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Plenary 3: Hysteroscopy

MODERATORS Philip G. Brooks, MD Donald L. Chatman, MD Richard J. Gimpelson, MD

DISCUSSANTS Aarthi Cholkeri-Singh, MD Jorge Dotto, MD Marit Lieng, MD, PhD Stephanie N. Morris, MD Kirsten Sasaki, MD George A. Vilos, MD

Attilio Di Spiezio Sardo, MD, PhD Ayman Oraif, MD Chandrew Rajakumar, MD Crystal M. Santiago, MD Tarek Shokeir, MD Michael W.H. Suen, MD

Sponsored by

Advancing MinimallyAAGL Invasive Gynecology Worldwide

Professional Education Information

Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology.

Accreditation AAGL is accredited by the Accreditation Council for Continuing to provide continuing medical education for .

The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ...... 1

Disclosure ...... 2

A Single Injection of Depomedroxyprogesterone Acetate (Dmpa) Immediately After Rollerball Endometrial Ablation Significantly Improves Clinical Outcomes in Women With Heavy Menstrual Bleeding Ayman Oraif ...... 4

Accuracy of Hysteroscopic Metroplasty With the Combination of Pre Surgical Three‐Dimensional Ultrasonography and a Novel Graduated Intrauterine Palpator: A Randomized Controlled Trial Attilio Di Spiezio Sardo ...... 7

Complications and Compliance of Hysteroscopic Sterilization With Essure in an Inner City Hospital Crystal M. Santiago ...... 10

Hysteroscopic Metroplasty in Women With Unexplained Primary Infertility: A Prospective Cohort Study Tarek Shokeir ...... 12

Hysteroscopic Management of a Stenotic Cervix Michael W.H. Suen ...... 15

Hysteroscopic Removal of Retained Placental Tissue Allieviates Postpartum Hypertension Chandrew Rajakumar ...... 16

Cultural and Linguistics Competency ...... 17

Plenary 3: Hysteroscopy

Moderators: Philip G. Brooks, Donald L. Chatman, Richard J. Gimpelson

Discussants: Aarathi Cholkeri-Singh, Jorge Dotto, Marit Lieng, Stephanie N. Morris, Kristen Sasaki, George A. Vilos

Faculty: Attilio Di Spiezio Sardo, Ayman Oraif, Chandrew Rajakumar, Crystal M. Santiago, Tarek Shokeir, Michael W.H. Suen

This session provides a group of advanced hysteroscopic techniques dealing with uterine anomalies and acquired abnormalities, along with several recommendations to make hysteroscopic procedures more effective.

Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Describe advanced indications; and 2) discuss additional surgical techniques to improve outcomes of hysteroscopic .

Course Outline

2:15 A Single Injection of Depomedroxyprogesterone Acetate (Dmpa) Immediately After Rollerball Endometrial Ablation Significantly Improves Clinical Outcomes in Women With Heavy Menstrual Bleeding A. Oraif 2:21 Discussant A. Cholkeri-Singh 2:25 Accuracy of Hysteroscopic Metroplasty With the Combination of Pre-Surgical Three-Dimensional Ultrasonography and a Novel Graduated Intrauterine Palpator: A Randomized Controlled Trial A. Di Spiezio Sardo 2:31 Discussant K. Sasaki 2:35 Complications and Compliance of Hysteroscopic Sterilization With Essure in an Inner City Hospital C.M. Santiago 2:41 Discussant M. Lieng 2:45 Hysteroscopic Metroplasty in Women With Unexplained Primary Infertility: A Prospective Cohort Study T. Shokeir 2:51 Discussant G.A. Vilos 2:55 Video: Hysteroscopic Management of a Stenotic Cervix M.W.H. Suen

3:01 Discussant S.N. Morris 3:05 Video: Hysteroscopic Removal of Retained Placental Tissue Allieviates Postpartum Hypertension C. Rajakumar 3:11 Discussant J. Dotto 3:15 Adjourn

1 PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Amber Bradshaw Speakers Bureau: Myriad Genetics Lab Other: Proctor: Intuitive Surgical Erica Dun* Frank D. Loffer, Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Johnny Yi*

SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: Intuitive Royalty: CooperSurgical Sarah L. Cohen* Jon I. Einarsson* Stuart Hart Consultant: Covidien Speakers Bureau: Boston Scientific, Covidien Kimberly A. Kho Contracted/Research: Applied Medical Other: Pivotal Protocol Advisor: Actamax Matthew T. Siedhoff Other: Payment for Training Sales Representatives: Teleflex M. Jonathon Solnik Consultant: Z Microsystems Other: Faculty for PACE Surgical Courses: Covidien

FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Philip G. Brooks* Donald L. Chatman* Aarathi Cholkeri-Singh Speakers Bureau: Bayer Healthcare Corp., Ethicon Endo-Surgery Other: Advisory Board Member: Bayer Healthcare Corp., Ethicon Endo-Surgery Consultant: Smith & Nephew Endoscopy Attilio Di Spiezio Sardo Consultant: Bayer Healthcare Corp., Johnson & Johnson, Karl Storz Jorge Dotto* Richard J. Gimpelson Contracted Research: Minerva Surgical Royalty: CooperSurgical, Inc., Halt Medical Other: Advisory Board: Boston Scientific Corp. Inc. Other: Clinical Events Committee: Halt Medical Other: Scientific Advisory Board: Mirabilis Medica Marit Lieng*

2 Stephanie N. Morris* Ayman Oraif* Chandrew Rajakumar* Crystal M. Santiago* Kirsten J. Sasaki* Tarek Shokeir* Michael W.H. Suen* George A. Vilos*

Asterisk (*) denotes no financial relationships to disclose.

3 A Single Injection of Depomedroxyprogesterone Acetate (Dmpa) Disclosure Immediately After Rollerball Endometrial Ablation Significantly Improves Clinical Outcomes in Women With Heavy Menstrual Bleeding

Ayman Oraif, MD,FRCSC I have no financial relationships to disclose.

The Fertility Clinic, LHSC, Department of and Gynecology, Western University, London, Canada Department of Obstetrics and Gynecology, King Abdulaziz University, Jeddah, Saudi Arabia

Background Objective: • First generation endometrial ablation techniques (FEATs) were introduced in Discuss clinical outcomes of DMPA in women with heavy the 1980’s as an alternative to hysterectomy to treat women with abnormal uterine bleeding from benign causes. menstrual bleeding • These included endometrial laser ablation and radiofrequency rollerball/bar or transcervical resection of the endometrium (TCRE).

Papadopoulos NP, Magos A (2007) First‐generation endometrial ablation: roller‐ball vs loop vs laser. Best Pract Res Clin Obstet Gynaecol 21:915–929

ACOG Practice Bulletin No. 81, May 2007: endometrial ablation. Obstet Gynecol 109(5):1233‐48

Background Problem with the FEATs & SEATs

•Following endometrial ablation by any technique, long‐term outcomes (within 10 years) • Second generation endometrial ablation technologies (SEATs), also referred indicate that 15 to 30 % of women require additional surgery such as hysterectomy for to as global endometrial ablation (GEA) or non‐hysteroscopic endometrial persistent AUB, uterine/pelvic pain, or both. ablation (non‐HEA), were introduced in the 1990’s as automated, easier, and safer alternatives to hysteroscopic endometrial ablation requiring less skill and could be performed in the office. •The subsequent 30 % hysterectomy rate after endometrial ablation together with a high satisfaction rate of women who chose hysterectomy as 1ry treatment of their AUB has raised some serious issues and concerns regarding the cost‐effectiveness, ongoing Garry R, for the Endometrial Ablation Group (2002) Evidence and techniques in endometrial ablation: utilization, and indeed the future of both hysteroscopic (HEA) and non‐hysteroscopic consensus. 2002. Gynecol Endosc 11(1):5–17 endometrial ablation (NHEA) for the treatment of AUB.

Madhu CK, Nattey J, Naeem T (2009) Second generation endometrial ablation techniques: an audit of clinical Munro MG (2006) Endometrial ablation. Where have we been? Where are we going? Clin Obstet Gynecol 49(4):736–766 practice. Arch Gynecol Obstet 280:599–602 Longinotti MK, Jacobson GF, Hung YY, Learman LA (2008) Probability of hysterectomy after endometrial ablation. Obstet Gynecol 112(6):1214–1220

Bhattacharya S, Middleton LJ, Tsourapas A et al (2011) Hysterectomy, endometrial ablation and Mirena® for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost‐effectiveness analysis. Health Technol Assess 15(19):iii–xvi, 1‐252

4 Solutions to FEATs & SEATs Potential Savior to FEATs & SEATs 1. Go back to hysterectomy 2. Use adjunct • Many gynecologists resort to hysterectomy for both as primary treatment of AUB and as the next logical step in women who fail • 1990 Townsend et al: 400 mg medroxyprogesterone given post‐rollerball primary endometrial ablation. ablation –amenorrhea rates at 6‐12 months were 100% (25/25) vs. 40% Zupi E, Centini G, Lazzeri L, et al. HEA v. LSH for AUB:Long‐term follow up of an RCT. JMIG 2015;22:841‐5 (10/25) in study group and control group, respectively

•However, in spite of major technological advances in minimally •1994 Jacobs and Blumenthal: injection of150 mg DMPA post‐TCRE invasive gynecological surgery, hysterectomy remains a major surgical ‐ amenorrhea rates at 6, 12 and >12 months were 66.7%, 59.3% and 55.6% procedure associated with significant morbidity, mortality, and health compared to 34.4%,d 31.3% an 26.1% in the DMPA group and control group, care costs and resources. respectively

Wright JD, Devine P, Shah M et al (2010) Morbidity and mortality of peripartum hysterectomy. Obstet gynecol 115:1187–1193 •1995 Goldrath: injection of 150 mg DMPA after hysteroscopic endometrial photocoagulation with the Nd:YAG laser fiber ‐amenorrhea rates at >6 Boyd LR, Novesky AP, Curtin JP (2010) Effect of surgical volume on route of hysterectomy and short‐term morbidity. Obstet Gynecol 116:909–915 months post‐ablation were 69% vs. 37% in the DMPA group and control group, respectively Roberts TE, Tsourapas A, Middleton LJ et al (2011) Hysterectomy, endometrial ablation, and levonorgestrel releasing intrauterine system (Mirena) for treatment of heavy menstrual bleeding: cost effectiveness analysis. BMJ 342:d2202. doi:10.1136/bmj.d2202 Clark‐Pearson DL, Geller EL (2013) Complications of hysterectomy. Clin Exp Ser Obstet Gynecol 121:654–673

Objective: Adjunct Therapy Proposed Mechanism of Action of DMPA

• Progesterone down regulates estrogen receptors To determine patient satisfaction and the clinical • When progesterone is given in the form of DMPA injection, its effect lasts 3 effectiveness of a single dose of Depo months Medroxyprogesterone Acetate (DMPA) injection immediately after rollerball endometrial ablation (REA) in women with heavy menstrual bleeding • By decreasing/eliminating the influence of estrogen on any residual endometrium through receptor down‐regulation for 3 months, any (HMB). residual/non‐ablated endometrium may atrophy/die or scar down before unopposed estrogen can revitalize it.

Materials and Methods Baseline Characteristics

• 83 women received a single dose of DMPA 150 mg, IM, immediately after REA. REA + DMPA REA Only • Inclusion criteria: Women receiving REA for HMB with a normal uterine cavity and normal endometrial biopsy pre‐operatively. Age 42.6 (25‐55) 40.7

• Endometrium was ablated using a 26F (9 mm) resectoscope with a 5 mm 2.1 (0‐6) 1.9 rollerball, 1.5% glycine and 120 w of power. Parity

27.2 (19‐45) 27.7 • Outcomes were compared with a historical control group (n=47) who had BMI REA only.

5 Main clinical outcomes at 12 months Results on Menstrual Blood Loss

REA + DMPA REA Only P Value Results of REA and DMPA at 12 months (N=77) (N=77) (N=47) Amenorrhea 75.3% (58) Amenorrhea 75.3% (58) 31.9% (15) P < 0.05 Hypomenorrhea 22.1% (17) 42.6% (20) P < 0.05 Spotting 13.0 % (10) Re‐Intervention 2.6% (2) 34.0% (16) P <0.05 Hypomenorrhea 9.1% (7) Repeat ablation 0 17.0% (8) P <0.05 Hysterectomy 2.6% (2) 17.0% (8) P <0.05 No change 1.3% (1) Satisfaction 96.1% (74) 66.0 % (31) P <0.05

References Conclusions Vilos GA, Lefebvre G, Graves G. Guidelines for the management of abnormal uterine bleeding. SOGC Clinical Practice Guidelines No. 106, August 2001. J Obstet Gynecol Can 23:704‐9, 2001. Kroft J, Liu G. First‐ versus second‐generation endometrial ablation devices for treatment of menorrhagia: a systematic review, meta‐ analysis and appraisal of economic evaluations. J Obstet Gynaecol Can 35(11):1010‐1019, 2013. MIRENA Product Monograph. 2014, Bayer Inc. 1. A single injection of DMPA concomitantly with REA produces Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. a significant increase in menstrual reduction (amenorrhea rate) Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI:10.1002/14651858.CD000329.pub2. Vilos GA, Pispidikis JT, Botz CK.: Economic evaluation of hysteroscopic endometrial ablation versus vaginal hysterectomy for the treatment and a decrease in the rate of re‐intervention for HMB at 12 of menorrhagia. Obstet Gynecol 85:244–252, 1996. Brumsted JR, Blackman JA, Badger GJ, et al: Hysteroscopy versus hysterectomy for the treatment of abnormal uterine bleeding: A months. comparison of cost. Fertil Steril 65:310–316, 1996. Matteson KA, Abed H, Wheeler TL 2nd et al. A systematic review comparing hysterectomy with less‐invasive treatment for abnormal uterine bleeding. J Minim Invasive Gynecol 19(1):13‐28, 2012. MacLean‐Fraser E, Penava D, Vilos GA. Perioperative complication rates of primary and repeat hysteroscopic endometrial ablations. J Am Assoc Gynecol Laparosc 9(2):175‐177, 2002. Further corroboration of these findings using different ablation Townsend DE, Richart RM, Paskowitz RA, Woolfork RE. “ Rollerball” coagulation of the endometrium. Am J Obstet Gynecol 76: 310‐313, methods and through RCT may be a game changer in the 1990. Jacobs SA, Blumenthal NJ. Endometrial resection follow up: late onset of pain and the effect of depot medroxyprogesterone acetate. Br J management of HMB. Obstet Gynaecol 101:605–609, 1994. Goldrath MH. Hysteroscopic endometrial ablation. Obstet Gynecol Clin NA 22:559‐72, 1995.

6 Accuracy of hysteroscopic metroplasty with the combination of pre‐surgical three‐dimensional ultrasonography and a novel graduated intrauterine palpator: A randomized controlled trial • Consultant: Attilio Di Spiezio Sardo, MD, PhD • Bayer Healthcare Corp., • Johnson & Johnson, University of Naples “Federico II” • Karl Storz Italy

METROPLASTY

• Discuss the accuracy of hysteroscopic metroplasty

Classification of female genital tract congenital anomalies

American Fertility Society (AFS), 1988 y

z

7 ACCURACY OF METROPLASTY ACCURACY OF METROPLASTY

fundus thickness Pre‐surgical three‐dimensional Fundal Notch II SURGICAL TIME transvaginal ultrasonography : 1cm (3D‐TVS)

Depth of the septum

Optimal Incomplete (residual septum > (residual septum Suboptimal 10 mm) 5 Fr graduated intrauterine palpator ≤ 5 mm) (residual septum between 5 and 10mm) POSSIBILITY TO MEASURE THE DEPTH OF SECTION

MATERIALS AND METHODS Metroplasty with miniature instruments PRE- SURGICAL ASSESSMENT 90 OF UTERINE CAVITY KEY POINTS

• Begin at the apex • Latero-lateral direction • Resection with 5 Fr HSC 3D- TVS bipolar electrode in pulsed mode GROUP T GROUP C • Finishing touch of the N: 45 N: 45 base of septum with 5Fr scissors POST- SURGICAL ASSESSMENT 3D- TVS OF UTERINE CAVITY HSC GROUP C

RESULTS (1) GROUP T

GROUP TGROUP C RR 95% CI p

Optimal 32 (71.5%) 19 (41.2%) 1.684 1.116‐2.506 0.006

Suboptimal 13 (28.5%) 14 (31.1%) 0.929 0.457‐1.874 1.0

Incomplete 012 ( 26.7%) 0 0‐0.392 <0.0001 fundus thickness

Depth of the septum

8 RESULTS (2) RESULTS (3)

OPTIMAL

INCOMPLETE

 Grimbizis GF, Gordts S, Di Spiezio Sardo A, et al. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Human Reproduction 2013; 28: 2032–2044. CONCLUSIONS  Francisco Raga, Celia Bauset, Jose Remohi, et al. Reproductive impact of congenital Mullerian anomalies. Human Reproduction 1997; 112: 2277–2281  Venetis CA, Papadopoulos SP, Campo .R, et al Clinical implications of congenital uterine anomalies: a meta‐analysis of comparative studies. Reprod Biomed Online 2014; 29(6): 665‐83.  American Fertility Society. The AFS classification of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, Mullerian anomalies and intrauterine adhesions. Fertil Steril 1988; 49: 944‐955.  Fedele L, Arcaini L, Parazzini F, et al. Reproductive prognosis after hysteroscopic metroplasty in 102 women: life ‐table analysis. Fertil Steril 1993; 59(4): 768‐72. 3D‐ TVS Graduate intrauterine palpator  Pabuccu R, Gomel V. Reproductive outcome after hysteroscopic metroplasty in women with septate uterus and otherwise unexplained infertility. Fertil Steril 2004; 81(6): 1675‐8.  Nappi C, Di Spiezio Sardo A. State‐of‐the‐art Hysteroscopic Approaches to of the Genital Tract. Endo‐ Press 2014.  Porcu G, Cravello L, D’ Ercole C et al. Hysteroscopic metroplasty for septate uterus and repetitive abortions: reproductive outcome. Eur J Obstet Gynecol Reprod Biol 2000; 88: 81–84.  Mollo A, Nazzaro G, Granata M et al. Combined hysteroscopic findings and 3‐dimensional reconstructed coronal view of the uterus to avoid laparoscopic assessment for inpatient hysteroscopic metroplasty: pilot study. J Minim Invasive Gynecol 2011; 18: 112–117.  Di Spiezio Sardo A, Spinelli M, Bramante S et al. Efficacy of a polyethylene oxide‐sodium carboxymethylcellulose gel in prevention of intrauterine adhesions after hysteroscopic surgery. J Minim Invasive Gynecol 2011; 18(4): 462‐9.  Ludwin A, Ludwin I, Kudla M et al. Diagnostic accuracy of three‐dimensional sonohysterography compared with office hysteroscopy and its interrater/intrarater agreement in uterine cavity assessment after hysteroscopic metroplasty. Fertil Steril 2014; 101(5): 1392–1399.  Di Spiezio Sardo A, Florio P, Nazzaro G et al. Hysteroscopic outpatient metroplasty to expand dysmorphic uteri (HOME ‐DU technique): a pilot study. Reprod Biomed Online 2015; 30(2): 166‐74.  Homer H, Li T, Cooke I. The septate uterus: a review of management and reproductive outcome. Fertil Steril 2000; 73: 1–14.  Grimbizis GF, Camus M, Tarlatzis BC, Bontis JN, Devroey P. Clinical implications of uterine malformations and hysteroscopic treatment results. Hum Reprod Update 2001; 7(2): 161‐74.  Kormányos Z, Molnár BG, Pál A. Removal of a residual portion of a uterine septum in women of advanced reproductive age: obstetric outcome. Hum Reprod 2006; 21(4): 1047‐51.  Woelfer B, Salim R, Banerjee S et al. Reproductive outcomes in women with congenital uterine anomalies detected by three‐dimensional ultrasound screening. Obstet Gynecol 2001; 98(6): 1099‐103. Pre-surgical assessment Intraoperative (objective)  Wu MH, Hsu CC, Huang KE. Detection of congenital müllerian duct anomalies using three‐dimensional ultrasound. J Clin Ultrasound 1997; 25(9): 487‐92.  Jurkovic D, Geipel A, Gruboeck K et al. Three‐dimensional ultrasound for the assessment of uterine anatomy and detection of congenital anomalies: a comparison data with hysterosalpingography and two‐dimensional sonography. Ultrasound Obstet Gynecol. 1995; 5(4): 233‐7.  Ghi T, Casadio P, Kuleva M et al. Accuracy of three‐dimensional ultrasound in diagnosis and classification of congenital uterine anomalies. Fertil Steril 2009; 92(2): 808‐13.  Gubbini G, Di Spiezio Sardo A, Nascetti D et al. New outpatient subclassification system for American Fertility Society Classes V and VI uterine anomalies. J Minim Invasive Gynecol 2009; 16(5): 554‐61. ONE SURGICAL STEP  Bajka M, Badir S. Fundus Thickness Assessment by 3D Transvaginal Ultrasound Allows Metrics‐Based Diagnosis and Treatment of Congenital Uterine Anomalies. Ultraschall in Med 2015

9 Complications and Compliance of Hysteroscopic Sterilization with Essure in an Inner City Hospital

Crystal Santiago, M.D. I have no financial relationships to disclose Lincoln Medical and Mental Health Center Department of Obstetrics and Gynecology Bronx, New York

Overview: • Discuss real life experience with Essure • Objective: assess complications from Essure compared to initial FDA studies sterilization and compliance rate for follow up with 3 – Complications month Hysterosalpingogram (HSG) – Failure of placement – Subsequent pregnancies • Design: Retrospective chart review • Follow up compliance rate in an inner city, • Setting: Academic affiliated community hospital high immigrant population • Patients: All patients with attempted hysteroscopic Essure sterilization from January 2008 through August 2014

Measurements & Main Results: Measurements & Main Results: • 175 procedures attempted on 173 patients • Of the 175 procedures, 16 (9.1%) were incomplete – 4 unilateral placements • Demographics • Only able to visualize single ostium and placed – 151 (87.3%) Hispanic • 1 returned for successful placement in other tube – 19 (11.0%) African/African‐American – 7 aborted procedures – 3 (1.7%) Asian • 5 unable to pass into 1 or both ostia – 1 due to tubal spasm – Average age 35 years • 1 proliferative endometrium, poor visualization – Average parity of 3 • 1 device misfired on 3 attempts – Body mass index (BMI) of 29.0 kg/m2 • 1 returned for successful placement bilaterally – 5 converted to laparoscopic sterilization – Average surgical time 37 minutes • 3 unable to visualize 1 or more ostia – Estimated blood loss 5 mL • 2 tubal spasm

10 Measurements & Main Results: Measurements & Main Results:

• Of the 161 successful bilateral Essure placements • Of the 161 successful bilateral Essure placements – 99 (62%) patients had HSG performed – 3 (1.8%) had subsequent pregnancies • 84 (85%) no spillage bilaterally • 2 (1.2%) with confirmed bilateral blockage on HSG • 14 (14%) with unilateral/bilateral spillage • 1 (0.6%) had no HSG performed • 1 (1%) incomplete studies – 62 (39%) patients did not have HSG • 35 (57%) failed to keep appointment • 16 (25%) HSG orders were cancelled from the system upon discharge (system error) • 10 (16%) had no HSG order placed • 1 (2%) has a pending appointment

Conclusions: Conclusions: • Expulsion rate • Failure rate of Essure placement at first attempt – 1.2% for our patients – 9.1% our patients – 2.9% for Pivotal study, 0.5% for Phase II study – 14% in Pivotal study • Perforation • Post procedure HSG noncompliance rate – 0% for our patients – 38% in our patients – 2.9% for Phase II study, 1.1% for Pivotal study – 4.4% in Pivotal study, 3.0% in Phase II study – Tubal spasm rate: 1.7% of our procedures • The rate of initial tubal patency on HSG • Phase 2: – 14.1% our patients – Recall process for all previous procedures (secondary analysis) – 3.5% from both Phase II and Pivotal studies – Up to date logw of ne procedures • Post procedure pregnancy rate – Fix system error of disappearing HSG appointments – 1.2% over the 8 years for our patients • Goals: – 0.2% over 2 years from Essure studies – Improve compliance with HSG follow up – Decrease complication rates

• Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000 Investigators Group. “Microinsert nonincisional hysteroscopic sterilization.” Obstet Gynecol. 2003 Jul;102(1):59‐67.

• Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela‐Font E, Cher D, Carignan CS. “Hysteroscopic sterilization using a micro‐insert device: results of a multicentre Phase II study.” Hum Reprod. 2003 Jun;18(6): 1223‐30.

11 Hysteroscopic metroplasty in women with unexplained primary infertility: A prospective cohort study I have no financial relationships to disclose. Tarek Shokeir,MD

Mansoura University, Egypt

Objectives Objectives (contin.)

• To evaluate the effect of hysteroscopic • Discuss clinical pregnancy rate (PR) according metropalsty as therapy for unexplained primary infertility in women with uterine to patient and septum characteristics using septum as a possible sole cause for HSG were the main outcome measures. reproductive failure. • To define the factors influencing reproductive success.

Materials and methods Materials and methods (contin.) • From August 2011 through December 2014 we enrolled 103 infertile women with uterine septum as a possible sole cause for • Elecrosurgical hysteroscopic metroplasty was unexplained primary infertility. performed in the early follicular phase, under

• Uterine anomalies were diagnosed by general anesthesia with no preoperative hysterosalpingography (HSG) and transvaginal endometrial preparation. sonography (TVS) . Diagnosis was further

confirmed by office hysteroscopy.

12 Materials and methods (contin.) Results

• Follow‐up was complete for 88 patients. • Only patients with follow‐up of at least 12 months duration are discussed in this study. • Forty‐two patients became pregnant (40.7%). • There was short delay to conception (mean ±SD time to conception was 7.5 ± 6.2 • Clinical pregnancy rate (PR) according to months). patient and septum characteristics defined by HSG (septum length) were the main outcome • Of 44 pregnancies in 42 women, 36 live measures. newborns were delivered.

Patients’ characteristics according to fertility Pts. who Pts. who did P Septum characteristics according to fertility conceived not conceive value ______(no=42) (n=46) Pts. Who Pts. Who P ______Mean follow‐up 28.3±7.4 26.4±7.5 conceived did not conceive value NS (n=42) (n=46) (months) ______Pts. Age (ys,%) Longtudinal septum length >40 0 (0) 22 (100) NS <40 42 (63.6) 24 (36.4) <.001 >½ uterus 12 (42.8) 6 (33.3) .12 ≥35 14 (25.9) 40 (47.1) NS <½ uterus 30 (66.2) 40 (57.2) NS <35 28 (82.4) 6 (17.6) <.001 ______Duration of infertility Values are pts.’ numbers (%) ≥3 ys. 6 (15) 34 (85) NS <3ys. 36 (75) 12 (25) <.001

Authors’ Conclusions Conclusions (contin.)

• Fertility and pregnancy after hysteroscopic • Women with a septum size larger than one‐ metroplasty in women with otherwise unexplained half of their uterine length have a higher primary infertility and uterine septum as a possible chance of successful pregnancy after sole cause for reproductive failure seems to depend hysteroscopic metroplasty. on patient age, duration of infertility, and uterine

septum length.

13

14 Hysteroscopic Management of a Stenotic Cervix

Michael W.H. Suen, MD University of British Columbia, Vancouver, British Columbia, Canada

Objective: To demonstrate a “see-and-treat” approach in an outpatient hysteroscopy setting for management of a stenotic cervix.

Design: Stepwise demonstration of the technique with narrated video and animations.

Setting: Cervical stenosis is defined as narrowing of a cervix os with difficulty inserting a 2.5mm dilator. It is found most commonly in nulliparous and postmenopausal women, and can obstruct a number of gynecologic procedures that require intrauterine access. Technical difficulty increases the risk of cervical laceration, uterine perforation and the formation of false passages, which can worsen cervical scarring and lead to failure of a procedure. Outpatient hysteroscopy shows operative success with patient satisfaction, and can be used to overcome a stenotic cervix to complete an intended procedure.

Interventions: Hysteroscopic management of a stenotic cervix involves:

1. Optimizing the surgical environment 2. Vaginoscopy and “no-touch” hysteroscopy 3. Revision of the cervical canal, with microscissors, micrograspers or a cutting loop electrode.

Conclusion: A number of strategies can be utilized when faced with a stenotic cervix. This video demonstrated the ease of a “see-and-treat” approach in an outpatient hysteroscopy setting.

15 Hysteroscopic Removal of Retained Placental Tissue Alleviates Postpartum Hypertension

Chandrew Rajakumar, MD, FRCSC The Ottawa Hospital, Ottawa, Ontario, Canada

Objective: Through office hysteroscopy identify an intrauterine cause for postpartum hypertension in a woman who had completed a pregnancy complicated by HELLP syndrome. Secondly, ameliorate the hypertension and dependence on antihypertensive medications through hysteroscopic-guided removal of retained placental fragments.

Design: Case report

Setting: Outpatient hysteroscopy suite and operating theater at university affiliated teaching hospitals

Interventions: Vaginoscopy followed by diagnostic hysteroscopy without sedation to confirm the presence of placental tissues within the uterine cavity followed by hysteroscopically-guided blunt curettage of placental tissues using a non-energized loop electrode.

Conclusion: Diagnostic hysteroscopy, when performed after vaginoscopy, allows of confirmation of retained placental fragments via biopsy without the need for sedation and can be performed in an outpatient setting. Visually guided removal of retained placental tissue fragments provided relief from post-partum hypertension and cessation of antihypertensive medications within 48 hours from the procedure. Furthermore, this technique replaces blind curettage, which may increase the risk of intrauterine synechiae and/or perforation.

16 CULTURAL AND LINGUISTIC COMPETENCY

Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians (researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

US Population California Language Spoken at Home Language Spoken at Home

Spanish English Spanish

Indo-Euro English Indo-Euro Asian Other Asian

Other 19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the program, the importance of the services, and the resources available to the recipient, including the mix of oral and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies, including those which provide federal financial assistance, to examine the services they provide, identify any need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every California state agency which either provides information to, or has contact with, the public to provide bilingual interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

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If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills. A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

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