Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nolè F, Andreoni B
Division of General Surgery, European Institute of Oncology, Milano, Italy.
Ann Oncol. 1998 Jul;9(7):767-73. doi: 10.1023/a:1008392423469.
A few data are available from analyses of the complications and costs of central venous access ports for chemotherapy. This prospective study deals with the complications and global costs of central venous ports connected to a Groshong catheter for deliverance of long-term chemotherapy.
Patients with a variety of solid neoplastic diseases requiring chemotherapy who were undergoing placement of implantable ports over a 30-month period (1 October 1994 to 31 March 1997) have been prospectively studied. Follow-up continued until the device was removed or the study was closed (30 September 1997); patients with uneventful implant experience and subsequent follow-ups of less than 180 days were not considered for this study. A single port, constructed of titanium and silicone rubber (Dome Port, Bard Inc., Salt Lake City, USA), was used, connected to an 8 F silastic Groshong catheter tubing (Bard Inc., Salt Lake City, USA). Two-hundred ninety-six devices were placed in the operating room under fluoroscopic control even in the patients treated and monitored in a day-hospital setting: 37 of them were in an angiographic suite. A central venous access form was filled in by the operator after the procedure and all ports were followed prospectively for device-related and overall complications. The average purchase cost of the device was obtained from the hospital charges, based on the costs applied during the 30-month period of the study. Insertion and maintenance costs were estimated by obtaining the charges for an average TIAP implant and its subsequent use; the costs of complication management were assessed analytically. The total cost of each device was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications, if any. The cost of removing the TIAP was also included in the economic analysis when required by the treatment of the complication.
Three hundred thirty-three devices, for a total of 79,178 days in situ, were placed in 328 patients. Five patients received second devices after removal of the first. In all cases the follow-up was appropriate (median 237 days, range 180-732). Early complications included 10 pneumothoraxes (3.4%; six tube-thoracostomies were applied, 1.8%) and six revisions for port and/or catheter malfunction (overall early complications = 16, 4.48%). Late complications comprised five instances of catheter rupture and embolization (1.5%, 0.063 episodes/1000 days of use), five of venous thrombosis (1.5%, 0.063 episodes/1000 days of use), one of pocket infection (0.3%, 0.012 episodes/1000 days of use), and eight of port-related bacteremia (2.4%, 0.101 episodes/1000 days of use). The infections were caused by coagulase-negative Staphylococcus aureus (five cases), Bacillus subtilis (one case), Streptococcus lactaceae (one case) and an unknown agent (one case); port removal was necessary in six of eight cases. The total cost per patient treated for a six-month period, consisting of the costs of purchase and implantation, treatment of early and late complications, and of maintenance of the device, is US$1,970.
This study represents the largest published series of patients with totally implantable access ports connected to a Groshong catheter. We have shown that US$2,000 are sufficient to cover six months of chemotherapy in one patient using the most expensive commercially available implantable port. According to the present study, totally implantable access ports connected to a Groshong catheter are associated with high purchase and insertion costs, a low complication rate and low maintenance costs. These data support their increasing use in current oncologic medical practice.
关于化疗用中心静脉通路端口的并发症及成本分析,现有数据较少。本前瞻性研究探讨了连接Groshong导管用于长期化疗的中心静脉端口的并发症及总体成本。
对在30个月期间(1994年10月1日至1997年3月31日)接受可植入端口置入术的各种实体肿瘤疾病且需要化疗的患者进行了前瞻性研究。随访持续至装置移除或研究结束(1997年9月30日);植入过程顺利且后续随访少于180天的患者未纳入本研究。使用了一个由钛和硅橡胶制成的单端口(Dome Port,美国盐湖城巴德公司),连接至一根8F硅橡胶Groshong导管(美国盐湖城巴德公司)。即使在日间医院环境中接受治疗和监测的患者,296个装置也是在荧光镜控制下于手术室置入的:其中37个在血管造影室置入。术后操作人员填写一份中心静脉通路表格,并对所有端口进行前瞻性随访,记录与装置相关的及总体并发症。装置的平均购置成本根据研究30个月期间适用的费用从医院收费中获取。通过获取平均隧道式中心静脉导管植入及其后续使用的费用来估算置入和维护成本;并发症管理成本进行分析评估。每个装置的总成本定义为购置成本加上置入成本加上维护成本加上并发症治疗成本(如有)。当并发症治疗需要时,移除隧道式中心静脉导管的成本也包含在经济分析中。
328例患者共置入333个装置,原位放置总时长79,178天。5例患者在移除首个装置后接受了第二个装置。所有病例的随访均充分(中位随访237天,范围180 - 732天)。早期并发症包括10例气胸(3.4%;6例进行了胸腔闭式引流,1.8%)以及6例因端口和/或导管故障进行的修复(早期总体并发症 = 16例,4.48%)。晚期并发症包括5例导管破裂和栓塞(1.5%,0.063次/1000天使用时间)、5例静脉血栓形成(1.5%,0.063次/1000天使用时间)、1例囊袋感染(0.3%,0.012次/1000天使用时间)以及8例与端口相关的菌血症(2.4%,0.101次/1000天使用时间)。感染由凝固酶阴性金黄色葡萄球菌(5例)、枯草芽孢杆菌(1例)、乳酸链球菌(1例)及一种未知病原体(1例)引起;8例中有6例需要移除端口。每位患者六个月治疗期的总成本,包括购置和植入成本、早期和晚期并发症治疗成本以及装置维护成本,为1970美元。
本研究是已发表的连接Groshong导管的完全可植入式通路端口患者系列中规模最大的。我们已表明,使用市面上最昂贵的可植入端口,2000美元足以支付一名患者六个月的化疗费用。根据本研究,连接Groshong导管的完全可植入式通路端口购置和置入成本高、并发症发生率低且维护成本低。这些数据支持其在当前肿瘤医学实践中使用的增加。