Capstone Claim 3

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A test rate is the actual number of outcomes. In the realm of artificial hearts, the outcomes are either life or death. A success rate is the percentage of success that occurred. In other words, it is the number of successes divided by the number of deaths. It is important to look at not only the number of successes but also the success rate. This is because the success rate is expected to stay true as more patients are added into the equation.

Even though the SynCardia artificial heart has been tested on more patients, giving more successes, the AbioCor artificial heart possesses a quality that the SynCardia severely lacks, this is a success rate of 86%. The SynCardia artificial heart possesses a success rate of 79%(“National Medical Policy”). This is a difference of 7%. Seven percent may not seem like much to some but when it comes to life and death, this is 7% more of the patients living by simply allowing the patient to be implanted with a AbioCor artificial heart, instead of a SynCardia artificial heart.

The AbioCor artificial heart is unfortunately only in the Humanitarian Device Exemption or “HDE” stage of approval. In this stage, only 4,000 patients may be treated with the AbioCor artificial heart each year (“National Medical Policy”). There is an average of 50,000 people needing a heart transplant, however only 5,000 heart transplants occur each year. This vast difference between the demand and the outcome is due to the shortage in supply of donor hearts (“Patient Information”). This leaves an average of 45,000 patients who could use an artificial heart to save their life. However, only about 35 artificial heart implantations occur each year (“SynCardia”). By using the AbioCor artificial heart instead of the SynCardia artificial heart, three more patients’ lives would be saved. This is an enormous difference in life or death from just switching the variable of the type of artificial heart being used. Not only does this effect the patient but also the patient’s family by keeping their cherished family member in this world. In order to save these lives, the AbioCor artificial heart system must be taken out of the investigational setting and put into full operation.

Analogous to the artificial heart, a one variable change that supports drastic differences can be seen in helmet laws for motorcyclists. Some states have enacted helmet laws that require motorcyclists to wear a helmet when riding. The three types of this law are a universal helmet law that requires riders to wear a helmet, a partial helmet law that require a certain group of riders to wear a helmet, such as young riders, the final is no helmet law within a state, this allows riders to ride without a helmet (“Helmet Use”).

The CDC examined National Highway Traffic Safety Administration or “NHTSA” data from the Fatality Analysis Reporting System or “FARS” to produce statistical data on the correlation between states’ helmet laws and fatality of motorcyclists. The data shows that states with a universal helmet law had a 12% fatality rate, states with partial helmet laws had a 64% fatality rate and states with no helmet law had a 79% fatality rate (“Helmet Use”). If all states switched to a universal helmet law, each state would drastically increase the amount of lives saved by simply requiring motorcyclists to wear a helmet.

This compares to artificial hearts because by changing one variable, many lives would be saved. For artificial hearts, switching to the AbioCor artificial heart would save lives that are being lost. For motorcyclists, states switching to universal helmet laws would save lives that are being lost. The difference between these two is that it is easier for a state to enact a law changing the helmet laws within that particular state, than it is for an artificial heart to be taken out of the investigational realm and put into full time use. This is due to the fact that for a law to be enacted it only has to be passed in legislation, but for the FDA to approve a product for full time use the product must pass the many required tests and stages that a product must pass before being approved for full time use through the FDA. This is not to mention all of the other products that the FDA is testing at the same time, which results in an even slower process. Approving the AbioCor artificial heart for full time use in hospitals would save many lives that are being lost; just as enacting universal helmet laws within a state would save many lives that are being lost.

Capstone Antithesis

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Some may say that a success rate is a very important aspect in many facets of life. In the world of artificial hearts, it is especially important because it deals with the life and death of a patient. A success rate in the world of artificial hearts is the percentage of how many patients live after having an artificial heart procedure. The SynCardia artificial heart may have a lower success rate than the AbioCor artificial heart but the SynCardia has also been tested on more patients. The SynCardia has been in use longer than the AbioCor, this means that it has had more time to work out any “kinks” in the system. Therefore the SynCardia should be a better choice of artificial heart.

            The SynCardia artificial heart first started to be constructed in 1911 (“FDA Approves”). Since that time there have been many alterations done to make the mechanism more effective, such as producing the Freedom Portable Driver and Synhall valves. These modifications to the system have been occurring for 104 years. The SynCardia artificial heart is the product of dozens of minds and over a century of work. This kind of history and years of work is no match to the AbioMed Company that was just recently founded in 1981 (“AbioMed”).

The SynCardia artificial heart has several different variations that have been used. With each new variation the system keeps improving. The synthetic heart has progressed from keeping a patient restricted to a hospital bed to now being able to move about with the Freedom Portable Driver. The system has also been improved by adding SynHall valves, which keep blood flowing in one direction (“FDA Approves”). Having many variations to approve upon puts the SynCardia artificial heart system leaps and bounds ahead of the AbioCor artificial heart system.

The AbioCor has a higher success rate but a lower test rate. In surgical trials involving fourteen patients, the AbioCor artificial heart produced a success rate of 86%, this means that twelve out of the fourteen patients given the new procedure survived. Of these twelve surviving patients 71% survived the sixty-day milestone from a prediction of only 20% living for sixty days after procedure. During the surgical trials of the SynCardia Artificial Heart System, eighty-one patients were allowed to participate. At the end of seventy-nine days, the artificial heart produced a 79% success rate of patients (“National Medical Policy”). The SynCardia has a lower success rate than the AbioCor. This is due to the fact that the SynCardia has been used in more patients than the AbioCor, thus giving the SynCardia a higher test rate. With a higher test rate, the SynCardia has not only been tested with more chances to fail but also more chances to succeed. Some consider a test rate more important that a success rate because a test rate is the actual application of the success rate. In other words, the test rate is the success rate in action. With more patients living with the SynCardia than the AbioCor artificial heart, the SynCardia seems to be a better choice for a patient who is looking for an artificial heart that has been put to the test.

Capstone Strongest Argument

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An artificial heart is a power-driven device used to replace a damaged heart. Presently, the SynCardia Total Artificial Heart is the go to artificial heart for most hospitals in the United States. The FDA approved the current version of this artificial heart on June 26, 2014 (“FDA Approves”). Recently, there has been a development of a new type of artificial heart; this is the AbioCor Implantable Replacement Heart. The AbioCor Implantable Replacement Heart is the first self-contained artificial heart, meaning that a patient does not have to be connected to large driver consoles or be tethered to wires and tubes protruding from their skin (“Abiomed”). The AbioCor Implantable Replacement Heart uses a wireless energy transfer system, which gives the patient the ability to avoid skin piercing wires and tubes. This is a more patient friendly system that only requires them to wear a belt that contains an external battery pack and external wireless driver. In contrast, SynCardia’s design requires the patient to wear a battery pack vest along with having tubes protrude from their body that are connect to an external driver.

Surgery is preformed for two reasons: to increase longevity and to improve quality of life (“Patient Information”). A patient friendly system is a necessity to be able to uphold the reasons for an operation. Having a system where a patient is in pain or attached to a bulky machine infringes on a person’s quality of life by preventing them in mobility aspects. When a person’s quality of life is going to be hindered, it will cause a patient to be discouraged from receiving an operation that they desperately need. Therefore having a patient friendly system can save the lives of patients.

A self-contained device makes an immense difference in the comfort to a patient. To put this in perspective, imagine a person spending all of their remaining days being connected to an exterior power source. This not only hinders a person’s quality of life by making them dependent on a large power source but also hinders a person’s freedom to be independent because in most instances assistance will be need for a person to get around with these circumstances. In addition to this already hindered quality of life, a person has to suffer through having tubes and wires protrude through their skin. These tubes and wires cause pain when pulled on and are a site for an increased risk of infection. With this said, imagine a life where a person only has to wear a wireless external battery pack that is on a belt. This eliminates painful wires and tubes, increases a person’s independence, and drastically improves the person’s quality of life. The difference between these two ways of life makes a self-contained device a necessity in a patient’s life.

The FDA has approved the SynCardia Artificial Heart System to be used in artificial heart implantation surgeries. There are many trials and approvals that must be met before a product receives this final approval for use. This is a main factor of why this system is being used more then the AbioCor Implantable Replacement Heart. AbioCor’s artificial heart is in the Humanitarian Device Exemption (HDE) stage. This stage allows for no more than 4,000 selectively treated patients a year in the U.S. to be treated with this product. The AbioCor artificial heart is newer than the SynCardia artificial heart causing the AbioCor to be behind the SynCardia in the approval process.

In surgical trials involving fourteen patients, the AbioCor artificial heart produced a success rate of 86%, this means that twelve out of the fourteen patients given the new procedure survived. Of these twelve surviving patients 71% survived the sixty-day milestone from a prediction of only 20% living for sixty days after the procedure. During the surgical trials of the SynCardia Artificial Heart System, eighty-one patients were allowed to participate. At the end of seventy-nine days, the artificial heart produced a 79% success rate of patients. This is a 7% difference in the success rates between the two artificial hearts with AbioCor success rate higher than that of SynCardia.

The AbioCor Implantable Replacement Heart is far more advanced with technology of today, allowing it to be wirelessly powered, keeping patients from having to deal with protruding wires and tubes. It is a self-contained artificial heart with a higher success rate than the current go to artificial heart, the SynCardia Artificial Heart System. The AbioCor Implantable Replacement Heart should be given full FDA approval. With this approval, it will become the new go to artificial heart.

Capstone Context

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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.

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