Heart transplantation can be a lifesaving option for individuals with end-stage heart failure that cannot be treated any other way. But patients may not be eligible due to a variety of factors, including age and certain medical conditions. Physicians at Froedtert Hospital are participating in a national clinical trial to determine if these patients can benefit from another alternative — a SynCardia 70cc Total Artificial Heart (TAH) implant.
“This is the only FDA-approved biventricular device that can support the patient, but it is only approved as a bridge to transplant,” said David Joyce, MD, cardiothoracic surgeon, MCW faculty and primary investigator of the study at Froedtert Hospital. “This trial evaluates the device as ‘destination therapy’ for patients who are not eligible for a transplant or a left ventricular assist device.”
The SynCardia TAH replaces both of the heart’s ventricles. “These are pneumatically activated ventricles, with two tubes out of the patient’s side and compressed air delivered from an external driver,” Dr. Joyce said. Either a bedside console or a mobile rechargeable driver can supply the compressed air. “It fits in a backpack, giving the patient mobility,” Dr. Joyce said.
Dr. Joyce has seen improvement in patients awaiting transplant with the device. “Individuals can usually walk a lot farther and are not held down by severe shortness of breath,” he said. The trial will determine if patients not undergoing transplant fare as well. “We fully expect to see improved survival and improved quality of life because we’ve seen that on the transplant side,” he said. “The trial creates a new potential for offering hope to patients who are ineligible for heart transplant but have severe heart failure that affects both ventricles of the heart.”