Biostable HAART 200 Instrucciones De Uso página 6

center of each leaflet section of the Device. Only after the Device has
been pushed off the Holder should the Holder be removed from beneath
the valve.
Sinus Section Sutures
Sinus section sutures loop around the Device and pass up through the
annulus, taking deep bites into the aorta and emerging above the valve
onto fine Pledgets (Figures 7 and 8). Use of 4-0 polypropylene suture is
recommended to allow the complex horizontal mattress sutures to be
pulled tightly at the ends. Three looping sutures are placed around the
non-fused sinus segment of the Device and four (4) looping sutures are
placed around the sinus segment corresponding to the fused leaflet, two
(2) on either side of the raphe (Figure 9).
Figure 7. Sinus section looping sutures
Figure 8. Suturing of the sinus sections with the device
below the valve leaflets.
2mm
Figure 9. Final suture configuration
DWG-01-023 Rev. B - ©2021
Suture Management
After all nine sutures are placed, each is tied firmly over the Pledget with
8 knots, ensuring that the leaflet posts are buried back into the subcom-
missural regions and the Device fabric is kept below leaflet tissues. The
knots should be thoroughly tightened to prevent the sutures from coming
untied.
Long annular suture tails in the coronary sinus can cause leaflet injuries.
As a final step of annular suturing, one or both needles from the tied
annular suture should be passed downward through the center of the
lateral aspect of the Pledget, and the suture should be again tied down
to the Pledget with 6 more knots. This maneuver directs the suture tails
down and away from the leaflets.
Figure 10 illustrates the procedure for proper management of the
suture tails.
Figure 10. Management of Annular Sutures
A
Leaflet
Suture tied
with 8 knots
Annulus
C
Suture tied again
and cut short
Panel A: The 4-0 polypropylene horizontal mattress sutures that hold
the Device firmly up under the annulus emerge above the annulus and
are supported by fine polyester Pledgets. The sutures are tied tightly
with 8 knots over the Pledgets (arrow). These suture lines are reducing
annular size significantly, and therefore, can be associated with signifi-
cant tension. Thus, extra care should be taken with tying good 8-throw
knots that will not come untied.
Panel B: Each suture is passed down through the lateral Pledget (arrow)
and tied again with 6 knots. This step positions the final knot and suture
tails laterally and under the Pledget.
Panel C: The suture tails are cut very short beneath the Pledgets (arrow).
Panel D: The double knot prevents each suture from coming untied, and
with the second knot beneath the Pledget, the suture tails are directed
laterally and down into the annulus, preventing contact with the leaflets.
At the end of the Device implant procedure, all annular sutures should
be carefully inspected by the surgeon, and if any question exists about
the position of a given suture tail, the knot tower should again be sutured
down and away from the leaflet with a fine 6-0 polypropylene suture.
B
Needle passed through
Lateral Pledget
D
Suture tails and knots
are buried behind
Pledgets
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