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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>

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