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THE TOTAL ARTIFICAL HEART: AN ETHICAL DILEMMA
Marade Bergen (mcb97@pitt.edu)
AN ENGINEER FACES AN ETHICAL
DILEMMA
As the director of engineering research at SynCardia
Systems Incorporated, I am closely involved with the research
and development of one of our most innovative products, the
CardioWest Total Artificial Heart (TAH). The total artificial
heart is a medical device that could eventually replace heart
transplantations as the main cure of heart failure. It has been
brought to my attention that the release of an article entitled
“Implant Ethics” by the Journal of Medical Ethics has
prompted the media to question the use of the CardioWest
Total Artificial Heart [1]. The media, through the release of
numerous newscasts and print articles, is questioning the
quality of life of a patient post implantation, and the costbenefit ratio of the device. The headlining newscast titled
“CardioWest TAH: The Solution or the Heart of the
Problem?” presented the claim that while the technology may
one day be beneficial, it is far too expensive for the average
patient to afford. It is proposed that maximum public benefit
would be obtained if biotech companies funneled some of the
money and resources away from the research and
development of “last resort” technologies, and instead invest
time and energy into preventative medicines.
SynCardia Systems Incorporated appreciates the points
made questioning the CardioWest Total Artificial Heart and
acts upon the opposition. I was asked by my supervisor to reevaluate the ethical dilemmas associated with this new
technology, in order to determine if continuing research as
normal is ethically supported. If the ethical evaluation
supports any of the points raised by the released newscasts, it
is my responsibility to determine the changes SynCardia
Systems needs to make to ensure that operations uphold the
highest degree of ethical integrity and honor. The National
Society for Professional Engineer’s Code of Ethics for
Engineers, the Biomedical Engineering Society’s Code of
Ethics, and various other resources will guide me in making
this ethical evaluation and will allow me to come to a
conclusion that will result in maximum public benefit.
THE CARDIOWEST TOTAL ARTIFICAL
HEART
Congestive Heart Failure occurs when the heart cannot
pump a sufficient amount of blood to the body. In the United
States, an estimated 5.1 million people suffer from this
disease [2]. Though the CardioWest artificial heart is
currently used as a last resort, meaning that it is only an option
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for those who have not benefited from any other medicine or
therapy (except for heart transplantation), it is an innovation
that has the potential to one day surpass heart transplants as
the main cure to Congestive Heart Failure.
The CardioWest TAH is a biventricular orthotropic pump
that replaces the lower chambers of the heart (known as the
ventricles) [3]. These artificial ventricles have both inflow
and outflow values and function like an actual heart. The TAH
is also equipped with two blood contacting diaphragms that
collect blood. By controlling the pressure within each
diaphragm, the bioengineers of SynCardia Systems have
created a flow system in which the outflow cuff can eject
blood at nearly 70 mL per beat (9.5 liters per minute in each
ventricle), therefore pumping enough blood to service the
entire body [3]. A driveline wire exists the body and connects
the artificial heart to the external console source (which
consists of a mechanism for battery recharge and a computer
system that allows doctors to monitor the functioning of the
TAH) [3].
During a ten year clinical trial, 65 % of recipients were
out of bed five days after the implantation of the device [4].
Within two weeks of the implantation, 60% of patients were
walking over one hundred feet [3]. While the device has
proven successful, the TAH is currently a “bridge
technology”: a temporary device that serves to increase the
amount of time that a patient can wait for a heart transplant
[3]. The TAH has the ability to keep a patient alive for far
longer than the average transplant waiting period (4-6
months), as the record for keeping a patient alive by means of
the TAH is four years. As of April 2014, 1,300 CardioWest
Total Artificial Hearts have been implanted, and SynCardia
Systems is on track to set a record of 161 implants in a single
year for 2014 [4]. However, it is the responsibility of the
ethically educated engineer to consider the larger positive and
negative consequences of this technology by adhering to the
engineering Codes of Ethics.
AN ETHICAL EVALUATION
Engineers are required to abide by codes of ethics when
researching and developing technologies that will impact the
public. Canon one of the National Society of Professional
Engineers Code of Ethics states that engineers must “hold
paramount the safety, health and welfare of the public” [5].
The CardioWest Total Artificial Heart benefits the health and
welfare of the public not only by increasing life expectancy
of patients with end stage Congestive Heart Failure, but also
by bridging the gap between the time spent on the organ
transplant list and the actual transplantation. Therefore, it is
imperative to note that the Total Artificial Heart helps resolve
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some of the ethical debates involving the ranking system of
the organ transplantation list. Increasing the amount of time
patients can wait on the list optimizes the number of people
can be saved through the combined efforts of the Organ
Transplantation and Procurement Network and of the
researchers at SynCardia Systems. Continuing research would
be beneficial for society’s health and welfare because,
according to Stephen Miles, professor of Medicine and
Bioethics at the University of Minnesota, “our society
encourages scientific innovation for problems like premature
death from presenescent heart failure”. [6] Advances in last
resort technologies are generally well funded and well
received by the public. Both this support and the
overwhelming shortage of hearts for transplantation act as
catalysts to the research of the TAH, a device who’s
application is supported by canon one of the NSPE Code of
Ethics for Engineers (to hold paramount the safety, health and
welfare of the public) [5].
in 2011 allowed for the discharge of patients from the hospital
while awaiting transplantation and greatly increased patient’s
quality of life, according to both the definition provided by
the CDC and by a professional in the field (Judith P. Swazey)
[10]. While the development of this device was a huge
improvement in the application of the TAH, it is the job of
engineers to continue research until the product reaches a
level of optimal public benefit. SynCardia Systems will
continue to make improvements in its products in order to
increase the quality of life of the recipients and uphold canon
one of the National Society for Professional Engineers.
COST EFFECTIVE ANALYSIS CONCERNS
Cost effectiveness is of great importance in determining
the ethics of a particular technology/innovation. According to
the Biomedical Engineering Society Code of Ethics,
engineers must consider the larger consequences of their work
in regard to cost, availability, and deliverability of health
care” [11]. The current cost of the CardioWest Total Artificial
Heart ranges from $190,000 to $220,000, which is
comparable the cost of a normal heart transplant [4]. This
means that the average recipient of a total artificial heart ends
up paying a total of about $410,000 for both the TAH and the
following heart transplantation. The ethical questions raised
regarding this technology and many of its kind focus on the
cost-benefit ratio both on an individual level and within the
larger context of the field. On an individual level, the cost of
the Total Artificial Heart is something that not many
individuals can realistically afford [12]. Paying for a Total
Artificial Heart, which may be the only option for patients
who are not candidates for heart transplantation, puts an
enormous burden on the family of the patient. The researchers
and developers at SynCardia Systems recognize this ethical
issue and are continuing to develop new artificial hearts made
of less expensive, equally efficient materials. Cutting funding
for researchers could severely restrict their ability to develop
products that can be available to the public at a cheaper price.
Therefore continuing research would be more beneficial to
the public as it could make the technology a more affordable
and realistic treatment option.
The cost-effective analysis must proceed with an
evaluation of the impact of the technology to society as a
whole. The media has put forth the following question: Is it
ethical to spend millions of dollars a year on the research and
development of a product that temporarily benefits roughly
140 people per year, as compared to the 5,000 heart
transplants that occur annually? [13]. It is suggested that
artificial replacements are taking the focus away from
preventative medicines, prompting a second question: Would
it be more beneficial to a greater percentage of the public to
invest this money not in artificial replacements but in
preventative medicines, both in the form of therapeutics and
in education for the public about the dangers of Congestive
Heart Failure? To evaluate this claim, I must begin by stating
the idea that artificial organs are taking away from
QUALITY OF LIFE CONCERNS
The educated engineer must respond to any ethical
questions about a technology in an honorable manner (canon
six of the NSPE Code of Ethics states that engineers must
“conduct themselves honorably, responsibly, ethically, and
lawfully”) [5]. One main ethical question about the
CardioWest TAH that the media has raised public awareness
of concerns the quality of life of patients after implantation.
The Centers for Disease Control and Prevention defines
“quality of life” as “a broad multidimensional concept that
usually includes subjective evaluations of both positive and
negative aspects of life, including the physical and mental
health, risks and conditions, functional status, social support
and socioeconomic status” [7]. Judith P. Swazey of the
Scientific Research Society explains that our ideas about what
it means to be human are closely related to “our capacity to
interact with others.” Therefore, impairments in an
individual’s ability to communicate, think, or function
physically threatens our sense of humanity, and raises
concerns regarding quality of life [8].
Quality of life issues are very much a concern to
engineers and medical professionals everywhere. Myself and
my colleagues at SynCardia Systems strive to deliver
products that will continually increase the recipient’s quality
of life. The company has proven its dedication to such
concerns. For example, prior to 2010, the TAH required the
recipient to be connected to an external power console known
as the “Big Blue”. This 400 pound charging/monitoring
system restricted TAH recipients to the hospital while waiting
for a transplantation [9]. Professionals within the company
recognized that the need for an external power source severely
limited patients’ independence and therefore decreased their
quality of life. The team at SynCardia Systems conducted a
clinical trial in which 90 U.S. patients used a Freedom
Wearable Driver [10]. This new device acted as a portable
charger for the TAH. The introduction of the Freedom Driver
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preventative medicines is misguided. Like many companies
of its kind, the research at SynCardia Systems is privately
funded, meaning the company has no obligation to invest in
preventative medicines. Unfortunately, as Dr. Gary C.
Augustin explained in an article entitled “Ethical Issues
Related to the Artificial Heart”, preventative health care has
been swept to the side, as the [United States] proves unwilling
to invest in preventive care and instead chooses to focus on
innovations related to curing end stage diseases [14]. Dr.
Augustin continues to include that from an ethical standpoint,
“it is hardly justifiable for an all-out effort for the use of the
artificial heart when many people in the [United States] are
without any form of health care…and cannot afford it”. [14]
This situation creates a dilemma for engineers who are
committed to and inspired by the work of a specific company,
but also recognize that the very root of the problem is not
being addressed. While from a financial perspective, biotech
companies benefit from the sickness of the public,
professionals in the fields of medicine and engineering must
remember that the Code of Ethics requires that they benefit
the health of the public first and foremost [5]. Of most benefit
to the public is the decision to distribute resources (engineers
and funding) in such a way that invests in both preventative
medicines and artificial replacements.
of this technology in a manner that focused both on the
individual and on society as a whole.
CONCLUSION AND IMPACT
These reference materials have allowed me to conclude
that the CardioWest Total Artificial Heart, with continued
research and development, will benefit a great number of
individuals in society and could eventually provide a long
term solution to one of the greatest dangers facing the
population (Congestive Heart Failure). SynCardia Systems
has proven itself as an ethically inclined company by
continuing work to increase the quality of life of patients
receiving a TAH, therefore holding paramount the welfare of
the public. Continued research will lead to the development
of TAH’s made of less expensive material, therefore
decreasing the cost burden on society. By this reasoning,
research on the total artificial heart must be continued.
However, I have found that it is of ethical importance for the
company to invest some time and money into preventative
medicines as well. While this action is not beneficial in terms
of business, engineers and researchers must consider the
health and safety of the public first. This is the one ethical
question raised by the media that I feel has a great deal of
merit.
Upon learning of my evaluation, the CEO of the company
will redistribute a portion of the company’s research funding
to a team that will specialize in preventative therapies for
Congestive Heart Failure. While researchers working on the
CardioWest TAH will not be pleased with the request to
deliver the same quality of research with a smaller amount of
funding, I know that I have done what is ethically correct in
making this decision. Society will be positively impacted both
by the continuing development of the TAH, as well as by the
increasing investment in preventative medicines. The future
promises to deliver a TAH that is more efficient, affordable
and effective. It is my responsibility to report this ethical
evaluation to SynCardia Systems Incorporated with the hope
of continuing the research and development of the
CardioWest Total Artificial Heart in a manner that holds true
all of the canons in the engineering Codes of Ethics.
DISCUISSION OF RESOURCES
I was asked by my supervisor to evaluate the ethics of the
CardioWest Total Artificial Heart in order to address two
ethical concerns that have been gaining public attention. In
order to proceed with this evaluation, I reflected on the points
raised against the TAH and responded in a manner that upheld
the integrity of the engineering profession (canon six of the
NSPE’s Code of Ethics) [5]. I turned to numerous resources
for information involving the quality of life of patients after
implantation, as well as for information regarding the
individual and societal costs of the device. Previous reports
on the ethics of the Total Artificial Heart played a great role
in this evaluation. The articles entitled “Ethics in
Cardiopulmonary Medicine”, “The Artificial Heart:
Prototypes, Policies and Patients”, “Ethical Issues of the
Artificial Heart” and “The Total Artificial Heart in a Cardiac
Replacement Therapy program” allowed for insight into these
issues through the eyes of other educated professionals within
the field. These articles (ranging from 1986 to 2012),
provided an understanding of which ethical arguments have
changed over time and which are still very relevant to the
field.
Finally, two codes of ethics provided guidelines which
played the most influential role in my ethical evaluation. I
found that canon one of the National Society of Professional
Engineers’ Code of Ethics for Engineers could be applied to
each point questioning the TAH. Similarly, canon two of the
Biomedical Engineering Health Care Obligations (BMES
Code of Ethics) forced me to evaluate the larger consequences
RECOMMENDATIONS TO ENGINEERS
This evaluation has shown me how serious ethical issues
need to be taken. I have learned the value of the different
engineering codes of ethics, as well as the importance of
visiting case studies and listening to opinions of other
professionals in the field when confronted with an ethical
dilemma about a particular technology. When presented with
such a concern, I highly recommended that engineers
approach the challenge by relying on the various resources
available to them. First and foremost, the codes of ethics
provide detailed canons that include what an engineer is and
is not to do in a given situation. In addition to the codes of
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ethics, getting opinions from other professionals in the field
is extremely helpful. While you may not agree with what
other professionals are thinking and feeling, hearing a
different viewpoint often clarifies your own opinion. And
lastly, consider all angles of the dilemma. Consider who you
will be affecting by making a decision and how you will be
affecting them. Consider whether this decision will bring
forth positive or negative change to society, to a
company/organization and to yourself as a professional in the
field of engineering.
beyond-the-basics#H11
[14] G. C. Augustin. (1986). “Ethical issues related to the
artificial heart”. Journal of Religion and Health. (Print
Article). Vol. 25, no. 3. pp. 177-187
ADDITIONAL SOURCES
“Ethics Cases”. (2014). Texas Tech University. (Website).
http://www.depts.ttu.edu/murdoughcenter/products/cases.ph
p
REFERENCES
“Ethics Cases in Biodesign”. (2014). Standford Biodesign.
(Website).
http://biodesign.stanford.edu/bdn/resources/ethicscases.jsp
[1] S.O. Hansson. (2005). “Implant ethics”. Journal of
Medical Ethics. (Print Article). Vol. 31, no 9. pp. 519-529
[2] Go, S. Alan, Mozaffarian D, Roger VL, Benjamin EJ,
Berry JD, et al. (2013) “AHA statistical update: heart disease
and stroke statistics”. American Heart Association. (Online
Article).
[3] M. J. Slepian, R. G. Smith, J. G, Copeland et al. (2005).
“The SynCardia CardioWest total artificial heart”. SynCardia
Systems
Inc.
(Online
Article).
[4] “Total artificial heart facts”. (2014). SynCardia Systems
Inc. (Website). http://www.syncardia.com/total-facts/totalartificial-heart-facts.html
[5] “NSPE code of ethics for engineers”. (2007). National
Society for Professional Engineers.
(Online Article)
http://www.nspe.org/Ethics/CodeofEthics/index.html
[6] S. H. Miles, et al. (1988). “The total artificial heart: an
ethics perpective on current clinical research and
deployment”. Ethics in Cardiopulmonary Medicine CHEST.
(Print Article). Vol. 92, no. 1. pp. 409-413
[7] “Health related quality of life”. (2014) Centers for
Disease
Control
and
Prevention.
(Website).
http://www.cdc.gov/hrqol/concept.htm
[8] J. P. Swazey. (1987). “Views: ethical issues of artificial
and transplanted organs”. American Scientist. (Print Article).
Vol.
75,
n/a,
pp.
192-196
[9] “The total artificial heart in a cardiac replacement therapy
programme”. (2013). SynCardia Systems Inc. (Online
Article). http://www.syncardia.com/PDF_Files/BJHM.pdf
[10] TexasChildrensVideo. (2011). “Texas children’s
hospital discharges first total artificial heart to wait for donor
heart at home”. Youtube.com (Uploaded video).
https://www.youtube.com/watch?v=DCB0M5JwOgU
[11] “Biomedical engineering society code of ethics”. (2004)
Biomedical Engineering Society. (Online Article)
http://www.bmes.org/aws/BMES/pt/sp/ethics
[12] OschnerHealth. (2012). “Alfed’s Story: Total Artifical
Heart Recipient”. Youtube.com (Uploaded video).
https://www.youtube.com/watch?v=DCB0M5JwOgU
[13] H. J. Eisen. (2014). “Heart transplantation (beyond the
basics)”. UpToDate-University of Pittsburgh Medical Center.
(Website).
http://www.uptodate.com/contents/heart-transplantation-
“Ethics Case Studies: Research Intergrity”. (2014).
WebGuru: Guide for Undergraduate Research. (Website).
http://www.webguru.neu.edu/professionalism/researchintegrity/ethics-case-studies
ACKNOWLEDGMENTS
I would like to thank a few individuals for their assistance
and support of this writing assignment. First and foremost, I
extend my gratitude to Nichole Faina, writing instructor at the
University of Pittsburgh. She supported my decision to shift
my topic from Assignment two into a closely related topic that
provided for a more effective essay. She responded swiftly to
any questions that I had on this assignment. My roommate,
Chantelle Farley, also provided a great deal of support for this
project and helped ease the writing process. Lastly, I would
like to thank my friends and family, who have supported me
in all my university assignments thus far, and have
encouraged me to follow my passion for engineering and
medical technologies. Thank you to all.
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