Normal saline versus heparin solution to lock totally implanted venous access devices: Results from a multicenter...

Area of Science:

• Vascular Access Devices
• Medical Device Patency
• Clinical Trials

Background:

• The use of heparin for flushing totally implanted venous access devices (TIVADs) is established but debated.
• Investigating alternative flushing solutions like normal saline is crucial for patient safety and cost-effectiveness.
• EudraCT number: 2009-013620-22.

Purpose of the Study:

• To determine if normal saline flushing is non-inferior to heparin flushing in maintaining TIVAD patency.
• To compare the incidence of TIVAD occlusion between normal saline and heparin flushing protocols.

Main Methods:

• A randomized controlled trial involving 430 patients across 14 Italian centers.
• Patients were randomized to receive either normal saline or heparin flushing for their TIVADs.
• The primary outcome measured was the rate of TIVAD occlusion.

Main Results:

• 203 patients received normal saline and 212 received heparin.
• Median follow-up was 204 days for normal saline and 294 days for heparin.
• Withdrawal occlusions occurred in 14/203 (6.9%) in the normal saline group and 10/212 (4.7%) in the heparin group. One total occlusion occurred in the normal saline group. The 90% CI for the absolute risk difference (2.67%) included the non-inferiority margin of 4%, indicating no significant difference.

Conclusions:

• The study failed to demonstrate the non-inferiority of normal saline compared to heparin for TIVAD flushing.
• While no statistically significant difference in occlusion rates was found, further prospective trials are needed.
• The clinical utility of heparin for TIVAD flushing remains controversial.