Abstract
Background. Ion implantation of silicone vascular catheters has been shown in preclinical and
pilot studies to alter the thrombogenicity of silicone surfaces through the reduced
adherence of thrombin. This prospective, randomized double-blinded study was designed
to detect differences in function related to thrombotic events between ion-implanted
and standard silicone chronic venous access devices (CVAD) placed in patients with
cancer who are receiving chemotherapy. Methods. Patients with nonleukemic malignancies who required venous access for chemotherapy
and who were not receiving anticoagulants were randomized to receive standard or ion-implanted
CVAD. Postoperative functional assessments of the ease of infusion or aspiration were
performed by oncology nurses caring for the patients. Results. Follow-up, available for 100 of 106 randomized patients, showed more episodes of
occlusion to aspiration in the ion implantation group (47%) than in the control group
(39%) but this difference was not significant. There were no significant differences
between the 2 groups in the number of occasions when anticoagulation or local thrombolytic
therapy was required nor were there differences in the numbers of infection or deep
venous thromboses. Conclusions. Ion implantation of silicone catheter material does not alter the incidence of local
thrombotic complications of CVAD. Although there were no serious complications resulting
from this treatment, the use of ion-implanted catheters cannot be recommended on the
basis of this trial. (Surgery 2001;129: 547-51.)
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to SurgeryAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Thromboembolic complications and central venous catheters [letter].Lancet. 1982; 2: 936
- Fibrin sleeve formation on indwelling subclavian central venous catheters.Arch Surg. 1971; 102: 353-357
- Autopsy findings after prolonged catheterization of the right atrium for chemotherapy in acute leukemia.Surg Gynecol Obstet. 1985; 160: 417-420
- Mechanism and management of persistent withdrawal occlusion.Ann Surg. 1988; 54: 326-328
- New processes for surface treatment of catheters.Artif Organs. 1994; 18: 266-271
- Surface-treated catheters with ion beam-based process evaluation in rats.Artif Organs. 1997; 9: 1039-1041
- A new vascular access catheter for hemodialysis.Am J Kidney Dis. 1993; 21: 270-277
- Statistical aspects of clinical trial design.The Statistician. 1982; 31: 1-18
- Intravenous access devices for supportive care of patients with cancer.Curr Opin Oncol. 1991; 3: 634-642
- Statistical power analysis for the behavioural sciences.: Lawrence Erlbaum Associates, Hillsdale (NJ)1988
- Statistical methods for rates and proportions.in: : John Wiley & Sons, New York1973: 143-147
- Maximum utilization of the life table method in analyzing survival.J Chron Dis. 1958; 8: 699-712
- Evaluation of survival data and two new rank order statistics arising in its consideration.Cancer Chemother Rep. 1966; 50: 163-170
- Analysis of binary data.: Methuen, London1970
- Statistical methods for survival data analysis.2nd ed. : John Wiley & Sons, New York1992
- Arterial thrombus formation during clinical percutaneous catheterization.Circulation. 1970; 61: 833-839
- Fibrin sleeve formation on indwelling subclavian central venous catheters.Arch Surg. 1971; 102: 353-357
- Complications of indwelling venous access devices in cancer patients.J Clin Oncol. 1995; 13: 233-238
- Superior vena cava thrombosis related to catheter malposition in cancer chemotherapy given through implanted ports.Cancer. 1993; 72: 2248-2252
- The role of catheter composition in the development of thrombophlebitis.Surg Gynecol Obstet. 1964; 138: 421-424
- A modified right atrial catheter for access to the venous system in marrow transplant recipients.Surg Gynecol Obstet. 1979; 148: 871-875
- Subclavian venous thrombosis due to indwelling catheters: a prospective study on 52 patients.JPEN J Parenter Enteral Nutr. 1983; 7: 560-562
- Material thrombogenicity in central venous catheterization: a comparison between soft, antebrachial catheters of silicone elastomer and polyurethane.JPEN J Parenter Enteral Nutr. 1984; 8: 399-406
- Clinical effect of nonthrombotic total parenteral nutrition catheters.JPEN J Parenter Enteral Nutr. 1984; 8: 705-707
- Heparin bonding reduces thrombogenicity of pulmonary-artery catheters.N Engl J Med. 1981; 305: 993-995
- Selected methods of investigation for blood contact surface.Ann N Y Acad Sci. 1987; 516: 68-77
- In vivo evaluation of anti-thrombogenicity for ion implanted silicone rubber using indium tropolene platelets.Jpn J Artific Organs. 1990; 19: 1092-1095
- Very low doses of warfarin can prevent thrombosis in central venous catheters.Ann Intern Med. 1990; 112: 423-428
Article info
Publication history
Accepted:
December 5,
2000
Footnotes
*Financial support for this study was provided by Gerard Medical, Charlton, Mass.
**Reprint requests: William P. Reed, Jr, MD, Department of Surgery/Winthrop Hospital, 259 First St, Mineola, NY 11501.
*Surgery 2001;129: 547-51.
Identification
Copyright
© 2001 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
