Port REMoval Outcomes (PREMO) study: A pilot study for functional, microbial, radiological, and macroscopic assessment of totally implantable venous access devices.

Abstract

Introduction: According to current guidelines Totally Implantable Venous Access Devices (TIVADs) require regular maintenance (i.e. flushing with 0.9% Sodium Chloride solution) when not in use. Existing evidence suggests that extending flushing intervals up to 12 weeks does not compromise catheter function, but longer intervals or omitting flushes require more research.

Methods: To facilitate a future randomized controlled trial (RCT), various methods were evaluated for assessing functional (CINAS classification, vacutainer filling time (VFT)), microbial (tip culture, swabs), radiological (linogram), and macroscopic (visual inspection) changes in TIVADs after a 12-weekly maintenance regimen. TIVADs from 70 patients were assessed upon TIVAD removal.

Results: Concerns over the perceived invasiveness of the linogram resulted in only 36% of eligible patients eventually consenting to participate in the trial. Eighty-six percent had normal TIVAD function, with an average VFT of 23 s/10 mL (SD 5 s/10 mL). Linograms were aberrant in 15% of patients, but the majority of anomalies did not correlate with visible thrombus on inspection or functional issues. No positive microbial cultures were found.

Conclusions: The primary end point of any future research on TIVAD maintenance should primarily be focused on the functionality of the TIVAD. The CINAS classification effectively standardizes reporting of TIVAD functionality. Although VFT offers a precise measurement of aspiration function, optimal target values remain unclear and clinical relevance might be limited in a functional TIVAD. The added value of a linogram seems to be negligible. An RCT trial comparing 12-weekly TIVAD maintenance versus no maintenance would be invaluable for both patients and health care providers. Clinical Trials register (NCT03948958).