Practical Approaches to Generating Clinical Evidence for the Treatment of Cardiogenic Shock
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD
July 24, 2019
8:00 – 8:15 Introduction and Purpose of Think Tank
Mitchell Krucoff, MD (Duke)
8:15 – 8:30 Summary of CSRC Shock I
Marc Samsky, MD (Duke)
8:30 – 9:10 Session 1: Plenary Session: Unmet needs in treating cardiogenic shock
Moderators: Mitchell Krucoff, MD (Duke)
- 8:30 – 8:40 Circulatory device perspective: William O’Neill, MD (Henry Ford)
- 8:40 – 8:50 An electro-physiologic device perspective: William Abraham, MD (Ohio State University Wexner Medical Center)
- 8:50 – 9:00 Industry Perspective: Charles (Chuck) Simonton, MD (Abbott Vascular)
- 9:00 – 9:10 Regulatory Perspective: Fortunato Fred Senatore, MD, PhD (FDA)
9:10 – 10:30 Session 2: Definitions of Cardiogenic Shock
Moderator: David Morrow, MD MPH (Brigham and Women’s Hospital) and Eric Chen, MS (Abbott Vascular)
- 9:10 – 9:15 Clinical Perspective: Is there a consensus definition? Do we need one? Judith Hochman, MD (NYU School of Medicine)
- 9:15 – 9:20 Advancing Definitions in CHF (HF Collaboratory, ARC-CHF): Relevance to Shock. William Abraham, MD (Ohio State University Wexner Medical Center)
- 9:20 – 9:25 Clinical Perspective: Deep phenotyping: Staging and grading cardiogenic shock – is this necessary? Navin Kapur, MD (Tufts Medical Center)
- 9:25 – 9:30 Regulatory Perspective: What is an acceptable definition? Meir Shinnar, MD, PhD (FDA)
9:30 – 10:30 Discussion
Lead Discussant: Ian Gilchrist, MD (Penn State)
10:30 – 10:45 Break
10:45 – 12:15 Session 3: Systems-based care for patients with cardiogenic shock: Organized Shock Teams and Centers of Excellence
Moderator: Joaquin Cigarroa, MD (Oregon Health and Sciences)
- 10:45 – 10:50 Clinical best practices: Are “Shock Teams” necessary? Behnam Tehrani, MD (INOVA)
- 10:50 – 10:55 Clinical Perspective: What should be considered a “Center of Excellence?” E. Magnus Ohman, MD (Duke)
10:55 – 12:15 Discussion
Lead Discussant: Alex Truesdell, MD (INOVA)
12:15 – 12:45 Break/Lunch
12:45 – 2:15 Session 4: What is the best approach to generating evidence? Registries, trials, both?
Moderator: Alastair Proudfoot, MD, PhD (St. Barts, London) and Ron Waksman, MD (MedStar)
- 12:45 – 12:50 FDA recap from previous meeting: John Sapirstein, MD (FDA)
- 12:50 – 12:55 Clinical Perspective: Enrollment, Follow Up and End Points – Who should be included? How frequent should we reassess? Timothy Henry, MD (The Christ Hospital)
- 12:55 – 1:00 Clinical Perspective: What can we learn from ongoing registries? William O’Neill, MD (Henry Ford)
- 1:00 – 1:05 Clinical Perspective: What can we learn from ongoing randomized trials? DangerShock and EuroShock Holger Thiele, MD (University of Leipzig)
- 1:05 – 1:10 Clinical Perspective: What avenues are available to incorporate data acquisition into routine care? Adam DeVore, MD (Duke)
- 1:10 – 1:15 Statistical Perspective: Andrew Althouse, PhD (University of Pittsburgh)
1:15 – 2:15 Discussion
2:15 – 2:25 Break
2:25 – 3:15 Open session for discussion and concluding thoughts: Where do we go from here?
Moderator: Sunil Rao, MD (Duke) and Fernando Aguel, MSE (FDA)
3:15 – 3:30 Summary and Adjourn