At the Intersection of Torah and Cardiology.
A. WHAT AND WHERE IS THE HEART? MEDICAL PERSPECTIVES
The heart is an organ
An organ is a mass of specialized cells and tissues that work together to perform a function in the body. Any part of the body that performs a specialized function is an organ. Therefore, the eye is an organ because its specialized function is to see, skin is an organ because its function is to protect the body and regulate its temperature, and the kidney is an organ that functions to remove waste from the blood.
The heart is a specialized muscular organ that pumps blood through the blood vessels comprising the circulatory system. The heart is divided into four chambers: upper left and right atria, and lower left and right ventricles. It is about the size of your clenched fist, weighs approximately 10.5 ounces, and is shaped like a cone.
The classical views: Aristotle, Galen, Harvey
Since antiquity the heart has been significant in understanding how the body works. In the fourth century BCE, Aristotle observed chick embryos and identified the heart as the most important organ of the body. He concluded that the heart was a hot, dry organ and the seat of intelligence, motion, and sensation. Incorrectly describing the heart as a three-chambered organ that was the center of vitality in the body, Aristotle thought that the lesser organs surrounding it simply existed to cool the heart. (1)
In his treatise On the Usefulness of the Parts of the Body, A.D. Galen (c. 199-126 BCE), the father of experimental physiology, reaffirmed common ideas about the heart as the source of the body's innate heat and as the organ most closely related to the soul. He also carefully observed many of its unusual physical properties and argued that the expansion and contraction of the heart was a function of its role as an "intelligent" organ (BRAIN 1986, p. 1).
However, Galen was not afraid to contradict others in matters of detailed anatomy, such as Aristotle's claim that the heart is the origin of the nerves. He further argued that the heart was secondary to the liver in importance, since it did not produce the humors. His ideas generally predominated until the mid-seventeenth century.
At the beginning of the eleventh century, for example, Avicenna, in his Canon of Medicine, integrated Aristotle's ideas within his largely Galenic physiology when he wrote: "[The heart is the] root of all faculties and gives the faculties of nutrition, life, apprehension, and movement to several other members." He incorrectly believed that the heart produced breath, the "vital power or innate heat" within the body, and was an intelligent organ that controlled and directed all others. (2)
The Renaissance revival of anatomy made it possible for physicians to clarify basic structures in the heart. (3) By now it was commonly agreed that the heart was divided into four parts with two ventricles and two auricles (now called atria). (4) Leonardo da Vinci, for all his ability to draw and observe the heart with a great deal of accuracy, did not deviate significantly from Galen's view. He offered an elaborate mechanical account of the heart, underscoring the relationship between heat and motion, but the actual movement of the heart puzzled him.
It was not until the British physician William Harvey wrote On the Circulation of the Blood in 1628 that a viable alternative to Galenic physiology became widely accepted. Harvey supported the Aristotelian notion of the heart. He examined carefully the function of all of its different parts and came to a reverse conclusion to that of Galen and Galen's medieval and Renaissance adherents. Harvey believed that the heart was actively at work when it was small, hard, and contracted (systole), expelling blood, and at rest when it was large and filled with blood (diastole).Yet he did not challenge the metaphysical interpretation of the heart. To underscore its cosmological significance, Harvey metaphorically described the heart as the "king" or "sun" of the body.
By the end of the seventeenth century, the anatomical knowledge of the heart was surprisingly accurate and Harvey's ideas were widely accepted. The French philosopher Rene Descartes, who was one of the first scholars to accept Harvey's new theory, expanded his ideas a step further when he argued that the heart was like a pump or a combustion engine. The heart became a key topic for debating the pros and cons of mechanistic and vitalistic accounts of the body, since it served both agendas.
Current scientific knowledge of the functions of right and left sides of the heart
To the casual eye, the human heart looks like a monolithic organ. But physiologically, the heart is really two organs, side by side, divided by the cardiac septum. The septum divides the low-pressure right heart from the high-pressure left heart. Thus, the heart functions as a double pump to provide pulsatile circulation of blood throughout the body.
Both circulations transport blood, but they can also be seen in terms of the gases they carry. The right heart (low-pressure pulmonary circulation) collects oxygen from the lungs and delivers carbon dioxide for exhalation. The left heart (high-pressure systemic circulation) transports oxygenated blood to the body and returns relatively deoxygenated blood and carbon dioxide to the right heart. See Figures 1 and 2 on page 76.
Is the heart merely a pump?
The heart is a smart pump because it responds to body needs on a beat-by-beat basis. It increases or decreases beats as we run, work, lift weights, or get excited. It adjusts its own cardiac output by the stunning mechanism of ventricular contractility.
But the heart can fail. When the left ventricle is incapable of developing the necessary high-systemic pressure, it falls into congestive heart failure. Congestive heart failure, which is the steadily declining ability of the heart to pump blood, is one of the leading causes of death. This disease is caused by sudden damage from heart attacks, deterioration from viral infections, valve malfunctions, high blood pressure, and other problems.
B. WHAT IS THE HEART? JEWISH CONSIDERATIONS
Torah: neshamah, nefesh, and ruah
Judaism teaches that the body and soul are separate yet indivisible partners in human life. Rather than imprisoning or corrupting the soul, the body is a divinely given tool for doing sacred work in the world. It requires protection, care, and respect, because it is holy. (5)
The Bible gives few clues to the ancient Israelite idea of the soul or spirit. Three words which over time developed the meaning of "soul" are present in Scripture: neshamah, nefesh, and ruah. Tracing the evolution of these terms gives us some idea of the ancient Israelites' beliefs regarding the soul.
Neshamah is related to neshimah (breath) in the Creation story of G-d blowing the "breath of life" into a human being of earth and dust (Genesis 2:7). Although neshamah later becomes associated with the soul, here neshimah only describes the element that animates a body. This animating element is not, in early Biblical tradition, separate from the body in life, nor does it possess any personality.
In the prohibition against eating blood, Leviticus 17:11 states that "the nefesh [life-force of the flesh] is in the blood."
Similarly, ruah is the animating force from G-d. Most often used as "wind," ruah may also be used as "breath." "G-d said, 'My breath [ruhi] will not govern man forever, since he is flesh'" (Genesis 6:3). Here, we see the added element of transience: ruah ends its association with the mortal body at death.
Tanya: nefesh behemit (animal soul) resides in the left ventricle
Is the heart the seat of the soul? According to Rabbi Shneur Zalman of Liadi, the author of the Tanya, the animal soul resides in the left ventricle:
The abode of the animal soul... in every Jew, i.e., the place where the nefesh ha'behamit [animal soul] resides and is most manifest, is in the heart; for, as mentioned in previous chapters, the animal soul is predominantly emotional, and the heart is the seat of emotion. More specifically, the abode of the animal soul is in the left ventricle, which is filled with blood, as it is written in Deuteronomy 12:23, "For the blood is the soul" (nefesh)--indicating that the soul resides in the ventricle that is filled with blood, the left ventricle. Because the animal soul resides in the heart, therefore all lusts and boasting and anger and similar passions are in the heart, and from the heart they spread throughout the entire body." (TANYA, CHAP. 9, ELUCIDATED BY RABBI YOSEF WINEBERG) (6)
In the next paragraph of chapter 9 the Tanya locates the divine soul in the right ventricle:
But the abode of the divine soul is in the brains that are in the head, and from there it extends to all the limbs; and also in the heart, in the right ventricle wherein there is no blood, as is written, "The heart of the wise man is on his right." It is [the source of] man's fervent love towards G-d.
If the animal soul resides in the left ventricle and the divine soul in the right ventricle, what happens to the original soul, if the patient's own heart is removed and a donor heart is implanted? Does the patient receive a "new soul" as a result of the transplanted heart? Who decides the answer? The surgeon, the rabbis, or the federal government? In my opinion, following Leviticus 17:11 and the Tanya, the nefesh resides uniformly throughout the entire body.
C. ORGAN TRANSPLANTATION
Organ transplantation is the surgical replacement of a malfunctioning organ with a donated healthy organ. Kidney, heart, pancreas, liver, and lungs have all been successfully transplanted, as well as organ parts or tissues such as bones, cornea, skin, or bone marrow. (7)
The ethical problems of organ transplantation result from the fact that it is a highly risky and, at the same time, highly beneficial procedure involving questions of personhood, bodily integrity, attitudes towards the dead, and the social and symbolic value of human body parts. Moreover, the terminology used in organ transplantation implicitly and often uncritically transports ethical meanings. An "organ donor," for example, implies that there is a person acting voluntarily to benefit someone else. "Heart donors," however, may be dead and no longer able to act. Hearts, particularly those obtained from accidental deaths, are "harvested" without the dead "donor's consent." In medical ethics debates, this problem of an adequate terminology has to be kept in mind. The medical term "harvesting" also is used inappropriately to denote either the "recovery" or "donation" of an organ, but it has entered the popular lexicon, as have many other donor and transplantation terms, as seen in the table below:
Technical Terms for Donation and Transplantation Appropriate Term Inappropriate Term "recover" organs "harvest" organs "recovery" of organs "harvesting" of organs "donation" of organs "harvesting" of organs "mechanical" or "ventilator" support "life" support "donated organs and tissues" "body parts" "deceased" donor "cadaveric" donor "deceased" donation "cadaveric" donation "registered as a donor" "signed a donor card" (antiquated) Source: California Donor Registry. Glossary of Terms for Organ Donation and Transplantation http://donatelifecalifornia.org/wp-content/uploads /2015/01/Organ-Tissue-Donation-Terms-for-Media.pdf
Heart transplantation: Why necessary? History and development
Heart failure occurs when the heart muscle is unable to pump enough blood to meet the metabolic needs of the body. The most common cause of damage to the heart muscle (myocardium) that results in heart failure is coronary artery disease. The typical symptoms of heart failure are shortness of breath, poor exercise tolerance, cough (especially at night), fatigue, and excessive fluid retention. If heart failure symptoms and heart function cannot be improved by medication or surgery, the patient may benefit from a heart transplant. It should be pointed out, however, that heart transplantation is a treatment and not a cure. A one-year survival rate is over 80 percent, with an average length of survival of 9.1 years (JURT, DELGADO, MALHOTRA, et al. 2002).
While heart transplantation may benefit many patients, there are not enough donor hearts for every patient in need, and many people unfortunately die while waiting for a transplant. Public campaigns urging people to sign an organ donor card and let loved ones know their wishes are very important in alleviating the shortage of organ donors. Donor hearts come from individuals who have been declared brain-dead, usually from severe head injuries resulting from car accidents, gunshot wounds, or bleeding in the brain (cerebral hemorrhage). The donor must be of similar weight and height as the recipient. Donor organs are given according to the severity of illness or status level of the patient, size and blood group compatibility, and the length of time spent on the waiting list.
In the decades since the first human heart transplant in 1967, heart transplantation has changed from an experimental operation to an established treatment for advanced heart disease. Only about 2,000 heart transplants are performed each year in the US. Thousands more patients would benefit from a heart transplant if more donated hearts were available.
D. ETHICAL AND HALAKHIC PROBLEMS WITH HEART TRANSPLANTATION
The secular medical ethics controversy over defining the moment of death of the donor: breathing, cessation of heart and other organs, and brain death
When we think of ethics, we think instinctively of rules for distinguishing between right and wrong. "Love your neighbor as yourself" (Leviticus 19:18) is indeed a basic principle of Jewish morality. But what does the Bible mean by "your neighbor"? In the case of heart transplants, can "your neighbor" be interpreted generally as another human being in need of a heart transplant?
Ethical and religious considerations relevant to cardiac transplantation and the "artificial heart" have continuously evolved since the first human tissue transplant nearly 75 years ago. The ethical issues raised have led to an ongoing debate that permeates our entire society. The growing number of implantations of artificial hearts and ventricular assist devices in patients with congestive heart failure has made these issues even more critical. Organ transplantation is one of the most exciting modern medical phenomena. As in many other disciplines, progress in solving ethical problems has not kept up with that of science and medicine, and this discrepancy creates serious problems. (8)
In Jewish law, donation of an organ from a "dead" person is permitted for the purpose of saving a life (pikuah nefesh). This simple statement of the issue belies, however, the complexity of defining death. The reason for this is simply because to take a life-sustaining organ from a person who is still alive is murder (JAKOBOVITS 1959, p. 2).
In order to define the moment of death--without getting involved in halakhic terminology and the debates among the halakhic authorities on this subject--let us clarify three important general principles.
1. The first principle is that the determination of the moment of death is not merely a medical decision. Whereas the role of the physician is primarily to establish the facts, the decision may be legal, halakhic, moral, or cultural depending on the particular society. Is death determined (a) when all physiological processes in the body have ceased (which can take a few days); (b) when breathing has stopped; (c) when the heart stops beating; or (d) when brain death occurs? In Japanese culture, for example, the concept of brain death has been difficult to accept because in that society the heart is of central importance.
We must clearly define "brain death: prior to removing a heart from a potential donor. The US President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, having "worked with the three organizations which had proposed model legislation" and with their endorsement, in 1981 recommended the adoption of the following statute in all jurisdictions of the United States:
Section 1. An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards. (US PRESIDENT'S COMMISSION 1981, PP. 117-118)
In 2008 the US President's Council on Bioethics issued a white paper entitled "Controversies in the Determination of Death." The paper acknowledged many changed understandings of both the brain and the body of a "brain-dead" person. The Council offered a fundamentally new rationale for the continued use of the brain death criterion, as previously accepted guidelines were based on obsolete information. The paper noted on page 1 that:
In the late twentieth century, as a response to certain advances in critical care medicine, a new standard for determining death became accepted in both the medical and legal communities in the United States and many other parts of the world. Until then, the prevailing standard was the traditional cardiopulmonary standard: the irreversible loss of heart and lung functions signals the death of a human being. The new standard, which took its place alongside the traditional one, is based on the irreversible loss of all brain-dependent functions. In most human deaths, the loss of these neurological functions is accompanied by the traditional, familiar markers of death: the patient stops breathing, his or her heart stops beating, and the body starts to decay. In relatively rare cases, however, the irreversible loss of brain-dependent functions occurs while the body, with technological assistance, continues to circulate blood and to show other signs of life. In such cases, there is controversy and confusion about whether death has actually occurred. (US. PRESIDENT'S COUNCIL ON BIOETHICS 2008, P. 1)
2. The second principle is that we may not kill one person in order to save another, or even several others. Otherwise, every one of us would be in danger daily, because we all possess healthy organs which could save a number of patients who are waiting for transplants.
3. The third principle is that the determination of death of the organ donor and the decisions regarding his treatment must not be affected by the needs of the patient awaiting the transplant. There must be complete separation between the respective medical teams caring for the prospective donor and the prospective recipient in order to assure optimal care for both patients morally and medically. For example, there is constant and growing pressure in some medical circles to change the definition of death from cessation of all brain activity to cessation of activity in the cerebral centers only. Thus, there would be no need to wait for cessation of breathing before removing organs. The main problem here concerns the persistent vegetative state, in which the patient is in a coma but still breathes spontaneously and may continue to live in this state for years.
Jewish criteria for determining the moment of death
How is the moment of death defined from a Jewish ethical perspective? Defining the criteria to identify when the potential donor has died is crucial in matters of vital organ donation (DORFF 1998). This is particularly important in heart transplants, where the donor heart deteriorates rapidly after it ceases to beat, making every minute count.
The majority view of the Talmudic and post-Talmudic sages is that the total cessation of spontaneous respiration determines death. (See Maimonides, Mishneh Torah, Shabbat 2:19.) A minority view in the Talmud Yoma 85a maintains that cessation of heartbeat is also required to determine death. The halakhic sages of the fourteenth to sixteenth centuries prescribed a breath test: a feather is placed beneath the patient's nostrils. Movement of the feather indicates life, whereas lack of movement signifies death. (9) The exegetical bases for the vital importance of respiration are the verses Genesis 2:6, according to which G-d breathes life into Adam, and the account of the Flood in Genesis 7:22 that killed "all in whose nostrils is the breath of the spirit of life."
There is clearly a cogent, practical reason for using the feather test, namely, that it is easy to administer. Today, however, there are more technologically sophisticated ways of testing for spontaneous respiration, including testing patients connected to respirators. (See Rabbi Moshe Feinstein, Iggrot Moshe, Yoreh Deah, Part 3, no. 132.)
Religious issues are of primary concern for patients involved with heart transplants or total artificial heart implants. It is less of an issue for kidney transplant donors. Since a person has two kidneys, the removal of one kidney does not threaten the life of the donor. (10) The same is true for lung transplantation: a person may donate one lung, and still resume a relatively normal life with his second lung. However, we have only one heart. A heart donor cannot survive having his heart surgically removed. Likewise, a patient receiving a total artificial heart must agree to his own diseased heart being removed before a total artificial heart is implanted in its place for the interim period until a deceased donor heart becomes available.
Halakhah brings its own unique perspective. It is deduced from the Talmud and Shulhan Arukh that hayyei shaah (life that can only continue for a brief period of time) is considered life that must be saved--even at the expense of the desecration of Sabbath--no differently than the life of a patient who has many years ahead of him. Similarly, the Talmud states that the life of one person may not be taken to save the life of another. Accordingly, if a potential heart donor is still alive, even if he has only minutes left, he is not considered an acceptable source for organs. This is the backdrop for the evaluation of all modern halakhic authorities on questions of recovering organs from the deceased.
In Judaism, the majority view holds that organ donation is permitted in the case of irreversible cardiac rhythm cessation in the donor. However, when the "donor" is dying or has died in an accident, most organs must be recovered before the heart has ceased. This has led to much debate between recognizing only the criterion of cardiac/respiratory cessation and recognizing also the criterion of brain/respiratory cessation. While there continues to be opposition to extricating organs after brain/respiratory cessation but before the cardiac/respiratory death of the donor, there are several authorities who argue that it is allowed, and this is now the official position of the government of the State of Israel and its chief rabbinate (11) (OLIVER, WOYWODT, AHMED, and SAIF 2010).
Time is of the essence in heart transplant surgery. A donor heart needs to be transplanted into the recipient four to six hours after retrieval from the donor (UNESCO CHAIR IN BIOETHICS 2010, p. 51). Otherwise, the heart muscle deteriorates and becomes physiologically useless.
There is no official universal halakhic consensus on when a donor is considered "dead." (12)*
We must distinguish the differences between transplanting a heart from a deceased donor and implanting total artificial hearts and mechanical assist devices. In a heart transplant, halakhah requires that the heart donor must be pronounced "dead" prior to surgical removal of his heart. To implant a total artificial heart (TAH), first the patient's diseased heart must be surgically excised. Mechanical assist devices (MAD), on the other hand, are implanted in series with the diseased heart. In neither case is the patient "dead," and in neither case is there a human donor. Thus, the use of artificial hearts and mechanical assist devices bypasses the thorny issue of halakhically defining the precise moment of death of a donor.
Pikuah nefesh vs. mutilation of the dead; postponement of burial; benefiting from the dead; and pig heart valves
Apart from the primary problem of establishing the moment of death, there are additional problems in Jewish law that may arise in connection with organ donation. Judaism attaches great importance to the dignity of the dead, and there are explicit laws as to the proper care to be given to the body, ensuring that dignity (WERBER 1996/1997).
Mutilation of the dead
The Torah prohibits unnecessary destruction and mutilation (Deuteronomy 20:19). However, if the mutilation is done with the purpose of saving life, the principle of pikuah nefesh allows it.
Postponement of burial
Although the Torah prohibits the postponement of burial (Deuteronomy 21:23)--and organ extraction may postpone it by a number of hours --if the postponement is done with the purpose of saving life, the principle of pikuah nefesh allows it.
Benefiting from the dead
The Torah prohibits benefiting from the dead (Maimonides, Mishneh Torah, Hilkhot Avel 14:20). Although the recipients of organs from the deceased benefit, because the organs were recovered with the purpose of saving life, the principle of pikuah nefesh allows it.
Pig heart valves
Artificial hearts use pig valves. All rabbis agree that pig organs may be implanted, since the Torah prohibits us only from eating swine flesh. The patient does not derive "pleasure" from any taste, and the implants are being used to save life.
While pig valves are used in conjunction with the manufacture of heart assist devices, the most common surgical use of pig valves is in heart valve replacements. These valves are used to replace diseased arteries.
There are approximately 90,000 valve substitutes in the US and 280,000 worldwide installed yearly (PIBAROT and DUMESNIL 2009), thus making it one of the most commonly performed heart surgeries, accounting for 10 to 20 percent of all cardiac procedures in the United States (MAGANTI, RIGOLIN, SARANO, et al. 2010). Approximately half are mechanical valves and half are bioprosthetic valves. Bioprosthetic valves are either porcine (pig) or bovine (cow). Mechanical valves are totally man-made of biocompatible materials. See Figures 3 and 4 on page 76.
E. THE VIEWS OF SECULAR MEDICAL ETHICS ON HEART TRANSPLANTS
How do the four principles of secular medical ethics apply to heart transplantation?
The four fundamental principles of secular medical ethics are: (1) respect of patient's autonomy; (2) non-maleficence, i.e., the duty to avoid harm or injury to patients; (3) beneficence, i.e., the duty to do good to patients, to relieve pain and suffering, and to save lives; and (4) justice and acting fairly ("Thou shall not judge unfairly" [Deuteronomy 16:18]).
The values that encompass these four fundamental principles are self-evident. They are considered to be the doctor's prima facie duties to the patients and society. It is necessary for a doctor to take all of them into account when they are applicable to the clinical case under consideration. Not infrequently, though, when two or more principles apply, they may be in conflict. For instance, the decision to operate on a case of acute appendicitis involves at least two competing prima facie duties on the part of the doctor. While the doctor is obligated to provide the greatest benefit to the patient by performing an immediate appendectomy, surgery and general anesthesia carry risks and the doctor is under the obligation to avoid causing harm to the patient.
The physician's decision must be based on a balance between the demands of the competing principles by determining which carries more weight in the particular case. In the case of appendicitis, the patient is at far greater risk of harm from a ruptured appendix if the doctor does not act quickly, than from anesthesia and surgery.
The historical guiding principle of health care is primum non nocere, first do no harm. While this was a logical guidepost for medicine in the ancient Greece of Hippocrates, it is less suitable in a world where people recognize and accept the risks of driving automobiles, smoking cigarettes, skiing, bungee jumping, having cosmetic facelifts, breast implants, and donating kidneys or portions of their liver and lungs.
Today, perhaps it is more appropriate to consider "a" Hippocratic Oath as opposed to "the" Hippocratic Oath, and in these terms, it is just as relevant today as when the concept was initially introduced in classical times. Perhaps, in the spirit of Hillel, we should consider a modern medical golden rule: "May I care for others as I would have them care for me."
Recently, Dr. Louis Lasagna of the University of California San Diego University Ethics Center proposed a "Hippocratic Oath--Modern Version," emphasizing a holistic and compassionate approach to medicine. For his revised oath Dr. Lasagna selected major themes of medicine: Do positive good, not just keep from harm. Promote knowledge and skills for the benefit of the patient. Provide sound advice and guidance to the person and family, not just manipulate the diseased organ systems. His oath also specifically includes the important Hippocratic concept of keeping confidentiality. Today, the "Lasagna Oath
(LASAGNA 1962) has been adopted by many medical colleges. (13)
II. EVALUATION OF HEART TRANSPLANTATION
Cardiac transplantation is the best option for patients in end-stage heart failure. According to the US Department of Health and Human Services, about 4,000 people await a donor heart transplant on any given day, while the supply of approximately 2,300 donor hearts annually has remained constant in the US for over twenty years, due to the paucity of donor hearts. The same is true for the rest of the world. Among European Union countries, 3,400 patients were on waiting lists for a donor heart in 2012. According to the European Commission's Department of Health and Consumers, only 2,004 transplants were conducted that year. (14)
After an initial wave of enthusiasm in 1968-1969, when hundreds of hearts were transplanted, most medical centers stopped heart transplants. Of 162 patients who underwent heart transplants from 1968 to 1970, 144 died within a few months. The results were similar for most of the leading heart surgeons. For example, of 23 patients operated on by Dr. Denton Cooley in Houston, Texas, not a single one survived in the long term.
The prognosis for heart transplant patients following orthotopic procedures15 has steadily improved since then, however, and as of June 5, 2009, the survival rates out of a total of 7,500 patients were:
* 1 year: 88.0 percent (males), 86.2 percent (females)
* 3 years: 79.3 percent (males), 77.2 percent (females)
* 5 years: 73.2 percent (males), 69.0 percent (females)
In a study from 1999 to 2007 conducted on behalf of the US federal government by Dr. Eric Weiss of the Johns Hopkins University School of Medicine, it was discovered that, compared to men receiving male hearts, "men receiving female hearts had a 15 percent increase in the risk of adjusted cumulative mortality" over five years. No significant differences were noted for females receiving hearts from male or female donors (Weiss 2009, p. 401).
For heart transplants, the geographic location of the transplant center is critical. Location of the transplant center with respect to the donor hospital is given priority due to the devastating effects of cold ischemic time (CIT). Once an organ is removed from the donor, blood no longer perfuses through the blood vessels and the cells begin to starve for oxygen (ischemia). A heart has to be transplanted within four to six hours after it is recovered. (16)
Former vice president of the United States Dick Cheney received a heart transplant on March 24, 2012.17 Because he was 71 years old at the time of the surgery, heated ethical discussions were sparked about the upper age limit of transplant patients (KATRANDJIAN 2012). Would society question the necessity of a heart transplant for a sitting US President, or a Justice of the Supreme Court?
There are a host of problems surrounding the priority list for organ transplants. In 2015 there were 35,000 patients in the United States awaiting transplantation of various organs. Approximately one-third of the patients requiring a liver, lung, kidney, or heart die while waiting. In Israel the waiting list comprises several hundred patients.
How do we decide which patient needs the organ "the most?" Do we decide according to the seriousness of the illness? Should we perhaps consider the degree of socioeconomic benefit to be achieved from the transplant? The most seriously ill do not always have the best chance of giving the most benefit to society. Should we give the organ to the patient who has waited the longest? Should we take into consideration the candidate's contribution to society? Is he a great rabbi, an outstanding scientist, someone with a wife and family? Do we give an organ to someone who continues to smoke or drink, behavior which is likely to harm the transplanted organ? Do we consider the candidate's age?
Given the scarcity of available heart donors in most countries, the following criteria are used to determine the suitability of a recipient eligible for a heart transplant (DEJONGE, BALK, KLOPPING, et al. 2007):
* Organ type, blood type, and organ size
* Distance from the donor organ to the patient
* Level of medical urgency
* Time on the waiting list
* Is the patient available and willing to be transplanted immediately?
* Is the patient healthy enough to be transplanted?
* What is the age of the recipient?
Among Jews there is a great discrepancy between the demand for transplants and the number of donors. Only a small percentage of potential Jewish donors actually donate organs--not only members of the major segments of the hareidi ("ultra-Orthodox") community whose rabbinic authorities do not accept the criterion of brain death, but also members of the secular and national-religious communities (who do accept the brain-death criterion). And not only are donated hearts scarce. There is a shortage of kidney and cornea transplants. Only a small percentage of potential organs are transplanted. The flip side of reluctance of families to agree to donate the heart of their deceased for religious reasons is reluctance to receive a heart donation for precisely the same reasons, that it will cause the murder of the "donor." (See, for example, the responsa of Rabbis Shlomo Zalman Auerbach and Yosef Shalom Elyashiv in 1992 in STEINBERG 2012, p. 72.)
Organ donation is a serious medical and ethical problem for Torahobservant Jews. Despite the educational efforts of HODS (Halachic Organ Donor Society in North America) and the Areivim Committee of rabbis and doctors and the Bilvavi donor card organization in Israel, organ donation among religious Jews is low. According to Rabbi Professor Avraham Steinberg, MD:
There is no doubt that there exists the potential in Israel for a reservoir of organ donors which would suffice to take care of the needs of all patients waiting for a transplant. However, in the year 2011, only half a million Israeli citizens had signed organ donor cards, representing only about 10% of the population. The number of families who consent in "real-time" to have their recently deceased relatives' organs taken for transplantation into needy patients on the waiting list is about 45%. According to various surveys, the most common reason for refusal of the families to sign an organ donor card, or to agree to salvaging organs from their recently deceased relatives, is because of religious reasons and convictions, whereby they claim that from the halachic viewpoint it is prohibited to transplant organs. A very high percentage of Israelis feel this way, even if they are not Torah observant in their own personal lives at all, but when it comes to death-related issues, they want to conduct themselves like believing and observant Jews. However, their halachic knowledge regarding what is permissible and what is prohibited about organ transplantation is severely lacking and is often distorted and incorrect. (STEINBERG 2012, PP. 81-82)
The Knesset has tried to increase voluntary organ donation by giving "extra points" to people who sign donor cards and who later themselves need an organ transplant:
The Israeli law on organ transplantation gives "extra points," i.e. a hypothetical advantage of priority to someone who signs the donor card in regard to a situation where two patients waiting for an organ transplant are identical in all respects, as per their medical status, their compatibility with the available organ, and if they have both been on the waiting list for the same amount of time. Such situations must be very rare, but nevertheless this reflects the intent of the society to recognize and admire the honorable act of signing the donor card. (STEINBERG 2012, P. 119)
III. WHY AND HOW THE ARTIFICIAL HEART (AH) AND MECHANICAL ASSIST DEVICES (MAD) WERE DEVELOPED
What was the need for the development of Artificial Hearts (AH) and Mechanical Assist Devices (MAD)? This question can be answered by considering the public health data and statistics on heart disease. According to some of the latest statistics, heart failure and coronary heart disease alone account for approximately 4.7 million patients per year in the United States. If conventional medical therapies are unsuccessful, cardiac transplantation or mechanical assists are the only viable options.
These statistics firmly place heart disease in the position of being the leading cause of mortality in the US, responsible for approximately 54 percent of all deaths, as compared with cancer, the next common cause. In the US, cardiovascular disease kills more patients than all forms of cancer combined.
Nearly two million patients in the US are seriously handicapped by cardiovascular disease. Many of these patients with diseased hearts are otherwise healthy and could benefit from a temporary or permanent replacement heart or assist device if available. Technical improvements in ventricular assist devices provide a growing number of patients with suitable mechanical alternatives.
In addition, the potential uses for such devices are not going to be limited to cardiovascular patients. These devices would also be life-saving in many other conditions where cardiac or cardiopulmonary failure is not normally considered the primary, but rather the secondary, cause of death and thus does not appear in the usual mortality statistics. It was obvious, therefore, that the need for development of ' effective, safe, and readily available temporary and permanent cardiovascular assist and replacement devices was central to the health of the nation as well as a challenge to our medical technology.
US government initiative
Acutely aware of the medical problem and convinced that new knowledge and approaches to deal with the problem could be accelerated, the National Advisory Heart Council requested the National Heart Institute to explore the feasibility of establishing a program for developing mechanical devices that might assist or replace a failing heart. In 1964, the Artificial Heart Program was established by the National Heart Institute to focus on developing cardiac prostheses and auxiliary supporting techniques. It was organized to bring together the national effort in an attempt to:
1. unify the isolated elements of existing research and to encourage further development;
2. mount a concerted attack upon heart disease by providing the patient and the medical care community with new therapeutic tools to support and augment current chemotherapy and heart surgery methodology.
This initiative was unprecedented. No other single federal program encompassed such an extensive spectrum of disciplines. It combined the fundamental knowledge of all medical and engineering disciplines. It was challenged to (a) define the problem in solvable terms, to establish requirements for therapeutic devices, (b) catalyze development of devices for diverse cardiovascular disorders, and (c) provide a unique surgical innovation at an affordable price.
Our research group, located in Boston, headed by renowned cardiac surgeon Dr. William Bernhard, responded to the initiative by submitting a comprehensive research proposal to the National Institutes of Health. We were one of only four research centers in the US selected for government funding.
THE THREE GENERATIONS OF MECHANICAL ASSIST DEVICES
Mechanical assist devices (MAD) can be classified into three successive generations: (1) intra-aortic balloon pumps, (2) ventricular assist devices (VAD), and (3) total artificial hearts (TAH).
The following table summarizes the current indications for MAD therapies:
Table 1. The terminology of MAD therapy: Types and Indications Device type Indications for use Bridge to Recovery (BTR) Short-term support for a condition anticipated to be reversible Bridge to Bridge (BTB) Short-term support (typically inserted in an emergency situation) until a more permanent device can be implanted Bridge to Transplant (BTT) Short-to-intermediate-term support in patients actively listed for transplantation Bridge to Decision (BTD) Patients for whom the ultimate therapy is undetermined. Device may be short- or long-term support. Destination Terapy (DT) Long-term support in patients who are not candidates for transplantation. Total artifcial heart (TAH) Irreversible heart failure.
Intra-aortic balloon pumps
Intra-aortic balloon pumps are currently being used to support the heart during open heart surgery, but are restricted to 2.5 liters per minute of cardiac output.
Total artificial hearts (TAH)
Total artificial hearts (TAH) are used in patients with irreversible congestive heart failure and who may die while awaiting a heart transplant.
Ventricular assist devices (VAD)
Ventricular assists continue to be one of the most frequently used types of mechanical assist devices for patients whose myocardium has a chance to recover. A ventricular assist device is a mechanical pump used to support left ventricular function and thus blood flow in patients who have weakened hearts. The device takes blood from the left ventricle of the heart and helps pump the blood to the body and vital organs, just as a healthy heart would. (18)
A VAD can help support the heart in three different ways:
1. During or after surgery, until the heart recovers
2. While a patient is waiting for a heart transplant
3. "Destination therapy" for long-term support (often for years) for patients with advanced heart failure not eligible for transplant
A VAD has several basic parts. A small tube carries blood out of the heart into a pump. Another tube carries blood from the pump to the blood vessels, which deliver the blood to the body. A VAD also has a power source that connects to a control unit. This unit monitors the functions of the VAD. It gives warnings, or alarms, if the power is low or the device isn't working well.
Some types of VAD pump blood like the heart does, with a pumping action. Other types of VAD keep up a continuous flow of blood. With a continuous flow VAD, the pulse might not be normal, but the body is receiving the blood it needs.
Types of ventricular assist devices
The two basic types of VAD are a left ventricular assist device (LVAD) and a right ventricular assist device (RVAD). If both types are used at the same time, they're called a biventricular assist device (BIVAD).
The LVAD is the most common type of VAD. It helps the left ventricle pump blood to the aorta. (The aorta is the main artery that carries oxygen-rich blood from the heart to the body.) RVADs usually are used only for short-term support of the right ventricle after LVAD surgery or other heart surgery. An RVAD helps the right ventricle pump blood to the pulmonary artery. (The pulmonary artery carries blood from the heart to the lungs to pick up oxygen.) A BIVAD might be used if both ventricles don't work well enough to meet the needs of the body. Another treatment option for this condition is a total artificial heart (TAH). A TAH is a device that replaces the ventricles, and will be discussed below.
VADs are available in two basic designs. A transcutaneous VAD has its pump and power source located outside of the body. Tubes connect the pump to the heart through small holes in the abdomen. This type of VAD might be used for short-term support during or after surgery.
Implantable valves and stents do not pump blood. Implantable one-way valves help direct the blood flow unidirectionally, whereas stents prevent small arteries from collapsing (stenosing). VADs contain valves. Implantable valves and coronary stents are cardiac surgeries independent of VADs. However, neither implantable valves nor stents pump blood. These devices help restore blood flow in situ, but do not have a pumping function per se.
Each generation of physicians has been faced with new therapies or technologies that have dramatically changed the way medicine is practiced. Usually, mainstream adoption of such medical advances has been an accepted and uncomplicated process. Occasionally, revolutionary advances require a thorough reexamination of the way in which we approach medical care because they represent such a change in patient management that our conventional assumptions no longer apply. Newgeneration ventricular assist devices (VADs) represent such a technology (ENTWISTLE, SADE, and PETRUCCI 2011).
In the 1990s, VADs were used primarily by patients awaiting transplantation who needed interim support until a suitable organ could be identified. For the most part, they were implanted only in transplant centers as a bridge to transplantation (BTT), and VAD candidates were judged by the same criteria used to evaluate patients for transplantation. Thus, if patients were not candidates for transplantation, they were not candidates for VAD insertion.
Since the 1990s the FDA has expanded the VAD Instructions for Use (IFU) to include patients whose heart failure is temporary. A VAD can be implanted for a few weeks or months to assist the heart during its recovery period. For example, if a patient is recovering from heart surgery, he or she may have a VAD implanted until the heart is strong enough to pump blood efficiently on its own, or as a "bridge to recovery." For patients with advanced heart failure not eligible for transplant, a VAD may be used as "destination therapy" for long-term support. Destination therapy allows heart failure patients to live a relatively normal life for years.
Although VADs have been used clinically for nearly 50 years, they have only recently been adopted so widely that they present today's clinicians with ethical challenges on a large scale. In some cases, these ethical issues arise from patient noncompliance or other disruptive behaviors. Similar issues have arisen in organ transplantation, but the scarcity of donor organs has led to the adoption of allocation guidelines that have largely mitigated these issues.
Total artificial heart (TAH)
In a study conducted by Jack Copeland and colleagues on 130 patients from 1993 to 2002, the survival rate for total artificial heart as a bridge to transplantation was 79 percent, with one-year and five-year survival rates of 86 and 64 percent respectively after receiving their transplanted hearts. In a different study, for patients who did not receive the total artificial heart, from initial diagnosis to death was a mere 8.5 days. Copeland and his colleagues concluded in the New England Journal of Medicine:
Implantation of the total artificial heart improved the rate of survival to cardiac transplantation and survival after transplantation. This device prevents death in critically ill patients who have irreversible biventricular failure and are candidates for cardiac transplantation. (COPELAND, SMITH, ARABIA, et al. 2004)
IV. MEDICAL AND TECHNICAL PROBLEMS AND SOLUTIONS
From the start of the artificial heart program, the research teams were fully aware of certain "challenges" we were going to confront. But the teams were supremely confident that existing knowledge would help us overcome those challenges. Not a single voice was raised in opposition or caution.
In retrospect, we were all incredibly naive. Patients suffered from multiple internal bleeding sites. Most artificial heart surfaces were prone to clotting, a phenomenon known as mural thrombosis. Blood-borne infections originating within the device surfaces became a common, and deadly, occurrence. Devices were susceptible to mechanical or pneumatic failures/malfunctions that required constant attention. The pumping action resulted in destruction of red blood cells during the decompression period, resulting in life-threatening hemolysis, and, depending on their own initial conditions, patients would be subject to either hypertension or hypotension, which needed to be treated pharmacologically at bedside.
While homologous heart transplants require the use of anti-rejection drugs (such as cyclosporine), using biocompatible metals and immunologically transparent, medical-grade polyurethane elastomers completely avoided any anti-rejection reaction from the host. No immunologically derived problems have been reported.
However, the problem of mural thrombus bedeviled us. Thromboembolic complications in mechanical assist devices were widely reported (LEVINSON, SMITH, CORK, et al. 1986; DESPOTIS, SUMMERFIELD, JOIST, et al. 1996, p. 40; SPANIER, OZ, LEVIN, et al. 1996). Because thromboembolic complications were life-threatening, our team decided to "texture" all blood-contacting surfaces, to encourage the formation of a living pseudointimal lining. Our hypothesis was that a living lining, derived from the patient's own circulating blood components, would be permanently non-thrombogenic.
Following this hypothesis, we textured the blood pumping surfaces with sintered titanium microspheres on the titanium surfaces. Similarly, we used an integral fibrillar texture on the polyurethane diaphragm. This unique textured surface, the only textured blood pump surface in use clinically, promoted a thin, adherent coagulum that organized into a non-thrombogenic biological matrix.
Histologically, this neointimal surface was composed of acellular elements, mostly collagen, and cells derived from circulating progenitor cells differentiating into fibroblasts, myofibroblasts, monocytes, and even endothelial cells. This host-synthesized neointimal lining remained thin, avoiding excessive hyperproliferative deposition or pannus formation. The combination of this bioengineered hybrid surface, the use of tissue valves, and well-engineered blood flow pathways produced a biocompatible interface for blood. The clinical result was a low propensity for thrombus formation that only required low-level antiplatelet anticoagulation medication with aspirin (LONG 2001; SLATER 1996). FN> FN>
V. HOW DEVELOPING ARTIFICIAL HEARTS AND MECHANICAL ASSIST DEVICES INSTILLED A BELIEF IN G-D
While working on the development of an artificial heart, my team encountered a complexity totally unexpected from a medical standpoint. At the beginning of the 1980s the medical community widely believed that developing an artificial heart would be a simple affair, since the heart was considered to be only a "pump." That was the conventional wisdom at the time.
We were forced to rewrite the books on hematology, hemodynamics, cardiovascular technology, implantable electronics, cardiac telemetry, the role of coagulation in bacterial infection, and so on. This led to the inference that life is too complex to be explained by random chance, as proposed by simple evolutionary theory.
We found that science alone cannot explain the totality of the world, and as a consequence many of the members of my scientific team and myself began to believe in G-d.
VI. WILL STEM CELL THERAPY ELIMINATE THE NEED FOR HEART TRANSPLANTS OR MAD?
Despite advances in surgical procedures, mechanical assistance devices, drug therapy, and organ transplantation, more than half of patients with congestive heart failure die within five years of initial diagnosis. Research has shown that therapies such as clot-busting medications can reestablish blood flow to the damaged regions of the heart and limit the death of cardiomyocytes.
Researchers are now exploring ways to save additional lives by using replacement cells for dead or impaired cells so that the weakened heart muscle can regain its pumping power. Recent research is providing early evidence that adult and embryonic stem cells may be able to replace damaged heart muscle cells and establish new blood vessels to supply them. Researchers are focusing on both stem cell therapy and muscle regeneration strategies for repairing a damaged heart, and these could eliminate surgical interventions.
Researchers are building their knowledge base about how stem cells are directed to become specialized cells. They have proven that under highly specific growth conditions in laboratory culture dishes, stem cells can be coaxed into developing as new cardiomyocytes and vascular endothelial cells. Scientists are interested in exploiting this ability to provide replacement tissue for the damaged heart. This approach would have immense advantages over heart transplants, particularly in light of the paucity of donor hearts available to meet current transplantation needs.
VII. THE TRUE TRANSPLANTATION
We can pray to merit the true transplantation promised to us by the prophet Ezekiel:
And I shall give you a new heart, and a new spirit shall I put within you. And I shall remove the heart of stone from your flesh, and will give you a heart of flesh. (EZEKIEL 36:26)
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MICHAEL SZYCHER, PHD, MBA
Presented at the Eleventh Miami International Conference on Torah and Science at The Shul of Bal Harbour, Surfside, Florida, December 13, 2015
ABOUT THE AUTHOR
A successful serial entrepreneur, DR. MICHAEL SZYCHER has conceptualized, financed, taken public, and run three public companies and founded a fourth over the last forty years. As chairman and/or CEO of companies he has been responsible for public offerings, acquisitions, product introductions, and spinouts. He obtained an MBA from Suffolk University and a PhD in medical sciences from the Boston University School of Medicine.
Dr. Szycher has a long history of being awarded government contracts and grants. He developed a state-of-the-art battlefield wound dressing for the US Army, an artificial heart for the National Institutes of Health, and an antimicrobial catheter for military and civilian use. He has served as chairman of government review committees and is considered an international expert on polyurethanes. He wrote Szycher's Handbook of Polyurethanes, which has become the industry's standard reference.
(7.) UNESCO Chair in Bioethics. Teaching Ethics in Organ Transplantation and Tissue Donation. http://www.oapen.org/download?type=document&docid=400080
(8.) Glick, S. "Ethical Aspects of Organ Transplantation." https://www.jewishvirtuallibrary.org/jsource/Judaism/OrganEthics.pdf
(9.) Kitsur. See Talmud Shabbat 329:4 and Yoma 85a, which say that the nostrils must be checked to determine death. This is probably the basis for the rulings in the Shulhan Arukh 194:6, as well as Hokhmat Adam 151:8 and Matsevet Moshe, Hanhagat Ha'Hevrah Kadishah V'Ha'Avel 63.
(10.) Rabbi Yeshayahu Heber, a Jerusalem yeshivah teacher, became the head of the Gift of Life organization after he himself received a kidney donation. Since 2009 Rabbi Heber has matched over 360 dialysis patients with volunteer donors. Following the late Rabbi Elyashiv's ruling that organs should not be removed from brain-dead patients, Rabbi Heber arranges kidney transplants from volunteer living donors only. The Gift of Life organization strives to deepen awareness about kidney donation in the Israeli public and helps identify potential donors for dialysis patients. See: www.kilya.org.il/en; Jeremy Sharon, "Haredi Rabbi Promoting Kidney Donations to Alleviate Transplant Waiting List," Jerusalem Post, Jul. 20, 2015; Kevin Sack, "A Clash of Religion and Bioethics Complicates Organ Donation in Israel," New York Times, Aug. 18, 2014.
(11.) The Israeli Chief Rabbinate, Protocol Number 7, from the meeting of the Council of the Chief Rabbinate of Israel on Tuesday, 4 Tishrei, 5770 (September 22, 2009). Decision:
1. The Council of the Israeli Chief Rabbinate takes note of the survey of the progression of the process for the determination of the death of a human being since the decision of the Israeli Chief Rabbinate on the 1st day of Cheshvan 5747, up to the present.
2. The Council of the Israeli Chief Rabbinate confirms that The Respiratory-Brain Death Act enacted in the year 5768 (2008)--which was approved by the Knesset (Israeli Parliament) on the 17th of Second Adar 5768 (March 24, 2008), and became law on the 9th of Sivan 5769 (June 1, 2009)--meets the requirements of the Chief Rabbinate of the 1st of Marcheshvan 5747.
3. The Council of the Israeli Chief Rabbinate calls on the physicians to respect, as specified by the law, the position of families who do not accept respiratory-brain death as the moment of death of a person, according to the halakhic ruling of their Rabbis, and who ask that the patient remain attached to the respirator until the heartbeat ceases.
(12.) *Editor's note: In a telephone conversation with B'Or Ha'Torah on August 8, 2016, Rabbi Benyamin (Bernard) Walfish stated that in the early 1980s when he was the executive vice president of the Rabbinical Council of America (connected with the Orthodox Union), he asked Rabbi Joseph B. Soloveitchik (the doyen of Modern Orthodoxy) about the halakhic status of brain stem death. Based on what Rabbi Moshe Dovid Tendler had explained to him about the Harvard Apnea Test, Rabbi Soloveitchik said that in his opinion brain stem death can be considered a halakhic definition of death. Since Rabbi Walfish conferred with Rabbi Soloveitchik, more sophisticated tests have been developed to determine brain death. Currently, the RCA does not have a position on the halakhic status of brain stem death and heart transplantation. Other more stringent rabbinical councils, such as Agudat Yisrael, reject brain stem death as a halakhic definition of death.
(17.) "Cheney undergoes heart transplant surgery." Fox News, 24 Mar. 2012.
(18.) National Heart, Lung, and Blood Institute, National Institutes of Health. "What Is a Ventricular Assist Device?" http://www.nhlbi.nih.gov/health/health-topics/topics/vad. 9 Dec. 2016
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