It’s something most of us take for granted. After all, the heart just beats and you don’t have to think about it. Or do you? It’s been five years since Charles Okeke walked out of a hospital to resume his life and get the chance to put that question behind him.
Okeke, a Phoenix resident, initially wasn’t sure that next beat would be coming in time as his body was rejecting an earlier heart transplant. Fortunately, he was given a second chance but it turned out to also be one of many tests of his fortitude.
It was Sept. 8, 2008, when he received the SynCardia Total Artificial Heart while awaiting the chance for another transplant. The Total Artificial Heart is the only approved device that eliminates the source of end-stage biventricular heart failure, which occurs when the two ventricles in a patient’s own heart cannot pump enough blood for the person to survive.
Next came the waiting. For 600 days, Okeke was confined to the Mayo Clinic Hospital in Phoenix tethered to a 418-pound hospital driver that powered the heart made by Tucson-based SynCardia. In the meantime, the FDA in March 2010 approved a clinical study into the effectiveness of the SynCardia Freedom® portable driver, a 13.5-pound unit that powers the company’s Total Artificial Heart. The driver offered the possibility of giving clinically stable patients nearly unlimited mobility.
Okeke saw the potential for being discharged if given the opportunity to receive the portable driver. However, he had concerns. “How have the human clinical trials been (going)?” he recalls saying, “and realizing from the stares, you are the (first patient that is part of the) … clinical trial."
He accepted the challenge. By that May, Okeke’s trial had progressed to the point that he could head to the door and go home. He recalls feeling free when he walked out of the hospital without a human heart. “You don't really know how much you miss fresh air (and) sun until it's been taken away from you for a long time,” he says.
Even though he could go home, Okeke wasn’t entirely out of the woods. Discharge allows the Freedom® portable driver patients to get in better shape for their heart transplants while getting back to their lives. After spending eight months at home with his family, he received a donor heart-kidney transplant January 15, 2011.
Part of Okeke’s legacy is his being a pioneer in his trial with the Freedom® portable driver. It contributed to the FDA on June 26, 2014, approving use of the portable driver for all clinically stable U.S. patients using the SynCardia Total Artificial Heart. The portable driver also is approved by Health Canada and has the CE Mark for use in Europe.
Seventy-four percent of patients who were supported by the SynCardia temporary Total Artificial Heart for more than a year were either bridged to a donor heart or awaiting one, according to a study published earlier this year in the ASAIO Journal for the American Society for Artificial Internal Organs.
Worldwide the Freedom® portable driver has been used by 221 patients, allowed 153 clinically stable patients to be discharged from the hospital and provided 143 patient years of support. Two patients who are waiting for their matching donor hearts are getting close to four years of support on the Total Artificial Heart powered by the portable driver.
SynCardia recently has received the green light to pursue a new milestone. Until now, the patients using its Total Artificial Heart have been using the 70cc model. For smaller adults and children, the size of the artificial heart was too large to fit in their bodies, perhaps depriving them of the chance to stay alive long enough to receive a donor organ. SynCardia has received FDA approval to conduct an investigational device exemption clinical study on the effective use of its 50cc mode of the temporary heart.
Under the study, the 50cc model initially will be available for implantation in:
- 10 pediatric patients 10 to 18 years old
- 10 adult patients 19 to 75 years old
- 10 patients who would not otherwise qualify under the study criteria.
In 2014, the 50cc Total Artificial Heart received humanitarian use device designations. This allowed it to be used in smaller patients ineligible for cardiac transplants and at risk of imminent death from non-reversible biventricular heart failure, and in children with the same heart problem and whose body could accommodate the size of the heart.
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