Jay M. Berman

Post-Essure Hysterosalpingography Compliance in a Clinic Population

STUDY OBJECTIVE To determine the follow-up rate for post-Essure hysterosalpingography (HSG) in a non-study, general clinic population in an urban environment. DESIGN Retrospective chart review (Canadian Task Force classification II-2). SETTING University teaching hospital. PATIENTS Eighty-three University Health Center (UHC) patients who underwent attempted placement of the Essure permanent birth control device at the ambulatory surgery center at Hutzel Womens Hospital from January 2003 through June 2007. INTERVENTION Hysteroscopic placement of the Essure permanent birth control device. MEASUREMENTS AND MAIN RESULTS Placement of the Essure permanent birth control device was attempted in 83 patients, of which 79 were successfully completed (95.2%). Of the 79 patients, 10 underwent post-Essure HSG (12.7%). HSG was performed 3 to 6 months after placement of the Essure device. Bilateral tubal occlusion was documented in all 10 patients. CONCLUSION Despite preoperative and postoperative counseling, the follow-up rate for post-Essure HSG for this clinic population was only 12.7%. For those in whom HSG was performed, bilateral tubal occlusion was confirmed in all. Steps or approaches to promote compliance with postprocedural confirmation of tubal occlusion should be utilized to improve future follow-up rates.

Trends in Sterilization since the Introduction of Essure Hysteroscopic Sterilization

STUDY OBJECTIVE To investigate trends in sterilization in women at the Detroit Medical Center, Michigan (DMC), since the introduction of Essure hysteroscopic sterilization. DESIGN Retrospective study (Canadian Task Force classification II-2). SETTING Outpatient surgery center and university teaching hospitals. PATIENTS Women who underwent interval sterilization procedures at the DMC (Hutzel Womens Hospital, Sinai-Grace Hospital, and the Berry Center) and postpartum sterilization procedures at Hutzel Womens Hospital between January 1, 2002, and December 31, 2007. INTERVENTIONS Permanent sterilization procedures including minilaparotomy tubal ligation, laparoscopic sterilization, Essure hysteroscopic sterilization, and postpartum tubal ligation performed at the time of cesarean section or after vaginal delivery. MEASUREMENTS AND MAIN RESULTS In all, 5509 permanent sterilization procedures were performed in the 6 years between January 1, 2002, and December 31, 2007, at the DMC facilities analyzed: 2484 interval sterilization procedures at Hutzel Womens Hospital, Sinai-Grace Hospital, and the Berry Center, and 3025 postpartum tubal ligations at Hutzel Womens Hospital. From 2002 through 2007, the decrease in laparoscopic sterilizations from 97.9% to 48.5% of all interval sterilization procedures corresponded significantly with the increase in Essure hysteroscopic sterilizations from 0.0% to 51.3% (p <.001). Postpartum tubal ligations performed after vaginal delivery also decreased significantly during the study period from 7.9% to 3.3% of all vaginal deliveries (p <.001) while the percentage of tubal ligations performed at the time of cesarean section remained constant (p =.051). CONCLUSION At the DMC facilities analyzed from January 1, 2002, through December 31, 2007, a significant decrease occurred in the percentage of laparoscopic sterilizations and postpartum tubal ligations performed after vaginal delivery. Of the interval sterilizations performed, the percentage of Essure hysteroscopic sterilizations increased significantly from 0.0% to 51.3% of all procedures. Since the approval of Essure hysteroscopic sterilization in November 2002, this minimally invasive method of hysteroscopic sterilization has increased in popularity at the DMC.

Conservative management of cervical ectopic pregnancy: utility of uterine artery embolization

OBJECTIVE To evaluate the use of uterine artery embolization (UAE) in conjunction with methotrexate in the conservative treatment of cervical ectopic pregnancy (CEP). DESIGN Case series. SETTING Tertiary-care university hospital. PATIENT(S) Cases of CEP treated at Hutzel Womens Hospital between January 1997 and December 2008. INTERVENTION(S) Multidose methotrexate treatment with or without UAE and intra-amniotic potassium chloride injection (KCl). MAIN OUTCOME MEASURE(S) Beta-human chorionic gonadotropin level, vaginal bleeding, length of hospital stay, and future fecundity. RESULT(S) A retrospective analysis of 15 patients with CEP treated conservatively using methotrexate with leucovorin rescue (MTx/Leu) alone (group 1, five cases), with UAE as an adjunctive therapy (group 2, six cases), or also having received intra-amniotic KCl before UAE (group 3, four cases) is reported. There was no significant difference in age, parity, or gestational age among treatment groups. The median β-hCG level on presentation was 9,606 mIU/mL for group 1, 26,516 mIU/mL for group 2, and 130,464 mIU/mL for group 3. The difference was found to be statistically significant. No patients developed complications from UAE. Of the 10 patients who underwent UAE, 2 subsequently had confirmed viable pregnancies. CONCLUSION(S) Uterine artery embolization with methotrexate is an option for minimally invasive intervention in the treatment of CEP.

Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas

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: 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: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00874029. LEVEL OF EVIDENCE: II

Small bowel obstruction subsequent to Essure microinsert sterilization: a case report

OBJECTIVE To report a case of small bowel obstruction (SBO) subsequent to Essure microinsert sterilization. DESIGN Case report. SETTING University teaching hospital. PATIENT(S) A 38-year-old woman, gravida 1, para 1, with a history of pelvic pain, vaginal spotting, nausea, vomiting, and constipation 1 month after Essure hysteroscopic sterilization. INTERVENTION(S) Radiologic investigation, including a computed tomography scan of the abdomen and pelvis, followed by operative laparoscopy. MAIN OUTCOME MEASURE(S) Alleviation of the SBO. RESULT(S) Radiologic investigation suggested a distal SBO, with the left Essure microinsert noted in the left lower pelvis. These findings, including an inflamed appendix, were confirmed at operative laparoscopy. Lysis of adhesions, removal of the Essure microinsert, appendectomy, and left salpingectomy were performed. CONCLUSION(S) This case is reported to increase awareness that SBO is a potential complication of Essure microinsert placement.

Hysteroscopic Endometrial Ablation Using Free Heated Saline for the Treatment of Menorrhagia

STUDY OBJECTIVE To assess the safety and efficacy of hysteroscopic endometrial ablation using controlled intrauterine instillation and circulation of heated (90 degrees C) saline. DESIGN Phase II clinical study (Canadian Task Force classification II-2). SETTING Preliminary study performed in an outpatient ambulatory surgery center of a university hospital. PATIENTS Twenty women with menorrhagia of benign causes. INTERVENTION Hysteroscopic endometrial ablation. MEASUREMENTS AND MAIN RESULTS There were no complications. At no time did fluid leak from the fallopian tubes or cervix during treatment. Six patients had concurrent laparoscopy to measure serosal temperatures and to observe fimbriae directly during the 10-minute treatment. Serosal and endocervical temperatures were not elevated. Eighteen women kept evaluable menstrual diaries for 2 months before and 12 months after surgery. Ten women (55.6%) became amenorrheic, four (22.1%) hypomenorrheic, and three (16.7%) returned to normal periods after 12 months of follow-up. One woman (5.6%) reported a 75% decrease in menstrual flow but continued to be menorrhagic by definition. One patient subsequently underwent hysterectomy for simple endometrial hyperplasia. CONCLUSION This procedure appears to be a safe method of globally ablating the endometrium, resulting in effective treatment of menorrhagia.

Three-Year Outcome of the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

STUDY 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 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 University hospitals and private surgical centers. PATIENTS 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 Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN 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 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.

Nickel hypersensitivity associated with an intratubal microinsert system

BACKGROUND: Although known nickel hypersensitivity is a contraindication to intratubal microinsert placement in the United States, this case demonstrates that nickel hypersensitivity to intratubal microinserts can occur. CASE: A young woman developed an allergic reaction after placement of intratubal microinserts. Nickel hypersensitivity was confirmed with skin patch testing. The microinserts were removed hysteroscopically, and the patient improved. CONCLUSION: If a patient experiences symptoms of an allergic reaction after hysteroscopic sterilization, referral to an allergy specialist is recommended. If nickel hypersensitivity is confirmed, the microinserts should be removed; this may be performed under hysteroscopic guidance.

Sensitivity of Myoma Imaging Using Laparoscopic Ultrasound Compared With Magnetic Resonance Imaging and Transvaginal Ultrasound

STUDY OBJECTIVE To determine the efficacy of laparoscopic ultrasound (LUS) as compared with contrast-enhanced magnetic resonance imaging (CE-MRI) and transvaginal ultrasound (TVUS) in detection of uterine myomas. DESIGN Retrospective study of imaging methods used in a trial of LUS-guided radiofrequency volumetric thermal ablation in women with symptomatic myomas (Canadian Task Force classification II-2). SETTING Eleven medical university or private outpatient surgery clinics in the United States (nine sites) and Latin America (two sites). PATIENTS One hundred thirty-five women with symptomatic myomas and objectively confirmed moderate to severe heavy menstrual bleeding. INTERVENTIONS LUS-guided radiofrequency volumetric thermal ablation of myomas. MEASUREMENTS AND MAIN RESULTS Preoperative TVUS scans and CE-MRIs were read at each site, and all CE-MRIs were read by a central reader. LUS-guided scans were obtained intraoperatively by each surgeon by mapping the uterus just before radiofrequency volumetric thermal ablation. The imaging methods and their yields in terms of number of myomas found per subject were as follows: TVUS, 403 myomas (mean [SD] 3 [1.8]; range, 1-8); site CE-MRI, 562 myomas (4.2 [3.8]; range, 1-18); central reader, 619 myomas (4.6 [3.7]; range, 0-20); and LUS, 818 myomas (6.1 [4.9]; range, 1-29) (p < .001). LUS was superior to TVUS, CE-MRI, and the central reader for detection of small (≤1 cm(3)) myomas. Most imaged myomas were intramural: 197 (50.9%) by TVUS, 298 (55.5%) by site CE-MRI, 290 (48.7%) by the central reader, and 386 (48.5%) by LUS. CONCLUSION Compared with CE-MRI and TVUS, LUS demonstrates the most myomas, regardless of size or type.

Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas

Purpose To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure® device. Patients and methods This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized. Results A total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events. Conclusion The MyoSure procedure for removal of polyps and myomas was well tolerated, with low pain scores reported for both the para/intracervical and intracervical block protocols.