Abstract | BACKGROUND: METHODS: A subgroup of experts convened by the National Heart, Lung, and Blood Institute and the US Department of Defense developed consensus recommendations for primary outcomes in cardiac surgery and mechanical circulatory support. RESULTS: For cardiac surgery the primary efficacy endpoint of total allogeneic blood products (units vs mL/kg for pediatric patients) administered intraoperatively and postoperatively through day 5 or hospital discharge is recommended. For mechanical circulatory support outside the perioperative period the recommended primary outcome for extracorporeal membrane oxygenation is a 5-point ordinal score of thrombosis and bleeding severity adapted from the Common Terminology Criteria for Adverse Events version 5.0. The recommended primary endpoint for ventricular assist device is freedom from disabling stroke (Common Terminology Criteria for Adverse Events AE ≥ grade 3) through day 180. CONCLUSIONS: The proposed composite risk scores could impact the design of upcoming clinical trials and enable comparability of future investigations. Harmonizing and disseminating global consensus definitions and management guidelines can also reduce patient heterogeneity that would confound standardized primary outcomes in future research.
|
Authors | Jerrold H Levy, David Faraoni, Christopher S Almond, Lisa Baumann-Kreuziger, Melania M Bembea, Jean M Connors, Heidi J Dalton, Ryan Davies, Larry J Dumont, Massimo Griselli, Keyvan Karkouti, M Patricia Massicotte, Jun Teruya, Ravi R Thiagarajan, Philip C Spinella, Marie E Steiner |
Journal | The Annals of thoracic surgery
(Ann Thorac Surg)
Vol. 113
Issue 3
Pg. 1026-1035
(03 2022)
ISSN: 1552-6259 [Electronic] Netherlands |
PMID | 34826386
(Publication Type: Journal Article, Review)
|
Copyright | Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved. |
Chemical References |
|
Topics |
- Cardiac Surgical Procedures
- Child
- Extracorporeal Membrane Oxygenation
(adverse effects)
- Heart-Assist Devices
(adverse effects)
- Hemostasis
- Hemostatics
- Humans
- Treatment Outcome
|