Abiomed Impella 5.5 User manual

USER MANUAL
BENUTZERHANDBUCH
MANUALE D‘USO
MANUEL D‘UTILISATION
UŽIVATELSKÁ PŘÍRUČKA
Impella 5.5®
with SmartAssist®
Circulatory Support System

TABLE OF CONTENTS
English............................................................................................................... 1
Deutsch ........................................................................................................... 17
Italiano ............................................................................................................ 35
Français ........................................................................................................... 53
Česky............................................................................................................... 69

1
Impella 5.5®with SmartAssist®Circulatory Support System
INTENDED AUDIENCE
This Instructions for Use and Clinical Reference Manual is designed for healthcare professionals. It contains clinical and technical information to guide healthcare
professionals in their use of the Impella 5.5®with SmartAssist®. To use the system you must understand and follow these instructions. The Impella 5.5 with
SmartAssist may be used only for its intended purpose.
WARNINGS
Warnings alert you to situations that can cause death or serious injury.
The dark gray symbol appears before warning messages.
Use of the Impella®System by trained and experienced practitioners
has been associated with improved outcomes. Consequently, the first
use of Impella should be preceded by the completion of a contemporary
Abiomed Impella training program and include on-site proctoring
during the first use by Abiomed clinical support personnel certified in
the use of Impella.
Fluoroscopy is required for the insertion of the Impella guidewire and
Impella 5.5 with SmartAssist Catheter.
During insertion, avoid manual compression of the inlet, outlet, or
sensor areas of the cannula assembly on the Impella 5.5 Catheter.
The sterile components of the Impella 5.5 System can be used only if
the packaging is not damaged, and the expiration date has not elapsed.
Do NOT resterilize or reuse the Impella 5.5 with SmartAssist Catheter.
It is a disposable device and is intended for single use only. Reuse,
reprocessing, or resterilization may compromise the structural integrity
of the catheter and/or lead to catheter failure which, in turn, may result
in patient injury, illness, or death.
Retrograde flow will occur across the aortic valve if the Impella 5.5 with
SmartAssist Catheter is set at P-level P-0.
Do NOT use saline in the purge system.
Do NOT use alcohol-based fluids for lubrication.
Do NOT use an Impella 5.5 with SmartAssist System if any part of the
system is damaged.
To prevent the risk of explosion, do NOT operate the Impella 5.5 with
SmartAssist System near flammable anesthetics.
If at any time during the course of support with the Impella 5.5 with
SmartAssist Catheter, the Automated Impella Controller alarms “Purge
Pressure Low” or “Purge System Open,” follow the instructions
presented in this manual.
MR Unsafe - Do NOT subject a patient who has been
implanted with an Impella 5.5 with SmartAssist Catheter to
magnetic resonance imaging (MRI). The strong magnetic
energy produced by an MRI machine may cause the Impella 5.5
System components to stop working, and result in injuries to the patient.
An MRI may also damage the electronics of the Impella 5.5 System.
During defibrillation, do NOT touch the Impella 5.5 with SmartAssist
Catheter, cables, or Automated ImpellaController.
Avoid overinserting the Impella 5.5 Catheter and possibly impinging the
catheter tip against the walls of the vasculature or ventricles.
Do NOT advance or withdraw the Impella 5.5 with SmartAssist
Catheter against resistance without using fluoroscopy to determine
the cause of the resistance. Doing so could result in separation of
the catheter or guidewire tip, damage to the catheter or vessel, or
ventricular perforation.
CAUTIONS
Cautions indicate situations in which equipment may malfunction, be
damaged, or cease to operate. The light gray symbol appears before
caution messages.
INTENDED USE (EU)
INTENDED USE IN THE EUROPEAN UNION
The Impella 5.5®with SmartAssist®heart pump is an intracardiac pump for
supporting the left ventricle. It is intended for clinical use in cardiology and
in cardiac surgery for up to 30 days for the following indications, as well as
others:
• The Impella 5.5 with SmartAssist is a cardiovascular support system
for patients with reduced left ventricular function, e.g., post-
cardiotomy, low output syndrome, cardiogenic shock after acute
myocardial infarction.
• The Impella 5.5 with SmartAssist may also be used as a cardiovascular
support system during coronary bypass surgery on the beating heart,
particularly in patients with limited preoperative ejection fraction with
a high risk of postoperative low output syndrome.
Handle with care. The Impella 5.5 with SmartAssistCatheter can be
damaged during removal from packaging, preparation, insertion, and
removal. Do NOT bend, pull, or place excess pressure on the catheter or
mechanical components at any time.
Patients with aortic stenosis or other abnormal aortic valve performance
may be compromised by the use of the Impella 5.5 with SmartAssist
Catheter. Patients with aortic valve disease should be observed for aortic
insufficiency.
Use only original accessories and replacement parts supplied by
Abiomed.
To prevent device failure, do NOT start the Impella 5.5 with SmartAssist
Catheter until the placement guidewire has been removed.
Do NOT remove the Impella 5.5 with SmartAssist Catheter over the
length of the placement guidewire.
When replacing the purge cassette, the replacement process must be
completed within 90 seconds. TheImpella 5.5 with SmartAssist Catheter
may be damaged if replacement takes longer than 90 seconds.
Do NOT kink or clamp any part of the Impella 5.5 with SmartAssist
Catheter.
Have a backup Automated Impella Controller, purge cassette, and
Impella 5.5 with SmartAssist Catheter available in the unlikely event of a
device failure.
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User Manual
2
CONTRAINDICATIONS (EU)
CONTRAINDICATIONS IN THE EUROPEAN UNION
The Impella 5.5®with SmartAssist®heart pump is contraindicated for the
following situations:
• Mechanical aortic valves, severe aortic valvular stenosis
• Hematological disorder causing fragility of the blood cells or hemolysis
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Aneurysm or necrotomy or severe anomaly of the ascending aorta
and/or the aortic arch
• Mural thrombus in the left ventricle
• Ventricular septal defect (VSD) after myocardial infarction
• Anatomic conditions precluding insertion of the pump
POSSIBLE COMPLICATIONS (EU)
There are risks of complications with every procedure using a blood pump.
These include among others:
• Hemolysis
• Bleeding
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• Positioning problems causing haemolysis or reduced
haemodynamic support
• Infection and septicemia
• Dislocation of the pump
• Cardiovalvular injuries due to extreme movement of the suction
cannula in relation to the cardiac valve or as a result of attachment
by suction of the pump to the valve system following incorrect
positioning
• Endocardiac injuries as a result of attachment of the pump due to
suction
• Pump failure, loss of pump components following adefect
• Patient dependency on the pump after use for support
OVERVIEW
The Impella 5.5 Catheter is an intravascular microaxial blood pump that
supports a patient’s hemodynamic system. The Impella 5.5 Catheter is
inserted via axillary artery cut-down through the artery and into the left
ventricle. The Impella 5.5 Catheter may also be surgically inserted when
there is access to the ascending aorta through a sternotomy or thoracotomy.
When properly positioned, the Impella 5.5 Catheter delivers blood from
the inlet area, which sits inside the left ventricle, through the cannula, to
the outlet opening in the ascending aorta. Physicians and device operators
monitor the correct positioning and functioning of the Impella 5.5 Catheter
on the display screen of the Automated Impella Controller.
This section describes the components of the Impella®Catheter and the
Automated Impella Controller, as well as the accessory components.
REUSABLE SYSTEM COMPONENTS
The Impella 5.5 System consists of the following reusable components:
• Automated Impella Controller—provides the user interface, alarm
indications, and portable battery
• Automated Impella Controller cart—for easy transport of the
Automated Impella Controller
SINGLE-USE SYSTEM COMPONENTS
The Impella 5.5 with SmartAssist System also includes the following single-
use components:
• Impella 5.5 with SmartAssist Catheter
• Purge cassette
• 0.018 inch, 260 cm placement guidewire
• Impella Axillary Insertion kit
• Silicone Plugs
• Incision template
SYSTEM CONFIGURATION
IMPELLA 5.5®WITH SMARTASSIST®
CATHETER
The Impella 5.5 with SmartAssist Catheter is an intravascular microaxial
blood pump that delivers up to 5.5 liters of blood per minute from the left
ventricle into the aorta.
Purge
Fluid
Automated Impella
Controller (AIC)
Impella 5.5
Catheter
Integrated
Patient Cable
Purge Cassette
Glucose/ Dextrose
GLUCOSE
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Impella 5.5®with SmartAssist®Circulatory Support System
PURGE CASSETTE
Do not use saline in the purge system.
The purge cassette delivers rinsing fluid to the Impella 5.5®with SmartAssist®
Catheter. The purge fluid (typically 5% glucose solution in water with heparin)
flows from the purge cassette through the catheter to the microaxial blood
pump to prevent blood from entering the motor.
Purge Disc
Yellow Luer
Connector
Purge Tubing
Supply Line
Purge
Cassette
Purge Fluid Spike
ACCESSORIES
The 0.018 inch, 260 cm guidewire is
used for the placement of the Impella 5.5
Catheter. The guidewire has a radiopaque,
shapable tip.
These alternative guidewires have been
tested and approved for use with the
Impella System: Boston Scientific Platinum
Plus™ ST 0.018 in, and Boston Scientific
V-18 Control Wire™ ST 0.018 in.
The Impella Axillary Insertion kit facilitates
placement of the Impella 5.5 Catheter
via the axillary artery. It contains a 23
Fr diameter x 6 cm length peel-away
introducer and two (2) graft locks used to
attach a graft onto the introducer. (Note:
Only one graft lock is required when used
with the recommended Hemashield™
Platinum graft; a back-up is provided.)
The kit is packaged with an 8 Fr
silicone-coated lubrication dilator. It is
recommended to be used in conjunction
with a 10 mm diameter x 20 cm length
Hemashield Platinum graft.
The incision template is used to assist
in correct placement of the Impella 5.5
Catheter during direct aortic insertion
by indicating the correct location for the
incision in the ascending aorta.
The two silicone plugs can be placed around
the catheter shaft to help control bleeding
during and after Impella 5.5 Catheter
insertion.
Hospital Provided:
Solution (typically 5% glucose in water
with 25 or 50 IU/mL of heparin) is used
as the purge fluid through the Impella 5.5
Catheter.
The Automated Impella Controller cart
holds the Automated ImpellaController. The
cart has wheels for easy transport of the
controller and a storage basket. (For more
information, including assembly instructions,
refer to the Automated Impella Controller
cart instructions for use.)
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User Manual
PRE-SUPPORT EVALUATION
Before initiating the procedure, evaluate the patient for factors that
may prevent successful placement of the Impella Catheter. Use imaging
technology to examine the patient’s vasculature access site. An echo
assessment of the left ventricle is also recommended to rule out left
ventricular thrombus, mechanical aortic valves, or severe aortic insufficiency.
Consider inserting a diagnostic Pulmonary Artery (PA) catheter to provide
continuous hemodynamic monitoring, including pulmonary artery and central
venous pressures, measurement of cardiac output, and SvO2.
STARTUP
SUPPLIES NEEDED
• Automated Impella Controller
• Impella 5.5®with SmartAssist®Catheter and accessories
• Diagnostic catheter (AL1 or MP without side holes or pigtail without
side holes)
• 500 cc bag of glucose solution for purge solution in water
(5% recommended; 5% to 20% acceptable) with 25 or 50 IU heparin/mL
• 10 mm x 20 cm Hemashield Platinum vascular graft (if using Axillary
Insertion kit)
• Impella Axillary Insertion kit for axillary insertion of the Impella
Note: If the purge solution is supplied in bottles, open the vent on the purge
fluid spike and follow the same procedure as if supplied in bags.
CASE START
If you miss a step in the process of setting up the Impella Catheter, or if
you exceed the amount of time allowed to complete a step, the Automated
Impella Controller will display additional instruction screens for continuing the
setup process for some steps. For the steps discussed below, all shaded steps
require sterile technique.
1. Press the START NEW CASE soft button from the startup screen or
plug in a new Impella Catheter. “Case Start” can also be selected by
pressing the MENU soft key.
2. The controller displays the screen shown below.
INSERT PURGE CASSETTE
1. Open the purge cassette package.
2. Secure the yellow luer connector on the purge tubing to the sterile field.
3. Pass the purge cassette and spike off the sterile field.
4. Spike the glucose bag/bottle.
5. Press the NEXT soft button to continue.
6. Open the purge cassette door by pressing the release on the left side
of the controller. Insert the purge cassette into the Automated Impella
Controller.
7. Insert the purge cassette into the compartment on the front of the
controller. Follow the diagram on the inside of the purge cassette door
for proper placement.
8. Slide the purge disc into the slot to the right of the purge cassette
until it snaps into place. The controller will automatically begin
priming the purge cassette.
9. Extend the purge tubing and close the purge cassette door. There is
sufficient room around the edges of the purge cassette door so that it
will not pinch the purge tubing as it exits.
10. The controller automatically begins priming the purge cassette after it
is inserted. The progress bar marks the progress of the purge cassette
priming.
CONNECT THE IMPELLA CATHETER
1. Remove the Impella Catheter from its package using sterile technique
and inspect the catheter for damage.
2. Inspect the cable for damage, including damage to the connector pins at
the controller end.
3. Pass the sterile connector cable from the Impella Catheter off the sterile
field.
4. Open the cover on the blue catheter plug by rotating clockwise. Line
up the notch on the connector cable with the notch in the blue
catheter plug on the front of the Automated Impella Controller and
plug the cable into the controller.
5. Once the purge cassette is primed and the controller detects that the
connector cable is plugged in, it prompts you to connect the luer to
the Impella Catheter.
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Impella 5.5®with SmartAssist®Circulatory Support System
6. Connect and tighten the yellow luer on the purge tubing to the Impella
Catheter sidearm if not already complete.
7. When the controller detects that the luer is connected, it
automatically begins priming the purge lumen.
8. Snap the purge clip (located on the pressure reservoir of the clear
sidearm) to the connector cable
9. Once the purge lumen is primed, the controller automatically advances to
the next screen.
10. The first step on the next screen prompts you to enter the purge
fluid information.
ENTER PURGE FLUID DATA
1. Enter the purge fluid information.
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 default purge fluid values will
be the purge fluid values from the last Case Start performed on a
given Automated Impella Controller.
3. To change the purge fluid information, press the EDIT soft buttons,
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 or press SELECT 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, or
1000 mL.
• Glucose (Dextrose) concentration can be set to 5%, 10% or 20%.
• Heparin concentration can be set to 0 IU/ml, 5 IU/ml, 6.25 IU/ml,
10 IU/ml, 12.5 IU/ml, 20 IU/ml, 25 IU/ml, 40 IU/ml, 50 IU/ml.
SECURE THE PURGE TUBING
1. To complete the setup, connect the purge tubing to the white
connector cable by pushing the purge tubing into the clips attached to
the white connector cable.
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User Manual
AXILLARY INSERTION OF THE IMPELLA
5.5®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.
If the Impella Catheter is used in the OR as part of open heart surgery,
manipulation may be performed only at the access site. Direct manipulation
of the catheter assembly through the aorta or ventricle may result in serious
damage to the Impella Catheter and serious injury to the patient.
When using a pigtail diagnostic catheter with side holes, ensure that the
guidewire exits the end of the catheter and not the side hole. To do so,
magnify the area one to two times as the guidewire begins to exit the pigtail.
During placement of the Impella Catheter, take care to avoid damage to the
inlet area while holding the catheter and loading the placement guidewire.
The introducer and graft lock are supplied sterile and can be used only if
the packaging is not damaged and the expiration date has not elapsed.
Fluoroscopy is required for the insertion of the Impella guidewire and
Impella Catheter.
During insertion, avoid manual compression of the inlet or outlet areas of
the Impella Catheter or the sensor area of the cannula on the Impella 5.5
with SmartAssist Catheter.
The graft must be affixed to the introducer proximal to the retainers on the
introducer repositioning unit to prevent the introducer from sliding out of the
graft.
When inserting the Impella Catheter through the introducer and into
the graft, be sure to clamp the graft with a vascular clamp just above
the anastomosis to avoid blood loss through the pump cannula during
insertion through the valve.
The Impella Axillary Insertion kit is intended to be used for insertion only.
To provide continued hemostasis, the introducer must be peeled away and
the repositioning unit inserted into the graft.
Do NOT resterilize or reuse any components of the Impella Axillary
Insertion kit. All components are disposable and intended for single use
only. Reuse, reprocessing, or resterilization may compromise performance.
The introducer is designed to be inserted into a graft. It is not intended for
direct insertion into the artery.
Abiomed recommends the use of a 10 mm diameter Hemashield Platinum
graft with the introducer for proper fit and hemostasis between the graft
and the introducer. A smaller diameter graft may not fit over the introducer.
Abiomed recommends the use of a 20 cm length graft to allow enough
length to fully insert the Impella Catheter cannula into the graft prior
to releasing vascular clamps at the anastomosis to minimize blood loss
through the cannula.
Do NOT kink or clamp the white portion of the Impella Catheter with cm
markings with anything other than a soft jaw vascular clamp.
Do NOT kink or clamp the peel-away introducer.
Proper positioning of the Impella Catheter is extremely important and it is
worthwhile to take extra time when positioning the catheter.
Take care to insert the guidewire with diagnostic catheter into the middle
of the hemostatic valve of the introducer to avoid tearing the valve.
When inserting the Impella Catheter into the introducer, take care to
insert it straight into the center of the introducer valve.
Be sure that the stopcock on the peel-away introducer is always kept in the
closed position. Significant bleed back can result if the stopcock is open.
The following steps describe the recommended technique for axillary artery
insertion of the Impella 5.5®with SmartAssist®Catheter.
1. Isolate and expose the axillary artery and obtain control via proximal and
distal vessel loops.
2. Attach a 10 mm diameter x 20 cm long vascular graft to the axillary
artery using a standard end-to-side anastomosis. NOTE: Abiomed
recommends using a Hemashield Platinum graft and recommends using
at least a 60 degree bevel on the end of the graft to facilitate passage of
the rigid motor housing into the artery.
3. Clamp the graft with a vascular clamp just above the anastomosis and
loosen the vessel loops to allow blood to flow into the graft to assess for
hemostasis at the anastomosis.
4. Insert the introducer into the graft and secure it with one (1) provided
graft lock. To place the graft lock, open it and place it between the
retainers and the hub on the introducer to prevent the introducer from
sliding out of the graft. NOTE: If a graft other than the Hemashield
Platinum is used, two graft locks may be required to maintain hemostasis
between the graft and the introducer. Correct positioning of the second
graft lock is illustrated in below.
Introducer, Graft Lock, and Hemashield Platinum Graft (Graft Not Supplied)
Correct Positioning If Second Graft Lock Required
5. Secure the graft lock by pressing both the outside tabs together. When
fully closed, the graft lock provides hemostasis. If hemostasis
is not achieved, make sure to press the two tabs together to fully close
the graft lock as shown below. The graft lock cannot be damaged by
over closing. NOTE: The graft may also be secured over the introducer
using heavy sutures or umbilical tape.
Closing the Graft Lock
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Impella 5.5®with SmartAssist®Circulatory Support System
6. Remove the vascular clamp on the graft and insert a 0.035 inch
diagnostic guidewire with a 4–6 Fr diagnostic catheter into the
introducer, taking care to center the wire and catheter in the center of
the hemostatic valve. Advance the guidewire and catheter into the left
ventricle.
7. Remove the diagnostic guidewire and exchange it for a stiff 0.018 inch
placement guidewire. With the 0.018 inch placement guidewire properly
positioned in the left ventricle, remove the diagnostic catheter.
8. Administer heparin per institutional protocol. When the ACT is greater
than or equal to 250 seconds, remove the dilator.
9. Remove the protective sleeve on the provided 8 Fr silicone-coated
lubrication dilator, being careful to avoid getting silicone on your hands.
Insert the dilator into the introducer over the 0.018 inch placement
guidewire to coat the hemostatic valve with silicone oil to facilitate
insertion of the Impella Catheter through the hemostatic valve assembly.
Once fully inserted, remove the dilator, keeping the 0.018 inch placement
guidewire in place.
10. Clamp the graft with a vascular clamp just above the anastomosis to
avoid blood loss through the pump cannula during insertion through the
valve.
11. While maintaining guidewire position, backload the Impella Catheter
onto the 0.018 inch placement guidewire and advance the catheter over
the guidewire through the introducer into the graft such that the entire
pump cannula and motor housing resides in the graft and only the
catheter shaft is seen exiting the valve.
12. Remove the vascular clamp and continue inserting the Impella Catheter
into the aorta. Continue advancing across the aortic valve using
fluoroscopic imaging to properly position the cannula bend at the aortic
valve annulus, placing inlet approximately 5 cm deep into ventricle.
Remove the placement guidewire and initiate Impella Catheter support
as described later in this section.
13. Clamp the graft adjacent to the axillary artery with a soft jawed vascular
clamp or have an assistant apply digital pressure to control bleeding at
the base of the graft so that the introducer can be removed and the graft
shortened. NOTE: To ensure the soft jaw vascular clamp is completely
sealing over the graft and the 9Fr catheter, open the sidearm flush valve
on the introducer and verify blood is not leaking from the system.
14. Slide the repositioning sheath back to the red Impella plug.
NOTE: For the 23F x 6cm peel-away introducer, it may be necessary to
pull the introducer over the repositioning sheath to remove the peel-away
completely from the artery
15. To remove the introducer, release the graft lock by pressing the two
adjacent long tabs together as shown below and remove it from the
graft.
Releasing the Graft Lock
16. Slide the introducer fully out of the graft prior to peeling it away. To peel
the introducer off the catheter shaft, crack the hub by applying pressure
to the thumb tabs and then peel the sheath off the catheter. NOTE:
When breaking the hemostatic valve in the sheath hub, the valve may
stretch before separating.
a). Grasp the two “wings” and bend back until the valve assembly
comes apart. Continue to peel the two wings until the introducer is
completely separated from the catheter shaft.
17. Trim any excess graft and slide the blue suture hub into the graft. NOTE:
The hub should be at the skin level and the length of the remaining graft
material should be just long enough to secure the graft around the blue
suture hub with all of the graft buried beneath the skin.
18. Using heavy silk suture, secure the graft around the blue suture hub so
that the position of the Impella Catheter can still be adjusted. Remove
the vascular clamp adjacent to the axillary artery.
19. The wound should be closed over the trimmed graft with the end of the
blue suture hub clearly visible. Anchor the hub securely to the skin.
20. If there is slack in the catheter, remove the excess slack. Verify placement
with fluoroscopy and with the placement signal. If the Impella 5.5
Catheter advances too far into the left ventricle and the controller
displays a ventricular waveform rather than an aortic waveform, follow
steps a-c below.
a) 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 3cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) The catheter should now be positioned correctly.
21. Attach the anticontamination sleeve to the blue suture hub. Lock the
anchoring ring in place by turning it clockwise. Secure the catheter
shaft in place by tightening the Tuohy-Borst. Extend the sterile sleeve to
maximum length and secure the end closest to the red Impella®plug by
tightening the anchoring ring.
ALTERNATE INSERTION TECHNIQUE USING A SIDEARM
GRAFT & SILICONE PLUGS
1. After exposing the axillary artery and making the incision as described in
the steps above, prepare a Dacron®vascular graft (10 mm x 20 cm) by
beveling the end of the graft at a 45 to 60 degree angle.
2. Tighten the distal and proximal vessel loops to control bleeding.
3. Attach the vascular graft using the standard end-to-side anastomosis
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User Manual
4. Assess the anastomosis for hemostasis.
5. Attach a standard 6 Fr introducer to the distal end of the graft.
6. Advance a diagnostic catheter (Abiomed recommends a 6 Fr AL1 or
Multipurpose without side holes or 4–5 Fr pigtail with or without side
holes) over a diagnostic 0.035 inch or 0.038 inch guidewire into the left
ventricle.
7. Remove the diagnostic guidewire and exchange it for the supplied 0.018
inch placement guidewire.
8. Tighten the vessel loops to control bleeding and remove the 6 Fr
introducer.
9. Moisten the Impella 5.5 Catheter and push one of the silicone plugs onto
the catheter shaft adjacent to the Impella 5.5 Catheter motor.
10. Backload the Impella 5.5 Catheter onto the 0.018 inch guidewire (as
described in the steps in previous step 11).
11. With the graft held at the base, place the Impella 5.5 Catheter into the
open end of the graft up to the level of the silicone plug.
12. Secure umbilical tape around the silicone plug.
13. Loosen both vessel loops and advance the Impella 5.5 Catheter along
the guidewire into the left ventricle until it is properly positioned.
To prevent device failure, do not start the Impella 5.5 Catheter until the
placement guidewire has been removed.
Do NOT remove the Impella 5.5 Catheter over the length of the
placement guidewire.
14. Remove the guidewire.
15. Place a soft-jawed clamp at the anastomosis and remove the silicone
plug.
16. Trim any excess graft and slide the repositioning sheath into position.
17. Using a heavy silk tie or umbilical tape, secure the graft around the blue
hub of the repositioning sheath.
18. Close the wound over the trimmed graft with the end of the blue suture
hub clearly visible. The steering catheter for the Impella 5.5 can be
manipulated if needed by unsecuring the repositioning unit and moving
the catheter in or out.
19. If there is slack in the catheter, remove the excess slack. Verify placement
with fluoroscopy and with the placement signal. If the Impella 5.5
Catheter advances too far into the left ventricle and the controller
displays a ventricular waveform rather than an aortic waveform, follow
steps a-c below.
a) 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 3cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) The catheter should now be positioned correctly.
20. Attach the anticontamination sleeve to the blue suture hub. Lock the
anchoring ring in place by turning it clockwise. Secure the catheter
shaft in place by tightening the Tuohy-Borst. Extend the sterile sleeve to
maximum length and secure the end closest to the red Impella®plug by
tightening the anchoring ring.
DIRECT AORTIC INSERTION
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.
Avoid manual compression of the inlet, outlet, or sensor areas of the
cannula assembly.
Do NOT kink or clamp the Impella Catheter with anything other than a soft
jaw vascular clamp. Do NOT kink or clamp the peel-away introducer.
Handle with care. The Impella 5.5 Catheter can be damaged during
removal from packaging, preparation, insertion, and removal. Do NOT
bend, pull, or place excess pressure on the catheter or mechanical
components at any time.
An incision larger than 6 mm may allow the front plug to advance into
the aorta.
The Impella 5.5 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.
INSERTION PREPARATION
When using a pigtail diagnostic catheter with side holes, ensure that the
guidewire exits the end of the catheter and not the side hole. To do so,
magnify the area one to two times as the guidewire begins to exit the pigtail.
1. Using the supplied sterile incision template for positioning, place a
sidebiter clamp on the aorta at least 7 cm above the valve plane. 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. 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. Note:
Maintaining ACT at or above 250 seconds will help prevent a thrombus
from entering the catheter and causing a sudden stop on startup.
*If the patient is receiving a GP IIb-IIIa inhibitor, the Impella 5.5 Catheter
can be inserted when ACT is 200 or above.
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 5.5 Catheter and push both silicone plugs up against
the motor housing as shown below.
Impella 5.5 Catheter with Silicone Plugs
7. With the graft clamped at the base, place the Impella 5.5 Catheter into
the open end of the graft up to the level of the rear plug.
8. 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.
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