impella presentation

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THE IMPELLA 5.0 PUMP SPENCER DONOVAN URI PHARMD CANDIDATE CLASS OF 2017

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Page 1: Impella Presentation

THE IMPELLA 50 PUMPSPENCER DONOVAN

URI PHARMD CANDIDATE

CLASS OF 2017

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

PATIENT CASEA 55 year old male experienced sudden onset chest pain No prior cardiac history

ECG revealed an acute ST-elevation anterior MI

Found to have an occluded LAD (Left Anterior Descending artery) with thrombus

Chest X-ray also revealed an occluded RCA (Right Coronary Artery)

LAD was wired and ballooned but then closed as he developed ventricular arrhythmias Vasopressors were titrated up given amiodarone and lidocaine

Transvenous pacer was placed to his right ventricle

Despite these interventions ventricular arrhythmias continued and he was hypotensive What would be the next appropriate step in management of this critically-ill patient

ANATOMY OF THE HEART

Blood Flow Through the Heart Available at httpsqphecquoracdnnetmain-qimg-8333fbd38b00369f4257573f90d681f3convert_to_webp=true Accessed October 12 2016

THE IMPELLA 50 PUMP

o The Impella 50 is named for its impeller blades located within the blood outlet area

o This model has been designated as ldquo50rdquo because it can produce a maximum cardiac output of 50 Lmin

o Previous models (ex Impella 25) have been smaller in diameter but generated less cardiac output

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

THE IMPELLA 50 PUMP

o When placed properly the pump will rest directly across the aortic valve

o Impeller blades at the outflow site pull blood from the inlet area across the aortic arch

o Blood is then released at the outflow site in the aorta

o Flow is constant and independent of ventricular contractions

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

AUTOMATED IMPELLA CONTROLLERbull The Impella 50 pump is controlled

by the Impella Automated Controller

bull This computer monitors and controls

bull Aortic pressure

bull Pump position

bull Purge solution flow rate

bull Pump speed

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 12 2016]

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 2: Impella Presentation

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

PATIENT CASEA 55 year old male experienced sudden onset chest pain No prior cardiac history

ECG revealed an acute ST-elevation anterior MI

Found to have an occluded LAD (Left Anterior Descending artery) with thrombus

Chest X-ray also revealed an occluded RCA (Right Coronary Artery)

LAD was wired and ballooned but then closed as he developed ventricular arrhythmias Vasopressors were titrated up given amiodarone and lidocaine

Transvenous pacer was placed to his right ventricle

Despite these interventions ventricular arrhythmias continued and he was hypotensive What would be the next appropriate step in management of this critically-ill patient

ANATOMY OF THE HEART

Blood Flow Through the Heart Available at httpsqphecquoracdnnetmain-qimg-8333fbd38b00369f4257573f90d681f3convert_to_webp=true Accessed October 12 2016

THE IMPELLA 50 PUMP

o The Impella 50 is named for its impeller blades located within the blood outlet area

o This model has been designated as ldquo50rdquo because it can produce a maximum cardiac output of 50 Lmin

o Previous models (ex Impella 25) have been smaller in diameter but generated less cardiac output

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

THE IMPELLA 50 PUMP

o When placed properly the pump will rest directly across the aortic valve

o Impeller blades at the outflow site pull blood from the inlet area across the aortic arch

o Blood is then released at the outflow site in the aorta

o Flow is constant and independent of ventricular contractions

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

AUTOMATED IMPELLA CONTROLLERbull The Impella 50 pump is controlled

by the Impella Automated Controller

bull This computer monitors and controls

bull Aortic pressure

bull Pump position

bull Purge solution flow rate

bull Pump speed

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 12 2016]

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 3: Impella Presentation

PATIENT CASEA 55 year old male experienced sudden onset chest pain No prior cardiac history

ECG revealed an acute ST-elevation anterior MI

Found to have an occluded LAD (Left Anterior Descending artery) with thrombus

Chest X-ray also revealed an occluded RCA (Right Coronary Artery)

LAD was wired and ballooned but then closed as he developed ventricular arrhythmias Vasopressors were titrated up given amiodarone and lidocaine

Transvenous pacer was placed to his right ventricle

Despite these interventions ventricular arrhythmias continued and he was hypotensive What would be the next appropriate step in management of this critically-ill patient

ANATOMY OF THE HEART

Blood Flow Through the Heart Available at httpsqphecquoracdnnetmain-qimg-8333fbd38b00369f4257573f90d681f3convert_to_webp=true Accessed October 12 2016

THE IMPELLA 50 PUMP

o The Impella 50 is named for its impeller blades located within the blood outlet area

o This model has been designated as ldquo50rdquo because it can produce a maximum cardiac output of 50 Lmin

o Previous models (ex Impella 25) have been smaller in diameter but generated less cardiac output

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

THE IMPELLA 50 PUMP

o When placed properly the pump will rest directly across the aortic valve

o Impeller blades at the outflow site pull blood from the inlet area across the aortic arch

o Blood is then released at the outflow site in the aorta

o Flow is constant and independent of ventricular contractions

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

AUTOMATED IMPELLA CONTROLLERbull The Impella 50 pump is controlled

by the Impella Automated Controller

bull This computer monitors and controls

bull Aortic pressure

bull Pump position

bull Purge solution flow rate

bull Pump speed

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 12 2016]

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 4: Impella Presentation

ANATOMY OF THE HEART

Blood Flow Through the Heart Available at httpsqphecquoracdnnetmain-qimg-8333fbd38b00369f4257573f90d681f3convert_to_webp=true Accessed October 12 2016

THE IMPELLA 50 PUMP

o The Impella 50 is named for its impeller blades located within the blood outlet area

o This model has been designated as ldquo50rdquo because it can produce a maximum cardiac output of 50 Lmin

o Previous models (ex Impella 25) have been smaller in diameter but generated less cardiac output

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

THE IMPELLA 50 PUMP

o When placed properly the pump will rest directly across the aortic valve

o Impeller blades at the outflow site pull blood from the inlet area across the aortic arch

o Blood is then released at the outflow site in the aorta

o Flow is constant and independent of ventricular contractions

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

AUTOMATED IMPELLA CONTROLLERbull The Impella 50 pump is controlled

by the Impella Automated Controller

bull This computer monitors and controls

bull Aortic pressure

bull Pump position

bull Purge solution flow rate

bull Pump speed

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 12 2016]

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 5: Impella Presentation

THE IMPELLA 50 PUMP

o The Impella 50 is named for its impeller blades located within the blood outlet area

o This model has been designated as ldquo50rdquo because it can produce a maximum cardiac output of 50 Lmin

o Previous models (ex Impella 25) have been smaller in diameter but generated less cardiac output

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

THE IMPELLA 50 PUMP

o When placed properly the pump will rest directly across the aortic valve

o Impeller blades at the outflow site pull blood from the inlet area across the aortic arch

o Blood is then released at the outflow site in the aorta

o Flow is constant and independent of ventricular contractions

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

AUTOMATED IMPELLA CONTROLLERbull The Impella 50 pump is controlled

by the Impella Automated Controller

bull This computer monitors and controls

bull Aortic pressure

bull Pump position

bull Purge solution flow rate

bull Pump speed

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 12 2016]

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 6: Impella Presentation

THE IMPELLA 50 PUMP

o When placed properly the pump will rest directly across the aortic valve

o Impeller blades at the outflow site pull blood from the inlet area across the aortic arch

o Blood is then released at the outflow site in the aorta

o Flow is constant and independent of ventricular contractions

ABIOMED Impella 50 Available at httpwwwabiomedcomproductsimpella-5-0 Accessed October 1 2016

AUTOMATED IMPELLA CONTROLLERbull The Impella 50 pump is controlled

by the Impella Automated Controller

bull This computer monitors and controls

bull Aortic pressure

bull Pump position

bull Purge solution flow rate

bull Pump speed

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 12 2016]

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 7: Impella Presentation

AUTOMATED IMPELLA CONTROLLERbull The Impella 50 pump is controlled

by the Impella Automated Controller

bull This computer monitors and controls

bull Aortic pressure

bull Pump position

bull Purge solution flow rate

bull Pump speed

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 12 2016]

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 8: Impella Presentation

INDICATIONS FOR USEo Intended for short-term use (le 6 days)

o Indicated for the treatment ofoOngoing cardiogenic shock that occurs immediately (lt 48h) following acute MI

oOpen heart surgery as a result of isolated LV failure that is not responsive too Optimal medical management (ex Pressors inotropes)

o Conventional treatment measures (ex Volume loading with or without IABP)

o Goals of useoReduce ventricular work

oProvide necessary circulatory supporto Allows for recovery of the heart

o Assessment of residual myocardial function

ABIOMED Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery URL httpfilesshareholdercomdownloadsABMD2805511985x0x88491454BACCCC-81E3-4E07-B06A-1344D4E02A6AABMD_News_2016_4_7_Generalpdf [accessed 2016 Oct 2]

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 9: Impella Presentation

CONTRAINDICATIONSo Prosthetic aortic valve

o Heavily calcified aortic valve

o LV mural thrombus

o Aortic insufficiency or aortic valve regurgitation

o Moderate-severe PAD

o Significant right heart failure

o Combined cardiorespiratory failure

o Atrial or ventricular septal defect

o Left ventricular rupture

o Cardiac tamponade

o Heparin intolerance

ABIOMED Impella Ventricular Support Systems for Use During Cardiogenic Shock Instructions For Use amp Clinical Reference Manual URL http2n13d91kz5dk19msjk37lesmwpenginenetdna-cdncomassets0042-9023rC_SHOCK_IFU_Updated_for_v51_August_2016pdf [accessed Oct 1 2016]

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 10: Impella Presentation

PHARMACOLOGICAL MANAGEMENTo The Impella 50 pump is continuously infused with fluid for prevention of clot formation and to keep the motor clear and functioning

o Per CMHs Impella protocol a purge solution of 25000 Units of heparin in 500 mL of 5 dextroseis infused through the pump for short term use

For patients with any form of heparin intolerance (ex HIT) an alternative anticoagulation agent may be used instead (ex Argatroban)o The alternative agent can be infused systemically while the pump continues to run using a dextrose-only

purge solution

o The alternative agent should NOT be administered in combination with the dextrose solution via the pump

McCulloch B Use of the Impella 25 in High-Risk Percutaneous Coronary Interventions Crit Care Nurse 201131e1-e16 URL httpccnaacnjournalsorgcontent311e1fullpdf [accessed Oct 4 2016]

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 11: Impella Presentation

PHARMACOLOGICAL MANAGEMENTAnticoagulation Patients If a patient requires additional anticoagulation while they have an Impella pump the weight-based

heparin protocol should be followed while taking into account the heparin purge solution

The amount of heparin a patient receives should be documented hourly to ensure that they receive the correct amount

Example A patient requires 900 unitshour of heparin

Their Impella pump is delivering 350 unitshour via the purge solution

Therefore their systemic heparin solution should be delivering the remaining 550 unitshour

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 12: Impella Presentation

CONCENTRATION ADJUSTMENTS

Heparin Base SolutionFinal HeparinConcentration

25000 U 500 mL of 5 Dextrose 50 UmL

12500 U 500 mL of 5 Dextrose 25 UmL

6250 U 500 mL of 5 Dextrose 125 UmL

3125 U 500 mL of 5 Dextrose 625 UmL

bull Patients on the Impella pump noted to have an elevated aPTT or have signs of hemolysisbull Hemolysis may typically be identified by either a drop in hemoglobin or redbrown urinebull Concentration of the heparin solution may be decreased in 50 increments as necessary

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 13: Impella Presentation

CMH ORDERADJUSTMENT

2 - 30 mLhrNormal range of Impella purge solution flow rates

50 reduction of normal heparin concentration

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 14: Impella Presentation

ALTERNATIVE OPTIONSIABP = Intra-Aortic Balloon Pump

o Inflation during diastole allows for increased perfusion of the coronary arteries

o Deflation during systole allows for reduction of afterload on the left ventricle

Jones H Kalisetti D Gaba M et al Left Ventricular Assist for High-Risk Percutaneous Coronary Intervention J Invasive Cardiol 201224 (10) 544-550 URL httpwwwinvasivecardiologycomarticlesleft-ventricular-assist-high-risk-percutaneous-coronary-intervention [accessed Oct 3 2016]

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 15: Impella Presentation

ISAR-SHOCK Trial IABP vs Impella 25o ldquoA Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarctionrdquo

o Primary Endpointo Change in cardiac index (ΔCI) from baseline to 30 minutes after implantation

oSecondary Endpointso Lactic acidosis

o Hemolysis

o 30-day mortality

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 16: Impella Presentation

ISAR-SHOCK Trial IABP vs Impella 25o Populationo n = 26 patients with acute MI lt 48h and cardiogenic shock

o 13 received IABP vs 12 received Impella (1 death prior to implantation)

o Resultso ΔCI (Lminm2) was significantly higher in the Impella 25 group (049 plusmn 046) than the IABP group (011 plusmn 031)

o The incidence of hemolysis was significantly higher in the Impella 25 group

o Lactate levels were similar between both groups

o 30-day mortality was 46 for both groups

o Limitationso Small population

o Funded by manufacturer Abiomed

Seyfarth M Sibbing D Bauer I et al A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction J Am Coll Cardiol 2008 52 (19) 1584-1588 URL httpwwwsciencedirectcomsciencearticlepiiS073510970802826X [accessed Oct 5 2016]

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 17: Impella Presentation

IABP vs IMPELLAIABP IMPELLA

Mechanism of ActionDecreases afterload Unloads LV

Increases CO

AdvantagesDoes not enter the heart Functions independently of

ventricular contractility

DisadvantagesMust be appropriately timed with ventricular contractions for efficacy

Enters the heart can potentially damage aortic valve

Adverse Events

Limb ischemiaBleedinghematomaEmbolizationInfectionBalloon rupture

Limb ischemiaBleedinghematomaEmbolizationInfectionDevice failureHemolysis

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 18: Impella Presentation

PATIENT CASEo An Impella 50 pump was inserted via the right femoral artery and the patientrsquos hemodynamics and BP both improved

o The patient then underwent CABG (Coronary Artery Bypass Grafts) x 3 and the Impella 50 pump was removed post-opo Pressure was held for 1 hour

oMinimal blood loss no hematoma distal pulses palpable

o On post-op day 1 he was found to have cool right lower extremity without palpable pulseo Taken for evaluation found to have thrombus in the popliteal artery

o Underwent thrombectomy + fasciotomy for revascularization

o He recovered well after this initial complicationo LVEF improved from baseline 20 35-40 post-op

o No recurrent arrhythmias

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care

Page 19: Impella Presentation

OBJECTIVESo Discuss the mechanism by which the Impella 50 pump unloads the left ventricle

o Identify when an Impella 50 pump is indicated for placement

o Discuss the role of pharmacological management in care of a patient with an Impella 50 pump

o Compare the Impella 50 pump with other standards of care