Review

. 2023 Oct 3;148(14):1113-1126.

doi: 10.1161/CIRCULATIONAHA.123.064527. Epub 2023 Oct 2.

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

Ron Waksman¹, Mohit Pahuja², Sean van Diepen³, Alastair G Proudfoot^{4

5}, David Morrow⁶, Ernest Spitzer^{7

8}, Graham Nichol⁹, Myron L Weisfeldt¹⁰, Mauro Moscucci¹¹, Patrick R Lawler^{12

13

14}, Alexandre Mebazaa¹⁵, Eddy Fan¹⁶, Neal W Dickert¹⁷, Marc Samsky¹⁸, Robert Kormos¹⁹, Ileana L Piña²⁰, Bram Zuckerman¹¹, Andrew Farb¹¹, John S Sapirstein¹¹, Charles Simonton²¹, Nick E J West²², Abdulla A Damluji²³, Ian C Gilchrist²⁴, Uwe Zeymer²⁵, Holger Thiele^{26

27}, Donald E Cutlip²⁸, Mitchell Krucoff²⁹, William T Abraham³⁰

Affiliations

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.).

PMID: 37782695
PMCID: PMC11025346
DOI: 10.1161/CIRCULATIONAHA.123.064527

Review

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

Ron Waksman et al. Circulation. 2023.

. 2023 Oct 3;148(14):1113-1126.

doi: 10.1161/CIRCULATIONAHA.123.064527. Epub 2023 Oct 2.

Authors

Affiliations

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.).

PMID: 37782695
PMCID: PMC11025346
DOI: 10.1161/CIRCULATIONAHA.123.064527

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.

Keywords: ST elevation myocardial infarction; heart failure; non-ST elevated myocardial infarction; shock, cardiogenic.

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Conflict of interest statement

Disclosures Dr Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; consulting for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and investing in MedAlliance and Transmural Systems Inc. Dr Morrow is a member of the Thrombolysis in Myocardial Infarction Study Group which has received institutional research grant support through Brigham and Women’s Hospital from Abbott, Abiomed, Amgen, Anthos Therapeutics, ARCA Biopharma, Inc., AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc., Daiichi-Sankyo, Eisai, Intarcia, Ionis Pharmaceuticals, Inc., Janssen Research and Development, LLC, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Roche, Siemens Healthcare Diagnostics, Inc., Softcell Medical Limited, and Zora Biosciences. Dr Morrow has received consulting fees from Abbott Laboratories, ARCA Biopharma, Inflammatix, Merck & Co., Novartis, and Roche Diagnostics. Dr Spitzer reports institutional contracts for which he receives no direct compensation with Boston Scientific, Cardiawave, Edwards Lifesciences, Medtronic, Occlutech US, LLC, Shanghai Microport Medical Co. Ltd., NVT GmBH, Pie Medical Imaging, Siemens Healthcare GmBH. Dr Dickert receives research funding from the National Institutes of Health’s Agency for Healthcare Research and Quality and Data Safety Monitoring Board service for National Institutes of Health and Patient-Centered Outcomes Research Institute–funded studies. Dr Dickert reports consulting for and research funding from Abiomed, Inc. Dr Mebaaza reports receiving research grants, consulting, and receiving speaker fees from Roche Diagnostics and receiving speaker fees from Merck. Dr Fan reports personal fees from ALung Technologies, Aerogen, Baxter, GE Healthcare, Inspira, Vasomune, and Zoll Medical outside the submitted work. Dr Kormos is an employee (Division Vice President Global Medical Affairs Heart Failure) of Abbott Laboratories. Dr Proudfoot has received institutional funding from Abbott Vascular and BD Biosciences, all outside of the submitted work. Dr Simonton is an employee (Chief Medical Officer) of Abiomed, a Johnson & Johnson Company. Dr Damluji received a mentored patient-oriented research career development award from the National Heart, Lung, and Blood Institute (K23-HL153771-01). Dr Cutlip reports consulting for and research funding from Corvia Medical, MedAlliance, and Abiomed. Dr Nichol reports salary support from Medic One Foundation via the University of Washington; research funding from National Institutes of Health, Centers for Disease Control and Prevention, Abiomed Inc, Zoll Medical, RCE Technologies Inc., Zoll Circulation Inc., and Vapotherm Inc; and consulting for BrainCool AB, CPR Therapeutics Inc., Heartbeam Inc., Invero Health LLC, Kestra Medical Technologies Inc., and Orixha Inc.

Figures

**Figure 1.. Society for Cardiovascular Angiography and Interventions (SCAI) classification of cardiogenic shock.**
Cardiac arrest (A) modifier: includes patients who require or receive cardiopulmonary resuscitation (CPR) or defibrillation for pulseless arrhythmia. CS indicates cardiogenic shock; ECMO, extracorporeal membrane oxygenation; and MCS, mechanical circulatory support.

**Figure 2.. Framework for classification of cardiogenic shock.**

**Figure 3.. Summary of classifications of cardiogenic shock for clinical research.**

**Figure 4.. Framework for enrollment with written consent or under exception from informed consent.**

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources