Clinical Evaluation of the Eurosets Trilly Oxygenator During Cardiopulmonary Bypass in a Pediatric Population.

The equipment selected for cardiopulmonary bypass (CPB) in pediatric cardiac surgery critically influences the safety, efficiency, efficacy and pathophysiological impact in perioperative use and the post-operative outcome. In this report, we present a single-center retrospective analysis of the clinical efficacy, efficiency and safety of the Trilly oxygenator (Eurosets Srl, Medolla, MO, Italy), which has an integrated arterial filter. It has a blood flow capacity of 500 to 3500ml/min, an AAMI index of 4.000ml / min, and a static fill prime (oxygenating module + heat exchanger) of 130 ml. We used this device on 42 pediatric patients who underwent repair of various congenital heart defects with cardiopulmonary bypass. Pre- and intraoperative patient data were collected for the evaluation of gas transfer and metabolic parameters in relation to blood flow, temperature and hematologic profiles. The mean age of the patients was 8.07 ± 2.9 years. Eight patients had cyanotic heart disease, 7 had chromosomal abnormalities and 9 had previously undergone cardiac surgery. The STAT Mortality Category Score was distributed as follows: Cat. 1 (37.5%), Cat. 2 (35%), Cat. 3 (5%), Cat. 4 (22.5%), Cat. 5 (0%). The mean bodyweight was 29.03 ± 8.25 kg and the blood flow rate was 2664.88 ± 508.43 ml / min. The mean cardiopulmonary bypass time was 95±51.4 min and the cross-clamp time was 37±34.6 min. The mean gas transfer values were as follows: partial pressure of oxygen, post oxygenator, 224.7±28 mmHg; partial pressure of carbon dioxide, post oxygenator, 42±4 mmHg; oxygen delivery 356.9± 88.8 ml/min/m2; carbon dioxide transfer, 52.81± 1.98 mmHg, mixed venous saturation 77.78 %; and mean hematocrit value 29.0±4 %. The Trilly oxygenator was effective in terms of oxygen uptake, carbon dioxide removal, and heat exchange in a pediatric population undergoing cardiopulmonary bypass. This retrospective analysis showed that the Trilly is both safe and effective in clinical practice without iatrogenic problems.