BBI Contributing Editor
SAN FRANCISCO Several new companies displayed their wares or presented clinical studies for the first time at the 33rd annual meeting of the American Association of Gynecological Laparoscopists (AAGL; Sante Fe Springs, California), held in mid-November at the San Francisco Hilton. The AAGL gathering is attended by the most advanced gynecologists in minimally invasive procedures. These new companies offered products ranging from new adhesion barriers to non-surgical treatments for fibroids and incontinence.
This annual meeting of the AAGL presented some of the most forward-thinking and revolutionary techniques for dealing with modern women's healthcare. Sessions on treatment for myomas, or benign tumors of the uterus, were some of the most well-attended due to the current trend toward uterus-conserving procedures unlike the past standard of care being that of hysterectomy for fibroids which was embraced by many even as recently as five years ago. About 200,000 hysterectomies have been performed each year in the U.S. as a definitive cure for fibroids, but this forward-thinking group of gynecologists has demonstrated the efficacy and patient benefits of keeping the uterus and treating the underlying pathology.
In a talk titled "Observation, Treatment, or Management of Myomas" Errico Zuppi, MD, of the University of Rome Tor Vergata (Rome), shared his approach to myoma management. He explained that 25% to 30% of all women have symptomatic fibroids, each being influenced by a combination of genetics, hormones, growth factors and enzymes. Although the risk of any myoma being cancerous is extremely low, he said he feels it is important to first rule out cancer by performing an endometrial biopsy. He determined the least invasive but most effective treatment for that specific myoma based on its size, vascularization, structure and location, and then discussed the inherit drawbacks of the various treatment options (see Table 4).
He said that his overall best results using uterus-conserving techniques were with cryomyolysis where he was able to attain myoma shrinkage up to 80% with no blood loss and few post-operative complications. By better understanding the characteristics of the myoma, patient expectations and the appropriate treatment modality, he was able to produce good results.
With uterus-conserving procedures, patients have an opportunity to maintain their fertility. With this in mind, Elizabeth Pritts, MD, of the University of Wisconsin (Madison, Wisconsin), examined the effects of the various myoma treatments on pregnancy. She performed a Meta analysis using the Cochrane library to attempt to determine how each type of myoma procedure would affect future pregnancies. She looked at fibroid recurrence rates, adhesion rates and pregnancy complications for each type of procedure (Table 5).
Pritts also found that different types of fibroids produced different types of pregnancy complications. Intramural fibroids produced more spontaneous abortions while intracavitary fibroids had several other adverse effects on pregnancy. If the fibroids were 4 cm or less, there were better pregnancy outcomes. Her conclusions were that with submucosal fibroids, a surgical removal using an adhesion barrier had the most favorable pregnancy outcomes. This information set the stage for new products that offered a better way to manage myomas in patients wishing to maintain their fertility.
FzioMed (San Luis Obispo, California) manufactures an adhesion barrier for abdominal/pelvic surgery and has received its CE-mark approval in the European Union, while clinical trials are currently under way in the U.S. Adhesions may negatively influence pregnancy, so an adhesion barrier gel that is easily applied through a trocar during laparoscopic surgery would be beneficial for women of child-bearing age. The gel goes on as a thick fluid and immediately sets up more like a gel. There are only two adhesion barrier products approved by the FDA currently on the market: Intercede by Johnson & Johnson (New Brunswick, New Jersey) and Seprafilm by Genzyme (Cambridge, Massachusetts), but the latter is for open surgery only. As reported by Per Lundorff, MD, of Viborg Hospital (Viborg, Denmark), 60 patients were followed post-operatively, half of whom had the FzioMed barrier gel applied during surgery, and the other half were controls with surgery only. Second-look laparoscopy was performed at six to 12 weeks to evaluate adhesions, and they found that 80% of the gel patients had the same or lower adhesions scores while only 27% of the control group had the same or lower scores. The application of the get took about one to two minutes for adequate tissue coverage and clinical benefit was demonstrated by statistically significant differences in scores. Should this study, when complete, prove efficacy, and given FDA approval, the use of an adhesion barrier on women undergoing pelvic surgery during childbearing years should be advantageous.
M.H.Emanuel, MD, of Spaarne Hospital (Haarlem, the Netherlands), presented "The Hysteroscopic Morcellator, a New Technique for the Removal of Endometrial Polyps and Submucous Myomas," which discussed the use of a new product manufactured by Smith & Nephew Endoscopy (Andover, Massachusetts). This new morcellator is a facilitator of laparoscopic myomectomy because it has a rotating blade that cuts and immediately removes myomas during a hysteroscopic approach without fogging the visualization or having to remove and re-insert the hysteroscope many times throughout the procedure. Resecting intracavitary myomas often is difficult though especially necessary in trying to re-instate fertility because of loss of vision due to excised intrauterine tissue and bubbles, as well as having to reinsert the scope multiple times, thus increasing the opportunity for air embolism. This was yet another new product designed to remove fibroids with minimal impact on future pregnancy.
George Vilos MD, of St. Joseph's Health Care (London, Ontario), presented "Temporary Incisionless Occlusion of Uterine Arteries for Treatment of Symptomatic Uterine Myomas: Is it Feasible and Safe?," in which he demonstrated a novel method of eliminating fibroids non-surgically by using the Flostat device from Vascular Control Systems (VCS; San Juan Capistrano, California). He performed this incisionless procedure on 17 women with menorrhagia caused by fibroids and then evaluated them at three months. He found that using this device, he simulated comparable outcomes as could be expected with uterine artery embolization (UAE) but without the extreme cramping often associated with UAE. He plans on re-evaluating these patients at six months and one year to follow their progress.
Moises Lichtinger, MD, of Holy Cross Hospital (Fort Lauderdale, Florida), presented "Transvaginal Occlusion of the Uterine Arteries for Symptomatic Leiomyomas: Clinical Outcome," where he also used the Flostat device from VCS and studied 10 patients with 3 cm or larger intramural fibroids. He placed the Doppler-guided vaginal clamps on the uterine artery using a vaginal approach and left the clamps on the patients for six hours, during which they were under a spinal epidural. The clamps were removed after six hours, and the patients were kept overnight, although it is expected that following the clinical trials the patients can go home immediately after the clamps are removed. MRIs were performed preand post-operatively to demonstrate fibroid infarction and death. He found 100% fibroid infarction with a reduction in volume of 31% to 51% at one month similar to that found with UAE. There were no adverse effects. Lichtinger had previously performed 100 laparoscopic uterine artery ligations for the treatment of fibroids and found that these 10 patients with temporary occlusion of their arteries behaved very similarly to those with permanent surgical occlusions. This suggests that ischemia to the uterus for even a short time may be enough to kill off fibroids. Of the 10 patients in Lichtinger's study, he was able to detect and close the uterine arteries transvaginally 100% of the time with no serious adverse effects. This initial data indicates that temporary occlusion of the uterine arteries may be a successful treatment for symptomatic fibroids.
Dr. Mark Glasser, MD, of Kaiser Permanente Medical Center (San Rafael, California), suggested from the podium that for next year's program there should be a study on patients with dysfunctional uterine bleeding that may have myoma involvement. He proposed that a combination treatment of endometrial uterine ablation, along with Vascular Control Systems' non-surgical uterine artery occlusion, be used to provide these patients with optimum outcomes and solicited e-mail responses from the audience on this subject.
Glasser also presented "Minilap Myomectomy: A Minimally Invasive Alternative to Laparoscopic Myomectomy," where he outlined the benefits and downsides to this hybrid procedure (Table 6). He found that performing minilap myomectomies produced similar outcomes as a laparoscopic myomectomy but was much less costly.
ACMI (Southborough, Massachusetts) did not have a new tangible product at its exhibit booth but rather described a novel gynecology residents' training program that can be utilized free of charge online. It is a comprehensive knowledge-based program that trains the resident in minimally invasive women's health procedures how to diagnose and treat most conditions, including myomas, and the various treatment modalities available.
Although not pertaining to uterus-conserving procedures, but definitely minimally invasive and non-surgical, Novasys Medical (Newark, California) had a booth for the first time at AAGL and was demonstrating its non-surgical, in-office approach to stress urinary incontinence. Results from an institutionally approved, prospective pilot clinical trial were presented by J.P. Lenihan, MD, of Tacoma Women's Specialists (Tacoma, Washington), on 16 patients that were treated with the Renessa system from Novasys, which uses radio frequency (RF) energy to remodel the collagen lining of the urethra. All 16 patients completed their non-surgical, transurethral treatment without the need to convert to intravenous anesthesia. This trial found that their device and treatment for female stress urinary incontinence could be safely performed using only local and oral anesthetic comparable to those routinely used for other in-office treatments performed in the U.S. Based on the demonstrated success of oral plus local anesthesia, a larger subsequent U.S. clinical trial of the non-surgical Novasys treatment has been initiated, with the treatment phase recently successfully completed.