Matching Patient and Pump in the New Era of Percutaneous Mechanical Circulatory Support

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1 Matching Patient and Pump in the New Era of Percutaneous Mechanical Circulatory Support Navin K. Kapur, MD, FACC, FSCAI, FAHA Associate Professor, Department of Medicine Interventional Cardiology & Advanced Heart Failure Programs Executive Director, The Cardiovascular Center for Research & Innovation

2 Relevant Disclosures Research Funding: Abiomed, Maquet, Cardiac Assist, Abbott, Boston Scientific Speaker/Consulting Honoraria: Abiomed, Maquet, Cardiac Assist, Abbott

3 2007: A Turning Point in Interventional Cardiology

4 The Field of MCS: Robust with Innovation IVADs HVAD Impella CP TH-RVAD TH Impella 5.0 CP RP BiPellas 5.0 as a Bridge to Recovery

5 The Spectrum of Temporary MCS Devices in 2017 Left Ventricle Right Ventricle

6 What is State of the Art in 2017? CULPRIT SHOCK: Exhausting Coronary Approaches for a Ventricular Problem Culprit Only Multivessel

7 National Cardiogenic Shock Initiative What s State of the Art in 2017? First FDA Approval for Perc MCS in Shock NATIONAL CSI ALGORITHM RAPID Identification of Cardiogenic Shock William O Neill Cath Lab Activation Obtain Femoral Access LVEDP < 15 mmhg 15 mmhg Consider Other Causes of Shock IMPELLA Door To Support Time Target < 90 minutes

8 What s State of the Art in 2017? The ARMS Registry Jamie McCabe & Raj Tayal Tufts Axillary Case

9 What s State of the Art in 2017? The ARMS Registry

10 JH-HLM Score What s State of the Art in 2017? Full Body Recovery: Quantifying Ambulation AM-PAC Score 8 6 One-way ANOVA p = One-way ANOVA p = Survivors (n=6) Withdrawal (n=4) Worsening HF (n=2) 0 Survivors (n=4) Withdrawal (n=4) Worsening HF (n=2) Non-survivors Non-survivors Esposito & Kapur et al. ASAIO 2017

11 What s State of the Art in 2017? The PHP Promise is Still Alive 14Fr Sheath 24Fr Impeller National PIs: Ulli Jorde David Kandzari Navin Kapur SHIELD-I : High Risk PCI Trial TCT 2015 SHIELD-II : High Risk PCI Trial in USA Randomized 2:1 (HeartMate PHP vs. Impella)

12 Hemodynamic Principles of Rotary Flow Pumps Higher Flow with Lower Transvalvular Pressure Gradient The more dysfunctional the ventricle, the more functional a CF-AMCS device becomes. Kapur NK. CathSAP V. 2016

13 What s State of the Art in 2017? First FDA Approval for Perc RV support Kuchibhotla, Esposito, Annamalai, and Kapur et al. JAHA 2017

14 What s State of the Art in 2017? Interventionalists are becoming VA-ECMO Specialists Antegrade Perfusion 6Fr Braided Sheath Impella CP 14Fr Sheath PA Catheter 8Fr Cordis Antegrade Perfusion 6Fr Braided Sheath 17Fr Arterial Cannula 25Fr MS Venous Cannula High Pressure 3-Way + 2 Male-to-Male Connectors

15 What s State of the Art in 2017? Interventionalists are Becoming Hemodynamicists Again RV +IMPELLA LV Daniel Burkhoff LVP & AoP PAP & RAP

16 What s State of the Art in 2017? 2007 Shifting the Paradigm of MCS 2017 Bi-VADs HVAD Impella CP Bi-Pellas Cardiac Replacement Cardiac Recovery

17 What s State of the Art in 2017? Trials that Move the Dial for AMI and Shock Kapur and Davila Eur H J 2017

18 Mechanical Circulatory Support: An Evolving Field with Expanding Potential Surgical Percutaneous Temporary Use Durable Use Open Space

19 Where are the new opportunities for Percutaneous MCS? High Risk Interventions Cardiogenic Shock Acute MI ± Shock Acute Systolic Heart Failure Chronic Systolic Heart Failure HF with Preserved EF IABP Impella Tandem VA-ECMO

20 Adapted from Miller LW Circ 2011 Heindrick, Konstam et al. Circ HF 2013 Why is Interventional Heart Failure the Future of Acute MCS? By 2030, 1 in 33 individuals in the US will have HF. LVAD and OHTx Candidacy is limited to <15% of patients with HF.

21 Where are the opportunities for Percutaneous MCS? Emerging Opportunity # 1: Acute Heart Failure* * Diuretic-resistance remains a major clinical problem in heart failure

22 Where are the opportunities for Percutaneous MCS? Emerging Opportunity # 2: Ambulatory Heart Failure Most heart failure patients live outside the hospital Circulation. 2012;126:

23 Where are the opportunities for Percutaneous MCS? Emerging Opportunity # 3: Heart Failure with Normal EF HFpEF Patient Profiles Elderly Female Hypertensive Renal insufficiency Neurohormonal activation LV Hypertrophy and Fibrosis Normal LVEF/Abnormal LV stiffness Current Treatment: Blood pressure control Diuresis Otkay et al Curr HF Rep 2015

24 Emerging Devices for Cardio-Renal Syndrome 1 Cardiac Goals of Therapy: 1. Reduce LV Afterload 2. Reduce LV Stroke Work 3. Increase Cardiac Output Renal Goals of Therapy 1. Increase Renal Blood Flow 2. Increase Urine Output 3. Avoid RV / Pulmonary Loading

25 Emerging Aortic Platforms for CRS Type 1 Potential Advantages of Aortic Pumps 1. Extracardiac positioning 2. Reduce LV Afterload & Work 3. Enhance Systemic Perfusion 4. Increase Renal Perfusion & UOP Reitan Aortix SecondHeart NuPulse Sunshine Heart

26 Emerging Aortic Platforms for CRS Type 1 Potential Advantages of Aortic Pumps 1. Extracardiac positioning 2. Reduce LV Afterload & Work 3. Enhance Systemic Perfusion 4. Increase Renal Perfusion & UOP Reitan Aortix SecondHeart Advantages of CF-Aortic Pumps 1. Cardiac-Renal Uncoupling 2. Less dependent on LV function 3. Ambulatory/Outpatient Viability

27 The Tufts Cardiovascular Center for Research and Innovation The CVCRI Innovation Engine Clinical Excellence Preclinical Testing Fundamental Discoveries Preclinical Trials Novel Clinical Trials

28 Micro-Axial Pump Stentless Anchoring Tines 18Fr Catheter Delivery System

29 Shabani et al ASAIO 2013

30 Kapur Lab

31 Retractable Propeller Retractable Stent Cage 18Fr Catheter Delivery System

32 SecondHeart ON SecondHeart OFF SecondHeart ON 0 Kapur Lab

33 Emerging Devices for Cardio-Renal Syndrome 1 White Swell

34 What s State of the Art in 2017? Innovative Training Programs Interventional Heart Failure : A Tufts Trademark Interventional Heart Failure

35 Thank you To Learn More about Acute MCS & Hemodynamics December Berlin, Germany Interventional Heart Failure November 8-9, 2018 CHICAGO, IL

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