Two weeks after his heart was replaced with an artificial organ made of plastic and titanium, the first human recipient of a fully implantable artificial heart is doing well, but remains extremely sick, his surgeons said Monday in a news conference.
The still-unidentified man, who was fitted with the artificial heart two weeks ago at Jewish Hospital in Louisville, Ky., is doing better than expected, said his surgeons, Dr. Laman Gray and Dr. Robert Dowling of the University of Louisville School of Medicine. "The heart is working flawlessly," Gray said.
But, the surgeon added, the patient is "extremely sick. He's going to be sick for a very, very long time."
The recipient, a man in his mid-50s, suffered from heart failure and diabetes and was believed to be within 30 days of death at the time of the seven-hour surgery July 2. He could walk only 10 to 15 feet unassisted and his weight had dropped from 200 pounds to 140. He was ineligible for a heart transplant because of his poor health.
The relative success of the device so far means that other hospitals that have been given permission to implant copies are likely to move ahead soon. UCLA is one of those sites and is in the process of screening potential patients. Surgeons there have several candidates in mind, said cardiologist and transplant specialist Dr. Jaime Moriguchi, medical director of the mechanical circulatory support team at UCLA Medical Center. The team hopes to implant one of the artificial hearts into a patient within the next month, he said.
"We're all terribly excited about the success of this artificial heart so far," Moriguchi said.
The two-chamber artificial heart, known as AbioCor, was developed by a Massachusetts company called Abiomed with financial help from the National Heart, Lung and Blood Institute. The device is quiet and fully encased in the body. Its motor is run by an implanted battery that is recharged through the skin.
The Food and Drug Administration has given five medical centers approval to implant a handful of the AbioCor products in people with severe heart problems who are believed to have less than 30 days to live and are ineligible for heart transplants.
The Louisville patient has not been able to walk after his operation but can sit in a chair, the doctors reported Monday. He has been exercising while in bed using light weights or by gripping a ball.
After a brief period breathing on his own, the patient now is breathing with the help of a ventilator.
"Breathing takes about 20% of the energy of the body," Gray said. "He's just not strong enough at this time to breathe on his own."
"He's been able to maintain a very positive outlook," Dowling added. Gray and Dowling also noted that there is no sign of an infection in the patient and that his liver is working well. His kidney function, very poor at the time of surgery, worsened for a while but now has improved to what it was six months to a year before he received the implant.
The patient, however, has several complications, including fluid in his lungs, minor bleeding and some fluid buildup at the site where the battery pack was implanted, which has had to be drained with a tube.
One of the main concerns with this kind of device is abnormal blood clotting that could cause strokes, according to UCLA's Moriguchi. However, animal studies have been encouraging. Researchers have implanted the two-pound device into calves and pigs and found that the implants performed well and showed very few signs of clots. One reason could be that the AbioCor product's interior is smooth and seamless, Moriguchi said.
Abiomed has been criticized by some bioethicists and doctors for being overly controlling about information about the patient and his progress. Abiomed released a statement Friday defending its actions, which it said were meant to protect the family's privacy and avoid distracting the doctors from their work. Dowling and Gray also defended the policy.
Moriguchi says he understands the frustration. Even though he is a member of a team scheduled to implant an AbioCor artificial heart, "we are receiving information primarily through the media."