Abstract
BackgroundThe high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure.Methods and DesignThis investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2–12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5).Ethics and DisseminationThe study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals.Trial RegistrationThe trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020.
Highlights
The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels, which prolongs the cardiopulmonary bypass time and total operation time and increases blood product use, inducing postoperative complications [4, 5]
The present study aims to evaluate the effects of BAX602 in preventing adhesions around the epicardium and the great vessels in patients undergoing extracorporeal ventricular assist device (VAD) implantation for refractory congestive heart failure
The adhesion prevention effects of BAX602 are similar to these products; BAX602 differs from other products in the following aspects
Summary
The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels, which prolongs the cardiopulmonary bypass time and total operation time and increases blood product use, inducing postoperative complications [4, 5]. The degree of intrapericardial and mediastinal adhesion influences the clinical outcome of redo surgery in patients with an implanted ventricular assist device (VAD) [6] This increased degree of adhesion after VAD implantation occurs because adhesion is more severe around prosthetic material than native tissue, and Cardiovasc Drugs Ther (2020) 34:651–657 the coagulopathic state associated with the VAD exacerbates bleeding during the adhesiolysis, deteriorating the hemodynamic state. It is suggested that inhibition of the recruitment, settlement, and activation of macrophages to the surgically exposed area for at least 7 days may substantially contribute to the prevention of adhesion tissue formation
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