SynCardia TAH-t User manual

950000-001 Rev. 004
SynCardia Systems Inc.
temporary Total Artificial
Heart (TAH-t)
INSTRUCTIONS FOR USE
1992 E. Silverlake Road
Tucson, AZ 85713 USA
[phone]
[phone]
STERILE EO
0086
16 MAY 2005
CAUTION: Federal (USA) law restricts this device to sale by
or on order of a physician.

SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc. Page 2
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

SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc. Page 3
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.

SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc. Page 4
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.

SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc. Page 5
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.