Pulse Brain · Growing Health Evidence Index
Tier 4 — Narrative / commentaryPeer-reviewed

Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium

Robert L. Kormos, Christiaan F J Antonides, Daniel J. Goldstein, Jennifer Cowger, Randall C. Starling, James K. Kirklin, J. Eduardo Rame, David N. Rosenthal, Martha L. Mooney, Kadir Çalişkan, Steven R. Messé, Jeffrey J. Teuteberg, Paul Mohaçsi, Mark S. Slaughter, Evgenij Potapov, Vivek Rao, Heinrich Schima, Josef Stehlik, Susan Joseph, S. Koenig, Francis D. Pagani

The Journal of Heart and Lung Transplantation · 2020

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Summary

This consensus statement from the Mechanical Circulatory Support Academic Research Consortium presents updated, standardised definitions of adverse events for trials and registries of mechanical circulatory support devices. The work aims to harmonise reporting of safety outcomes across MCS research and clinical practice, facilitating comparison of device efficacy and safety profiles. As suggested by the authorship and journal scope, the consensus represents international clinical and regulatory expertise in device-based circulatory support.

Regional applicability

The standardised definitions will be applicable to UK-based MCS trials and clinical centres adopting these consensus definitions, improving consistency with international safety reporting standards and facilitating participation in multi-centre international studies.

Key measures

Standardised definitions of adverse events associated with MCS devices; classification schemes for adverse event severity and relatedness to device use

Outcomes reported

The study established consensus-based standardised definitions and classifications of adverse events specific to mechanical circulatory support (MCS) devices, intended for use in clinical trials and device registries.

Theme
Measurement & metrics
Subject
Measurement methods & nutrient profiling
Study type
Guideline
Study design
Consensus statement / Guideline development
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/j.healun.2020.03.010
Catalogue ID
SNmojg093f-4ggdya

Topic tags

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