Comparative clinical efficacy of novel bidirectional cannula in cardiac surgery via peripheral cannulation for cardiopulmonary bypass

Abstract

Objectives: The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula that ensures stable distal perfusion compared to conventional cannula in patients undergoing femoral arterial cannulation for cardiopulmonary bypass (CPB). Methods: During a 1-year period, 64 patients undergoing surgery via peripheral cannulation were prospectively randomized to receive 19 F bidirectional (Biflow™, LivaNova, Italy) or 19 F conventional (HLS Peripheral cannula, Getinge Group™, Germany) cannula with 6 F downstream line (Bicakcilar™, Turkey) for femoral artery cannulation. The primary outcome included the efficacy (adequacy of antegrade/retrograde comparative flow via cannula measured by doppler ultrasonography) and the secondary outcome was the safety (early/late complications and adverse events). Results: Percent flow (distal/proximal) after cannulation measured by doppler ultrasonography was significantly better in study group (33.1 ± 5 ml/min) versus downstream cannula (16.1 ± 4, p = 0.012). SpO2 measured by near infrared spectroscopy (NIRS) also demonstrated significantly better saturation in distal calf of the cannulated leg in bidirectional cannula group (67.5% ± 10% vs 52.5 ± 8, p = 0.04). The incidence of serious adverse events was seroma on femoral region (one patient), superficial wound infection (one patient), pseudo-hematoma (two patients) in bidirectional cannula group and in-hospital femoral embolectomy/artery repair (two patients), superficial wound infection (three patients), cannulation site hematoma (three patients) in conventional cannula group. Conclusions: This study demonstrates that in patients undergoing femoral arterial cannulation for CPB during cardiac surgery, the use of a novel bidirectional cannula is safe and easy to insert and provides stable distal perfusion of the cannulated limb.