Download listing consent for heart transplant

Heart Transplant Program
LISTING CONSENT FOR HEART TRANSPLANT
CONSENT FORM
The following information is provided in order to help inform you of the heart transplant 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 placed on the waiting list to receive a donor heart. 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 treatment, some of which the
transplant team has already discussed with you or will be discussed at your listing. 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 listing if you wish to proceed. You will be given a copy of this consent form for your records.
PURPOSE
Because you have been diagnosed as having end stage cardiac disease with no options for other surgical or
medical therapy, a heart transplant has been identified as the one remaining 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.
SELECTION CRITERIA
The following information on selection criteria has been provided and discussed with you at the time of your
evaluation and was included in the evaluation consent that you signed.
Inclusion criteria include:
 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
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LISTING CONSENT FOR HEART TRANSPLANT
WAITING PERIOD
There is no way to know when a donor heart will become available. There is a system in place through United
Network for Organ Sharing (UNOS) to ensure that all patients in need of a heart transplant are given fair and
equitable access to available donor organs. UNOS coordinates efforts among donor hospitals and transplant
centers throughout the country to allocate donated organs for transplantation. After the donor heart is matched for
compatible blood type and body size, it is allocated to the sickest patient with the longest waiting time who is
closest to the donor heart. From the time you are placed on the waiting list, you need to be ready to receive a
transplant. At some point during the waiting period, you may become too sick to receive a transplant. This could
be a temporary condition in which you can get better and go back on the list, or it could become a permanent
condition where you will no longer be eligible to receive a donor heart. If either of these happens, they will be
discussed with you at that time. If your listing status is changed at any time during the waiting period, you will be
notified of this change and the reasoning for it will be discussed with you. All reasonable efforts will be made to
accept a suitable donor organ for you. There may be a time due to bed availability, surgeon availability, weather,
or some other unforeseen circumstance when a donor heart suitable for you may have to be turned down. There
is no guarantee that a suitable donor heart will ever be located.
You could also clinically deteriorate to the point where IV medications cannot keep you alive to wait for a heart. At
this point you may need one or more of the following three mechanical means of keeping you suitable for a
transplant:
 Intra-Aortic Balloon Pump (IABP) – This is a metal wire with a small balloon attached to it and is inserted
through an artery in your groin. It is placed in the main artery leading to the heart. The end of the wire
remaining outside of your body is attached to a machine which will help push blood through the heart and
body each time the machine pumps. You will receive sedation and local anesthesia for the insertion of the
device. It is a temporary means of stabilizing your condition. You must remain in bed while this device is in
place. You have the right to refuse to have the IABP placed, at which point you will likely die.
 Ventilator (Vent) – This is a device that breathes for you when you are unable to breathe on your own. It is
also used immediately after surgery until you are awake and able to breath on your own. To be placed on a
vent, you will have a large tube inserted through your mouth into your airway. The tube is then connected to
the ventilator. For insertion of this tube, you will receive sedation. You will not be able to speak while this
tube is in place. You will most likely have to remain in bed while this device is in place. You have the right to
refuse to be placed on the ventilator, at which point you will likely die.
 Ventricular Assist Device (VAD) – This is a device or devices that may be used to support right heart function,
left heart function, or both at the same time. Implantation of ventricular assist devices requires major cardiac
surgery with having your breastbone opened and being placed on the heart-lung machine. Tubes for these
devices go into the aorta and ventricle(s) of the heart – the pumps attached to the tubes may be either
implanted into your chest or left outside your chest. Rarely can these pumps be removed for any reason other
than transplant. Once you have a VAD, it will remain implanted until you are either transplanted or die.
Possible complications include but are not limited to bleeding, need for blood transfusions, infection, stroke,
any major organ system failure, and death. After insertion of this device(s), you may not be eligible to be
placed on the list for a transplant for several to many months, and may experience complications that will
prevent you from ever being eligible to being placed on the list. You will be able to get up and around once
you have recovered from the operation and may even be able to go home with the pump, depending on which
one you have. Prior to insertion of this device, the surgeon will discuss any additional potential risks or
Patient Initials
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LISTING CONSENT FOR HEART TRANSPLANT
complications with you or your family. You have the right to refuse having a VAD or VADs implanted, at which
point you will likely die.
RISKS
Please refer to your patient education manual for further information related to the transplant operation, other
procedures, and possible complications.
Donor Selection - Before the transplant, both you and the potential donor will be tested for hepatitis and several
other viruses including HIV (the virus that causes AIDS). Potential donors go through a rigorous screening
process to ensure that their organs are appropriate to be transplanted. Despite this process, donors are
representative of the general public and may have risk factors that potentially could affect your long-term health,
including, but not limited to, the donor’s history, age, or their potential risk of contracting the HIV virus and other
infectious diseases that cannot yet be detected.
High Risk Donor – When an appropriate donor heart has been accepted for you, we may inform you that
the donor is considered “high risk” for transmission of HIV, as defined by the Centers for Disease Control
and Prevention (CDC). The CDC criteria for this high risk group are including, but not limited to, male to
male sexual contact, sexually transmitted diseases, needle tracks or other signs of intravenous drug
abuse, known contact with persons exposed to HIV-infected blood, and inmates of correctional systems.
Be assured that if we have accepted this heart for you with this remote risk, we have considered the risks
and benefits specifically to your case.
Transplant Operation – One of the heart transplant surgeons has discussed the surgical risks of the transplant
operation with you. As with any cardiothoracic surgery, there are potential risks, including, and not limited to,
bleeding, need for blood transfusions, infection, stroke, any major organ failure, and/or death. You will sign a
consent for the heart transplant surgical procedure immediately before transplant. The risks associated with
general anesthesia will be specifically discussed with you by your anesthesiologist at the time of your transplant.
After you are taken to the operating room, it will take about half an hour until you are given general anesthesia.
This half hour will be spent preparing you to receive your new heart. After you are asleep, the transplant team
begins your surgery. An incision is made down the center of your chest and the breastbone is opened. At the
proper time, you will be placed on the heart lung machine which will mechanically take over the function of your
heart and lungs during the surgery. After your donor heart arrives in the operating room, most of your old heart will
be removed. A portion of the left and right atria are left to attach your new heart. During the process of removing
your old heart, connections of the nerves to the heart are cut. After surgery, it will take a very long time for
some of the nerves to grow back. In most patients, they never do. More importantly, these nerves help regulate
your heartbeat. After surgery you will have small pacing wires attached to your new heart. The wires will come
out through the skin and may be attached to a small box called a pacemaker. These wires are temporary and
will be removed before you leave the hospital. During your operation, your family will be updated regarding your
progress. The average transplant operation takes about four to five hours. When the surgery is finished, the
surgeon will come to talk with your family. Your family will be allowed to see you in the intensive care unit, but not
visit in your room until you are awake. It will be about an hour before the nurse will call your family to come see
you.
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Biopsies – A biopsy of the heart muscle is the only way to accurately diagnose rejection. You will experience
biopsies on a scheduled basis, more frequently the first six months after transplant. Clinical suspicion of rejection
may mean that you require a biopsy on an unplanned basis. To do a biopsy, the cardiologist will first inject the
area on the right side of your neck (or in your groin) with a local anesthesia, which will sting. He will then insert a
tube into your neck (or groin) and thread a biopsy forcep through the tube into the right side of your heart. He will
take four or five small tissue samples, called biopsies. You may feel your heart fluttering, or occasionally tugging,
but this is not painful. When the biopsies have been obtained, the biopsy forcep and tube will be withdrawn, and
a bandage placed over the site. Complications of a biopsy are very rare and include a hole in the heart or your
heart changing into a different rhythm.
Blood Draws - Whenever possible, blood will be drawn at the time of your biopsy. 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.
Risk to the Unborn – Because of the immunosuppressive and other drugs that you must take following a heart
transplant, it is not recommended that female recipients become pregnant. Males who have had a transplant can
father children.
Rejection – Many patients experience at least one rejection in the first three months after transplant. A change in
medication is usually enough to reverse the rejection although rejection can be fatal. The incidence of rejection is
never zero. There are no specific signs and symptoms of rejection. You cannot do anything to cause rejection
EXCEPT not take your medication as prescribed.
Infection – Because your immune system is suppressed with medicines, you are at increased risk for all types of
infections. Risks of infection include wound infection at the time or surgery, pneumonia, or one related to any of
the tubes you will have at the time of surgery. The risk of infection is the greatest in the first few months after
surgery, but risk remains throughout your life. Although with treatment you can recover from most infections,
sometimes infection results in death.
Graft Arteriosclerosis – This is the development of coronary artery disease in your new heart – even though you
did not have coronary artery disease before transplant, you may develop it in your new heart. This is different
than regular coronary artery disease which consists of a distinct narrowing in one part of a blood vessel. Graft
arteriosclerosis is a narrowing of the blood vessel throughout the length of the vessel – the entire lumen of the
vessel becomes smaller. Diet, exercise, and control of cholesterol can help in reducing the chance, but you can
still develop it. Occasionally some patients with graft arteriosclerosis can be treated by placing a stent in the
coronary artery. Coronary artery bypass surgery is almost never an option. Occasionally a patient with graft
arteriosclerosis may be a candidate for a second transplant. You can live for several years with graft
arteriosclerosis, but it may also be fatal in a short period of time.
Osteoporosis – This is weakening of the bones due to the steroid Prednisone that you take to help prevent
rejection. Osteoporosis can lead to compression fractures of the bones in your back, or may result in the need for
replacement of joints such as hips, knees, or shoulders.
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Cancer – After a transplant, you are at higher risk for developing cancers due to being on immunosuppressive
medications. Skin cancer is the most common type, followed by lymphoma – a cancer of the lymph system. You
can also develop any other type of cancer – breast, lung, colon, prostate, brain or others. Other than some skin
cancers, cancer in a transplant patient is nearly always fatal.
Psycho-Social – Heart transplantation is stressful for both you and your family. You may experience stresses
related to and including, but not limited to depression, body image changes, changes in inter-personal
relationships, and finances. The social worker and transplant financial specialist can help you deal with these.
Medications – for information on additional medications, please refer to your transplant education manual.
 Tacrolimus or Cyclosporine- This medication will cause immune suppression with increased risk of infection
and may also cause kidney and liver damage, headache, tremors in hands, an imbalance of sodium and
potassium (electrolyte) levels, and high blood pressure.
 Mycophenolate – This medication will cause immune suppression with increased risk of infection and may
also cause low white blood cell counts, stomach upset, or diarrhea.
 Prednisone/Methylprednisolone - This medication will cause immune suppression with increased risk of
infection and may cause fluid retention, weight gain, high blood pressure, high blood sugar, increased
appetite, mood changes, loss of calcium from bone (osteoporosis) with increased risk of broken bones, and
erosion of the bone (bone damage). Diabetes or vision abnormalities (cataracts) are rare, but may occur.
 Thymoglobulin - This drug will cause immune suppression with increased risk of infection, allergic reactions,
fever, muscle pain, joint pain, and rash. It is used specifically to treat rejection and is not an everyday
medicine.
BENEFIT
When the heart transplant is successful, you may experience improvement in your quality of life and a longer
lifespan. Currently, according to SRTR, the Scientific Registry for Transplants, patient and graft survival rates for
heart transplantation are as follows:
 National one year patient survival rate
%
 National one year graft survival rate
%
 Our program one year expected survival rate
%
 Our program one year actual survival rate
%
 Our program one year expected graft survival rate
%
 Our program one year actual graft survival rate
_%.
Date _/
ALTERNATIVES
If you choose not to proceed with transplantation, you may continue to have the current medical treatment that
you have now. You may also choose to receive no treatment for your disease, in which case your doctor will
continue to provide care to you.
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LISTING CONSENT FOR HEART TRANSPLANT
CONFIDENTIALITY
We are required by law to maintain the privacy/confidentiality of your health information. All information that is
obtained in connection with this procedure, which can be linked to you, will remain as confidential as possible
within the requirements of state and federal law. The results of this procedure will be reviewed and may be
published in a scientific journal or book without identifying you by name. Records will be kept regarding this
procedure and will be made available for required reviews/audit by representatives of the Food and Drug
Administration (FDA), members of XXX heart transplant program, members of the Heartmate/Thoratec Register,
and representatives of United Network for Organ Sharing (UNOS) under the guidelines established by the
Federal Privacy Act. Federal and State reviewers/auditors may also have access to your medical records, which
contain your identity however they are required to maintain confidentiality. Your insurance company may also
review your record.
LIABILITY AND COMPENSATION
Adverse complications and outcomes are possible in any transplant procedure despite the use of high standards.
Complications and outcomes that we are aware of are described in this consent form. However, we are unable to
predict all complications that may occur and could require care. Sometimes, despite all the best efforts by both
you and the heart transplant team, unexpected complications or outcomes occur. If you become sick or hurt
because you received a transplant, the hospital and doctors will treat you. The hospital and doctors will also send
the bill to you or your insurance company. You do not give up any of your legal rights by signing this form. By
signing this form, you indicate that members of the transplant team have informed you about this procedure, your
questions have been answered sufficiently, and that you agree to proceed.
You can obtain further information by calling the Heart Transplant Office at 816-932-3264.
ILLEGAL SALE OF ORGANS
The sale or purchase of human organs is a federal crime and it is unlawful for any person to knowingly acquire,
receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation.
VOLUNTARY PARTICIPATION
Your participation is voluntary, and you may choose to not participate or may withdraw – be taken off the list at
your request - at any time without adversely affecting your relationship with your doctors and nurses. The
treatment plan you receive from your doctors and nurses is based upon their experience plus ongoing review of
the scientific literature related to care of heart transplant patients. If you elect to change dosages or discontinue
any or all of your immunosuppressive medications on your own, you will likely die.
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LISTING CONSENT FOR HEART TRANSPLANT
CMS INFORMATION
Specific outcome requirements need to be met by transplant centers and we are required to notify you if we do
not meet those requirements. Currently, X X X meets all Center of Medicare & Medicaid Services (CMS)
requirements and is an approved Medicare heart and kidney transplant center. If at some point during the
time you are waiting for a heart transplant, the hospital does not meet CMS transplant criteria, we will notify
you in writing. If you receive a transplant at a non-Medicare-approved transplant center, it could affect your
ability to have your immunosuppressive drugs paid for under Medicare Part B.
AUTHORIZATION
Your signature certifies that you have decided to proceed, having read the information contained in the consent
form, having received and read the patient educational manual provided to you at the time of your evaluation, and
having had the risks and benefits explained to you, either today or previously. Upon signing this form, you will
receive a copy.
Patient Signature
Date
Time
Transplant Team Physician Signature
Date
Time
Transplant Coordinator or Nurse Practitioner Signature
Date
Time
Transplant Surgeon Signature
Date
Time
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