George A. Vilos

Pregnancy after uterine artery embolization for leiomyomata: the Ontario multicenter trial.

OBJECTIVE: To report on pregnancies and deliveries occurring in a large cohort of women who underwent uterine artery embolization instead of surgery for symptomatic leiomyomata. METHODS: A total of 555 women underwent uterine embolization in a multicenter clinical trial. The primary embolic agent was 355–500 μm polyvinyl alcohol particles with treatment end-point as bilateral stasis in the uterine arteries. Women desiring pregnancy were informed of the uncertain effect of embolization on fertility and pregnancy. Average age at embolization was 43 years (range 18–59 years). Thirty-one percent were younger than age 40 years. Women were followed up prospectively by telephone, and obstetric records of the women who conceived were reviewed. RESULTS: Twenty-one women of average age 34 years (range 27–42 years) conceived, (3 of these twice), and 13 women were nulliparous. Twenty-three of the 24 pregnancies were conceived spontaneously (1 woman had in vitro fertilization). There were 4 spontaneous abortions (16.7%, 95% confidence interval 5.4–41.9%) and 2 elective pregnancy terminations. Fourteen of the 18 live births were full term and 4 were preterm. There were 9 vaginal deliveries and 9 cesarean deliveries, 4 of which were elective. Abnormal placentation occurred in 3 cases, all nulliparas (12.5% 95% confidence interval 3.1–36.3%). Two cases developed placenta previa (1 had a clinical partial accreta) and the third developed a placenta membranacea with accreta resulting in cesarean hysterectomy. Three postpartum hemorrhages all secondary to placental abnormalities occurred. Four newborns were small for gestational age (≤ 5th percentile); 2 of these pregnancies were complicated by gestational hypertension. CONCLUSION: Women are able to achieve pregnancies after uterine artery embolization, and most resulted in term deliveries and appropriately grown newborns. Close monitoring of placental status, however, is recommended. LEVEL OF EVIDENCE: II-3

The Management of Uterine Leiomyomas

OBJECTIVES The aim of this guideline is to provide clinicians with an understanding of the pathophysiology, prevalence, and clinical significance of myomata and the best evidence available on treatment modalities. OPTIONS The areas of clinical practice considered in formulating this guideline were assessment, medical treatments, conservative treatments of myolysis, selective uterine artery occlusion, and surgical alternatives including myomectomy and hysterectomy. The risk-to-benefit ratio must be examined individually by the woman and her health care provider. OUTCOMES Implementation of this guideline should optimize the decision-making process of women and their health care providers in proceeding with further investigation or therapy for uterine leiomyomas, having considered the disease process and available treatment options, and reviewed the risks and anticipated benefits. EVIDENCE Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2013, using appropriate controlled vocabulary (uterine fibroids, myoma, leiomyoma, myomectomy, myolysis, heavy menstrual bleeding, and menorrhagia) and key words (myoma, leiomyoma, fibroid, myomectomy, uterine artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia). The reference lists of articles identified were also searched for other relevant publications. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date limits but results were limited to English or French language materials. Searches were updated on a regular basis and incorporated in the guideline to January 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, and national and international medical specialty societies. BENEFITS, HARMS, AND COSTS The majority of fibroids are asymptomatic and require no intervention or further investigations. For symptomatic fibroids such as those causing menstrual abnormalities (e.g. heavy, irregular, and prolonged uterine bleeding), iron defficiency anemia, or bulk symptoms (e.g., pelvic pressure/pain, obstructive symptoms), hysterectomy is a definitive solution. However, it is not the preferred solution for women who wish to preserve fertility and/or their uterus. The selected treatment should be directed towards an improvement in symptomatology and quality of life. The cost of the therapy to the health care system and to women with fibroids must be interpreted in the context of the cost of untreated disease conditions and the cost of ongoing or repeat investigative or treatment modalities. VALUES The quality of evidence in this document was rated using the criteria described in the Report of the Caadian Task Force on Preventive Health Care (Table 1). Summary Statements 1. Uterine fibroids are common, appearing in 70% of women by age 50; the 20% to 50% that are symptomatic have considerable social and economic impact in Canada. (II-3) 2. The presence of uterine fibroids can lead to a variety of clinical challenges. (III) 3. Concern about possible complications related to fibroids in pregnancy is not an indication for myomectomy except in women who have had a previous pregnancy with complications related to these fibroids. (III) 4. Women who have fibroids detected in pregnancy may require additional maternal and fetal surveillance. (II-2) 5. Effective medical treatments for women with abnormal uterine bleeding associated with uterine fibroids include the levonorgestrel intrauterine system, (I) gonadotropin-releasing hormone analogues, (I) selective progesterone receptor modulators, (I) oral contraceptives, (II-2) progestins, (II-2) and danazol. (II-2) 6. Effective medical treatments for women with bulk symptoms associated with fibroids include selective progesterone receptor modulators and gonadotropin-releasing hormone analogues. (I) 7. Hysterectomy is the most effective treatment for symptomatic uterine fibroids. (III) 8. Myomectomy is an option for women who wish to preserve their uterus or enhance fertility, but carries the potential for further intervention. (II-2) 9. Of the conservative interventional treatments currently available, uterine artery embolization has the longest track record and has been shown to be effective in properly selected patients. (II-3) 10. Newer focused energy delivery methods are promising but lack long-term data. (III) Recommendations 1. Women with asymptomatic fibroids should be reassured that there is no evidence to substantiate major concern about malignancy and that hysterectomy is not indicated. (III-D) 2. Treatment of women with uterine leiomyomas must be individualized based on symptomatology, size and location of fibroids, age, need and desire of the patient to preserve fertility or the uterus, the availability of therapy, and the experience of the therapist. (III-B) 3. In women who do not wish to preserve fertility and/or their uterus and who have been counselled regarding the alternatives and risks, hysterectomy by the least invasive approach possible may be offered as the definitive treatment for symptomatic uterine fibroids and is associated with a high level of satisfaction. (II-2A) 4. Hysteroscopic myomectomy should be considered first-line conservative surgical therapy for the management of symptomatic intracavitary fibroids. (II-3A) 5. Surgical planning for myomectomy should be based on mapping the location, size, and number of fibroids with the help of appropriate imaging. (III-A) 6. When morcellation is necessary to remove the specimen, the patient should be informed about possible risks and complications, including the fact that in rare cases fibroid(s) may contain unexpected malignancy and that laparoscopic power morcellation may spread the cancer, potentially worsening their prognosis. (III-B) 7. Anemia should be corrected prior to proceeding with elective surgery. (II-2A) Selective progesterone receptor modulators and gonadotropin-releasing hormone analogues are effective at correcting anemia and should be considered preoperatively in anemic patients. (I-A) 8. Use of vasopressin, bupivacaine and epinephrine, misoprostol, peri-cervical tourniquet, or gelatin-thrombin matrix reduce blood loss at myomectomy and should be considered. (I-A) 9. Uterine artery occlusion by embolization or surgical methods may be offered to selected women with symptomatic uterine fibroids who wish to preserve their uterus. Women choosing uterine artery occlusion for the treatment of fibroids should be counselled regarding possible risks, including the likelihood that fecundity and pregnancy may be impacted. (II-3A) 10. In women who present with acute uterine bleeding associated with uterine fibroids, conservative management with estrogens, selective progesterone receptor modulators, antifibrinolytics, Foley catheter tamponade, and/or operative hysteroscopic intervention may be considered, but hysterectomy may become necessary in some cases. In centres where available, intervention by uterine artery embolization may be considered. (III-B).

Laparoscopic Entry: A Review of Techniques, Technologies, and Complications

OBJECTIVE To provide clinical direction, based on the best evidence available, on laparoscopic entry techniques and technologies and their associated complications. OPTIONS The laparoscopic entry techniques and technologies reviewed in formulating this guideline include the classic pneumoperitoneum (Veress/trocar), the open (Hasson), the direct trocar insertion, the use of disposable shielded trocars, radially expanding trocars, and visual entry systems. OUTCOMES Implementation of this guideline should optimize the decision-making process in choosing a particular technique to enter the abdomen during laparoscopy. EVIDENCE English-language articles from Medline, PubMed, and the Cochrane Database published before the end of September 2005 were searched, using the key words laparoscopic entry, laparoscopy access, pneumoperitoneum, Veress needle, open (Hasson), direct trocar, visual entry, shielded trocars, radially expanded trocars, and laparoscopic complications. VALUES The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on the Periodic Health Examination. RECOMMENDATIONS AND SUMMARY STATEMENT: 1. Left upper quadrant (LUQ, Palmers) laparoscopic entry should be considered in patients with suspected or known periumbilical adhesions or history or presence of umbilical hernia, or after three failed insufflation attempts at the umbilicus. (II-2 A) Other sites of insertion, such as transuterine Veress CO(2) insufflation, may be considered if the umbilical and LUQ insertions have failed or have been considered and are not an option. (I-A) 2. The various Veress needle safety tests or checks provide very little useful information on the placement of the Veress needle. It is therefore not necessary to perform various safety checks on inserting the Veress needle; however, waggling of the Veress needle from side to side must be avoided, as this can enlarge a 1.6 mm puncture injury to an injury of up to 1 cm in viscera or blood vessels. (II-1 A) 3. The Veress intraperitoneal (VIP-pressure </= 10 mm Hg) is a reliable indicator of correct intraperitoneal placement of the Veress needle; therefore, it is appropriate to attach the CO(2) source to the Veress needle on entry. (II-1 A) 4. Elevation of the anterior abdominal wall at the time of Veress or primary trocar insertion is not routinely recommended, as it does not avoid visceral or vessel injury. (II-2 B) 5. The angle of the Veress needle insertion should vary according to the BMI of the patient, from 45 degrees in non-obese women to 90 degrees in obese women. (II-2 B) 6. The volume of CO(2) inserted with the Veress needle should depend on the intra-abdominal pressure. Adequate pneumoperitoneum should be determined by a pressure of 20 to 30 mm Hg and not by predetermined CO(2) volume. (II-1 A) 7. In the Veress needle method of entry, the abdominal pressure may be increased immediately prior to insertion of the first trocar. The high intraperitoneal (HIP-pressure) laparoscopic entry technique does not adversely affect cardiopulmonary function in healthy women. (II-1 A) 8. The open entry technique may be utilized as an alternative to the Veress needle technique, although the majority of gynaecologists prefer the Veress entry. There is no evidence that the open entry technique is superior to or inferior to the other entry techniques currently available. (II-2 C) 9. Direct insertion of the trocar without prior pneumoperitoneum may be considered as a safe alternative to Veress needle technique. (II-2) 10. Direct insertion of the trocar is associated with less insufflation-related complications such as gas embolism, and it is a faster technique than the Veress needle technique. (I) 11. Shielded trocars may be used in an effort to decrease entry injuries. There is no evidence that they result in fewer visceral and vascular injuries during laparoscopic access. (II-B) 12. Radially expanding trocars are not recommended as being superior to the traditional trocars. They do have blunt tips that may provide some protection from injuries, but the force required for entry is significantly greater than with disposable trocars. (I-A) 13. The visual entry cannula system may represent an advantage over traditional trocars, as it allows a clear optical entry, but this advantage has not been fully explored. The visual entry cannula trocars have the advantage of minimizing the size of the entry wound and reducing the force necessary for insertion. Visual entry trocars are non-superior to other trocars since they do not avoid visceral and vascular injury. (2 B).

Laparoscopic treatment of interstitial pregnancy

The conventional treatment of interstitial pregnancy has been cornual resection of hysterectomy by laparotomy. We have used a laparoscopic approach to treatment of interstitial pregnancy, consisting of cornual excision in four patients and salpingotomy incision via the myometrium in another. In all five cases, the procedure was associated with minimal bleeding and no complications.

Consensus Guidelines for the Management of Chronic Pelvic Pain

OBJECTIVE To improve the understanding of chronic pelvic pain (CPP) and to provide evidence-based guidelines of value to primary care health professionals, general obstetricians and gynaecologists, and those who specialize in chronic pain. BURDEN OF SUFFERING: CPP is a common, debilitating condition affecting women. It accounts for substantial personal suffering and health care expenditure for interventions, including multiple consultations and medical and surgical therapies. Because the underlying pathophysiology of this complex condition is poorly understood, these treatments have met with variable success rates. OUTCOMES Effectiveness of diagnostic and therapeutic options, including assessment of myofascial dysfunction, multidisciplinary care, a rehabilitation model that emphasizes achieving higher function with some pain rather than a cure, and appropriate use of opiates for the chronic pain state. EVIDENCE Medline and the Cochrane Database from 1982 to 2004 were searched for articles in English on subjects related to CPP, including acute care management, myofascial dysfunction, and medical and surgical therapeutic options. The committee reviewed the literature and available data from a needs assessment of subjects with CPP, using a consensus approach to develop recommendations. VALUES The quality of the evidence was rated using the criteria described in the Report of the Canadian Task Force on the Periodic Health Examination. Recommendations for practice were ranked according to the method described in that report (Table 1). RECOMMENDATIONS The recommendations are directed to the following areas: (a) an understanding of the needs of women with CPP; (b) general clinical assessment; (c) practical assessment of pain levels; (d) myofascial pain; (e) medications and surgical procedures; (f) principles of opiate management; (g) increased use of magnetic resonance imaging (MRI); (h) documentation of the surgically observed extent of disease; (i) alternative therapies; (j) access to multidisciplinary care models that have components of physical therapy (such as exercise and posture) and psychology (such as cognitive-behavioural therapy), along with other medical isciplines, such as gynaecology and anesthesia; (k) increased attention to CPP in the training of health care professionals; and (l) increased attention to CPP in formal, high-calibre research. The committee recommends that provincial ministries of health pursue the creation of multidisciplinary teams to manage the condition. CHAPTER 7: MYOFASCIAL DYSFUNCTION: 1. Health care providers should become more aware of myofascial dysfunction as a cause of chronic pelvic pain (CPP) and the available treatment options (IB). 2. Patients should participate in the management of CPP due to myofascial dysfunction by actively using a home stretching and exercise program (ll-2B). CHAPTER 8: MEDICAL THERAPY--EVIDENCE ON EFFECTIVENESS: 1. Opioid therapy can be considered for pain control under adequate supervision (II-3B). 2. Hormonal treatment of chronic pelvic pain of gynaecologic origin, including oral contraceptives, progestins, danazol, and gonadotropin-releasing hormone agonists, has been studied extensively and should be considered as the first line for many women, especially those with endometriosis (I and II-1A). 3. Adjuvant medications, such as antidepressants and antibiotics, can be of supporting help in specific situations (II-3B). CHAPTER 9: SURGERY-EVIDENCE ON EFFECTIVENESS: 1. The lack of robust clinical trials of the surgical management of chronic pelvic pain should be addressed. The use of alternative epidemiologic models, including case-controlled and cohort-controlled trials, should be considered (III-A). 2. Further delineation of the role of appendectomy and of presacral neurectomy appears warranted in the management of endometriosis-related pain (III-A). CHAPTER 11: MULTIDISCIPLINARY CHRONIC PAIN MANAGEMENT: 1. Multidisciplinary chronic pain management should be available for women with chronic pelvic pain within the publicly funded health care system in each province and territory of Canada (III-B). CHAPTER 14: FUTURE DIRECTIONS 1. The curriculum for professional development should be expanded to include theory and techniques in the management of myofascial dysfunction (A). 2. Research into CPP should be encouraged, particularly in the areas of the impact of CPP on the use of health services, the pathophysiology of myofascial dysfunction, and gene therapy. Because randomized trials for qualitative outcomes are exceedingly difficult, alternative robust models, such as case-controlled or cohort-controlled trials, should be pursued (A). 3. Methods of improving interaction with patients should be explored. They might include formal contractual approaches to managing pain with opiates and efforts to better appreciate the patients perceived needs (A).

Tolerance, hospital stay, and recovery after uterine artery embolization for fibroids: The Ontario uterine fibroid embolization trial

PURPOSE Uterine artery embolization (UAE) is gaining popularity as an alternative to hysterectomy for the treatment of fibroids. Although minimally invasive treatments such as UAE offer the potential of fewer complications, shorter hospital stay, and quicker recovery than surgery, there have been few published data on tolerance and recovery in patients undergoing UAE. MATERIALS AND METHODS This was a multicenter prospective single-arm clinical treatment trial involving the practices of 11 interventional radiologists in eight Ontario university-affiliated and community hospitals. Between November 1998 and November 2000, 555 women underwent UAE for symptomatic uterine fibroids. Follow-up included ultrasound examinations and telephone interviews. UAE was performed under conscious sedation. Polyvinyl alcohol particles (355-500 micro m) were the primary embolic agent, and the procedural endpoint involved stasis in the uterine arteries. Pain protocols included antiinflammatory medications and narcotics and a planned overnight hospital admission. Tolerance and recovery were measured by patient-reported pain intensity (10-point numeric rating and five-point descriptor scale), hospital length of stay (LOS), and time until return to work. RESULTS Intraprocedural pain was reported by 30% of patients and postprocedural pain was reported by 92% of patients (mean pain rating +/- SD, 7.0 +/- 2.47). The mean hospital LOS was 1.3 nights. Postprocedural pain was the most common indication for an LOS greater than 1 night (18%) or 2 nights (5%). Return visits to the hospital (10%) and readmissions (3%) were primarily for pain. The overall postprocedural complication rate was 8.0% (95% CI: 5.9%-10.6%). Of the 44 complications, 32 (73%) were pain-related. The mean recovery time after UAE was 13.1 days (median, 10.0 d). CONCLUSION The majority of patients had a 1-night LOS after UAE and recovered within 2 weeks. Postprocedural pain varied considerably and was the major indication for extended hospital stay and recovery.

EXPERIENCE WITH 800 HYSTEROSCOPIC ENDOMETRIAL ABLATIONS

STUDY OBJECTIVE To determine the safety and efficacy of hysteroscopic endometrial ablation in women with menometrorrhagia. DESIGN Retrospective record review. SETTING A credentialing program in teaching and nonteaching hospitals. PATIENTS Eight hundred women who underwent endometrial ablation in 54 hospitals, with indications of abnormal uterine bleeding disrupting lifestyle, postmenopausal bleeding during hormone replacement therapy, poor surgical risk for hysterectomy, or desire to preserve the uterus. INTERVENTIONS Seventy percent of the patients were treated with danazol 100 to 600 mg/day for 6 to 12 weeks, 8% received gonadotropin-releasing hormone analogs, 7% received progestins, and 15% were given no preoperative treatment. Under appropriate anesthesia the cervix was dilated to 10 mm and the uterine cavity was distended with 1.5% glycine solution under gravity inflow of 80 to 100 cm water and outflow suction of 80 to 100 mm Hg pressure. Electrocoagulation with or without resection was completed using 100 and 125 W, respectively. MEASUREMENTS AND RESULTS At 12 months 60% of patients reported amenorrhea, 29% hypomenorrhea, 6% eumenorrhea, and 5% no change. Repeat ablation was performed in 4% of patients. An additional 2% had hysterectomy for malignancy (endometrium 2, sarcoma 1, atypical hyperplasia 1), pelvic pain (4), fibroids (4), persistent bleeding (3), and endometritis (2). The complication rate was 3.9%: false passage during cervical dilatation (6), uterine perforation (dilator 4, resectoscope 2, Laminaria 1), fluid absorption greater than 1500 ml (8), minor bleeding (5), endomyometritis (4), and intrauterine pregnancy (1). CONCLUSIONS Hysteroscopic endometrial ablation is a safe and effective treatment for women with menometrorrhagia.

Clinical trial of the uterine thermal balloon for treatment of menorrhagia.

STUDY OBJECTIVES To evaluate the safety and efficacy of thermal balloon endometrial ablation in women with menorrhagia, and to identify factors influencing outcome. DESIGN Prospective, observational study (Canadian Task Force classification II-2). SETTING Three Canadian university-affiliated teaching hospitals. PATIENTS One hundred twenty-one women suffering from menorrhagia serious enough to make them candidates for endometrial ablation or hysterectomy. Patients without obvious structural or (pre)malignant abnormalities were included if their uterine cavities sounded to less than 12 cm, they were in good health, and had undergone hysteroscopy or pelvic ultrasound and endometrial biopsy within 6 months and had a normal Papanicolaou smear within 1 year. INTERVENTIONS A balloon catheter was placed through the cervix and after inflation in the endometrial cavity with 5% dextrose in water, was heated to 87 +/- 5 degrees C. Two-thirds of patients avoided general anesthesia and very few required cervical dilatation to admit the 4.5-mm diameter catheter. Balloon pressures were 90 to 140 mm Hg in 13 patients; pressures between 140 and 190 mm Hg were well tolerated by the rest. Nineteen women underwent 12 minutes of therapy, and the rest had 8-minute sessions. MEASUREMENTS AND MAIN RESULTS No intraoperative complications occurred, and minor postoperative morbidity occurred in 4% of patients. Preoperative and postoperative bleeding was assessed by pad counts and patient self-reports. The degree of dysmenorrhea was recorded similarly. A paired t test was used to compare pretreatment with posttreatment pad counts. A Wilcoxon signed rank test was employed to evaluate the effect of treatment on dysmenorrhea. The effects on outcome of several independent variables were analyzed by multiple and logistic regression. Success of the procedure was constant over the year (range 86-90%). Treatment led to significant decreases in menstrual flow, duration, and pain (p <0.0001). No significant effects of parity, uterine position or cavity depth, timing, or various endometrial-thinning regimens were found. Increasing age was significantly associated with increased odds of success (p < 0.05). Excluding the 19 women who underwent 12 minutes of therapy did not change statistical results, whereas excluding the 13 treated with balloon pressures less than 140 mm Hg improved the results. Conclusion. The facts that bleeding and dysmenorrhea were significantly reduced by thermal balloon endometrial ablation, that no intraoperative complication occurred, and that postoperative morbidity was minimal, lead us to conclude that this is potentially a safe and effective technique. Larger studies and longer follow-up are required to substantiate this impression.

ENDOMETRIAL ABLATION WITH A THERMAL BALLOON FOR THE TREATMENT OF MENORRHAGIA

STUDY OBJECTIVE To evaluate the safety and clinical efficacy of a uterine thermal balloon endometrial ablation system for the treatment of menorrhagia. DESIGN Prospective pilot study. SETTING University-affiliated teaching hospital. PATIENTS Thirty women with menorrhagia who met inclusion and exclusion criteria and signed informed consent. INTERVENTIONS Under general (9 women) or neuroleptic (21) anesthesia and paracervical block, a 16-cm long, 3-mm diameter catheter with a latex balloon at its tip, housing a heating element, was inserted blindly transcervically into the uterus and filled with sterile 5% dextrose in water solution (range 2-21 ml, mean 9.2 ml). The catheter was connected to a control unit that maintained the temperature at 87 degrees C, monitored the pressure, and terminated the treatment after 8 minutes. MEASUREMENTS AND MAIN RESULTS There were no intraoperative or postoperative complications. At 6 months 25 patients (83%) reported significant improvement in menorrhagia (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 7). By 12 months 23 women (77%) reported significant improvement (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 5). CONCLUSIONS Uterine balloon thermal therapy is a safe and effective option for women with menorrhagia. The procedure does not require additional training and expertise in operative hysteroscopy and the presently used energy sources. It requires no cervical dilatation (5 mm), is tolerated well under neuroleptic anesthesia, and potentially can be offered as an office procedure under local anesthesia.

Economic evaluation of hysteroscopic endometrial ablation versus vaginal hysterectomy for menorrhagia

Objectives To estimate societys expenses and benefits of hysteroscopic endometrial ablation and vaginal hysterectomy for the treatment of women with menorrhagia. Methods Between June 1992 and July 1993, 40 women with menorrhagia underwent vaginal hysterectomy by five surgeons in one hospital. These patients were compared retrospectively with the first 40 patients having had endometrial ablation for menorrhagia during the same period by the senior author (GAV). The age, parity, weight of patients, and uterine size were similar in both groups. Measurable variables that would incur costs included surgical time, procedure time (anesthetist and resource use in operating room), length of hospital stay, convalescence (value of patient time), and indirect costs associated with subsequent surgical procedures. Measurable benefits included reduction in blood loss and complications, and effectiveness of procedure. Results The total cost per episode of care was estimated to be