SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 7
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.
