SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that Harvard-affiliated Brigham and Women’s Hospital in Boston has performed New England’s first implant of the SynCardia temporary Total Artificial Heart.
“If I didn’t have this device, I probably would have ended up dying,” said patient Jim Carelli, Jr. “It’s not a difficult choice when you want to live – and I wanted to live."
Mr. Carelli, 66, is a former high school science teacher and track coach who taught for 32 years before retiring in 2004. He was an avid runner and golfer until three years ago, when he experienced an irregular heartbeat. In 2010, he was diagnosed with late-stage cardiac amyloidosis, a disorder that causes protein in the blood to build up in the heart muscle. Over time, the protein causes the heart muscle to thicken and weaken until eventually the heart begins to fail.
By February 2012, he was in need of a heart transplant to survive, but no matching donor heart was available. To save his life, on Feb. 17, doctors at Brigham and Women’s performed the region’s first implant of the Total Artificial Heart to bridge him to a heart transplant.
“This was the power of teamwork and the strength and courage of an individual,” said Dr. Michael Givertz, medical director of the Heart Transplant and Mechanical Circulatory Support Program. “He’s a courageous, resilient man with an amazing joy for life.”
At a press conference at Brigham and Women’s Hospital, Mr. Carelli’s surgeon, Dr. Gregory Couper, said he had “never seen a heart this thick,” when describing his patient’s pre-surgery condition. “This procedure is life-saving and life-restoring for these patients,” he added.
Prior to receiving the SynCardia Total Artificial Heart, Mr. Carelli’s heart problems caused fluid to build up in his body, which created kidney problems and swelling of his legs that made it hard to walk. He is currently undergoing dialysis and has been listed for a combined heart and kidney transplant. Except for his pre-existing kidney issues, doctors said his recovery so far has been “complication free.”
"You’ve got to have faith,” said Mr. Carelli. “This is a big leap of faith. They remove your heart, and there is no turning back. Once it's gone, they're not going to give it back to you.”
Today, Mr. Carelli says he feels so good that if he wasn’t tethered to the hospital driver that powers his Total Artificial Heart, he’d be out running. He’s currently walking 1.5 miles at a time on the treadmill.
“I’m glad people will realize that if you have a serious heart problem, you now have an alternative with this device,” said Mr. Carelli. “It might take months to get a donor, but at least you’ll get through it. This procedure provides great hope, which matters because sometimes people have no hope at all.”
During the 10-year pivotal clinical study that resulted in FDA approval, the SynCardia Total Artificial Heart achieved the highest bridge to transplant rate, 79%, of any approved mechanical circulatory support device in the world (NEJM 2004; 351:859-67).
CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.