Outcomes From Severe ARDS Managed Without ECMO. Roy Brower, MD Johns Hopkins University Critical Care Canada Forum Toronto November 1, 2016

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1 Outcomes From Severe ARDS Managed Without ECMO Roy Brower, MD Johns Hopkins University Critical Care Canada Forum Toronto November 1, 2016

2 Severe ARDS Berlin Definition 2012 P:F ratio 100 mm Hg Prevalence: 28% of ARDS patients Mortality: 45% (95% CI: %) LUNG-SAFE 2016 P:F ratio 100 mm Hg Prevalence: 23.4% of patients Mortality: 46.1% (95% CI: )

3 Interventions for Severe ARDS Lung-protective ventilation Infection management Fluid management Neuromuscular blockade Prone positioning ECMO?

4 The ECMO Argument Appeal of ECMO Physiologic rationale Preserve life Buy time for treatment and healing Lung rest Downside of ECMO May only prolong death Invasive, complications Resource-intensive Expensive

5 Early RCTs in ECMO Zapol et al. JAMA 1979 Morris et al. AJRCCM 1994

6 ECMO Volumes: Bartlett, RH J Am Coll Surg 2014

7 68 Patients With H1N1-Influenza-ARDS PaO 2 /FiO 2 56 (48-63) PEEP 18 (15-20) ALI Score 3.8 ( ) Mortality 25% Davies et al. JAMA 2009 JAMA 2009

8 68 Patients With H1N1-Influenza-ARDS PaO 2 /FiO 2 56 (48-63) PEEP 18 (15-20) ALI Score 3.8 ( ) Mortality 25% Age 34 (27-43) Comorbidity 8% Davies et al. JAMA 2009 JAMA 2009

9 Survival (%) 2009: CESAR Trial Conventional group 90 patients Death: 45% ECMO center 90 patients 68 received ECMO Death: 33% P= 0.027

10 2009: CESAR TRIAL Treatment Conventional ECMO Volume/Pressure limited ventilation at any time 70% * 93% * Time under low volume/pressure strategy 15.0 days * 23.9 days * Steroids 64% * 84% * MARS (Liver Assist) 0% * 17% * Transport to High-Volume Center 0% 100% * p< 0.05

11 Pham. AJRCCM 2013 Noah. JAMA, 2011

12 Objective Characterize the features and outcomes of patients with severe ARDS who met criteria for ECMO at other institutions but were managed with usual care

13 Criteria for ECMO Consideration Our Criteria Brodie Criteria ELSO Criteria Hypoxemia PaO2/FiO2 ratio < 100 despite levels of PEEP > 10 cm H2O for at least 6 hours Hypercapnia PCO2 > 50 with arterial ph < 7.15 or venous ph < 7.12 High plateau pressure Pplat > 35 cm H2O with either tidal volume 6 ml/kg PBW or arterial ph < 7.15 PaO2/FiO2 ratio < 80 despite high levels of PEEP (typically cm H2O) for at least 6 hrs ph < 7.15 despite best accepted standard of care with MV Consider when PaO2/FiO2 < 150 on FiO2 > 90% or ALI score 2-3 Indicated when PaO2/FiO2 < 100 on FiO2 > 90% and/or ALI score 3-4 despite optimal care > 6 hrs CO2 retention on mechanical ventilation despite high Pplat > 30 cm H2O Other: Severe air leak, need for Excessive plateau pressures: intubation in patient on transplant Pplat > cm H2O despite best list, sudden cardiac or respiratory accepted standard of care with MV collapse (PE, blocked airway, unresponsive to optimal care) Brodie and Bachetta, NEJM 2011 ELSO Website, Dec 2013

14 Prospective Observational Study Methods Daily screening of JHH MICU census from February 2014 June 2015 for patients with severe ARDS + ECMO consideration criteria 46 patients identified 5 patients received ECMO

15 Patient characteristics N = 46 Age (17.18) Female Gender 22 (47.8) APACHE II (7.40) SOFA (3.94) ARDS Risk Factor Pneumonia 28 (60.8) Non-Pulmonary Sepsis 13 (28.2) Aspiration 2 (4.3) Pancreatitis 1 (2.2) Blood Product Transfusion 1 (2.2) Other 2 (2.2) PaO2/FiO (33) FiO2 100 (30) PEEP (4.41) Pplat (5.78) PCO (27) ph 7.15 (0.11) Overall: 46 patients Average 51 years SOFA 12.6 P/F 60.5 Low VT 5.23 cc/kg PBW Mortality: 56% Tidal Volume 5.23 (0.88) *Stats reported as mean (SD), median (IQR), or number(%) *Other Cause of ARDS Diffuse Alveolar Hemorrhage

16 Contraindications to ECMO Our Criteria Brodie Criteria ELSO Criteria Anticoagulation contraindicated Anticoagulation contraindicated CNS hemorrhage, recent or expanding High pressure ventilation > 7 days High pressure ventilation > 7 days MV at high settings (FiO2 > 0.9, Pplat > 30) for > 7 days High FiO2 requirement (>0.8) > 7 days High FiO2 requirement (>0.8) > 7 days Major pharmacologic immunosuppression (ANC < 400) Limited potential benefit for ECMO Limited potential benefit for ECMO Limited potential benefit for ECMO Limited vascular access

17 All Patients (n = 46) Eligible for ECMO (n = 25) Not Eligible for ECMO (n = 16) Age (17.18) (14.28) (18.9) Female 22 (47.8%) 14 (56%) 5 (31.2%) APACHE II (7.40) (7.43) (7.3) SOFA (3.94) 13.2 (3.62) (4.61) Pneumonia 28 (60.8%) 16 (64%) 8 (50%) PaO 2 /FiO (33) 66 (35) 57.5 (25.5) FiO2 100 (30) 90 (30) 95 (30) PEEP (4.41) 14 (6) 12 (5.5) Pplat (5.78) 32 (6) 34.5 (6) PCO (27) 61 (20) 70.5 (24.5) ph 7.15 (0.11) 7.16 (0.12) 7.16 (0.10) Tidal Volume 5.23 (0.88) 5.32 (0.77) 5.56 (0.62) Mortality 27 (56%) 11 (44%) 12 (75%) *Stats reported as mean (SD), median (IQR), or number(%)

18 Clinical Course and Outcomes All Patients (n = 46) Eligible for ECMO (n = 25) Not Eligible for ECMO (n = 16) Rescue Therapies 22 (52) 12 (48) 5 (31) Neuro Blockade 21 (45.6) 12 (48) 5 (31.2) Prone 7 (15) 3 (12) 1 (6.2) Inhaled vasodilator 1 (2) 1 (4) 0 ICU LOS 15 (18) 13 (16.5) 20 (27) Hospital LOS 21.5 (22) 21 (22) 22 (28.5) Mortality 27 (56%) 11 (44%) 12 (75%) *Stats reported as median (IQR), or number(%)

19 Predicting ECMO Survival RESP Score RESP Score Risk Class Survival 6 I 92% 3-5 II 76% -1 to 2 III 57% -5 to -2 IV 33% -6 V 18% Schmidt et al, AJRCCM 2014 Schmidt et al AJRCCM 2014

20 RESP Score All Pts Eligible Not Eligible RESP score 0 (4) 1 (4) -1 (6) Survival 44% 56% 25% Schmidt et al, AJRCCM 2014

21 Conclusions Survival in ECMO eligible patients managed without ECMO comparable to survival predicted with ECMO ECMO may not improve outcomes in population of severe ARDS patients Need good randomized controlled trials Which patients? When? How?

22 ECMO Complications Ventetuolo and Muratore AJRCCM 2014

23 RCTs of Interventions We Believed In (but were not working) Flecainide for arrhythmia suppression (NEJM, 1991) Engineeered molecules for sepsis (1990s) Milrinone for acute CHF (JAMA 2002) Nesiritide for acute CHF (JAMA 2005) Surfactant for ARDS (NEJM 2004; AJRCCM 2011) Higher PEEP for ARDS (NEJM 2006; JAMA 2008) Intra-aortic Balloon Pump for M.I. with shock (NEJM 2012) HFOV for ARDS (NEJM 2013) Glutamine for oxidant stress in critically ill (NEJM 2013) Pulmonary Artery Catheters for: High risk surgery (NEJM 2003) Critically ill (Lancet 2005) Shock or ARDS or both (JAMA 2003) ARDS (NEJM 2006)

24 Thank You

25 ECMO patients ECMO patients (n = 5) Age 29 (7) APACHE II 21.6 (2.30) SOFA 12.6 (3.21) Pneumonia 4 (80%) PaO 2 /FiO 2 49 (9) FiO2 100 (0) PEEP 18 (4) Pplat 44 (5) pco (29.34) ph 7.15 (0.10) Tidal Volume 3.76 (0.70) Days on MV 6.4 (2.88) ECMO patients (n = 5) Rescue Therapies 5 (100%) Paralytic 4 (80) Prone 3 (60) ino 0 ICU LOS 8 (5) Hospital LOS 30 (17) RESP score 0 (2) Mortality 4 (80) *Stats reported as mean (SD), median (IQR), or number(%)

26 Coming Enlightenment? EOLIA: ECMO to rescue Lung Injury in severe ARDS Multi-national, multi-center Randomized, controlled VV-ECMO with lung rest Vent:FiO ; PEEP 10 cm H 2 O; Pplat <10 Conventional ARDS management Pplat < cm H 2 O Cross-over to ECMO for refractory hypoxemia Primary Endpoint: Mortality at Day 60

27 EOLIA: Inclusion/Exclusion Inclusion criteria : ARDS defined as: Intubation and mechanical ventilation for 6 days Bilateral pulmonary infiltrates c/w edema PaO2/FiO2 ratio < 200 mm Hg Absence of clinical evidence of elevated LAP One of the 3 following criteria of disease severity: PaO2/FiO2 < 50 mm Hg with FiO2 80% for > 3 hrs, despite optimization of MV (Vt set at 6 ml/kg and trial of PEEP 10 cm H2O) and despite possible adjunctive therapies (NO, recruitment maneuvers, prone position, HFO ventilation, almitrine infusion) PaO2/FiO2 < 80 mm Hg with FiO2 80% for > 6 hrs, despite optimization of MV and despite possible recourse to adjunctive therapies ph < 7.25 for > 6 hours (with RR increased to 35/min) resulting from MV settings adjusted to keep Pplat 32 cm H2O (first, tidal volume reduction by steps of 1 ml/kg to 4 ml/kg then PEEP reduction to a minimum of 8 cm H2O. Exclusion Criteria: Intubation and mechanical ventilation for 7 days Age < 18 years Pregnancy Weight > 1 kg/cm or BMI > 45 kg/m² Chronic respiratory insufficiency treated with oxygen therapy of long duration and/or long-term respiratory assistance Cardiac failure requiring veno-arterial ECMO Previous history of heparin-induced thrombopenia Malignancy with fatal prognosis within 5 years Patient moribund on the day of randomization or has a SAPS II > 90 Non drug-induced coma following cardiac arrest Irreversible neurological pathology, for example, flat EEG tracing cerebral herniation Decision to limit therapeutic interventions ECMO cannula access to femoral vein or jugular vein impossible. CardioHelp device not immediately available

28 Adult ECMO at Johns Hopkins Formal ECMO program started in 2014 C. Sciortino, Surgical Director S. Stephens, Medical Director 3-ECMO 2014: 37 runs (VV and VA) 7 deaths (3 ARDS) 2015 (to date): 13 runs (VV and VA) 3 deaths (1 ARDS) Projected 2015 volume: 52 runs

29 ECMO for ARDS: the JHH Experience Since January, 2014 All Survivors Non-Survivors Patients (%) 7 3 (43%) 4 (57%) Median Age (Range) 30 (23-78) 37 (24-63) 28.5 (23-78) Mean APACHE II (SD) 27 (7.4) Mean SOFA (SD) 10.3 (3.7)

30 Bartlett, RH J Am Coll Surg 2014 Changing ECMO Indications 2009

31 H1N1 Patients Managed Without ECMO 168 critically ill patients with H1N1 81% mechanically ventilated at ICU admission Mean age 32.3 years Only 4.2% of patients placed on ECMO 17.3% mortality Kumar et al, JAMA 2009

32 2009 H1N1 Influenza

33 CESAR Trial 180 adults with severe ARDS ALI Score >3.0 or Hypercapnia with ph < 7.20 For < 7 days Randomized to either: Conventional Management at home hospital: 90 patients Referral to a single tertiary center for consideration of ECMO: 90 patients Peek et al Lancet 2009; 374:

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