title: Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of General Surgery, European Institute of Oncology, Milano, Italy. rbiffi@ico.cilea.it
authors.forename: R
authors.initials: R
authors.lastname: Biffi
authors.forename: F
authors.initials: F
authors.lastname: de Braud
authors.forename: F
authors.initials: F
authors.lastname: Orsi
authors.forename: S
authors.initials: S
authors.lastname: Pozzi
authors.forename: S
authors.initials: S
authors.lastname: Mauri
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: F
authors.initials: F
authors.lastname: Nolè
authors.forename: B
authors.initials: B
authors.lastname: Andreoni
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002408:Catheters, Indwelling / Q000009:adverse effects / Q000191:economics; D005260:Female; D006801:Humans; D015918:Infusion Pumps, Implantable / Q000009:adverse effects / Q000191:economics; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000970:Antineoplastic Agents