Department of Cardiovascular Surgery, Ankara City Hospital, University of Health Sciences, Ankara, Turkey.
Department of Radiology, Ankara City Hospital, University of Health Sciences, Ankara, Turkey.
Perfusion. 2023 Jan;38(1):44-50. doi: 10.1177/02676591211033945. Epub 2021 Jul 24.
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).
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).
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). SpO 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.
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.
本研究旨在评估新型双向导管在体外循环（CPB）股动脉插管患者中的安全性和有效性，与传统导管相比，该导管能确保稳定的远端灌注。
在为期 1 年的时间内，前瞻性随机选择 64 例行外周插管手术的患者，分别接受 19F 双向（Biflow™，LivaNova，意大利）或 19F 传统（HLS 外周插管，Getinge Group™，德国）导管和 6F 下游导管（Bicakcilar™，土耳其）进行股动脉插管。主要结局包括有效性（通过多普勒超声测量导管内顺行/逆行比较流量），次要结局为安全性（早期/晚期并发症和不良事件）。
多普勒超声测量的插管后远端/近端流量百分比（%）在研究组（33.1 ± 5ml/min）显著优于下游导管（16.1 ± 4，p = 0.012）。近红外光谱（NIRS）测量的 SpO2也显示在双向导管组，插管腿的远端小腿的饱和度明显更好（67.5% ± 10% vs 52.5 ± 8，p = 0.04）。双向导管组发生的严重不良事件包括股部区域的血清肿（1 例）、浅表伤口感染（1 例）、假性血肿（2 例），而传统导管组的不良事件包括住院期间股动脉栓塞/动脉修复（2 例）、浅表伤口感染（3 例）、插管部位血肿（3 例）。
本研究表明，在心脏手术中进行 CPB 股动脉插管的患者中，使用新型双向导管是安全、易于插入的，并且可以为插管肢体提供稳定的远端灌注。
