Abstract Background The PrismaLung+ (PL + ) blood gas exchanger features a polymethylpentene hollow-fiber membrane enhanced with an antithrombogenic phosphorylcholine coating, enabling extracorporeal carbon dioxide removal (ECCO2R) at blood flow rates of 200-450 mL/min. Due to past challenges with hemolysis and thrombosis observed in both laboratory studies and clinical trials with other gas exchangers for ECCO2R, we conducted a comprehensive safety evaluation of the PL+ device in a sheep model, with particular focus on hemolysis and thrombogenicity. Methods Six adult female Swifter sheep were included in the study, which was conducted under Good Laboratory Practice GLP conditions. Following anesthesia and intravenous anticoagulation, a double-lumen cannula (18 Fr) was surgically implanted in the right jugular vein. The tubing was then tunneled to the back of the animal to prevent kinking, which can occur with excessive movement. ECCO2R was initiated, using PL + coupled to a PRISMAX console, with an average blood flow rate of 444 ± 24 mL/min and a sweep gas flow rate of 0.4 ± 0.1 L/min. Hemolysis, thrombogenicity, mechanical failure, gas exchange, and gas embolism were investigated. Histopathological examinations were performed on specimens from the lungs, liver, heart, kidneys, and spleen. Results The six sheep recovered without complications and remained alert throughout the 4.5-day study.DS1 As expected, a slight decrease in hematocrit from 29.7 ± 3.9 % to 22.3 ± 2.3 % was observed. A transient reduction in platelet count from 300 ± 48 109/L to 195 ± 45 109/L occurred on Day 1, but values normalized by the study’s conclusion (306 ± 65 109/L). D-dimer levels remained within baseline ranges throughout the experiment. No hemolysis was observed, with plasma-free hemoglobin (pfHb) consistently below the detection limit (27.3 mg/L). No mechanical failure was observed during this 4.5-day study. In one sheep, small intra-arterial clots were found in the left distal pulmonary artery, but microscopic examination revealed no concurrent lung damage. These clots were determined to have occurred post-mortem and were unrelated to the device, as confirmed by the absence of fibrin and the lack of clinical symptoms. Conclusion These findings demonstrate that ECCO2R with PL + is well-tolerated in a sheep model, with minimal hemolysis, negligible thrombogenicity, and no mechanical failures over 4.5 days, supporting its safety profile for clinical evaluation. This abstract is funded by: VANTIVE
Goldstein et al. (Fri,) studied this question.