SynCardia Artificial Heart

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AbioCor Implantable Replacement Heart

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Posted on,_by_Manuel_Escanciano_and_Charles_Beyrouthy

Capstone Annotated Bibliography

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“AbioCor® Implantable Replacement Heart – H040006.” AbioCor® Implantable Replacement                  Heart – H040006. N.p., n.d. Web. 16 Feb. 2015.

This source presents the AbioCor IRH with a full gamut of information about the device from the FDA. The source is credible because it is from the government, more specifically the FDA. This source is extremely useful because of its vast amount of information. The FDA is the Federal Drug Administration. The audience is those who are interested in the device and have knowledge of this field of subject. This source is very helpful in the amount of information it possesses.

“AbioCor Implantable Replacement Heart – Texas Heart Institute – Heart Assist Devices.”                       AbioCor Implantable Replacement Heart – Texas Heart Institute – Heart Assist Devices.                       N.p., n.d. Web. 16 Feb. 2015.

This source provides additional information of the AbioCor IRH. This is from the Texas Heart Institute, which is a very credible source. The Texas Heart Institute is a research hospital in Houston, Texas that I was given the chance to visit. This source is relevant because it directly involves my topic. The audience is people who have knowledge of this device. There is no bias within the source. This source will be very beneficial to my paper with its information.

“Abiomed.” AbioCor –. N.p., n.d. Web. 13 Apr. 2015.

This source has valuabe information on the AbioCor IRH. This product is a key piece to my paper. This source could be slightly biased because it is the company’s site. This site is very helpful and very useful.

“Artificial Hearts.” The British Medical Journal 1.5449 (1965): 1510. Web.

This source provides current status of artificial hearts. This is credible because it is from the British Medical Journal. This source is very useful with the information it presents. The British Medical Journal is a very popular and accurate source of information for medical topics. The intended audience is leaned toward people who are interested in medicine and are familiar with the terms. This source was very helpful to me because of its up to date information.

“Artificial Hearts, by Manuel Escanciano and Charles Beyrouthy.” OpenWetWare RSS. N.p., n.d. Web. 19 Apr. 2015.

This source provides valid and factual information on many artificial hearts. It is credible because it is from an organization. This source is not bias because it presents factual evidence with no slanted point of view. This source will prove very helpful to me in finding prices of artificial hearts and surgeries.

Cooley, Denton A. 100,000 Hearts: A Surgeon’s Memoir. Austin, TX: Dolph Briscoe Center for            American History, U of Texas at Austin, 2012. Print.

Dr. Cooley wrote this book that tells all about his life. This is a very credible source because a leading pioneer in health care wrote it. This book is relevant because it is an actual surgeon’s account on health care. Dr. Cooley is one of the leading pioneers in health care. The intended audience would be those who are interested in health care or in health care. I feel like this is a great source for me to use in order to get a surgeon’s prospective on health care and artificial heart implantation and use. I have also met and talked with this great man. There is not a biased to the book.

E Right To End-Of-Life Care (Johns Hopkins, and University Press 2002). Physician-Assisted Suicide: Threat to Improved Palliative Care (n.d.): n. pag. Web. 2 May 2015.

This source is from the USCCB, making it credible. I will use this as my theological source. This source presents a study on patient pain that will be very useful to me.

“FDA Approves the SynCardia Total Artificial Heart With SynHall Valves.” – 2014 MultiMedia Releases. N.p., n.d. Web. 13 Apr. 2015.

This source is a timeline of approvals from the FDA. It is not bias because it is a factual timeline. This is a useful source because it keeps track of approvals and has them listed chronologically. I feel that this source is very useful and that it has educated me on up to date affairs.

“Helmet Use Among Motorcyclists Who Died in Crashes and Economic Cost Savings

Associated With State Motorcycle Helmet Laws — United States, 2008–2010.” Centers

for Disease Control and Prevention. Centers for Disease Control and Prevention, 15 June

  1. Web. 15 Apr. 2015.

This site provides me with information to use in my analogy argument, which is my third

Claim. This source is from the CDC so it is credible because this is a government agency.

There is no bias present, just statistical data. This source will be very instrumental in my


Landry, Fr. Roger J. Pope John Paul II’s Theology of the Body (n.d.): n. pag. Web.

This source is cliff notes version of Pope St. John Paul II’s theology of the body. This source is credible because a Priest of the Catholic Church produced it. I plan to use this source as my theological source by relating the heart as not only the physical body but also the spiritual body containing the soul.

“National Medical Policy.” National Medical Policy. N.p., n.d. Web. 16 Feb. 2015.

This source presents information about many policies. This source is credible because it is from the Heath Net. This source contains policies about my topic. The Health Net is an agency that provides policies. The audience is someone informed about medical policy due to the terms used. This source is very helpful with determining policy.

“News Releases.” Abiomed Receives FDA Approval of The AbioCor. N.p., n.d. Web. 16 Feb.                    2015.

This source provides information of the Humanitarian Device Exemption that the FDA gave to AbioCor IRH. This is a credible source because it is from a university. This is relevant because it deals directly with my topic. The University of Louisville is an established university. There is no bias present. The intended audience is someone who is knowledgeable on the subject. This source is very helpful in determining information about the device.

“Organ Transplants and Cloning.” Organ Transplants and Cloning. N.p., n.d. Web. 16 Feb.                     2015.

This source presents teachings of the Catholic Church over organ transplants. This is credible because it is from the teachings of the Catholic Church. This is relevant because my topic deals with organ transplant. The Catholic Church is a major religious faith. The intended audience is people wanting to know more of the Catholic Church’s teaching. This source helped me to find the Church’s teaching on my topic but could be biased toward the church.

“Organ Transplantation: The Process.” N.p., n.d. Web. 19 Apr. 2015.

This source contains information about a heart transplant. It is credible because it is from an organization. It does not contain bias because it is a factual piece of information that is not arguing or pushing the side of an issue. This source will be very helpful to me in writing my claims.

“Patient Information: Heart Transplantation (Beyond the Basics).” Heart Transplantation. N.p.,

n.d. Web. 15 Apr. 2015.

This source provides up to date information concerning heart transplantations.

It has many valuable facts that will be useful in my paper. This source is credible because the information comes from the Heart and Lung Transplantation Society. I do not detect any bias because this source is primarily facts. I will use this source to keep up to date information within my paper.

“Patient Story.” Jim Hennigan. N.p., n.d. Web. 21 Apr. 2015.

This source provides a patient story. Jim Hennigan is a patient that was given a SynCardia artificial heart after his first heart transplant failed. His artificial heart was used as a bridge to transplant for his second heart transplant. This source is credible because it is from SynCardia. It could have some bias because SynCardia could use it as marketing to promote its product. This source will be very helpful to me in adding a real life patient story into my claim.

“Result Filters.” National Center for Biotechnology Information. U.S. National Library of              Medicine, n.d. Web. 16 Feb. 2015.

This source presents information about the AbioCor IRH. It has information about trials and statics of the device. This is a credible source from a national center. This is relevant because it directly deals with my topic. The national center studies biotechnology information. This source is very helpful in learning more about this device.

Capstone Conclusion

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Artificial hearts are an essential technology to have in a time when no other option is available to save a patient’s life. It is imperative that this technology is used wisely to avoid abuse and also to keep cost in check. The need for this technology is increasing as the population ages and more people develop heart problems. In the words of Dr. Neelan Doolabh, a highly distinguished and accomplished heart surgeon, “FDA approval is required for the safe use and protection of liabilities for patients.” With an increase in need for artificial heart technology, the FDA should approve the AbioCor Implantable Replacement Heart system for use outside of the investigational setting. This would give patients and doctors an option between the AbioCor and the SynCardia artificial hearts. Further more, competition would develop between the two man-made devices that are designed to replicate God’s divine work. In addition, competition will force the two companies to keep improving their products in a struggle to produce the product that patients and doctors prefer, resulting in continuous enhancement to both devices. This will also keep a monopoly from developing, which will keep the prices in check and give patients an option for which device will accommodate life support measures for sustaining a quality of life that allows happiness to both patient and family.

Capstone Claim 5

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When determining the correct artificial heart to treat a patient with chest cavity size, quality of life, and preference of patient must be taken into effect within the doctor to patient consultation. With today’s laws in place, doctors and patients are very restricted in their choice of artificial heart. If the AbioCor Implantable Replacement Heart were given full use access by the FDA, then there would be greater option for both doctor and patient when determining the proper artificial heart to use as treatment.

Chest cavity size is a major factor in determining the proper artificial heart to surgically insert into the patient’s body. Placing a synthetic heart into the chest cavity of a patient that is larger than the space that God allotted within the patient’s chest will cause severe pain to the patient. A study published by the USCCB states that “Higher levels of pain have profound effects on seriously ill patients”(“End-of-Life”). A patient that needs an artificial heart is a seriously ill patient. Physicians do not want to cause harmful effects on their patients by overfilling the chest cavity of their patient.

Surgery can often times effect the quality of life for a patient, especially when a surgery requires that the patient’s heart be removed from their body. Quality of life is an important aspect in a patient’s life that physicians want to avoid taking away through surgery. The current artificial heart in full time use, the SynCardia, requires driver wires to protrude from the patient’s body that connect to the bulky driver that the patient must keep within close proximity to themselves. This requirement will decrease a patient’s quality of life. However this depriving of quality of life can be avoided with the AbioCor Implantable Replacement Heart. This artificial heart works through a wireless driver, allowing the patient to be free from the bondage of being connected to a bulky driver (“AbioMed”).

Presently, the options presented to a patient regarding artificial hearts are very limited. Unless the patient is one of the lucky 4,000 a year that are privileged to receive the AbioCor replication of God’s created organ, the only option for most is the SynCardia replication of a God made organ. This fault in medical care leaves patients with a miniscule option for preference. However, if the man made AbioCor heart were granted full use by the FDA, all patients would have an option to choose their manufactured heart.

By granting the AbioCor Implantable replacement Heart full use, the options for doctor and patient when determining the proper artificial heart to use would increase. In fact the options would double by adding a whole other full use artificial heart option into the equation. In order to increase the doctor and patient options for artificial heart implantation, the FDA should approve the AbioCor Implantable Replacement Heart system for use outside of the investigational setting.

Capstone Claim 4

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Artificial heart implantation surgeries are very expensive. The artificial heart alone makes up a large portion of the total cost of the surgery. With a less expensive artificial heart more patients would be able to afford the cost of the surgery, therefore more lives would be saved.

The cost of the SynCardia artificial heart is $125,000. This makes the average cost of surgery $350,000 to $400,000 (“Artificial”). This is the only option in cost for all patients other than the lucky 4,000 that are able to receive the AbioCor artificial heart. This self-sustaining AbioCor artificial heart gives patients greater comfort made and cost $75,000 to $100,000, which is significantly cheaper not only to the patient but also to the hospital to purchase. With this wirelessly charging artificial heart, the cost of surgery is decreased to an average of $350,000 (“Artificial”). This decrease in price allows for more patients to be able to afford an already extremely expensive surgery. With more patients having financial access to the surgery, more lives would be saved as more patients receive the surgery.

Being self-sustaining is a major factor in the price difference between the two synthetic hearts. With the AbioCor artificial heart, the patient only has to wear a battery pack belt that holds the wireless battery that links to the receiver inside of the patient’s body. However, in the case of the SynCardia artificial heart, the patient is wired to a 418-pound driver through wires piercing their skin that is only located in hospitals. This adds to the patient’s bill because the patient is using hospital equipment. For a patient to be able to move around outside of the hospital, the patient must purchase a Freedom Portable Driver that weighs thirteen and a half pounds and can be worn as a backpack (“Artificial”). However the Freedom Portable Driver has not yet been FDA approved, making it rare for a patient to be able to attain one of these devices. This is a highly unnecessary purchase when a patient can be given an AbioCor artificial heart that is cheaper than its competitor.

A patient that received a SynCardia artificial heart, Jim Hennigan, released a story about his experience with the SynCardia. In his story Jim said “I…pushed my 450-lb driver around the hospital.” He later went on to say, “It was sort of like a hotel stay that I couldn’t leave,” (“Patient Story”). If Jim were to have been given the AbioCor artificial heart, he would have been able to avoid pushing around the “450-lb driver” with him through the hospital. He would have also been able to leave his “hotel stay,” meaning the hospital.

The AbioCor artificial heart is the cheaper option for patients to receive. This cheaper option also allows for greater patient comfort. Furthermore, by only using a wireless battery, the patient is granted more freedom by not being hooked up to an external driver. For this patient advantage to be possible for more than 4,000 patients a year, the AbioCor artificial heart must be taken out of the investigational setting.