Abou-Mrad Adel, Marano Luigi, Oviedo Rodolfo J
Centre Hospitalier Universitaire d'Orléans, 45100 Orléans, France.
Department of Medicine, Academy of Applied Medical and Social Sciences-AMiSNS: Akademia Medycznych I Spolecznych Nauk Stosowanych, 82-300 Elbląg, Poland.
Cancers (Basel). 2024 Aug 9;16(16):2802. doi: 10.3390/cancers16162802.
Daily clinical practice requires repeated and prolonged venous access for delivering chemotherapy, antibiotics, antivirals, parenteral nutrition, or blood transfusions. This study aimed to investigate the performance and the safety of totally implantable vascular access devices (TIVADs) over a 5-year follow-up period through a standardized well-trained surgical technique and patient management under local anesthesia.
In a retrospective, observational, and monocentric study, 70 patients receiving POLYSITE TIVADs for chemotherapy were included. The safety endpoints focused on the rate of perioperative, short-term, and long-term complications. The performance endpoints included vein identification for device insertion and procedural success rate.
The study demonstrated no perioperative or short-term complications related to the TIVADs. One (1.4%) complication related to device manipulation was identified as catheter flipping, which led to catheter adjustment 56 days post-placement. Moreover, one (1.4%) infection due to usage conditions was observed, leading to TIVAD removal 3 years and 4 months post-surgery. Catheter placement occurred in cephalic veins (71.4%), subclavian veins (20%), and internal jugular veins (8.6%). The procedural success rate was 100%. Overall, the implantable ports typically remained in place for an average of 22.4 months.
This study confirmed the TIVADs' performance and safety, underscored by low complication rates compared to published data, thereby emphasizing its potential and compelling significance for enhancing routine clinical practice using a standardized well-trained surgical technique and patient management.
日常临床实践中,为进行化疗、输注抗生素、抗病毒药物、肠外营养或输血,需要反复且长时间的静脉通路。本研究旨在通过标准化的、训练有素的外科技术及局部麻醉下的患者管理,对完全植入式血管通路装置(TIVADs)进行为期5年的随访,以调查其性能和安全性。
在一项回顾性、观察性单中心研究中,纳入了70例接受POLYSITE TIVADs进行化疗的患者。安全性终点集中在围手术期、短期和长期并发症的发生率。性能终点包括装置插入时的静脉识别和操作成功率。
该研究表明,未出现与TIVADs相关的围手术期或短期并发症。发现1例(1.4%)与装置操作相关的并发症为导管翻转,导致在放置后56天进行导管调整。此外,观察到1例(1.4%)因使用情况导致的感染,导致在手术后3年4个月移除TIVADs。导管放置于头静脉(71.4%)、锁骨下静脉(20%)和颈内静脉(8.6%)。操作成功率为100%。总体而言,植入式端口通常平均保留22.4个月。
本研究证实了TIVADs的性能和安全性,与已发表数据相比并发症发生率较低,从而强调了其在采用标准化的、训练有素的外科技术及患者管理来改善常规临床实践方面的潜力和重要意义。