Deep phenotyping: Staging & Grading Cardiogenic Shock

Is This Necessary?

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

Relevant Disclosures

Research Funding & Speaker/Consulting Honoraria: Abiomed, Abbott, Boston Scientific, LivaNova, MD Start, Precardia

Herbert J. Levine Foundation

Tufts Medical Center

Charlton Award Tufts Medical Center

RO1HL139785, RO1H133215

How Severe is Cardiogenic Shock in this Trial?

What would you use to support this patient profile? 1. Drug therapy 2. VA-ECMO 3. Impella CP 4. IABP

Randomized Trials without Defining Shock Severity

Without clear definitions for cardiogenic shock severity we will not improve outcomes for patients

Ouweneel and Henriques JACC 2017

IABP vs Impella ?

Here are the Problems No Stratification + No Shock Algorithm

INSERT ANY DEVICE

HERE

Noise Drives Non-Significance

Why are we here today?

Hemodynamic Support Options Exist

IABP SHOCK II IMPRESS Trial (n=130)

Why are we here today? Cardiogenic Shock is a Complex

Multi-factorial Syndrome

CLINICAL CATEGORIES Acute Myocardial Infarction STEMI vs NSTEMI vs RVMI Post-AMI Complications Dilated Cardiomyopathy

Non-Dilated Cardiomyopathy Myocarditis vs Post-Partum

Post-Cardiotomy Valvular Shock

Other

PATHOPHYSIOLOGIC GROUPS Cardiac vs Circulatory Collapse

LV-Dominant RV-Dominant BiV-Dominant

Hemo-Metabolic Cardiorenal

Cardiopulmonary (RV-PA-LA Axis) Valvular Shock

Vascular Resistance

The Cardiogenic Shock Working Group

The mission of the CGWG is to improve clinical outcomes for cardiogenic shock by promoting rigorous scientific investigation inclusive of a multi-center registry of patients receiving short-term mechanical circulatory support for cardiogenic shock.

10 Primary Data-Contributing Centers 6 Centers Processing IRB and Data Agreements

• Largest contemporary US registry of Cardiogenic Shock

• >2000 shock patients inclusive of MI and HF (2017-2019)

• Real world experience across secondary & tertiary centers

• Hemodynamic data for over 1100 patients in shock

• Inclusive of all acute mechanical circulatory support devices

Classes and Stages A Game-Changer for Heart Failure

Proposed SCAI Stages of CG Shock

SCAI Stages and In-Hospital Mortality

CSWG Report – Under Review 2019

Heart Failure Classes, Stages, and Levels INTERMACS Levels Identified High Risk Patients

Treatment Intensity & In-Hospital Mortality

CSWG Report – Under Review 2019

Levels of Cardiogenic Shock

CSWG Report – Under Review 2019

Invasive Hemodynamics and Outcomes

CSWG Report – Under Review 2019

Invasive Hemodynamics and Outcomes

CSWG Report – Under Review 2019

Hemodynamic and Metabolic Parameters

CSWG Report – Under Review 2019

Stages and Levels of Cardiogenic Shock

CSWG Report – Under Review 2019

Challenges with Phenotyping Shock

Sanjiv Shah, MD (Medscape: HFpEF)

Challenges with Phenotyping Shock

Sanjiv Shah, MD (Medscape: HFpEF)

CSWG Research Program Proposal

Retrospective Registry

Retrospective Phenotypes Registry (Cluster Analysis)

(Machine Learning)

Stages and Levels Development Cohort

Testing Cohort Simulation Study

Prospective Registry

Longitudinal Outcomes Escalation Analysis

Focused RCT Development

Acknowledgements CSWG Board Members

Navin K. Kapur, MD A. Reshad Garan, MD

Jaime Hernandez-Montfort, MD Claudius Mahr, MD

Daniel Burkhoff, MD PhD

Research Team Development Team Sarah Newman (Coordinator) Ryan Kelly (CVCRI Lead Administrator) Katherine Thayer (Statistician) Erin Gilbert (Business Development) Jillian Haywood (Coordinator) Nancy Wetherbee (Industry Relations) Moyhee Ayouty (Res. Assoc) Debbie Slater (Research Administrator) Elric Zweck (Res. Assoc)

Deep phenotyping: Staging & Grading Cardiogenic Shock

Is This Necessary?

Navin K. Kapur, MD, FACC, FSCAI, FAHA nkapur@tuftsmedicalcenter.org