Preliminary Results of a Multicenter Trial of Safety and Efficacy of the AEGEA Vapor System for the Treatment of Menorrhagia

Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S136–S190 Intervention: All women who had failed conservative managment of their heavy Menstrual bleeding were offered a Local Anaesthetic Ablation. Long term follow up and out comes were determined on a hospital based database and by contacting their primary care physician. Measurements and Main Results: Of the 176 who underwent a TA under local in an out patient setting no patients were admitted immediately after the procedure. All received a 24hr post ablation nurse call. 1 patient was admitted after 48 hrs with a presumed infection and was sent home. At a median follow up of 19 months, Range 0.5-5 years, 93 patients (53%) had light periods and 34 amenorrhoea (19.5%). Further medical interventions such as a MIRENA or progesterone therapy produced an eventual satisfactory result in 2%. A General Anaesthetic resection of residual endometrium occurred in a further 17.7% and an eventual hysterectomy in 8%. Conclusion: Thermablation TA has demonstrated to be an extremely well tolerated device ideal to be employed in an out patient setting. The long term results also show a high satisfaction rate and a low intervention rate in the form of an hysterectomy which has inmportant consequences in terms of cost implications for the health service.

S147

Measurements and Main Results: Successful completion of procedures without anaesthesia. Percentage of patients reporting amenorrhea, hypomenorrhea or who have undergone a subsequent hysterectomy for uncontrolled bleeding. Main Results: The Minitouch procedure was successfully performed by a solo operator in an office setting on 100% (n = 37) of patients. All patients tolerated the procedure without any anaesthesia. Intra-procedural pain was tolerable and stopped immediately at the end of energy delivery. None of the patients reported any unusual post-procedure discomfort and all could leave immediately after the procedure. No adverse events were reported. At follow-up (range: one to twenty eight months), the rates of amenorrhea, hypomenorrhea, and hysterectomy were 84% (n = 31), 5% (n = 2), and 11% (n = 4) respectively. These results are comparable to previously reported results [Tas at al. JMIG 20:6 Supplement (2013) S50-51]. Conclusion: The long-term outcomes of Minitouch Global Endometrial Ablation procedure performed without anaesthesia in an office setting are comparable to similar endometrial ablation procedures. 489

487 Short Term Complication Rate of Operative Hysteroscopy Using Only Bipolar Technology: Analysis of 709 Cases Sroussi J,1 Hamidouche A,2 Mezzadri M,1 Chevalier AS,1 Piketty M,2 Benifla JL.1 1Obstetrics and Gynecology, Hopital Lariboisiere, Paris, France; 2Obstetrics and Gynecology, Hopital Trousseau, Paris, France Study Objective: To evaluate short term complication rate of operative hysteroscopy using only bipolar energy with normal saline solution. Design: A retrospective descriptive study. Setting: University hospital. Patients: Six hundred and fifty eight patients were operated from 2009 to 2012. Intervention: Seven hundred and six operative hysteroscopic procedures using bipolar technology with saline solution. Measurements and Main Results: Clinical data was recorded, including context, indication, type of anesthesia, and short term complications were collected. Main indications were endometrial polyp (31.3%), submucosal myoma (30%), and intrauterine adhesions (19.1%). Global complication rate was 5.1% (36/706). We collected 18 perforations (2.5%), 6 false cervical paths (0.8%), 11 anormal bleedings with hemostatic treatments (1.6%), and one pulmonary edema (0.1%). No Turp syndrome was noted. Perforation rate was 7.3% among 136 sections of intrauterine adhesions whereas it was only 1.4% within 573 other indications. Significantly anormal bleedings occurred mostly in myomectomy (5/11, 45,4%). Conclusion: Our short term complication rate of operative hysteroscopy is low, except for section of intrauterine adhesions which has a specific 7.3% perforation rate. These findings seem to consist with series using monopolar energy, however exclusive use of bipolar technology with saline solution prevent from Turp syndrome and neurological complications. 488 Long-Term Outcomes with Minitouch Endometrial Ablation in an Office Setting without Anaesthesia Tas B, Van Herendael B. Obstetrics and Gynaecology, ZNA Stuivenberg, Antwerpen, Belgium Study Objective: To study long-term outcomes of the Minitouch procedure performed in a consulting office without anaesthesia. Design: Retrospective analysis of 37 cases of the Minitouch procedure performed in an office setting since 2012. Setting: Consulting office at one hospital in Belgium. Patients: 37 women with menorrhagia and no desire to retain fertility. Intervention: The procedures were performed without any pretreatment, menstrual cycle timing, anaesthesia or cervical dilation. 400mg oral NSAID was prescribed to be taken one hour before the procedure. Transvaginal pre- and post-procedure ultrasonography was used as an additional step to visualize the endometrium.

Emerging Results from the Crystal Trial: A Feasibility Study of the Channel Medsystems Device for Endometrial Cryoablation (DEC) Thiel J,1 Fortin C,2 Sanders B,3 Rattray D,1 Weins L.1 1Obstetrics and Gynecology, University of Saskatchewan, Regina, Saskatchewan, Canada; 2 Obstetrics and Gynecology, McGill University, Lasalle, Quebec, Canada; 3 Obstetrics and Gynecology, University of British Columbia, Vancouver, British Columbia, Canada Study Objective: To evaluate the initial effectiveness of the Channel Medsystems DEC and assess procedure tolerability, quality of life (QOL), patient satisfaction and uterine healing. Design: Prospective, single-arm, feasibility study with 6-month follow up. Setting: 3 centers in Canada (2 hospital settings, 1 office setting). Patients: Up to 60 pre-menopausal, female subjects (age > 25 years) with menorrhagia due to selected benign causes and for whom childbearing is complete. Intervention: Endometrial ablation with the Channel Medsystems DEC. Measurements and Main Results: The primary efficacy evaluation is reduction in menstrual bleeding at six months compared with baseline. Success is defined as a reduction in menstrual bleeding score from R 150 to \ 75, as measured by a pictorial blood loss assessment chart (PBLAC). Secondary efficacy evaluations include subject-reported procedure pain, QOL outcomes at three and six months post-procedure compared with baseline (measured using the Menorrhagia Impact Questionnaire), evaluation of uterine healing at six months post-procedure (visualized with hysteroscopy and scored with a modified American Fertility Society score), and patient satisfaction at six months post-procedure compared with baseline. As this study is ongoing, emerging results will be presented at the conference. Conclusion: The results from this study build on prior safety and tolerability studies and give an initial indication of QOL and patient satisfaction, in addition to procedure-related pain scores and uterine healing. Effectiveness rates from this feasibility study will be used to guide the design of a clinical study in support of Food and Drug Administration (FDA) approval. 490 Preliminary Results of a Multicenter Trial of Safety and Efficacy of the AEGEA Vapor System for the Treatment of Menorrhagia Thurkow A. St. Lucas Andreas Hospital, Amsterdam, Netherlands Study Objective: Multi-center, non-randomized, single arm feasibility study. Design: Three hospital centers in the Netherlands. Setting: Eligible patients were women ages 30-50 with a history of menorrhagia due to benign causes. Patients were qualified using an alkaline hematin test and fibroids >4cm were excluded.

S148

Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S136–S190

Patients: Patients were treated with the AEGEAVapor System consisting of a Vapor Generator, Vapor Probe, and Integrity Test System. Following treatment, the alkaline hematin test and Quality of Life (QOL) questionnaires evaluated efficacy 3, 6, and 12 months. Safety was assessed postprocedure through 24 months. Intervention: 22 Patients were treated with the AEGEA Vapor System. At this time, all patients have completed the 12-month follow up visit. No device or ablation procedure related adverse events were reported. Primary effectiveness results meet the requirement of menstrual blood loss volume \80 ml by alkaline hematin at 3, 6 and 12 months posttreatment in the following percentages: 75% of patients at 3 months; 85% at 6 months, and 95% at 12 months. Secondary effectiveness results meet the requirement of reduction of menstrual blood loss volume >50% by alkaline hematin at 3, 6 and 12 months post-treatment in the following percentages: 90% of patients at 3 months; 90% at 6 months, and 100% at 12 months. All patients reported an improvement in their quality of life per questionnaire results. Measurements and Main Results: Results from this study support the safety and effectiveness of the AEGEA Vapor System to achieve endometrial ablation. 491 Endometrial Cancer Following Endometrial Ablation Tsafrir Z,1 Schiff L,1 Sangha R,1 Theoharis E,1 Mangat C,1 Siddiqui F,2 Elshiakh M,2 Eisenstein D.1 1Minimally Invasive Gynecologic Surgery, Henry Ford Hospital, Detroit, Michigan; 2Radiation Oncology, Henry Ford Hospital, Detroit, Michigan Study Objective: To evaluate clinical aspects of patients who had Endometrial cancer after Endometrial Ablation (EA). Design: Retrospective study (Canadian Task Force classification II-3). Setting: University affiliated Tertiary medical center in Southeastern Michigan. Patients: 3 patients who underwent endometrial ablation after exclusion of endometrial malignancy by biopsy, and were diagnosed later as having Endometrial cancer. Intervention: Patient who underwent endometrial ablation. Measurements and Main Results: All patients had multiple risk factors for endometrial cancer prior to EA [Table 1]. At time of EA, 2 patients were postmenopausal and additional patient was 37 years old. In all cases, endometrial cancer was excluded by endometrial sampling prior to EA. The EA method was Hysteroscopic endometrial resection. Vaginal bleeding was the first ominous symptom in all cases, and it occurred in a time range of 70-120 months post EA. Endometrial cancer was confirmed by office sampling. Surgery included total hysterectomy, bilateral salpingo-oophorectomy and LN sampling. Final pathology was Endometroid Adenocarcinoma in all 3 cases, at a stage of IA, IB and IIIC, respectively. The patient with stage IA disease did not receive adjuvant treatment, the patient with stage IB disease received pelvic radiation and the patient with stage IIIC disease received radiation +chemotherapy. Patients with stage I disease are in remission for at least 4 years, while the patient with stage III disease died 9 month from diagnoses. Table 1 Risk Factors for Endometrial Cancer

492 Quality of Life after Hysteroscopic Myomectomy: A Prospective Observational Study Uchil D,1 Vandrevala T.2 1Obstetrics and Gynaecology, Universiity Hospital Lewisham, London, United Kingdom; 2Research Design Service South East, University of Surrey, Guidlford, United Kingdom Study Objective: To assess difference in quality of life measures following hysteroscopic myomectomy in women with submucous fibroids. Design: Prospective observational study. Setting: Secondary care teaching hospital in inner London. Patients: Prememopausal women with submucosal fibroids undergoing hysteroscopic myomectomy. Intervention: Patients completed the UFS-QoL (Uterine fibroid symptoms and Quality of Life) questionnaire and an additional questionnaire on impact on daily activities and VAS scores for pain before hysteroscopic myomectomy. Women completed the same questionnaires at 3 and 6 months postoperatively. The UFS-QoL consists of 37 questions which are grouped to produce a Symptom Severity scale and a Health related quality of life (HRQL) scale which consists of 6 subscales. Measurements and Main Results: Sample size calculation suggested that 16 women needed to be recruited to demonstrate adequate power.Twenty women completed questionnaires at baseline and 3 months post surgery. Eighteen women completed questionnaires at 6 months. Prior to surgery, women had poor quality of life as evidenced by high symptom severity score and low HRQL scores. These scores were lower than those in the published literature suggesting that women with submucous fibroids are more symptomatic. In addition, there was considerable impact on daily

UFS-QoL and VAS scores at baseline and 3 months post surgery Subscale

Baseline (Mean) 3 months (mean) p value

Symptom severity score Concern Activities Energy Control Self-consciousness Sexual function Total HRQL VAS score

70.78 9.0 17.5 25.71 25.25 27.92 24.34 20.15 68.4

32.66 59.75 67.32 70.71 67.50 67.08 57.50 66.16 25.2

\0.001 \0.001 \0.001 \0.001 \0.001 \0.001 \0.001 \0.001 0.004

NB: Higher the symptom severity score, the poorer the quality of life. The higher the HRQL scores, the better the quality of life UFS-QoL and VAS scores at baseline and 6 months after surgery

Risk Factor

Case 1

Case 2

Case 3

Age (years) Obesity Hypertension Diabetes Mellitus Dysfunctional Uterine Bleeding Post Menopausal Bleeding Family h/o Cancer (Uterine/Ovarian/ Breast/Colon)

66 + + + +

37 + +

62 + + + + -

h/o: history of

Comparison of demographic, historical and clinical parameters did not distinguish these 3 cases except that the patient with stage III disease had prolonged undiagnosed postmenopausal bleeding. Conclusion: EA should be utilized with caution in patients with risk factors for endometrial cancer, particularly in postmenopausal age group. Further studies are needed to establish a risk assessment model to guide application of EA for abnormal uterine bleeding.

Subscale

Baseline (Mean)

6 months (Mean)

p value

Symptom severity Concern Activities Energy Control Selfconsciousness Sexual function Total HRQL VAS score

70.78 9.0 17.5 25.71 25.25 27.92

39.58 49.71 54.41 59.03 66.18 51.96

\0.001 0.002 \0.001 \0.001 \0.001 0.006

24.34 20.15 68.4

71.32 57.66 28.1

\0.001 \0.001 \0.001