Valved Central Venous Catheter Connected to Subcutaneous Port: A Multicenter Phase IV Study Based on a Cohort of 50 Oncology Patients

Abstract

Purpose

Since technical aspects and clinical features of central venous valved catheters are far from being completely understood, a multinational group of investigators has decided to assess a new distally-valved catheter connected to a port, in the clinical setting of oncology patients undergoing chemotherapy, in an attempt to verify its safety and viability, while also investigating its practical features.

Methods

Our project was structured as a phase IV multicenter study. Hospitalized adults (ages 18–80 years) who had solid tumors and were candidate for intravenous chemotherapy met the criteria to enter the study. One single type of port was used (made of titanium, plastic and silicone) connected to a silicone, distally valved catheter (as manufactured by B. Braun Aesculap). A case report form was provided for each treated case; all relevant data regarding implantation and follow-up were entered into the form, mailed to a coordinating center (G. Chevillon, B. Braun Medical, France) and stored in a software database for statistical analysis.

Results

50 patients (from 6 participating centers) were included in this study. No major complications occurred at insertion. The most frequent clinical problem during follow-up was inability to draw blood samples (9% during the first chemotherapy cycle; 8% after the second cycle); blood obtained from the device was defined “unsuitable for hematology test” in 9% of the cases at first chemotherapy cycle and in 23% of the cases after the second cycle. No catheter obstruction occurred.

Conclusion

The distally valved catheter port tested in this study was reliable, safe and practical for long-term treatment of an oncology patients’ population undergoing chemotherapy. As most other reports and clinical trials dealing with other types of distally valved catheters pointed out, inability to draw viable blood samples (so called withdrawal occlusion) is a major concern in their clinical use. Mechanisms underlying this technical problem are still unclear.

Keywords

Central venous catheters Ports Valved intravenous catheters Chemotherapy

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References

Malviya

V.K.

, Gunter

, Gove

, Malone

Jr. . Vascular access in gynecologic cancer using the Groshong right atrial catheter. Gynecol Oncol 1989; 33: 313–6.

Delmore

J.E.

, Horbelt

D.V.

, Jack

B.L.

, Roberts

R.K.

Experience with the Groshong long-term central venous catheter.

Gynecol Oncol 1989; 34: 216–8.

Hoffer

E.K.

, Bloch

R.D.

, Borsa

J.J.

, Santulli

, Fontaine

A.B.

, Francoeur

Peripherally inserted central catheters with distal versus proximal valves: prospective randomized trial.

J Vasc Interv Radiol 2001; 12: 1173–7.

Biffi

, De Braud

, Orsi

Totally implantable central venous access ports for long-term chemotherapy. A prospective study analising complications and costs in 333 devices with a minimum 180 days of follow-up.

Ann Oncol 1998; 9: 767–73.

Mueller

B.U.

, Skelton

, Callender

D.P.E.

A prospective randomized trial comparing the infectious and noninfectious complications of an externalised catheter versus a subcutaneously implanted device in cancer patients.

J Clin Oncol 1992; 10: 1943–8.

Biffi

, Corrado

, De Braud

Long term, totally implantable central venous access ports connected to Groshong catheter for chemotherapy of solid tumours: experience on 178 cases using a single type of device.

Eur J Cancer 1997; 33: 1190–4.

Pasquale

M.D.

, Campbell

J.M.

, Magnant

C.M.

Groshong versus Hickman catheters.

Surg Gynecol Obstet 1992; 10: 1942–8.

Hull

J.E.

, Hunter

C.S.

, Luiken

G.A.

The Groshong catheter: initial experience and early results of imaging-guided placement.

Radiology 1992; 185: 803–7.

Biffi

, De Braud

, Orsi

A randomized, prospective trial of central venous ports connected to standard open-ended or Groshong catheters in adult oncology patients.

Cancer 2001; 92: 1204–12.

10.

Tolar

, Gould

J.R.

The timing and sequence of multiple device-related complications in patients with long-term indwelling Groshong catheters.

Cancer 1996; 78: 1308–13.

11.

Mayo

D.J.

, Helsabeck

C.B.

, Horne

III . Intraluminal clots in Groshong catheters. J Vascular Access Devices 1995; 1: 20–2.

12.

Campisi

, Camillucci

, Campopiano

, Fanizza

, Sardonio

Groshong catheters: technical aspects and clinical features.

The Journal of Vascular Access 2000; 1: 36–9.

13.

Petersen

, Delaney

J.H.

, Brakstad

M.T.

, Rowbotham

R.K.

, Bagley

Jr. . Silicone venous access devices positioned with their tips high in the superior vena cava are more likely to malfunction. Am J Surg 1999; 178: 38–41.