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Neonatal ECMO: An Update Amir M. Khan, MD Associate Professor of Pediatrics UT Houston Medical School Medical Director NICU, Neonatal Transport and Respiratory Care Children’s Memorial Hospital, Houston, TX The speaker has signed a disclosure form and indicated he has no significant financial interest or relationship with the companies or the manufacturer(s) of any commercial product and/or service that will be discussed as part of this presentation. Session Summary During this session the presenter will review the historical trend and current uses of ECMO and changes in approach such as VV versus VA, changes in diagnoses, and change in management while on ECMO. Session Objectives Upon completion of this presentation, the participant will be able to: give a brief history of ECMO; understand common indications of ECMO; understand typical management and outcome on ECMO; evaluate the outcome and utilization data of ECMO; recognize indications for ECMO. References Bartlett, R., Roloff, D., Cornell, R., Andrews, A., Dillon, P. & Zwischenberger, J. (1985). Extracorpeal circulation in neonatal respiratory failure: A prospective randomized study. Pediatrics, 76(4): 479-87. O'Rourke, P., Crone, R., Vacanti, J., Ware, J., Lillehei, C., Parad, R. & Epstein, M. (1989). Extracorpeal membrane oxygenation and conventional medical therapy in neonates with persistent pulmonary hypertension of the newborn: A prospective randomized study. Pediatrics, 84(6): 957-63. UK Collaborative ECMO Trial Group (1996). UK collaborative randomized trial of neonatal extracorpeal membrane oxygenation. Lancet, 348(9020): 75-82. Session Outline See presentation handout on the following pages. A9 FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW A9: NEONATAL ECMO: AN UPDATE Page 1 of 8

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Neonatal ECMO: An Update Amir M. Khan, MD Associate Professor of Pediatrics UT Houston Medical School Medical Director NICU, Neonatal Transport and Respiratory Care Children’s Memorial Hospital, Houston, TX

The speaker has signed a disclosure form and indicated he has no significant financial interest or relationship with the companies or the manufacturer(s) of any commercial product and/or service that will be discussed as part of this presentation.

Session Summary

During this session the presenter will review the historical trend and current uses of ECMO and changes in approach such as VV versus VA, changes in diagnoses, and change in management while on ECMO.

Session Objectives

Upon completion of this presentation, the participant will be able to:

give a brief history of ECMO;

understand common indications of ECMO;

understand typical management and outcome on ECMO;

evaluate the outcome and utilization data of ECMO;

recognize indications for ECMO.

References

Bartlett, R., Roloff, D., Cornell, R., Andrews, A., Dillon, P. & Zwischenberger, J. (1985). Extracorpeal circulation in neonatal respiratory failure: A prospective randomized study. Pediatrics, 76(4): 479-87.

O'Rourke, P., Crone, R., Vacanti, J., Ware, J., Lillehei, C., Parad, R. & Epstein, M. (1989). Extracorpeal membrane oxygenation and conventional medical therapy in neonates with persistent pulmonary hypertension of the newborn: A prospective randomized study. Pediatrics, 84(6): 957-63.

UK Collaborative ECMO Trial Group (1996). UK collaborative randomized trial of neonatal extracorpeal membrane oxygenation. Lancet, 348(9020): 75-82.

Session Outline

See presentation handout on the following pages.

A9 FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 1 of 8

Neonatal ECMOAn Update

Amir M. Khan, MD

INTRODUCTION TO ECMO

What is ECMO?

• A constellation of biomedical devices(heart, lung, kidney, GI tract) compiled to provide life support when biologic organs are failing despite maximal “conventional” care

• A form of extrathoracic partial cardiopulmonary bypass designed as an oxygen delivery system to meet tissue needs

• A system based on a non-porous silicone oxygenator to allow prolonged life support

ECMOHistorical Background

1937 - Gibbon - 1st Oxygenator 1956 - Clowes - Membrane Oxygenator 1972 - 1st Adult Survivor 1974 - 1st Neonatal Survivor 1979 - NIH Trial 1980’s (Early) - Bartlett, Others 1980’s (Late) - Boston/Michigan Trials

Explosion of ECMO Centers 1996 - Lancet/UK Trial

FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 2 of 8

ECMO UtilityRandomized Trials

• Bartlett, et al Pediatrics 1985; 76:479-487

• O’Rourke, et al Pediatrics 1989; 84:957-963

• UK Trial Lancet 1996; 348:75-82

Neonatal ECMOUK Trial

ECMO C ti lECMO Conventional

63/93 (68%) 38/92 (41%) p<0.0005

59/75 (79%) 38/75 (51%) p<0.0006)

(No CDH)

Lancet 1996

ELSO

Extracorporeal LifeSupport Organization

Est. 1989Membership Voluntary

Data CollectionStandards

Scientific Exchange

ECMO Circuit

PumpVenous Reservoir

OxygenatorHeat Exchanger

Safety MechanismsCannula

FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 3 of 8

FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 4 of 8

When is ECMO needed (generally)?

• When tissue oxygen requirements are not being met by biologic organs and “conventional” care ... usually manifest by progressive metabolic acidosis mixed venousmanifest by progressive metabolic acidosis, mixed venous desaturation (SvO2), and multiple organ failure

• When irreversible biologic organ damage is occurring with conventional care

• When expected mortality likelihood approached 80-90% with conventional care

Indications for ECMO

• Severe Respiratory Failure

• Severe Barotrauma

• Cardiac Failure

Neonatal ECMO

• No lethal anomaly

• No cyanotic heart diseaseNo cyanotic heart disease

• No bleeding diathesis

• No intracranial hemorrhage (relative)

• < 10 days of mechanical ventilation (relative)

Criteria for ECMO

• Alveolar-arterial gradient• Oxygenation indexyg• Barotrauma• Cardiac arrest• Acute deterioration• Failure to respond

Contraindicationsfor ECMO*

• Severe PrematuritySevere Prematurity• Profound Neurological Deficit• Severe Anomalies• Bleeding Diathesis

*( Never Rule it Out!)

FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 5 of 8

Oxygenation Index

Mean Airway Pressure x FiO2 x 100y 2

Postductal paO2

ECMO Complications

Patient

Mechanical

Patient Complications

• Seizures

• Intracranial hemorrhage

• Renal failure

• Bleeding

• Hypertension

• Hemolysis

• Others

Mechanical Complications

• Oxygenator failure

• Pump malfunction

• Cl t• Clots

• Air in circuit

• Cannula problems

• Cracks in tubing

• Raceway rupture

• Others

Time on ECMO

Neonates

Survivors Non-SurvivorsSurvivors Non Survivors128 Hours 172 Hours

Cause of Death

• Intracranial Hemorrhage

• Sepsisp

• Cardiac Failure

• Failure To Respond

• Other

FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 6 of 8

ELSO Registry Data Summaryy

July 2011

Active ECLS Centers

2000

2500

3000

3500

80

100

120

140

160

of

Ru

ns

f C

en

ters

0

500

1000

1500

0

20

40

60

80

90 92 94 96 98 00 02 04 06 08 10

Nu

mb

er

o

Nu

mb

er

o

Centers

Cases

ELSO Registry July 2011

Texas ECMO Centers

Overall Patient Outcomes

Total Surv ECLS Surv to DC Neonatal Respiratory 24,770 20,951 85% 18,558 75% Cardiac 4,375 2,649 61% 1,723 39% ECPR 694 438 63% 270 39% Pediatric Respiratory 5,009 3,251 65% 2,785 56% Cardiac 5,423 3,468 64% 2,609 48% ECPR 1,347 720 53% 539 40% Adult Respiratory 2,620 1,655 63% 1,428 55% Cardiac 1,680 894 53% 660 39% ECPR 591 225 38% 173 29% Total 46,509 34,251 74% 28,745 62%

ELSO Registry July 2011

Initial Mode of Neonatal Respiratory Support

VA, 67%VA

VV

VVDL

ELSO Registry July 2011

VV, 2%VVDL, 23%

VA+V, 5%

VV-VA, 3%Other, 0%

VA+V

VV-VA

Other

Runs by Year

60%

80%

100%

Card (16 years and over)

Card (1 year < 16 years)

Card (31 days < 1 year)

Card (0 - 30 days)

Adult Pulm

Ped Pulm

0%

20%

40%

Ped Pulm

Neo Pulm

ELSO Registry July 2011

FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 7 of 8

Neonatal Survival by Diagnosis and Year

75%

100%

0%

25%

50%

<=87 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011

CDH MAS PPHN RDS Sepsis Others

ELSO Registry July 2011

Neonatal Respiratory Cases

20000

25000

30000

1000

1200

1400

1600

Run

s

ns

0

5000

10000

15000

20000

0

200

400

600

800

1000

Cum

ulat

ive

R

Annu

al R

un

ELSO Registry July 2011

Neonatal Diagnoses and Survival

5000

6000

7000

8000

un

s

51%94%

78%

0

1000

2000

3000

4000

CDH MAS PPHN/PFC RDS Sepsis OtherNon-Surv 3082 492 929 239 672 1006

Surv 3198 7322 3200 1269 1974 1717

Tota

l Ru

75%

84%

78%

63%

ELSO Registry July 2011

Neonatal Cases by Year and Diagnosis

80%

100%Others

Sepsis

RDS

PPHN/PFC

0%

20%

40%

60%PPHN/PFC

MAS

CDH

ELSO Registry July 2011

Neonatal Cases by Diagnosis

No. Runs % Survived

MAS 7 814 94

ELSO Registry July 2011

MAS 7,814 94 CDH 6,280 51 Sepsis 2,646 75 PFC/PPHN 4,129 78 RDS 1,508 84 Other 2,723 63

FANNP 24TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW

A9: NEONATAL ECMO: AN UPDATE Page 8 of 8