Washington (AFP) — An artificial heart may help patients survive while awaiting a heart transplant, although the devices remain risky 10 years after they were approved, according to a U.S. study Thursday.
Researchers followed 22 patients with end-stage heart failure over the course of two months to see how they responded to implantation with a Syncardia total artificial heart, the only such device that is approved by the U.S. Food and Drug Administration.
By the end of the 60 day period, five of the patients had died, said the research presented at the American College of Cardiology conference in Washington.
Among the rest, four had undergone successful heart transplants and 13 were alive and awaiting donor hearts.
“We were pleased to see how well many of these patients did,” said lead author Swaminatha Gurudevan, a cardiologist at Cedars-Sinai Heart Institute, where the study was carried out from 2012 to 2013.
“Given how sick these patients were, we expected to see higher mortality rates.”
The deaths in the study tended to be among patients who were sickest before the procedure.
The artificial heart used in the study was FDA approved in 2004 but is not widely used.
It requires complex surgery for implantation, for which only a few health care centers are certified.
Risks include blood clots, bleeding, infections and device malfunctions.
The device attaches to the patient’s upper heart chambers and pumps blood through its mechanical valves.
The artificial heart is connected to a power source outside the body that can be carried in a backpack.
If the artificial heart were to be considered for longer-term use, more research would be needed to create easier ways to recharge the external battery, or have a backup power option to decrease the risk of device failure, researchers said.
Some 50,000 people worldwide are candidates for heart transplants, though just 5,000 of these operations take place each year.
A French biomedical firm, Carmat, is in the process of developing an artificial heart that could be used for longer periods of time.
Its first trial of the device on a 76-year-old man ended March 2 with the patient’s death after two and a half months.
Copyright 2014 The National Memo