Advantages of Cryotherapy Endometrial Ablation.
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 investigatar 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. In that group, 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 last year, 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 staggered 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 an 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, according to Dr. Heppard. It is easy to perform because gynecologists 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.
The patient's level of distress is also markedly diminished compared with other methods of endometrial ablation because the cyrotherapy procedure can be performed using regional anesthesia, and periprocedural and postprocedural pain is minimal, Dr. Heppard noted.
Although 46% of the participants in the larger study received general anesthesia, most of the time it was administered 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 of the procedure is a watery discharge, which patients have experienced 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 endometrial ablation by cryotherapy only when it's performed in the hospital.
"This is unfortunate, because I see this procedure moving into the office," Dr. Heppard said.
Right now, most insurance companies will pay the physician's fee if he or she performs the cryotherapy procedure in the office. But insurers will not pay for related items and services such as the facility's fee, other employees' time, gowns, drapes, or disposable instruments, a spokeswoman for CryoGen said in an interview with this newspaper.
The equipment to perform endometrial cryotherapy costs about $20,000 to buy. But it may also be leased, according to Dr. Heppard.
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|Publication:||OB GYN News|
|Date:||Jan 1, 2000|
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