Assist Devices in STEMI- Intra-aortic Balloon Pump Ioannis Iakovou, MD, PhD Onassis Cardiac Surgery Center Athens, Greece
Cardiogenic shock 5-10% of pts after a heart attack 60000-70000 pts in Europe/year In the last years the mortality rate was reduced mainly by early reopening of the infarct-related artery Still extremely high, approx. 50% @ 30 days
PREDICTION OF CARDIOGENIC SHOCK IN THE CARDIAC CATHETERISATION LABORATORY Poor coronary reperfusion (TIMI Grade <3) Left main coronary occlusion Left ventricular ejection fraction <25% Age >75 years All with 2 of the 4 risk factors died. Garcia-Alverez A et al. Am j Cardiol 2009; 103:1073-77
OUTLOOK FOR SURVIVORS OF CARDIOGENIC SHOCK GUSTO: 88% of those discharged from hospital are alive at one year SHOCK: 3 and 6 year survival 79% and 62% Around 50% of patients remain free from heart failure symptoms.
The Damaging Effects of High Dose Inotropes Elevated stroke work and wall tension. Increased myocardial oxygen consumption. Depletion of energy reserves. Endocardial necrosis & impaired diastolic function. Overall negative effect on myocardial recovery.
CPS/ECMO Percutaneous heart lung-machine Centrifugal pump Hemodynamic support>4.5l/min Can increase preload and afterload No randomized control trials or large cohorts.
Routine vs prophylactic use of CPS for high-risk PCI Teirstein et al JACC 1993
IABP history History: 1962 Animal studies Moulopoulos et al, Am Heart J 1962;63:669-675 1968 clinical description in shock Kantrowitz et al, JAMA 1968;203:135-140 1973 Hemodynamic effects in shock, Mortality unchanged Scheidt et al, NEJM 1973;288:979-984 > 40 years > 1 Million patients treated, low complication rate, Benchmark registry Ferguson et al, JACC 2001;38:1456-1462
IABP - why use it? Increase coronary perfusion pressure Increase myocardial oxygen supply without increasing demand Decrease afterload But increase in cardiac output is only 0.5-0.8 L/min
Indications for IABP Cardiogenic shock Refractory angina despite maximal medical management Cardiac failure after a cardiac surgical procedure Perioperative treatment of complications due to myocardial infarction Failed PCI Mitral regurgitation As a bridge to cardiac transplantation
Contraindications to IABP Severe aortic insufficiency Aortic aneurysm Aortic dissection Limb ischemia Thromboembolism
Complications Limb ischemia Thrombosis Emboli Bleeding and insertion site Groin hematomas Aortic perforation and/or dissection Renal failure and bowel ischemia Neurologic complications including paraplegia Heparin induced thrombocytopenia Infection
PAMI-II trial High risk patients were randomized to 36 to 48 h of IABP (n = 211) or traditional care (n = 226) a prophylactic IABP strategy after primary PTCA in hemodynamically stable high risk patients with AMI does not decrease the rates of infarct-related artery reocclusion or reinfarction (p=ns for both), promote myocardial recovery or improve overall clinical outcome Stone et al JACC 1997
BCIS-1 Trial
BCIS-1 Trial
CRISP-AMI 340 pts with ST elevation MI within 6 hours of the onset of pain Among patients with acute anterior STEMI without shock, IABC plus primary PCI compared with PCI alone did not result in reduced infarct size. Patel et al JAMA 2011
7 RCT, 1000 patients No difference in Death, LVEF
IABP prior to PCI vs. IABP after PCI
Rapid Reperfusion. Would you go the same speed on these two Cases?
N Patients Stopped slow recruitment Underpowered Stopped Slow recruitment Surrogate endpoint Stopped due to missing effect Patient Inclusion in Cardiogenic Shock-Studies 700 600 600 500 400 302 398 300 200 100 55 80 57 45 0 SHOCK TRIUMPH SMASH PRAGUE - 7 TACTICS IABP- SHOCK I IABP- SHOCK II
IABP-shock II study 600 pts randomized to conventional optimal Rx vs. IABP Theile et al ESC 2012
30 Day Mortality: Good to be YOUNG
12 mo data good if <50 yo!
Guidelines IABP in STEMI complicated by cardiogenic shock Antman et al. Circulation. 2004;110:82-292 O Gara et al. Circulation. 2013;127:e362-e425 Van de Werf et al. Eur Heart J. 2008;29:2909-2945 Steg et al. Eur Heart J. 2012;33:2569-2619
New Devices and Strategies to Manage CGS LVAD THEORETICAL ADVANTAGES Superior LV pressure and volume unloading with enhanced remodeling capability Decreased wall tension with improved endocardial blood flow Beating, non-working heart has low metabolic requirement Presumed enhanced ability for cellular repair and survival
Tandem Heart plvad Left atrial-to-femoral arterial LVAD Low speed centrifugal continuous flow pump 21F venous transseptal cannula 17F arterial cannula Maximum flow 4L/minute
30 day mortality (%) Tandem Heart Outcome Data 50% 45% 42% 45% p=ns 47% Tandem Heart IABP 40% 36% 35% 30% 25% 20% 15% 10% 5% 0% Thiele (n=41) Burkhoff (n=33) Improved haemodynamic parameters Increase in bleeding, limb ischaemia, and sepsis Thiele EHJ 2005;26:1276. Burkhoff AHJ 2006;152:e1
Impella Axial flow pump Much simpler to use Increases cardiac output & unloads LV LP 2.5 12 F percutaneous approach; Maximum 2.5 L flow LP 5.0 21 F surgical cutdown; Maximum 5L flow Blood Inlet Blood outlet Motor Pressure Lumen
Impella outcome data 1 RCT of Impella 2.5 in AMI Cardiogenic Shock ISAR-SHOCK 26 patient RCT Impella vs IABP Cardiac Index, MAP (by 10mmHg) vs IABP Complications IABP Overall 30-day mortality was 46% in both groups JACC 2008;52:1584-8
PLVAD vs. IABP for treatment of cardiogenic shock: a meta-analysis of controlled trials Thiele et al. Burkhoff et al. Seyfarth et al. LVAD TandemHeart TandemHeart Impella LP2.5 Control IABP IABP IABP N of patients 41 33 26 Setting Single-center Multi-center Two-center Inclusion period 2000-2003 2002-2004 2004-2007 Randomization Yes Yes Yes Cheng et al. Eur Heart J 2009;30:2102-2108
Cardiac index Percutaneous LVAD patients had higher CI LVAD mean sd IABP mean sd Cardiac Index Mean Difference P(heterogeneity) = 0.22 I 2 = 34.0% Thiele et al. 2.3 0.6 1.8 0.4 0.55 (0.23 ; 0.87) Burkhoff et al. 2.2 0.6 2.1 0.2 0.16 (-0.14 ; 0.46) Seyfarth et al. 2.2 0.6 1.8 0.7 0.36 (-0.16 ; 0.88) Pooled 0.35 (0.09 ; 0.61) -2-1 0 1 2 Favors IABP Favors LVAD
Mean Arterial Pressure Percutaneous LVAD patients had higher MAP LVAD mean sd IABP mean sd Mean Arterial Pressure Mean Difference P(heterogeneity) = 0.10 I 2 = 55.9% Thiele et al. 76 10 70 16 5.5 (-2.9 ; 13.9) Burkhoff et al. 91 16 72 12 18.6 (9.4 ; 27.9) Seyfarth et al. 87 18 71 22 16.0 (0.5 ; 31.5) Pooled 12.8 (3.6 ; 22.0) -50-25 0 25 50 Favors IABP Favors LVAD
Pulmonary Capillary Wedge Pressure Percutaneous LVAD patients had lower PCWP LVAD mean sd IABP mean sd Thiele et al. 16 5 22 7 Pulmonary Wedge Pressure Mean Difference P(heterogeneity) = 0.01 I 2 = 76.6% -5.6 (-9.2 ; -2.1) Burkhoff et al. 16 4 25 3-8.4 (-11.0 ; -5.8) Seyfarth et al. 19 5 20 6-1.0 (-5.2 ; 3.2) Pooled -5.3 (-9.4 ; -1.2) -20-10 0 10 20 Favors LVAD Favors IABP
30-day mortality Percutaneous LVAD patients had similar mortality LVAD n/n IABP n/n 30-day mortality Relative Risk P(heterogeneity) = 0.83 I 2 = 0% Thiele et al. Burkhoff et al. Seyfarth et al. Pooled 9/21 9/20 9/19 5/14 6/13 6/13 24/53 20/47 0.95 (0.48 ; 1.90) 1.33 (0.57 ; 3.10) 1.00 (0.44 ; 2.29) 1.06 (0.68 ; 1.66) 0.1 1 10 Favors LVAD Favors IABP
LVAD or IABP? Complications Thiele et al Burkhoff et al LVAD n/n IABP n/n 19/21 8/20 8/19 2/14 Bleeding P (heterogeneity)=0.73 Relative Risk R 2 =0% 2.26 (1.30 3.94) 2.95 (0.74 11.80) Thiele et al Burkhoff et al LVAD n/n IABP n/n 7/21 0/20 4/19 2/14 Limb ischemiap (heterogeneity)=0.38 Relative Risk R 2 =0% 14.32 (0.87 235.4) 1.47 (0.31 6.95) Pooled 27/40 10/34 2.35 (1.40 3.93) 0.01 0.1 1 10 100 LVAD better IABP bstter Seyfarth et al1/13 0/13 Pooled 12/53 2/47 3.00 (0.13 67.51) 2.59 (0.75 8.97) 0.0001 0.01 1 100 10000 LVAD better IABP better Thiele et al Burkhoff et al LVAD n/n IABP n/n 17/21 10/20 4/19 5/14 Fever or sepsisp (heterogeneity)=0.10 Relative Risk R 2 =62.1% 1.62 (1.00 2.63) 0.59 (0.19 1.80) Pooled 21/40 15/34 1.11 (0.43 2.90) 0.01 0.1 1 10 100 LVAD better IABP better Cheng et al. Eur Heart J 2009;30:2102-2108
LVAD or IABP? LVAD + - Better LV-unloading Hemodynamic support Bleeding Invasiveness Costs Implantation procedure
Potential treatment algorithm for patients with CS complicating AMI (asterisks denote supported by randomized controlled trials). Thiele H et al. Eur Heart J 2010;31:1828-1835
Recommendations on how to approach shock If a pt has a SBP of 75-80 mm Hg the aim is to increase BP over the next couple of days while keeping them out of shock; use IABP Do not use IABP in all high risk pts; but consider in the following situations: Severe HF Bridge to surgery Impeding CS Mild CS
Conclusions For more severe cases of CS (SBP approx 40,50,60, 70 mmhg) or pts requiring high doses of inotropes or vasopressors we (may) have the option of percutaneous LVAD (Tandemheart or Impella) which provide superior hemodynamic support compared to IABP Until now, we cannot recommend to replace IABP by percutaneous LVAD as first-choice approach in the mechanical management of cardiogenic shock Routine use of IABP in AMI is not evidence based Studies with pre-pci deployment of IABP are needed
Thank You! Email: iako@hol.gr