Post-Market Analysis of the Xenios Console With the Xlung Tubing Kit 230 for Extracorporeal Membrane Oxygenation After Cardiac Surgery

Abstract

Objectives

The use of veno-arterial extracorporeal membrane oxygenation (V-A ECMO) has led to an increasing number of devices available on the market. Most studies pay less attention to which devices have been used; therefore, the information on performance for each device is limited. The current study is a comprehensive post-market analysis of all the major functions and adverse events rates of the Xenios console and XLung kit 230 preconfigured ECMO tubing set in post-cardiotomy applications.

Methods

This retrospective, single-center analysis, conducted between 2017 and 2021, included 47 adult patients who received V-A ECMO support using the Xenios system following cardiac surgery at our institution.

Results

The Xenios device was found to effectively improve and maintain microcirculation, organ perfusion, gas exchanges, organ function support, and stabilization of the cardiocirculatory system, while maintaining pump performance and stable body core temperature. Device-related adverse events occurred in 28% of patients but resolved in 81% of cases without leaving clinical sequelae. Fewer hemolysis events than reported in the literature were recorded. Every patient experienced at least two patient-related adverse events, but 43% had no relation to the device and 45% resolved without permanent damage.

Conclusions

The performance of the evaluated device was demonstrated in all key clinical areas, with an adequate safety profile.