The total artificial heart has come a long way since Dr. Denton Cooley performed the first implantation at the Texas Heart Institute in 1969. That patient lived for 64 hours on the device until a donor heart became available. Now, 40 years later, heart transplantation remains the treatment of choice for patients with failing hearts, but the supply of donor hearts is limited and the wait-list growing. Those patients who can’t receive a heart transplant—either because they don’t meet transplant criteria or a suitable human heart isn’t available—may be treated with mechanical devices such as ventricular assist devices or total artificial hearts.
The only total artificial heart currently available in the United States, the SynCardia temporary total artificial heart, was originally approved by the Food and Drug Administration (FDA) in 2004 as a bridge to transplantation for patients at risk of imminent death. Approval was limited to in-hospital use only, meaning that patients had to remain in the hospital until they died or received a heart transplant, which could be a long time. But as of last June, patients with temporary total artificial hearts have another option if they are well enough to leave the hospital. SynCardia’s Freedom portable driver was FDA approved for use in patients who are clinically stable, allowing them to be discharged while awaiting a new heart. This not only could improve patients’ quality of life, it also potentially reduces the costs associated with lengthy hospital stays.
Given our aging population and the rising number of adults with heart failure, we predict that the demand for total artificial hearts and other mechanical circulatory support devices is only going to increase. To optimize patient outcomes in the future, we’ll need to know with certainty which devices work the best for which patients—and to do that will require robust, high-quality evidence.
Hayes has reviewed the evidence that currently exists so that payers and providers can make evidence-based decisions about the use of these devices. Our report, Total Artificial Heart, Temporary or Permanent, Biventricular Mechanical Circulatory Support Device, analyzes the results from 18 studies published from 1997 to 2014. These studies looked at how the temporary total artificial heart compared with other devices such as left ventricular or biventricular assist devices or historical control patients who did not receive an artificial heart; main outcome measures include survival to transplantation, duration of device support, posttransplant survival, and overall survival.
This report is available to Hayes subscribers through the Knowledge Center. If you aren’t a Hayes customer, contact us to purchase it.