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2<br />

Both failing<br />

ventricles<br />

are removed.<br />

The four<br />

native valves<br />

are removed.<br />

The atria, aorta<br />

and pulmonary<br />

artery remain<br />

intact.<br />

Quick connects are<br />

sewn into the atria,<br />

aorta and pulmonary<br />

artery.<br />

The Total Artificial<br />

Heart (TAH) is implanted<br />

and attached via four<br />

quick connects.<br />

When a donor heart<br />

becomes available,<br />

the TAH and quick<br />

connects are<br />

removed.<br />

The donor<br />

heart is<br />

transplanted.<br />

For patients dying from end-stage biventricular<br />

heart failure, there are only two options:<br />

1. An immediate donor heart transplant, availability uncertain.<br />

2. The <strong>SynCardia</strong> temporary Total Artificial Heart as a bridge to transplant,<br />

Donor Hearts: Only 3,500 Available Worldwide Annually<br />

# of Donor Heart Transplants<br />

immediately available at <strong>SynCardia</strong> Certified Centers.<br />

2500 –<br />

2000 –<br />

1500 –<br />

1000 –<br />

500 –<br />

US Donor Heart Transplants<br />

0 – 90 95 00 05 10<br />

Year<br />

Despite growing demand worldwide, only 3,500 donor hearts become available annually.<br />

It is estimated that each year, up to 100,000 people in the U.S. alone could benefit<br />

from mechanical circulatory support devices such as the <strong>SynCardia</strong> Total Artificial Heart.<br />

<strong>SynCardia</strong> Total Artificial Heart<br />

Originally used as a permanent replacement heart, the Total Artificial Heart is currently<br />

approved as a bridge to transplant for transplant-eligible patients at risk of imminent<br />

death from biventricular failure. It is the world’s first and only FDA, Health Canada and<br />

CE approved Total Artificial Heart.<br />

Bridge to Second Transplant<br />

The <strong>SynCardia</strong> Total Artificial<br />

Heart is the only device that<br />

allows surgeons to remove the<br />

failing transplanted heart and<br />

stop immunosuppressant<br />

medication until a second<br />

matching donor heart can be<br />

transplanted.<br />

“I have witnessed several patients who needed a second transplantation,<br />

but died before a donor heart became available. Those patients would<br />

have been excellent candidates for an immediately-available heart.<br />

The Total Artificial Heart is the only device that allows us to remove the<br />

failing donor heart completely and bridge patients to a second transplant<br />

without immunosuppressive therapy.”<br />

David Luís Simón Morales, MD<br />

Executive Co-Director, The Heart Institute<br />

Professor and Endowed Chair of Pediatric Cardiothoracic Surgery<br />

Chief, Pediatric Cardiothoracic Surgery<br />

Cincinnati Children’s Hospital Medical Center<br />

The University of Cincinnati College of Medicine<br />

Survival (%)<br />

100<br />

80<br />

60<br />

40<br />

20<br />

Survival Curve After Heart Transplantation<br />

N = 66,751<br />

# of Donor Heart Transplants<br />

Europe Donor Heart Transplants<br />

2500 –<br />

2000 –<br />

1500 –<br />

1000 –<br />

500 –<br />

0 – 01 02 03 04 05 06 07 08<br />

Year<br />

0<br />

Years 0 4 8 12 16 21<br />

Source: Journal of the American College of Surgery 2006; 203(2): 226-39.

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