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Press Release:

Oklahoma Man 1st in Region to Receive Total Artificial Heart

INTEGRIS Baptist Medical Center Becomes 13th U.S. SynCardia Certified Center

Back row: Susan Golden (Troy's mom), Dr. James Long (cardiovascular surgeon and director of the INTEGRIS Advanced Cardiac Care program), Laura Golden (Troy's daughter), and Dr. Douglas Horstmanshof (heart failure cardiologist and co-director of the INTEGRIS Advanced Cardiac Care program) Front row: Total Artificial Heart patient Troy Golden, Darla Golden (Troy's wife), Billy Golden (Troy's father)Back row: Susan Golden (Troy's mom), Dr. James Long (cardiovascular surgeon and director of the INTEGRIS Advanced Cardiac Care program), Laura Golden (Troy's daughter), and Dr. Douglas Horstmanshof (heart failure cardiologist and co-director of the INTEGRIS Advanced Cardiac Care program) Front row: Total Artificial Heart patient Troy Golden, Darla Golden (Troy's wife), Billy Golden (Troy's father)

TUCSON, Ariz. – Oct. 5, 2010 – On Sept. 15, 45-year-old Troy Golden of Geary, Okla., became the first person in the region to have his heart replaced with the SynCardia temporary Total Artificial Heart at INTEGRIS Baptist Medical Center in Oklahoma City. It is a distinction that was years in the making.

Golden was born with a broken heart. A genetic condition called Marfan syndrome has been slowly attacking the connective tissue in his body since birth.

The primary purpose of connective tissue is to hold the body together and provide a framework for growth and development. In Marfan syndrome, the connective tissue is defective and does not act as it should. Because connective tissue is found throughout the body, Marfan syndrome can affect many body systems, including the heart and blood vessels.

Golden began taking heart medication when he was just 27 years old. The disease progressed as he aged, until he finally required surgery when he was 35. Six years later, he went under the knife again. "This time it was a major overhaul," explains Golden. "I had an aortic valve replacement, an aortic root repair, a mitral valve replacement and the Maze rhythm procedure on my atrium. Pretty much everything they could do to my heart, they did."

Troy Golden, Oklahoma's first recipient of the SynCardia temporary Total Artificial Heart, with his wife Darla at a news conference at INTEGRIS Baptist Medical CenterTroy Golden, Oklahoma's first recipient of the SynCardia temporary Total Artificial Heart, with his wife Darla at a news conference at INTEGRIS Baptist Medical Center.

This bought him some time, but inevitably the shortness of breath and fatigue returned as his condition once again worsened. He was put on the heart transplant list in January this year.

Golden is familiar with the transplant process. His younger brother, who also suffers from Marfan syndrome, received a heart transplant 15 years ago. His health is remarkable today. Golden hoped for the same outcome as his brother, and began the long wait for a donor heart.

"However, time ran out for Troy," says Doug Horstmanshof, M.D., heart failure cardiologist and co-director of the INTEGRIS Advanced Cardiac Care program. "The only alternative to imminent death was a mechanical heart pump. But, our experience told us that Troy's heart disease was so bad that a traditional heart pump wouldn't be enough. So, we decided to try something different – completely replacing the heart with the Total Artificial Heart."

The Total Artificial Heart is the only FDA approved device of its kind in the world. Unlike traditional heart pumps that assist one side of the heart or the other, left (or right) ventricular assist devices, the Total Artificial Heart actually replaces both ventricles of the failing heart, along with the four native heart valves. Instead of working with a person's existing heart, this device replaces the heart as a bridge to transplant. Similar to a heart transplant, the natural heart is physically removed.

Golden was understandably nervous to be the first in the region to try such a radical procedure, but his strong desire to live helped him make the decision. "As a registered nurse, I understand the extremes of my medical situation and know the odds. As a pastor, I know the healing power of God and have faith He will pull me through."

After six hours of surgery, James Long, M.D., cardiovascular surgeon and director of the INTEGRIS Advanced Cardiac Care program, calls the event an inspiring success. "It was admittedly rather awe-inspiring to know that our patient was alive and well with a "flat-line" ECG on the rhythm monitor. And it was ominous to look inside the chest and know that the only thing keeping him alive was the synthetic pump that we had just replaced his heart with."

"It was also humbling to recognize that it had taken more than half a century of pioneering endeavor for mankind to just barely begin mimicking the marvelous organ endowed by our Creator."

Dr. Long adds, "The operation and recovery have been everything we could have hoped for. Our remaining hope is that the completely mechanical heart will keep Golden alive until a donor heart becomes available and grants him a new lease on life."

Golden plans to participate in the FDA Investigational Device Exemption (IDE) clinical study of the wearable Freedom® driver system. The system is designed to allow patients to wait for a matching donor heart at home instead of staying in the hospital, as is currently the case, sometimes remaining hospitalized for months on end.

Golden is a minster at the New Life Assembly of God in Geary. He credits his family's experience with Marfan syndrome in part for shaping his life. "I entered the medical profession and the ministry to help people like me and my brother. If this new technology can do that and I can play a small role in it, then it will all be worth it."

CAUTION - The Freedom® driver system is undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. The IDE clinical study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and that it can be safely used at home. Through the IDE clinical study, stable Total Artificial Heart patients who meet study criteria may have the option to be discharged from the hospital using the Freedom portable driver, to wait for their matching donor heart at home and in their communities. 

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SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart.

Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved 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 1,350 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by over 190 patients, accounting for over 110 years of support.

 

Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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