Protocol for Adult Human Cardiac Transplantation

I. Preoperative Period

A.

B.

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Selection of a recipient

1. The recipient should be a patient with terminal
heart disease for whom no other treatment is
available and for whom life expectancy is limited
to days or weeks.

The following will be done:

a. Full cardiac workup, including cardiac
catheterization and angiocardiographic
studies.

b. Elimination of any cardiac lesion treatable
by currently acceptable methods.

c. Elimination of any other general medical
condition which would sharply limit the life
span of the patient.

Selection of a donor

1. The donor shall be an individual whose death is
imminent from irreversible noncardiac disease.

a. Evaluation of potential donor

(1) Medical review - all medical data will
be evaluated to establish suitability
of the donor, with particular emphasis
to insure exclusion of malignancy and
occult infection.

(2) Cardiac evaluation - alli clinical and,
when indicated, laboratory studies
(cardiac catheterization and angio-
cardiography) will be performed to
establish the suitability of the
potential donor heart.

(3) Immunologic compatibility - immunologic
acceptability will be established if
the potential donor could serve as a
blood donor for the recipient. Complete
red cell antigen typing and histo-
compatibility studies will be performed
to collect data for correlation with
potential rejection phenomena.

Attachment C, page 1 of 3
(4) Cause of death - a diagnosis of an
irreversible cause of imminent death
(irreversible brain damage incompatible
with life) will be established. The
possibility of poisoning must be ruled
out.

2. Clinical death of the donor in the presence of an
established diagnosis of irreversible brain damage
incompatible with life is defined by:

a. Fixed, dilated pupils; and no reflexes,
spontaneous respiration, or muscle activity.

b. Flat isoelectric FEG, no clinical or EEG
response to noise or pinch - repeated after
24 hours.
Procedures

i. The Principal Investigator will personally establish
that the recipient has been selected in the manner
specified above, and, in consultation with a neurologist
or neurosurgeon, that the criteria for death of the
donor have been met.

2. The Principal Investigator, in consultation of the team,
will make the final decision as to the suitability of
any potential donor and recipient presented to the team
for transplantation.

3. The Principal Investigator will personally ascertain
that informed, signed consent (attached) has been obtained
for the donor, and that informed, signed consent (attached)
has been obtained for the recipient.

If. Operative Period

A.

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The Procedure

Upon clinical death of the donor, as defined above, the donor
heart will be excised and perfused. During the perfusion, the
donor heart will be evaluated on the basis of visual observation,
electrocardiograms, and arterial gas determinations. If the
heart is judged to be suitable, the recipient will be placed on
cardiopulmonary bypass, and the donor heart will be implanted
following established procedure.

Attachment C, page 2 of 3
III. Postoperative Period
A. Isolation and Monitoring

To insure strict asepsis, the patient will remain in an
operating room during the first portion of the postoperative
period. During this time, the same monitoring of the patient's
condition as employed during the surgical procedure will be
continued, and arterial gas and other determinations will be
made periodically. A clinical laboratory and a cardiopulmonary
technician will be available.

When the patient's condition permits, he will be transferred to
the heart study area which has been thoroughly cleaned and
furnished with sterilized mattress and bed linen. Every effort
will be made to maintain surgical cleanliness in this area.

B. Immuno logy
Studies to detect onset of graft rejection will be done daily.
The principle studies to be performed are clinical cardiac

functional evaluation, EKG, leukocyte counts, temperature.

Immediate immunosuppressive measures will consist of adminis-
tration of ALS and Imuran.

Cc. Assignment of Team Personnel
To be made by Principal Investigator. Only previously designated

personnel observing standard aseptic precautions are to approach
the patient.

Attachment C, page 3 of 3
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