Iguchi Toshihiro, Kawabata Takahiro, Matsui Yusuke, Tomita Koji, Uka Mayu, Umakoshi Noriyuki, Okamoto Soichiro, Munetomo Kazuaki, Hiraki Takao
Department of Radiology, Okayama University Hospital, 2-5-1 Shikata-Cho Kita-Ku, Okayama, 700-8558, Japan.
Department of Radiological Technology, Faculty of Health Sciences, Okayama University, 2-5-1 Shikata-Cho Kita-Ku, Okayama, 700-8558, Japan.
Jpn J Radiol. 2025 Feb;43(2):282-289. doi: 10.1007/s11604-024-01658-5. Epub 2024 Sep 17.
This study retrospectively evaluated the feasibility and safety of implanting a newly developed central venous access port (CV-port) that allows catheter insertion into a vein without the use of a peel-away sheath, with a focus on its potential to minimize risks associated with conventional implantation methods.
All procedures were performed using a new device (P-U CelSite Port™ MS; Toray Medical, Tokyo, Japan) under ultrasound guidance. The primary endpoint was the implantation success rate. The secondary endpoints were the safety and risk factors for infection in the early postprocedural period (< 30 days).
We assessed 523 CV-port implantations performed in a cumulative total of 523 patients (240 men and 283 women; mean age, 61.6 ± 13.1 years; range, 18-85 years). All implantations were successfully performed using an inner guide tube and over-the-wire technique through 522 internal jugular veins and one subclavian vein. The mean procedural time was 33.2 ± 10.9 min (range 15-112 min). Air embolism, rupture/perforation of the superior vena cava, or hemothorax did not occur during catheter insertion. Eleven (2.1%) intraprocedural complications occurred, including Grade I arrhythmia (n = 8) and subcutaneous bleeding (n = 1), Grade II arrhythmia (n = 1), and Grade IIIa pneumothorax (n = 1). Furthermore, 496 patients were followed up for ≥ 30 days. Six early postprocedural complications were encountered (1.1%), including Grade IIIa infection (n = 4), catheter occlusion (n = 1), and skin necrosis due to subcutaneous leakage of trabectedin (n = 1). These six CV-ports were withdrawn, and no significant risk factors for infection in the early postprocedural period were identified.
The implantation of this CV-port device demonstrated comparable success and complication rates to conventional devices, with the added potential benefit of eliminating complications associated with the use of a peel-away sheath.
本研究回顾性评估了一种新开发的中心静脉通路端口（CV端口）植入的可行性和安全性，该端口允许在不使用剥脱鞘的情况下将导管插入静脉，重点关注其将与传统植入方法相关的风险降至最低的潜力。
所有操作均在超声引导下使用一种新设备（P-U CelSite Port™ MS；日本东京东丽医疗株式会社）进行。主要终点是植入成功率。次要终点是术后早期（<30天）的安全性和感染风险因素。
我们评估了总共523例患者（240例男性和283例女性；平均年龄61.6±13.1岁；范围18 - 85岁）进行的523次CV端口植入。所有植入均通过522条颈内静脉和1条锁骨下静脉，使用内导管和导丝技术成功完成。平均操作时间为33.2±10.9分钟（范围15 - 112分钟）。在导管插入过程中未发生空气栓塞、上腔静脉破裂/穿孔或血胸。发生了11例（2.1%）术中并发症，包括I级心律失常（n = 8）和皮下出血（n = 1）、II级心律失常（n = 1）以及IIIa级气胸（n = 1）。此外，496例患者进行了≥30天的随访。术后早期出现了6例并发症（1.1%），包括IIIa级感染（n = 4）、导管堵塞（n = 1）以及曲贝替定皮下渗漏导致的皮肤坏死（n = 1）。这6个CV端口被取出，未发现术后早期感染的显著风险因素。
该CV端口装置的植入显示出与传统装置相当的成功率和并发症发生率，并且具有消除与使用剥脱鞘相关并发症的潜在额外益处。
