TUCSON, Ariz., Sept. 2, 2015 /PRNewswire/ -- A successful bridge to a donor heart transplant (BTT) 30 years ago revolutionized the treatment of end-stage biventricular (both sides) heart failure when Michael Drummond received a Total Artificial Heart implant -- a direct predecessor of the modern SynCardia temporary Total Artificial Heart (TAH-t).
The initial five implants of the Total Artificial Heart were for permanent use. This was the first time a Total Artificial Heart, or any long-term mechanical assist device, was used to successfully bridge a patient to a donor heart transplant.
"This was the very first successful BTT—the beginning of the bridge-to-transplant era with the Total Artificial Heart. Now, we are surpassing 1,500 SynCardia Heart implants and 500 years of patient support," says Richard Smith. Smith is the chief technology officer and one of three founders of SynCardia Systems, Inc., which manufacturers the SynCardia Total Artificial Heart powered by the Freedom® portable driver.
On August 29, 1985, Dr. Jack Copeland, a cardiac surgeon with then University Medical Center (now Banner—University Medical Center Tucson), and biomedical engineer Richard Smith, implanted a Total Artificial Heart (Jarvik 7 100cc heart, now known as the SynCardia TAH-t) into Drummond, a 25-year-old grocery store clerk.
It was the first time a surgeon implanted the Total Artificial Heart to allow a patient time to get a matching donor heart for transplant when one became available. Copeland had sought to have the Total Artificial Heart as a backup in the operating room after seeing heart failure patients die because they couldn't get donor hearts in time or the donor heart was not viable to save the patient's life.
Not knowing what to expect from Drummond's implant, Smith was particularly struck by the immediate change in Drummond's appearance. Recalling an ashen, gray-colored patient before the implant, after the surgery "I could remember him turning pink right in front of me as Drummond's body was finally receiving a healthy level of blood flow," Smith says.
Following the implant, Drummond's parents told Smith that their son always had cold hands and feet prior to the surgery. "The SynCardia Heart pumps up to 9.5 liters of blood a minute through each ventricle and this healthy blood flow is what these patients desperately need," explains Smith.
On September 8, 1985, after nine days on the SynCardia Total Artificial Heart, Drummond received a donor heart transplant. While Drummond was supported by the TAH-t, Smith meticulously watched and monitored his patient nearly around the clock to be sure he was doing well. "We were obsessed because it was a brand new arena," he says. "We couldn't relax until this guy was through the transplant and out of the hospital."
"The most important thing we learned from the Michael Drummond implant was that the Total Artificial Heart worked beautifully," says Copeland. "The patient who had been dying 24 hours before was extubated and out of bed the next day. All end-organ function returned to normal, enabling us to do a successful heart transplant nine days later. He lived for five and half years with his donor heart, eventually dying of B-cell lymphoma (cancer)."
"Since then we have learned that selection of patients in the acute phase of their disease (INTERMACS 1) is very important, allowing the patient maximal chance of survival rather than procrastinating," Copeland continues. "Now we are just beginning to use the 50cc* heart device that should eliminate sizing problems in most adults and many children and adolescents.
"Finally, we are starting a destination therapy study* at a time when many non-transplant eligible patients with biventricular failure have been dying on medical therapy or languishing with right ventricular failure on LVAD support."
Dr. Francisco Arabia, an expert on implanting and caring for patients with the SynCardia Total Artificial Heart, remembers Michael Drummond and his family. "It was my first day at UMC when I met Michael Drummond," says Arabia. "It was a humbling experience to see him and his family were making history that would change everyone."
Thirty years later, more than 100 specially trained SynCardia Certified Centers implant the SynCardia Total Artificial Heart to treat end-stage biventricular heart failure in which a patient's heart can no longer pump enough blood for the person to survive.
Like a heart transplant, the SynCardia Heart replaces the heart's two failing ventricles and four heart valves. It is the only approved device in use that eliminates the source of end-stage biventricular heart failure.
The regular use of the SynCardia Heart was established with that first successful bridge-to-transplant patient 30 years ago and created a new standard of care. Over those 30 years, cardiovascular disease, including heart failure, has grown to be the leading cause of death – more than all cancers combined.
Demand for donor hearts have increased dramatically, causing donor-heart wait times to grow to months and years. Some patients develop unique body chemistry, which makes it more difficult to match that chemistry to the right donor heart. This can extend wait times to years.
*(CAUTION – In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.)
(CAUTION- The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.)
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is the manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,475 implants of the SynCardia Total Artificial Heart account for over 480 patient years of life on the device. Since January 2012 more than 500 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart and received a successful donor heart transplant was nearly four years (1,374 days).
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital and live at home and in their communities. The Freedom® portable driver has been used by more than 235 patients, accounting for over 160 patient years of support.
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SOURCE SynCardia Systems, Inc.