Abiomed Impella LD, User Manual

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User Manual
INSERTING AND STARTING THE
IMPELLA LD
®
CATHETER
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. When the Impella
LD Catheter is used in the OR as part of open heart surgery,
manipulation may be performed only through the 9 Fr steering
catheter. Direct manipulation of the catheter assembly through
the aorta or ventricle may result in serious damage to the Impella
LD Catheter and serious injury to the patient.
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.
Note: An incision too close to the aortic valve annulus could result in
the catheter outlet area in the graft rather than the aorta.
2. Make an incision (or punch) no larger than 6 mm at the insertion site
on the ascending aorta.
Note: The incision must be ≤ 6 mm in length to prevent the front
silicone plug from advancing into the aorta through the incision.
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.
Note: 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.
Rear
Sillicone
Plug
Front
Sillicone
Plug
POSITIONING AND STARTING THE IMPELLA LD CATHETER
Retrograde flow will occur across the aortic valve if the Impella LD
Catheter is set at P-level P-0.
1. Confirm purge fluid is exiting the Impella Catheter.
2. With the graft clamped at the base, place the Impella LD Catheter into
the open end of the graft up to 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 LD Catheter into the aorta.
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.
Note: Low pulsatility may lead to catheter position unknown alarms
in conjunction with CPB.
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 is flat. 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.
8.
To aid in passing the catheter through the aortic valve, apply slight
pressure to the posterior aspect of the aortic valve to produce
temporary aortic insufficiency.
9.
Gently advance the catheter forward until a pulsatile waveform is
present on the placement signal screen. This signal is generated when
the inlet area of the catheter crosses the aortic valve.
10. Confirm that the controller displays a pulsatile waveform and the
tip of the inlet area of the Impella LD
®
Catheter is 3.5 cm below the
aortic valve. Confirm catheter position using TEE.
Note: When the Impella Catheter is not correctly placed, there is no
effective unloading of the ventricle. The patient may not be benefiting
from the flow rate shown on the controller.
11. Press START IMPELLA soft button to open the P-level menu.
12. Turn the selector knob to increase the P-level from P-0 to P-2.
13. Press the selector knob to select the new P-level.
14.
The catheter operation icon in the lower left corner of the screen
begins rotating when the Impella LD Catheter begins to operate.
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