27th Annual ELSO Conference San Diego, CA€¦ · Impella 2.5 receiving an FDA indication for use in elective and high- risk PCI procedures in 2015 Protect 1 Trial • Aug 2016- The

VA ECMO in the cath lab – best timing? Impella or ECMO?

Michael R. Mooney, MD, FACC, FSCAI, FAHADirector, Coronary Therapeutics

Minneapolis Heart Institute® at Abbott Northwestern Hospital

27th Annual ELSO ConferenceSan Diego, CA

• MHI@ANW--5000 “Level One” STEMIs since 2003– 12% present with shock

• “COOL IT” Program—Resuscitated Cardiac Arrests– MHI@ANW--347 patients (3/4 transferred)– 36.5% (not including DOA) in shock upon arrival.

Mortality rate exceeds 50%

These patients account for the majority of STEMI mortality

A new systems based approach was needed

New Acute CV Systems of Care – more acute CS and RCS

3

Evolution in care – CS and RCSFailed Progress – Persistent Limitation

• Multiple failed trials in CS mortality remains high• Cornerstones of therapy largely unproven

benefit• Pressors may be cardiotoxic• IABP mild help with no survival benefit• New approaches needed

• Cardiac arrest is common– 295,000 OHCA per year in US

• 23% VF• 31% Bystander CPR

– Median survival all rhythms 7.9%, VF 21%– Best EMS systems: ie: Seattle 1998-2001 (resuscitated)

• 17.5% survival to hospital discharge • 34% VT/VF subgroup

– IHCA adults: 19% (despite 95% witnessed or monitored)

• Mortality among patients surviving to be hospitalized– Ontario 72% (1994-2002)– Taipei 75% (2003-4)– Goteborg 68% (2003-5)– Rochester 65% (1998-2001)

Circulation 2010;Jan 26:e12-13

Epidemiology of OHCA

STEMI-Guidelines and Shock

Steg et al. Eur Heart J. 2012;33:2569-2619

Trial n/N n/NRelative Risk

95% CIRelative Risk95% CI

0 0.5 1 2 3

Randomized Studies in Cardiogenic Shock

Follow-up

Revascularization (PCI/CABG)SHOCKSMASHTotal

76/15222/32

103/184

83/14918/23

117/172

0.80 (0.66;0.98)0.87 (0.66;1.29)0.82 (0.70;0.98)

1-year30 days

Early revascularization better

Medical treatmentbetter

0.75 1.5 2.50.25

Norepinephrinebetter

0.75 (0.55;0.93)64/145 50/13528 daysDopamine better

CatecholaminesSOAP II (CS Subgroup)

In-hospital 15/40 13/40 1.15 (0.59;2.27)Up-stream Abciximabbetter

Standard treatmentbetter

Glycoprotein IIb/IIIa-InhibitorsPRAGUE-7

30 days30 days30 days

97/20124/59

4/15125/275

76/1807/20

10/1593/215

1.14 (0.91;1.45)1.16 (0.59;2.69)0.40 (0.13;1.05)1.05 (0.85;1.29)

NO Synthase inhibitionbetter

Placebobetter

NO Synthase InhibitorsTRIUMPHSHOCK-2Cotter et alTotal

30 days 7/19 6/21

IABPbetter

Standard treatmentbetter

1.28 (0.45;3.72)IABPIABP-SHOCK I

30 days30 days30 days

9/219/196/13

24/53

9/205/146/13

20/47

0.95 (0.48;1.90)1.33 (0.57-3.10)1.00 (0.44-2.29)1.06 (0.68-1.66)

LVADbetter

IABPbetter

LVADThiele et alBurkhoff et alSeyfarth et alTotal

Thiele et al. Eur Heart J 2010,31:1828-1835

Causes of Cardiogenic Shock

Predominant LV Failure

74.5%

Acute Severe MR8.3%

VSD4.6%

Isolated RV Shock3.4%

Tamponade/rupture1.7%

Other7.5%

Adapted From Sanborn T. et al, JACC. 2000

AMI Shock

Acute on Chronic

The Shock Trial

Hochman et al NEJM 1999;341:625

Shock Trial: 30 day Mortality (1o Endpoint)

Hochman et al NEJM 1999;341:625

P=NS

The SHOCK Trial: All Patients (6 Yrs)

Hochman et al JAMA 2006; 295:2511

Post-hospital Outcomes of Patients With Acute MI With Cardiogenic Shock: NCDR Findings

Conclusion: The risk carried by cardiogenic shock in acute MI seems to be clustered within the first 60 days, after which patients seem to fare similarly whether or not they experienced shock.

112,668 patients in ACTION Registry-GWTG who survived hospitalization for acute MI, 2007-2012. Among them, 5% had cardiogenic shock.

Shah RU, et al. J Am Coll Cardiol. 2016:67:739-747.

Outcomes With vs Without Cardiogenic Shock Adjusted HR 95% CIDeath

1-60 Days61-365 Days

1.621.08

1.46-1.801.00-1.18

Death or All-Cause Rehospitalization1-60 Days61-365 Days

1.481.10

1.27-1.611.02-1.18

Frequency of CS Has Remained Steady Over Time

NRMI STEMI Registry1

N=25,311

• Inclusion of 293,633 patients from Jan 1995-May 2004 with STEMI or new LBBB

• 775 US Hospitals with on-site PCI• CS developed in 25,311 (8.6%) pts• CS present on admission in 29%

Frequency of Cardiogenic Shock NRMI Registry1

Worcester Heart Attack Study2

• 1975-88 7.5%Gusto-13

• 1995 7.2%1Babaev et al JAMA 2005 294:448

2Goldberg RJ NEJM 1991; 325:11173 Holmes DR JACC 1995 26:668

In-hospital Mortality

Aissaoui et al. Eur Heart J 2012; 33:2535–2543

USIK 1995, USIC 2000, FAST-MI France National Registry

1995 2000 2005

9080706050403020100

Dea

th a

t 30

days

(%)

8.7(7.5-10.0) 4.2

(3.4-5.1)3.6

(3.0-4.4)

51(44-59)

63(56-70)

70(62-77)

ShockNo Shock

Cardiogenic Shock Pathophysiology

• When a critical mass of LV is necrotic and fails to pump, stoke volume and CO falls

• Myocardial and coronary perfusion are compromised causing tachycardia and hypotension

• Increased LVEDP further decreases coronary perfusion

• Increase LV wall stress increases myocardial oxygen demand

• Lactic acidosis worsens myocardial performance

Hollenberg Ann Int Med 1999; 131:47-99

Paradigm Shift in Use of Short-term MCS

Stretch et al. JACC 2014;64:1407-1415

Patient withAcute myocardial infarction (AMI),Congestive heart failure (CHF), or

Coronary artery disease and other heart disease (CAD)

PRE-2007

MCS instituted aftercirculatory collapse

(reactive)

Limited or nopercutaneous MCSdevices available

Organ dysfunctionhas already occurred

Most MCSimplanted surgically

(primarily by cardiac surgeons)

Longer hospitalstay post-surgery

Highermortality

Higherhospital costs

Shorter hospital stayand higher rate ofhome discharges

Avoidanceof organ

dysfunction

POST-2007Percutaneous MCS

devices morereadily available

MCS instituted beforecirculatory collapse

(anticipatory)

MCS increasinglyimplemented without need

for surgical consultation

Lowermortality

Reducedhospital costs

Overview of LV Support Devices

Cannula size (French)Flow (l/min)

Pump speed (rpm)

Insertion/Placement

Anticoagulation

Rec. Duration

Relative Costs to IABP

Tandem Heart

21 venous12-19 arterial

Max. 4.0

Max. 7,500

Peripheral (Femoral

artery + LA)

+

14 Days

+++++

Impella 5.0

21

Max. 5.0

Max. 33,000

Peripheral surgical

(Femoral artery)

+

10 Days

++++

Impella 2.5

12

Max. 2.5

Max. 51,000

Percutaneous(Femoral

artery)

+

10 Days

+++

Impella CP

14

3.7-4.0

Max. 46,000


artery)

+

10 Days

+++

PercutaneousECMO

17-21 venous,

16-18 arterialMax 7.0

Max. 5,000


artery + Vein)

+

7 Days

++

Thiele et al, Eur Heart J 2007; 28:2057-2063Thiele et al. Eur Heart J 2010; 31,1828–1835

Control

IABP

0%

10%

20%

30%

40%

50%

60%

0 30 60 90 120 150 180 210 240 270 300 330 360 390 420

Mor

talit

y

Days after randomization

Logrank p = 0.94

RR 1.0295% CI 0.88-1.19

12-monthmortality

49.2%

48.7%

6-monthmortality

30-daymortality

41.3%

39.7%

51.8%

51.4%

301 181 171 165 161 159 154 152 149 147 146 144 136 45 21

299 174 166 165 159 154 154 152 147 147 146 144 140 55 29

No. at risk

IABP

Control

Thiele et al. Lancet 2013

IABP SHOCK II: 1 year Mortality

No Hemodynamic Benefit of IABP ina Recent Prospective Randomized Trial

Prondzinsky et al. SHOCK 2012;37:378-384

Time in hours

1.5

1.0

0.5

0

Car

diac

Pow

er O

utpu

t (C

PO in

Wat

ts)

Prior 24 48 72 96

p<0.011

N.S

IABP (n=19)No IABP(n=21)

Inotrope dosage was similar between the 2 groups

Inflow(ventricle)

Outflow(aortic root)

aorticvalve

Coronary Perfusion

MicrovascularResistance

LVEDP and LVEDV

O2 Demand

Unloading to Myocardial Recovery

O2 Supply

Mechanical Work

WallTension

Cardiac Power Output

Flow

End Organ Perfusion

MAP

Hemodynamic Effects of Impella Support

Fincke J, et al. Am Coll Cardiol 2004den Uil CA, et al. Eur Heart J 2010Mendoza DD, et al. AMJ 2007Torgersen C, et al. Crit Care 2009Torre-Amione G, et al. J Card Fail 2009

Suga H. et al. Am J Physiol 1979Suga H, et al. Am J Physiol 1981Burkhoff D. et al. Am J Physiol Heart Circ 2005Burkhoff D. et al. Mechanical Properties Of The Heart And Its Interaction With The Vascular System. (White Paper) 2011

Sauren LDC, et al. Artif Organs 2007Meyns B, et al. J Am Coll Cardiol 2003 Remmelink M, et al. atheter.Cardiovasc Interv 2007Aqel RA, et al. J Nucl Cardiol 2009Lam K,. et al. Clin Res Cardiol 2009

Reesink KD, et al. Chest 2004Valgimigli M, et al.Catheter Cardiovasc Interv 2005Remmelink M. et al. Catheter Cardiovasc Interv 2010 Naidu S. et al. Novel Circulation.2011Weber DM, et al. Cardiac Interventions Today Supplement Aug/Sep 2009

20

Impella and the FDA

• Impella 2.5 receiving an FDA indication for use in elective and high-risk PCI procedures in 2015 Protect 1 Trial

• Aug 2016- The FDA approved four Impella heart pumps—including the 2.5, CP, 5.0, and LD devices (Abiomed)—for ongoing cardiogenic shock that occurs within 48 hours of MI or open-heart surgery as a result of left ventricular failure unresponsive to medical therapy and conventional treatment. The devices are approved for use in patients with or without an intra-aortic balloon pump. Recover 1 Trial

ISAR-SHOCK TrialAMI Cardiogenic Shock N=26

STEMI Patients in Profound Cardiogenic Shock

PCI +IMPELLA LP

2.5

PCI +IABP

Primary Endpoint = Hemodynamic Improvement after 20 min of support

1:1R

Seyfarth et al. American College of Cardiology, 2007

Impella

0.53

0.15

0.60

Primary Endpoint: Increase in Cardiac Index From Baseline

(measured after 20 min of support)

Car

diac

Inde

x (L

/min

/m2 )

IABPP<0.01

0.45

0.30

0.75

0 0.11

1.10

0.200.25

1.25

Car

diac

Out

put (

L/m

in)

0.75

0.50

1.50

0

P<0.01

.

ISAR-SHOCK Randomized Trial: IMPELLA 2.5 Provides a Better Hemodynamic Support Than IABP in AMI Cardiogenic Shock

Seyfarth et al. American College of Cardiology, 2007

Improved Hemodynamics and Tissue Perfusion with Impella 5.0 in Shock Patients

p=0.003 p=0.003

Mea

n A

rteria

l Pre

ssur

e(m

mH

g)

0

20

40

60

Pre-Pump

57±13

On-Pump

80 75±13

0

10

20

30

Left

Atri

al P

ress

ure

(l/m

in)

Pre-Pump

25±11 p=0.03

On-Pump

16±6

Pla

sma

Lact

ate

(mm

ol/L

)0

1

2

3

Pre-Pump

2.7±1p=0.004

On-Pump

4

1.3±0.5

Meyns and al. Thoracic Cardiov Surg 2003:51:1-6

01

3

5

2

4

6

Car

diac

Out

put

(l/m

in)

Pre-Pump

4.1±1.3

On-Pump

5.5±1.3

Cardiac Output Mean Arterial Pressure

Left Atrial Pressure Plasma Lactate

(N= 16)

Meta-analysis of Percutaneous LVAD in CGSCGS

Cheng et al, European Heart Journal 2009;30:2102-2108

* Not reported whether the envelopes were opaque and sequentially numbered.IABP, intra-aortic balloon pump; LVAD, left ventricular assist device.

.Study characteristics of included trialsThieleet al.

Burkhoffet al.

Seyfarthet al.

Percutaneous LVAD used TandemHeart TandemHeart Impella LP25

Control IABP IABP IABPTotal number of patients 41 33 26

Setting Single-centre Multi-centre Two-centreRandomization Yes Yes YesSequence generation Drawing

EnvelopesNot reported Not reported

Concealment ofallocation

Sealed envelopes Not reported Not reported

Blinding Not possible Not possible Not possibleHandling of patient attrition

Complete follow-up Complete follow-up Complete follow-up

Hemodynamics


Cardiac indexMean Difference

LVADMean + SD

Thiele et al.

Pooled

Burkoff et al.

P(heterogeneity) = 0.22l2 = 34.0%

Seyfarth et al.

IABPMean + SD

Mean Arterial PressureMean Difference

LVADMean + SD

Thiele et al.

Pooled

Burkoff et al.


Seyfarth et al.

IABPMean + SD

Pulmonary wedge pressureMean Difference

LVADMean + SD

Thiele et al.

Pooled

Burkoff et al.


Seyfarth et al.

IABPMean + SD

Favors IABP Favors LVAD

2.3 + 0.62.2 + 0.62.2 + 0.6

1.8 + 0.42.1 + 0.21.8 + 0.7

0.55 (0.23-0.87)0.16 (-0.14-0.46)0.35 (-0.16-0.88)0.35 (0.09-0.61)

-2 -1 0 1 2

76 + 1091 + 1687 + 18

70 + 1672 + 1271 + 22

0.55 (-2.9-13.9)18.6 (9.4-27.9)16.0 (0.5-31.5)12.8 (3.6-22.0)

-50 -25 0Favors IABP Favors LVAD

25 50

-20 -10 0Favors LVAD Favors IABP

16 + 516 + 419 + 5

22 + 725 + 320 + 6

-5.6 (-9.2 to -2.1)-8.4 (-11.0 to -5.8)-1.0 (-5.2-3.2)-5.3 (-9.4 to -1.2)

10 20

30 Day Mortality

30-day MortalityRelative Risk

LVADn/N

Thiele et al.

Pooled

Burkoff et al.

P(heterogeneity) = 0.83l2 = 0%

Seyfarth et al.

IABPn/N

9/19

6/13

5/14

6/13

0.95 (0.48-1.90)

1.33 (0.57-3.10)

1.00 (0.44-2.29)

1.06 (0.68-1.66)

0.1 1 10

Favors IABPFavors LVAD

9/21 9/20

24/53 20/47


ComplicationsReported Leg Ischemia

Relative RiskLVADn/N

Thiele et al.

Pooled

Burkoff et al.


Seyfarth et al.

IABPn/N

Favors LVAD Favors IABP

7/214/191/13

0/202/140/13

14.32 (0.87-235.4)1.47 (0.31-6.95)3.00 (0.13-67.51)2.59 (0.75-8.97)

0.0001 0.01 1 100 10,000

12/53 2/47

Reported BleedingRelative Risk

LVADn/N

Thiele et al.

PooledBurkoff et al.


IABPn/N


19/218/19

8/202/14

2.26 (1.30-3.94)2.95 (0.74-11.80)2.35 (1.40-3.93)

0.01 0.1 1 10 100

27/40 10/34

Reported Fever or SepsisRelative Risk

LVADn/N


IABPn/N


17/214/19

10/205/14

1.62 (1.00-2.63)0.59 (0.19-1.80)1.11 (0.43-2.90)

0.01 0.1 1 10 100

21/40 15/34

Thiele et al.

Pooled

Burkoff et al.


US Pella Registry: Main Indications for Support

AMI Shock,

20%

Other Forms of Shock,

14%

Urgent PCI**, 37%

Elective PCI*, 29%

Others includes Myocarditis with shock, Post-cardiotomy shock, septic shock, toxic shock, post partum cardiomyopathy, other cardiomyopathies with shock

High Risk PCI

(66%)

(N=352 patients at 24 centers)

* Elective = Stable angina or silent ischemia** Urgent = Unstable angina or Non ST elevation Myocardial Infarction

Inclusion Criteria:• STEMI or NSTEMI patients with Cardiogenic shock • Shock defined clinically as:

• SBP < 90mmHg for > 30min or need of inotropes to maintain SBP• or Cardiac index <2.2 l/min/m2

• Pump placed emergently to restore hemodynamics

AMI Shock Registry DesignImpella 2.5 used for AMI Cardiogenic Shock

(physician’s decision)

Survival to Discharge or 30-days

Exclusion Criteria:• AMI patients with stable hemodynamics• Other forms of Shock with no AMI• Prophylactic support for high risk PCI• Contra-indication to use Impella 2.5

Cardiac Index

Car

diac

Inde

x(l/

min

/m2 )

Wedge Pressure

OnImpella

PC

WP

(mm

Hg)

PreImpella*

1.9±0.6

SVR

SV

R(x

100

0 dy

nes/

sec

x cm

-5)

2.2±0.8

OnImpella

PreImpella*

OnImpella

PreImpella*

2.7±0.9

28±9

21±12

p=0.002

p=0.04p=0.04

Mean Arterial Pressure

62±17

92±21p<0.0001

* Pre-Impella measurements were recorded under clinical conditions (i.e, with inotropes + IABP)

1.5±0.4

MA

P(m

mH

g)

OnImpella

PreImpella*

Impella Improves Immediately the Hemodynamics in AMI Shock

60 mmHg in MAP is the considered minimum threshold for adequate

coronary, cerebral and renal perfusion

On IABP

82±19

Switchedto Impella

113±30

47±16

66±16

Systolic Blood Pressure Diastolic Blood Pressure Mean Arterial Pressure

Comparisons made for ALL AMI shock patients that were on IABP then switched to Impella forwhom pre and post blood pressure values were available (N=20)

P=0.0002 p<0.0001p<0.0001

Patient serve as his/her own control (N=20)

On IABP Switchedto Impella

Bloo

d Pr

essu

re (m

mH

g)

Gain = + 38% Gain = + 40% Gain = + 41%

59±1583±17

On IABP Switchedto Impella

Gain on Hemodynamics WhenSwitching from IABP to Impella in AMI Shock

Largest Cohort To Study The Current Use of Impella in Cardiogenic Shock

O’Neill et al, Jour of Interv. Cardiol. 2013 (In press)

Impella Insertion Timing(N= 154)

41.0%59.0%Prior to

PCI(n=63)

Post PCI(n=91)

pre

post

Outcome100

80

60

40

20

0

0 5 10 15 20 25 30

Surv

ival

(%)

Post-PCI

Pre - PCI

Days from initiation of Impella 2.5 support

154 101 88 79 69 67 63

Number of patients at risk

Log-rank test, p=0.004

DanShock Trial – Enrolling• Lactate > 2.5 mmol/l

• SBP < 100 mmHg oder Vasopressoren

• LV-EF < 35%

Conventional Therapy + IABP + PCI

(n=180)

Acute MI (STEMI < 36 h)

Shock

PCI (CABG)

Eligible

Randomization

Conventional Therapy + Impella cVAD + PCI

(n=180)

1 Endpoint: All Cause Mortality

Potential Indications for Mechanical Circulatory Support

36

CardiacAssist TandemHeart

• Access to LA via standard transseptal technique

• Catheter exchanges made with Valvuloplasty guidewire or Amplatz soft tip wire

• Dilate septum with 2-stage (14/21 Fr.) dilator

• Place cannula in LA

0200400600800

1000120014001600

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

300% Growth in Annual Procedures in Last 2 years

ELSO Registry

Adult Cardiac ECMO UseAn

nual

Rep

orte

d Pr

oced

ures

CPR with ECLS vs. Conventional CPR:In-Hospital Cardiac Arrest

Survival to Discharge Based Upon Duration of CPR

Chen et al, Lancet 2008

ECMO – Not A Free Lunch!

• Possibility of centrally deoxygenated blood Brain Perfusion

• Limb Ischemia• Bleeding• Need for Transfusion• Inflammatory Response• Increased Afterload ??

Protek DUO

Coaxial dual lumen29 Fr outer, 16 Fr inner

Compatible with multiple centrifugal flow pumps

4242

STATE OF CURRENT KNOWLEDGE

• TTM for CA is effective, guideline supported,and best done within the STEMI network system of care

• Survival for CA should be 50%• ECMO is a fast moving trend for RCS and refractory CA• ECMO is best done within the STEMI network system of

care• The best ECMO candidate has a STEMI and refractory CS,

the most challenging ECMO has OOH refractory CA

Percutaneous Left Ventricular Support Devices

Werdan et al, EHJ 2014

1.Percutaneous MCS provides superior hemodynamic support compared to pharmacologic therapy. This is particularly apparent for the Impella and Tandem-Heart devices. These devices should remain available clinically and be appropriately reimbursed.

2.Patients in cardiogenic shock represent an extremely high risk group in whom mortality has remained high despite revascularization and pharmacologic therapies. Early placement of an appropriate MCS may be considered in those who fail to stabilize or show signs of improvement quickly after initial interventions.

3.MCS may be considered for patients undergoing high-risk PCI, such as those requiring multivessel, left main, or last patent conduit interventions, particularly if the patient is inoperable or has severely decreased ejection fraction or elevated cardiac filling pressures.

4.In the setting of profound cardiogenic shock, IABP is less likely to provide benefit than continuous flow pumps including the Impella CP and TandemHeart. ECMO may also provide benefit, particularly for patients with impaired respiratory gas exchange.

5.Patients with acute decompensated heart failure may benefit from early use of percutaneous MCS when they continue to deteriorate despite initial interventions. MCS may be considered if patients are candidates for surgically implanted VADs or if rapid recovery is expected (e.g., fulminant myocarditis or stress-induced cardiomyopathy).

6.When oxygenation remains impaired, adding an oxygenator to a TandemHeart circuit or use of ECMO should be considered based upon local availability.

7.There are insufficient data to support or refute the notion that routine use of MCSs as an adjunct to primary revascularization in the setting of large acute myocardial infarction is useful in reducing reperfusion injury or infarct size. Exploratory studies are underway.

8.MCSs may be used for failure to wean off cardiopulmonary bypass, considered as an adjunct to high-risk electrophysiologic procedures when prolonged hypotension is anticipated, or rarely, for valvular interventions.

9.Severe biventricular failure may require use of both right- and left-sided percutaneous MCS or veno-arterial ECMO. Certain patients may respond to LVAD implantation with inotropes and/or pulmonary vasodilators to support the right heart. MCS may also be considered for isolated acute RVF complicated by cardiogenic shock.

10.Registries and randomized controlled trials comparing different strategies in different clinical scenarios are critically needed.

11.Early analyses suggest cost-effectiveness of MCS for emergent use in comparison to surgical ECMO or VAD support, and for elective use in comparison to IABP. Further data are necessary.

• MHI@ANW--5000 “Level One” STEMIs since 2003– 12% present with shock

• “COOL IT” Program—Resuscitated Cardiac Arrests– MHI@ANW--347 patients (3/4 transferred)– 36.5% (not including DOA) in shock upon arrival.

Mortality rate exceeds 50%

These patients account for the majority of STEMI mortality

A new systems based approach was needed

New Acute CV Systems of Care – more acute CS and RCS

Emergency “E-ECMO” Multidisciplinary, experienced team members that rapidly respond and come together when a patient is evaluated for emergent ECMO.

Pharmacist

Cardiac DiagnosticTech

Perfusion Team/Hemodynamic

SupportTeam

RespiratoryTherapy CV Emergency

Nurse Clinician

CV Surgeon,Vascular Surgeon

Chaplain

ICU charge RN

Emergency Shock/ ECMOResponse Team.

CV EmergencyProgram Manager

PhysiciansCardiology, Intensivist,

Interventionalist, Heart Failure

CV Lab Team

Shock Team Internal Communications Protocol

OR

SHOCK TEAM PAGER ACTIVATION

Ward/CCU Inpatient

Initiate MCS (Cath Lab/OR)

Outside Call to HF Intensivist

Shock Patient Accepted for

Transfer

Cath Lab Patient

Shock Interventionalist Shock Surgeon Shock Fellow Shock

Intensivist

Shock Team Recommendation

Medical Management

ECLYPSISNOTE

CCU Fellow

48

Utilization of TTM, a Systems of Care Approach

49

Unstable patient Assessment

• Frequent looks in transitioning patients• ABG, A- line, oximetry, mentation• Right heart cath with CI• Lactate clearance• Stat echo• Revasc – but just as a start• If problem likely acute with reversible elements• Collaborate early

• Rate of PCI increased from 44.9% before shock was excluded from NY reporting requirements to 49.2% afterwards across all states, with a greater increase seen in New York

• PCI rates remained lower in New York than in other states throughout the study period

• In-hospital mortality fell from 44.7% to 37.9% across all states, with a greater decline in New York

45,977 patients treated in New York, three nonreporting states (Michigan, New Jersey, and California), or Massachusetts.

McCabe JM, et al. JAMA Cardiol.2016;Epub ahead of print.

Treatment, Outcomes of Acute MI Complicated by Shock After Public Reporting Policy Changes in New York

Conclusion: Exclusion of patients with cardiogenic shock from New York’s public reporting requirements for PCI coincided with an uptick in PCI use for these high-risk patients.

51

Today’s Cardiac Cath Lab…

• Treatment Space– Where we do PCI/Structural and Peripheral

Interventions but also Resucitation and Critical Care

• Hemodynamic Laboratory– Right and left left heart catheterizations – under

utilized but critical to patient management• Learning Space to Improve Future Patient Care• Ideal space for multidisciplinary collaboration

52

Hemodynamics are Key to Patient Management

• We make people ischemic during PCI! Catheters interfere with aorto-ostial flow,

• LM lesions and large bore catheters

Contrast does not contain hemoglobin and is a myocardial depressant

Inflated microcatheters, inflated balloons, stents obstruct blood flow!

• Adverse hemodynamics can make what appears to be a controlled and stable situation unstable –cannot be ignored

Cardiogenic Shock is a Spectrum

Three HighDose

2% 3% 7.5%21%

42%

80%

Pre-Shock Profound ShockShock

No HemodynamicSupport

Needs Partial Hemodynamic Support

Needs Full Hemodynamic Support

Mortality Risk with Inotrope Dosing

Samuels LE et al , J Card Surg. 1999 Jul-Aug;14(4):288-93

Mortality

Card

iac

Inde

x

1.0

Medical Therapy

3.0

2.0

Pre-Shock Shock Severe Shock

Trea

tmen

t

IABPImpella

ECMO/VAD

Consider acidosis, lactate clr, oxygenation , RV function

COLLABORATE with TEAM

Team Decisions are Key in Good Outcomes

55 Seder ,Crit Care Med 2009;37 (Suppl):S211-S222.

Venous to arterial conduit with oxygenator

Can deliver 6 l/min CO Generally 18-21 Fr venous

and 14-16 Fr arterial catheters

No randomized trials Observational data only

Percutaneous Cardiopulmonary Bypass (ECMO or CPS)

Lifebridge B2T Pump

58

The best TH and E-CPR ecmo patient is/has:

• OOH with <15 min down time• Witnessed• VF/VT and age <75 yo• Bystander CPR• Has a STEMI• Lives in Minnesota, Seattle , Arizona, Tennessee,

Ottawa, Lehigh Valley (systems of care)• Gets cooling in the first hour after rosc

59

Cardiac – 5603 pts56% survived ECLS41% survived to DCECPR 1657 28% survived to DC

Respiratory – 7008 pts65% survived ECLS57% survived to DC

60

ECPR - survival

0

10

20

30

40

50

60

70

80

90

ELSO ANW

n= 1657 n= 45

Mostly RCS

0

10

20

30

40

50

60

70

ECMO Discharge

EF %

Ejection Fraction: % at ECMO placement and % at Discharge

What have we learned?• ECMO can be incorporated into a STEMI program and be

implemented w/in 40 min• Lucas or mechanical CPR is now essential in our CV labs• Antegrade perfusion limbs must be established early and

ultrasound guidance reduces complications• LV unloading is not essential for LV recovery –as LV emptying

and return of pusatile flow is very early and common• TH can be used in ECMO pts safely and lead to favorable CPC• Patient Selection- collaboration with CHF/transplant team

RCS and ECMO – What have we learned

• ECMO can be a life saving technique when instituted by an experienced Shock Team in the CV Laboratory for refractory Cardiogenic Shock.

• Striking recovery of LV function can also occur in several days• ECMO should be developed in selected PCI centers as part of

a system of care for acute cardiac emergencies. It is best delivered in the Cath lab by Interventionalists/Intensivist.

• Many issues will need to be verified by clinical trials, but should not delay the programatic offering of this therapy.

• Many common understanding of ECMO are outdated. ECMO is a transformative therapy.

6464

GAPS IN CURRENT KNOWLEDGE

• SCAI and Mission Lifeline involvement• Clinical trials and registry formation• We are behind many centers in Europe• Raise awareness• Maquet systems w/o emergency perfusionist may enable

dispersion and subsequent transfer to ECMO Center• Accurate early neuro-prognostication• Integration of E-ECMO and E-CPR into regional STEMI

Networks• Systems of care that support regional Centers of Excellence in

ECMO and CA

65

The End

Documents

27th Annual ELSO Conference San Diego, CA€¦ · Impella 2.5 receiving an FDA indication for use in elective and high- risk PCI procedures in 2015 Protect 1 Trial • Aug 2016- The