If it was a drug ?

Created - 14.06.2009

We all recognise that uterine fibroid embolisation (UFE) is now an established procedure and should be offered to women as a treatment option for symptomatic fibroids. But there is still so much to learn and we must not become complacent. Let's look at what we do know. There have been 4 published randomised controlled trials and these have all reported broadly similar results. When compared with hysterectomy, UFE offers similar outcomes as measured by the generic quality of life (SF36) instruments. Complication rates are similar but differ in type and temporal profile, for example complications after surgery usually arise in the first 30 days whereas UFE complications usually appear beyond this time period and up to 12 months post embolisation . Recovery times and return to work (so important in a young population) are significantly faster with UFE. More importantly UFE appears more cost effective when compared with surgery at least in the short term, and you keep your uterus. 

The Achilles heel lies with the re-intervention rate. Further invasive treatment is required in 10 – 30 % for either persistent or recurrent symptoms. This usually results in a hysterectomy, the very procedure the patient was trying to avoid. A familiar bell should ring in the heads of interventional radiologists, think of EVAR, of angioplasty and stenting, less invasive yes, more rapid recovery yes, but a significant need for further intervention over the long term.

So what is it with UFE, why the need for reintervention in up to a third of patients? Incomplete fibroid infarction in a nutshell. Katsumori recently showed a cumulative need for further intervention of only 3% at 5 years provided infarction was complete, this rose to 20 % where infarction was incomplete. Factors governing fibroid infarction are clearly multifactorial (collateral supply, technique, end points and embolic agent) and not all are within our control. The embolic agent itself is becoming of increasing importance however and something we can study and influence. Spherical PVA for example in spite of being promoted actively as an ideal agent for UFE turned out not so good in two small RCT`s when compared with Embospheres. More recently colourful language from an eminent Interventionalist has suggested Embozene may be the ideal agent. Has Embozene been tested through the rigours of a RCT – no it has not. Has gelfoam been compared with other agents or Beadblock – no they have not. Yet these agents are all available in the European market. Do we know whether there is any difference between these agents regarding ovarian or endometrial function – no we do not. In women wishing to preserve fertility who ask us “UFE or myomectomy?” another question we cannot answer.

The way ahead is obvious we need more RCT`s and these should be appropriately funded and powered with clear questions and achievable answers. Ah you may say Interventional Radiologists have not been good at trials and that is true but it's changing. Proper trials are a concerted team effort involving the skills of many, epidemiologists, health economists, trial units, statisticians and for UFE gynaecologists and radiologists. Anything is achievable if you want to do it and you have the right tools.

Fanciful talk? no anything but. A grant application sits with the HTA as we talk and another is in the pipeline. These will hopefully address some of the unknowns in UFE and will require your cooperation as an individual to see them through to fruition so watch this space.

Back to my first question “if it was a drug?” – well there is little doubt that UFE would probably have struggled for approval in this much tighter regulatory environment. But it's not a drug and we all know that UFE has saved countless hysterectomies and improved the quality of life of hundreds of thousands of women. We just need to make it even better and safer, can Interventional Radiology do that? YES WE CAN

Professor Jon Moss