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Press Release:

13-Year-Old Boy with Failed Fontan Circulation Bridged to Transplant Using the SynCardia Total Artificial Heart, Published in Annals of Thoracic Surgery

Peer-reviewed case report says implantation of the SynCardia Total Artificial Heart restores
“normal biventricular circulation” to a congenital patient with only one functioning ventricle.
The male patient was bridged to a donor heart 61 days later.


Successful Use of the Total Artificial Heart in the Failing Fontan Circulation” is a peer-reviewed case report that describes the implantation of the SynCardia Total Artificial Heart into a 13-year-old boy who was bridged to a heart transplant 61 days later. Successful Use of the Total Artificial Heart in the Failing Fontan Circulation” is a peer-reviewed case report that describes the implantation of the SynCardia Total Artificial Heart into a 13-year-old boy who was bridged to a heart transplant 61 days later. TUCSON, Ariz. – Sept. 16, 2014 – Surgeons at The Children’s Hospital of Philadelphia describe in a case report the first successful use of a SynCardia temporary Total Artificial Heart (TAH) in a 13- year-old boy with failing Fontan circulation to bridge him to a heart transplant.

When he was 3 years old, the patient received a Fontan circulation procedure to address his congenital condition known as functional single ventricle. “The Fontan operation is the final planned palliative operation for children with functional single ventricles…This circulation is usually tolerated initially, but eventually fails secondary to chronic low cardiac output and elevated venous pressure,” wrote the authors from The Children’s Hospital of Philadelphia.

At age 13, “(h)e was hospitalized at an outside institution with severely depressed left ventricular systolic function, respiratory failure, hepatic insufficiency with coagulopathy and plastic bronchitis,” wrote the authors.

Read the Case Report: “Successful Use of the Total Artificial Heart
in the Failing
Fontan Circulation”

On transfer to The Children’s Hospital of Philadelphia, “the patient was in extremis with multi-organ failure and respiratory decompensation,” the report continued. Surgeons opted to implant the SynCardia Total Artificial Heart because a ventricle assist device (VAD) doesn’t address the “fundamental issue” of a failing Fontan circulation.

“Because of the passive flow of blood through the pulmonary vascular bed, inadequate preload is often the underlying cause of diminished cardiac output,” according to the case report in the April 2014 The Annals of Thoracic Surgery. “Indeed, filling and function of the VAD is likely to be limited by inadequate preload.”

With informed consent from the family, a 70cc SynCardia Total Artificial Heart was implanted.

Like a heart transplant, the SynCardia Total Artificial Heart, manufactured by SynCardia Systems, Inc. in Tucson, Arizona, replaces the single congenital ventricle with two new ventricles and four heart valves. During the implant surgery the congenital malformations of the heart’s vascular system are corrected so that the patient receives normal flow through both ventricles. The SynCardia Heart provides immediate safe blood flow of up to 9.5 liters of blood per minute through each ventricle.

Over several weeks, the patient demonstrated recovery of all end-organ function, including resolution of plastic bronchitis. The patient underwent rehabilitation therapy and was able to ambulate without assistance.

On postoperative day 61, a suitable donor heart became available and the patient underwent orthotopic heart transplantation.

“There is a growing population of children and young adults who develop ‘Fontan failure’” because of chronic low cardiac output and elevated venous pressure, the case report says.

“The TAH may allow for resolution of the myriad manifestations of the failing Fontan circulation, thereby facilitating rehabilitation and improving suitability for eventual transplantation,” according to the report.

The case report’s six authors are from The Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia: Joseph W. Rossano, M.D.; David J. Goldberg, M.D.; Stephanie Fuller, M.D.; Chitra Ravishanker M.D.; Lisa M. Montenegro, M.D., and J. William Gaynor, M.D.

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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