A sound alternative In a new method, an MRI finds the fibroids, ultrasound destroys them.

Posted: January 24, 2005

Through a fog of sedation

and painkillers, Alina

Columbus heard a

voice say, "We're going to

start another treatment."

She lay on her stomach in

the magnetic resonance imaging

machine, hearing a

rumbling and feeling heat

build up deep inside her.

High-intensity ultrasound

waves were passing through

her abdomen, reaching a fibrous

tumor in her uterus,

and raising the temperature

at the target point to about

158 degrees Fahrenheit -

hot enough to destroy the unwanted

speck of tissue.

After 20 seconds, the noise

and heat stopped, and the

technician in the nearby control

room asked how she felt.

"A little cramping. Not too

bad," Columbus mumbled.

It was mid-December, and Columbus,

47, a teacher from Newark,

Del., had come to Virtua

Health System's hospital in

Voorhees, one of the first in the

country to offer ExAblate, a novel

treatment for benign uterine

growths called fibroids. The

MRI-guided, high-intensity ultrasound

system, made by Israel-

based InSightec Ltd., is a new

way to avoid hysterectomy. It

was approved by the Food and

Drug Administration in October.

(Because it may affect fertility,

it is not approved for women

who desire future pregnancy.)

Columbus, Virtua's sixth Ex-

Ablate patient, was a challenging

case. MR images

showed six fibroids,

a few as big

as grapefruits, embedded

in the walls

of her uterus,

crowding and distorting

the cavity.

The tumors had

been causing constant

pain and so much monthly

bleeding that Columbus had become

anemic. The pressure on

her bladder had forced her to

make frequent, inconvenient

trips to the bathroom.

After the maximum four

hours of carefully calibrated, intermittent

"sonications," Paul

Curtis, the interventional radiologist

directing her treatment

from the control room, was

pleased. Spot by spot, he and

his team had ablated, or destroyed,

enough of four fibroids

so the sinewy masses would

wither and shrink.

But only time would tell

whether it was enough to relieve

her symptoms.



Several nonsurgical treatments

for fibroids and abnormal

uterine bleeding have developed

in recent years. A popular

example is uterine artery embolization

- the procedure that

Secretary of State nominee Condoleezza

Rice underwent in November

- in which salt-grainsize

pellets are injected into

uterine blood vessels to cut off

the fibroids' blood supply. Other

treatments involve ablating the

uterine lining by heating or

freezing it.

The trend reflects the growing

number of baby boomers

dealing with menopausal changes,

and their demand for treatments

less radical than hysterectomy,

which requires several

days of hospitalization and four

to six weeks of recuperation.

Fibroids, which develop in

more than 70 percent of women

over age 35, usually have no

symptoms and shrink after

menopause as hormone

levels decline.

But women

like Columbus can't

wait that long; the

pain and bleeding

become too disruptive

to their lives.

Indeed, government

health data

show that fibroids are the reason

for almost a third of the

600,000 hysterectomies done annually

in the United States.

Columbus, a mother of two,

had actually scheduled a hysterectomy

but was worried she

might need a transfusion -

something her Jehovah's Witness

beliefs preclude. That's

when she read about ExAblate

in a Virtua newsletter.

"I felt as though, the very first

time I went to my doctor, hysterectomy

was presented as my

only option," she said. "Hysterectomy

sounded very drastic,

and I just didn't want to take

the risk."

ExAblate is noninvasive, requires

no incision, and women

go home the same day. But it,

too, has risks, is not suitable for

all fibroids, and is expected to

cost about $16,000 - as much

as surgery, according to company

and Virtua officials.

The technology capitalizes on

the ability of ultrasound waves

to pass through or be absorbed

by bodily tissues, depending on

the tissue density and the intensity

and focus of the beam.

ExAblate excites the molecules

within a tumor, generating

enough friction to create

heat energy - much the way

sunlight focused by a magnifying

glass can cause tinder to

burst into flame.

Using the technology safely is

tricky because ultrasound energy

is blocked by air and absorbed

at different rates by

bone, scars, hair, fat and water.

Company data presented to

the FDA showed that in clinical

trials of 109 women, five suffered

nerve injuries, including

one patient who had left leg

numbness and weakness that

took almost a year to fully heal.

Safeguards have since been

added to the equipment and the

treatment protocols. "We get

feedback after each sonication,"

Curtis said.

Indeed, only twice did Columbus

complain of intense discomfort,

prompting adjustments to

the treatment.

Three weeks later, she gave

the results mixed reviews.

But four weeks later, she was

thrilled. The pain and pressure

were gone.

"I even went skiing this past

weekend," Columbus said. "I

could never have done that before

the procedure."

The true effectiveness of Ex-

Ablate is still unclear because

so few women have used it. But

Columbus has no regrets.

"Would I do it again? Yes."

Contact staff writer Marie

McCullough at 215-854-2720 or

mmccullough@phillynews.com.

For more on ExAblate, call Virtua at

1-888-847-8823, or see

http://www.insightec.com.

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