Capstone Context

Posted on May 11, 2015

There is one artificial heart currently in full use; this is the SynCardia artificial heart. Its competitor the AbioCor Implantable Replacement Heart is in the HDE stage of FDA approval. In the Humanitarian Device Exemption or “HDE” stage, only 4,000 patients a year may be treated with the device (“National Medical Policy”). Most artificial hearts are used in a temporary implantation or bridge to transplant that is used to keep a patient alive until a donor heart can be transplanted into them. The other option is a permanent implantation is used to keep a patient alive for the rest of their life without receiving a heart transplant. There is debate over which artificial heart should be used. The main factors in the debate are the success rates of each and the longevity of life that each provides.

An artificial heart is a power-driven pump that is used to substitute a damaged heart temporarily or permanently (Merriam-webster). In a permanent implantation, parts of the heart are taken out to then allow the artificial heart to function permanently because there is not going to be a transplant surgery after the artificial heart surgery. In a temporary implantation, certain parts of the heart are left intact to then allow for a transplant surgery to occur successfully. A heart transplant is a surgery to remove a person’s weakened heart and replace it with a healthy heart of a deceased donor (NHLBI). The problem with a transplant is that there are more people in need of a transplant than hearts available for transplant. There have been many advances in the technologies and techniques of artificial hearts and the ways to implant them. The most recent advancement is self-sustaining artificial heart technology. This new synthetic heart technology allows the patient to be free of having to be connected to an external driver that drives the artificial heart. This breakthrough technology is present in the AbioCor Implantable Replacement Heart but not in the SynCardia artificial heart (“AbioCor”).

This issue effects people with heart disease, especially those in need of a transplant or artificial heart because they are the ones receiving a surgery that could potentially save or end their life. This issue also affects heart surgeons because they are the ones who have to decide which artificial heart to use. When using an artificial heart as a bridge to transplant or “BTT” implantation to lead to a heart transplant has been used more often and has seen much success, which is when a donor heart is available (“barnesjewish”).

The FDA governs the use of the artificial heart. There are certain standards of performance that the artificial heart must possess as well as laws that govern the staff of who may implant the device (“nytimes”). There are also laws that the surgeon and those of the medical staff must follow, these change from state to state, but the code of medical ethics remains the same. This code is set by the American Medical Association. According to UCLA’s statistics on the Syncardia artificial heart used as a bridge to transplant, seventy-five percent of the patients were out of bed in one week. After two weeks, sixty percent of the patients were walking more than one hundred feet and had liver and kidney function to normal or had shown significant improvement (“Syncardia”), Think tanks say that much has been accomplished, but there are still many more advances that need to be made (“Mediatrackers”). The Fifth Commandment and the natural law require that all ordinary means be used to preserve a person’s life. The ordinary means are water, food, exercise, and medical treatment. The church rules that human beings are not morally obligated to undergo all possible medical treatments to save their life (“EWTN”).

A person should be concerned about this issue because if they have heart failure or have a friend or family member that has a failing heart, they will be educated on what can be done to treat this illness. Along with treatment, they will be aware of the success rates that different artificial hearts provide. This issue is on the forefront of public discussion today because new advancements are constantly being made in this field.