BBI Contributing Editor

SAN FRANCISCO Topics at the 53rd annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG; Washington), held here in early May, were broad and far-reaching, covering general health issues for women along with gynecology-related issues. One of the key themes resounding throughout the presentation halls was that gynecologists are the frontline physicians for women often being the only doctor a woman ever sees throughout young adulthood. To this end, there were non-gynecologic women's health topics addressed, including guidance for patients regarding their cardiovascular health, obesity counseling, and breast cancer screening along with specific topics surrounding pregnancy, delivery and gynecology.

Screening for breast cancer in young women is often neglected because insurers do not cover routine mammograms under the age of 40 and most women are not religious about self exams, leaving breast cancer detection in young women up to the very conscientious or up to their gynecologist. Most gynecologists are not as comfortable with breast exams as they are with gynecological exams, especially in younger women whose breasts have denser tissue, making it more difficult to detect a small mass. Currently, no reliable breast cancer-screening tool exists for women under the age of 40.

Data indicates that when women under the age of 40 develop breast cancer, it is often discovered at a later, more palpable stage. Since it is known that the bioelectrical signal is altered early on in atypical cancer cells, Alexander Stojadinovic, MD, of Walter Reed Army Medical Center, (Washington), presented "A Novel Technique for Primary Breast Cancer Screening in Young Women," where he evaluated the use of electrical impedance scanning for early detection of breast cancer in younger women. A total of 1,163 women were examined with an electrical impedance scanning system (T-Scan), which measures impedance across the breast in multiple frequencies. A post-processing algorithm provides a binary "suspicious" or "normal" result, and they sent those patients with "suspicious" readings on to diagnostic mammogram, ultrasound, and MRI for a more definitive diagnosis. They were able to show that women under the age of 40 with a positive electrical impedance score were seven times more likely to have breast cancer than women in the general population. Patients completed a satisfaction questionnaire following the procedure that averaged a score of 4.8 out of 5 in terms of comfort, speed, and reporting of results.

Mirabel Medical Systems (Austin, Texas) has developed this technology and is planning to apply for FDA approval for this indication. In the ob-gyn setting, this examination appears valuable for the identification of younger women who are at elevated risk for breast cancer and thus more likely to benefit from earlier, additional breast imaging. This could prove to be an efficacious screening process that will help millions of young women as well as provide for a more objective breast screening procedure that gynecologists can include in their annual exam.

Cardiovascular disease remains the No. 1 killer of women, and contrary to persistent misconceptions, cardiovascular disease claims the lives of more women each year than of men. Vivian Dickerson, MD, president of ACOG and director of ob-gyn at the University of California, Irvine, is so passionate about women's cardiovascular health that she made it one of the presidential themes and a major focus of ACOG's scientific program this year. The message was one of improving awareness for both the gynecologist and for their patients, since heart disease is a woman's greatest health threat, killing nearly 500,000 women each year more than all the cancers combined.

Of the women who survive a cardiovascular event, 35% will have another event within six years, as compared to only 18% of men survivors. A recent National Institutes of Health (NIH; Bethesda, Maryland) survey reported that only 4% of women maintain a healthy lifestyle embracing a healthy diet, regular exercise, moderate alcohol intake, and not smoking. Dickerson stressed that gynecologists need to empower their patients with knowledge of their risk factors and preventative measures they can take to enjoy a long healthy life.

Focusing more specifically on ob-gyn but still within the realm of prevention, Adeza Biomedical (Sunnyvale, California) had one of the busiest booths on the ACOG exhibit floor, indicating growing interest in its diagnostic test for indication of pre-term delivery. In normal pregnancies, labor begins after week 37 and anything prior to that is considered pre-term. About one out of every eight babies born in the U.S. is born pre-term, often resulting in serious side effects or death. Pre-term birth occurs in 12.3% of all births, but accounts for 85% of all perinatal complications and death.

Adeza has developed a simple diagnostic test for fetal fibronectin, a glycoprotein and biochemical marker, in a women's vaginal secretions at 22 to 35 weeks of pregnancy, that predicts the possibility of pre-term delivery within 99% accuracy of delivery happening within the next two weeks. This allows the physician time to determine best management for this patient and their unborn child in advance of being in a crisis situation. The exact causes of pre-term labor are not known, which is why half of the women who go into pre-term labor have no known risk factors.

In the U.S., about 1 million pregnant women come into an ER with signs and symptoms of pre-term labor every year. Of these, Adeza views about 800,000 of them as their available market and has penetrated roughly 60% of hospitals that have more than 2,000 births per year, and 65% of teaching hospitals. A stat fetal fibronectin test could be obtained in the ER, performed in the hospital lab, and provide results within one hour as to whether the patient was going into labor or could be sent back home; lending confidence to both patient and obstetrician regarding that decision. The company also is looking at high-risk pregnancies as an additional market, offering another 36 million potential tests annually based on a recommendation of three tests throughout the pregnancy.

Uterine fibroids continue to arouse interest among gynecologists because more women than ever who are presenting with symptomatic fibroids want a non-invasive way to deal with them avoiding hysterectomy if possible. This is because the aging baby boomers have kept their uteruses unlike many of their mothers and now have fibroids, a phenomenon of an "older" uterus. Many of these women have delayed pregnancy and are now facing fertility issues possibly created by the fibroids and are looking for ways to eliminate the fibroids without compromising their fertility.

A course on "Treatment of Uterine Fibroids: Non-invasive Therapy for the 21st Century" was conducted at ACOG by Elizabeth Stewart, MD, associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School (Boston). She presented the benefits and risks of uterine artery embolization (UAE), high-intensity focused ultrasound (HIFU), mechanical and electrocautery resection via hysteroscopy, as well as off-label use of mifepristone.

Stewart cautioned that when fertility is an issue, one must best match the therapy with the case specifics in order to optimize outcome. She re-minded the audience that although the literature sites successful pregnancies following UAE, more data on potential complications needs to be investigated. In general she has found that intramural fibroids are ideal for UAE while pedunculated fibroids are best suited to a laparoscopic approach her other findings are outlined in Table 7 below.

Victor Fujimoto, MD, associate professor of obstetrics, gynecology at the University of California, San Francisco, presented his findings using the InSightec (Dallas) HIFU system in the same course. He found that there was virtually no pain with HIFU, unlike the post-procedure pain found with UAE, and attributed that to the difference between ischemic necrosis (UAE) and coagulative necrosis (HIFU). According to an InSightec representative at the meeting, the company had nine HIFU units placed in the U.S. at that point, with 11 waiting to be delivered. At about $1 million each, which must be used in conjunction with a real-time MRI unit also costing about the same amount, they have priced the procedure at $12,000 to $14,000, similar to that of a UAE. Reimbursement codes for HIFU do not yet exist and the company noted that so far the patients are all self-paying a real testament towards patient demand for a non-invasive method of eliminating symptomatic fibroids.

Just around the corner from the uterine fibroids course was a presentation by Moises Lichtinger, MD, of Holy Cross Hospital (Fort Lauderdale, Florida) on "Vaginal Occlusion of the Uterine Arteries for Symptomatic Leiomyomas with a Doppler Guided Paracervical Device." His video demonstrated the use of Vascular Control Systems (San Juan Capistrano, California) non-invasive, clamp-like device that temporarily occludes the uterine artery causing the fibroids to shrink.

And, showing still more interest in non-invasive fibroid treatment, down the hall from that presentation was another on cost comparisons of the various uterine fibroid treatments. Anne Bussard, MD, of Jefferson Medical College (Philadelphia) presented "Cost and Reimbursement for Three Fibroid Treatments: Hysterectomy, Myomectomy, and Uterine Fibroid Embolization." She compared both direct and indirect costs of each of the procedures and found that only UAE made money for the hospital, albeit just $57.

She studied 540 women who were treated for fibroids only without any other concomitant disease and combined all costs including length of stay, OR costs, radiology suite costs, physician fees, and all other associated costs per procedure. She then took the total cost of each procedure and subtracted it from the reimbursement that was received. She found that the hospital makes money on UAE while losing it on myomectomies and hysterectomies, largely due to the time in the very costly OR, but the biggest loser was the gynecologist, who loses $1,018 for a procedure he doesn't perform (see Table 8). This fact, coupled with the fact that radiologists are not as comfortable with the follow-up care, may help explain why gynecologists have been reluctant to refer their patients to radiologists for UAE. However, in those areas of the country where the radiologist works with the gynecologist in caring for a UAE patient, all parties win.