Implant Procedure; Patient Preparation - Edwards PASCAL Gebrauchsanweisung

Step Procedure
7 Once saline is seen exiting from the distal end of the Implant
Catheter, lower the Implant Catheter Handle and raise the distal
end of the Implant Catheter while continuing to flush with
heparinized saline .
8 Fully retract Steerable Catheter . Advance the Sliders and the
Actuation Knob to set Implant in Elongated position .
9 Remove Loader cap and guide the Loader cap onto the
Implant System .
10 Insert the Implant through the proximal end of the Loader until
it exits the distal end . Connect the Loader and Loader cap .
11 While keeping Loader and distal tip raised, flush heparinized
saline through the Steerable Catheter .
12 Gradually retract Implant Catheter into Steerable Catheter and
Implant into the Loader while continuing to flush through
Steerable Catheter until the distal end of the Implant is fully in
the Loader .
7.4

Implant Procedure

Delivery of the implant should be performed under general anesthesia with
hemodynamic monitoring in an operating room, hybrid operating room or
cath lab with fluoroscopic and echocardiographic imaging capabilities .
Note: Prior to implant procedure, refer to Anatomic Considerations
(Section 3.1) as use outside of stated conditions may interfere with
placement of the Implant or native valve leaflet insertion.
CAUTION: During the procedure, heparin should be administered so
that the ACT is maintained at ≥ 250 sec.
CAUTION: Excessive contrast media may lead to renal failure.
Measure the patient's creatinine level prior to the procedure.
Contrast media usage should be monitored.

7.4.1 Patient Preparation

Step Procedure
1 Prior to sterile draping the patient, assemble and position the
Table(s) between the legs of the patient, adjusting height of
the Table(s) as needed . Use towels as support between Table(s)
and patient's legs .
WARNING: The Table is provided non-sterile;
introduction of the Table into the sterile field may result
in infection.
7.4.2 Femoral Vein Access and Sheath Introduction
Step Procedure
1 Access the common femoral vein using conventional
percutaneous puncture methods .
Step Procedure
2 For PASCAL Mitral Procedures:
Access the left atrium via transvenous, transseptal techniques
using conventional percutaneous methods and place guidewire
in left atrium . Dilate the vessel, as needed .
CAUTION: (for mitral procedures only) Inappropriate
puncture may result in cardiac structure damage
requiring surgical repair or other intervention.
For PASCAL Tricuspid Procedures:
Access the right atrium using conventional percutaneous
methods and place guidewire in right atrium . Dilate the vessel,
as needed .
3 For PASCAL Mitral Procedures:
Insert Guide Sheath with Introducer over guidewire until Guide
Sheath tip is securely across the septum, using flex mechanism
as needed .
For PASCAL Tricuspid Procedures:
Insert Guide Sheath with Introducer over guidewire until Guide
Sheath tip is inside the right atrium .
CAUTION: Excessive manipulation may result in
dislodgement or disturbance of a previously implanted
device, cardiac structure damage requiring surgical
repair or other intervention.
4 Remove the Introducer and guidewire . Do not aspirate and
flush the Guide Sheath until the Implant System is inserted .
CAUTION: Aspiration or connection of a continuous
physiological saline flush to the Guide Sheath prior to
implant system insertion may result in air embolism.
7.4.3 Implant Delivery
Step Procedure
1 Insert the Implant System with the Loader into the
Guide Sheath .
2 Advance Implant System until the Implant exits the Loader .
Retract and peel away the Loader .
3 Aspirate and flush Guide Sheath with heparinized saline .
Utilizing the specified syringe, aspirate a minimum of 45 cc .
CAUTION: Failure to fully aspirate guide sheath may
result in air embolism.
4 If desired, connect the continuous physiological saline drip to
the Implant Catheter .
CAUTION: Connection of the continuous physiological
saline drip to the Implant System prior to aspiration
may result in air embolism.
5 Advance Implant System until the Implant exits the distal end
of the Guide Sheath .
6 Retract the Actuation Knob to get the Implant in Closed
position . Retract the Sliders .
7 Adjust Guide Sheath and secure to Stabilizer as needed .
5