Artificial heart sees most patients to donor heart within a few years

Print 20 February 2015
Stacy Lawrence / Fierce Medical Devices

Artificial, mechanical hearts are effective in getting almost three-quarters of patients to a donor heart transplant, recent data on the SynCardia Total Artificial Heart suggest. But that feat doesn't contain SynCardia's ambitions--it recently started a trial for permanent use of its artificial heart that's ultimately designed for FDA submission.

Also in pivotal U.S. testing is a smaller 50-cc version of the SynCardia Heart that's designed for people of smaller stature, including most women, smaller men and many adolescents.

The most recent data from SynCardia stems from 47 patients who have lived for more than one year with its artificial heart. Of these patients, 34 of them, or 72%, successfully received a donor heart transplant during that period, while one patient (2%) remained on the artificial heart. The other 12 patients, or 24%, died while they had the artificial heart.

Infections and hemorrhagic events were the leading causes of death among study patients. Of the deaths, two were attributed to device failure. Three of the 34 patients with donor heart transplants later died to graft rejection, with a median post-transplant survival time of 145 days.

The SynCardia Total Artificial Heart is FDA-approved and CE-marked as a bridge to a donor heart transplant for patients dying of end-stage biventricular heart failure, a condition in which the two ventricles no longer pump enough blood for the patient to survive.

The study was a retrospective analysis of patient medical records for those who had received the artificial heart between 1989 and 2011 and were on the device for at least one year. The mean age of the patients was 50, with a median time on support of 554 days.

The study authors conclude that although it's effective, the artificial heart success rate could benefit from "further improvements in the device, patient selection and long-term patient management" in order to "further reduce the major complications of infection, thromboembolic and hemorrhagic events."

More than 1,400 patients have received the SynCardia Total Artificial Heart. Together, they've logged over 400 patient life years on the device. The longest a patient has lived with the device is nearly four years prior to receiving a successful donor heart transplant. The device also works with the hand-held Freedom portable driver, which allows for mobile use of the artificial heart; more than 200 patients have used it.

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