An Alternative to Resectoscopy
A new device may one day allow gynecological surgeons to remove intracavitary abnormalities, such as endometrial polyps and fibroids, on an outpatient basis.

The Intra-Uterine Shaver, developed at Spaarne Hospital in the Netherlands, uses an angled blade and vacuum to remove abnormal tissue. The vacuum sucks the tissue into a tube, where it is cut and discharged through the device.

If the device comes to fruition, it may make lesion removal significantly easier, quicker, and less painful than traditional resectoscopy. In that technique, surgeons use monopolar high-frequency electrical current to cut tissue with a 5-mm wire loop-electrode. Once the tissue is cut, the surgeon must use the loop to manually remove the tissue from the site. "The surgeon must pass in and out of the cervix numerous times to remove the excised tissue," says IntraUterine Shaver inventor Mark Emanuel, MD. "This causes some discomfort for the patient. With the IntraUterine Shaver the surgeon would only have to enter the cervix once for the initial entry," Dr. Emanuel explains.

Dr. Emanuel lists several other advantages, as well. As the process does not rely on electrical current, there is no danger of burns. Also, the surgeon can use saline solution for distension and irrigation instead of electrolyte-free solutions, which have been known to cause life-threatening electrolyte changes in the blood, he says. Finally, the learning curve is shorter.

"Resectoscopy is time-consuming and difficult to master," he says, because the surgeon must manually cut the tissue and remove it. The IntraUterine Shaver, in contrast, only requires the surgeon to guide the device to the lesion. The instrument does the rest. All of these factors may ultimately allow surgeons to use only local anesthesia and do the procedure on an outpatient basis.

Other surgeons say the device is interesting, but wonder just how wide its application will be. George Vilos, MD, a gynecologist and the Director of Endoscopic Surgery at the University of Western Ontario, points out that only about 15 percent of women who are symptomatic and suffering from abnormal bleeding have uterine fibroids where the shaver would be effective. He also points out that the loop used in resectoscopy not only cuts and removes tissue, but also coagulates the wound, whereas the shaver would not.

Dr. Emanuel admits that it is still uncertain whether his technique could cause excessive bleeding in specific cases. He adds that another disadvantage is the device's cutting and aspiration power. At present, the shaver works best on polyps, which tend to be soft. Fibroids, which are generally more rubbery, require more work.

The device is also larger than Dr. Emanuel would like for it to be. The shaver blade is 4.5 mm and the diameter of the hysteroscope's outer sheath is 9 mm.

In a small, 15-patient preliminary trial, the device successfully removed endometrial polyps and small superficial fibroids. A more extensive trial involving 100 patients is planned.

Smith and Nephew Endoscopy has contracted with Dr. Emanuel to further develop and produce the shaver, searching for ways to improve the blade and reduce the diameter. The company plans a product launch by the second half of next year.

Insurers Limit ASC Business
In at least two states, Blue Cross Blue Shield seems to be trying to keep business in hospitals and out of freestanding ambulatory surgery centers. In January, Blue Cross Blue Shield of Central New York announced that it was suspending contract negotiations with any outpatient surgery centers beyond the six with which it had already contracted.

Late last month, the insurer announced an update of sorts on what it refers to as "the ambulatory surgery issue." The insurer declared that instead of automatically including freestanding ASCs into the system, it will make contracting decisions on a case by case basis.

When asked to respond to critics who claim that the company made the decision due to extensive lobbying by hospitals, Kathy Dwyer, Director of Media Relations said, "We definitely refute those charges. This new policy affects everyone, independent freestanding ASCs and hospital-run freestanding ASCs alike." She says the policy is meant to prevent duplication of services and adds that hospitals aren't off the hook either. The insurer is currently developing a "hospital efficiency review" to try to cut the fat from hospitals and make them run more effectively.

This isn't the only state in which Blue Cross is taking a hard line on independent ASCs; in Michigan, it requires all non-hospital owned and operated ASCs to perform a minimum of five procedures in specific specialty areas before being reimbursed. Accordingly, single-specialty centers cannot receive reimbursement.

When asked whether there was a similar requirement for hospitals and hospital-owned and operated ASCs, BCBSM's Media Relations Director Helen Stojic declined to comment.