Funding for this research was provided by:
Edwards Lifesciences (VUMC42951)
Received: 30 April 2020
Accepted: 29 October 2020
First Online: 23 November 2020
Ethics approval and consent to participate
: This study was approved by the Institutional Review Board (IRB) (protocol #140558) at our institution (Vanderbilt University Medical Center, Nashville, TN, USA), with waiver of requirement for written informed patient consent, as all care components were standard of care. All included patients received the standard of care at the time of their surgical intervention.
: Not applicable. The study does not contain identifiable details or images from any individual person.
: MDM receives Research funding from Edwards Lifesciences for this project and funding for unrelated research projects from Cheetah Medical and GE Foundation. JPW, YS, KSR, TMG, and MSS have no competing interests to declare. ADS is a consultant for Edwards Lifesciences. ATH and BJM have no competing interests to declare. MGM is University Chair, sponsored by Smiths; director, UCL Discovery Lab; consultant for Edwards Lifesciences; shareholder and scientific advisor, Medical Defense Technologies LLC.; shareholder and director, Clinical Hydration Solutions ltd (patent holder “QUENCH”). WSS is consultant for Edwards Lifesciences.