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Background. ARDS200,000 US cases per year30-80% mortalityTrials with a mortality benefit:6 ml/kg vs 12 ml/kgARDSnet, NEJM 1998Trials without a mortality benefit:HFOVWunsch, Cochrane Database 2004INOGriffiths, NEJM 2005Prone positioningGattinoni, NEJM 2001Liquid ventilationHirschl, Am J
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1. ECMO and Acute Lung Injury:Is There An Indication? Kristen C. Sihler, MD, MS
8. Trial Design Randomized controlled clinical trial
ECMO versus “conventional therapy”
ECMO conducted at Glenfield Hospital, Leicester, England
Only adult ECMO center in Great Britain
“Conventional therapy” at select Conventional Treatment Centers (CTC)
High volume hospitals
17. Results
18. Results
19. Results Reasons for not receiving ECMO
16 improved
3 late deaths
2 Died before transfer
3 died in transport
1 required amputation
13/22 (59%) patients randomized to ECMO but did not receive ECMO survived
20. Results
21. Results
23. Results Subgroup analysis: no differences in outcomes
Age group
Requirement for transport
Duration of high pressure/FiO2 >48 hrs
Pneumonia vs ARDS vs trauma
No. of organs failed
24. Conclusions ECMO improves survival in adult patients with early, severe, and potentially reversible respiratory failure
One additional survivor for every six patient treated
25. Strengths No crossover
Conventional treatment could not get ECMO
Limited selection bias
ECMO not available outside of clinical trial
“Pragmatic” trial design
“Conventional treatment” reflects current practice
Similar design to neonatal ECMO trial
26. Limitations Small size
Initially intended to include 240 patients
Halted by DSMB at 180 patients
No standard protocol for “conventional therapy”
Every intensivist thinks their own protocol would be superior
Many patients randomized to ECMO did not receive ECMO
Perhaps outcome advantage is related to transfer to better hospital rather than ECMO itself
31. Overall Patient Outcomes
32. Adult Respiratory Cases
36. ECMO and Influenza1990-2009 196 patients, 200 runs between 1990 and 2009
Age: mean 8.5 + 12, median 2.6 years
range 1h to 68.5 years
Gender 53% female
47% male
Indication pulmonary 80%
cardiac 16%
ECPR 4%
Mode: VV or VVDL 34%
VA 53%
VAV, other 13%
Pre ECMO 4.5 + 9 d, med 1.9 (0-
Run Times: mean 263 + 202 h, median 210
range 1h to 954 hours
Overall Survival: 103/196 =52.6%
37. ECMO and Influenza1990-2009
38. ECMO and Influenza1990-2009
39. ECMO and Influenza1990-2009 Overall survival 52.6%
Pediatric ECMO for influenza
Total number of reported patients to date 174
54.0% survival
Adult ECMO for influenza
not reported to ELSO until 2000
Total number of reported patients to date 22
40.9% survival
40. Australia/New Zealand Approximately 340,000 cases, >750 ICU admits
68 on ECMO
VV 63
VA 4
Central 1
Many young adults, 3 children, 4 adolescents
Transports
Almost 3/4 transferred in to ECMO center
79% (38/49) cannulated at referral hospital for transport
Mortality 21%
41. ELSO February 16, 2010H1N1 Registry 227 Cases Age 23.9 years, median 23
Gender 51% female 49% male
BMI mean approx 30
Mode VV 145, VA 37, other 28
42. ELSO February 16, 2009H1N1 Registry Traditional Risk Factors reported in 203 patients
43. ELSO February 16, 2009H1N1 Registry
44. Risk Factors
27% women reported in sample pregnant
ELSO February 16, 2009H1N1 Registry
45. ELSO February 16, 2009H1N1 Registry Intubation to Time on ECMO
Mean 5.6 days, median 3.6 (0 – 41.7)
Longest with survivor to date, 7 yo, 29 days
Run times
Mean 280 hours, median 211 (0 – 1438)
Longest with survivor to date, 22 yo, 50 days
Outcome known in 195 cases
Survival 61% (119/195)
46. ELSO February 16, 2009H1N1 Registry
47. Preliminary Summary 2/16/10 Australia/ELSO H1N1data At least 300 cases worldwide to date
**Kudos to Australia/New Zealand**
Patients requiring ICU admission appear to be minority of H1N1 patients, however respiratory failure can be severe
Many Young Adults
Few prior traditional influenza risk factors
Overall survival to date: range 60-80%
48. ECMO is a Bridge
49. Make sure it isn’t a bridge to nowhere
Make sure it isn’t a bridge to nowhere