世界妇产科学内窥镜检查法大会 （ 2000-11）

 

世界妇产科学内窥镜检查法大会

2000年11月15-19日

美国佛罗里达州奥兰多

Conference Report
The Global Congress on Gynecologic Endoscopy
November 15-19, 2000
Orlando, Florida

Mark D. Levie, MD

 

Introduction

The Global Congress on Gynecologic Endoscopy was convened at the Orlando World Center Marriott from November 15-19, 2000. Physicians from 45 countries attended this year's meeting, which was sponsored by the American Association of Gynecologic Laparoscopists. A broad spectrum of topics was covered, including reviews of many aspects of both laparoscopy and hysteroscopy. Attendants were treated to lively debates between leaders in the field as well as live telesurgery from around the world.

The meeting began with a live cadaveric dissection of pelvic anatomy performed by Dr. Andrew I. Brill, University of Illinois at Chicago, and Robert M. Rogers, Jr., University of Pennsylvania School of Medicine, West Reading. This demonstration allowed attendants a rare opportunity to view all the structures that course the pelvic brim into the pelvis and to visualize the 3 surgical layers of the pelvic sidewall as well as the anatomy of the space of Retzius. The importance of knowing the anatomy of the pelvis and retroperitoneal spaces for all gynecologic surgeons was stressed.

Hysteroscopy

The evaluation and management of patients with abnormal uterine bleeding was a central issue at the meeting. The proper evaluation of these patients was discussed as were the successes and advantages of many of the new technologies for endometrial ablations. Also debated were the preparation of the endometrial lining with such agents as gonadotropin-releasing hormone (GnRH) agonists and the effects of medical therapy and its influence on cervical dilatation and fluid intravasation.

Evaluation of Abnormal Uterine Bleeding: Office Hysteroscopy vs Saline Infusion Sonography (SIS)

In the past, evaluation of abnormal uterine bleeding entailed the blind sampling of the endometrial cavity with either dilatation and curettage or office endometrial biopsy. These techniques are relatively accurate for detecting cancer but are not sensitive for detecting structural abnormalities such as polyps or fibroids. Office hysteroscopy has become part of the gynecologist's armamentarium for the evaluation of abnormal uterine bleeding. It is well tolerated by patients and enables direct visualization and sampling of the endocervical canal as well as the endometrial lining. This allows for greater accuracy in detecting intracavitary lesions that may have been missed using a blind technique. However, it is important to realize that the technique is not perfect, and there is a false-negative rate of 2% to 4%.^[1]

During a postgraduate course discussion, Dr. Linda Bradley, The Cleveland Clinic Foundation, Cleveland, Ohio, discussed the advantages of using transvaginal ultrasound and SIS for the evaluation of abnormal uterine bleeding. Given the fact that most gynecologists perform diagnostic hysteroscopies in the operating room and that the office equipment for hysteroscopy is expensive, Bradley noted, hysteroscopy will be used as a purely operative procedure, for directed biopsies of focal lesions, or when the SIS is equivocal. Support for this position was provided by Dr. H.K. Basu, Fawklan Manor Hospital, Longford, Kent, UK, who presented a study of patients with menorrhagia resistant to medical management.^[2] She found that SIS may be used as a screening tool to decrease the need for hysteroscopy.

Transvaginal ultrasound is especially useful in postmenopausal patients to determine endometrial thickness. In a large multicenter study of postmenopausal women with an endometrial echo of less than 4 mm, the sensitivity and specificity of this technique for detecting endometrial pathology were 96% and 68%, respectively.^[3] Of note is that if 5 mm was used as a cutoff limit, 2 endometrial carcinomas would have been missed in 1168 women with postmenopausal bleeding. Transvaginal ultrasound also allows for the evaluation of the entire uterus as well as the adnexa. The problem with transvaginal ultrasound is that it is not sensitive for diagnosing such intracavitary lesions as polyps or fibroids. In such cases, the addition of SIS has helped. Polyps and fibroids within the endometrial lining are easily delineated with the installation of 5-30 cc of saline. Goldstein and colleagues^[4] have reported on the benefits of this technique in triaging patients with perimenopausal bleeding and for evaluation of patients on tamoxifen.^[5] The addition of SIS improves both sensitivity and specificity when compared with transvaginal ultrasound.^[6] SIS is a safe, well-tolerated, and cost-effective procedure that can help direct appropriate management of abnormal uterine bleeding.

Endometrial Ablation

Menorrhagia is a common condition. .Excessive menstruation can alter the quality of a woman's life. Many women with menorrhagia have been treated with hysterectomy. However, more recently, women are choosing more conservative surgical options that allow for maintenance of the uterus.

In a randomized trial comparing hysterectomy with ablation techniques, it was found that ablation was superior to hysterectomy in terms of operative complications and postoperative recovery. Satisfaction after hysterectomy was significantly higher, but between 70% and 90% of women were satisfied with the outcome of hysteroscopic surgery. After 12 months, 89% in the hysterectomy group and 78% in the hysteroscopy group were very satisfied with the effect of surgery (P < .05); 95% and 90%, respectively, thought that there had been an acceptable improvement in symptoms. The investigators concluded that hysteroscopic surgery can be recommended as an alternative to hysterectomy for dysfunctional uterine bleeding.^[7]

The current gold standards for endometrial ablation are the first-generation techniques, including the Nd:YAG laser, the resectoscopic loop, and the electrosurgical rollerball, all performed under hysteroscopic guidance. Dr. Ray Garry, WEL Foundation, South Cleveland Hospital, Middlesborough, UK, cited a yet unpublished Scottish audit of 11,664 endometrial ablations performed and noted a very low complication rate with perforations occurring in 1.4% of cases, bleeding in 2.4%, burns in 0.03%, and death in 0.03%.^[8] The overall complication rate is low, between 1.25% and 4.6%, and very few cases have severe complications. In general, the rate of repeat procedures is in the range of 13% to 15%, and subsequent hysterectomy will be required in 11% to 21%.

Although a subsequent hysterectomy rate of 20% after endometrial ablation may seem high, 80% of women who otherwise would have had a hysterectomy will avoid it with an endometrial ablation. Of note was the fact that those patients with intrauterine pathology (fibroid or polyps) had a lower risk of subsequent hysterectomy.^[9] The overall satisfaction rates for all these procedures is in the range of 85% to 90%, with amenorrhea rates of 25% to 60%.

Second-generation Endometrial Ablation Techniques

It has become clear that the first-generation endometrial ablation techniques are safe and effective, yet they continue to be underutilized. This is largely due to the need for specialized training and fear of complications such as excessive fluid absorption. It is because of this that several new technologies for endometrial ablation have come to the forefront. These techniques seek to destroy the full thickness of the endometrial lining while avoiding the risks associated with and expertise needed to use the first-generation techniques.

There are several problems associated with these newer technologies, however. First and foremost is their safety. Many of the second-generation techniques require blind placement of laser, thermal, or microwave energy. While complication rates are low in the hands of the experts, there is the concern of higher rates of perforations and subsequent catastrophic injuries when the technology is used by the general gynecologist. Another issue is the cost of these new technologies, as many require expensive generators and use disposable instrumentation. The additional cost as compared with the cost for first-generation techniques can only be justified if these devices are significantly easier and quicker to use and at least as, if not more, effective.

At the conference, all these new technologies were presented in detail, with information on the rates of amenorrhea, hypomenorrhea, eumenorrhea, and persistent menorrhagia.

Cryogen First-Option Uterine Cryoablation

Data were presented from a multicenter randomized trial that investigated cryoablation (using 2 freeze cycles, 4 minutes and 6 minutes) under ultrasound guidance for women with abnormal uterine bleeding.^[10] The overall success rate was 80%, with an amenorrhea spotting rate of 48%. The amenorrhea and success rates were improved with longer first-freeze times of 5-7 minutes.

NovaSure Endometrial Ablation Device

This system consists of a disposable 3-dimensional bipolar device and radiofrequency generator that enables a customized, controlled, contoured endometrial ablation in an average of 90 seconds. At 12-month follow-up, an approximate 55% amenorrhea rate was noted, and the overall success rate ranged from 83% at 6 months to 100% at 1 year.^[11]

Endometrial Laser Intrauterine Thermal Therapy

This technique uses intrauterine laser thermotherapy with a diode laser. There are 3 prongs to this diode laser that fan out on introduction into the uterine cavity. The power used per unit area is far less than that used in the Nd:YAG laser. The amenorrhea rate at 1 year was 71%, and the amenorrhea/severe hypomenorrhea rate was 90%.^[12]

Microwave Endometrial Ablation (MEA)

MEA was the subject of many presentations at this year's meeting. Microwave energy is introduced into the endometrial cavity via an 8-mm intrauterine applicator. The intrauterine temperature is monitored on a display and helps guide the ablation process. In a randomized trial that compared MEA with transcervical resection (TCRE) of the endometrium, Dr. K. Cooper (Aberdeen Royal Infirmary, Aberdeen, UK) and colleagues^[13] noted that both techniques led to substantial and equivalent reductions in bleeding and pain scores. Amenorrhea rates were 50% for MEA and 40% for TCRE. Operating times, analgesic requirements, length of postoperative stay, and morbidity were all less for MEA than for TCRE. One out of 1433 patients reported by Dr. E. Downes (Women's Diagnostic Unit Chase Farm Hospital, The Ridgeway, Enfield, Middlesex, UK) and colleagues^[14] had a major complication involving a small burn in the bowel.

One of the potential advantages of MEA is the possibility of treating patients with submucosal myoma who would be excluded from some of the other global techniques. Dr. T. Hayes (Royal United Hospital Bath, Combe Park, Bath, UK) and colleagues^[15] noted that in 27 patients with submucosal myomas, 84% reported satisfaction with MEA. Dr. N.C. Sharp (Royal United Hospital, Bath, UK) and colleagues^[16] concluded from a study of 526 women who had MEA that on the basis of life survival analysis, 81% of patients would avoid hysterectomy 5 years after initial MEA.

Thermal Balloon Techniques

These techniques entail the use of heated solution within a balloon. The Cavaterm thermal balloon ablation is used predominately in Europe, and the Thermachoice system is used in the United States. In a comparative study by Dr. J.A. Abbott (South Cleveland Hospital, Middlesborough, UK) and colleagues,^[17] the Cavaterm achieved amenorrhea rates equal to those of Nd:YAG laser endometrial ablation. The duration of treatment with Cavaterm is 15 minutes.

Dr. B. Fridberg^[18] (LUND University Hospital, Lund, Sweden) reported a 94% success rate with this technique at 6-year follow-up. Excellent satisfaction was reported by 91% of women, and good satisfaction by 6%. In the past, the Thermachoice has been found to have lower amenorrhea rates than the rollerball technique, but patient satisfaction rates were similar. In a follow-up of 150 patients undergoing Thermachoice endometrial ablation 2-4 years prior, a 90% success rate was achieved, which had not decreased with time.^[19] No repeat treatments and no complications were noted. Use of this method in patients with renal disease (making them high risk for hysterectomy) was presented.^[20] The amenorrhea, hypomenorrhea, and eumenorrhea rates were 45%, 34%, and 21%, respectively. No patients had menorrhagia, and all tolerated the procedure well.

Hydro ThermAblator (HTA)

Unlike all of the other global endometrial ablation techniques, HTA is not a blind procedure but is carried out under direct visualization. The HTA sheath is inserted under hysteroscopic visualization. A cool flushing hysteroscopy is performed with 0.9% saline and followed by infusion of saline heated to 90°C and circulated for 10 minutes. In a study presented by Dr. S.L. Corson^[21] (Thomas Jefferson University School of Medicine, Philadelphia, Pennsylvania), ThermAblator and rollerball endometrial ablation were compared at 1-year follow-up. HTA treatment was as efficacious overall as hysteroscopic rollerball ablation with regard to amenorrhea rates.

Conclusions

It seems from all the above data that most of these second-generation techniques have similar success and satisfaction rates when compared with the first-generation techniques. The major concern of safety is addressed differently by the various technologies. The Thermachoice and NovaSure technologies have certain safety checks before initiation that should prevent activation if perforation occurs. The HTA is done under direct visualization and, given the low pressures used, has not been associated with tubal spillage, which might lead to bowel burns. Concerns about the blind nature of the MEA technique, which was realized in a bowel injury, may be addressed by using transvaginal ultrasonography to establish proper placement.

With regard to the fear of perforation and activation of the endometrial laser intrauterine thermotherapy system, Dr. J. Donnez (Catholic University of Louvain, Cliniques Universitaires St.Luc, Brussels, Belgium) believed that the unit could not be deployed anywhere if not in the endometrial cavity. A note of caution is warranted, however, because most of the studies presented involved small samples followed up for short periods of time. The long-term safety and efficacy of these devices remains to be determined. Hopefully, 1 or more of these technologies will become a cost-effective and simple method that can be widely used.

Preoperative Preparation for Endometrial Ablation

The issue of whether preoperative preparation of the endometrial lining is necessary was the topic of a panel that discussed improving results with adjuvant therapy for endometrial ablation. Dr. G.A. Vilos (University of Western Ontario, London, Ontario, Canada) and colleagues^[22] presented the results of a double-blind, randomized study that compared the use of goserelin acetate with placebo. Injections were given every 28 days for 8 weeks; endometrial ablation was performed 6 weeks after the first injection. At 3 years, 337 of 350 women were evaluated. Patients who had received goserelin acetate had an amenorrhea rate of 21%, as compared with 14% in the placebo group (P = .0571). The surgical intervention rate was low in both groups: the rate of hysterectomy was 21% in the goserelin-treated group and 15% in the placebo group; repeat ablation was necessary for 5.6% of patients in the goserelin-treated group and for 2.1% of patients in the placebo group.

On discussion of this paper, it was clear to all that, especially in less experienced hands, preparation with a GnRH agonist makes the procedure easier, faster, and safer and may lead to better success. However, many of the more experienced hysteroscopists were not convinced that the additional cost, especially of multiple injections, warranted its use over simple mechanical preparation at the time of endometrial ablation. The discussants did not believe that use of birth control pills or medroxyprogesterone acetate (MPA) was good for preparation, because they can lead to an edematous stroma. Dr. Douglas R. Phillips (School of Medicine, SUNY at Stony Brook, Stony Brook, New York) did believe that success was slightly improved with a second GnRH agonist injection at the conclusion of endometrial ablation. Dr. M. Goldrath^[23] (Wayne State University, Detroit Michigan) presented a small study that evaluated whether the administration of MPA immediately postoperatively would improve endometrial ablation results in patients with submucosal myomas or adenomyosis. He noted a higher amenorrhea rate and lower failure rate in the treated group.

Medical Therapy and its Influence on Cervical Dilatation and Fluid Intravasation

Dr. Phillips presented some interesting findings on the use of dilute vasopressin injected into the cervix before endometrial ablation. He found that cervical dilatation was significantly easier when dilute pitressin was used. Furthermore, fluid intravasation was significantly decreased and blood loss decreased with use of vasopressin.^[24] He also presented his findings of different temperatures distending fluid on intravasation, blood loss, and the likelihood of developing hypothermia. No clinically significant differences were seen with distention medium used at 4°C or heated to 37°C.^[25]

Medical Management With a Levonorgestrel-Releasing Intrauterine Device (IUD) Compared With Endometrial Ablation

In an interesting presentation, Dr. A. Maucher^[26](Theresienhoehe, Huerth, Germany) reported on a retrospective analysis that compared hysteroscopic endometrial ablation with a levonorgestrel-releasing IUD in patients with normal cavities. Successful treatment occurred in 100% of women with the IUD (hypomenorrhea, amenorrhea). All women had slight but annoying acyclic uterine bleeding over a period of 2-8 months. No other problems or complications were noted. Endometrial ablation failed in 8% of women, and 15% were amenorrheic, 50% were hypomenorrheic, and 27% were eumenorrheic. This study points out the role of medical intervention in treatment of abnormal uterine bleeding when no pathology is identified. Using this IUD may reduce surgical risks with reasonable success rates.

Managing Patients With Large Symptomatic Fibroids

The management of patients with large uterine myomas by uterine artery embolization (UAE) vs myomectomy was the topic of a general session debate. Transient uterine ischemia by uterine artery occlusion has been shown to be effective in treating the primary symptoms of myomas, namely menorrhagia and bulk symptoms. Resolution of symptoms, with the bulk symptoms improving over 12 months, occurs in 85% to 90% of patients.^[27] The procedure has the advantage of being global,^[28] affecting all fibroids, and being durable over time.^[29]

The patients who fail UAE may be predictable, as they may already have undergone degeneration. Patients who respond to GnRH analog therapy should respond to UAE. Dr. A. Al-Badr (University of Ottawa, Ottawa Hospital-General Campus, Ottawa, Ontario, Canada) and colleagues^[30] presented their experience with UAE and noted a 96% success rate with no major complications. Mean myoma shrinkage was 69% at 1.5 years. Symptomatic improvement at 3 months was 86%. At 18 months, symptomatic improvement occurred in 4 of 6 patients. Although there are many advantages to this procedure, some of the negative aspects were pointed out by those who favor laparoscopic myomectomy. First, they noted that although the quoted complication rates are lower than those for both myomectomy and hysterectomy, some of the side effects can be quite undesirable. Premature ovarian failure can occur after embolization with polyvinyl alcohol particles in approximately 5% of cases.^[31] This can also occur in patients undergoing hysterectomy even without bilateral salpingo-oophorectomy. This sequelae certainly could affect the patient's ability to conceive as well as putting her at increased risk of a prolonged hypoestrogenic state.

In a study of surgical conversions after uterine myoma embolization, 361 women underwent UAE; 14 surgical conversions, 12 hysterectomies, and 2 myomectomies occurred. Indications for conversions included infection, delayed postembolization pain, treatment failures, suspicion of malignancy, and actual malignancy. Rates of infection requiring urgent hysterectomy were low.^[32] Anecdotally, patients undergoing surgery after embolization, especially with large subserous myomas, had extensive adhesive disease. At the FIGO meeting held earlier this year in Washington, Dr. J.H. Ravina, Hôpital Lariboisière, Paris, France, has suggested that possible myomectomy after embolization, especially of dominant subserosal myomas, may be warranted. Furthermore, the large submucosal myoma may be prone to infection as well as prolapse.

The largest controversy has to do with fertility and subsequent pregnancies. Those who support myomectomy rely on a large body of evidence showing improvement in patients receiving fertility treatment whose only etiology for infertility is fibroids. Pregnancies in such patients are relatively uncomplicated except for the possible need for cesarean section for delivery, and there is a slight increase in risk of uterine rupture when the endometrial integrity is compromised. Information regarding fertility and pregnancy post-UAE is much more limited. While successful pregnancies have been reported, some questions of increased pregnancy loss have been raised. Furthermore, the risk of premature ovarian failure must be considered in these patients.

Last, 2 papers were presented that dealt with surgical uterine artery ligation for myomas.^[33,34] This procedure allows for management of the myomas by the gynecologist without involvement of interventional radiologists. Furthermore, it allows for visualization of the entire pelvis and treatment of any concomitant pathology. This does require the ability to isolate the uterine arteries, however, and, as seen in one of the series, does entail a risk of ureteric injuries.^[34] The results seem to be comparable to those seen with UAE, although decrease in bulk may be slower.

References

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