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Adiana System for Transcervical Sterilization: 3-Year Efficacy Results
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Abstracts / Journal of Minimally Invasive Gynecology 16 (2009) S1eS51
Measurements and Main Results: There were no major complications encountered in any of the cases. There were 13 (5.3%) minor complications including 2 uterine perforations (0.8%), 4 aborted or failed procedures (1.7%), 3 episodes of significant postoperative cramping or discomfort (1.2%), 2 instrument or equipment malfunctions (0.8%), 1 allergic reaction (0.4%), and 1 vasovagal response to lidocaine (0.4%). Of the 62 EssureÒ procedures the overall minor complication rate was 8%, including a failure to place rate of 4.8%. Forty nine endometrial ablation procedures were performed with a minor complication rate of 14.3%, with postoperative nausea/vomiting (4%) and cramping (4%) being most common. Thirty three operative hysteroscopy cases were performed with a minor complication rate of 9%. Seventy two diagnostic hysteroscopies with dilation and curettage were performed with a minor complication rate of 2.8%. Twenty seven loop electrode excision procedures were performed with no complications. Individual surgeon complication rates ranged from 0% to 33%. The practitioner with the most office experience, a total of 157 cases, had a minor complication rate of 6.4% and no major complications. Conclusion: Office based procedures are a safe method of providing patients with care for multiple gynecologic concerns.
131
Open Communications 6dHysteroscopy (11:48 AM d 11:53 AM)
Adiana System for Transcervical Sterilization: 3-Year Efficacy Results Anderson TL,1 Vancaillie TG.2 1Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN; 2Endo-Gynecology Department, University of New South Wales, Randwick, New South Wales, Australia Study Objective: To evaluate the efficacy of the Adiana System for preventing pregnancy in women desiring permanent sterilization. Design: This study is a prospective, single-armed, multi-center, international trial. The primary endpoint was pregnancy prevention rate at 12 months. Pregnancy prevention rates at 24 and 36 months were also calculated. Setting: The study was conducted at 16 sites in the United States (14), Australia (1) and Mexico (1). Patients: 645 women (intent to treat group). Intervention: Hysteroscopic placement of polymer matrix was attempted in all patients. Tubal occlusion confirmed by HSG at 12 weeks. Ongoing monitoring for pregnancy. Measurements and Main Results: There was a 95% bilateral matrix placement rate and 88.4% bilateral occlusion by HSG, as previously published (Vancaillie TG, TL Anderson, DA Johns (2008) Obstetrics & Gynecology 112(6):1270e1277). As of July 2008, a total of 24,968 person-months of wearing were accrued. Pregnancy prevention rates were summarized with descriptive statistics using 95% one-sided confidence bound based on life-table methods. Completed 36-month data were available for 481 subjects.
# Subjects # Pregnancies Cumulative Pregnancy Prevention Rate
12 months
24 months
36 months
553 6 98.9%
510 3 98.4%
481 none 98.4%
During the first year, 6 pregnancies were reported. Three were determined to be the result of misinterpretation of HSG results. The remaining 3 were attributed to method failure, as were the 3 pregnancies during the second year. No additional pregnancies occurred in year 3. The cumulative pregnancy prevention rates at 12, 24, and 36 months compare favorably with the CREST data and other published reports documenting efficacy of established permanent sterilization procedures. Conclusion: These data demonstrate the effectiveness of the Adiana System for pregnancy prevention is similar to other permanent sterilization methods.
132
Open Communications 6dHysteroscopy (11:54 AM d 11:59 AM)
Feasibility of Hysterosalpingography Following a Combined Radiofrequency Global Endometrial Ablation and Hysteroscopic Sterilization Procedure Carey ET, El-Nashar S, Creedon DJ, Famuyide AO, Hopkins MR. OB/ GYN, Mayo Clinic, Rochester, MN Study Objective: To describe the feasibility of performing hysterosalpingography after patients undergo a combined radiofrequency global endometrial ablation and hysteroscopic sterilization procedure. Design: Descriptive feasibility study. Setting: Midwestern United States, academic medical center. Patients: Sixty-six women (ages 20e50) underwent radiofrequency global endometrial ablation followed by hysteroscopic sterilization during a single procedure for menorrhagia and permanent sterilization. Intervention: Evaluation of the rate and efficacy of hysterosalpingograms following the procedure. Measurements and Main Results: Sixty-six women underwent the combined procedure between January 2004 and January 2009. The inserts were successfully placed bilaterally in 65 of the 66 women. Of the 65 women, 50 (77%) women returned for the recommended hysterosalpingogram (HSG) at 3 months. Two of the 50 were unable to proceed with the test secondary to cervical stenosis. In all 48 of the women who where able to undergo HSG, the study was adequate to assess device placement and tubal occlusion. Three (3/48, 6.2%) women had unilateral tubal patency at three months. All of these women returned at 6 months with documentation of total occlusion of both ostia. Conclusion: Hysterosalpingography is a practical method to document tubal occlusion in women who undergo a combined radiofrequency global endometrial ablation and hysteroscopic sterilization procedure. Cervical stenosis is a rare complication that may preclude the use of HSG.
133
Open Communications 7dOncology (11:00 AM d 11:05 AM)
Laparoendoscopic Single-Site Surgery (LESS) in Gynecologic Oncology: Technique and Initial Report Nickles Fader A, Escobar PF. Section of Gynecologic Oncology, Department of OB/GYN and Women’s Health Institute, Cleveland Clinic, Cleveland, OH Study Objective: Recent reports suggest that laparoendoscopic single-site surgery (LESS), also known as single-port surgery, is technically feasible in treating a variety of disease processes. The purpose of this study was to assess the feasibility of LESS for the surgical treatment of various
Abstracts / Journal of Minimally Invasive Gynecology 16 (2009) S1eS51
Measurements and Main Results: There were no major complications encountered in any of the cases. There were 13 (5.3%) minor complications including 2 uterine perforations (0.8%), 4 aborted or failed procedures (1.7%), 3 episodes of significant postoperative cramping or discomfort (1.2%), 2 instrument or equipment malfunctions (0.8%), 1 allergic reaction (0.4%), and 1 vasovagal response to lidocaine (0.4%). Of the 62 EssureÒ procedures the overall minor complication rate was 8%, including a failure to place rate of 4.8%. Forty nine endometrial ablation procedures were performed with a minor complication rate of 14.3%, with postoperative nausea/vomiting (4%) and cramping (4%) being most common. Thirty three operative hysteroscopy cases were performed with a minor complication rate of 9%. Seventy two diagnostic hysteroscopies with dilation and curettage were performed with a minor complication rate of 2.8%. Twenty seven loop electrode excision procedures were performed with no complications. Individual surgeon complication rates ranged from 0% to 33%. The practitioner with the most office experience, a total of 157 cases, had a minor complication rate of 6.4% and no major complications. Conclusion: Office based procedures are a safe method of providing patients with care for multiple gynecologic concerns.
131
Open Communications 6dHysteroscopy (11:48 AM d 11:53 AM)
Adiana System for Transcervical Sterilization: 3-Year Efficacy Results Anderson TL,1 Vancaillie TG.2 1Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN; 2Endo-Gynecology Department, University of New South Wales, Randwick, New South Wales, Australia Study Objective: To evaluate the efficacy of the Adiana System for preventing pregnancy in women desiring permanent sterilization. Design: This study is a prospective, single-armed, multi-center, international trial. The primary endpoint was pregnancy prevention rate at 12 months. Pregnancy prevention rates at 24 and 36 months were also calculated. Setting: The study was conducted at 16 sites in the United States (14), Australia (1) and Mexico (1). Patients: 645 women (intent to treat group). Intervention: Hysteroscopic placement of polymer matrix was attempted in all patients. Tubal occlusion confirmed by HSG at 12 weeks. Ongoing monitoring for pregnancy. Measurements and Main Results: There was a 95% bilateral matrix placement rate and 88.4% bilateral occlusion by HSG, as previously published (Vancaillie TG, TL Anderson, DA Johns (2008) Obstetrics & Gynecology 112(6):1270e1277). As of July 2008, a total of 24,968 person-months of wearing were accrued. Pregnancy prevention rates were summarized with descriptive statistics using 95% one-sided confidence bound based on life-table methods. Completed 36-month data were available for 481 subjects.
# Subjects # Pregnancies Cumulative Pregnancy Prevention Rate
12 months
24 months
36 months
553 6 98.9%
510 3 98.4%
481 none 98.4%
During the first year, 6 pregnancies were reported. Three were determined to be the result of misinterpretation of HSG results. The remaining 3 were attributed to method failure, as were the 3 pregnancies during the second year. No additional pregnancies occurred in year 3. The cumulative pregnancy prevention rates at 12, 24, and 36 months compare favorably with the CREST data and other published reports documenting efficacy of established permanent sterilization procedures. Conclusion: These data demonstrate the effectiveness of the Adiana System for pregnancy prevention is similar to other permanent sterilization methods.
132
Open Communications 6dHysteroscopy (11:54 AM d 11:59 AM)
Feasibility of Hysterosalpingography Following a Combined Radiofrequency Global Endometrial Ablation and Hysteroscopic Sterilization Procedure Carey ET, El-Nashar S, Creedon DJ, Famuyide AO, Hopkins MR. OB/ GYN, Mayo Clinic, Rochester, MN Study Objective: To describe the feasibility of performing hysterosalpingography after patients undergo a combined radiofrequency global endometrial ablation and hysteroscopic sterilization procedure. Design: Descriptive feasibility study. Setting: Midwestern United States, academic medical center. Patients: Sixty-six women (ages 20e50) underwent radiofrequency global endometrial ablation followed by hysteroscopic sterilization during a single procedure for menorrhagia and permanent sterilization. Intervention: Evaluation of the rate and efficacy of hysterosalpingograms following the procedure. Measurements and Main Results: Sixty-six women underwent the combined procedure between January 2004 and January 2009. The inserts were successfully placed bilaterally in 65 of the 66 women. Of the 65 women, 50 (77%) women returned for the recommended hysterosalpingogram (HSG) at 3 months. Two of the 50 were unable to proceed with the test secondary to cervical stenosis. In all 48 of the women who where able to undergo HSG, the study was adequate to assess device placement and tubal occlusion. Three (3/48, 6.2%) women had unilateral tubal patency at three months. All of these women returned at 6 months with documentation of total occlusion of both ostia. Conclusion: Hysterosalpingography is a practical method to document tubal occlusion in women who undergo a combined radiofrequency global endometrial ablation and hysteroscopic sterilization procedure. Cervical stenosis is a rare complication that may preclude the use of HSG.
133
Open Communications 7dOncology (11:00 AM d 11:05 AM)
Laparoendoscopic Single-Site Surgery (LESS) in Gynecologic Oncology: Technique and Initial Report Nickles Fader A, Escobar PF. Section of Gynecologic Oncology, Department of OB/GYN and Women’s Health Institute, Cleveland Clinic, Cleveland, OH Study Objective: Recent reports suggest that laparoendoscopic single-site surgery (LESS), also known as single-port surgery, is technically feasible in treating a variety of disease processes. The purpose of this study was to assess the feasibility of LESS for the surgical treatment of various