Extracorporeal Membrane Oxygenation (ECMO)
DESCRIPTION
Extracorporeal membrane oxygenation (ECMO) is used to temporarily replace functioning of the heart and lungs for pulmonary support during pulmonary dysfunctioning. Extracorporeal life support is done by draining venous blood, removing carbon dioxide, and adding oxygen through an artificial lung, and returning the blood to the circulation via a vein for pulmonary support. ECMO is indicated for the neonates with acutely severe, potentially lethal, respiratory failure that is unresponsive to conventional management, when the primary condition is reversible.
ECMO maintains systemic oxygen delivery and carbon dioxide removal from the blood in proper proportion to systemic metabolism. This allows for the lungs to rest and recover from the acute illness. As pulmonary function begins to improve, extracorporeal blood flow is decreased, allowing more blood to flow through the lungs. When the lung function is adequate with low ventilatory support, the neonate is removed from ECMO. The entire treatment usually takes five to ten days for neonates.
POLICY
Extracorporeal membrane oxygenation for treatment of a select population of neonates who are in a dying condition with intractable respiratory failure is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Extracorporeal membrane oxygenation for treatment of other conditions/diseases and for children and adults is considered investigational.
MEDICAL APPROPRIATENESS
Extracorporeal membrane oxygenation is considered medically appropriate for an individual neonate who is in a dying condition with intractable respiratory failure when ALL the following criteria are met:
Gestational age greater than 34 weeks
Birth weight greater than 2,000 grams
Mechanical ventilation less than 10 to 14 days
Reversible lung injury
Optimal medical management has failed
There is a reasonable medical probability for quality of life
ABSENCE of ALL of the following:
Significant coagulopathy or uncontrollable bleeding
Major intracranial hemorrhage
Lethal malformations
Major cardiac malformation
Pre-existing neurological impairment
Immunosuppression
Irreversible lung damage
Severe brain damage
Multiple major congenital anomalies
Congenital diaphragmatic hernia with bilateral pulmonary hypoplasia
ADDITIONAL INFORMATION
ECMO centers must meet Extracorporeal Life Support Organization (ELSO) guidelines for neonatal ECMO centers.
Published data is inadequate to permit scientific conclusions regarding the application of extracorporeal membrane oxygenation for the treatment of other conditions/diseases, and for children and adults.
SOURCES
Agus, M., Javid, P. J., Piper, H. G., Wypij, D., Duggan, C. P., Ryan, D. P., et al. (2006). The effect of insulin infusion upon protein metabolism in neonates on extracorporeal life support. Annals of Surgery, 244 (4), 536-544. (Level 2 Evidence - Independent study)
Beardsmore, C. S., Westaway, J., Killer, H., Firmin, R. K., & Pandya, H. (2007). How does the changing profile of infants who are referred for extracorporeal membrane oxygenation affect their overall respiratory outcome? Pediatrics, 120 (4), e762-e768.
Chen, Y. S., Yu, H. Y., Huang, S. C., Lin, J. W., Chi, N. H., Wang, C. H., et al. (2008). Extracorporeal membrane oxygenation support can extend the duration of cardiopulmonary resuscitation. Critical Care Medicine, 36 (9), 2529-2535. (Level 2 Evidence - Independent study)
Elbourne D, Field D, Mugford M. Extracorporeal membrane oxygenation for severe respiratory failure in newborn infants. The Cochrane Database of Systematic Reviews 2002, Issue 1. Art. No.: CD001340. DOI: 10.1002/14651858.CD001340.
Extracorporeal Life Support Organization. (2005, February). ELSO guidelines for ECMO centers. Retrieved October 25, 2005 from http://www.elso.med.umich.edu/WordForms/ELSO%20Guidelines-Center%202-05.pdf.
Fiser, R. T., & Morris, M. C. (2008). Extracorporeal cardiopulmonary resuscitation in refractory pediatric cardiac arrest. Pediatric Clinics of North America, 55 (4), 929-941.
Greenough, A. & Donn, S. M. (2007). Matching ventilatory support strategies to respiratory pathophysiology. Clinics in Perinatology, 34 (1), 35-53.
Hayes. Medical Technology Directory. (2006, March). Extracorporeal Membrane Oxygenation for Heart Failure (Children and Adults). Retrieved November 3, 2008 from www.Hayesinc.com/subscribers. (45 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2006, March). Extracorporeal Membrane Oxygenation for Organ Transplantation. Retrieved November 3, 2008 from www.Hayesinc.com/subscribers. (33 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2006, May). Extracorporeal Membrane Oxygenation for Respiratory Failure (Children and Adults). Retrieved November 3, 2008 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2007, December). Extracorporeal Apheresis for Conditions Affecting the Circulatory System and Blood. Retrieved November 3, 2008 from www.Hayesinc.com/subscribers. (46 articles and/or guidelines reviewed)
Hemmila, M. R., Rowe, S. A., Boules, T. N., Miskulin, J., McGillicuddy, J. W., Schuerer, D. J., et al. (2004). Extracorporeal life support for severe acute respiratory distress syndrome in adults. Annals of Surgery, 240 (4), 595–607. (Level 1 Evidence - Independent study)
National Guideline Clearinghouse. (2004, November). Levels of neonatal care. Retrieved November 3, 2008 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2005, December). Transfusion guidelines for neonates and older children. Amendments and corrections to the transfusion guidelines for neonates and older children. Retrieved November 3, 2008 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2006). Coagulation. Laboratory medicine practice guidelines: Evidence-based practice for point-of-care testing. Retrieved November 3, 2008 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2008, January). Surviving sepsis campaign: International guidelines for management of severe sepsis and septic shock: 2008. Retrieved November 3, 2008 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2008, May). Management of invasive meningococcal disease in children and young people. A national clinical guideline. Retrieved November 3, 2008 from http://www.guidelines.gov.
Peek, G. J., Clemens, F., Elbourne, D., Firmin, R., Hardy, P., Hibbert, C, et al. (2006). CESAR: Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure. BMC Health Services Research, 23 (6), 163. (Level 3 Evidence - Independent study)
Petrou, S., & Edwards, L. (2004). Cost effectiveness analysis of neonatal extracorporeal membrane oxygenation based on four-year results from the UK Collaborative ECMO Trial. Archives of Disease in Childhood Fetal and Neonatal Edition, 89 (3), F263-268.
Thalanany, M. M., Mugford, M., Hibbert, C., Cooper, N. J., Truesdale, A., Robinson, S., et al. (2008). Methods of data collection and analysis for the economic evaluation alongside a national, multi-centre trial in the UK: Conventional ventilation or ECMO for Severe Adult Respiratory Failure (CESAR). BMC Health Services Research, 8 (94). (Level Evidence - Independent study)
U.S. Food and Drug Administration. (2003, August). Center for Devices and Radiological Health. 510 (k) Premarket Notification Database. K032213. Retrieved November 3, 2008 from http://www.fda.gov/cdrh/pdf3/K032213.pdf.
U.S. Food and Drug Administration. (2003, March). Center for Devices and Radiological Health. 510 (k) Premarket Notification Database. K030462. Retrieved November 3, 2008 from http://www.fda.gov/cdrh/pdf3/K030462.pdf.
ORIGINAL EFFECTIVE DATE: 5/1987
MOST RECENT REVIEW DATE: 12/11/2008
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.