[Role of totally implantable systems for long-term vascular access in the treatment of the neoplastic patient].

OBJECTIVE

To assess retrospectively the effectiveness, the safety and the impact on the quality of life of the Subcutaneous Infusion Ports (SIPs) for prolonged venous access in the treatment of neoplastic patients.

DESIGN

Retrospective analysis of a case series collected-during 30 months (April 1991-September 1993).

SETTING

General Surgery Division and Radiochemotherapy Service.

PARTICIPANTS

35 patients (23 male, 12 female), aged between 27-80 years, received 37 SIPs. 2 patients received 2 SIPs. 34 patients were affected by neoplasm; 1 patient had short gut syndrome secondary to massive small bowel resection.

INTERVENTIONS

The SIP was implanted in all patients in the operating room with the Seldinger technique ("catheter over wire"). The suclavian vein, through an infraclavicular approach, was the only site of venous access. One SIP was implanted in the hepatic artery. All neoplastic patients received chemotherapy. The patient with short gut syndrome had parenteral nutrition. An external infusion device (CADD-1, CADD-plus, Pharmacia) was used in 13 patients for the continuous infusion of either 5-Fluoro-Uracil (1000 mg/m2/die for 5 days, every 28 days) or 5-Fluoro-Deoxy-Uridine (0.15-0.30 mg/kg/die for 14 days, every 28 days). SIP management required the port "flush" with normal saline solution with heparin (100 U/ml) at least every 40 days, using Huber needle. All patients were treated as outpatients.

MAIN OUTCOME MEASURES

All intraoperative and long-term complications, recorded in the charts of the patients, were reviewed. The rate of intraoperative complications was assessed over 37 procedures. Long-term complications were assessed over 28 patients (7 patients were excluded for lack of follow up data). Incidence of complications was analyzed over patient days, considering the cumulative permanence time of the SIP in a single patient.

RESULTS

We recorded 4 intraoperative complications (10.8%). None of them required to stop the procedure and to delay the implant of the SIP. During the follow-up period (range 1-18 months) we had 1 major complication (pleural effusion secondary to TPN extravasation), that is 3.5% of the patients (1/8255 patient days), and 3 minor complications (10.7% of the patients; 1/2751.6 patient days). Patient tolerance was good in all cases.

CONCLUSIONS

SIP is a safe and effective device for prolonged venous access. We stress the need of a wider use of this type of device for the management of neoplastic patients.