Faculty Bibliography

STUDY OBJECTIVE/OBJECTIVE:To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas. DESIGN/METHODS:Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1). SETTING/METHODS:University hospitals and private surgical centers. PATIENTS/METHODS:One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL). INTERVENTIONS/METHODS:Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS/RESULTS:One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. CONCLUSION/CONCLUSIONS:RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.

OBJECTIVE:To estimate the safety and efficacy of laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women. METHODS:A cohort of 135 premenopausal symptomatic women with uterine myomas, uteri 14 weeks of gestation-sized or less with no single myoma exceeding 7 cm, and objectively confirmed heavy menstrual bleeding participated in this prospective, international trial of outpatient laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation. Bleeding outcomes were measured by alkaline hematin analysis at baseline and again at 3, 6, and 12 months posttreatment. Validated quality-of-life and patient satisfaction scales and objective measurements of uterine and myoma volume were conducted at 3, 6, and 12 months. RESULTS:The mean baseline menstrual blood loss of women in the full analysis set (n=127) was 272.7±82.3 mL. At 3-, 6-, and 12-month follow-ups, mean alkaline hematin and associated menstrual blood loss decreased from baseline levels by 31.8%, 40.7%, and 38.3%, respectively (P<.001, paired t test). Symptom severity decreased from a baseline mean transformed score of 61.1 to 26.6 at 12 months postprocedure (P<.001, paired t test). Health-related quality of life improved from a mean transformed score of 37.3 at baseline to 79.5 at 12 months (P<.001, paired t test). At 12 months postprocedure, total mean myoma volume decreased from baseline by 45.1% (measured by magnetic resonance imaging). There was one serious adverse event (one of 135 [0.7%]) requiring readmission 5 weeks postprocedure and one surgical reintervention for persistent bleeding. Ninety-four percent of the women reported satisfaction with the treatment. CONCLUSION/CONCLUSIONS:Radiofrequency volumetric thermal ablation of myomas is well tolerated and results in rapid recovery, high patient satisfaction, improved quality of life, and effective symptom relief. CLINICAL TRIAL REGISTRATION/BACKGROUND:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00874029. LEVEL OF EVIDENCE/METHODS:II.

OBJECTIVE:To determine the prevalence of nucleolar channel systems (NCSs) by uterine region, applying continuous quantification. DESIGN/METHODS:Prospective clinical study. SETTING/METHODS:Tertiary care academic medical center. PATIENT(S)/METHODS:Forty-two naturally cycling women who underwent hysterectomy for benign indications. INTERVENTION(S)/METHODS:NCS presence was quantified by a novel method in six uterine regions-fundus, left cornu, right cornu, anterior body, posterior body, and lower uterine segment (LUS)-with the use of indirect immunofluorescence. MAIN OUTCOME MEASURE(S)/METHODS:Percentage of endometrial epithelial cells (EECs) with NCSs per uterine region. RESULT(S)/RESULTS:NCS quantification was observer independent (intraclass correlation coefficient 0.96) and its intrasample variability low (coefficient of variation 0.06). Eleven of 42 hysterectomy specimens were midluteal, ten of which were analyzable with nine containing >5% EECs with NCSs in at least one region. The percentage of EECs with NCSs varied significantly between the LUS (6.1%; interquartile range [IQR] 3.0-9.9) and the upper five regions (16.9%; IQR 12.7-23.4), with fewer NCSs in the basal layer of the endometrium (17 ± 6%) versus the middle (46 ± 9%) and luminal layers (38 ± 9%) of all six regions. CONCLUSION(S)/CONCLUSIONS:NCS quantification during the midluteal phase demonstrates uniform presence throughout the endometrial cavity, excluding the LUS, with a preference for the functional luminal layers. Our quantitative NCS evaluation provides a benchmark for future studies and further supports NCS presence as a potential marker for the window of implantation.

BACKGROUND: Immediate postplacental insertion of intrauterine devices (IUDs) during cesarean delivery could reduce a substantial barrier to access to long-term effective contraception. Initiating IUD use prior to discharge from the hospital postpartum eliminates a 6-week postpartum waiting period and an additional office visit. STUDY DESIGN: This was a prospective cohort study of 90 patients undergoing cesarean delivery. After delivery of the placenta, a copper T380A IUD was inserted into the endometrial cavity through the incision. The study participants were followed up at 6 weeks and 6 months postpartum. This study was conducted at the Weiler Division of the Montefiore Medical Center and at the Jacobi Medical Center in the Bronx, NY. RESULTS: Forty-three (48%) women returned for their 6-week follow-up visits, and among those, no expulsions were recorded. Forty-two (47%) women were reached for phone follow-up at 6 months postpartum, and 80% reported being "happy" or "very happy" with their IUD. CONCLUSIONS: Immediate postplacental IUD insertion at the time of cesarean delivery is safe and acceptable.

OBJECTIVE:To assess the effectiveness of an educational program in visual inspection with acetic acid (VIA) for cervical cancer screening among healthcare providers in 2 low-resource countries. METHODS:A cohort of multidisciplinary healthcare workers in Uganda and El Salvador were recruited to the study. A pretest was administered before the intervention of a 5-day educational program on VIA. A posttest was performed immediately after the educational program and again at a 6-month follow-up visit to assess retention of knowledge. RESULTS:In total, 42 (93%) of the healthcare workers who participated in the educational program completed the initial posttest evaluation, and 18 (40%) healthcare workers completed the 6-month follow-up evaluation. Mean test scores increased after participation in the training session (62% versus 81%; P<0.001). The self-reported comfort level for identifying cellular abnormalities also increased (2.1 versus 3.3; P<0.001). At 6-month follow-up, the mean test score remained higher than pretest scores (79% versus 57%; P<0.001). There was no significant difference in the initial and 6-month posttest scores (80% versus 79%; P=0.20). CONCLUSION/CONCLUSIONS:The educational program in VIA provided healthcare workers with the tools potentially to decrease the morbidity and mortality of cervical cancer in the 2 low-resource countries.

OBJECTIVE:To assess whether a novel educational curriculum using a simulation teaching laboratory improves resident knowledge, comfort with, and surgical performance of hysteroscopic sterilization. DESIGN/METHODS:An educational prospective, pretest/posttest study. SETTING/METHODS:The Montefiore Institute of Minimally Invasive Surgery Laboratory. PATIENT(S)/SUBJECT(S): Thirty-four OB/GYN residents in an academic medical center. INTERVENTION(S)/METHODS:Hysteroscopic sterilization simulation laboratory and a brief didactic lecture. MAIN OUTCOME MEASURE(S)/METHODS:Differences in scores on validated skill assessment tools: Task specific checklist, Global Rating Scale (GRS), pass fail assessment, and a multiple-choice examination to evaluate knowledge and attitude. RESULT(S)/RESULTS:In the entire cohort improvements were observed on all evaluation tools after the simulation laboratory, with 31% points (SD+/-11.5, 95% confidence interval [CI] 27.3-35.3) higher score on the written evaluation; 63% points (SD+/-15.7, 95% CI 57.8-68.8) higher score on the task specific checklist; and 54% points (SD+/-13.6, 95% CI 48.8-58.3) higher score on the GRS. Higher PGY status was correlated with better pretest performance, but was not statistically significant in posttest scores. Residents reported an improvement in comfort performing the procedure after the laboratory. CONCLUSION(S)/CONCLUSIONS:Simulation laboratory teaching significantly improved resident knowledge, comfort level, and technical skill performance of hysteroscopic sterilization.