Impella

ICU check in

- Recommend an echo to verify Impella catheter position • Impella CP with SmartAssist will measure 3.5cm • Impella 5.5 with SmartAssist will measure 5.0cm - verify Tuohy Burst is tightened - Access site should be secured while still maintaining insertion angle - Consider a knee immobilizer to prevent unwanted movement (Impella CP with SmartAssist Only) - For Impella CP with SmartAssist, secure the Impella catheter to the inside of the patient's leg (not on top or outside of leg), if not already complete - For Impella 5.5 with SmartAssist secure the Impella catheter following the 3-point fixation recommendation and verify that the sidearm retainer has been installed on the purge sidearm - Maintain ACT at 160-180 seconds during support - Assess volume status - Urine output and color - Monitor distal perfusion - Review the Clinical Support Center as a 24/7 resource: 1-800-422-8666

Explain what to do if you suspect hemolysis and see clinical indicators of inadequate filling volume (e.g., low CVP, PCWP, AOP)

- Reduce flow rate or performance level as tolerated by patient hemodynamics - Correct input and output balance - Consider giving volume; additional volume will expand the end diastolic ventricular volume - With Impella CP with SmartAssist and Impella 5.5 with SmartAssist, utilize the LV Placement signal to determine intermittent suction related to end diastolic ventricular volume - Improve right heart function

Actions when impella is fully in the ventricle

- Reduce performance level to P-2 and access the repositioning guide located under the MENU soft key - Treat patient medically until catheter can be repositioned - Without imaging and utilizing the Repositioning Guide located under the MENU, pull the catheter back into position - Once the device is repositioned using the Repositioning Guide, it is still recommended to get an echo to verify placement when feasible

signs of right heart failure in patients supported with a left-sided Impella device

- Reduced flow from the Impella Catheter - Suction alarms - Elevated filling pressures (CVP) - Signs of liver failure - Elevated pulmonary pressures - If a patient is exhibiting signs of right heart failure, assess the need for biventricular support

Describe the best echocardiographic views for positioning the Impella RP

- Short axis for transesophageal echocardiography (TEE) - Mid-esophageal long axis view is used to visualize the RVOT - Parasternal short axis for transthoracic echocardiography (TTE) use to assess PV and outlet cage in the PA - Subcostal view with TTE used to visualize the IVC and inlet cage (Color Doppler may be helpful)

Describe the physiologic effects of suction

- Suction limits the amount of support that the Impella Catheter can provide to the patient - Suction results in a decrease in arterial pressure and cardiac output - Suction can damage blood cells, leading to hemolysis

Describe how suction can occur, what it may indicate, and how to handle it

- Suction may occur if the blood volume available for the Impella Catheter is inadequate or restricted - Suction may occur if the inlet area is incorrectly positioned - Suction may indicate right heart failure

Explain why Surgical Mode would be used

- To allow the Impella Catheter to be turned off, but maintain the purge fluid delivery through the motor during routine procedures in the Operating Room when the Impella does not need to run - This keeps the controller from alarming while the device is turned off □ Explain how to enable Surgical Mode. - Reduce the performance level to P-0 - Select the MENU soft button > Settings & Service > Enable Surgical Mode *Surgical Mode should ONLY be used when the device remains across the aortic valve and the aorta is cross-clamped.

Impella 5.5 with SmartAssist Direct Aortic Insertion

- Using the supplied sterile incision template for positioning, place a side biter clamp on the aorta at least 7 cm above the valve plane - Make an incision (or punch) no larger than 6 mm at the insertion site of the ascending aorta - Attach the 10 mm x 15 cm woven Dacron vascular graft to the aorta using the standard end-to-side anastomosis - Administer heparin and achieve ACT of at least 250 seconds - 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 re-clamp the graft at the base - If using the Impella 5.5 with SmartAssist, attach the two pre-split silicone plugs - Moisten the Impella Catheter and push both silicone plugs up against the motor housing - With the graft clamped at the base, place the Impella Catheter into the open end of the graft up to the level of the rear plug - When the catheter is in position, secure umbilical tape around the rear silicone plug. Tighten the umbilical tape sufficiently to control bleeding around the rear plug while still allowing the catheter to slide through the plug - Release the clamp and advance the Impella Catheter into the aorta - If the patient is on cardiopulmonary bypass, allow the heart to fill by restricting the return flow to the bypass machine and reducing CPB flow to a minimum setting, as long as acceptable physiologic systemic flow is maintained - As soon as the motor housing has passed the aorta, use a ligature to loosely secure the front silicone plug flush to the graft. The silicone plug should be in the most proximal portion of the graft. (There should be no movement of the front plug in the graft; however, the catheter shaft should move without resistance within the plug) - While the catheter is being advanced into the aorta, do NOT allow the front plug to advance beyond the base of the graft - To aid in passing the catheter through the aortic valve, apply slight pressure to the posterior aspect of the aortic valve to produce temporary aortic insufficiency - Press START IMPELLA soft button and slowly increase performance level to P-9 to confirm correct and stable placement - Verify placement with transesophageal echocardiography (TEE) and the placement and motor current waveforms - Reposition the catheter as necessary - Position the front silicone plug as close as possible above the aorta. Secure the silicone plug to the graft using a penetrating suture ligature - After achieving correct and stable placement, decrease the performance level to the target flow rate - Clear the vascular graft of excess blood and re-secure the rear silicone plug to the end of the graft - Maintain ACT at 160 to 180 seconds after implantation and until explant

5.5 w/ SA insertion kit

- impella with white connector cable - purge cassette - sterile incision template - 2X 9mm silicone plugs - 0.018"x260cm guide wire - axillary insertion kit

Causes of suction

- preload - positioning - RV failure

AIC battery life

1 hour

To enable Surgical Mode:

1. Turn P-Level to P-0 2. Select the MENU Soft Button 3. Settings/Service > 4. Enable Surgical Mode

CP introducer kit

14fr peel away introducer (13cm and 25cm), 14fr dilator, 8/10/12fr sequential dilators, 0.035"x150cm stiff access guide wire

What is the range for normal purge flow?

2 - 30 mL/hr

CP max flow

3.7 L/min

What is the range for normal purge pressure?

300 - 1100 mmHg

5.5 max flow

5.5 L/min

What are the maximum Impella RP flows?

> 4L /min

Plasma Free Hemoglobin level

A plasma-free hemoglobin >40 mg/dL indicates clinically significant hemolysis.

Impella RP sizes

- 11fr catheter - Non-tapered, 15 Fr. OD repositioning sheath - 21 Fr. motor housing - 22 Fr. cannula

Sheath sizes

- 2.5: 13fr - CP: 14fr - 5.5/RP: 23fr

What is the size of the Impella RP cannula and motor housing?

- 21 Fr. Motor - 22 Fr. Cannula

5.5 axillary insertion kit items

- 23fr x 6cm peel away introducer - 2 graft locks - 8fr dilator

Impella CP sizes

- 9fr catheter - 14fr sheath, cannula, and motor housing - repo sheath: Tapered 9-13 Fr, 12cm

Impella 5.5 sizes

- 9fr catheter - 21fr cannula - no repo sheath; blue suture pad only

RP insertion

- Access the right femoral vein (preferred) with a 5-8 Fr introducer and perform a venogram (optional) - Over the provided stiff 0.035" guidewire, dilate the femoral vein with the sequence of dilators (8, 12, 16, 20 Fr) prior to inserting the 23 Fr peel-away introducer and dilator over the wire. Remove the 0.035" guidewire - Administer heparin and verify ACT ≥ 250 seconds prior to removing dilator from 23 Fr introducer - Advance a femoral length balloon-tipped, flow directed catheter to the right or left pulmonary artery (left PA branch preferred) - Insert the 0.027" x 260 cm placement guidewire through the PA catheter and remove the PA catheter using a fixed wire technique - Backload the Impella RP over the 0.027" placement guidewire - Advance the Impella RP carefully by making short advances through the introducer to prevent catheter kinking. Avoid manipulating the pressure sensor - Zero the pressure sensor when the Impella RP motor is out of the introducer and in the abdominal inferior vena cava by pressing the ZERO SENSOR soft button After zeroing the sensor, the placement signal should read 4/4 ±10 mmHg. - Advance the Impella RP under fluoroscopic guidance through the inferior vena cava into the right atrium and past the tricuspid valve into the right ventricle - Gently clockwise torque the Impella RP toward the pulmonic valve, and pull slight tension on the wire while advancing past the pulmonic valve - Impella RP should be 2-4 cm above the PV with the pigtail deflecting into the left PA branch - If Swan is placed in the RPA branch, the outflow can be positioned at or above the bifurcation - Remove the 0.027" x 260 cm placement guidewire before turning on the Impella RP - Press START IMPELLA, select P-2 to start the Impella RP and confirm that the placement guidewire has been removed by pressing the YES soft button to initiate support - Increase P-level to achieve desired Impella RP flow and hemodynamics - Confirm placement signal waveform resembles PA waveform - Remove excess slack in the Impella RP catheter - Once the Impella RP is in correct position, while using fluoroscopy, hold pressure above the venous entry site and remove the 23 Fr introducer over the Impella RP catheter shaft, ensuring the Impella RP remains in proper position - When the 23 Fr introducer is completely out of the body, snap the wings and peel the introducer completely apart - Under fluoroscopy, slide the repositioning sheath into the vein - Use a deep subcutaneous mattress suture and manual pressure to achieve hemostasis - Secure the repositioning sheath to the skin with a suture through the eyelet - Attach the anticontamination sleeve to the repositioning sheath, and lock the catheter shaft to the repositioning sheath with the anchoring ring - Reconfirm Impella RP position with fluoroscopy - Secure remainder of the Impella RP to the inside of the patient's leg - Maintain ACT at 160 to 180 seconds after implantation and until explant - Monitor patient fluids status, preload and maintain positive CVP

Alternate 0.018 wires

- Boston scientific platinum plus - Boston scientific v-18

Micropuncture — femoral access

- CFA is punctured under fluoroscopic and/or ultrasonic guidance using a 21-gauge needle - Once the needle is in the artery, a 0.018" guidewire is placed through the needle under fluoroscopic guidance - Needle is removed and a 4 Fr. introducer is placed over the 0.018" guidewire into the artery - Guidewire and dilator are removed, and angiography in the oblique ipsilateral projection is performed via the 4 Fr. sheath, confirming the puncture site - A procedural 0.035" guidewire is placed through the sheath, and the sheath is then replaced with a larger introducer

vessel size for Impella CP® with SmartAssist

- CFA must be ≥ 4 mm vessel - 14 Fr sheath = 4.67 mm ID - A 13 Fr. cannula is 4.33 mm

Describe what TEE or TTE show if the Impella Catheter is correctly positioned

- Catheter inlet area approximately 3.5 cm below the aortic valve annulus □ The Impella 5.5 with SmartAssist inlet area should be located approximately 5 cm below the aortic valve annulus - Catheter outlet area well above the aortic valve annulus (frequently not visible on TEE or TTE images) - Catheter angled toward the left ventricular apex away from the heart wall and not curled up or blocking the mitral valve

5.5 hospital required supplies

- D5W Axillary set up - 4 or 5fr pigtail diagnostic catheter (or 6fr AL-1, or an MP) - standard 0.035" guide wire - 10mmX20cm woven Dacron graft - soft jaw clamp - suture or ties - Vessel loops Direct insertion set up items - 10mm X 15cm woven Dacron graft - soft jaw clamp - side biter clamp - suture or ties

Describe the signs of hemolysis

- Decreased hemoglobin levels - Dark or blood-colored urine - Hemolyzed lab samples - Acute renal failure is possible - Plasma free hemoglobin (PfHgb) is the most specific indicator to confirm whether a patient is exposed to an unacceptable level of hemolysis

Factors to evaluate before inserting the Impella RP Catheter

- Echo assessment to rule out contraindications - Assess the ability to place the Impella RP from the right femoral vein (preferred) - Venogram (optional if anatomy or patency of inferior vena cava is in doubt) - Presence of IVC Filter

Impella RP insertion kit

- Impella RP Catheter - White connector cable - Purge cassette - 0.027"/260 cm placement guidewire - 23 Fr peel-away sheath - Introducer kit - 23 Fr peel-away introducer - 23 Fr silicone-coated dilator - 8, 12, 16, 20 Fr dilators - 0.035"/150 cm stiff access guidewire

Best echocardiographic views for positioning the Impella Catheter in the left ventricle

- Long axis for transesophageal echocardiography (TEE) - Parasternal long axis for transthoracic echocardiography (TTE)

Alternate Dacron grafts

- Maquet Hemashield Platinum Woven - Terumo Vascutek Gelweave

Weaning CP

- Once desired ACT has been achieved, reduce to P-1 and have the physician pull the device back into the aorta until the motor current is flat - Reduce to P-0 and have the physician continue to pull the device back until they meet resistance. This is when the motor has reached the repositioning sheath. - While someone is holding pressure at the access site, the physician can continue to pull the repositioning sheath and catheter out of the body as one unit - Hold pressure until hemostasis is achieved (~40 minutes)

PaPi

- PaPi < 1.0 = severe RVF - PaPi 1.0 - 2.0 = RV dysfunction - PaPi 2.0 = likely 'normal' RV

Which of the following are common symptoms of right heart failure?

- Palpitations - Shortness of breath - Swelling of feet and ankles - Fatigue

Left sided device potential adverse events

Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury

Single access procedural steps

After placing the Impella catheter using access best practices... - Aspirate and flush Impella sheath - Place needle through diaphragm of Impella 14F sheath at the 10:00 or 2:00 position to allow for placement of 0.035" guidewire - Secure the Impella catheter to avoid any movement and insert PCI sheath over 0.035" guidewire - Perform Protected PCI - Remove PCI sheath at end of procedure, while securing the Impella catheter - Remove Impella and close access site per recommendations

LV waveform numbers

AoP - 🔼P(A0-LV)

Axillary artery size recommendation

Avoid vessel diameters < 7mm

Preload

Blowing up the balloon: Preload is the stretching of muscle fibers in the ventricle. This stretching results from blood volume in the ventricles at end-diastole. According to Starling law, the more the heart muscles stretch during diastole, the more forcefully they contract during systole. Think of preload as the balloon stretching as air is blown into it. The more air, the greater the stretch.

Impella stopped

If the alarm indicates controller failure, switch to a backup controller. If the alarm does not indicate controller failure and the on-screen instructions tell you to restart Impella: ☐ Immediately try to restart Impella at previous P-level ☐ If restart fails, try to restart again at previous P-level ☐ If restart fails twice, wait 1 to 2 minutes and try to restart it again at P2 ☐ Replace Impella after third unsuccessful restart attempt ☐ If able to restart Impella, consider weaning as Impella may stop again If the alarm does not indicate controller failure and the on-screen instructions tell you to replace the white connector cable: ☐ Follow instructions and replace the connector cable ☐ If Impella does not restart with the new connector cable, switch to a backup controller ☐ Replace Impella if it does not restart with the new controller

RP p-levels

Keep P-level above P-6 unless suction is present or actively weaning.

AIC soft buttons

MUTE ALARM silences or clears an alarm; bell icon with red X displayed when alarm is muted for two minutes or until a new alarm is detected FLOW CONTROL sets the flow rate to AUTO or BOOST, or P-level settings: P-0 though P-9 (device-dependent) DISPLAY opens a menu from which you can select different display screens and change time and display scale PURGE MENU opens the Purge System menu for selecting various purge procedures MENU - Repositioning Guide (on SmartAssist devices) - Enter Cardiac Output (on SmartAssist devices) - Settings/Service - Alarm History - Start Data Snapshot - Case Start

5.5 aortic incision measurement

Make an incision (or punch) no larger than 6 mm at the insertion site on the ascending aorta

What are disorders of the PA wall that would preclude placement of the Impella RP?

Mostly congenital defects that would not allow the Impella RP to be properly positioned with the inlet in the IVC and the outlet in the PA. Additionally, post heart-transplant patients can have PA anatomical differences.

Is there an alternative sheath to the 23 Fr peel-away for the Impella RP?

No

RP emergency use authorization

Only the Impella RP System is authorized to be used by healthcare providers (HCP) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to Coronavirus Disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb‐3(b)(1), unless the authorization is terminated or revoked sooner

RP closure

Perclose should never be used with the Impella RP.

Which AIC display screen displays waveforms to help monitor Impella position?

Placement screen

Purge cassette

Purge cassettes are rated to perform for five days. The frequency of purge fluid and cassette changes should be completed in practice with hospital protocols.

When to use surgical mode

Surgical Mode is ONLY used if Impella is left across the aortic valve while cross clamped

Left sided device contraindications

The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssistand Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade* *This condition is a contraindication for the cardiogenic shock indication only

Cardiogenic shock indications

The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0®, Impella 5.5® with SmartAssist® and Impella LD® Catheters, in conjunction with the Automated Impella ControllerTM (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, Impella 5.5 with SmartAssist and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function

Impella 5.5 locations

The Impella 5.5 with SmartAssist should only be placed in the axillary artery due to 70 cm catheter length. (Or direct aortic insertion)

RP contraindications

The Impella RP System and Impella RP with SmartAssist are contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP devices. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter

RP indications

The Impella RP® System and Impella RP with SmartAssist® are indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery.

Describe suction with an Impella CP with SmartAssist or Impella 5.5 with SmartAssist catheter

The LV waveform will display extremely low diastolic values in the event of intermittent suction and low systolic and diastolic values in the event of continuous suction □ intermittent suction would be more common in the event of volume related issues □ continuous suction would be more common in the event of positioning issues

SvO2 (mixed venous oxygen saturation)

The amount of o2 left in the blood before it travels to the lungs to be re-oxygenated - normal 65%-75% - if low: Can indicate an imbalance between o2 supply and demand; low supply and/or high demand.

Contractility

The balloon's stretch: Contractility refers to the inher- ent ability of the myocardium to contract normally. Contractility is influenced by preload. The greater the stretch, the more forceful the contraction-or, the more air in the balloon, the greater the stretch, and the far- ther the balloon will fly when air is allowed to expel.

Afterload

The knot that ties the balloon: Afterload refers to the pressure that the ventricular muscles must generate to overcome the higher pressure in the aorta to get the blood out of the heart. Resistance is the knot on the end of the balloon, which the balloon has to work against to get the air out.

RP potential adverse events

The potential adverse effects (eg, complications) associated with the use of the Impella RP System and Impella RP with SmartAssist: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non- central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.

LVEDP

Volume and pressure of blood in LV at the end of diastole when the ventricle is at its fullest - considered a preload measure of the LV - 6 to 12 mmHG

5.5 aortic side biter clamp location

at least 7 cm above the valve plane.

What is the most common cause of right-sided heart failure?

left sided heart failure

DIFFERENTIAL PRESSURE SENSOR

• An electronic sensor that measures the pressure difference between the inside and outside of the cannula • Flexible membrane integrated into the cannula • Generates the placement signal used to monitor position and calculate flow

OPTICAL SENSOR OVERVIEW

• Durable fiberoptic sensor with a glass membrane that is located on the pump outflow, at the junction of the outflow cage and the cannula, for more accurate positioning of the Impella • In conjunction with the motor current, generates the placement signals used to monitor position, calculate metrics, and troubleshoot on the Impella CP with SmartAssist and Impella 5.5 with SmartAssist catheters

When to use fluoro with RP

• Inserting 23 Fr sheath (tracking and potential wire buckling issues) • Slowly removing the 0.027" placement guidewire (monitor outflow for potential downward displacement) • Pulling placement guidewire into pigtail and re-evaluate position prior to complete removal (allows re-advancement or re-positioning one last time) • Removing 23 Fr sheath (monitor outflow for potential downward displacement) • Inserting repositioning sheath (monitor inflow for potential over-insertion into RA)

RP proper placement

• Pigtail in left or right PA (left PA preferred due to catheter design for stability) • Outlet in main PA • "Silver ball" of the outlet should measure 2-4 cm above the pulmonic valve • 1st turn should reside approximately at the level of the pulmonic valve • 2nd turn should reside approximately at the level of the tricuspid valve • 3rd turn should reside approximately at the IVC and RA junction • The inlet should rest in the IVC, at the level of the diaphragm or apex of the heart IUM-0384 .v5

RP hospital required supplies

▪ Dextrose solution with 25-50U/mL of heparin ▪ 5-8 Fr introducer for venogram (optional) ▪ Swan-Ganz Catheter or other balloon-tipped, flow directed catheter, femoral length

AIC alarms

Critical Alarms - Critical alarms indicate an immediately harmful or life-threatening situation - Alarm header is displayed on a red background - Indicated by 10 beeps every 6.7 seconds Serious Alarms - Serious alarms indicate a situation that may become harmful or life-threatening if not addressed immediately - Alarm header is displayed on a yellow background - Indicated by 3 beeps every 15 seconds Advisory Alarms - Advisory alarms are information notifications - Alarm header is displayed on a white background - Indicated by 1 beep every 5 minutes

HRPCI indications

High-Risk PCI The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Explain the weaning and removal process of the Impella RP Catheter

- Perform a trial wean of Impella RP, and view echo to confirm RV contractility - Decrease to P-2 temporarily, for no longer than 15-20 minutes. Record the VAD flow, P-level, CVP, echo parameters, and hemodynamics. Once RV contractility is confirmed, resume previous P-level and initiate slow wean - Decrease by 2 P-levels every 2-3 hours and monitor patient hemodynamics - Always maintain flow > 1.5 L/min until removal of Impella RP *If flows are ≤ 1.5 L/min, ≥ 20 minutes, it is strongly recommended to increase the ACT to ≥ 250* - The Impella RP is ready to be removed when the weaning steps are complete and the ACT is ≤ 150 sec - Remove original mattress suture - Place a new mattress suture at venous puncture site, but do not tie off - Pull Impella RP outlet into the inferior vena cava and reduce to P-0 - Pull motor back just before it reaches the distal end of the repositioning sheath - Allow venous site to bleed ~10-15 ml - Tie off the mattress suture and hold manual pressure for 10-15 minutes to achieve hemostasis

If impella is fully in the ventricle...

- Placement signal will show a ventricular pressure waveform with systolic/diastolic values indicating ventricular pressure - Impella CP and Impella 5.5 with SmartAssist will show a ventricular waveform on both the Placement Signal and LV Placement Signal - Motor current will be dampened or flat because there is little or no difference in pressure between the inlet and outlet areas - The Home screen will show an image of the heart with the Impella Catheter too far into the ventricle and "Impella in Ventricle" message

5.5 external fixation

- Position the Red Impella Handle/Purge Sidearm more midline above the waist and away from the patient's side - Loop catheter as needed with shorter torso patients - 3-Point Fixation using commercial catheter locks (e.g. Foley Anchor, CathGripTM Statlock®) - Near Tuohy-Borst - Both sides of Red Impella Handle - Attach Impella Sidearm Retainer to Purge Sidearm - Check security of external fixation, centimeter marker, and Tuohy-Borst at shift change ** Avoid fixation to shoulder or upper arm Avoid the use of alcohol or alcohol-based solution on the purge sidearm **

CP insertion steps

1. Femoral access using ultrasound and micropuncture 2. Insert 5-8fr introducer over 0.035 guide wire 3. Perform angiogram to assess vessel size 4. Remove 5-8fr introducer over 0.035 and sequentially dilate up to 14fr peel away introducer with dilator 5. Before removing the dilator, be sure the ACT is ≥ 250 6. Insert diagnostic catheter into introducer and advance it over 0.035 into left ventricle 7. Remove 0.035, leaving diagnostic cath in place 8. Form curve on end of 0.018 and insert into diagnostic catheter and advance it to apex of LV 9. Remove diagnostic cath and leave 0.018 in place 10. To backload the catheter using the EasyGuide lumen: Advance the 0.018" placement guidewire until it exits the red lumen near the label. Remove the EasyGuide lumen by gently pulling the label along the line of the catheter while holding the Impella Catheter. To backload the catheter without using the EasyGuide lumen: Wet the cannula with sterile water and backload the catheter onto the 0.018" placement guidewire. Advance the guidewire into the Impella Catheter, ensuring it exits the outlet area on the inner radius of the cannula and aligns with the straight black line on the catheter 11. Advance the catheter through the hemostatic valve into the femoral artery and over the placement guidewire and across the aortic valve, positioning the radiopaque marker on the cannula at the level of the aortic valve annulus. Ensure the inlet area is approximately 3.5 cm below the aortic valve annulus 12. Remove the placement guidewire 13. Confirm position with fluoroscopy and confirm that an aortic waveform is displayed on the AIC

Adjust LV signal

1. Press the MENU soft buttons 2. Select "Adjust LV Signal" option with rotary knob 3. The LV Adjustment defaults to the suggested adjustment value 4. Press DONE to confirm suggested adjustment. LV waveform adjustments occur in increments of 1 mmHg from -60 to 60 mmHg. 5. An adjustment is not recommended if the Ao placement signal is less than 20 mmHg

If RP is fully in the RV

AIC shows: Placement signal will show a waveform resembling a RV pressure waveform + Actions to take: - Under fluoroscopic or echo guidance determine catheter position - Reposition the catheter as necessary with fluoroscopic guidance until the placement signal waveform resembles a PA pressure waveform *There are no positioning alarms with the Impella RP

If Impella outlet area is on or near the aortic valve . . .

AIC shows: Placement signal will show normal aortic pressure waveform with systolic/diastolic values like those on the patient monitor The Home screen will show an image of the heart overlaid with a translucent yellow question mark and the "Impella Outflow Blocked" and/or "Impella Position Unknown" message ► If Impella outlet area is on or near the aortic valve - Impella CP with SmartAssist and Impella 5.5 with SmartAssist . . . In this situation, the AIC may not be able to determine the catheter position. You may see a "Placement Signal Low" indication on the screen. The "Placement Signal Low" alarm is a yellow alarm that will be displayed if the diastolic aortic pressure on the placement signal drops below 30 mmHg and motor current remains pulsatile

If the Impella CP with SmartAssist or Impella 5.5 with SmartAssist Catheter is completely in the aorta . . .

AIC shows: Impella Position in Aorta - Placement signal will show a normal aortic pressure waveform with systolic/diastolic values like those on the patient monitor - The LV Placement signal will mirror an aortic pressure waveform with systolic/diastolic values like those on the patient monitor - Motor current will be dampened or flat because there is little or no difference in pressure between the inlet and outlet areas + Actions to take: Reduce performance level to P-2 and reposition the catheter as necessary Treat patient medically until catheter can be repositioned Under fluoroscopic or echocardiographic guidance, determine the catheter position

Purge fluid

D5W with Heparin 25U/mL standard purge solution D5W with Sodium Bicarbonate 25mEq/L preferred purge replacement within the indicated duration of use for patients intolerant to heparin (CP and RP only) (D5W preferred; D5W - D20W acceptable) Concentration of dextrose proportional to viscosity

CP hospital required items

D5W, 5-8fr introducer, diagnostic catheter (pigtail, 6fr AL-1, MP) standard 0.035"x175cm j-tipped guide wire

Impella 5.5 with SmartAssist Axillary Insertion Technique using Axillary Insertion Kit

Expose the axillary artery and attach a 10 mm x 20 cm graft beveled at an angle of at least 60 degrees - Clamp the graft at the anastomosis - Insert 23 Fr peel-away introducer and secure with graft lock; remove clamp - Insert 4-5 Fr pigtail without side holes or 6 Fr AL 1 or MP diagnostic catheter without side holes over a diagnostic 0.035" or 0.038" guidewire through the direct center of the hemostatic valve of the 23 Fr introducer until it is in the left ventricle - Remove the diagnostic guidewire and exchange it for the supplied 0.018" placement guidewire, ensuring there is a large "J" on the distal tip of the wire - After positioning the 0.018" placement guidewire in the left ventricular apex, remove the diagnostic catheter and clamp the vascular graft - Insert the 8 Fr silicone coated dilator over the 0.018" placement guidewire into the introducer to lubricate the hemostatic valve. Remove the dilator - Backload the Impella Catheter over the 0.018" placement guidewire and insert fully into the graft - Remove the clamp and advance the Impella Catheter over the 0.018" placement guidewire until the inlet area of the 5.0 catheter is no more than 3.5 cm below the aortic valve or the Impella 5.5 with SmartAssist is no more than 5 cm below the aortic valve - Remove the 0.018" wire and start the pump - Clamp the graft adjacent to the axillary artery with a soft jawed vascular clamp OR have an assistant secure the catheter manually so that the 23 Fr peel-away introducer can be removed from the graft - Grasp the two "wings" and bend back until the valve assembly comes apart. Continue to peel the two wings until the sheath is completely separated from the catheter shaft - The graft should be shortened to ensure it will not extend outside of the skin once the incision is closed □ While pinning the Impella 5.0 catheter, slide the repositioning sheath over the catheter shaft and advance it into the shortened graft to the blue suture pads □ While pinning the Impella 5.5 with SmartAssist catheter, advance the blue suture hub into the graft - Secure the shortened graft to the blue suture hub so that the position of the Impella Catheter can still be adjusted - Remove excess slack from the Impella Catheter and re-check position - Attach the anticontamination sleeve to the blue section of the repositioning sheath. Lock the Tuohy-Borst valve in place by turning it clockwise - Close the incision over the remaining graft segment and anchor the repositioning sheath securely to the skin - Carefully extend the anticontamination sleeve to maximum length, and secure the end closest to the red Impella plug by tightening the Tuohy-Borst valve - Use 4-point external fixation on the Impella 5.5 with SmartAssist by securing the Tuohy-Borst valve, and then fixating the catheter shaft behind the blue hub and above and below the red Impella plug. Secure the plug above the level of patient's umbilicus and away from the hip. Ensure the Sidearm Retainer is attached.

Left sided device emergency use authorization

Impella Left Ventricular (LV) Support Systems (Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist) are authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients (i.e. patients in the intensive care unit) with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. The Impella LV Support Systems have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

CP insertion kit

Impella catheter, purge cassette, introducer kit, 0.018"x260cm

CPO

Indicator of cardiac function accounting for pressure and flow generated by the the heart - CPO = CO x MAP / 451 - normal: 1-1.5 watts - Impella goal: >0.7 - below 0.6 is indicator of increased mortality of 50%

RP tip to tail

► 6 Fr Pigtail—designed for atraumatic placement in the pulmonary artery, serves as a position landmark on radiograph ► Outlet Area—located at the distal tip of the cannula, has 5 openings (windows) that allow blood to exit the cannula ► 22 Fr Cannula—designed for the anatomy of the right heart; provides optimal and stable positioning ► Inlet Area—located at the proximal end of the cannula; where blood enters the cannula ► Differential Pressure Sensor - a sensor that measures the pressure difference between the inside and outside of the cannula. The pressure value is used for monitoring flow during catheter operation ► Motor Housing—the 21 Fr motor housing contains an encapsulated motor. The motor rotates the impeller which draws blood toward the inlet area and propels it out of the outlet area, creating a forward flow in the same direction as the native heart; this flow unloads the right side of the heart, decreases CVP and increases mean pulmonary artery pressure and flow to the lungs. A purge system delivers a viscous purge solution to prevent blood from entering the motor ► 11 Fr Catheter— contains the purge lumen, electrical cable and a differential pressure measurement cable; 1 cm marks on the catheter used for positioning ► Repositioning Sheath—15 Fr sheath (outer diameter) with hemostatic valve allows for repositioning of the catheter and can be secured to the patient's skin using the yellow eyelet ► Blue Impella Plug— "the brains" of the system; contains the pressure transducer, memory to retain operating parameters ► Clear Sidearm - attached to the purge cassette tubing ► Infusion Filter - prevents bacterial contamination and air from entering the purge lumen ► Pressure Reservoir - includes a flexible rubber diaphragm that provides additional filling volume by means of an expansion chamber during purge solution changes ► Check Valve - ensures that purge fluid does not flow in the reverse direction when the purge solution is exchanged

CP tip to tail

► 6 Fr Pigtail—stabilizes the catheter across the aortic valve ► Inlet Area—cage with open ports to allow blood to be drawn from the ventricle into the cannula ► Radiopaque marker—aids in the proper placement across the valve; place at valve annulus ► 12 Fr or 14 Fr Cannula—flexible, smooth surface allows atraumatic positioning ► Optical Sensor--located on the pump outflow ► Outlet Area—delivers blood from the cannula to the ascending aorta ► EasyGuide Lumen—facilitates loading the catheter onto the placement guide wire ► Motor Housing—14 Fr (Impella CP with SmartAssist) motor housing contains a motor. The motor rotates the impeller which draws blood toward the inlet area and propels it out of the outlet area, creating a forward flow in the same direction as the native heart; this flow directly unloads the left ventricle, decreases left ventricular end diastolic volume and pressure, and increases mean aortic pressure and systemic flow. A purge system delivers a viscous purge solution to prevent blood from entering the motor ► 9 Fr Catheter—has a maximum interventional length of 93 to 99 cm; the catheter shaft contains a (purge lumen, a nitinol wire, a fiber optic cable and electrical cable); 1 cm marks on the catheter used for positioning ► Guidewire Access Repositioning Sheath—helps reduce the risk of distal limb ischemia during support and can be secured to the patient's skin with StatLock compatible suture pads, and also allows for access to be maintained with a guidewire if necessary ► Red Impella Plug—"the brains" of the system; contains the pressure transducer, memory to retain operating parameters, and the placement signal lumen that allows for pressure and waveform displays ► Clear Sidearm - attached to the purge cassette tubing ► Infusion Filter - prevents bacterial contamination and air from entering the purge lumen ► Pressure Reservoir - includes a flexible rubber diaphragm that provides additional filling volume by means of an expansion chamber during purge solution changes ► Check Valve - ensures that purge fluid does not flow in the reverse direction when the purge solution is exchanged

5.5 tip to tail

► No Pigtail on the Impella 5.5 with SmartAssist ► Inlet Area—cage with open ports to allow blood to be drawn from the ventricle into the cannula ► 21 Fr Cannula—3.5 x more rigid then the Impella 5.0 cannula for enhanced deliverability and torque response. ► Optical Pressure Sensor--located on the pump outflow ► Outlet Area—delivers blood from the cannula to the ascending aorta ► Motor Housing—19 Fr motor housing contains a motor. The motor rotates the impeller which draws blood toward the inlet area and propels it out of the outlet area, creating a forward flow in the same direction as the native heart; this flow directly unloads the left ventricle, decreases left ventricular end diastolic volume and pressure, and increases mean aortic pressure and systemic flow. A purge system delivers a viscous purge solution to prevent blood from entering the motor ► 9 Fr Catheter—70 cm in length contains a Steel Coil, a purge lumen, a fiber optic cable and an electrical cable; 1 cm marks on the catheter used for positioning ► Blue Suture Hub - secures the graft and helps reduce the risk of distal limb ischemia during support and can be secured to the patient's skin with StatLock compatible suture pads ► Red Impella Plug— "the brains" of the system; contains the pressure transducer, memory to retain operating parameters and a preconnected white cable ► Clear Sidearm - attached to the purge cassette tubing ► Purge Sidearm Retainer - designed to protect the purge sidearm; recommended use with all Impella 5.5 pumps along with the 3-point fixation ► Infusion Filter - prevents bacterial contamination and air from entering the purge lumen ► Pressure Reservoir - includes a flexible rubber diaphragm that provides additional filling volume by means of an expansion chamber during purge solution changes ► Check Valve - ensures that purge fluid does not flow in the reverse direction when the purge solution is exchanged