Which mechanical assistance for cardiogenic shock?

Which mechanical assistance for cardiogenic shock? Alain Combes, MD, PhD, Hôpital Pitié-Salpêtrière, AP-HP Inserm UMRS 1166, ican, Institute of Cardiometabolism and Nutrition Pierre et Marie Curie Sorbonne University, Paris, France www.paris-ecmo.org alain.combes@aphp.fr

Conflicts of interest Principal Investigator: EOLIA trial VV ECMO in ARDS NCT01470703 Sponsored by MAQUET, Getinge Group Received honoraria from MAQUET, XENIOS, GAMBRO, ALUNG

The case of the IABP

40% 50%

2010 2012 2014

Therapeutic Strategy: For Whom? Medical cardiogenic shock AMI, end-stage DCM, myocarditis, drug overdose, Tako- Tsubo, sepsis Refractory to conventional treatments Before evolution towards end-stage multiple organ failure Cardiac arrest Post cardiotomy Failure to wean from CPB

Therapeutic Strategy: When to initiate mechanical assistance? Parameters to evaluate: Etiology/Time course of the disease Treatments administered Rapid increase in inotropes Clinical status, in particular neurological status: Is it futile to insert a device? Other clinical signs associated with rapid deterioration of LV function: Nausea, abdominal pain, Alteration of consciousness, skin mottling Tachycardia, rhythm disturbances Ionic disturbances, Acidosis Hepatic / Renal failure Doppler-Echocardiography +++ LVEF <20% Signs of low cardiac output, Ao VTI <7-8cm

Independent predictors of ICU death

The classical indications of mechanical assistance 4 types of indications: «Bridge to recovery» «Bridge to bridge» «Bridge to transplantation» «Destination therapy» But now In the acute setting Bridge to whatever seems reasonable Including withdrawal after a few days If refractory MOF

Which mechanical pump? In the context of acute disease INTERMACS Short-term devices Tandem Heart Impella Thoratec PHP VA-ECMO/ECLS+++ LVADs (HMate II, HWare,TAH) NOT for acute cardiogenic shock?

Tandem Heart pvad

Tandem Heart pvad After transseptal puncture a venous inflow cannula is inserted into the left atrium Oxygenated blood is drawn from there and returned via a centrifugal pump and via an arterial cannula in the femoral artery

Tandem Heart pvad

9,000 to 15,000

Miniature Intraaortic pump: Impella

Miniature Intraaortic pump: Impella The Impella LP2.5 device, a catheter-based miniaturized rotary blood pump, inserted via a 13-F sheath in the femoral artery and placed retrogradely through the aortic valve The microaxial pump continuously aspirates blood from the left ventricle and expels it to the ascending aorta with a maximal flow of 2.5 l/min

Impella 5.0

Impella CP Looks like the Impella 2.5 But with a maximum flow of 4 L/min Like the Impella 2.5, the Impella cvad is percutaneously implanted via a 9 Fr catheter into the LV, Powered by the same console CE Mark in Europe Intended for use for up to 5 d

HeartMate PHP Cannula and integrated impeller expand from 13F at insertion to 24F across the aortic valve Near-physiological mean flow >4 L/min

HeartMate PHP

VA-ECMO is now the first line device In the context of acute refractory cardiac failure

VA-ECMO is best because Easy and rapid set-up, cannulation Limited cut-down, No sterno/cardiotomy Local anesthesia Emergency situations

Peripheral cannulation

VA-ECMO is best because It provides high and stable output flow

The ECMO circuit: Centrifugal pump Electrical Centrifugal pump 0->4000 RPM Can deliver flows up to 8 L/min Very reliable Up to 21 days

The ECMO circuit: Membrane Oxygenator Hollow fiber membrane oxygenator Polymethylpentene Heparin-coated High performance CO2 elimination Blood oxygenation Low pressure drop Long duration 15-21 d

Centrifugal pumps, Consoles Sorin Xenios CardioHelp, Maquet

Results of ECMO In the context of STEMI with refractory cardiac failure

ECMO for fulminant myocarditis

2003-2009 41 patients refractory cardiogenic shock due to fulminant myocarditis Mean age 38±12 years 66%, women Mechanical assistance Thoratec BiVAD (n=6) or ECMO (n=35)

ECMO after complicated cardiac surgery

517 adult patients CABG (37.4%) Isolated valve surgery (14.3%) CABG plus valve surgery (16.8%) Organ transplantation (6.5%) Other combinations (25.0%) Thoracic (61%) vs. Extrathoracic (39%) Hospital outcomes 63% weaned, 24% discharged alive Predictors of hospital death Age>70, diabetes, PreOp renal failure Obesity, Euroscore >20%, Lactate >4

After heart transplantation

In the case of massive pulmonary emboli

Remaining indications for pulmonary embolectomy???

ECMO after cardiac arrest

3-year prospective observational study ECMO for 59 patients Aged 18 75 years With witnessed in-hospital cardiac arrest of cardiac origin Undergoing CPR of more than 10 min Compared with patients Receiving conventional CPR Matching process based On a propensity-score

ECMO

60 min

This poor outcome suggests that the use of ECLS should be more restricted following OH refractory cardiac arrest

ECMO for septic shock with severe LV failure

Venoarterial extracorporeal membrane oxygenation support for refractory cardiovascular dysfunction during severe bacterial septic shock Bréchot et al, Crit Care Med, 2013 Venoarterial ECMO n=222 Refractory septic shock n = 14 2 Deaths under ECMO 2 Deaths in ICU 10 Long-term survivors

Venoarterial extracorporeal membrane oxygenation support for refractory cardiovascular dysfunction during severe bacterial septic shock Bréchot et al, Crit Care Med, 2013 Patients n=14 Value Age, yr, median (range) 45 (28 66) ECMO implantation by UMAC, n 8 Shock onset-to-ecmo interval, hrs, median 24 (3 108) Femoral ECMO, n 14 Left ventricular ejection fraction (%), median 16 (10 30) Catecholamine dose, g/kg/min, median Dobutamine, n= 4 17.5 (6 30) Norepinephrine, n= 9 2.0 (0.5 4.9) Epinephrine, n=13 1.25 (0.1 4.2) Pre-ECMO mean arterial pressure, mmhg, median 72 (53-105) Pre-ECMO central venous pressure, mmhg, median 18 (10-35) Pre-ECMO cardiac index, L/min/m 2, median 1.3 (0.7 2.2) Pre-ECMO systemic resistance vascular index, 3162 (2047-7685) SOFA score, median 18 (8 21) ph, median 7.16 (6.68 7.39) Blood lactate, median 9 (2 17) N-Terminal pro-brain natriuretic peptide, pg/ml 29,788 (1,843 35,000)

Venoarterial extracorporeal membrane oxygenation support for refractory cardiovascular dysfunction during severe bacterial septic shock Bréchot et al, Crit Care Med, 2013 *** ***

The case of a 54 yrs old patient with severe CA pneumonia Had VA-ECMO for septic shock and evolution towards cardiogenic shock

At ECMO initiation

On Day one

On day 5

On day 7

Latest series of VA-ECMO for AMI Intensive Care Med 2016

Latest case series of VA-ECMO for CS-AMI Intensive Care Med 2016

Latest case series of VA-ECMO for CS-AMI Intensive Care Med 2016 47% ICU survival

ENCOURAGE SCORE to predict the outcomes of CS-AMI VA-ECMO. Intensive Care Med 2016 Parameter OR (95% CI) P Component score Age >60 years 2.63 (1.01 6.85) 0.048 5 Female 4.35 (1.29 14.72) 0.018 7 Body mass index >25 kg/m² 3.10 (1.21 7.92) 0.018 6 Glasgow Coma Score <6 3.09 (1.19 8.05) 0.021 6 Creatininemia >150 mmol/l 2.60 (1.05 6.49) 0.04 5 Serum lactate <2 mmol/l 1 0 2 8 mmol/l 4.71 (1.31 17.01) 0.02 8 >8 mmol/l 8.71 (1.76 43.10) 0.004 11 Prothrombin activity <50% 2.80 (1.01 7.77) 0.049 5

ENCOURAGE SCORE to predict the outcomes of CS-AMI VA-ECMO. Parameter OR (95% CI) P Component score Age >60 years 2.63 (1.01 6.85) 0.048 5 Female 4.35 (1.29 14.72) 0.018 7 Score = 13 points Intensive Care Med 2016 Body mass index >25 kg/m² 3.10 (1.21 7.92) 0.018 6 Glasgow Coma Score <6 3.09 (1.19 8.05) 0.021 6 Creatininemia >150 mmol/l 2.60 (1.05 6.49) 0.04 5 Serum lactate <2 mmol/l 1 0 2 8 mmol/l 4.71 (1.31 17.01) 0.02 8 >8 mmol/l 8.71 (1.76 43.10) 0.004 11 Prothrombin activity <50% 2.80 (1.01 7.77) 0.049 5

Cumulative Probability of Survival ENCOURAGE SCORE to predict the outcomes of CS-AMI VA-ECMO. Intensive Care Med 2016 1.0 SCORE 0 12 0.8 SCORE 13 18 0.6 SCORE 19 22 0.4 0.2 P<0.001, log-rank test SCORE 23 27 SCORE 28 0 0 10 20 30 Days after ECMO Initiation

Sensitivity ENCOURAGE SCORE to predict the outcomes of CS-AMI VA-ECMO. 1 Intensive Care Med 2016 0.8 0.6 0.4 0.2 ENCOURAGE, 0.84 (0.77 0.91) CHENG, 28 0.75 (0.66 0.83) SLEEPER, 14 0.72 (0.64 0.81) SAVE, 19 0.71 (0.62 0.80) SAPSII, 25 0.67 (0.58 0.76) SOFA, 25 0.64 (0.55 0.73) 0 1 Specificity GRACE, 27 0.58 (0.49 0.68) 0 0.2 0.4 0.6 0.8 1

IABP + ECMO? To decrease LVEDP and pulmonary edema on ECMO

Do we need specialized ECMO centers???

We need high-volume centers for complex procedures Limitation of the number of ECMO centers is associated with better outcomes

Urgent need for Mobile ECMO retrieval teams Regional network of hospitals connected to a referral medical/surgical cardiac center

The Mobile ECMO rescue team at La Pitié: 2005-2009 experience for refractory cardiac failure

The mobile ECMO rescue team Centres Patients Median distance Median time N (%) (range), Km (range), min Paris urban agglomeration (7 centres) 25 (29) 4 (4-18) 4 (4-26) Paris region (26 centres) 54 (62) 13 (4-53) 19 (7-46) Outside Paris region (4 centres) 8 (9) 88 (87-243) 60 (64-134) Total (37 centres) 87 17 (4-243) 20 (4-134)

The mobile ECMO rescue team 87 patients 2005-2009 57 males, 28 females Mean age: 46.1 [13-76] Etiologies AMI 46% Chronic DCM 16% Other Acute HF= 38% Myocarditis 14 Intoxication 5 Rythmic 4 Post-Partum 3 Hypoxemia 2 Takotsubo 3 Anaphylactic 1 Septic 1

Comparison with in-house patients In the multivariate analysis Adjusted for the inotrope score Stratified for diagnosis and CPR at ECMO start Mortality at hospital discharge in the Cardiac-RESCUE group was not statistically different between groups OR 1.48, 95% CI 0.72 3.00, p=0.29

8.000 km Transatlantic ECMO

8.000 km Transatlantic ECMO 12 patients transported from Martinique/La Réunion To La Pitié, Paris Commercial transatlantic flight No incident during flight

Short-term Mechanical Support for Refractory Cardiogenic Shock What is the evidence?

Short-term Mechanical Support for Refractory Cardiogenic Shock Urgent need for Level A evidence

Assessment of ECMO in AMI with Non-reversible Cardiogenic shock to Halt Organ failure and Reduce mortality

Conclusion AMI-CS is the most frequent indication For emergency mechanical support Initiation before evolution towards end-organ failure +++ VA-ECMO is Cheaper, Easier to set up, More versatile ECMO as a bridge to whatever seems reasonable Regional netwok of hospitals and medical/surgical ECMO center Mobile ECMO rescue team for highly unstable patients New treatment strategies for cardiogenic shock AMI patients ANCHOR trial of early ECMO???