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Washington University School of Medicine

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1 Washington University School of Medicine
Percutaneous Mechanical Devices For Circulatory Support- IABP and Impella John M. Lasala, MD, PhD Professor of Medicine Washington University School of Medicine St. Louis, MO

2 Short-term Devices for Cardiogenic Shock
Impella Recover Short-term Percutaneous Axial flow 2.5-5 L/min Percutaneous IABP 0.5 L/min ECMO TandemHeart pVAD Percutaneous Centrifugal axial flow L/min As technology improves, distinction between short, intermediate and long term is blurred. But this will not be aboput weaning from short-term, which is a separate and difficult issue. Centrifugal axial flow extracorporeal Bridge 3M Sarns Medtronic Bio-Medicus Levitronix Centrimag 1

3 5 Simple Reasons IABP are Currently 1st Line Therapy for “Cardiogenic Shock”
Avaliability/Convenience (in multiple settings including chronic use) Significantly smaller access size compared to alternatives Cost (up to 10x difference compared to alternatives) Despite the naysayers… IABP does have clinical benefits! Differences between trials (the podium) and clinical practice Cardiogenic shock is a mixed bag of clinical scenarios! For true shock, only alternatives are devices that provide “full support”

4 Problems with IABP “Mono”therapy
More modest hemodynamic effects But these can be beneficial – don’t discount completely! No active unloading of the ventricle Minimal effects in patients with awful forward function or arrhythmias (particularly the dangerous ones) Physician INERTIA can set in!!

5 No Mortality Benefit of IABP in Prospective Randomized Trials
Sjauw et al. Eur Heart J 2009:30:

6 No Hemodynamic Benefit of IABP in
a Recent Prospective Randomized Trial 1.5 1.0 0.5 Cardiac Power Output (CPO in Watts) Prior 24 48 72 96 p<0.011 N.S IABP (n=19) No IABP(n=21) Inotrope dosage was similar between the 2 groups Time in hours Prondzinsky et al. SHOCK 2012;37: (Clinical Trials.gov ID NCT )

7 Higher Stroke and Bleeding Rates With IABP in AMI Cardiogenic Shock
Sjauw et al. Eur Heart J 2009:30:

8 No Survival Benefit With IABP in AMI Cardiogenic Shock

9 ESC 2014 Guidelines for AMI Shock
Routine use of IABP in CGS not recommended; Class III, Level A

10 Paradigm Shift in The Near Future:
Percutaneous Cardiac Assist Devices Have Been Integrated in the 2011 PCI Guidelines Adapted from The purpose of this meeting is to make sure that you take full advantage of all of the services that are offered under the Partnership in Healthcare support Program. Some of the goals that I would like to achieve today is finding out Key contacts for each element so that when information is new or updated From this day forward….we would be able to contact you with that update. I Would also like to spend some time talking about the Six Sigma Performance Improvement Service that is part of this program. Percutaneous Cardiac Assist Device

11 ISAR-SHOCK RANDOMIZED TRIAL:
IMPELLA 2.5 vs. IABP in AMI Cardiogenic Shock Primary Endpoint: Increase in Cardiac Index From Baseline (measured after 20 min of support) 0.75 1.50 P<0.01 P<0.01 0.60 1.25 0.45 0.75 1.10 0.53 Cardiac Index Increase (L/min/m2) Cardiac Output (L/min) 0.30 0.50 0.15 0.25 0.11 0.20 Impella IABP Impella IABP Seyfarth et al. JACC 2007

12 EUROSHOCK-Registry 9/10/2018
HCS-PP00611 rA_Impella Technology - Clinical Evidence and Investigations_DRAFT, SF edits incorporated

13 Lauten et al, Circ heart Fail. 2013;6:23-30
9/10/2018 Lauten et al, Circ heart Fail. 2013;6:23-30 HCS-PP00611 rA_Impella Technology - Clinical Evidence and Investigations_DRAFT, SF edits incorporated

14 Outcome Lauten et al, Circ heart Fail. 2013;6:23-30 9/10/2018
1.0 0.8 0.6 0.4 0.2 Years Cum survival 1.0 0.8 0.6 0.4 0.2 Days Cum survival Lactate≥3.8 mmol/l Lactate<3.8 mmol/l Lauten et al, Circ heart Fail. 2013;6:23-30 HCS-PP00611 rA_Impella Technology - Clinical Evidence and Investigations_DRAFT, SF edits incorporated

15 Outcome First step Final step OR (96% CI) P Age>65 6.6 (1.6-27.5)
9/10/2018 First step Final step OR (96% CI) P Age>65 6.6 ( ) 0.009 6.2 ( ) 0.001 Renal insufficiency 0.73 ( ) 0.70 Previous MI 0.45 ( ) 0.20 CPR 1.9 ( ) 0.38 IABP 2.2( ) 0.31 Systolic BP<90mmHg 1.5 ( ) 0.56 Lactate>3.8 mmol/l 5.0 ( ) 0.02 5.2 ( ) 0.01 Lauten et al, Circ heart Fail. 2013;6:23-30 HCS-PP00611 rA_Impella Technology - Clinical Evidence and Investigations_DRAFT, SF edits incorporated

16 How fast can LV assist be initiated
How fast can LV assist be initiated ? PTCA with CPR in double stent thrombosis Strong tendency to vessel thrombosis Profound circulatory depression QRS broader and broader Repeated VT/VF -> Defibrillations Severe pump failure CPR =>MAP 60, but less and less efficient over time (MAP->35mmHg) © Patrick Hunziker, Basel

17 In cath lab –during CPR: Emergency percutaneous LV assist device (Impella 2.5)
Implantation of Impella during CPR => Stabilization of ABP >50mmHg without CPR Continue PTCA w/o CPR Successful PTCA Patient alive and well © Patrick Hunziker, Basel

18 Results from the USpella Registry
The Current Use of Impella 2.5 in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the USpella Registry William W. O’Neill, MD*; Theodore Schreiber, MD‡; David H. W. Wohns, MD±; Charanjit Rihal, MD¶; Srihari S. Naidu, MD#; Andrew B. Civitello, MD†; Simon R. Dixon, MBChB**; Joseph M. Massaro, PhD ║; Brijeshwar Maini, MD††; E. Magnus Ohman, MD ¶¶. From the *Henry Ford Hospital, Detroit, MI, USA; ‡ Detroit Medical Center, Detroit, MI, USA; ± Spectrum Health, Grand Rapids, MI, USA; ¶ Mayo Clinic, Rochester, MN, USA; # Winthrop University Hospital, Mineola, NY, USA; † Texas Heart Institute, Houston, TX, USA; ** Beaumont Hospital, Royal Oak, MI, USA; ║Harvard Research Institute, Boston, MA, USA; ††Pinnacle Health Medical Center, Wormleysburg, PA, USA; ¶¶Duke University Medical Center, Durham, NC, USA. O’Neill et al, J Interven Cardiol 2013;9999:1-11

19 Impella® Insertion Timing (N= 154)
O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP rA

20 O’Neill et al, J Interven Cardiol 2013;9999:1-11
Hemodynamics P<0.0001 Pre-Support On Support Pre- Support On Support Mean arterial pressure (n=143) P<0.0001 Pre-Support On Support P=0.04 Cardiac power output (n=23) All patients N = 154 Impella Pre-PCI N = 63 Impella Post-PCI N = 91 Pre Support On Support p value MAP, mmHg 62.7±19.2 (143) 94.4±23.1 (143) <0.0001 67.9±20.7 (59) 94.5±21.3 (59) 59.1±17.3 (84) 94.4±24.4 (84) PCWP, mmHg 31.9±11.1 (25) 19.2± (25) 30.8±7.8 (11) 19.7±7.9 (11) 0.004 32.7±13.4 (14) 18.9±11.1 (14) Cardiac Index, L/min/m2 1.9±0.7 (23) 2.7± (23) 1.9±0.9 (7) 2.3±0.8 (7) 0.055 1.9± (16) 2.9±0.6 (16) Cardiac Power Output, Watt 0.48±0.17 (23) 1.06±0.48 (23) 0.54±0.2 0.83±0.4 (7) 0.035 0.46±0.1 (16) 1.2±0.5 (16) O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP rA

21 O’Neill et al, J Interven Cardiol 2013;9999:1-11
Hemodynamics P<0.0001 Pre-Support On Support P=0.04 Cardiac power output (n=23) All patients N = 154 Impella Pre-PCI N = 63 Impella Post-PCI N = 91 Pre Support On Support p value MAP, mmHg 62.7±19.2 (143) 94.4±23.1 (143) <0.0001 67.9±20.7 (59) 94.5±21.3 (59) 59.1±17.3 (84) 94.4±24.4 (84) PCWP, mmHg 31.9±11.1 (25) 19.2± (25) 30.8±7.8 (11) 19.7±7.9 (11) 0.004 32.7±13.4 (14) 18.9±11.1 (14) Cardiac Index, L/min/m2 1.9±0.7 (23) 2.7± (23) 1.9±0.9 (7) 2.3±0.8 (7) 0.055 1.9± (16) 2.9±0.6 (16) Cardiac Power Output, Watt 0.48±0.17 (23) 1.06±0.48 (23) 0.54±0.2 0.83±0.4 (7) 0.035 0.46±0.1 (16) 1.2±0.5 (16) O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP rA

22 Procedural Characteristics
All N = 154 Impella Pre-PCI N = 63 Impella Post-PCI N = 91 p value Duration of support, (hrs) 23.7 [ ] 22.8 [ ] 24.2 [ ] 0.3873 Median DTB Time*, min 63.5 [ ] 112 [79 112] 52 [34 81] <0.0001 Suspected IRA Territory LM 16.1% 23.8% 9.5% 0.0226 LAD 52.6% 53.9% 51.4% 0.7598 Left Cx. 10.9% 4.8% 16.2% 0.0324 RCA 16.8% 12.7% 20.3% 0.2373 Graft 3.7% 2.7% 0.5218 Number of diseased vessels 1.8±0.76 1.94±0.72 1.70±0.79 0.0735 Number of significant Lesions 2.57±1.39 2.74±1.49 2.42±1.28 0.1868 Number of vessel treated 1.42±0.63 1.57±0.67 1.30±0.57 0.0102 TIMI Flow [0-1] Prior to PCI 80.2% 71.9% 84.8% 0.1411 TIMI Flow [0-1] Post PCI 8.7% 4.6% 11.9% 0.1932 p=0.01 p=0.006 p=0.007 Pre-PCI Post-PCI Extent of Revascularization O’Neill et al, J Interven Cardiol 2013;9999:1-11 *: DTB time for patients admitted for STEMI HCS-PP rA

23 Procedural Characteristics
All N = 154 Impella Pre-PCI N = 63 Impella Post-PCI N = 91 p value Duration of support, (hrs) 23.7 [ ] 22.8 [ ] 24.2 [ ] 0.3873 Median DTB Time*, min 63.5 [ ] 112 [79 112] 52 [34 81] <0.0001 Suspected IRA Territory LM 16.1% 23.8% 9.5% 0.0226 LAD 52.6% 53.9% 51.4% 0.7598 Left Cx. 10.9% 4.8% 16.2% 0.0324 RCA 16.8% 12.7% 20.3% 0.2373 Graft 3.7% 2.7% 0.5218 Number of diseased vessels 1.8±0.76 1.94±0.72 1.70±0.79 0.0735 Number of significant Lesions 2.57±1.39 2.74±1.49 2.42±1.28 0.1868 Number of vessel treated 1.42±0.63 1.57±0.67 1.30±0.57 0.0102 TIMI Flow [0-1] Prior to PCI 80.2% 71.9% 84.8% 0.1411 TIMI Flow [0-1] Post PCI 8.7% 4.6% 11.9% 0.1932 p=0.01 p=0.006 p=0.007 Pre-PCI Post-PCI Extent of Revascularization EuroShock O’Neill et al, J Interven Cardiol 2013;9999:1-11 *: DTB time for patients admitted for STEMI HCS-PP rA

24 Outcome Cum survival Days from initiation of Impella 2.5 support
9/10/2018 1.0 0.8 0.6 0.4 0.2 Cum survival Post-PCI Pre - PCI Number of patients at risk 154 101 88 79 69 67 63 Days from initiation of Impella 2.5 support O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP00611 rA_Impella Technology - Clinical Evidence and Investigations_DRAFT, SF edits incorporated HCS-PP rA

25 Survival to Discharge by Timing of PCI
Timing of Support Initiation (154) Pre-PCI 65.1% Post-PCI 40.7% Impella Support Initiation Survival to Discharge By timing of PCI P=0.003 N=63 N=91 All Pts 50.9% Post-PCI 60.0% Pre-PCI 40.0% Impella Support Initiation STEMI N=35 N=80 71.4% 45.5% NSTEMI N=28 N=11 O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP rA

26 O’Neill et al, J Interven Cardiol 2013;9999:1-11
Independent Predictors of In-Hospital Mortality Using a Multivariate Analysis* Parameter Tested* Odds-ratio [CI 95%] p-value Initiation of Impella support prior to PCI 0.37 0.0105 Age 1.05 0.0025 Number of inotropes 1.56 0.0098 Cardiogenic shock onset prior to admission 2.42 0.0248 Mechanical ventilation 4.59 0.0003 * The multivariate analysis logistic model included the following as candidates for entry age, gender, history of chronic obstructive pulmonary disease, diabetes, peripheral vascular disease or prior stroke, STEMI vs. NSTEMI, cardiac arrest prior to admission, onset and duration of CS, patient transfer from outlying facility, evidence of anoxic brain injury pre-Impella support, need for mechanical ventilation, systolic and diastolic blood pressure , level of inotropic support pre-Impella support and potential use of IABP prior to Impella support, and baseline serum creatinine levels. O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP rA

27 Outcome to Discharge by Sub-groups
O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP rA

28 Outcome By Support Strategy
Support Strategy (N=154) No support Pre-PCI (N=38) IABP Pre-PCI (N=53) Impella Pre-PCI (N=63) PCI PCI PCI Impella Post PCI Impella Post PCI Continue Impella N=38 N=53 N=63 Survival to discharge HCS-PP rA O’Neill et al, J Interven Cardiol 2013;9999:1-11

29 Conclusion and Limitations
These results are in favour of early initiation of hemodynamic support with active unloading of the LV prior to PCI in terms of completeness of revascularization and survival in the setting of CS complicating an AMI. Retrospective data, therefore hypothesis generating and no definite conclusion on causality Decision for the timing to implant Impella and extent of revascularization was operator Although multivariate analysis reduces the bias of potential confounding factors there might be still some biases O’Neill et al, J Interven Cardiol 2013;9999:1-11 HCS-PP rA

30 Griffith et. al. J Thorac Cardiovasc Surg. 2013 Feb;145(2):548-54

31 Hemodynamics Improvement After Pump Support
Cardiac Index Mean Arterial Pressure P=0.001 P=0.01 2.5±0.4 2.6 100 2.4 83.1±7.5 90 MAP (mmHg) 2.2 80 71.4±12.5 Cardiac Index (l/min/m2) 2.0 70 1.8 1.6±0.4 60 1.6 50 Pre Impella On Impella Pre Impella On Impella Pulmonary Artery Diastolic Pressure P<0.0001 35 28.0±3.9 30 PAD (mmHg) 25 19.8±3.2 20 15 10 Pre Impella On Impella Griffith et. al. J Thorac Cardiovasc Surg Feb;145(2):548-54

32 Outcome to Next Therapy (n=16)
Over all 88% were weaned of Impella and recovered native heart function making heart recovery the most likely outcome following use of Impella BTB 6% (1) Alive 94 % (15) Recovery of native heart function 88 % (14) Expired 6% (1) BTB: Bridge to bridge Griffith et. al. J Thorac Cardiovasc Surg Feb;145(2):548-54

33 Survival Outcome is Favorable (N=16)
30 day 6 months 1 year Survival 94% 81% 75% Griffith et. al. J Thorac Cardiovasc Surg Feb;145(2):548-54

34

35 Indication for Support
Postcardiotomy Cardiogenic Shock (n=32) Other (n=15) AMICS (n=11) ADIC (n=3) Myocarditis with CS (n=1) AMICS: Acute Myocardial Infraction with Cardiogenic shock ADIC: Acute Decompensated Ischemic Cardiomyopathy CS: Cardiogenic Shock Lemaire A et al. Ann Thorac Surg Jan;97(1):133-8.

36 Outcome to Next Therapy (n=47)
Over all 72% were weaned of Impella and recovered native heart function making heart recovery the most likely outcome following use of Impella BTB: Bridge to bridge Lemaire A et al. Ann Thorac Surg Jan;97(1):133-8.

37 Lemaire A et al. Ann Thorac Surg. 2014 Jan;97(1):133-8.
Survival to One year Lemaire A et al. Ann Thorac Surg Jan;97(1):133-8.

38 IABP drawbacks Only modestly augments cardiac output and coronary blood flow Unable to provide total circulatory support when hemodynamic collapse occurs . Although the IABP restored epicardial perfusion in animal models, it had little effect on microvascular flow in the setting of acute myocardial infarction . Requires a certain level of left ventricular function- it is not a pump! Has not been independently associated with improved cardiac function or able to reverse cardiogenic shock and provide a survival benefit.

39 Conclusions Management of Cardiogenic shock remains a challenge despite the progress made in reperfusion techniques and pharmacotherapy Without clear supporting evidence, hemodynamic support with IABP remains controversial and is being challenged The newly developed percutaneous left ventricular assist devices provide better hemodynamic support compared IABP As the technology continues to evolve and the experience matures, paradigm shifts and new protocols will emerge for the management of cardiogenic shock with circulatory support Stronger clinical evidence is required to define the selection criteria to identify the patients who would benefit the most from these new technologies

40 Rise of the Machines * Surgical VADs Percutaneous MCSDs
LVADs can be grouped according to mode of implantation… Next Gen: Minimally Invasive VADs * Fang J, NEJM 2001 Synergy Symphony 57


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