CONSENT FORM
The following information is provided in order to help inform you of the heart transplant evaluation procedure including the purpose, treatment course, and potential risks and benefits. If you have any questions, please do not hesitate to ask. You are ready to be evaluated to see if you are a candidate for heart transplantation. In order to decide whether or not you should agree to this treatment plan, you should understand enough about its risks and benefits to make an informed judgment. This consent form gives detailed information about the evaluation, some of which the transplant team has already discussed with you or will be discussed during your evaluation. Please be aware that you have the right to review with your transplant team any part of this consent that you do not understand. Once you have read this consent and have had all your questions answered, you will be asked to sign this form at the time of the evaluation if you wish to proceed. You will be given a signed copy of this consent form for your records.
PURPOSE
Because you have been diagnosed as having end stage cardiac disease, a heart transplant evaluation has been recommended to see if heart transplantation is the best treatment option for you. The purpose of heart transplantation is to restore a meaningful quality of life to you, as well as extend your life.
Inclusion criteria include:
SELECTION CRITERIA
· End-stage cardiac disease defined by New York Heart Association Class III/IV with limited expected survival of less than 1 year.
· Age generally less than age 65.
· Absence of systemic disease or infection.
· Psychosocial stability and supportive family/social structure as defined by social assessments.
· No expectation of improvement with alternative medical or surgical treatment.
Exclusion criteria include:
· Sepsis or active infection
· Irreversible renal or hepatic dysfunction – consider dual organ transplant for renal failure.
· History of chronic noncompliance
· Recent pulmonary infarction – delay activation
· Extensive peripheral vascular disease
· Evidence of end organ damage due to diabetes (retinopathy, nephropathy, neuropathy).
· Severe Chronic Obstructive Pulmonary Disease
· Active mental illness or psychosocial instability
· Evidence of drug, tobacco or alcohol abuse currently or within the past six months.
· Obesity (>150% IBW or BMI > 42)
· Severe pulmonary hypertension as evidenced by a fixed pulmonary vascular resistance of greater than 4 Wood units.
· Malignancy – varies by type and date of diagnosis
Patient Initials
Date Time
EVALUATION
The evaluation consists of a series of examinations and tests conducted to determine that you are otherwise healthy and free of other serious problems which would limit the success of a transplant. Part of this evaluation includes assessing your personal support system and your previous medical compliance, as well as providing you information about your financial obligations.
The evaluation may reveal certain conditions which need to be corrected before transplant surgery. It could also reveal certain conditions which would make the transplant surgery a poor choice. We understand that you will be undergoing many unpleasant and frustrating tests. We understand that, but will be concerned if you show a lack of cooperation or lack of commitment to the process. We are looking for you to be willing to take an active role in your health care. This will play a major role in recovery after surgery.
Most evaluations are done while you are in the hospital, although part may require you to see some physicians or have some tests after you have been discharged. During the evaluation, you will see many different people who function as part of the heart transplant team.
The transplant nurse coordinator will provide you and your family with a patient education manual with information about heart transplantation and the evaluation process. Along with the physicians, she will keep you informed about the results of the tests and procedures.
The transplant cardiologist will oversee your care. This doctor may be different from the cardiologist who is taking care of you during your stay. The transplant cardiologist has special knowledge, training, and interest in heart transplantation.
The transplant surgeon is the doctor who will perform the operation. We have several surgeons who perform heart transplants and you will meet one of them during this evaluation.
The transplant social worker will assist you in your social and financial concerns of living with a new heart. She will talk with you and your family about home health needs, family support, insurance concerns, and financial obligations and needs.
The psychiatrist, psychologist, or psychiatric nurse practitioner will talk with you about any emotional or psychological concerns that you may have now or have had in the past and potential stresses that you may incur related to the evaluation and possible transplant. Psychological concerns about the waiting period, operation and follow up care may be discussed at this time.
The pulmonologist, or lung doctor, will examine your lungs to ensure that they are healthy, since healthy lungs are required for a new heart to function.
One of the infectious diseases physicians will visit you. This doctor will talk with you about your childhood and adult diseases, any serious infections that you may have had, travel, pets, and your environment.
You will need to see the oral surgeon or your dentist. Oral hygiene is important since infections in the teeth and gums can travel to the heart. If you have dental problems which cannot be repaired, the dentist or oral surgeon may recommend that all of your teeth be pulled. This would need to be done before transplantation.
Patient Initials
Date Time
An up to date Pap smear and mammogram are necessary for our female patients. If these have recently been done, you may have the reports sent to us. If not, we can arrange to have them done here.
Our male patients need to have a recent PSA (prostate screening test) and a recent prostate exam. If these have been recently done, you may have the reports sent to us. If not, we can arrange to have them done here.
Depending upon your previous medical history, there are other physicians you may need to see. Some of the possibilities are listed below:
· The endocrinologist specializes in the care of diabetic patients. If you are diabetic, you will see the endocrinologist.
· If you are diabetic, you will also see an ophthalmologist (eye doctor) who will examine your eyes for symptoms of advanced diabetes.
· If you are diabetic, or have had previous kidney problems, you may be seen by the nephrologist (kidney specialist).
· If you have had ulcers, stomach, or bowel problems, or are over the age of 50, you will be examined by the gastroenterologist, who is a specialist in the care of esophagus, stomach, and intestinal problems.
· The neurologist specializes in diseases of the brain. If you have had seizures, stroke, or difficulties involving the brain, you may see this doctor.
EVALUATION TESTS AND PROCEDURES
Many tubes of blood will be drawn at the time of the evaluation. These include testing for blood type, tissue type, hepatitis, kidney function, liver function, syphilis, and chickenpox.
You may have a drug or tobacco screen done. You will also have an HIV or AIDS blood test.
· AIDS, or Acquired Immune Deficiency Syndrome, is a disease that causes the body to lose its natural immunity to
certain infections.
· AIDS is caused by the HIV virus. The HIV virus can be transmitted from person to person through sexual contact, exposure to or sharing of contaminated intravenous needles and through exposure to infected blood or its components. Certain behaviors, including sharing drug needles, practicing unprotected sex (without a condom) or any exchange of infected blood, semen or vaginal fluids, increases a person’s risk of acquiring HIV.
· When infected by a virus, the body produces substances called antibodies to fight off the infection. The blood test shows if you have antibodies to HIV, the virus that causes AIDS.
· A screening test (called the ELISA test) will be performed on a sample of your blood. If that test shows that you have HIV antibodies, an additional confirmation test (called the Western Blot) will be done on the same blood sample to make sure the first test was correct.
· The accuracy and reliability of the HIV test is uncertain. (HIV antibody testing is considered to be quite accurate but not 100%). A negative test means that you are probably not infected with the virus, but does not conclusively exclude the possibility of infection with the virus. A positive test usually means that you have been exposed to the virus but does not mean that you have AIDS or will develop AIDS in the future. In addition, false positives may occur. Your physician or designee will notify and explain the results to you.
· State law requires positive HIV test results to be reported to the state Department of Health. XXX, to the best of its ability, will not disclose the results of these tests to others except to the extent required by law.
Patient Initials
Date Time
You will receive two skin tests - one on each forearm - one is for mumps and the other is for tuberculosis. These will need to be checked 24 and 48 hours after they are given. If you will be discharged from the hospital before that time, you will need to make arrangements with your family doctor to check your arm and send us the results of the test.
If you have not had a flu shot for this year, nor a pneumonia vaccination in the past six years, you will receive those.
Pulmonary function tests which measure your lung capacity will be done. You will go to another department in the hospital to have these done.
Your urine will be saved for 24 hours to do a special test of kidney function. The nurse will place a jug in a pan of ice in your bathroom. Every time you urinate the specimen must be put into the jug. If any is discarded, the test must be started over.
You will be sent to the radiology department for a chest x-ray and a panorex (teeth and jaw x-ray). An abdominal sonogram will be done - it is a sound wave test which will look at your gallbladder, kidneys, liver, and abdominal aorta.
You may go to the vascular laboratory to have a sound wave test of the arteries in your neck and the ones in your legs. These tests are called carotid duplex and peripheral vascular doppler studies. This test is not painful.
The gastrointestinal doctor may decide that you need tests to look at your stomach or your colon. These tests will be done in another department called the GI laboratory. Preparation for these tests includes cleansing the bowel and not being able to eat or drink for several hours. The preparation can be frustrating and uncomfortable. You will be sedated for the actual procedure.
Last, but not least, you will need some studies of your heart. You may have recently had some of them done, and not every patient needs every one of these tests.
· Electrocardiogram (ECG)
· Right heart catheterization to measure the pressure in the right side of your heart. This is different from the cardiac cath you may have had which looks at your coronary arteries for blockages. Preparation for a right heart catheterization involves not being able to eat or drink for several hours. After local anesthesia, the cardiologist places a tube into a vein in either the neck or groin and then will insert a measuring type catheter into the tube. Depending upon the results of the test, this catheter may be removed or it may be left in for additional measurements. When the test is finished, a dressing will be placed over the site. If the tube is removed, you will be returned to your room. If it is left in, you will be moved to the intensive care unit (ICU). Possible complications of the right heart catheterization include, but are not limited to, bleeding and change in heart rhythm.
· Echocardiogram (Echo). This is a sound wave test of your heart.
A test of your oxygen consumption may be scheduled either while you are in the hospital or shortly after you leave. It is called a MVO2 test. This is done in the pulmonary lab and takes about an hour. You will either walk on a treadmill or ride a bicycle and breathe into a machine. This test measures your exercise capacity.
Patient Initials
Date Time
While these tests and procedures are in progress, the nurse coordinator will visit you regularly to keep you informed of the results. After the tests are completed, you may be discharged from the hospital before all of the results are available. The decision about your suitability for transplantation is made by the transplant team after all of the results of the tests are gathered. Each case is examined individually and many factors are weighed before a final decision is made. The nurse coordinator or the cardiologist will notify you after a decision is made. The cardiologist will also correspond with your primary care physician.
If you do not have a primary care physician, this is a good time to get one. You will need to check with your insurance company for a list of physicians. If you need help in choosing, please talk with the social worker or the nurse coordinator.
RISKS
Blood Draws - When you have your vein stuck directly with a needle to draw blood, you may feel slight discomfort and have a small amount of bleeding or bruising at the site where the needle is inserted. A small risk that you could get an infection or clot in the vein exists with any blood collection.