SynCardia (Tucson, Arizona), maker of the temporary CardioWest Total Artifical Heart, reported that the world's first Total Artificial Heart (TAH) to dual heart and liver transplant was performed at the Cleveland Clinic.
"Cleveland Clinic has made medical history with their use of the Total Artificial Heart to bridge a very ill patient to a dual heart and liver transplant," said Jack Copeland, MD, internationally renowned transplant surgeon and TAH pioneer. "My congratulations go out to Drs. Nicholas Smedira and Randall Starling, two world class physicians."
After living with the TAH for 113 days, on May 1, Michael Zabell, a 63-year-old dentist, received the donor heart and liver during a 14-hour landmark surgery involving two different transplant teams.
"I've had more doctors than the Cleveland Browns have had quarterbacks," Zabell said. "Dr. Smedira is not only an outstanding surgeon but he's really a wonderful guy. Cleveland Clinic has an outstanding group of surgeons, physicians and hospital staff, including my cardiologist Dr. Starling. I can't say enough about the care."
Zabell was first admitted to the hospital to wait for a heart transplant on Aug. 18, 2008. He was given medication to help his heart function, but his condition continued to deteriorate. By Jan. 8, his heart had become so weak that doctors needed to implant the TAH to buy him more time until a matching donor heart and liver could be found, SynCardia said.
The company noted that Smedira is a paid consultant for SynCardia.
"When the heart gets weak it's like turning the water off to your garden," Roger Ford, president/CEO of SynCardia, told Medical Device Daily. "The heart [infuses] life just like the garden hose [infuses] the garden. When that gets turned off or turned down, all those plants in the garden will wilt and eventually they can't return to their normal function."
So what the TAH does is infuse the body, and that infusion is like turning back on the hose, Ford explained. The device assists in bringing those organs back to a more normal state.
"In the case of this recent implant in Cleveland everything came back pretty well except the liver, so the body was ready and they implanted a human heart and a new liver and that patient goes on to live another day," Ford said.
The TAH is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. According to SynCardia, it is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
The TAH is the only FDA, Health Canada and CE mark-approved total artificial heart in the world. There have been more than 800 implants of the TAH, accounting for more than 170 patient years of life on the device, the company said.
Last spring Copeland performed a Total Artificial Heart to dual heart and kidney transplant at the University Medical Center (Tucson), marking the second such surgery. Mayo Clinic Arizona (Scottsdale) surgeon Francisco Arabia, MD, performed the first Total Artificial Heart to dual heart and kidney transplant.
Don Isaacs, a spokesman for SynCardia, told MDD that these dual transplants are not part of the company's current indication and that as a manufacturer SynCardia does not promote nor encourage such use. "These notable surgical events and the recovery and return to society of these patients demonstrate the healing power of the Total Artificial Heart," Isaacs said. "When the patient's heart no longer supplies enough blood to sustain the body, patients need a high volume of safe blood flow. The Total Artificial Heart has no equal."
Amanda Pedersen, 229-471-4212;