnel

Page 4: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

You Make a Difference!

• Patient education and understanding• Patient coping mechanisms and

perceptions of control• Patient shock plans/programming• Increased well-being and reduced medical

care

•(Sotile W, Psychosocial Interventions for Cardiopulmonary Patients, Champaign: Human Kinetics, 1996)•(Golin CE et al. Journal of Acquired Immune Deficiency Syndrome, 2006 May; 42(1): 42-51)

•(Sears SF, Shea JB, Conti JB. How to respond to an implantable cardioverter defibrillator shock Circulation, June 14, 2005; 111(23): e380-e382)

Page 5: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

– ↑ well-being measures

– ↓ hospitalizations

– ↓ outpatient consultations

– ↑ medial adherence

Psychosocial Interventions

•(Sotile W, Psychosocial Interventions for Cardiopulmonary Patients, Champaign: Human Kinetics, 1996)•(Golin et al. Journal of Acquired Immune Deficiency Syndrome, 2006 May; 42(1): 42-51)

Page 6: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• What is the main adjustment issue you have observed among ICD patients?

Reflection

•Body image concerns•Concern about shock•Concern about possible device malfunction •Coping with family concerns about the device

Page 7: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• 450 ICD pts. (82% male; mean age = 65 yrs.)

• 395 significant others (85% female)

• 103 MD’s

• 157 RN’s & PA’s

•(Sears SF, Todaro JF, Lewis TS, Sotile WM & Conti JB, Clinical Cardiology, 1999; 22: 481-489)

Quality of Life

U.S. National Survey of ICD Recipients

Page 8: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Good to excellent general health 71%

• Same or better quality of life 91%

• Same or better family functioning 98%

• Same or better emotional well-being 85%

•(Sears SF, Todaro JF, Lewis TS, Sotile WM & Conti JB, Clinical Cardiology, 1999; 22: 481-489)

Life After ICD: Patient Ratings

Page 9: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Anxiety (13-38%)

• Depression (24-33%)

•(Sears SF, Todaro JF, Lewis TS, Sotile WM & Conti JB, Clinical Cardiology, 1999; 22: 481-489)•(Sears SF & Conti JB. Quality of life and psychological functioning of ICD patients. Heart 2002; 87: 488-493)•(Burke JL, Hallas CN, Clark-Carter D, White D & Connelly D, British Journal of Health Psychology, 2003; 8 (Pt 2): 165-178)•(Bilge AK, Ozben B, Demircan S, Cinar M, Yilmaz E, Adalet K, PACE, 2006; 29: 619-626)

Living with an ICD: What are Possible Negatives?

Page 10: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Quality of Life – CIDS Study

Amiodarone ICD (n = 160) (n = 157)

QOL > for ICD pts.Except if ≥ 5 shocks

•(Steinberg JS, et al. The AVID Investigators. Antiarrhythmic drug use in the implantable defibrillator arm of the Antiarrhythmics vs Implantable Defibrillators (AVID) Study, JACC, Feb 1998; 31(Supp 2): 514A.)

•(Irvine J et al. Quality of life in the Canadian Implantable Defibrillator Study, American Heart Journal, 2002; 144(2): 282-289)

Page 11: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Predictive value of preexisting psychological variables– Pessimism

– Anxious personality

• Other factors– Disease progression post-implant

– Symptomatic HF

– Primary vs. Secondary indication

Research Review

•(Bostwick JM & Sola CL, An updated review of implantable cardioverter/defibrillators, induced anxiety, and quality of life. Psychiatric Clinics of North America, Dec 2007; 30(4): 677-688)•(Pedersen SS, van Domburg RT, Theuns DA, Jordaens L, Erdman RA., Concerns about the implantable cardioverter defibrillator: A determinant of anxiety and depressive symptoms independent of experienced shocks. American Heart Journal, 2005; 149: 664-669) •(Pedersen SS, van Domburg RT, Theuns DA, Jordaens L, Erdman RA: Type D personality is associated with increased anxiety and depressive symptoms in patients with an implantable cardioverter defibrillator and their partners. Psychosomatic Medicine, 2004; 66: 714-719)

Page 12: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Young (<50 years)• Female• Premorbid psychological stress• Type D Personality

Most at Risk for Potential Stress

•(Sears SF & Conti JB, Quality of life and psychological functioning of ICD patients. Heart 2002; 87: 488-493)•(Denollet J, DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosomatic Medicine, Jan-Feb 2005; 67(1): 89-97)•(Pedersen SS, Holkamp PG, Caliskan K, van Domburg RT et al., Type D personality is associated with impaired health-related quality of life 7 years following heart transplantation. Journal of Psychosomatic Research, Dec 2006; 61(6): 791-795)•(Van den Broek KC, Nyklicek I, van der Voort PH, Alings M, Meijer A, Denollet J, Risk of ventricular arrhythmia after implantable defibrillator therapy in anxious type D patients. JACC, Aug 2009; 54(6): 531-537)

Page 13: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Combination of two traits:– 1. Negative affectivity – “gloomy” view across time and

situations– 2. Social inhibition – contains emotions due to concern

about how others will react

• Associated with arrhythmia, mortality, and psychological stress

Type D Personality

•(Denollet J, DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosomatic Medicine, Jan-Feb 2005; 67(1): 89-97)•(Pedersen SS, Holkamp PG, Caliskan K, van Domburg RT et al., Type D personality is associated with impaired health-related quality of life 7 years following heart transplantation. Journal of Psychosomatic Research, Dec 2006; 61(6): 791-795)•(Van den Broek KC, Nyklicek I, van der Voort PH, Alings M, Meijer A, Denollet J, Risk of ventricular arrhythmia after implantable defibrillator therapy in anxious type D patients. JACC, Aug 2009; 54(6): 531-537)

Page 14: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• The Type D Scale (DS14) • 2 scales of 7 items each

– Measures negative affectivity (i.e., “I often feel unhappy”)

– Measures social inhibition (i.e., “I am a closed kind of person”)

– Score > 10 on both subscales = Type D

Type D Personality

•(Denollet J, DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosomatic Medicine, Jan-Feb 2005; 67(1): 89-97)•(Pedersen SS, Holkamp PG, Caliskan K, van Domburg RT et al., Type D personality is associated with impaired health-related quality of life 7 years following heart transplantation. Journal of Psychosomatic Research, Dec 2006; 61(6): 791-795)•(Van den Broek KC, Nyklicek I, van der Voort PH, Alings M, Meijer A, Denollet J, Risk of ventricular arrhythmia after implantable defibrillator therapy in anxious type D patients. JACC, Aug 2009; 54(6): 531-537)

Page 15: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Poor understanding of device, disease

• Medical co-morbidities

• Prior shocks

Most at Risk for Potential Stress

•(Sears SF & Conti JB, Quality of life and psychological functioning of ICD patients. Heart 2002; 87: 488-493)

Page 16: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Evidence Driving Shock Reduction

• For patients, the fear of shocks can be disruptive to a normal active life

• Shock reduction has been shown to improve ICD patient quality of life and, in the process, may reduce a patient’s fear of getting shocked

• Post-shock care can tie up valuable clinic time and can also generate unnecessary calls for emergency vehicles and ER, hospital, and clinic visits

• (Irvine J et al. Quality of life in the Canadian Implantable Defibrillator Study, American Heart Journal, 2002; 144(2): 282-289)• (Sears SF & Conti JB, Understanding implantable cardioverter defibrillator shocks and storms: medical and psychosocial

considerations for research and clinical care. Clinical Cardiology, March 2003; 26(3): 107-111)• (Ahmad M, Bloomstein L, Roelke M, Bernstein AD & Parsonnet V, Patients’ attitudes toward implanted defibrillator shocks. PACE,

2000;23:934-938)• ( Wathen MS, et al. Circulation. 2004;110(17):2591-2596)

Page 17: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Perception of Shock

Perception of shock

is very important!

Page 18: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Phantom Shock

• Phantom Shock– Manifestation of patient’s

heightened body awareness and anxiety

– Do not dismiss based on device data

•(Prudente LA, Reigle J, Bourguignon C, Haines DE, DiMarco JP, Psychological indices and phantom shocks in patients with ICD. Journal of Interventional Cardiac Electrophysiology, April 2006; 15(3): 185-190)•(Prudente LA, Psychological disturbances, adjustment, and the development of phantom shocks in patients with implantable cardioverter defibrillator. Journal of Cardiovascular Nursing, Jul-Aug 2005; 20(4): 288-293)

Page 19: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Encourage Paradigm Shifts

You cannot control the event;

learn to control your reactions.

Page 20: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

What to do, who to call, after hours phone numbers

Families/caregivers should have this info plus copy of device ID card and medication list

Encourage Shock Plans

• (Sotile WM & Sears SF, You Can Make A Difference: Brief Psychosocial Interventions for ICD Patients and Their Families, Minneapolis, Minn: Medtronic, 1999)

• (Trupp R. In-booth presentation; Heart Failure Society of America, 2008) • (Sears SF, Shea JB, Conti JB, How to respond to an implantable cardioverter defibrillator shock.

Circulation, June 14, 2005; 111(23): e380-e382)

Page 21: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

How Will You Make a Difference?

• What new steps can you take to help patients with adjustment issues?

• What one step can you take immediately?

Page 22: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Patient Education

Page 23: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Key Education Points

• Clearly explain the patient’s risk of SCA without an ICD

• Clarify the patient’s understanding of their device indication, the implant surgery, and the device function

• Emphasize that ICDs may be programmed for painless therapy first

• Normalize feelings of anxiety and depression that patients may experience

• Emphasize that most patients report good QoL after implant

• (Gehi, Mehta & Gomes. JAMA Dec 20 2006; 296(23): 2839-2847)

• (Kapa et al. PACE 2010)

• (Sears, Matchett & Conti. Journal of Cardiovascular Electrophysiology 2009; vol. 1-8)

Page 24: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Incision/site discomfort• Sleep disturbances• Driving• Shocks• Return to activities

Potential ICD Adjustment Issues

•(Dunbar SB, Jenkins LS, Hawthorne, M, et al. Heart & Lung 1999:28: 303-315)•(Dougherty CM. American Journal of Critical Care 1994; 3: 145-154)•(Carroll DL, Hamilton GA. Heart & Lung 2005; 34: 169-178)•(Kuhl EA, Dixit NK, Walker RL, Conti JB, Sears SF. PACE 2006; 29: 614-618)

Page 25: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Pre-Implant Education

• Explanation of device indication• Expectations for implant• Instructions for living with an ICD• Information about ICD function

•(Doughtery CM, Pyper GP, Frasz HA. Heart Lung 2004; 33: 183-190)•(Sears SF, Kovacs AH, Conti JB, Handberg E. Journal of Cardiopulmonary Rehabilitation 2004; 24: 209-215)•(Sotile WM, Sears SF. You Can Make a Difference: Brief Psychosocial Interventions for ICD Patients and Their Families. Minneapolis, MN, Medtronic, Inc. 1999)

Page 26: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Accurate Patient ExpectationsAccurate expectations

- Less depression and anxiety- Less healthcare utilization- Better device acceptance

(Sears et al., 2004)•(Dunbar SB, Langberg JJ, Reilly CM et al. PACE (Oct 2009); 32: 1259-1271)•(Lewin R, Coulton S, Frizelle DJ et al. Heart 2009; 95(1): 63-69)•(Kohn CS, Petrucci RJ, Baessler C et al. PACE 2000; 23(4 Pt 1): 450-456)•(Sears SF, Serber ER, Lewis TS et al. Journal of Cardiopulmonary Rehab 2004; 24: 324-331)

Page 27: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Education Preferences

• Visual – brochures, heart and device images, anatomy posters, videos

• Auditory – explanations, patient success stories

• Kinesthetic - “hands on” to touch and feel a heart model, demo devices

•(James, W., Galbraith, M. W. Perceptual Learning Styles: Implications and Techniques for the Practitioner. Lifelong Learning, (January 1985) 20-23)

Page 28: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Personality Types

• Give me …– facts, details, evidence– multiple options and pros/cons– examples and stories– professional opinions – empathy and reassurance

•(Keirsey, D., Bates, M. Please Understand Me: Character & Temperament Types. Gnosology Books Ltd., Fourth edition (1984) 13-26)

Page 29: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• When patients can choose method of support/education:

– ↑ satisfaction– ↓ distress– ↓ health care utilization

(Serber et al., 2009, PACE, 32: 383-390)(Lewin R, Coulton S, Frizelle DJ et al. Heart 2009; 95(1): 63-69)

Education

Page 30: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

How Will You Make a Difference?

• In your experience, what is the most challenging aspect of patient education?

• What new steps can you take to help educate patients and normalize their concerns?

• What one step can you take immediately?

Barker, Joel. The Star Thrower Story, DVD Format, Item #DTF05S01, Star Thrower Distribution, Inc., St. Paul, MN. www.starthrowerstory.com.

Page 31: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Family Stress and Support Resources

Page 32: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Similar % among caregivers!!

• RISK:– Increased odds of

marital and family tensions

(Williams, R. & Williams, V. Lifeskills (1997))(Shanefield, SB. Psychosomatics 31 (1990): 138-145)(Cohen, D. Medical Clinics of North America 78 (1994): 795-809)(Dickerson, S. Clinical Nursing Research 7, no.1 (1998))

THE BIG 5 •Chronic Worry•Depression•Anger/Hostility•Isolation•Conflict

The Big 5

Page 33: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

DepressionObvious Symptoms

• Depressed mood • Crying spells• Loss of pleasure• Struggle to control mood • Hopelessness• Self blame• Feelings of being punished• Withdrawal• Thoughts of death

Subtle Symptoms• Sleep problems• Poor concentration or

memory• Problems with

decision-making• Vague pain complaints• Slowed coordination• Low sexual interest• Change in appetite• Change in weight

•(Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (2000))

Page 34: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

When heart disease strikes…

• Families are teams → stress affects everyone→ all are vulnerable to worry and struggle

• Family members may have more concern than patients

• Family members may feel they lack information and attention

• (Sotile, WM Thriving With Heart Disease (2003))• (Moser, DK, Dracup, K , Marsden, C. International Journal of Nursing Studies 30 (1993): 105-114)

Page 35: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Patient recovers, mate does not…Why?– Observer: patient is helpless, in hospital,

perhaps close to death– After effects: sleepless, worried, replaying past

events, worrying about future events

Families Under Stress

•(Shanefield, SB. Psychosomatics 31(1990): 138-145)•(Dickerson, S. Clinical Nursing Research 7, no. 1 (1998): 6-24)•(Sotile, WM. Thriving With Heart Disease (2003))•(O’Farrell, J. et al., Heart & Lung 29, no.2 (March-April 2000): 97-104)•(Arefjord, K. et al. Psychological Reports 83, no.3, Pt. 2 (December 1998): 1203-1216)

Page 36: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Shocks & Stress

•(Dunbar et al., Depression and Anxiety, 1999) •(Gibelli et al., PACE, 2008) •(Kop et al, Circulation, 2004) •(Lampert et al, Circulation, 2002)•(Narayan, JACC, 2006)

Page 37: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Microvolt T-wave Alternans (MTWA)– Correlated with ventricular arrhythmias – Shown to increase during exercise and mental

stress/anger– Mood states such as anxiety and depression may

trigger arrhythmias

Stress and Arrhythmia

•(Dunbar et al., Depression and Anxiety, 1999) •(Gibelli et al., PACE, 2008) •(Kop et al, Circulation, 2004) •(Lampert et al, Circulation, 2002)•(Narayan, JACC, 2006)

Page 38: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Anger-induced TWA predicts future ventricular arrhythmias in ICD patients (1 year follow-up and beyond)

• Stress and sudden death linked by emotion-induced repolarization instability

• (Lampert, Shusterman, Burg et al., JACC 2009)

Stress and Arrhythmia

Page 39: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

StressLevel

Time

150

130

110

90

70

50

40

30

20

10

00 A B C D E E

Stressed

Arousal Calming

The Stress Response

•(Sotile, WM. Thriving With Heart Disease (2003))

Page 40: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

StressLevel

Time

150

130

110

90

70

50

40

30

20

10

00 A B C D E F

STRAINED

LDL HDL Ischemia, SCD, MI Arrhythmias

Immune System

THE BIG 5 •Chronic Worry•Depression•Anger/Hostility•Isolation•Conflict

The Stress Response

•(Williams, R & Williams, V. Lifeskills (1997))•(Sotile, WM. Thriving With Heart Disease (2003))•(Tofler, GH et al. JACC 66 (1990): 22-27)•(Kawachi, D. et al. Circulation 90 (1994): 2225-2229)•(Kop, WJ. Psychosomatic Medicine 61, no. 4 (July-Aug 1999): 476-487)

Page 41: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• How often do you encounter ICD patients with mild to moderate depression or anxiety? Severe?

Reflection

•(Bostwick & Sola, The Psychiatric Clinics of North America, 2007)

Page 42: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

42

Stress Management

•(Pedersen, van den Broek, and Sears, PACE (30), 2007))

Page 43: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Combination of Cognitive Behavioral Therapy (CBT) and Exercise Training may be most beneficial at reducing anxiety and increasing exercise capacity

• Cognitive Behavioral Therapy (CBT)– Focuses on reframing negative thoughts about ICD

shocks– Confronts ICD-related fears and avoidance behaviors

• (Pedersen, van den Broek, and Sears, PACE 30 (2007))

Stress Management

Page 44: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Stress Management

• Screen/refer patients with poor QoL and psychological distress

• Address avoidance behaviors (with or without shock history)

• Make exercise and QoL recommendations

• Address critical events effectively

• Refer to support groups

Page 45: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Are you aware of ICD support groups in your area?

• Have you referred patients and caregivers to support groups in the past?

• What do you feel are the main ways in which support groups benefit patients and their families?

Reflection

Page 46: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Support Groups

• 96% patients and caregivers find support groups “very helpful”

• Reduced: stress, anxiety, hostility, anger• Increased: adjustment, happiness, sociability, return to

work• (Heller et al., PACE (1998))• (Wallace et al., Journal of Cardiopulmonary Rehabilitation

(2002))

Page 47: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Support Group Benefits

• Benefits to patient and caregiver:– Hearing and telling stories– Fears of shock normalized– Meaningful information about ADL’s, do’s and don’ts– Group camaraderie, therapeutic friendship– Questions answered by facilitator– Technical information

(Dickerson, Posluszny & Kennedy, Heart and Lung, (2000))

Page 48: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Support Group Benefits

• Overall Theme = People coping with mortality– Most prominent right after SCD survival or shock– Group environment of sharing stories and getting

information is cathartic

(Dickerson, Posluszny & Kennedy, Heart and Lung, (2000))

Page 49: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

How Will You Make a Difference?

• How can you be on guard for signs of patient or family distress?

• What new steps might you take to encourage stress management and support families?

• What one step can you take immediately?

Page 50: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Shock Reduction

Page 51: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Primary vs. Secondary Prevention Statistics

Page 52: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

>1 million Americans meet primary prevention indications

• Similar Statistics– Good overall quality of life– Positive device appraisal– Return to normal, active life

• Similar Main Concerns

– Lifting children/heavy objects (40%)– Inhibited sexual activity (19%)– Driving (14%)

Primary vs. Secondary Prevention Similarities

•(Bardy et al., New England Journal of Medicine, 352, no.3, (Jan 20 2005) : 225-237)•(Groeneveld et al., PACE, 30, (2007): 463-471)

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• QoL effect was greatest within first month after shock

• Smaller effect after two months

• Differences between ICD patients and other heart patients continue to diminish over time, insignificant at one year

(Bardy et al., New England Journal of Medicine, 352, no.3, (Jan 20 2005) : 225-237)

Primary Prevention: Quality of Life

Page 54: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Clinical Data & Programming Options

Page 55: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• Before these Trials: – ATP not used for VT > 188 bpm

– Why? – concern of efficacy, delay of shock, fear of acceleration

(Wathen MS, et al. “Shock reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary arterydisease,” Circulation 104 (2001):796-801)

(Wathen MS, DeGroot PJ, Sweeney MO et al., for the PainFREE Rx II Investigators. “Prospective randomized multicenter trial of empiricalantitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators:pacing fast ventricular tachycardia reduces shock therapies (PainFREE Rx II) trial results. Circulation 110, no. 17 (October 26 2004): 25912596)

PainFREE™ RX I and II

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ICDs Proven to Terminate Fast VTs with 77% Overall Efficacy

•(Wathen MS, et al. “Shock reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary artery disease,” Circulation 104 (2001):796-801)

Truth About Arrhythmias – PainFREE™ I

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• 634 patients

• 42 U.S. centers

• Single-Blinded

• Enrollment: 1/2001 to 3/2002

• Follow-up ended April 2003

• (Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)

PainFREE™ RX II

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ATP Arm Shock ArmRx1 Burst ATP Shock DFT+10 J

- 1 sequence- 8 pulses- 88% of VTCL

Rx2 Shock DFT+10 J Shock max output

Rx3-6 Shock max output Shock max output

Required FVT Therapy

•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)

Page 59: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Required Detection ProgrammingFast VT via VF

Slow VT

240 ms(250 bpm)

320 ms(188 bpm)

Fast VTVF

360 ms(167 bpm)

# intervals to detect = 18/24

PR Logic “ON” in all dual chamber ICDsSVT limit of 320ms

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True Ventricular Episodes (n=1342 )

* Rhythms adjudicated by a physician panel

Truth About ArrhythmiasFrom the PainFREE™ RX II Clinical

Study

76% of episodes in the traditional VF zone(<320ms)

were Fast VT*

“Slow” VT777, 58%

VF134, 10% FVT

431, 32%

•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)

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Conclusions – PainFREE™ RX II

1. A single empiric ATP attempt terminated 72% (adjusted) of Fast VTs

2. ATP did not increase negative outcomes in terms of acceleration, syncope and mortality

3. Patients treated by ATP have improved QoL score as compared to patients treated with shock

4. Investigators of the PainFREE™ Rx II trial recommend ATP as the preferred therapy for FVT in most ICD patients

•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)

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PainFREE™ Solutions Change in Physical and Mental QoL

Mentalhealth

Ch

ang

e i

n S

core

fro

m B

asel

ine

to 1

2 m

on

ths

ATP arm (n=43 pts) SHOCK arm (n=55 pts)

Physical Subscales Mental Subscales

* p<0.05

*

*

*

Physical function

Role physical

Bodily pain

Generalhealth

PhysicalSummary

MentalSummary

Vitality Socialfunctioning

Roleemotional

Greater QoL improvement in ATP Arm!

-5

0

5

10

15

20

25

Baseline to 12 months

•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)

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Potential benefits of shock reduction:

• Improved patient quality of life

• Fewer calls to physicians

• ICD acceptance

• ICD longevity

PainFREE™ Programming

•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)

Page 64: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

• In follow-up, how often do you see ATP successfully terminate arrhythmias without a shock?

Reflection

Page 65: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Current Shock Reduction Study

• PREPARE Trial

– Primary prevention patients– VF NID = 30/40– ATP for FVT– VT Monitor zone up to 182 bpm

•(Wilcoff et al., JACC 52, no.7 (2008): 541-550)

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Current Shock Reduction Clinical Data• PREPARE Trial • Bi-V and Non Bi-V Controls

– MIRACLE ICD Trial (978 patients enrolled)• All received Bi-V devices• 415 primary prevention patients with physician-tailored programming

– EMPIRIC Trial (900 patients enrolled)• All received dual chamber ICDs• 276 primary prevention patients with physician-tailored programming

Total Control Cohort691 primary prevention patients, Bi-V and Non Bi-V From the MIRACLE ICD Trial and the EMPIRIC Trial

• (Wilkoff et al., JACC 52, no.7 (2008): 541-550)• (Abraham, WT, Fisher, WG, Smith, AL et al., “Cardiac resynchronization in chronic heart failure (MIRACLE Trial),” N Eng J Med 346, no. 24 (June 13 2002): 1845-1853) • (Wilkoff, BL, Ousdigian, KT, Sterns, LD et al., “A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial,” J Am Coll Cardiol 48, no. 2 (July 18 2006): 330-339)

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Current Shock Reduction Data

• PREPARE Trial – Reduced shocks by 63% vs controls– 8.5% shocked in first year vs 17% in control

group– No increases in syncope or mortality vs

controls

•(Wilkoff et al., JACC 52, no.7 (2008): 541-550)

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Steps to Consider

• For Primary Prevention patients - explain the shock event, emphasize shock benefits, program to minimize inappropriate shocks

• For all patients – discuss driving, sex and exertion

• Assess patient’s understanding of the do’s and don’ts, what to do if shocked, etc.

• (Bardy et al., New England Journal of Medicine 352, no. 3 (Jan 20 2005): 225-237))• (Groeneveld et al., PACE 30 (2007): 463-471)

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How Will You Make a Difference?

• Are there ways that you can improve how you are programming ICDs for shock reduction?

• Do you consider different programming options for primary prevention patients?

• What one step can you take immediately?

Page 70: The Psychology of the ICD Patient This presentation is provided for general educational purposes only and should not be considered the exclusive source

Summary

• Psychological health affects outcomes• Some patients may be more at risk• Thorough education, positive communication• Shock planning• Acknowledge family’s concerns• Program for shock reduction when appropriate