One-year results from a randomised study comparing fibred platinum coils to vascular plugs for the embolization of pelvic varices in order to treat pelvic congestion syndrome have shown that plugs are as good as coils with regard to safety and efficacy. In addition, plugs also significantly reduce procedure and fluoroscopy time, and radiation dose, the study finds.
The study conducted in Zaragoza in Spain, set out to compare the safety and efficacy of two embolic agents for the treatment of pelvic congestion syndrome: Nester coils (Cook Medical) and Amplatzer vascular plugs (St Jude Medical). The results of the study also showed that device migration and incomplete embolization is more frequent with the coils.
Alicia Laborda, University of Zaragoza, Group of Research in Minimally Invasive Techniques Research (GITMI), presented the results at CIRSE 2014 (12–17 September, Glasgow, UK).
The researchers enrolled 55 consecutive patients from May 2010 to September 2012, with a mean age of about 44 years (range 29–60) diagnosed with pelvic congestion syndrome who had chronic pelvic pain of more than six months duration, increased venous calibre (>6mm pelvic venous calibre and one of the following: venous ecstasia; venous reflux or presence of communicating veins across the mid-line. These patients were randomised to receive embolization with either coils (n=28) or vascular plugs (n=27) and there were no significant differences between the patient groups at the beginning of the study.
Laborda told delegates: “The median cubital or jugular approach was used interchangeably, using 5F for the coils and 6F for the plugs. Both ovarian and hypogastric veins were targeted. Safety, efficacy, procedure time, fluoroscopy time, and radiation dose were compared.”
All veins were successfully embolized with no differences in both groups. The mean number of coils per case was 17.82±1.39 vs. 4.18±0.48 plugs. There were six cases of repeat embolization procedures due to no improvement in the coil group and two in the plug group. “At one-year follow-up, there were no significant differences in clinical success (complete disappearance or improvement of symptoms 89.3% vs 92.6%) or in subjective improvement self-assessment (by VAS). Two Nester coils migrated and were retrieved without complications. The procedure time, fluoroscopy time and radiation dose were significantly higher in the coil group (all p<0.0001),” Laborda said. The vascular plugs were significantly more expensive than the coils.