Endometrial Ablation by Cryotherapy Reduces Flow.
The First Option Uterine Cryoblation therapy device reduced uterine bleeding to eumenorrhea or better 6 months after treatment in 89% of the 206 patients enrolled in a recent multicenter trial of the new technology. These results were presented at the annual meeting of the American Association of Gynecologic Laparoscopists.
Minimal spotting was reported by 53% of the patients and eumenorrhea was seen in 36%, said study investigator Dr. Martha Heppard of the University of Colorado, Denver.
The results were even better in a separate series of 25 of Dr. Heppard's patients. Eumenorrhea or better occurred in 100% of patients at 1 year, including amenorrhea in 50%, eumenorrhea in 40%, and light spotting in 10%.
First Option Uterine Cryoblation therapy approved for commercial use in 1998; involves a cryogenic probe that is used to ablate the endometrium. One side of the uterus receives a 4-minute freeze followed by a 6-minute freeze of the contralateral side, said Dr. Heppard, who has no financial interest in the device or its San Diego-based manufacturer, CryoGen Inc.
Freezing times are adjusted to allow the probe to be moved easily from one side of the uterus to the other to perform both freezes. The investigators found that if a 5-minute freeze is used on the first side, the resulting iceball tends to cross the midline of the uterus, which can make it difficult to move the probe to the opposing side, Dr. Heppard said in an interview.
The probe, which is inserted to within 2 cm of the serosa of the uterus, forms a 1.8-cm-wide iceball. However, actual tissue destruction occurs only up to about 8 mm from the end of the probe, providing a buffer edge of about 1 cm, Dr. Heppard noted. Shorter freezing times can be used in women with uterine walls less than 2 cm thick, she added.
Ultrasound guidance allows the technician to place the probe in abnormally shaped uteri and helps ensure a good result. This is an advantage over other recent methods of endometrial destruction, such as thermal ablation, which are done without direct visualization. These methods require a perfectly shaped uterus to be successful, which is often not seen in women with abnormal uterine bleeding, he said.
Cryoblation provides other advantages as well, Dr. Heppard said. It is easy to perform for physicians who are familiar with cryotherapy for cervical lesions. The equipment is easy to operate, and the procedure can be performed using only the physician and a resident or circulator to pass the instruments and operate the ultrasound.
Patient distress is limited because the procedure can be performed using regional anesthesia, and periprocedural and postprocedure pain is minimal.
Although 46% of patients in the larger study received general anesthesia, it was usually given early in the trial and was later replaced by a paracervical block, because the investigators found that the procedure could be performed comfortably using regional anesthesia.
Patients are typically discharged 30 minutes after the procedure is performed, and NSAIDs are usually all that is required for postoperative pain control. And 99% of patients return to work by the following day Dr. Heppard said.
The main after-effect is a watery discharge, which can last for up to 3 weeks following the ablation.
Fluid imbalance, which can be a problem with other methods of endometrial ablation, is not a concern with cryoblation because only 10-20 cc of saline are injected during the 10-minute procedure.
At present, Dr. Heppard sees only two main drawbacks with this modality. The first is the cost of the ultrasound, which is added to the cost of the procedure. The second is that most insurance plans reimburse physicians for the procedure only when it's performed in the hospital.
"This is unfortunate, because I see this procedure moving into the office," he said.
Equipment costs about $20,000 to buy and may also be leased, according to Dr. Heppard.
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|Comment:||Endometrial Ablation by Cryotherapy Reduces Flow.|
|Publication:||Family Practice News|
|Article Type:||Brief Article|
|Date:||Mar 15, 2000|
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