After decades of research and plenty of money having been spent, the Food and Drug Administration has approved the country’s first artificial heart that is completely implantable. The device will allow a patient to move around for up to two hours in a row. The FDA gave the Massachusetts-based company a humanitarian exemption, because there are still questions about the safety of the device, but since it offers such a big possibility to those who have little hope left, the company is free to sell up to 4,000 artificial hearts a year.
The device isn’t cheap at $250,000, so for most of us it isn’t a viable option should we need one, but instead represents a step forward in technology. Today we have this device; tomorrow perhaps we’ll see another, better version.
This is a story about scientific intervention in our bodies in one of our most critical body parts. In the study, 14 men had the device implanted from 2001 to 2004. All died a relatively short time later, with the longest survivor making it to 512 days after implantation.
The low survival rates are not really the issue, though, as all patients were near death to begin with. Their hearts could no longer pump blood properly. They were ineligible for a transplant and their life expectancy was only estimated to be a month without the device. This device allows individuals to live longer and be less confined to a bed for their remaining months.
In an operation, a person’s heart is removed and in its place goes the two-pound artificial device. A coil leads outside of the body, where it is plugged in, recharging the device. There is also an internal battery as well as a control that monitors the heart rate, which is implanted in the abdomen. One battery allows the patient to be free from any external connections for one hour; two batteries allows for two hours of freedom. Because of the device’s size, only those with larger chest cavities will be suitable for implantation.
The man who lived for 17 months after having the heart implanted had “ups and downs” according to his wife, but “a lot of ups.” He celebrated their 56th anniversary and he was able to see his first great-grandchild. He survived recovery from the surgery, a hefty fever, an adverse drug reaction, and even pneumonia. He was able to spend 10 months at home that he wouldn’t have otherwise, during which time his family said he lived a “fairly normal” life.
The company’s goal is to give patients 18 to 24 months of life with the device. They are working to make the device smaller by 30% so it’s available to more people. It is one of about 35 companies in the race to develop an artificial heart. Their next goal is to obtain insurance coverage, so those of any financial state can benefit.