Prospective, Randomized Un-Blinded Three Arm Controlled Study in Coronary Artery Revascularization with Minimal Invasive Extracorporeal Circulation Systems (MiECC): Surrogate Parameter Analysis of Biocompatibility

Abstract

Objectives: Minimal extracorporeal circulation techniques and systems (MiECC) may reduce the negative side effects of conventional extracorporeal circulation (ECC). However, it is still unclear as to what this is caused by, the reduced priming volume and hemodilution, or the avoidance of blood-air contact and dispersion of mediastinal debris into the systemic circulation. The aim of the trial was the comparison of MiECC to an open ECC setup (openECC) or a system with reduced blood air and debris interaction (closeECC). Methods: In a prospective randomized trial, 72 patients (73 ± 5.3 years; 83% male) referred for coronary artery bypass graft (CABG) were randomly assigned either to MiECC (priming volume 550mL), closeECC, or openECC (priming volume 1250mL). The laboratory surrogate endpoints (renal function, inflammatory response, ischemia, coagulation, and hemolysis) and clinical data were measured at six different time points (T1-6). Results: Patients were comparable for all preoperative variables. The operation times (MiECC 261 ± 79min; openECC 264 ± 75min; closeECC 231 ± 68min) and perfusion times (MiECC 115 ± 49min; openECC353 107 ± 37min; closeECC 99 ± 22min) revealed a trend of faster performance in the closeECC group (P < .05). Pro-inflammatory cytokines, ischemia, and coagulation markers were significantly elevated postoperatively in all cardiopulmonary bypass types, and decreased to pre-baseline levels at discharge (T5) without identifiable statistical differences between the three study groups. Free-hemoglobin was not significantly increased by centrifugal pump or cell saver procedures. Significant intraoperative hemodilution effects due to the different priming volumes were demonstrated only at the end of operation (T2) (MiECC Hb 9.6 ± 1.1g/dL; openECC Hb 9.0 ± 0.8g/dL; closeECC Hb 8.7 ± 1g/dL; P =. 01).Conclusion: Neither the hemodilution, suction technique (MiECC), nor blood-air interface (closeECC) could show sustainable benefits in this underpowered study, compared to conventional ECC systems (openECC) in a high volume series of surrogate parameters.