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.
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