BB&T Contributing Editor

CHICAGO – The American Association of Gynecologic Laparoscopists (AAGL; Cypress, California) held its Global Congress of Minimally Invasive Gynecology annual meeting here in early November, with representation from around the world. The AAGL’s vision is to serve women by advancing the safest and most efficacious diagnostic and therapeutic techniques that provide less-invasive treatments for gynecologic conditions through the integration of clinical practice, research, innovation and dialogue.

The 650,000 hysterectomies performed annually in the U.S. has remained steady in spite of the 15,000 uterine artery embolizations and 250,000 endometrial ablations also performed which were predicted to cannibalize two-thirds of the hysterectomy procedures. Instead, with the population growth of women in their 40s and 50s and their recently found self-advocacy, there are more women actively seeking treatment for pelvic disorders, often resulting in a hysterectomy. If anything, the advancement of the new technologies such as uterine artery embolization and endometrial ablation have heightened the awareness level that women do not have to suffer in silence and that there are procedures that can remedy their ailments, thus driving more of the already growing population into the gynecologists’ offices.

Another contributing factor to the steady production of hysterectomies is that with an average 80% effectiveness of these new technologies, the remaining 20% go on to get a hysterectomy. What is unusual is that of these 650,000 hysterectomies, 60% to 80% are performed using an open abdominal approach, contrary to popular practice in other surgical specialties that has been trending toward minimally invasive or laparoscopic techniques for the past 10 years.

“While it is estimated that 40% of all women in the U.S. will have had a hysterectomy by the age of 60, only 15% of women in the Scandinavian countries will have,” according to Olaf Istre, MD, of Ulleval University Hospital (Hamar, Norway). Although he asked in jest “which country was treating their women better?,” he said that his presentation was about the type of hysterectomy, not the quantity. In his presentation, “Changing Hysterectomy Technique: New Trend in Oslo, Norway,” Istre evaluated the trend in hysterectomy techniques in Oslo over a four-year period and found that there was a trend shift from 2001 to 2004 from 21% to 58% toward endoscopic hysterectomies. The number of laparoscopic hysterectomies increased 300% in that time frame, primarily due to new enabling equipment that allowed new techniques to be performed safely.

This trend toward laparoscopic hysterectomies also was reported by M.J. Canis, MD, of CHU Polyclinque (Clermont-Ferrand, France), in his talk, “How Often Do We Need a Laparotomy to remove the Uterus?,” where he assessed the number of times an open surgical hysterectomy was required, as opposed to a minimally invasive technique. In a series of 1,647 cases, he found that 93% of the time a laparoscopic approach allowed for a hysterectomy while still maintaining very low complication rates.

Why then are 60% to 80% of all hysterectomies performed in the U.S. done abdominally and not laparoscopically? While the move toward laparoscopic surgery was relatively rapid in most surgical subspecialties, when it comes to laparoscopic hysterectomies, the U.S. falls short in comparison to other countries. F.F Tu, MD, of Evanston Northwestern Healthcare (Evanston, Illinois), looked at all hysterectomies performed in Illinois in 2003 in order to profile laparoscopic, vaginal and abdominal hysterectomies and also to learn what impact the advance of minimally invasive procedures now available to treat uterine problems has had on the number of hysterectomies performed.

Hysterectomies remain one of the most common procedures performed on U.S. women for the primary indications of abnormal uterine bleeding, fibroids, pelvic pain and uterovaginal prolapse. The median age for hysterectomy is 44; length of hospital stay is two to three days and complication rate 1% to 3%. Across the U.S., there are significant regional variations with the South having the highest number of hysterectomies and the Northeast the lowest. Studying data from 1993 forward, Tu noticed a 20% to 40% decline in hysterectomies in 1996 when the first endometrial ablation device became available for the treatment of abnormal bleeding. The dip in the number of hysterectomies was transient, however, with 38% of the endometrial ablation patients having a repeat procedure and 9% going on to have a hysterectomy after five years. He also studied the impact of uterine artery embolization for the treatment of fibroids on hysterectomy rates and found that after five years, 73% of the patients had recurring symptoms although 27% enjoyed amenorrhea.

One could conclude that while the alternatives to hysterectomy offer many advantages for the patient, they may in fact only delay the inevitable hysterectomy, or require a repeat minimal procedure. The goal of the less invasive treatments now appears to be to eliminate or delay the symptoms until the patient reaches menopause at which time most symptoms resolve themselves. Although less-invasive procedures have had some impact on the number of hysterectomies performed, the total number of hysterectomies remains somewhat constant due to the growth of the target patient population along with a more informed patient that requests medical attention where these disorders previously went untreated.

Tu also looked at the type of hysterectomy being performed and found that 60% to 66% of hysterectomies were performed abdominally, 20% vaginally and only 10% laparoscopically. Fifteen years after the introduction of the laparoscopic hysterectomy, there still was not much of an impact. The most underutilized type of hysterectomy being performed was vaginal, which is less invasive than abdominal, but not as minimal as laparoscopic. Tu said it is “almost embarrassing that the U.S. still does 60% abdominal hysterectomies.” He also concurred with other panel members that despite increased attention to the feasibility of laparoscopic hysterectomy, minimally invasive approaches remain infrequent. Audience members suggested to the panel that this may be due to lack of laparoscopic training in their residency and felt that as newer residents enter private practice, more lap-aroscopic hysterectomies will be performed.

Endometrial ablation procedures have grown exponentially in recent years with the advancement of several enabling technologies and the education of the 7 million women in the U.S. who experience heavy bleeding. Of these, 1.8 million are treated medically with hormones as a first line of defense and in 2004 about 250,000 women in the U.S. had an endometrial ablation – doubling the amount from just two years earlier. This number is expected to reach 400,000 procedures by 2008, primarily due to direct to consumer advertising and the web-enabled patient. Most of the women seeking endometrial ablation as a treatment are doing so to avoid both the surgery of a hysterectomy and side effects of hormone treatments, with endometrial ablation filling this gap between medical and surgical treatment.

With women seeking this treatment, physicians are concerned about the safety of endometrial ablation devices. To this end, Carl Della Badia, DO, associate professor at Drexel University College of Medicine (Philadelphia), and Ata Atogho, MD, resident at Hahnemann University Hospital (also Philadelphia), presented a review of the MAUDE (Manufacturer and User Device Experience) database from 2003-2004 on endometrial ablations in order to evaluate serious adverse events associated with FDA-approved endometrial ablation devices. The MAUDE database represents reports of adverse events involving medical devices maintained by the FDA. Atogho noted that not all reports are major adverse events (Table 5) and said it is important to separate major events from minor events (Table 6 below), as well as to see if the event was physician-induced or device-induced (Table 7 below). About 57% of the time, the cause of adverse events was due to the procedure or the instrument; while the remaining 43% it was due to the physician. The majority of adverse events occurred when the device was used outside of the manufacturers’ recommendations.

Atogho said that “the data reported to the MAUDE database is not accurate in determining safety of ablation devices because not all incidents are reported and the information reported is not complete. Therefore, the MAUDE database should not be used to determine the safety of ablation devices. In addition, if the manufacturer’s protocol is followed, ablation devices show a good safety profile.” He told the audience that all of the manufacturers are improving their current products in order to further improve their safety profile.

According to Badia, Boston Scientific (Natick, Massachusetts) is tightening the seal around the tenaculum, Gynecare (Cinncinnati) has developed a new balloon, Microsulis (Hants, UK) is adding a “stop” on its probe, and Cytyc (Marlborough, Massachusetts) is removing the override button for the integrity test.

In an expert panel, “Management of Fibroids without Abdominal Entry,” Fred Burbank, MD, chairman of Vascular Control Systems (San Juan Capistrano, California), compared the various methods of achieving uterine artery occlusion for the treatment of fibroids, including embolization and surgical occlusion. After pointing out that there are at least seven ways to occlude the uterine arteries (Table 8), he presented the IRB pilot experience using the company’s flostat system, which temporarily occludes the uterine arteries using a transvaginal Doppler-guided clamp. In the study, it was demonstrated that 81% of patients saw a reduction in their bleeding score (RUTA), while 80% saw a decrease in uterine volume – similar to results achieved using conventional, more-invasive methods. Once cleared by the FDA, the flostat system may in fact have an impact on the 200,000 hysterectomies being performed for fibroids because the device can be used by any gynecologist without the assistance of an interventional radiologist and without specific surgical training.

Risks of other types of hysteroscopic procedures may be vaginal or perineal burns resulting from stray energy. George Vilos, MD, professor of surgery at the University of Western Ontario (London, Ontario) and St. Joseph’s Health Care, reported on a pilot study using Encision’s (Boulder, Colorado) active electrode monitoring (AEM) technology in hysteroscopy. In the study, a series of patients underwent resectoscopic surgery using a conventional resectoscope adapted with AEM technology. Vilos said, “baseline currents combined with the surges can produce heat loading that can cause [perineal/vaginal] burns. The adaptation of AEM may be effective in mitigating the hazards from insulation failure, capacitive coupling and directly coupled currents associated with the stray energy to the resectoscope.”