Hand Transplant Patient Guide
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- Harvey Ford
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1 Hand Transplant Patient Guide Institute for Plastic Surgery 747 North Rutledge - Third Floor PO Box Springfield, IL Phone:
2 What is a Hand Transplant? A hand transplant is surgery that attaches the hand and portions of the arm from a deceased donor to another person. It may also describe the entire upper extremity, up to where the shoulder and arm meet. You may hear terms such as below elbow or above elbow. These refer to the extent of the amputation if it is below or above the elbow. Recipients of hand transplants have experienced the return of critical hand functions. More importantly, though, they have regained their sense of touch, which is something that prostheses cannot provide. Why do a Hand Transplant? The procedure of hand transplantation is a new method to restore the single dominant hand or both hands of amputees. However, this procedure is new and not without significant risks. Therefore, hand transplantations are usually performed as part of a research study. The hand transplant team at the Institute for Plastic Surgery at Southern Illinois University School of Medicine (SIUSOM) is conducting a research study to find out more about the results of hand transplantation. We are studying people who have suffered amputation of their single dominant hand or both hands at any level below the shoulder joint. We hope this research study allows us to learn about how to do a hand transplant in the best possible way and how to stop the body from rejecting the transplant. In this study, eligible patients have already lost their hand(s) and perhaps a significant portion of the arm(s). Some patients may have lost only the hand itself, while others may have lost the entire arm below the shoulder. Most patients in our study have used different kinds of prostheses, and some have tried traditional limb reconstruction, with unsatisfactory progress. The transplantation of one or both hands from one person (the donor) to another (the recipient) is a new surgical procedure for patients with amputations. Long-term effects of this method are unknown, but our past experience with replant patients (patients who have had their own limbs reattached) and information about current transplants are encouraging. Research shows that all modern hand transplant patients gained protective sensation in their transplanted hands (the ability to tell if something is hot or sharp, for example); and 84% of patients recovered their discriminatory sensation (the ability to tell textures and figure out what an object is without looking at it). These patients have had enough muscle recovery in their transplanted hands to perform daily activities, such as eating, writing, using a telephone, driving, and riding a bike or motorbike. A majority of patients reported improved quality of life after transplantation, with going back to work being a strong predictor of satisfaction. However, we do not know how easy it will be to find tissue donors for this purpose in the local area. There are many different colors and textures of skin, so it might be hard to find a perfect match. In addition to the actual surgery, we will also examine the transplant drugs to find the best medications to prevent transplant rejection. Normally, the body treats any new organ or tissue as an invader, like a germ, and tries to destroy it. Transplant drugs, however, partially shut down the immune system so that the body can accept the new organ or tissue. Patients may have to take these strong drugs for the rest of their lives to prevent rejection of the transplant. This is a research study. The purpose of this research study is to investigate the outcomes of hand transplants, along with the standard combination of immune system suppression medications. We are doing a study on a small group of patients to learn more about the hand transplant procedure and what we can do to prevent rejection of the new tissue. Study Requirements The age requirement for participation in the study is between 18 and 60 years. Patients must be strongly motivated to proceed with the transplant and dedicated to continue with extensive hand therapy for at least two years after the transplant. Patients must also be willing to take drugs that help prevent rejection of the transplant, called immunosuppressants, for the rest of their lives. Finally, pregnant women cannot participate, as the transplant drugs may harm an unborn baby. Women who are pregnant must wait until at least six weeks after the completion of their pregnancy before a transplant can be considered. 2 Each patient considering a hand transplant in our program has to go through a screening process that could require several visits to our clinics. During this time, the patient will meet with various specialists on the hand transplant team. The purpose of the screening is to find out whether a patient is a suitable candidate for hand transplantation. The hand injury, overall
3 3 physical condition, and mental health of each potential participant will be thoroughly assessed. These evaluations include various blood tests, imaging tests, and appointments with physicians, nurses and other professionals from many different medical specialties. Screening results may identify potential participants as ineligible, so not every person interested in the procedure will meet the requirements to enter the study. Pre-and Post-Operative Procedures Patients enrolled in the study will have several different examinations before and after the procedure. These exams are important to plan and prepare for the procedure, monitor for complications, and evaluate the results. We also want to make sure that all patients accepted for the procedure have the necessary social/family support and overall ability to cope with the different psychological and practical aspects of this procedure. X-rays and other imaging will be performed before and after the transplant surgery. Some of these tests are invasive (require minor surgical procedures), and some are non-invasive. Prior to transplant, patients must have a formal angiogram of their amputated limb(s) in order to provide the location of the arteries and veins in the injured area(s). The patient is put to sleep, and a temporary IV is inserted into the blood vessel near the groin, which injects a special dye into the bloodstream to give a picture of the arteries and veins. In addition, patients will need non-invasive imaging studies, like CT (CAT scan) and magnetic resonance imaging (MRI), to provide images of internal tissues, nerves, and blood vessels. We will also perform a test called functional MRI (fmri). The functional MRI measures brain activity and blood flow when the patient moves, sees, hears, speaks, reads, or remembers. The muscles and tissues of the hand are involved in most of our daily activities, so we are interested in how the brain adapts to injury and subsequent repair of the hand though transplantation. This test may show changes in the brain that result from the gradual return of feeling and motor activity in the hand. It is done like a normal MRI but focuses on the brain instead of the body. We have also included two tests, electromyography (EMG) and nerve conduction study (NCS), that measure the electrical activity in the arm muscles and nerves. During EMG, small needles are inserted into the muscles, which may be mildly painful. However, these needles are much thinner than the needles used for shots, and there is no injection of fluids, so the discomfort is much less than when getting a shot. The needles are also disposable, so there is no risk for infection. During NCS, small electrodes are placed on the skin. There is a brief, mild shock, which may cause discomfort, but most people find it only slightly uncomfortable. Muscle activity is monitored through a speaker during the test, which may make a popping or soft roaring noise. There will be no restriction of activities after having these procedures. Finally, we will use an ultrasound machine to provide additional information about the structure of the blood vessels in the amputated extremity. During this test, a special gel is applied to the skin on the arm(s), and a transducer wand is passed back and forth. There may be some pressure from the wand, which may be uncomfortable, but it should not cause any pain. Surveys are included to measure changes in the way the participant uses and thinks about his or her limbs. Quality-oflife surveys will be used to measure the participant s feelings of health and well-being. The surveys will be given at the time of listing on the transplant list, approximately every six months while the patient is on the list, and periodically after transplantation. The Hand Transplant Procedure Local organ banks will find donors for hand transplantation in the same way they do for solid organ transplants, like kidneys or livers. The search may take days or weeks, but, more commonly, months. If we have not located a suitable donor within one year, then we will talk with the patient to make sure they still want to take part in this study. Upper extremity donation is the result of a generous gift by the family of a recently deceased individual. Local organ banks screen for a variety of diseases (viral and bacterial) and health conditions (like rheumatoid or osteoarthritis), as well as testing of tissues and blood to make sure the donated tissues match the recipient s tissues. Additional characteristics are reviewed for hand transplants, as well. Since the transplant area is highly visible, special effort is made to match skin color, skin tone, hand size, and arm and finger length as much as possible.
4 Once a donor is found, we will contact the patient with instructions about when to arrive in for the operation. The timing is very important, and the transplant staff should be able to reach the patient at all times. The total travel time for the patient to reach our local hospital cannot be over 12 hours. Hand transplantation requires that the recipient be under general anesthesia (fully asleep) for a long period of time. Prior hand transplantation procedures have taken anywhere from 10 to 24 hours to complete, depending on whether the procedure involves one or both hands. Once the recipient patient is asleep, the amputated limb(s) are prepared to receive the donor hand(s)/arm(s). This portion of the procedure is performed by one or two surgical teams, depending on the number of limbs involved. At the same time, one or two additional surgical teams begin harvesting the donor limb(s) while the recipient preparation procedure is taking place. Depending on where the donor patient is located, the limb harvest may or may not be performed at Memorial Medical Center in Springfield, IL. At times, the organ donor is located at a separate hospital. In this case, one or two surgical teams travel to the donor s location, obtain the limb(s), and transport the donor limb(s) back to our transplant hospital. Or, surgeons at the external site detach the limbs and arrange for transportation to our local hospital. Once both the donor and recipient limbs are ready, the transplantation procedure is performed. Hand transplantation includes the transfer of soft tissues and bone from the donor to the recipient. The survival of the transferred tissues depends on the success of re-establishing blood circulation by connecting blood vessels of the hand transplant to the recipient s vessels. Nerves also are connected to allow for the return of sensation and movement of the hand, along with muscles and tendons. Surgeons use microscopes to connect the tissues. After the surgery, the patient is closely observed in the Intensive Care Unit (ICU) and then moved to a private transplant room on a patient floor. Different specialists on the transplant team will follow all aspects of the patient s gradual recovery. A physical/hand therapist will start working with the patient shortly after surgery to develop splints to stabilize the area and exercises to rehabilitate the hand(s), and a psychiatrist or counselor will help with any psychological concerns. The hospital stay may last approximately 7 to 14 days, but it could be up to 21 days total. Follow-up Care After discharge from the hospital, patients will come to SIUSOM and/or Memorial Medical Center for routine visits. Close observation and a demanding test schedule helps monitor for any complications and evaluates the results of the procedure. We will provide patients the help and support needed to cope with the psychological and social changes that result from this procedure. Patients will visit the Institute for Plastic Surgery s Hand Therapy Center for therapy several hours a day, every day, during the first several months. Hand therapy is very important for the recovery of the transplanted hand(s). The rehabilitation program is difficult, and progress is usually slow. Highly trained hand therapists will help the patient during the rehabilitation process. Support from the patient s family, psychiatrist/counselor, and therapist will be important to maintain the patient s motivation. Other follow-up visits will include checking transplant drug levels through regular blood draws; taking small tissue samples from the transplanted hand to look for any signs of rejection; monitoring the transplanted hand for the return of sensation and mobility; imaging tests to see the connections between the tissues; and quality-of-life surveys. In order to make the intense follow-up feasible, we highly recommend that our patients reside in the Springfield area for at least three months after the procedure. When the hand transplant has fully stabilized, patients will continue to make regular visits to the Institute for Plastic Surgery for progress checks. The planned visits will be less frequent, and some check-ups may be done through video conferences with collaborating medical centers closer to the patient s home. As with any organ transplantation, hand transplant patients will need to reside near a qualified medical center for the rest of their lives. Medication and Monitoring 4 Hand transplant patients need to take several different medications on a daily basis. The most important ones are the different types of medications that suppress the immune system. The blood level of these transplant drugs will be monitored by regular blood tests. Any signs of side effects will be closely checked. It is important that all transplant patients, for any organ or tissue, closely follow instructions for these medications and keep their follow-up appointments.
5 Drug doses that are too high may cause serious side effects, and drug doses that are too low may cause rejection of the transplant. The risks and side effects of these medications are described below. Unfortunately, if the hand transplant is completely rejected by the patient s immune system, the transplanted tissues will have to be removed. This has happened in two cases when patients did not comply with their medication regime. If this happens, the surgical team will discuss different treatment options with the patient. Other options include conventional reconstructive hand surgery according to an already prepared plan or another hand transplant at a later time. Publicity and Privacy Because this type of transplant is so new, it is likely that the news media will be very interested in both the donors and the people who receive the transplants. We will make every effort to protect the privacy of our patients. Despite this, the press may still find out the names of both the donor and recipient. This may cause emotional problems, including the stress and anxiety that come with such a loss of privacy. Risks and Discomforts There are psychological risks and discomforts associated with participation in this study, as well as the physical risks of the actual surgical hand transplant procedure and associated medications. General Transplant Risks The risks of the transplant surgery are the same as any surgical procedure and include pain, bleeding, swelling, scarring, infection, delayed healing, blood clots, complications with anesthesia, and death. Transplant patients may also have the following challenges: Stress relating to medical procedures, Difficulty following the strict medication dosing required after the operation, Difficulty understanding the lists of complicated side effects and risks of the required drugs that stop your immune system from working normally, Depression, anxiety, and mood swings before or after the transplant surgery, Psychological changes before or after the procedures that may include changes in self-identity, difficulty coping with body image, and stress relating to other new feelings and thoughts, and Stress caused by fear of transplant failure. We will provide psychiatric support to all patients before and after hand transplantation. This support will help the patients to cope with this life-changing event and learn to live with the changes, both positive and negative, that it brings. Changes in self-identity and body image are common, and a support system helps patients deal with these new feelings about themselves. Risks of Taking Transplant Drugs for a Lifetime The transplant medications, which suppress the immune response and thus prevent rejection of the transplanted tissue, have multiple side effects: Infections: Patients will receive certain vaccinations prior to transplant (pneumococcal vaccine, flu vaccine, etc.) to prevent infections. 5
6 Medications that prevent the occurrence of infections will be given at the time of the procedure and for some time afterwards. Diabetes: Some of the transplant drugs may increase risk of diabetes. Blood sugar levels will be monitored and, if needed, antidiabetes medication will be given. Cancer: Certain cancers are more common in people who have undergone transplantation. This probably happens because, after the transplant, the immune system is not as effective at eliminating very early cancer cells. Please note that most transplant patients do not develop serious cancers. Some cancers that are more common after transplant are those of the: Skin (especially in white people) Lymph glands Cervix (of the uterus) in women To minimize the chances of having cancer before a transplant, all patients will receive the following medical screening: Patients over 50 years will have a colonoscopy (screening test for bowel cancer). All men over 50 years will have a PSA (screening test for prostate cancer). Because prostate cancer is more common in African-Americans, they should have a PSA if age is over 40 years. All women over 40 years will have a mammogram. All women will have a Pap smear. Kidney failure: Immunosuppressive medications may harm kidney function. A small number of transplant patients experience kidney failure and require dialysis because of these medications. Therefore, it is very important to test kidney function during the regular visits and possibly change medications to prevent kidney failure from happening. Blood or urine tests can check the health of the kidneys. The lifetime risk of losing kidney function is unknown, but we believe that it should not exceed 10 percent. Benefits of Hand Transplantation We do not know if hand transplants will have more long-term success than the use of prostheses. We are optimistic, but there is no guarantee. Although the experience with the existing hand transplants in the world has been good, there are still few patients who have had the procedure done, and their success does not guarantee the success of others. We hope that this procedure will allow patients to regain independence by having functional arms/hands. In addition, we hope that the information learned in this study will minimize the need for immunosuppression and will provide additional knowledge that can be shared with other patients who receive hand transplants in the future. 6
7 Contact Information: Michael W. Neumeister, MD Principal Investigator Institute for Plastic Surgery Southern Illinois University School of Medicine 747 North Rutledge PO Box Springfield, IL Phone: Funding provided by the Memorial Medical Center Foundation, Springfield IL. Adapted from informational handouts with permission from Brigham & Women s Hospital 7 and University of Texas Southwestern.
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