Patient Preparation - Edwards PASCAL Manual Del Usuario

7.3.3 Guide Sheath
Step Procedure
1
Remove the Guide Sheath, Loader, and Introducer from packaging and
inspect for gross damage.
2
While keeping distal tip raised, flush and de-air Guide Sheath with
heparinized saline.
3 While keeping the distal tip raised, insert Introducer into Guide Sheath.
Flush the Introducer and wipe Guide Sheath with heparinized saline
prior to use.
7.3.4 Implant System
Step Procedure
1
Remove Implant System and Loader from packaging and inspect for
gross damage. Verify both Slider Stopcocks are in open position.
WARNING: If Slider Stopcocks are not in open position, use of the
device may result in infection.
2
Advance the Actuation Knob (rotate the Actuation Knob
counterclockwise or press the Actuation Button to push forward the
Actuation Knob) until it is flush against the Clasp Positioning Tool.
3
Remove the Slider Pin and remove suture slack. Lock Slider Stopcocks
and secure Slider Pin. Remove Clasp Positioning Tool.
4
Fully retract and advance Sliders to confirm proper Clasp motion and
close the Implant (rotate the Actuation Knob clockwise or press the
Actuation Button to retract the Actuation Knob).
5 Advance the Steerable Catheter. Ensure Sliders are fully retracted and
Actuation Knob fully retracted. Orient Implant Catheter Handle
vertically so the Release Knob is against the table.
6
Flush heparinized saline through the Implant Catheter.
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.
2 After sterile draping, assemble and attach Stabilizer as needed any time
during procedure.
7.4.2 Femoral Vein Access and Sheath Introduction
Step Procedure
1
Access the common femoral vein using conventional percutaneous
puncture methods.
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.
Step Procedure
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 as needed.
8
At the discretion of the treating physician, if pressure monitoring is
used to continuously assess atrial pressure during procedure, please
follow the pressure monitor manufacturer s instruction of use. Connect
a fluid filled pressure monitoring device to the steerable catheter.
Aspirate and then calibrate at the patient s heart level before obtaining
measurement.
Note: Pressure monitoring should be used in conjunction with
echo. Pressure should be reconciled against echo and Doppler
readings. When assessing atrial pressure, ensure that the distal tip
of the Implant Catheter is fully exposed from the Steerable
Catheter.
9
Advance Implant System as needed. Manipulate Steerable Catheter and
Guide Sheath (flex-unflex, torque in opposing directions, advance-
retract) as needed until Implant is centered in the target coaptation
zone with the appropriate trajectory.
CAUTION: Excessive manipulation may result in dislodgement or
disturbance of a previously implanted device, cardiac structure
damage requiring surgical repair, or other intervention.
Note: The radiopaque marker band on the Steerable Catheter
indicates the end of the flex section and can be visualized on
fluoroscopy.
10
Advance the Actuation Knob to get the Implant into Leaflet-Capture-
Ready position.
Note: For a tricuspid procedure, after placing implant in Leaflet-
Capture-Ready Position, pull the Slider Pin and move one slider to
identify which Implant Clasp it controls via imaging and secure
Slider Pin.
11 Torque the Implant Catheter, as needed, to orient the Paddles.
12
Advance the Implant through the valve until Paddles are below the free
edge of the leaflets.
13
Verify location and orientation of the Implant and adjust position
slightly as needed.
CAUTION: Excessive manipulation of the Implant below the leaflets
may cause the Implant to be entangled in the chords; chordal
entanglement may result in cardiac injury, worsening
regurgitation, difficulty or inability to remove the Implant
requiring additional intervention.
14
Under imaging guidance, retract the Implant until leaflets are
positioned between Paddles and Clasps.
15
Advance Slider(s) so the leaflet(s) are secured between the Clasps and
Paddles.
This can be performed for both leaflets simultaneously (Slider Pin
engaged to move both Clasps) or each leaflet individually (Slider Pin
disengaged to move individual Clasp).
16
Verify leaflet insertion with imaging.
If leaflets are not secured between Clasps and Paddles, retract the
Sliders to release the leaflets and reattempt.
17
Once leaflets are secured between the Clasps and Paddles, close the
Implant.
18
Advance Implant Catheter slightly to release tension on leaflets.
3