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DATASCOPE IS NOW MAQUET CARDIOVASCULAR CLINICAL SUPPORT SERVICES MANAGING IABP THERAPY - CS300

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Page 1: CLINICAL SUPPORT SERVICES MANAGING IABP …files.sulli.us/IABP/CS300_6_hour_Sem_Managing_IABP_Therapy.pdf · CLINICAL SUPPORT SERVICES MANAGING IABP THERAPY ... operation of the central

DATASCOPE IS NOW MAQUET CARDIOVASCULAR

CLINICAL SUPPORT SERVICESMANAGING IABP THERAPY - CS300

Page 2: CLINICAL SUPPORT SERVICES MANAGING IABP …files.sulli.us/IABP/CS300_6_hour_Sem_Managing_IABP_Therapy.pdf · CLINICAL SUPPORT SERVICES MANAGING IABP THERAPY ... operation of the central

CS300 Color Display and Keypad Controls

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Datascope is now MAQUET Cardiovascular

In early 2009, the purchase agreement between Datascope and Getinge AB was completed. As a result, Datascope’s innovative cardiovascular product portfolio will be integrated into MAQUET Cardiovascular, a global leader representing the Medical Systems Business area of Getinge AB.

Cardiac professionals have always relied on gold-standard Cardiac Assist products from Datascope, helping them to feel confident that they are delivering the highest quality of care to their patients. Now, as a part of MAQUET Cardiovascular, Datascope is even better positioned to focus on the future advancement of Cardiac Assist products and seeks to explore the full potential of this technology through our continued dedication to innovation, service and clinical excellence.

Quality Products:

Expect the same great quality products you have relied on over the years with names you are familiar with like: Fidelity, Linear and Sensation IAB’s, CS300 balloon pumps, SafeGuard and StatLock.

Quality Service:

Rest assured that you will receive the same amazing service and clinical support you have become accustomed to from Datascope. We are still here for you 24/7 with technical support, loaner equipment and clinical help.

Worldwide:

MAQUET ranks among the leading providers of medical products, therapies and services for Surgical Workplaces, Critical Care and Cardiovascular applications. Since its foundation more than 170 years ago, MAQUET has stood for innovation and the advancement of patient care technologies in the field of medicine. The portfolio of MAQUET products is extensive, providing a comprehensive solution that is designed for efficient workflows, safety and the improvement of patient lives and outcomes.

Welcome to MAQUET Cardiovascular:

With a fresh vision of the future, this new, combined organization is committed to providing the highest quality patient care solutions for cardiologists, interventional radiologists, cardiothoracic and vascular surgeons, critical care clinicians and their teams.

For further information please visit www.datascope.com

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Managing Intra-Aortic Balloon Therapy

Course Description

This six hour program is designed for the experienced healthcare professional directly involved with the care of the

patient requiring intra-aortic balloon pump therapy. Participants should have experience with hemodynamic

monitoring and 6 months critical care experience. Previous experience with intra-aortic balloon pump therapy is

preferred.

This program is comprised of 3 modules consisting of theoretical, technical, and clinical considerations for a patient

requiring IABP therapy. The theoretical module will briefly review cardiac physiology and the theory of intra-aortic

balloon pumping. The technical module will discuss percutaneous insertion and removal of the intra aortic-balloon

catheter followed by a detailed explanation of the Datascope IABP, highlighting troubleshooting in the clinical setting.

Case studies will be utilized to further reinforce troubleshooting techniques. The clinical module provides a

discussion of clinical considerations for patients requiring IABP therapy. A skills workshop utilizing the system trainer

and Abbreviated Operator’s Guide will be provided.

Behavioral Objectives

At the conclusion of this program, the participants will be able to:

1) Define the two physiologic effects achieved by the mechanics of inflation and deflation of the IAB as it relates to

the cardiac cycle illustrated by an augmented arterial pressure waveform.

2) Identify four indications and three contraindications for IABP therapy.

3) Identify the potential complications associated with IABP therapy.

4) Demonstrate the set up, operation, and troubleshooting of the Datascope IABP utilizing the system trainer for

practice and the abbreviated operators guide for reference.

Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician. Refer to package insert for current indications, warnings, contraindications, precautions and instructions for use.

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Course Schedule 8:00 – 8:10 Introduction

Review Program

8:10 – 9:30 MODULE I - Theoretical Aspects

Review Cardiac Mechanics

Measurement of Cardiac Performance

Left Ventricular Failure

Theory of IABP

Factors Affecting Diastolic Augmentation/Timing Errors

Indications/Contraindications

9:30 – 9:45 Break

9:45 – 10:45 MODULE II IAB - Catheter and Technical Introduction to IABP

IAB Catheter Insertion

Technical Features of the IABP

10:45 – 11:00 Break

11:00 – 12:00 Troubleshooting Alarm and Advisory Messages

Hands On

12:00 – 12:30 Lunch

12:30 – 1:15 Additional Hands on

1:15 – 1:45 MODULE III - Clinical Considerations

Side Effects/Potential Complications

Care Management/Case Studies

1:45 – 2:00 Open Discussion

Program Evaluation

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Module I

Theoretical Aspects of IABP

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I. Review Physiology of Cardiac Mechanics A. Cardiac Cycle

1. Atrial Systole

2. Isovolumetric Contraction

3. Ventricular Ejection

a. Slow Ejection

b. Rapid Ejection

c. Slow Ejection

4. Isovolumetric Relaxation

5. Ventricular Filling

a. Rapid Filling

b. Slow Filling

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B. Pressure Waves 1. Ventricular Waveform

a. Pressure

b. Volume

2. Arterial

a. Radial/Brachial

b. Aortic

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C. Myocardial Oxygen Supply and Demand

SUPPLY DEMAND 1. Coronary artery anatomy 1. Heart Rate

2. Diastolic pressure 2. Afterload

3. Diastolic time 3. Preload

4. O2 extraction 4. Contractility

a. HBG

b. PaO2

MVO2

D. Frank-Starling Law of Heart

Ventricular function curve. As the end-diastolic volume increases, so does the force of ventricular contraction. Thus the stroke volume becomes greater up to a critical point after which stroke volume decreases. [Cardiac failure]

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LV Failure

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II. Theory of IABP Therapy

A. Counterpulsation 1. Balloon Structure and Position

2. Increased Coronary Perfusion

a. Inflation

b. Augmentation of Diastolic Pressure

3. Decreased Left Ventricular Workload

a. Deflation

b. Afterload Reduction

4. Physiological Pressure Wave Changes

a. Dicrotic Notch

b. Diastole: Augmentation

c. Decreased End-Diastolic Pressure

d. Systole: Decreased Assisted Systolic Pressure

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ARTERIAL WAVEFORM VARIATIONS DURING IABP THERAPY 1:1 IABP Frequency

1:2 IABP Frequency

1:3 IABP Frequency

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B. Effects of IABP 1. Primary

a. Supply

b. Demand

2. Secondary

a. CO/CI

b. HR

c. PAD-PCWP

d. SVR

e. B/P-SYSTOLIC

DIASTOLIC

MAP

DIASTOLIC AUGMENTATION

3. Systemic

a. Neuro

b. Renal

c. Vascular

d. Respiratory

C. Factors Affecting Diastolic Augmentation 1. Patient Hemodynamics

a. Heart Rate

b. Stroke Volume

c. Mean Arterial Pressure

d. System Vascular Resistance

2. Intra-Aortic Balloon

a. IAB in Sheath

b. IAB Not Unfolded

c. IAB Position

d. Kink in IAB Catheter

e. IAB Leak

f. Low Helium Concentration

3. IABP

a. Timing

b. Position of IAB Augmentation Control

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D. Timing Errors 1. Early Inflation

Inflation of the IAB prior to aortic valve closure

Waveform Characteristics: • Inflation of IAB prior to dicrotic notch

• Diastolic augmentation encroaches onto

systole (may be unable to distinguish)

Physiologic Effects: • Potential premature closure of aortic valve

• Potential increase in LVEDV and LVEDP or PCWP

• Increased left ventricular wall stress or afterload

• Aortic Regurgitation

• Increased MVO2 demand

2. Late Inflation

Inflation of the IAB markedly after closure

of the aortic valve

Waveform Characteristics: • Inflation of the IAB after the dicrotic notch

• Absence of sharp V

• Sub-optimal diastolic augmentation

Physiologic Effects: • Sub-optimal coronary artery perfusion

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3. Early Deflation

Premature deflation of the IAB

during the diastolic phase

Waveform Characteristics • Deflation of IAB is seen as a sharp

drop following diastolic augmentation

• Sub-optimal diastolic augmentation

• Assisted aortic end diastolic pressure

may be equal to or less than the

unassisted aortic end diastolic pressure

• Assisted systolic pressure may rise

Physiologic Effects: • Sub-optimal coronary perfusion

• Potential for retrograde coronary and

carotid blood flow

• Angina may occur as a result of retrograde

coronary blood flow

• Sub-optimal afterload reduction

• Increased MVO2 demand

4. Late Deflation

Waveform Characteristics: • Assisted aortic end-diastolic pressure may

be equal to the unassisted aortic end

diastolic pressure

• Rate of rise of assisted systole is prolonged

• Diastolic augmentation may appear widened

Physiologic Effects: • Afterload reduction is essentially absent

• Increased MVO2 consumption due to the

left ventricle ejecting against a greater

resistance and a prolonged isovolumetric

contraction phase

• IAB may impede left ventricular

ejection and increase the afterload

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E. Indications

1. Refractory Unstable Angina

2. Impending Infarction

3. Acute MI

4. Refractory Ventricular Failure

5. Complications of Acute MI [i.e. acute MR or VSD, or papillary muscle rupture]

6. Cardiogenic Shock

7. Support for diagnostic, percutaneous revascularization, and interventional procedures

8. Ischemia related intractable ventricular arrhythmias

9. Septic Shock

10. Intraoperative pulsatile flow generation

11. Weaning from bypass

12. Cardiac support for non-cardiac surgery

13. Prophylactic support in preparation for cardiac surgery

14. Post surgical myocardial dysfunction/low cardiac output syndrome

15. Myocardial contusion

16. Mechanical bridge to other assist devices

17. Cardiac support following correction of anatomical defects

F. Contraindications

1. Severe aortic insufficiency

2. Abdominal or aortic aneurysm

3. Severe calcific aorta-iliac disease or peripheral vascular disease

4. Sheathless insertion with severe obesity, scarring of the groin, or other contraindications to

percutaneous insertion

Please Refer to the Instructions for Use Prior to Insertion of the IAB

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Module II

Technical Aspects

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I. Intra-Aortic Balloon Catheter A. Designed for sheathless or sheathed insertion Fiberoptic IAB catheter

Conventional IAB Catheter

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B. Clinical Considerations for Central Aortic Pressure Monitoring

PRECAUTION: For optimal signal quality, use no more than 8 feet (2.5 meters) maximum of pressure

tubing between the transducer and female luer hub of the Y-fitting.

The Instructions For Use (IFU) booklet included in the intra-aortic balloon catheter package should be carefully reviewed. For Conventional IAB Catheters: NOTE: All fittings should be luer lock. When monitoring pressure through the inner lumen of a conventional IAB catheter, use a standard arterial pressure monitoring apparatus connected to a three-way stopcock. Connect the three-way stopcock to the female luer hub of the inner lumen. Per hospital policy, a fast forward flush may be performed hourly to help maintain patency of the inner lumen. 1. All personnel responsible for the maintenance of the central aortic pressure line and inner lumen of the IAB catheter should read and follow these warnings. WARNINGS: Careful and cautious technique should be used to prevent thrombus or air from embolizing off the tip of the catheter. Such an embolus could potentially enter the carotid or coronary arteries from the aortic arch. Do not pulsate the intra-aortic balloon when manipulating the central aortic pressure line or inner lumen of the IAB catheter. Following initial insertion, do not manually flush the central aortic pressure line or inner lumen with a syringe. 2. The following clinical considerations should be adhered to during the set-up and operation of the central aortic pressure line and inner lumen of the IAB catheter. A. Follow standard protocols for arterial pressure monitoring. The heparin dosage should be in accordance with standard hospital practice for arterial pressure lines and may be modified on physician discretion for patients receiving anticoagulation.

B. A 3cc per hour continuous flush device should be incorporated into the arterial pressure monitoring apparatus. Fast forward flushing once every hour using the 3cc per hour flush device is recommended. C. Always aspirate 3cc initially if the central aortic pressure line or inner lumen becomes damped. Whenever the inner lumen of the IAB becomes filled with blood (such as after aspiration), the flush valve should be activated for a minimum of 15 seconds in addition to the time it takes to clear the pressure tubing of blood. Should resistance be met upon aspiration, consider the lumen to be occluded. Discontinue use of the central aortic pressure line and inner lumen by placing a sterile male luer lock cap on the port. D. Troubleshooting of the central aortic pressure line should be conducted with the same considerations as a standard arterial line. 1 E. The inner lumen of the IAB catheter should not be used for blood sampling. F. Do not use a R.O.S.E. (Resonance Over Shoot Eliminator) or other damping device. 1Daily EK; Schroeder JS, �Intra-arterial Pressure Monitoring Techniques in Bedside Hemodynamic Monitoring, Edition IV, CV Mosby Company, 1989

For Datascope fiber-optic IAB catheters: 1. Once the catheter is in place, aspirate

and discard 3cc of blood from the inner lumen and then immediately perform a manual flush using a syringe filled with 3cc to 5cc of flush solution. This will minimize the chances of stagnant blood clotting the inner lumen.

2. Using current hospital protocol, connect a standard arterial pressure flush apparatus to the hub of the inner lumen. A continuous 3cc/hour flush is recommended.

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II. Technical Components of the CS300 Intra-Aortic Balloon Pump

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A. Rear Panel

1. Fiberoptic Module

a. IAB Sensor Input

b. Vent Key

c. To bedside monitor

2. Safety Disk/Condensate Removal System

a. DC Input

b. IAB Fill Port

c. Drain Port

3. Helium Supply

a. Pressure Gauge

b. Manual Fill Port

4. Patient Connections

a. ECG

b. Pressure

c. Monitor Input - ECG - Pressure

d. ECG/Pressure Output

5. Data Communications Outputs

a. RS-232

b. Phone Line

c. Diagnostic Output

6. Power Cord/Mains

7. System Timer

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B. Monitor CS300

1. Alarm and Advisory Messages 7. IAB Status Indicator

2. ECG 8. Trigger

a. Lead 9. Heart Rate Display

b. Gain 10. Pressure Display

3. Pressure Source 11. Augmentation Alarm

4. IAB Fill Mode 12. Battery Indicator

5. Slow Gas Alarm Status 13. Helium Indicator

6. Operation Mode

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C. CS300 IABP Key Pad Controls 1. Operation Mode Keys

a. AUTO

b. Semi-Auto

c. Manual

2. Zero Pressure Key

3. START key and Indicator

4. STANDBY Key and Indicator

5. Trigger Source Key

a. ECG

b. Pressure

c. Pacer V/AV

d. Pacer A

e. Internal

6. IAB Frequency

7. IAB Augmentation

8. IAB Inflation Controls

9. IAB Deflation Controls

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D. CS300 Key Pad Control Panel

1. Alarm Mute Key

2. IAB Fill Key

3. Help Key Indicator

4. Menu Guide

a. Ref Line

b. Aug. Alarm

c. ECG/AP Sources

d. Pump Options

e. User Preferences

5. Inflation Interval Key

6. Freeze Display Key

7. Print Strip Key

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E. Recorder

1. ECG

2. Pressure

3. Balloon Pressure Waveform

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F. System Battery 1. Charge Status 2. Portable Operation

G. Doppler Storage

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The inflation marker shows the period of inflation. Vertical timing marks located below the arterial waveform are also available to aid with initial timing. The timing markers indicate the point at which the inflate and deflate commands are sent. A unique automatic timing algorithm allows effective balloon pumping even during atrial fibrillation. Press the Inflation Interval key to observe the period of inflation while pumping. Vertical markers located below the arterial waveform and the highlighted portion indicate the period of balloon inflation.

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III. Troubleshooting A. High Priority Alarms:

All Modes:

Augmentation Below Limit Set*

No Trigger

IAB Disconnected

Check IAB Catheter

Leak in IAB Circuit

Rapid Gas Loss

Blood Detected

Autofill Failure

Autofill Failure – No Helium

High Pressure Drive

Low Vacuum

AUTO Operation Mode:

Poor Signals Persist

Semi Auto or Manual Mode:

ECG Detected*

No Pressure Trigger

Trigger Interference

Check Pacer Timing

Autofill Required

Other:

Safety Disk Test Fails

* Pumping NOT suspended

B. Medium Priority Alarms:

All Modes:

IAB Optical Sensor Failure

Low Battery

Low Battery

AUTO Operation Mode:

Poor Signal Quality

No Pressure Source Available

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C. Low Priority Alarm:

AUTO Operation Mode:

Unable to Update Timing

D. Technical Alarms:

Electrical Test Fails Code #_____

System Failure

No Patient Status Available

E. Informational Messages:

All Modes:

A.P. Optical Sensing Module Failure

Unable to Calibrate IAB Optical Sensor

IAB Optical Sensor Calibration Expired

No Trigger

Prolonged Time In Standby

Autofilling

Auto Zeroing

Autofilling and Zeroing

Function Not Available

Low Helium

Battery in Use (EXT)

Battery In Use

System Test OK

System Trainer

Maintenance Required Code #_____

Slow Gas Loss Alarm is OFF

Leak In IAB Circuit – Overridden

Blood Detected – Overridden

AUTO Operation Mode:

Function Unavailable in Auto Operation Mode

AUTO or SemiAuto Operation Mode:

Auto R-Wave Deflate

R-Wave Deflate

SemiAuto:

Irregular Pressure Trigger

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SemiAuto or Manual:

Verify Proper Timing

IAB Not Filled

Manual Fill IAB

Auto Operation Mode is Disabled

Gas Loss and Catheter Alarms Disabled

Manual Mode:

Manual Timing Selected – See Help

Other:

Install Safety Disk

Unplug Disk Outlet

Plug Disk Outlet

Leak Testing Safety Disk

F. Patient Conditions 1. Atrial Fibrillation

2. Ectopics

3. Cardiac Arrest

4. Cardioversion/Defibrillation

G. Changing Helium Tank H. Safety Disk Leak Test I. Manual Fill J. Manual Timing

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IV. Normal Balloon Pressure Waveform

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A. Variations in Balloon Pressure Waveforms Variations in balloon pressure waveforms may be due to the following conditions:

1. Heart Rate Bradycardia Increased duration of

plateau due to longer

diastolic phase

Tachycardia Decreased duration of

plateau due to shortened

diastolic phase.

2. Rhythm Varying R-R intervals

result in irregular plateau

durations.

3. Blood Pressure Hypertension Increased height or

amplitude of the

waveform.

Hypotension Decreased height or

amplitude of the waveform

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4. Gas Loss

Leak in the closed system causing the balloon pressure waveform to

fall below zero baseline. This may be due to a loose connection, a leak

in the IAB catheter, H2O condensation in the external tubing, or a

patient who is tachycardiac and febrile which causes increased gas

diffusion through the IAB membrane.

5. Catheter Kink

Rounded balloon pressure waveform, loss of plateau resulting from a

kink or obstruction of shuttle gas. This may be caused by a kink in the

catheter tubing, improper IAB catheter position, sheath not being

pulled back to allow inflation of the IAB, the IAB is too large for the

aorta, the IAB is not fully unwrapped, or H2O condensation in the

external tubing.

6. Sustained Inflation

Theoretical possibility if the IAB remains inflated longer than 2

seconds. The Datascope intra-aortic balloon pump will activate the

System Failure alarm and deflate the IAB.

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DATASCOPE IABP PERFORMANCE CHECKLIST – CS300

Name: ________________________________________ Date ____________________ Hospital policy and procedures review: Date __________ Initials ______ Basic Intra - aortic balloon pump course: Date __________ Initials ______ Technical Seminar / Advanced Troubleshooting: Date(s) ________/________ Initials ________ Challenge Exam (if applicable): Date __________ Score: __________ ( P / F ) Directions for Instructor: Place your initials next to the skills the participant is able to perform. Leave blank the skills requiring repeat performance. Clarify learning needs if necessary in the comment section. The “Clinical Setting” column is an optional checklist for use by a preceptor or resource person for reinforcement of skills acquired on system trainer.

Skills System Trainer Clinical Setting INITIAL SET UP

• Establish Power: Main power switch & IABP On/Off switch ⇒ ON

• Open helium tank and verify helium pressure • Establish ECG and Pressure connections If using a sensor IAB: • Ensure the IAB Sensor Cable is connected to the sensor module

and clipped to helium extender tubing

If using conventional IAB/Transducer: • Open transducer to air • Press zero pressure key for 2 seconds • Close transducer

CONFIRM OPERATION MODE – AUTO INITIATE PUMPING

• Attach IAB catheter & appropriate extender to safety disk • Press the Start key If using a sensor IAB: • Observe for the “Autofilling & Zeroing” message

If using conventional IAB/ transducer: • Observe for the “Autofilling” message

• Verify optimal diastolic augmentation VERIFY AUG. ALARM

• Verify Aug. Alarm setting is approximately 10mmHg less than the patient’s augmented diastolic pressure

• Adjust, if necessary by pressing Aug. Alarm key and using the up and down arrow keys, in the navigation circle, to change value displayed on the screen

ASSESS HEMODYNAMIC BENEFITS • Ensure optimal augmentation • Ensure optimal afterload reduction • If desired, IAB deflation can be fine tuned using the IAB deflation

control.

RECORD PRESSURES: ASSISTED & UNASSISTED • Press Print Strip key to record waveforms • Use Printer Menu in User Preferences to change printer settings

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DATASCOPE IABP PERFORMANCE CHECKLIST – CS300

Skills System Trainer Clinical Setting AUTO OPERATION MODE

• Describe ECG and pressure source selection • Describe Trigger source selection • Describe automatic timing and Cardiosync 2 with R-Trac

SEMI-AUTO OPERATION MODE • Describe ECG and pressure source selection • Describe Trigger source selection • Describe automatic timing and Cardiosync 2 with R-Trac

PRESSURE SOURCE - Describes understanding of how pressure source is originated and calibrated

• Fiberoptics • Conventional IAB/Transducer

TROUBLESHOOTING System Trainer Clinical Setting DEMONSTRATES ABILITY TO IDENTIFY VARIABLE TRIGGER SELECTION CRITERIA AND APPROPRIATE USE OF EACH TRIGGER

• Atrial Fibrillation • Demand Ventricular Pacemaker, Rate 60 • AV sequential pacemaker, demand mode • Unobtainable ECG signal, regular rhythm, BP 100/50 • Cardiac arrest with good chest compressions • Sinus Tachycardia • Sinus Rhythm with frequent PVC'S • Fixed rate AV sequential pacemaker • Atrial pacemaker - 100% paced

EVALUATES SITUATIONS THAT MAY CAUSE AN IAB CATHETER ALARM AND DESCRIBES APPROPRIATE INTERVENTION • Kink in the catheter or tubing • Patient sitting straight up in bed • IAB has not exited the sheath

IDENTIFIES AND RECOMMENDS APPROPRIATE ACTION FOR POTENTIAL LOSS OF HELIUM (“GAS LOSS”) • Blood in the IAB catheter shuttle gas tubing • IAB catheter disconnected from the console

DISCUSSES THE FOLLOWING ALARM AND INFORMATIONAL MESSAGES • Poor Signal Quality • Poor Signals Persist • No Pressure Source Available • Unable to Update Timing • IAB Optical Sensor Failure • AP Optical Sensing Module Failure • Unable to Calibrate IAB Optical Sensor • IAB Optical Sensor Calibration Expired

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DATASCOPE IABP PERFORMANCE CHECKLIST – CS300

SKILLS System Trainer Clinical Setting DISCUSSES THE HEMODYNAMIC RELATIONSHIP BETWEEN THE PATIENT AND IABP THERAPY IN REGARDS TO DIASTOLIC AUGMENTATION

• Increased heart rate • Decrease in patient stroke volume • Ectopy • Increase in patient BP • Decreased SVR

DEMONSTRATES APPROPRIATE INTERVENTION FOR THE FOLLOWING ERRORS IN TIMING AND VERBALIZES POTENTIAL CLINICAL IMPLICATIONS

• Early inflation • Late inflation • Early deflation • Late deflation

PORTABLE OPERATION • Initiates and terminates portable operation • Identifies location of battery charge light

SLAVE CABLES ( IF APPLICABLE): • Identifies location and use of ECG and/or pressure slave cables • Describes proper use of ECG slave cable in the presence of

pacemakers

LOW LEVEL OUTPUT CABLE (IF APPLICABLE): • Identifies location and use of low level output cable

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TROUBLESHOOTING For the following sections indicate 1 for SATISFACTORY OR 2 FOR REPEAT PERFORMANCE NECESSARY:

SCORE:

A. OPERATING MODE AUTO OPERATION MODE

1. Describe ECG and Pressure Source selection

2. Describe Trigger Source selection

3. Describe Auto Timing and Cardiosync 2 with R-Trac

SEMI-AUTO OPERATION MODE 1. Describe ECG and Pressure Source selection

2. Describe Trigger Source selection

3. Describe Auto Timing and Cardiosync 2 with R-Trac

B. PRESSURE SOURCE – DESCRIBES UNDERSTANDING OF HOW PRESSURE SOURCE IS ORIGINATED AND CALIBRATED

1. Fiberoptics

2. Conventional IAB/Transducer

C. TRIGGER - DEMONSTRATES ABILITY TO IDENTIFY VARIABLE TRIGGER SELECTION CRITERIA AND APPROPRIATE USE OF EACH TRIGGER WHICH TRIGGER IS THE MOST APPROPRIATE FOR:

1. Atrial Fibrillation

2. Demand Ventricular Pacemaker, Rate 60

3. AV sequential pacemaker, demand mode

4. Unobtainable ECG signal, regular rhythm, BP 100/50

5. Cardiac arrest with good chest compressions

6. Sinus Tachycardia

7. Sinus Rhythm with frequent PVCs

8. Fixed rate AV sequential pacemaker

9. Atrial pacemaker - 100% paced

D. IAB CATHETER - DEMONSTRATES UNDERSTANDING OF SITUATIONS THAT MAY CAUSE AN IAB CATHETER ALARM AND DESCRIBES APPROPRIATE INTERVENTION DESCRIBE WHY THE FOLLOWING SITUATIONS MAY CAUSE AN IAB CATHETER ALARM

1. Kink in catheter or tubing

2. Pt. sitting straight up in bed

3. IAB has not exited the sheath

E. GAS LOSS - IDENTIFIES AND RECOMMENDS APPROPRIATE ACTION FOR POTENTIAL LOSS OF HELIUM

1. What does blood in the IAB catheter shuttle gas tubing indicate?

2. Describe the nursing considerations that would be involved

3. What status message would appear if the IAB catheter became disconnected from the console?

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F. DEMONSTRATES UNDERSTANDING OF THE HEMODYNAMIC RELATIONSHIP BETWEEN THE PATIENT AND IABP THERAPY DESCRIBE WHY THE FOLLOWING FACTORS WOULD CAUSE THE DIASTOLIC AUGMENTATION

ALARM TO SOUND:

1. Increased heart rate

2. Decrease in patient stroke volume

3. Ectopy

4. Decrease in patient BP

5. Decreased SVR

G TIMING - RECOGNIZES, INDICATES POTENTIAL CLINICAL IMPLICATIONS, AND DEMONSTRATES APPROPRIATE INTERVENTION FOR THE FOLLOWING:

1. Early inflation

2. Late inflation

3. Early deflation

4. Late deflation

H. MISCELLANEOUS PORTABLE OPERATION: 1. Initiates and terminates portable operation

2. Identifies location of battery charge light

SLAVE CABLES: (IF APPLICABLE) 1. Identifies location and use of ECG and/or pressure cables

2. Describes proper use of ECG slave cable in the presence of pacemakers

3. Low Level Output (if applicable)

a. Identifies location and use of low level output cable

INSTRUCTOR SIGNATURE:

COMMENTS:

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Module III

Clinical Considerations

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I. Side Effects/Complications II. Weaning and Removal A. Frequency B. Balloon Augmentation III. Nursing Care Kardex/System Review Care Plan IV. Critical Pathway/Clinical Progression V. Considerations for Transport

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I. Side Effects and Complications of IABP Therapy

Assessment

Prevention

Treatment Options

1. Limb Ischemia

• Check distal pulses, color, temp.

and capillary filling Q30 min x 2

hrs, then Q2 hrs.

• Monitor differential toe

temperatures.

• Use smallest sheath/catheter sizes

indicated.

• Risk factors: female, diabetics,

peripheral vascular diseases.

• Select limb with best pulse.

• Remove sheath and observe for

bleeding.

• Subcutaneous Xylocaine injection

for arterial spasm.

• Change insertion site to opposite

limb.

• Bypass graft femoral artery.

2. Excessive bleeding from insertion

site

• Observation - anteriorly and

posteriorly for blood or

hematoma.

• Careful insertion technique.

• Monitor anticoagulation therapy.

• Prevent catheter movement at

insertion site.

• Apply pressure. Assure distal

flow.

• Surgical repair.

3. Thrombocytopenia • Daily platelet count. • Avoid excessive heparin. • Replace platelets as needed.

4. Immobility of balloon catheter.

• DATASCOPE RECOMMENDS THAT THE IAB NOT BE LEFT IMMOBILE IN THE PATIENT FOR MORE THAN 30".

• Observation of IAB status

indicator movement.

• Observation of augmentation.

• Maintain adequate trigger.

• Observe movement of IAB Status

indicator.

• If unable to inflate the IAB with

the IABP, inflate and deflate the

IAB by hand, using a syringe and

stopcock once every 3-5 min.

• Notify the physician if the IAB is

immobile for > 30".

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Assessment

Prevention

Treatment Options

5. Balloon leak

• Observe tubing for blood with or

without the presence of a blood

detect, low augmentation, and/or

gas loss or IAB catheter alarm.

• Do not remove the IAB from its

tray until it is ready to be inserted.

• If blood is observed in the

pneumatic tubing, disconnect

the balloon from the IABP and

notify the physician immediately.

6. Infection

• Observation of insertion site.

• Blood cultures for symptoms of

infection.

• Sterile technique during insertion

and dressing changes as per

infection control policy.

• Antibiotics.

7. Aortic Dissection

• Assess for pain between

shoulder blades.

• Daily hematocrit.

• If suspected, aortogram may be

indicated.

• Insertion of IAB over guide wire

with fluoroscopic control.

• Balloon removal.

• Surgical repair.

8. Compartment syndrome may

develop after IAB removed.

• Observation of limb for swelling

and/or hardness.

• Measure calf girth.

• Monitor interstitial pressure.

• Use the smallest catheter/ sheath

appropriate.

• Maintain adequate colloid osmotic

pressure.

• Fasciotomy if necessary.

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Plan of Care for IABP Patient Vital Signs: Monitor Q15'-Q30' until stable Including hemodynamic parameters Heart Rate Mean Arterial Pressure CVP Pulmonary Artery Pressure Pulmonary Capillary Wedge Pressure Note and record: Cardiac Output/Cardiac Index

System Vascular Resistance Notify physician if: IABP: Accepted hemodynamic parameters deviate Refill IAB Q2H/PRN Significant change ABG studies or chest film Maintain optimal augmentation afterload Low urine output < 30cc/hr Reduction by adjusting timing PRN Signs of limb ischemia Zero transducer PRN IABP non-functioning > 15" Note placement IAB on chest X-ray

Change Helium tank PRN Special Treatment Needs: Note and record quality of pedal pulses Q30" after insertion x 2H, then Q2H Change IABP dressing - PRN with sterile technique Utilize air mattress/heel protectors PRN Maintain anti-coagulant protocol Observe for side effects/complications of IABP Routine care associated with:

Respiratory and O2 therapy N-G tube Hemodynamic monitoring lines Chest tube IV’s Foley catheter

Intake/Output: Q1H (Strict) Urine Specific Gravity - Q8H Sugar/Acetone PRN Activity: Bedrest with log rolling Do not elevate HOB > 30o-45o

Do not flex balloon leg at groin or knee Utilize fracture bedpan ROM Q8H to uninvolved extremity Dorsiflexion of involved foot Diet: NPO - clear liquid - soft as tolerated Supplemental nutritional support Tube feedings - hyperalimentation Respiratory Therapy: Evaluate breath sounds Q4H & PRN Routine respiratory care of patient with endo tube/trach Sterile suction technique Modified respiratory therapy Coughing and deep breathing, incentive spirometry and nasotrachial suctioning may be utilized Daily Lab Work/PRN Blood Work: SMA - 18 QD Monitor K+, BUN, creatinine closely PRN Cardiac enzymes CPK, isoenzymes QD CBC with Diff. QD/PRN Platelets, PT, PTT, clotting times QD/PRN ABG - monitor closely QD/PRN Chest X-ray QD Urine and serum osmolarity - QD EKG QD - rhythm strips PRN Blood, urine and sputum cultures for temperature 102o

Unit Number:

Bedspace:

Name:

DX:

Physician:

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Nursing Care of the Patient on an Intra-Aortic Balloon Pump

System Potential Problems Nursing Interventions

Cardiac Left Ventricular Failure Monitor Vital Signs q15-30" until stable Blood Pressure MAP, Syst, DA, AOEDP Heart Rate PAP PCWP/LAP Cardiac Output/Cardiac Index CVP SVR (Systemic Vascular Resistance)

Maintain Optimal Diastolic Augmentation and Afterload Reduction Maintain Clarity of ECG Pattern Serving as Trigger Rhythm Strips prn 12 Lead ECGs QD and prn Cardiac Enzymes Check Pacer Function Caution: In the event of Asystole, assure balloon movement by placing Trigger on ECG, Arterial Pressure or Internal (bear in mind a Mean Arterial Pressure of about 50 mmHg is required to visualize augmentation).

Respiratory Pulmonary EdemaPulmonary Emboli Atelectasis Pneumonia Pleural Effusions

Monitor ABGs closely prn Observe Chest X-ray QD

Lung fields Balloon position

Provide appropriate ventilatory support Standard respiratory care on intubated patient with sterile suctioning technique Post-extubation, modified respiratory therapy is utilized

Deep breathing, coughing, chest physiotherapy and naso-tracheal suctioning may be used Elevate HOB 30o

Turning (if hemodynamically stable) cautiously

Neurological Psychiatric

Altered Level of Consciousness Psychosis Over Sedation Cerebral Embolization

Neurological assessment q2h/prn (Pupils, LOC, motor function)

Appropriate sedation Normalization of environment (TV and radio, if appropriate) Uninterrupted rest periods are essential to these patients Emotional support regarding fears and anxieties should be provided to patient and family

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Nursing Care of the Patient on an Intra-Aortic Balloon Pump

System Potential Problems Nursing Interventions

Renal Prerenal Failureacute Renal Failure Urinary Tract Infection Occlusion of Renal Artery

Observe urine output q1h Notify physician if < 30cc or > 200 cc/hr. In absence of diuretics or fluid challenge

Strict Intake and Output Observe patient’s fluid volume status - Intake and output Daily Serum K+, BUN, Creatinine or Blood chemistries qd/prn Daily weight Urine Specific Gravity q8h Urine Electrolytes and Osmolarity qd Note appearance of urine Watch for sings of urinary tract infection Check position of IAB catheter on chest film

Vascular Peripheral Ischemia

Thrombocytopenia Peripheral Embolism Bleeding from Anticoagulation

Check peripheral pulse (q15" x 1 hr, then q2h post-insertion Pedal, Posterior Tibial, Popliteal

Observe color and temperature of involved leg q2h Maintain anticoagulation protocol:

Heparin Aspirin Rheomacrodex

Observe coagulation studies: PT, PTT, Platelets, Hbg and Hct Observe for side effects of anticoagulation therapy: petechiae, ecchymosis, excessive bleeding from catheter insertion sites Avoid flexing the patient’s hip and knee of involved leg due to IAB catheter Apply anti-embolism stockings to non-involved leg

Immunologic Wound InfectionSystemic Sepsis

Monitor temperature Observe WBC Maintain antibiotics Change IAB dressing qd - strict sterile technique Maintain “Best Practice” for all hemodynamic lines and observe for drainage Culture appropriate sites including blood, urine and sputum if specific signs and symptoms

of infection process are present.

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Nursing Care of the Patient on an Intra-Aortic Balloon Pump

System Potential Problems Nursing Interventions

Gastro-intestinal NutritionalStress Ulceration Paralytic Ileus

May have diet as tolerated (clear liquid/soft) Hyperalimentation or tube feedings may be necessary with prolonged intubation Measure abdominal girth q8h Assess bowel sounds q8h Observe for abdominal distention. Use stool softeners and fracture bedpan as appropriate Portable KUB X-ray may be required without interrupting IABP Naso-Gastric tube if appropriate Naso-Gastric drainage q8h for occult blood Provide appropriate antacid regimen

Musculoskeletal ThrombosisDecubitus Ulcer Foot Drop

ROM - Active and Passive to uninvolved leg Dorsiflexion of foot on involved leg Turn (log roll) q1-2h – cautiously if hemodynamically stable Apply air mattress and utilize heel and elbow protectors Use footboard or high top tennis shoes to prevent foot drop

Patient and Family Teaching

Family anxiety Late Distal Emboli Late Aortic Dissection

Reinforce simple explanation to patient and family Discharge planning – communication of progress to nursing floor Observe for and instruct in manifestations of late peripheral ischemia or emboli

Cardiac Assist Device Mechanical Function of IABP Note and record settings according to hospital policy Obtain optimal diastolic augmentation and optimal afterload Reduction prn Notify physician of difficulty Prevent inflation of IABP during Ventricular Ejection Maintain adequate ECG and arterial trace Change Helium tank prn Note IAB autofill q2h/refill prn Watch for signs of balloon leak: frequent loss of augmentation, blood in extender tubing If IAB catheter is immobile for greater than 30 minutes, notify physician for appropriate intervention

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Critical Pathway of the Intra-aortic Balloon Pump Patient

Insertion Pumping Weaning Removal

Blood Work H&H, pt, ptt Platelet count, WBC Prior to removal, obtain: H&H, pt, ptt, platelet count

Diagnostic Procedures Fluoroscopy

Portable CXR Routine CXR qd, radiopaque tip at 2nd to 3rd ICS

Treatments Shave and prep both potential

insertion sites

Monitor insertion site frequently.

Arterial line care per policy.

Dressing change per policy.

Pressure applied and site

dressed per policy.

Activity

Maintain bed rest:

Do not raise HOB > 30 degrees.

Do not flex or bend the leg in which the IAB was inserted.

Assist the patient with log rolling and positioning.

Bed rest per policy.

OOB as tolerated.

Nutrition Will depend on the patient’s condition and the indication for IAB insertion.

Nursing Interventions

Assess patient and monitor hemodynamic alterations per ICU routine.

Administer IV fluids, vasodilator and/or inotropic agents per orders.

Assess patient for pain or discomfort and medicate per physician order.

Assess vascular status (color, sensation and movement) as well as pulse quality

(pedal, posterior tibial, popliteal, femoral, and radial bilaterally).

* Note: diminished left radial pulse may indicate IAB migration.

Maintain anticoagulation protocol per physician order and observe for side effects.

Encourage deep breathing.

Assist the patient with turning and positioning at least q2h.

Observe for urine output > 30cc/hr

* Note: urine output < 30cc/hr may be an indication that the IAB is occluding the renal arteries.

Assure IAB movement, verify IABP controls in accordance with hospital policies.

* Note: IAB should not remain immobile for > 30 minutes in situ.

* Note: change of pedal pulses in affected leg could be a sign of limb ischemia.

Patient Teaching

Educate the patient and family members on IABP therapy utilizing the patient education brochure.

Explain each phase of the IABP process. Instruct patient to:

- apply pressure to insertion site if they should cough or sneeze

- report any chest pain or heaviness

- report any pain, numbness or tingling in their arms or legs

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Critical Pathway of the Intra-aortic Balloon Pump Patient

Insertion Pumping Weaning Removal

Expected Outcomes

Patient and family will have adequate knowledge base of IABP therapy.

Relief of patient and family anxiety.

The patient will experience clinical improvement from the IAB by:

- increasing the supply of myocardial oxygen

- decreasing the demand for myocardial oxygen

This will be evidenced by:

- increased cardiac output

- increased MAP

- decreased PAP/PCWP

- decreased chest pain

Smooth progression through IABP therapy.

Patient hemodynamically stable.

The foregoing is intended to serve as a guideline for the development of a critical pathway. It is not a recommendation from Datascope Corp.

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Clinical Progression - Intra-aortic Balloon Pump Therapy Insertion Pumping Weaning Removal

Description of Phases

A balloon is positioned in your aorta

after being introduced through an

artery.

The IABP shuttles gas from

the console to the balloon

and is timed with your

heart beat.

Decreasing the amount

of assistance your heart

needs from the IABP

Removing the balloon from

your artery.

Teaching

Most insertions of the IAB can be

completed in approx. 15 minutes.

The insertion site will be numbed

prior to insertion. During the

insertion, you may feel some

pressure at the insertion site.

The IABP is helping your

heart but not beating for it.

Pumping will stop every 2

hours for a short period of

time. This is normal.

The amount of time it

takes to wean varies for

each patient.

Removal is typically done

at the bedside and only

takes a few minutes to

complete.

Activity

Bed Rest

- To ensure that the IAB remains in the proper position, you should not sit up or attempt to get out of

bed.

- The leg in which the IAB is inserted should not be bent or flexed.

Your nurse will assist you with turning and changing your position.

Take deep breaths frequently.

Once the IAB is removed,

you will remain in bed for

a specific length of time

depending on what your

physician has ordered.

This is usually 6-8 hours.

Nursing Interventions

Your condition will be monitored according to ICU routine.

The nurse will assess your vital signs, which include:

- Heart rate and rhythm, blood pressure, respirations, pulse checks and other measurements as your

condition warrants.

The insertion site will be checked frequently by your nurse.

The dressing will be changed on a regular basis.

Your nurse will give you pain medication. Please report any of the following:

- chest pain or heaviness, pain, numbness or tingling in your arms or legs.

Report any wetness at the

insertion site.

Diagnostic Procedures

Fluoroscopy (X-ray guidance) may be

utilized during insertion. Chest X-ray

will be done to verify placement of

the IAB.

Routine chest X-rays will be obtained during IABP therapy.

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Clinical Progression - Intra-aortic Balloon Pump Therapy Insertion Pumping Weaning Removal

Nutrition Your diet will depend on your condition and the reason the IAB was inserted.

Lab Tests Blood tests will be obtained

prior to the insertion. Blood tests will be obtained as your condition warrants it.

The foregoing is intended to serve as a guideline for developing a clinical progression for IABP Therapy. It is not a recommendation from Datascope Corp.

This clinical progression is an outline of what to expect for patients and families who require Intra-aortic Balloon Pump Therapy.

Patient Name

Date of IAB insertion

The process will vary for each patient

Patient Questions

Comments

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V. Considerations for Transport A. Purpose of Transport Program

B. Planning the Transport Program 1. Retrieval vs. Referral

2. Coordinator of Transport Team

C. Transport Team 1. Physician

2. Nurse, IABP Technician

D. Transport Program Considerations 1. Team Leader

2. Liabilities

3. Communication and Response Procedure

4. Consent Form and Patient Chart

5. Family Education

6. Patient Management During Transport

E. Vehicle Used for Transport 1. Ambulance

a. power supply

b. equipment on board

c. ramp

d. response time

2. Aircraft

a. power supply

b. equipment on board

F. Equipment Considerations 1. IABP Supplies

2. Drugs

3. Infusion Pumps

4. Respiratory Care

G. Post Transport Considerations 1. Equipment Check

2. Follow-up

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REFERENCE LIST

Barron HV, Bowlby LJ, Breen T, et al. Use of reperfusion therapy for acute myocardial infarction in the United States - data from the National Registry of Myocardial Infarction 2. Circulation 1998;97(12):11.

Barron HV, Every NR, Parsons LS, et al. The use of intra-aortic balloon counterpulsation in patients with cardiogenic

shock complicating acute myocardial infarction: Data from the National Registry of Myocardial Infarction 2.

American Heart Journal 2001;141:933–9. Benchmark Counterpulsation Outcomes Registry 2005. Christenson JT, Licker M, Kalangos A. The role of intra-aortic counterpulsation in high-risk OPCAB surgery: a prospective randomized study. Journal of Cardiovascular Surgery 2003 Jul-Aug;18(4):286-94. Christenson JT, Cohen M, Ferguson JJ III, et al. Trends in intraaortic balloon counterpulsation complications and outcomes in cardiac surgery. Annals of Thoracic Surgery 2002 Oct;74(4):1086-91. Christenson JT, Simonet F, Schmuziger M. Economic impact of preoperative intraaortic balloon pump therapy in high-risk coronary patients. Annals of Thoracic Surgery 2000 Aug;70:510-5. Christenson JT, Simonet F, Badel P, Schmuziger M. Optimal timing of preoperative intraaortic balloon pump support in high-risk coronary patients. Annals of Thoracic Surgery 1999 Sep;68(3):934-9. Christenson JT, Schmuziger M. Preoperative intra-aortic balloon pump therapy in high-risk coronary patients - impact on postoperative inotropic drug use. Today's Therapeutic Trends 1999;17(3):217-225. Christenson JT, Simonet F, Badel P, Schmuziger M. Evaluation of preoperative intra-aortic balloon pump support in high risk coronary patients. European Journal of Cardiothoracic Surgery 1997 Jun;11(6):1097-1103; discussion 1104. Christenson JT, Simonet F, Schmuziger M. The effect of preoperative intra-aortic balloon pump support in high risk patients requiring myocardial revascularization. Journal of Cardiovascular Surgery 1997 Aug;38(34):397-402. Claflin, N, guest editor. AACN Clinical Issues in Critical Care Nursing - Standards and Quality Assurance. Vol. 2, No. 1 J.B. Lippincott Company Philadelphia February 1991. Craver JM, Murrah CP. Elective intraaortic balloon counterpulsation for high-risk off-pump coronary artery bypass operations. Annals of Thoracic Surgery 2001 Apr;71(4):1220-3. Gould KA. Mechanical assist for the failing heart. Critical Care Nursing Clinics of North America WB Saunders Company Philadelphia 1989. Guyton AC. Textbook of Medical Physiology. Seventh Edition; WB Saunders Company Philadelphia 1986. Hasdai D, Califf RM, Thompson TD, et al. Predictors of cardiogenic shock after thrombolytic therapy for acute myocardial infarction. Journal of the American College of Cardiology 2000 Jan; 35(1):136-43. Hasdai D, Holmes DR Jr, Califf RM, et al. Cardiogenic shock complicating acute myocardial infarction: predictors of death. American Heart Journal 1999 Jul;138(1 Pt 1):21-31.

Hochman JS. Cardiogenic shock complicating acute myocardial infarction. Expanding the paradigm. Circulation

2003;107:2998–3002.

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Hochman JS, Sleeper LA, Godfrey E, et al. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK: an international randomized trial of emergency PTCA/CABG-trial design. American Heart Journal 1999 Feb;127(2):313-21. Hollenberg SM, Kavinsky CJ, Parrillo JE. Cardiogenic shock. Annals of Internal Medicine 1999 Jul 6;131(1):47-59. Hudson MP, Granger CB, Stebbins AL, et al. Cardiogenic shock survival and use of intraaortic balloon counterpulsation: results from the GUSTO I and III trials - Abstract #1942. Circulation 1999 Nov;100 Suppl(18):I370. Kahn JK. Intra-Aortic Balloon Pumping/Theory and Clinical Applications in the 21st Century. A Monograph for the Clinician Datascope Corp. December 2004. Kim KB, Lim C, Ahn H, Yang JK. Intraaortic balloon pump therapy facilitates posterior vessel off-pump coronary artery bypass grafting in high-risk patients. Annals of Thoracic Surgery 2001 Jun;71(6):1964-8. Kinney MR, Dear CB, Packa DR, Voorman DN. AACN's Clinical Reference for Critical Care Nursing. Fourth Edition McGraw Hill Book Company 2001. Kovack PJ, Rasak MA, Bates ER, et al. Thrombolysis plus aortic counterpulsation: Improved survival in patients who present to community hospitals with cardiogenic shock. Journal of the American College of Cardiology 1997 Jun;29(7):1454-8. Millar S, Sampson LK, Soukup M. AACN Procedure Manual for Critical Care. WB Saunders Company Philadelphia 1985. Mishra S, Chu WW, Torguson R, et al. Role of prophylactic intra-aortic balloon pump in high-risk patients undergoing percutaneous coronary intervention. American Journal of Cardiology 2006 Sep 1;98(5):608-12. Epub 2006 Jun 30. Ohman EM. Counterpulsation and thrombolysis together improve survival after cardiogenic shock – the TACTICS results. Presented at the 22nd Congress of European Society of Cardiology on August 27, 2000 in Amsterdam, the Netherlands. Quaal SJ. Comprehensive Intra-aortic Balloon Pumping. CV Mosby Company St. Louis 2nd Edition 1993. Quaal SJ, guest editor. AACN Clinical Issues in Critical Care Nursing - Cardiac Assist Devices Vol 2, No. 3, JB Lippincott Company Philadelphia August 1991. Ryan EW, Foster E. Images in cardiovascular medicine. Augmentation of coronary blood flow with intra-aortic balloon pump counter-pulsation. Circulation 2000 Jul 18;102(3):364-5. Sanborn TA, Sleeper LA, Bates ER, et al. Impact of thrombolysis, intra-aortic balloon pump counterpulsation, and their combination in cardiogenic shock complicating acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? Journal of the American College of Cardiology 2000 Sep;36(3 Suppl A):1123-9. Stone GW, Ohman EM, Miller MF, et al. Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction. Journal of the American College of Cardiology 2003 Jun 4;41(11):1940-45. Comment in: Journal of the American College of Cardiology 2003 Jun 4;41(11):1946-7. Suzuki T, Okabe M, Handa M, et al. Usefulness of preoperative intraaortic balloon pump therapy during off-pump coronary artery bypass grafting in high-risk patients. Annals of Thoracic Surgery 2004 Jun;77(6):2056-9; discussion 2059-60. Underhill Sl, Wood SL, Sivarajan ES, Halpenny CJ. Cardiac Nursing. Second Edition. JB Lippincott Philadelphia 1989.

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Vazquez M, Engman Lazear S, Larson EL. Critical Care Nursing. Second Edition WB Saunders Company Philadelphia 1992. Vender JS, guest ed. Intensive care monitoring. Critical Care Clinics WB Saunders Company Philadelphia 1989. Wolvek S. The evolution of the intra-aortic balloon: The Datascope contribution. Journal of Biomaterials Applications 1989 April; 3:527-542.

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BIBLIOGRAPHY THEORY Bolooki H. Clinical Application of Intra-aortic Balloon Pump. Third Edition. Futura Publishing Company Inc, 1998. Cadwell CA, Quaal SJ. Intra-aortic balloon counterpulsation timing, American Journal of Critical Care. July 1996; 5(4):254-261. Donelli A, Jansen JRC, Hoeksel B, et al. Performance of a real-time dicrotic notch detection and prediction algorithm in arrhythmic human aortic pressure signals. Journal of Clinical Monitoring and Computing 2002;17:181–5. Joseph D, Bates S. Intra-aortic balloon pumping - How to stay on course. American Journal of Nursing 1990 Sep; 90(9):42-47. Maccioli GA, Ed. Intra-aortic balloon pump therapy. Baltimore Williams & Wilkins 1997. Maccioli GA, Lucas WJ, Norfleet EA. The intra-aortic balloon pump: A review. Journal of Cardiothoracic Anesthesia 1988;2:365-373. Mahaffey KW, Kruse KR, Ohman EM. Perspectives on the use of intra-aortic balloon counterpulsation in the 1990s. In: Topol EJ, ed. Textbook of Interventional Cardiology St. Louis WB Saunders 1996:303-321. Quaal SJ, guest ed. Critical Care Nursing Clinics of North America. Philadelphia WB Saunders December 1996;8(4). Shinn AE, Joseph D. Concepts of intraaortic balloon counterpulsation. Journal of Cardiovascular Nursing 1994; 8(2):45-60. Takeuchi M, Nohtomi Y, Yoshitani H, et al. Enhanced coronary flow velocity during intra-aortic balloon pumping assessed by transthoracic Doppler echocardiography. Journal of the American College of Cardiology. 2004;43:368–76. Whitman G. Intra-aortic balloon pumping and cardiac mechanics: A programmed lesson. Heart and Lung 1978; 7(6):1034-1050. INDICATIONS Anwar A, Mooney MR, Stertzer SH. Intra-aortic balloon counterpulsation support for elective coronary angioplasty in the setting of poor left ventricular function: A two center experience. The Journal of Invasive Cardiology 1990 July/August;1(4):175-180. Arafa OE, Geiran OR, Anderson K, et al. Intra-aortic balloon pumping after predominantly right ventricular failure after heart transplantation. Annals of Thoracic Surgery 2000;70:1587–93. Baskett RJF, Ghali WA, Maitland A, Hirsch GM. The intra-aortic balloon pump in cardiac surgery. Annals of Thoracic Surgery 2002;74:1276–87. Baskett RJF, O’Connor GT, Hirsch GM, et al. A multicenter comparison of intra-aortic balloon pump utilization in isolated coronary artery bypass graft surgery. Annals of Thoracic Surgery 2003;76:1988–92. Bates ER, Stomel RJ, Hochman JS, Ohman EM. The use of intra-aortic balloon counterpulsation as an adjunct to reperfusion therapy in cardiogenic shock. International Journal of Cardiology 1998;65(Suppl 1):S37–42.

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Bolooki H. Emergency cardiac procedures in patients in cardiogenic shock due to complications in coronary artery disease, Circulation 1989 June;79(6)(Suppl I):I-137-I-147. Briguori C, Sarais C, Pagnotta P, et al. Elective versus provisional intra-aortic balloon pumping in high-risk percutaneous transluminal coronary angioplasty. American Heart Journal 2003;145:700–707. Califf, R.M.; Ohman, E.M., Reocclusion after thrombolytic therapy and percutaneous transluminal coronary angioplasty. Cardiac Assists 1990 March; 5(2). David JS, Gueugniaud PY, Hepp A, et al. Severe heart failure secondary to 5-fluorouracil and low doses of folinic acid: Usefulness of an intra-aortic balloon pump. Critical Care Medicine 2000;28:3358–60. Demas C, Flancbaum L, Scott G. The intra-aortic balloon pump as an adjunctive therapy for severe myocardial contusion. American Journal of Emergency Medicine 1987;5:499–502. Dietl CA, Berkheimer MD, Woods EL, et al. Efficacy and cost effectiveness of preoperative IABP in patients with ejection fraction of 0.25 or less. Annals of Thoracic Surgery 1996;62:401-409. Emmerman CL, Pinchak AC, Hagen JF. Hemodynamic effects of the intra-aortic balloon pump during experimental cardiac arrest. American Journal of Emergency Medicine 1989 July;7:373-383. Emery RW, Eales F, Joyce LD. Mechanical circulatory assistance after heart transplantation. Annals of Thoracic Surgery 1991; 51:43-7. Ferguson JJ, Cohen M, Freedman RJ Jr, et al. The current practice of intra-aortic balloon counterpulsation: Results from the Benchmark Registry. Journal of the American College of Cardiology 2001;38:1456–1462. Freedman RJ Jr. Myoconservation in cardiogenic shock - The use of intra-aortic balloon pumping and other treatment modalities. Cardiac Assists 1992 January;6(2). Freedman RJ Jr. The intra-aortic balloon pump system: Current roles and future directions. Journal of Applied Cardiology 1991;6:313-318. George BS. Thrombolysis and intra-aortic balloon pumping following acute myocardial infarction - Experience in four TAMI studies. Cardiac Assists 1988 October;4(3). Georgen RF, Dietrick JA, Pifarre R. Placement of intra-aortic balloon pump allows definitive biliary surgery in patients with severe cardiac disease. Surgery 1989 September;106(4):808-814. Goodwin M, Hartman J, McKeever L, et al. Safety of intra-aortic balloon counterpulsation in patients with acute myocardial infarction receiving streptokinase intravenously. The American Journal of Cardiology 1989; 64:937-938. Grotz RL, Yeston NS. Intra-aortic balloon counterpulsation in high-risk cardiac patients undergoing non-cardiac surgery. Surgery 1989 July;106(1):1-5. Gunnar RM, Bourdillon PDV, Dixon DW. Guidelines for the early management of patients with acute myocardial infarction. American College of Cardiology 1990 August;16(2):249-292. Gurbel PA, Anderson RD, MacCord CS, et al. Arterial diastolic pressure augmentation by intra-aortic balloon counterpulsation enhances the onset of coronary artery reperfusion by thrombolytic therapy, Circulation 1994; 89(1):361-365. Gutfinger DE, Ott RA, Miller M, et al. Aggressive preoperative use of intra-aortic balloon pump in elderly patients undergoing coronary artery bypass grafting. Annals of Thoracic Surgery 1999;67:610–613.

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Hochman JS, Buller CE, Sleeper LA, et al. Cardiogenic shock complicating acute myocardial infarction--etiologies, management and outcome: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? Journal of the American College of Cardiology 2000 Sep;36(3 Suppl A):1063-70. Hochman JS, Sleeper LA, Webb JG, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. New England Journal of Medicine 1999 Aug; 341(9):625-34. Hochman JS, Boland J, Sleeper LA, et al. Current spectrum of cardiogenic shock and effect of early revascularization on mortality. Results of an international registry. Circulation 1995 Feb 1;91(3):873-881. Comment in: Circulation. 1995 Sep 1;92(5):1349-50. Ishihara M, Sato H, Tateishi H, et al. Intra-aortic balloon pumping as the postangioplasty strategy in acute myocardial infarction. American Heart Journal August 1991;122(2):385-389. Kahn JK, Rutherford BD, McConahay DR. Supported "high risk" coronary angioplasty using intraaortic balloon pump counterpulsation. Journal of the American College of Cardiology 1990 April;15:1151-5. Kern MJ, Aguirre F, Bach R, et al. Augmentation of coronary blood flow by intra-aortic balloon pumping in patients after coronary angioplasty. Circulation 1993 Feb;87(2):500-511. Kern MJ, Aguirre FV, Tatineni S, et al. Enhanced coronary blood flow velocity during intraaortic balloon counterpulsation in critically ill patients. Journal of the American College of Cardiology 1993 Feb;21(2):359-368. Kern MJ. Intra-aortic balloon pumping post-angioplasty - Documentation of increased coronary blood flow. Cardiac Assists 1992 June;6:1-5. Kern MJ. Intra-aortic balloon counterpulsation. Coronary Artery Disease August 1991;2(6):649-660. Lane AS, Woodward AC, Goldman MR. Massive propranolol overdose poorly responsive to pharmacologic therapy: Use of the intra-aortic balloon pump. Annals of Emergency Medicine 1987 Dec;16(12):1381-1383. Lazar HL, Yang XM, Rivers S, et al. Role of percutaneous bypass in reducing infarct size after revascularization for acute coronary insufficiency. Circulation 1991;84(Suppl III):III-416-III-421. Mangano DT, Browner WS, Hollenberg M. Association of perioperative myocardial ischemia with cardiac morbidity and mortality in men undergoing noncardiac surgery. The New England Journal of Medicine 1990 Dec 27; 323(26):1781-8. Marra C, de Santo LS, Amarelli C, et al. Coronary bypass grafting in patients with severe left ventricular dysfunction: A prospective randomized study in timing of perioperative intra-aortic balloon pump support. International Journal of Artificial Organs 2002;25:141–6. Masaki E, Takinami M, Kurata Y, et al. Anesthetic management of high-risk cardiac patients undergoing noncardiac surgery under the support of intra-aortic balloon pump. Journal of Clinical Anesthesia 1999;11:342–5. McNamara NS, Wharton WP, La Rochelle T, Deboard D. Use of intra-aortic counterpulsation in patients with acute myocardial infarction who present to community hospitals. Critical Pathways in Cardiology 2002;1:159–179. Mercer D, Doris P, Salerno TA. Intra-aortic balloon counterpulsation in septic shock. The Canadian Journal of Surgery 1981 Nov;24(6):643-645. Ohman EM, George BS, White CJ, et al. Use of aortic counterpulsation to improve sustained coronary artery patency during acute myocardial infarction. Results of a randomized trial. Circulation 1994 Aug;90(2):792-799. Ohman EM, Califf RM, George BS, et al. The use of intra-aortic balloon pumping as an adjunct to reperfusion therapy in acute myocardial infarction. American Heart Journal 1991 Mar;121(3):895-901.

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Reiss N, el-Banayosy A, Posival H, et al. Transport of hemodynamically unstable patients by a mobile mechanical circulatory support team. Artificial Organs 1996;20:959–63. Ryan TJ, Antman EM, Brooks N, et al. 1999 Update: ACC/AHA guidelines for the management of patients with acute myocardial infarction: Executive summary and recommendations: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). Circulation 1999;100:1016–1030. Schreiber TL, Kodali UR, O’Neill WW, et al. Comparison of acute results of prophylactic intra-aortic balloon pumping with cardiopulmonary support for percutaneous transluminal coronary angioplasty (PTCA). Catheterization and Cardiovascular Diagnosis 1998;45:115–119. Schreiber TL, Miller DH, Zola B. Management of myocardial infarction shock: Current status. American Heart Journal 1989 Feb;117(2):435-443. Siu SC, Kowalchuk GJ, Welty FK, et al. Intra-aortic counterpulsation support in the high-risk cardiac patient undergoing urgent noncardiac surgery. Chest 1991 Jun;99(6):1342-1345. Stomel RJ, Rasak M, Bates ER. Treatment strategies for acute myocardial infarction complicated by cardiogenic shock in a community hospital. Chest 1994;105(4):997-1002. COMPLICATIONS Arceo A, Urban P, Dorsaz PA, et al. In-hospital complications of percutaneous intra-aortic balloon counterpulsation. Angiology 2003;54:577–85. Barnett MG, Swartz MT, Peterson GJ, et al. Vascular complications from intraaortic balloons: Risk analysis. Journal of Vascular Surgery 1994 Jan;19(1):81-89. Brodell GK, Tuzcu EM, Weiss SJ. Intra-aortic balloon pump rupture and entrapment. Cleveland Clinic Journal of Medicine 1989 Oct;56(7):740-742. Cohen M, Ferguson JJ, Freedman RJ Jr, et al. Comparison of outcomes after 8 vs. 9.5 French size intra-aortic balloon counterpulsation catheters based on 9,332 patients in the prospective Benchmark Registry. Catheterization and Cardiovascular Interventions 2002;56(2):200–206. Eltchaninoff H, Dimas AP, Whitlow PL. Complications associated with percutaneous placement and use of intraaortic balloon counterpulsation. American Journal of Cardiology 1993 Feb;71:328-332. Funk M, Gleason J, Foell D. Lower limb ischemia related to use of the intra-aortic balloon pump. Heart and Lung 1989;18:542-552. Goran SF. Vascular complications of the patient undergoing intra-aortic balloon pumping. Critical Care Nursing Clinics of North America 1989 Sep;1(3):459-467. Gottlieb SO, Brinker JA, Borken AM, et al. Identification of patients at high risk for complications of intra-aortic balloon counterpulsation: A multivariate risk factor analysis. American Journal of Cardiology 1984; 53:1135-1139. Kantrowitz A, Wasfie T, Freed PS, et al. Intra-aortic balloon pumping 1967 through 1982: Analysis of complications in 733 patients. American Journal of Cardiology 1986;57(11):976-983. Kvilekval KH, Mason RA, Newton GB, et al. Complications of percutaneous intra-aortic balloon pump Use in patients with peripheral vascular disease. Archives of Surgery 1991 May;126:621-623.

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Lazar JM, Ziady GM, Dummer SJ, et al. Outcome and complications of prolonged intraaortic balloon counterpulsation in cardiac patients. American Journal of Cardiology 1992,Apr;69:955-958. Robicsek F, Holleman JH, Roush TS, et al. Peri-operative intra-aortic balloon assist, decreasing complications to the minimum. Thoracic and Cardiovascular Surgeon 2003;51:115–125. Schecter D, Murali S, Uretsky BF. Vascular entrapment of intra-aortic balloon after short term balloon counterpulsation. Catheterization and Cardiovascular Diagnosis 1991;22:174-176. Stahl KD, Tortolani AJ, Nelson RL, et al, Intra-aortic balloon rupture. ASAIO Journal 1988;XXXIV:496-499. Velez CA, Kahn JK. Compartment syndrome from balloon pump. Catheterization and Cardiovascular Interventions 2000;51:217–219. INSERTION Gorton ME, Soltanzadeh H. Easy removal of surgically placed intra-aortic balloon pump catheter. Annals of Thoracic Surgery 1991;51:325-6. Heebler RF. Simplified technique for open placement and removal of intra-aortic balloon. Annals of Thoracic Surgery 1989;48:134-6. Nash IS, Lorell BH, Fishman RF, et al. A new technique for sheathless percutaneous intra-aortic balloon catheter insertion. Catheterization and Cardiovascular Interventions 1991 May;23(1):57-60. Phillips SJ, Tannenbaum M, Zeff RH, et al. Sheathless insertion of the percutaneous intra-aortic balloon pump: An alternate method. Annals of Thoracic Surgery 1992; 53:162. Shahian DM, Jewell ER. Intra-aortic balloon pump placement through dacron aortofemoral grafts. Journal of Vascular Surgery 1988 Jun;7:795-7. PEDIATRICS Anella J, McCloskey A, Vieweg C. Nursing dynamics of pediatric intra-aortic balloon pumping. Critical Care Nurse 1990 Apr;10(4):24-28. del Nido PJ, Benson LN, Bohn D, et al. Successful use of intra-aortic balloon pumping in a 2-kilogram infant. Annals of Thoracic Surgery 1988 Nov;46:574-576. Dunn JM. The use of intra-aortic balloon pumping in pediatric patients. Cardiac Assists 1989 June; 5(1). Nawa S, Sugawara E, Murakami T, et al. Efficacy of intra-aortic balloon pumping for failing fontan circulation. Chest 1988 Mar;93(3):599-603. Pinkney KA, Minich LL, Tani LY, et al. Current results with intra-aortic balloon pumping in infants and children. Annals of Thoracic Surgery 2002;73:887–91. Veasy LG, Blalock RC, Orth J. Intra-aortic balloon pumping in infants and children. Circulation 1983;68(5):1095-1100. Webster H, Veasy LG. Intra-aortic balloon pumping in children. Heart and Lung 1985;14(6):548-555.

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TRANSPORT Bellinger RL, Califf RM, Mark DB. Helicopter transport of patients during acute myocardial infarction. American Journal of Cardiology 1988 Apr;61:718-722. Gottlieb SO, Chew PH, Chandra N. Portable intra-aortic balloon counterpulsation: Clinical experience and guidelines for use. Catheterization and Cardiovascular Diagnosis 1986;12:18-22. Kramer RP Jr. Helicopter-transported intra-aortic balloon pumping: advanced technology made airborne. Cardiac Assists 1988 Jun;4(2). Mertlich G, Quaal SJ. Air transport of the patient requiring intra-aortic balloon pumping. Critical Care Nursing Clinics of North America 1989 Sep;1(3):443-458. NURSING CARE Bavin TK, Self MA. Weaning from intra-aortic balloon pump support. American Journal of Nursing 1991 Oct;91(10): 54-59. Patacky MG, Garvin BJ, Schwirian PM. Intra-aortic balloon pumping and stress in the coronary care unit. Heart and Lung 1985 Mar;14(2):142-8. Quaal SJ, guest ed. Critical Care Clinics of North America. Philadelphia WB Saunders 1996 Dec;8(4). Shoulders O. Managing the challenge of IABP therapy. Critical Care Nurse 1991 Feb;11(2):60-76. Weinberg LA. Buying time with an intra-aortic balloon pump. Nursing 1988 Sep;18(9):44-49.

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PROGRAM AND SPEAKER EVALUATION Managing IABP Therapy Date: Program Code 05 Please rate the program and speaker items by placing a mark in the appropriate column. Program Evaluation 1

Poor 2

Fair 3

Good 4

Very Good

5 Excellent

1. Program met the stated objectives 2. Content covered topic adequately 3. Overall quality of this program 4. Overall quality of speaker(s) 5. Quality of the program facilities 6. Program met my personal objectives 7. I can incorporate program content

into my practice

Speaker Name: Speaker Evaluation 1

Poor 2

Fair 3

Good 4

Very Good

5 Excellent

1. Objectives – Stated learning objectives met

2. Audiovisual – Contributed to presentation

3. Content – Relevance of content to objectives

4. Presentation – Speaker qualified and held interest

5. Effectiveness – Speaker was organized and effective

6. Practice – Validated and/or changed practice

Comments: Participant Name:

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Datascope Corp.Cardiac Assist Division15 Law DriveFairfield, NJ 07004Tel. 1.973.244.6100

For local contact: Please visit our Websitewww.datascope.comwww.maquet.com

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