Transcript Phantom Shock

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.
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
ICD Patient Circle of Influence
Patient
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)
Psychosocial Interventions
– ↑ well-being measures
– ↓ hospitalizations
– ↓ outpatient consultations
– ↑ medial adherence
•(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)
Reflection
• What is the main adjustment
issue you have observed
among ICD patients?
•Body image concerns
•Concern about shock
•Concern about possible device
malfunction
•Coping with family concerns about
the device
Quality of Life
U.S. National Survey of ICD Recipients
• 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)
Life After ICD: Patient Ratings
• 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)
Living with an ICD: What are
Possible Negatives?
•
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)
Quality of Life – CIDS Study
Amiodarone
(n = 160)
ICD
(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)
Research Review
• Predictive value of preexisting psychological
variables
– Pessimism
– Anxious personality
• Other factors
– Disease progression post-implant
– Symptomatic HF
– Primary vs. Secondary indication
•(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)
Most at Risk for Potential Stress
•
•
•
•
Young (<50 years)
Female
Premorbid psychological stress
Type D Personality
•(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)
Type D Personality
• 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
•(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)
Type D Personality
• 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
•(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)
Most at Risk for Potential Stress
• Poor understanding of device, disease
• Medical co-morbidities
• Prior shocks
•(Sears SF & Conti JB, Quality of life and psychological functioning of ICD patients. Heart 2002; 87: 488493)
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)
Perception of Shock
Perception of shock
is very important!
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)
Encourage Paradigm Shifts
You cannot control the event;
learn to control your reactions.
Encourage Shock Plans
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
• (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)
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?
Patient Education
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)
Potential ICD Adjustment Issues
•
•
•
•
•
Incision/site discomfort
Sleep disturbances
Driving
Shocks
Return to activities
•(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)
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)
Accurate Patient Expectations
Accurate expectations
- Less depression and anxiety
- Less healthcare utilization
- Better device acceptance
•(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)
–
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)
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)
Education
• 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)
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.
Family Stress and Support
Resources
The Big 5
•
•
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
Depression
Obvious
Symptoms
•
•
•
•
•
•
•
•
•
Subtle Symptoms
Depressed mood
Crying spells
Loss of pleasure
Struggle to control mood
Hopelessness
Self blame
Feelings of being punished
Withdrawal
Thoughts of death
• 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))
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)
Families Under Stress
• 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
•(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)
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)
Stress and Arrhythmia
• 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
•(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)
Stress and Arrhythmia
• 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)
The Stress Response
150
130
Stressed
110
90
Stress
Level
70
 Calming
Arousal 
50
40
30
20
10
0
0
A
•(Sotile, WM. Thriving With Heart Disease (2003))
B
C
Time
D
E
E
The Stress Response
THE BIG 5
•Chronic Worry
•Depression
•Anger/Hostility
•Isolation
•Conflict
150
130
110
90
Stress
Level
70
LDL HDL
Ischemia, SCD, MI
Arrhythmias
 Immune System
STRAINED
50
40
30
20
10
0
0
A
B
•(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)
C
Time
D
E
F
Reflection
• How often do you
encounter ICD patients
with mild to moderate
depression or anxiety?
Severe?
•(Bostwick & Sola, The Psychiatric Clinics of North America, 2007)
Stress Management
•(Pedersen, van den Broek, and Sears, PACE (30), 2007))
42
Stress Management
• 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
• 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
Reflection
• 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?
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))
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))
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))
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?
Shock Reduction
Primary vs. Secondary Prevention Statistics
Primary vs. Secondary
Prevention Similarities
>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%)
•(Bardy et al., New England Journal of Medicine, 352, no.3, (Jan 20 2005) : 225-237)
•(Groeneveld et al., PACE, 30, (2007): 463-471)
Primary Prevention: Quality of Life
• 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)
Clinical Data & Programming Options
PainFREE™ RX I and II
• 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 artery
disease,” Circulation 104 (2001):796-801)
(Wathen MS, DeGroot PJ, Sweeney MO et al., for the PainFREE Rx II Investigators. “Prospective randomized multicenter trial of empirical
antitachycardia 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): 2591
2596)
Truth About Arrhythmias –
PainFREE™ I
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)
PainFREE™ RX II
•
•
•
•
•
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)
Required FVT Therapy
Rx1
ATP Arm
Shock Arm
Burst ATP
Shock DFT+10 J
- 1 sequence
- 8 pulses
- 88% of VTCL
Rx2
Shock DFT+10 J
Rx3-6 Shock max output
Shock max output
Shock max output
•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)
Required Detection Programming
Fast VT via VF
# intervals to detect = 18/24
VF
Fast VT
Slow VT
240 ms
(250 bpm)
320 ms
(188 bpm)
 360 ms
(167 bpm)
PR Logic “ON” in all dual chamber ICDs
SVT limit of 320ms
Truth About Arrhythmias
From the PainFREE™ RX II Clinical
Study
76% of episodes in the traditional VF zone
(<320ms)
were Fast VT*
“Slow” VT
777, 58%
* Rhythms adjudicated by a
physician panel
VF
134, 10%
True Ventricular Episodes
(n=1342 )
FVT
431, 32%
•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)
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)
PainFREE™ Solutions
Change in Physical and Mental QoL
Change in Score from Baseline to 12 months
Baseline to 12 months
*
25
SHOCK arm (n=55 pts)
ATP arm (n=43 pts)
* p<0.05
20
Greater QoL improvement in ATP Arm!
15
*
10
5
*
0
-5
Physical
function
Role
physical
Bodily
pain
General
health
Physical Subscales
Physical
Summary
Mental
Summary
Vitality
Social
Role
functioning emotional
Mental Subscales
•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)
Mental
health
PainFREE™ Programming
Potential benefits of shock reduction:
• Improved patient quality of life
• Fewer calls to physicians
• ICD acceptance
• ICD longevity
•(Wathen MS, DeGroot PJ, Sweeney MO et al., Circulation 110, no. 17 (October 26 2004): 2591-2596)
Reflection
• In follow-up, how
often do you see
ATP successfully
terminate
arrhythmias
without a shock?
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)
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 Cohort
691 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)
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)
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)
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?
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