1/5/2017. The Next Frontier: Advanced Cardiogenic Shock U MICHIGAN EPERIENCE

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1 % SURVIVAL 1/5/2017 The Next Frontier: Advanced Cardiogenic Shock William W. O Neill, MD Henry Ford Health System Medical Director Center for Structural Heart Disease Detroit, MI U MICHIGAN EPERIENCE Cardiogenic Shock Complicating Acute Myocardial Infarction Intervention Non-Intervention MONTHS Lee et al Circulation

2 1/5/2017 SHOCK Trial 1-Year Survival % p=0.025 p=0.01 Overall < 75 years INCIDENCE OF CARDIOGENIC SHOCK GROWING 6 Cardiogenic Shock in STEMI Increasing 1 STEMI Cardiogenic Shock in Medicare Age Increasing 2 56,508 36,969 53% Age >65 only, excludes non-medicare population 1. Dhaval Kolte et al. J Am Heart Assoc 2014 NATIONWIDE INPATIENT SAMPLE 2. Centers for Medicare and Medicaid database, MEDPAR FY14 2

3 1/5/ LIMITATIONS OF CONVENTIONAL THERAPY Mortality Risk with Inotropes/Vasopressors 1 N = 40 IABP-SHOCK II Randomized Controlled Trial 2 N = 600 IABP (n=301) Medical Therapy (n=299) 41.3% 39.7% 1- Samuels LE et al, J Card Surg Thiele H et al. NEJM Clinicaltrial.gov # NCT Inotrope Harm in Cardiogenic Shock 1. Marked increase in MVO2 at a time of oxygen starvation. 2. Tachycardia increases MVO2 and decreases diastolic interval. 3. Marked increase in LVEDP causes further decrease in diastolic perfusion pressure and increased wall tension. 4. Tachycardia mediated apoptosis may decrease myocardial recovery. 3

4 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 Est. In-Hospital Mortality 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 Fincke, et. al. JACC, 2009 SHOCK TRIAL 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 /5/2017 HEMODYNAMIC EFFECTS OF IMPELLA SUPPORT 10 Outflow (aortic root) Inflow (ventricle) aortic valve Flow MAP Cardiac Power Output (MAP x Cardiac Output x ) LVEDP and LVEDV (n=189) Wall Tension Mechanical Work Microvascular Resistance Coronary Perfusion Cardiac Power Output End Organ Perfusion O 2 Supply O 2 Demand Cardiac Power Output (Watts) Unloading to Myocardial Recovery 11 IMPELLA REDUCES NEED FOR INOTROPES/PRESSORS Impella 2.5 Reduction in Inotropes/Pressors in 24 Hours ISAR-SHOCK RCT 1 N=25 Impella 5.0 Reduction in Inotropes/Pressors Over days RECOVER I FDA IDE Study 2 (N=16) 1- Seyfarth et al. JACC Griffith et a. J Thorac Cardiovasc Surg 2012 CARDIOGENIC SHOCK OUTCOME EUROPEAN EECMO Experience EuroIntervention

5 Impella Approved: USA, Canada, Panama, Colombia, Venezuela, Brazil, Portugal, Spain, France, Italy, Greece, Switzerland, Austria, Germany, Belgium, Luxemburg, Netherland, Ireland, UK, Denmark, Norway, Sweden, Finland, Russia, China, Saudi Arabia, Kuwait Impella Approved and cvad Registry Active: USA, Canada, Spain, France, Italy, Switzerland, Germany, Netherland, UK, Denmark 1/5/2017 THE CVAD REGISTRY: A GLOBAL INITIATIVE The catheter based VAD Registry is a worldwide observational clinical registry designed to monitor patient safety and real-world outcomes of patients supported with Impella 2.5/CP/5.0/LD/RP 13 Basir, O Neill, et al. TCT Abstract 121 (2016) Basir, O Neill, et al. TCT Abstract 121 (2016) 5

6 1/5/2017 Basir, O Neill, et al. TCT Abstract 121 (2016) DETROIT CARDIOGENIC SHOCK INITIATIVE DETROIT CSI

7 1/5/ Detroit CSI Cardiac Power Output Pre-Impella Post-Impella 7

8 Probability of Survival (%) 1/5/2017 DETROIT CSI Observations 1. MCS can be initiated in a majority of patients within 60 minutes if arrival. 2. Door to support may become a quality marker for shock management. 3. Most patients have inotropic support eliminated or markedly reduced before cath lab discharge. 4. Cardiac power output >0.6 watts can be achieved in all patients prior to cath lab discharge. 5. Promising trends in coronary perfusion and survival ( 80 % hospital survival) exist. CARDIOGENIC SHOCK A CHANGE IN PARADIGM DOOR TO BALLOON DOOR TO SUPPORT Probability of Survival Based On Arterial Blood Lactate Lactate mm 8

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10 1/9/2017 The Importance of Collaboration in the Treatment of Cardiogenic Shock Navin K. Kapur, MD, FACC, FSCAI, FAHA Associate Professor, Department of Medicine Interventional Cardiology & Advanced Heart Failure Programs MCRI No Improvement in Shock Outcomes What are we missing when it comes to cardiogenic shock? Lower incidence of CGS. Increased use of PCI and IABP. Mortality remains exceedingly high. Jeger RV et al Ann Intern Med Nov 4;149(9): Message 1: We don t support the heart effectively or early enough in the Shock Spectrum Circulatory Support Systemic Perfusion Ventricular + Support LV/RV Unloading + Coronary Perfusion Mean Arterial Pressure Lactate Creatinine LV-ESP & EDP Ao Pulse Pressure Vent Tachycardia BNP MAP - LVEDP ST-Changes Troponin/CKMb Hemodynamic Problem Recovery Time in Cardiogenic Shock Hemo-Metabolic Problem Death Rx: Hemodynamic Bridge to Recovery Support Detroit Circulatory Cardiogenic and Ventricular Shock Initiative Rx: It s Multi-organ Too Late Support for AMCS Unloading, Impress Ventilator, Trial CVVHD 1

11 In-Hospital Mortality (%) % In-hospital Mortality % Mortality 1/9/2017 Mortality vs Number of Vasopressors/inotropes Pre-Device Implant Among the Total Cohort One-way ANOVA p= One-way ANOVA p=0.08 Total Cohort Number of Vasopressors / Inotropes >10 Lacate Levels (meq/l) Early and Effective Device Support is Critical for Survival Esposito and Kapur et al. TCT 2016 Message 2: We don t use hemodynamic data to guide decision-making often enough CPO = MAP x CO 451 Therapy CPO (W) Medical Therapy Impella LVAD TandemHeart RVAD Cardiac Power Output (CPO) Fincke et al JACC 2004 Early Use of a PA Catheter Improves Outcomes in Acute HF and CG-Shock Sotomi et al. Intl J Card

12 PCWP 1/9/2017 Message 3: We must manage total body congestion, not just. cardiac output Cooper and Rogers et al. J Card Fail 2016 The impact of congestion, not just cardiac output Cooper and Rogers et al. J Card Fail 2016 Defining Profiles of Cardiogenic Shock by Congestive Status 60 LV Dominant 14 BiV Dominant 40 ECMO Impella Euvolemic RV Dominant CVP Esposito and Kapur et al. TCT

13 1/9/2017 Acute MI and Acute HF are Primary Causes of Shock Acute MI Cardiogenic Shock Advanced HF Cardiogenic Shock 50-60% 20-30% Modified from Goodlin. JACC 2009;54:386 Who do you want on your Shock Team? Acute MI Cardiogenic Shock 1. Interventional Cardiologist 2. Cardiac Surgeon 3. Critical Care / Intensivist (MD) 4. Advanced HF Specialist 5. Critical Care Nursing Team 6. Perfusion Team 7. Respiratory Specialists 8. Physical and Occupational Therapy 9. Palliative Care Advanced HF Cardiogenic Shock 1. Advanced HF Specialist 2. Interventional Cardiologist 3. Cardiac Surgeon 4. Critical Care / Intensivist (MD) 5. Critical Care Nursing Team 6. Palliative Care 7. Perfusion Team 8. Respiratory Specialists 9. Physical and Occupational Therapy The Role of Interventional Cardiology Acute MI Cardiogenic Shock Advanced HF Cardiogenic Shock 1. Coronary Revascularization (Infarct related artery / Multivessel revasc) 2. Hemodynamic evaluation 3. Acute mechanical circulatory support (LV, RV, and BiV) 4. Cardiopulmonary support (VA-ECMO or VV-ECMO) 5. Assessment and treatment of valvular heart disease as needed 4

14 % of Durable MCS Device Implants 1/9/2017 The Role of Cardiac Surgery Acute MI Cardiogenic Shock Advanced HF Cardiogenic Shock 1. Management of post-mi mechanical complications 2. Coronary Revascularization (CABG) if no PCI option 3. Cardiopulmonary support (VA-ECMO or VV-ECMO) 4. Assist with acute mechanical circulatory support (LV, RV, and BiV) 5. Once stable, decision about LVAD, RVAD, or BiVAD The Role of Advanced Heart Failure Acute MI Cardiogenic Shock Advanced HF Cardiogenic Shock 1. Evaluate candidacy for advanced HF therapies (LVAD/OHTx) 2. Hemodynamic optimization 3. Assist with management of acute MCS or VA-ECMO 4. Assist with end-of-life decision making / palliation / medical futility Durable MCS Devices are Not Commonly Used for Acute Circulatory Support Higher Mortality with INTERMACS 1 and 2 Patients > 65 years of Age 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% BTR Rescue Therapy Rare use of Durable MCS as a Bridge to Recovery or Rescue Therapy Option Adapted from Kirklin et al JHLT

15 1/9/2017 Recovery is Rare with Durable MCS Devices in AMI and Cardiogenic Shock AMCS Device Options for Advanced HF & Shock Left Ventricle Acute MCS Devices are Not VADs Durable MCS Acute MCS Primary Objectives Outpatient Discharge Inpatient Stabilization Clinical Scenarios Stable, but sick Sick and unstable Technical Implant Features Cardiotomy Vascular Puncture Post-procedural Right Ventricle Management Surgical Medical Outcomes/Metrics of Success OHTx or DT-VAD Recovery, VAD, OHTx Withdrawal of Care Failure Success in select cases If you manage CG-Shock in 2017, you should be an Acute MCS Specialist Hemodynamic Problem Recovery Time in Cardiogenic Shock Hemo-Metabolic Problem Death AMI Shock ED Cath Lab CCU/ICU Interventional Cardiology SHOCK TEAM vs AMCS TEAM Cardiac Surgery AMCS Specialist Advanced Heart Failure Diagnosis Drugs Delay YES/NO AMCS Critical Care Team AMCS 6

16 1/9/2017 The Role of the Cardiac Intensivist Acute MI Cardiogenic Shock Advanced HF Cardiogenic Shock 1. Optimize hemodynamic status 2. Pulmonary stabilization 3. Renal stabilization 4. Sepsis/infectious issues (prevention and management) 5. Nutrition, mobilization, prophylaxis against DVT/ulcers 6. Optimize metabolic parameters (ie lactate) 7. Assist with Acute MCS, VA-ECMO, and VV-ECMO management Cardiac Intensivists Improve Clinical Outcomes for Patients with Cardiogenic Shock Na and Yang et al. JACC 2016 Multidisciplinary Case 70 year old man with inferior STEMI. 18 hours after symptom onset. BP 110/80 and HR 90 on Cath Lab arrival. 7

17 1/9/2017 PCI of the RCA with 4 overlapping BMS. Distal rpl and rpda thrombus. BP 80/60 and HR 110 post-pci. Now what? PCI of the RCA with 4 overlapping BMS. Distal rpl and rpda thrombus. BP 80/60 and HR 110 post-pci. IABP inserted. Now what? RHC: RA 18, PA 34/28, PCWP 18, MVO2: 38% on IABP support Echocardiogram: Mod-severe RVF and LVEF 40% Now what? RHC: RA 18, PA 34/28, PCWP 18, MVO2: 38% on IABP support Echocardiogram: Mod-severe RVF and LVEF 40% Now what? VA-ECMO Initiated 29Fr Venous Inflow 17Fr Arterial Outflow IABP left 1: RPM/4.7LPM Flow MAP improves to Patient extubated in 48 hours, but unable to wean VA-ECMO Now what? 8

18 1/9/2017 Transferred to Tufts for Advanced HF/BiVAD/OHTx Evaluation On arrival, severe bleeding from IABP site. MAP 100. HR 90. RA: 8; PA 20/14; MVO2 63%; FA O2 100% IABP removed at the beside. Recurrent VT and VF. Now what? Polymorphic VT: LV Distention due to VA-ECMO or LAD ischemia? Get some Hemodynamic Data. Cath Lab PA Numbers: RA: 10 PA: 27/15 PCWP: 12 MVO2: 45% Not due to LV Distention Polymorphic VT: LV Distention due to VA-ECMO or LAD ischemia? Impella CP inserted for BiV support and LAD PCI What s this? Impella for LV vent should be at P3-P4 All cf-mcs devices are preload dependent 9

19 1/9/2017 Clinical Outcome On EcPella Configuration for 1 week. LV and RV function improve. Tolerated ECMO turndown on Day 5 post EcPella. ECMO decannulated on Day 11 post-implant CP removed and Impella 5.0 implanted via left axilla Impella 5.0 for 5 days. LVEF 40%. RV improved. RA 8; PA 25/10; PCWP 10; MVO2 68% on P3 Impella removed and patient recovered to discharge home. Essential Components of the Shock Team Interventional Cardiology Cardiac Surgery Advanced Heart Failure Cardiac Intensive Care Critical Care Nursing, Perfusion, Respiratory Therapy, PT/OT, Palliative Care Thank you nkapur@tuftsmedicalcenter.org MCRI 10

20 Hemodynamic Support in High Risk PCI and Cardiogenic Shock Using Percutaneous LV Assist Device Jon C. George, MD Director, Cardiac Cath Lab Einstein Medical Center Philadelphia, PA Clinical Goals in Complex Interventions Maintain Hemodynamics avoiding disruptions in cardiac output, clinical challenges to end-organ function and neurological instabilities More Time for Balloon Inflation & Stent Placement by raising the patient s ischemic threshold to minimize cell damage from balloon inflation or coronary dissection Prophylactic Safety Profile & Ease-of-Use reduce complications such as bleeding or embolization to end organs such as stroke or limb ischemia Clinical Goals in Emergent Patients Restore Stable Hemodynamics reversing decline of end-organ perfusion, reducing risk of end-organ failure, breaking cycle of cardiogenic shock Minimize Infarct Size reducing myocardial ischemia, halting cell damage, maximizing residual cardiac function Ease-of-Use & Safety consistent with critical treatment time scenarios and riskbenefit considerations of emergency care 1

21 Evolution of Cardiac Support in Cath lab ECMO IABP CPS Hemopump TandemHeart Impella 70 s 80 s 90 s 00 s Complex Multivessel PCI 2

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24 Left Main Bifurcation PCI 5

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26 LM Bifurcation In-Stent Restenosis 7

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28 Figure 1 Figure 1b 9

29 Figure 2 Figure 3 Figure 4 10

30 Figure 4b Cardiogenic Shock and PAD 11

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34 Incremental Support 15

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36 Mechanical Aortic Valve & Complex PCI 17

37 Severe Peripheral Arterial Disease RFA 6 Fr sheath RFV 8 Fr sheath RFA selective angio Severe common Iliac and external Iliac diffuse stenosis of about 80% Severe Bilateral PAD Selective angiogram of LFA severe common Iliac and external iliac artery stenosis of 70% 18

38 PTA of L EIA for Tandem Heart Placement Mustang 5 x 40mm balloon Complete SE 6 x 60 mm self-expanding stent was deployed in L EIA and postdilated with mustang 6 x 40 mm balloon Express 7 x 27 mm stent was then deployed at lesion in the Common Iliac artery L CFA was then upsized to a 10 Fr sheath Crossing Inter-atrial septum w ICE guidance Tandem Heart into LA for Assist Systemic Output of up to 2 L/min was obtained 19

39 6 Fr JL4 guide NC balloon 2.5 x 12 to predilate LM and mid-lad LM was further pre-dilated with 4 x 12 balloon Integrity BMS 2.5 x 12 was deployed in mid-lad Integrity BMS 4 x 12 was deployed from distal LM into proximal LAD LM stent was post-dilated with 4 x 12 NC balloon LAD Intervention Right Coronary Intervention Damping of pressure with catheter engagement 6 Fr JR4 guide NC 2.5 x 12 balloon for pre-dilatation of ostial lesion Integrity 3 x 12 BMS deployed in proximal RCA Post-dilated with 3 x 12 NC balloon It should be the function of medicine to help people die young as late in life as possible - Ernst Wynder 20