Impella

Potential adverse events

1. Acute renal dysfunction 2. AV injury 3. Bleeding 4. Cardiogenic shock 5. Cerebral vascular accident/stroke 6. Death 7. Hemolysis 8. Limb ischemia 9. MI 10. Thrombocytopenia

Impella RP adverse events

1. Arrhythmia 2. AFib 3. Bleeding 4. Cardiac tamponade 5. Cardiogenic shock 6. Death 7. Device malfunction 8. hemolysis 9. thrombocytopenia 10. Tricuspid valve injury 11. Venous thrombosis 12. Vascular injury 13. VFib/ VTach

RP ICU check in

1. Call clinical support system or local abiomed rep to check them in 2. Ensure the tuohy borst valve is locked 3. Record the CM marking on the impella catheter 4. Assess volume status - maintain CVP of at least 10 5. Urinary amount and color documented 6. Baseline echo should verify position 7. Hang purge fluid 8. Address alarms

Impella RP contraindications

1. Disorders of the pulmonary artery that prevent placement or positioning 2. Mechanical valves 3. Severe valvular stenosis 4. Severe regurgitation of tricuspid or pulmonic valves 5. Mural thrombus of the RA or vena cava 6. Presence of a vena cava filter or interruption device unless there is clear access from the femoral vein to the RA that can accommodate a 22Fr catheter

Echocardiography is recommended...

1. to confirm positioning 2. After moving patient 3. If you suspect catheter movement 4. If controller suggests incorrect position 5. If you suspect blood damage 6. During weaning to document LV recovery

RP components

15 Fr repositioning sheath

ACT recommendation

160-180 - enough might be delivered by purge system in patients less than 80kg - if an ACT greater than 180 is achieved by the impella heparin alone, heparin concentration can be reduced to 12.5 U/mL in purge

What differentiates 5.0 and LD from 2.5 and CP

5.0 and LD use a differential pressure sensor for placement and flow calculation

AIC battery life

60 mins

TEE for position assessment

A mid-esophageal long axis view can visualize the RVOT

5.0 overview

- 21 Fr microaxial pump on a 9 Fr catheter platform - Low anticoagulation regimen - Inserted femorally or via the axillary artery into LV - No septal puncture - No extracorporeal flow - Unloads up to 5 LPM from LV

LD overview

- 21 Fr microaxial pump on a 9 Fr catheter platform - Low anticoagulation regimen - Single vascular insertion via ascending aorta - Unloads up to 5 LPM from LV - Inserted directly through the ascending aorta into the LV

Radiography for RP position monitoring

Acceptable

Preparing for insertion

Assessment 1. 5.0 - Avoid problematic arteries and severe peripheral arterial obstruction disease - Vessel diameter should be 7mm or greater 2. LD - Avoid calcified aortas - Avoid access points greater than 7cm from the aortic valve When inserted, click "start new case" 1. Spike dextrose bag - open purge cassette and spike dextrose bag 2. Insert purge cassette - controller automatically primes 3. Connect cable to AIC 4. Connect luer connections 5. Confirm purge fluid - confirm purge fluid type and volume

How often should anticoagulation levels be monitored for first 24 hours

Every 3 hours

Septum is supplied by what coronary

LAD and Posterior descending artery

AIC functions/buttons

Mute - mutes alarm for 2 mins or clears resolved alarms Flow control - sets flow rate to p-0 to p-9

Impella in cardiac surgery

Options include 1. Complete removal 2. Retreat device into aorta - Set device at P1 - Turn off placement alarms 3. Device support continues in addition to CPB - turn down device to avoid suction events 4. Impella remains in ventricle, aorta is cross clamped - Set device at P0 - Maintain purge by activating surgical mode - surgical mode allows the purge to be maintained and silences impella stopped alarm when p=0

RP P-Levels

P1 - P6 generate pulsatile flow p1 - P9 = continuous flow

Impella RP crossing the pulmonic valve

PA catheter and the impella RP device outlet should cross at the bifucation of the pulmonary areteries and should clock toward the left artery Always use fluoro when removing the wire to avoid displacement of the catheter

Assessing volume status

Patient considerations 1. Diuretics? 2. Continuous dialysis? 3. Bleeding? 4. VA ECMO?

Impella does not cause hemolysis if

Patient has adequate filling pressure and device is positioned correctly Hemolysis can be caused by 1. Inflow obstruction - like inflow blocked by papillary muscle 2. Cannula obstruction - like clot 3. Outflow obstruction - blockage by aortic wall or valve All create increased blood velocity and hemolysis

RP positioning

Pigtail should be positioned in L or R pulmonary artery - L if preferred "silver ball" of the outlet to the pulmonic valve should be about 2-4 cm The cannula makes 3 turns 1. at the pulmonic valve 2. tricuspid valve 3. at the IVC and RA junction Inlet should rest in the IVC at the level of the diaphragm or heart apex

Displays

Placement screen - placement signal - motor current waveform Home screen - indicates whether placement is adequate Purge screen - purge flow and purge pressure - Pressure is regulated to below 600 mmHg - purge flow is 2-30 mL/hr - alarms sound when pressure is to high/low, blockage is detected, purge rate increases by 2.5 mL/hr Infusion history - amount of heparin and dextrose infused each hour - only begins recording when case start is initiated and flow is greater than 0 LPM - calculated by entries from user and flow rate

Position monitoring

Placement signal waveform should be pulsatile when correct, and flat when improperly positioned One side of the differential pressure sensor is exposed to the aortic pressure (outside the cannula), the other is exposed to ventricular pressure (inside cannula) If yellow question mark is displayed - use imaging to determine placement of cannula

RP waveforme

Placement signal waveform should resemble PA waveform If it resembles RV waveform, use fluoroscopy for assessment Placement signals should not be a substitute hemodynamic monitoring

Radiography for RP position monitoring 2

Poor position Daily xrays are helpful to detect migration

Impella is _____ dependent

Preload

When performing CPR

Reduce P level to P2 Order echo Defibrillation requires no change to AIC

RV free wall is supplied by what coronary artery

Right coronary artery - 85% of population

5.0 repositioning unit

To prepare the unit 1. Flush unit via sidearm, then cap off 2. Advance sheath over catheter at least 2-3 cm into vessel 3. Securely ligate graft to the repositioning sheath 4. Ensure not bleeding into sheath 5. Close insertion site 6. Suture sheath to skin 7

Zeroing pressure sensor

Zero transducer once outside of introducer and in IVC Press zero sensor soft key - verify signal value is 4/4 +- 10 mmHg

RP should remain at P6 or higher unless

actively weaning

When should fluid be considered if suction occurs?

if CVP is less than 10

Axillary insertion kit

inlet should be 3.5 cm distal to AV annulus and free from chordae

If position and suction can't be resolved at p2 or p3, you can

stop the RP momentarily and restart immediately to break the suction event - this is different from left pump devices

40% of the RV ejection is dependent on

the interventricular septum

Automated Impella Controller

- Provides an interface for monitoring and controlling the Impella catheter - Provides purge fluid to the Impella Catheter - Provides backup power when the Impella system is opertaed away from AC power. Can operate on its internal battery at least 60 minutes when fully charged. - One touch automatic priming and deairing - Automatically adjusts purge pressure for more efficient patient management

Indications

1. High-risk PCI - Impella 2.5, CP - < 6 hours (temporary) VAD for use during high-risk percutaneous coronary intervention (prevent hemodynamic instability) 2. Cardiogenic shock - Impella 2.5, CP, 5.0, LD - Temporary VAD for less than or equal to 4 days: 2.5, CP - Temporary VAD for less than or equal to 14 dyas: 5.0, LD - for treatment of cardiogenic shock that occurs immediately after MI OHS or due to cardiomyopathy or myocarditis that are not responsive to optimal medical management - The intent is to reduce ventricular work and provide circulatory support to allow heart recovery

Impella box colors

1. Impella catheter 2. Impella device kit with placement guidewire 3. 500 mL bag of 5% dextrose in water with 25 u/ml heparin 4. Automated controller 5. 4 or 5 Fr pigtail catheter or AL 1 or MP diagnostic catheter without side holes 6. Standard 0.035" x 175cm J tip guidewire 7. 10mm x 20 cm Dacron graft (10 x 15 for LD)

Contraindications

1. Mural thrombus in LV 2. Mechanical AV 3. AV stenosis (0.6 cm2 or less) 4. Moderate to sever AI 5. Sever peripheral artery disease 6. Severe right heart failure 7. Cardiorespiratory failure 8. ASD or VSD 9. LV rupture 10. Taponade

Causes of RV dysfunction

1. RV MI 2. Heart transplant 3. Valvular disease leading to RV loading 4. LVAD surgery

Impella RP indications

1. Temporary RV support for up to - 14 days if BSA greater than or equal to 1.5 - who develop acute RH failure or decompensation following LV assist implantation, MI, transplant, or OHS

Monitoring RP position

Characteristics of well positioned RP

Prior to initiating RP insertion

Gather supplies and equipment Assess the patient 1. Echo to assess contraindications 2. Venogram - evaluate access route 3. Place IJ swan-ganz catheter

Purge system

Delivers rinsing fluid (purge fluid) to prevent blood from entering the Impella Catheter Motor. It consist of: Purge Cassette, Purge Pressure Transmitter, Purge Tubing, Y Connnector Purge fluid - 5% dextrose in water with heparin (D5W-D20 acceptible) - The lower the dextrose concentration, the lower the viscosity - D20 dextrose reduces flow by about 40% - 25 U/mL heparin Purge cassette - delivers purge fluid to the motor Controller automatically adjusts purge flow

Starting impella

Ensure the guidewire is removed before starting 1. Press START IMPELLA 2. Confirm guidewire is removed by clicking YES 3. Select P2 to start device 4. Increase P level to the desired amount of support

What CO calculation must be used while using RP?

Fick calculation

Target RP ACT

For Insertion - 250-500 For continuous support - 160-180

RP overview

Inserted femorally and into the pulmonary artery Inlet = IVC Outlet = Pulmonary artery First and only FDA approved percutaneous heart pump for right heart support Reduces RV workload Reduces CVP Increases cardiac index Size - 22Fr pump - 11 Fr catheter Flow - 4LPM