Download Cardiac devices in the Golden Cardiac devices in the Golden Years

Cardiac devices in the Golden
Years
All that glitters
glitters…
James N. Kirkpatrick, MD
Cardiovascular Division
Center for Bioethics
University of Pennsylvania
Di l
Disclosures
• No related disclosures
• No industry affiliations
• Grant from Greenwall Foundation:
Caregiver Stress in Destination
Ventricular Assist Devices
• 2 NIH Data Safety Monitoring Boards
Outline
• Device Therapy for Advanced Heart
Failure
• Ethical conflicts/considerations
• Complexities of Advance Care Planning
in Heart Failure
• “Shiny”
“Shi ” P
Projects
j t
MAGAZINE | June 20,, 2010
What Broke My Father's Heart
By KATY BUTLER
How putting in a pacemaker wrecked a
family'ss life
family
life.
• “Th
“The pacemaker
k b
bought
ht my parents
t ttwo
years of limbo, two of purgatory and two
off hell…”
h ll ”
• “…If we did nothing, his pacemaker
would not stop for years. Like the
tireless charmed brooms in Disney’s
“Fantasia,” it would prompt my father’s
heart to beat after he became too
demented to speak, sit up or eat.”
Heart Failure
23,000,000 worldwide ((5.7 million US))
Incidence: 500-700,000/year in US
20% of population will get it
Including 11% of patients with no CAD
5-10% NYHA class IV: 13-40% 2 year
survival
Swedberg, et al. Eur Heart J. 2005;26(11):1115-40.
Lloyd-Jones,DM, et al. Circulation. 2002;106(24):3068–72.
Dembitsky WP. Semin Cardiothorac Vasc Anesth 2006; 10:253–255.
Rosamond W, et al. Cir 2007 115:e69-171
Stevenson, LW. ISHLT Monograph Series, 2006. 1 Chapter 11: p. 181-204.
Prevalence of heart failure by sex and age (National Health and Nutrition Examination Survey:
2005–2008).
Roger V L et al. Circulation 2011;123:e18-e209
Copyright © American Heart Association
Framingham Heart Study: 1980–2003. Source: National Heart, Lung, and Blood Institute.
Roger V L et al. Circulation 2011;123:e18-e209
Copyright © American Heart Association
Goodlin et al. J Card Fail. 2004 Jun;10(3):200-9.
“Can
Can vs
vs. Do”
Do
Heart Failure Devices
Ventricular Assist Devices
Flow
R t
Rotor
Outflow
Bearing Set
Inflow
Bearing Set
Ventricular Assist Devices
• Acute Cardiogenic Shock
– Post cardiac surgery
– Myocarditis
– Massive MI
• Chronic Heart failure
– Stabilize until transplant
• Bridges
–
–
–
–
To Transplant (BTT)
T Recovery
To
R
(BTR)
To Decision
To the rest of one’s
life=Destination
life
Destination Therapy (DT)
Ben Franklin Bridge
Ventricular Assist Devices
Variable
DT patients
(N = 385)
Gender, No.
(%)
Male
Female
Race, No. (%)
White
African
American
Other
Age at implant
Mean
years
Range
All other
LVADs
(N = 2134)
p-value
0.01
322 (84)
63 (16)
1,663 (78)
471 (22)
0.01
291 (76)
69 (18)
1,452 (68)
506 (24)
25 ((6))
176 ((8))
61.7
52.7
23–
23
–82
19–
19
–88
<0.0001
Table 5. Demographics—Adult Primary Implants: INTERMACS, June 2006–June 2010
VADS
• Improved organ
preservation
ti ((perfusion)
f i )
pre transplant
• Improved survival and
QOL
Rose,N Engl J Med 2001;345(20):1435–43;
VADs
Durability?
Durability?
Risks
GI bleeding (VWF
def?)
Infections (driveline)
Strokes
Patlolla V, J. Am. Coll. Cardiol. 2009;53;264-271
Examples of Criteria for Implantable
LVAD
for Lifetime Support
More objective
• Clinical profiles
– Not crash and burn
– Not post-surgical
– Ambulatory for DT?
•
•
•
•
•
•
•
Renal function-not on dialysis.
eGFR>50* , BUN < 50*
Hepatic function > 2X normal*
Lung function
function-not
not intubated or on
home O2 or steroids
Infection - Not on systemic
antibiotics
Nutrition pre-albumin
Nutritionpre albumin >15*
>15*, albumin
> 3*
RV function-not yet defined well
2 year prognosis
**Proposed in:JHLT Supplement
S
2010; 29:4S
Slaughter,et al. HMII Investigators
C i lB
Crucial
But A
Arguable
bl
•
•
•
•
•
•
“Frailty”
Other Co
Co-morbidities
morbidities
Psychosocial limitations
Cognitive limitations
Social support
A ?
Age?
Adapted from Lynne Warner Stevenso
Pacemakers
• Symptomatic
Bradycardia
• US IImplants
l t per year
– 250,000
• Increased 50% during
the 1990s
Mond, Pacing and Clinical Electrophysiology 2008; 31(9): 1202-1212.
Implantable Cardioverter Defibrillator (ICD)
• 100,000
100 000 ICDs implanted/year
in USA
• Aborting
Ab i sudden
dd cardiac
di
arrest
• Termination of many lethal
arrhythmias with
antitachycardia pacing (ATP)
• Primary prevention and
secondary prevention
--adapted from Ralph Verdino
Darn
SCD HeFT
SCD-HeFT
36%
29%
Bardy, et al. NEJM 2005;352:225
ICD
• Inappropriate Shocks
– Anxiety
– Depression
– ED resource utilization
Hunt, Circulation. 2005; 112(12):e154-235
Sanders, et al NEJM, 2005. 353(14): p. 147180
Moss, A.J., et al. NEJM, 1996. 335(26): p.
1933-40.
Stevenson, LW. Circ 2006. 114;101-103
Time Horizon of Lives Saved by
ICDs
100
Mortality (%)
80
No b
N
benefit
fit for
f
first year
ICD Lives Saved
60
Benefit flat
after 2-3 years
40
20
0
1 Year Interim
1.7 Years
MADIT II
MADIT-II – Moss, et al. N Engl J Med 2002;346:877-83.
DEFINITE – Ellenbogan et al. Circulation 2006;113:776-82.
SCD-HeFT – Bardy et al. N Engl J Med 2005;352:225-37.
3 Years
DEFINITE
5 Years
SCD-HeFT
Adapted from Lynne Warner Stevenson
Patients With ICD for Primary Prevention:
How Many Lives Like Yours Will Be Saved?”
Saved?
“How
100
80
%o
of
Patients
With
60
HF
symptoms
40
And
LVEF <35
20
7.2 from SCD-HeFT
None in first year
0
Less than 10
10
25-40
At least 50
Lives to be saved/ 100 during 5 years
Stewart , Stevenson et al,
J Cardiac Failure, 2009
Adapted from Lynne Warner Stevenson
If we put an ICD in 100 patients with heart
disease like y
yours,
over the next 5 years we would expect:
• 30 patients will die
anyway
• 7-8 p
patients will be
saved by the ICD
• 10-20 would have a
shock they don’t need
• 5-15 would have other
complications
• The rest of patients will
not experience their
devices at all
Some patients will request to have the device
Inactivated to allow natural death.
Desai A et al
J Cardiac Failure
2006
Adapted from Lynne Warner Stevenson
Bi V
• Save lives
• Improve symptoms
• EF <35%
• QRS>120ms
• NYHA Class III-IV symptoms
Yao, G., et al. Eur Heart J. 2007;28(1):42-51.
Cleland, J.G., et al.N Engl J Med, 2005. 352(15): p. 1539-49.
Cleland JG, et al. N Engl J Med. 2005 Apr 14;352(15):1539-49.
Holzmeister J, Lancet. 2011;378(9792):722-30.
Figure 2. CCS and LVESV response rates.
Chung E S et al. Circulation 2008;117:2608-2616
Copyright © American Heart Association
Implant complications
• 3.2% (CI, 2.8% to 3.6%)
– sinus dissection or perforation
– pericardial effusion or tamponade
– Pneumothorax
– hemothorax
Al‐Majed, Annals of Internal Medicine. 154(6):401‐412, 2011.
“There are no ethical dilemmas;
the technology is proved and
the patients have short
wretched lives.”
Westaby and Poole-Wilson, BMJ. 2007 334(7586): 167–168
Who gets a VAD?
• Transition from “rescue”
rescue to “chronic
chronic
disease management tool”
• How like transplant should it be?
– Age requirements?
– Psychosocial Requirements?
– Ideal candidacy?
– Palliative VAD?
– VAD “waiting list”?
Discrimination
•
•
•
•
•
Physiological vs. Numerical Age
Financial
Social support
Mild d
dementia
ti
Addictions
End of Life: When the heart is
taken out of the equation…
• Life prolongation
• Relief of symptoms
There may be more time to consider goals
of care
There may be more time for patients and
surrogates to change their minds about
goals of care
Renal Failure
Cancer
Unknown
Other
Respiratory failure
Other chronic illness
=38%
Palliative and End of Life VAD
care
• Surgical removal incompatible with
palliative care?
• “Letting nature take its course”?
• Deactivation as a terminal (planned)
event
• Physician Assisted Suicide?
(constitutive or replacement therapy)
VAD discontinuation
• Back pressure on failing heart
• Disruption of apical contractility
• Thrombus formation
H t
Hastens
d
death
th
Leaving endotrachal tube in after
extubation
Bramstedt KA, J Heart Lung Transplant. 2001;20:544–8.
VAD discontinuation
• Physician Assisted Suicide/Euthanasia
– Constitutive therapy—integrated part of the
body
– Replacement therapy
– Surrounding responsibility
– OK if Non-cardiac cause of death
Asscher J. Bioethics. 2008;22(5):278-85
Rizzieri, A.G.,Philosophy, Ethics, and Humanities in Medicine, 2008; 3,
20 35.
20-35
Sulmasy DP. J Gen Intern Med. 2008;23 Suppl 1:69–72.
Simon, J. Hastings Center Report, 2008; 38(1), 14-15.
VAD withdrawal/witholding
• Planned withdrawal
– Anxiolytics
– Analgesics
– Palliative sedation
• Withholding device changeout
Von Gunten C, et al. 2nd edition. Fast Facts and
Concepts. July 2005; 34.
VADs in Hospice
• How should they be managed?
• When and how should devices be
deactivated?
• Can hospice meet the growing need?
• What to do if there is no hospice?
Self discontinuation
© 2003 Mayo Foundation for Medical Education and Research
Volume 78(8)
August 2003
pp 959-963
Ethical Analysis of Withdrawal of Pacemaker or Implantable
Cardioverter-Defibrillator Support at the End of Life
[Original Article]
Mueller,, Paul S. MD;; Hook,, C. Christopher
p
MD;; Hayes,
y , David L. MD
From the Division of General Internal Medicine (P.S.M.), Division of Hematology and Internal Medicine
(C.C.H.), and Division of Cardiovascular Diseases and Internal Medicine (D.L.H.), Mayo Clinic, Rochester,
Minn.
Address reprint requests and correspondence to Paul S. Mueller, MD, Division of General Internal Medicine,
Mayo Clinic, 200 First St SW, Rochester, MN 55905.
“Every
y 20 minutes, he would [g
[get a
shock and get] jolted awake. Meanwhile
p
. . . I saw this
he was on morphine.
pattern . . . he was waking up from like
y bad dream type
yp of thing
g . . . and
a really
he would say a word or something, and
after 20 seconds he would be
unconscious again.”
Deactivation: ICD vs. PPM
• ICD
• PPM
– Shocking function +
ATP?
– Backup pacing?
– Predictability of lethal
arrhythmia?
– DNR=deactivation?
– Symptom relief vs.
life prolongation
• Indication?
• Underlying rhythm?
• CRT
– d/c defibrillation
only?
 EP consult
What do patients think about
ICDs?
• Would you want your device turned off if
yyou had
– Cancer: 30%
– Certain death within 1 month: 40%
– Daily shocks: 50%
– I would never want the device turned off:
10-40%
Weintraub, et al. Heart Rhythm 2006;3(5) S139.
278 ICD patients
• 5.15 years since implant
• 1/3 received shocks (avg
(avg. 4.7
4 7 shocks)
• 50% had advance directives
– Only
O l 3 had
h d included
i l d d plan
l ffor ICD
What should be done with
your ICD?
What should be done with
ICDs?
ICD
Q lit off Death
Quality
D th
“…we rescue people from a relatively
sudden death from myocardial
i f
infarction
ti
only
l tto inflict
i fli t on them
th
a more
prolonged death from progressive heart
failure.
failure.”
Taking away your chance to die quickly
and painlessly. Goodman NW. BMJ. 314(7092):1484, 1997
Costs
Congressional Budget Office
Projections ….
BIL
LLION
NS
Projected Cost Increases of
CVD
Heidenreich, Circulation. 2011;123:933-944
Estimated Direct and Indirect Costs of HF in US
Total Cost
$39 2 billion
$39.2
Hospitalization
$20 9
$20.9
53%
14%
8%
Nursing Home
$4.7
7%
8% 10%
Lost Productivity/
Mortality*
$4.1
Home Healthcare
$3.8
Physicians/Other
Professionals
$2.5
Drugs/Other
Medical Durables
$3 2
$3.2
--Lynne Warner Stevenson
American Heart Association. Heart Disease and Stroke Statistics. American Heart Association. 2010.
VADs
$ Implant costs: $122,785 – $264,839
$ 360,407 / 5 years
$ ICER*= $198,184
(CE benchmark: $50
$50,000-100,000)
000-100 000)
☻Prevent (CV)
hospitalizations
☻Cheaper than
Transplant
*incremental
incremental cost-effectiveness
cost effectiveness ratio over medical therapy
Rogers JG, et al. Circ Heart Fail. 2011
PPM and ICD
• Basic pulse generators
– $2,200-5,100
• Basic
B i lleads
d
– $400 to $1,000
• ICD generator
– $20,000 to $40,000
• ICD leads
– $10,000
$10 000
Personal communication, device purchasing
agents for the Hospital of the University of Pennsylvania,
2009 and Syracuse VA, 2011
Costs
• CRT-D
CRT D (additional
$4,000 to $16,000
above ICD)
Stevenson, Am Heart J 161(6) ;2011
Costs
 How do we fairlyy (j
(justly)
y) allocate
resources?
 What is “cost
cost effective
effective” and how is it
determined?
 Should we ration devices?
 Who Rations?
 Inclusion vs. exclusion
 How do we identify a high enough risk
group?
Sulmasy DP. Ann Int Med. 116(11):920-6, 1992
Implant Restrictions
• Medicare funding
g restrictions—what
does this mean for cardiac devices?
• Discrimination
– Elderly vs. young—physiological age
– Mild dementia—Am.
dementia—Am With Disabilities Act
– Severe Depression-“
Waiting list?
”Device committee”?
Complexities
p
in Advance Care
Planning
Complexities
• Changing preferences
• Timing of AD discussions
• Who is responsible for the
discussions?
• What should be discussed?
• How do you bring up the topic?
Lewis, et al J Heart Lung Transplant 2001;20:1016–10
Change their minds
Stevenson, et al JACC 2008;52(21):1702–8
Patient p
preferences correlated
poorly with MLHFQ, symptom
and overall health scores.
Although not statistically significant, there
was a trend toward patients with worse
quality of life and symptom scores
preferring more aggressive treatment.
When should AD for ICD be
discussed?
Who should discuss AD for
ICD?
HRS Expert Consensus Statement on Management of
CIEDs in patients nearing end of life or requesting
withdrawal of therapy. Heart Rhythm. 2010; 7(7):1008-26.
Timing of
Conversation
Points to be
Covered
Helpful Phrases to
Consider
Patients at End of
Life
Re-evaluation of
benefits and
burdens of device
“I think at this point we
need to re-evaluate what
your [device] is doing for
you Given how
you.
advanced your disease
is we need to discuss
whether it makes sense
to keep it active.
I know this may be
p
g to talk about,,
upsetting
but can you tell me your
thoughts at this point?”
Discussion of
option of
deactivation /
disabling device
addressed with all
patients,, though
p
g not
required
Introducing the
“…Heart failure is a very serious disease, from which
many patients ultimately die
die. Thankfully we have
notion that heart some extremely good treatments...”
failure is
“People may die from heart failure, but it is not like
potentially fatal
cancer in that it is very hard to predict how long
people with heart failure will live.”
Assessing
readiness
“…is there anyone you trust to make medical
decisions for you, and have you talked with this
person about what is important to you?...
you? ”
McKelvie, et al. Canadian Journal of Cardiology 27 (2011) 319–338
Complicated
p
Issues
 Multidisciplinary approach
 Geriatrics
 Cardiology
 Primary care
 Palliative
P lli ti care
 Subspecialty cardiology
 Nursing
 Social work
 Ethics
 Dialogue
 Joint Consensus Statements/Guidelines
Pacemaker/ICD Reuse
VAD Advance Directive
Pacemaker Implant Disparities
• Western world implants/million
p
population
– >450 for each western countryy
– USA: 752
• Lower/Middle Income Countries (LMIC)
– Peru: 14
– Bangladesh: 4
– Thailand: 22
– South Africa: 54
Mond, Pacing and Clinical Electrophysiology 2005;31:1202-12
Overseas Need
• Cardiovascular disease
burden in LMIC
– Increased 137% 1990 to
2020
– 14 million cardiovascular
d th
deaths
– Younger age
• Loss of economic
productivity
Joshi, J Am Coll Cardiol. 2008; 52:1817-25
WHO. Cardiovascular Disease. Factsheet
Cost
• “The average wage in
Bolivia is between $50
and $100
$
a month…”
• LMIC Healthcare
budgets focus on
prevention
Device Donations
• New, expired Devices
• Used Devices
– Upgrades
U
d
– Post mortem
Post Mortem
• Pacemaker deaths
– 20% within 33 months
– 40% within 4 years
• Patients > 80 y/o
– 32% of pacemaker
i l t
implants
• Pacemaker longevity:
10 years
Pringle, Pacing Clin
C Electrophysiol. 1986;9:1295-8.
Schmidt, Am Heart J 2003;146:908–913.
Schmidt,Eur Heart J 2004;25:88 –95.
Pyatt, Europace 2002;4:113–119.
Post Mortem Removal
• Pacemakers and ICDs explode and
damage
g the crematorium chamber
• Cremation projected to reach 59% of all
deaths in the United States by 2025
National Funeral Directors Association.
2010 Selected Funeral Service Information and Statistics.
Infection
Reuse
Study
Rosengarten8
New
TotalEvents TotalEvents
OR
95%-CI
18
1
52
1
3.00 [0.18; 50.61]
Pescariu7
365
6
358
5
1.18 [0.36; 3.90]
Linde6
100
2
100
7
0 27 [0.05;
0.27
[0 05; 1.34]
1 34]
Panja27
120
6
4479
237
0.94 [0.41; 2.16]
Grendahl5
310
14
1690
20
3.95 [1.97; 7.91]
Meta-analysis 913
29
6679
270
1.31 [0.50; 3.40]
0.2 0.5 1 2
5
Favors Reuse Favors New
Baman, Circ Arrhythm Electrophysiol. April, 2011
Device Malfunction
• Low rate:
– 0.68% (0.27 to 1.28)
• Increased compared with new
– OR 5
5.80
80 [1
[1.93
93 to 17.47],
17 47] p= 0
0.002
002
– Set screws
– “technical
technical errors
errors”
Baman, Circ Arrhythm Electrophysiol. April, 2011
Precedent for Reuse
• 1991: 14% of
primary
p
y implants
p
were reused device
• 1996: 5%
(incorporation in
European Common
Market)
Kirkpatrick, J Cardiovasc Electrophysiol 2007; 18:478–482.
“Living
Living Wills for Pacemakers”
Pacemakers
Device specific advance directive
– Options for post
post-mortem
mortem handling of device
– Information
• Donation
• Return to manufacturers
– Appointment
pp
of surrogate
g
– (Deactivation at end of life)
Kirkpatrick, JCE, 2007
Reuse of Pacemakers
• Survey patients in hospice re:
willingness
g
to donate their devices
• Pilot test “pacemaker living will” in
hospice patients
• Establish Penn as a collection and
distribution center for cardiac devices
overseas
Cardiac Device
Advance Directives
• Specific/individualized
decisions
dec
s o s re:
e de
devices
ces
– ICDs (discontinuation at
DNR, hospice, ATP)
– Pacemakers and QOL
vs life prolongation
vs.
(pacemaker dependent)
– CRT (QOL)
– VAD withdrawal
Swetz, Mayo Clin Proc 2011;86(6):493-500
VAD Advance Directives
• Supplement to 5 wishes
• Offer pre-implant
pre implant
• Re-address at 3 months
post implant
• VAD specific issues
Recap
• Cardiac devices definitely glitter, but
there ARE ethical dilemmas, especially
in the golden years
• Cardiac advance directives “are golden”
but complicated and require
multidisciplinary input
• Reused pacemakers are worth their
weight in gold for poor patients in
developing world countries
Thanks for your attention
HF Scores and Palliative Care
“Although these scores may be useful for
defining a population for a clinical
t i l th i applicability
trial…their
li bilit in
i facilitating
f ilit ti the
th
decision between aggressive care and
palliative care remains somewhat
limited by the inability to precisely
determine p
prognosis
g
for the individual
patient within the framework of rapidly
changing parameters.”
Lewis, Current Treatment Options in Cardiovascular Medicine (2011) 13:7
Definitions of Death
• Irreversible cessation of
cardiopulmonary
p
y function
• Irreversible cessation of (whole or
brainstem) neurological function
President’s Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research.
Guidelines for the determination of death. JAMA 1981;246(19):2184–6.
Futile Therapy
• What is “futility?”
– Physiological futility
• Won’t work (defibrillation in PEA arrest)
– Quantitative futilityy
• Very little chance of working (LVAD in
myocardial depression from bacterial sepsis)
– Qualitative futility
• Won’t produce adequate QOL (DT LVAD in end
stage Alzheimer)
Pope, T.M. Journal of Clinical Ethics, 2009;20, 274-286.
Ethics and
Cardiology
AJC, 2001
Pilot Data: LVAD DT
caregivers
i
• 10 caregivers
• 90% female, mean age 59 years
• 60% reported
p
feeling
g emotionally
y and p
physically
y
y
overwhelmed
• 70% reported feeling uninformed or ill prepared
• 60% reported feeling have no choice in accepting
caregiver role
• 90% had not considered plans for deactivating
LVAD
• Employed caregivers: 100% reported adverse
impact on work
Sarah Hull, MD, MBE
Brush, et al, J Heart and Lung Transpl 29(12), 2010
Chaga’s
Chaga
s Disease
•
•
•
•
•
Trypanosoma cruzi
Reduviid “kissing” bugs
H t bl
Heart
block
k
Heart failure/aneurysms
Ventricular arrhythmias
SUDS
• Sudden Unexplained
Death Syndrome
– the leading cause of death
in young, healthy
Southeast Asian males
– Ventricular fibrillation
– High risk of recurrence
– ICD superiority over Beta
blockers
Nademanee K, Circulation. 2003;107:2221-6
Used Devices
• Upgrades
– RV pacing
– ICD
– CRT
• Infections
– 0.13% to 12.6%
– Mean
M
time
ti
52 d
days ((quartile
til 1 tto 3
3, 24 tto
162 days)
Wilkhoff, JAMA. 2002; 288:3115-3123
Klug, Circulation. 2007;116:1349-55
Preliminary Experience Regarding ReUse of Explanted,
Explanted Resterilized
Defibrillators
• 31 patients Mean age 52±15 (range 16 –
77)
• Follow
F ll
up: 795
795±579
579 ((range 13 – 2237)
days
• No infectious complications
• LV lead dislodgement
g
in 1 p
pt.
• 42% pts experienced appropriate shocks
• 5 pts received a second explanted ICD
after 1057±807, range Pavri,
362Circulation.
– 21622010;122:A18350
days
Feasibility of Device Acquisition
with Adequate Battery Life for
Potential Reuse in Underserved
Nations
Timir S. Baman, Lindsey Gakenheimer, Nathan E Sovitch,
Patricia Sovitch, Joshua Romero, James N. Kirkpatrick, Brad
Wasserman, George Samson, Howard Jones, Thomas
Crawford, Hakan Oral, Kim A Eagle
• 2172 devices donated
• 10% with ≥75% battery life or 4 years
• Average time since implantation was
2 1±1 0 years
2.1±1.0
Caregivers
• Majority of VAD patients traditionally men,
but with smaller devices entering the
market more women expected to benefit
from this technology
• Traumatic spinal cord injury patients’
relationships do not fare as well when
patient is woman and caregiver is man
• Will this translate to VAD patients as well?
Bridge vs. Destination
Caregivers
• The few small studies that do exist
suggest
gg
that p
partners/caregivers
g
of VAD
patients experience significant
psychological
p
y
g
distress
• This is often counterbalanced by feelings
of pride and hope in caregivers of bridge
patients (has not yet been studied
specifically in Destination Therapy)
Competing Interests
• Post-market
surveillance
ill
• “Bench” analysis of
generators
• Post-mortem≠
changeouts
Ellenbogen KA,
KA et al.
al JACC 2003;41:73-80
Kron J, et al. Am Heart J 2001;141:92-98.
Gradaus T, et al. Pacing Clin Electrophysiol 2003;26:649-657
Heart Rhythm Society. Task Force on Device Performance
Policies and Guidelines. 2006
Return all devices
to manufacturers!
Competing Interests
• All devices with inadequate battery life
sent to manufacturers
• Increased return from
donationsincrease rate of return to
manufacturers