Abstract
Purpose To assess the therapeutic effect of advanced organ preservation technology compared to conventional methods on heart transplant recipient perioperative and short-term clinical outcomes. Methods The Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN) study is an international multi-center retrospective-prospective registry assessing clinical outcomes after heart transplantation. This is the first publication of a multi-center study comparing two methodologies of hypothermic storage: patients with donor hearts preserved by the only FDA cleared and CE marked heart preservation and transportation system [Paragonix SherpaPak Cardiac Transport System], and patients with donor hearts transported by conventional preservation methods (ice protocol). Data on baseline donor, recipient, and procedure characteristics are captured to compare baseline characteristics of the two cohorts. Endpoints Comparisons will be made on peri-operative and short-term patient outcomes including hemodynamic characteristics, required surgical and medical interventions, and length-of-stay data.
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