SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 26
Appendix A
Patient Selection and Management
Management and coordination of successful SynCardia TAH-t support requires a
multidisciplinary team that has experience with circulatory support systems. Teams can
include surgeons, cardiologists, heart transplant coordinators, perfusionists, engineers, nurses,
cardiac rehabilitation therapists and coagulation specialists. The following reports the
experience and recommendation of the largest enrolling clinical site, University Medical
Center, Tucson, Arizona.
Patient Selection
Successful bridge to transplant with the SynCardia TAH-t involves selecting patients who are
transplant eligible and who additionally are assessed in two main areas: 1) evaluation of fit of
the SynCardia TAH-t in the patient’s chest, and 2) evaluation of the potential for reversal of
any end organ dysfunction.
Once the SynCardia TAH-t is implanted, and there are no fit issues, flow is maximized
through the TAH-t. The controller nominal settings are: left drive pressure of 180-220
mmHg, right drive pressure of 50-70mmHg, device rate of 110-130 BPM, percent systole of
50-55%, and diastolic vacuum of 8-12 mmHg. With these settings an average device output
of 6.5-7.5 LPM should be achieved, with a CVP of 8-12 mmHg.
The SynCardia TAH-t is specified for patients with body surface areas of at least 1.7 m². At a
cardiac index of 2.5 l/min/m², the calculated flow would be 4.25 liters/min. This is the flow
used to simulate hypotensive conditions tested during product reliability testing. The TAH-t
console is pre-set with an alarm to indicate flows <3.5 l/min.
With normalized hemodynamics, device outputs remain relatively constant, changing as the
CVP fluctuates. This “Starling like response”, (where an increase in CVP fills the SynCardia
TAH-t with more volume, which is ejected on the next beat, increasing device output),
requires no controller adjustments. Constant device output and high flow under normal CVP
provides washing of the artificial ventricles.
Anticoagulation therapy
The level of anticoagulation will vary depending on the patient’s coagulation status. In
general, the patients require systemic anticoagulation, similar to that used for patients with
mechanical valves. The following guidelines are recommended based on the experience of
the largest enrolling clinical site, University Medical Center.
Pre-operative baseline
Obtain results of PT, PTT, bleeding time, TEG, platelet count, platelet aggregation studies
and fibrinogen.
Intra-operative period
Heparinize for CBP per usual routine. Protamine may be used for reversal per usual routine.
