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Treatment Patterns for Women with Newly Diagnosed Uterine Fibroids
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S91–S135 Conclusion: Our data suggests that hysteroscopy can be utilized in diagnosis of tamoxifen treated endometrium. Benign and malignant changes can be classified based on visual inspection. While endometrial sampling is still critical for complete evaluation, hysteroscopic impression appears to be a reliable adjunct. 448 Treatment Patterns for Women with Newly Diagnosed Uterine Fibroids Bonafede MM,1 Cappell KA,1 Pohlman SK,2 Troeger KA.2 1Truven Health Analytics, Inc., Cambridge, Massachusetts; 2Hologic, Inc., Marlborough, Massachusetts Study Objective: To describe treatment patterns and diagnostic pathways for women with newly diagnosed uterine fibroids. Design: Retrospective analysis using US administrative claims from 20042013. Patients: Women with fibroids (ICD-9 code:218.9) and at least 12 months of continuous enrollment in the Truven Health MarketScan Commercial and Medicare Supplemental Databases. Measurements and Main Results: The use of specific diagnostic and treatment procedures and medications were described in the 12 months prior to (pre-index) and following (post-index) the diagnosis (index event). Utilization rates were compared using Fisher’s Exact Test. 359,672 women met the selection criteria. Mean age was 46.1 years (SD=9.3); 22.8% of women were \40 at diagnosis, 45.8% were 40-49 and 31.3% were R50. Overall, 29.3% underwent hysterectomy in the year following diagnosis, with higher rates among women ages 40-49 (35.7%) than those \40 (21.9%, p\0.001) or R50 (25.4%, p\0.001). Other surgical interventions included endometrial ablation (5%) curettage (3.6%) and either hysteroscopic myomectomy, laparascopic myomectomy, abdominal myometcomy, or uterine emobolization (\2% each). Approximately one-third of patients (34.0%) used prescription NSAID post-index, with slightly higher use among patients age \40 (37.2%) than patients 40-49 (35.0%) or R50 (30.0%). Oral contraceptive use was more common among patients \40 pre- and post-index (19.0%, 19.8%) than patients 40-49 (12.5%, 10.5%) or R50 (4.5%, 3.0%) (p\0.001). IUDs or Gnrh agonists were used by approximately 1% of women. Transvaginal ultrasound was the most common imaging procedure both pre- and post-index (29.3%, 47.1%), followed by abdominal/pelvic ultrasound (26.3%, 38.0%). Computerized tomography utilization was similar between women \40 and 40-49 both pre- (6.3% versus 6.4%) and post-index (7.5% versus 7.7%) and more common among women R50 pre- (12.8%) and post-index (10.6%). Conclusion: Despite advances in minimally invasive approaches to treat uterine fibroids, w30% of women with newly diagnosed fibroids underwent hysterectomy within one year of initial diagnosis. 449 Minerva Endometrial Ablation System: Technology Overview Bril AI. CPMC, San Francisco, California Study Objective: To describe a novel global endometrial ablation technology. Measurements and Main Results: The Minerva Endometrial Ablation System delivers a customized endometrial ablation, using plasma energy, with a total procedure time of approximately 3 minutes, without the need for pre-treatment, and/or hysteroscopy.
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The RF Controller, which does not require cavity dimensions, incorporates a two-phase, sequential, safety check for the integrity of the uterine wall and/ or device membrane. The controller provides a self-adjustable power level, based on changes in the electrical characteristics of tissue during ablation. The initial power is automatically set, limited to 40 watts, and then drops as the ablation progresses, terminating on reaching a 2-minute limit. When closed, the Minerva ablation device is w 6 mm in diameter and consists of a cavity compliant expandable frame, covered by a soft silicone membrane. Opening and seating of the device is accomplished within a few seconds due to the lubricious nature of the membrane. An integrated balloon on the sheath assures sealing of the endocervix. After passing the safety check, the therapy cycle starts automatically. Argon gas is delivered and circulated inside the silicone membrane under low pressure of approximately 25mmHg. Then, applied bi-polar RF energy creates plasma within the membrane, ablating by combining three complementary methods: Tissue Penetrating Bi-polar RF, Hot Tissue Contacting Membrane, and Hot Saline/Fluid. Upon completion of the cycle, the device is unlocked and removed from the uterine cavity, without sticking to the ablated surface. Conclusion: The Minerva Endometrial Ablation System is a small diameter device with easy opening/seating, effective cervical sealing, and the fastest endometrial ablation time to date. By combining three fundamental ablation methodologies into a single treatment, Minerva has now been demonstrated to produce excellent clinical results. 450 Evaluation of Minitouch Endometrial Ablation Device Compared to Currently Available Endometrial Ablation Systems for Outpatient Setting Burns S, Soltan O. Obstetrics and Gynaecology, Leigh Infirmary, Leigh, Lancashire, United Kingdom Study Objective: To assess current endometrial ablation procedures for their suitability for outpatient use. Design: Retrospective analysis of our experience with Thermachoice, Novasure, Thermablate and Minitouch procedures. Setting: Outpatient treatment centre and operation theatres at Wrightington, Wigan & Leigh NHS Trust. Patients: Women undergoing endometrial ablation procedures. Intervention: Endometrial ablation in outpatient and theatre setting. Measurements and Main Results: Observations of our departmental agreed criteria for outpatient use: safety, short duration of ablation, no need for anaesthesia/only analgesia, no need for cervical dilatation, ease of use and set up, setting for the training and time taken to train clinician. Main Results: Analysis of 50 ablation procedures. The breakdown of the cases: Thermachoice - 14 outpatient, Thermablate - 11 inpatient (daycase), 7 outpatient, Novasure - 10 inpatient (daycase), Minitouch - 7 outpatient. All theatre cases were done under general anaesthesia. Novasure and Thermablate both required dilatation and therefore training commenced in a theatre setting. One Novasure procedure had to be abandoned due to uterine perforation. Thermablate was trialled as outpatient but required local anaesthesia for cervical dilatation. All Thermachoice procedures performed as an outpatient but 1 procedure abandoned because of pain during treatment cycle. All Minitouch procedures were completed in an outpatient setting without dilatation or local anaesthesia and treatment time significantly shorter. Conclusion: Minitouch endometrial ablation procedure met all of our established criteria for outpatient setting in terms of set up, ease of use and duration and was superior to current alternative devices.
S135
The RF Controller, which does not require cavity dimensions, incorporates a two-phase, sequential, safety check for the integrity of the uterine wall and/ or device membrane. The controller provides a self-adjustable power level, based on changes in the electrical characteristics of tissue during ablation. The initial power is automatically set, limited to 40 watts, and then drops as the ablation progresses, terminating on reaching a 2-minute limit. When closed, the Minerva ablation device is w 6 mm in diameter and consists of a cavity compliant expandable frame, covered by a soft silicone membrane. Opening and seating of the device is accomplished within a few seconds due to the lubricious nature of the membrane. An integrated balloon on the sheath assures sealing of the endocervix. After passing the safety check, the therapy cycle starts automatically. Argon gas is delivered and circulated inside the silicone membrane under low pressure of approximately 25mmHg. Then, applied bi-polar RF energy creates plasma within the membrane, ablating by combining three complementary methods: Tissue Penetrating Bi-polar RF, Hot Tissue Contacting Membrane, and Hot Saline/Fluid. Upon completion of the cycle, the device is unlocked and removed from the uterine cavity, without sticking to the ablated surface. Conclusion: The Minerva Endometrial Ablation System is a small diameter device with easy opening/seating, effective cervical sealing, and the fastest endometrial ablation time to date. By combining three fundamental ablation methodologies into a single treatment, Minerva has now been demonstrated to produce excellent clinical results. 450 Evaluation of Minitouch Endometrial Ablation Device Compared to Currently Available Endometrial Ablation Systems for Outpatient Setting Burns S, Soltan O. Obstetrics and Gynaecology, Leigh Infirmary, Leigh, Lancashire, United Kingdom Study Objective: To assess current endometrial ablation procedures for their suitability for outpatient use. Design: Retrospective analysis of our experience with Thermachoice, Novasure, Thermablate and Minitouch procedures. Setting: Outpatient treatment centre and operation theatres at Wrightington, Wigan & Leigh NHS Trust. Patients: Women undergoing endometrial ablation procedures. Intervention: Endometrial ablation in outpatient and theatre setting. Measurements and Main Results: Observations of our departmental agreed criteria for outpatient use: safety, short duration of ablation, no need for anaesthesia/only analgesia, no need for cervical dilatation, ease of use and set up, setting for the training and time taken to train clinician. Main Results: Analysis of 50 ablation procedures. The breakdown of the cases: Thermachoice - 14 outpatient, Thermablate - 11 inpatient (daycase), 7 outpatient, Novasure - 10 inpatient (daycase), Minitouch - 7 outpatient. All theatre cases were done under general anaesthesia. Novasure and Thermablate both required dilatation and therefore training commenced in a theatre setting. One Novasure procedure had to be abandoned due to uterine perforation. Thermablate was trialled as outpatient but required local anaesthesia for cervical dilatation. All Thermachoice procedures performed as an outpatient but 1 procedure abandoned because of pain during treatment cycle. All Minitouch procedures were completed in an outpatient setting without dilatation or local anaesthesia and treatment time significantly shorter. Conclusion: Minitouch endometrial ablation procedure met all of our established criteria for outpatient setting in terms of set up, ease of use and duration and was superior to current alternative devices.