Background: 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. Methods: 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. Results: 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. Conclusions: 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.
背景：日常临床实践中，为进行化疗、抗生素治疗、抗病毒治疗、肠外营养或输血，常需反复且长期建立静脉通路。本研究旨在通过标准化的专业外科技术及局部麻醉下的患者管理，探讨完全植入式静脉输液港（TIVADs）在5年随访期内的性能与安全性。方法：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。安全性终点重点关注围手术期、短期及长期并发症发生率。性能终点包括输液港置入时的静脉识别情况及操作成功率。结果：研究显示，未发生与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，即导管翻转，导致置入后56天进行导管调整。此外，观察到1例（1.4%）因使用条件导致的感染，致使术后3年4个月取出TIVAD。导管置入部位包括头静脉（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，植入式输液港平均留置时间为22.4个月。结论：本研究证实了TIVADs的性能与安全性，其并发症发生率低于已发表数据，凸显了通过标准化专业外科技术及患者管理，其在改善常规临床实践中的潜力与重要意义。
肿瘤(癌症)患者之家