U.S. Heart Surgeons Accept Only 34% of Available Donor Hearts for Transplant

TUCSON, Ariz. – Mar. 24, 2015 – Cardiovascular disease, which includes heart failure, is the leading cause of death in the modernized world, taking more lives than all cancers combined.

The supply of donor hearts in the United States and other countries is flat or declining, while the rate of deaths from heart failure continues to rise.

“National Decline in Donor Heart Utilization With Regional Variability: 1995-2010,” published in the March 2015 American Journal of Transplantation, studied the characteristics of available donor hearts that were declined for heart transplant.

The SynCardia Total Artificial Heart and its direct predecessors account for 96% of all implants of 13 artificial heart designs. A paper in the March 2015 American Journal of Transplantation suggests surgeons are reluctant to transplant a “marginal” heart in a patient who’s stabilized with a mechanical circulatory support device.

From 1995 to 2010, “a total of 82,053 potential donors met study inclusion criteria,” says the report. “Of these, hearts from 28,098 (34%) were accepted and 39,529 (48%) were declined for transplantation. Three-quarters of the remaining 18% of donor hearts were recovered for uses other than transplantation, such as for heart valve procurement or research purposes.”

“There was a significant decrease in donor heart acceptance from 44% in 1995 to 29% in 2006, and subsequent increase to 32% in 2010,” the five authors wrote.

The loss of using available donor hearts for transplant makes the organ shortage even worse, the report says. “Despite estimates showing that more than 20,000 patients could benefit from this life-saving procedure each year,” according to the report, “only 1,949 heart transplants were performed in the United States in 2011.”

The authors suggest several reasons for the decline in using available donor hearts.

• Among available donor hearts, there was an increase in donor age and an increase in the prevalence of hypertension and diabetes over the time period studied. Between 1995 and 2010, mean donor age increased from 40.3 to 43.2 years, prevalence of diabetes increased from 3.5% to 13.7% and prevalence of hypertension increased from 23.3% to 38.9%.
• Doctors may have “increased risk aversion” to transplants of “marginal” donor hearts that could result in punitive action from federal oversight of performance metrics.
• The ability to stabilize critically ill patients with mechanical circulatory support devices may make doctors “reluctant to transplant a ‘marginal’ donor heart into a stable device recipient.”

The SynCardia temporary Total Artificial Heart is the first and only FDA, Health Canada and CE mark approved Total Artificial Heart in the world. From 1969 through 2014 there have been 1,458 implants of 13 different artificial heart designs. The SynCardia Total Artificial Heart and its direct predecessors account for 1,397 or 96% of all implants.

Unlike donor hearts, the SynCardia Total Artificial Heart is available at over 100 SynCardia Certified Centers around the world.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only approved device that eliminates the source of end-stage biventricular heart failure.

In Europe, the 70cc and 50cc SynCardia Hearts are approved as a bridge to a donor heart transplant and for destination therapy, also known as permanent use. Use of SynCardia Hearts for destination therapy varies by country.

In the United States, the 70cc SynCardia Total Artificial Heart is approved as a bridge to a donor heart transplant. The FDA has approved a clinical study to investigate the effectiveness of the SynCardia 70cc temporary Total Artificial Heart for destination therapy. (Caution-The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.)

SynCardia also is seeking final approval for an FDA clinical study for the use of its smaller, 50cc version of the SynCardia Total Artificial Heart intended for women, smaller men and many adolescents. (Caution-In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.)

The approved 70cc version and the 50cc version under study together are designed to make the SynCardia Total Artificial Heart available to most adults and many adolescents.

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About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.

More than 1,400 implants of the SynCardia Total Artificial Heart account for over 400 patient years of life on the device. Since January 2010 more than 550 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 200 patients, accounting for over 130 years of support.