27th Annual ELSO Conference San Diego, CA

Transcription

1 27th Annual ELSO Conference San Diego, CA VA ECMO in the cath lab best timing? Impella or ECMO? Michael R. Mooney, MD, FACC, FSCAI, FAHA Director, Coronary Therapeutics Minneapolis Heart Institute at Abbott Northwestern Hospital

2 New Acute CV Systems of Care more acute CS and RCS Level One STEMIs since % present with shock COOL IT Program Resuscitated Cardiac Arrests patients (3/4 transferred) 36.5% (not including DOA) in shock upon arrival. Mortality rate exceeds 50% These patients account for the majority of STEMI mortality A new systems based approach was needed

3 Evolution in care CS and RCS Failed Progress Persistent Limitation Multiple failed trials in CS mortality remains high Cornerstones of therapy largely unproven benefit Pressors may be cardiotoxic IABP mild help with no survival benefit New approaches needed 3

4 Cardiac arrest is common 295,000 OHCA per year in US 23% VF 31% Bystander CPR Median survival all rhythms 7.9%, VF 21% Best EMS systems: ie: Seattle (resuscitated) 17.5% survival to hospital discharge 34% VT/VF subgroup IHCA adults: 19% (despite 95% witnessed or monitored) Mortality among patients surviving to be hospitalized Ontario 72% ( ) Taipei 75% (2003-4) Goteborg 68% (2003-5) Rochester 65% ( ) Circulation 2010;Jan 26:e12-13 Epidemiology of OHCA

5 STEMI-Guidelines and Shock Steg et al. Eur Heart J. 2012;33:

6 Randomized Studies in Cardiogenic Shock Trial Follow-up n/n n/n Revascularization (PCI/CABG) SHOCK SMASH Total 1-year 30 days 76/152 22/32 103/184 83/149 18/23 117/172 Relative Risk 95% CI Relative Risk 95% CI 0.80 (0.66;0.98) 0.87 (0.66;1.29) 0.82 (0.70;0.98) Catecholamines SOAP II (CS Subgroup) Glycoprotein IIb/IIIa-Inhibitors PRAGUE-7 NO Synthase Inhibitors TRIUMPH SHOCK-2 Cotter et al Total IABP IABP-SHOCK I 28 days 64/145 50/135 Early revascularization better Norepinephrine better Medical treatment better Dopamine better 0.75 (0.55;0.93) In-hospital 15/40 13/ (0.59;2.27) 30 days 30 days 30 days 97/201 24/59 4/15 125/275 76/180 7/20 10/15 93/ days 7/19 6/21 Up-stream Abciximab better NO Synthase inhibition better Standard treatment better Placebo better 1.14 (0.91;1.45) 1.16 (0.59;2.69) 0.40 (0.13;1.05) 1.05 (0.85;1.29) 1.28 (0.45;3.72) LVAD Thiele et al Burkhoff et al Seyfarth et al Total 30 days 30 days 30 days 9/21 9/19 6/13 24/53 9/20 5/14 6/13 20/47 IABP better LVAD better Standard treatment better IABP better 0.95 (0.48;1.90) 1.33 ( ) 1.00 ( ) 1.06 ( ) Thiele et al. Eur Heart J 2010,31:

7 Causes of Cardiogenic Shock Tamponade/rupture 1.7% Isolated RV Shock 3.4% VSD 4.6% Other 7.5% AMI Shock Acute Severe MR 8.3% Predominant LV Failure 74.5% Acute on Chronic Adapted From Sanborn T. et al, JACC. 2000

8 The Shock Trial Hochman et al NEJM 1999;341:625

9 Shock Trial: 30 day Mortality (1 o Endpoint) P=NS Hochman et al NEJM 1999;341:625

10 The SHOCK Trial: All Patients (6 Yrs) Hochman et al JAMA 2006; 295:2511

11 Post-hospital Outcomes of Patients With Acute MI With Cardiogenic Shock: NCDR Findings 112,668 patients in ACTION Registry-GWTG who survived hospitalization for acute MI, Among them, 5% had cardiogenic shock. Outcomes With vs Without Cardiogenic Shock Adjusted HR 95% CI Death 1-60 Days Days Death or All-Cause Rehospitalization 1-60 Days Days Conclusion: The risk carried by cardiogenic shock in acute MI seems to be clustered within the first 60 days, after which patients seem to fare similarly whether or not they experienced shock. Shah RU, et al. J Am Coll Cardiol. 2016:67:

12 Frequency of CS Has Remained Frequency of Cardiogenic Shock NRMI STEMI Registry 1 N=25,311 Steady Over Time NRMI Registry 1 Inclusion of 293,633 patients from Jan 1995-May 2004 with STEMI or new LBBB 775 US Hospitals with on-site PCI CS developed in 25,311 (8.6%) pts CS present on admission in 29% Worcester Heart Attack Study % Gusto % 1Babaev et al JAMA :448 2Goldberg RJ NEJM 1991; 325: Holmes DR JACC :668

13 In-hospital Mortality USIK 1995, USIC 2000, FAST-MI France National Registry Death at 30 days (%) (62-77) 63 (56-70) 8.7 ( ) 4.2 ( ) 51 (44-59) Shock No Shock 3.6 ( ) Aissaoui et al. Eur Heart J 2012; 33:

14 Cardiogenic Shock Pathophysiology When a critical mass of LV is necrotic and fails to pump, stoke volume and CO falls Myocardial and coronary perfusion are compromised causing tachycardia and hypotension Increased LVEDP further decreases coronary perfusion Increase LV wall stress increases myocardial oxygen demand Lactic acidosis worsens myocardial performance Hollenberg Ann Int Med 1999; 131:47-99

15 Paradigm Shift in Use of Short-term MCS Patient with Acute myocardial infarction (AMI), Congestive heart failure (CHF), or Coronary artery disease and other heart disease (CAD) PRE-2007 POST-2007 MCS instituted after circulatory collapse (reactive) Limited or no percutaneous MCS devices available Percutaneous MCS devices more readily available MCS instituted before circulatory collapse (anticipatory) Organ dysfunction has already occurred Most MCS implanted surgically (primarily by cardiac surgeons) MCS increasingly implemented without need for surgical consultation Avoidance of organ dysfunction Longer hospital stay post-surgery Shorter hospital stay and higher rate of home discharges Higher mortality Higher hospital costs Reduced hospital costs Lower mortality Stretch et al. JACC 2014;64:

16 Overview of LV Support Devices Tandem Heart Impella 5.0 Impella 2.5 Impella CP Percutaneous ECMO Cannula size (French) Flow (l/min) 21 venous arterial Max Max Max venous, arterial Max 7.0 Pump speed (rpm) Max. 7,500 Max. 33,000 Max. 51,000 Max. 46,000 Max. 5,000 Insertion/ Placement Peripheral (Femoral artery + LA) Peripheral surgical (Femoral artery) Percutaneous (Femoral artery) Percutaneous (Femoral artery) Percutaneous (Femoral artery + Vein) Anticoagulation Rec. Duration 14 Days 10 Days 10 Days 10 Days 7 Days Relative Costs to IABP Thiele et al, Eur Heart J 2007; 28: Thiele et al. Eur Heart J 2010; 31,

17 Thiele et al. Lancet 2013 IABP SHOCK II: 1 year Mortality 30-day mortality 6-month mortality 12-month mortality 60% 50% 41.3% 48.7% 49.2% 51.8% 51.4% IABP Control Mortality 40% 30% 20% 39.7% Logrank p = 0.94 RR % CI % No. at risk IABP Control 0% Days after randomization

18 No Hemodynamic Benefit of IABP in a Recent Prospective Randomized Trial Cardiac Power Output (CPO in Watts) IABP (n=19) No IABP(n=21) Inotrope dosage was similar between the 2 groups p<0.011 Time in hours Prior N.S Prondzinsky et al. SHOCK 2012;37:

19 Hemodynamic Effects of Impella Support Outflow (aortic root) Inflow (ventricle) aortic valve Flow MAP LVEDP and LVEDV Wall Tension Mechanical Work Microvascular Resistance Coronary Perfusion Cardiac Power Output O 2 Supply O 2 Demand End Organ Perfusion Unloading to Myocardial Recovery Fincke J, et al. Am Coll Cardiol 2004 den Uil CA, et al. Eur Heart J 2010 Mendoza DD, et al. AMJ 2007 Torgersen C, et al. Crit Care 2009 Torre-Amione G, et al. J Card Fail 2009 Suga H. et al. Am J Physiol 1979 Suga H, et al. Am J Physiol 1981 Burkhoff D. et al. Am J Physiol Heart Circ 2005 Burkhoff D. et al. Mechanical Properties Of The Heart And Its Interaction With The Vascular System. (White Paper) 2011 Sauren LDC, et al. Artif Organs 2007 Meyns B, et al. J Am Coll Cardiol 2003 Remmelink M, et al. atheter.cardiovasc Interv 2007 Aqel RA, et al. J Nucl Cardiol 2009 Lam K,. et al. Clin Res Cardiol 2009 Reesink KD, et al. Chest 2004 Valgimigli M, et al.catheter Cardiovasc Interv 2005 Remmelink M. et al. Catheter Cardiovasc Interv 2010 Naidu S. et al. Novel Circulation.2011 Weber DM, et al. Cardiac Interventions Today Supplement Aug/Sep 2009

20 Impella and the FDA Impella 2.5 receiving an FDA indication for use in elective and high-risk PCI procedures in 2015 Protect 1 Trial Aug The FDA approved four Impella heart pumps including the 2.5, CP, 5.0, and LD devices (Abiomed) for ongoing cardiogenic shock that occurs within 48 hours of MI or open-heart surgery as a result of left ventricular failure unresponsive to medical therapy and conventional treatment. The devices are approved for use in patients with or without an intra-aortic balloon pump. Recover 1 Trial 20

21 ISAR-SHOCK Trial AMI Cardiogenic Shock N=26 STEMI Patients in Profound Cardiogenic Shock PCI + IABP R 1:1 PCI + IMPELLA LP 2.5 Primary Endpoint = Hemodynamic Improvement after 20 min of support Seyfarth et al. American College of Cardiology, 2007

22 Cardiac Index (L/min/m 2 ) ISAR-SHOCK Randomized Trial: IMPELLA 2.5 Provides a Better Hemodynamic Support Than IABP in AMI Cardiogenic Shock 0. Primary Endpoint: Increase in Cardiac Index From Baseline (measured after 20 min of support) Impella IABP P< Cardiac Output (L/min) P< Seyfarth et al. American College of Cardiology, 2007

23 Cardiac Output (l/min) Improved Hemodynamics and Tissue Perfusion with Impella 5.0 in Shock Patients ±1.3 Pre-Pump Cardiac Output p= ±1.3 On-Pump (N= 16) Mean Arterial Pressure (mmhg) 80 75± Mean Arterial Pressure 57±13 Pre-Pump p=0.003 On-Pump Left Atrial Pressure Plasma Lactate Left Atrial Pressure (l/min) ±11 p= ±6 Pre-Pump On-Pump Plasma Lactate (mmol/l) ±1 Pre-Pump p= ±0.5 On-Pump Meyns and al. Thoracic Cardiov Surg 2003:51:1-6

24 Meta-analysis of Percutaneous LVAD in CGSCGS.Study characteristics of included trials Thiele et al. Burkhoff et al. * Not reported whether the envelopes were opaque and sequentially numbered. IABP, intra-aortic balloon pump; LVAD, left ventricular assist device. Seyfarth et al. Percutaneous LVAD used TandemHeart TandemHeart Impella LP25 Control IABP IABP IABP Total number of patients Setting Single-centre Multi-centre Two-centre Randomization Yes Yes Yes Sequence generation Concealment of allocation Drawing Envelopes Not reported Not reported Sealed envelopes Not reported Not reported Blinding Not possible Not possible Not possible Handling of patient attrition Complete follow-up Complete follow-up Complete follow-up Cheng et al, European Heart Journal 2009;30:

25 Thiele et al. Burkoff et al. Seyfarth et al. Pooled Thiele et al. Burkoff et al. Seyfarth et al. Pooled Thiele et al. Burkoff et al. Seyfarth et al. Pooled LVAD Mean + SD LVAD Mean + SD LVAD Mean + SD Hemodynamics IABP Mean + SD Cardiac index Mean Difference Favors IABP Favors LVAD IABP Mean Arterial Pressure Mean + SD Mean Difference Favors IABP Favors LVAD IABP Pulmonary wedge pressure Mean + SD Mean Difference Favors LVAD Favors IABP P(heterogeneity) = 0.22 l 2 = 34.0% 0.55 ( ) 0.16 ( ) 0.35 ( ) 0.35 ( ) P(heterogeneity) = 0.10 l 2 = 55.9% 0.55 ( ) 18.6 ( ) 16.0 ( ) 12.8 ( ) P(heterogeneity) = 0.01 l 2 = 76.6% -5.6 (-9.2 to -2.1) -8.4 (-11.0 to -5.8) -1.0 ( ) -5.3 (-9.4 to -1.2) Cheng et al, European Heart Journal 2009;30:

26 30 Day Mortality LVAD n/n IABP n/n 30-day Mortality Relative Risk P(heterogeneity) = 0.83 l 2 = 0% Thiele et al. 9/21 9/ ( ) Burkoff et al. 9/19 5/ ( ) Seyfarth et al. 6/13 6/ ( ) Pooled 24/53 20/ ( ) Favors LVAD Favors IABP Cheng et al, European Heart Journal 2009;30:

27 Thiele et al. Burkoff et al. Seyfarth et al. Pooled LVAD n/n Complications IABP n/n 7/21 0/20 4/19 2/14 1/13 0/13 12/53 2/47 Reported Leg Ischemia Relative Risk P(heterogeneity) = 0.38 l 2 = 0% ( ) 1.47 ( ) 3.00 ( ) 2.59 ( ) ,000 Favors LVAD Favors IABP LVAD n/n IABP n/n Reported Bleeding Relative Risk P(heterogeneity) = 0.73 l 2 = 0% Thiele et al. Burkoff et al. Pooled 19/21 8/20 8/19 2/14 27/40 10/ ( ) 2.95 ( ) 2.35 ( ) Favors LVAD Favors IABP LVAD n/n IABP n/n Reported Fever or Sepsis Relative Risk P(heterogeneity) = 0.10 l 2 = 62.1% Thiele et al. Burkoff et al. Pooled 17/21 10/20 4/19 5/14 21/40 15/ ( ) 0.59 ( ) 1.11 ( ) Favors LVAD Favors IABP Cheng et al, European Heart Journal 2009;30:

28 US Pella Registry: Main Indications for Support (N=352 patients at 24 centers) High Risk PCI (66%) Elective PCI*, 29% Urgent PCI**, 37% AMI Shock, 20% Other Forms of Shock, 14% Others includes Myocarditis with shock, Post-cardiotomy shock, septic shock, toxic shock, post partum cardiomyopathy, other cardiomyopathies with shock * Elective = Stable angina or silent ischemia ** Urgent = Unstable angina or Non ST elevation Myocardial Infarction

29 AMI Shock Registry Design Impella 2.5 used for AMI Cardiogenic Shock (physician s decision) Exclusion Criteria: AMI patients with stable hemodynamics Other forms of Shock with no AMI Prophylactic support for high risk PCI Contra-indication to use Impella 2.5 Inclusion Criteria: STEMI or NSTEMI patients with Cardiogenic shock Shock defined clinically as: SBP < 90mmHg for > 30min or need of inotropes to maintain SBP or Cardiac index <2.2 l/min/m2 Pump placed emergently to restore hemodynamics Survival to Discharge or 30-days

30 Cardiac Index (l/min/m 2 ) SVR (x 1000 dynes/sec x cm -5 ) Impella Improves Immediately the Hemodynamics in AMI Shock Cardiac Index p= ±0. 6 Pre Impella* 2.2±0.8 Pre Impella * 2.7±0. 9 On Impella SVR p= ±0.4 On Impella MAP (mmhg) PCWP (mmhg) Mean Arterial Pressure p< ±17 Pre Impella * Wedge Pressure 28±9 Pre Impella* 92±21 On Impella p= ±12 On Impella * Pre-Impella measurements were recorded under clinical conditions (i.e, with inotropes + IABP)

31 Blood Pressure (mmhg) Gain on Hemodynamics When Switching from IABP to Impella in AMI Shock Systolic Blood Pressure Diastolic Blood Pressure Mean Arterial Pressure 82±19 On IABP p< Patient serve as his/her own control (N=20) Gain = + 38% Gain = + 40% Gain = + 41% 113±30 Switched to Impella 47±16 On IABP P= ±16 Switched to Impella p< mmhg in MAP is the considered minimum threshold for adequate coronary, cerebral and renal perfusion 59±15 On IABP 83±17 Switched to Impella Comparisons made for ALL AMI shock patients that were on IABP then switched to Impella for whom pre and post blood pressure values were available (N=20)

32 Largest Cohort To Study The Current Use of Impella in Cardiogenic Shock O Neill et al, Jour of Interv. Cardiol (In press)

33 Impella Insertion Timing (N= 154) Prior to PCI (n=63) 41.0% pre post 59.0% Post PCI (n=91)

34 100 Outcome 80 Survival(%) Pre - PCI Post-PCI 20 0 Log-rank test, p= Days from initiation of Impella 2.5 support Number of patients at risk

35 DanShock Trial Enrolling 1 Endpoint: All Cause Mortality Acute MI (STEMI < 36 h) Shock Eligible PCI (CABG) Lactate > 2.5 mmol/l SBP < 100 mmhg oder Vasopressoren LV-EF < 35% Randomization Conventional Therapy + IABP + PCI (n=180) Conventional Therapy + Impella cvad + PCI (n=180)

36 Potential Indications for Mechanical Circulatory Support 36

37 CardiacAssist TandemHeart Access to LA via standard transseptal technique Catheter exchanges made with Valvuloplasty guidewire or Amplatz soft tip wire Dilate septum with 2-stage (14/21 Fr.) dilator Place cannula in LA

38 Adult Cardiac ECMO Use Annual Reported Procedures % Growth in Annual Procedures in Last 2 years ELSO Registry

39 CPR with ECLS vs. Conventional CPR: In-Hospital Cardiac Arrest Survival to Discharge Based Upon Duration of CPR Chen et al, Lancet 2008

40 ECMO Not A Free Lunch! Possibility of centrally deoxygenated blood Brain Perfusion Limb Ischemia Bleeding Need for Transfusion Inflammatory Response Increased Afterload??

41 Protek DUO Coaxial dual lumen 29 Fr outer, 16 Fr inner Compatible with multiple centrifugal flow pumps

42 STATE OF CURRENT KNOWLEDGE TTM for CA is effective, guideline supported,and best done within the STEMI network system of care Survival for CA should be 50% ECMO is a fast moving trend for RCS and refractory CA ECMO is best done within the STEMI network system of care The best ECMO candidate has a STEMI and refractory CS, the most challenging ECMO has OOH refractory CA 42

43 Percutaneous Left Ventricular Support Devices Werdan et al, EHJ 2014

44 1.Percutaneous MCS provides superior hemodynamic support compared to pharmacologic therapy. This is particularly apparent for the Impella and Tandem-Heart devices. These devices should remain available clinically and be appropriately reimbursed. 2.Patients in cardiogenic shock represent an extremely high risk group in whom mortality has remained high despite revascularization and pharmacologic therapies. Early placement of an appropriate MCS may be considered in those who fail to stabilize or show signs of improvement quickly after initial interventions. 3.MCS may be considered for patients undergoing high-risk PCI, such as those requiring multivessel, left main, or last patent conduit interventions, particularly if the patient is inoperable or has severely decreased ejection fraction or elevated cardiac filling pressures. 4.In the setting of profound cardiogenic shock, IABP is less likely to provide benefit than continuous flow pumps including the Impella CP and TandemHeart. ECMO may also provide benefit, particularly for patients with impaired respiratory gas exchange. 5.Patients with acute decompensated heart failure may benefit from early use of percutaneous MCS when they continue to deteriorate despite initial interventions. MCS may be considered if patients are candidates for surgically implanted VADs or if rapid recovery is expected (e.g., fulminant myocarditis or stress-induced cardiomyopathy). 6.When oxygenation remains impaired, adding an oxygenator to a TandemHeart circuit or use of ECMO should be considered based upon local availability. 7.There are insufficient data to support or refute the notion that routine use of MCSs as an adjunct to primary revascularization in the setting of large acute myocardial infarction is useful in reducing reperfusion injury or infarct size. Exploratory studies are underway. 8.MCSs may be used for failure to wean off cardiopulmonary bypass, considered as an adjunct to high-risk electrophysiologic procedures when prolonged hypotension is anticipated, or rarely, for valvular interventions. 9.Severe biventricular failure may require use of both right- and left-sided percutaneous MCS or veno-arterial ECMO. Certain patients may respond to LVAD implantation with inotropes and/or pulmonary vasodilators to support the right heart. MCS may also be considered for isolated acute RVF complicated by cardiogenic shock. 10.Registries and randomized controlled trials comparing different strategies in different clinical scenarios are critically needed. 11.Early analyses suggest cost-effectiveness of MCS for emergent use in comparison to surgical ECMO or VAD support, and for elective use in comparison to IABP. Further data are necessary.

45 New Acute CV Systems of Care more acute CS and RCS Level One STEMIs since % present with shock COOL IT Program Resuscitated Cardiac Arrests patients (3/4 transferred) 36.5% (not including DOA) in shock upon arrival. Mortality rate exceeds 50% These patients account for the majority of STEMI mortality A new systems based approach was needed

46 Emergency E-ECMO Multidisciplinary, experienced team members that rapidly respond and come together when a patient is evaluated for emergent ECMO. ICU charge RN Physicians Cardiology, Intensivist, Interventionalist, Heart Failure CV Emergency Program Manager Chaplain Cardiac Diagnostic Tech CV Surgeon, Vascular Surgeon Emergency Shock/ ECMO Response Team. Perfusion Team/ Hemodynamic Support Team Respiratory Therapy CV Emergency Nurse Clinician Pharmacist CV Lab Team

47 Ward/CCU Inpatient Shock Team Internal Communications Protocol Cath Lab Patient Shock Patient Accepted for Transfer Outside Call to HF Intensivist SHOCK TEAM PAGER ACTIVATION ECLYPSIS NOTE Shock Interventionalist Shock Surgeon Shock Fellow Shock Intensivist Shock Team Recommendation CCU Fellow Medical Management OR Initiate MCS (Cath Lab/OR)

48 Utilization of TTM, a Systems of Care Approach 48

49 Unstable patient Assessment Frequent looks in transitioning patients ABG, A- line, oximetry, mentation Right heart cath with CI Lactate clearance Stat echo Revasc but just as a start If problem likely acute with reversible elements Collaborate early 49

50 Treatment, Outcomes of Acute MI Complicated by Shock After Public Reporting Policy Changes in New York 45,977 patients treated in New York, three nonreporting states (Michigan, New Jersey, and California), or Massachusetts. Rate of PCI increased from 44.9% before shock was excluded from NY reporting requirements to 49.2% afterwards across all states, with a greater increase seen in New York PCI rates remained lower in New York than in other states throughout the study period In-hospital mortality fell from 44.7% to 37.9% across all states, with a greater decline in New York Conclusion: Exclusion of patients with cardiogenic shock from New York s public reporting requirements for PCI coincided with an uptick in PCI use for these high-risk patients. McCabe JM, et al. JAMA Cardiol. 2016;Epub ahead of print.

51 Today s Cardiac Cath Lab Treatment Space Where we do PCI/Structural and Peripheral Interventions but also Resucitation and Critical Care Hemodynamic Laboratory Right and left left heart catheterizations under utilized but critical to patient management Learning Space to Improve Future Patient Care Ideal space for multidisciplinary collaboration 51

52 Hemodynamics are Key to Patient Management We make people ischemic during PCI! Catheters interfere with aorto-ostial flow, LM lesions and large bore catheters Contrast does not contain hemoglobin and is a myocardial depressant Inflated microcatheters, inflated balloons, stents obstruct blood flow! Adverse hemodynamics can make what appears to be a controlled and stable situation unstable cannot be ignored 52

53 Cardiogenic Shock is a Spectrum Pre-Shock Shock Profound Shock No Hemodynamic Support Mortality Needs Partial Hemodynamic Support Needs Full Hemodynamic Support 80% 42% 2% 3% 7.5% 21% Mortality Risk with Inotrope Dosing Three High Dose Samuels LE et al, J Card Surg Jul-Aug;14(4):288-93

54 Consider acidosis, lactate clr, oxygenation, RV function Treatment COLLABORATE with TEAM IABP Medical Therapy Impella ECMO/VAD 3.0 Cardiac Index Pre-Shock Shock Severe Shock Team Decisions are Key in Good Outcomes

55 55 Seder,Crit Care Med 2009;37 (Suppl):S211-S222.

56

57 Percutaneous Cardiopulmonary Bypass (ECMO or CPS) Lifebridge B2T Pump Venous to arterial conduit with oxygenator Can deliver 6 l/min CO Generally Fr venous and Fr arterial catheters No randomized trials Observational data only

58 The best TH and E-CPR ecmo patient is/has: OOH with <15 min down time Witnessed VF/VT and age <75 yo Bystander CPR Has a STEMI Lives in Minnesota, Seattle, Arizona, Tennessee, Ottawa, Lehigh Valley (systems of care) Gets cooling in the first hour after rosc 58

59 Cardiac 5603 pts Respiratory 7008 pts 56% survived ECLS 65% survived ECLS 41% survived to DC 57% survived to DC ECPR % survived to DC 59

60 ECPR - survival ELSO ANW Mostly RCS 60 n= 1657 n= 45

61 Ejection Fraction: % at ECMO placement and % at Discharge EF % ECMO Discharge

62 What have we learned? ECMO can be incorporated into a STEMI program and be implemented w/in 40 min Lucas or mechanical CPR is now essential in our CV labs Antegrade perfusion limbs must be established early and ultrasound guidance reduces complications LV unloading is not essential for LV recovery as LV emptying and return of pusatile flow is very early and common TH can be used in ECMO pts safely and lead to favorable CPC Patient Selection- collaboration with CHF/transplant team

63 RCS and ECMO What have we learned ECMO can be a life saving technique when instituted by an experienced Shock Team in the CV Laboratory for refractory Cardiogenic Shock. Striking recovery of LV function can also occur in several days ECMO should be developed in selected PCI centers as part of a system of care for acute cardiac emergencies. It is best delivered in the Cath lab by Interventionalists/Intensivist. Many issues will need to be verified by clinical trials, but should not delay the programatic offering of this therapy. Many common understanding of ECMO are outdated. ECMO is a transformative therapy.

64 GAPS IN CURRENT KNOWLEDGE SCAI and Mission Lifeline involvement Clinical trials and registry formation We are behind many centers in Europe Raise awareness Maquet systems w/o emergency perfusionist may enable dispersion and subsequent transfer to ECMO Center Accurate early neuro-prognostication Integration of E-ECMO and E-CPR into regional STEMI Networks Systems of care that support regional Centers of Excellence in ECMO and CA 64

65 65 The End