Abiomed Impella LD Gebrauchsanweisung Seite 12

Use TEE for Placement
Transesophageal
echocardiography (TEE) is
required for placement of the
Impella LD Catheter.
®
Positioning the Aortic
Incision
It is important to make the
incision in the ascending aorta
7 cm above the aortic valve so
that the Impella LD Catheter
®
can be positioned properly. An
incision too close to the aortic
valve annulus could result in the
catheter outlet area in the graft
rather than the aorta.
The incision must be ≤ 6 mm
in length to prevent the front
silicone plug from advancing into
the aorta through the incision.
GP IIb-IIIa Inhibitors
If the patient is receiving a GP
IIb-IIIa inhibitor, the Impella LD
®
Catheter can be implanted when
ACT is 200 or above.
Crossing the Aortic Valve
The aortic valve must be
opening during the cardiac
cycle to allow the Impella ® LD
Catheter to pass into the left
ventricle. If CPB is maintained at
a full flow state and if the valve is
not opening to allow the catheter
to pass through, it may be
difficult to place the catheter.
Securing the Front Silicone
Plug
There should be no movement of
the front silicone plug within the
graft; however, the catheter shaft
should move without resistance
within the plug.
When securing the front
silicone plug to the graft, do
not penetrate the silicone plug
too deeply as this could cause
damage to the Impella ® LD
Catheter.
10
2.
To select the default values displayed on the screen, press the ACCEPT soft button. This will select those
values and automatically advance to the next screen. NOTE: the Automated Impella
remember the purge fluid value entered on the previous Case Start.
3. To change the purge fluid information, press the EDIT soft button, scroll to the appropriate item and
push the selector knob to select it or use the white arrow soft buttons. Then scroll through the values and
push the selector knob to make a new selection. Press the DONE button to finish editing. The controller
will use the default values if no other selections are made.
• Purge fluid can be set to 50 mL, 100 mL, 250 mL, 500 mL (default), or 1000 mL.
• Dextrose concentration can be set to 5% (default), 10%, 20%, 30%, or 40%.
• Heparin concentration can be set to 0 (default), 5, 10, 12.5, 15, 20, 25, or 50 units/mL.
INSERTING AND STARTING THE IMPELLA
NOTE – Proper surgical procedures and techniques are the responsibility of the medical professional.
The described procedure is furnished for information purposes only. Each physician must evaluate
the appropriateness of the procedure based on his or her medical training and experience, the type
of procedure, and the type of systems used.
The Impella LD Catheter is surgically inserted when there is access to the ascending aorta through a sternotomy or
®
thoracotomy. Transesophageal echocardiography (TEE) is required to guide placement.
PREPARATION
1.
Using the supplied sterile incision template for positioning (see sidebar), place a sidebiter clamp on the
aorta at least 7 cm above the valve plane.
2.
Make an incision (or punch) no larger than 6 mm at the insertion site on the ascending aorta.
3.
Attach the Dacron vascular graft (10 mm x 15 cm) to the aorta using the standard end-to-side
®
anastomosis.
4. Administer heparin and achieve ACT of at least 250 seconds.
5.
When the anastomosis is complete, place a clamp at the distal end of the graft and then release the
proximal clamp at the base of the graft. Examine the suture line for leaks and reclamp the graft at the
base.
6. Moisten the Impella LD Catheter and push both silicone plugs up against the motor housing.
®
POSITIONING AND STARTING THE IMPELLA
Retrograde flow will occur across the aortic valve if the Impella
1.
Confirm purge fluid is exiting the Impella Catheter.
2.
With the graft clamped at the base, place the Impella
the level of the rear plug.
3.
When the catheter is in position, secure a tourniquet around the rear silicone plug. Tighten the tourniquet
sufficiently to control bleeding around the rear plug while still allowing the catheter to slide through the
plug.
4. Release the clamp and advance the Impella
5.
If the patient is on cardiopulmonary bypass (CPB), allow the heart to fill by restricting the return flow
to the bypass machine and reducing CPB flow to a minimum setting, as long as acceptable physiologic
systemic flow is maintained.
6. As soon as the motor housing has passed into the aorta, use a ligature to loosely secure the front silicone
plug flush to the graft. The silicone plug should be in the most proximal portion of the graft.
7. While the catheter is being advanced in the aorta, the initial placement signal has the characteristics
shown in the figure below. The inlet area of the catheter has not passed the aortic valve. Do not allow the
front plug to advance beyond the base of the graft.
LD CATHETER
®
LD CATHETER
®
® LD Catheter is set at P-level P-0.
® LD Catheter into the open end of the graft up to
LD Catheter into the aorta.
®
® Controller will
User Manual