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Alleviating Healthcare Disparities with Re-used Pacemakers
Thomas Crawford, MDAssistant Professor of Medicine
The University of Michigan
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Global Cardiovascular Disease Mortality
Mendis S. J Hypertension. 25, 1578-1582
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Cardiovascular Disease Burden Overwhelming majority of deaths due to CVD
occur in low and middle income countries 1 million people die annually from untreated
brady-arrhythmia worldwide
Joshi R J Am Coll Cardiol. 2008 Dec 2;52(23):1817-25.
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Bradyarrhythmia Therapy Disparities
Mond HG. PACE 2008 Sep;31(9):1202-12.
0
100
200
300
400
500
600
700
800
Num
ber o
f Im
plan
ts
U.S. Peru Thailand
New Pacemaker Implants (per million)New ICD Implants (per million)
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My Heart Your Heart – The Mission
Bridge the gap between the demand for pacemakers and their inadequate supply in the low and middle income countries
Create a blueprint for a safe and legal pacemaker reuse
Establish a non-profit with the goal of device acquisition, sterilization, and distribution to patients in need outside the U.S.
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MHYH – Who Are We?
The University of Michigan Cardiovascular Center
Michigan Funeral Directors Association World Medical Relief Implant Recycling, Inc. Patients and families nationwide
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Making the Case for Device Reutilization
1) Preliminary Safety Data2) Patient and General Population Views3) Funeral Home Director Surveys4) Feasibility of device acquisition5) Pivotal clinical trial
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Prior Studies of Pacemaker Reutilization
Medical databases searched for studies that examined pacemaker re-use (1970 to 2011)
18 small studies have examined the safety of pacemaker re-use
Meta-analysis to compare complication rate of new vs. reused devices
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Baman et al Circ-EP 2011
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Pacemaker Meta-Analysis
Reutilized pacemakers are not at higher risk of infection when compared to new device implant
Baman et al Circ-EP 2011
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Pacemaker Meta-Analysis
Reutilized pacemakers are at a higher risk of device malfunction when compared to new device
implantationBaman et al Circ-EP 2011
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Patient and General Population Survey 100 device patients
1009 members of general population in U of M Clinics waiting rooms
% In
Fav
or
*Responses were not mutually exclusive
87
7158
53
37 42
<0.01
P=0.80
P=0.10
0102030405060708090
100
Donate to those inneed in 3rd world
countries*
Donate tomanufacturer for
technologyimprovement*
Donate toveterinarian for usein animal hospitals*
PatientPopulationN=100GeneralPopulationN=1009
Gakenheimer et al JICE 2011
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Funeral Director Survey
Survey Questions % Funeral Directors (n=90)
Discard pacemakers in waste or store with no intended purpose
84%
Return pacemakers to device manufacturer
4%
Willing to donate the devices to charitable organizations if given the opportunity
89%
Gakenheimer et al JICE 2011
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Devices with Acceptable Batteries
Pacem
akers
Impla
ntable
Defibri
llator
s
Biven
tricula
r ICDs
0
1000
2000
3000
118 (18%)
320 (15%)
112 (30%)
Adequate battery life defined as ≥75% remaining or ≥4 years longevity
68% 21% 12%
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Study Design
Prospective multicenter study of safety and efficacy
Standardized and validated sterilization protocol
500 patients Interim analysis at 12 months
(complications). Longevity analysis Up to 7 years
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Funeral Homes &Crematories
Legal Counsel
• Provide consent and guidelines for distribution
• Consent family and explant devices
• Facilitate awareness and interaction between funeral homes and academic center
LMIC DeviceImplantation Center
• Establish communication with funeral homes to facilitate device collection
• Sterilize and package devices
• Assess qualifications and safety record of implanting centers
• Maintain database of all devices received and distributed
• Assess financial status of possible recipients • Safely and effectively implant devices• Provide follow-up data for implanted
devices
• Authorize safe and legal device distribution
Center(s) of Excellence
Non Profit CharitableOrganization
FuneralDirectors Association
Food and Drug Administration
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Conclusion
1. Prior studies support the safety of pacemaker re-use
2. General public, pacemaker patients, and funeral home directors support reutilization
3. Approximately 1 out of 5 devices have >75% original battery life
4. Establishing a validated pacemaker reuse program could transform a currently wasted resource into an opportunity for a new life
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Date: Tuesday, September 4, 2012 9:59 AM
Dear Sir/Madam: My wife recently passed away (August 11, 2012) and one of her final wishes was that her pacemaker be donated for someone in need. At my request, our funeral director removed the device and I have the pacemaker, a Medtronic Sigma Sdr dual lead, at home. Our family would very much like to donate this device to a needy person overseas. Your attention to this matter will allow me to complete this final request. Thank you, DJA
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Letter to Project My Heart “I am blessed to be helped by
your humanitarian and godly efforts which gave me hope and life. Truly I have a happy life because you made me feel loved even though you didn’t know me.”
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Thank you! Kim A Eagle, M.D. Timir S Baman, M.D. Patricia Sovitch, NP
Sandra Arlinghaus, Ph.D.
Frank Arlinghaus, M.D. John Nystuen , Ph.D.
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Acknowledgements
MHYH is supported by grants from:
The Hewlett FoundationThe Mardigian Foundation
University of Michigan Cardiovascular CenterMr. Sheldon DavisThe Sincock Family
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www.myheartyourheart.org