Cardiac devices in the GoldenCardiac devices in the Golden Years

All that glittersAll that glitters…

James N. Kirkpatrick, MDCardiovascular Division

Center for BioethicsUniversity of Pennsylvania

Di lDisclosures• No related disclosures

• No industry affiliations

• Grant from Greenwall Foundation: Caregiver Stress in DestinationCaregiver 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• Complexities of Advance Care Planning

in Heart Failure“Shi ” P j t• “Shiny” Projects

MAGAZINE | June 20, 2010| ,

What Broke My Father's Heart By KATY BUTLERBy KATY BUTLER

How putting in a pacemaker wrecked a family's lifefamily s life.

“Th k b ht t t• “The pacemaker bought my parents two years of limbo, two of purgatory and two f h ll ”of hell…”

• “…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 FailureHeart Failure23,000,000 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:e69-171Stevenson, 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 vs Do”Can vs. Do

Heart Failure Devices

Ventricular Assist Devices

Flow

R t

Inflow Bearing Set

Outflow Bearing Set

Rotor

Ventricular Assist Devices• Acute Cardiogenic Shock

– Post cardiac surgeryPost cardiac surgery– Myocarditis– Massive MI

• Chronic Heart failure– Stabilize until transplant

• Bridges– To Transplant (BTT)

T R (BTR)– To Recovery (BTR)– To Decision– To the rest of one’s

life=Destination Therapy (DT)

Ben Franklin Bridge

life Destination Therapy (DT)

Ventricular Assist DevicesVariable DT patients All other p-value

LVADs(N = 385) (N = 2134)

Gender, No. (%)

0.01(%)Male 322 (84) 1,663 (78)Female 63 (16) 471 (22)Race, No. (%) 0.01White 291 (76) 1,452 (68)African American

69 (18) 506 (24)

Other 25 (6) 176 (8)( ) ( )Age at implantMean Mean yearsyears

61.761.7 52.752.7 <0.0001

RangeRange 2323––8282 1919––8888Table 5. Demographics—Adult Primary Implants: INTERMACS, June 2006–June 2010

VADS

• Improved organ ti ( f i )preservation (perfusion)

pre transplant• Improved survival and

QOL

Rose,N Engl J Med 2001;345(20):1435–43;

VADs

Durability?Durability?RisksGI bleeding (VWFGI bleeding (VWF

def?)Infections (driveline)Infections (driveline)Strokes

Patlolla V, J. Am. Coll. Cardiol. 2009;53;264-271

Examples of Criteria for Implantable LVAD

for Lifetime SupportC i l B A bl

More objectiveCrucial But Arguable

• “Frailty”• Other Co-morbidities

More objective• Clinical profiles

– Not crash and burn– Not post-surgical– Ambulatory for DT? Other Co morbidities

• Psychosocial limitations• Cognitive limitations• Social support

A ?

Ambulatory for DT?• Renal function-not on dialysis.

eGFR>50* , BUN < 50*• Hepatic function > 2X normal*• Lung function not intubated or on • Age?• Lung function-not intubated or on

home O2 or steroids• Infection - Not on systemic

antibiotics • Nutrition pre albumin >15* albumin• Nutrition- pre-albumin >15*, albumin

> 3*• RV function-not yet defined well• 2 year prognosis

* S*Proposed in:JHLT Supplement2010; 29:4SSlaughter,et al. HMII Investigators Adapted from Lynne Warner Stevenso

PacemakersPacemakers

• Symptomatic• Symptomatic BradycardiaUS I l t• US Implants 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 ICDs implanted/year

Implantable Cardioverter Defibrillator (ICD)

100,000 ICDs implanted/year in USA

Ab i dd di• Aborting sudden cardiac arrest

• Termination of many lethal arrhythmias with antitachycardia pacing (ATP)antitachycardia pacing (ATP)

• Primary prevention andPrimary prevention and secondary prevention

--adapted from Ralph Verdino

Darn

SCD-HeFTSCD HeFT

36%

29%29%

Bardy, et al. NEJM 2005;352:225

ICD

• Inappropriate ShocksInappropriate Shocks– Anxiety

Depression– Depression– ED resource utilization

Hunt, Circulation. 2005; 112(12):e154-235 Sanders, et al NEJM, 2005. 353(14): p. 1471-8080 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 ICDsICDs100

N b fit f

60

80ICD Lives Saved

(%)

No benefit forfirst year

40

60

Mor

talit

y Benefit flatafter 2-3 years

20

01 Year Interim 1.7 Years

MADIT II3 Years

DEFINITE5 Years SCD-HeFT

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. Adapted from Lynne Warner Stevenson

Patients With ICD for Primary Prevention:“How Many Lives Like Yours Will Be Saved?”How Many Lives Like Yours Will Be Saved?

80

100

% of 7.2 from SCD-HeFTNone in first year

60

% oPatientsWith HF symptoms

None in first year

20

40symptomsAnd LVEF <35

0Less than 10 10 25-40 At least 50

Stewart , Stevenson et al, J Cardiac Failure, 2009

Lives to be saved/ 100 during 5 years

Adapted from Lynne Warner Stevenson

If we put an ICD in 100 patients with heart disease like yours,

30 patients will die• 10-20 would have a

yover the next 5 years we would expect:

• 30 patients will die anyway

• 7-8 patients will be

shock they don’t need• 5-15 would have other

complicationspsaved by the ICD

complications• The rest of patients will

not experience their devices at all

Some patients will request to have the deviceInactivated to allow natural death.Inactivated to allow natural death.

Desai A et alJ Cardiac Failure2006 Adapted from Lynne Warner Stevenson

Bi VBi V

• Save lives• Improve symptoms• 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 perforationsinus dissection or perforation– pericardial effusion or tamponade– PneumothoraxPneumothorax– 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 shortthe patients have short wretched lives.”

Westaby and Poole-Wilson, BMJ. 2007 334(7586): 167–168

Who gets a VAD?• Transition from “rescue” to “chronic• Transition from rescue to chronic

disease management tool”• How like transplant should it be?• How like transplant should it be?

– Age requirements?– Psychosocial Requirements?Psychosocial Requirements?– Ideal candidacy?– Palliative VAD?Palliative VAD?– VAD “waiting list”?

Discrimination

• Physiological vs. Numerical Age• FinancialFinancial• Social support

Mild d ti• Mild dementia• Addictions

End of Life: When the heart isEnd of Life: When the heart is taken out of the equation…

• Life prolongation• Relief of symptomsRelief of symptomsThere may be more time to consider goals

of careof careThere may be more time for patients and

surrogates to change their minds aboutsurrogates to change their minds about goals of care

Renal Failure

Cancer

Renal Failure

Other

Unknown

Other chronic illness

Respiratory failure =38%

Palliative and End of Life VAD carecare

• Surgical removal incompatible with palliative care?

• “Letting nature take its course”?• Deactivation as a terminal (planned)Deactivation as a terminal (planned)

event• Physician Assisted Suicide?• Physician Assisted Suicide?

(constitutive or replacement therapy)

VAD discontinuation

• Back pressure on failing heart• Disruption of apical contractilityDisruption of apical contractility • Thrombus formationH t d thHastens deathLeaving endotrachal tube in after extubation

Bramstedt KA, J Heart Lung Transplant. 2001;20:544–8.

VAD discontinuationVAD 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, 20-3520 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/witholdingVAD withdrawal/witholding• Planned withdrawalPlanned withdrawal

– Anxiolytics– AnalgesicsAnalgesics– Palliative sedation

• Withholding device changeout

Von Gunten C, et al. 2nd edition. Fast Facts andConcepts. 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?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 MD; Hayes, David L. MD, ; , p ; y ,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 20 minutes, he would [get a y [gshock and get] jolted awake. Meanwhile he was on morphine. . . . I saw this ppattern . . . he was waking up from like a really bad dream type of thing . . . and y yp ghe would say a word or something, and after 20 seconds he would be unconscious again.”

Deactivation: ICD vs. PPM

• ICD– Shocking function +

• PPM– Symptom relief vs.

ATP?– Backup pacing?

Predictability of lethal

life prolongation• Indication?• Underlying rhythm?– Predictability of lethal

arrhythmia?– DNR=deactivation?

Underlying rhythm?

• CRT– d/c defibrillation

only?

EP consult EP consult

What do patients think aboutWhat do patients think about ICDs?

• Would you want your device turned off if you hady– Cancer: 30%– Certain death within 1 month: 40%Certain death within 1 month: 40%– Daily shocks: 50%– I would never want the device turned off: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 4 7 shocks)1/3 received shocks (avg. 4.7 shocks)• 50% had advance directives

O l 3 h d i l d d l f ICD– Only 3 had included plan for ICD

What should be done with your ICD?your ICD?

What should be done with ICDs?ICDs?

ICDQ lit f D thQuality of Death

“…we rescue people from a relatively sudden death from myocardial i f ti l t i fli t th infarction only to inflict on them a more prolonged death from progressive heart failure.”failure.

Taking away your chance to die quicklyTaking away your chance to die quickly and painlessly.

Goodman NW. BMJ. 314(7092):1484, 1997

Costs

Congressional Budget Office Projections ….

Projected Cost Increases of CVDCVD

NS

NS

LLIO

NLL

ION

BIL

BIL

Heidenreich, Circulation. 2011;123:933-944

Estimated Direct and Indirect Costs of HF in USEstimated Direct and Indirect Costs of HF in US

Hospitalization$20 9

Total Cost$39 2 billion

53%$20.9 $39.2 billion

14% Nursing Home$4.7

8%8% 10%

7%Lost Productivity/ Physicians/Other

ProfessionalsMortality* $4.1 Home Healthcare

$3.8Drugs/Other

Medical Durables$3 2

Professionals$2.5

$3.2

American Heart Association. Heart Disease and Stroke Statistics. American Heart Association. 2010.

--Lynne Warner Stevenson

VADs

$ Implant costs: $122,785 – $264,839

$ 360,407 / 5 years☻Prevent (CV)

hospitalizations

$ ICER*= $198,184(CE benchmark: $50 000-100 000)

☻Cheaper than Transplant(CE benchmark: $50,000-100,000) Transplant

*incremental cost-effectiveness ratio over medical therapy

Rogers JG, et al. Circ Heart Fail. 2011

incremental cost effectiveness ratio over medical therapy

PPM and ICD• Basic pulse generators• Basic pulse generators

– $2,200-5,100B i l d• Basic leads– $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 (additionalCRT D (additional $4,000 to $16,000 above ICD)above ICD)

Stevenson, Am Heart J 161(6) ;2011

CostsCostsHow do we fairly (justly) allocate y (j y)

resources?What is “cost effective” and how is itWhat is cost effective and how is it

determined?Should we ration devices?Who Rations?Who Rations? Inclusion vs. exclusion

How do we identify a high enough riskHow do we identify a high enough risk group?

Sulmasy DP. Ann Int Med. 116(11):920-6, 1992

Implant RestrictionsImplant Restrictions• Medicare funding restrictions—what g

does this mean for cardiac devices?• DiscriminationDiscrimination

– Elderly vs. young—physiological age– Mild dementia—Am With Disabilities Act– Mild dementia—Am. With Disabilities Act– Severe Depression-- “

Waiting list?Waiting list?”Device committee”?

Complexities in Advance Care pPlanning

Complexities• Changing preferences• Changing preferences• Timing of AD discussions• Who is responsible for the

discussions?• What should be discussed?• How do you bring up the topic?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

Although not statistically significant, there was a trend toward patients with worsePatient preferences correlated was a trend toward patients with worse quality of life and symptom scores preferring more aggressive treatment.

ppoorly with MLHFQ, symptom and overall health scores.

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

Discussion of option of deactivation /

you. Given how advanced your disease is we need to discuss whether it makes sensedeactivation /

disabling device addressed with all patients, though not

whether it makes sense to keep it active. I know this may be upsetting to talk about, p , g

requiredp g ,

but can you tell me your thoughts at this point?”

Introducing the “…Heart failure is a very serious disease, from which

many patients ultimately die Thankfully we have

notion that heart many patients ultimately die. Thankfully we have

some extremely good treatments...”

failure is

potentially fatal“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 “…is there anyone you trust to make medical

readinessdecisions for you, and have you talked with this

person about what is important to you? ”person about what is important to you?...

McKelvie, et al. Canadian Journal of Cardiology 27 (2011) 319–338

Complicated IssuespMultidisciplinary approachGeriatricsGeriatricsCardiologyPrimary careP lli tiPalliative careSubspecialty cardiologyNursingSocial workEthics

Dialogue

Joint Consensus Statements/Guidelines

Pacemaker/ICD ReusePacemaker/ICD ReuseVAD Advance Directive

Pacemaker Implant DisparitiesPacemaker Implant Disparities• Western world implants/million p

population– >450 for each western countryy– USA: 752

• Lower/Middle Income Countries (LMIC)Lower/Middle Income Countries (LMIC)– Peru: 14

Bangladesh: 4– Bangladesh: 4– Thailand: 22

South Africa: 54– South Africa: 54

Mond, Pacing and Clinical Electrophysiology 2005;31:1202-12

Overseas NeedOverseas Need

• Cardiovascular diseaseCardiovascular disease burden in LMIC– Increased 137% 1990 to

2020– 14 million cardiovascular

d thdeaths– Younger age

• Loss of economic• Loss of economic productivity

Joshi, J Am Coll Cardiol. 2008; 52:1817-25WHO. Cardiovascular Disease. Factsheet

Cost• “The average wage in

Bolivia is between $50 $and $100 a month…”

• LMIC Healthcare budgets focus onbudgets focus on prevention

Device Donations

• New, expired Devices

• Used DevicesU d– Upgrades

– Post mortem

Post MortemPost Mortem• Pacemaker deaths

– 20% within 33 months– 40% within 4 years

• Patients > 80 y/o– 32% of pacemaker

i l timplants• Pacemaker longevity:

10 years10 years

CPringle, Pacing Clin 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 the crematorium chamberg

• Cremation projected to reach 59% of all• 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.

InfectionInfection

Study TotalEventsReuse

TotalEventsNew

OR 95%-CI

Rosengarten8

Pescariu7

Linde6

18

365

100

1

6

2

52

358

100

1

5

7

3.00

1.18

0 27

[0.18; 50.61]

[0.36; 3.90]

[0 05; 1 34]Linde6

Panja27

Grendahl5

100

120

310

2

6

14

100

4479

1690

7

237

20

0.27

0.94

3.95

[0.05; 1.34]

[0.41; 2.16]

[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)0.68% (0.27 to 1.28)

• Increased compared with new OR 5 80 [1 93 to 17 47] p= 0 002– OR 5.80 [1.93 to 17.47], p= 0.002

– Set screws“technical errors”– technical errors

Baman, Circ Arrhythm Electrophysiol. April, 2011

Precedent for Reuse

• 1991: 14% of primary implants p y pwere reused device

• 1996: 5% (incorporation in(incorporation in European Common Market)Market)

Kirkpatrick, J Cardiovasc Electrophysiol 2007; 18:478–482.

“Living Wills for Pacemakers”Living Wills for Pacemakers

Device specific advance directive– Options for post-mortem handling of deviceOptions for post mortem handling of device– Information

• DonationDonation• Return to manufacturers

– Appointment of surrogatepp g– (Deactivation at end of life)

Kirkpatrick, JCE, 2007

Reuse of Pacemakers

• Survey patients in hospice re: willingness to donate their devicesg

• Pilot test “pacemaker living will” in hospice patientshospice patients

• Establish Penn as a collection and distribution center for cardiac devicesdistribution center for cardiac devices overseas

Cardiac DeviceCardiac Device Advance Directives

• Specific/individualized decisions re: devicesdec s o s e de ces– ICDs (discontinuation at

DNR, hospice, ATP)DNR, hospice, ATP)– Pacemakers and QOL

vs life prolongationvs. life prolongation (pacemaker dependent)

– CRT (QOL)– CRT (QOL)– VAD withdrawal

Swetz, Mayo Clin Proc 2011;86(6):493-500

VAD Advance Directives

• Supplement to 5 wishes• Offer pre-implantOffer pre implant• Re-address at 3 months

post implantpost 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 inweight 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 li bilit i f ilit ti thtrial…their applicability in facilitating the decision between aggressive care and palliative care remains somewhatpalliative care remains somewhat limited by the inability to precisely determine prognosis for the individual p gpatient within the framework of rapidly changing parameters.”

Lewis, Current Treatment Options in Cardiovascular Medicine (2011) 13:7

Definitions of Death

• Irreversible cessation of cardiopulmonary functionp y

• Irreversible cessation of (whole or• 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 futilityPhysiological 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)stage Alzheimer)Pope, T.M. Journal of Clinical Ethics, 2009;20, 274-286.

Ethics and Cardiology

AJC, 2001

Pilot Data: LVAD DT icaregivers

10 caregivers• 10 caregivers • 90% female, mean age 59 years• 60% reported feeling emotionally and physically p g y p y y

overwhelmed • 70% reported feeling uninformed or ill prepared• 60% reported feeling have no choice in accepting• 60% reported feeling have no choice in accepting

caregiver role• 90% had not considered plans for deactivating

LVADLVAD• 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 DiseaseChaga s Disease

• Trypanosoma cruziTrypanosoma cruzi• Reduviid “kissing” bugs

H t bl k• Heart block• Heart failure/aneurysms• Ventricular arrhythmias

SUDS• Sudden UnexplainedSudden Unexplained

Death Syndromethe leading cause of death– the leading cause of death in young, healthy Southeast Asian males

– Ventricular fibrillation– High risk of recurrenceHigh risk of recurrence– ICD superiority over Beta

blockers

Nademanee K, Circulation. 2003;107:2221-6

Used Devices• UpgradesUpgrades

– RV pacing– ICDICD– CRT

• Infections• Infections– 0.13% to 12.6%

M ti 52 d ( til 1 t 3 24 t– Mean time 52 days (quartile 1 to 3, 24 to 162 days)

Wilkhoff, JAMA. 2002; 288:3115-3123Klug, Circulation. 2007;116:1349-55

Preliminary Experience Regarding Re-Use of Explanted ResterilizedUse of Explanted, Resterilized

Defibrillators• 31 patients Mean age 52±15 (range 16• 31 patients Mean age 52±15 (range 16 –

77)F ll 795 579 ( 13 2237)• Follow up: 795±579 (range 13 – 2237)days

• No infectious complications• LV lead dislodgement in 1 pt. g p• 42% pts experienced appropriate shocks • 5 pts received a second explanted ICD• 5 pts received a second explanted ICD

after 1057±807, range 362 – 2162 daysPavri, Circulation. 2010;122:A18350

Feasibility of Device Acquisition with Adequate Battery Life for

Potential Reuse in UnderservedPotential 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 years10% with ≥75% battery life or 4 years• Average time since implantation was

2 1±1 0 years2.1±1.0 years

CaregiversCaregivers

• 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?Will this translate to VAD patients as well?

Bridge vs. Destination CaregiversCaregivers

• The few small studies that do exist suggest that partners/caregivers of VAD gg p gpatients experience significant psychological distressp y g

• This is often counterbalanced by feelings• This is often counterbalanced by feelings of pride and hope in caregivers of bridge patients (has not yet been studiedpatients (has not yet been studied specifically in Destination Therapy)

Competing Interests

• Post-market illsurveillance

• “Bench” analysis of generators

• Post-mortem≠ changeouts

Ellenbogen KA et al JACC 2003;41:73-80Return all devices

Ellenbogen KA, et al. JACC 2003;41:73-80Kron J, et al. Am Heart J 2001;141:92-98.Gradaus T, et al. Pacing Clin Electrophysiol 2003;26:649-657Heart Rhythm Society. Task Force on Device Performance Policies and Guidelines. 2006

to manufacturers!

Competing Interests

• All devices with inadequate battery life sent to manufacturers

• Increased return from donationsincrease rate of return todonationsincrease rate of return to manufacturers