clinical support services managing iabp...

DATASCOPE IS NOW MAQUET CARDIOVASCULAR

CLINICAL SUPPORT SERVICESMANAGING IABP THERAPY - CS100

CS100 Color Display and Keypad Controls

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

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]

MVO2

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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

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1:3 IABP Frequency

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

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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

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. When monitoring pressure through the inner lumen, 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. A 3cc/hour continuous flow through the inner lumen is recommended. The anticoagulation dosage should be in accordance with standard hospital practice for arterial pressure lines and may be modified, on physician discretion, for patients receiving anticoagulation therapy. Per hospital policy, a fast forward flush may be performed hourly to help maintain patency of the inner lumen.

PRECAUTIONS DURING PRESSURE MONITORING THROUGH IAB CATHETER 1. Use a standard flushing apparatus for

arterial pressure monitoring with the inner lumen. Careful technique should be used in the set up and flushing of the arterial pressure monitoring apparatus to minimize the risk of an embolus entering the aorta where it could potentially enter the carotid or coronary arteries.

2. Aspirate and discard a 3cc volume of blood from the inner lumen prior to attaching a flushing apparatus to the female luer hub.

3. Ensure that all air bubbles are removed from the inner lumen and flushing apparatus. In addition, tap the Y-fitting to remove all air bubbles.

4. Prior to fast flushing, stop IAB pumping to reduce the risk of an embolus entering the aortic arch should an embolus be ejected from the inner lumen.

5. For optimal signal quality the inner lumen should not be used for blood sampling.

6. Always aspirate 3cc initially if the inner lumen aortic pressure line or the inner lumen becomes damped. If you meet resistance during aspiration, consider the inner lumen to be occluded. Discontinue the use of the inner lumen by placing a luer cap on the female luer hub.

7. The use of in-line filters or other devices can potentially alter the appearance of the arterial pressure waveform.

8. Do not over-tighten connections.

RECOMMENDATIONS FOR ACHIEVING OPTIMAL PRESSURE SIGNAL QUALITY 1. Use no more than 8 ft. (2.5 m) of a low

compliance pressure tubing such as that supplied by Datascope in the IAB Insertion Kit between the transducer and Y-fitting of the catheter.

2. 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 in the inner lumen.

3. Apply only gentle force to the syringe when aspirating the inner lumen.

4. Do not use a R.O.S. E. (Resonance Over Shoot Eliminator) or other damping device.

5. Remove air from flush bag prior to pressurizing.

6. Prime the pressure set-up using gravity flush.

7. Maintain 300 mmHg of pressure on the flush solution and elevate it above the transducer.

8. 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.

9. Ensure that all air bubbles are removed from the inner lumen and flushing apparatus.

10. Use room temperature flush solution.

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II. Technical Components of the CS100 Intra-Aortic Balloon Pump

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A. Rear Panel

1. Safety Disk/ Condensate Removal System

a. DC Input

b. IAB Fill Port

c. Drain Port

2. Helium Supply

a. Pressure Gauge

b. Manual Fill Port

3. Patient Connections

a. ECG b. Pressure c. Monitor Input d. ECG/Pressure Output

4. Data Communications Outputs a. RS-232 b. Phone Line c. Diagnostic Output 5. Power Cord/Mains

6. System Timer

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B. Monitor CS100

1. Alarm Messages 2. Advisories 3. ECG

a. Lead b. Gain 4. Pressure Source 5. IAB Fill Mode 6. Slow Gas Alarm Status

7. Operation Mode 8. IAB Status Indicator 9. Trigger 10. Heart Rate Display 11. Pressure Display 12. Augmentation Alarm 13. Battery Indicator 14. Helium Indicator

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C. CS100 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. CS100 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. 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. Alarm Messages

1. Trigger Alarms AUTO Operation Mode

a. No Trigger b. Poor Signal Persists

Semi-Auto or Manual Operation Modes a. No Trigger b. No Pressure Trigger c. Check Pacer Timing d. Trigger Interference 2. Catheter Alarms a. Leak in IAB Circuit b. Rapid Gas Loss

c. IAB Disconnected d. Check IAB Catheter e. Blood Detected f. AutoFill Failure - No Helium g. AutoFill Failure h. AutoFill Required

3. Pneumatic Alarms a. High Drive Pressure b. Low Vacuum

4. System Surveillance Alarms a. Electrical Test Fails Code # ________________ b. System Failure c. Safety Disk Test Fails

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B. Advisory Messages 1. Alert Messages AUTO Operation Mode a. Poor Signal Quality

b. No Pressure Source Available c. Unable to Update Timing

Semi-Auto or Manual Operation Modes a. Irregular Pressure Trigger b. Verify Proper Timing c. ECG Detected d. IAB Not Filled e. Manual Fill IAB

All Operation Modes a. Prolonged Time in Standby

b. Maintenance Required Code # _________________ c. No Patient Status Available d. Low Helium e. Low Battery f. Low Battery [EXT]

2. Status Messages AUTO Operation Mode a. Function Unavailable in the AUTO Operation Mode

Semi-Auto and Manual Operation Modes a. Automatic Operation Mode is Disabled b. Gas Loss and Catheter Alarms Disabled

c. Auto R-Wave Deflate d. R-Wave Deflate

All Operation Modes a. System Trainer b. System Test OK c. Autofilling d. Leak Testing Safety Disk e. Slow Gas Alarm Is Off f. Battery in Use g. Battery in Use [EXT)

3. Prompt Messages a. Unplug Disk Outlet b. Plug Disk Outlet c. Manual Fill IAB

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C. Patient Conditions 1. Atrial Fibrillation 2. Ectopics 3. Cardiac Arrest 4. Cardioversion/Defibrillation

D. Changing Helium Tank

E. Safety Disk Leak Test

F. Manual Fill

G. 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. System 90 Series intra-aortic balloon pump will activate the System Failure alarm and deflate the IAB.

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Datascope CS100 IABP Performance Checklist Name: Date: Date and initial the following as completed: Review of hospital policy and procedures: Attends IABP Seminar: Written exam taken: Score: For the following: indicate 1 for Satisfactory, 2 for Repeat Performance Necessary. Initial Set Up

System Trainer

Clinical

Instructor

Initials Establish Power, verify Mains power switch On & IABP On/Off switch ON

Establish Gas Pressure

Establish ECG and Pressure

Zero Transducer

Confirm Initial Control Settings a. IABP controls b. Auxiliary controls c. Override controls

Initial Timing

Identify Inflate Point

Identify Deflate Point

Fill the IAB Catheter and Initiate Pumping a. Attach IAB to appropriate connector

b. Attach connector to safety disk/condensate removal module

c. Press START – observe for the “Autofilling” message

d. Verify optimal augmentation

e. Fine tune deflation timing

f. Assess hemodynamic benefits 1. augmentation 2. afterload reduction

g. Record pressures 1. assisted 2. unassisted

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Troubleshooting For the following sections indicate 1 for SATISFACTORY OR 2 FOR REPEAT PERFORMANCE NECESSARY: SCORE: A. 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

B. 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. Pt. sitting straight up in bed 2. IAB has not exited the sheath

C. 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

D. 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

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E. 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

F. MISCELLANEOUS

1. PORTABLE OPERATION: a. Initiates and terminates portable operation b. Identifies location of battery charge light 2. SLAVE CABLES: (IF APPLICABLE) a. Identifies location and use of ECG and/or pressure cables b. Describes proper use of ECG slave cable in the presence of pacemakers

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 Edema Pulmonary 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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Renal Prerenal Failure acute 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 Infection Systemic 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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Gastro-intestinal Nutritional Stress 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 Thrombosis Decubitus 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

46

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.

47

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.

48

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.

Patient Questions Comments

Patient Name Date of IAB insertion This clinical progression is an outline of what to expect for patients and families who require Intra-aortic Balloon Pump Therapy. The process will vary for each patient.

49

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 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 Gould, K.A., Critical Care Nursing Clinics of North America, Mechanical Assist For The Failing Heart, W.B. Saunders Company, Philadelphia, 1989 Guyton, A.C., Textbook of Medical Physiology, Seventh Edition; W.B. Saunders Company, Philadelphia, 1986 Kinney, M.R.; Dear, C.B.; Packa, D.R.; Voorman, D.N., AACN's Clinical Reference For Critical Care Nursing, Second Edition; McGraw Hill Book Company, 1988 Millar, S.; Sampson, L.K.; Soukup, M., AACN Procedure Manual for Critical Care, W.B. Saunders Company, Philadelphia, 1985 Quaal, S.J., Comprehensive Intra-aortic Balloon Pumping, CV Mosby Company, St.Louis, 2nd Edition 1993 Quaal, S.J.; guest editor, AACN Clinical Issues in Critical Care Nursing - Cardiac Assist Devices, Vol 2, No. 3, J.B. Lippincott Company, Philadelphia, August 1991 Underhill, S.l.; Wood, S.L.; Sivarajan, E.S.; Halpenny, C.J., Cardiac Nursing, Second Edition; J.B. Lippincott, Philadelphia, 1989 Vazquez, M.; Engman Lazear, S.; Larson, E.L., Critical Care Nursing, Second Edition, W.B. Saunders Company, Philadelphia, 1992 Vender, J.S.; guest editor, Critical Care Clinics - Intensive Care Monitoring, W.B. Saunders Company, Philadelphia, 1989

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Bibliography Theory 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 Shinn AE, Joseph D. Concepts of Intraaortic Balloon Counterpulsation. Journal of Cardiovascular Nursing 1994;8(2):45-60 Whitman G. Intra-aortic Balloon Pumping and Cardiac Mechanics: A Programmed Lesson. Heart and Lung 1978;7(6):1034-1050 Wolvek S. The Evolution of the Intra-aortic Balloon: The Datascope Contribution. Journal of Biomaterials Applications 1989 Apr;3:527-542 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 Jul/Aug;1(4):175-180 Barron HV, Every NR, Parsons LS, Angeja B, Goldberg RJ, Gore JM, Chou TM, Investigators in the National Registry of Myocardial Infarction 2. 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 Jun;141(6):933-9 Baskett RJ, O'Connor GT, Hirsch GM, Ghali WA, Sabadosa K, Morton JR, Ross CS, Hernandez F, Nugent WC Jr, Lahey SJ, Sisto DA, Dacey LJ, Klemperer JD, Helm RE Jr, Maitland A, Northern New England Cardiovascular Disease Study Group. A multicenter comparison of intraaortic balloon pump utilization in isolated coronary artery bypass graft surgery. Annals of Thoracic Surgery 2003 Dec;76(6):1988-92;discussion 1992 Bolooki H. Emergency Cardiac Procedures in Patients in Cardiogenic Shock Due to Complications in Coronary Artery Disease. Circulation 1989 Jun;79(6)(Suppl I):I-137-I-147 Briguori C, Sarais C, Pagnotta P, Airoldi F, Liistro F, Sgura F, Spanos V, Carlino M, Montorfano M, Di Mario C, Colombo A. Elective versus provisional intra-aortic balloon pumping in high-risk percutaneous transluminal coronary angioplasty. American Heart Journal 2003 Apr;145(4):700-7

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Brodie BR, Stuckey TD, Hansen C, Muncy D. Intra-aortic balloon counterpulsation before primary percutaneous transluminal coronary angioplasty reduces catheterization laboratory events in high-risk patients with acute myocardial infarction. American Journal of Cardiology 1999 Jul; 84(1):18-23 Chen EW, Canto JG, Parsons LS, Peterson ED, Littrell KA, Every NR, Gibson CM, Hochman JS, Ohman EM, Cheeks M, Barron HV, Investigators in the National Registry of Myocardial Infarction 2. Relation between hospital intra-aortic balloon counterpulsation volume and mortality in acute myocardial infarction complicated by cardiogenic shock. Circulation 2003 Aug 26;108(8):951-7. Epub 2003 Aug 11 Christenson JT, Cohen M, Ferguson JJ III, Freedman RJ, Miller MF, Ohman M, Reddy RC, Stone GW, Urban PM. Trends in intraaortic balloon counterpulsation complications and outcomes in cardiac surgery. Annals of Thoracic Surgery 2002 Oct;74(4):1086-91 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, 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. Optimal timing of preoperative intraaortic balloon pump support in high-risk coronary patients. Annals of Thoracic Surgery 1999 Sep;68(3):934-9 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 Dietl CA, Berkheimer MD, Woods EL, Gilbert CL, Pharr WF, Benoit CH. 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 Eagle KA, Guyton RA, Davidoff R, Ewy GA, Fonger J, Gardner TJ, Gott JP, Herrmann HC, Marlow RA, Nugent W, OConnor GT, Orszulak TA, Rieselbach RE, Winters WL, Yusuf S, Gibbons RJ, Alpert JS, Garson A Jr, Gregoratos G, Russell RO, Ryan TJ, Smith SC Jr. ACC/AHA guidelines for coronary artery bypass graft surgery: executive summary and recommendations : A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 1999 Sep 28;100(13):1464-80 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 Fasseas P, Cohen M, Kopistansky C, Bowers B, McCormick DJ, Kasper K, Christenson JT, Parris TM, Miller MF. Pre-operative intra-aortic balloon counterpulsation in stable patients with left main coronary disease. Journal of Invasive Cardiology 2001;13(10):679-83 Ferguson JJ, Cohen M, Freedman RJ Jr, Stone GW, Miller MF, Joseph DL, Ohman EM. The current practice of intra-aortic balloon counterpulsation: results from the Benchmark Registry. Journal of the American College of Cardiology 2001 Nov 1;38(5):1456-62

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Freedman RJ Jr. The Intra-Aortic Balloon Pump System: Current Roles and Future Directions. Journal of Applied Cardiology 1991;6:313-318 Georgen RF, Dietrick JA, Pifarre R. Placement of Intra-Aortic Balloon Pump Allows Definitive Biliary Surgery In Patients with Severe Cardiac Disease. Surgery 1989 Sep;106(4):808-814 Ghali WA, Ash AS, Hall RE, Moskowitz MA. Variation in hospital rates of intraaortic balloon pump use in coronary artery bypass operations. Annals of Thoracic Surgery 1999 Feb;67(2):441-5 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 Jul;106(1):1-5 Gunnar RM, Bourdillon PDV, Dixon DW. Guidelines for the Early Management of Patients With Acute Myocardial Infarction, Journal of the American College of Cardiology 1990 Aug;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, Selvan A, Codini MA, Alimadadian H, Tanner TM. Aggressive preoperative use of intraaortic balloon pump in elderly patients undergoing coronary artery bypass grafting. Annals of Thoracic Surgery 1999 Mar;67(3):610-3 Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. New England Journal of Medicine 1999 Aug;341(9):625-34 Hochman JS. Cardiogenic shock complicating acute myocardial infarction. Expanding the paradigm. Circulation 2003 Jun 24;107:2998-3002 Holman WL, Li Q, Kiefe CI, McGiffin DC, Ptereson ED, Allman RM, Nielsen VG, Pacifico AD. Prophylactic value of preincision intra-aortic balloon pump: analysis of a statewide experience. Journal of Thoracic and Cardiovascular Surgery 2000 Dec;120(6):1112-9 Ishihara M, et al. Intra-Aortic Balloon Pumping as the Postangioplasty Strategy in Acute Myocardial Infarction. American Heart Journal 1991 Aug;122(2):385-389 Kahn JK, Rutherford BD, McConahay DR. Supported "High Risk" Coronary Angioplasty Using Intraaortic Balloon Pump Counterpulsation. Journal of American College of Cardiology 1990 Apr; 15:1151-5 Kang N, Edwards M, Larbalestier R. Preoperative intraaortic balloon pumps in high-risk patients undergoing open heart surgery. Annals of Thoracic Surgery 2001 Jul;72(1):54-7

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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 Counterpulsation. Coronary Artery Disease 1991 Aug;2(6):649-660 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 Kumbasar SD, Semiz E, Sancaktar O, Yalçinkaya S, Ermis C, Deger N. Concomitant use of intraaortic balloon counterpulsation and streptokinase in acute anterior myocardial infarction. Journal of Vascular Diseases 1999 Jun;50(6):465-71 Lane, A.S.; Woodward, A.C.; Goldman, M.R., 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, Harold L,.MD; 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, D.T.; Browner, W.S.; 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, Della Corte A, Onorati F, Torella M, Nappi G, Cotrufo M. Coronary artery bypass grafting in patients with severe left ventricular dysfunction: a prospective randomized study on the timing of perioperative intraaortic balloon pump support. International Journal of Artificial Organs 2002 Feb;25(2):141-6 McNamara NS, Wharton Jr TP, LaRochelle T, Deboard D. Use of intraaortic balloon counterpulsation in patients with acute myocardial infarction who present to community hospitals. Critical Pathways in Cardiology 2002 Sep;1(3):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 Pt 1): 895-901

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Ryan TJ, Antman EM, Brooks NH, Califf RM, Hillis LD, Hiratzka LF, Rapaport E, Riegel B, Russell RO, Smith EE III, Weaver WD. 1999 Update: ACC/AHA Guidelines for the management of patients with acute myocardial infarction: Executive summary and recommendations: A report of the ACC/AHA Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). Circulation 1999 Aug 31;100(9):1016-1030 Schreiber TL, et al. Management of myocardial infarction shock: Current status. American Heart Journal 1989 Feb;117(2):435-443 Siu,SC, 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 Stone GW, Ohman EM, Miller MF, Joseph DL, Christenson JT, Cohen M, Urban PM, Reddy RC, Freedman RJ, Staman KL, Ferguson JJ III. 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):1940-5. Comment: 1946-7 Thiele H, Lauer B, Hambrecht R, Boudriot E, Sick P, Niebauer J, Falk V, Schuler G. Short- and long-term hemodynamic effects of intra-aortic balloon support in ventricular septal defect complicating acute myocardial infarction. American Journal of Cardiology 2003 Aug 15;92(4):450-4. Comment: 419-20 Toyota E, Goto M, Nakamoto H, Ebata J, Tachibana H, Hiramatsu O, Ogasawara Y, Kajiya F. Endothelium-derived nitric oxide enhances the effect of intraaortic balloon pumping on diastolic coronary flow. Annals of Thoracic Surgery 1999 May;67(5):1254-61 van t Hof AW, Liem AL, de Boer MJ, Hoorntje JC, Suryapranata H, Zijlstra F. A randomized comparison of intra-aortic balloon pumping after primary coronary angioplasty in high-risk patients with acute myocardial infarction. European Heart Journal 1999 May;20(9):659-65 Complications Arafa OE, Pedersen TH, Svennevig JL, Fosse E, Geiran OR. Vascular complications of the intraaortic balloon pump in patients undergoing open heart operations: 15-year experience. Annals of Thoracic Surgery 1999 Mar;67(3):645-51 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 III, Freedman RJ Jr, Miller MF, Reddy RC, Ohman EM, Stone GW, Christenson J, Joseph, DL on behalf of the Benchmark Registry Collaborators. Comparison of outcomes after 8 vs. 9.5 French

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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, et al. Intra-aortic Balloon Pumping 1967 through 1982: Analysis of Complications in 733 Patients. American Journal of Cardiology 1986;57:976-983 Kvilekval KHV, et al. Complications of Percutaneous Intra-aortic Balloon Pump Use in Patients With Peripheral Vascular Disease. Archives of Surgery 1991 May;126:621-623 Lazar HL, et al. Outcome and Complications of Prolonged Intraaortic Balloon Counterpulsation in Cardiac Patients. American Journal of Cardiology 1992 Apr;69:955-958 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 Shin H, Yozu R, Sumida T, Kawada S. Acute ischemic hepatic failure resulting from intraaortic balloon pump malposition. European Journal of Cardiothoracic Surgery 2000 Apr;17(4):492-4 Stahl KD, et al. Intra-aortic Balloon Rupture. ASAIO Journal 1988;XXXIV:496-499 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, et al. A New Technique for Sheathless Percutaneous Intra-aortic Balloon Catheter Insertion. Archives of Surgery 1991 May;126:57-60 Phillips SJ, 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

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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, et al. Successful Use of Intra-aortic Balloon Pumping in a 2-kilogram Infant. Annals of Thoracic Surgery 1988 Nov;46:574-576 Nawa S, 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, Di R, Veasy LG, McGough EC, Hawkins JA. Current results with intraaortic balloon pumping in infants and children. Annals of Thoracic Surgery 2002 Mar;73(3):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 Nov;14(6):548-55 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 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;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:

59

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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