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Hysteroscopic Evacuation of Retained Products of Conception: Two Case Reports and a Systematic Literature Review
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Abstracts / Journal of Minimally Invasive Gynecology 22 (2015) S1–S253
Setting: Tertiary level facility in metropolitan area. Patients: Removal of intrauterine pathology, including submucosal myomas, polyps and retained products of conception, by the MyoSureÒ intrauterine mechanical morcellator. Measurements and Main Results: A total of 220 MyoSureÒ procedures were performed, with 68% performed by trainees. 42% were resections of myomas, 42% resections for polyps, 5% had a combination of pathology, 6% were pregnancy products and 5% were hyperplasia or cancer. Complete resection of pathology was achieved in 97% of polyps, 65% of myomas and 100% of pregnancy tissue, and there was no difference in completeness of pathology resected for trainees when compared to consultants. When myomas were stratified according to size, 82% of myomas % 40mm were resected completely and 36% of myoma > 40mm were resected completely. No intraoperative complications occurred. Post operative outcomes included symptom resolution in 73%, further surgery (repeat hysteroscopy or hysterectomy) in 20% and medical management in 7% of patients. Out of the patients undergoing myoma resection, 3 patients (4%) experienced prolapsed submucosal fibroids post procedure, 2 of which required unplanned reoperations. Conclusion: The MyoSureÒ device is very effective when used to resect endometrial polyps. Myomas above 40mm in size are unlikely to be completely resected at a single operation with use of the MyoSureÒ. Similar patient outcomes were obtained when procedures were performed by trainees compared to senior clinicians. 115 Final Results of a Multicenter Trial of Safety and Effectiveness of Endometrial Ablation With the AEGEA Vapor System for the Treatment of Menorrhagia Thurkow A,1 Van Baal M,2 Van Eijndhoven H.3 1Sint Lucas Andreas Ziekenhuis, Amsterdam, Netherlands; 2Flevoziekenhuis, Almere, Netherlands; 3Isala Klikien, Zwolle, Netherlands Study Objective: To evaluate the safety and effectiveness of using adaptive water vapor (AEGEA Vapor System) to achieve endometrial ablation. Design: Multi-center, non-randomized, single arm feasibility study. Setting: Three hospital centers in the Netherlands. Patients: Eligible subjects were women ages 30-50 with a history of menorrhagia due to benign causes. The study allowed inclusion of subjects with uterine length >10cm and uterine fibroids up to 4cm. Subjects were qualified with a quantitative alkaline hematin (AH) assay performed by a central laboratory. A baseline AH score of R160ml was required for study inclusion. Intervention: Endometrial ablation was performed with the AEGEAVapor System. The alkaline hematin test evaluated effectiveness at the 12-month follow-up visit. Safety, Quality of Life and Patient Satisfaction were assessed through 24-month follow-up. Measurements and Main Results: A total of 22 women underwent endometrial ablation with the AEGEA Vapor System. No device-related adverse events were reported. Success, defined as menstrual blood loss reduction to %80ml as measured by alkaline hematin, was achieved in 95% (18/19) of subjects at 12 months. A secondary endpoint of menstrual blood loss reduction of R50% was achieved in 100% (19/19) at 12 months. At two-year follow-up, there were no changes to therapeutic outcomes. All available subjects reported continued satisfaction and improvement in their quality of life when compared to baseline. Conclusion: Results from this study support the long-term safety and effectiveness of endometrial ablation with the AEGEA Vapor System. Additionally, patient satisfaction and improved quality of life are maintained through long-term follow-up. 116 Hysteroscopic Evacuation of Retained Products of Conception: Two Case Reports and a Systematic Literature Review Tam T, Placek J, Juarez L. Obstetrics and Gynecology, Presence Saint Joseph Hospital, Chicago, Illinois
Study Objective: To evaluate evacuation of retained products of conception using a hysteroscopic tissue removal device. Design: Case report and systematic review of the literature. Setting: Community teaching hospital. Patients: Two patients with spontaneous abortion in their first trimester with retained products of conception diagnosed by ultrasonography. The first patient had a large intrauterine hematoma while the second patient has a bicornuate uterus. Intervention: Both patients have undergone suction dilation and curettage for spontaneous miscarriage in the first trimester. Pelvic ultrasound revealed retained products of conception. Hysteroscopic evacuation of retained products of conception was subsequently performed. Measurements and Main Results: The benefits of hysteroscopic evacuation of retained products of conception include safe and efficient removal of intrauterine pathology. The ability to view the intrauterine cavity provides a guided evaluation and targeted removal of intrauterine contents thus limiting the risk of perforation, bleeding, infection, intrauterine adhesions, and subsequent infertility. We present two cases reports using a hysteroscopic tissue removal device for directed evacuation of retained products of conception. Conclusion: Hysteroscopic removal of RPOC continues to demonstrate both diagnostic and therapeutic benefits to patients. Through its continued use, the hysteroscopic technique for removal of RPOC will see an increase in safety and efficiency in the future, making blind dilation and sharp curettage a thing of the past. 117 Endometrial Ablation With the AEGEA Vapor System in Challenging Uterine Anatomies Garza-Leal J,1 Castillo L,1 Harris M.2 1Gineco-Obstetrico, Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico; 2Clinical Research, Women’s Health Research, Phoenix, Arizona Study Objective: To evaluate the AEGEA Vapor System (AEGEA Medical, Redwood City, CA, U.S.A.) using an in-vivo peri-hysterectomy model within uterine anatomies that may present treatment challenges for current endometrial ablation technologies with FDA approval. Case studies evaluated the uniqueness of vapor therapy provided during a rapid, two minute treatment in terms of extent of ablation coverage. Design: Retrospective Case Study Review. Setting: An Urban University Hospital Medical Center. Patients: Twenty women with the previous diagnosis of uterine myomata (including types 0 and 1), bicornuate or septate uteri, cavitary deformation, or cavity lengths greater than 10cm who were consented to undergo endometrial ablation prior to undergoing hysterectomy for abnormal uterine bleeding. Intervention: In-vivo endometrial ablation using pressure-controlled water vapor was performed using a 120 second treatment time. Pre-treatment hysteroscopy and ultrasound were performed to record intra-cavitary anatomy. The uteri were examined by hysteroscopy or histopathologic analysis to determine the extent of endometrial ablation. Measurements and Main Results: All 20 patients with atypical uterine anatomies, post vapor therapy, demonstrated gobal endometrial ablation with an average 94% endometrial coverage. Conclusion: Endometrial ablation with the AEGEA Vapor System has the potential to provide excellent cavitary coverage in patients suffering from abnormal uterine bleeding and who have intra-cavitary myomata, uterine cavitary malformations and cavity lengths greater than 10cm. 118 Saline Contrast Sonohysterography for the Diagnosis of Cesarean Scar Defect Capmas P, Giral E, Fernandez H. Gynecology, Hopital Bicetre, Le Kremlin Bicetre, France Study Objective: To determine the interest of saline contrast sonohysterography in the evaluation of size and shape of cesarean scar defects in comparision with 3D-transvaginal ultrasound examination.
Abstracts / Journal of Minimally Invasive Gynecology 22 (2015) S1–S253
Setting: Tertiary level facility in metropolitan area. Patients: Removal of intrauterine pathology, including submucosal myomas, polyps and retained products of conception, by the MyoSureÒ intrauterine mechanical morcellator. Measurements and Main Results: A total of 220 MyoSureÒ procedures were performed, with 68% performed by trainees. 42% were resections of myomas, 42% resections for polyps, 5% had a combination of pathology, 6% were pregnancy products and 5% were hyperplasia or cancer. Complete resection of pathology was achieved in 97% of polyps, 65% of myomas and 100% of pregnancy tissue, and there was no difference in completeness of pathology resected for trainees when compared to consultants. When myomas were stratified according to size, 82% of myomas % 40mm were resected completely and 36% of myoma > 40mm were resected completely. No intraoperative complications occurred. Post operative outcomes included symptom resolution in 73%, further surgery (repeat hysteroscopy or hysterectomy) in 20% and medical management in 7% of patients. Out of the patients undergoing myoma resection, 3 patients (4%) experienced prolapsed submucosal fibroids post procedure, 2 of which required unplanned reoperations. Conclusion: The MyoSureÒ device is very effective when used to resect endometrial polyps. Myomas above 40mm in size are unlikely to be completely resected at a single operation with use of the MyoSureÒ. Similar patient outcomes were obtained when procedures were performed by trainees compared to senior clinicians. 115 Final Results of a Multicenter Trial of Safety and Effectiveness of Endometrial Ablation With the AEGEA Vapor System for the Treatment of Menorrhagia Thurkow A,1 Van Baal M,2 Van Eijndhoven H.3 1Sint Lucas Andreas Ziekenhuis, Amsterdam, Netherlands; 2Flevoziekenhuis, Almere, Netherlands; 3Isala Klikien, Zwolle, Netherlands Study Objective: To evaluate the safety and effectiveness of using adaptive water vapor (AEGEA Vapor System) to achieve endometrial ablation. Design: Multi-center, non-randomized, single arm feasibility study. Setting: Three hospital centers in the Netherlands. Patients: Eligible subjects were women ages 30-50 with a history of menorrhagia due to benign causes. The study allowed inclusion of subjects with uterine length >10cm and uterine fibroids up to 4cm. Subjects were qualified with a quantitative alkaline hematin (AH) assay performed by a central laboratory. A baseline AH score of R160ml was required for study inclusion. Intervention: Endometrial ablation was performed with the AEGEAVapor System. The alkaline hematin test evaluated effectiveness at the 12-month follow-up visit. Safety, Quality of Life and Patient Satisfaction were assessed through 24-month follow-up. Measurements and Main Results: A total of 22 women underwent endometrial ablation with the AEGEA Vapor System. No device-related adverse events were reported. Success, defined as menstrual blood loss reduction to %80ml as measured by alkaline hematin, was achieved in 95% (18/19) of subjects at 12 months. A secondary endpoint of menstrual blood loss reduction of R50% was achieved in 100% (19/19) at 12 months. At two-year follow-up, there were no changes to therapeutic outcomes. All available subjects reported continued satisfaction and improvement in their quality of life when compared to baseline. Conclusion: Results from this study support the long-term safety and effectiveness of endometrial ablation with the AEGEA Vapor System. Additionally, patient satisfaction and improved quality of life are maintained through long-term follow-up. 116 Hysteroscopic Evacuation of Retained Products of Conception: Two Case Reports and a Systematic Literature Review Tam T, Placek J, Juarez L. Obstetrics and Gynecology, Presence Saint Joseph Hospital, Chicago, Illinois
Study Objective: To evaluate evacuation of retained products of conception using a hysteroscopic tissue removal device. Design: Case report and systematic review of the literature. Setting: Community teaching hospital. Patients: Two patients with spontaneous abortion in their first trimester with retained products of conception diagnosed by ultrasonography. The first patient had a large intrauterine hematoma while the second patient has a bicornuate uterus. Intervention: Both patients have undergone suction dilation and curettage for spontaneous miscarriage in the first trimester. Pelvic ultrasound revealed retained products of conception. Hysteroscopic evacuation of retained products of conception was subsequently performed. Measurements and Main Results: The benefits of hysteroscopic evacuation of retained products of conception include safe and efficient removal of intrauterine pathology. The ability to view the intrauterine cavity provides a guided evaluation and targeted removal of intrauterine contents thus limiting the risk of perforation, bleeding, infection, intrauterine adhesions, and subsequent infertility. We present two cases reports using a hysteroscopic tissue removal device for directed evacuation of retained products of conception. Conclusion: Hysteroscopic removal of RPOC continues to demonstrate both diagnostic and therapeutic benefits to patients. Through its continued use, the hysteroscopic technique for removal of RPOC will see an increase in safety and efficiency in the future, making blind dilation and sharp curettage a thing of the past. 117 Endometrial Ablation With the AEGEA Vapor System in Challenging Uterine Anatomies Garza-Leal J,1 Castillo L,1 Harris M.2 1Gineco-Obstetrico, Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico; 2Clinical Research, Women’s Health Research, Phoenix, Arizona Study Objective: To evaluate the AEGEA Vapor System (AEGEA Medical, Redwood City, CA, U.S.A.) using an in-vivo peri-hysterectomy model within uterine anatomies that may present treatment challenges for current endometrial ablation technologies with FDA approval. Case studies evaluated the uniqueness of vapor therapy provided during a rapid, two minute treatment in terms of extent of ablation coverage. Design: Retrospective Case Study Review. Setting: An Urban University Hospital Medical Center. Patients: Twenty women with the previous diagnosis of uterine myomata (including types 0 and 1), bicornuate or septate uteri, cavitary deformation, or cavity lengths greater than 10cm who were consented to undergo endometrial ablation prior to undergoing hysterectomy for abnormal uterine bleeding. Intervention: In-vivo endometrial ablation using pressure-controlled water vapor was performed using a 120 second treatment time. Pre-treatment hysteroscopy and ultrasound were performed to record intra-cavitary anatomy. The uteri were examined by hysteroscopy or histopathologic analysis to determine the extent of endometrial ablation. Measurements and Main Results: All 20 patients with atypical uterine anatomies, post vapor therapy, demonstrated gobal endometrial ablation with an average 94% endometrial coverage. Conclusion: Endometrial ablation with the AEGEA Vapor System has the potential to provide excellent cavitary coverage in patients suffering from abnormal uterine bleeding and who have intra-cavitary myomata, uterine cavitary malformations and cavity lengths greater than 10cm. 118 Saline Contrast Sonohysterography for the Diagnosis of Cesarean Scar Defect Capmas P, Giral E, Fernandez H. Gynecology, Hopital Bicetre, Le Kremlin Bicetre, France Study Objective: To determine the interest of saline contrast sonohysterography in the evaluation of size and shape of cesarean scar defects in comparision with 3D-transvaginal ultrasound examination.