TUCSON, Ariz., Sept. 16, 2014 /PRNewswire/ -- 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-t) 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.
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.
Read the Case Report: “Successful Use of the Total Artificial Heart in the 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 2014The 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 the SynCardia temporary Total Artificial Heart
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.
Photo - http://photos.prnewswire.com/prnh/20140915/146252
SOURCE SynCardia Systems, Inc.
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