FDA Approves Temporary Artificial Heart
Last Resort for Some Heart Transplant Patients
Oct. 18, 2004 -- The FDA has approved a temporary partial artificial heart intended to keep hospitalized patients alive while waiting for a heart transplant.
The device is called the CardioWest Total Artificial Heart. Made by SynCardia Systems of Tucson, Ariz., it's not intended to replace the human heart, and it's not a permanent solution.
Instead, it serves as a "bridge transplant," keeping hospitalized patients alive until donated hearts become available.
Implanted in the chest, the artificial heart replaces the bottom half of the heart and is sewn onto the top half of the patient's original heart. Tubes running through the chest wall connect to a large power-generating console, which operates and monitors the artificial heart, according to an FDA news release.
The artificial heart is expected to be used rarely.
It's seen as an option only in the most severe cases where all other approaches have failed and death is imminent within 30 days, according to news reports.
Specifically, the artificial heart is intended for heart transplant candidates with irreversible heart failure from loss of function of the lower chambers of the heart. That is, the left and right bottom quadrants of their hearts don't work.
About 4,000 people in the U.S. per year need heart transplants, but only about 100 of them might qualify for the artificial heart.
The FDA is requiring SynCardia to continue to study and monitor the device.
Prior to FDA approval, SynCardia tested the artificial heart on 81 patients at five U.S. medical centers; 79% of recipients lived long enough to receive a donor heart (an average of 79 days).
In SynCardia's study, the longest length of time a recipient lived with the device was 400 days, according to news reports.
Infection was the most common complication, affecting 72% of participants in SynCardia's study. Bleeding was seen in 42% of patients, while 25% suffered neurological events such as major or minor stroke.
The device malfunctioned in 18% of recipients, and 17 patients died before a donor heart could be found.
Organ donations don't keep pace with the demand.
Every year, about 2,200 donated hearts become available in America. That's about 1,800 fewer than what's needed, according to the FDA.
Since the new artificial heart is a temporary measure of last resort, the need for donated hearts remains as strong as ever.