Abiomed Impella 5.5, Руководство пользователя

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9 Impella 5.5
®
with SmartAssist
®
Circulatory Support System
9.
Release the clamp and advance the Impella 5.5 Catheter into the aorta.
10.
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.
11.
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.
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 5.5 Catheter.
12.
While the catheter is being advanced in the aorta, the initial placement
signal has the characteristics of an aortic placement signal. Do not allow
the front plug to advance beyond the base of
the graft.
13.
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.
14.
Gently advance the catheter forward until the inlet crosses the aortic
valve and the bend of the catheter is at the level of the aortic valve
annulus. Confirm with TEE guidance.
POSITIONING AND STARTING THE
IMPELLA 5.5
®
WITH SMARTASSIST
®
CATHETER
When the Impella 5.5 with SmartAssist Catheter is not correctly placed, there
is no effective unloading of the ventricle (hydraulic short circuit). The patient
may not be benefiting from the flow rate shown on the controller.
1. Reconfirm that the placement guidewire has been removed and
Confirm that the controller displays a pulsatile waveform and the
cannula bend at the aortic valve annulus, placing inlet approximately
5 cm deep into ventricle. (See step 6 if the controller displays a
ventricular waveform.)
2. Press START IMPELLA soft button to open the P-level menu. Turn
the selector knob to increase the P-level from P-0 to P-2.
3. Press the selector knob to select the new P-level. Increase the P-level
to P-9 to confirm correct and stable placement.
Retrograde flow will occur across the aortic valve if the flow rate of
the Impella Catheter is less than 0.5 L/min.
4.
Evaluate the catheter position in the aortic arch. If there is slack in
the catheter, loosen the Touhy-Borst, remove the excess slack, and
RE-TIGHTEN THE TUOHY-BORST. The catheter should align against the
lesser curvature of the aorta rather than the greater curvature. Verify
placement with fluoroscopy and with the placement signal screen.
5.
Reposition the catheter as necessary.
6.
If the Impella Catheter advances too far into the left ventricle and the
controller displays a ventricular waveform (shown above) rather than an
aortic waveform, follow these steps to reposition the catheter.
a)
Loosen the Touhy-Borst, pull the catheter back until an aortic
waveform is present on the placement screen.
b)
When the aortic waveform is present, pull the catheter back an
additional 3 cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c)
RE-TIGHTEN THE TUOHY BORST
d)
The catheter should now be positioned correctly.
USE OF THE REPOSITIONING UNIT
1.
Slide the blue suture hub and advance the ribs into the graft.
2.
Secure the repositioning unit to the patient with the blue suture pads or
a StatLock ® stabilization device.
3.
Evaluate the catheter position in the aortic arch. If there is excess slack,
loosen the Touhy-Borst, remove the excess slack, and RE-TIGHTEN THE
TUOHY-BORST. The catheter should align against the lesser curvature
of the aorta rather than the greater curvature. Verify placement with
fluoroscopy and with the placement signal.
4.
Attach the anticontamination sleeve to the blue section of the
repositioning unit. Lock the anchoring ring in place by turning it
clockwise. Secure the catheter shaft in place by tightening the connected
anchoring ring.
5.
Carefully extend the anticontamination sleeve to maximum length
and secure the end closest to the red Impella plug by tightening the
anchoring ring.
6.
Select the lowest P-level that will enable you to achieve the highest
flow rate necessary for patient support. You can select one of ten
P-levels (P-0 to P-9) for the Impella 5.5 Catheter.
P-LEVEL
In
P-LEVEL
mode you can select one of ten P-levels (P-0 to P-9) for the
Impella 5.5 with SmartAssist Catheter (see table below). Select the lowest
P-level (P-2 or higher) that will enable you to achieve the highest flow rate
necessary for patient support.
P-level
Mean Flow (L/min)
30 - 60 mmHg
Revolutions Per
Minute (rpm)
P-0 0 0
P-1 0 12,000
P-2 0.0 - 1.9 17,000
P-3 1.1 - 2.7 20,000
P-4 1.9 - 3.3 22,000
P-5 2.8 - 3.7 24,000
P-6 3.4 - 4.1 26,000
P-7 3.9 - 4.5 28,000
P-8 4.3 - 4.9 30,000
P-9 5.0 - 5.5 33,000
*Flow rate can vary due to suction or incorrect positioning
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