Five years is a long time for people who would only live for a few days without the implantation of a new heart. And yet it took so long until the world’s only artificial heart – permitted by Administration in 2006 – was actually implanted by American cardiologists. The operation at UC San Diego Medical Center lasted four-hours, in which the diseased heart of a young man was replaced by the life-saving device, looking reminiscent of something from an earlier Terminator film. It was established that only the high-tech bionic device could save the patient after a virus had brought the man’s original organ to an almost complete standstill.
Just before organ failure
From a medical point of view, the “Total Artificial Heart” is appropriate when, due to an existing heart failure, there is the threat of a collapse of the vital functions of the kidney, liver, intestine, lung or brain. “The patients therefore face a soon-to-happen organ failure, but the damage is still reversible,” explains Jack Copeland, director of the Center for heart transplantation and mechanical circulatory support at the UC San Diego Health System, as the criteria for the life-saving surgery.
The surgery itself is complex, Copeland however considers it as routine. Already in 1985 he successfully accomplished the world’s first bypass using an external artificial heart until transplantation. Since 2004 he has in turn performed, on 100 occasions, further operations with newer devices. Yet, the operations have always been regarded as the exception, not the rule, in the fight against the effects of heart failure. Since San Diego, according to Copeland, that might just change.
This “new reality“ comes in what is, from a technical perspective, a simple form. Sometime after the beginning of the operation, Copeland starts with the removal of the dying heart, and joins the new device to the upper chambers of the heart. What happens then fascinates medical practitioners: After switching off the heart-lung machine, the “total artificial heart” starts to pump blood. Eight litres per minute is enough to do the job of bringing the “elixir of life” to the rest of the patient’s ailing organs and “bringing life back to them,” as Copeland describes.
Unlike previous artificial hearts, which in the form of external and usually monstrous machinery act as a bridge in time until normal transplant, the U.S. artificial heart has a crucial advantage: it is fully implantable, and protects the patient from a “metabolic catastrophe“, as Copeland underlines. However, the device is not a panacea. The pump effect seems to only help young people. People suffering from other illnesses or are in a weakened state have little chance of getting an implantation of the artificial heart. In addition there are serious risks, such as blood clotting and slow healing in the chest tissues.
Everyday clinical practice rather than an exceptional operation
Despite these obstacles, what constitutes the possible emergence of a new era in heart medicine is not the device itself. The FDA decided in 2006 in favour of the world’s first approval of it, within the framework of the existing 1990 Humanitarian Use Device (HUD) Scheme. Underlying this is the idea to make complex medical technology products for rare diseases available to the market. Inclusion in the HUD program is only allowed to those manufacturers whose target patient group is not greater than 4000 people per year. For a long time, the easier marketing approval was regarded as an extension of the Orphan Drug Regulations. The operation in San Diego indicates, however, that the so-called “artificial heart” is not so rarely required at all. Each year, more than 5 million Americans are diagnosed with cardiac defects, 2,500 U.S. citizens get a donor organ. The original FDA approval primarily aimed at patients as a target group who, despite the artificial organ, still only had just months to live. The artificial heart, as was considered by the authority, would improve the life quality of their remaining time – nothing more.
Copeland however wants to prevent death finding its way to his young patients by means of a trick. The observed rapid regeneration of his charges lets the cardiologist have hope, that the fully implantable hearts can in the future be used as reinsurance to life. About 80 percent of his patients have a good chance of getting a human heart transplant within six months, virtually all are statistically-speaking provided with a donor organ within twelve months. This time period is handled with ease by the machine inside the chest cavity, as indicated by the 1,100-day record. After that, a human original then beats away.