Artificial hearts have been a source of ethical problems ever since the first artificial heart was given to Dr. Barney Clark in 1982 [1]. It has raised questions about the cost of the device and issues with who should have access to the technology. These problems can affect a single individual or they might affect a major segment of the population. This paper will look at two of the ethical dilemmas that have are relevant to its continued used in our society.

The AbioCor Implantable Replacement Heart was the first Totally Implantable Artificial Heart (TIAH) approved by the Food and Drug Administration (FDA) for use in patients that have less than a month to live and who are not eligible to receive a replacement heart [3]. This classification means that the heart will be applicable to less than 4,000 people a year because this is still an experimental treatment and hasn’t been shown to be a cure for the diseases and only extend the life of the recipient for several months [3]. The TIAH completely replaces the heart of the recipient and because of this it is not reversible and the only viable long term solution is a heart transplant [2].

A requirement of a TIAH is that it be able to operate without external connections of any kind. The AbioCor system is comprised of an artificial heart with two chambers that a hydraulic pump alternatively fills while emptying the other, a controller/power pack that is implanted into the patients chest cavity, and a transfer coil to recharge the internal battery using an external source [2]. The internal battery allows for the patient to be completely free of any external system for 1 hour and included with the system are two batteries that each allow the system to run for up to two hours [3]. The system can be plugged into an electrical outlet when the patient is asleep or when the batteries need to be charged [3].

The Cost

The major ethical dilemma of the TIAH is related to the cost of the unit and its installation. The device itself costs $75,000 but is expected to drop down to $25,000 after the volume of the demand for the device has increased [1]. While the cost of the device itself is quite high it is ultimately dwarfed by the cost of the surgery and the resulting hospital stay. This cost is expected to be around $200,000 but will vary based on complications that may occur due to infections and rehabilitation [1]. Every year, more than 700,000 patients die due to heart failure in the United States but only 2,000 donor hearts become available every year resulting in a 698,000 patient deficit [4]. Assuming that only 350,000 are eligible for or want a TIAH at a mean cost of $200,000 the total cost to the health system of the United States will be $70 billion a year.

Most of the patients receiving a totally implantable heart fall into a very well defined category. They will need to be individuals that have a large chest cavity that will allow for the device to be easily implanted [2]. This generally rules out children and most women due to their small size. Because the patient’s biological heart must be completely removed only patients that have “severe biventricular failure; elevated, fixed pulmonary vascular resistance; resectable malignant cardiac tumors; or massive cardiac necrosis after a myocardial infarction” [2] should be considered for this procedure. These afflictions are all problems that will cause a patient to die without a replacement heart. Currently, the patient will have to have insurance that is willing to pay for the replacement or the available cash to pay the bills [1]. This rules out patients that are uninsured or underinsured which has been shown to be unevenly distributed among minor groups [1]. Hispanic Americans usually suffer from a lack of insurance and don’t have access to medical care on a regular basis [1].

Overall the ethical dilemma is this: spend $270,000 to allow a patient to live a few months longer or society could use this money to implement and support programs, employers, and organizations that could cure diseases or provide jobs for productive members of our society. There are lots of facts on either side of the argument that should be addressed. The argument that another person’s life is in the balance is an argument for the pro side that is hard to overlook. The person’s family is most likely willing to spend the money to purchase the heart and have it implanted into the patient to give them more time to be with their loved one. As with any medical procedure as it is performed on more patients over time the cost and recovery time will decrease to the point where it could be more affordable to more people. Also, as more research is put into the TIAH it is possible that the mean time that patients are able to stay alive could increase. The cost is the biggest con to the concept of replacing someone’s heart with a TIAH. The money that is used for the patients transplant could be used for other things that could benefit more than a small group of individuals such as immunizations for small children or WIC type social programs that feed mothers and their young children.

The section of the IEEE code of ethics that relates most to this dilemma is number 1 “to accept responsibility in making decisions consistent with the safety, health, and welfare of the public, and to disclose promptly factors that might endanger the public or environment”. The section that is important is accepting the responsibility of making decisions consistent with the welfare of the public. Because of the large cost associated with the installation of the TIAH the welfare of other members of the public is affected because of this loss of money for other programs. This is an issue that should be left for the businesses and politicians to decide because the problem could affect a broad portion of the population in the future which will shape the budget of the government and institutions that provide insurance for the people who will receive the TIAH.

Access

The other major dilemma is based on how disproportionate access to the device is. This can be looked at as the option of allowing only those who can pay for the device to have it installed or having a government program to allow for people who have little or no insurance to have the device implanted for a price their family is willing to pay. This problem has severe ethical implications involved with it and once again boils down to the fact that this technology has a high price tag associated with it. It is estimated that the number of Americans without insurance is 38.7 million that will be unable to have access to technology like this [1]. Another option is to give the technology to people who need it and will benefit from the health that technologies like the TIAH will bring [1]. Lifestyle is the other factor that needs to be brought into deciding who gets access to this technology [1]. For people who are later in life the afflictions that may require the use of a TIAH could be caused by lifestyle choices that exacerbated their problem. The severity of these diseases can be reduced if not prevented if behavioral modifications can be made [1].

The section of the IEEE code ethics that relates most to this dilemma is number eight. This states that an engineer should “treat fairly all persons regardless of such factors as race, religion, gender, disability, age, or national origin”. This is the key point to this dilemma because of the fact that race, disability and age are all contributing factors to people needing a TIAH but not having the possibility of being able to pay for the technology involved with these devices. It doesn’t seem like there is an easy way to reduce the cost because the device needs to be have the highest quality because it will keep a human being alive. This is a dilemma that needs to be solved by the politicians and businesses because an engineer has no control over who will have access to technologies that while expensive could provide a longer life for members of our society.

Conclusion

In conclusion, there are major ethical dilemmas that must be answered before the totally implantable artificial heart can be used in large quantities. This problems must be solved in our political systems because they involve problems that are really larger than the ethical dilemmas that are involved in just the TIAH. The issue of money and access to insurance will surely be the deciding factor for widespread adoption of this technology to give patients with heart failure more time with their family and maybe in the future a replacement heart can be created that will allow a patient to live out the rest of their lives.

References

1. Rothstein MA, Anderlik MR: The AbioCor Artificial Replacement Heart: Bioengineering Meets Bioethics. Journal of Cardiothoracic and Vascular Anesthesia Vol 16, Issue 2, pp 239-239.
2. Nemeh, HW, Smedira NG: Mechanical Treatment of Heart Failure: The growing role of LVADs and Artificial Hearts. Cleveland Clinic Journal of Medicine Vol 70 Number 3 pp 223-233.
3. FDA (September 5, 2006). FDA News. Retrieved 2007-10-07. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01443.html
4. Rowland, Rhonda. “Patient Gets First Totally Implanted Artificial Heart”. cnn.com Retrived 2007-10-07. http://cnn.health.printthis.clickability.com/pt/cpt?action=cpt&title=CNN.com+-+Patient+gets+first+totally+implanted+artificial+heart+-+July+3%2C+2001&expire=-1&urlID=11931766&fb=Y&url=http%3A%2F%2Farchives.cnn.com%2F2001%2FHEALTH%2Fconditions%2F07%2F03%2Fartificial.heart%2F&partnerID=2012