Type II Minimal-Invasive Extracorporeal Circuit for Aortic Valve Replacement: A Randomized Controlled Trial.

Extracorporeal circulation triggers systemic inflammatory response and coagulation disorders which may lead to unfavorable clinical outcome. A type II minimally-invasive extracorporeal circuit (MiECC) is a closed system with markedly reduced artificial surface as compared to conventional extracorporeal circuits (CECC). The aim of this study was to investigate and compare inflammatory responses, complement activation and selected clinical end-points in isolated surgical aortic valve replacement (SAVR) performed with a type II MiECC circuit or a CECC. Fifty patients were prospectively randomized to MiECC or CECC perfusion regimen. Complement activation (sC5b-9), inflammation (IL-6, TNF-α, sCD40-ligand) and activation of the coagulation system (D-dimer, TAT-complex) were determined before operation, at 2 hours and 24 hours after surgery. Clinical end-points included perfusion time, transfusion of allogeneic blood products, postoperative bleeding, sepsis, new onset of atrial fibrillation, stroke and in-hospital mortality. Patient characteristics and baseline plasma markers were similar in both groups. Levels for sC5b-9, TNF-α, sCD40 ligand, TAT-complex and D-dimers were not significantly different between MiECC and CECC at 2 hours and 24 hours after surgery. The IL-6 plasma concentration was lower in the CECC group at 24 hours (P = 0.026, vs. MiECC). Comparisons of the baseline level to values at 2 hours and 24 hours, adjusted for the type of oxygenator and hemoglobin, showed a significantly lower sC5b-9 in MiECC at 2 hours (P = 0.013), but no difference at 24 hours (P=0.990). Compared with CECC, MiECC patients had a shorter perfusion time (P = 0.037) and less transfusion requirements (P = 0.04). In this selected cohort of SAVR patients, the type II MiECC was not inferior to CECC in terms of inflammatory response and complement activation. Thus, MiECC might be an alternative perfusion strategy to conventional.