It started with a case on Thanksgiving Day in 1994. I had been
called in to embolize the uterine arteries on a patient who had a
myomectomy and was bleeding heavily post-operatively. The Ob/Gyn
called me and asked if I would come in and embolize her. That kind
of work had been going for a while in terms of embolizing arteries
in patients bleeding after childbirth or surgery. It turned on a
light bulb for us, though.
Was
anyone using artery embolization (UAE) for fibroids before then?
A French group was the first to publish a study, in 1995 (J.H.
Ravina, et al., "Arterial embolization to treat uterine
myomata," Lancet 346[8976]:671-672, 1995). We took note
of that paper, and the gynecologist and I discussed the idea of
starting a uterine fibroid embolization practice. So we started that
in 1996 and I presented our early results, the preliminary results,
at the Society of Interventional Radiology meeting in 1997. That
year we published the paper in the Journal of Vascular and
Interventional Radiology. That was the first report in the U.S.
and in the radiology literature in a peer-reviewed journal.
So
that started UAE off in the U.S.?
After our article a number of people got interested, most notably
Robert Worthington-Kirsch and Jim Spies at Georgetown. And it’s
sort of grown exponentially since then. The last time I looked maybe
30,000 of these procedures had been done worldwide, at least.
What
was the purpose of UAE pre-1994 and your light bulb experience?
Patients had been embolized since the 1960s for bleeding from a
variety of causes. It took a couple of decades until people started
embolizing patients who had bleeding after childbirth or after
gynecologic surgery. What happened was that this French group was
referred patients to be embolized prior to myomectomy to reduce
bleeding during surgery, and they noticed that some of their
patients were canceling surgery because their symptoms had been
resolved. So it was a serendipitous observation. They started
embolizing patients with fibroid symptoms, as I understand, in 1989,
and then they published that article in 1995 in The Lancet.
What
was the most challenging aspect of doing these procedures and the
study that led to the 1997 paper?
|

“As a global statement, I'd say the hardest thing about the procedure becoming successful has been overcoming the resistance of the gynecology community.”
|
|
As a global statement, I’d say the hardest thing about the
procedure becoming successful has been overcoming the resistance of
the gynecology community.
What’s
the basis of the resistance from gynecologists?
They’ll say it’s an investigative or experimental procedure.
Finally the American College of Obstetrics and Gynecology (ACOG) and
the gynecologists themselves have finally stopped saying that. They
finally acknowledged last year that UAE has a legitimate role in
these patients. It was viewed as a patient-care issue by
gynecologists and ACOG for many years.
What
is their preferred procedure for uterine fibroids?
Hysterectomy, by far.
What
are the risks of UAE?
The largest risk is death, which happens approximately once in
every 5,000 patients. But that’s in contradistinction to
hysterectomy, where it is about one in 1,000. There’s now been a
paper published comparing UAE to hysterectomy and one comparing it
to myomectomy that’s been presented at national meetings, and they
show that UAE is safer than either of the two.
How
does UAE compare in efficacy?
It’s very similar. There are no significant differences in
outcome measures in those studies. The same thing goes for
quality-of-life studies. Whatever you want to measure, they’re
similar.
What
the difference between your 1999 and 1997 papers in The Journal of
Vascular and Interventional Radiology? They have almost identical
numbers of cites.
The 1999 paper was the larger paper, with more patients and
multiple years of follow-up.
What
are you concentrating on now?
I’m still involved in a number of studies here. I’m the lead
author of a multi-institutional national trial comparing UAE to
myomectomy. That’s in press in Fertility and Sterility
right now. I’m also on the fibroid registry steering committee,
and we have multiple papers in press right now on UAE outcomes in
several thousand patients, and I’ll be the lead author on the
two-year follow-up paper in that group. I’ll probably start
working on that next year. Maybe late this year.
Are
you surprised at how successful UAE has become?
Well, actually I’d have to put it another way. I’m actually
disappointed at how little inroad it’s made into the hysterectomy
statistics. At least 200,000 women a year in the U.S. are getting
hysterectomies for fibroid disease. So less than 10 percent of that
number is getting UAE.
Okay,
so when you put it like that, why do you think it’s been so slow to
be adopted?
Patients aren’t told. The gatekeeper is the gynecologist, and
many patients come to me and say they had to find out about the
option on their own. They weren’t informed about it when they were
told about hysterectomy or myomectomy. And if they are told, what
they’re given is all negatives. Instead of having a fair
comparison with hysterectomy or myomectomy, they’re just given a
laundry list of all the complications that could occur with UAE.
Do
you think it would be different if UAE had been developed by
gynecologists instead of radiologists?
I think we’d see tens of thousands more of these procedures
performed annually.
Considering
that your audience must be gynecologists, why choose to put both
papers in a radiology journal?
The first paper, the preliminary results paper, I didn’t really
know what the impact of that was going to be. I thought it was a
minor paper, and the next thing I know I’m on all the national
news programs. I didn’t realize what an enormous iceberg I had
just taken a piece out of. That said, you could ask the same
question about a lot of this work having been published in radiology
journals. And part of the reason is because many of the papers have
been turned down by the major journals and the gynecology journals,
even the better papers. The same thing is true of grant
applications. If you look in the Ob/Gyn literature, you’ll find
that any report of complications on UAE was always published and
sometimes even fast-tracked. When Jim Spies tried to publish his
paper comparing UAE with hysterectomy, he spent years struggling
with the Ob/Gyn journals. That finally did come out in an Ob/Gyn
journal but it was a huge study. It took him a long time to get it
accepted. The paper comparing UAE with myomectomy was turned down by
both the New England Journal of Medicine and JAMA. Now
I’m going to the Ob/Gyn literature. I think it will be published
successfully, but that’s because I’ve talked to the editor at Fertility
and Sterility who I know has an open mind. I’ve decided to
bypass the two major Ob/Gyn journals because of Jim Spies’s
experience with his paper.
Why
did the New England Journal and JAMA reject it?
They said there weren’t enough patients and not enough years of
follow-up, and it wasn’t a randomized study. I was a little
unhappy with that. My point was that it’s a novel technology that
needed broader exposure, but that didn’t overcome their
objections. To JAMA’s credit, they said if we come back in
a couple of years with longer follow-up, they might be interested in
publishing it.
What
was the response of the lay press to these papers?
It was enormous. Our paper in 1997 was carried by all the
newswires and most major newspapers and news programs. There’s
been some additional interest whenever another major paper breaks.
The lay press has been much more favorably inclined than the medical
literature outside of my particular field. Still, the lay public has
no idea what’s going on out there in medicine. Their impression is
that they’re going to walk into any doctor’s office on any
street corner and they’ll get the best care, and that’s just not
the case.
The
internet must be making a difference in your case?
I don’t think we would have had anywhere near the success we’ve
had without the Internet. I think it’s had an enormous impact on
patients educating themselves, finding out for themselves what’s
out there.
Is
there a final message you’d like to convey to the public about your
work and uterine artery embolization?
Just one thing. You asked me about complications, and I think one
important thing to note is that I personally still don’t believe
this should be the first-round therapy for women who desire
fertility. That still has to be worked out, particularly for women
past the age of forty. For those women, myomectomy is still the gold
standard.