Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas.

OBJECTIVE: To evaluate the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas. METHODS: In this prospective, multicenter, single-arm interventional trial, transcervical ablation was performed on 1-10 leiomyomas per patient with leiomyoma diameters ranging from 1 to 5 cm. Treated leiomyomas included all nonpedunculated types. Coprimary endpoints assessed at 12 months were reduction in menstrual blood loss and absence of surgical reintervention. Additional assessments included symptom severity, quality of life, patient satisfaction, reductions in uterine and leiomyoma volumes, and safety. RESULTS: One hundred forty-seven patients were enrolled and treated in the United States and Mexico. The study met its coprimary endpoints at 12 months (N=143; full analysis set), because 64.8% of patients (95% CI 56.3-72.6%) experienced 50% or greater reduction in menstrual bleeding and 99.3% of patients (95% CI 95.1-99.9%) were free from surgical reintervention. The mean pictorial blood loss assessment chart score decreased by 38.9%, 48.4%, and 51.1% at 3, 6, and 12 months, respectively (P<.001), and 95.1% of patients experienced a reduction in menstrual bleeding at 12 months. There were significant mean improvements in symptom severity and health-related quality of life of 32.1 points and 43.7 points, respectively, at 12 months (all P<.001). Mean maximal leiomyoma volume reduction per patient was 62.4% (P<.001). More than half of patients returned to normal activity within 1 day, 96.3% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the treatment at 12 months. There were no device-related adverse events. CONCLUSION: Transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events and a low surgical reintervention rate through 12 months, demonstrating its potential to safely and effectively treat all nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02228174. FUNDING SOURCE: Supported by Gynesonics, Inc.

Use of Uterine Characteristics to Improve Fertility-Sparing Diagnosis of Adenomyosis.

Objective: To describe patient demographics, determine accuracy of clinical diagnosis, and evaluate reliability of laparoscopic uterine characteristics in the diagnosis of adenomyosis. Materials and Methods: Enrollment included 117 patients undergoing laparoscopic hysterectomy for benign indications. Intraoperatively, the attending surgeon predicted uterine weight; evaluated the presence of fibroids; and commented on the uterus' shape, color, and consistency while probing it with a blunt instrument. A prediction was also made about whether final pathology would reveal adenomyosis. Standardized video recordings were obtained at the start of the case. Each video was viewed retrospectively twice by three expert surgeons in a blinded fashion. Uterine characteristics were reported again with a prediction of whether or not there would be a pathologic diagnosis of adenomyosis. These data were used to calculate inter-and intrarater reliability of diagnosis. Results: Women with adenomyosis were more likely to complain of midline pain as opposed to lateral or diffuse pain (p = 0.048) with no difference in the timing of the pain (p = 0.404), compared to patients without adenomyosis. Uterine tenderness on examination was not an accurate predictor of adenomyosis (p = 0.566). Preoperative diagnosis of adenomyosis by clinicians was poor, with an accuracy rate of 51.7%. None of the intraoperative uterine characteristics were significant for predicting adenomyosis on final pathology, nor was any combination of the features (p = 0.546). Retrospective video reviews failed to reveal any uterine characteristics that generated consistent inter- or intrarater reliability (Krippendorff's α < 0.7) in making the diagnosis of adenomyosis. Conclusions: Clinical and video diagnosis of adenomyosis have low accuracy with no uterine characteristics consistently or reliably predicting adenomyosis on final pathology. (J GYNECOL SURG 34:183).

Characterization and Preoperative Risk Analysis of Leiomyosarcomas at a High-Volume Tertiary Care Center.

INTRODUCTION: Uterine morcellation in minimally invasive surgery has recently come under scrutiny because of inadvertent dissemination of malignant tissue, including leiomyosarcomas commonly mistaken for fibroids. Identification of preoperative risk factors is crucial to ensure that oncologic care is delivered when suspicion for malignancy is high, while offering minimally invasive hysterectomies to the remaining patients. OBJECTIVES: The aim of this study was to characterize risk factors for uterine leiomyosarcomas by reviewing preoperative, intraoperative, and postoperative data with an emphasis on the presence of concurrent fibroids. METHODS: A retrospective case-control study of women undergoing hysterectomy with pathologic diagnosis of uterine leiomyosarcoma at a tertiary care center between January 2005 and April 2014. RESULTS: Thirty-one women were identified with leiomyosarcoma and matched to 124 controls. Cases with leiomyosarcoma were more likely to have undergone menopause and to present with larger uteri (19- vs 9-week sized), with the most common presenting complaint being a pelvic mass (35.5% vs 8.9%). Controls were ten times more likely to have undergone a tubal ligation (30.6% vs 3.2%). Endometrial sampling detected malignancy preoperatively in only 50% of cases. Leiomyosarcomas were more commonly present when pelvic masses were identified in addition to fibroids on preoperative imaging. Most leiomyosarcoma cases (77.4%) were performed by oncologists via an abdominal approach (83.9%), with only 2 of 31 leiomyosarcomas being morcellated. Comparative analysis of preoperative imaging and postoperative pathology showed that in patients with leiomyosarcoma, fibroids were misdiagnosed 58.1% of the time, and leiomyosarcomas arose directly from fibroids in only 6.5% of cases. CONCLUSIONS: Leiomyosarcoma risk factors include older age/postmenopausal status, enlarged uteri of greater than 10 weeks, and lack of previous tubal ligation. Preoperative testing failed to definitively identify leiomyosarcomas, although the presence of synchronous pelvic masses in fibroid uteri should raise clinical suspicion. Given the difficulty of preoperative identification, future efforts should focus on the development of safer minimally invasive techniques for uterine morcellation.

Should endocervical curettage routinely be performed at the time of colposcopy? A cost-effectiveness analysis.

OBJECTIVES: Endocervical curettage (ECC) has been used with colposcopy-directed biopsy to increase diagnostic sensitivity for detecting cellular abnormality. Our objective was to determine if routine ECC was cost-effective compared with colposcopy alone in women with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion cervical cytology, who are older and younger than 50 years. MATERIALS AND METHODS: We generated a cost-effectiveness model using outcomes from cervical screening including repeat Pap smears, colposcopy, and loop electrosurgical excision procedure. Cervical cancer costs, survival, as well as incidence and complications after loop electrosurgical excision procedure (preterm birth, cervical stenosis, dysmenorrhea, amenorrhea, and infertility) were modeled. Cost and probability values were obtained from published literature and Medicare databases. Direct medical costs were analyzed in 2011 US dollars. Effectiveness outcomes were cervical cancer deaths and incident cases of cancer prevented. Model robustness was evaluated using probabilistic sensitivity analysis. RESULTS: For women older than 50 years, routine ECC is the dominant strategy (less expensive and more effective at reducing cervical cancer deaths/incidence). For women younger than 50 years, routine ECC costs $96,737 more per cervical cancer death prevented. Cost per incident cancer case prevented ranged from $21,894 (local spread or greater) to $235,873 (distal spread). Sensitivity analysis confirmed these conclusions. In women older than 50 years, routine ECC was always the most likely cost-effective choice. In women younger than 50, routine ECC was most likely cost-effective for all willingness-to-pay thresholds greater than $80,000 to prevent 1 cancer death. CONCLUSIONS: In women older than 50 years, routine ECC is favored over colposcopy alone because this strategy is cost saving and reduces the number of cancer deaths and incident cancer cases. For women younger than 50 years, cost-effectiveness is dependent on willingness to pay to prevent 1 cancer death but still seems to be cost-effective.