BBI Contributing Editor
LAS VEGAS, Nevada The 32nd annual meeting of the American Association of Gynecological Laparoscopists (AAGL; Santa Fe Springs, California), was held here the week prior to Thanksgiving, with the buzz in the exhibit area during peak hours resembling the cacophany of nearby casinos. One of the most-discussed topics was treatment for menorrhagia, a condition that drives six million women in for medical treatment annually, whether it is caused from dysfunctional uterine bleeding or fibroids. The distinction between the two causes is in itself a debate, but basically if fibroids can be ruled out as the cause of the excessive menstrual bleeding, then it is called dysfunctional uterine bleeding (DUB).
Currently, treatment for DUB is different than the treatment for fibroids, although until recently, both were reasons for hysterectomy, accounting for about 200,000 hysterectomies performed annually in the U.S. For bleeding caused by DUB, endometrial ablation is rapidly becoming the widely accepted alternative to hysterectomy. Endometrial ablation removes the inner lining of the uterus using an energy source, provides some percentage of patients with amenorrhea, and is recommended only for women who have completed their families. This is an outpatient, and sometimes office-based, procedure performed under local anesthesia or conscious sedation, and the patient returns home shortly afterwards.
Fibroids often are removed one by one surgically, frequently laparoscopically, in order to allow the patient to keep her uterus and maintain her fertility. Interventional radiologists developed a procedure in 1999 called a uterine fibroid embolization (UFE), which stops the blood flow through the uterine arteries to the uterus killing all the fibroids, and upon a natural reperfusion process, the uterus returns to normal with normal monthly menses. The problem with UFE is that it requires a referral from gynecologists who intrinsically want to keep and treat the patient themselves.
A new entry into the endometrial ablation market was presented in several of the sessions and poster presentations. Microsulis Americas (Pompano Beach, Florida), a privately funded and privately held company, launched its Microwave Endometrial Ablation System (MEA) with a show-stopping booth performance rivaling Las Vegas shows. Since Microsulis received its FDA approval in September as the latest of five firms with endometrial ablation (EA) products, the grandiose launch was warranted in order to get the attention of doctors who may already have been considering using another competitive device. The company's product uses microwave energy that heats the uterus to 70 degrees and takes 3.5 minutes to perform. Because it paints the uterus rather than inserts a standard-size balloon, any uterus, including those with anatomical anomalies, can be treated.
Although the risk is low, Ted Anderson, MD, chairman of gynecology at Centennial Women's Hospital (Nashville, Tennessee), discussed corrective interventions in his presentation, "Optimizing Outcomes by Proactive Physician Engagement." He showed that with proper patient selection, ultrasound screening and preoperative hysteroscopy, there were no adverse events in 6,640 procedures using the Microsulis system.
Five companies currently are selling into the EA market, each with an individual approach to the form of energy delivery that destroys the uterine lining which stops the bleeding. A poster presentation by S.E. Gurtchef, MD, of the University of Utah (Salt Lake City, Utah), collected and compared all data related to the five companies' endometrial ablation procedures as reported in both Medline PubMed and the FDA's MAUDE database. All showed very low complication rates and high patient satisfaction rates (see Table 1).
Still in clinical trials and not yet available in the U.S. is the Thermablate endometrial ablation device, manufactured by MDMI Technologies (Richmond, British Columbia), which will be the sixth such device on the market once it receives approval. It delivers a high-temperature fluid through a balloon that is placed in the uterus then expanded until pressure is applied to all surfaces of the uterus obtaining uniform contact throughout. Although somewhat similar to the Thermachoice product from Johnson & Johnson's (New Brunswick, New Jersey) Gynecare (Somerville, New Jersey) unit, the Thermablate device heats the fluid externally instead of inside the balloon, creating higher temperatures and shorter treatment times as well as being totally automated. A multicenter trial is set to begin soon at eight hospitals in Canada and U.S. and, with positive results, anticipated FDA approval following this year.
Gynecare and Conceptus (San Carlos, California) have joined forces in an interesting play to boost sales of both the Thermachoice EA product and the permanent contraception Essure product. Under the terms of the agreement, Gynecare sales reps will position the Essure product as an adjunct to Thermachoice EA procedure since, as with all endometrial ablation procedures, a subsequent pregnancy could be risky to the mother and fetus, and according to all FDA labeling for EA devices, contraception is required following EA procedures. The idea focuses on patient convenience and resource conservation, allowing the patient to have two procedures done at the same time. This provides the Gynecare sales force a new product to sell and the Conceptus sales force entree to a broad base of installed customers. It will be interesting to see if other endometrial ablation companies also join forces with a permanent contraception company.
While endometrial ablation treats the inside lining of the uterus, treatments for fibroids address the entire uterus, including the intramural area and even fibroids that protrude outside of the uterus (see Table 2 on below). Uterine fibroids are the most common tumor found in women, causing symptoms which may include severe pain and excessive menstrual bleeding in approximately 15 million women in the U.S. alone. If a woman wants to maintain her fertility, the only option to treat her fibroids and avoid a hysterectomy is myomectomy, or surgical excision of fibroids, which can be performed in a number of ways, but the fibroids often recur.
Uterine artery embolization (UAE) is an interventional procedure introduced in 1995 that injects small microspheres into the uterine artery, stopping blood flow to the uterus, causing the uterus to clot; effectively starving all fibroids of their blood supply. Collateral blood flow to the uterus ensues shortly thereafter, returning the uterus to normal menses but the fibroids necrose and are flushed out of the woman's system. Although UAE is very effective, performed in an outpatient setting and maintains a woman's fertility, it appears to have leveled off in popularity to approximately 25,000 procedures annually in the U.S. a mere pittance of the potential patient pool available. This lack of growth in procedure numbers stems from the fact that interventional radiologists must rely on a gynecologist's referral, and most gynecologists prefer to treat their own patients rather than refer them to a non-gynecologist, especially since many of these patients will continue on as an obstetrical patient.
This all may be changing, though, due to a start-up company's efforts to enable gynecologists to perform essentially the same UAE procedure, but with a small device that is inserted through the vagina, temporarily cutting off the blood supply to the uterine arteries and thus killing all the fibroids. Privately held Vascular Control Systems (VCS; San Juan Capistrano, California) has developed a set of tools that can identify and occlude blood vessels without visualization or surgery designed for gynecologists to perform several procedures that rely on blood flow management, the primary one being for uterine artery occlusion (UAO). In fact, Vascular Control's VCS device which received FDA approval just as this issue was going to press in mid-December was the recipient of the award for "Best New Instrumentation" at the AAGL meeting. The award was presented to Olaf Istre, MD, of Ullevaal Univerity Hospital (Oslo, Norway), the author of the winning paper, "Temporary Bilateral Uterine Artery Occlusion with Paracervical Clamp for Treatment of Symptomatic Fibroids." In his presentation, he evaluated the feasibility and safety of temporary bilateral uterine artery occlusion using a Doppler-guided paracervical clamp for treating women with symptomatic fibroids. He found that this new technique enabled gynecologists to treat these women without incision or surgery in an outpatient setting that avoids a hysterectomy. The uterine and fibroid volume reductions reported were similar to the results reported for uterine artery embolization and uterine artery occlusion.
In a similar presentation, J.G. Garza-Leal, of the School of Medicine at the Universidad Autonoma De Nuevo Leon (Monterrey, Mexico), demonstrated the use of the same device for the treatment of adenomyosis in addition to uterine fibroids. He found that the incisionless intravaginal occlusion of the uterine arteries for a short period of time may be an efficacious therapeutic modality in the treatment of menorrhagia associated with fibroids or adenomyosis.
By far the most well-attended session at AAGL, a standing-room-only affair, was a panel discussion titled, "The Obsolescence of Hysterectomy for the Treatment of Uterine Fibroids," chaired by Francis Hutchins Jr., MD, of the department of obstetrics and gynecology at Thomas Jefferson University (Philadelphia, Pennsylvania). Hutchins is the gynecologist who pioneered the study of UAE to treat fibroids. The session discussed the advantages and disadvantages of all current modalities to treat fibroids including medical treatments, mechanical uterine artery occlusion (Vascular Control's device), surgical uterine artery occlusion (which is technically challenging), and uterine artery embolization.
James Spies, MD, associate professor of radiology at Georgetown University (Washington), presented the UAE data and maintained that the biggest "con" to the debate point was that it was not performed by gynecologists. There were six other presentations, all using the same device from Vascular Control Systems that demonstrated safety and efficacy of temporary artery occlusion. Vascular Control Systems also will be conducting additional trials for prevention of obstetrical bleeding and the treatment of fibroids. It appears that the company may have found a way for gynecologists to perform uterine artery occlusion safely, in an outpatient setting, and most importantly, with the ability to follow the patient themselves throughout the entire treatment process.