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.

中文翻译：

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新型双向插管在体外循环外周插管心脏手术中的临床疗效比较

目标：

本研究的目的是评估新型双向插管的安全性和有效性，与传统插管相比，这种双向插管在接受股动脉插管进行体外循环 (CPB) 的患者中确保稳定的远端灌注。

方法：

在 1 年期间，64 名接受外周插管手术的患者被前瞻性随机分配接受 19 F 双向（Biflow™，意大利 LivaNova）或 19 F 常规（HLS 外周插管，Getinge Group™，德国）下游插管 6 F用于股动脉插管的线（Bicakcilar™，土耳其）。主要结果包括疗效（通过多普勒超声测量的插管顺行/逆行比较流量的充分性），次要结果是安全性（早期/晚期并发症和不良事件）。

结果：

研究组 (33.1 ± 5 ml/min) 与下游插管 (16.1 ± 4, p = 0.012) 相比，通过多普勒超声测量插管后的百分比流量（远端/近端）明显更好。通过近红外光谱 (NIRS) 测量的SpO ₂还表明，双向插管组插管腿远端小腿的饱和度明显更好（67.5% ± 10% 对比 52.5 ± 8，p = 0.04）。严重不良事件的发生率是股骨区域血清肿（1 例患者）、浅表伤口感染（1 例患者）、双向插管组假性血肿（2 例患者）和院内股骨取栓/动脉修复（2 例患者），浅表常规插管组伤口感染（3例）、插管部位血肿（3例）。

结论：

这项研究表明，在心脏手术期间接受股动脉插管进行 CPB 的患者中，使用新型双向插管安全且易于插入，并为插管肢体提供稳定的远端灌注。