ECMO for ARDS Ave CESAR?
ECMO for ARDS Ave CESAR?
ECMO for ARDS Ave CESAR?
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<strong>ECMO</strong> <strong>for</strong> <strong>ARDS</strong><br />
<strong>Ave</strong> <strong>CESAR</strong><br />
Richard Peter von Rahden<br />
BSc(LabMed) MBBCh DA(SA) FCA(SA) CertCriticalCare(SA)<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
RP von Rahden : Affiliations<br />
Pietermaritzburg Department of Anaesthesia,<br />
Critical Care & Pain Management<br />
Head Clinical UnitI<br />
(Critical Care)<br />
Department of Anaesthesia<br />
Honorary Lecturer<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
RP von Rahden : Declarations<br />
• Lectured <strong>for</strong>, with honoraria:<br />
o Scientific Group<br />
o Adcock-Ingram Critical Care<br />
• Prize conference sponsorships:<br />
o Teleflex Medical<br />
• Conference sponsorships:<br />
o Fresenius-Kabi<br />
o Adcock-Ingram Critical Care<br />
o Aspen Pharmacare<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
<strong>ECMO</strong><br />
Extra-Corporeal Membrane Oxygenation<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
Cardiopulmonary bypass<br />
• Made open cardiac<br />
surgery possible<br />
• Pump system<br />
o complete artificial<br />
circulation<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
• Oxygenator<br />
o bubble<br />
o membrane
Concept development<br />
• Use of CPB to support<br />
gas exchange.<br />
o Hill NEJM 1972<br />
• Partial artificial<br />
circulation.<br />
• Simplified circuit.<br />
• More automation<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
o “attendant” still needed
pvr<br />
T11_07<br />
<strong>ECMO</strong><br />
Venoarterial <strong>ECMO</strong>
Types<br />
• Veno - arterial<br />
SpO 2 ++++<br />
• Veno – venous<br />
o (ECCO 2 R)<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
SpO 2 ++
Cardiac support by <strong>ECMO</strong><br />
[LVAD, IABP]<br />
A separate topic.<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
Focus:<br />
Injured lung : <strong>ARDS</strong>, H1N1...<br />
Unsupportable oxygenation on IPPV.<br />
Ongoing lung damage from IPPV.<br />
Organ failure from hypoxaemia.<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
In severe ALI…<br />
Appealing concept!<br />
Anecdotal evidence abounds!<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
But…<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
• Major risks<br />
o bleeds<br />
o cannulation injury<br />
o embolism<br />
o heparinization<br />
o …<br />
• Major expense<br />
o equipment<br />
o consumables<br />
o personnel : placement, management
EVIDENCE!<br />
RC<br />
T<br />
RC<br />
T<br />
RC<br />
T<br />
Acceptable big trials needed!<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
RC<br />
T<br />
RC<br />
T<br />
RC<br />
T
Decades ago…<br />
• Proponents : select good cases!<br />
• But: general wisdom : “last resort”<br />
o Randomize to <strong>ECMO</strong> “if nothing left to lose”.<br />
• 1979: “Acute ()” Respiratory Failure : NIH<br />
o <strong>ECMO</strong> vs conventional<br />
9.5% 8.3%<br />
Zapol, JAMA, 1979<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
<strong>CESAR</strong><br />
Efficacy and economic assessment of conventional<br />
ventilatory support versus extracorporeal<br />
membrane oxygenation <strong>for</strong> severe adult respiratory<br />
failure (<strong>CESAR</strong>): a multicentre randomised<br />
controlled trial<br />
Peek GJ, Mug<strong>for</strong>d M, Tiruvoipati R et al<br />
The Lancet, Volume 374, Issue 9698, Pages 1351- 63<br />
17 October 2009<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
<strong>CESAR</strong> enrollment<br />
766 patients screened.<br />
180 enrolled.<br />
18-65 yrs;<br />
severe reversible respiratory failure<br />
exclude: high Paw, FiO 2 ; bleeds; care limits<br />
Randomized: conventional management (90)<br />
consideration <strong>for</strong> <strong>ECMO</strong> (90)<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
<strong>CESAR</strong> outcomes<br />
Survival to 6 months without disability:<br />
Conventional : 41 of 87 patients (47%)<br />
<strong>ECMO</strong>-consideration: 57 of 90 (63%)<br />
NB : only 68 of 90 (=75%) actually got <strong>ECMO</strong><br />
Relative Risk 0.69 (95% CI 0.05-0.97)<br />
p=0.03<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
Announcing the good news<br />
“Use of <strong>ECMO</strong> results in 1 extra survivor <strong>for</strong><br />
every 6 patients treated,<br />
so I would suggest to you that this is „right<br />
care, right now.‟ ”<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
Dr Giles Peek<br />
at SCCM 37 th Critical Care Conference<br />
Honolulu, February 2008<br />
Medscape viewarticle/569740
pvr<br />
T11_07<br />
<strong>ECMO</strong><br />
So what are we waiting <strong>for</strong>!
Evidence-Based Medicine<br />
IS THIS EVIDENCE<br />
ACTUALLY EVIDENCE<br />
OF WHAT IS CLAIMED<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
Groups<br />
• Intention-to-Treat Analysis<br />
<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
• Experimental group<br />
o “CONSIDERATION <strong>for</strong> <strong>ECMO</strong>”<br />
o 25% (22 of these 90) DID NOT GET <strong>ECMO</strong>!<br />
• IPPV at the specialist referral centre
Groups in more detail<br />
• Control group<br />
o left at referring hospitals<br />
o continued conventional ventilation<br />
o only loose guidelines<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
• Experimental group<br />
o transferred to Glenfield Hospital in Leicester<br />
• optimal specialist mechanical ventilation<br />
o 17 improved so much they no longer needed<br />
<strong>ECMO</strong>! (82% of these ultimately lived)
So…<br />
Is this a trial of <strong>ECMO</strong><br />
or<br />
Is this a trial of benefits of<br />
transfer to a centre of expertise<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
“Intention to treat” best<br />
Would a “per protocol” analysis<br />
be more useful here<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
Even as is… are we secure<br />
• “p=0.03”<br />
o one extra experimental patient with morbidity<br />
p=0.07<br />
• Three known-living conventional patients<br />
withdrew<br />
o not analyzed <strong>for</strong> morbidity /QALY balance<br />
o potential influence<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
Personal opinions ahead<br />
!<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
Is <strong>CESAR</strong> an imperative<br />
• <strong>CESAR</strong> is a good study, but<br />
• Doesn‟t convincingly prove <strong>ECMO</strong> per se.<br />
• It re-opens the door to consideration of<br />
<strong>ECMO</strong>.<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
I like the concept of <strong>ECMO</strong>.<br />
• Anecdotal survival in the right patients<br />
o severe lung disease<br />
o other organ failures secondary to lung disease<br />
o likely to recover if oxygenated<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
• Observational trials in the right patients<br />
o 48 of 68 severe influenza A(most H1N1)<br />
survived ICU with <strong>ECMO</strong> in Aus/NZ<br />
• high likely mortality on conventional<br />
ventilation<br />
Davies et al JAMA 2009
But<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
• Setup is expensive.<br />
o Cost :<strong>ECMO</strong> 1 patient could buy 3+ advanced<br />
conventional ventilators<br />
-could ventilate hundreds of patients in 5<br />
years<br />
even <strong>CESAR</strong> nnt = 6<br />
• It requires lots of expertise: HR costs<br />
o critical care<br />
o surgical<br />
o nursing<br />
o perfusion
“Apex therapy”<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong><br />
NO BENEFIT<br />
if lower levels<br />
not developed.<br />
Quaternary<br />
ICU<br />
Working transport<br />
system<br />
Working referral<br />
mechanism<br />
Excellent basic<br />
ventilation capabilities<br />
Good fundamental<br />
ICU care<br />
<strong>ECMO</strong>
In my area:<br />
• Immediate priority is to build the<br />
supporting infrastructure.<br />
• So that the logically apparent benefits of<br />
<strong>ECMO</strong> have an environment in which to<br />
function.<br />
• “It SHOULD come… but maybe not yet”.<br />
rpvr<br />
T11_07<br />
<strong>ECMO</strong>
pvr<br />
T11_07<br />
<strong>ECMO</strong>