Second Report of the GUARDIAN Registry: An International Consortium Examining the Effect of Controlled Hypothermic Preservation in Heart Transplantation

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 second annual report of the multi-center study comparing two methodologies of hypothermic storage: patients with donor hearts preserved by advanced organ preservation [Paragonix SherpaPak Cardiac Transport System], and patients with donor hearts transported by conventional preservation methods (ice protocol). This analysis will be based on a data freeze of the registry in January 2022, which is projected to include data on over 1,000 heart transplant outcomes from 14 international centers. This will be the largest dataset on organ preservation technologies to be presented to date. 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, Primary Graft Dysfunction, and length-of-stay data. Previous reports from this database have demonstrated statistically significant reductions in ICU length of stay despite longer ischemic times.