Alleviating Healthcare Disparities with Re-used Pacemakers

Thomas Crawford, MDAssistant Professor of Medicine

The University of Michigan

Global Cardiovascular Disease Mortality

Mendis S. J Hypertension. 25, 1578-1582

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.

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)

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.

MHYH – Who Are We?

The University of Michigan Cardiovascular Center

Michigan Funeral Directors Association World Medical Relief Implant Recycling, Inc. Patients and families nationwide

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

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

Baman et al Circ-EP 2011

Pacemaker Meta-Analysis

Reutilized pacemakers are not at higher risk of infection when compared to new device implant

Baman et al Circ-EP 2011

Pacemaker Meta-Analysis

Reutilized pacemakers are at a higher risk of device malfunction when compared to new device

implantationBaman et al Circ-EP 2011

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

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

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%

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

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

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

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

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.”

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.

Acknowledgements

MHYH is supported by grants from:

The Hewlett FoundationThe Mardigian Foundation

University of Michigan Cardiovascular CenterMr. Sheldon DavisThe Sincock Family

www.myheartyourheart.org