Intraoperative Hemoadsorption (Cytosorb™) during Open Thoracoabdominal Aortic Repair: A Pilot Randomized Controlled Trial

Journal of Clinical Medicine, vol. 12, pp. 546

Abstract

Background: The efficacy of cytokine adsorption in controlling the early inflammation cascade after open thoracoabdominal aortic (TAAA) repair has not been investigated. The aim of this pilot randomized controlled trial was to assess the feasibility and effect of perioperative hemoadsorption during open TAAA repair. Methods: Patients scheduled for open TAAA repair with the use of cardiopulmonary bypass (CPB) were included. The patients were randomized the day before surgery to either intraoperative hemoadsorption during CPB or standard of care. Results: A total of 10 patients were randomly assigned to the intervention group, whereas the control group consisted of 17 patients (mean age of the total cohort, 51.1 ± 11.2 years, 67% male, 3 patients not randomized). The majority of baseline and perioperative characteristics were similar, and no device-related adverse events were reported. A trend to shorter ventilation times in the intervention group was observed (median 88 h vs. 510 h, p = 0.08, Δ422). Severe acute respiratory distress syndrome was significantly less in the intervention patients (p = 0.02). Conclusions: This is the first pilot study showing that the intraoperative use of hemoadsorption in open TAAA repair patients may be feasible and safe, yet larger trials are needed to evaluate whether intraoperative hemoadsorption is associated with improved clinical outcomes.

Authors 8

1. Panagiotis Doukas corresponding Aachen Department of Vascular Surgery

   RWTH Aachen University

   Affiliation as printed

   European Vascular Centre Aachen-Maastricht, Department of Vascular Surgery, RWTH Aachen, 52074 Aachen, Germany

2. Gabriel Hellfritsch Aachen Department of Vascular Surgery

   RWTH Aachen University

   Affiliation as printed

   European Vascular Centre Aachen-Maastricht, Department of Vascular Surgery, RWTH Aachen, 52074 Aachen, Germany

3. Daniel Wendt

   Essen University Hospital · CytoSorbents (United States) · West German Heart and Vascular Center Essen

   Affiliation as printed

   CytoSorbents Inc., Princeton, NJ 08540, USA

   Westgerman Heart & Vascular Center, University Hospital Essen, 45147 Essen, Germany

4. Mirko Magliani Aachen Department of Cardiothoracic Surgery

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiothoracic Surgery, RWTH Aachen, 52074 Aachen, Germany

5. Mohammad Esmaeil Barbati Aachen Department of Vascular Surgery

   RWTH Aachen University

   Affiliation as printed

   European Vascular Centre Aachen-Maastricht, Department of Vascular Surgery, RWTH Aachen, 52074 Aachen, Germany

6. Houman Jalaie Aachen Department of Vascular Surgery

   RWTH Aachen University

   Affiliation as printed

   European Vascular Centre Aachen-Maastricht, Department of Vascular Surgery, RWTH Aachen, 52074 Aachen, Germany

7. Michael Johan Jacobs Aachen Department of Vascular Surgery

   RWTH Aachen University

   Affiliation as printed

   European Vascular Centre Aachen-Maastricht, Department of Vascular Surgery, RWTH Aachen, 52074 Aachen, Germany

8. Alexander Gombert Aachen Department of Vascular Surgery

   RWTH Aachen University

   Affiliation as printed

   European Vascular Centre Aachen-Maastricht, Department of Vascular Surgery, RWTH Aachen, 52074 Aachen, Germany