Aetna considers extracorporeal membrane oxygenation (ECMO) medically necessary for members who meet the following criteria:

ECMO for Neonates:

ECMO is considered medically necessary in neonates who meet all of the following criteria:

1. Diagnosis of any of the following:

   1. Hyaline membrane disease; or
   2. Meconium aspiration; or
   3. Persistent fetal circulation; or
   4. Congenital diaphragmatic hernia; or
   5. Uncontrollable air leak; or
   6. Possible cardiac anomaly; or
   7. Respiratory distress syndrome; or
   8. Refractory neonatal septic shock

   and

2. Gestational age of at least 34 weeks; and

3. Birth weight of 2,000 grams or greater; and

4. Age less than 10 days (preferably less than 7 days).

ECMO for neonates is considered experimental and investigational when criteria are not met.

ECMO for Children and Adults:

ECMO and extracorporeal life support (ECLS) are considered medically necessary for children and adults with any of the following diagnoses when the risk of death is very high despite optimal conventional therapy:

1. Adult respiratory distress syndrome (ARDS); or
2. Non-necrotizing pneumonias (both bacterial and viral); or
3. Pulmonary contusion; or
4. Refractory pediatric septic shock; or
5. Other reversible causes of respiratory or cardiac failure that is unresponsive to all other measures; or 
6. Following heart surgery to ease transition from cardiopulmonary bypass to ventilation; or
7. As a short-term (i.e., hours to a few days) bridge to heart transplant.

ECMO for children and adults is considered experimental and investigational for all other indications.

See also CPB 518 - Nitric Oxide, Inhalational (INO).

ECMO in Neonates:

Extracorporeal membrane oxygenation (ECMO) is a term used to describe prolonged (days to weeks) mechanical support for patients with reversible heart or lung failure.  The technology is similar to cardiopulmonary bypass as used during cardiac surgery, only modified for prolonged use at the bedside intensive care unit.  ECMO is capable of effectively and safely supporting respiration and circulation in neonates with severe reversible respiratory failure and a moribund clinical presentation.  Such a system provides excellent oxygen saturation and carbon dioxide removal.  When applied early in the course of severe failure, newborns who would have otherwise died will regularly survive.  Contraindications to ECMO therapy in neonates include any severe diagnosis which would decrease the probability of survival of the neonate candidate. Some of the limiting diagnoses include: intracerebral hemorrhage; severe brain damage; multiple congenital anomalies; irreversible brain damage; and age greater than 10 days.

In a randomized controlled study (n = 59), Griffin et al (2004) concluded that dexamethasone given during the first 3 days of ECMO results in significant improvement in lung injury scores by day 3 of ECMO but does not significantly decrease the duration of ECMO or improve survival.  The preponderance of evidence would not support the use of dexamethasone in this setting.

The American College of Critical Care Medicine's clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock (Brierley et al, 2009) noted that children with septic shock, compared with adults, require ECMO for refractory shock.

ECMO in Children and Adults:

ECMO and extracorporeal life support (ECLS) are used in children and adults with irreversible heart or lung failure for prolonged (days to weeks) mechanical support.  The goal of ECMO/ECLS for pediatric or adult patients is to provide lung rest from the high levels of oxygen and higher airway pressures that are necessary to support oxygenation and ventilation.  Proper selection involves determining in which patients the disease process itself is reversible (with 1 to 2 weeks of ECMO/ECLS).  Contraindications to ECMO/ECLS in pediatric and adult patients include: necrotizing pneumonia; multiple organ failure in addition to respiratory or cardiac failure; metastatic disease; major CNS injury; quadriplegia; and more than 10 days on mechanical ventilation prior to the start of ECMO/ECLS.

An assessment of ECMO by the National Institute for Clinical Excellence (NICE, 2004) stated that its use is established in postneonatal children to treat respiratory or cardiac failure that is unresponsive to all other measures, but is considered to have a reversible cause.  According to NICE guidelines, ECMO may also be used following heart surgery in postneonatal children to ease the transition from cardiopulmonary bypass to ventilation.  NICE (2004) concluded that the use of ECMO for these indications in adults is currently the subject of investigation in the CESAR trial (Conventional ventilatory support versus Extracorporeal membrane oxygenation for Severe Adult Respiratory failure).

Thiagarajan et al (2007) reported on outcomes and predictors of in-hospital mortality after ECMO used to support cardiopulmonary resuscitation (E-CPR).  Outcomes for patients aged less than 18 years using E-CPR were analyzed with data from the Extracorporeal Life Support Organization, and predictors of in-hospital mortality were determined.  Of 26,242 ECMO uses reported, 695 (2.6 %) were for E-CPR (n = 682 patients).  Survival to hospital discharge was 38 %.  In a multi-variable model, pre-ECMO factors such as cardiac disease (odds ratio [OR] 0.51, 95 % confidence interval [CI] 0.31 to 0.82) and neonatal respiratory disease (OR 0.28, 95 % CI 0.12 to 0.66), white race (OR 0.65, 95 % CI 0.45 to 0.94), and pre-ECMO arterial blood pH greater than 7.17 (OR 0.50, 95 % CI 0.30 to 0.84) were associated with decreased odds of mortality.  During ECMO, renal dysfunction (OR 1.89, 95 % CI 1.17 to 3.03), pulmonary hemorrhage (OR 2.23, 95 % CI 1.11 to 4.50), neurological injury (OR 2.79, 95 % CI 1.55 to 5.02), CPR during ECMO (OR 3.06, 95 % CI 1.42 to 6.58), and arterial blood pH less than 7.2 (OR 2.23, 95 % CI 1.23 to 4.06) were associated with increased odds of mortality.  The authors concluded that ECMO used to support CPR rescued one-third of patients in whom death was otherwise certain.  Patient diagnosis, absence of severe metabolic acidosis before ECMO support, and uncomplicated ECMO course were associated with improved survival.  This is in agreement with the observations of Alsoufi et al (2007) who noted that acceptable survival and neurological outcomes (30 %) can be achieved with E-CPR in children after prolonged cardiac arrest (up to 95 minutes) refractory to conventional resuscitation measures.

In a review and quantitative analysis, Chawlin and colleagues (2008) stated that the role of ECMO has not been formally validated for patients with adult respiratory distress syndrome (ARDS).  In anticipation of publication of the conventional ventilation versus ECMO in severe adult respiratory failure (CESAR) trial, the role of ECMO in this setting was reviewed. An electronic search for studies reporting the use of ECMO for the treatment of ARDS revealed 2 randomized controlled trials (RCTs) and 3 non-controlled trials.  Bayesian analysis on the 2 RCTs produced an odds ratio mortality of 1.28 (credible interval 0.24 to 6.55) showing no significant harm or benefit.  Pooling was not possible for the non-controlled studies because of differing admission status and ECMO selection criteria and an inability to control for these differences in the absence of individual patient data.  A large number (n = 35) of case series have been published with generally more positive results.  The authors concluded that ECMO, as rescue therapy for ARDS, appears to be an unvalidated rescue treatment option.  Analysis and review of trial data does not support its application; however the body of reported cases suggests otherwise.

The primary results paper for the CESAR trial, a multicenter randomized controlled clinical trial comparing conventional ventilation methods with extra-corporeal membrane oxygenation for the treatment of severe acute respiratory failure in adults, has been accepted for publication in the Lancet.