Percutaneous cardiovascular valve replacement - Biomaterials and Devices for the Circulatory System - page 134

5.10 Different steps of a conventional human implantation.

limited. The fi rst human implantations were conducted with success in early
summer 2004. The fi rst patient was a 62-year-old male with terminal inoper-
able lung cancer and with severe calcifi ed stenosis and regurgitation of the
aortic valve (Fig. 5.10). The implantation was uneventful, through a right
inferior limb artery cut-down. Post-implantation, no valvular gradient and
no signifi cant paravalvular or centrovalvular leaks were recognized, and an
improved cardiac function was maintained until his death due to respiratory
insuffi ciency at day 6.
In a second case, it was found that, similar to the animal study, implan-
tation through a right inferior limb artery cut-down was easy. Post-
implantation, no paravalvular or valvular regurgitation were documented,
and selective canulation of the left coronary ostium confi rmed the freedom
of the coronary ostium and the feasibility of a selective approach to the
coronary artery. Ultrasonic evaluation at 48 hours showed less than 3 mmHg
of transvalvular gradient and a signifi cant improvement in left ventricular
function. This patient died at day 10 with no valvular or heart dysfunction
from a 'crush syndrome' complication from the lengthy arterial cross-
clamping (a right inferior limb artery approach for the introduction of the
catheter and a left femoral approach for femoro-femoral circulatory
assistance).
In February 2005, a 60-year-old female with severe aortic regurgitation
received a revalving procedure through a right inferior limb artery cut-down.

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