Cardiac Safety Research Consortium: Shock VI Virtual Thinktank
Shock Evidence Collection: Needs & Solutions Going Forward

March 18, 2022

PART I: An Overview of Shock and Selected CSRC Shock Working Group Updates 

Plenary Session: Updates & Perspectives on Cardiogenic Shock Evidence 
Moderators: Andrew Farb (FDA), Poornima Sood (AV), JoAnn Lindenfeld (Vanderbilt) 

Brief Update Contemporary Shock Trials In EU: Holger Thiele (Heart Center Leipzig) View Slides 

Brief Update Contemporary Shock Trials in USA: Navin Kapur (Tufts) View Slides

MCS Evidence: What Are the Highest Priorities At FDA? Bram Zuckerman (FDA) View Slides

New Directions in SCAI Shock Stages: Tim Henry (SCAI) 

Shock Data: A View From the AHA Mariel Jessup (AHA) View Slides

Maximizing Information from Shock Evidence: A Statistical Perspective Andrew Althouse (U of Pittsburgh) View Slides

Industry Roundtable: Navigating Innovation Pathways Advancing MCS Technologies for Shock (5 min each)

 Moderators: Stavros Drakos ( U of Utah), Fernando Aguel (MCRA) 

Andres Beiras (Getinge) 

• Chuck Simonton/Seth Bilazarian (Abiomed) 

• Bob Kormos (Abbott Vascular) 

Brief Discussion: Lead Discussants: Meir Shinnar (FDA); Nicole Gillette (FDA); Eric Chen (AV) 

Novel Informed Consent Model for Acute Cardiogenic Shock Trials 

 Moderators: John Sapirstein 

• Background and Specifics of the CSRC “Hybrid” Model: Neal Dickert (Emory) View Slides 

• Critical Issues for Consent in Recover IV: Chuck Simonton 

• Panel Discussion: Graham Nichol (University of Washington) , Bram Zuckerman (FDA), Gregg Stone (Mt. Sinai), Changfu Wu (FDA) 

Inclusive, Sustainable AHA Shock Registry: Standing Up a New Public Health Resource

Moderators: Joanna Chikwe (Cedars-Sinai), Andres Beiras (Getinge) 

Consensus, Consistent Data Structure for MCS Device Innovation & Best Practice– The Vision: David Morrow (Harvard)/Mitch Krucoff (Duke) 

Shock Evidence and Diversity: Re-calibrating Our Commitments to Public Health: Wayne Batchelor (Innova) 

Translating the Visions into Reality: Christine Rutan (AHA) View Slides

The Utility of Evidence for Reimbursement Decisions for Shock Devices: Tamara Syrek-Jensen (CMS) 

Panel Discussion: Sunil Rao (Duke); JoAnn Lindenfeld (Vanderbilt University); William Abraham (Ohio State University); Nicole Gillette (FDA) 

PART II: Finalizing SHARC Definitions 

SHARC: Finalizing SHARC Consensus Core Data Definitions 

Co-Moderators: William Abraham (Ohio State), Ron Waksman (Medstar Health), Marc Samsky (Duke); Ernest Spitzer (ARC/Cardialysis); Andy Farb (ARC/FDA) 

Summary of Work To Date and Objective for Today
o William Abraham (Ohio State) 

Session 1: Final Issues for Definition of Cardiogenic Shock for Clinical Trial Enrollment Criteria
o Ron Waksman (Medstar Health), Sean Van Diepen (University of Alberta) View Slides

Session 2: Final Issues for Classifying Populations to be Studied in Cardiogenic Shock Trials
o Patrick Lawler (Toronto General Hospital), David Morrow (Brigham and Women’s), Alexandre Mebazza (Lariboisiere Hospital) View Slides

Session 3: Final Issues for Defining Patient Criteria for Exemption From Informed Consent (EFIC)
o Neil Dickert (Emory), Changfu Wu (FDA), John Sapirstein (FDA), Graham Nichol (University of Washington) View Slides

Session 4: Final Issues for Standardization of Effectiveness Outcomes for Shock Research
o Ernest Spitzer (Cardialysis), Eddy Fan (Toronto General Hospital), Alastair Proudfoot (St. Barts Hospital) View Slides

Session 5: Final Issues for Safety Outcomes for Shock Research
o Mauro Moscucci (FDA), Abdulla Damluji (Johns Hopkins), Ian Gilchrist (Hershey Medical Center), Marc Samsky (Duke) 

The Immediate Relevance of Final SHARC Definitions Panel: 

 Bram Zuckerman (FDA); Navin Kapur (Tufts); Chuck Simonton/Seth Bilazarian (Abiomed); David Morrow/Mitchell Krucoff (Duke)