Impella 2.5/CP/5.0/5.5

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Identify the parts of the Impella CP device from tip to tail:

-6 Fr pigtail -inlet area (5 windows) -radiopaque marker for fluoro -14 Fr cannula w/ 145 degree bend -outlet area -red easy guide lumen -14 Fr motor housing -9 Fr catheter shaft w/ purge lumen, electrical cable, nitinol wire, & fiber-optic cable (93-99cm) -repo sheath (reaccess sheath) - tapered 9-13 Fr, *12 cm total length* -blue suture hub, T-lock, tuohy Borst, anticontamination sleeve, tuohy Borst -red impella plug (brains) -clear sidearm, infusion filter, pressure reservoir, yellow check valve (*does not have red side arm*)

Identify the parts of the Impella 2.5 device from tip to tail:

-6 Fr pigtail -inlet area w/ 4 windows -radiopaque marker for fluoro -12 Fr cannula with 145 degree bend -outlet area -red easy guide lumen -12 Fr motor housing -open pressure area (distal open pressure lumen) -9 Fr catheter (93-99cm working length) - contains electrical cable, purge lumen, and placement lumen -repo sheath tapered 9-13 Fr (or OD 11-15 Fr) - *10 cm total length* -blue suture hub, T-lock, tuohy borst valve, anticontamination sleeve, tuohy Borst -red impella plug (brains) -red pressure sidearm (for standard config) -clear sidearm -infusion filter, pressure reservoir, check valve

Prior to the insertion of an impella 5.5, what should you ensure has been assessed for?

-7 mm vessel diameter -rule out PVD in axillary artery -rule out calcification in aorta (*may preclude securing graft to aorta*) -that there is 7cm of space between AoV and insertion point for anastomosis (And echo, angiogram, MRA/CTA or U/S to rule out contraindications obviously)

Which devices use an optical sensor to derive an LV waveform?

-CP w/ SA -5.5 w/ SA -RP w/ SA (in addition to diff. pressure sensor)

What are the hospital required items *not included* but necessary for the insertion of an Impella 5.0/5.5?

-Dextrose solution w/ Heparin (primed w/ heparin) -0.035" J wire -diagnostic catheter to cross AoV -*10 mm x 20cm woven vascular graft* (hemashield platinum woven or vascutek gelweave) -soft jaw clamp (8mm graft technically can be used but veryyyyy tight fit and prob won't fit on back end) (cannot be used if using 9 mm silicone plugs)

What are the approved alternative impella guidewires?

-boston scientific platinum plus ST 0.018" -boston scientific V-18 control wire 0.018"

What does the AIC show if the patient has low native heart pulsatility?

-dampened aortic placement signal -dampened/flat motor current (small pressure gradients) -"impella position unknown" on Home Screen bc can't detect difference in pressure to indicate position) *assess cardiac function/MAP and treat the patient, not the machine!*

What are the different signs of hemolysis and how do you test for it?

-drop in Hgb (check trending labs) -dark/blood-colored urine (send UA) -hemolyzed lab samples -acute renal failure -*PfHgb* (gold standard) --> this is a send off lab so UA = faster although not conclusive -spun plasma

What are the best practices for improving outcomes in AMI/CGS cases?

-early pt identification (appropriate documentation for ED, ICU, CCL) -early hemodynamic stabilization (*impella support pre-PCI*, reduce inotropes/vasopressors, reduce door to unloading time) -complete revascularization -assess for myocardial recovery (weaning protocol, early ambulation, transfer to other hospital or escalation if needed)

Explain the process of removing the peel-away sheath:

-ensure repo sheath/re-access sheath and sterile sleeve are slid all the way back to the red impella plug -under fluoro guidance, slowly remove sheath completely from arteriotomy and allow 10mL of bleed back before holding slight pressure over site (to ensure impella doesn't move) -while still under fluoro and while scrub is holding light pressure, slowly advance repo sheath into access site until blue suture hub -advance sterile sleeve up to hub and lock in place with T lock and tuohy borst valve after slack is removed and position is confirmed

You are in the OR while the team is prepping for a 5.5 insertion, what should you go ahead and suggest they do before the doc is ready to insert the device?

-ensure vessel size >7mm -avoid PVD/tortuosity (& other contraindications) -reiterate that this is not for femoral access *lay catheter straight out & remove any torque *power on, plug in, start new case, spike/prime *hold catheter upright to ensure purge fluid exits outflow cage while priming *attach sidearm retainer

Explain what to do if you receive an "Impella Stopped" alarm:

-if controller failure, switch to backup controller -immediately try to restart at previous P-level -if fails, try to restart at P2 -if fails, wait 1-2 minutes and try again at P2 -if after several fails, pull catheter back into aorta & *prepare for pump replacement* *if ever able to restart, assess ability to wean as pump failure will likely happen again*

Explain how to troubleshoot hematuria/hemolysis:

-if flow less than expected given the P-level, check volume status/preload (Give volume if CVP/PAD <10) -if volume status WNL, check positioning with echo -if caught in pap muscle, gently pull back until releases and torque toward apex of LV until correctly positioned -if UOP still red in 1-2 hrs (could be longer depending on pt renal fx), reposition pump again -rule out non-device related causes (traumatic foley insertion, bladder tumors, etc.) -*obtain UA to evaluate for red cells* (bleeding can occur simultaneously w/ hemolysis) *in order to rule out hemolysis, a pfHgb level should be sent to the lab*

What are the circumstances in which to zero the differential pressure sensor on the impella 5.0?

-if placement signal waveform has shifted upward/downward (< -6 or > +6 on lower #) -if flow doesn't match P-level *when zeroing, must be in P2* -MENU —> start manual zero -ok to confirm the drop to P2 -ok to accept new setting after calculated -will automatically return to previous P-level

What are the components of the Impella 5.5 with Smart assist Set up?

-impella 5.5 catheter w/ connector cable preattached -purge cassette -0.018"/260 cm placement guidewire -silicone plugs -axilliary insertion kit -surgical template -sidearm retainer *axillary insertion kit*: -23 Fr peel away sheath -graft locks -8 Fr silicone coated dilator (just used to lubricate) (5.0 is the same set up except: white cable separate, no template or sidearm retainer)

What are the physiological effects that suction can cause?

-limits support impella can provide -decrease in CO & arterial pressure -hemolysis

What is the placement signal waveform useful for determining?

-location of open pressure port on 2.5 -location of optical sensor/derived LV pressure waveform on CP & 5.5 -differential pressure sensor for 5.0 & RP

What are the five components that make up the *trend* screen?

-mean arterial pressures (RED) -LVEDP (GRAY) -cardiac output (YELLOW) -impella flow (GREEN) -native cardiac output (WHITE)

If using silicone plugs for a 5.0/5.5 insertion, which steps are different?

-no peel-away sheath (use *8Fr introducer sheath* and secure w/ umbilical tape/heavy sutures) -after 0.018" in place & diagnostic catheter is removed, clamp vascular graft -then you attach silicone plug to the actual impella catheter shaft proximal to the motor and insert into graft then secure silicone plug to graft w/ tape or tie (loose enough to allow impella to advance while keeping graft in place) -remove clamp & advance impella into LV & follow same steps -then clamp above anastomosis, remove silicone plug & trim graft & follow same steps from here

What should you do if suction alarms or lower than expected flows indicate incorrect impella position & potential hemolysis?

-reduce flow rate as tolerated by pt hemodynamics (return after repositioned) -reposition using imaging guidance (move inlet away from ventricular wall) *w/ SA devices, use LV waveform to determine if suction is related to position or volume* -for Impella RP verify volume status & reposition if necessary (usually not position issue)

What are the steps to turning off the AIC?

-reduce to P0 -disconnect catheter from controller -press & hold power switch for 3 seconds -confirm pop-up by clicking knob to turn off *if power switch is held down for longer than 30 seconds during use, the controller will initiate emergency shutdown*

Explain what to do when receiving an "Impella position wrong" alarm:

-reduce to P2 -assess position With imaging -reposition if necessary (aortic placement signal and pulsatile motor current) -remove slack until inlet starts to move & tighten tuohy -return to previous P level after position confirmed

Explain what to do when receiving "Impella position in Ventricle" alarm:

-reduce to P2 -assess position with imaging -reposition if necessary using imaging and waveforms -remove all slack until inlet starts to move -tighten and lock tuohy -return to previous P-level

When monitoring a patient for right heart failure, what are things to look for?

-reduced flows -suction alarms -elevated filling pressures (CVP) -signs of liver failure -reduced PAPI scores

What if the physician decides that it's in the patient's best interest to operate the purge system without heparin?

-suggest continuing some type of heparin in the purge fluid even if it's 1/5th of recommendation (5 u/ml) -resume heparin in purge once bleeding resolves -consider alternative systemic anticoag per hospital protocol -if absolutely no heparin, switch to 25 mEq NaBicarb in 1L D5W

How do you transfer from an AIC to a backup controller?

-turn backup controller on & ready -remove white connector cable & plug into new -confirm to re-start at previously set P-level (Press OK within 10 seconds) -briefly disconnect yellow luer & then reconnect (releases pressure & reduces risk of damaging disc) -transfer purge cassette/purge fluid to new controller (*can be done before or after white connector cable*) -PURGE MENU —> change purge fluid bag to enter values of purge solution (has no way of knowing remaining volume or settings from previous controller)

Explain what to do if you receive an "Impella position in Aorta" alarm:

-verify aortic placement waveform & flattened motor current -reduce to P2 -under imaging guidance, reposition catheter correctly & until waveforms resolve -return to previous P-level & confirm positioning again -remove slack until inlet starts to move, tighten tuohy back & confirm new cm marking

Explain what to do if you receive a "Placement Signal Low" alarm:

-verify placement signal diastolic is <30 (but is not actually <30 on hemodynamic monitor) and motor current still pulsatile (and flows good) -call echo to assess position -reposition if necessary *this alarm happens right before catheter is fully in ventricle*

Explain what to do if you receive an "Impella position in Ventricle" alarm:

-verify ventricular placement signal & flattened motor current -reduce to P2 -*utilize repositioning guide* if SA device (if not, call echo to reposition) ("MENU" —> follow prompts, pulling back slowly 1cm at a time until aortic waveforms return & motor current is pulsatile, then *pull back additional 3cm* then done) -tighten tuohy, return to previous P level, note new cm marking -call echo to verify new placement

What two ports go into the motor?

1 port delivers electrical wire to run motor 1 port delivers purge solution that creates a pressure barrier between motor & blood (keeps blood from entering motor)

What should you recommend doing if suction alarms occur?

1. decrease P level by 1 or 2 levels to break suction 2. assess volume status (give IVF if CVP <10) 3. check impella position if volume status is adequate once resolved, return to previous P level

What are the 3 functions of the AIC?

1. provides interface for monitoring & controlling impella heart pumps 2. provides purge fluid via the purge system to the impella devices 3. provides backup power when the impella system is away from AC power

What Fr is the cannula/motor housing on an Impella 2.5?

12 Fr

What is the recommended ACT while on Impella support?

160-180 (check ACT levels q3hrs for first 24 hrs) always offer our recommendation but encourage nurses to follow hospital/pharmacy driven protocol

What size is the peel-away sheath for each of the impella devices?

2.5 = 13 Fr CP = 14 Fr 5.0 = 23 Fr 5.5 = 23 Fr RP = 23 Fr

What is the recommended vessel size for an Impella 2.5 and an Impella CP?

2.5 = 4.3 mm CP = 4.6 mm

How are the P-levels different on 2.5 compared to CP?

2.5 P-levels range from 0-P8 with a *BOOST* level that can only be used for 5 min before returning to P8 CP P-levels range from 0-P9 with no limit

How many windows are located on the inlet area of the impella 2.5 and the impella CP?

2.5 has 4 windows CP has 5 windows

A white advisory alarm is displayed in the alarm window when purge flow rate increases or decreases by ______ mL/hr.

2.5 mL/hr --> aids in patient management by making aware of changes in rates (This notification is disabled by default and has to be enabled via Menu --> setting/services --> enable purge flow change notifications) (the alarm clears & sets the new baseline if muted)

The physician is planning on inserting an impella 2.5 on a very large patient because he wants to use their last one before it expires. However, what do you tell him about the bleeding risks associated with using a 2.5 vs a CP, especially on larger patients?

2.5 repo sheaths can cause more bleeding issues than CP because: 2.5: 10 cm total length CP: 12 cm total length (*has additional 4 cm of length for accessing deep vessels which is full-width*) (this means the CP can reach deeper to get to an occlusive pt vs the 2.5)

How many RPMs does the Impella 2.5 use to get its max flow compared to the CP to get its max flow?

2.5: 51,000 RPMs to reach 2.1-2.5 L/min CP: 46,000 RPMs to reach 3.7 L/min (mean) *this means less risk for hemolysis with CP*

What is the max amount of flow the Impella 2.5 device can provide?

2.5L

What is the size of the Impella 5.5 cannula, motor housing, and catheter shaft?

21 Fr cannula, 19 Fr motor housing (cannula is *3.5x more rigid than 5.0* for enhanced deliverability and torque response) 9Fr catheter with *70 cm working length* (contains a *STEEL COIL* on the 5.5) *optical sensor located on pump outflow*

Fr size / 3 = vessel diameter in mm -->

21 Fr catheter / 3 = 7mm vessel diameter needed (that's why we recommend a 10mmx20cm vascular graft because an 8mm would be too small at the top end and would have no room for error at the bevel site)

What is the size of the cannula & motor housing on the impella 5.0?

21 Fr for both (this was an improvement on the 5.5 because the motor housing is *smaller [19 Fr] and 45% shorter*)

What is the size of the Impella RP cannula?

22 Fr (16cm long) with a 21 Fr motor housing- BIGGEST device

For an impella 2.5, how long will the controller stay in AUTO mode?

3 hours then will automatically switch to p-level mode

Put the steps in order: 1. backload impella device over 0.018" guidewire 2. insert AL1, MP, or pigtail diagnostic catheter 3. pre-dilate the vessel & place the peel-away introducer sheath 4. exchange the 0.035" guidewire for the 0.018" placement guidewire

3. pre-dilate vessel & place peel-away introducer sheath 2. insert AL1, MP, or pigtail diagnostic catheter 4. exchange 0.035" guidewire for 0.018" placement guidewire 1. backload impella device over 0.018" guidewire

What is the peak flow (during systole) for Impella CP?

4.3 L/min *mean = 3.7 L/min*

What is the recommended incision size for an axillary insertion?

45 degree cut down of 3-5 cm

How long will an alarm sound when the battery switch is turned off?

5 min (must be turned off when shipping)

In regards to insertion location, what is the difference between an impella 5.0 vs. impella 5.5?

5.0 can be inserted femorally or axillary 5.5 can only be inserted axillary or direct due to the *70 cm* catheter length

Which impella device does not have a pigtail?

5.5

What size is the pigtail on the impella devices and what is it's purpose?

6 Fr, assists in stabilizing the catheter in correct position in LV

How long can Impella 2.5 & CP be used for?

6 hours if used for PPCI 4 days if used for CGS

What is the max amount of flow that the Impella 5.5 delivers?

6.0 L/min but mean flow = 5.0-5.5L/min *only uses 33,000 RPMs = less risk for hemolysis

How long can the AIC operate on its internal battery when fully chagred?

60 min *must be charged for 5 hours prior to system operation to ensure full charge

What size is the catheter shaft on an Impella 2.5 & CP device?

9 Fr (93-99 cm of working length)

How fast should purge changes be completed?

90 seconds

What are the different soft buttons on the AIC?

*M(mute)* - mutes alarms *F(flow control)* - controls P-levels to determine speed of motor/flow of device *D(display)* - option to change screens between placement, home, infusion history, or purge *P(purge menu)* - allows for changes to purge system & *transferring to standard configuration* *M(menu)* - controller settings, alarm history, & *case start*

A patient has been weaned off ECMO but has started to decline again. The physician wants to insert an RP device to provide support, what should you look out for?

*anytime talking ECMO think CLOT with RP* (always assess for clots prior to insertion of RP post ECMO) flows will be down and placement signal alarms will be present (triple #'s --> higher pressures due to clots, whereas usually it's double/double or double/single #'s) *sometimes suction alarms as well

What are the steps for a direct aortic insertion of the 5.5 impella catheter?

*confirm exit strategy prior to insertion* -expose aorta & place side-biter clamp 7cm above AoV plane using incision template -make incision *no larger than 6 mm* on ascending aorta -attach vascular graft using end-to-side anastomosis & clamp at base (examine suture for bleeding) -administer heparin to achieve ACT > 250 -wet impella & attach 2 silicone plugs & push against motor housing -insert into graft up to level of rear plug & secure w/ tape -release clamp & advance impella into aorta -as motor housing passes aorta, loosely secure front silicone plug flush to graft with ligature -front plug should NOT be able to advance beyond base of graft -pass catheter through aortic valve into LV (*to help pass through, apply slight pressure to posterior aspect of AoV to produce temporary AI*) -start impella & slowly increase P-level -*verify placement w/ TEE & with waveforms* -pg. 44 of study guide (very confusing) *WATCH VIDEOS*

Anytime a position alarm occurs, what is the first step?

*reduce P level to P2* then check positioning & reposition until placement signal is aortic again: —-> for 2.5: under fluoro or echo confirm position & *pull catheter back additional 4 cm* —->for CP/5.5 w SA: access *repositioning guide* under MENU, and reposition *without imaging* until waveform is aortic, but always recommended to confirm with imaging *treat pt medically (w/ gtts) until repositioned*

What does the performance level do when a new case is started on an Impella 2.5/CP?

AUTO mode (increases flow rate over 30 seconds to level equivalent to P8 or P9 without causing suction) *for 5.0/5.5/RP --> must choose P level when impella is started and must gradually increase

What is the purpose of the re-access sheath on the Impella CP?

Allows for escalation of care and is designed to improve hemostasis

What is the difference in placement screens when inserting a 5.0 vs inserting a 5.5?

During insertion, placement signal is dampened/flat on 5.0 and then once in LV across the AoV, it turns pulsatile During insertion of 5.5 the placement signal is aortic and remains aortic when in LV across the AoV

Which impella devices use a differential pressure sensor to evaluate placement?

Impella 5.0 & RP

What are the main contraindications for left sided impella devices?

Mechanical aortic valve LV thrombus aortic stenosis severe aortic insufficiency severe peripheral arterial obstructive disease

During a case, the doc asks if a "Gore Dry Sheath" can be used, what do you say?

No --> we cannot legally recommend, plus this sheath can easily be broken/deflated which causes bleeding issues (fluid-filled balloon system that has an extra flush arm that can be easily broken)

review 5.0 femoral cut down insertion?

PICS ON PHONE

What is the preferred echo view for left-sided impella devices?

PLAX view (parasternal long axis view)

Which screen displays real time operating data for the impella system?

Placement screen (the default screen once case-start is complete) -placement signal (red) -motor current (green) -LV waveform (gray) (if smart assist device)

If during insertion, the physician feels any resistance as the impella catheter passes the tip if the introducer, what can you suggest they do?

Pull back about 1 cm, advance the impella, and reposition the introducer (follow under fluoro)

Where will you find the option to Transfer to Standard Configuration on the impella 2.5 devices?

Purge menu

What should you suggest if the team is using a 30 cm graft during the insertion of an impella 5.5?

Shorten 30 cm graft to 20cm before insertion to avoid pushing pump through excess graft

TRUE OR FALSE: Recognize *low pulsatility* before re-zeroing Impella 5.0: if the A-line is non-pulsatile, the patient may not tolerate dropping to P2 for the re-zeroing procedure

TRUE

True or False: Surgical Mode option is only available under "Menu" when Impella is in P0

TRUE

True or false: Consider adding volume if hemolysis is accompanied by CVP or PCWP <10mmHg

TRUE

True or False: The only way to have an LV waveform is to have a motor current, and we will only have a motor current if we are across the AoV

TRUE (this is how we know position is okay when alarm says "impella position unknown")

True or False: Purge flow will adjust between 2-30 mL/hr to maintain a purge pressure between 300-1100 mmHg

TRUE (will alarm if pressure falls below 300 mmHg at a max flow of 30 mL/hr or if pressure rises above 1100 mmHg at a min flow of 2 mL/hr)

True or False: You should not reduce Impella flow below P2 until just removing the catheter from the ventricle

TRUE (don't ever run at P2 level)

True or False: Repositioning Guide option under "Menu" is only available with an active "Impella in Ventricle" alarm

TRUE (only on CP/5.5 w SA)

Explain what to do when receiving an "Impella Flow Reduced" alarm:

This white advisory alarm displays when on *auto mode* and the controller has detected suction and automatically decreased motor speed/flow —> if at the lowest motor speed and still getting suction on auto mode, the controller will display regular yellow suction alarm (treat same as suction alarm)

True or False: CPO = End Organ Perfusion

True

True or False: On the Impella 5.0 only, the 6Fr pigtail stabilizes the *cannula* across the aortic valve vs stabilizing the catheter

True

True or False: TEE is used for insertion of the Impella 5.5 with Smart Assist catheters

True

True or False: A minimum of 7mm vessel diameter is required for inserting an Impella 5.0/5.5 catheter

True (21 Fr /3 = 7mm) *assess vasculature before-hand for tortuousity or PAD that could impede insertion*

True or False: When repositioning an impella catheter, you are supposed to return to previous P-level THEN remove slack

True (final pull back should be at higher P level to make sure slack has been removed from the aorta)

When is the *repositioning guide* option under MENU available on CP/5.5 with SA devices?

When *pump position in LV* alarm is active

When should volume be recommended on an impella patient?

When CVP <10 *AND* suction alarms are present and/or signs of hemolysis

What is the PfHgb result if hemolysis has occurred?

a reading of > 40mg/dL twice within a 24hr period indicates significant hemolysis

What are probable causes of a suction alarm? (SATA) a) inadequate filling of LV due to poor right heart function b) impella is too far into LV c) pt blood pressure is too high d) inadequate volume status

a, b, d

How do you start a case on the AIC?

access through the *menu* soft button

When Impella is transferred to ICU, what should you do? (SATA) a) document UOP both color & amount b) assess pt volume status c) ensure Tuohy-Borst is tightened & locked and note cm marking d) notify echo to confirm placement once arrived

all of the above (if 5.5--> ensure external fixations are secure) (if RP --> notify XR for confirmation)

Why can't NS be used as purge solution?

any amount of saline (sodium chloride) will corrode the motor & pump failure is imminent

Where does the outlet area sit on a correctly placed impella?

ascending aorta (above the aortic valve)

With suction alarms, what should you think of with *continuous* suction?

continuous suction think *position* (*low systolic & diastolic values = decoupled*) red & gray waveforms are completely de-coupled and negative systole & diastole pressures on LV waveform (doesn't get fixed with volume)

How does the impella affect EDV/EDP, AOP, and flow?

decreases EDV & EDP while increasing AOP & flow

How does the impella affect O2 supply & demand?

decreases O2 demand and increases O2 supply (direct unloading)

With suction alarms, what should you think of with *diastolic* suction alarms?

diastolic - think *VOLUME* (recovers at the end of diastole) (*intermittent suction*) -systole is normal (red/gray peaks line up) -diastole valley is much lower (gray lower than red)

How is the Impella 5.5 inserted?

either axillary or directly into the aorta (via graft) *vessel diameter must be >7 mm*

What should you do before the physician removes the dilator during insertion?

ensure ACT > 250 to prevent thrombus from entering the catheter

What is the normal flow & pressure for the purge system?

flow: 2-30mL/hr pressure: 300-1100 mmHg (ideal = 600mmHg) *AIC will increase/or decrease flow of solution to increase/decrease pressure if too high or too low before it alarms

When does the CPO value appear in yellow on the AIC for smart assist devices?

if the CPO < or equal to 0.6

Which device has a normal purge flow rate from 1-30 ml/hr vs the usual 2-30 mL/hr?

impella 5.5 with smart assist

When using color doppler on TTE, what does it mean if the dense mosaic pattern is beneath or at the level of the AoV?

indicates that the outlet area is incorrectly positioned (too far into LV or entangled in papillary muscle) *mosaic pattern of turbulence should be above the AoV near the outlet if positioned correctly*

Where does blood enter the impella device from the left ventricle?

inlet area

How are impella 2.5/CP inserted anatomically?

inserted at the groin into the left or right *iliac artery* (pref right) and advanced into the *common femoral artery* then into the *descending aorta* over the *aortic arch/root* (preferably hugging the inner/lesser curvature of the aorta) then across the aortic valve into the *left ventricle*

After 2 hours of operation in the initial set-up mode, a white advisory alarm will appear on the screen for an Impella 2.5. What is this alarm?

instructing operators to transfer to standard configuration from set-up configuration *hitting mute will silence for THIRTY minutes*

Where should the red impella plug/sidearm on an Impella 5.5 sit?

midline above the pt waist (away from their side) *external fixation w/ 3 pts*

Which waveform provides information about the catheter position relative to the aortic valve?

motor current (can't have LV waveform without motor current)

When weaning Impella support, what should you see happen with the trend screen?

native cardiac output (white) increases while impella flow (green) decreases and patient's cardiac output remains desireable also maintains MAPs and LVEDP within normal range

Where is the differential pressure sensor located?

next to the *outlet* (it reads pressure outside the cannula -aortic, and pressure inside the cannula -ventricular)

What is the purpose of the spiral wrapped nitinol & polyurethane covering of the cannula for the 2.5/CP?

nitinol = flexibility & shape memory while polyurethane = smooth surface for atraumatic positioning

If the controller detects that the purge system is blocked, it will allow purge pressure to increase up to 1500 mmHg to clear the blockage. How long will this be allowed?

only 5 min

When would you need to turn the AIC into *SURGICAL MODE*?

only if the impella is being used in the OR and *left in ventricle across the aortic valve* --> must turn off flow (P0) but *THIS LEAVES PURGE FLUID ON* *(surgical mode only an option if P0)*

Which part helps determine placement of the Impella device only found on a 2.5 and where is it located?

open pressure area next to the motor housing (open distal tip of placement signal lumen)

Where does blood exit the impella device into the ascending aorta?

outlet area

What are the waveforms supposed to look like on the placement screen if the Impella is correctly positioned?

placement signal = *AORTIC* (unless 5.0/RP because of the differential pressure sensor, it will then be *pulsatile*) motor current = *PULSATILE*

What can a diastolic pressure of less than 30 indicate?

poor positioning (sensor might be sitting right at valve and not sensing much of a differential pressure) *low diastolic = prob in ventricle*

Most common causes of suction alarms are:

preload (volume), position, RV failure, clot

How do you turn an Impella device on?

press & hold the power button for 3 seconds on the right side of the AIC (like you're giving a hug)

What will the placement signal look like on Impella devices with a differential pressure sensor?

pulsatile (5.0/RP) *peak = diastole (because more of a pressure difference) *valley = systole (because less pressure difference)

What is the sensor in the controller that senses the purge pressure from the purge disc on the purge cassette and enables the controller to display and maintain purge pressure?

purge disc

Which part of the purge system reads purge pressure?

purge disc

How is the motor/impeller protected from the blood entering and altering its function?

purge system: purge solution is forwardly expelled and forms an umbrella like shield/bubble (pressure barrier) against the flow of the blood just around the motor housing to prevent blood from entering

How long are alarms muted for when using the "Mute" soft button?

red & yellow alarms mute for 2 minutes while white alarms mute for 5 minutes (silences transferring to standard configuration for 30 min)

You are in a case where the physician has stated that the patient's axillary access is too deep, what do you do?

suggest moving further back towards the shoulder, discuss how a deeper access would create a 90 degree bevel instead of a 60 degree which would make advancing the impella more difficult (not smooth lateral)

During the insertion of an RP, the doc is having trouble advancing the RP across the tricuspid valve on a placement that just had a tricuspid valve replacement. What do you suggest?

suggest using a buddy wire (stiff) to help straighten the anatomy and help advance the RP catheter across the valve and into the RV (then across the pulmonic valve and into the PA)

On echo, what is the ideal measurement of the impella device to ensure correct placement?

the *inlet* is 3.5 cm (or 5 cm for 5.5) below the aortic annulus floating freely in the left ventricle (mid-ventricular space) (look for shiny teardrop on distal end of train tracks)

How is the LV waveform derived?

the optical sensor located at *outflow cage* senses the Aortic pressure (AoP) and the moicro-axial motor senses the difference in pressure between the Aorta & LV (AO-LV) LV waveform = AoP-change in pressure (AO-LV)

What happens to the placement signal waveform on an Impella device with a differential pressure sensor when the device is *incorrectly* positioned?

the placement signal waveform *FLATTENS* because there is no difference in the pressure indicating the cannula is all in one place (left ventricle) motor current will be flat as well (?) = *flat, flat, echo stat* *double hump = happy pump*

How often should purge cassettes be changed?

they are rated to perform for 5 days but should follow hospital protocols

What is the purpose of adjusting an LV Placement Signal and when should it be done?

to reduce variability -at start of case (when notification pops up) -at 24 hrs after start-up (when notification pops up) -if dextrose concentration is changed -if drastic change in hematocrit (or any other patient variable that would affect motor current) *not suggested if Ao placement signal is <20* *to disable LV placement signal --> "display"

True or False: If a suction alarm is present and the patient is not receiving the desired amount of flow, the P-level must be decreased to avoid *shearing*

true

True or False: Impella flow will be displayed in the lower left screen in WHITE if the position is correct or in YELLOW if the position is incorrect or unknown

true

True or False: Impella flow (at the bottom of the screen) will show a max flow (systole), a min flow (diastole) and a mean flow

true

True or False: Critical alarms (red) are indicated by 10 beeps every 6.7 seconds while serious alarms (yellow) are indicated by 3 beeps every 15 seconds

true (and advisory alarms are 1 beep every 5 minutes)

True or False: Purge pressure must always be GREATER than systolic BP

true (in order to create forward flow/pressure barrier)

True or False: If volume status and position are adequate, but suction alarms remain even at P2 or P3, the Impella *RP* can be momentarily stopped to break suction and then immediately restarted

true (only for impella RP)

True or False: If an alarm has been resolved, it is displayed on a gray background for 20 minutes or until you press mute alarm

true (this allows you to identify the alarm that occurred)

True or false: LVEDP = PCWP = PAD

true (typically)

How long can the Impella 5.0/5.5/RP be used for?

up to 14 days

How many alarms can the AIC display simultaneously?

up to 3 alarms, with the highest priority at the top

How does the impeller work?

uses negative pressure to pull blood from the left ventricle (inlet area) into the device and spits it out into the aorta (outlet area) *flow controlled on AIC --> the faster the rotation (P-level) the higher the flow

When/how do you transfer to standard configuration on the AIC for a patient with a 2.5 device?

when a patient remains on Impella support beyond the cath lab *purge menu* (must have NS + IV tubing + pressure bag)

Explain how hemolysis occurs physiologically?

when blood is pumped, it is subjected to mechanical shear forces that can damage blood cells, allowing hemoglobin to enter the plasma

When does the heart icon that is displayed on the home screen have a translucent yellow "?"?

when the controller cannot determine catheter position

What is the only time *surgical mode* should be used?

when the devices remains across the AoV in the LV in P0 and the aorta is cross-clamped *surgical mode is disabled by simply increasing the P-level* or MENU —> settings & service —> disable surgical mode (this keeps purge fluid running & the device from alarming)

When does "placement monitoring suspended" in yellow appear on the home screen next to the heart icon?

when there is a fault in the pressure sensor or if flows drop below 1.0 L/min (displays "placement monitoring disabled" if placement monitoring is turned off through the menu)

On an Impella 2.5, what icon is displayed in the purge system area on the AIC?

y-connector icon above the purge system marquee

Side note: avoid using alcohol or hemostats on plastics components

yep

When will you receive a "Placement signal Low" alarm?

If diastolic pressure on placement signal drops below *30* and motor current remains *pulsatile* (Usually when outlet area is on/near AoV) *confirm positioning & treat the patient not the machine*, reposition if needed (might see "impella outflow blocked" and/or "impella position unknown" if diastolic remain WNL but still on/near AoV)

Before a 5.5 axillary insertion, the doc notices that the patient's vessel is too small, what do you suggest?

If patient could tolerate, suggest inserting a CP device axillary to provide support instead (could accommodate smaller vessels due to small catheter/cannula size)

Explain the Impella 5.0/5.5 axillary insertion steps:

(ACT must be > 250 prior to insertion) -expose axillary aftery & attach graft w/ *60 degree bevel* using *end-to-side* anastomosis -clamp above anastomosis -insert 23 Fr peel-away sheath & secure w/ graft locks -remove clamp & insert diagnostic catheter over 0.035" guidewire into sheath until in LV -remove 0.035" guidewire & exchange for 0.018" placement guidewire w/ formed J on tip -remove diagnostic catheter & clamp graft over 0.018" -insert 8Fr silicone dilator over 0.018" to lubricate sheath then remove dilator -backload impella over 0.018" & insert into graft -remove clamp & advance impella across AoV into LV (3.5 cm below AoV for 5.0 & 5 cm below AoV for 5.5) -confirm position then remove 0.018" placement guidewire & start pump *slowly increase P-level* -clamp graft over device w/ soft jaw clamp (can use vessel loops proximal/distal if bleeding not controlled) -snap & peel-away sheath -trim graft (advance repo sheath if 5.0, or just advance blue suture hub if 5.5) -secure trimmed graft to blue suture hub -remove excess slack & confirm position -attach sterile sleeve to blue suture hub & tighten tuohy-borst valves -close incision & secure blue suture hub to skin -apply sterile dressing -4 pt external fixation above waist & at midline -confirm sidearm retainer attached and note cm marking

Explain what to do when receiving a "Low Purge Pressure" alarm:

(Purge pressure <300 mmHg & rate > 30mL/hr) -check for leaks in purge cassette, luers, purge sidearms, (or anywhere in purge system) -if no leaks, change purge fluid bag to D20W w/ same heparin concentration -change purge cassette if leaking -monitor motor current for upward trends indicating impending pump failure/need for impella catheter change

Explain what to do when receiving a "High Purge Pressure" alarm:

(Purge pressure > 1100 mmHg & rate < 2mL/hr) -check for kinks in tubing, catheter shaft, purge system -if no kinks, change purge fluid bag to lower dextrose concentration -contact CSC for additional support (may need tPA) -monitor motor current for upward trends indicating impending pump failure/need for impella catheter change

What should you look for if AIC is alarming *low purge pressure*?

(purge pressure <300 mmHg & purge flow rate >30mL/hr) -check for leaks in the system & resolve -check if dextrose concentration is too *low* & increase -if unresolved, monitor for increases in *motor current* which can indicate pump failure

What should you look for if AIC is alarming *high purge pressure*?

(purge pressure >1100 mmHg & purge flow rate <2 ml/hr) -check for kinks in the system & resolve -check if dextrose concentration is too *high* & reduce -if unresolved, monitor for increases in *motor current* which can indicate pump failure

What alarm occurs before the device moves fully into the ventricle?

*"PLACEMENT SIGNAL LOW"* -usually because outlet (sensor) is sitting right at AoV -*check to see if diastolic <30 but still pulsatile motor current* --> order echo to confirm position

Explain what to do when receiving "Placement Signal Lumen Blocked" alarm:

*(Impella 2.5)* -confirm roller clamp on pressure bag is open & pressure is 300-350 mmHg -if necessary, close roller clamp & disconnect IV from red luer (careful not to grip white flush valve) —>attach 20mL syringe to red luer, squeeze white flush valve and aspirate until 1-2mL of blood is pulled into syringe —> remove syringe and discard -unclamp roller clamp and flood red luer while reconnecting -squeeze white flush valve (if still unable to get proper placement signal waveform, use motor current to ensure proper positioning across Aov)

What is the size of the repo sheath on the impella 5.0?

*9 Fr NON-TAPERED*

*be able to talk through the million dollar slide*

*INFLOW* decreases LVEDV/LVEDP which decreases wall tension and microvascular resistance... this increases myocardial perfusion which increases O2 supply. The inflow also decreases LAP which decreases pulmonary congestion and this also increases O2 supply. the inflow will also decrease the mechanical work of the heart which *decreases O2 demand* this *increased O2 supply* paired with *decreased O2 demand*= direct unloading to myocardial recovery along with decreased reperfusion injury *OUTFLOW* will obviously increase flow which *increases CPO* and it will increase MAP which will in turn *increase CPO* along with *increasing myocardial perfusion* which increases O2 supply.

A nurse calls in the middle of the night to ask you what all is needed for a 5.5 insertion, what do you tell her they will need?

*Impella 5.5 kit which includes:* -5.5 catheter + connector cable -purge cassette -0.018" placement guidewire *Axillary insertion kit:* -23 Fr axillary sheath -8 Fr silicone-coated dilator (just for lubing) -graft locks, silicone plugs, incision template -impella sidearm retainer *Hospital supplies* -D5W w/ heparin (must be primed with heparin) -4-5 Fr pigtail diagnostic catheter (or AL1/MP w.out sideholes) -0.035" standard J tip guidewire *****10 mm x 20 cm hemashield platinum vascular graft (or vascutec gel weave)

Explain the steps for inserting impella 2.5/CP:

-obtain femoral access (w/ US & micropuncture) -insert 5-8 Fr introducer over 0.035" guidewire -perform angiogram to assess vessel -----> 2.5: insert 10 Fr dilator over 0.035" then exchange w/ 13 Fr peel away sheath & dilator ------>CP: sequentially dilate over 0.035" w/ 8, 10, 12 Fr dilators then exchange w/ 14 Fr peel away sheath & dilator -administer heparin & ensure ACT >250 -remove dilator -insert diagnostic catheter into sheath over 0.035" into LV -remove 0.035" & replace w/ 0.018"x 260cm placement guidewire (form curve on tip before inserting) -advance 0.018" into LV & remove diagnostic catheter -backload impella catheter (use easy guide lumen if available, if not, wet & ensure wire exits outlet area on inner radius) -*always flush sheath prior to inserting impella* -advance impella through sheath over placement guidewire and up across AoV into LV (putting radiopaque marker at AoV annulus & inlet 3.5 cm below AoV annulus) -confirm position & remove placement guidewire -confirm position again w/ fluoro & aortic waveforms

What are the Abiomed recommendations as far as obtaining femoral access goes?

-obtain using micro-puncture with U/S guided access -obtain below inguinal ligament and above bifurcation of SFA/Profunda -35-40 degree angle of entry w/ micro puncture needle -obtain access using Seldinger technique -perform angiogram through micro-puncture catheter

Explain the steps for inserting & priming the purge cassette:

-open package and secure luers to sterile field -pass cassette & spike off sterile field -spike dextrose bag -press "next" soft button -open cassette door on left side & insert cassette into controller with writing facing out -slide disc into slot to the right until snaps into place -close purge cassette door & priming will automatically begin

What do you do when pressure sensor fails on an impella 5.0?

-placement monitoring & suction detection is turned off if it fails -monitor motor current & imaging for position confirmation -estimate flows based off flow chart provided in flow area

What will the waveforms look like on the placement screen if the Impella is *fully in the ventricle*?

-placement signal = *ventricular* (taller/wider) w/ ventricular pressures (low diastolic) -LV waveform = ventricular -motor current = *FLAT/dampened* (bc little to no pressure difference in inlet/outlet areas) *AIC will alarm that catheter is in ventricle *echo stat! decrease to P2 while repositioning!*

What will the AIC show on an Impella CP/5.5 with smart assist if the catheter is completely in the aorta?

-placement signal = aortic w/ normal pressures -LV waveform = aortic w/ normal values -*motor current = dampened/flat* bc of little/no difference in pressure between inlet/outlet areas *reduce to P2, treat pt medically, reposition under fluoro/echo when available* (repositioning guide only available if in ventricle)

On an *impella 5.0* what will you see on the AIC if the outlet area is on/near the AoV?

-placement signal will have *negative* values -"impella outflow blocked" or "impella position unknown" —> use imaging guidance to assess/adjust position —-> if imaging unavailable, reduce to P2, *gently pull back catheter 2 cm* to see if condition resolves (only on 5.0)

What will the AIC show on the impella 2.5 if the catheter is completely in the aorta or if the inlet/outlet areas are in the ventricle and the pressure area is in the aorta (too far back)?

-placement signal will show normal aortic waveform w/ normal pressures -motor current will be *dampened/flat* because there is little/no difference in pressure between inlet/outlet areas -home screen will show yellow question mark over heart and "impella position wrong" bc it cannot determine position

What are the steps to changing the purge cassette?

-purge menu --> change cassette & bag --> start -disconnect yellow luer & pop open cassette door to remove & discard old cassette & fluid bag -spike new fluid bag w/ new cassette --> insert into slot -system will automatically prime once inserted -confirm purge fluid info on screen -connect yellow luers together & press done

What are the steps to changing purge fluid:

-purge menu --> change purge fluid bag --> start -replace fluid & hit next -confirm fluid info on screen/ edit to change then done -if fluid is different, disconnect yellow luer to flush (if same fluid used, press SKIP PRIME) -once primed, connect yellow luer & press done

Describe the steps to De-Air the purge system:

-purge menu --> de-air --> start -ensure fluid bag is not empty/inverted & no kinks -disconnect tubing from catheter & allow to de-air -if needed, press back to repeat air removal -once done, connect purge tubing back to catheter & press done

What are the steps to transfer to standard configuration (Impella 2.5):

-purge menu --> transfer to standard configuration --> start -spike NaCl bag w/ straight IV tubing and place in pressure bag -clamp & disconnect red luer on y-connector from red sidearm on impella plug -prime/create slow drip from NaCl bag and flood red luer on red sidearm & then connect then fully open clamp -remove y connector and connect yellow luer of purge tubing to yellow luer of catheter -press done (*once completed, controller will automatically convert to P-level mode and AUTO will no longer be an option*)

Explain what to do when receiving a "Suction" alarm:

-reduce P-level by 1 to 2 P levels until broken -consider giving volume if *CVP or PAD <10* *if Smart Assist:* —> consider giving volume if *low diastolic impella flows* & *negative LV placement signal diastolic value* (big dip in diastolic LV waveform) -check position of catheter *if Smart Assist:* —> check position if *drop in both systolic & diastolic LV waveform & drop in both systolic & diastolic impella flows* (de-coupled) -reposition if necessary -assess RV function while using echo (can contribute to low preload causing suction) *hyperdynamic LV contractility can result in competition for volume

What would you do if you suspect hemolysis and have clinical indicators of inadequate filling volume (*low CVP, PCWP, AOP*)?

-reduce flow rate as tolerated by hemodynamics (*always run at lowest P-level necessary to achieve max flow desired*) -correct volume status (*additional volume = increased LVEDV* — preload dependent) -use LV waveform on SA devices to determine if suction is related to volume (intermittent/low diastolic) -improve right heart function (I.e. suggest milrinone)

Your device is alarming "Impella position unknown", what do you do?

Check to see if *FLOWS* and LV/MC WAVEFORMS* are normal --> if they are all good, position is okay *this alarm happens when patient is fully unloading —> dampened waveforms

What happens when Impella 2.5 has *NOT* been transferred to standard configuration after *3 HOURS*?

AIC automatically changes to P-level mode (P-8 if on auto mode or same p-level if on p-level mode) auto mode will no longer be an option

What will the AIC show on an impella 5.0 if the catheter is fully in the aorta OR fully in the ventricle?

Bc this device uses a differential pressure sensor, the placement signal waveform AND motor current waveform will be *FLAT* for both incorrect positions (*FLAT FLAT = ECHO STAT*) (*double lump = happy pump* [pulsatile waveforms]) -Home Screen will have yellow ? And "impella position wrong" —-> reduce to P2, use fluoro or echo to assess position, and reposition until *pulsatile waveforms*

What do you need to remind the team when using the provided 8 Fr dilator during the insertion of the impella 5.0/5.5?

Careful to not wipe the silicone coating off the dilator when handling because it is used to lubricate the hemostatic valve prior to the insertion of the pump

What is the formula for CPO?

CO x MAP / 451 *normal = 1.0-1.5 watts *<0.6 = significant mortality rate* (451 is not random, it's the average of CO's & MAP's

A physician is preparing for a 5.5 insertion using a direct approach, but he notices the aorta is heavily calcified. What do you suggest?

Direct approach is *NOT* an option for a heavily calcified aorta, so suggest an axillary insertion instead (anastomosis issue)

What is the Abiomed preferred purge solution?

D5W (or up to D20W) with 25 U/mL Heparin *Dextrose concentration is proportional to the viscosity of the purge solution *Sodium Bicarb now acceptable as well for CP/RP*

True or False: You can use NS as a purge solution if the patient is intolerant to heparin

FALSE (NS will corrode the motor & cause pump failure) *only D5W w/ heparin or NaBicarb

True or False: P-level must be decreased to P2 for CPR and/or defibrillation

FALSE (only for CPR, not for shocking) *order echo (or CXR if RP) to confirm placement after both

True or False: If the red Easy Guide Lumen is removed from the Impella prior to backloading onto the guidewire, it is okay to re-insert in order to help guide the placement guidewire through

FALSE *do not reinsert* just guide placement guidewire through pigtail and out of the outflow cage lined up with the black line (inner curvature of cannula)

True or False: When ready to explant, you turn the P level all the way to P0 and then remove the impella catheter

FALSE: reduce to P1 and pull into *AORTA* then once in aorta, reduce to P0 and remove catheter W/ sheath when ACT <150, and apply manual pressure (40 min recommended) can remove white impella connector cable and shut off AIC once impella catheter is removed

True or False: You can visualize the guidewire during placement of the impella using echo or fluoro

FALSE: only fluoro (cannot see guidewire on echo)

What alarm happens when a patient is fully unloading & the heart is resting?

Impella Position Unknown *low native LV function= low pulsatility = not enough pressure to indicate location* (okay if still have good flows and LV waveform)

Which impella device does *NOT* have a heart icon on the home screen?

Impella RP (the rest have the heart icon) *the home screen is not available for RP*


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