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Mechanism of Action of the Adiana Device: A Histologic Perspective
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Abstracts / Journal of Minimally Invasive Gynecology 16 (2009) S52eS102
cycles. Post-treatment hysteroscopy was performed in all patients and micro-inserts (Essure) were inserted in 13 women. In 9 women the microinserts were placed prior to Thermablate and in 5 after balloon ablation. Measurements and Main Results: There were no intra- nor postoperative adverse events. AT 3 to 12 months (median 6), patients reported amenorrhea-30%, spotting/hypomenorrhea-53%, eumenorrhea7%, menorrhagia-10%, and overall satisfaction rate of 85%. All microinserts were placed successfully and at 3 months one tube (4%) was patent. Conclusion: 1. Following Thermablate balloon endometrial ablation, patient satisfaction was 85% with amenorrhea rate of 30%. 2. Microinserts (Essure) can be inserted before or after Thermablate balloon ablation.
247
Open Communications 14dHysteroscopy (3:38 PM d 3:43 PM)
Office Endometrial Ablation under Local Anesthesia Using the Hydrothermablation (HTAÒ) System: A Comparison of Outcomes in Patients with Submucous Myomas to Those with Normal Cavities in 246 Cases Performed over Five and One-Half Years Glasser MH,1 Heinlein PK,1 Hung Y-Y.2 1Obstetrics and Gynecology, Kaiser Permanente Medical Center, San Rafael, CA; 2Division of Research, Kaiser Permanente, Oakland, CA Study Objective: To compare the results obtained in those patients with submucous myomas (group F) to those with normal endometrial cavities (group N) who underwent Hydrothermablation (HTA) for abnormal uterine bleeding in the medical office setting using local anesthesia and minimal oral sedation. Design: A retrospective cohort analysis of 246 HTA procedures. Setting: The medical offices of a large health maintenance organization. Patients: 246 women ages 28-63 yrs. (ave.45.1) with abnormal uterine bleeding followed 6-66 mos with an average follow up of 34.1 mos. 105 patients (42.7%) had fibroids, of which 82% were type 0 or type I submucous myomas. Intervention: Endometrial ablation was performed in the medical office using the HTA system under paracervical/intracervical block following oral premedication. Measurements and Main Results: Of the 233 patients used in the analysis, the overall amenorrhea, oligomenorrhea, eumenorrhea and menorrhagia rates were 53.7%, 25.3%, 8.2%, and 7.3% respectively. Thirteen patients (5.6%) underwent hysterectomy for bleeding. The amenorrhea, oligomenorrhea, eumenorrhea and menorrhagia rates in group N compared to group F were 63.2% vs. 40.2%, 24.3% vs.26.8%, 8.8% vs.7.2% and 2.9% vs. 13.4% respectively. Twelve patients underwent hysterectomy for menorrhagia (12.4%) in group F. All had multiple fibroids and 9 of the 12 (75%) also had adenomyosis. The success rate (eumenorrhea or better) in group N was 96.3% while that achieved in group F was 74.2% (Odds Ratio 9.1; 95% CI: 3.3-24.8, p!0.0001). The hysterectomy for bleeding avoidance rate, was 94.4% overall. The avoidance rate in group N was 99.3% while that achieved in group F was 87.6% (Odds Ratio 19.1; 95% CI: 2.4-149.2, p!0.0001). Complications were 4 endometritis and 2 false passages. Conclusion: Hydrothermablation (HTA) can performed in the medical office safely and easily under local anesthesia. The success rate in patients with submucous myomas is less than in patients with normal cavities but 87.6% of our patients with this diagnosis avoided hysterectomy.
248
Open Communications 14dHysteroscopy (3:44 PM d 3:49 PM)
Mechanism of Action of the Adiana Device: A Histologic Perspective Vancaillie TG,1 Harrington D,1 Carr-Brendel V,1 Anderson J.2 1University of New South Wales, Sydney, New South Wales, Australia; 2Pathology, Case Western, Cleveland, OH Study Objective: To investigate the mechanism of action of tubal occlusion for a method employing a biocompatible matrix (Adiana) via histology. The mechanism of action is assumed to be as follows: phase 1: removal of the
tubal endothelium by bipolar current; phase 2: insertion of a biocompatible matrix in apposition with the denuded submucosa; phase 3: during the healing phase an acute inflammatory response leads to colonization of the matrix with fibroblasts as well as polymorphonuclear cells; phase 4: over the next weeks, the acute cell population is replaced by a chronic cell population of macrophages, giant cells and fibrocytes and is maintained long term. Design: N/A Setting: The EASE (A multi-Centre, Prospective Evaluation of the Adiana System for Transcervical Sterilization using Electrothermal Energy in Women Aged 18-45) trial was conducted in 16 Centres throughout the USA, Mexico and Australia. Patients: From 2005 on, 15 participants underwent a hysterectomy for benign conditions. Intervention: Eight of the fifteen specimens were available for detailed analysis. The cornua of the uteri were processed for histology using Hemotoxylin-Eosin staining as well as Epithelial Membrane Antibody (EMA). EMA is a histo-chemical stain, which is aimed at identifying epithelial cells. A positive EMA stain would indicate the presence of epithelial cells. In this particular situation, that could be interpreted as the presence of either endometrial or tubal epithelium and be an indicator of re-canalisation. The specimens were serially sectioned and the special stain was applied to alternate blocks. Measurements and Main Results: Analysis of all long-term specimens shows that the cell ingrowth, expected to surround a compatible biomaterial, is maintained over the years. Most importantly, EMA staining highlights the continued absence of epithelial cells. Conclusion: Our proposed mechanism of action of the Adiana device appears to be correct.
249
Open Communications 14dHysteroscopy (3:50 PM d 3:55 PM)
Trends in Sterilization Since the Introduction of Essure Hysteroscopic Sterilization Shavell VI, Abdallah ME, Shade GH, Diamond MP, Berman JM. Department of Obstetrics and Gynecology, Wayne State University and the Detroit Medical Center, Detroit, MI Study Objective: To investigate trends in sterilization in women at the Detroit Medical Center, Michigan (DMC), since the introduction of Essure hysteroscopic sterilization. Design: Retrospective study. Setting: Outpatient surgery center and university teaching hospitals. Patients: Women who underwent interval sterilization procedures at the DMC (Hutzel Women’s Hospital, Sinai-Grace Hospital, and the Berry Center) and postpartum sterilization procedures at Hutzel Women’s Hospital between January 1, 2002, and December 31, 2007. Intervention: Permanent sterilization procedures including minilaparotomy tubal ligation, laparoscopic sterilization, Essure hysteroscopic sterilization, and postpartum tubal ligation performed at the time of cesarean section or after vaginal delivery. Measurements and Main Results: In all, 5509 permanent sterilization procedures were performed in the 6 years between January 1, 2002, and December 31, 2007, at the DMC facilities analyzed: 2484 interval sterilization procedures at Hutzel Women’s Hospital, Sinai-Grace Hospital, and the Berry Center, and 3025 postpartum tubal ligations at Hutzel Women’s Hospital. From 2002 through 2007, the decrease in laparoscopic sterilizations from 97.9% to 48.5% of all interval sterilization procedures corresponded significantly with the increase in Essure hysteroscopic sterilizations from 0.0% to 51.3% (p!.001). Postpartum tubal ligations performed after vaginal delivery also decreased significantly during the study period from 7.9% to 3.3% of all vaginal deliveries (p !.001) while the percentage of tubal ligations performed at the time of cesarean section remained constant (p 5 .051). Conclusion: At the DMC facilities analyzed from January 1, 2002, through December 31, 2007, a significant decrease occurred in the percentage of laparoscopic sterilizations and postpartum tubal ligations performed after vaginal delivery. Of the interval sterilizations performed, the percentage of Essure hysteroscopic sterilizations increased significantly from 0.0% to
Abstracts / Journal of Minimally Invasive Gynecology 16 (2009) S52eS102
cycles. Post-treatment hysteroscopy was performed in all patients and micro-inserts (Essure) were inserted in 13 women. In 9 women the microinserts were placed prior to Thermablate and in 5 after balloon ablation. Measurements and Main Results: There were no intra- nor postoperative adverse events. AT 3 to 12 months (median 6), patients reported amenorrhea-30%, spotting/hypomenorrhea-53%, eumenorrhea7%, menorrhagia-10%, and overall satisfaction rate of 85%. All microinserts were placed successfully and at 3 months one tube (4%) was patent. Conclusion: 1. Following Thermablate balloon endometrial ablation, patient satisfaction was 85% with amenorrhea rate of 30%. 2. Microinserts (Essure) can be inserted before or after Thermablate balloon ablation.
247
Open Communications 14dHysteroscopy (3:38 PM d 3:43 PM)
Office Endometrial Ablation under Local Anesthesia Using the Hydrothermablation (HTAÒ) System: A Comparison of Outcomes in Patients with Submucous Myomas to Those with Normal Cavities in 246 Cases Performed over Five and One-Half Years Glasser MH,1 Heinlein PK,1 Hung Y-Y.2 1Obstetrics and Gynecology, Kaiser Permanente Medical Center, San Rafael, CA; 2Division of Research, Kaiser Permanente, Oakland, CA Study Objective: To compare the results obtained in those patients with submucous myomas (group F) to those with normal endometrial cavities (group N) who underwent Hydrothermablation (HTA) for abnormal uterine bleeding in the medical office setting using local anesthesia and minimal oral sedation. Design: A retrospective cohort analysis of 246 HTA procedures. Setting: The medical offices of a large health maintenance organization. Patients: 246 women ages 28-63 yrs. (ave.45.1) with abnormal uterine bleeding followed 6-66 mos with an average follow up of 34.1 mos. 105 patients (42.7%) had fibroids, of which 82% were type 0 or type I submucous myomas. Intervention: Endometrial ablation was performed in the medical office using the HTA system under paracervical/intracervical block following oral premedication. Measurements and Main Results: Of the 233 patients used in the analysis, the overall amenorrhea, oligomenorrhea, eumenorrhea and menorrhagia rates were 53.7%, 25.3%, 8.2%, and 7.3% respectively. Thirteen patients (5.6%) underwent hysterectomy for bleeding. The amenorrhea, oligomenorrhea, eumenorrhea and menorrhagia rates in group N compared to group F were 63.2% vs. 40.2%, 24.3% vs.26.8%, 8.8% vs.7.2% and 2.9% vs. 13.4% respectively. Twelve patients underwent hysterectomy for menorrhagia (12.4%) in group F. All had multiple fibroids and 9 of the 12 (75%) also had adenomyosis. The success rate (eumenorrhea or better) in group N was 96.3% while that achieved in group F was 74.2% (Odds Ratio 9.1; 95% CI: 3.3-24.8, p!0.0001). The hysterectomy for bleeding avoidance rate, was 94.4% overall. The avoidance rate in group N was 99.3% while that achieved in group F was 87.6% (Odds Ratio 19.1; 95% CI: 2.4-149.2, p!0.0001). Complications were 4 endometritis and 2 false passages. Conclusion: Hydrothermablation (HTA) can performed in the medical office safely and easily under local anesthesia. The success rate in patients with submucous myomas is less than in patients with normal cavities but 87.6% of our patients with this diagnosis avoided hysterectomy.
248
Open Communications 14dHysteroscopy (3:44 PM d 3:49 PM)
Mechanism of Action of the Adiana Device: A Histologic Perspective Vancaillie TG,1 Harrington D,1 Carr-Brendel V,1 Anderson J.2 1University of New South Wales, Sydney, New South Wales, Australia; 2Pathology, Case Western, Cleveland, OH Study Objective: To investigate the mechanism of action of tubal occlusion for a method employing a biocompatible matrix (Adiana) via histology. The mechanism of action is assumed to be as follows: phase 1: removal of the
tubal endothelium by bipolar current; phase 2: insertion of a biocompatible matrix in apposition with the denuded submucosa; phase 3: during the healing phase an acute inflammatory response leads to colonization of the matrix with fibroblasts as well as polymorphonuclear cells; phase 4: over the next weeks, the acute cell population is replaced by a chronic cell population of macrophages, giant cells and fibrocytes and is maintained long term. Design: N/A Setting: The EASE (A multi-Centre, Prospective Evaluation of the Adiana System for Transcervical Sterilization using Electrothermal Energy in Women Aged 18-45) trial was conducted in 16 Centres throughout the USA, Mexico and Australia. Patients: From 2005 on, 15 participants underwent a hysterectomy for benign conditions. Intervention: Eight of the fifteen specimens were available for detailed analysis. The cornua of the uteri were processed for histology using Hemotoxylin-Eosin staining as well as Epithelial Membrane Antibody (EMA). EMA is a histo-chemical stain, which is aimed at identifying epithelial cells. A positive EMA stain would indicate the presence of epithelial cells. In this particular situation, that could be interpreted as the presence of either endometrial or tubal epithelium and be an indicator of re-canalisation. The specimens were serially sectioned and the special stain was applied to alternate blocks. Measurements and Main Results: Analysis of all long-term specimens shows that the cell ingrowth, expected to surround a compatible biomaterial, is maintained over the years. Most importantly, EMA staining highlights the continued absence of epithelial cells. Conclusion: Our proposed mechanism of action of the Adiana device appears to be correct.
249
Open Communications 14dHysteroscopy (3:50 PM d 3:55 PM)
Trends in Sterilization Since the Introduction of Essure Hysteroscopic Sterilization Shavell VI, Abdallah ME, Shade GH, Diamond MP, Berman JM. Department of Obstetrics and Gynecology, Wayne State University and the Detroit Medical Center, Detroit, MI Study Objective: To investigate trends in sterilization in women at the Detroit Medical Center, Michigan (DMC), since the introduction of Essure hysteroscopic sterilization. Design: Retrospective study. Setting: Outpatient surgery center and university teaching hospitals. Patients: Women who underwent interval sterilization procedures at the DMC (Hutzel Women’s Hospital, Sinai-Grace Hospital, and the Berry Center) and postpartum sterilization procedures at Hutzel Women’s Hospital between January 1, 2002, and December 31, 2007. Intervention: Permanent sterilization procedures including minilaparotomy tubal ligation, laparoscopic sterilization, Essure hysteroscopic sterilization, and postpartum tubal ligation performed at the time of cesarean section or after vaginal delivery. Measurements and Main Results: In all, 5509 permanent sterilization procedures were performed in the 6 years between January 1, 2002, and December 31, 2007, at the DMC facilities analyzed: 2484 interval sterilization procedures at Hutzel Women’s Hospital, Sinai-Grace Hospital, and the Berry Center, and 3025 postpartum tubal ligations at Hutzel Women’s Hospital. From 2002 through 2007, the decrease in laparoscopic sterilizations from 97.9% to 48.5% of all interval sterilization procedures corresponded significantly with the increase in Essure hysteroscopic sterilizations from 0.0% to 51.3% (p!.001). Postpartum tubal ligations performed after vaginal delivery also decreased significantly during the study period from 7.9% to 3.3% of all vaginal deliveries (p !.001) while the percentage of tubal ligations performed at the time of cesarean section remained constant (p 5 .051). Conclusion: At the DMC facilities analyzed from January 1, 2002, through December 31, 2007, a significant decrease occurred in the percentage of laparoscopic sterilizations and postpartum tubal ligations performed after vaginal delivery. Of the interval sterilizations performed, the percentage of Essure hysteroscopic sterilizations increased significantly from 0.0% to