Imagine walking 4 miles. No big deal, right?
Imagine walking 4 miles carrying a 13lb weighted backpack. Maybe a little more of a challenge?
Now imagine walking 4 miles carrying a 13lb weighted backpack…without a human heart.
That is exactly what Randy Shepherd of Mesa, Arizona was able to do in April of 2014, thanks to the SynCardia temporary Total Artificial Heart from Tucson, Arizona-based SynCardia Systems, Inc.
As a child, Randy survived two bouts of severe rheumatic fever, but his heart was damaged. Eventually, his heart failed and on June 20 of 2013, he received the SynCardia Total Artificial Heart at age 40. Once he had recovered from the implant surgery and his clinical condition had stabilized, he was fitted with a Freedom® portable driver, which powers the heart and provides SynCardia Heart patients with significant mobility. He was able to be discharged from the hospital to wait for a donor heart at home.
Less than a year later, Randy became the first person without a human heart to complete the 4.2 mile Pat’s Run course in Tempe, Arizona on April 26, 2014, carrying the 13.5lb Freedom® portable driver in a backpack. That’s a pretty big deal.
How does the Total Artificial Heart help a patient?
Cardiovascular disease, which includes heart failure, is the leading cause of death in the modern world, more than all cancers combined. The growing demand and the flat or shrinking international supply of usable donor hearts is a major issue today, according to a peer-reviewed paper published in the American Journal of Transplantation.
Annually, over 20,000 patients need a heart transplant, meaning a solution that helps bridge the gap while patients wait for that transplant can make a difference to a life. Increasingly, the Total Artificial Heart is the bridge between a dying organ and a donor heart.
Similar to a heart transplant, the SynCardia Total Artificial Heart implant replaces both failing heart ventricles and the four heart valves, helping patients recover and regain their health and strength enough to qualify for a donor heart transplant. The artificial heart might only be a temporary measure, but the impact is still life-changing, as many of SynCardia’s case studies show – including Randy Shepherd’s.
The longest a person has been supported by a total artificial heart before receiving a successful donor heart transplant was Italian patient Pietro Zorzetto, who had a SynCardia heart for nearly four years (1,374 days). One-third of patients implanted with the current generation of the company’s Total Artificial Heart have been supported for more than a year – 47 percent outside of the US and 21 percent in the US. Some have been supported for two or more years SynCardia Total Artificial Hearts account for 98.4 percent of the time patients have been supported by any type of total artificial heart – a combined total of 443 patient years of support.
The SynCardia Systems story highlights the national and global impact companies within Arizona’s bioscience and healthcare industry are having.
A history of Arizona innovation
Dr. Jack Copeland, co-founder of SynCardia Systems, has been a pioneer in cardiovascular medicine in Arizona since 1977 when he began his career at was then the University of Arizona (UA), now Banner-University Medical Center Tucson Campus. In 1979, he performed the hospital’s first heart transplant. He served as the chief of cardiothoracic surgery at the UA College of Medicine until 2010.
Among Dr. Copeland’s impressive list of accomplishments include the first use in the world of the Jarvik 7 Total Artificial Heart as a bridge-to-transplant. The Jarvik 7, the Symbion Heart and the Cardiowest are all direct predecessors to the modern SynCardia Heart. Copeland did Arizona’s first double-lung transplant and he was the first to use in the US a Berlin Heart assist device designed for infants and children. He is also a founder and past president of the International Society for Heart and Lung Transplantation.
SynCardia Systems was founded in Tucson in 2001, and its Total Artificial Heart became the world’s first FDA-approved Total Artificial Heart in October 2004. The artificial heart received the CE Mark in Europe and Health Canada approval in 2005, making it the only Total Artificial Heart with regulatory approvals from many countries.
The company recently announced FDA approval to conduct an investigational clinical study with up to 72 patients for a new smaller 50cc (as opposed to the current 70cc) total artificial heart. Patients enrolled in this study will receive the 50cc artificial heart as a temporary bridge-to-donor heart transplant.
SynCardia President and CEO Michael P. Garippa stated, “This study will allow smaller patients who can’t fit the 70cc Total Artificial Heart to benefit from SynCardia’s Total Artificial Heart technology. Together, both device sizes are intended to make Total Artificial Hearts available to most women and men as well as many adolescents.”
While this smaller size is under study in the US, both sizes of the SynCardia Heart are already in use under the CE Mark in Europe for use as a bridge-to-donor heart. A clinical study for use of the SynCardia heart as destination therapy in the US has been approved by the FDA.
The SynCardia Heart is available at more than 100 SynCardia Certified Centers in 17 countries and is implanted when physicians specializing in heart failure determine that the SynCardia Heart is needed to save the life of a patient and prevent damage to other vital organs such as the kidneys, liver, stomach, lungs and brain.
By addressing the decline in availability of donor hearts and bridging the gap until a transplant is available, SynCardia’s Total Artificial Heart technology is giving patients who are facing death with end-stage biventricular heart failure all over the world a new chance at life.
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.