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

Ron Waksman, Mohit Pahuja, Sean Van Diepen, Alastair G. Proudfoot, David Morrow, Ernest Spitzer, Graham Nichol, Myron L. Weisfeldt, Mauro Moscucci, Patrick R. Lawler, Alexandre Mebazaa, Eddy Fan, Neal W. Dickert, Marc Samsky, Robert Kormos, Ileana L. Piña, Bram Zuckerman, Andrew Farb, John S. Sapirstein, Charles SimontonNick E.J. West, Abdulla A. Damluji, Ian C. Gilchrist, Uwe Zeymer, Holger Thiele, Donald E. Cutlip, Mitchell Krucoff, William T. Abraham

Research output: Contribution to journalReview articlepeer-review

6 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1113-1126
Number of pages14
JournalCirculation
Volume148
Issue number14
DOIs
StatePublished - Oct 3 2023

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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