SynCardia TAH-t Instructions For Use Manual
SynCardia Systems Inc.
temporary Total Artificial
Heart (TAH-t)
INSTRUCTIONS FOR USE
1992 E. Silverlake Road
Tucson, AZ 85713 USA
(520) 545-1234
(866) 771-9437
STERILE EO
CAUTION: Federal (USA) law restricts this device to sale by
or on order of a physician.
0086
16 MAY 2005
950000-001 Rev. 004
SynCardia TAH-t Instructions for Use
Table of Contents
Page
1.0 Device Description.…………………………………………...…... 3
1.1 Implantable TAH-t…………………………...………...…… 3
1.2 External Console………………………………….….......... 4
2.0 Indications for Use………………………………………....…..… 4
3.0 Contraindications………………………………………………... 4
4.0 Warnings ...........................………………………………………. 5
5.0 Precautions……………………………………………........…..... 6
6.0 Summary of Clinical Study……………………………………… 7
6.1 Trial Success……………………………………………….. . 7
6.2 Hemodynamics……………………………………………….. 7
6.3 Adverse Events……………………………………………….. 8
6.4 TAH-t Reliability……………………………………………….. 9
7.0 Implant Procedures.......................................................................... 10
7.1 Materials Needed but not Provided………………………… 10
7.2 Preparation.............................................................................. 11
7.3 Removal of Native Ventricles................................................. 11
7.4 Preparing the Atria................................................................... 13
7.5 Outflow Connectors.................................................................. 15
7.6 Connect Artificial Ventricles.................................................... 16
8.0 Operator’s Manual for Console………………………………… 20
8.1 Warnings for Console Operation…………............................. 20
8.2 Readying Console for Clinical Use............................................ 21
8.3 TAH-t Startup Procedure...................................................……… 21
9.0 Explant Procedures…………………………………...……...…… 23
10.0 System Components............................................................................. 24
Appendix A: Patient Selection and Management……………………………….. 25
Patient Selection...……………………………....…...…….……………… 25
Anticoagulation………………………………..…......…………….....…... 25
Exit Site…………………………………………………………………… 26
Appendix B: Outline of Training Program…………………………………….. 27
Appendix C: Materials Matrix…………………………………………………… 28
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SynCardia TAH-t Instructions for Use
1.0 Device Description
The SynCardia temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular
device that replaces a patient's native ventricles and valves and pumps blood to both the
pulmonary and systemic circulation. The system consists of the implantable SynCardia
TAH-t and an external console connected by drivelines (Figure 1).
Figure 1: SynCardia TAH-t System
1.1 The Implantable SynCardia TAH-t
The implantable SynCardia TAH-t consists of two artificial ventricles, each made of a
semi-rigid polyurethane housing with four flexible polyurethane diaphragms
separating the blood chamber from the air chamber. The diaphragms allow the
artificial ventricle to fill and then eject blood when compressed by air from the
external console. Mechanical valves, mounted in the inflow (27mm) and outflow
(25mm) ports of each artificial ventricle, control the direction of blood flow. The
maximum dynamic stroke volume of each ventricle is 70 ml, which allows for
generating a flow rate up to 9.5 liters per minute.
The left artificial ventricle is connected via the left atrial inflow connector to the left
atrium, and via the aortic outflow connector to the aorta. The right artificial ventricle
is connected via the right atrial inflow connector to the right atrium and via the
pulmonary artery outflow connector to the pulmonary artery. Each artificial ventricle’s
driveline conduit is tunneled through the chest wall. The right and left artificial
ventricle’s driveline conduits are attached to seven-foot pneumatic drivelines that
connect to the back of the external console.
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SynCardia TAH-t Instructions for Use
1.2 The External Console
The external console operates and monitors the SynCardia TAH-t. The console
includes a monitoring computer that provides noninvasive diagnostic and monitoring
information to the user. Device rate, dynamic stroke volumes, and calculated cardiac
outputs are displayed on a beat-to-beat basis. Drive pressure and flow waveforms,
along with cardiac output trends are provided. Patient related alarms (e.g., low cardiac
output) are also displayed on the computer screen.
A separate alarm panel on the console provides information on critical drive pressure
and backup air and battery status. In addition, an alarm is generated if the computer is
not monitoring the patient. All alarms generate audio and visual feedback to the user.
A backup air supply (two air tanks) and electrical power (backup power supply and
console battery) are automatically activated if the external compressed air and/or AC
power are interrupted. This can occur during patient transport or in the event of a
failure in the hospital’s air or electrical supply.
The controller is the major component of the external console, and supplies pulses of
pneumatic pressure to the right and left drivelines, which connect into the air
chambers of the respective implanted artificial ventricles. These pulses cause the
diaphragms to distend and thereby eject blood from the right artificial ventricle into
the pulmonary circulation (typically 50-70mmHg) and from the left artificial ventricle
into the systemic circulation (typically 180-200mmHg).
2.0 Indications for Use
The SynCardia temporary Total Artificial Heart (hereinafter called the TAH-t) is
indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates
at risk of imminent death from biventricular failure. The SynCardia TAH-t System is
intended for use inside the hospital.
3.0 Contraindications
The SynCardia TAH-t is contraindicated for use in:
Patients who are not cardiac transplant eligible.
Patients who do not have sufficient space in the chest area vacated by the natural
ventricles. Generally this includes patients who have body surface areas <1.7m², or
who have a distance between the sternum and the 10th anterior vertebral body
measured by computed tomography imaging (CT scan) < 10 cm.
Patients who cannot be adequately anticoagulated on the TAH-t.
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SynCardia TAH-t Instructions for Use
4.0 Warnings
1) Setup and operation of this device should only be undertaken by personnel trained
in accordance with the SynCardia training program. A thorough understanding of
the technical principles, clinical applications, and risks associated with the device
is necessary. Prior to use, refer to this IFU and to the Circulatory Support System
(CSS) User’s Manual for important operating instructions.
2) Sterile components of the SynCardia TAH-t are intended for single use only. Do
not use if package is opened or damaged. Do not re-sterilize or reuse.
3) Safe use of this system has not been established in pregnant patients.
4) Do not subject patients implanted with the SynCardia TAH-t to magnetic
resonance imaging (MRI) scans.
5) Safety and effectiveness in populations other than those of idiopathic and ischemic
cardiomyopathies has not been established.
6) Do not use this device if the implantable artificial ventricles cannot fit in the chest
area vacated by the natural ventricles. Inferior vena cava and left pulmonary
venous compression are possible consequences.
7) Do not allow any catheter to get near the inflow valves of the SynCardia TAH-t. If
a catheter gets into an inflow valve, the valve could become stuck, limiting flow.
Confirm by x-ray after catheter insertion. A percutaneously inserted central
catheter may migrate into the inflow valve when the patient raises his/her arm.
8) There is a potential for air embolism. De-air the artificial ventricles to minimize
the possibility of air inadvertently entering the device.
9) Do not allow the external drivelines to become kinked. If there is any low cardiac
output alarm, inspect the external drivelines for kinking.
10) A reduction in the maximum stroke volume on the external console’s monitoring
computer to below 50 milliliters may indicate a failure of one of the diaphragms in
an artificial ventricle of the SynCardia TAH-t.
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5.0 Precautions
1) Measures should be taken to prevent infection or sepsis. Use strict aseptic
techniques during implantation.
2) The outflow grafts must be pre-clotted before use.
3) When closing the chest, a reduction in device output may indicate inflow
obstruction. Reposition the artificial ventricles by anchoring to a rib or moving
into the left plural space.
4) Do not use an antifibinolitic agent like Aprotinine or Amicar with an active
clotting agent like FEIBA.
5) Use only water-soluble antiseptic cleaners around the exit site. Ointments may
delay tissue in-growth into the driveline conduits.
6) Each external console contains a primary and a backup controller. An
additional external console should also be available for use.
7) A sudden reduction in SynCardia TAH-t flow may be due to a kink in the
pneumatic drivelines, or some inflow obstruction to the TAH-t, such as
tamponade. Defibrillation or CPR will not be effective.
8) Flows should be kept at a reasonable output so that proper washing of the
ventricles is established.
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6.0 Summary of Clinical Study
The multi-center (5) clinical study focused on use of the SynCardia TAH-t as a bridge
to cardiac transplantation in transplant eligible patients at risk of imminent death from
biventricular failure. Ninety-five patients (ages 16-67) were implanted with the
SynCardia TAH-t; 81 (70 males, 11 females) met all inclusion/exclusion criteria and
were designated the core implant group. All patients were in NYHA Class IV at time
of enrollment. Additional characteristics of the core implant group at the time of entry
into the study are: 1) 15 patients were on heart-lung machine/ECMO support, 2) 51
patients had central venous pressure > 18 mmHg, 3) 11 patients had right ventricular
ejection fraction < 20%, and 4) all patients had relative or absolute contraindications
to VAD support as evidenced by refractory arrhythmias or unresuscitatable cardiac
arrest (25), hypokinetic right/left/global ventricles (23), aortic regurgitation, stenosis
or prosthesis (13), massive myocardial infarction or direct myocardial injury that
affects technical insertion of a VAD through the left ventricle (10), failure to wean
from cardiopulmonary bypass with bi-ventricular injury (4), left, right ventricular or
mural thrombus (3) or septal defect (3). All patients were on maximal medical therapy
and at imminent risk of death before a donor heart could be obtained.
6.1 Trial Success
Treatment success was defined as patients who, at 30 days post transplant,
were 1) alive; 2) NYHA Class I or II, 3) ambulatory; 4) not ventilator
dependent; and 5) not on dialysis.
Trial success was achieved in 56 (69%) of the 81 core patients. Sixty-four of
the 81 core patients (79%) reached transplant after a mean time of 79 days
(range 1-414). Fifty eight (72%) survived to 30 days post transplant.
6.2 Hemodynamics
The hemodynamic performance of the SynCardia TAH-t was assessed through
a comparison of pre- and post-implant values of cardiac index, systolic arterial
blood pressure, and central venous pressure. Hemodynamic indices were
effectively restored to near normal values. Average cardiac index increased
from 1.9 to 3.0 L/min/m², average systolic blood pressure increased from
93mmHg to 120mmHg, and average CVP decreased from 20mmHg to
14mmHg.
The average perfusion pressure (mean aortic pressure minus CVP) increased
from 49mmHg to 63mmHg, which was associated with recovery of renal and
hepatic function.
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6.3 Adverse Events
Adverse events collected for all 81 core patients while on the SynCardia TAHt device are presented in descending order below. The adverse events
represent 17.6 device years of experience for an overall event rate of 1.9 events
per month while on the device awaiting transplant.
Incidence of Adverse Events in Core Patients During
in Decreasing Order of Frequency
(Represents 17.6 years or 6411 days on the device)
Table 1
Device Implantation,
Adverse Event
Any Adverse Event 400 76 (93.8%)
Infection 125 58 (71.6%)
Bleeding 55 34 (42.0%)
Respiratory Dysfunction 44 24 (29.6%)
Hepatic Dysfunction 30 29 (35.8%)
Neurological Event 26 20 (24.7%)
Renal Dysfunction 23 21 (25.9%)
Reoperation 18 17 (21.0%)
Device Malfunction 18 15 (18.5%)
Peripheral
Thromboembolism
Reduced Blood Pressure 13 12 (14.8%)
Number of
Events
14 9 (11.1%)
Number (%) of
Patients
n=81
Reduced Cardiac Index 11 7 (8.6%)
Technical/Procedural 11 3 (3.7%)
Fit Complication 5 5 (6.2%)
Hemolysis 3 3 (3.7%)
Miscellaneous 3 3 (3.7%)
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SynCardia TAH-t Instructions for Use
6.4 SynCardia TAH-t Reliability:
Reliability testing was conducted to determine with reasonable assurance how
long a device would perform as intended, without failure.
Three separate sets of in vitro reliability testing were conducted. In one test,
four TAH-t units were run for a period of 180 days. During this time there
were no failures or abnormalities observed.
In a second in vitro reliability trial, four TAH-t units were tested in a “run to
failure” study design and are ongoing. After 35 months of testing, there were
no failures or abnormalities observed.
A third test was initiated using three TAH-t units which had expired their 3
year sterilization expiration date. This provided information about the effects
of long-term storage on the fatigue resistance properties of the TAH-t. After
24 months of testing, there were no failures or abnormalities observed.
In conclusion, a total of eleven units have been run for various lengths of time
over the last six years with no device-related failures. The cumulative number
of days used for calculation was 6715 and there have been no failures or signs
of appreciable wear observed. When the 11 units are used to calculate
reliability with a 90% confidence, the reliability at 30, 60 and 365 days is as
reported in the table below.
Reliability Test Results with 90% Confidence
# days run MTBF*
6715 2916 0.99 0.98 0.88
Table 2
Reliability in number of days run
30 60 365
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