- Highest bridge to human heart transplant rate of any approved heart device, 79%
- Over 1,350 implants account for nearly 400 patient years on the SynCardia Total Artificial Heart
Heart Failure: You're Not Alone
If you or someone you love has heart failure, you're not alone. According to the World Health Organization (WHO), heart failure affects more than 20 million people worldwide with an additional 2 million new cases diagnosed annually. For people who progress to end-stage heart failure affecting both sides of the heart, there are two treatment options:
Shortage of Donor Hearts
Heart transplants are the current standard of care for end-stage heart failure. However, despite growing demand, over the last 20 years, the supply of donor hearts has remained flat. Only approximately 3,500 donor hearts become available each year worldwide, with the U.S. accounting for approximately 2,200 of them. Waiting times vary by country and level of organ donation:
- In the U.S., according to the Organ Procurement and Transplantation Network (OPTN), as of Aug. 17, 2012, nearly half of the people (49%) on the waiting list for a heart transplant had been waiting a year or more.
- In Europe, according to the Eurotransplant International Foundation*, 57% of people listed for a donor heart had been waiting for a year or more, and 34% had been waiting for 2 years or more.
*Data as of Dec. 31, 2011 - includes Austria, Belgium, Croatia, Germany, Luxembourg, the Netherlands and Slovenia
The Total Artificial Heart as a Bridge to Transplant
Originally used as a permanent replacement heart, the SynCardia temporary Total Artificial Heart is currently approved as a bridge to transplant for patients suffering from end-stage heart failure affecting both ventricles. It is the first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart in the world.
According to data published in the New England Journal of Medicine1 from the 10-year pivotal clinical study which led to FDA approval, 79% of patients who received the Total Artificial Heart were bridge to transplant. This is the highest bridge to transplant rate for any approved heart device in the world.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing ventricles and the four heart valves. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers. It is the only device that elminates the symptoms and source of end-stage heart failure.
1N Engl J Med 2004; 351:859-67