Original Communications| Volume 129, ISSUE 5, P547-551, May 2001

Ionic implantation of silicone chronic venous access devices does not alter thrombotic complications: A double-blinded, randomized clinical trial


      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.)
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        • Lindblad B
        Thromboembolic complications and central venous catheters [letter].
        Lancet. 1982; 2: 936
        • Hoshal VL
        • Ause RG
        • Hoskins PA
        Fibrin sleeve formation on indwelling subclavian central venous catheters.
        Arch Surg. 1971; 102: 353-357
        • Reed WP
        • Newman KA
        • Tenney JH
        • Schimp FFSC
        Autopsy findings after prolonged catheterization of the right atrium for chemotherapy in acute leukemia.
        Surg Gynecol Obstet. 1985; 160: 417-420
        • Tschirhart JM
        • Rao MK
        Mechanism and management of persistent withdrawal occlusion.
        Ann Surg. 1988; 54: 326-328
        • Sioshansi P
        New processes for surface treatment of catheters.
        Artif Organs. 1994; 18: 266-271
        • Bambauer R
        • Mestres P
        • Schiel R
        • Klinkmann J
        • Shioshansi P
        Surface-treated catheters with ion beam-based process evaluation in rats.
        Artif Organs. 1997; 9: 1039-1041
        • Uldall PR
        • DeBruyne M
        • Besley M
        • McMillan J
        • Simons M
        • Francoeur R
        A new vascular access catheter for hemodialysis.
        Am J Kidney Dis. 1993; 21: 270-277
        • Pocock S
        Statistical aspects of clinical trial design.
        The Statistician. 1982; 31: 1-18
        • Reed WP
        Intravenous access devices for supportive care of patients with cancer.
        Curr Opin Oncol. 1991; 3: 634-642
        • Cohen J
        Statistical power analysis for the behavioural sciences.
        : Lawrence Erlbaum Associates, Hillsdale (NJ)1988
        • Fleiss JL
        Statistical methods for rates and proportions.
        in: : John Wiley & Sons, New York1973: 143-147
        • Cutler SJ
        • Ederer F
        Maximum utilization of the life table method in analyzing survival.
        J Chron Dis. 1958; 8: 699-712
        • Mantel N
        Evaluation of survival data and two new rank order statistics arising in its consideration.
        Cancer Chemother Rep. 1966; 50: 163-170
        • Cox DR
        Analysis of binary data.
        : Methuen, London1970
        • Lee ET
        Statistical methods for survival data analysis.
        2nd ed. : John Wiley & Sons, New York1992
        • Formanek G
        • Frech RS
        • Amplatz K
        Arterial thrombus formation during clinical percutaneous catheterization.
        Circulation. 1970; 61: 833-839
        • Hoshal VL
        • Ause RG
        • Hoskins PA
        Fibrin sleeve formation on indwelling subclavian central venous catheters.
        Arch Surg. 1971; 102: 353-357
        • Eastridge BJ
        • Lefor AT
        Complications of indwelling venous access devices in cancer patients.
        J Clin Oncol. 1995; 13: 233-238
        • Puel V
        • Caudry M
        • Letmayer P
        • Baste JC
        • Midy D
        • Marsault C
        Superior vena cava thrombosis related to catheter malposition in cancer chemotherapy given through implanted ports.
        Cancer. 1993; 72: 2248-2252
        • Welch GW
        • McKeel DW
        • Silverstein P
        • Walker HL
        The role of catheter composition in the development of thrombophlebitis.
        Surg Gynecol Obstet. 1964; 138: 421-424
        • Hickman RO
        • Buckner CD
        • Clift RA
        • Sanders JE
        • Stewart P
        • Thomas ED
        A modified right atrial catheter for access to the venous system in marrow transplant recipients.
        Surg Gynecol Obstet. 1979; 148: 871-875
        • Bozzetti F
        • Scarpa D
        • Terno G
        • Scotti A
        • Ammatuna M
        • Bonalumi MG
        • et al.
        Subclavian venous thrombosis due to indwelling catheters: a prospective study on 52 patients.
        JPEN J Parenter Enteral Nutr. 1983; 7: 560-562
        • Linder L
        • Curelaru I
        • Gustavsson B
        • Hansson H
        • Sternquist O
        • Wojciechowski J
        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
        • Fabri PJ
        • Mirtallo JM
        • Ebbert ML
        • Kudsk KA
        • Powell C
        • Ruberg RL
        Clinical effect of nonthrombotic total parenteral nutrition catheters.
        JPEN J Parenter Enteral Nutr. 1984; 8: 705-707
        • Hoar PF
        • Wilson RM
        • Mangano DT
        • Avery GJ
        • Szarnicki RJ
        • Hill JD
        Heparin bonding reduces thrombogenicity of pulmonary-artery catheters.
        N Engl J Med. 1981; 305: 993-995
        • Baier RE
        Selected methods of investigation for blood contact surface.
        Ann N Y Acad Sci. 1987; 516: 68-77
        • Suzuki Y
        • Kusakabe M
        • Akiba H
        • Kusakabe K
        • Iwaki M
        In vivo evaluation of anti-thrombogenicity for ion implanted silicone rubber using indium tropolene platelets.
        Jpn J Artific Organs. 1990; 19: 1092-1095
        • Bern MM
        • Lokich JJ
        • Wallach SR
        • Bothe A
        • Benotti PN
        • Arkin CF
        • et al.
        Very low doses of warfarin can prevent thrombosis in central venous catheters.
        Ann Intern Med. 1990; 112: 423-428