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

By Marie McCullough
Inquirer Staff Writer

Radiologist Paul Curtis examines MRI images of fibroids at Virtua-West Jersey Hospital Voorhees.

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 ExAblate 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-grain-size 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 ExAblate is still unclear because so few women have used it. But Columbus has no regrets.

"Would I do it again? Yes."

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ExAblate MR-guided Focused Ultrasound Treatment for uterine fibroids.
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