BBI Contributing Editor
MIAMI, Florida Nearly half of the almost 1,500 members of the American Association of Gynecological Laparoscopists (Sante Fe Springs, California) attended the organization's annual meeting here in late November. This select group of gynecologic surgeons is trained in hysteroscopy, laparoscopy, endoscopy and other minimally invasive gynecologic procedures designed to improve the health of women. Many innovative technologies were highlighted during the conference, addressing issues from patient safety to early uterine prolapse.
Focusing on patient safety during laparoscopic surgery, Encision (Boulder, Colorado) offers a complete line of reusable and disposable laparoscopic instruments that incorporates "active electrode monitoring" (AEM). Each instrument is shielded and monitored so as to dynamically and continuously monitor the flow of electrosurgical current, thereby eliminating unintended burns to the patient, a recognized risk in minimally invasive surgery. Remote burns from monopolar electrosurgical instruments have been well documented over many years and can cause delayed and sometimes deadly complications following surgery.
In laparoscopic surgery, the risk is even greater because the instrument is long and the stray current may easily be out of the surgeon's view since he can only see 10% of the surgical field at any one time. The Encision active electrode monitoring system completely eliminates any risk of stray electrosurgical burns. In fact, some hospital insurers offer a 10% discount to hospitals that incorporate the Encision monitoring system and instruments because it can prevent potential lawsuits due to stray burns.
The market potential is large (see Table 4 on page 11) and although Encision has doubled its sales and converted 300 hospitals over the past three years, it has only scratched the surface of the potential $650 million market worldwide. That is due to the fact that it is going up against industry giants such as United States Surgical (Norwalk, Connecticut), a division of Tyco Healthcare (Exeter, New Hampshire), and Ethicon Endo-Surgery (Cincinnati, Ohio), a division of Johnson & Johnson (New Brunswick, New Jersey), as well as other laparoscopic instrument manufacturers including Gyrus (Maple Grove, Minnesota) and Valleylab (Boulder, Colorado).
Hysterectomies are the most commonly performed procedure for benign uterine problems, with more than 600,000 hysterectomies performed each year in the U.S. A growing number of women today no longer accept removal of an otherwise healthy organ they want the underlying problem resolved. Likewise, insurance carriers prefer not to pay for a potentially unnecessary surgery. Because of these pressures to retain a symptomatic but healthy uterus, new ways of dealing with fibroids, endometrial bleeding, painful intercourse and pelvic pain have had to be developed in order to avoid performing a hysterectomy.
With fewer hysterectomies being performed, and more women keeping their uterus, two common conditions often occur: Prolapse, where the uterus drops from its normal position in the pelvic cavity, and retroversion, a condition in which the uterus is tipped backwards. With a retroverted uterus, there can be pain associated with intercourse or menstruation. In a standing-room-only breakfast seminar during the AAGL meeting, privately held Inlet Medical (Eden Prairie, Minnesota) introduced its procedure kits designed to simplify pelvic reconstructive surgical procedures that address these conditions, as well as others.
Inlet Medical's Metra procedure kit contains specialized medical instruments, designed to help gynecologists treat women who suffer from a retroverted uterus by shortening and strengthening the round ligaments via the Uplift procedure. The Uplift procedure is a surgical procedure used to treat a retroverted uterus whereby the round ligaments are shortened and strengthened to restore the uterus to its anatomically correct position and relieve symptoms. The minimally invasive laparoscopic procedure can be performed in about 12 minutes and requires minimal recovery time. James Presthus, MD, of Fairview Southdale Hospital (Minneapolis, Minnesota), emphasized the demand he is seeing from young patients who are contacting him to perform the Uplift procedure for retroverted uterus because it allows them to keep their uterus, relieve their pain, and have pregnancies later objectives that a hysterectomy cannot meet (see Table 5).
Before Inlet's Elevest procedure kit was available for treating uterine prolapse, the conventional treatment was biofeedback, pessaries, or if those failed, hysterectomy. Industry estimates are that 11% of the female population actually has surgery for prolapse, although it is believed that a much larger patient pool exists but is unaware that there are therapies for this condition. It is known that about one-third or 200,000 of all hysterectomies are performed because of uterine prolapse, and according to Karen Rae Abbott, MD, of Athena Women's Medical Group (San Carlos, California), by 2020, some 40 million women in the U.S. alone will have uterine prolapse. The Elevest procedure repositions the uterus to its normal place in the pelvis by utilizing both the round and uterosacral ligaments. One of the target markets for this product is the post-delivery woman suffering from prolapse who still may want to have another child. Another target is active baby boomers who do want to undergo a hysterectomy and have uterine prolapse. Inlet said it believes the possibilities for its products are numerous.
Vaginal vault support or the lack thereof is considered to be the highest morbidity following hysterectomy. Weakened ligaments that support the vagina can lead to a variety of gynecological problems. The newest procedure kit from Inlet Medical, Avesta, is designed to address this condition. The kit makes it faster and easier for surgeons to reattach the uterosacral ligaments during vaginal vault suspension post-hysterectomy. It simplifies the suturing process, making this type of surgery accessible to more surgeons. Presthus advocates that prophylactic support be performed on all laparoscopic supracervical or laparoscopic hysterectomies. Reimbursement codes are assigned for both therapeutic and prophylactic vaginal vault support procedures
Sometimes a simple, elegant medical solution to a problem becomes embroiled in a political battle over patient management and the procedure is not made readily available to patients until the issues are resolved. That is the case with uterine artery embolization (UAE), a procedure that noninvasively eliminates fibroids but it is not performed by a gynecologist who first sees the patient, but rather by an interventional radiologist who is not trained in gynecology. Fibroids that cause heavy bleeding account for one-third of the 600,000 hysterectomies performed annually in the U.S. In addition, it is predicted that another 750,000 myomectomies (fibroid removal) will be performed in the U.S. in 2002. But currently fewer than 35,000 of these cases are treated noninvasively by UAE because gynecologists do not perform uterine artery embolization.
In 1995 in an effort to reduce bleeding during myomectomy, a gynecologist and a neuroradiologist in Paris tried embolizing the uterine arteries that feed the fibroids, causing the blood flow to be stopped long enough to clot the uterus. With surprising results, not only did they temporarily stop the bleeding during the surgery, but any remaining fibroids died. Since then, the UAE technique has become popular among interventional radiologists for shrinking fibroids without surgery. Typically, small microspheres are injected into the uterine arteries to occlude blood flow to the uterus and when blood flow is re-established through collateral vessels, the uterus recovers but the fibroids die. Biosphere Medical (Rockland, Massachusetts), the first company to manufacture microspheres for this purpose, gained FDA clearance for its Embosphere in November.
Four independent studies on UAE have been performed, all showing between 86% and 91% effectiveness in the control of uterine bleeding from fibroids, and uterine volume decreases of 48% to 58% in all four studies as well, further demonstrating the procedure's effectiveness. Francis Hutchins, MD, professor of ob/gyn at Howard University (Washington), moderator of a panel discussion during the AAGL gathering, compared the cost of UAE at $3,100 to that of a total abdominal hysterectomy at $4,900. But even with positive surgical and economic outcomes for this procedure, it remains difficult for a patient to get a UAE because most gynecologists do not want to refer to a interventional radiologist (IR), who is the physician actually performing the procedure. Ob/gyns often fear losing control over the patient, other times they fear the loss of income for a hysterectomy. But Robert Worthington-Kirsch, MD, of Roxborough Memorial Hospital (Philadelphia, Pennsylvania), demonstrated that a) there are more than enough fibroid patients to keep both a gynecologist and an interventional radiologist busy and b) that a gynecologist actually receives far lower compensation for a hysterectomy than he does for routine office visits.
In the discussion that followed these presentations, it was agreed upon by all three panel members that in the case of a single, resectable, submucosal fibroid, it should be excised using operative hysteroscopy and that UAE should be reserved for multiple, large, or deep fibroids. Indications and contraindications for UAE are listed in Table 6.
All indications are that it is better for both the gynecologist and the patient for the patient to undergo a UAE rather than a hysterectomy or a myomectomy. But unless there is widespread cooperation among interventional radiologists and gynecologists, the 15,000 to 20,000 UAE procedures out of a potential 200,000 plus probably will grow very slowly.
In response to the success that the interventional radiologists have had with uterine artery embolization, there have been several attempts at methods that would allow a gynecologist to perform a similar procedure. Olav Istre, MD, of Ulleval University Hospital (Oslo, Norway), presented his experience with ligating (as opposed to embolizing) the uterine arteries to treat fibroids. He compared two groups of patients, 26 who had a UAE performed and 26 who underwent laparoscopic ligation of the uterine artery. The volume reduction of the uterus and fibroids was practically equivalent for both groups, as was the amount of pain and patient satisfaction. The main concern among U.S. surgeons in ligating the uterine artery is that the procedure is permanent. Many U.S.-trained gynecologists have been taught to use uterine artery ligation as a last-ditch effort to stop uterine bleeding during delivery or surgery. Using the "ligation option" leaves the patient vulnerable for any future event.
In another attempt to at least locate the uterine arteries intravaginally, JG Garza-Leal, MD, of Universidad Autonoma de Nuevo Leon (Monterrey, Mexico), presented findings assessing the feasibility of audible Doppler-guided intravaginal identification and occlusion of uterine arteries. He concluded that it was feasible to access and control uterine arteries through the vagina without incisions. This could form the groundwork for a technique by which gynecologists could address UAE in their own way and maintain control of their patients without having to refer them to an interventional radiologist. If so, hundreds of thousands of patients will be able to gain relief from symptomatic fibroids without surgery.