Case Report on 14-Year-Old Pediatric Patient Bridged to Transplant With SynCardia Systems, Inc. Total Artificial Heart Published in the Journal Perfusion

TUCSON, Ariz., Oct. 1, 2013 /PRNewswire/ -- Surgeons in Phoenix, Arizona, successfully implanted the SynCardia temporary Total Artificial Heart into a 14-year-old boy with biventricular (both sides) heart failure and diffuse clot formation in the left ventricle using diagnostic technology to ensure its proper fit prior to actual surgery. The patient was supported and rehabilitated for 11 days and subsequently transplanted.

(Photo: http://photos.prnewswire.com/prnh/20131001/LA89500)

The multidisciplinary team determined the SynCardia Heart was the only available choice for the patient because of his conditions, according to a professional paper authored by 15 doctors and professors at Phoenix Children's Hospital and an Arizona heart transplant center. But the device might have been too large to implant into the teenager's body.

"Cat-scan imaging of the chest, in conjunction with a virtual 3D modeling system, helped determine whether the SynCardia Total Artificial Heart could actually be placed in the child's chest," explained D. Bradford Sanders, chief perfusionist at Phoenix Children's Hospital and the corresponding author of the report. "It also guided the postoperative course."

Following the implant, the patient experienced progressive respiratory insufficiency stemming from mucus obstructions in the airway. The team obtained additional chest CTs and virtual 3D modeling to determine there were no blockages of major vascular structures, no evidence of left pulmonary vein compression, and the primary airways were open.

"In selected pediatric patients, the Total Artificial Heart is the assist device of choice for decompensating biventricular heart failure. Commonly encountered VAD (ventricular assist devices) issues, such as valve-related problems, left ventricular clot formation, right heart failure, arrhythmias and need for inotropes, are eliminated with the Total Artificial Heart," the paper said in its conclusion.

Phoenix Children's Hospital's experience using the SynCardia Total Artificial Heart is published online in the journal Perfusion. Publication in the paper version is scheduled for January.

Dilated cardiomyopathy is the primary indication with an estimated 1,000 to 1,500 new pediatric cases diagnosed each year. The disease accounts for 65 percent of heart transplants in children 11 to 17 years old. This subgroup of patients is subject to the highest waiting-list mortality in solid-organ transplant medicine in the United States.

The success of using visualization technology to conduct a virtual implantation is designed to expand the boundaries of patient sizes that can accommodate the SynCardia Total Artificial Heart. Most of these patients also suffer from a cardiomyopathy that most often results in an enlarged heart, which provides more space for the Total Artificial Heart in patients.

"Virtual implantation is a critically important new development for treating end stage biventricular heart failure in pediatric and adult congenital heart patients," said Michael P. Garippa, president and CEO of SynCardia Systems, Inc. "The ability to plan in advance for the individual's unique anatomic abnormalities and past surgeries to address these issues at the pre-operative stage helps create good outcomes for implantation patients."

The SynCardia Total Artificial Heart is the only device that eliminates the symptoms and source of end stage biventricular heart failure. It is immediately available at 87 SynCardia Certified Centers worldwide with an additional 33 centers in the process of certification. The company has a smaller Total Artificial Heart in development that is designed for patients of smaller stature such as women and adolescents.

Read Arizona State University story on 3D technology for heart surgery

Watch video on virtual implantation of the Total Artificial Heart

About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. (Tucson, AZ) is the privately-held 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 heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,200 implants of the Total Artificial Heart, accounting for more than 335 patient years of life on the device.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 87 SynCardia Certified Centers worldwide with 33 others in the process of certification.

The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

Forbes Ranks SynCardia #69 Among "America's Most Promising Companies"

In its February 2013 issue, Forbes selected SynCardia as one of "America's Most Promising Companies" for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was selected #69, moving up eight spots from its #77 ranking last year. See the full list of SynCardia Awards & Recognition.

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SOURCE SynCardia Systems, Inc.