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SUPPORT RÉANIMATION CARDIORESPIRATOIRE Indications for ECPR:

Dans le document Annexes complémentaires - ECMO (Page 31-40)

• AHA [American Heart Association] guidelines for CPR recommends consideration of ECMO to aid cardiopulmonary resuscitation in patients who have an easily reversible event, have had excellent CPR.

• ECPR may be indicated on prolonged CPR if good perfusion and metabolic support is documented.

Contraindications for ECPR:

• All contraindications to ECMO use (such as Gestational age < 34 weeks) should apply to ECPR patients.

• DNR orders

• Futility: Unsuccessful CPR (no return of spontaneous circulation) for 5-30 minutes.

ELSO Guidelines – ECPR 2013

• There is insufficient evidence to recommend the routine use of ECPR for patients with cardiac arrest. In settings where it can be rapidly implemented, ECPR may be considered for select patients for whom the suspected etiology of the cardiac arrest is potentially reversible during a limited period of mechanical cardiorespiratory support (Class IIb, LOE C-LD).

INDICATIONS/CONTRE-INDICATIONS

• Extracorporeal CPR (ECPR) should be considered as a rescue therapy for those patients in whom initial ALS measures are unsuccessful and, or to facilitate specific interventions (e.g.

coronary angiography and percutaneous coronary intervention [PCI] or pulmonary thrombectomy for massive pulmonary embolism).

Resuscitation

1. Out-of-hospital cardiac arrest which is refractory to standard advanced life support (ACLS) treatment and:

• The patient meets the enrolment criteria of the CHEER trial, which are o initial cardiac rhythm of ventricular fibrillation; and

o chest compressions were commenced at scene within 10 minutes, and o the cardiac arrest has been prolonged (i.e. > 30 minutes); and

o there are no major co-morbidities, and

o there has been no return of spontaneous circulation despite standard advanced cardiac life support in the field

• The patient is profoundly hypothermic (< 32oC) due to accidental exposure

• The patient has taken a significant overdose of vaso-active drug(s) (i.e. β-blockers, tricyclic acid, digoxin, etc.)

• Any other cause where there is likely to be reversibility of the cardiac arrest if an artificial circulation can be provided.

2. In-hospital cardiac arrest [for which] the cause may be reversible, such as:

• The patient with suspected acute coronary syndrome who arrest in the E&TC (or just prior to arrival) and does not respond to atandard ACLS and the cause is likely to be reversible with treatment in the cardiac catheterisation laboratory

• The patient in the cardia catheterisation laboratory undergoing coronary

angiography who suffers a cardiac arrest and who does not immediately respond to standard CRP

• The patient with suspected massive pulmonary embolism

• Any other cause where there is likely to be reversibility of the underlying condition if an artificial circulation canbe provided.

Exclusions [for ECMO-CPR]:

• Where the prognosis for neurological recovery after prolonged CPR is poor. Examples include out-of-hospital cardiac arrest where the initial cardiac arrest was not witnessed, the initial cardiac rhythm was not ventricular fibrillation and there are no other factors that would have provided neurological protection such as peri-arrest hypothermia

• Where there is no realistic prospect of reversal of the underlying cardiac condition

• Advanced age precludes prolonged intensive care and mechanical support

• Limitation of medical treatement or advanced care plan that preculdes further resuscitation

• Outside normal working hours (9 AM-5 PM, Monday-Friday) unless 2 ICU consultants are immediately available.

ANNEXE C

Synthèse des études cliniques présentement en cours évaluant l’efficacité de l’ECMO chez les patients adultes inscrites sur ClinicalTrials.gov

Titre Comparateurs Population Résultats Fin prévue

Extracorporeal

• Rapidly deteriorating or severe cardiogenic shock

• Central venous pressure >7 mmHg or pulmonary capillary wedge pressure >12 mmHg

Exclusion Criteria:

• Life expectancy <1 year

• Pulmonary emboli or cardiac tamponade

• Untreated bradycardia or tachycardia

• Coma following cardiac arrest

• Hypertrophic obstructive cardiomyopathy

• Peripheral artery disease

• Aortic regurgitation

• Aortic dissection

• Uncontrolled bleeding or TIMI major bleeding within last 6 months

• Known encephalopathy

Primary Outcome:

• Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device at 30 days Secondary Outcomes:

• All-cause mortality at 30 days, 6 months, and 12 months

• Cerebral Performance Category Scale

• Witnessed out-of-hospital cardiac arrest or presumed cardiac cause

• Minimum of 5 minutes of ACLS without sustained ROSC

• Unconsciousness (Glasgow Coma Score <8)

• ECMO team and bed-capacity in cardiac center Exclusion criteria:

• Pregnancy

Primary outcome:

Composite endpoint of survival with good neurological outcome (CPC 1-2) at 6 months

Secondary outcomes:

• Neurological recovery at 30 days

• Cardiac recovery at 30 days

Mai 2018

Titre Comparateurs Population Résultats Fin prévue Standard of Care. A

Randomized

• Known bleeding diathesis or intracranial bleeding

• Acute stroke

• Severe chronic organ dysfunction or other limitations in therapy

• “Do not resuscitate” order or unlikely to survive 180 days

• Pre-arrest cerebral performance category CPC≥3 Emergency

• Patients with witnessed out-of-hospital cardiac arrest, with presumed cardiac cause, immediate initiation of bystander CPR and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support are eligible.

• Patients who do achieve ROSC at first but suffer rearrest afterwards and do not achieve ROSC again after 15 minutes of advanced cardiac life support are considered eligible as well.

Exclusion Criteria:

• Patients younger than 18 years or older than 75 years

• Traumatic cardiac arrest

• Cardiac arrest due to exsanguination, strangulation, hanging or drowning

• Accidental hypothermia as a cause of cardiac arrest

• Women suffering life-threatening amniotic fluid embolism

• Cardiac arrest due to pulmonary artery embolism

• Cardiac arrest due to intoxication

• Cardiac arrest due to intracranial hemorrhage

• Other initial ECG-rhythm than ventricular fibrillation

• Known or clinically apparent pregnancy

Rate of return of spontaneous

circulation (ROSC) Mai 2018

Titre Comparateurs Population Résultats Fin prévue

• Patients with an Allow-natural-death- (AND) or Do-not-attempt-resuscitation (DNAR) order or patients with a terminal illness

• Patients who, for any reason, can not be transported with ongoing CPR

• Insufficient quality of bystander CPR (at the discretion of the emergency physician or EMT)*

• Estimated transportation time exceeding 30 minutes

• Patients with psychiatric conditions

• Mentally handicapped patients

• Patients with severe neurological conditions

• Patients of a nursing institution or other institutionalized patients

• Ward of the state/prisoner A Comparative

ECMO insertion on pre hospital setting In Hospital ECMO

N=210 Age 18-65 Inclusion Criteria:

• Eligible patients have the following combination of criteria:

Adults over 18 years of age and under 65 years of age

And Refractory cardiac arrest (defined by the failure of professionals to resuscitate at the 20th minute of cardiac arrest with a minimum of 3 Automatic External Defibrillator [AED] or equivalent analyze) And Beginning of external cardiac massage within the first 5 minutes after cardiac arrest (no flow < 5 min.) with shockable rhythm or the presence of signs of life during resuscitation (any rhythm): spontaneous movement, absence of mydriasis and/or pupillary response, respiration

And Medical cause of the cardiac arrest

And End-Tidal CO2 (ETCO2) above 10 mm Hg at the time of inclusion

And Absence of major co-morbidity. And Extra-corporeal Membrane Oxygenation (ECMO) team available

Primary Outcome Measures:

Survival with good neurological outcome (CPC 1 or 2) at 6 months Secondary Outcome Measures:

Success rate of the implementation of ECMO ECMO implementation time Immediate complications:

haemorrhage, infection Number of organ harvesting

The quality of survivors' neurological status according to the CPC neurological

classification at D 28 The quality of survivors' neurological status according to the CPC neurological

classification at 2 months The quality of survivors' neurological status according to the CPC neurological

classification at 1 year

Mars 2019

Titre Comparateurs Population Résultats Fin prévue Exclusion Criteria:

Children under 18 years of age Adults over 65 years of age

Period of more than 5 minutes without cardiac massage after collapsing

Known co-morbidity that compromises the prognosis for short or medium-term survival

Cardiac arrest during transportation times

Predictive indicators of the prognosis during cardiac arrest via cerebral and biological monitoring (pupils reflex, breathing, gasp, movement, Cerebral saturation, pupils diameters, and lactates)

Bypass vs. ECMO

• The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

Exclusion Criteria:

• Patients undergoing concomitant cardiac operations with indication for obligate use of cardiopulmonary bypass

• Patient with specific anatomy that require full cardiac decompression such as severe pulmonary hypertension or large heart that are shifted severely into the left chest

• Patients with high likelihood of significant pleural bleeding that will require returning the blood back into the cardiotomy reservoir

• Patients bridged to transplant with ECMO

• Cystic fibrosis/bronchiectasis/resistant infection patients where surgeon will need to remove both lungs prior to implantation

• Patients who the surgeon feels would be better served with CPB rather than ECMO- These patients will be entered into a registry and followed

Primary Outcome Measures:

Bleeding [Time Frame: 72 hours after surgery]

total number of pRBC transfusion Secondary Outcome Measures:

• Mechanical Ventilation Time (days) [Time Frame: 30 Days or discharge date (if earlier than 30 days)]

o Number of days to extubation post transplant

• Intraoperative pRBC transfusion rates

[Time Frame: Intraoperative peri od]

o Number of units of pRBC transfused intraoperatively

• Primary Graft Dysfunction [Time Frame: 72 hours]

o Graft failure or reperfusion injury measured by pgd grade

• Transfusion other than pRBC [Time Frame: 72 hours]

o FFP, platelets,

cryoprecipitate transfusion

• Composite safety outcome [Time Frame: 30 days (if earlier than 30 days)]

Mai 2022

Titre Comparateurs Population Résultats Fin prévue o 30 day mortality, bleeding

requiring reoperation, new ECMO, new renal failure, chronic dialysis

• Initial rhythm of VF/VT or AED administered

• Bystander BLS

• No ROSC Exclusion Criteria:

• ROSC

• Terminal heart failure (NYHA III or IV)

• Severe pulmonary disease (COPD GIII of GIV)

• Oncological disease

• Pregnancy

• Bilateral femoral bypass surgery

• Pre-arrest CPC-score of 3 or 4

• Advanced directive

• Multitrauma (ISS >15)

• Start cannulation > 60 min after arrest

Primary Outcome Measures:

• 30-day survival rate with favorable neurological status [Time Frame: 30 days]

o Favorable neurological status is defined as 1 or 3 on the

o Favorable neurological status is defined as 1 or 3 on the

Primary Outcome Measures: Mai 2018

Titre Comparateurs Population Résultats Fin prévue arrest

(ECPB4OHCA) ECR

NCT01605409

Inclusion Criteria:

• Patients with witnessed out-of-hospital cardiac arrest, with presumed cardiac cause, immediate initiation of bystander CPR and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support are eligible. Patients who do achieve ROSC at first but suffer rearrest afterwards and do not achieve ROSC again after 15 minutes of advanced cardiac life support are considered eligible as well.

Exclusion Criteria:

• Patients younger than 18 years or older than 75 years

• Traumatic cardiac arrest

• Cardiac arrest due to exsanguination, strangulation, hanging or drowning

• Accidental hypothermia as a cause of cardiac arrest

• Women suffering life-threatening amniotic fluid embolism

• Cardiac arrest due to pulmonary artery embolism

• Cardiac arrest due to intoxication

• Cardiac arrest due to intracranial hemorrhage

• Other initial ECG-rhythm than ventricular fibrillation

• Known or clinically apparent pregnancy

• Patients with an Allow-natural-death- (AND) or Do-not-attempt-resuscitation (DNAR) order or patients with a terminal illness

• Patients who, for any reason, can not be transported with ongoing CPR

• Insufficient quality of bystander CPR (at the discretion of the emergency physician or EMT)*

• Estimated transportation time exceeding 30 minutes

• Patients with psychiatric conditions

• Mentally handicapped patients

• Patients with severe neurological conditions

• Patients of a nursing institution or other institutionalized patients

• Ward of the state/prisoner

• Rate of return of spontaneous circulation (ROSC)

[Time Frame: 2-48h]

Titre Comparateurs Population Résultats Fin prévue

• Witnessed arrest

• Bystander CPR (performed by laypersons or EMS if the arrest was EMS-witnessed) or EMS arrival in less than 10 minutes

• Cause of the arrest is presumed to be one of the following:

o No obvious non-cardiac cause is identified o Known overdose of one of the following drugs:

beta-blocker, calcium channel blocker, tricyclic antidepressants or other psychiatric

medications, or digoxin o Hypothermia (with T < 32 °C)

o (5) The patient is pulseless after a minimum of 3 cycles of CPR (by any professional provider) and intubation.

Exclusion Criteria:

• An alternate cause of the arrest is most likely

• Do Not Resuscitate status

• Co-morbidities including congestive heart failure, chronic obstructive pulmonary disease or other significant lung disease, dialysis, liver failure (if co-morbidities are unknown to paramedics they will be assumed not present)

• Active malignancy

• Pre-existing major neurological deficit

Primary Outcome Measures:

• Neurological Status will be assessed at hospital discharge using the Cerebral Performance Category scale

[Time Frame: Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.]

o Cerebral Performance Categories 1 and 2 will be considered favourable outcomes. Adjudication for these outcomes will be assessed with a structured algorithm via chart review blinded to treatment group.

Secondary Outcome Measures:

• Survival will be assessed at hospital discharge

[Time Frame: Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.]

Mai 2023

ANNEXE D

Dans le document Annexes complémentaires - ECMO (Page 31-40)

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