Biocompatibility of a new synthetic oxyganator coating (SOFTLINE COATING): A multicenter clinical evaluation

Purpose: To compare the hemocompatibility of a novel synthetic surface coating (Glycerol-polyethylenglycol-rizinoleate, SOFTLINE COATING, Maquet Cardiopulmonary) with standard protein coating (SAFELINE COATING) on membrane oxygenators (MO) used for cardiopulmonary bypass (CPB) in adult cardiac surgery.

Methods: 80 patients scheduled for adult cardiac procedures with open CPB were randomized (40 vs. 40) to either SOFTLINE COATING or conventional SAFELINE COATING on their MO (QUADROX, Maquet Cardiopulmonary). The remaining CPB components were left uncoated. Patients were operated on according to the centers preference with the exception of using only blood cardioplegia. A set of standard laboratory parameters (CRP, Leukocytes, Platelets, Urea, Creatinin, Bilirubin, GPT, LDH, CK, CK-MB) was measured at timepoints 0, 1, 6, 12, and 24 hours postoperatively. In addition, the trans-MO pressure gradient was monitored on-line during the entire perfusion period while CPB flow was set at 2.3 L/min/m².

Results: Demographic and hemodynamic data were comparable between the groups. The time course of the laboratory values revealed no significant differences between the two coatings. Over time (up to 100min) during perfusion the trans-MO pressure gradient was stable in both groups with no tendency to rise in the later phase. There was a trend towards less pressure gradient in the SOFTLINE group.

Conclusion: SOFTLINE COATING can safely be used as an oxygenator coating for adult cardiac surgery. It is as effective as the conventional protein coating in terms of hemocompatibility. It appeared that SOFTLINE COATING might be advantageous with respect to the lower pressure drop over the membrane oxygenator.