impella program protocols & tools...iii introduction effective impella® heart pump programs are...

IMPELLA® PROGRAM

Protocols & Tools

INDICATIONS FOR USE

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.

Cardiogenic ShockThe Impella 2.5®, Impella CP®, Impella CP with SmartAssist®, Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella® Controller (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, 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.

Important Risk Information for Impella devices CONTRAINDICATIONSThe Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and 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.

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

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit www.abiomed.com/important-safety-information to learn more.

Impella RP®

The Impella RP® System is 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.

Important Risk Information for Impella RP System CONTRAINDICATIONSThe Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. 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.

POTENTIAL ADVERSE EVENTSThe potential adverse effects (eg, complications) associated with the use of the Impella RP System: 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.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP. Visit www.abiomed.com/important-safety-information to learn more.

Product Approval Information

ContentsSummary iIntroduction iii

Protected PCI with Impella ivImproving Outcomes in Cardiogenic Shock vClinical Guidelines for Impella vi

Impella Heart Pump Clinical Protocols 2Sample Protected PCI with Impella Device Clinical Decision Tree 3Sample AMI Cardiogenic Shock Algorithm 3-9Impella 2.5 / Impella CP Catheter Set-Up Procedures 10Impella 5.0 / Impella LD Catheter Set-Up Procedures 13Impella 2.5 / Impella CP Catheter Insertion Procedures 16Impella 5.0 Catheter Insertion Procedure 21Impella LD Catheter Insertion Procedure 24Impella Purge System Management Procedures 27Transferring Impella 2.5 / Impella CP–Supported Patient 30Transferring Impella 5.0 / Impella LD –Supported Patient 35Impella 2.5 / Impella CP Patient Care Procedures 38Impella 5.0 /Impella LD Patient Care Procedures 43Impella Catheter Weaning Procedures 47Impella 2.5 / Impella CP Catheter Explant Procedures 48Impella 5.0 Catheter Explant Procedure 50Impella LD Catheter Explant Procedure 51

Impella Skills Evaluation Worksheets 53Impella 2.5 and Impella CP Setup and Insertion 54 Impella 2.5 / Impella CP / Impella 5.0–Patient Management 58Impella 5.0 Setup and Insertion 64

Impella Supply Lists Impella 2.5 / Impella CP Supply List 68Impella 5.0 / Impella LD Supply List 69

Appendix A: Program Resources 70References 71

i

Summary A Protected PCI is an Impella 2.5® and Impella CP® device–supported heart procedure that maintains hemodynamic stability for a patient, allowing a cardiologist to do a more complete revascularization in a single session.

Impella 2.5 and Impella CP is the only percutaneous hemodynamic support device proven safe and effective at reducing peri-procedural and post-procedural adverse events in elective and urgent high-risk patients.

In addition, Impella 2.5, Impella CP, Impella 5.0, and Impella LD heart pumps are now FDA indicated to provide treatment of ongoing cardiogenic shock.

iii

IntroductionEffective Impella® heart pump programs are most successful when the program has structure provided by algorithms, protocols and tools for success as well as ongoing training initiatives. The following key components are vital to the successful implementation and growth of an Impella heart pump program:

Structure and ownership

Implementation and training initiatives

Patient management and clinical protocols

Impella technology logistics

Optimized economics

Quality improvement

Marketing and public awareness

Outreach education

The purpose of the Impella Heart Pumps Clinical Protocols and Tools is to provide your hospital with the patient management and clinical protocols that assist programs in launching and maintaining successful program practices. The programs that excel utilize standard protocols and tools while offering continuous training to all members of the multidisciplinary team that is involved in the care of Impella heart pump patients. Abiomed, Inc., the maker of the Impella heart pumps, offers a thorough training program for both physicians and hospital staff. Training covers the full spectrum of therapy, from an overview of the technology, controller, and system set-up and insertion, through patient management topics. Abiomed offers numerous training avenues, including:

Clinical support and on-site, hands-on customer training

Print and web-based educational materials

Quick skills videos

Hands-on Automated Impella® Controller (AIC) console training

24/7 clinical and technical telephone support through the Clinical Support Hotline (1-800-422-8666)

Advanced programs for more experienced users

Physician certification

Masters Programs

Impella Clinical Expert (ICE) Programs

Mobile Learning Laboratories

Smartphone Apps

Reimbursement Hotline (1-877-256-0861)

Please visit www.abiomed.com for a full listing of resources available from Abiomed, Inc.

iv

Executive Summary Protected PCI with Impella®

Clinical outcomes of the PROTECT II randomized controlled trial demonstrated a 29% reduction in MACCE at 90 days.10

Extensive revascularization was also associated with the largest reduction of adverse events.33

On March 23, 2015, the Impella 2.5® received PMA approval from the U.S. FDA* and on December 2, 2016 the Impella CP® received PMA approval from the U.S. FDA for the indication of Protected PCI. On February 14, 2018, the Impella 2.5 and Impella CP received an expanded PMA approval from the FDA for high-risk PCI with or without depressed ejection fraction (EF).

The clinical data demonstrating the Impella heart pump’s safety and effectiveness includes > 1,600 patients from an FDA- randomized, controlled trial and a FDA-audited, IRB Approved multi-center registry, as well as over 200 peer-reviewed publications in the high-risk PCI setting. The Impella heart pumps are the only percutaneous temporary ventricular support devices that are FDA-approved as safe and effective for high- risk PCI.

Impella 2.5 and Impella CP maintain patient hemodynamics during planned temporary coronary occlusions by maintaining mean arterial pressure (MAP), which may allow for a more thorough procedure and a more complete revascularization in a single session.

* The Impella 2.5 and Impella CP 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 and Impella CP 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.

9.0

N=211

p=0.008

IABP

Median days in hospital; index stay through 90 days,

N=427, Readmissions N=208

Impella

7.0

2 daysor 22%

N=216

Total Days in Hospital

17%

45%

31%

7%

8%

18%

30%

44%

Baseline 90 daysN=223 patients from both arms of PROTECT II trial

with NYHA measurements available at baseline and 90 days

PROTECT II STUDY

p<0.001

58% Reduction in

Class III, IVClass IV

NYHA Class of heart failure

Class III

Class II

Class I

Readmissions from repeat revascularization31

Reduced length of stay31

Total days in hospitalNYHA Class improvement post PCI6

NYHA Class improvement post procedure12%

IABP Impella

6%

52% Reductionin repeat revascularizationN=427; p=0.024

90 DAYS

Patient Comorbidities

Complex Coronary Artery

Disease

HemodynamicCompromise

Protected PCI

Patients

• Surgical Ineligibility • Prior Cardiac Surgery• Heart Failure• Diabetes• Advanced Age• Unstable Angina/NSTEMI• Renal Insufficiency

• Multi-Vessel Disease• Distal Left Main Disease• Complex Lesions (Bifurcation, Calcification)• CTO Retrograde

• Mild, Moderate, Severely Depressed Ejection Fraction • High LVEDP

In addition, published clinical data has shown that the use of Impella heart pumps is associated with reduction of kidney injury during high-risk PCI procedures. Kidney protection is critical as chronic kidney disease is a common comorbidity and high-risk procedures are usually longer using higher levels of contrast. A retrospective study showed incidence of all AKI was 27.8% without Impella compared to 5.2% with Impella.48 Additionally, cost effectiveness of the Impella platform has been demonstrated through a randomized controlled trial, all-payer population based studies, and a systemic review of reduced length of stay.5 Study observations include fewer readmissions, less days in the hospital, and a better quality of life through reduced heart failure symptoms, after a Protected PCI.

Seven society clinical guidelines now reference Impella including ACC/AHA/SCAI/ISHLT/HFSA

Control

27.8%

Impella* Devicee

5.2%

Incidence of All AKI

Control

6.1%

Impella* Device

0.9%

AKI Requiring Dialysis

N=230

p=0.001

p=0.0316xReduction in

Acute Kidney Injury Requiring Dialysis

Use of Impella® Device During a High-Risk PCI Procedure* is Associated with Reduction of Kidney Injury

v

Executive Summary Improving Outcomes in Cardiogenic Shock

Improving Outcomes in Cardiogenic Shock Impella 2.5®, Impella CP®, Impella 5.0®, and Impella LD® heart pumps are now FDA indicated to provide treatment of ongoing cardiogenic shock. In this setting, the Impella heart pumps have the ability to stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs, and allow for recovery of the native heart. Impella devices have also been proven to be cost effective through reduction in length of hospital stay, readmissions, and overall costs compared with alternative treatment.66

The FDA has also approved Impella 2.5 and Impella CP for elective and urgent high-risk percutaneous coronary intervention (PCI), or Protected PCI.

The Impella RP® heart pump has the ability to stabilize hemodynamics, unload the right ventricle and allow for native heart recovery in patients with right ventricular failure. Delivered through a minimally-invasive catheterization technique using the femoral vein as the access point, the Impella RP heart pump is designed to provide the flow and pressure needed to compensate for right heart failure. The device provides more than four liters of blood per minute for hemodynamic support.

Cardiac Output

MAP

End OrganPerfusion

Death Spiral of Cardiogenic Shock

ReverseSpiral

MyocardialRecoveryPatients

AMI, SCAD, Cardiomyopathy, (Peripartum, Myocarditis), Post-cardiotomyCardiogenic Shock Therapy

Identify Cardiogenic Shock Early• Systolic blood pressure (SBP) <90 mmHg or on inotropes/pressors • Cold, clammy, tachycardia • Lactate elevated >2 mmoI/L

Cardiogenic Etiology Evaluation• EKG (STEMI/NSTEMI)

• Echocardiography

• If available, PA catheter, assessment of cardiac output, CPO, CI, PCWP, SVO2

Hemodynamic Effects of Impella Support

Early Stabilization Can Improve Outcomes in Cardiogenic Shock

“Early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI”. 46

William W. O’Neill, MD., Theodore Schreiber, M.D., David H. W. Wohns, M.D., Charanjit Rihal, M.D., Srihari S. Naidu, M.D., Andrew B. Civitello, M.D. Simon R. Dixon, M.D., CH.B., Joseph M. Massaro, Ph.D., Brijeshwar Maini, M.D., & E. Magnus Ohman, M.D.

Major society clinical guidelines now reference Impella devices, including ACC/AHA/SCAI/ISHLT/HFSA

P<0.0001

Pre-Support

OnSupport

62.7 ± 19.2

94.4 ± 23.1

51%

(n=143)

P<0.0001

Pre-Support

OnSupport

3.4 ± 1.3

5.3 ± 1.7

56%

(n=23)

P<0.0001

Pre-Support

OnSupport

0.48 ± 0.17

1.06 ± 0.48

120% (n=23) P<0.0001

Pre-Support

OnSupport

31.9 ± 11.1

19.2 ± 9.740% (n=25)

Outflow(aortic root)

aortic valve

Inflow(ventricle)

Flow

Cardiac Power Output O2 Supply

Coronary Perfusion

Microvascular Resistance

O2 Demand

MAP LVEDP and LVEDV

Wall Tension Mechanical Work

Unloading to Myocardial RecoveryEnd Organ Perfusion

Outflow(aortic root)

aortic valve

Inflow(ventricle)

Reperfusion Injury*

CardioprotectiveSignalling

* Under study

SURV

IVAL

RAT

E

302520151050

1.0

0.8

0.6

0.4

0.2

0

DAYS FROM INITIATION OF IMPELLA

Log-Rank, p=0.004

Impella Pre-PCI

Impella Post-PCI

* The catheter based VAD Registry is a worldwide, multicenter, IRB approved, monitored clinical registry of all patients at participating sites; registry data is used for FDA PMA submissions

cVAD Study*MAP

Cardiac Power Output

Cardiac Output

PCWP

vi

2014 AHA/ACC Guideline for the Management of Patients with Non-ST-elevation Acute Coronary Syndromes30 Journal of the American College of Cardiology Revascularization in Heart Failure: Class I Revascularization strategy based on the degree, severity, and extent of CAD; cardiac lesions pVADS: Large amount of ischemic territory/poor LV function

2011 ACCF/AHA/SCAI Guidelines for Percutaneous Coronary Intervention31 Journal of the American College of Cardiology

High-risk patients: Class IIb Class III: HARM without hemodynamic support; for PCI at hospitals without on-site cardiac surgery

Additional Guidelines

2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Journal of the American College of Cardiology31

PCI and Cardiogenic Shock: Class I

Use of Mechanical Circulatory Support: American Heart Association (2012)32 Circulation Acutely decompensated heart failure patients: Class IIa

2013 lnt'I Society for Heart & Lung Transplantation Guidelines for Mechanical Circulatory Support33 The Journal of Heart and Lung Transplantation Temporary mechanical support for patients with multi-organ failure: Class I

2013 ACCF/AHA Guideline for the Management of Heart Failure34 Circulation

"Bridge to Recovery" or "Bridge to Decision" for patients with acute, profound hemodynamic compromise: Class IIa

2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction35 Circulation

STEMI and Cardiogenic Shock: Class Ib STEMI and Urgent CABG: Class IIa

Protected PCI with Impella

Clinical Guidelines for Impella®

2

Impella® Heart Pump Clinical ProtocolsThis section includes several templates for Protected PCI with Impella Program protocols. (For more information, contact [email protected].)

Sample Protected PCI with Impella Clinical Decision Tree

Sample Cardiogenic Shock Algorithm

Impella 2.5 and Impella CP Catheter Set-Up Procedure

Impella 5.0 and Impella LD Catheter Set-Up Procedure

Impella 2.5 and Impella CP Catheter Insertion Procedure

Impella 5.0 and Impella LD Catheter Insertion Procedure

Impella Purge System Management Procedures

Transfer of Care Impella 2.5 / Impella CP

Transfer of Care Impella 5.0 / Impella LD

Impella 2.5 / Impella CP Catheter Patient Care Procedure

Impella 5.0 / Impella LD Catheter Patient Care Procedure

Impella Catheter Weaning Procedure

Impella 2.5 Catheter Explant Procedure

Impella 5.0 / Impella LD Catheter Explant Procedure

These protocols are a compilation of best practices. Review each protocol with your hospital’s committee and customize as needed before putting it into place, keeping in mind your particular institution's policies and procedures concerning the practice of medicine. For the latest product information, refer to the Impella device Instructions For Use (IFU) manuals, available on the Abiomed website: www.abiomed.com.

3

Sample Protected PCI with Impella Device Clinical Decision Tree

YesHemodynamicsupport indicated?

Medical Management Revascularization

CABG PCI

No

Heart Team decision

Conventional PCI Protected PCIwith Impella 2.5™

Diagnosis: High-risk patient

No Yes Choice of appropriate treatment (PCI vs. CABG) by multidisciplinary “Heart team”, per Guidelines (Class I)31

Hemodynamic compromise with complex CAD and/or comorbidities- FDA-Approved Indication- Per Guidelines30,31

Treatment Decision

Goal: More Complete Revascularization

4

Sample AMI Cardiogenic Shock Algorithm

5

Sample Identify: Minimize Duration of Shock

IMP-1270-16 .v4

IDENTIFY: MINIMIZE DURATION OF SHOCK

ActivateHeart Recovery Team/

Cardiac Cath Lab

Suspect ShockConsider any of these criteria:• Cool, clammy, pale skin• Confusion/anxiety• Rapid, shallow breathing• SBP < 90 mmHg > 30 min• Inotrope/vasopressor and/or IABP to

maintain SBP > 90 mmHg • Decrease in urine output (<0.5 cc/kg/h)• Serum lactate level > 2 mmol/L

ASuspectCardiogenic Shock

See A

Diagnose CGS• STEMI/Non-STEMI• ECG ST segment abnormalities• Troponin• ECHO (assess cardiac function)

If PA Catheter (PAC) available:• Cardiac Index (CI) < 2.2 L/min/m2 AND

Pulmonary Capillary Wedge Pressure (PCWP) > 15 mmHg

B

ConfirmCGS Diagnosis

reassess every 1-2 hours if criteria not initially met

See B

6

Sample Stabilize Early and Complete Revascularization

IMP-1270-16 .v4IMP-1270-16 .v4

STABILIZE EARLY AND COMPLETE REVASCULARIZATION

Activate Cardiac Cath Lab

Yes

No

Access

Assess Hemodynamics

Impella 2.5®

or Impella CP®

Reassess Hemodynamics

Acute MI?

Coronary Angiogramwith PCI

Begin Weaning Catecholamines*

PCI:Coronary angiography andPCI with goal of complete revascularization

Access:1. Femoral arterial access using micropuncture with

image guidance (ultrasound and/or fluoroscopy)1

2. Angiography via 4F micropuncture dilator to confirm puncture site & vessel size

3. Place appropriately sized (5 or 6 Fr) arterial sheath4. Obtain venous access (femoral or internal jugular)

Assess Hemodynamics: LVEDP or PAC

• If sustained hypotension (SBP < 90 mmHg)for > 30 min

Or

• CI < 2.2 with LVEDP or PCWP >18 mmHg,consider mechanical circulatory support If femoral arterial anatomy suitable and no

contraindications, place, or escalate to(if IABP already in place), Impella 2.5 or Impella CP

BEST PRACTICEBEST PRACTICE

Reassess Hemodynamics: PAC (if not done initially)

1. CPO = MAP × CO/451 W2. PAPI = sPAP-dPAP/RA

* If consistent with overall hemodynamic management

CO, cardiac output; CPO, cardiac power output; dPAP, diastolic pulmonary arterial pressure; MAP, mean arterial pressure;PAC, pulmonary arterial catheter; PAPI, pulmonary artery pulsatility index;RA, right arterial pressure; sPAP, systolic pulmonary arterial pressure.

Soverow J, Lee MS. J Invasive Cardiol. 2014;26(12):659-667.

7

Sample Reassess Prior to Discharge from Cath Lab

IMP-1270-16 .v4

CPO < 0.6 CPO > 0.6PAPI

< 1 ≥1

RV Preserved: Escalate MCS or consider transfer

to LVAD/Transplant Center

RV Dysfunction:Right-sided MCS

(Impella RP®)

Reassess Hemodynamics via PAC prior to Discharge from the Cath Lab:1. Cardiac Power Output (CPO) = (CO × MAP) / 451 2. Pulmonary Artery Pulsatility Index (PAPI) = (sPAP-dPAP) / CVP

Admit to ICU to maximizesupportive care and to actively

assess for myocardial recovery

Yes

No

Persistent Hypoxemia?PaO2 < 55 on 100% FiO2

VA orVV-ECMO: Recommend maintaining Impella® at low

speed for LV decompression

REASSESS PRIOR TO DISCHARGE FROM CATH LAB

Anderson MB, et al. J Heart Lung Transplant. 2015;34(12):1549-1560.

RV Failure as defined by Recover Right1:

• CI < 2.2 L/min/m2 (despite continuous infusion of ≥ 1 high dose inotrope, ie, da/dobutamine≥ 10 µg/kg/min or equivalent) and any of the following:

1. CVP > 15 mmHg, or 2. CVP/PCWP or LAP ratio >0.63, or3. RV dysfunction on TTE

(TAPSE score ≤14 mm)

8

Sample Escalation, Weaning and Transfer

9

Sample No Recovery: Escalate (& ambulate) or Transfer

IMP-1270-16 .v4

NO RECOVERY: ESCALATE (& AMBULATE) OR TRANSFER

No RecoveryEscalate (& Ambulate) or Transfer

Guidance by RHC Is Critical

Worsening / not improvingclinical, echocardiographic & hemodynamic parameters (concordant):• ↓ Cardiac output• ↓ CPO• ↓ Urine output• ↑ Lactate• Inotrope dependent• Absent pulsatility

CPO remains < 0.6, Lactate non-responder

@ 12 and 24 hours

PAPI < 1 (RV Failure)

Biventricular supportwith Impella RP® on the right side

(transfer if not available)

RV Failure as defined by Recover Right1:

• CI < 2.2 L/min/m2 (despite continuous infusion of ≥ 1 high dose inotrope, ie, da/dobutamine≥ 10 µg/kg/min or equivalent) and any of the following:1. CVP > 15 mmHg, or 2. CVP/PCWP or LAP ratio >0.63, or3. RV dysfunction on TTE

(TAPSE score ≤14 mm)

CPO = (CO × MAP) / 451.PAPI = (sPAP – dPAP) / RA.

Anderson MB, et al. J Heart Lung Transplant. 2015;34(12):1549-1560.

PAPI ≥ 1 (acceptable RV function)

Consider left-side escalationwith Impella 5.0®

(transfer if not available)

10

Impella 2.5® / Impella CP® Catheter Set-Up Procedures

Purpose To set up the Impella 2.5 or Impella CP Catheters for insertion

Audience Healthcare providers involved in setting up the Impella 2.5 and Impella CP Catheters prior to insertion

Desired Outcomes Impella 2.5 or Impella CP Catheter will be ready to insert

Equipment • Automated Impella® Controller

• Impella 2.5 or Impella CP Catheter Insertion kit

• Diagnostic catheter (6 Fr AL1 or MP without side holes or 5 Fr pigtail with or without side holes)

• 5-8 Fr Introducer and 10 Fr Dilator

• Standard 0.035" x 180 cm J-Tip Guidewire

• 500 mL bag of D5W (5% recommended; 5% to 20% acceptable) with 50 IU/mL Heparin (recommended)

• 500 mL bag of NaCl with pressure bag if patient transferred to ICU on Impella support

• Back-up Automated Impella Controller, purge cassette, connector cable, and Impella 2.5 or Impella CP Catheter, in the event they are needed

Preparation • Gather supplies and equipment

• The Li-ion batteries in the Automated Impella Controller must be charged for 5 hours prior to system operation in order to ensure 1 hour of battery operation

• Dedicated AC power source

Alerts • Do NOT open the Impella 2.5 or Impella CP Catheter tray until you receive confirmation that the physician is proceeding with the insertion based on results of the clinical evaluation of the patient. (For more information, refer to the Pre-Support Evaluation section of the Instructions for Use Manual.)

Procedure Impella 2.5 and Impella CP Catheter Set-Up Procedure: CASE START

Action Notes

1. Performed at Controller:

Turn the Automated Impella Controller on.

(Screen will advance when completed)

Press and hold the black power switch found on the right side of the controller for 3 seconds.


Press "START NEW CASE" soft key.


Screen reads "Anticoagulate once sheath is in".

3. Performed in Sterile Field:

Open purge cassette in sterile field.

Pass spike and cassette off sterile field.


STEP 1:

Spike Dextrose Bag

Press NEXT soft key


D5W recommended.

If D5W supplied in bottles, open the vent on the purge fluid spike and proceed.

(continued)

11


STEP 2:

a) Open front purge cassette door using button on left side.

Button located on left side of controller screen.

b) Insert purge cassette and disc then close door.


Insert cassette first, then slide disc in, with flat side inward.

6. Performed in sterile field:

Open Impella Catheter and cable in sterile field.

Pass white, round end of cable off sterile field.

7. Performed simultaneously:

STEP 3: a) Connect white cable to Impella catheter: connect grey end arrow to arrow.

b) Connect white end to Controller.


Performed in sterile field.

Performed at Controller.


STEP 4: a) Snap on purge clip.

Connects purge lines to catheter cable.

b) Connect purge tubing to Impella catheter using luers: Yellow to Yellow Red to Red


Luers attach purge tubing to matching sidearm ports.


STEP 5:Squeeze and hold sides of white flush valve until controller beeps.


Squeeze continuously until beep sounds.


STEP 6:Confirm Purge Fluid information.

Press ACCEPT soft key if no change.

Press EDIT soft key to change information. Turn the selector knob to each individual value. Press the selector knob to open options. Scroll to desired value and press selector knob to confirm value. Continue procedure until all values are selected. Select OK by pressing selector knob.


Use selector knob to EDIT information.

"Priming Impella" screen may appear if still priming. (Screen will advance when completed)

11. Performed at Controller:DO NOT press START IMPELLA soft key until physician confirms successful insertion, proper position and removal of guidewire from catheter.

Read alerts on controller screen.

Confirm that appropriate steps are taken.

Confirm anticoagulation.Confirm Purge Fluid exit.Confirm Guidewire removal.

(continued)

12

Follow-up Proceed with Impella 2.5 or Impella CP Catheter insertion.

References (Supportive Data)

Impella 2.5 or Impella CP Catheter with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

13

Impella 5.0® / Impella LD® Catheter Set-Up Procedures

Purpose To set up the Impella 5.0 or Impella LD Catheter for insertion

Audience Healthcare providers involved in setting up the Impella 5.0 or Impella LD Catheter prior to insertion

Desired Outcomes Impella 5.0 or Impella LD Catheter will be ready to insert

Equipment • Automated Impella® Controller

• Impella 5.0 or Impella LD Catheter Insertion kit


• Back-up Automated Impella Controller, purge cassette, connector cable, and Impella 5.0 and Impella LD Catheter, in the event they are needed

Impella 5.0 only:

• Diagnostic catheter (6 Fr AL1 or MP without side holes or 5 Fr pigtail with or without side holes)

• Standard 0.035" x 180 cm J-Tip Guidewire

Additional equipment for Axillary insertion of Impella 5.0:

• Axillary Insertion Kit

• Dacron vascular graft 10 mm x 20 cm

Impella LD

• Dacron vascular graft 10 mm x 15 cm

Preparation • Gather supplies and equipment

• The Li-ion batteries in the Automated Impella Controller must be charged for 5 hours prior to system operation in order to ensure 1 hour of battery operation


Alerts • Do NOT open the Impella 5.0 and Impella LD Catheter until you receive confirmation that the physician is proceeding with the insertion based on results of the clinical evaluation of the patient. (For more information, refer to the Pre-Support Evaluation section of the Instructions for Use Manual.)

Procedure Impella 5.0 and Impella LD Catheter Set-Up Procedure: CASE START

Action Notes


Turn the Automated Impella Controller on.


Press and hold the black power switch found on the right side of the controller for 3 seconds.


Press "START NEW CASE" soft key.



Open purge cassette in sterile field.

Pass spike and cassette off sterile field.

(continued)

14

4. Performed at Controller: STEP 1:

Spike Dextrose bag Press "Next" soft key (Screen will advance when completed)

D5W recommended.

If D5W supplied in bottles, open the vent on purge fluid spike and proceed.


STEP 2:

a) Open front purge cassette door using button on left side.

Button located on left side of controller screen.

b) Insert purge cassette and disc then close door.


Insert cassette first, then slide disc in, with flat side inward.


Open Impella Catheter and cable in sterile field. Pass white, rounded end of cable off sterile field.

7. Performed simultaneously:

STEP 3:

a) Connect white cable to Impella catheter: connect gray end arrow to arrow

Performed in sterile field.

b) Connect white end to controller


Performed at Controller.


STEP 4:a) Snap on purge clip.

b) Connect purge tubing to Impella Catheter using luer: yellow to yellow

(Remove and discard Y-Connector)


Connects purge lines to catheter cable.

Luer attaches purge tubing to matching sidearm port.


STEP 5:

Confirm Purge Fluid information

Press ACCEPT soft key if no change

Press EDIT soft key to change information.

Turn the selector knob to each individual value. Press the selector knob to open options. Scroll to desired value and press selector knob to confirm value. Continue procedure until all values are selected. Select OK by pressing selector knob.

Use selector knob to EDIT information.

"Priming Impella" screen may appear if still priming.(Screen will advance when completed)


DO NOT press START IMPELLA soft key until physician confirms successful insertion, proper position and removal of Guidewire from Impella 5.0 Catheter. Read alerts on controller screen. Confirm that appropriate steps are taken.

Confirm alerts associated with specific device.

(continued)

15

Follow-up Proceed with Impella 5.0 or Impella LD Catheter insertion.


Impella 5.0 or Impella LD Catheter with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

16

Impella 2.5® / Impella CP® Catheter Insertion ProceduresPurpose To insert the Impella 2.5 or Impella CP Catheter

Audience Healthcare providers involved in the insertion of the Impella 2.5 and Impella CP Catheter

Desired Outcomes Impella 2.5 or Impella CP will be successfully inserted and provide hemodynamic support to the patient

Preparation • Gather supplies


Alerts • Fluoroscopy is required to guide placement of the Impella 2.5 and Impella CP Catheter. The placement guidewire must be reliably observed at all times.

• Remove the placement guidewire prior to turning the Impella 2.5 and Impella CP Catheter on.

• Avoid manual compression of the Impella 2.5 and Impella CP Catheter inlet or outlet areas.

• Maintain ACT at 160–180 seconds during support.

• Retrograde flow may occur across the aortic valve if the Impella 2.5 and Impella CP Catheter is set at a performance level below P-2.

Procedure Inserting the Impella 2.5 or Impella CP Catheter (Wired Insertion Technique)

Action Notes

1. Obtain access to femoral artery.

2. Insert 5–8 Fr introducer over the 0.035" guidewire.

3. Remove 5–8 Fr introducer over 0.035" guidewire. Predilate the artery with a 10 Fr dilator prior to inserting the 13 Fr or 14 Fr peel-away introducer with dilator. While inserting the introducer, hold the shaft of the introducer to slide it into the artery.

(continued)

17

4. Administer Heparin. When ACT is 250 seconds or above, remove the dilator.

5. Insert diagnostic catheter (Abiomed recommends using a 5 Fr pigtail with or without side holes or 6 Fr AL1 or MP without side holes) over a 0.035" diagnostic guidewire into the introducer and advance it into the left ventricle.

When using a pigtail with side holes, magnify the area one to two times as the guidewire begins to exit the pigtail to ensure that the guidewire exits the end of the catheter and not the side holes. To do so, magnify the area one to two times as the guidewire begins to exit the pigtail.

6. Remove the 0.035" diagnostic guidewire, leaving the diagnostic catheter in the ventricle. Form a curve or bend on the end of the 0.018" x 260 cm placement guidewire, following the instructions.

Bend the shaping ribbon against the tool, using minimal force. Do not use a shaping tool with a sharp tip or edge. Do not pull the shaping tool along the length of the shaping ribbon as this could strip the coil off the guidewire and cause it to unfurl and separate. Inspect the coil and guidewire for damage after shaping and before using.

7. Advance the placement guidewire into the apex of the left ventricle.

8. Remove the diagnostic catheter.

To backload the catheter using the EasyGuide lumen:

9. Insert the placement guidewire into the red EasyGuide lumen at the tip of the pigtail of the Impella 2.5 and Impella CP Catheter.

a) Advance the guidewire until it exits the red lumen near the label.

b) Remove the red EasyGuide Lumen by gently pulling the label in line with the catheter shaft while holding the Impella 2.5 and Impella CP Catheter.

c) If you suspect that a portion of the red lumen remains in the catheter, do NOT use the Impella 2.5 and Impella CP device Catheter. Measure red lumen length using catheter markings (intact length is between 21.5 cm and 22.5 cm).

d) Skip to step 11 if the catheter is successfully backloaded on the guidewire.

If catheter does not have a red EasyGuide lumen, follow the procedure outlined in step 10.

(continued)

18

To backload the catheter without the EasyGuide lumen:

10. Wet the cannula with sterile water and backload the catheter onto the placement guidewire. One or two people can load the catheter on the guidewire.

One-person technique:

a) Advance the guidewire into the Impella 2.5 or Impella CP Catheter and stabilize the cannula between the fingers. This prevents pinching of the inlet area. The guidewire must exit the outlet area on the inner radius of the cannula and align with the straight black line on the catheter. The cannula can be hyperextended as necessary to ensure the guidewire exits on the inner radius of the cannula.

Two-person technique:

b) The scrub assistant can help stabilize the catheter by holding the catheter proximal to the motor. This will allow the implanting physician to visualize the inner radius. The guidewire must exit the outlet area on the inner radius of the cannula and align with the straight black line on the catheter. The physician can focus on advancing the guidewire and, if the cannula needs to be hyperextended, the scrub assistant is available to assist.

11. Advance the catheter through the hemostatic valve into the femoral artery and along the placement guidewire and across the aortic valve using a fixed-wire technique. Follow the catheter under fluoroscopy as it is advanced across the aortic valve, positioning the inlet area of the catheter 3.5 cm below the aortic valve annulus and in the middle of the ventricular chamber, free from the mitral valve chordae. Be careful not to coil the guidewire in the left ventricle.

Be careful not to coil the guidewire in the left ventricle.

While inserting the Impella 2.5 or Impella CP Catheter, push the catheter from a few centimeters behind the hub of the peel-away introducer. This prevents the catheter from buckling during insertion.

Do not touch inlet or outlet areas.

12. Remove the placement guidewire.

13. Confirm position with fluoroscopy and confirm that an aortic waveform is displayed on the Automated Impella® Controller.

(continued)

19

Procedure Positioning and Starting the Impella 2.5 or Impella CP Catheter

1. Place the catheter plug at the level of the patient's heart.

2. Prior to starting the pump, reconfirm that the placement guidewire has been removed. Also reconfirm that the controller displays an aortic waveform and the radiopaque marker band is located at the aortic valve annulus.

3. Press the START PUMP soft button. Confirm the wire is removed and press OK to start the pump and the controller starts in AUTO, which automatically increases the flow rate over 30 seconds.

AUTO increases the flow rate over a period of up to 30 seconds to the maximum possible flow without causing suction.

NOTE: BOOST maximizes the Impella 2.5 or Impella CP Catheter flow for 5 minutes and then returns to the AUTO setting or P-8.

4. Once the controller has begun to run in AUTO, pressing the FLOW CONTROL soft button will open other options: BOOST, P-levels ranging from P-0 to P-8.

5. Wait 30 seconds for flow to reach its maximum value, then confirm correct and stable placement. Evaluate the catheter position in the aortic arch and remove any excess slack. The catheter should align with the lesser curvature of the aorta rather than the greater curvature. Verify placement with fluoroscopy and with the placement signal screen.

6. Reposition the catheter as needed.

7. If the Impella 2.5 or Impella CP Catheter advances too far into the left ventricle and the controller displays a ventricular waveform rather than an aortic waveform, follow these steps to reposition the catheter:

a) With fluoroscopy guidance, pull the catheter back until an aortic waveform is present on the placement screen.

b) When the aortic waveform is present on the placement screen, you may need to pull the catheter back an additional 4 cm. (The distance between adjacent markings on the catheter is 1 cm.) The catheter should now be positioned correctly.

When the Impella 2.5 or Impella CP Catheter is not correctly placed, there is no effective unloading of the ventricle. The patient may not be benefiting from the flow rate shown on the controller.

(continued)

20

Procedure Handling Low Flows or Suction at Start-Up

Follow these steps if the Impella 2.5 and Impella CP Catheter has sudden low flows or suction at startup

1. Obtain Echo to assess for:• LV Thrombus• RV Failure• Hypovolemia

2. If above causes are eliminated, remove the catheter from the patient and ensure that ACT is 250 seconds or above.

3. Replace the Impella pump.

Follow-up Once the patient is on Impella 2.5 and Impella CP heart pump support, refer to Impella 2.5 and Impella CP patient support procedures.


Impella 2.5 or Impella CP Catheters with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

21

Impella 5.0® Catheter Insertion ProcedurePurpose To insert the Impella 5.0 Catheter

Audience Healthcare providers involved in inserting the Impella 5.0 Catheter

Desired Outcomes Impella 5.0 will be successfully implanted and provide hemodynamic support to the patient

Preparation Complete Impella 5.0 Catheter Set-Up Procedure

Alerts • Fluoroscopy is required to guide placement of the Impella 5.0 Catheter. The small placement guidewire must be reliably observed at all times.

• Avoid manual compression of the inlet, outlet, or sensor areas of the cannula assembly.

• Do not kink or clamp any part of the Impella 5.0 Catheter.

• Handle with care. The Impella 5.0 Catheter can be damaged during removal from packaging, preparation, insertion, or removal. Do not bend, pull, or place excess pressure on the Catheter or mechanical components at any time.

• Be sure to remove the placement guidewire before turning the Impella 5.0 Catheter on.

• Maintain ACT 160–180 seconds during support.

• Retrograde flow may occur across the aortic valve, if the Impella 5.0 Catheter is set at a P-level below P-2.

Procedure Inserting the Impella 5.0 Catheter Via Axillary Artery

Action Notes

1. Open sterile Axillary Insertion Kit.

Open sterile Dacron vascular graft

10 mm x 20 cm (not supplied in kit).

Kit contains:• Short 23 Fr peel-away sheath with

hemostatic value• 2 graft locks (to facilitate fixation of 10 mm

vascular graft to sheath)• 8 Fr silicone coated dilator

2. Expose axillary artery in the subclavian fossa. Use proximal and distal vessel loops to obtain control.

3. A longitudinal arteriotomy is fashioned and the 60–70 degree beveled, 10 mm vascular graft is anastomosed to the axillary artery using a standard end-to-side anastomosis.

4. Clamp graft with soft-jawed clamp just above the anastomosis. Loosen the vessel loops to assess for hemostasis at the anastomosis.

5. Flush the sidearm of the peel-away sheath. Insert the provided peel-away sheath into the end of the graft.

(continued)

22

6. Use graft lock(s) to attach the graft to the proximal end of the sheath. If hemostasis is not achieved, press the two tabs together until fully engaged.

Place graft lock between the hub and the retainers to prevent introducer migration.

Graft may also be secured to the introducer using Number 2 sutures or umbilical tape.

7. Remove soft-jawed clamp from graft

8. Insert 0.035" guidewire and 6 Fr diagnostic catheter through the center of the hemostatic valve, of the peel-away sheath, and advance across the aortic valve under fluoroscopic guidance.

9. Exchange the 0.035" guidewire for the supplied 0.018" placement guidewire.

10. Remove the diagnostic catheter, leaving the 0.018" guidewire in place.

11. Clamp the graft, near the anastomosis, using the soft-jawed clamp.

Clamping the graft prevents bleeding through the cannula during initial Impella 5.0 Catheter advancement across the hemostatic valve.

12. Advance silicone-coated dilator over the 0.018" guidewire, into the hemostatic valve, then remove.

Lubrication of the hemostatic valve with silicone facilitates catheter insertion.

13. Advance Impella 5.0 Catheter over the 0.018" guidewire into the sheath.

Ensure soft-jawed clamp is in place to prevent bleeding through the device as it passes through hemostatic valve.

14. Remove the soft-jawed clamp once the motor housing is within the graft.

15. Advance Impella 5.0 Catheter into the left ventricle under fluoroscopic guidance.

16. Remove guidewire prior to starting Impella support.

17. Begin Impella support by increasing P-level on Automated Impella® Controller.

18. Re-apply the soft-jawed clamp to graft above the anastomosis and distal to the tip of the sheath, sealing over the 9 Fr catheter shaft of the Impella 5.0 Catheter.

Ensure a tight seal by opening the sidearm flush valve of the sheath.

19. Remove the graft locks.

20. Withdraw peel-away sheath from graft and peel away.

(continued)

23

21. Shorten the graft as desired. Tighten vessel loops to allow removal of soft-jawed clamp

Shorten graft so that graft material will not be exposed once the incision is closed.

22. Advance the repositioning Unit into the graft and secure, using suture ties along the suture ribs on the proximal end of the Repositioning Sheath.

23. Close the subcutaneous tissue and skin. Secure blue suture wings to the skin.

24. Advance the sterile sleeve and to the repositioning sheath. Secure the Impella 5.0 Catheter by tightening the Tuohy-Borst valve.

Procedure Starting the Impella 5.0 Catheter

Action Notes

1. Press START IMPELLA soft key

2. Turn selector knob to increase the P-level from P-0 to P-2. Press selector knob to confirm selection. Confirm wire has been removed and press OK.

3. Confirm appropriate increase in Impella Flow.

4. Press FLOW CONTROL and turn selector knob with each P-level increase and press selector knob to confirm selection.

5. Evaluate catheter position in the aortic arch and remove any excess slack. Verify placement with fluoroscopy and the Placement Signal Screen.

Follow-up Refer to Patient Care Procedures.


Impella 5.0 or Impella LD Catheters with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

24

Impella LD® Catheter Insertion ProcedurePurpose To insert the Impella LD Catheter

Audience Healthcare providers involved in inserting the Impella LD Catheter

Desired Outcomes Impella LD will be successfully implanted and provide hemodynamic support to the patient

Alerts • Transesophageal Echocardiography (TEE) is required for placement of the Impella LD Catheter.

• It is important to make the incision, in the ascending aorta, 7 cm above the aortic valve so that the Impella LD Catheter can be positioned properly. An incision too close to the aortic valve annulus could result in the catheter outlet area in the graft rather than the aorta.

• The incision must be ≤ 6 mm in length to prevent the front silicone plug from advancing into the aorta through the incision.

Procedure Insertion of the Impella LD Catheter

Action Notes

1. Using the supplied sterile incision template for positioning, place a side biter clamp on the aorta at least 7 cm above the valve plane.

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

3. Attach the Dacron vascular graft (10 mm x 15 cm) to the aorta using the standard end-to-slide anastomosis.

4. Administer Heparin and achieve ACT of at least 250 seconds.

5. When the anastomosis is complete, place a clamp at the distal end of the graft and then release the proximal clamp at the base of the graft. Examine the suture line for leaks and re-clamp the graft at the base.

6. Moisten the Impella LD Catheter and push both silicone plugs up against the motor housing.

7. With the graft clamped at the base, place the Impella LD Catheter into the open end of the graft up to the level of the rear plug.

(continued)

25

8. When the catheter is in position, secure a tourniquet around the rear silicone plug. Tighten the tourniquet sufficiently to control bleeding around the rear plug while still allowing the catheter to slide through the plug.

9. Release the clamp and advance the Impella LD Catheter into the aorta.

10. If the patient is on cardiopulmonary bypass (CPB), 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.

The aortic valve must be opening during the cardiac cycle to allow the Impella LD to pass.

11. As soon as the motor housing has passed into the aorta, the initial placement signal will be dampened. The inlet area of the catheter has not passed the aortic valve. Do not allow the front plug to advance beyond the base of the graft.

12. 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.

13. Gently advance the catheter forward until the tip of the inlet area of the Impella LD Catheter is approximately 4 cm below the aortic valve.

14. Position the front silicone plug as close as possible above the aorta. Secure the silicone plug to the graft using a penetrating suture ligature.

When securing the silicone plug to the graft, ensure that the penetrating suture does not go all the way through the silicone plug and damage the catheter.

15. After achieving correct and stable placement, clear the vascular graft of excess blood and re-secure the rear silicone plug to the end of the graft.

16. When closing the skin incision, the sternum may or may not be closed, per surgeon.

Left heart structures should not be opened when the catheter is in place in the left ventricle.

Do not cross-clamp the aorta when the Impella LD Catheter is in place. The catheter must be pulled back into the descending aorta prior to cross-clamp.

(continued)

26

Procedure Starting the Impella LD Catheter

1. Press START IMPELLA soft key.

2. Turn selector knob to increase the P-level from P-0 to P-2. Press selector knob to confirm selection.

3. Confirm appropriate increase in Impella Flow.

4. Press FLOW CONTROL and turn selector knob with each P-level increase and press selector knob to confirm selection.

5. Evaluate catheter position with echocardiography and the Placement Signal Screen.

Follow-up Refer to Patient Care Procedures.


Impella 5.0 or Impella LD Catheters with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

27

Impella® Purge System Management ProceduresPurpose To maintain the Impella purge system

Audience Healthcare providers involved in the care of patients supported with the Impella Catheter and Automated Impella® Controller

Desired Outcomes Maintain purge system function of the Impella Catheter and Automated Impella Controller

Equipment • Automated Impella Controller

• Additional purge cassettes for the Automated Impella Controller


Preparation Gather supplies prior to beginning Purge System sequence

Alerts When replacing the purge cassette, the process must be completed within 2 minutes. The Impella Catheter may be damaged if replacement takes longer than 2 minutes.

Procedure Change Cassette and Bag

Action Notes

1. Press PURGE MENU and turn the selector knob to select “Change Cassette and Bag” from the menu. Press the selector knob to confirm selection.

2. Follow prompts on the screen: Disconnect luers, then remove cassette and bag.

If the system is in the standard configuration (connected to the 0.9% NaCl bag), disconnect the Y connector from the purge cassette tubing and discard.

3. Spike the D5W bag/bottle with new purge casette then press NEXT soft button.

If the purge solution is supplied in bottles, open the vent on the purge tubing spike and proceed.

4. Insert new cassette as shown on screen. Confirm that the luer is disconnected by pressing the NEXT soft button. Confirm the purge fluid information by pressing CONFIRM or select EDIT to change values.

Open the front door of the controller by pressing button on left side of controller.

Slide the purge cassette transmitter, flat side inward, into place and extend the purge tubing through the gap in door.

The controller will use the default values if no other selections are made.

5. Connect luers when prompted.

6. Press DONE to exit the purge wizard.

(continued)

28

Procedure Change Purge Fluid Bag (Fluid only)

1. Press PURGE MENU and turn the selector knob to select “Change Purge Fluid Bag” from the menu. Press the selector knob to confirm selection.

2. A blue bar shows the progress of the bolus. When the bolus is delivered, the Controller advances to the next screen.

3. Replace the D5W bag/bottle. If the purge solution is supplied in bottles, open the vent on the purge tubing spike and proceed.

4. Enter Purge Fluid Values

• To select default purge fluid values press CONFIRM. Press the selector knob to confirm selection. The controller will advance to the next screen.

• To change purge fluid values: Press EDIT to open options. Scroll to the desired value and press selector knob to confirm value. Continue procedure until all values are selected. Select CONFIRM. The controller will advance to next screen.

The controller will use default values if no other selections are made.

5. Disconnect the luer(s) as directed on the screen to allow the tubing to be primed; once it is completed it will direct the user to re-connect the luer(s).

• To skip flush: Press SKIP PRIME soft button. (Procedure complete.)

It may be helpful to flush fluid through the purge cassette when changing Dextrose concentration or Heparin concentration.

Procedure De-Air the Purge System

Action Notes

1. Press PURGE MENU and turn the selector knob to select “De-air Purge System.” Press selector knob to confirm selection.

2. Confirm that purge fluid bag/bottle is NOT empty or inverted and that tubing is not kinked as directed on the screen.

3. Disconnect the yellow luer of the purge tubing from the Impella Catheter.

4. Confirm that no air remains in the purge tubing. If air remains, press BACK to repeat the air removal process.

5. Connect the yellow luer to the Impella Catheter to complete the de-air procedure.

(continued)

29

Follow-up Impella Heart Pump Purge System change per hospital protocol.


Impella Catheter with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

30

Purpose To transfer patients supported with the Impella 2.5 or Impella CP catheter to care outside the cardiac cath lab

Audience Healthcare providers transitioning patients from the cardiac cath lab to care outside the cardiac cath lab

Desired Outcomes Maintain quality care for Impella 2.5 or Impella CP heart pump–supported patients outside the cardiac cath lab

Equipment • StatLock stabilization device (optional)

• 0.9% NaCl infusion bag with pressure bag and provided standard IV infusion set (for transfer to standard configuration)

Preparation Trained Transport Team in place

Alerts • Completely remove the peel-away introducer from the artery before peeling the wings.

• After 3 hours of operation, if you have not transferred to the standard configuration, the controller displays a message that it has automatically switched to P-level mode. The AUTO setting is no longer an option. Select OK to acknowledge.

Procedure Preparation for Moving the Patient

Action Notes

1. Verify correct Impella 2.5 or Impella CP Catheter position:• Verify correct placement using

echocardiography or fluoroscopy• Remove any excess slack in the catheter

to ensure that the catheter is laying along the lesser curve of the aorta

2. Identify a “landmark” on the red Impella 2.5 or Impella CP device plug and mark that location on the patient using a sterile marker or tape.

You will use this “landmark” to help ensure correct Impella 2.5 or Impella CP Catheter positioning after removal of the repositioning sheath and peel-away introducer.

3. Flush the sidearm of the repositioning sheath and replace the cap.

4. Remove the 13 Fr or 14 Fr or peel-away introducer completely from the artery over the catheter shaft and apply manual pressure above the puncture site.

(continued)

Transferring Impella 2.5® / Impella CP®–Supported PatientTransferring Impella 2.5 or Impella CP–supported patient to care outside the cardiac cath lab

The Impella 2.5 or Impella CP device product labeling acknowledges that situations may arise whereby a patient will need to be transferred from the cath lab to another location (either within the same hospital, or to another institution).

31

5. Grasp the two “wings” and bend back until the valve assembly comes apart. Continue to peel the two wings until the introducer is completely separated from the catheter shaft.

6. Slide the repositioning sheath over the catheter shaft and advance it into the artery to the blue hub.

7. Confirm that the “landmark” on the Impella 2.5 or Impella CP red plug is still aligned with the marking on the patient.

8. Secure the repositioning unit to the patient with the blue suture pads using suture or a StatLock stabilization device.

9. Confirm dead-end cap is on the repositioning sidearm port.

The sideport should not be used to give medication or draw blood due to possible clot formation.Pressure bags should not be connected to the sideport of the repositioning sheath.

10. Attach the anticontamination sleeve to the blue section of the repositioning sheath. Lock the anchoring ring in place by turning it clockwise. Secure the catheter shaft in place by tightening the connected anchoring ring. Be sure to tighten the Tuohy-Borst valve on the Impella 2.5 or Impella CP Catheter to prevent catheter migration.

11. Carefully extend the anticontamination sleeve to maximum length and secure the end closest to the red Impella 2.5 or Impella CP device plug by tightening the anchoring ring.

12. As soon as practical after catheter placement, change the purge fluid to include Heparin (D5W with 50 IU/mL Heparin recommended), if not already done.

Follow the Change Purge Fluid Bag procedure, which is described in the Impella Purge System Management Procedures.

(continued)

Hold here and fully tighten the Tuohy-Borst valve to prevent catheter migration

Impella CP with reaccess sheath shown

32

Procedure Transfer for Standard Configuration

Upon transfer to the standard configuration, the controller will switch to P-level mode and operate at P-8 if previously running in AUTO. If the controller was already in P-level mode at the time of the transfer, it will continue operating at the P-level at which it was operating at the time of the transfer. Once the controller is operating in the standard configuration, AUTO is no longer an option on the flow menu.

Action Notes

1. Press PURGE MENU and turn the selector knob to select “Transfer to Standard Configuration” from the menu. Press the selector knob to confirm selection. Follow the prompts on the screen and press NEXT to begin.

Transition from the initial set-up configuration to the standard configuration (using the NaCl bag) as soon as practical.

2. Set up the sodium chloride (0.9% NaCl) infusion bag with pressure bag using straight tubing without injection ports or transducer.

Pressurize bag to 300–350 mmHg.

3. Clamp the red luer on the Y connector from the red pressure sidearm. Disconnect and end cap the red luer.

4. Create a slow drip from the NaCl pressure bag to flood the luer connector of the red pressure sidearm and make a wet-to-wet connection. Fully open the roller clamp. Press the NEXT soft button.

The controller may alarm during this step.

5. Remove the Y-connector and re-connect yellow to yellow. Press the NEXT soft button. Press the DONE soft button to complete procedure.

You will no longer see the set-up icon on the bottom of the screen.

The advisory alarm message will be gray.

NOTE: When you transfer to the standard configuration, the purge pressure is no longer regulated at 600 mmHg. In standard configuration, purge flow can range from 2–30 mL/hr and purge pressure can range from 300–1100 mmHg.

(continued)

33

Impella 2.5/Impella CP ICU Check-in • Create a Standard of Care around Impella 2.5 and Impella CP ICU Admission Assessments and

Procedures

• Ensure every patient transferred to the ICU is settled in with proper positioning, purge system configuration, and volume status

• Minimize alarms and clinical issues with proactive management

• Call the Clinical Support Center (CSC) at 1-800-422-8666 or your local Abiomed representative to check-in every ICU admission to facilitate assistance with:

• Impella 2.5 or Impella CP ICU Admission Assessment

• Transfer to standard configuration if not done prior to transfer to ICU

• Proper positioning

Impella 2.5/Impella CP ICU Admissions

Assessment

1. Complete an echo to verify Impella 2.5 or Impella CP Catheter position as soon as practical. Ensure the measurement from the Impella 2.5 or Impella CP device inlet to the annulus of the aortic valve is 3.5 cm.

2. Verify that the Tuohy-Borst valve on the Impella 2.5 or Impella CP Catheter is locked to prevent catheter migration.

3. Chart the centimeter marking on the Impella 2.5 or Impella CP Catheter closest to the sheath.

4. If the transfer to the standard configuration is not complete, follow the "Transfer to Standard Configuration" steps.

5. Ensure the roller clamp is completely open on the line to the NaCl pressure bag.

6. Verify that the pressure bag is inflated to 300–350 mmHg.

7. Use a knee immobilizer if needed in accordance with hospital policy.

8. Secure the Impella 2.5 or Impella CP Catheter to the inner aspect of the patient's leg.

9. Chart urinary output and color.

10. Monitor CVP to optimize patient and support device management. Additional volume should be considered if any of the following are observed in the presence of CVP<10 or PCWP (PAD)<10, correct catheter placement, normal right ventricular function.

• Hemolysis as evidenced by hemoglobinuria or elevated plasma-free hemoglobin (PfHgb) levels.

• Suction alarms or evidence of motor current drops indicative of suction events.

• Inability to run at P-levels required for adequate support without suction alarms.

• Lower than expected flows for a given P-level.

(continued)

34

Patient Transfer Call the Clinical Support Center (CSC) at 1-800-422-8666 or your local Abiomed representative:

• To inform Abiomed of patient transfer

• For assistance with preparing for transport

• For assistance with preparing to receive a patient on Impella 2.5 or Impella CP heart pump therapy

Questions Dedicated and highly skilled Clinical Team available 24 hours a day, 7 days a week to provide:

• Technical Support

• Troubleshooting

• Clinical Support

• Device and Controller overview

• Best practice consulting

Clinical Support Center phone system connects you directly to a Clinical Support Specialist, not an operator.

(Call will route to an answering service if all consultant lines are busy.)

Follow-up See Impella 2.5 or Impella CP Patient Care Procedures for post-implant care of Impella 2.5 or Impella CP heart pump–supported patients.



Approval

Effective Date

Revision Date(s)

35

Purpose To transfer patients supported with the Impella 5.0 or Impella LD catheter to care outside the operating room

Audience Healthcare providers transitioning patients from the operating room or cardiac cath lab to another care location

Desired Outcomes Maintain quality care for Impella 5.0 or Impella LD heart pump–supported patients outside the operating room or cardiac cath lab

Equipment • Fully charged Automated Impella® Controller

Preparation Trained Transport Team in place

Alerts • The Automated Impella Controller is designed to operate for 60 minutes on battery power. Transport teams should take this into consideration when planning a transport. If the total transport time is expected to include more than 60 minutes during which the system will be disconnected from AC power, make arrangements to use a vehicle with a built in DC to AC power inverter.

• The Transport Team should include person(s) fully trained in the use of the Automated Impella Controller, Impella 5.0 and Impella LD.

Procedure Preparation and Transfer of the Patient

Action Notes

1. Verify correct Impella 5.0 or Impella LD Catheter position: a) Verify correct position using

echocardiography or fluoroscopy. b) Remove slack from Impella 5.0 catheter

to ensure that the catheter is laying along the lesser curve of the aorta.

2. Flush the sidearm of the repositioning sheath, of the Impella 5.0 and cap.

3. Make sure there is no bleeding at the transition from the repositioning sheath of the Impella 5.0 Catheter to the graft. Close and dress the wound.

4. Secure the repositioning unit by suturing it to the skin using the blue suture pads.

Transferring Impella 5.0®/Impella LD®–Supported PatientTransferring Impella 5.0 or Impella LD–supported patient to care outside the operating room

The Impella 5.0 or Impella LD device product labeling acknowledges that situations may arise whereby a patient will need to be transferred to another location (either within the same hospital, or to another institution).

(continued)

36

5. Attach the anticontamination sleeve to the repositioning sheath. Lock it in place by turning it clockwise.

6. Tighten the Tuohy-Borst valve on the Impella 5.0 to prevent catheter migration.

7. The Impella Automated Controller should be fully charged prior to transport.

The Automated Impella Controller, Impella 5.0 and Impella LD have been cleared by the FDA for Hospital-to-Hospital transport via ambulance, helicopter, or fixed-wing aircraft.

8. DO NOT stress the connector cable from the Controller to the Impella 5.0/Impella LD Catheter.

9. Carefully monitor purge pressures during changes in altitude.

10. The Automated Impella Controller should be positioned to allow easy access to the display screen to view alarms and make any necessary changes.

(continued)

37

Impella 5.0/Impella LD ICU Check-in

• Create a Standard of Care around Impella 5.0 and Impella LD ICU Admission Assessments and Procedures

• Ensure every patient transferred to the ICU is settled in with proper positioning

• Minimize alarms and clinical issues with proactive management

• Call the Clinical Support Center (CSC) at 1-800-422-8666 or your local Abiomed representative to check-in every ICU admission to facilitate assistance with:

• Impella 5.0 or Impella LD ICU Admission Assessment

• Proper positioning

Impella 5.0/Impella LD ICU Admissions

Assessment

1. Complete an echo, as soon as practical, to verify Impella 5.0 or Impella LD Catheter position.

2. Verify that the Tuohy-Borst valve on the Impella 5.0 Catheter is locked.

3. Chart the centimeter marking on the Impella 5.0 or Impella LD Catheter

4. Chart urinary output and color.

5. Monitor CVP to optimize patient support and device management. Additional volume should be considered if any of the following are observed in the presence of CVP <10 or PCWP (PAD) <10, correct catheter placement, normal right ventricular function.

• Hemolysis as evidenced by hemoglobinuria or elevated plasma-free hemoglobin (PfHgb) levels.

• Suction alarms or evidence of motor current drops, indicative of suction events.

• Inability to run at P-levels required for adequate support without suction alarms.

• Lower than expected flows for a given P-level.

Patient Transfer Call the Clinical Support Center (CSC) at 1-800-422-8666 or your local Abiomed representative:

• To inform Abiomed Team of patient transfer

• For assistance with transport preparation

• For assistance with receiving a patient supported with Impella 5.0/Impella LD therapy

Clinical Support Center

1-800-422-8666

Dedicated and highly skilled clinical team available 24 hours/day to provide:

• Technical support

• Troubleshooting

• Clinical support

• Device and controller overview

• Best practice consulting

Clinical Support Center phone system connects you directly to a clinical support specialist, not an operator (Call will route to an answering service if call specialist lines are busy).

Follow-up See Impella 5.0/Impella LD Patient Care Procedures for post-insertion care of the Impella 5.0/Impella LD heart pump–supported patients.

References Impella 5.0 or Impella LD Catheter with Automated Impella Controller Instructions for User Manuals

38

Purpose To care for a patient supported with the Impella 2.5 or Impella CP Catheter when unable to be weaned after Protected PCI procedures

Audience Healthcare providers involved in the post-implant care of patients supported with the Impella 2.5 or Impella CP Catheter

Desired Outcomes Proper post-implant care for all patients supported with the Impella 2.5 or Impella CP Catheter

Equipment Various hospital equipment; as described below

Preparation Gather supplies prior to patient arrival

Alerts • Patient care to be managed by attending cardiologist or cardiac surgeon, as per hospital policy

• Notify physician or Heart Team as appropriate of any changes in patient status and any Impella 2.5 or Impella CP Catheter or Automated Impella® Controller issue

Orders Documentation Guidelines

Action Notes

1. Initially and throughout Impella 2.5/ Impella CP heart pump support, assess and document:

• Hemodynamics (every 15 minutes for first hour, every 30 minutes for second hour, and then hourly when clinically stable)

2. Initiate Impella 2.5 or Impella CP heart pump support electronic or paper Flowsheet. Document parameters hourly during Impella 2.5 or Impella CP support.

Parameter Expected values Notes

Impella flow 1.1–2.5 L/min (Impella 2.5)

1.7–3.7 L/min (Impella CP)

Flow rate can vary due to suction or incorrect positioning

Motor current Variable

Purge flow rate 2–30 mL/hr

Purge pressure 300–1100 mmHg

Purge infusion volume Variable; see Infusion History screen

Heparin dosing Variable; see Infusion History screen

Purge D5W dose Variable; see Infusion History screen

Impella 2.5®/Impella CP® Patient Care Procedures

(continued)

39

3. Document ACT and Heparin dose

• In cardiac cath lab, maintain ACT at 250 seconds during Impella insertion and per procedural guidelines.

• Outside the cardiac cath lab, maintain ACT between 160–180 seconds.

4. Document position of Impella 2.5/ Impella CP Catheter at insertion site using centimeter markings on the Impella 2.5/ Impella CP Catheter.

5. Document urine output and color.

6. Document vascular assessment, per hospital protocol

• Include ABI

• Pre-insertion (when available)

• Upon arrival to the ICU

• Doppler or palpable pulses

• During support and post removal

7. Document laboratory testing results per hospital protocol:

• PTT

• CBC

• Complete metabolic panel

• Plasma-free hemoglobin (PfHgb)

• Liver enzymes

Reason for PfHgb: To evaluate for hemolysis.No need to duplicate tests found on other order sets.

Orders Patient / Impella 2.5 or Impella CP Catheter Care

Action Notes

1. Complete bed rest.

2. Head of bed at or below 30 degrees.

3. Moving the patient:

a) Be careful not to pull on the Impella 2.5 or Impella CP Catheter when transferring a patient from one bed to another.

b) Patient may be log-rolled.

c) Do NOT torque chest or hips.

Use care when moving the patient because the Impella 2.5/ Impella CP Catheter could move out of position and cause a positioning alarm.When log-rolling the patient, ensure you do not damage the infusion filter or pressure reservoir on the sidearm of the red Impella 2.5 or Impella CP device plug.

(continued)

40

4. Immobilize affected leg; use knee immobilizer if needed, per hospital protocol.

5. Bladder catheter recommended for all patients unless contraindicated.

6. For the red placement monitoring sidearm on the Impella 2.5 or Impella CP device:

• Maintain pressure bag at 300–350 mmHg.

• Change solution per hospital protocol.

The red sidearm of the Impella 2.5 or Impella CP Catheter is used to flush the line of the placement signal.

7. Do NOT use or infuse any solution into the white sidearm of the repositioning unit of the Impella 2.5 or Impella CP Catheter.

8. To prevent kinking in the purge tubing:

• Do NOT allow the red Impella 2.5 or Impella CP device plug to hang freely from the catheter.

• Do NOT bend the catheter near the red Impella 2.5 or Impella CP device plug.

• May attach the red Impella 2.5 or Impella CP device plug and catheter to a short armboard to prevent kinking near the plug.

9. Dressing change:

• Sterile dressing change of femoral insertion site per hospital protocol and if dressing integrity becomes compromised or site appears wet.

• Use chlorhexidine (no ointment) and transparent non-gauze dressing.

• Use additional staff to stabilize catheter and monitor Impella 2.5 or Impella CP device position throughout dressing change.

Do NOT clean the Impella 2.5 or Impella CP Catheter infusion filter or pressure reservoir with alcohol and AVOID exposing these components to products, such as skin preps and lotions, containing alcohol. Alcohol may cause cracks in the luer fitting connecting the clear sidearm components, resulting in leaking.

(continued)

41

Orders Impella 2.5 or Impella CP Positioning

Action Notes

The distal tip of the Impella 2.5 or Impella CP Catheter must be in the left ventricle. When the catheter is positioned correctly, the placement signal waveform will be aortic and the motor current waveform will be pulsatile (similar to image on the right).

If the distal tip of the Impella 2.5 or Impella CP Catheter becomes displaced:

• Reduce flow rate to P-2.

• Notify physician or Heart Team as appropriate.

• Obtain Echo STAT.

(continued)

42

Orders Automated Impella Controller

Action Notes

Do NOT use the Automated Impella Controller placement signal for patient management. Use the arterial line or non-invasive cuff blood pressure.

Maintain Impella 2.5 or Impella CP device flow to achieve target hemodynamics. Do NOT reduce flow below P-2.

P-levels below P-2 may result in retrograde flow.

Assure that patient has adequate supply of purge cassettes for purge system changes before cardiac cath lab closes for the evening or weekend.

Refer to Impella Purge System Management Procedures.

Automated Impella Controller management:

• Have back-up controller plugged in close to patient room

• Controller will operate on battery power for 60 minutes if batteries are fully charged

• Press and hold the power switch for 30 seconds for Emergency Shut Down, if necessary

Procedure Impella 2.5 / Impella CP Chest Compressions and Defibrillation

Action Notes

1. Chest compression and defibrillation may be administered during Impella 2.5 or Impella CP support when necessary.

2. Impella 2.5 or Impella CP Catheter or Controller do not need to be turned off (stopped at P-0) or unplugged to defibrillate the patient.

3. Reduce P-level to P-2 prior to and during chest compressions.

4. When cardiac function has been restored, assess Impella 2.5 or Impella CP Catheter position using placement signal waveform on Controller or Echo, then return to previous P-level.

Follow-up Abiomed 24-hour Clinical Support Center (CSC): 1-800-422-8666.


Impella 2.5 and Impella CP Catheter with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

43

Purpose To care for a patient supported with the Impella 5.0 or Impella LD Catheter when unable to be weaned after Protected PCI procedures

Audience Healthcare providers providing post-implant care of patients supported with the Impella 5.0 or Impella LD Catheter

Desired Outcomes Proper post-op care for all patients supported with the Impella 5.0 or Impella LD Catheter

Equipment Various hospital equipment; as described below

Preparation Gather supplies prior to patient arrival

Alerts • Patient care to be managed by attending cardiologist or cardiac surgeon, per hospital policy

• Notify physician or Heart Team as appropriate of any changes in patient status and any Impella 5.0 or Impella LD Catheter or Automated Impella® Controller issue

Orders Documentation Guidelines

Action Notes

1. Initially and throughout Impella 5.0 or Impella LD heart pump support, assess and document:

• Hemodynamics (every 15 minutes for first hour, every 30 minutes for second hour, and then hourly when clinically stable)

2. Initiate Impella 5.0 or Impella LD heart pump support electronic or paper Flow Sheet. Document parameters hourly during Impella 5.0 or Impella LD support.

Parameter Expected values Notes

Impella flow 1.4–5.3 L/min (Impella 5.0)

1.4–5.3 L/min (Impella LD)

Flow rate can vary due to suction or incorrect positioning.

Motor current Variable

Purge flow rate 2–30 mL/hr

Purge pressure 300–1100 mmHg

Purge infusion volume Variable; see Infusion History screen

Heparin dosing Variable; see Infusion History screen

Purge D5W dose Variable; see Infusion History screen

Impella 5.0®/Impella LD® Patient Care Procedures

(continued)

44

3. Document ACT and Heparin dose

a) During insertion, maintain ACT at 250 seconds and per procedural guidelines.

b) Post-implant, maintain ACT between 160–180 seconds.

4. Document position of Impella 5.0 or Impella LD at femoral, axillary, or direct insertion site using catheter centimeter markings.

5. Document urine output and color.

6. Document vascular assessment, per hospital protocol, distal to insertion site

a) Include ABI

b) Pre-insertion (when available)

c) Upon arrival to the ICU

d) During support and post removal

7. Document laboratory testing results per hospital protocol:

a) PTT

b) CBC

c) Complete metabolic panel

d) Plasma-free hemoglobin (PfHgb)

e) Liver enzymes

Reason for PfHgb: To evaluate for hemolysis. No need to duplicate tests found on other order sets.

Orders Patient/Impella 5.0 or Impella LD Care

Action Notes

1. Complete bed rest with Impella 5.0 femoral artery insertion.

2. Head of bed at or below 30 degrees for Impella 5.0 femoral artery insertion.

3. Moving the patient:

a) Be careful not to pull on the Impella 5.0 or Impella LD Catheter when transferring a patient from one bed to another.

b) Patient may be log-rolled.

c) Do NOT torque chest, hips, or arm.

(continued)

45

4. For femoral artery insertion, immobilize affected leg using knee immobilizer.

Use per hospital protocol.

5. Bladder catheter recommended for bed rest patients unless contraindicated.

6. DO NOT use or infuse any solution into the white sidearm of the repositioning sheath of the Impella 5.0 Catheter.

7. To prevent kinking in the purge tubing:

• DO NOT allow the red Impella 5.0 or Impella LD device plug to hang freely from the catheter.

• DO NOT bend the catheter near the red plug.

• May attach the red plug of the Impella 5.0 or Impella LD Catheter to a short arm board to prevent kinking.

8. Dressing change:

• Sterile dressing change of insertion site per hospital protocol and if dressing integrity becomes compromised or site appears wet.

• Use chlorhexidine (no ointment) and transparent non-gauze dressing.

• May use additional staff to stabilize catheter and monitor position during dressing change.

DO NOT clean the Impella 5.0 or Impella LD Catheter infusion filter or pressure reservoir with alcohol and AVOID exposing these components to products, such as skin preps and lotions, containing alcohol. Alcohol may cause cracks in the luer fitting, resulting in leaking.

(continued)

46

Orders Impella 5.0 or Impella LD Positioning

Action Notes

The distal tip of the Impella 5.0 or Impella LD must be in the left ventricle. When positioned correctly, the placement signal (Differential Pressure) and Motor Current Waveform will be pulsatile

If the distal tip of the Impella 5.0 or Impella LD Catheter becomes displaced:

• Reduce P-level to P-2

• Notify physician or Heart Team as appropriate STAT

• Obtain Echo STAT

Orders Automated Impella Controller

Maintain Impella 5.0 or Impella LD device flow to achieve target hemodynamics. Do not reduce P-level to level below P-2.

P-levels below P-2 may result in retrograde flow.

Assure that patient has adequate supply of purge cassettes for purge system changes.

Refer to Impella 5.0 or Impella LD device purge system management procedures

Automated Impella Controller management:

• Have back-up controller plugged in close to patient room

• Controller will operate on battery power for 60 minutes if batteries are fully charged

• Press and hold the power switch for 30 seconds for Emergency Shut Down, if necessary

Procedure Impella 5.0 / Impella LD Chest Compressions and Defibrillation

Action Notes

1. Chest compression and defibrillation may be administered during Impella 5.0 or Impella LD support when necessary.

2. Impella 5.0 or Impella LD Catheter or Controller do not need to be turned off (stopped at P-0) or unplugged to defibrillate the patient.

3. Reduce P-level to P-2 prior to and during chest compressions.

4. When cardiac function has been restored, assess Impella 5.0 or Impella LD Catheter position using placement signal waveform on Controller or Echo, then return to previous P-level.

Follow-up Abiomed 24-hour Clinical Support Center (CSC): 1-800-422-8666.

References (Supportive

Data)

Impella 5.0 or Impella LD Catheter with Automated Impella Controller Instructions for Use Manuals

Approval

Effective Date

Revision Date(s)

47

Impella® Catheter Weaning Procedures

Purpose To wean Impella–supported patient in preparation for Impella Catheter removal

Audience Healthcare providers involved in weaning procedure for Impella Catheter

Desired Outcomes Patient will remain hemodynamically stable throughout weaning procedure

Equipment Equipment in place

Preparation Multidisciplinary decision to proceed with weaning procedure

Alerts The following weaning instructions are provided as guidance only

Procedure Weaning

Action Notes

1. To initiate weaning, press FLOW CONTROL. Turn selector knob to reduce P-level by 2-level increments over time intervals as cardiac function allows. Press selector knob to confirm selections.

2. Maintain Impella Catheter P-level at P-2 or above until the catheter is ready to be removed from the left ventricle.

3. If the patient's hemodynamics remain stable, reduce the P-level to P-1 and pull the Impella Catheter across the aortic valve into the aorta.

4. If the patient's hemodynamics continue to remain stable, follow instructions for removing the Impella Catheter.

Follow-up Remove Impella Catheter after weaning successfully completed.

References Impella Catheter with Automated Impella Controller Instructions for Use Manuals

NOTE: The Impella 2.5® and Impella CP® Catheters are approved for use for periods of up to 6 hours in patients undergoing Protected PCI. The Impella 2.5 and Impella CP Catheters, in conjunction with the Automated Impella® Controller, are indicated for use for periods of up to 4 days in the treatment of ongoing cardiogenic shock. However, the Instructions for Use manuals recognize that the devices might be used for longer durations at the discretion of the physician due to unforeseen circumstances.

The Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella Controller, are indicated for use for periods of up to 6 days in the treatment of ongoing cardiogenic shock. However, the Instructions for Use manuals recognize that the devices might be used for longer durations at the discretion of the physician due to unforeseen circumstances.

48

Impella 2.5®/Impella CP® Catheter Explant ProceduresPurpose To explant the Impella 2.5 or Impella CP Catheter

Audience Healthcare providers involved in explanting the Impella 2.5 or Impella CP Catheter

Desired Outcomes Patient maintains adequate hemodynamics

Equipment None for manual compression

Compression assist devices (optional)

Preparation Patient must be weaned to P-level of P-2 prior to explanting the Impella 2.5 or Impella CP Catheter. (Refer to the Impella 2.5 or Impella CP Catheter Weaning Procedure.)

Alerts Control bleeding at arteriotomy site during the explant procedure

Procedure Removing the Impella 2.5 or Impella CP Catheter with the Introducer in Place

Action Notes

1. Wean the patient by following the Weaning Procedure.

2. Pull Impella catheter across Aortic Valve at P-level of P-1.

The controller will alarm.

3. Once the Impella 2.5 or Impella CP device is out of the left ventricle, reduce the P-level to P-0.

4. Remove the Impella 2.5 or Impella CP Catheter through the introducer.

5. Disconnect the connector cable from the Automated Impella Controller and turn the controller off.

Press the black power switch on the right side of the Automated Impella Controller for 3 seconds to turn the controller off.

6. Wait until ACT drops below 150 seconds.

7. When ACT is below 150 seconds, remove the introducer.

8. Apply direct pressure with fingers positioned over and proximal to the arteriotomy site, while maintaining a faint distal pulse. Duration: 40 minutes or per hospital protocol.

Maintain consistent pressure as inconsistent pressure can lead to formation of hematoma.

For patients requiring prolonged pressure, a mechanical compression device can be used per hospital protocol.

(continued)

49

Procedure Removing the Impella 2.5 or Impella CP Secured with the Repositioning Sheath

Action Notes

1. Wean the patient by following Weaning Procedure.

2. Leave the Impella 2.5 or Impella CP Catheter in the ventricle at a P-level of P-2 until ACT drops below 150 seconds or reduce the P-level to P-1, pull the Impella 2.5 or Impella CP Catheter into the aorta (approximately 30 to 40 cm), and wait until the ACT drops below 150 seconds.

3. When the ACT is below 150 seconds, reduce the P-level to P-0.

4. Remove the Impella Catheter and repositioning sheath together.

The Impella Catheter will NOT come through the repositioning sheath.

5. Disconnect the connector cable from the Automated Impella Controller and turn the controller off.

Press the black power switch on the right side of the Automated Impella Controller for 3 seconds to turn the controller off.

6. Apply manual compression for 40 minutes or per hospital protocol.

Maintain consistent pressure as inconsistent pressure can lead to formation of hematoma.

For patients requiring prolonged pressure, a mechanical compression device can be used per hospital protocol.

Follow-up Per hospital protocol.



Approval

Effective Date

Revision Date(s)

50

Impella 5.0® Catheter Explant ProcedurePurpose To explant the Impella 5.0 Catheter

Audience Healthcare providers involved in explanting the Impella 5.0 Catheter


Equipment Institutional supplies for explant via femoral or axillary artery and graft closure procedure (Impella 5.0)

Preparation • Transport patient to Operating Room suite

• Patient must be weaned to P-level of P-2 prior to explanting the Impella 5.0 Catheter

Alerts • The Impella 5.0 Catheter should only be removed when the P-level is set to P-0

• Perform the following steps under fluoroscopy guidance

Procedure Removing The Impella 5.0 Catheter

Action Notes

1. Gain exposure and clear access to the femoral or axillary artery insertion site.

2. If the patient's hemodynamics remain stable, decrease the P-level to P-1.

3. Pull the Impella 5.0 Catheter across the aortic valve into the aorta.

4. Stop the motor by decreasing the P-level to P-0.

5. Explant the Impella 5.0 Catheter. Removal of the Impella 5.0 Catheter must be completed with care to avoid damage to the Catheter assembly.

6. Disconnect the connector cable from the Automated Impella® Controller by pressing the black power switch on the right side for 3 seconds.

7. Follow institutional guidelines for femoral artery closure or axillary graft closure.

51

Impella LD® Catheter Explant ProcedurePurpose To explant the Impella LD Catheter

Audience Healthcare providers involved in explanting the Impella LD Catheter


Equipment Institutional supplies for explant via ascending aortic graft and graft closure procedure

Preparation • Transport patient to Operating Room suite

• Patient must be weaned to P-level of P-2 prior to explanting the Impella LD Catheter

Alerts • The Impella LD Catheter should only be removed when the P-level is set to P-0

• Perform the following steps under Transesophageal Echocardiography (TEE) guidance

Procedure Removing the Impella LD Catheter

Action Notes

1. Gain exposure and clear access to the ascending aorta insertion site, the Dacron vascular graft, and the sites at which the silicone plugs are secured to the graft.

2. Undo the penetrating suture from the front silicone plug and remove the suture entirely.

3. Remove the ligature from the rear silicone plug and remove the plug from the end of the vascular graft.

4. Maintaining distal control digitally, remove the final circumferential ligature from the front silicone plug.

5. Allow controlled bleed-back through the graft to clear any residual thrombus from the lumen of the graft.

6. Immediately reduce the P-level to P-1.

7. Carefully pull the Impella LD Catheter back through the aortic valve and into the ascending aorta.

Depending on the level of the insertion site, a portion of the catheter may be pulled through the aortotomy and into the vascular graft.

8. Immediately reduce the P-level to P-0.

9. Gently pull the Impella LD Catheter through the aortotomy and into the vascular graft.

10. Explant the Impella LD Catheter.

11. Disconnect the connector cable from the Automated Impella® Controller and turn Controller off by pressing the black power switch on the right side for 3 seconds.

12. Close the vascular graft.

53

Impella® Skills Evaluation Worksheets

Impella 2.5 and Impella CP Setup and Insertion

Impella 2.5 / Impella CP / Impella 5.0–Patient Management

Impella 5.0 Setup and Insertion

54

Impella 2.5® and Impella CP® Setup and Insertion

This form provides an observation checklist of the trainee’s knowledge and skill for insertion of the Impella 2.5 and Impella CP Heart Pumps. Please provide your acknowledgment signature when complete.

Hospital: Date of Training:

Trainee: ABIOMED Trainer(s):

Reviewed and Understood

INSERTION, PLACEMENT, AND MANAGEMENT(Cath Lab or Procedure Suite) YES NO Not Evaluated

Power on Automated Impella Controller by pressing the On/Off button on the right hand side of the console for three seconds

Circulator should hand off purge cassette, sterile white cable, introducer kit and Impella catheter to scrub table

Scrub: Hand off spike and purge cassette to circulatorCirculator: Press START NEW CASE. Spike dextrose bag and press NEXT. Insert purge cassette into the AIC; AIC will automatically prime purge tubing

Scrub: Connect white connector cable to Impella plug and hand off other end to circulator. Ensure purge sidearm is secured to the connector cable.Circulator: Plug white cable into the AIC; AIC will automatically detect catheter

Scrub: Connect luers, yellow to yellow, red to red; AIC automatically de-airs purge lumen. When prompted, squeeze the flush valve for 10 seconds until console beepsCirculator: Enter purge fluid information and select DONE

Dilate and prepare the femoral artery for atraumatic insertion by using the sequence of dilators (8, 10, and 12 Fr) prior to inserting the 13 Fr (Impella 2.5) or 14 Fr (Impella CP) peel-away introducer

Verify ACT ≥ 250 seconds prior to dilator removal from sheath

Place a gentle J on the soft portion of the 0.018” guidewire. Insert diagnostic catheter with 0.035” guidewire through sheath and across the aortic valve; Remove 0.035” guidewire and replace with 0.018” guidewire. Advance the 0.018” guidewire into the apex of the left ventricle

Remove the diagnostic catheter

Backload the Impella catheter on the 0.018” guidewire

Advance the Impella catheter carefully by making short advances through the sheath to prevent catheter kinking

Place the pump across aortic valve with the mid-inlet approximately 3.5 cm below the valve

Remove the wire before turning on the pump

55

Impella 2.5 and Impella CP Setup and Insertion (continued)


INSERTION, PLACEMENT, AND MANAGEMENT(Cath Lab or Procedure Suite) YES NO Not Evaluated

Press START IMPELLA soft button, confirm that the wire is removed by pressing the YES soft button to initiate support

Use fluoro during ramp up of support to visualize possible pump migration; reposition if necessary

Use display screens and waveforms to verify catheter position

Secure the catheter in place

Resolve all alarms that occur during support

Review evaluation for explant: look for signs of native heart function such as stable AoP and CVP, native ejections visible on patient pressure monitor, pronounced aortic valve opening by echo

Follow proper weaning procedures • Decrease 2 P-levels as patient tolerates hemodynamically• Decrease to P-1 and pull the device out of the LV under fluoro• Turn the device off • Remove the Impella slowly through the peel away

Ensure catheter is properly removed and pump turned off

PREPARATION FOR TRANSITION TO ICU/CCU YES NO Not Evaluated

Review recommendations for transfer to standard configuration (see purge wizard below)

Use the repositioning sheath if patient is headed for ICU/CCU• Flush the repositioning sheath• Have scrub assistant hold pressure over the insertion site• Remove the peel away sheath completely from the arteriotomy site • Crack and peel away• Insert the repositioning sheath into the arteriotomy site

Remove slack under fluoro by pulling Impella Catheter back until it starts to move across the aortic valve. Catheter should be along inner curvature of aorta. Check entire length of catheter with fluoro.

Secure Tuohy-Borst to repositioning sheath to lock sheath to Impella Catheter

Secure the blue suture wings via sutures or Stat-Lock to patient’s leg without changing the catheter position

Secure remainder of Impella Catheter to the inside of the patient’s leg

56


Purge Wizards Reviewed and Understood

CHANGE PURGE FLUID BAG YES NO Not Evaluated

Press the PURGE MENU soft button, highlight and select Change Purge Fluid Bag

Gather supplies necessary as noted on screen and press the START soft button

When prompted, remove the previous fluid bag and spike with new bag, press NEXT

Confirm the purge fluid values; select CONFIRM if accurate or select EDIT to change

If purge fluid values remain the same, press the DONE soft button to confirm completion of purge wizard

If purge fluid changes, disconnect the yellow luer when prompted to prime the tubing

Reconnect yellow luer after priming is completed and press the DONE soft button to confirm completion of the purge wizard

CHANGE CASSETTE AND BAG YES NO Not Evaluated

Press the PURGE MENU soft button, highlight and select Change Cassette and Bag


When prompted, disconnect the yellow luer from the Impella catheter

Open the purge door and remove and discard the used purge cassette

Spike the new purge fluid bag with the new purge cassette

Insert new purge cassette, confirming that the yellow luer remains disconnected


Connect the yellow luer after priming is completed and press the DONE soft button to confirm completion of the purge wizard


Press the PURGE MENU soft button, highlight and select Change De-Air Purge System

Ensure that the purge tubing is not kinked and that the purge fluid bag is not inverted or empty and press the NEXT soft button


Confirm the purge tubing is free of air and press the NEXT soft button

Connect the yellow luer and press the DONE soft button to confirm completion of the purge wizard

57



TRANSFER TO STANDARD CONFIGURATION YES NO Not Evaluated

Press the PURGE MENU soft button, highlight and select Transfer to Standard Configuration


Spike normal saline bag with IV tubing and prime until free of air bubbles

Pressurize saline bag to 300–350 mmHg

Clamp and disconnect the red luer from the red sidearm; flood the red sidearm with saline from the pressure bag to make a wet-to-wet connection; fully open the roller clamp on the IV tubing and press the NEXT soft button

Remove Y-connector as shown on screen and connect yellow luer directly to Impella catheter and press the NEXT soft button

Press the DONE soft button to confirm completion of the purge wizard

Additional Comments:

Trainee Signature Date

Trainer(s) Signature Date

58

Impella 2.5®/ Impella CP®/ Impella 5.0–Patient Management

This form provides an observation checklist of the trainee’s knowledge and skill for managing a patient with the Impella 2.5 and Impella CP and Impella 5.0 Heart Pumps. Please provide your acknowledgment signature when complete.




ICU CHECK-IN YES NO Not Evaluated

Recommend an echo to verify Impella Catheter position

Verify the Tuohy-Borst valve is tight

Switch to standard configuration; Ensure the roller clamp is completely open on the saline line and the saline pressure bag is inflated to 300–350 mmHg (Impella 2.5 and Impella CP only)

Access site should be secured while still maintaining insertion angle

Consider a knee immobilizer to prevent unwanted movement

Secure the Impella catheter to the inside of the patient’s leg (not on top or outside of leg), if not already complete

Maintain ACT at 160–180 seconds during support

Assess volume status

Chart urine output

Monitor distal perfusion

Review the Clinical Support Center as a 24/7 resource: 800-422-8666

TROUBLESHOOTING ALARMS:

"IMPELLA POSITION WRONG" YES NO Not Evaluated

Reduce to P-2

Determine Impella position with TTE, TEE, or fluoro (echo preferred); Impella mid-inlet should be approximately 3.5 cm below the aortic valve annulus

Loosen Tuohy-Borst valve prior to repositioning

Use placement signal and motor current as position indicators

Verify pulsatile motor current after repositioning

Under echo return to previous P-level setting; tighten Tuohy-Borst valve after complete

59

Impella 2.5 / Impella CP / Impella 5.0–Patient Management (continued)


"PLACEMENT SIGNAL LUMEN BLOCKED" (IMPELLA 2.5/IMPELLA CP ONLY) YES NO Not Evaluated

Check that the roller clamp on the saline pressure bag is open

Verify pressure in bag is 300–350 mmHg

If necessary, close the roller clamp and disconnect the IV from the red luer; do NOT grip the white flush valve when trying to disconnect the IV

Attach a 20 mL syringe to the red luer, squeeze the white flush valve and aspirate until 1 to 2 mL of blood is pulled into the syringe

Remove the syringe and discard contents

Hold the red luer on the upright and open the roller clamp of the IV pressure bag slightly to flood with saline while reconnecting, ensuring there is no air introduced into the system and ensuring the roller clamp is completely open

Squeeze or pinch the white flush valve side-to-side to flush

If still unable to get proper placement signal waveform, use the motor current waveform to ensure proper positioning across the aortic valve

NOTE: The Impella Catheter will still function properly without the placement signal.

"LOW PURGE PRESSURE" (Purge Pressure < 300 mmHg and Purge Rate 30 mL/hr) YES NO Not Evaluated

Check for leaks and/or loose connections in the (1) purge cassette (2) yellow luer connection to the Y-connector (Impella 2.5 and Impella CP only), (3) yellow luer connection to the purge sidearm, or (4) purge sidearm

Check the yellow check valve, pressure reservoir and infusion filter for leaks

If no leaks are visualized, open the PURGE MENU and select “Change Purge Fluid Bag.” Follow the instructions on the screen and change the purge fluid to D20W with the same heparin concentration.

Change purge cassette, if leaking. To change the purge cassette, open the PURGE MENU and select “Change Cassette and Bag.” Follow the instructions on the screen to change the purge cassette.

Monitor the motor current for any upward trends in motor current. Consider replacing the Impella Catheter whenever a rise in motor current is seen.

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"HIGH PURGE PRESSURE" OR "PURGE SYSTEM BLOCKED" (Purge Pressure > 1100 mmHg and Purge Rate ≤ 2 mL/hr) YES NO Not Evaluated

Check for kinks in (1) purge tubing, (2) purge sidearm, (3) catheter shaft

Make sure the plastic clip on the pressure reservoir of the purge sidearm is snapped to the connector cable such that the purge sidearm is not kinked

If running higher than D5W, decrease the dextrose concentration. Open the PURGE MENU and select “Change Purge Fluid Bag.” Follow the instructions on the screen and change the purge fluid.

Change the purge cassette. Open PURGE MENU and select “Change Purge Cassette.” Follow the instructions on the screen and change the purge cassette.

Monitor the motor current for any upward trends in motor current. Consider replacing the Impella Catheter whenever a rise in motor current is seen.

"IMPELLA FLOW REDUCED" OR "SUCTION" YES NO Not Evaluated

The main causes of suction are: (1) low volume (preload), (2) incorrect Impella position and (3) RV failure

In AUTO mode (Impella 2.5 and Impella CP only)• “Impella Flow Reduced” white advisory alarm

- If the controller detects suction it displays this alarm and automatically reduces motor speed to reduce flow

• “Suction” audible yellow alarm- If suction is still detected at the lowest motor speed, the controller displays

this alarm

In P-level• “Suction” audible yellow alarm

- If suction is detected, the controller displays this alarm• Reduce Performance level by 1-2 P-levels until suction is broken• Consider giving volume if CVP or PCWP (PAD) < 10 mmHg • Check placement of the Impella Catheter• Perform echo (parasternal long axis (TTE) or long axis (TEE)) for positioning; the

mid-inlet area should be approximately 3.5 cm below the aortic valve annulus• Reposition the Impella Catheter; it should be floating freely in the mid-

ventricular space• Assess RV function when using echo for repositioning; RV dysfunction can

contribute to low preload• Hyperdynamic left ventricular contractility can result in competition for volume

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"IMPELLA STOPPED" YES NO Not Evaluated

If alarm indicates Controller Failure, switch to backup controller

If alarm does not indicate Controller Failure, immediately try to restart pump at previous setting

If restart fails, wait 1–2 minutes and try to restart again at P-2

If after several attempts you cannot restart the Impella Catheter, pull it back into the aorta as soon as possible to avoid aortic regurgitation

Replace the Impella Catheter

If able to restart pump, assess patient ability to be weaned, as pump failure may occur again

TROUBLESHOOTING: HEMATURIA/HEMOLYSIS YES NO Not Evaluated

Evaluate P-level and associated flow. If flow is less than expected for given P-level, check volume status/preload. Consider giving volume if CVP or PCWP (PAD) <10 mmHg.

If flows and volume status are within proper range, check positioning; Call for echo (parasternal long axis for TTE, long axis for TEE)

Evaluate position of Impella: should be in the mid-ventricular cavity toward the apex and away from the mitral chordae, papillary muscle, and septum

Measure distance from the aortic valve annulus to mid-inlet area or artifact area within ventricle (should be no more than 3.5 cm)

If caught behind papillary muscle, pull Impella back until pigtail releases from papillary muscle; torque toward apex and advance into LV under echo guidance until the mid-inlet area is approximately 3.5 cm from the aortic annulus. Tighten Tuohy.

If urine is still red in 1-2 hours, this could be longer depending on patient's renal status, reposition pump again

Rule out non-device related causes

WEANING AND REMOVAL YES NO Not Evaluated

Reduce P-level by 2 level increments over time intervals as cardiac function allows. Maintain support at P-2 and verify that hemodynamics are stable.

Remove sutures/Stat-Lock, loosen Tuohy-Borst and disconnect hub from sheath, exposing Impella Catheter

Decrease P-level to P-1 and pull the Impella back across the aortic valve into the aorta

When ACT is below 150 seconds, turn pump OFF

Pull Impella until it hits distal end of the repositioning sheath

For Impella 2.5 and Impella CP, this may be done bedside, for the Impella 5.0, removal is completed in the surgical suite

62



Hold pressure and remove from vessel as one unit. The catheter will not come through the repositioning sheath.

Apply manual compression for 40 min or per hospital protocol (Impella 2.5 and Impella CP only)

Remove Impella 5.0, tie off graft and close incision site

TRANSFER TO STANDARD CONFIGURATION YES NO Not Evaluated

Press the PURGE MENU soft button, highlight and select Transfer to Standard Configuration


Spike normal saline bag with IV tubing and prime until free of air bubbles

Pressurize saline bag to 300-350 mmHg

Clamp and disconnect the red luer from the red sidearm; flood the red sidearm with saline from the pressure bag to make a wet-to-wet connection; fully open the roller clamp on the IV tubing and press the NEXT soft button

Remove Y-connector as shown on screen and connect yellow luer directly to Impella catheter and press the NEXT soft button

Press the DONE soft button to confirm completion of the purge wizard

CHANGE PURGE FLUID BAG YES NO Not Evaluated

Press the PURGE MENU soft button, highlight and select Change Purge Fluid Bag


When prompted, remove the previous fluid bag and spike with new bag, press NEXT


If purge fluid values remain the same, press the DONE soft button to confirm completion of purge wizard

If purge fluid changes, disconnect the yellow luer when prompted to prime the tubing

Reconnect yellow luer after priming is completed and press the DONE soft button to confirm completion of the purge wizard

63




Press the PURGE MENU soft button, highlight and select Change Cassette and Bag



Open the purge door and remove and discard the used purge cassette

Spike the new purge fluid bag with the new purge cassette

Insert new purge cassette, confirming that the yellow luer remains disconnected


Connect the yellow luer after priming is completed and press the DONE soft button to confirm completion of the purge wizard

DE-AIR PURGE SYSTEM YES NO Not Evaluated

Press the PURGE MENU soft button, highlight and select Change De-Air Purge System

Ensure that the purge tubing is not kinked and that the purge fluid bag is not inverted or empty and press the NEXT soft button


Confirm the purge tubing is free of air and press the NEXT soft button

Connect the yellow luer and press the DONE soft button to confirm completion of the purge wizard




64

Impella 5.0® Setup and Insertion

This form provides an observation checklist of the trainee’s knowledge and skill for the Impella 5.0 Heart Pump. Please provide your acknowledgment signature when complete.




USE OF THE AXILLARY INSERTION KIT YES NO Not Evaluated

Perform a cut down of 3–5 cm to isolate and expose the axillary artery and obtain control via proximal and distal vessel loops.

Attach a 10 mm diameter x 20 cm long vascular Dacron woven graft (Hemashield™ Platinum or Vascutek Gelweave™ recommended) to the axillary artery using a standard end-to-side anastomosis. Note: preferable to shorten 30 cm graft to 20 cm to avoid pushing pump through excess graft.

At least a 60 degree bevel should be placed on the distal end of the graft to facilitate passage of the rigid motor housing into the artery.

Clamp the graft with a vascular clamp (1 or 2 clamps can be used) just above the anastomosis and loosen the vessel loops to assess for hemostasis at the anastomosis.

Insert the short 23 Fr peel away introducer into the graft and secure it with a graft lock.

To place the graft lock, open and place it between the retainers and the hub on the introducer to prevent the introducer from sliding out of the graft.

Secure the graft lock by pressing both outside tabs together.

Remove the vascular clamp on the graft. If hemostasis is not achieved, press the two tabs of the graft lock together until fully engaged. The graft may also be secured to the introducer using heavy silk ties, Number 2 sutures or umbilical tape.

With a 4 Fr – 6 Fr diagnostic or pigtail catheter, insert a 0.035” diagnostic guide wire into the introducer, ensuring to center the wire/catheter on the center of the hemostatic valve.

Advance the catheter and guide wire into the left ventricle.

Place a large curve on the soft end of the 0.018” guidewire. Remove 0.035” guidewire and replace with 0.018” guidewire. Place a large curve on the soft end of the 0.018” guidewire and advance it into the apex of the left ventricle.

Remove the diagnostic catheter and place the vascular clamp above the anastomosis to avoid blood loss through the pump cannula during insertion through the valve.

Insert the provided 8 Fr silicone-coated dilator into the introducer over the 0.018” placement guide wire to coat the hemostatic valve with silicone. Do not wipe the dilator, and avoid touching the dilator shaft when removing it from its protective covering or inserting into the valve (Axillary Insertion Kit only)

Once fully inserted, remove the dilator, keeping the 0.018” placement guide wire in place. (Axillary Insertion Kit only)

65

Impella 5.0 Setup and Insertion (continued)


Ensure the vascular clamp remains clamped just above the anastomosis to avoid blood loss through the pump cannula during insertion through the valve.

Backload the Impella 5.0 Catheter onto the 0.018” placement guide wire and advance the catheter using a fixed wire technique through the hemostatic valve until the motor housing passes the hemostatic valve and is completely inside the graft.

Take care to insert the Impella 5.0 Catheter straight into the center of the introducer.

Avoid manual compression of the inlet, outlet, or sensor areas of the cannula assembly.

Remove the vascular clamp and continue advancing the Impella 5.0 Catheter into the aorta to position the cannula across the aortic valve. Use fluoroscopic imaging and TEE to properly position the inlet area in the left ventricle no more than 3.5 cm below the aortic valve.

Remove the 0.018” guide wire, and initiate Impella 5.0 Catheter support. Use fluoro and TEE during ramp up of support to visualize possible pump migration; reposition if necessary.

Using a soft-jawed vascular clamp, clamp the anastomosis and remove the peel away introducer from the graft and snap and peel away.

Trim the vascular graft so the graft remains under the skin upon closure and advance the repositioning sheath into the trimmed graft.

Tighten the proximal vessel loop to maintain hemostasis with the insertion of the repositioning sheath and remove the vascular clamp.

Advance the repositioning sheath into the graft and secure with a 2.0 suture or umbilical tape.

The wound should be closed over the trimmed graft with the end of the repositioning sheath clearly visible.

Anchor the repositioning sheath securely to the skin with suture or Stat-Lock.

Remove any slack from the Impella 5.0 Catheter and re-check position. Tighten the Tuohy-Borst valve to prevent catheter migration.

Extend the sterile sleeve. Attach one end to the repositioning hub and anchor the other to the catheter.

USE OF THE SILICONE PLUGS YES NO Not Evaluated

Perform a cut down of 3–5 cm to isolate and expose the axillary artery and obtain control via proximal and distal vessel loops.

Attach a 10 mm diameter x 20 cm long vascular Dacron woven graft (Hemashield Platinum or Vascutek Gelweave recommended) to the axillary artery using a standard end-to-side anastomosis. Note: preferable to shorten 30 cm graft to 20 cm to avoid pushing pump through excess graft.

At least a 60 degree bevel should be placed on the distal end of the graft to facilitate passage of the rigid motor housing into the artery

Clamp the graft with a vascular clamp just above the anastomosis and loosen the vessel loops to assess for hemostasis at the anastomosis.

66



Insert a 8 Fr introducer into the graft and secure it with umbilical tape or heavy silk ties.

Remove the vascular clamp on the graft.

With a 4 Fr–6 Fr diagnostic or pigtail catheter, insert a 0.035” diagnostic guide wire into the introducer, ensuring to center the wire/catheter on the center of the hemostatic valve.

Advance the catheter and guide wire into the left ventricle.

Remove 0.035” guidewire and replace with 0.018” guidewire. Place a large curve on the soft end of the 0.018” guidewire and advance it into the apex of the left ventricle.

Remove the diagnostic catheter and place the vascular clamp above the anastomosis.

Remove the introducer from the graft.

Attach a provided pre-split silicone plug to the catheter shaft, just distal to the motor housing.

Avoid manual compression of the inlet, outlet, or sensor areas of the cannula assembly.

Backload the Impella 5.0 Catheter onto the 0.018” placement guidewire and advance into the graft. Secure the silicone plug to the graft with umbilical tape or a silk tie.

Remove the vascular clamp and continue advancing the Impella 5.0 Catheter into the aorta to position the cannula across the aortic valve while grasping the silicone plug. Use fluoroscopic imaging and TEE to properly position the inlet area in the left ventricle no more than 3.5 cm below the aortic valve.

Remove the 0.018” guide wire, and initiate Impella 5.0 Catheter support. Use fluoro and TEE during ramp up of support to visualize possible pump migration; reposition if necessary.

Using a soft-jawed vascular clamp, clamp the anastomosis and remove the silicone plug from the graft.

Trim the vascular graft so the graft remains under the skin upon closure and advance the repositioning sheath into the trimmed graft.

Tighten the proximal vessel loop to maintain hemostasis with the insertion of the repositioning sheath and remove the vascular clamp

Advance the repositioning sheath into the graft and secure with a 2.0 suture or umbilical tape.

The wound should be closed over the trimmed graft with the end of the repositioning sheath clearly visible.

Anchor the repositioning sheath securely to the skin with suture or stat-lock.

Remove any slack from the Impella 5.0 Catheter and re-check position. Tighten the Tuohy-Borst valve to prevent catheter migration.

Extend the sterile sleeve. Attach one end to the repositioning hub and anchor the other to the catheter.

67





68

Impella 2.5®/ Impella CP® Supply List

Impella 2.5 / Impella CP Insertion Kit contains:

• Impella Catheter

• 0.018" x 260 cm placement guidewire

• White connector cable

• Purge cassette

• IV infusion set

• Introducer Kit

• Peel-away introducer (13 Fr Impella 2.5, 14 Fr Impella CP)

• 18 G Seldinger needle (Impella 2.5)

• 12 mL syringe (Impella 2.5)

• 0.035" stiff access wire

• 8 Fr, 10 Fr, 12 Fr, 14 Fr dilators (Impella CP)

Hospital supplied items:

• Automated Impella® Controller

• 500 mL bag of D5W (5% recommended; 5% - 20% acceptable) with Heparin 50 IU/mL (recommended)

• 5–8 Fr Introducer

• 8 Fr, 10 Fr, 12 Fr dilators

• 6 Fr MP, AL-1 diagnostic catheter without side holes OR 5 Fr; pigtail with or without side holes

• Standard 0.035” x 180 cm J-Tip guidewire

Case savers/Extra items:

• Boston Scientific Platinum Plus™, 0.018" guidewire

• Boston Scientific V-18 ControlWire™ 0.018" guidewire

Supplies for Transfer to Standard Configuration

• 500 mL bag of NaCl with pressure bag

• IV infusion set without transducer (90" recommended)

• 500 mL bag of D5W (5% recommended, 5%–20% acceptable) with Heparin 50 IU/mL (recommended)

• Back-up purge cassette

69

Impella 5.0®/ Impella LD® Supply List

Impella 5.0 / Impella LD Insertion Kit contains:


• 0.018" x 260 cm placement guidewire


• Purge cassette

• Impella Axillary Insertion Kit

• 23 Fr x 6 cm peel-away introducer

• 2 Graft locks

• 8 Fr silicone-coated lubrication dilator

• 2 Silicone plugs

Impella LD Insertion Kit



• Purge cassette

• Incision template

Hospital supplied items:

• Automated Impella® Controller

• 500 mL bag of D5W (5% recommended; 5%–20% acceptable) with Heparin 50 IU/mL (recommended)

• 10 mm x 20 cm vascular graft (Impella 5.0)

• 10 mm x 15 cm vascular graft (Impella LD)

• 6 Fr MP, AL-1 diagnostic catheter without side holes OR 5 Fr pigtail with or without side holes (Impella 5.0)

• Standard 0.035” x 180 cm J-Tip guidewire (Impella 5.0)

Appendix A: Program Resources Patient Education and Outreach Program

Patient EducationAbiomed has resources available to assist in education of patients and family members. Please visit our website at www.protectedpci.com.

Outreach EducationAbiomed has resources available to assist outreach education. Please visit our website at www.protectedpci.com for more information on outreach education.

Additional Staff Training ResourcesImpella® Quick Skills Mobile by Abiomed, Inc., puts key Impella information at your fingertips. Instantly review set-up and insertion videos and instructions by downloading the Impella App from the iTunes or GooglePlay directly to your smartphone or tablet.

Download The IMPELLA APPToday

70

71

Peer-reviewed articles used in support of the safety and effectiveness of Impella®

1. Maini B, Naidu SS, Mulukutla S, et al. Real-world use of the Impella 2.5 circulatory support system in complex high risk percutaneous coronary intervention: The USpella Registry. Catheter Cardiovas Interv. 2012;80(5):717-725.

2. Kovacic JC, Kini A, Banerjee S, et al. Patients with 3-vessel coronary artery disease and impaired ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II Trial. J Interv Cardiol. 2015;28(1):32-40.

3. Dangas GD, Kini AS, Sharma SK, et al. Impact of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump on prognostically important clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (from the PROTECT II randomized trail). Am J Cardiol. 2014;113(2):222-228.

4. O’Neill, PROTECT II. Abstract presented at: TCT 2013 Transcatheter Cardiovascular Therapeutics. October 28, 2013-November 1, 2013; San Francisco, CA; 2013.

5. Gregory D, Scotti DJ, de Lissovoy G, et al. A value-based analysis of hemodynamic support strategies for high-risk heart failure patients undergoing a percutaneous coronary intervention. Am Health Drug Benefits. 2013;6(2):88-99.

6. O’Neill WW, Kleiman NS, Moses J, et al. A prospective randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012;126(4):1717-1727.

7. Maini B, Scotti DJ, Gregory D. Health economics of percutaneous hemodynamic support in the treatment of high-risk cardiac patients: a systematic appraisal of the literature. Expert Rev Pharmacoecon Outcomes Res. 2014;14(3):403-416.

8. Cohen MG, Kelly RV, Kong DF, et al. Pulmonary artery catheterization in acute coronary syndromes: Insights from the GUSTO IIb and GUSTO III trials. Am J Med. 2005;118(5):482-488.

9. Kahwash R, Leier CV, Miller L. Role of the pulmonary artery catheter in diagnosis and management of heart failure. Cardiol Clin. 2011;29(2):281-288.

10. Chatterjee K. The Swan-Ganz catheters: past, present, and future. A viewpoint. Circulation. 2009;119(1):147-152.

11. Aqel RA, Hage FG, Iskandrian AE. Improvement of myocardial perfusion with a percutaneously inserted left ventricular assist device. J Nucl Cardiol. 2010;17(1):158-160.

12. Burkhoff D, Mirsky I, Suga H. Assessment of systolic and diastolic ventricular properties via pressure-volume analysis: a guide for clinical, translational, and basic researchers. Am J Physiol Heart Circ Physiol. 2005;289(2):H501-H512.

13. den Uil CA, Lagrand WK, van der Ent M, et al. Impaired microcirculation predicts poor outcome of patients with acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. 2010;31(24):3032-3039.

14. Fincke, R, Hochman JS, Lowe AM, et al. Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol. 2004;44(2):340-348.

15. Lam K, Sjauw KD, Henriques JP, et al. Improved microcirculation in patients with an acute ST-elevation myocardial infarction treated with the Impella LP 2.5 percutaneous left ventricular assist device. Clin Res Cardiol. 2009;98(5):311-318.

16. Mendoza DD, Cooper HA, Panza JA. Cardiac power output predicts mortality across a broad spectrum of patients with acute cardiac disease. Am Heart J. 2007;155(3):366-370.

17. Meyns B, Stolinski J, Leunens V, Verbeken E, Flameng W. Left ventricular support by catheter-mounted axial flow pump reduces infarct size. J Am Coll Cardiol. 2003;41(7):1087-1095.

18. Naidu SS. Novel percutaneous cardiac assist devices: the science of and indications for hemodynamic support. Circulation. 2011;123(5):533-543.

19. Reesink KD, Dekker AL, Van Ommen V, et al. Miniature intracardiac assist device provides more effective cardiac unloading and circulatory support during severe left heart failure than intraaortic balloon pumping. Chest. 2004;126(3):896-902.

20. Remmelink M, Sjauw KD, Henriques JP, et al. Effects of left ventricular unloading by Impella recover LP2.5 on coronary hemodynamics. Catheter Cardiovasc Interv. 2007;70(4):532-537.

21. Remmelink M, Sjauw KD, Henriques JP, et al. Effects of mechanical left ventricular unloading by Impella on left ventricular dynamics in high-risk and primary percutaneous coronary intervention patients. Catheter Cardiovasc Interv. 2010;75(2):187-194.

22. Sauren LD, Accord RE, Hamzeh K, et al. Combined Impella and intra-aortic balloon pump support to improve both ventricular unloading and coronary blood flow for myocardial recovery: an experimental study. Artif Organs. 2007;31(11):839-842.

23. Suga H, Hayashi T, Shirahata M. Ventricular systolic pressure-volume area as predictor of cardiac oxygen consumption. Am J Physiol. 1981;240(1):H39-H44.

24. Suga H. Total mechanical energy of a ventricle model and cardiac oxygen consumption. Am J Physiol. 1979;236(3):H498-505.

References

72

25. Torgersen C, Schmittinger CA, Wagner S, et al. Hemodynamic variables and mortality in cardiogenic shock: a retrospective cohort study. Crit Care. 2009;13(5):R157.

26. Torre-Amione G, Milo-Cotter O, Kaluski E, et al. Early worsening heart failure in patients admitted for acute heart failure: time course, hemodynamic predictors, and outcome. J Card Fail. 2009;15(8):639-644.

27. Valgimigli M, Steendijk P, Sianos G, et al. Left ventricular unloading and concomitant total cardiac output increase by the use of percutaneous Impella Recover LP 2.5 assist device during high-risk coronary intervention. Catheter Cardiovasc Interv. 2005;65(2):263-267.

28. Weber DM, Raess DH, Henriques JP, et al. Principles of hemodynamics: the new science of cardiac support in the cath lab. Cardiac Interventions Today Supp. August/September 2009.

29. O’Neill WW, Schreiber T, Wohns DH, et al. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry. J Intervent Cardiol. 2014;27(1):1-11.

30. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;130(25):e344-e426.

31. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Am Coll Cardiol. 2011;58(24):e44-e122.

32. Peura JL, Colvin-Adams M, Francis GS, et al. Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association. Circulation. 2012;126(22):2648-2667.

33. Feldman D, Pamboukian SV, Teuteberg JJ, et al. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 201332(2):157-187.

34. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128(16):e240-e327.

35. O'Gara PT, Kushner FG, Ascheim DD, et al; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61(4):e78-e140.

36. Reyentovich A, Barghash MH, Hochman JS. Management of refractory cardiogenic shock. Nat Rev Cardiol. 2016(8):481-492.

37. Hochman JS, Sleeper LA, Webb JG, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock). N Engl J Med. 1999;341(9):625-634.

38. Rihal CS, Naidu SS, Givertz MM, et al. 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care. J Am Coll Cardiol. 2015;65(19):e7-e26.

39. Picard MH, Davidoff R, Sleeper LA, et al. Echocardiographic predictors of survival and response to early revascularization in cardiogenic shock. Circulation. 2003;107(2):279-284.

40. Joseph SM, Brisco MA, Colvin M, et al. Women with cardiogenic shock derive greater benefit from early mechanical circulatory support: an update from the cVAD Registry. J Interv Cardiol. 2016;29(3):248-256.

41. Schroeter MR, Köhler H, Wachter A, et al. Use of the Impella device for acute coronary syndrome complicated by cardiogenic shock—experience from a single heart center with analysis of long-term mortality. J Invasive Cardiol. 2016 Aug 15. pii: JIC2016815-3. [Epub ahead of print]

42. Samuels LE, Kaufman MS, Thomas MP, et al. Pharmacological criteria for ventricular assist device insertion following postcardiotomy shock: experience with the Abiomed BVS system. J Card Surg. 1999;14(4):288-293.

43. De Backer D, Biston P, Devriendt J, et al. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010;362(9):779-789.

44. teg PG, James SK, Atar D, et al; Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC). Eur Heart J. 2012;33(20):2569-2619.

45. Casassus F, Corre J, Leroux L, et al. The use of Impella 2.5 in severe refractory cardiogenic shock complicating an acute myocardial infarction. J Interv Cardiol. 2015;28(1):41-50.

46. Lemaire A, Anderson MB, Lee LY, et al. The Impella device for acute mechanical circulatory support in patients in cardiogenic shock. Ann Thorac Surg. 2014;97(1):133-138.

47. Anderson MB, Goldstein J, Milano C, et al. Benefits of a novel percutaneous ventricular assist device for right heart failure: the prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015;34(12):1549-1560.

48. Flaherty MP, Pant S, Patel SV, et al. Hemodynamic support with a microaxial percutaneous left ventricular assist device (Impella) protects against acute kidney injury in patients undergoing high-risk percutaneous coronary intervention. Circ Res. 2017;120(4):692-700.

References (cont.)

IMP-1388-16.v5 | © 2019 ABIOMED, INC. ALL RIGHTS RESERVED.

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impella program protocols & tools...iii introduction effective impella® heart pump programs are...

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