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Experience With the Symbion Total Artificial Heart

as a Bridge to Transdantation
U I
Robert W. Emery, MD, Lyle D. Joyce, MD, Mike1 Prieto, MD, Kristen Johnson, RN,
Irvin F. Goldenberg, MD, and Marc R. Pritzker, MD
Division of Mechanical Circulatory Support and Cardiothoracic Transplantation Program, Minneapolis Heart Institute, Minneapolis,
Minnesota
From December 1985 through January 1991, 9 patients
underwent bridging to transplantation using a Symbion
J-7-70 total artificial heart. There were 4 female and 5
male patients aged 31 f 14 years (range, 15 to 52 years).
Five patients were supported on an intraaortic balloon
pump before total artificial heart support, and 2 had
biventricular assist devices as well. Total artificial heart
support was maintained for 17 f 12 days (range, 4 to 44
days); all patients underwent transplantation. Three pa-
tients died after transplantation on day 0 (primary donor
organ failure), 25 (acute rejection), and 256 (multiorgan
failure). The remainder were discharged at 41 f 32 days
(range, 13 to 101 days). One patient died 28 months after
transplantation of late acute rejection. Actuarial 1-year
he first attempt to bridge a patient to cardiac trans-
T plantation occurred in 1969 when Cooley and asso-
ciates [l] used the Liotta heart. Successful circulatory
support and transplantation occurred but the patient died
in the early period after transplantation. This experience
documented that total hemodynamic support could be
obtained with an artificial device replacing both ventri-
cles. Thirteen years later, DeVries and colleagues [2, 31
attempted cardiac replacement on a permanent basis
using the Symbion J-7-100 (Jarvik-7) total artificial heart
(TAH). Long-term survival was obtained but all patients
who received permanent implants suffered major compli-
cations and died. Copeland and associates [4, 51 for the
first time successfully used a TAH as a bridge to trans-
plantation, ushering in an era of heightened enthusiasm
for the use of total circulatory support in critically ill
patients. Although permanent replacement has not been
realized, the use of a TAH as a bridge has become firmly
established.
Multiple models of TAH have been used as bridge
devices (Table 1); however, only the Symbion J-7 and
more recently the Vienna heart have resulted in substan-
tial long-term survival. Since 1985 the Symbion TAH has
been used more than 170 times [6]. Shifts in research
interest to the use of sophisticated univentricular and
biventricular support devices and the Food and Drug
Administration restrictions on the manufacture and ship-
Accepted for publication Aug 12, 1991.
Address reprint requests to Dr Emery, 920 E 28th St, Suite 420, Minneap-
olis, MN 55407.
and 3-year survival is 67% and 55%. There were no
surgical wound infections. Problems encountered in the
J-7-70 period and the period after transplantation were
for the most part related to patient condition in the
period before implantation. The Symbion J-7-70 total
artificial heart is an effective device for total circulatory
support in patients with end-stage cardiogenic shock
when an organ donor is not available. Organ system
failure and infection before implantation may persist
into the transplantation period resulting in long-term
complications, increased mortality, and prolonged hos-
pital stay; therefore, early implantation of the device
when indicated should be applied.
(Ann Thorac Surg 1992;53:282-8)
ping of the Symbion device have recently diminished the
frequency of its use. This report documents the total
experience at the Minneapolis Heart Institute using the
Symbion J-7-70 as a bridge to transplantation. Patients'
complications and adverse events were recorded during
the preoperative, implantation, and posttransplantation
periods. This examination was made in an attempt to
differentiate secondary events that arose during each of
the above periods from directly device-related problems.
Material and Methods
The hospital charts of all patients were reviewed to obtain
details of the bridging and the patient's hospital course.
Indications for implantation included candidacy for trans-
plantation with regard to pulmonary vascular resistance
and negative cytotoxic screen coupled with refractory
cardiogenic shock after exhaustion of other forms of
circulatory support therapy. The TAH was not used as a
resuscitative device except in 1 case in which a patient
who had been previously selected suffered cardiac arrest.
The Symbion J-7 devices have been previously described
[A. Surgical technique for implantation is similar to that of
Levinson and Copeland [8] with the exception that fibrin
sealant [9] was used on all suture lines to prevent bleed-
ing. Anticoagulation was begun 12 to 24 hours after
implantation when chest tube output was less than 50
mWh and consisted of increasing dosages of intravenous
heparin to maintain thrombin time between 20 and 40
seconds at 1:4 dilution. Dipyridamole (Persantine; Boehr-
inger Ingelheim, Ridgefield, CT) was also added when
0 1992 by The Society of Thoracic Surgeons 0003-4975/92/$5.00
Ann Thorac Surg
1992;53:282-8
EMERY ET AL 283
BRIDGE TO TRANSPLANTATION
Table 1 . Models of Artificial Hearts Used as Bridges to
Transplan tat ion"
Model
N
(percent transplanted) Survival
Liotta
Askutsu
Phoenix
Symbion J-7-70
Symbion J-7-100
Berlin
UngerEllipsoid
Penn State
Vienna
Moscow Poisk
Czech
a Johnson et al 1991 (61.
platelet function returned to normal. Most patients were
not immediately listed for priority transplantation. Our
philosophy has been consistent with that of Griffith [lo] in
that several days were cleared for patient recovery from
operation and any secondary organ system dysfunction
that might be present. Outpatient records documented
follow-up, which is 100%.
Immunosuppressive regimens have been described
previously [HI. Briefly, standard triple-drug therapy was
used for the first 2 patients; however, in May 1987 a
regimen of OKT3 induction with steroid-free maintenance
immunosuppression was initiated under the philosophy
of minimizing posttransplantation toxic manifestations of
these agents in critically ill patients and sparing the
Table 2. Immunosuppression Regimens
long-term side effects of steroids. The regimen used in 7
patients is shown in Table 2.
Actuarial calculations were performed using the Kap-
lan-Meier technique. Linearized continuous data are ex-
pressed as mean f standard deviation.
Results
From December 1985 through December 1990, a total of 9
patients (4 were female and 5, male) underwent cardiac
transplantation at the Minneapolis Heart Institute, pre-
ceded by the use of the Symbion J-7-70 TAH as a bridging
device. The demographic data and patient characteristics
before implantation are listed in Table 3. The mean patient
age was 31 f 14 years (range, 15 to 52 years). The cause of
the underlying heart disease was idiopathic cardiomyop-
athy (in 3 patients), acute viral cardiomyopathy in 2, and
ischemic heart disease, rheumatic heart disease, giant cell
myocarditis, and idiopathic hypertrophic cardiomyopathy
in 1 patient each.
Events occurring before implantation are delineated in
Table 3. Five patients were in cardiogenic shock before
device implantation. Three patients had operation imme-
diately before device placement. One patient could not be
weaned from bypass after a coronary artery bypass graft
operation, and 2 patients (one heart transplant, one valve
replacement) were supported on biventricular assist de-
vices for 12 hours and 4 days, respectively, before TAH
implantation. All patients but 1 were on inotropic sup-
port. A 15-year-old patient was placed emergently on
cardiopulmonary bypass while cardiopulmonary resusci-
tation was being performed and underwent J-7-70 implan-
tation. He had been selected for TAH use before cardiac
arrest. Six patients had an intraaortic balloon pump
placed before the TAH (2 had biventricular assist devices).
TDI (n = 2) OKT3 (n = 7)
Cyclosporine
Pretransplanta tion
Posttransplantation
Azathioprine
OKT3
Methylprednisolone
P r e d ni s o n e
Dopamine
4 mgikg
3-5 mg kg-' day-' PO
Levels: 200 f 25 ng/mL 6 wk
150 f 25 ng/mL 6-26 wk
100 f 25 ng/mL 1-6 mo
1.53 mg - kg-' - day-' PO
WBC = 3,oo(r5,000/pL
None
500 mg IV bolus after CPB then
125 mg IV q 12 h x 3 doses
1.5 mgkg (first dose) PO, taper to
0.5 mgikg by 1 mo, to 0.15 mgikg by
6 mo, and to 0.1 mg/kg at 1 year
1 mg kg-' - min-' for 1 wk IV
c-4mgikg"
1-5 mg * kg-' * day-' PO
Levelb, 0-100 ng/mL posttransplant
weeks 1-2 then as TDI
Same
5 mg/day from POD 2 to 15
Same
Same, 250 mg IV bolus on POD 15
0.15 mg - kg-' - day-' POD 2-14, 1.5 mgkg on
POD 16, tapered to 0.5 mgikg by 10 days then
2.5 mg/wk to discontinuation
1 mg - kg-' - mir-' for 1 wk IV
a Pending renal function.
CPB = cardiopulmonary bypass; IV = intravenously; PO = per oral; POD = postoperative day; ID1 = triple-drug immunosuppression;
WBC = white blood cell count.
Whole blood 12-hour trough level as measured by high-performance liquid chrumotography.
284 EMERYETAL
BRIDGE TO TRANSPLANTATION
Ann Thorac Surg
1992;53282-8
Table 3. Patient Demographics Before Symbion 1-7-70 Implantation
Variable 1 2 3 4 5 6 7 8 9
40
F
154
28
F
161
15 50 45
M M F
163 182 152
19
M
170
16
M
180
66
Postviral
19 52
M F
187 162
55 63 46 94 48 69 86 57
Postviral Giant cell
myo-
carditis
IDC Ischemic RHD
cardiomy-
opathy
Congenital
hyper-
trophic
myopathy
Donor organ
failure
IDC IDC
Indication Cardiogenic
shock
Cardiogenic
shock
Cardiogenic Failure to Failure to
shock weanCPB wean
VAD
Emergent Inotropic, Inotropic,
CPB IABP IABP,
BIVAD
Renal, - Respira-
neurologic tory
Cardiogenic
shock
Cardiogenic Cardiogenic
shock shock
Pre-J-7-70
support
Inotropic,
IABP
Inotropic Intropic,
BIVAD,
IABP
-
Inotropic Inotropic, Inotropic,
IABP IABP
Pre-J-7-70
organ
dysfunc-
tion
Renal, leg
ischemia
Superior Pulmonary
caval infiltrate,
thrombosis respira-
tory
CPB = cardiopulmonary bypass; IDC = idiopathic dilated cardiomyopathy; RHD = rheumatic heart disease.
Three of 9 patients had organ system dysfunction of the
kidneys (2) or lung (2) and an embolic cerebrovascular
accident (1) before implantation. One patient had acute
superior vena cava thrombosis. Four patients had moder-
ate to severe cognitive disturbance before TAH implant.
Two were mildly impaired. Three others were anesthe-
tized from a prior operation or on VAD support.
In all cases, the TAH sustained life until a suitable
donor heart was found and transplanted. No patient died
while on the J-7-70. The mean time spent on TAH support
was 17 2 12 days, with a range of 4 to 44 days. Surpris-
ingly few complications directly related to the device and
implant period occurred. These are detailed in Table 4.
Two patients required prolonged ventilator support, but
ventilatory difficulties were related to preoperative dete-
rioration with severe cardiogenic shock in 1 and a pre-
operative embolic stroke with cardiac arrest in a second.
There were no device failures or evidence of hemolysis.
Although there were no mediastinal surgical wound in-
fections, infectious complications developed in 4 patients.
Two of these were nonascending drive line infections
with Staphylococcus aureus. One further patient on biven-
tricular support for 4 days before implantation had devel-
opment of positive blood cultures while on the TAH and
was found to have enterococcus from the mediastinum,
urine, driveline and the central venous pressure tip as
well. Positive blood cultures for Serratia, the source of
which remains unknown, developed in a fourth patient.
None of these infections affected the pretransplantation or
posttransplantation course. One patient with renal failure
before implantation required dialysis, and neurologic
symptoms developed in 2 patients while they were on the
J-7-70. One patient had a transient right hemispheric
visual disturbance, and a second had a prolonged episode
of confusion, aphasia, and incontinence. Although both
episodes resolved, the latter resulted in catatonia for
several days of TAH support which persisted in the
period after transplantation. Because of immobility of this
patient, a sacral decubitus ulcer developed and required
flap closure after transplantation. One patient required
prolonged ventilator support because of preimplantation
embolic cerebrovascular accident and cardiac arrest. He
was extubated and reintubated three times during his
25-day implantation for a total of 21 ventilator-dependent
days. The patient with the most complications, our first,
suffered severe multiorgan failure before implantation
from cardiogenic shock; multiple complications devel-
oped after implantation from which she never recovered
over the 256-day posttransplantation course (see Table 4).
Over the time of implantation, leg ischemia from intraaor-
tic balloon pump placement and renal, respiratory, and
hepatic failure were persistent and peptic ulcer disease
arose with the development of pancreatitis and pancreatic
pseudocyst formation later requiring operation. These
problems persisted into the period after transplantation
and, coupled with intermittent infectious processes (cyto-
megalovirus, Pneumocystis, Pseudomonas), resulted in the
patient's death of multiorgan system failure [12].
After completion of the implant procedure, meticulous
hemostasis was obtained and patients were observed in
the operating room for several hours. Over the first 48
hours, the average blood replacement was 6.8 units with
a range of 2 to 19 units. One patient was returned to the
operating room during this period. Two others were
returned for evacuation of a mediastinal hematoma on the
fifth and sixth days after implantation, respectively.
Three patients died during their posttransplantation
hospitalization (Table 5). The first patient died of sepsis-
Ann Thorac Surg
1992;53282-8
EMERY ET AL 285
BRIDGE TO TRANSPLANTATION
Table 4. Complications on 1-7-70 Support
Variable 1 2 3 4 5 6 7 8 9
Implant
duration
Ventilator (d)
Blood loss in
Surgical
(4
48 h (U)
wound
infection
infection
Other
44 4 25 17 5 18 15 25
20 1 21 1
19 5 11 8
4 1 1 1
2 3 2 2
Drive line -
Blood, CVP,
driveline,
urine,
mediastinum
- - Driveline Blood,
pneumonia
Dialysis
Stroke
- - Confusion, -
TIA
- - - -
Late Late - -
Hemolysis
Reop for
bleeding
Device
malfunction
Other
PUD, - Prolonged -
pancreatic ventilator
pseudocyst support
- - Catatonia, Pneumonia
sacral
decubitus
CVP = central venous pressure tip; I'UD = peptic ulcer disease; TIA = transient ischemic accident.
associated multiple organ system failure at 256 days after
transplantation after a protracted postoperative course
[12]. A second patient died of acute rejection at 28 days
after transplantation 1111. The third patient death oc-
curred on the day of transplantation and was due to
primary donor organ failure after a difficult donor organ
implantation when severe weather delayed return of the
donor organ. Right heart failure occurred during the early
Table 5. Posttransplantation Course
Variable 1 2 3 4 5 6 7 8 9
Survival at 1 mo
Survival at 3 mo
Survival at 1 y
Posttransplantation
Rejection
survival (mo)
(days after
transplantation)
Infections at 1 y
+
+
- a
9b
+
+
+
29b
+
+
+
46
+
+
+
44
- a
NA
NA
lb
+
+
+
34
+
+
+
33
+a
+
+
26
a -
NA
NA
Ob
6,38,854 367 23 NA
CMV,
pneumonitis,
Pneumocystis,
Pseudomonas
sepsis
Leg ischemia,
multiorgan
failure
NA
12561
Mumps NA Sacral ulcer,
confusion
NA
Other
complications
Ganaclovir
leukopenia
NA BVAD support
of donor
heart
NA
Current steroids
Posttransplantation
NA
11
NA
1281
NA
la
-
139
-
17
-
15 17 63
a Died during hospitalization after transplantation.
BVAD = biventricular assist device;
Late death.
CMV = cytomegalovirus; NA = not available.
286 EMERY ET AL
BRIDGE TO TRANSPLANTATION
Percent
................................................................................................................
............................
................................................
0 6 12 18 24 30 36 42 48
Months
Fig 1 . Actuarial survival of patients undergoing bridging to trans-
plantation using the Symbion 1-7-70 total artificial heart.
postoperative period and was rapidly followed by cardiac
arrest. One patient required use of an intraaortic balloon
pump and biventricular assist device for support of car-
diac function for 4 days after transplantation. He was
discharged on the 63rd day after transplantation and
remains well [13]. The remainder were discharged at 36 f
23 days (range, 13 to 73 days) after transplantation. One
patient died of late acute rejection at 28 months after
transplantation following treatment. The remaining 5
patients are in functional status 1 at 23, 30, 31, 41, and 42
months. The 30-day, 1-year, and 3-year actuarial survival
rates were 78%, 67%, and 55% respectively (Fig 1).
Rejection was seen in three patients (33%). One patient
had rebound acute rejection after OKT3 therapy. From
this time a protocol of a steroid bolus followed by slow
tapering of steroids after OKT3 therapy was instituted
[ll]. One patient (who did not receive OKT3) had three
rejection episodes on days 6, 38, and 854 after transplan-
tation. Each responded to steroid therapy, but the patient
died after the last rejection episode. A third patient
(OKT3) had a rejection episode more than a year after
transplantation (see Table 5) treated with steroid taper.
Bacterial infection was a major cause of morbidity, but
none of the infections were related to the surgical wound.
One patient had a protracted postoperative course with
multiple processes [12]. Another patient had Enterobucter
pneumonia. Both of these patients died before discharge
in the posttransplantation period, but not of infection. No
other bacterial infections were seen in these patients
during the posttransplantation period. Posttransplanta-
tion cytomegalovirus infection was seen in 3 patients
(33%), and 2 patients suffered herpes simplex virus infec-
tions (22%). Of the 5 patients alive, one has a pre-TAH
neurologic deficit. The remainder are in functional status
1, and all surviving patients are free of steroids.
Ann Thorac Surg
1992;53:282-8
FDA suspension of the Symbion TAH have severely
limited the use and availability of the TAH. In 1990 only
14 devices were implanted worldwide [6]. Yet, it is appar-
ent from our experience with an absence of mortality
related to circulatory failure during device implantation
that the TAH successfully maintains vital functions and
allows successful transplantation in all cases. It is also of
interest that most major complications occurring over the
patient’s entire hospital course emanated from preexisting
complications or debilitation due to cardiogenic shock
before implantation [14]. In those cases in which the TAH
was implanted while the patient was free of organ system
dysfunction, complications relating to the device were
relatively few. This would indicate the factors relating to
organ recovery are progressive and not related to the
TAH, similar to data reported by others [15]. Mortality
after transplantation was high, with 3 patients (33%)
dying before discharge from the hospital. It was apparent
from our experience that the better the preoperative
condition of the patient before TAH implantation, the
more benign the postoperative course [16, 171. Operative
survivors with organ system dysfunction before implan-
tation (n = 3) required an average hospital stay of 153
days after transplantation; there was one death in this
group. For patients with no preoperative organ system
dysfunction or infection (n = 4) the average hospital stay
after transplantation was 15 days. Two other patients with
complications before implantation died in the operative
period. Age in and of itself was not a factor in survival as
in the experience of others [16]. Yet it is apparent that
younger patients have more reserve to tolerate multiple
surgical procedures.
The formation of extensive adhesions may occur over a
short period of time, and as previously noted, may make
explantation of the Symbion device difficult as well as
complicate the implantation of the donor organ [MI. This
occurred in 1 of our patients and posttransplantation
intraaortic balloon pump and ventricular assist device
support was required. The use of continued forms of
mechanical support of the donor heart after transplanta-
tion has been successful and allowed long-term survival
With the high incidence of complications extending into
the period after transplantation, coupled with the usually
prolonged recovery after multiple surgical procedures,
minimizing the additional toxic side effects of immuno-
suppressive agents is highly desirable if secondary organ
system dysfunction and sepsis are to be prevented [lo,
111. To accomplish this an induction protocol using OKT3
monoclonal antibody was devised and used in 7 of 9
patients [ll]. Although OKT3 has in itself some undesir-
able side effects, most are associated with the first and
second dosages and dramatically decrease thereafter.
Those early side effects can effectively be minimized by
withholding the first administration until the patient is
within 10% of dry weight and by pretreatment with
~3 1 .
antihistamines, hydrocortisone, acetaminophen, and ran-
itidine. Use of this powerful agent early in the posttrans-
plantation period has allowed the dosage of other immu-
nosuppressive agents to be minimized. No rejection
Comment
The shift of direction in cardiovascular research to the use
of univentricular support devices coupled with the recent
Ann Thorac Surg
1992;53282-8
EMERYETAL 287
BRIDGE TO TRANSPLANTATION
episodes have been seen during OKT3 administration in
this group or in a larger group of high-risk patients
managed similarly [ 191. OKT3 has become our first-choice
immunotherapy for all patients bridged to transplanta-
tion, as well as for all high-risk transplant patients.
Although rejection was not seen in any patient during
OKT3 administration, 1 patient died of rebound rejection
on posttransplantation day 28. This patient was not given
steroids after the OKT3 course because of concern for
mediastinal contamination, and is described in detail
elsewhere [20].
To further prevent the development of pulmonary
infection and sepsis we, as others, attempt to extubate
patients as early as possible after implantation or trans-
plantation [16]. Only patients with organ system dysfunc-
tion before implantation required prolonged ventilator
support (see Table 3). Infection was not a cause of early
posttransplantation mortality in our series [16, 211. On
long-term follow-up, steroid-related complications in all
surviving patients have been eliminated as none are
taking the drug. All patients are in status 1 from a
cardiovascular standpoint, but 1 has a permanent neuro-
logical deficit as a consequence of a preimplantation
cardiac arrest and cerebrovascular accident. The only late
death occurred in a patient who, 28 months after trans-
plantation, suffered late acute rejection and died.
The 30-day survival of 77% and 1-year actuarial survival
rate of 67% is not comparable with that achieved in heart
transplantation. However, all these patients were premor-
bid with death imminent. With these results, we believe
that the Symbion TAH presents a unique alternative for
patients in cardiogenic shock who are eligible for trans-
plantation but have not been able to obtain a donor heart.
As the success in heart transplantation continues to im-
prove and the limited resource of donor hearts becomes
even more problematic, the need for a bridging device is
going to continue to be a factor in determining survival for
patients awaiting a heart transplant [lo, 221. Selection of
patients is of utmost importance, and early placement of
the TAH before the development of multiorgan system
dysfunction improves long-term results [MI. We concur
with strict selection criteria previously published, which
may maximize results [lo, 18, 231. Although a scoring
system as described by Pennington and associates [23] is
useful for patient selection, such situations are dynamic,
and decisions regarding patient selection often must be
made rapidly because of declining hemodynamics. Stabi-
lization by additional drug therapy may allow some
postponement of device selection, but delayed implanta-
tion may result in complications that carry through the
bridging period affecting the posttransplantation course
or even preclude transplantation once implantation has
been accomplished [24]. Additionally, should established
organ system dysfunction or infection be present, revers-
ibility is always a question [15]. It may be possible to
convert a nontransplant patient into a transplant candi-
date by the application of circulatory assistance, but
higher mortality and morbidity must be accepted if such a
decision is made [16, 241. Although external pressure on
the implant team from the patient, family, or attending
physician and a "last chance" philosophy may exist, such
considerations should not predominate in patient selec-
tion. With the availability of multiple types of support
systems, the TAH is not suitable for all patients and its
use should be individualized, taking into account the
availability of other devices, their benefits, and their limits
[22, 25, 261. Yet marginal hemodynamic stability should
not exclude a patient from device consideration. Many
real and potential complications are accentuated with the
use of a TAH [27]. Problems encountered with the initial
use of the device including massive bleeding, severe
hemolysis, reoperation, renal failure, thromboembolism,
sepsis, and others did not affect our patients unless
present before implantation and have been infrequent.
Importantly, there were no posttransplantation surgical
wound infections [28]. The fit of the device is an impor-
tant factor in function of the device, and the absence of
atrial compression must be assured [18, 271.
The Symbion J-7-70 TAH satisfactorily accomplishes a
bridge function. Improvements, especially relating to the
driving system and power source, should be made to
achieve longer, morbidity-free bridging periods and better
quality of life while on the device. Easing of strict restric-
tions by the FDA would benefit researchers pursuing this
goal. In spite of restricted availability, these results sup-
port the use of the TAH in selected patients as a bridge to
transplantation. We concur with the opinions of others
that use of the TAH is lifesaving, but in poorly selected
patients the course is fraught with complications, one
begetting the other, expensive, and potentially wasteful
of the scarce resource of a donor heart for an individual
with limited potential for survival thus opening the con-
cept of bridging to social criticism [16, 18, 23, 281.
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