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The 1-Year Estimated Efficacy Rate of the Adiana® Permanent Contraception System in Community Use
Abstracts / Journal of Minimally Invasive Gynecology 18 (2011) S1–S23
S19
Conclusion: Our study is the largest to date, with a cohort spanning over 10 years. The results indicate clearly that hysteroscopy does not significantly upstage patients to stage 3A, specifically indicating that disease spread had progressed out of the uterus. From this, it can be deduced that hysteroscopy imposes no risk of dissemination. In addition, there was no difference in death rates between hysteroscopy groups. Thus, hysteroscopy should be considered a safe diagnostic tool for endometrial cancer. 64
Open Communications 2dHysteroscopy (2:33 PM d 2:38 PM)
The 1-Year Estimated Efficacy Rate of the AdianaÒ Permanent Contraception System in Community Use Anderson TL,1 Evantash EG.2 1Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee; 2Hologic, Inc., Marlborough, Massachusetts
on AdianaÒ. One patient became pregnant before the 3-months follow-up. In 3 of the 4 pregnancies the device could not be visualized by ultrasound. Conclusion: The Adiana sterilization technique is a safe and effective sterilization technique that is well-tolerated in an outpatient setting. If the devices are placed correctly and tubal occlusion is confirmed by HSG, the Adiana system provides a pregnancy prevention rate of 98%.
63
Open Communications 2dHysteroscopy (2:27 PM d 2:32 PM)
The Risk of Pre-Operative Hysteroscopy in Patients with Endometrial Cancer: Is There an Effect on Peritoneal Dissemination of Malignant Cells and Ultimately Mortality? Soucie JE, Chu P, Wood S, Ross S, Snodgrass T. Obstetrics & Gynecology, University of Calgary, Calgary, Alberta, Canada Study Objective: To evaluate whether pre-operative hysteroscopy performed in patients with endometrial cancer had an effect on staging of disease, and thus peritoneal dissemination of malignant cells, and ultimately mortality. Design: A retrospective cohort analysis of data linked between a provincial registry of women who have been diagnosed with endometrial cancer over a period of ten years and billing data on hysteroscopy for the same cohort. Intervention: Diagnostic hysteroscopy. Measurements and Main Results: 1972 cases with complete endometrial cancer staging were matched to billing data on preoperative hysteroscopy; and the match found that 672 (34.1%) had had a hysteroscopy performed. There was no statistical difference found between hysteroscopy groups with regards to stage of endometrial cancer less than or greater than and equal to 3 (p = 0.38). There was also no difference found in death rates for those who had had a hysteroscopy (13.2%) compared to those who had not (15.2%). When evaluating only those women who had died, there was no statistical difference found in staging between hysteroscopy groups. When evaluating the cause of death, the proportion of women dying of ‘‘female genital organ’’ cancer was approximately equivalent in the hysteroscopy and no hysteroscopy groups, 46.1% versus 42.1%.
Study Objective: To estimate the 1-year efficacy rate of the AdianaÒ Permanent Contraception system in community use. Design: Life table analysis. Setting: Community use in the U.S. Patients: Women estimated to be relying on the Adiana device for permanent contraception. Intervention: Life table analysis was used to estimate the 1-year pregnancy rate from July 6, 2009 through April 30, 2011, allowing for the 3-month interval required for the confirmatory hysterosalpingogram (HSG). Model assumptions included: 1) estimated utilization rate of commercial units sold (2 devices per unit), 2) bilateral occlusion rate of 85% at 3-months based on pivotal trial data and 3) consistent fecundity rate in the first year of relying on the device for contraception. The estimated number of patients relying for 1-year or longer and less than 1-year was determined, respectively. The estimated 1-year pregnancy rate was calculated as the ratio of reported pregnancies and patient relying-years. Measurements and Main Results: Between FDA approval of the Adiana system on July 6, 2009 and January 31, 2010, an estimated 2121 procedures were performed, with 1352 patients relying on Adiana for contraception as of April 30, 2010. As of January 31, 2011, an estimated cumulative 11432 procedures were performed. The total number of patients relying on Adiana as of April 30, 2011 is estimated to be 9717. Of these, an estimated 1352 patients have been relying on Adiana for 1 year or longer, while an estimated 8365 patients have been relying for less than 1 year. Through April 30, 2011, 30 intra-uterine pregnancies (no ectopic pregnancies) were reported through a post-marketing quality assurance system, resulting in an estimated 0.54% pregnancy rate at 1-year. Conclusion: The 1-year estimated pregnancy rate for Adiana in the community setting is consistent with the rate reported in the pivotal clinical trial demonstrating safety and efficacy.
65
Open Communications 2dHysteroscopy (2:39 PM d 2:44 PM)
Levonorgestrel Intrauterine System Is an Effective Therapy for Fibroid-Related Heavy Menstrual Bleeding: A Secondary Analysis of a Randomized Clinical Trial El-Nashar SA,1 Zakherah MS,2 Sayed GH,2 Shaaban MM.2 1Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota; 2Obstetrics and Gynecology, Assiut University, Assiut, Egypt Study Objective: To compare the efficacy of levonorgestrel intrauterine system (LNG-IUS) in treating heavy menstrual bleeding (HMB) in women with fibroids to women with no fibroids. Design: This study is a secondary analysis of a randomized clinical trial (RCT) which compared LNG-IUS to combined oral contraception(COC). Setting: University hospital in Egypt. Patients: Out of the 170 patients included in the original RCT, 85 patients with HMB who desire contraception had LNG-IUS. This included 56 patients who presented with idiopathic HMB and 29 women who presented with fibroid related HMB.
S19
Conclusion: Our study is the largest to date, with a cohort spanning over 10 years. The results indicate clearly that hysteroscopy does not significantly upstage patients to stage 3A, specifically indicating that disease spread had progressed out of the uterus. From this, it can be deduced that hysteroscopy imposes no risk of dissemination. In addition, there was no difference in death rates between hysteroscopy groups. Thus, hysteroscopy should be considered a safe diagnostic tool for endometrial cancer. 64
Open Communications 2dHysteroscopy (2:33 PM d 2:38 PM)
The 1-Year Estimated Efficacy Rate of the AdianaÒ Permanent Contraception System in Community Use Anderson TL,1 Evantash EG.2 1Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee; 2Hologic, Inc., Marlborough, Massachusetts
on AdianaÒ. One patient became pregnant before the 3-months follow-up. In 3 of the 4 pregnancies the device could not be visualized by ultrasound. Conclusion: The Adiana sterilization technique is a safe and effective sterilization technique that is well-tolerated in an outpatient setting. If the devices are placed correctly and tubal occlusion is confirmed by HSG, the Adiana system provides a pregnancy prevention rate of 98%.
63
Open Communications 2dHysteroscopy (2:27 PM d 2:32 PM)
The Risk of Pre-Operative Hysteroscopy in Patients with Endometrial Cancer: Is There an Effect on Peritoneal Dissemination of Malignant Cells and Ultimately Mortality? Soucie JE, Chu P, Wood S, Ross S, Snodgrass T. Obstetrics & Gynecology, University of Calgary, Calgary, Alberta, Canada Study Objective: To evaluate whether pre-operative hysteroscopy performed in patients with endometrial cancer had an effect on staging of disease, and thus peritoneal dissemination of malignant cells, and ultimately mortality. Design: A retrospective cohort analysis of data linked between a provincial registry of women who have been diagnosed with endometrial cancer over a period of ten years and billing data on hysteroscopy for the same cohort. Intervention: Diagnostic hysteroscopy. Measurements and Main Results: 1972 cases with complete endometrial cancer staging were matched to billing data on preoperative hysteroscopy; and the match found that 672 (34.1%) had had a hysteroscopy performed. There was no statistical difference found between hysteroscopy groups with regards to stage of endometrial cancer less than or greater than and equal to 3 (p = 0.38). There was also no difference found in death rates for those who had had a hysteroscopy (13.2%) compared to those who had not (15.2%). When evaluating only those women who had died, there was no statistical difference found in staging between hysteroscopy groups. When evaluating the cause of death, the proportion of women dying of ‘‘female genital organ’’ cancer was approximately equivalent in the hysteroscopy and no hysteroscopy groups, 46.1% versus 42.1%.
Study Objective: To estimate the 1-year efficacy rate of the AdianaÒ Permanent Contraception system in community use. Design: Life table analysis. Setting: Community use in the U.S. Patients: Women estimated to be relying on the Adiana device for permanent contraception. Intervention: Life table analysis was used to estimate the 1-year pregnancy rate from July 6, 2009 through April 30, 2011, allowing for the 3-month interval required for the confirmatory hysterosalpingogram (HSG). Model assumptions included: 1) estimated utilization rate of commercial units sold (2 devices per unit), 2) bilateral occlusion rate of 85% at 3-months based on pivotal trial data and 3) consistent fecundity rate in the first year of relying on the device for contraception. The estimated number of patients relying for 1-year or longer and less than 1-year was determined, respectively. The estimated 1-year pregnancy rate was calculated as the ratio of reported pregnancies and patient relying-years. Measurements and Main Results: Between FDA approval of the Adiana system on July 6, 2009 and January 31, 2010, an estimated 2121 procedures were performed, with 1352 patients relying on Adiana for contraception as of April 30, 2010. As of January 31, 2011, an estimated cumulative 11432 procedures were performed. The total number of patients relying on Adiana as of April 30, 2011 is estimated to be 9717. Of these, an estimated 1352 patients have been relying on Adiana for 1 year or longer, while an estimated 8365 patients have been relying for less than 1 year. Through April 30, 2011, 30 intra-uterine pregnancies (no ectopic pregnancies) were reported through a post-marketing quality assurance system, resulting in an estimated 0.54% pregnancy rate at 1-year. Conclusion: The 1-year estimated pregnancy rate for Adiana in the community setting is consistent with the rate reported in the pivotal clinical trial demonstrating safety and efficacy.
65
Open Communications 2dHysteroscopy (2:39 PM d 2:44 PM)
Levonorgestrel Intrauterine System Is an Effective Therapy for Fibroid-Related Heavy Menstrual Bleeding: A Secondary Analysis of a Randomized Clinical Trial El-Nashar SA,1 Zakherah MS,2 Sayed GH,2 Shaaban MM.2 1Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota; 2Obstetrics and Gynecology, Assiut University, Assiut, Egypt Study Objective: To compare the efficacy of levonorgestrel intrauterine system (LNG-IUS) in treating heavy menstrual bleeding (HMB) in women with fibroids to women with no fibroids. Design: This study is a secondary analysis of a randomized clinical trial (RCT) which compared LNG-IUS to combined oral contraception(COC). Setting: University hospital in Egypt. Patients: Out of the 170 patients included in the original RCT, 85 patients with HMB who desire contraception had LNG-IUS. This included 56 patients who presented with idiopathic HMB and 29 women who presented with fibroid related HMB.