Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC)-Reference-Cited by-同舟云学术

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC)

Published:2023-10-03 Issue:14 Volume:148 Page:1113-1126
ISSN:0009-7322
Container-title:Circulation
language:en
Short-container-title:Circulation

Author:

Waksman Ron¹^ORCID,Pahuja Mohit²^ORCID,van Diepen Sean³^ORCID,Proudfoot Alastair G.⁴⁵^ORCID,Morrow David⁶^ORCID,Spitzer Ernest⁷⁸^ORCID,Nichol Graham⁹^ORCID,Weisfeldt Myron L.¹⁰,Moscucci Mauro¹¹^ORCID,Lawler Patrick R.¹²¹³¹⁴^ORCID,Mebazaa Alexandre¹⁵^ORCID,Fan Eddy¹⁶^ORCID,Dickert Neal W.¹⁷^ORCID,Samsky Marc¹⁸^ORCID,Kormos Robert¹⁹^ORCID,Piña Ileana L.²⁰^ORCID,Zuckerman Bram¹¹,Farb Andrew¹¹,Sapirstein John S.¹¹,Simonton Charles²¹,West Nick E.J.²²^ORCID,Damluji Abdulla A.²³^ORCID,Gilchrist Ian C.²⁴^ORCID,Zeymer Uwe²⁵^ORCID,Thiele Holger²⁶²⁷^ORCID,Cutlip Donald E.²⁸^ORCID,Krucoff Mitchell²⁹,Abraham William T.³⁰^ORCID

Affiliation:

1. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC (R.W.).

2. Division of Cardiology, University of Oklahoma Health Sciences Center, Oklahoma City (M.P.).

3. Department of Critical Care Medicine and Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada (S.v.D.).

4. Department of Perioperative Medicine, Barts Heart Centre, London, UK (A.G.P.).

5. Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany (A.G.P.).

6. Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (D.M.).

7. Cardialysis, Rotterdam, The Netherlands (E.S.).

8. Cardiology Department, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands (E.S.).

9. University of Washington-Harborview Center for Prehospital Emergency Care, University of Washington Harborview Center, Seattle (G.N.).

10. Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD (M.L.W.).

11. Office of Cardiovascular Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (M.M., B.Z., A.F., J.S.S.).

12. Peter Munk Cardiac Centre, Toronto General Hospital Research Institute, Canada (P.R.L.).

13. McGill University Health Centre, Montreal, Canada (P.R.L.).

14. Interdepartmental Division of Critical Care Medicine, University of Toronto, Canada (P.R.L.).

15. Université Paris Cité, Department of Anesthesiology and Critical Care Medicine, Hôpital Lariboisière, France (A.M.).

16. Interdepartmental Division of Critical Care Medicine, University of Toronto, Canada (E.F.).

17. Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA (N.W.D.).

18. Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT (M.S.).

19. Global Medical Affairs Heart Failure, Abbott Laboratories, Austin, TX (R.K.).

20. Division of Cardiology, Thomas Jefferson University, Philadelphia, PA (I.L.P.)

21. Abiomed, Danvers, MA (C.S.).

22. Abbott Vascular, Santa Clara, CA (N.E.J.W.).

23. Inova Center of Outcomes Research, Inova Heart and Vascular Institute, Falls Church, VA (A.A.D.).

24. Department of Interventional Cardiology/Heart and Vascular Institute, Penn State Health/Hershey Medical Center (I.C.G.).

25. Institut für Herzinfarktforschung Ludwigshafen, Germany (U.Z.).

26. Heart Center Leipzig at University of Leipzig, Germany (H.T.).

27. Leipzig Heart Science, Germany (H.T.).

28. Beth Israel Deaconess Medical Center and Harvard Medical School, Boston MA (D.E.C.).

29. Department of Medicine, Duke University School of Medicine, Durham, NC (M.K.).

30. Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, The Ohio State University College of Medicine/Ohio State University Wexner Medical Center, Columbus (W.T.A.).

Abstract

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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