Evaluation of the Organ Care System in Heart
Transplantation With an Adverse Donor/Recipient
Profile
Diana García Saez, MD, Bartlomiej Zych, MD, Anton Sabashnikov, MD,
Christopher T. Bowles, PhD, Fabio De Robertis, MD, Prashant N. Mohite, MD,
Aron-Frederik Popov, MD, PhD, Olaf Maunz, CCP, Nikhil P. Patil, MRCS, MCh,
Alexander Weymann, MD, Timothy Pitt, CCP, Louise McBrearty, CCP,
Bradley Pates, CCP, Rachel Hards, RN, Mohamed Amrani, MD, PhD,
Toufan Bahrami, MD, Nicholas R. Banner, MD, PhD, and Andre R. Simon, MD, PhD
Department of Cardiothoracic Transplantation and Mechanical Circulatory Support, Harefield Hospital, Royal Brompton and Harefield
NHS Foundation Trust, London, United Kingdom
Background. A severe shortage of available donor or-
gans has created an impetus to use extended criteria or-
gans for heart transplantation. Although such attempts
increase donor organ availability, they may result in an
adverse donor-recipient risk profile. The TransMedics
Organ Care System (OCS) (TransMedics, Inc, Boston)
allows preservation of the donor heart by perfusing the
organ at 34
C in a beating state, potentially reducing the
detrimental effect of cold storage and providing addi-
tional assessment options. We describe a single-center
experience with the OCS in high-risk heart transplant
procedures.
Methods. Thirty hearts were preserved using the OCS
between February 2013 and January 2014, 26 of which
(86.7%) were transplanted. Procedures were classified as
high risk based on (1) donor factors, ie, transport time
more than 2.5 hours with estimated ischemic time longer
than 4 hours, left ventricular ejection fraction (LVEF) less
than 50%, left ventricular hypertrophy (LVH), donor
D espite ongoing improvements in mechanical circu-
latory support, heart transplantation remains the
gold standard treatment for appropriately selected
patients with advanced heart failure, leading to the best
long-term outcome [1]. However, heart transplantation
has a high early mortality, caused almost entirely by
donor organ failure. Under conventional conditions of
donor organ preservation, ie, cardioplegic arrest and
cold storage, prolonged cold ischemia time is by far the
greatest risk factor for primary allograft dysfunction and
death [2, 3]. Moreover, cold ischemia time multiples
Accepted for publication June 2, 2014.
Presented at the Fiftieth Annual Meeting of The Society of Thoracic
Surgeons, Orlando, FL, Jan 25–29, 2014.
Address correspondence to Dr García S aez, Cardiothoracic Trans-
plantation and Mechanical Circulatory Support, Royal Brompton and
Harefield NHS Trust, Hill End Road, Harefield, UB96JH, United Kingdom;
e-mail: d.garciasaez@rbht.nhs.uk.
Ó 2014 by The Society of Thoracic Surgeons
Published by Elsevier
ADULT CARDIAC
cardiac arrest, alcohol/drug abuse, coronary artery disease
or (2) recipient factors, ie, mechanical circulatory support
or elevated pulmonary vascular resistance (PVR), or both.
Results. Donor and recipient age was 37 ± 12 years
and 43 ± 13 years, respectively. Allograft cold ischemia
time was 85 ± 17 minutes and OCS perfusion time was
284 ± 90 minutes. The median intensive care unit stay
was 6 days. One death (3.8%) was observed over the
follow-up: 257 ± 116 (109–445 days). There was preserved
allograft function in 92% of patients, with a mean LVEF
of 64% ± 5%.
Conclusions. Use of the OCS is associated with mark-
edly improved short-term outcomes and transplant
activity by allowing use of organs previously not
considered suitable for transplantation or selection of
higher risk recipients, or both.
(Ann Thorac Surg 2014;98:2099–106)
Ó 2014 by The Society of Thoracic Surgeons
other risk factors, such as donor left ventricular hyper-
trophy (LVH).
The TransMedics Organ Care System (OCS) is the first
commercially available system that allows the beating
donor heart to be maintained in a warm (34
C) perfused
oxygenated state during transfer from donor to recipient.
This allows for an extended “out of body” time and min-
imizes the detrimental effects of cold ischemic storage [4].
The OCS also allows ex vivo donor heart assessment.
Data presented by Hamed and colleagues [5] along
with interim results from the PROCEED II trial (a
prospective, randomized [1:1] multicenter noninferiority
study comparing the safety and efficacy of the OCS
with the cold storage of donor hearts) suggest that a
Drs García Saez, Maunz, and Simon disclose financial
relationships with TransMedics Inc.
0003-4975/$36.00
http://dx.doi.org/10.1016/j.athoracsur.2014.06.098
 2100 GARCIA SAEZ
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ORGAN CARE SYSTEM IN HEART TRANSPLANTATION 2014;98:2099–106

Abbreviations and Acronyms

HVAD = HeartWare left ventricular assist
device
IABP = intraaortic balloon pump
ADULT CARDIAC

LVAD = left ventricular assist device

LVEF = left ventricular ejection fraction
OCS = Organ Care System
PVR = pulmonary vascular resistance

rising lactate level is a reliable marker of donor heart

abnormality [5, 6]. The heart OCS may be particularly
well suited to the assessment of “extended criteria” donor
hearts with reduced left ventricular ejection fraction
(LVEF), LVH, previous donor cardiac arrest, prolonged
predicted ischemic time (> 4 hours), alcohol/substance
abuse, and unknown coronary artery disease status
because of a lack of coronary angiography [7–9].
Previous attempts to use extended criteria allografts,
with the aim of addressing the severe shortage of avail-
able donor organs has increased organ availability but
Fig 1. Organ Care System (OCS) support unit (resting
has also resulted in high-risk organ/recipient combina-
perfusion mode).
tions and poor outcomes [2]. The individual risk-benefit
ratio is further affected by the ever-increasing com-
plexity of today’s recipients, such as the presence of left
detailed organ assessment at the time of donation
ventricular assist devices (LVADs) and severe pulmonary
that included transesophageal echocardiography, cardiac
hypertension. In particular, transplantation in patients
output studies using a pulmonary artery catheter, direct
with LVADs is challenging, and the concept of LVAD
evaluation of the coronary arteries, and measurement of
bridging on outcomes after transplantation has been
left and right atrial pressures.
controversial. Some experienced centers have compara-
Donors were transfused with red blood cells, if neces-
ble posttransplantation results in this group [10, 11];
sary, to raise the serum hemoglobin level to 10 g/dL.
however, the international registries continue to identify
Immediately before aortic cross-clamping, the right atrial
it as a risk factor for increased mortality [12, 13].
appendage was cannulated using a 34F venous cannula,
In this article, we report a single-center experience of 30
thereby allowing approximately 1.5 L of donor blood to be
consecutive donor procurements using the OCS, 26 of
collected to prime the OCS module. Unfractionated
which were subsequently used for high-risk heart
heparin 10,000 IU was added to the blood collection bag
transplantation.
in addition to the standard donor heparinization protocol
(300 IU/kg). Cardioplegia was instituted with Custodiol
Material and Methods HTK (Essential Pharmaceuticals, Ewing, NJ) at 4
C (800–
1,000 mL depending on donor size) was used to induce
The Heart OCS cardiac arrest and protect against ischemic injury during
The heart OCS (Transmedics Inc, Boston, MA) is the period before the heart was connected to the OCS.
composed of an organ-specific perfusion module with
disposable and nondisposable parts and a compact
wireless monitor. The monitor displays real-time system Heart Management and Assessment on OCS
and organ measurements, such as aortic pressure, coro- Donor hearts were implanted on the OCS using the
nary flow, blood temperature, and heart rate. The heart is proprietary heart instrumentation tool set. Four double-
perfused in the resting mode (Fig 1). Warm oxygenated pledgeted 2-0 Ethibond sutures (Ethicon, Inc, Somer-
blood is pumped into the aorta, thereby perfusing the ville, NJ) were applied at 90-degree intervals to the cut
coronary arteries, and deoxygenated blood enters the edge of the ascending aorta, and an appropriate aortic tip
right atrium through the coronary sinus and passes insert (4 different sizes from 19.1–31.8 mm) was placed in
through the tricuspid valve to the right ventricle. The the aorta. A cable tie tool was used to secure the tip of the
blood is then ejected through the pulmonary artery to aorta to the aortic tissue. The pulmonary artery was
the blood oxygenator and is returned to the reservoir. cannulated using a 30F cannula, which was inserted into
the lumen of the pulmonary artery and secured with a 3-0
Organ Procurement and Connection to the OCS polypropylene purse-string suture. The pulmonary artery
After provisional acceptance of the donor hearts based cannula was then retracted to avoid any interference with
on available clinical information, our team performed a the pulmonary valve motion and was secured with a
Ann Thorac Surg
2014;98:2099–106
heavy suture. The superior vena cava was oversewn with
a continuous 4-0 polypropylene suture.
The heart was placed in the perfusion module with the
posterior aspect facing upward and the left atrium and
aorta toward the top of the heart chamber. Perfusion of
the heart was initiated with a pump flow of 900 to 1200
mL/min, with the aim of achieving the target coronary
flow range of 750 to 850 mL/min. If the heart did not beat


spontaneously after rewarming to 34 C, manual massage
was performed to prevent distention. If the heart con-
tinued not to beat or return to sinus rhythm, a defibril-
lation shock of 5 to 10 J was delivered and, if required,
was repeatedly increased by 5 J until normal rhythm
was restored. The inferior vena cava was oversewn with a
4-0 polypropylene continuous suture in the perfusion
module on the OCS. A vent was inserted through the
mitral valve to decompress the left ventricle.
Venous and arterial blood gas samples were taken
simultaneously at 30-minute intervals for lactate quanti-
fication using a CG4 cartridge in the IStat portable
analyzer (Abbott Point of Care Inc, Princeton, NJ). At 60-
minute intervals, the electrolyte status was evaluated
using a CG8 cartridge. Using data derived from PRO-
CEED II, organ acceptance criteria included a venous
blood lactate level lower than the arterial blood value and
a decreasing or stable trend in lactate levels over time,
lactate level less than 5 mmol/L at the end of the period of
OCS support, stable perfusion measurement, and overall
good contractility.
Immediately before disconnection from the OCS and
implantation, donor hearts were perfused with 1,000 mL of
cold Custodiol HTK cardioplegic solution with a mean
aortic pressure of 40 mm Hg as displayed on the OCS
monitor. The total allograft cold ischemia time was defined
as the duration from donor aortic cross-clamping to the
connection of the allograft on the OCS plus the duration
from administration of the cold cardioplegia solution on
the OCS immediately before implantation to the release of
the cross-clamp after implantation in the recipient.
Study Design and Donor/Recipient Cohort
The study design was a retrospective single-center review
of prospectively collected data. A total of 26 consecutive
patients who underwent OCS heart transplantation from
February 2013 to January 2014 at Harefield Hospital were
included in this study. A further 4 donor hearts procured
using the OCS during the same study period were
declined for transplantation. A protocol including consent
procedures for the OCS heart preservation/assessment
was reviewed and accepted by the Royal Brompton and
Harefield NHS Foundation Trust Clinical Practice Com-
mittee. All patients gave written informed consent for
orthotopic cardiac transplantation as well as OCS pres-
ervation/assessment.
Main indications for OCS were (1) donor risk factors
such as estimated ischemia time longer than 4 hours,
LVEF less than 50%, previous donor cardiac arrest, LVH
with an interventricular septum in diastole of more than
13 mm, alcohol/drug abuse, and presence of palpable
coronary artery disease without coronary angiography
GARCIA SAEZ
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ORGAN CARE SYSTEM IN HEART TRANSPLANTATION
and (2) recipients who were high risk because of the
presence of severe pulmonary hypertension, defined as
pulmonary vascular resistance (PVR) greater than 4
Wood units (WU) before reversibility assessment or
presence of a long-term LVAD preoperatively, or both.
ADULT CARDIAC
Results
Donor characteristics are presented in Table 1. Mean donor
age was 37  12 years, with 7 female (23%) and 23 male
donors (77%). Sixteen donors (53.3%) died of traumatic
or spontaneous intracranial hemorrhage, 4 (13.3%) died of
ischemic stroke, 9 (30%) died of hypoxic brain damage,
and 1 (3.3%) died of a brain tumor (meningioma).
Evaluation of the donor hearts during retrieval revealed a
reduced LVEF of less than 50% in 5 cases (16.6%). Five
donors had palpable coronary artery disease and 6 had
LVH with a diastolic interventricular septal thickness
greater than 13 mm and electrocardiographic criteria
diagnostic of LVH. Prolonged cardiac arrest of a mean
duration of 30  7 minutes was documented in 8 (26.6%)
donors. Estimated total cold ischemic time was greater
than 4 hours in 14 cases; 46.6% had a mean transport time
of 200  33 minutes.
Recipients
Recipient characteristics are presented in Table 2. The mean
age was 43  13 years and 19% (n ¼ 5) were women. All
patients had advanced heart failure (19% had ischemic
cardiomyopathy and 81% had dilated cardiomyopathy)
and were considered high risk because of (1) an LVAD in
situ (n ¼ 11 [42%]) with a median duration of support of
425 days (6–2,452 days) or (2) PVR greater than 4 WU
before reversibility assessment (n ¼ 7 [30%]) with a mean
PVR of 4.98  0.6 WU. All patients with an increased PVR
also had a baseline transpulmonary gradient of 12 mm Hg
or more and a mean transpulmonary gradient of 15 
2 mm Hg. The Index for Mortality Prediction After Cardiac
Transplantation (IMPACT) score for all recipients was
12.9  7.7 points (range, 0–19), with a predicted risk
of mortality at 1 year of 12.9%  7.7% (range, 6.03%–
43.14%) [14].
Furthermore, 2 recipients (7.6%) were supported with
an intraaortic balloon pump (IABP), 10 (38.4%) had
moderate impairment of renal function (defined as a
glomerular filtration rate of 30–59 mL/min/1.73m2), and 1
patient (3.8%) had liver dysfunction (defined as at least a
2-fold increase in at least 2 liver function measurements).
Of the 11 recipients who received LVAD support preop-
eratively, 4 (36%) had an ongoing severe pump pocket
infection at the time of transplantation.
OCS Instrumentation and Assessment
The mean time from aortic cross-clamping in the donor to
reperfusion of the heart to the OCS was 26  7 minutes
(range, 13–39 minutes). One donor heart started beating
spontaneously on the OCS. The remainder required 1 to 2
shocks (maximum energy delivered, 10 J).
Four donor hearts with a previous history of cardiac
arrest (30  4 minutes) were considered unsuitable for
 ADULT CARDIAC

2102

Table 1. Donor Characteristics

Cardiac
Patient Cause of Death Age (y) Sex Arrest (min) LVEF (%) Risk Factors Outcome

1 Cerebrovascular accident 44 Male No 60 Estimated ischemic time > 4 h Transplanted



2 Hypoxic brain damage 50 Male 40 60 Cardiac arrest, diabetes mellitus Transplanted

GARCIA SAEZ

3 Intracranial hemorrhage 47 Male No 65 Estimated ischemic time > 4 h Transplanted

4 Cerebrovascular accident 46 Female No 56 Obesity, alcohol abuse, palpable Transplanted
ET AL

coronary artery disease

5 Intracranial hemorrhage 24 Male No 62 ... Transplanted
6 Hypoxic brain damage 20 Male 15 50 Cocaine-alcohol overdose, cardiac arrest Transplanted
7 Intracranial hemorrhage 54 Male No 72 Obesity, palpable coronary artery disease Transplanted
8 Intracranial hemorrhage 23 Male No 57 LVH (diastolic interventricular septum 15 mm) Transplanted
9 Intracranial hemorrhage 28 Male No 58 Estimated ischemic time > 4 h Transplanted
10 Intracranial hemorrhage 33 Male No 55 Estimated ischemic time > 4 h, LVH (diastolic Transplanted
interventricular septum 15 mm)
11 Intracranial hemorrhage 53 Male No 60 ... Transplanted
12 Intracranial hemorrhage 54 Male No 60 Estimated ischemic time > 4 h Transplanted
13 Hypoxic brain damage 24 Female 35 45 Reduced LVEF, cardiac arrest Declined
ORGAN CARE SYSTEM IN HEART TRANSPLANTATION

14 Cerebrovascular accident 44 Male No 66 Estimated ischemic time > 4 h Transplanted

15 Meningioma 49 Male No 65 LVH (diastolic interventricular septum 16 mm) Transplanted
16 Hypoxic brain damage 17 Female No 43 Estimated ischemic time > 4 h, reduced LVEF Transplanted
17 Intracranial hemorrhage 34 Male No 70 LVH (diastolic interventricular Transplanted
septum 14 mm), alcohol abuse
18 Intracranial hemorrhage 26 Female No 60 Estimated ischemic time > 4 h Transplanted
19 Intracranial hemorrhage 52 Male No 65 Estimated ischemic time > 4 h Transplanted
20 Intracranial hemorrhage 40 Male No 65 Palpable coronary artery disease Transplanted
21 Hypoxic brain damage 36 Female 30 55 Alcohol abuse, cardiac arrest Declined
22 Intracranial hemorrhage 24 Male No 55 Electrocardiographic ischemia Transplanted
23 Hypoxic brain damage 35 Male 30 60 Cardiac arrest, estimated ischemic time > 4 h Transplanted
24 Intracranial hemorrhage 55 Male 25 55 Cardiac arrest, LVH (diastolic interventricular Declined
septum 16 mm), Estimated ischemic time > 4 h
25 Intracranial hemorrhage 51 Male No 45 Reduced LVEF, palpable coronary artery disease Transplanted
26 Intracranial hemorrhage 48 Female No 55 Estimated ischemic time > 4 h, palpable Transplanted
coronary artery disease
27 Cerebrovascular accident 38 Male No 60 Cocaine overdose, estimated ischemic time > 4 h, Transplanted
right ventricular dysfunction
28 Hypoxic brain damage 22 Female 30 60 Cardiac arrest, estimated ischemic time > 4 h Declined
29 Hypoxic brain damage 42 Male 30 48 Cardiac arrest, reduced LVEF, LVH (diastolic Transplanted
interventricular septum 15 mm)
30 Hypoxic brain damage 21 Female 40 60 Cardiac arrest Transplanted

LVEF ¼ left ventricular ejection fraction; LVH ¼ left ventricular hypertrophy.

2014;98:2099–106
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Ann Thorac Surg GARCIA SAEZ
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2014;98:2099–106 ORGAN CARE SYSTEM IN HEART TRANSPLANTATION

Table 2. Recipient Characteristicsa

Donor
Number Diagnosis Age (y) Sex LVAD Risk Factors

1 Dilated cardiomyopathy 39 Male No PVR > 4 WU

ADULT CARDIAC
2 Ischemic cardiomyopathy 58 Male HVAD LVAD, 5 sternotomies, moderate renal impairment
3 Dilated cardiomyopathy 29 Male No Moderate renal impairment
4 Ischemic cardiomyopathy 61 Male No Previous sternotomy, liver function impairment
5 Dilated cardiomyopathy 25 Male HVAD LVAD
6 Dilated cardiomyopathy 36 Male Synergy LVAD
7 Dilated cardiomyopathy 37 Female No ...
8 Dilated cardiomyopathy 24 Male HVAD LVAD, moderate renal impairment
9 Dilated cardiomyopathy 44 Female No IABP, moderate renal impairment
10 Dilated cardiomyopathy 56 Male HeartMate II LVAD, pump pocket infection,
PVR > 4, moderate renal impairment
11 Dilated cardiomyopathy 61 Male HeartMate II LVAD, pump pocket infection,
moderate renal impairment
12 Dilated cardiomyopathy 48 Male No PVR > 4 WU
14 Dilated cardiomyopathy 22 Male No IABP, moderate renal impairment
15 Dilated cardiomyopathy 57 Male No PVR > 4 WU
16 Dilated cardiomyopathy 26 Female No PVR > 4 WU, moderate renal impairment
17 Dilated cardiomyopathy 33 Male HVAD LVAD
18 Ischemic cardiomyopathy 48 Male No ...
19 Ischemic cardiomyopathy 33 Male HeartMate II LVAD, pump pocket infection
20 Dilated cardiomyopathy 48 Male HeartMate II LVAD, pump pocket infection, 4 previous sternotomies
22 Dilated cardiomyopathy 56 Male No ...
23 Dilated cardiomyopathy 58 Male HVAD LVAD þ RVAD Levitronix, severe renal impairment
25 Dilated cardiomyopathy 34 Male No -
26 Dilated cardiomyopathy 59 Female HVAD LVAD, PVR > 4 WU
27 Dilated cardiomyopathy 30 Male No IABP
29 Dilated cardiomyopathy 57 Male No PVR > 4 WU
30 Dilated cardiomyopathy 56 Female No Moderate renal impairment
a
Donor hearts 13, 21, 24, and 28 were declined.
HVAD ¼ HeartWare ventricular assist device; IABP ¼ intraaortic balloon pump; LVAD ¼ left ventricular assist device; PVR ¼ pulmonary
vascular resistance; RVAD ¼ right ventricular assist device; WU ¼ Wood unit.

transplantation after OCS assessment because of re-
fractory increasing lactate levels. These organs were
also associated with poor contractility on the system
and ongoing hemodynamic instability in the presence
of increased aortic pressure, which was suggestive of
myocardial damage with increasing coronary vascular
resistance. This was an important additional reason to
decline donor hearts for transplantation after 305  20
minutes of assessment.
None of the donor hearts were discarded because of
operator/technical failures related to the OCS support.
We observed a favorable downward trend in lactate levels
(Fig 2), with a lower venous than arterial level, indicating
myocardial lactate consumption. The mean total out of
body time was 371  102 minutes, and the mean OCS
perfusion time was 285  92 minutes. The longest
period of OCS support was 464 minutes.
Recipient Intraoperative and Postoperative Course and
Survival
The mean operative duration for heart implantation was
60  13 minutes, and the mean total allograft ischemic
time was 87  15 minutes. The allografts were reperfused
for 78  38 minutes before disconnection from cardio-
pulmonary bypass. Three patients required IABP support
for weaning from cardiopulmonary bypass: 1 patient had
severe pulmonary hypertension, and the other 2 received
hearts from donors who died of cocaine overdose. In all
the cases, the allograft function improved and the IABP
could be weaned after 4 days. The mean duration on
inotropic support was 113  85 hours and the median
duration of inhaled nitric oxide administration was 22
hours interquartile range (15; 40) after transplantation.
Five patients (19.2%) experienced moderate right
ventricular failure according to Interagency Registry
Mechanically Assisted Circulatory Support (INTER-
MACS) definition, requiring inotropic support/inhaled
nitric oxide for more than 1 week. The mean post-
operative blood loss in 24 hours was 812  501 mL. The
median intensive care unit stay was 6 days interquartile
range (4; 8), (range, 2–149 days).
One patient undergoing implantation with a HeartMate II
(Thoratec, Pleasanton, CA) LVAD who had a severe pump
infection became septic after the transplantation procedure
 2104 GARCIA SAEZ
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ORGAN CARE SYSTEM IN HEART TRANSPLANTATION
ADULT CARDIAC
Fig 2. Venous and arterial lactate levels (mmol/L) before and during
Organ Care System (OCS) support.
and needed extracorporeal membrane oxygenation support
on postoperative day 3, which was successfully dis-
continued after 5 days. He had preserved allograft function
but died on postoperative day 44 resulting from bowel
ischemia.
Twenty-four recipients were discharged from the hos-
pital with a mean hospital stay of 39  29 days; 1 patient
has not yet been discharged. Survival at 1 month was
100%. At follow-up of 257  116 days (range, 109–445
days), survival was 96%. One outpatient had a reduced
LVEF of 50%. Biventricular allograft function was well
preserved in the remaining 24 patients (92%), with a
mean LVEF of 66.3%  5.6%, mean fractional shortening
of 37%  6%, and a mean longitudinal right ventricular
systolic function of 13.6  3.1 mm.
Comment
This is the first clinical report of heart transplantation
using the OCS in the context of an adverse donor-recipient
risk profile. The highly favorable early outcomes demon-
strate the clinical effectiveness of this approach.
A crucial advantage of the OCS is a substantial reduction
in the total cold ischemic time for conventional cold donor
organ preservation; total cold ischemic time has been
shown to be a risk factor for mortality, with an odds ratio
for death within 30 days of 1.06 per 15-minute increment
[2]. The OCS allows for extended out of body time of at
least 8 hours, expanding potential geographic zones for
organ procurement, reducing the detrimental effects of
cold ischemic storage, improving short-term heart allo-
graft function, and leading to favorable outcomes.
Increased donor age has also been identified as a risk
factor for reduced survival at 1 year [13] and should
be carefully considered when it is associated with
prolonged cold ischemia. Furthermore, older donors with
cardiovascular risk factors are at higher risk of coronary
artery disease, which can only be reliably diagnosed with
an angiogram, and because of logistic constraints it
cannot normally be performed at the time of donation.
Although the OCS allows for angiography of the donor
heart while it is in the system [15], the presence of
significant coronary artery disease can also be predicted
from an increasing aortic pressure trend during organ
Ann Thorac Surg
2014;98:2099–106
perfusion. In this series, 5 donor hearts had palpable
coronary artery disease, which was tentatively deemed to
be nonsignificant but could not be confirmed because of
the unavailability of a donor angiogram; the presence of
stable pressure and lactate trends during OCS support
suggested that the coronary artery disease was not severe
and consequently these hearts were transplanted, leading
to favorable early outcomes.
On the basis of publication of interim results from the
PROCEED II trial, which implied that a rising lactate level
on the system is a predictor of donor heart abnormality,
we made the decision to use the OCS for the assessment
of extended criteria donor hearts. Our data confirm the
importance of the trend in venous and arterial lactate
levels and the difference between them as markers of
donor heart function. Some of the donor hearts assessed
on the OCS had sustained previous cardiac arrest with
increased troponin levels or a reduced LVEF, or both.
Transplanting these organs may potentially increase the
risk of primary allograft dysfunction and the requirement
of mechanical support after transplant. We assessed the
behavior of these organs on the OCS; whenever the
lactate trend was favorable in combination with stable
perfusion measurements, the organs were transplanted
with excellent outcomes.
Other groups [16, 17] did not find differences in the
outcome when transplanting selected allografts with good
LV function from donors with previous cardiac arrest of
20 minutes using cold storage preservation. However,
allografts with longer downtimes may have reduced LV
function, increased troponin levels, or regional wall mo-
tion abnormalities. Ex vivo assessment combined with
reduced cold ischemic time would minimize the risk of
primary allograft dysfunction and potentially increase the
donor pool. Four allografts with a donor downtime of 25
to 35 minutes—2 with normal LVEF and the other 2 with
reduced contractility—were assessed on the OCS and
considered unsuitable for transplantation, thus avoiding
any risk to the recipients.
The International Society for Heart and Lung Trans-
plantation registry continues to identify LVAD bridging
as a risk factor for increased mortality after trans-
plantation. The ex vivo heart perfusion allows optimiza-
tion of logistics and meticulous preparation of the
recipients with LVADs. In these cases, we observed a low
incidence of right heart failure, improved allograft func-
tion, reduced blood transfusion requirement, and shorter
intensive care unit and hospital stays.
Several limitations of this study merit attention. The
main limitation is the analysis of a small cohort of patients
from a single institution who underwent heart trans-
plantation using the OCS as a method of allograft pres-
ervation/assessment. Moreover, because some of these
donors would not have been considered suitable for
transplantation, on ethical grounds the donor hearts
could not be randomized to standard of care preserva-
tion/cold storage. Long-term follow-up is also required,
particularly in the group of patients who received allo-
grafts with LVH, reduced LVEF, or palpable coronary
artery disease, because such risk factors may have an
Ann Thorac Surg
2014;98:2099–106
as yet undetectable impact on long-term outcome.
Conversely, it is conceivable that the minimization of total
cold ischemic time by the OCS may limit reperfusion
injury and favorably influence the long-term progression
of allograft vasculopathy.
A multicenter Food and Drug Administration–
approved single-arm non-randomized trial is currently
under way in the United States and will evaluate the rate
of use of extended criteria donor hearts and early out-
comes after transplantation.
In conclusion, this is the first experience using the OCS
in a high-risk donor/recipient cohort. The OCS minimizes
total cold ischemic time and the deleterious effects of cold
storage on the myocardium. It also allows optimization of
logistics, ie, assessment of extended criteria allografts and
meticulous preparation of recipients, particularly those
who have undergone LVAD implantation with previous
sternotomies. It increases the donor pool by using organs
previously not considered for transplantation and de-
creases the risk of primary allograft failure, which is
encouraging given the combined risk profile of donor and
recipient. As a result of highly favorable postoperative
outcomes, use of the OCS has become standard of care in
our institution.
References
1. Kirklin JK, Naftel DC, Kormos RL, et al. Fifth INTERMACS
annual report: risk factor analysis from more than 6,000
mechanical circulatory support patients. J Heart Lung
Transplant 2013;32:141–56.
2. Banner NR, Thomas HL, Curnow E, et al. The importance of
cold and warm cardiac ischemic for survival after heart trans-
plantation. Steering Group of the United Kingdom Cardio-
thoracic Transplant Audit. Transplantation 2008;86:542–7.
3. Russo MJ, Iribarne A, Hong KN, et al. Factors associated with
primary allograft failure after heart transplantation. Trans-
plantation 2010;90:444–50.
4. Ozeki T, Kwon MH, Gu J, et al. Heart preservation using
continuous ex vivo perfusion improves viability and func-
tional recovery. Circ J 2007;71:153–9.
DISCUSSION
DR MATTHIAS LOEBE (Houston, TX): Thank you very much
for this impressive presentation. Let me ask you, do you have any
measurements while the organ is in support that help you to
decide whether to use this organ or not, or is the advantage of the
system that you believe you provide better preservation and then
feel more comfortable to accept marginal organs or longer
ischemic times?
DR GARCIA SAEZ: We certainly believe that the preservation
provided by the system is much better compared with the cold
storage. The cold ischemic time is reduced significantly and we
can push the boundaries and utilize extended criteria donors. The
visual assessment of the graft, the lactate trend, and the stability of
the perfusion parameters such as coronary flow or aortic pressure
are usually enough to decide whether the heart is performing well
in the system or not. Several grafts with previous donor cardiac
arrest were considered unsuitable for transplantation after the
OCS assessment due to persistently increasing lactate. In addi-
tion, there was a reduced contractility of the graft on the system
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and ongoing hemodynamic instability with increased aortic
pressure suggesting myocardial damage with associated coronary
vascular resistance or coronary artery disease.
DR LOEBE: And that is based on solid numbers or it just helps to
have a better gut feeling in making the decision whether to use it
or not?
DR GARCIA SAEZ:
 The lactate trend is a very reliable marker of
graft abnormalities, and the grafts are usually considered not
transplantable when the final lactate level is above 5 mmol/L. We
have transplanted hearts that had an increased lactate on the
system, however with venous lactate lower than the arterial one,
which indicates lactate myocardial consumption in a good graft
despite not being optimally perfused. In these particular cases,
other parameters as the visual contractility and the stability of the
perfusion data on the system are usually enough to decide. In
cases of extreme extended criteria donors, the final decision may
not be easy and it comes with the experience using the system.
 2106 GARCIA SAEZ
 ET AL
ORGAN CARE SYSTEM IN HEART TRANSPLANTATION
DR DANNY CHU (Pittsburgh, PA): Is this OCS a closed system
or an open system, and if it’s an open system with a reservoir, do
you see much hemolysis and thrombocytopenia issues
postoperatively?
DR GARCIA SAEZ:

ADULT CARDIAC
This is a closed system on the right side of the
heart. The oxygenated blood is pumped into the aorta to perfuse
the coronary arteries. Deoxygenated blood enters the right atrium
(closed superior and inferior vena cava) via coronary sinus and is
then drained through the pulmonary artery with a cannula in it to
the blood oxygenator and returned to the reservoir. The left atrium
is open and the left ventricle is beating empty.
The system could produce hemolysis after several hours;
however, without clinical impact on the graft or the recipient’s
postoperative period. We haven’t seen cases with severe throm-
bocytopenia in recipients either. The amount of blood transfusion
in recipients with OCS preserved grafts is much more reduced
when compared with patients transplanted with grafts with cold
storage.
DR DOMENICO MAZZITELLI (Munich, Germany): I enjoyed
the presentation. A very short question about the donors
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Published by Elsevier
Ann Thorac Surg
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with poor or with worse ventricular function. What happens
after the transplant? Did it improve or remain the same or
worsen it?
DR GARCIA SAEZ:  All the patients transplanted have normal
left ventricular function on the follow-up. It is surprising that
some of the donors had reduced function down to 45%, and we
decided to transplant them after a successful assessment on the
system, however with the possibility of requiring initial me-
chanical support. All these grafts came easily off bypass, and the
recipients are doing extremely well.
Some of the grafts are under stress conditions in the donor due
to the catecholamine response following brain death. That may
justify the reduced function during the donor assessment. The
OCS may have the potential to recondition such grafts.
DR MAZZITELLI: So you mean the ventricle becomes better in
the follow-up?
DR GARCIA SAEZ:
 Yes, it does. We haven’t had any cases of
reduced function on the follow up.
If you have any questions about how this might
affect you, please call the Board office at (312) 202-
5900.
Richard J. Shemin, MD
Chair
The American Board of Thoracic Surgery
Ann Thorac Surg 2014;98:2106  0003-4975/$36.00