Download Criteria for Heart Transplant - KR-index.

Pediatric Heart Transplant Evaluation and Waiting List:
Education to Support Informed Consent
This document is for pediatric patients who will be evaluated for
a heart transplant and for their families. It explains the
evaluation and waiting list, the risks of a transplant, the care
your child will have before, during and after the transplant,
and other key information. It’s important that you read and
understand this document. Ask questions about anything you
do not understand.
WH AT’ S INSI DE






Evaluation Tests and Procedures ............................... 2
Criteria for Heart Transplant ...................................... 3
Donor Hearts and the Waiting List ............................ 6
Transplant Risks, Your Rights, and Alternatives ....... 7
Other General Information ......................................... 9
Acknowledgement Form .......................................... 10
What is the process?

Evaluation: An evaluation for a heart transplant involves
many tests, procedures and visits with doctors and other
members of the transplant team (see the list at right).
Some patients may also be referred to another service for
consultation. For example, some patients may need to be
seen by a pulmonologist (lung doctor) or a nephrologist
(kidney doctor) to assess other medical conditions, or a
psychiatrist for a more in-depth mental health evaluation.
All these visits, tests and procedures will help us know if
a heart transplant is right for your child. Your transplant
team members will discuss all test results with you and
your child. Learn more about the tests and evaluation
criteria on pages 2 through 5.

Waiting list: If your child meets specific criteria for
patients who should have a heart transplant, your child
will be put on a waiting list, explained on page 6.

Surgery: The heart transplant surgery involves various
risks. Learn more on pages 7 and 8.
Transplant Team Members
 A Transplant Cardiologist is a doctor who treats
heart disease and who specializes in
transplantation and the treatment of heart failure.
This doctor will determine if your child is medically
suitable for a transplant, if further tests are
needed, or if a transplant is not right for your child.
The transplant cardiologist will also discuss
medication your child would need and possible
complications after a transplant.
 A Transplant Surgeon will discuss the transplant
surgery, the risks of the surgery, and the possible
complications during and after the transplant.
 An Advanced Practice Clinician (APC) is a
Nurse Practitioner or Physician Assistant. The
APC will help the doctor with your child’s care and
may also perform Transplant Coordinator
responsibilities.
 A Transplant Coordinator is a nurse who
provides education about the evaluation, the
transplant waiting list, and you and your child’s
responsibilities before and after the transplant.
 A Social Worker will meet with you and your child
to evaluate your ability to cope with the stress of a
heart transplant and follow a rigorous treatment
plan afterward. The social worker will also help to
identify your support network.
 A Financial Coordinator will discuss the costs of
a heart transplant and medications your child will
need afterward. He or she will help you
understand your child’s insurance coverage and
any costs not covered by the insurance.
 A Transplant Pharmacist will be available to
answer questions and explain the medications
your child will need before and after the
transplant.
 A Dietitian will do a nutritional assessment and
give you nutrition education regarding your child.
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 1 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
Evaluation Tests and Procedures
Many different tests are done to determine if your child is a suitable transplant recipient. Additional tests
may be done if further assessment is required. Common tests are described below.

Blood tests are done to determine your child’s blood type and markers that are important for organ
matching. Your child will also get screening tests for immunity to specific viruses or the presence of
these viruses, including HIV, hepatitis, and syphilis. Other blood tests will be done to evaluate your
child’s overall health, including routine chemistry, thyroid, cholesterol, complete blood counts, and
clotting factor tests. (Note: Utah state law requires healthcare providers to report cases of HIV and
hepatitis to the state health department.)

Urine tests are used to screen for the presence of urinary tract diseases or abnormal cells in your child’s
urine. The Schwartz formula or a 24-hour urine collection test will evaluate your child’s kidney function.

Heart tests will help your child’s doctors decide if a heart transplant is the best treatment option for your
child:
 An electrocardiogram (ECG), combined with an echocardiogram and/or stress test, will show
how well your child’s heart is beating and the function of your child’s heart valves.
 Right heart catheterization and a left heart catheterization, if indicated, will evaluate the pressures
and anatomy of your child’s heart.

Lung tests will help your child’s doctors evaluate your child’s lungs:
 A chest x-ray will help your child’s doctor identify any problems with your child’s lungs.
 Pulmonary function tests may be indicated to analyze your child’s lung function and capacity, if
indicated.
 A metabolic treadmill stress test (VO2) will determine your child’s physical endurance level, if
indicated.

Other tests, procedures, and consults (office visits) to evaluate specific conditions. These may include:
 A stool guaiac test to evaluate for blood in your child’s feces, a problem that can be caused by
several conditions
 A TB skin test, a tuberculosis test, placed on your child’s forearm, will need to be checked in 48
to 72 hours.
 Dental exam
 Cardiothoracic surgeon consult
 Dietician consult
 Pharmacist consult
 Psychosocial consult
 Immunization record
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 2 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
Criteria for Heart Transplant
In evaluating whether a heart transplant is the right treatment for your child, your child’s transplant team
will look at three types of criteria:
 Inclusion criteria are indications that mean a heart transplant is NEEDED.
 Absolute exclusion criteria are conditions that mean your child IS NOT a heart transplant candidate.
 Relative exclusion criteria are conditions that mean your child MAY NOT be a heart transplant candidate,
and will require a case review.
INCLUSION CRI TERI A
If your child has one or more of the conditions listed below, a heart transplant is needed. (See the “In other
words…” column for notes to help with the medical language.)
Condition
End-stage cardiac disease that is irreversible,
progressive, and has a limited life expectancy or
progressive (but reversible) pulmonary
hypertension, or both, and with no available
reasonable alternative medical or surgical
therapy.
In other words…
End-stage cardiac disease is heart failure that is
severe and persists, despite optimal medical and
surgical therapy. Pulmonary hypertension is high
blood pressure in the arteries that feed the lungs.
Cardiomyopathies of the following type:
 Dilated
 Idiopathic
 Familial
 Metabolic
 Hypertrophic
 Myocarditis
 Restrictive
 Cardiac tumor
 Cardiomyopathy due to anthracycline
toxicity
A person with cardiomyopathy has a heart that is
bigger or stiffer than it should be. This can be caused
by infections, medications, genetics, tumors, or for
unknown reasons. Cardiomyopathies can affect how
the heart works.
Congenital heart disease for which there are no
other reasonable surgical option.
Life-threatening ventricular arrhythmias,
refractory to medical therapy.
Congenital heart disease involves a structural defect
in the heart that is present at birth.
NYHA Class III-IV heart failure symptoms
(when criteria can be applied).
With Class III-IV symptoms, even limited physical
activity makes your child tired or short of breath, or
your child can’t do any physical activity without
discomfort.
In this condition, heart rhythm problems keep
coming back, cause symptoms, and are life
threatening-despite medication, devices, cath lab
procedures, or surgery.
Family structure should be able to support the long-term medical needs of the child pre- and posttransplant
Parents or legal guardian and the child should demonstrate adequate emotional stability to go through the
transplant process
Candidate must be able to reside within 4 hours of PCMC for up to 3-6 months post-transplant
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 3 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
Your child must also meet BOTH conditions below to meet the inclusion criteria.
Condition
If pulmonary vascular resistance is present, it
must be lower than 6 indexed Wood units with
nitroprusside or other vasodilator. This does not
apply to infancy.
Absence of noncardiac disease that could
impact the survival of the graft:
 No significant degree (irreversible) of renal,
hepatic, or pulmonary disease
 No rapidly progressive neuromuscular
disorder
 No evidence of sepsis or active infection
In other words…
Pulmonary vascular resistance, measured in “Wood
units,” is resistance in the blood vessels of the lungs.
The heart must overcome this resistance to pump
blood into the lungs. The resistance must be kept
under 6 Wood units through medication.
Renal disease affects the kidneys. Hepatic disease
affects the liver. Pulmonary disease affects the lungs.
Neuromuscular disorders affect nerves that
communicate with muscles—examples include
muscular dystrophy and myasthenia gravis. Sepsis is
infection that spreads to the blood.
ABSO LUTE EXCLUSION C RI TERI A
If your child has any of the conditions listed below, heart transplant is not appropriate and your child IS NOT
a heart transplant candidate.
Condition
In other words…
Severe pulmonary hypertension (PA
pressure) or pulmonary vascular resistance
(PVR) greater than 6 Wood units/m2, with
inability of medications to reduce PVR and
PA pressure to acceptable levels
Pulmonary hypertension (PA pressure) is high blood
pressure in the arteries that supply blood to the lungs.
PVR is resistance in the blood vessels of the lungs—
the heart must overcome it to pump blood into the
lungs. Either of these may be too high to control with
medication.
Recent pulmonary infarct
Pulmonary infarct is dead lung tissue, caused when a
clot blocks an artery that supplies the lungs.
Persistent acidosis with pH less than 7.1
Acidosis is excess acidity in the blood.
Irreversible renal, hepatic, or pulmonary
dysfunction
Unclear cardiac diagnosis
Active, uncontrolled infection
Active, unresolved substance abuse
The word “renal” refers to the kidneys. “Hepatic”
refers to the liver. “Pulmonary” refers to the lungs.
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 4 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
REL ATI VE EXCLUSION C RI TERI A
If your child has any of the conditions listed below, your child MAY NOT BE a heart transplant candidate.
These conditions require a case-by-case review.
Condition
Uncontrolled diabetes mellitus
In other words…
In diabetes, the body cannot control the level of sugar
in the blood.
Weight < 2.2 kg and < 36 weeks gestational age
Psychosocial considerations:

Strong history of parental or legal guardian alcohol and/or substance abuse

Documented parental or legal guardian child abuse or neglect

Family unable to support the long-term medical needs of the recipient

Parent or legal guardian with cognitive or psychiatric impairment that is severe enough to limit
comprehension of medical regimen

Documented noncompliance with previous medical care
Malignancy: A history of malignancy or cancer will be evaluated to determine the chance that the
cancer will recur, the chance that the cancer could spread (metastasize) and to determine the overall
survivability from the cancer. *A history of lymphoma and splenectomy (removal of the spleen),
particularly with a history of chest irradiation, is considered high risk*
History of substance abuse, alcohol abuse and smoking
HIV positive
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 5 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
Donor Hearts and the Waiting List
Where do donor hearts come from? Hearts for transplantation come from deceased organ donors who are age
appropriate and who do not have significant health problems. The donor’s cause of death is usually an
accident or sudden illness. Donors are expected to have good heart function. Heart donors are screened and
may be excluded for positive HIV, hepatitis B, hepatitis C, heart abnormalities and/or damage, or high-risk
activity. Any high-risk donor characteristics will be discussed with you before the donor heart is
transplanted, if your child is a potential recipient.*
*What is a high risk donor? A high risk donor has a greater risk of having HIV (the virus that causes AIDS), HBV (hepatitis B), or HCV (hepatitis C) infection. According to
the Centers for Disease Control, the following people are at increased risk for these infections:

People who have used illicit drugs (injected or inhaled) or who have had certain sexually transmitted diseases in the past year

People who have had risky sexual behaviors: sex with over 2 partners in the past year, sex with someone suspected of having HIV, HBV, or HCV infection, or sex
with people who are at higher risk for these infections (based on their sexual behaviors or drug use)

Prison inmates

Infants/toddlers born to a mother infected with HIV, HBV or HCV

People who have been on hemodialysis in the past 12 months (increases risk for HCV only)

People who have, in the past year, immigrated from a country where HBV is prevalent (increases risk for HBV only)
How are donor hearts allocated? Hearts from deceased donors are
allocated according to the policy of the United Network for Organ
Sharing (UNOS). Factors that contribute to the allocation process
include: acuity level (severity of your child’s condition), ABO blood
type, body size, antibody levels, waiting list status, and wait time.
How does my child get on the waiting list? If your child is accepted as a
transplant candidate, your child’s name will be placed on the UNOS
waiting list at Primary Children’s Medical Center. While on the
waiting list, your child will be monitored by his or her transplant
cardiologist.
What is UNOS?
The United Network for Organ Sharing
(UNOS) is a private, non-profit membership
organization that coordinates the nation’s
transplant system through a government
contract. UNOS:
 Facilitates matching of organs with
recipients
 Collects, manages, and reports data on
transplant outcomes
 Increases donor awareness
How does a “heart offer” work? When a donor organ becomes available, the transplant coordinator will
contact you by phone or pager. You will always have the option to decline an organ for your child. If your
child’s surgeon decides the organ is unusable, your child will continue to wait for a suitable heart either at
home or in the hospital, depending on his or her condition.
Are there risks from the donor heart itself? Certain conditions in the donor may affect the success of your
child’s heart transplant. These include the donor’s history, the condition of the organ when it is received,
and the potential risk that your child may contract infectious diseases or cancer if the doctor cannot detect
them in the donor.
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 6 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
Heart Transplant Risks, Your Rights, and Alternatives
Heart transplant is a treatment option for end-stage heart disease, but the transplant team cannot predict
exactly how your child’s body will respond to a heart transplant. The potential benefits do not result from
surgery alone, but also depend on you and your child following the rigorous treatment plan prescribed by
your child’s transplant team. As part of the evaluation process, your child will see a surgeon. You must be
aware of the potential risks and complications of cardiac transplant for your child.
There are inherent risks in all surgeries, especially surgeries conducted under general anesthesia. Many
complications are minor and get better on their own. In some cases, the complications are serious enough to
require another surgery or medical procedure. You must be aware of the potential risks and complications
outlined in this document, including those that may result in serious injury and death.
RISKS
The problems listed below are not common. If they do occur, they are often treatable. Please ask a member of
your child’s transplant team if you have any questions about these risks.

Bleeding during or after surgery may require blood transfusions or blood products.

Blood products or the donated organ could possibly contain bacteria and viruses that can cause infection.
Although rare, these infections include, but are not limited to, the human immunodeficiency virus (HIV),
hepatitis B virus (HBV), hepatitis C virus (HCV), and cytomegalovirus (CMV).
There may be a delay in the function of your child’s transplanted heart. Such a delay may increase the length
of your child’s hospital stay and increase the risk of other complications.
There is a possibility that the transplanted heart may not function. In this instance, a temporary ventricular
assist device may be placed. This will keep the heart working until the transplanted heart is able to
recover from the shock of two operations and begin functioning, or until another heart is located, if
needed.
Side effects from immune-suppressing drugs may include, but are not limited to: high blood pressure, high
cholesterol, hyperglycemia (high blood sugar), poor wound healing, thinning of the skin, water weight
gain, changes of hair, acne, seizures, ulcers, glaucoma, cataracts, damage to your child’s transplanted
heart or to other organs, and bone loss.
There is an increased risk of certain kinds of cancer (including skin cancer and post-transplant
lymphoproliferative diseases or lymphoma) because of the immune-suppressing medications.
Despite the use of compression boots, in older children blood clots may occasionally develop in the legs
and can break free. Occasionally they may move through the heart to the lungs or brain. This can cause
serious interference with breathing or brain function, which can lead to death. Blood clots are treated
with blood-thinning drugs that may need to be taken for an extended period of time.
Damage to nerves may occur. This can happen from pressure or positioning of the arms, legs, or back
during the surgery. Nerve damage can cause numbness, weakness, paralysis and/or pain. In most cases
these symptoms are temporary, but in rare cases they can last for extended periods or even become
permanent.
Depression, anxiety, dependence on others, or guilt: Older children may feel sad or depressed after cardiac
surgery or after a prolonged hospitalization. These emotions may be the result of not knowing what to
expect, not being able to do simple tasks without becoming overly tired, or feeling dependent on others
which may cause feelings of guilt. Temporary feelings of sadness are normal, and should gradually go
away within a few weeks as your child gets back to a routine of normal activities. Sometimes, however, a







Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 7 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012

depressed mood can prevent your child from leading a normal life. When a depressed mood is severe and
accompanied by other symptoms that happen every day for two or more weeks, treatment is necessary to
help your child cope and recover.
Other risks and possible complications associated with heart transplants include: infections from bacteria,
viruses, or fungi; chronic or acute rejection; injury to structures in the chest; pressure sores on the skin
due to positioning; burns caused by the use of electrical equipment during surgery; damage to arteries
and veins; pneumonia; heart attack; stroke; and permanent scarring at the site of the incision.
YOUR RIGHTS



You have the right to refuse a transplant for your child. If you choose for your child not to have a
transplant, please discuss your child’s treatment options with the cardiologist.
If your child is on the waiting list for a heart transplant, you have the right to transfer your child’s waiting
time from one center to another. Your child can also be listed at multiple centers.
You have the right to file a grievance with UNOS on your child’s behalf. Call 1-888-894-6361.
ALTERN ATI VES TO HE AR T TR ANSPL ANT
Alternate treatment options include surgical palliation, mechanical assist devices, or medical management.
Please discuss your child’s condition and these alternative therapies with your child’s transplant team.
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 8 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
Other General Information
National outcomes and transplant center outcomes: Statistics about transplant outcomes from the Scientific
Registry of Transplant Recipients (SRTR) have been provided to you. We will explain our program’s 1-year
patient survival and graft survival and how our program compares to national averages and Medicare
outcome requirements. Please see attached document for this data. Please let us know if you have any
further questions. You may also find this information on the internet at www.srtr.org and www.optn.org.
Notification of Medicare outcome requirements: Specific outcome requirements need to be met by transplant
centers and we are required to notify you if we do not meet those requirements. Transplant centers must also
be approved by Medicare for patients to receive Medicare Benefits such as Part A and Part B. Currently, the
Primary Children’s Medical Center Heart Transplant Program meets all Medicare outcome requirements for
heart transplant centers.
Transplantation by a transplant center not approved by Medicare: If you have your transplant at a facility that
is not approved by Medicare for transplantation, Medicare Part B may not pay for the anti-rejection
medication that you must take.
Privacy Information: Intermountain complies with the patient privacy guidelines required by HIPAA (the
Health Insurance Portability and Accountability Act). To safeguard patient safety during the organ
transplant process, we must verify that your child’s blood type is compatible with your donor’s blood type.
To do this, we need to include your child’s medical record number/UNOS ID number on an ABO & Vital
Information Form that may be kept in the donor’s medical record. The donor’s medical record
number/UNOS ID number may be kept on the same form in your child’s medical record.
Health and Life Insurance: After your child turns 18, if they lose insurance coverage or have a break in
insurance coverage health insurance companies may consider your child to have a pre-existing condition
and may refuse payment for medical care, treatments or procedures. After the surgery, health insurance and
life insurance premiums may increase and remain higher. In the future, insurance companies could refuse to
insure your child for medical, disability, or life insurance. If you have any questions please contact your
Transplant Financial Coordinator.
Program Coverage Plan: A transplant surgeon and/or a transplant cardiologist is available 365 days a year, 24
hours a day, 7 days a week to provide coverage at all times. The assigned covering physician and/or surgeon
are available in a timely manner to address patient and donor concerns and to facilitate organ acceptance,
procurement of organs, and transplantation of organs.
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 9 of 10: Patient Initials: ______
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be used
to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 02/2012
Acknowledgement Form for
Pediatric Heart Transplant Evaluation and Waiting List
Process: Education to Support Informed Consent
I have received a copy of Pediatric Heart Transplant Evaluation and Waiting List Process: Education to
Support Informed Consent from the cardiac transplant team, along with the educational materials listed
below. I have been given the opportunity to read the information and ask questions.
 Partnering with Your Transplant Team “The Patient’s Guide to Transplantation” from Health
Resources and Services Administration (HRSA)
 Questions and Answers for Transplant Candidates about Multiple Listing and Waitlist Time Transfer
(UNOS)
 “About Heart Transplants” (American Heart Association)
 What Every Patient Needs to Know (UNOS)
 SRTR results for Heart Transplant at Primary Children’s Medical Center; Version date__________
 Fact Sheet for Patients and Families: Cardiac Catheterization for You or Your Child
(Intermountain Healthcare)
 Talking about Transplantation: Facts and Figures (UNOS)
 Transplant Living (UNOS)
 Notice of Privacy Practices (Intermountain Healthcare)
Patient’s Signature: _________________________________
Date: ___________ Time: _______
Printed Name: ________________________________________________________________
OR
Patient’s Authorized Agent or Legal Representative: __________________________________
Printed Name: ______________________________________
Date: ______________ Time: _______
Relationship to Patient: __________________________________________________________
Specify reason for Representative/Agent signing document: _____________________________
_____________________________________________________________________________
I have reviewed the information in Pediatric Heart Transplant Evaluation and Waiting List Process:
Education to Support Informed Consent and the other education documents with the patient (or patient’s
representative) and have provided opportunities for questions and clarification.
Transplant Team Member Signature: _______________________________
Print Name: ____________________________ Date: _________________ Time: _______________
Pediatric Heart Transplant Evaluation and Waiting List Process: Education to Support Informed Consent, Page 10 of 10
©2010-2012 Intermountain Healthcare. All rights reserved. This content is for your information only. It is not a substitute for professional medical advice and should not be
used to diagnose or treat a health problem or disease. Please consult your healthcare provider with questions or concerns. IHCTRP008 – 04/2010