Download 8.01.60 Extracorporeal Membrane Oxygenation for Adult Conditions

MEDICAL POLICY
POLICY
RELATED POLICIES
POLICY GUIDELINES
CODING
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
APPENDIX
HISTORY
Extracorporeal Membrane Oxygenation for Adult
Conditions
Number
Effective Date
Revision Date(s)
Replaces
8.01.60
August 1, 2016
07/12/16; 03/10/15
N/A
Policy
[TOP]
The use of extracorporeal membrane oxygenation (ECMO) in adults may be considered medically necessary for
the management of adults with acute respiratory failure when all of the following criteria are met:
 Respiratory failure is due to a potentially reversible etiology (see Policy Guidelines); AND
 Respiratory failure is severe, as determined by 1 of the following:
o
A standardized severity instrument such as the Murray score (see Policy Guidelines ); OR
o
One of the criteria for respiratory failure severity outlined in the Policy Guidelines.
AND
 None of the following contraindications are present:
o High ventilator pressure (peak inspiratory pressure >30 cm H2O) or high FIO2 (>80%) ventilation for
more than 168 hours;
o Signs of intracranial bleeding
o Multisystem organ failure;
o Prior (i.e., before onset of need for ECMO) diagnosis of a terminal condition with expected survival <6
months;
o A do-not-resuscitate (DNR) directive;
o Cardiac decompensation in a patient already declined for ventricular assist device (VAD) or
transplant;
o KNOWN neurologic devastation without potential to recover meaningful function;
o Determination of care futility (see Policy Guidelines section).
The use of ECMO in adults may be considered medically necessary as a bridge to heart, lung, or combined
heart-lung transplantation for the management of adults with respiratory, cardiac, or combined cardiorespiratory
failure refractory to optimal conventional therapy.
The use of ECMO in adult patients is considered investigational when the above criteria are not met, including
but not limited to acute and refractory cardiogenic shock and as an adjunct to cardiopulmonary resuscitation.
Related Policies
[TOP]
None
Policy Guidelines
[TOP]
Extracorporeal membrane oxygenation (ECMO) is considered investigational for most cases of cardiogenic
shock. However, In individual clinical situations, ECMO may be considered beneficial/life-saving for relatively
short-term support (i.e., days) for cardiogenic shock refractory to standard therapy in specific situations when
shock is thought to be due to a potentially reversible condition, such as ST elevation acute myocardial infarction,
acute myocarditis, peripartum cardiomyopathy, or acute rejection in a heart transplant, AND when there is
reasonable expectation for recovery.
Applications and Definitions
Adults are considered patients older than age 18. The evidence review addresses the use of long-term (i.e., over
6 hours) extracorporeal cardiopulmonary support. It does not address the use of extracorporeal support, including
ECMO, during surgical procedures.
Respiratory Failure Reversibility
The reversibility of the underlying respiratory failure is best determined by the treating physicians, ideally
physicians with expertise in pulmonary medicine and/or critical care. Some of the underlying causes of respiratory
failure which are commonly considered reversible are as follows:
 Acute respiratory distress syndrome (ARDS)
 Acute pulmonary edema
 Acute chest trauma
 Infectious and noninfectious pneumonia
 Pulmonary hemorrhage
 Pulmonary embolism
 Asthma exacerbation
 Aspiration pneumonitis
ARDS refers to a clinical condition characterized by bilateral pulmonary infiltrates and severe hypoxemia in the
absence of cardiogenic pulmonary edema. A consensus definition for ARDS was first developed in 1994 with the
American-European Consensus Conference (AECC) on ARDS. The AECC definition was revised in 2012 by a
panel convened by the European Society of Intensive Care Medicine, with endorsement from the American
Thoracic Society and the Society of Critical Care Medicine, into the Berlin Definition, which was validated with
empirically evaluated using a patient-level meta-analysis of 4188 patients with ARDS from 4 multicenter clinical
data sets and 269 patients with ARDS from 3 single-center data sets containing physiologic information.1 Table 1
shows the Berlin definition of ARDS.
Table 1: Berlin Definition of Acute Respiratory Distress Syndrome (1)
Timing
Chest imaging (CT or
CXR)
Origin of edema
Oxygenation
Mild
Moderate
Severe
Criteria
Within 1 week of a known clinical insult or new or worsening respiratory symptoms
Bilateral opacities—not fully explained by effusions, lobar/lung collapse, or nodules
Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective
assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factors
present.
200 mm Hg <PaO2/FIO2 <300 mm Hg with PEEP or CPAP >5 cm H2O
100 mm Hg <PaO2/FIO2 ≤200 mm Hg with PEEP or CPAP ≥5 cm H2O
PaO2/FIO2 ≤ 100 mmHg with PEEP or CPAP≥ 5 cm H2O
Source: ARDS Definition Task Force et al (2012).
CPAP: continuous positive airway pressure; CT: computed tomography; CXR: chest x-ray; FIO2: fraction of inspired oxygen; PaO2: partial
pressure of oxygen in arterial blood; PEEP: peak end expiratory pressure.
Respiratory Failure Severity
Murray Score
One commonly used system for classifying the severity of respiratory failure is the Murray scoring system, which
was developed for use in ARDS but has been applied to other indications. This score includes 4 subscales, each
of which is scored from 0 to 4. The final score is obtained by dividing the collective score by the number of
subscales used. A score of 0 indicates no lung injury; a score of 1-2.5 indicates mild or moderate lung injury; and
a score of 2.5 indicates severe lung injury e.g., ARDS. Table 2 shows the components of the Murray scoring
system.
Table 2: Murray Lung Injury Score
Subscale
Chest x-ray score
Hypoxemia score
PEEP score (when ventilated)
Respiratory system compliance score
(when available)
Criteria
No alveolar consolidation
Alveolar consolidation confined to 1 quadrant
Alveolar consolidation confined to 2 quadrants
Alveolar consolidation confined to 3 quadrants
Alveolar consolidation in all 4 quadrants
PaO2/FIO2 >300
PaO2/FIO2 225-299
PaO2/FIO2 175-224
PaO2/FIO2 100-174
PaO2/FIO2 ≤100
PEEP ≤ 5 cm H2O
PEEP 6-8 cm H2O
PEEP 9-11 cm H2O
PEEP 12-14 cm H2O
PEEP ≥15 cm H2O
Compliance >80 mL/cm H2O
Compliance 60-79 mL/cm H2O
Compliance 40-59 mL/cm H2O
Compliance 20-39 mL/cm H2O
Compliance ≤19 mL/cm H2O
Score
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
FIO2: fraction of inspired oxygen; PaO2: partial pressure of oxygen in arterial blood; PEEP: peak end expiratory pressure.
Alternative Respiratory Failure Severity Criteria
Respiratory failure is considered severe if the patient meets one or more of the following criteria:
 Uncompensated hypercapnea with a pH less than 7.2; or
 PaO2/FiO2 of <100 mm Hg on fraction of inspired oxygen (FiO2) >90%; or
 Inability to maintain airway plateau pressure (Pplat) <30 cm H20 despite a tidal volume of 4-6 mL/kg
ideal body weight (IBW); or
 Oxygenation Index >30: Oxygenation Index = FiO2 x 100 x MAP/PaO2 mm Hg. [FiO2 x 100 = FiO2 as
percentage; MAP = mean airway pressure in cm H20; PaO2=partial pressure of oxygen in arterial blood];
or
 CO2 retention despite high Pplat (>30 cm H2O).
Assessment of ECMO Futility
Patients undergoing ECMO treatment should be periodically reassessed for clinical improvement. ECMO should
not be continued indefinitely if the following criteria are met:
 Neurologic devastation as defined by the following:
o Consensus from two attending physicians that there is no likelihood of an outcome better than
“persistent vegetative state” at 6 month, AND
o At least one of the attending physicians is an expert in neurologic disease and/or intensive care
medicine, AND
o Determination made following studies including CT, EEG and exam.
OR
 Inability to provide aerobic metabolism, defined by the following:
o Refractory hypotension and/or hypoxemia, OR
o Evidence of profound tissue ischemia based on creatine phosphokinase (CPK) or lactate levels,
lactate-to-pyruvate ratio, or near-infrared spectroscopy (NIRS)
OR

Presumed end-stage cardiac or lung failure without “exit” plan (i.e., declined for assist device and/or
transplantation).
Coding
33946
33947
33948
33949
33952
33954
33956
33958
33962
33964
33966
33984
33986
33987
33988
33989
CPT
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician;
initiation, veno-venous
initiation, veno-arterial
daily management, each day, veno-venous
daily management, each day, veno-arterial
insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes
fluoroscopic guidance, when performed)
insertion of peripheral (arterial and/or venous) cannula(e), open, 6 years and older
insertion of central cannula(e) by sternotomy or thoracotomy, 6 years and older
reposition peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes
fluoroscopic guidance, when performed)
reposition peripheral (arterial and/or venous) cannula(e), open, 6 years and older (includes fluoroscopic
guidance, when performed)
reposition central cannula(e) by sternotomy or thoracotomy, 6 years and older (includes fluoroscopic
guidance, when performed)
removal of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older
removal of peripheral (arterial and/or venous) cannula(e), open, 6 years and older
removal of central cannula(e) by sternotomy or thoracotomy, 6 years and older
Arterial exposure with creation of graft conduit (e.g., chimney graft) to facilitate arterial perfusion for
ECMO/ECLS (List separately in addition to code for primary procedure)
Insertion of left heart vent by thoracic incision (e.g., sternotomy, thoracotomy) for ECMO/ECLS
Removal of left heart vent by thoracic incision (e.g., sternotomy, thoracotomy) for ECMO/ECLS
Description
[TOP]
Extracorporeal membrane oxygenation (ECMO) provides extracorporeal circulation and physiologic gas exchange
for temporary cardiorespiratory support in cases of severe respiratory and cardiorespiratory failure. ECMO
devices use an extracorporeal circuit, combining a pump and a membrane oxygenator, to undertake oxygenation
of and removal of carbon dioxide from the blood.
Background
ECMO has been investigated as an intervention since the late 1960s following the development of the first
membrane oxygenator for extracorporeal oxygenation. ECMO has been widely used in the pediatric population,
particularly in neonates with pulmonary hypertension and meconium aspiration syndrome. Over time, interest has
developed in the use of ECMO for cardiorespiratory support for adult conditions. Early studies of the use of
ECMO for adult respiratory and cardiorespiratory conditions, particularly severe acute respiratory distress
syndrome (ARDS), included 1 RCT conducted in the United Kingdom in the 1970s that showed poor survival and
high complications rates due to the anticoagulation required for the ECMO circuit. (1)
Over time, with improvements in ECMO circuit technology and methods of supportive care, interest in the use of
ECMO in adults has resurged. In particular, during the period of 2009-2010 H1N1 pandemic influenza, the
occurrence of cases of influenza-related ARDS, particularly in relatively young and generally healthy people,
prompted resurgence in the interest of ECMO for ARDS.
ECMO has generally been used in clinical situations in which there is respiratory or cardiac failure, or both. In
these situations, death would be imminent unless medical interventions can immediately reverse the underlying
disease process or physiologic functions can be supported for long enough that normal reparative processes or
treatment can occur (eg, resolution of ARDS, treatment of infection) or other life-saving intervention can be
delivered (eg, provision of a lung transplant).
Disease-Specific Indications for Extracorporeal Membrane Oxygenation
Venoarterial (VA) and venovenous (VV) ECMO have been investigated for a wide range of adult conditions that
can lead to respiratory or cardiorespiratory failure, some of which overlap clinical categories (e.g., H1N1 influenza
infection leading to ARDS and cardiovascular collapse), which makes categorization difficult. However, in general,
indications for ECMO can be categorized as follows:
 Acute respiratory failure due to potentially reversible causes. Acute respiratory failure refers to the failure
of either oxygenation, removal of carbon dioxide, or both, and may be due to a wide range of causes.
ARDS has been defined by consensus in the Berlin definition, which includes criteria for the timing of
symptoms, imaging findings, exclusion of other causes, and degree of oxygenation. (2) In ARDS cases,
ECMO is most often used as a bridge to recovery. Specific potentially reversible or treatable indications
for ECMO may include ARDS, acute pneumonias, and a variety of other pulmonary disorders.
 Bridge to lung transplant. Lung transplant is used for management of chronic respiratory failure, most
frequently in the setting of advanced chronic obstructive pulmonary disease (COPD), idiopathic
pulmonary fibrosis, cystic fibrosis, emphysema due to alpha-1-antitrypsin deficiency, and idiopathic
pulmonary arterial hypertension. In the end stages of these diseases, patients may require additional
respiratory support while awaiting an appropriate donor. In addition, patients who have undergone a
transplant may require retransplantation due to graft dysfunction after the primary transplant.
 Acute-onset cardiogenic or obstructive shock is defined as shock that is due to cardiac pump failure or
vascular obstruction, refractory to inotropes and/or other mechanical circulatory support. Examples of
this category include postcardiotomy syndrome (ie, failure to wean from bypass), acute coronary
syndrome, myocarditis, cardiomyopathy, massive pulmonary embolism, and prolonged arrhythmias.
 ECMO-assisted cardiopulmonary resuscitation (E-CPR). ECMO can be used as an adjunct to CPR in
patients who do not respond to initial resuscitation measures.
ECMO: Technology Description
The basic components of ECMO include a pump, an oxygenator, sometimes referred to as a “membrane lung,”
and some form of vascular access. Based on the vascular access type, ECMO can be described as venovenous
(VV) or venoarterial (VA). VA ECMO has the potential to provide cardiac and ventilatory support.
Venovenous ECMO
Technique
In venovenous extracorporeal membrane oxygenation (VV ECMO), the ECMO oxygenator is in series with the
native lungs, and the ECMO circuit provides respiratory support. Venous blood is withdrawn through a large-bore
intravenous line; oxygen is added and CO2 removed, and oxygenated blood is returned to the venous circulation
near the right atrium. Venous access for VV ECMO can be configured through 2 single lumen catheters (typically
in the right internal jugular and femoral veins), or through 1 dual lumen catheter in the right internal jugular vein. In
the femorojugular approach, a single large multiperforated drainage cannula is inserted in the femoral vein and
advanced to the cavo-atrial junction, and the return cannula is inserted into the superior vena cava via the right
internal jugular vein. Alternatively, in the bi-femoral-jugular approach, drainage cannulae are placed in both the
superior vena cava and the inferior vena cava via the jugular and femoral veins, and a femoral return cannula is
advanced to the right atrium. In the dual-lumen catheter approach, a single bicaval cannula is inserted via the
right jugular vein and positioned to allow drainage from the inferior vena cava and superior vena cava and return
via the right atrium.
Indications
VV ECMO provides only respiratory support, and therefore is used for conditions in which there is progressive
loss in ability to provide adequate gas exchange due to abnormalities in the lung parenchyma, airways, or chest
wall. Right ventricular (RV) dysfunction due to pulmonary hypertension that is secondary to parenchymal lung
disease may sometimes be effectively treated by VV ECMO. However, acute or chronic obstruction of the
pulmonary vasculature (e.g., saddle pulmonary embolism) may require VA ECMO. There may be cases in which
RV dysfunction due to pulmonary hypertension caused by severe parenchymal lung disease may be severe
enough to require VA ECMO. In adults, VV ECMO is generally used only in situations in which all other
reasonable avenues of respiratory support have been exhausted, including mechanical ventilation with lung
protective strategies, pharmacologic therapy, and prone positioning.
Venoarterial ECMO
Technique
In venoarterial extracorporeal membrane oxygenation (VA ECMO), the ECMO oxygenator is in parallel with the
native lungs and the ECMO circuit provides both cardiac and respiratory support. In VA ECMO, venous blood is
withdrawn and oxygen is added and CO2 removed similar to VV ECMO, but blood is returned to the arterial
circulation. Cannulation for VA ECMO can done peripherally, with withdrawal of blood from a cannula in the
femoral or internal jugular vein and return of blood through a cannula in the femoral or subclavian artery.
Alternatively, it can be done centrally, with withdrawal of blood directly from a cannula in the right atrium and
return of blood through a cannula in the aorta. VA ECMO typically requires a high blood flow extracorporeal
circuit.
Indications
VA ECMO provides both cardiac and respiratory support. Thus, it is used in situations of significant cardiac
dysfunction that is refractory to other therapies, when significant respiratory involvement is suspected or
demonstrated, such as treatment-resistant cardiogenic shock, pulmonary embolism, or primary parenchymal lung
disease severe enough to compromise right heart function. Echocardiography should be used before ECMO is
considered or started to identify severe left ventricular dysfunction which might necessitate the use of VA ECMO.
The use of peripheral VA ECMO in the presence of adequate cardiac function may cause severe hypoxia in the
upper part of the body (brain and heart) in the setting of a severe pulmonary shunt. (1)
Extracorporeal Carbon Dioxide Removal
In addition to complete ECMO systems, there have been developed ventilation support devices that provide
oxygenation and removal of CO2 without the use of a pump system or interventional lung assist devices (eg, iLA®
Membrane Ventilator; Novalung GmbH). At present, none of these systems have Food and Drug Administration
approval for use in the United States. These technologies are not the focus of this evidence review, but are
described briefly because there is overlap in patient populations treated with extracorporeal carbon dioxide
removal (ECCO2R) and those treated with ECMO, and some studies have reported on both technologies.
In contrast to VA and VV ECMO, which use large-bore catheters and generally high flow through the ECMO
circuits, other systems use pumpless systems to remove CO2. These pumpless devices achieve ECCO2R via a
thin double-lumen central venous catheter and relatively low extracorporeal blood flow. They have been
investigated as a means to allow low tidal volume ventilator strategies, which may have benefit in ARDS and
other conditions where lung compliance is affected. Although ECMO systems can effect CO2 removal, dedicated
ECCO2R systems are differentiated by simpler mechanics and the fact that they do not require dedicated staff. (3)
Medical Management During ECMO
During ECMO, patients require supportive care and treatment for their underlying medical condition, including
ventilator management, fluid management, and systemic anticoagulation to prevent circuit clotting, nutritional
management, and appropriate antimicrobials. Maintenance of the ECMO circuit requires frequent (i.e., multiple
times in 24 hours) monitoring by medical and nursing staff and evaluation at least once per 24 hours by a
perfusion expert.
ECMO may be associated with significant complications, which can be related to the vascular access required to
the need for systemic anticoagulation, including hemorrhage, limb ischemia, compartment syndrome, cannula
thrombosis, and limb amputation. Patients are also at risk of progression of their underlying disease process.
Regulatory Status
The regulatory status of ECMO devices is complex. Historically, FDA evaluated the components of an ECMO
circuit separately, and the ECMO oxygenator has been considered the primary component of the circuit.
ECMO Oxygenator
The ECMO oxygenator (membrane lung, FDA product code: BYS), defined as a device used to provide to a
patient for extracorporeal blood oxygenation for more than 24 hours, has been classified as a class III device but
cleared for marketing by FDA through the preamendment 510(k) process (for devices legally marketed in the
United States before May 28, 1976, which are considered “grandfathered” devices not requiring a 510(k)
approval).
In 1977, the Membrane Lung (William Harvey Life Products), for long-term respiratory support, was cleared for
marketing by FDA through the 510(k) process.
In 1979, FDA reclassified the membrane lung as a class III device, but that designation has since been reversed
(see Regulatory Changes section).
ECMO procedures can also be performed using cardiopulmonary bypass (CPB) circuit devices on an off-label
basis. Multiple CPB oxygenators have been cleared for marketing by FDA through the 510(k) process (FDA
product code: DTZ).
Other ECMO Components
In addition to the ECMO oxygenator, FDA regulates other components of the ECMO circuit through the 510(k)
process, including the arterial filter (FDA product code DTM), the roller pump (FDA product code DWB), the
tubing (FDA product code DWE), the reservoir (FDA product code DTN), and the centrifugal pump (FDA product
code KFM).
Several dual lumen catheters have approval for use during extracorporeal life support (e.g., Kendall Veno-Venous
Dual-Lumen Infant ECMO Catheter; Origen Dual Lumen Cannulas; Avalon Elite Bi-Caval Dual Lumen Catheter.)
Regulatory Changes
FDA has convened several Circulatory System Device Advisory Committees to discuss the classification of the
ECMO oxygenator and other components. On January 8, 2013, FDA issued a proposed order to make the class
III II (premarket approval) ECMO devices class II (special controls) subject to 510(k) premarket notification. On
September 12, 2013, FDA’s Circulatory System Devices Advisory Committee discussed the classification of the
membrane lung for long-term pulmonary support specifically for pediatric cardiopulmonary and failure-to-wean
from cardiac bypass patient population. The committee approved FDA’s proposed premarket regulatory
classification strategy for extracorporeal circuit and accessories for long-term pulmonary/cardiopulmonary support
to reclassify from class III to class II for conditions in which an acute (reversible) condition prevents the patient’s
own body from providing the physiologic gas exchange needed to sustain life in conditions where imminent death
is threatened by respiratory failure (eg, meconium aspiration, congenital diaphragmatic hernia, pulmonary
hypertension) in neonates and infants, or cardiorespiratory failure (resulting in the inability to separate from
cardiopulmonary bypass following cardiac surgery) in pediatric patients. The committee agreed with the proposed
reclassification of ECMO devices from class III to class II for conditions where imminent death is threatened by
cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to
separate from cardiopulmonary bypass following cardiac surgery. As of February 12, 2016, the proposed order
was approved. (4)
On May 7, 2014, FDA convened a Circulatory System Devices Advisory Committee to discuss the classification of
the ECMO oxygenator for adult pulmonary and cardiopulmonary indications and to discuss the overall
classification of the ECMO components. FDA’s Center for Devices and Radiological Health proposed a
classification regulation to change the title of the regulation from “Membrane Lung for Long-Term Pulmonary
Support” to “Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiopulmonary Support,” move
the regulation from an anesthesia device regulation to a cardiovascular device regulation, and to define “longterm” as extracorporeal support longer than 6 hours. These proposals were approved as of February 12, 2016.
Scope
[TOP]
Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject
to the limits and conditions of the member benefit plan. Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
Benefit Application
[TOP]
N/A
Rationale
[TOP]
Populations
Individuals:
 With acute respiratory
failure in adulthood
Interventions
Interventions of interest are:
 Extracorporeal membrane
oxygenation
Comparators
Comparators of interest
are:
 Standard ventilator
management
Individuals:
 Who are lung
transplant candidates
in adulthood
Interventions of interest are:
 Extracorporeal membrane
oxygenation as a bridge to
transplant
Comparators of interest
are:
 Medical management
 Standard ventilator
management
Individuals:
 With acute cardiac
failure in adulthood
Interventions of interest are:
 Extracorporeal membrane
oxygenation
Individuals:
 With cardiac arrest in
adulthood
Interventions of interest are:
 Extracorporeal membrane
oxygenationassisted
cardiopulmonary
resuscitation
Comparators of interest
are:
 Medical management
 Other cardiac devices
(eg, ventricular assist
devices)
Comparators of interest
are:
 Standard
cardiopulmonary
resuscitation
Outcomes
Relevant outcomes include:
 Overall survival
 Change in disease status
 Morbid events
 Treatment-related mortality
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Change in disease status
 Morbid events
 Treatment-related mortality
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Change in disease status
 Morbid events
 Treatment-related mortality
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Change in disease status
 Morbid events
 Treatment-related mortality
 Treatment-related morbidity
This policy with evidence review was created in September 2014 and has been updated periodically with literature
reviews via searches of the MEDLINE database. The most recent update with literature review covered the period
through March 28, 2016.
The ideal study design for the evaluation of either venoarterial (VA) or venovenous (VV) extracorporeal
membrane oxygenation (ECMO) for adult respiratory and cardiorespiratory conditions would be multicenter
randomized controlled trials (RCTs) that compare treatment with ECMO with best standard therapy, using
standardized criteria for enrollment and standardized management protocols for both the ECMO and control
groups. Outcomes should include both short- and long-term mortality, along with measures of significant morbidity
(e.g., intracranial hemorrhage, thrombosis, vascular access site hemorrhage, limb ischemia) and short- and longterm disability and quality-of-life measures. However, there are likely significant challenges to enrolling patients in
RCTs to evaluate ECMO, including the possibly of overlap in medical conditions leading to respiratory and
cardiorespiratory failure, lack of standardization in alternative treatments, and the fact that ECMO is typically used
as a treatment of last resort in patients who are otherwise at high risk of death. Nonrandomized comparative
studies and uncontrolled studies can sometimes provide useful information on health outcomes related to ECMO.
Nonrandomized studies of ECMO are unlikely to be affected by the placebo effect; in many cases, the underlying
condition will have a reasonably well-defined natural history without therapy. However, these studies are prone to
bias in the selection of patients for treatments, limiting their ability to provide comparisons of ECMO relative to
alternative treatments.
The evidence related to the use of ECMO in adults is discussed separately for studies that primarily address
respiratory failure, that address primarily cardiac failure, and studies that evaluate mixed populations. Although
VA and VV ECMO have different underlying indications (i.e., cardiorespiratory failure versus respiratory failure),
studies reporting outcomes after ECMO do not always separate VA and VV ECMO; therefore, studies related to
the use of VA and VV ECMO are discussed together next. Extracorporeal carbon dioxide removal (ECCO2R) is
not the focus of this review, but it is mentioned if studies report results separately for ECCO2R.
Literature on the use of ECMO in adults includes a single RCT and multiple noncomparative cohort studies and
case series. Two RCTs of ECMO were conducted in 1979 and 1994, but are not discussed at length because
they were conducted before the use of lung-protective ventilation and are likely not representative of current
treatment practices.
ECMO for Adult Respiratory Failure
In adults, ECMO has been used most often to manage acute respiratory failure due to a variety of causes, often,
but not exclusively, in the setting of acute respiratory distress syndrome (ARDS). Although the largest body of
literature for the use of ECMO in adults relates to its use in the management of ARDS, often but not exclusively
secondary to H1N1 influenza, the largest and most recent RCT available evaluated the use of VV ECMO for
severe acute respiratory failure due to one of several causes.
Randomized Controlled Trials (RCT)
In 2009, Peek et al. reported results of the CESAR trial, a multicenter “pragmatic” RCT that compared
conventional management with referral to a center for consideration for VV ECMO treatment for 180 adult patients
with severe acute respiratory failure. (5) Inclusion criteria were age 18 to 65 years, with severe but potentially
reversible respiratory failure (Murray score >3.0 or pH <7.20). Exclusion criteria were: high pressure (>30 cm H2
for peak inspiratory pressure) or high FIO2 (>0.8) ventilation for more than 7 days; intracranial bleeding; other
contraindication to limited heparinization; or any contraindication to continuation of active treatment. Seven
hundred sixty-six patients were screened; of those, 180 were allocated to consideration for treatment with ECMO
(n=90) or conventional management (n=90). Of those in the ECMO group, 68 (75%) actually received ECMO.
Patients were enrolled from 3 types of facilities: an ECMO center (to which all patients who were randomly
allocated to ECMO consideration were transferred); tertiary intensive care units (conventional treatment centers);
and referral hospitals (which sent patients to conventional treatment centers if they were randomly allocated to
receive conventional treatment). For patients in the conventional management group, a specific management
protocol was not mandated, but treatment centers were advised to follow a low-volume, low-pressure ventilation
strategy. The primary outcome measure was death or severe disability at 6 months after randomization (defined
as death by 6 months or before discharge from hospital at any time to the end of data collection). Six-month
follow-up outcomes were evaluated in the patients’ homes by researchers masked to allocation. The primary
analysis was intention-to-treat.
Sixty-two patients in the ECMO group (69%) required transport to the ECMO center; a mean of 6.1 hours
occurred between randomization and treatment. In the conventional management group, 11 patients (12%)
required transport to a tertiary intensive care unit. For the primary outcome, 63% (57/90) of patients allocated to
consideration for ECMO survived to 6 months without disability compared with 47% (41/87) of those allocated to
conventional management (relative risk [RR], 0.69; 95% confidence interval [CI], 0.05 to 0.97; p=0.03). There
were differences in treatment management other than the use of ECMO between the ECMO consideration group
and the conventional management group, including the fact that low-volume, low-pressure ventilation was used in
more patients (93% vs 70%; p<0.001) and on a greater proportion of days (23.9% vs. 15%; p<0.001) for patients
allocated to the ECMO consideration group compared with those in the conventional management group. Patients
allocated to the ECMO consideration group more frequently received steroids (76% vs. 58%; p=0.001) and were
more frequently managed with a molecular albumin recirculating system (17% vs 0%; p<0.001).
The CESAR trial suggests that the use of a treatment strategy involving transfer of patients with severe
respiratory failure for consideration for ECMO is associated with improved disability-free survival.
Strengths of the CESAR trial include its randomized design and standard ECMO treatment protocol. However,
patients randomized to conventional management were not managed by a standardized protocol, which was
noted to be due to the inability of participating centers to agree on a management protocol. Several aspects of
treatment other than the use of ECMO differed between the ECMO strategy and the conventional management
strategy groups. In addition, it is possible that patients randomized to the ECMO consideration strategy benefited
from transfer to the ECMO center, if larger patient volumes there lead to improved treatment outcomes for severe
respiratory failure. About 20% of patients randomized to the ECMO consideration group improved after transport
to the ECMO center sufficiently to not require ECMO; 82% of these patients survived to discharge, while 63% of
patients treated with ECMO survived to discharge. The authors attribute this difference to slightly less severe lung
disease in the patients who did not require ECMO. However, it is also possible that some aspect of the
conventional management delivered at the ECMO center contributed to this improved outcome.
Two earlier RCTs were identified that compared some form of extracorporeal support with standard care. They
are described here briefly. In 1994, Morris et al reported the results of an RCT comparing a ventilator strategy of
low-frequency positive-pressure ventilation (LFPPV) ECCO2R (ECCO2R; n=21) to standard care (n=19) in adults
with ARDS. (6) In this trial, there was no significant difference in 30-day survival between groups (33% for
LFPPV-ECCO2R patients vs 42% for conventional ventilation patients; p=0.8), although the trial was stopped
early due to futility. The clinical practices in this trial are likely not representative of current practice.
In 2013, Bein et al reported results of the Xtravent study, which randomized patients with ARDS to a strategy of
low tidal volume ventilation combined with ECCO2R (n=40) or a conventional ventilation strategy (n=39). (7) For
the study’s primary end point (28- and 60-day ventilator-free days), there was no significant difference between
treatment groups. However, the interventions evaluated are better characterized as pumpless extracorporeal lung
assist devices (CO2 removal only), making them less relevant to the evaluation of ECMO. In a very early RCT,
Zapol et al (1979) compared mechanical ventilation with partial VA bypass (n=42) to conventional ventilation
(n=48) in individuals with severe hypoxemic respiratory failure. (8)
A 2016 RCT was identified that compared 3 different ECMO systems in adults with severe ARDS who required
VV ECMO. (9) Among the 54 patients included, there were no differences in measures of hemostasis or
inflammation across the different systems.
Systematic Reviews and Meta-Analyses
Several systematic reviews including both randomized and nonrandomized studies have addressed the use of
ECMO for acute respiratory failure in general and specific etiologies of acute respiratory failure.
In 2015, Tramm et al published a Cochrane review on the use of ECMO for critically ill adults. (10) The reviewers
included RCTs, quasi-RCTs, and cluster RCTs that evaluated VV or VA ECMO compared with conventional
respiratory and cardiac support. Four RCTs were identified (Peek et al [2009], (5) Morris et al [1994], (6) Bein et al
[2013], (7) Zapol et al [1979] (8). Combined, the trials included 389 subjects. Inclusion criteria (acute respiratory
failure with specific criteria for arterial oxygen saturation and ventilator support) were generally similar across
studies. Risk of bias was assessed as low for the trials by Peek, Bein, and Zapol, and high for the trial by Morris.
The reviewers were unable to perform a meta-analysis due to clinical heterogeneity across studies. The Morris
and Zapol trials were not considered to represent current standards of care. The reviewers summarized the
outcomes from these studies (findings described individually above). They concluded: “We recommend combining
results of ongoing RCTs with results of trials conducted after the year 2000 if no significant shifts in technology or
treatment occur. Until these new results become available, data on use of ECMO in patients with acute
respiratory failure remain inconclusive. For patients with acute cardiac failure or arrest, outcomes of ongoing
RCTs will assist clinicians in determining what role ECMO and ECPR [extracorporeal membrane
oxygenationassisted cardiopulmonary resuscitation] can play in patient care.”
Acute Respiratory Failure
In 2015, Schmidt et al reported on a systematic review of studies reporting outcomes for extracorporeal gas
exchange, including both ECMO and ECCO2R, in adults with acute respiratory failure. (11) The review identified
56 studies, of which 4 were RCTs, 7 were case-control studies, and 45 were case series. Two of the RCTs
evaluated ECCO2R in ARDS patients, while the other 2 evaluated ECMO in ARDS. One RCT evaluating ECMO in
ARDS was from the 1970s and was noted to have significant methodologic issues. The second RCT evaluating
ECMO in ARDS was the CESAR trial (described previously). The reviewers have reported that retrospective
cohort studies of ECMO using more updated technology reported high rates (approximately 60%-80%) of shortterm survival. The RCTs reporting on ECCO2R in ARDS patients included those by Morris in 1994 (6) and Bein in
2013. (7) As noted in the Randomized Controlled Trials section, the Morris trial was stopped early due to futility. In
the second RCT of ECCO2R in ARDS (Bein et al), the number of ventilator-free days did not differ significantly
between groups.
In 2013, Zampieri et al. reports results of a systematic review and meta-analysis evaluating the role of VV ECMO
for severe acute respiratory failure in adults. (12) The authors searched for RCTs and observational case-control
studies with severity-matched patients that evaluated the use of ECMO in severe acute respiratory failure in
adults. Three studies were included in the meta-analysis that comprised a total of 353 patients of whom 179
received ECMO, 1 RCT (CESAR trial,3 previously described) and 2 case-control studies with severity-matched
patients (Noah et al. (13) and Pham et al. (14). For the primary analysis, the pooled in-hospital mortality in the
ECMO-treated group was not significantly different from the control group (odds ratio [OR], 0.71; 95% CI: 0.34 to
1.47; p=0.358). Both nonrandomized studies included only patients treated for H1N1 influenza A infection, which
limits their generalizability to other patient populations.
Also in 2013, Zangrillo et al. reported the results of a systematic review and meta-analysis that evaluated the role
of ECMO for respiratory failure due to H1N1 influenza A infection in adults. (15) The meta-analysis included 8
studies, all observational cohort studies, that included 1357 patients with confirmed or suspected H1N1 infection
requiring ICU admission, 266 (20%) of whom were treated with ECMO. The median age of those receiving ECMO
was 36 years, with 43% men. In 94% of cases, VV ECMO was used, with VA ECMO used only in patients
presenting with respiratory and systolic cardiac failure or unresponsive to VV ECMO. The median ECMO use time
was 10 days. Reported outcomes were variable across the studies, but in a random-effects pooled model, the
overall in-hospital mortality was 27.5% (95% CI: 18.4% to 36.7%), with a median ICU stay of 25 days and an
overall median length of stay of 37 days.
In 2010, Mitchell et al. conducted a systematic review and meta-analysis to attempt to evaluate the role of ECMO
in acute respiratory failure due to H1N1 influenza. (16) The authors were unable to identify any studies meeting
their inclusion criteria, so they broadened their search to include studies that evaluated acute respiratory failure
due to any causes. Three RCTs were identified: the CESAR trial previously described and 2 older trials, 1 from
1994 and 1 from 1979. The summary risk ratio for mortality for patients treated with ECMO compared with
controls was 0.93 (95% CI: 0.71 to 1.22). However, there was significant heterogeneity across studies. Given
changes in the technology over time, pooling outcomes from studies conducted over more than 30 years may not
be meaningful.
Acute Respiratory Distress Syndrome (ARDS)
In 2008, Chalwin et al. conducted a systematic review and meta-analysis of the use of ECMO as salvage therapy
for adults with ARDS. (17) The authors identified 2 RCTs, including the 1994 and 1979 RCTs included in Mitchell
et al., and 3 nonrandomized comparative studies. Pool analysis of the 2 RCTs using a Bayesian random effects
model found an OR for mortality of 1.28 (95% credible interval, 0.24 to 6.55), demonstrating no significant
evidence of benefit or harm. Given differences in patient populations and criteria for ECMO in the nonrandomized
comparative studies, pooled analysis was not attempted.
Nonrandomized Comparative Studies
Pham et al. reported results from a matched cohort study using data from a French national registry that
evaluated the influence of ECMO on intensive-care unit (ICU) mortality in patients with H1N1 influenza A‒related
ARDS. (14) One hundred twenty-seven patients with H1N1 influenza A treated with ECMO were included in the
registry; 4 were excluded for not meeting the definition of ARDS. The median ECMO duration was 11 days. Fortyfour patients (36%) died in the ICU. One hundred three patients who received ECMO within in the first week of
mechanical ventilation were compared with 157 patients who had severe ARDS but did not receive ECMO.
ECMO-treated patients were younger, more likely to be pregnant women or obese patients, had fewer
comorbidities and immune suppression and less bacterial infection on admission, were less likely to receive early
steroid treatment, and had more organ failure and more severe respiratory failure. After propensity score
matching without replacement, 52 pairs of patients were matched for analysis. In this group of matched pairs,
there was no significant difference in ICU mortality between the ECMO group and non-ECMO controls (50% in
the ECMO group vs. 40% in the conventional treatment group; OR for death of ECMO patients 1.48; 95% CI: 0.68
to 3.23; p=0.32). In a secondary matched-pair analysis that used a different matching technique that included 102
ECMO-treated patients, treatment with ECMO was associated with a significantly lower risk of ICU death
(OR=0.45; 95% CI: 0.35 to 0.78; p<0.01).
Noah et al. reported results from a case-control study using data from a registry from the United Kingdom that
evaluated the influence of referral and transfer to an ECMO center on in-hospital mortality in patients with H1N1
influenza A‒related ARDS. (13) The study included 80 patients with H1N1 influenza A‒related ARDS who were
referred, accepted, and transferred to 1 of 4 ECMO centers; ECMO was initiated if adequate gas exchange could
not be achieved with conventional lung-protective ventilation. Patients were matched with patients who were
potential ECMO candidates with H1N1 influenza A‒related respiratory distress who did not receive ECMO,
resulting in 3 sets of matched pairs depending on the matching methods (1 with 59 matched pairs, 2 with 75
matched pairs). In each set, ECMO referral was associated with a lower in-hospital mortality rate. Depending on
the matching method, the following RRs were calculated: RR of 0.51 (95% CI: 0.31 to 0.84; p=0.008); RR of 0.47
(95% CI: 0.31 to 0.72; p=0.001); and RR of 0.45 (95% CI: 0.26 to 0.79; p=0.006).
Roch et al. conducted a prospective observational cohort study to compare outcomes for adults with H1N1
influenza A‒related ARDS treated with and without ECMO. (10) Eighteen patients were admitted to a singlecenter ICU for ARDS; 10 patients met institutional criteria for ECMO and had refractory hypoxemia and metabolic
acidosis, but 1 died before ECMO could be organized. The remaining 9 patients were treated with mechanical
ventilation. On presentation, patients who received ECMO were more likely to have shock requiring vasopressors
(7/9 vs. 2/9; p=0.05) and had higher median lactate levels (4.9 vs. 1.6; p<0.05). In-hospital mortality was the same
in both groups (56%). Four ECMO patients experienced hemorrhagic complications.
A 2009 retrospective cohort study described adult and pediatric patients treated in Australia and New Zealand
with H1N1 influenza A‒associated ARDS. (19) The study included 68 patients treated with ECMO who met
eligibility criteria, at 15 centers that provided ECMO support, with mean age 34.4 years (range, 26.6 to 43.1). As
of September 7, 2009, 53 of the 68 included patients (78%) had been weaned from ECMO, 13 had died while
receiving ECMO, and the other 2 were still receiving ECMO. (20) Of the 53 patients weaned from ECMO, 1 had
died and 52 (76%) were still alive. Patients treated with ECMO were compared with a concurrent cohort of 133
patients with influenza A and respiratory failure, although not necessarily ARDS, who were treated with
mechanical ventilation but not ECMO. ECMO patients had a longer duration of mechanical ventilation (median 18
vs 8 days; p=0.001), longer ICU stay (median 22 vs 12 days; p=0.001), and greater ICU mortality (23% vs 9%;
p=0.01).
Guirand et al. reported results of a retrospective cohort study that compared VV ECMO with conventional
ventilation for the management of acute hypoxemic respiratory failure due to trauma. (21) The study included 102
patients, 25 who received ECMO and 76 who received conventional ventilation. Adjusted survival was higher in
the ECMO group (adjusted OR=0.193; 95% CI: 0.042 to 0.884; p=0.034), although ventilator days, ICU days, and
hospital days did not significantly differ between the groups. In a cohort of 17 ECMO patients and 17 conventional
management patients matched for age and lung injury severity, there was significantly greater survival in the
ECMO group (adjusted OR=0.038; 95% CI: 0.004 to 0.407; p=0.007).
Noncomparative Studies
A large number of noncomparative cohort studies and case series have reported outcomes after the use of
ECMO for acute respiratory failure
The largest study of ECMO for acute respiratory failure, published by Brogan et al. in 2009, is a retrospective
case review of patients included in the Extracorporeal Life Support Organization (ELSO) registry from 1986 to
2006. (22) The ELSO registry is a voluntary registry that collects patient data from 116 U.S. and 14 international
centers. A total of 1,473 patients were supported with ECMO for respiratory failure from 1986 to 2006. Most
patients (78%) received VV ECMO initially. During the period from 2002 to 2006, 50% of subjects survived to
hospital discharge. Survivors were significantly younger than nonsurvivors (mean 32.1 years vs 37.8 years;
p<0.001). ECMO complications were more common in nonsurvivors; the most common complications in both
groups in the 2002-2006 period were need for inotropic medications (occurring in 52% and 67% of survivors and
nonsurvivors, respectively), need for renal replacement therapy (occurring in 42% and 55% of survivors and
nonsurvivors, respectively), surgical hemorrhage (occurring in 29% and 35% of survivors and nonsurvivors,
respectively), and mechanical circuit complications (occurring in 25% and 36% of survivors and nonsurvivors,
respectively). In multivariable modeling, during the period from 2002 to 2006, independent predictors of mortality
included increasing age, pre-ECMO arterial PaCO2 of 70 or greater, VA ECMO, the need for CPR, radiographic
evidence of central nervous system (CNS) infarction or hemorrhage, renal insufficiency, gastrointestinal or
pulmonary hemorrhage, and abnormal arterial pH (>7.6 or <7.2).
Other noncomparative studies that include at least 50 patients and report survival outcomes are summarized in
Table 3.
Table 3: Noncomparative Studies of ECMO in Adult Acute Respiratory Failure
Study
N
Indications for ECMO
Acute respiratory failure: multiple causes
Camboni (2011)
127
Bilateral pneumonia due to:
(23)
bacterial infection (n=45) or
aspiration (n=19)
Summary of Outcomes
Survival to hospital discharge: 51.2%
Survival based on ECMO support time (p=0.029):
0-10 days: 59%
Enger (2014) (24)
304
Schmid (2012) (25)
176
extra-pulmonary sepsis (n=27)
major surgery (n=17)
severe trauma (n=12)
Acute lung injury due to:
pulmonary disorder (n=163)
extra-pulmonary disorder
(n=72)
trauma (n=39)
other cause (n=30)
Primary lung failure, including:
bacterial, fungal, viral, and
aspiration pneumonia (n=102)
sepsis with secondary lung
failure (n=43)
trauma with ARDS (n=14)
other cause (n=17)
Acute respiratory distress syndrome
Schmidt (2013) (26) 140 ARDS due to:
bacterial infection (n=63)
H1N1 influenza A (n=36)
postoperative pneumonia (n=24)
other cause (n=17)
Pappalardo (2013)
(27)
60
ARDS due to
2009 H1N1 influenza A
11-20 days: 31%
>20 days: 52%
Survival to hospital discharge: 61.5%
Prediction model that included age, presence of
immunocompromised state, artificial minute
ventilation, and pre-ECMO lactate and hemoglobin,
and data available on day 1 of ECMO
(norepinephrine dose, FIO2, and C-reactive protein,
and fibrinogen levels) had positive and negative
predictive values of 81% and 80.4%, respectively,
for classifying patients as lower (<40%) or higher
(>80%) mortality risk
Overall survival: 56%
Survival to discharge based on lung failure etiology:
Primary lung failure: 58%
Sepsis: 44.1%
Trauma: 71.4%
Other cause: 58.8%
Survival to ICU discharge: 64%
Survival ≥6 mo after ICU discharge: 60%
Survival to discharge based on lung failure
etiology:
Bleeding events: 46%
Ventilator-associated pneumonia: 74%
ECMO cannula infection: 16%
Requirement for RRT: 56% Primary lung failure:
58%
Requirement for tracheostomy: 63%
Overall survival: 68.3%
Factors significantly associated with risk of death:
Bilirubin level: OR=2.32, 95% CI, 1.52 to 3.52,
p<0.001
Creatinine level: OR=7.38, 95% CI, 1.43 to 38.11,
p=0.02
Systemic MAP: OR=0.92, 95% CI, 0.88 to 0.97,
p<0.001
Hct: OR=0.82, 95% CI, 0.72 to 0.94, p=0.006
Pre-ECMO hospital LOS: OR=1.52, 95% CI, 1.12
to 2.07, p=0.008
ARDS: acute respiratory distress syndrome; CI: confidence interval; ECMO: extracorporeal membrane oxygenation; F IO2: fraction of inspired
oxygen; Hct: hematocrit; ICU: intensive care unit; LOS: length of stay; MAP: mean arterial pressure; OR: odds radio; RRT: renal replacement
therapy.
Smaller case series describe use of ECMO for acute respiratory failure due to other causes, including 2009 H1N1
influenza A (N=12 patients), (28) pneumonia due to Staphylococcus aureus (N=4 patients), (29) status
asthmaticus (n=24 patients), (30) hypoxemic respiratory failure due to trauma (N=10), (31) ARDS due to multiple
causes (N=36), (32) and ARDS due to pancreatitis (N=8).(33) Several small case series describe the use of
ECMO specifically for ARDS due to H1N1 influenza A. (20,34,35)
Section Summary: ECMO for Adult Respiratory Failure
The evidence related to the use of ECMO in adult acute respiratory failure consists of 1 pragmatic RCT, several
nonrandomized comparative studies, and multiple case series. Two additional RCTs evaluating ECMO that may
not be representative of current practice given their publication dates (1979, 1994) are not the focus of this
review. Two additional trials evaluating extracorporeal lung assist devices are also not emphasized here. The
most direct evidence about the efficacy of ECMO in adult respiratory failure comes from the CESAR trial.
Although the CESAR trial had limitations, including nonstandardized management in the control group and
unequal intensity of treatment between the experimental and control groups, for the study’s primary outcome of
disability-free survival at 6 months there was a large effect size, with an absolute risk reduction in mortality of
16.25% (95% CI, 1.75% to 30.67%). Nonrandomized comparative studies generally report improvements in
outcomes with ECMO, but are subject to bias if patients treated with ECMO are generally healthier.
ECMO as a Bridge to Pulmonary (Lung) Transplant
The evidence related to the use of ECMO as a bridge to lung transplantation consists primarily of multiple small
case series. Some retrospective studies have compared outcomes for patients treated with and without ECMO
preoperatively. For example, in a series of 143 patients who underwent lung transplant at a single institution,
patients who required mechanical lung assist treatment (“n” reported as 13 and 15 at different sections in the
publication) did not have significantly different survival rates than non-ECMO patients. (36)
Representative case series describing outcomes for patients who receive ECMO before transplant are outlined in
Table 4. There has been interest in developing techniques for “awake ECMO,” particularly in the bridge-totransplant population so that patients may participate in active rehabilitation while awaiting transplant. Several
case series include “awake ECMO” patients (Nosotti et al, (37) Rehder et al (38)).
Table 4: Case Series of ECMO as Bridge to Lung Transplantation
Study
N
Indications for Lung
Transplant
Not reported
ECMO
Technique
 VV (n=10)
 VA (n=4)
 iLA (n=5)
Combination
(n=7)
Inci (2015) (39)
30
Bermudez
(2011) (40)
17
 Retransplant (n=6)
 PF (n=6)
 CF (n=4)
COPD (n=1)
 VV (n=8)
 VA (n=9)
Hammainen
(2011) (41)
13
 VV (n=7)
VA (n=6)
Hoopes (2013)
(42)
31
Lefarge (2013)
(43)
36
 PF (n=5)
 Retransplant (n=2)
 Idiopathic PAH (n=2)
AIP, ARDS, PVOD, CF
(n=1 each)
 PF (n=9)
 CF (n=7, 2 with prior
transplant)
 ARDS (n=3)
 ILD (n=3)
 PVOD (n=3)
 PAH (n=2)
BOS, coal-workers
pneumoconiosis,
sarcoid, AIP (n=1 each)
 CF (n=20)
 PF (n=11)
Other diagnoses (n=5)
Nosotti (2013)
(37)
11
Rehder (2013)
(38)
9
 CF (n=6)
 Chronic rejection
(n=2)
 PF (n=2)
Systemic sclerosis
(n=1)
 CF (n=5)
 PF (n=2)
UIP, fibrosing
nonspecific interstitial
pneumonia (n=1 each)
 VV (n=11)
 Awake
ECMO (no
IMV; n=7)
IMV-ECMO
(n=4)
 VV (n=9)
 Awake
ECMO (with
rehab; n=5)
IMV-ECMO
(n=4)
Summary of Outcomes
 Bridge to transplant success: 86.6%
Compared with 160 patients who underwent
lung transplant without ECMO during same
time period, more ECMO patients required
tracheostomy (73% vs 27.5%, p=0.001) and
had longer ICU stays (18 d vs 3 d, p=0.001),
but 30-day mortality did not differ
 Median ECMO support time: 78 h
 Survival: 81% at 30 d; 74% at 1 y; 65% at 3
y
Adverse events: renal failure (n=17 [35%]),
requiring temporary dialysis in 4 (23%);
pulmonary infections (n=9 [52%]); sepsis (n=7
[41%]); tracheostomy requirement (n=7;
[41%]); distal digital ischemia (n=2 [11%])
 Mean ECMO support time: 2.8 d
 For all patients: Success for bridge to
transplant, 81%; 1-y survival, 75%
For transplant recipients: 1-y survival 92%
VV (n=13)
VA (n=17)
“hybrid” (n=1)
 Mean ECMO support time: 13.7 d
 Survival: 93% at 1 y; 80% at 3 y; 66% at 5 y
Compared with non-ECMO controls identified
from the United Network for Organ Sharing
database, survival significantly worse than for
similar patients transplanted without ECMO
 VV (n=27)
VA (n=9)
 For all patients: Success for bridge to
transplant, 83%; 1-y survival, 75%
For transplant recipients: 75% survived
transplant; 56% survived to hospital
discharge; 60.5% survived to 2 y
Survival: 85.7% at 1 y for awake-ECMO
group and 50% in IMV-ECMO group
 Survival: 100% at 1 y
For patients participating in pretransplant
rehabilitation (vs no rehabilitation): shorter
mean posttransplant mechanical ventilation (4
d vs 34 d; p=0.01); shorter ICU stay (11 d vs
45 d; p=0.01); shorter hospital stay (26 d vs
Schafii (2012)
(44)
19
 UIP (n=13)
 PAH (n=3)
a.
CF (n=3)
 VV (n=11)
b.
VA
(n=8)
80 d; p=0.01)
 For all patients: success for bridge totransplant, 74%.
A.
For transplant recipients: 75%
survived to 1 y; 63% survived to 3 y.
AIP: acute interstitial pneumonitis; ARDS: acute respiratory distress syndrome; BOS: bronchiolitis obliterans syndrome; CF: cystic fibrosis;
COPD: chronic obstructive pulmonary disease; ECMO: extracorporeal membrane oxygenation; ICU: intensive care unit; iLA: interventional
lung assist; ILD: interstitial lung disease; IMV: invasive mechanical ventilation; interventional PAH: pulmonary arterial hypertension; PF:
pulmonary fibrosis; PVOD: pulmonary veno-occlusive disease; UIP: usual interstitial pneumonia; VA: venoarterial; VV: venovenous.
In a retrospective analysis of data from the United Network for Organ Sharing (UNOS), Hayes et al evaluated the
impact of pretransplant ECMO on outcomes after lung transplantation. (45) Of 15,772 lung transplants identified
from 2001 to 2012, 189 were receiving ECMO at the time of transplantation. In Kaplan-Meier analysis, patients
who required ECMO pretransplant had worse survival than non-ECMO patients (p<0.001). In a multivariable Cox
proportional hazards analysis, a requirement for ECMO pretransplant was associated with high risk of death
(hazard ratio [HR], 2.226; 95% CI, 1.79 to 2.78; p<0.001).
Section Summary: ECMO as a Bridge to Pulmonary (Lung) Transplant
The evidence related to the use of ECMO as a bridge to lung transplantation consists of small case series, which
generally report high rates of success as a bridge to transplant and survival after transplant. These studies are
limited due to small numbers and lack of a comparison group. However, given the limited number of lung
transplants conducted in a year, large studies would not be feasible.
ECMO for Adult Cardiorespiratory Failure
In adults, in addition to its use for respiratory support, VA-ECMO can be used for cardiorespiratory support in
conditions where there is a potentially reversible cardiac condition, pulmonary blood flow disorder, or
parenchymal disease severe enough to compromise right heart function. Major categories of use of ECMO
include postcardiotomy syndrome (failure to wean off bypass) and refractory cardiogenic shock due to multiple
causes.
No RCTs were identified that evaluated the use of ECMO for cardiorespiratory failure.
ECMO for Postcardiotomy Failure to Wean Off Bypass
The evidence related to use of ECMO postcardiotomy consists of case series and cohort studies. A large cohort
study that included 517 patients with postcardiotomy cardiogenic shock was published by Rastan et al (2010).
(46) The study included consecutive patients treated at a single institution from 1996 to 2008 who received VA
ECMO for refractory postcardiotomy syndrome, instituted intraoperatively during the primary cardiac procedure
(41.9%) or secondarily within 30 minutes of deciding to support a patient with secondary postcardiotomy
syndrome (58.1%). Successful ECMO weaning was possible in 63.5%, with 56.4% of the total surviving ECMO
explantation for longer than 24 hours. The overall in-hospital mortality was 75.2%. There were a large number of
complications, with 82.2% of patients requiring rethoracotomy, 65.0% requiring renal replacement therapy, 19.9%
developing leg ischemia, and 17.4% with cerebrovascular events.
Other smaller cases series have reported similarly high morbidity and mortality rates after ECMO for
postcardiotomy cardiac shock. In a study of 77 patients who underwent ECMO support after surgery for acquired
heart disease, Slottosch et al reported that 62% of patients were weaned from ECMO (after a mean 79 hours of
ECMO support) and 30-day mortality was 70%. (47) Bakhtiary et al reported outcomes for a cohort of 45 patients
treated with ECMO for postcardiotomy cardiac shock, with a 30-day and in-hospital mortality rates of 53% and
71%, respectively, and an average ECMO duration of 6.4 days. (48)
ECMO for Refractory Cardiogenic Shock Due to Other Causes
The literature related to the use of ECMO for refractory cardiogenic shock outside of the postcardiotomy setting
includes multiple case series; the largest includes 147 patients though most have fewer than 50 patients and case
reports that include a range of underlying etiologies for cardiogenic shock.
In 2015, Xie et al reported on a meta-analysis evaluating VA ECMO for cardiogenic shock and cardiac arrest that
included observational studies and clinical trials with at least 10 adult patients. (49) Twenty-two studies, all
observational, with a total of 1199 patients (12 studies [n=659 patients] with cardiogenic shock; 5 studies [n=277
patients] with cardiac arrest; 5 studies [n=263 patients] with both patient types) met inclusion criteria. Across the
16 studies (n=841 patients) that reported survival to discharge, the weighted average survival was 40.2% (95%
CI, 33.9% to 46.7%). Across the 14 studies that reported 30-day survival, the weighted average survival was
52.8% (95% CI, 43.9% to 61.6%), with similar survival rates at 3, 6, and 12 months across studies that reported
those outcomes. Across studies that reported on cardiogenic shock only, the weighted average survival to
discharge was 42.1% (95% CI, 32.2% to 52.4%; I2=79%). Across all studies, complications were common, most
frequently acute kidney injury (pooled incidence, 47.4%; 95% CI, 30.2% to 64.9%; I2=92%), followed by renal
dialysis (pooled incidence, 35.2%; 95% CI, 23% to 47.4%; I2=95%) and reoperation for bleeding (pooled
incidence, 30.3%; 95% CI, 1.8% to 72.2%; I2=98%). However, the authors noted that it is uncertain that the
complications were entirely due to ECMO, given the underlying illness in patients who receive ECMO.
Two relatively large series, not included in the Xie meta-analysis, were identified and are described next.
In the largest series identified, Diddle et al reported on 147 patients (150 ECMO runs), treated with ECMO for
acute myocarditis, who were identified from the Extracorporeal Life Support Organization database. (50) Patients
in this group were relatively young (median age, 31 years) and were most often treated with VA ECMO (91%). Of
the cohort, 101 (69%) were decannulated from ECMO and 90 (61%) survived to discharge. In multivariable
analysis, the occurrence of pre-ECMO cardiac arrest and the need for higher ECMO support at 4 hours were
significantly associated with in-hospital mortality (odds ratio [OR], 2.4; 95% CI, 1.1 to 5.0; p=0.02 for pre-ECMO
arrest; OR=2.8; 95% CI, 1.1 to 7.3; p=0.03 for increased ECMO support at 4 hours).
Lorusso et al reported on a series of 57 adults with acute fulminant myocarditis treated with VA ECMO identified
from institutional databases from 13 centers. (51) Primary inclusion criteria were the presence of sudden and
refractory cardiogenic shock, cardiac arrest, or severe hemodynamic instability despite aggressive inotropic drugs
with or without intraortic balloon pump (IABP), demonstration of normal coronary artery anatomy and
echocardiographic signs of myocardial tissue swelling and biventricular involvement. The series excluded patients
with organic valvular or coronary artery disease, chronic dilated cardiomyopathy, toxic myocarditis, mediastinal
radiotherapy, or other mechanical circulatory support other than IABP. Mean VA ECMO time was 9.9 days (range,
2-24 days), and 43 patients (75.5%) had cardiac recovery. Complications were common (40 patients [70.1%]),
most frequently acute kidney injury (10 patients [17.5%]) and neurologic complications (10 patients [17.5%]).
Sixteen (28.1%) patients died before hospital discharge.
Other case reports have reported on use of ECMO for cardiogenic shock associated with a variety of conditions,
including refractory cardiogenic shock, (52) myocardial infarction, (53-56) peripartum cardiomyopathy, (57) and
left-ventricular assist device failure. (58)
Section Summary: ECMO for Adult Cardiorespiratory Failure
The evidence on ECMO for refractory cardiogenic shock consists of case series and case reports. The largest
body of literature relates to the use of ECMO in the failure-to-wean from bypass population. For this indication,
case series report some successful cases of weaning patients from ECMO in the setting of very high expected
morbidity and mortality rates. However, without comparative studies, it is difficult to assess whether rates of
weaning from bypass are improved with ECMO compared with standard care.
ECMO-Assisted Cardiopulmonary Resuscitation (ECPR)
Some centers have evaluated relatively portable ECMO systems in the management of in- or out-of-hospital
cardiac arrest, so-called ECPR. No RCTs were identified evaluating ECPR.
In 2015, the American Heart Association (AHA) issued updated guidelines on cardiopulmonary resuscitation
(CPR) and emergency cardiovascular care. (59) These guidelines included recommendations on use of ECPR
based on a systematic review by the International Liaison Committee on Resuscitation comparing ECPR with
conventional CPR for adult patients with in- or out-of-hospital cardiac arrest. The systematic review identified no
RCTs evaluating ECPR for cardiac arrest. A subset of studies (Shin et al, (60) Chen et al, (61) Lin et al (62)) are
described below. The review concludes: “The low-quality evidence suggests a benefit in regard to survival and
favorable neurologic outcome with the use of ECPR when compared with conventional CPR.” However, variability
in the inclusion and exclusion criteria of the studies was noted, which potentially affects generalizability
Nonrandomized Comparative Studies
In 2011, Shin et al. compared ECPR with conventional CPR in adult patients who had undergone CPR for more
than 10 minutes after witnessed in-hospital cardiac arrest. (60) Four hundred six patients were included, 85 who
underwent ECPR and 321 who underwent conventional CPR. The cause of arrest was considered to be cardiac
in most cases (N=340 [83.7%]), and noncardiac (secondary to respiratory failure or hypovolemia) in the remainder
(N=66 [16.3%]). The decision to initiate ECPR was dependent on the CPR team leader. Typically, the ECMO
device was available in the catheterization laboratory, coronary care unit, and operating room, and an ECMO cart
was transported to the CPR site within 5 to 10 minutes during the day and within 10 to 20 minutes at night. After
propensity-score matching, 120 patient pairs were included; in the matched group, ECPR was associated with
significantly higher rates of survival to discharge with minimal neurologic impairment (OR for mortality or
significant neurologic deficit 0.17; 95% CI: 0.04 to 0.68; p=0.012) and survival at 6 months with minimal
neurologic impairment (hazard ratio [HR], 0.48; 95% CI: 0.29 to 0.77; p=0.003).
In an earlier prospective study, Chen et al. compared ECPR with conventional CPR in adult patients who had
undergone prolonged (>10 minutes) conventional CPR after in-hospital cardiac arrest of cardiac origin. (61) One
hundred seventy-two patients were included, 59 in the ECPR group and 113 in the conventional CPR group. The
decision to call the extracorporeal life-support team was made by the attending doctors in charge. The average
duration from the call to team arrival was 5 to 7 minutes during the day and 15 to 30 minutes overnight. Survival
to discharge occurred in 17 patients in the ECPR group (28.8%) and in 14 patients in the conventional CPR group
(12.3%). In a multivariable logistic regression model to predict survival at discharge, the use of ECPR was
associated with reduce risk of death before discharge (adjusted HR=0.50; 95% CI: 0.33 to 0.74; p=0.001).
In contrast, in a cohort of 122 patients with in-hospital cardiac arrest of cardiac origin with prolonged (>10
minutes) conventional CPR, Lin et al. demonstrated no survival difference between patients who had return of
spontaneous breathing after ECMO and those who had return of spontaneous circulation after conventional CPR.
(62) The study included 59 patients with return of spontaneous breathing after ECPR and 63 patients with
sustained return of spontaneous circulation after conventional CPR treated at a single institution and propensityscore matched. Acute coronary syndrome was the most common etiology of cardiac arrest, occurring in 50.9% of
the conventional CPR patients and 73% of the ECPR patients. In the 27 ECPR response group, 8 patients
survived to discharge (29.6%), while in the conventional CPR response group, 5 patients survived to discharge
(18.5%). In a multivariable model, ECPR was not associated with reduced mortality (adjusted HR=0.618; 95% CI:
0.325 to 1.176; p=0.413).
Maekawa et al. reported results from a prospective observational cohort study of adult patients who underwent
ECPR after prolonged conventional CPR after out-of-hospital cardiac arrest. (63) The study included 162 patients,
53 in the ECPR group and 109 in the conventional CPR group. After propensity-score matching, 24 patients in
each group were analyzed. The survival rate was higher in the matched ECPR group than in the matched
conventional CPR group (29.2% vs. 8.3%; p=0.018).
Noncomparative Studies
Park et al developed a predictive score for survival to discharge using a series of 152 consecutive patients who
received ECPR for in-hospital cardiac arrest. (64) In this series, in-hospital death occurred in 104 (68.4%)
patients. Factors significantly associated with improved survival were an age of 66 years or less, the presence of
an arrest rhythm of pulseless electrical activity or ventricular fibrillation or pulseless ventricular tachycardia,
shorter CPR to ECMO time, higher initial mean arterial pressure, and higher Sequential Organ Failure
Assessment scores. A score developed from these factors and evaluated in a test set generated from the initial
sample using a bootstrap method was associated with a sensitivity and specificity of 89.6% and 75.0%,
respectively, for predicting survival to discharge. This score may help select patients for ECMO, but further
validation is needed.
Other noncomparative case series and case reports, including Stub et al, (65) Peigh et al, (66) Avalli et al, (67)
Johnson et al, (68) Bednarczyk et al, (69) Chiu et al, (70) Chiu et al, (71) Shinar et al, (72) and Tweet et al, (55)
have described the use of ECPR for refractory cardiac arrest. Overall, these studies suggest that ECPR is
feasible, particularly for in-hospital cardiac arrests, although mortality rates are high.
Section Summary: ECMO-Assisted Cardiopulmonary Resuscitation
The most direct evidence related to the use of ECMO-assisted CPR in cardiac arrest consists of several
nonrandomized comparative studies, the largest of which consisted of 406 patients, most of which demonstrated
a survival benefit with ECPR. However, selection for ECMO in these studies was at the discretion of the treating
physician, and treatment groups were not likely to be comparable. Multiple unanswered questions remain about
the role of ECPR in refractory cardiac arrest, including appropriate patient populations, duration of conventional
CPR, and assessment of futility.
ECMO for Outcomes in Mixed Populations
Studies that include mixed populations of ECMO patients have reported factors that are associated with
outcomes.
In the largest study identified, Gray et al reported on 2000 patients treated with ECMO at a single center from
1973 to 2010. (73) Most patients in this series were pediatric, but 353 adults were included. Survival for adults
treated with ECMO for respiratory failure (n=207) in the period after 1998 was 52%, and for cardiac failure (n=88)
was 40%. Overall, need for dialysis or hemofiltration and nonintracranial bleeding were the most common adverse
events.
Guttendorf et al reported on factors associated with discharge outcomes in ECMO-treated patients in a singlecenter retrospective cohort. (74) The cohort included 212 patients, of whom 126 had a primary cardiac indication
and 86 had a primary respiratory indication. Overall, 57% of patients were weaned from ECMO and 33% lived to
hospital discharge (“good outcome”). Compared with “good outcome” patients, patients with a poor outcome
(death before hospital discharge) were more likely to have had a primary cardiac indication (69.7% of poor
outcome patients vs 38.6% of good outcome patients, p<0.001), and be older (53.1 years vs 47.4 years, p=0.007)
and sicker (Murray acute lung injury score 2.74 vs 3.04, p=0.02) at baseline. Complication rates were more
frequent among “poor outcome” patients.
In a series of 171 patients treated with ECMO at a single institution from 2007 to 2014, Omar et al reported on
predictors of ischemic stroke. (75) The most common indication for ECMO was cardiogenic shock (42.4%),
followed by post cardiac surgery (13.3%). Overall, 10 (5.8%) subjects had a radiologically confirmed ischemic
stroke. In univariate analysis, patients with ischemic stroke had higher lactic acid levels at baseline (10.6 mmol/L
vs 6.3 mmol/L, p=0.039) and were more likely to require ECMO for a cardiac indication (100% vs 73.3%, p=0.05).
In multivariable analysis, only an elevated pre-ECMO lactic acid level remained associated with ischemic stroke
risk.
Aubron et al reported outcomes from a prospective cohort of 151 patients who were treated with ECMO over a 5year period, 99 with VA ECMO and 52 with VV ECMO. (76) The most common indication for VA ECMO was
postheart transplant, while the most common indication for VV ECMO was ARDS. Overall mortality was 37.3%
(37.1% for the patients who had VA ECMO and 37.7% for the patients who had VV ECMO, p=NS). In
multivariable analyses, the number of red blood cell units transfused was independently associated with
increased mortality for VA ECMO (OR=1.057; 95% CI, 1.016 to 1.102; p=0.007), while the number of bags of
platelets transfused was independently associated with increased mortality for VV ECMO (OR=1.572; 95% CI,
1.125 to 2.197; p=0.008).
Several studies have compared different ECMO systems, (77, 78) but in themselves these studies provide
relatively little evidence about the efficacy of ECMO compared with alternative treatments.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 5.
Table 5. Summary of Key Trials
NCT No.
Ongoing
NCT01990456
NCT01470703
NCT01605409
NCT01511666
Trial Name
Planned
Enrollment
Completion
Date
Strategies for Optimal Lung Ventilation in ECMO for ARDS: The
SOLVE ARDS Study
Extracorporeal Membrane Oxygenation(ECMO) for Severe Acute
Respiratory Distress Syndrome (ARDS)
Emergency Cardiopulmonary Bypass After Cardiac Arrest With
Ongoing Cardiopulmonary Resuscitation - a Pilot Randomized Trial
Hyperinvasive Approach to Out-of Hospital Cardiac Arrest Using
Mechanical Chest Compression Device, Prehospital Intraarrest
Cooling, Extracorporeal Life Support and Early Invasive Assessment
20
331
Dec 2015
(ongoing)
Feb 2017
40
May 2018
170
May 2018
Compared to Standard of Care. A Randomized Parallel Groups
Comparative Study. "Prague OHCA Study"
Unpublished
NCT01685112
NCT01763060
NCT01186614
Comparison of ECMO Use and Conventional Treatment in Adults
With Septic Shock
Long Term Follow up of Patients Who Were Treated With
Extracorporeal Membrane Oxygenation for Pandemic Influenza
A/H1N1 Induced Severe Respiratory Failure
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical
CPR, Hypothermia, ECMO and Early Reperfusion
300
7
24
Aug 2013
(unknown)
Oct 2013
(abstract
published )
Jul 2014
(unknown)
Summary of Evidence
Extracorporeal membrane oxygenation (ECMO) provides extracorporeal circulation and physiologic gas
exchange for temporary cardiorespiratory support in cases of severe respiratory and cardiorespiratory failure.
ECMO has generally been used in clinical situations in which there is respiratory or cardiac failure, or both, in
which death would be imminent unless medical interventions can immediately reverse the underlying disease
process, or physiologic functions can be supported for long enough that normal reparative processes or treatment
can occur (eg, resolution of acute respiratory distress syndrome, treatment of infection) or other life-saving
intervention can be delivered (eg, provision of a lung transplant). Potential indications for ECMO in the adult
population include acute, potentially reversible respiratory failure due to a variety of causes; as a bridge to lung
transplant; in potentially reversible cardiogenic shock; and as an adjunct to cardiopulmonary resuscitation
(ECMO-assisted cardiopulmonary resuscitation [ECPR]).
For individuals who have acute respiratory failure in adulthood who receive extracorporeal membrane
oxygenation (ECMO), the evidence includes 1 moderately sized randomized controlled trial, nonrandomized
comparative studies, and multiple case series. The most direct evidence about the efficacy of ECMO in adult
respiratory failure comes from the CESAR trial. Although the CESAR trial had limitations, including
nonstandardized management in the control group and unequal intensity of treatment between the treatment and
the control groups, for the study’s primary outcome of disability-free survival at 6 months, there was a large effect
size, with an absolute risk reduction in mortality of 16.25%. Recent nonrandomized comparative studies generally
report improvements in outcomes with ECMO. The available evidence supports the conclusion that outcomes are
improved for adults with acute respiratory failure, particularly those who meet the criteria outlined in the CESAR
trial. However, questions remain about the generalizability of findings from the CESAR trial and nonrandomized
study results to other patient populations, and further clinical trials in more specific patient populations are
needed. The evidence is sufficient to determine qualitatively that the technology results in a meaningful
improvement in the net health outcome.
For individuals who are lung transplant candidates in adulthood who receive ECMO as a bridge to pulmonary
transplant, the evidence includes small case series. Single-arm series have reported rates of successful bridge to
transplant on the order of 70% to 80%. For this population, there are no other options, the alternative is likely
death, and controlled trials would be extremely difficult to perform. The evidence is insufficient to determine the
effects of the technology on health outcomes.
For individuals who have acute cardiac failure in adulthood who receive ECMO, the evidence includes case series
and case reports. The largest body of literature for cardiorespiratory failure is in patients with postcardiotomy
failure to wean off bypass. Case series in this population report rates of successful decannulation from ECMO on
the order of 60%. Case series in populations affected by other causes of acute cardiac failure report rates of
survival to discharge of 40% to 60%. Rates of complications are high. Evidence comparing ECMO with other
medical therapy options is lacking. The evidence is insufficient to determine the effects of the technology on
health outcomes.
For individuals who have cardiac arrest in adulthood who receive ECMO-assisted cardiopulmonary resuscitation
(ECPR), the evidence includes nonrandomized comparative studies and case series. The most direct evidence
comes from 1 observational study comparing ECPR to standard CPR, using propensity score matching, which
reported higher rates of survival to discharge, with minimal neurologic impairment with ECPR. Other
nonrandomized studies report higher survival in ECPR groups. However, the benefit associated with ECPR is
uncertain given the potential for bias in nonrandomized studies. Additionally, factors related to the implementation
of ECPR procedures in practice need to be better delineated. The evidence is insufficient to determine the effects
of the technology on health outcomes.
Clinical Input Received From Physician Specialty Societies and Academic Medical
Centers
While the various physician specialty societies and academic medical centers may collaborate with and make
recommendations during this process, through the provision of appropriate reviewers, input received does not
represent an endorsement or position statement by the physician specialty societies or academic medical centers,
unless otherwise noted.
In response to requests, input was received on the policy from 2 academic medical centers, one of which
provided 3 responses, and 3 physician specialty societies, 1 of which provided 2 responses and 1 of which
provided 2 responses and a consensus letter, while this policy was under review in 2015. There was consensus
that ECMO is medically necessary for adults with respiratory failure that is severe and potentially reversible.
There was consensus that ECMO is medically necessary for adults as a bridge to heart, lung, or heart-lung
transplant. There was no consensus that ECMO is medically necessary for adults with refractory cardiac failure.
There was consensus that ECMO is investigational as an adjunct to cardiopulmonary resuscitation.
Practice Guidelines and Position Statements
The Extracorporeal Life Support Organization (ELSO)
The Extracorporeal Life Support Organization (ELSO) provides education, training, and guidelines related to the
use of EMCO, along with supporting research and maintaining an ECMO patient registry. In addition to general
guidelines that describe ECMO, ELSO has published specific recommendations related to the use of ECMO in
adult respiratory failure, adult cardiac failure, and in adult ECMO-assisted cardiopulmonary resuscitation (ECPR),
which are outlined in Table 6. (79-81)
Table 6: Extracorporeal Life Support Organization Indications for ECMO in Adults
Conditions
Adult respiratory
failure (79)
Adult cardiac
failure (80)
Indications
1. In hypoxic respiratory failure due to any
cause (primary or secondary) ECLS should
be considered when the risk of mortality is
≥50%, and is indicated when the risk of
mortality is≥80%.
a. 50% mortality risk is associated with a
PaO2/FIO2 <150 on FIO2 >90% and/or
Murray score 2-3
b. 80% mortality risk is associated with a
PaO2/FIO2 <100 on FIO2 >90% and/or
Murray score 3-4, despite optimal care
for 6 h
2. CO2 retention on mechanical ventilation,
despite high Pplat (>30 cm H2O)
3. Severe air leak syndromes
4. Need for intubation in a patient on lung
transplant list
5. Immediate cardiac or respiratory collapse
(PE, blocked airway, unresponsive to
optimal care)
Indications for ECLS in adult cardiac failure is
cardiogenic shock, defined by the following:
1. Inadequate tissue perfusion manifested as
hypotension and low cardiac output, despite
adequate intravascular volume.
2. Shock persists despite volume
administration, inotropes and
vasoconstrictors, and intra-aortic balloon
counterpulsation, if appropriate.
3. Typical causes: acute myocardial infarction,
myocarditis, peripartum cardiomyopathy,
decompensated chronic heart failure,
postcardiotomy shock.
Septic shock is an indication in some centers.
Contraindications
Relative contraindications:
1. Mechanical ventilation at high settings
(FIO2 >0.9, Pplat >30) for 7 d
2. Major pharmacologic
immunosuppression (absolute neutrophil
3
count <400/mm )
3. CNS hemorrhage that is recent or
expanding
4. Nonrecoverable comorbidity such as
major CNS damage or terminal
malignancy
5. Age: no specific age contraindication but
consider increasing risk with increasing
age
Absolute contraindications:
4. Unrecoverable heart and not a candidate
for transplant or VAD.
5. Advanced age.
6. Chronic organ dysfunction (emphysema,
cirrhosis, renal failure).
7. Compliance (financial, cognitive,
psychiatric, or social limitations).
8. Prolonged CPR without adequate tissue
perfusion.
Relative contraindications:
1. Contraindication for anticoagulation.
2. Advanced age (Note: advanced age
appears in both relative and absolute
Adult ECPR (81)
AHA guidelines for CPR recommend
consideration of ECMO to aid CPR in patients
who have an easily reversible event, have had
excellent CPR
contraindication lists).
3. Obesity.
1. All contraindications to ECMO use (eg,
gestational age <34 wks.)
2. Do-not-resuscitate orders
3. Futility: unsuccessful CPR (no return of
spontaneous circulation for 5-30 min);
however, ECPR may be indicated for
prolonged CPR if good perfusion and
metabolic support is documented
AHA: American Hospital Association; CNS: central nervous system; CPR: cardiopulmonary resuscitation; ECLS: extracorporeal lung support;
ECMO: extracorporeal membrane oxygenation; ECPR: extracorporeal membrane oxygenation assisted cardiopulmonary resuscitation; FIO2:
fraction of inspired oxygen; PaO2: partial pressure of oxygen in arterial blood; Pplat: airway plateau pressure; PE: pulmonary embolus; VAD:
ventricular assist device.
International ECMO Network
In 2014, the International ECMO Network, with endorsement by ELSO, published a position paper detailing
institutional, staffing, and reporting requirements for facilities providing ECMO, (82) with recommendations
including but not limited to the following:
 Organization of ECMO programs on a regional or national level is needed to provide the best, safest and
most efficient care possible to the population.
 Local, regional or interregional networks of hospitals with a mobile ECMO team should ideally be created
around each ECMO center.
 Staff training and continuing education, as well as regular audits evaluating program performance should
be routinely organized to assure quality.
National Institute for Health and Care Excellence (NICE)
In 2014, NICE issued guidance on the use of ECMO for acute heart failure in adults, which made the following
recommendations (83):
The evidence on the efficacy of extracorporeal membrane oxygenation (ECMO) for acute heart failure in
adults is adequate but there is uncertainty about which patients are likely to benefit from this procedure,
and the evidence on safety shows a high incidence of serious complications. Therefore, this procedure
should only be used with special arrangements for clinical governance, consent and audit or research.
In 2011, NICE issued guidance on the use of extracorporeal membrane oxygenation for severe acute respiratory
failure in adults, which made the following recommendations (61):
Evidence on the safety of extracorporeal membrane oxygenation (ECMO) for severe acute respiratory
failure in adults is adequate but shows that there is a risk of serious side effects. Evidence on its efficacy
is inadequate to draw firm conclusions: data from the recent CESAR (Conventional ventilation or
extracorporeal membrane oxygenation for severe adult respiratory failure) trial were difficult to interpret
because different management strategies were applied among many different hospitals in the control
group and a single centre was used for the ECMO treatment group. Therefore this procedure should only
be used with special arrangements for clinical governance, consent and research.
American Heart Association (AHA)
In 2015, the AHA issued updated guidelines on cardiopulmonary resuscitation (CPR) and emergency
cardiovascular care, which included a new systematic review of the evidence for ECPR and recommendations
about the use of ECPR for adults with in- or out-of-hospital cardiac arrest. (59) The findings of the systematic
review are discussed in the Rationale. The guidelines make the following recommendations related to ECPR:
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 cardiac arrest patients
for whom the suspected etiology of the cardiac arrest is potentially reversible during a limited period of
mechanical cardiorespiratory support” (Class IIb, level of evidence C—limited data).
U.S. Preventive Services Task Force Recommendations
Not applicable.
Medicare National Coverage
There is no national coverage determination (NCD) for extracorporeal oxygenation/membrane lung. In the
absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.
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Trauma Acute Care Surg. May 2014;76(5):1275-1281. PMID 24747460
22. Brogan TV, Thiagarajan RR, Rycus PT, et al. Extracorporeal membrane oxygenation in adults with
severe respiratory failure: a multi-center database. Intensive Care Med. Dec 2009;35(12):2105-2114.
PMID 19768656
23. Camboni D, Philipp A, Lubnow M, et al. Support time-dependent outcome analysis for veno-venous
extracorporeal membrane oxygenation. Eur J Cardiothorac Surg. Dec 2011;40(6):1341-1346;discussion
1346-1347. PMID 21700473
24. Enger T, Philipp A, Videm V, et al. Prediction of mortality in adult patients with severe acute lung failure
receiving veno-venous extracorporeal membrane oxygenation: a prospective observational study. Crit
Care. 2014;18(2):R67. PMID 24716510
25. Schmid C, Philipp A, Hilker M, et al. Venovenous extracorporeal membrane oxygenation for acute lung
failure in adults. J Heart Lung Transplant. Jan 2012;31(1):9-15. PMID 21885295
26. Schmidt M, Zogheib E, Roze H, et al. The PRESERVE mortality risk score and analysis of long-term
outcomes after extracorporeal membrane oxygenation for severe acute respiratory distress syndrome.
Intensive Care Med. Oct 2013;39(10):1704-1713. PMID 23907497
27. Pappalardo F, Pieri M, Greco T, et al. Predicting mortality risk in patients undergoing venovenous ECMO
for ARDS due to influenza A (H1N1) pneumonia: the ECMOnet score. Intensive Care Med. Feb
2013;39(2):275-281. PMID 23160769
28. Beurtheret S, Mastroianni C, Pozzi M, et al. Extracorporeal membrane oxygenation for 2009 influenza A
(H1N1) acute respiratory distress syndrome: single-centre experience with 1-year follow-up. Eur J
Cardiothorac Surg. Mar 2012;41(3):691-695. PMID 22228837
29. Noah MA, Dawrant M, Faulkner GM, et al. Panton-Valentine leukocidin expressing Staphylococcus
aureus pneumonia managed with extracorporeal membrane oxygenation: experience and outcome. Crit
Care Med. Nov 2010;38(11):2250-2253. PMID 20711071
30. Mikkelsen ME, Woo YJ, Sager JS, et al. Outcomes using extracorporeal life support for adult respiratory
failure due to status asthmaticus. ASAIO J. Jan-Feb 2009;55(1):47-52. PMID 19092662
31. Biderman P, Einav S, Fainblut M, et al. Extracorporeal life support in patients with multiple injuries and
severe respiratory failure: a single-center experience? J Trauma Acute Care Surg. Nov 2013;75(5):907912. PMID 24158215
32. Michaels AJ, Hill JG, Long WB, et al. Adult refractory hypoxemic acute respiratory distress syndrome
treated with extracorporeal membrane oxygenation: the role of a regional referral center. Am J Surg. May
2013;205(5):492-498; discussion 498-499. PMID 23592154
33. Bryner BS, Smith C, Cooley E, et al. Extracorporeal life support for pancreatitis-induced acute respiratory
distress syndrome. Ann Surg. Dec 2012;256(6):1073-1077. PMID 22824856
34. Chan KK, Lee KL, Lam PK, et al. Hong Kong's experience on the use of extracorporeal membrane
oxygenation for the treatment of influenza A (H1N1). Hong Kong Med J. Dec 2010;16(6):447-454. PMID
21135421
35. Cianchi G, Bonizzoli M, Pasquini A, et al. Ventilatory and ECMO treatment of H1N1-induced severe
respiratory failure: results of an Italian referral ECMO center. BMC Pulm Med. 2011;11:2. PMID
21223541
36. Lehmann S, Uhlemann M, Leontyev S, et al. Fate of patients with extracorporeal lung assist as a bridge
to lung transplantation versus patients without--a single-center experience. Perfusion. Mar
2015;30(2):154-160. PMID 24988948
37. Nosotti M, Rosso L, Tosi D, et al. Extracorporeal membrane oxygenation with spontaneous breathing as
a bridge to lung transplantation. Interact Cardiovasc Thorac Surg. Jan 2013;16(1):55-59. PMID
23097371
38. Rehder KJ, Turner DA, Hartwig MG, et al. Active rehabilitation during extracorporeal membrane
oxygenation as a bridge to lung transplantation. Respir Care. Aug 2013;58(8):1291-1298. PMID
23232742
39. Inci I, Klinzing S, Schneiter D, et al. Outcome of extracorporeal membrane oxygenation as a bridge to
lung transplantation: an institutional experience and literature review. Transplantation. Aug
2015;99(8):1667-1671. PMID 26308302
40. Bermudez CA, Rocha RV, Zaldonis D, et al. Extracorporeal membrane oxygenation as a bridge to lung
transplant: midterm outcomes. Ann Thorac Surg. Oct 2011;92(4):1226-1231; discussion 1231-1222.
PMID 21872213
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transplantation. J Thorac Cardiovasc Surg. Mar 2013;145(3):862-867; discussion 867-868. PMID
23312979
Lafarge M, Mordant P, Thabut G, et al. Experience of extracorporeal membrane oxygenation as a bridge
to lung transplantation in France. J Heart Lung Transplant. Sep 2013;32(9):905-913. PMID 23953818
Shafii AE, Mason DP, Brown CR, et al. Growing experience with extracorporeal membrane oxygenation
as a bridge to lung transplantation. ASAIO J. Sep-Oct 2012;58(5):526-529. PMID 22929896
Hayes D, Jr., Higgins RS, Kilic A, et al. Extracorporeal membrane oxygenation and retransplantation in
lung transplantation: an analysis of the UNOS registry. Lung. Aug 2014;192(4):571-576. PMID 24816903
Rastan AJ, Dege A, Mohr M, et al. Early and late outcomes of 517 consecutive adult patients treated
with extracorporeal membrane oxygenation for refractory postcardiotomy cardiogenic shock. J Thorac
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2013;181(2):e47-55. PMID 22878151
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of cardiogenic shock: clinical experiences in 45 adult patients. J Thorac Cardiovasc Surg. Feb
2008;135(2):382-388. PMID 18242273
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and cardiac arrest: a meta-analysis. J Cardiothorac Vasc Anesth. 2015;29(3):637-645. PMID 25543217
Diddle JW, Almodovar MC, Rajagopal SK, et al. Extracorporeal membrane oxygenation for the support
of adults with acute myocarditis. Crit Care Med. May 2015;43(5):1016-1025. PMID 25738858
Lorusso R, Centofanti P, Gelsomino S, et al. Venoarterial extracorporeal membrane oxygenation for
acute fulminant myocarditis in adult patients: a 5-year multi-institutional experience. Ann Thorac Surg.
Mar 2016;101(3):919-926. PMID 26518372
Formica F, Avalli L, Colagrande L, et al. Extracorporeal membrane oxygenation to support adult patients
with cardiac failure: predictive factors of 30-day mortality. Interact Cardiovasc Thorac Surg. May
2010;10(5):721-726. PMID 20123890
Alozie A, Kische S, Birken T, et al. Awake extracorporeal membrane oxygenation (ECMO) as bridge to
recovery after left main coronary artery occlusion: a promising concept of haemodynamic support in
cardiogenic shock. Heart Lung Circ. Oct 2014;23(10):e217-221. PMID 25043583
Koutouzis M, Kolsrud O, Albertsson P, et al. Percutaneous coronary intervention facilitated by
extracorporeal membrane oxygenation support in a patient with cardiogenic shock. Hellenic J Cardiol.
May-Jun 2010;51(3):271-274. PMID 20515862
Tweet MS, Schears GJ, Cassar A, et al. Emergency cardiac support with extracorporeal membrane
oxygenation for cardiac arrest. Mayo Clin Proc. Jul 2013;88(7):761-765. PMID 23809321
Gregoric ID, Mesar T, Kar B, et al. Percutaneous ventricular assist device and extracorporeal membrane
oxygenation support in a patient with postinfarction ventricular septal defect and free wall rupture. Heart
Surg Forum. Jun 2013;16(3):E150-151. PMID 23803239
Gevaert S, Van Belleghem Y, Bouchez S, et al. Acute and critically ill peripartum cardiomyopathy and
'bridge to' therapeutic options: a single center experience with intra-aortic balloon pump, extra corporeal
membrane oxygenation and continuous-flow left ventricular assist devices. Crit Care. 2011;15(2):R93.
PMID 21392383
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Jul 31 2013;167(2):e41-42. PMID 23608393
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American Heart Association guidelines update for cardiopulmonary resuscitation and emergency
cardiovascular care. Circulation. Nov 3 2015;132(18 Suppl 2):S444-464. PMID 26472995
Shin TG, Choi JH, Jo IJ, et al. Extracorporeal cardiopulmonary resuscitation in patients with inhospital
cardiac arrest: A comparison with conventional cardiopulmonary resuscitation. Crit Care Med. Jan
2011;39(1):1-7. PMID 21057309
Chen YS, Lin JW, Yu HY, et al. Cardiopulmonary resuscitation with assisted extracorporeal life-support
versus conventional cardiopulmonary resuscitation in adults with in-hospital cardiac arrest: an
observational study and propensity analysis. Lancet. Aug 16 2008;372(9638):554-561. PMID 18603291
Lin JW, Wang MJ, Yu HY, et al. Comparing the survival between extracorporeal rescue and conventional
resuscitation in adult in-hospital cardiac arrests: propensity analysis of three-year data. Resuscitation. Jul
2010;81(7):796-803. PMID 20413202
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Med. May 2013;41(5):1186-1196. PMID 23388518
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arrest patients who undergo extracorporeal membrane oxygenation. Int J Cardiol. Dec 20
2014;177(3):1031-1035. PMID 25443259
65. Stub D, Bernard S, Pellegrino V, et al. Refractory cardiac arrest treated with mechanical CPR,
hypothermia, ECMO and early reperfusion (the CHEER trial). Resuscitation. Jan 2015;86:88-94. PMID
25281189
66. Peigh G, Cavarocchi N, Hirose H. Saving life and brain with extracorporeal cardiopulmonary
resuscitation: A single-center analysis of in-hospital cardiac arrests. J Thorac Cardiovasc Surg. Nov
2015;150(5):1344-1349. PMID 26383007
67. Avalli L, Maggioni E, Formica F, et al. Favourable survival of in-hospital compared to out-of-hospital
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care centre experience. Resuscitation. May 2012;83(5):579-583. PMID 22056265
68. Johnson NJ, Acker M, Hsu CH, et al. Extracorporeal life support as rescue strategy for out-of-hospital
and emergency department cardiac arrest. Resuscitation. Nov 2014;85(11):1527-1532. PMID 25201611
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case report and review of the literature. J Emerg Med. Jul 2012;43(1):83-86. PMID 22325553
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Accessed June 2016
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severe acute respiratory failure in adults IPG391. 2011. Source URL:
http://www.nice.org.uk/guidance/IPG391/chapter/1-guidance. Accessed June 2016
Appendix
[TOP]
N/A
History
[TOP]
Date
03/10/15
07/12/16
Reason
New Policy. Policy created with literature review through July 28, 2014, and review of clinical input.
ECMO for adults considered medically necessary for acute respiratory failure meeting criteria
outlined in policy guidelines and as a bridge to heart, lung, and heart-lung transplant, and
investigational for other indications.
Annual Review. Policy updated with literature review through March 28, 2016. Multiple references
added, others renumbered/removed. Policy statements unchanged.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts
policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical
technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in
their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific
medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
©2016 Premera All Rights Reserved.
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この通知には重要な情報が含まれています。この通知には、Premera Blue
Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
ります。この通知に記載されている可能性がある重要な日付をご確認くだ
さい。健康保険や有料サポートを維持するには、特定の期日までに行動を
取らなければならない場合があります。ご希望の言語による情報とサポー
トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話
ください。
Română (Romanian):
Prezenta notificare conține informații importante. Această notificare
poate conține informații importante privind cererea sau acoperirea asigurării
dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie
în această notificare. Este posibil să fie nevoie să acționați până la anumite
termene limită pentru a vă menține acoperirea asigurării de sănătate sau
asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste
informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471
(TTY: 800-842-5357).
한국어 (Korean):
본 통지서에는 중요한 정보가 들어 있습니다. 즉 이 통지서는 귀하의 신청에
관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를
포함하고 있을 수 있습니다. 본 통지서에는 핵심이 되는 날짜들이 있을 수
있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기
위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다.
귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는
권리가 있습니다. 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오.
Pусский (Russian):
Настоящее уведомление содержит важную информацию. Это
уведомление может содержать важную информацию о вашем
заявлении или страховом покрытии через Premera Blue Cross. В
настоящем уведомлении могут быть указаны ключевые даты. Вам,
возможно, потребуется принять меры к определенным предельным
срокам для сохранения страхового покрытия или помощи с расходами.
Вы имеете право на бесплатное получение этой информации и
помощь на вашем языке. Звоните по телефону 800-722-1471
(TTY: 800-842-5357).
ລາວ (Lao):
ແຈ້ ງການນ້ີ ມີຂ້ໍ ມູ ນສໍາຄັ ນ. ແຈ້ ງການນ້ີ ອາດຈະມີຂ້ໍ ມູ ນສໍາຄັ ນກ່ ຽວກັ ບຄໍາຮ້ ອງສະ
ໝັ ກ ຫື ຼ ຄວາມຄຸ້ ມຄອງປະກັ ນໄພຂອງທ່ ານຜ່ ານ Premera Blue Cross. ອາດຈະມີ
ວັ ນທີສໍາຄັ ນໃນແຈ້ ງການນີ້. ທ່ ານອາດຈະຈໍາເປັນຕ້ ອງດໍາເນີນການຕາມກໍານົ ດ
ເວລາສະເພາະເພື່ອຮັ ກສາຄວາມຄຸ້ ມຄອງປະກັ ນສຸ ຂະພາບ ຫື ຼ ຄວາມຊ່ ວຍເຫື ຼ ອເລື່ອງ
ຄ່ າໃຊ້ ຈ່ າຍຂອງທ່ ານໄວ້ . ທ່ ານມີສິດໄດ້ ຮັ ບຂ້ໍ ມູ ນນ້ີ ແລະ ຄວາມຊ່ ວຍເຫື ຼ ອເປັນພາສາ
ຂອງທ່ ານໂດຍບໍ່ເສຍຄ່ າ. ໃຫ້ ໂທຫາ 800-722-1471 (TTY: 800-842-5357).
ភាសាែខម រ (Khmer):
េសចកត ីជូនដំណឹងេនះមានព័ត៌មានយា៉ងសំខាន់។ េសចកត ីជូនដំណឹងេនះរបែហល
ជាមានព័ត៌មានយា៉ងសំខាន់អំពីទរមង់ែបបបទ ឬការរា៉ប់រងរបស់អនកតាមរយៈ
Premera Blue Cross ។ របែហលជាមាន កាលបរ ិេចឆ ទសំខាន់េនៅកនុងេសចកត ីជូន
ដំណឹងេនះ។ អន ករបែហលជារតូវការបេញច ញសមតថ ភាព ដល់កំណត់ៃថង ជាក់ចបាស់
នានា េដើមបីនឹងរកសាទុកការធានារា៉ប់រងសុខភាពរបស់អនក ឬរបាក់ជំនួយេចញៃថល ។
អន កមានសិទធិទទួ លព័ត៌មានេនះ និងជំនួយេនៅកនុងភាសារបស់អនកេដាយមិនអស
លុយេឡើយ។ សូ មទូ រស័ពទ 800-722-1471 (TTY: 800-842-5357)។
ਪੰ ਜਾਬੀ (Punjabi):
ਇਸ ਨੋਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ
ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ
ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ
ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ
ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ
800-722-1471 (TTY: 800-842-5357).
‫( فارسی‬Farsi):
‫اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم‬. ‫اين اعالميه حاوی اطالعات مھم ميباشد‬
‫ به تاريخ ھای مھم در‬.‫ باشد‬Premera Blue Cross ‫تقاضا و يا پوشش بيمه ای شما از طريق‬
‫شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه‬. ‫اين اعالميه توجه نماييد‬
‫شما حق‬. ‫ به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد‬،‫ھای درمانی تان‬
‫ برای کسب‬.‫اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد‬
‫( تماس‬800-842-5357 ‫ تماس باشماره‬TTY ‫ )کاربران‬800-722-1471 ‫اطالعات با شماره‬
.‫برقرار نماييد‬
Polskie (Polish):
To ogłoszenie może zawierać ważne informacje. To ogłoszenie może
zawierać ważne informacje odnośnie Państwa wniosku lub zakresu
świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na
kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie
przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub
pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej
informacji we własnym języku. Zadzwońcie pod 800-722-1471
(TTY: 800-842-5357).
Português (Portuguese):
Este aviso contém informações importantes. Este aviso poderá conter
informações importantes a respeito de sua aplicação ou cobertura por meio
do Premera Blue Cross. Poderão existir datas importantes neste aviso.
Talvez seja necessário que você tome providências dentro de
determinados prazos para manter sua cobertura de saúde ou ajuda de
custos. Você tem o direito de obter esta informação e ajuda em seu idioma
e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Fa’asamoa (Samoan):
Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau
ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala
atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua
atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei
fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le
aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai
i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua
atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i
ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471
(TTY: 800-842-5357).
Español (Spanish):
Este Aviso contiene información importante. Es posible que este aviso
contenga información importante acerca de su solicitud o cobertura a
través de Premera Blue Cross. Es posible que haya fechas clave en este
aviso. Es posible que deba tomar alguna medida antes de determinadas
fechas para mantener su cobertura médica o ayuda con los costos. Usted
tiene derecho a recibir esta información y ayuda en su idioma sin costo
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Tagalog (Tagalog):
Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon
tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue
Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring
mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang
panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na
walang gastos. May karapatan ka na makakuha ng ganitong impormasyon
at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471
(TTY: 800-842-5357).
ไทย (Thai):
ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน
สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง
ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่
มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร
800-722-1471 (TTY: 800-842-5357)
Український (Ukrainian):
Це повідомлення містить важливу інформацію. Це повідомлення
може містити важливу інформацію про Ваше звернення щодо
страхувального покриття через Premera Blue Cross. Зверніть увагу на
ключові дати, які можуть бути вказані у цьому повідомленні. Існує
імовірність того, що Вам треба буде здійснити певні кроки у конкретні
кінцеві строки для того, щоб зберегти Ваше медичне страхування або
отримати фінансову допомогу. У Вас є право на отримання цієї
інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за
номером телефону 800-722-1471 (TTY: 800-842-5357).
Tiếng Việt (Vietnamese):
Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông
tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua
chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông
báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn
để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có
quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình
miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).