A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.
A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure. Clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year. This exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)
Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram
TIVAD colonization will be investigated by microbiological culture of the tip and chamber content
University Hospitals Leuven
Leuven, Belgium
TIVAD function
will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification.
Time frame: during the 1 day of TIVAD removal, before the linogram
Catheter tip position visualization by fluoroscopy
The patient will be positioned in a nearly standing position with chest elevation of 17°
Time frame: during the 1 day of TIVAD removal, just before the linogram
Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory
will be visualised by linogram (digital substraction angiography)
Time frame: during the 1 day of TIVAD removal
Catheter tip and port chamber culture
microbial culture
Time frame: during the 1 day of TIVAD removal (following TIVAD removal)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.
Macroscopic evaluation of the port chamber and catheter will be performed after port removal.