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

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.)