Q&A ROLE PLAY SCENARIOS

How often should the D5 solution and purge cassette be changed?

...According to hospital P/P

CPO Normal limits ?

1-1.5 watts (normal) the formula is CPO = CO x MAP x 0.0022

Why protect II is a "failed trial"

1. Could not meet MI (because looking at CKMB 3x the normal limit) but that "3x" was not a maker for an arthrectomy patient. Therefore Harvard recommended we stop because too many patients with MI 2. Variation that happens from 1st time use (learning curve) with Impella. When you removed the 1st patient out of every center, all the numbers looked WAY better)

Identify the parameters on the ICU check in list for an Impella 2.5 and CP w / AIC

1. Echo- Verify placement and ensure the measurement from the inlet to the annulus of the aortic valve is 3.5 cm 2. Verify touhy valve is locked, and chart cm marker on the impella catheter closest to the sheath. 3. Change P-level off auto and Transfer to standard config ( D5W w 50u/cc, NS bag, pressure bag 300-350mmhg and IV tubing). 4. knee immobilizer, secure impella cath to pt leg 5. Chart UOP and Pulses 6. Monitor hemodynamic- CVP, PCWP, MAP, CI, PA, SVR, SVO2 and Inotropes/presseors 7. Impella Parameters- P-levels, Flow, Motor Current, Placement Signal, Purge flow/Pressure and anticoagulation or hemolysis. 8. Nursing rounds and CSC check in.

What are the MAX RPM for the 2.5 and the CP

2.5 = 51,000 @ p-8 50,000 CP= 46,000@ p-8 44,000

ECMO

433% growth (important number) Know percentage of transfusion (100%) La Forte guy who did a lot of stuff with ECMO research (blood transfusions)

MD asks you for a reminder of what is needed for anticoagulation with impella for maintenance. What do you tell him?

>250 in CCL and 160-180 in the CCU

Unit nurse changed purge system an hour ago. she reports that the purge rate was 10cc/hr, but w new cassette in now 26cc/hr and still has D20W50h/ml. you ask of there have been any alarms and she says the only alarm is white and purge flow > 2.5ml or more but no action needed. What do you advise her to check, and where specifically?

Advise her to check for leaks, and confirm no leaks with the new cassette changed.

Implanting MD tell you last 2 pt he sent to ICU have had almost immediate positioning issues. What is the best practices and tips for success.

Advise him that you will discuss with the nurses the need to be sure the slack has been removed, and that the catheter is secure to ensure proper placement. I will also provide education for the unit ASAP

CCL call you impella 2.5 placed and they report alarm and the AIC say "position unknown" due to low pulsatility and the MD says looks to be prefect position w flouro and flows are 2.4LPM. Address the causes of this alarm and emphasize the importance of how they should Treat the pt.

Assess cardiac function, may try pulling back 2 cm.

Physician calls to tell you he got a pt that he'd like to support w impella for his planned PCI, but echo show LV thrombus and wonders if that is a contraindication. What should you discuss with him?

Discuss his concerns, planned case w LV thrombus and that this would be an contraindication, and the risk of LV thrombus dislodging clot with or without the Impella, the risk is that the clot will get pulled up into the pump and you will get a pump-stop...

Physician tells you he has a patient in shock and would like to provide support with Impella, but the pat has mild AI. he ask if this is a contraindication?

Moderate to severe: risk: put it in and won't help pt or we might have positioning issues, benefit: put it in and it helps your patient. "wide open won't help, anything below is a risk vs benefit, the studies all looked at >/= +2

CCL calls and asks if you if any part of impella contain latex?

NO

In PT who are hemo compromised, What are the main goals w hemo support while on Impella in terms of MAP,CI, CPO, Filling pressure, UOP and Mixed venous sats?

Note that the Impella optimal function parameters are-MAP >60, CI > 2.2, CPO >1, filling pressure CVP/ PCWP > 10, UOP > 30 and SVO2 > 60 SVR=MAP X CVP X 80 / CO PVR= PAMAP / PAWP X 80

What are the different ways you can enter an SPR?

ONLINE INTRANET OR SALESFORCE, PHONE, FAX, MAIL

Describe the wireless insertion technique?

ONLY RECCOMENDED FOR THE 2.5 AND TREAT LIKE A PIG TAIL.

UN RN calls and reports purge flow on d20/w50u/ml of heparin is down below 2cc's and AIC is giving a red alarm that says. "Purge Pressure High" or "purge lumen blocked". what causes this alarm & how do you advise the RN to troubleshoot?

Please check to make sure there are no kinks the purge line, and please get a order to change the D20/50/ml to D5/50H/ml.

MD tell you he had to use a cook 14fr x 30cm sheath b/c of the anatomy was tortuous. What should you advise related to the use of the repo sheath now, along with management of the long cool sheath in the ICU?

Please make sure that the reposition sheath is secure against the cook sheath and will need a pressure bag attached to the cook sheath.

What are the expected motor current thresholds at which the Impella 2.5 and CP with shut down when running at P8?

THE 2.5 THRESHOLDS IS 1010 -----THE CP THRESHOLD IS 1130----------------THE 5.0 IS 1190

a physician has just finished implanting a cp & fellow calls to let you know pt is going to unit and request check in, before hanging up, fellow asks you to remind them what to do with the peel away sheath

Tell him that the 14fr peel a way sheath will need to be removed form the ateriotomy and replaced with the standard repositioning sheath

Perfusionist call you saying that he has completely lost the placement signal. " placement signal blocked" alarm. a. what the cause for lost placement signal? b. what would you ask him to check (2) most common root causes. c. To regain the placement signal what would advise him to do? d. IF treatment still does not resolve, what reminder should you give support of patient and position monitoring? e. What else would you advise him related to preventing further alarms if the placement signal is truly lost?

a. Clotted off, Closed or partially closed roller clamp or less than 300mmHg, and <10 mmHg of low pulsatility can cause alarm. b. Roller Clamp and pressure bag c. Clamp and disconnect the IV from red lure, attach a 20cc syringe to the red luer and aspirate 1-2 mls, remove syringe and preform a wet to wet and reconnect IV to the red luer. open roller clamp and attempt to squeeze the white flush valve for 10 sec. d. use the motor current vaveform to ensure proper positioning. e. go to settings>Disable audio-placement signal lumen blocked to silence, and note that the impella still functions properly

Unit nurse reports to you that physicians feel pt has developed HIT and they want to d/c use of heparin in purge solution?

adddress the MD concerns, Elisa or serotonin panel and agree to HIT anticoagulation comes from Robert Wood Johnson Hospital

What is the MAX tissue depth that is appropriate when considering using the reposition sheath?

find the answer to this question! 10cm length, graduation at 6cm for 15 Fr OD

Your on site in the CCL and MD has just implanted the impella & you note the drips of D5 coming from the AIC, the nurse open the door and the purge transmitter is leaking, how would advise the customer to respond to this leaking purge cassette?

gather all new pruge cassette, bolus and prime tubing reconnect yellow luer to yellow luer and assess for any leaks

What are the MD codes for Impella?

• 3399O: in (insertion) • 33992: out (removal) • 33993: wriggle (reposition)

What are the ICD 10 codes?

• 5A0221D percutaneous heart assist: 2.5, CP, 5.0 Femoral (MS-DRG-216, 217, 218) • 02HA0RZ: 5.0 Axillary and LD (MS-DRG-215) • 02HA3RS: Rt and Lt support (bi-VAD Impella support) (MS-DRG-215)

Physician calls from the CCL and tells you he has a patient with AS & valve area is 0.9cm2. He wants to place impella for support but heard that this is a contraindication for use. What considerations should you share with him related to AS and what is our experience in patients with AS?

Converse with the surgeon his concerns related to the pt, and explain that the PMA states we can treat the MD patient as we have indications for 0.6cm2.

Weaning comped. walk through explant procedure and address recommendation for anticoagulation and achieving hemostasis?

Have suture remove kit and towels available, and ACT < 150, pull power cable, mute and hold on/off button for 3 sec. Apply manual compression for 40mins no peaking.

SHOCK II TRIAL (IABP vs. medical management)

IABP wasn't any better than medical management (same statistical survivability)

Where would you find a list of potential adverse events for the Impella products?

IFU's

What are the indications and contraindications for the following Impella CP

INDICATIONS: Partial circulatory support for up to 6 hrs during procedures not requiring cardiopulmonary bypass. CONTRAINDICATIONS : mechanical valve, AS 1.5cm2 or less, AI >+2, PAD that precludes DEVICE placement

What are the indications and contraindications for the following Impella 2.5

INDICATIONS: Temporary up to 6 hours of ventricle support for elective and urgent HRPCI, hemodynamically stable pt with CAD depressed LVEF. CONTRAINDICATIONS : Mural thrombus, mechanical valve, AS 0.6cm2 or less, AI >+2, PAD that precludes placement

What are the indications and contraindications for the following Impella 5.0 & LD

INDICATIONS: The Impella® 5.0 Circulatory Support System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. CONTRAINDICATIONS : (1) Mechanical aortic valve or heart constrictive device; (2) Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of1.5 cm2 or less); (3) Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2); and (4) Severe peripheral arterial obstructive disease that would preclude Impella® 5.0 device placement.

Impella in OR

If pulled back into aorta go to P-1 if support while on bypass Turn down flow to avoid suction. in left across the aortic valve while cross clamped turn off flows and put in surgical mode on AIC in MENU

Md calls you for support of an impella case in a patient already on IABP and he wants to leave both devices in place. 1. What are the potential negative impacts? 2, What should you advise him on in the situation? 3. If the IABP will be left in place due to prolonged anticoagulation concerns, what should you recommend?

1. IAB can negatively impact the ability- Reduction in forward flow generated the IAB False positive suction detection, thus reduce flows Potential for hemolysis due to IAB interaction with Impella False position alarms due to misinterpretation of pressure-based position sensing algorithms. ONE IMPELLA IN PLACE SET THE IAB TO WEANING MODE AND REMOVE ASAP

Physician independently placed 2.5, pt in ICU and is in P-mode. you arrive and note a yellow suction alarm on the AIC. nurse tell you flows have dropped from 2.3 to 1.6. Name the 3 most likely causes of the suction alarm and the appropriate steps identify the cause and resolve.

1. Inadequate LV Filling (preload) 2, Incorrect position in LV (placement) 3. RV Failure reduce P-level P2, assess volume status CVP/PCWP< 10, evaluate position via placement signal, motor current and imaging and reposition if needed. confirm RV functional status, and return flow rate to pre-alarm setting when suction resolved.

Night RN calls and states that an alarm is coming up that says purge VOL is critically low, bag was changed by days shift few hours ago. What could have caused this alarm?

Check roller clamp and inspect the tubing for any kinks.

Address 3 reasons why we recommend removal of the peel-away sheath with the 2.5/cp and replacing with the repositioning sheath for pt being left on support in the ICU?

Bleeding, Clott, Limb ischemia and catheter movement

on site elective 2.5 and just initiated support on the AIC and in auto. An immediate suction alarm occurs just after the pump in turned on and flows will not rise above 0.5LPM. Appropriate position/ volume are confirmed. What is the problem. How to rectify this issue?

Clot or obstruction noted, will need to remove the impella catheter and washout, rinse, test and re-insert.

You note "Placement Signal Lumen Blocked" alarm but you are able to easily withdraw from and flush the placement signal lumen. What could be causing this alarm?

Clotted.

Name 3 differences b/t 2.5 and the CP

CP - >1 liter flow 14fr vs 13fr locking peel away vs peel away 5 window vs 4 reinforced pig tail extended infow cage- thus on wireless insertions

Unit nurse calls frantic and says Impella is alarming Impella stopped, reverse flow, what do you advise the customer to do?

Call for new AIC and Possible drips, Then try to restart @ P8, then restart @ P2, of not then wait 1 min and P2 again. If not then replace catheter if yes then try to wean

ICU changed the purge fluid about fifteen min ago and is now getting an "AIR IN LINE" alarm???

Check roller clamp and connections, assess for air in the tubing, and de air if so

Primary endpoints: composite rate of MAEs at discharge or 30 day follow-up (whichever is first), follow-up at 90 days (10 major adverse event primary endpoints...know all 10!)

DEATH, MI, AI, stroke/TIA, repeat revascularization, ARF, CPR, VENTRICULAR ARRHYTHMIA, aortic valve damage, HYPOTENSION, ANGIOGRAPHIC FAILURE

ICU call and say the AIC is alarming! Postion Wrong! Placement signal AO 85/45 and dampened/flat motor current. Address both consideration, and should to get it resolved.

Decrease the AIC to P2 and order an echo, may need to be repositioned, and please obtain orders to TX patients hemodynamic with medications.