Plenary 6 Reproductive Issues

Transcription

1 Plenary 6 Reproductive Issues MODERATORS G. David Adamson, MD & Patrick P. Yeung, MD Christopher Allphin, MD Herve Fernandez, MD Perrine Capmas, MD Anna Lyapis, MD Caterina Exacoustos, MD Rosa M. Neme, MD, PhD Sponsored by AAGL Advancing Minimally Invasive Gynecology Worldwide

2 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 Medical Education to provide continuing medical education for physicians. 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.

3 Table of Contents Course Description Fertility Outcome after Laparoscopic Segmental Bowel Resection for Endometriosis R.M. Neme... 3 Accuracy of Hysteroscopic Versus Laparoscopic Chromopertubation for Assessment of Tubal Patency A. Lyapis... 6 Ectopic Pregnancy: A Prospective Cohort on Conservative Surgical Management with Systematic Postoperative Injection of Methotrexate P. Capmas... 9 The Efficacy and Cost Effectiveness of a Combined Laparoscopic and Hysteroscopic Approach in the Treatment of Female Infertility C. Allphin Proximal Occlusion of Hydrosalpinges by Essure before In Vitro Fertilization: A French Survey Herve Fernandez Three Dimensional Sonographic Assessment of Tubal Patency with Gel Foam: Hysterosalpingo Foam Sonography C. Exacoustos Cultural and Linguistics Competency... 21

4 Plenary 6 Reproductive Issues Moderators: G. David Adamson and Patrick Yeung Faculty: Christopher Allphin, Perrine Capmas, Caterina Exacoustos, Herve Fernandez, Anna Lyapis, Rosa M. Neme This session provides some of the latest data on issues important for fertility and reproduction, including: imaging modalities and techniques of evaluation of female anatomy particularly the fallopian tubes, and of the effect of bowel resection and reanastomosis on fertility. There is an on-going search for less invasive ways to evaluate the female reproductive anatomy, and the impact of bowel resection on fertility (separate from pain) is not well documented, and the need for methotrexate after salpingectomy for ectopic pregnancy is not well characterized. Innovative techniques, and the latest studies address these issues. Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Discuss the latest minimally invasive techniques to image and evaluate the fallopian tubes; 2) discuss the impact on bowel resection and reanastomosis for DIE on fertility; and 3) discuss the impact of postoperative methotrexate after salpingectomy for ectopic pregnancy. Course Outline 12:05 Fertility Outcome after Laparoscopic Segmental Bowel Resection for Endometriosis R.M. Neme 12:15 Accuracy of Hysteroscopic Versus Laparoscopic Chromopertubation for Assessment of Tubal Patency 12:25 Ectopic Pregnancy: A Prospective Cohort on Conservative Surgical Management with Systematic Postoperative Injection of Methotrexate 12:35 The Efficacy and Cost Effectiveness of a Combined Laparoscopic and Hysteroscopic Approach in the Treatment of Female Infertility A. Lyapis P. Capmas C. Allphin 12:45 Proximal Occlusion of Hydrosalpinges by Essure before In Vitro Fertilization: A French Survey 12:55 Three-Dimensional Sonographic Assessment of Tubal Patency with Gel Foam: Hysterosalpingo-Foam Sonography H. Fernandez C. Exacoustos 1:05 Closing Remarks/Adjourn 1

5 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* Viviane F. Connor Consultant: Conceptus Incorporated Kimberly A. Kho* Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathan Solnik* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Ceana H. Nezhat Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Arnold P. Advincula Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical Linda D. Bradley* Victor Gomel* Keith B. Isaacson* Grace M. Janik Grants/Research Support: Hologic Consultant: Karl Storz C.Y. Liu* Javier F. Magrina* Andrew I. Sokol* 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). G. David Adamson Grants/Research: Auxogyn Christopher Allphin* Perrine Capmas* Caterina Exacoustos* Herve Fernandez* Ama Lyapis* Rosa M. Neme* Patrick P. Yeung Consultant: Lumenis Asterisk (*) denotes no financial relationships to disclose.

6 I have no financial relationships to disclose. Fertility outcome after laparoscopic segmental bowel resection for endometriosis approach Dr Rosa Maria Neme, MD, PhD University of Sao Paulo, Brazil 2013 Introduction Introduction Bowel endometriosis is the most severe forms of the disease that accounts for3,8to37%ofwomenwithendometriosis rectum and rectosigmoid 70% to 93% Infertility, chronic pelvic pain, pain at defecation, and altered quality of life Infertility >40% of women anatomical abnormalities of genital organs, functional alterations of peritoneal enviroment Several studies have confirmed the feasibility of colorectal ressection for endometriosis and its efficiency to relief symptoms and improve fertility rates of up to 50% Surgery considered the first line treatment of choice In the 1990s pregnancy rates of up to 50% after laparotomic resection of colorectal endometriosis Coronado, % pregnancy rate among 22 women wishing to conceive after laparoscopic colorectal resection for bowelendometriosis, with 75% of the pregnancies obtained spontaneously Darai, 2005 Material and Methods Objective Evaluate fertility and pregnancy outcomes after laparoscopic segmental bowel ressection in women with symptomatic endometriosis From July 2009 to July 2012 Prospective study 250 women submitted to segmental bowel resection for endometriosis referred to private clinic 92% had bowel symptoms as pain during evacuation, diarrhea, constipation, abdominal bloating, and/or dyschezia 62% had an associated infertility 3

7 Material and Methods Diagnosis: clinical examination and transvaginal sonography with bowel preparation Endometriosis evolving at least the internal muscularis of the rectum Material and Methods Mean age 32.3 years (range years) MeanBMI 23 (range 18 35) Median duration of infertility before surgery was 18 months (range, months) 78% (121 women) underwent some infertility treatment (IUI or IVF) before surgery 18% had an associated male infertility Surgical Technique Material and Methods Previous pelvic surgery 69 % Symptom: dysmenorrhoea, non menstrual pelvic pain and dyspareunia, diarrhea and/or constipation, pain on bowel movement, intestinal cramping, pain on defecation, tenesmus and cyclic rectal bleeding, lower back pain and asthaenia Mean operative time 117 minutes (range ) SURGERY Extensive ureterolysis (80 %) US ligament (10 %/ 80 %) Ovarian cystectomy (70 %) Partial vaginal resection (20 %) Torus resection (100%) Appendectomy (20 %) 96 (62%) pregnancies were obtained 71 spontaneous (74%) and 25 by IVF (26%) Median time to conceive was 8 months. Four patients had miscarriage. No blood transfusion None intra operative or post operative complications Length of stay 3days Evolution of symptoms and quality of life Mean follow up 6months Symptoms : dysmenorrhoea, dyspareunia and pain on defecation, intestinal cramping, diarrhea or constipation disappeared in all women after colorectal resection 4

8 Histology Segmental laparoscopic bowel ressection for endometriosis in symptomatic women with associated infertility is feasible effective and safe and offers high pregnancy rates Stromal and glandular endometriosis 5

9 Accuracy of Hysteroscopic Versus Laparoscopic Chromopertubation for Assessment of Tubal Patency DISCLOSURE I have no financial relationships to disclose. Anna Lyapis, MD Danielle Luciano, MD Anthony Luciano, MD The Hospital of Central Connecticut in affiliation with University of Connecticut November, 2013 OBJECTIVES Review literature on evaluation of tubal patency Demonstrate the technique of hysteroscopic chromopertubation Describe our study design Evaluate accuracy data Hysteroscopic versus laparoscopic assessment LITERATURE REVIEW Laparoscopy HSG HYCOSY Hysteroscopy Sensitivity 75 96% 67 96% 72 88% 83% Specificity % 71 94% 68 89% 82% PPV 72 94% 50 92% 70 94% 88% NPV 50 96% 83 96% 56 76% 77% Exacoustos et al JAAGL 10(3):367-72, Degenhardt et al: Clin Radiol 51(1):15-18, Reis MM et al. Hum Reprod 13(11): , Dijkman AB et al. Eur J of Radiol 35:44-8, Tamasi F et al.. J Ob Gynecol 121:186-90, Adelusi B et al. Fer Steril 63(5): , Torok P et al. J of Min Invasive Gynecol 19(5):627-30, 2012 Luciano D et al. Am J Obstet Gynecol 204(1):79, 2011 HYSTEROSCOPIC CHROMOPERTUBATION HYSTEROSCOPIC CHROMOPERTUBATION PATENT TUBE OCCLUDED TUBE 6

10 STUDY DESIGN RESULTS Prospective analysis 54 patients undergoing concomitant hysteroscopy and laparoscopy March 2012 through March 2013 Exclusion: Age < 18 years old Malignant condition Pregnancy Active Pelvic Inflammatory Disease 108 tubes evaluated 99 tubes evaluated by hysteroscopy and laparoscopy 9 tubes not visualized 91 Concordant 8 Discordant 82 tubes patent on both 9 occluded on both 5 patent on hysteroscopy but occluded on laparoscopy 3 occluded on hysteroscopy but patent on laparoscopy RESULTS How Do Our Compare? + Disease (tube occluded on Laparoscopy) Disease (tube patent on Laparoscopy) + Test (occluded on Hysteroscopy) Test (patent on hysteroscopy) 9 3 a b 5 c d 82 Laparoscopy HSG HYCOSY Hysteroscopy Our Study Sensitivity 75 96% 67 96% 72 88% 83% 64.3% Specificity % 71 94% 68 89% 82% 96.5% PPV 72 94% 50 92% 70 94% 88% 75.0% Sensitivity: a/(a+c) 9/14 = 64.3% Specificity: d/(d+b) 82/85 = 96.5% Positive predictive value: a/(a+b) 9/12 = 75.0% Negative predictive value: d/(d+c) 82/87 = 94.3% NPV 50 96% 83 96% 56 76% 77% 94.3% Exacoustos et al JAAGL 10(3):367-72, Degenhardt et al: Clin Radiol 51(1):15-18, Reis MM et al. Hum Reprod 13(11): , Dijkman AB et al. Eur J of Radiol 35:44-8, Tamasi F et al.. J Ob Gynecol 121:186-90, Adelusi B et al. Fer Steril 63(5): , Torok P et al. J of Min Invasive Gynecol 19(5):627-30, 2012 Luciano D et al. Am J Obstet Gynecol 204(1):79, 2011 CONCLUSIONS Hysteroscopic chromopertubation has poor sensitivity By using this test, we would call an occluded tube patent in 35.7% Hysteroscopic chromopertubation has excellent specificity By using this test, we would call a patent tube occluded in 3.5% REFERENCES Exacoustos et al JAAGL 10(3):367 72, Degenhardt et al: Clin Radiol 51(1):15 18, Reis MM et al. Hum Reprod 13(11): , Dijkman AB et al. Eur J of Radiol 35:44 8, Tamasi F et al.. J Ob Gynecol 121:186 90, Adelusi B et al. Fer Steril 63(5): , Torok P et al. J of Min Invasive Gynecol 19(5):627 30, 2012 Luciano D et al. Am J Obstet Gynecol 204(1):79,

11 QUESTIONS THANK YOU! 8

12 ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 ECTOPIC PREGNANCY: a prospective cohort on conservative surgical management with systemic postoperative injection of methotrexate No financial relashionships to disclose. Perrine CAPMAS (MD) Bicetre hospital France Objectives Methods Flow chart Salpingectomy rate ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 Objectives Methods Flow chart Salpingectomy rate Objectives Report failure of conservative surgery = SALPINGECTOMY RATE Report failure of surgery =PERSISTENT TROPHOBLAST ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 Objectives Methods Flow chart Salpingectomy rate Methods Prospective data from a randomized trial Conservative surgery with postoperative injection of methotrexate (1mg/kg) Statistic: Student s test Chi2 test Logistic regression model ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 Ectopic pregnancy ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 LESS ACTIVE ECTOPIC PREGNANCY Fernandez score < 13 No suspicion of tubal rupture ACTIVE ECTOPIC PREGNANCY Fernandez score 13 Suspicion of tubal rupture 196 women 96 with less active EP 100 with active EP Randomisation Randomisation Objectives Methods Flow chart Salpingectomy rate Medical management (Methotrexate) CONSERVATIVE SURGERY with a postoperative injection of Methotrexate Radical surgery Objectives Methods Flow chart Salpingectomy rate Initial salpingectomy rate=15% Persistent trophoblast=0.6% [0 1.8%] 9

13 ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 Flow chart 196 women with ectopic pregnancy ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 Salpingectomy rate Radical surgery: n=30 (15%) 15% Objectives Methods Flow chart Salpingectomy rate 25 (15%) with no injection of MTX No failure 166 women with conservative surgery 141 (85%) with conservative surgery and systematic injection of MTX 1 failure (0.7%) Objectives Methods Flow chart Salpingectomy rate Less active pregnancy=9% Active ectopic pregnancy=21% p=0.02 ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 Objectives Methods Flow chart Salpingectomy rate Initial failure of conservative surgery First time reported in an important population Very high Depending on activity of ectopic pregnancy (HCG progesterone) Objectives Methods Flow chart Salpingectomy rate Low rate of persistent trophoblast after postoperative methotrexate injection is confirm in current practice As in randomized trial Interesting when persistent trophoblast is more than 7% ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 ECTOPIC PREGNANCY: a prospective cohort P. CAPMAS AAGL 2013 Objectives Methods Flow chart Salpingectomy rate Women has to be inform of the high risk of radical surgery even when a conservative surgery us decided Postoperative injection of methotrexate is confirmed to avoid persistent trophoblast Objectives Methods Flow chart Salpingectomy rate 1. Fernandez H, Capmas P, Lucot JP, Resch B, Panel P, Bouyer J. Fertility after ectopic pregnancy: the DEMETER randomized trial. Human Reprod 2013;28: Graczykowski JW, Mishell JR. Methotrexate prophylaxis for persistent ectopic pregnancy after conservative treatment by salpingostomy. Obstet Gynecol 1997;89: Akira S, Negishi Y, Abe T, Ichikawa M, Takeshita T. Prophylactic intratubal injection of methotrexate after linear salpingostomy for prevention of persistent ectopic pregnancy. J Obstet Gynaecol Res 2008;34: Gracia CR, Brown HA, Barnhart KT. Prophylactic methotrexate after linear salpingostomy: a decision analysis. Fertil Steril 2001;76: Sowter MC, Farquhar CM, Petrie KJ, Gudex G. A randomised trial comparing single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured tubal pregnancy. BJOG 2001;108:

14 I have no financial relationships to disclose. Chris Allphin MD Minimally invasive gynecologic surgery (MIGS) involves vaginal surgery, laparoscopy and hysteroscopy Involves small or no incisions Continuing to define the role for MIGS in all facets of an Ob/Gyn practice Laparoscopy and Hysteroscopy at the same operating room visit Performed by two different surgeons at the same time Treatment of patients with uterine pathology such as leiomyomata or septa Benefits Diagnose and treat uterine pathology inside and outside the uterus Often Only one procedure needed??? 11

15 Is there a role for MIGS, specifically the dual procedure, in a sub-fertile population seeking pregnancy? Hypothesis: The dual procedure will diagnose and treat uterine pathology helping women achieve pregnancy with similar rates to a fertile population Cost analyses: The dual procedure will cost less than if the procedures were done at separate O.R. admissions Patients that had the dual procedure from at a MIGS clinic Narrowed down to only patients referred to the MIGS clinic from fertility specialists All the patients had a complete fertility workup and had abnormal findings on ultrasound 30 patients were found that met the criteria since chart reviews were completed between the infertility offices and the electronic medical record. The remaining 7 patients were contacted by telephone and asked about pregnancy results before and after the procedure. 13 patients had a septum and 17 patients had leiomyomata Septum Pathology Leiomyomata Procedure Hysteroscopic metroplasty with diagnostic laparoscopy Diagnostic laparoscopy with hysteroscopic and/or laparoscopic myomectomy 21/30 (70%) patients were able to achieve pregnancy Live birth rate of 54% (17/30) Miscarriage rate of 17% (5/30) 21 live births, 2 sets of twins 5 patients were able to conceive twice 14 spontaneous pregnancies including one twin pregnancy 4 IUI pregnancies 7 IVF pregnancies 12

16 Age range (n) Pregnancy Rate <35 (13) 82% (9) 62.5% Age > 40 (8) 60% Pathology Procedure Pregnancy rate Septum Leiomyomata Hysteroscopic metroplasty with diagnostic laparoscopy Hysteroscopic and laparoscopic myomectomy 84.6% (11/13 pts) 58.8% (10/17 pts) Procedure Average cost Laparoscopy $38, and hysteroscopy at different admissions Dual $23, procedure, one admission Average of $15,000 saved per every patient that had the dual procedure at the same visit. 30 patients saved the system $450, patients had no antral follicles at the return to the fertility specialist 2 patients attempted one cycle of IVF then discontinued therapy 3 patients continue to go through IVF cycles 1 patient has postponed attempting conception until finishes her masters 1 patient discontinued after 2 cycles of IUI. MIGS, specifically hysteroscopy and laparoscopy, is an excellent tool to offer to patients with infertility for diagnosis and treatment of uterine pathology After treatment, many of these patients can achieve pregnancy spontaneously without the use of assisted reproductive technology (ART) Significant cost savings are achieved if the procedures are done at the same time Retrospective case review Low number of patients No standardization of follow up time 13

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18 Proximal occlusion of hydrosalpinges by Essure before assisted reproduction techniques: a French survey. Hervé FERNANDEZ I have no financial relationships to disclose. Service de Gynécologie Obstétrique, Assistance publique des hôpitaux de Paris Hôpital de Bicêtre78 rue du général Leclerc, Le Kremlin Bicêtre, France Introduction Hydrosalpinx halves the pregnancy rate after IVF of women with tubal infertility Zeyneloglu HB & al., Fertil Steril Camus E & al. Hum Reprod Numerous authors have demonstrated that salpingectomy can correct this effect by increasing the likelihood of clinical pregnancy Strandell A & al. Hum Reprod Déchaud H& al.fertil Steril Johnson N & al. Cochrane Database Syst. Rev. Online. 2010; Kontoravdis A, Fertil Steril 2006 Moshin V & al.hum Reprod 2006 Introduction (2) Proximal tubal occlusion by laparoscopy has an effect similar to that of salpingectomy Kontoravdis A & al. Fertil Steril 2006 Moshin V & al. Hum Reprod 2006 The surgical risk during laparoscopy, especially for women with major pelvic adhesions, has led some surgeons to use Essure for hysteroscopic tubal occlusion, an off label use different from its primary purpose of tubal sterilization. Study Objectives To study the feasibility and results (live birth and complication rates) of the placement of Essure microinserts before assisted reproduction technology (ART) treatment of women with hydrosalpinx. Material and methods National survey of 45 French hospital centers providing ART treatment, with a retrospective analysis of all women with unilateral or bilateral hydrosalpinges. 15

19 Of the 45 centers contacted, 7 centers responded that they had performed such procedures, and 23 that they had not, for an overall response rate of 66.6% (30/45). Fifteen centers did not respond, despite four reminders. (2) The placement success rate reached 92.8% (65/70 tubes), and the mean number of visible intrauterine coils was 1.61 (range: 0 to 6). Pyosalpinx occurred in one case, and expulsion of the device into the uterus in two others. Of 43 women, 29 (67.4%) had a total of 54 fresh or frozen embryos transferred. The clinical pregnancy rate was 40.7% (22/54) and the live birth rate 25.9% (14/54). The implantation rate was 29.3% (27/92). 45% 40% 35% 30% 25% 20% 15% 29,3% (27/92) 40,7% (22/54) 31,8% (7/22) 25,9% (14/54) Use of the Essure system is an effective method for occlusion of hydrosalpinges. The live birth rate after embryo transfer makes it the method of choice when laparoscopy should be avoided, with rates similar to those for salpingectomy or tubal ligation. 10% 5% 0% Implantation rate (%, n per embryo transferred) Tx implantation Tx grossesse clinique*** Tx FCS** Tx naissance vivante*** Clinical pregnancy rate per embryo transfer (%) Spontaneous abortion (%, n per clinical pregnancy) Live birth rate per transfer (%) Zeyneloglu HB, Arici A, Olive DL. Adverse effects of hydrosalpinx on pregnancy rates after in vitro fertilization embryo transfer. Fertil Steril 1998;70(3): Camus E, Poncelet C, Goffinet F, Wainer B, Merlet F, Nisand I, et al. Pregnancy rates after invitro fertilization in cases of tubal infertility with and without hydrosalpinx: a meta analysis of published comparative studies. Hum Reprod 1999;14(5): Strandell A, Lindhard A. Hydrosalpinx and ART. Salpingectomy prior to IVF can be recommended to a well defined subgroup of patients. Hum Reprod 2000;15(10): Déchaud H, Daurès JP, Arnal F, Humeau C, Hédon B. Does previous salpingectomy improve implantation and pregnancy rates in patients with severe tubal factor infertility who are undergoing in vitro fertilization? A pilot prospective randomized study. Fertil Steril 1998;69(6): Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BWJ. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst. Rev. Online. 2010;(1):CD Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril 2006;86(6): Moshin V, Hotineanu A. Reproductive outcome of the proximal tubal occlusion prior to IVF in patients with hydrosalpinx. Hum Reprod 2006;21:i193 i194. Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril 2006;86(6):

20 Università degli Studi di Roma Tor Vergata Department of Biomedicine and Prevention Obstetrics and Gynecology Università degli Studi di Siena Department of Molecular and Developmental Medicine Obstetrics and Gynecology ITALY Three dimensional sonographic assessment of tubal patency with gel foam: Hysterosalpingo-foam sonography HyFoSy I have no financial relationships to disclose. Caterina Exacoustos MD, HyCoSy with air+saline benefits: Reproducible and simple technique Office procedure Used in combination with ultrasound imaging Less need for radiology No esposure to ionizing radiation No anesthesia required Low economic costs Reduced discomfort for patient Well tolerated by patients No adverse reactions to contrast Real time diagnosis of tubal patency Accuracy is similar to HSG HyCoSy limitations and difficulties encountered with conventional 2D TVS with air+saline or with ultrasound dedicated contrast media : Signals from the total length of the tube has rarely been depicted in a single scanning plan because of tubal tortuosity Need of skill examiner: To see tubal course To mentally reconstruct an image of the tube from partial visualization To repeat manipulation of the transducer and injection of saline to obtain tubal course visualization Aim of the study to assess the feasibility of three dimensional (3D) hystero-salpingocontrast-sonography (TVS HyCoSy) with gel foam (HyFoSy) in the evaluation of tubal patency and visualization of tubal course. Study population 144 patients undergoing TVS HyFoSy 12 with hysteroscopic tubal sterilization at least after 3 months of ESSURE application during the proliferative phase of the cycle(day 5-12) or at any time of the cycle if on OC informed written consent was obtained from all patients 132 infertile patients during the proliferative phase of the cycle (day 5-12). informed written consent was obtained from all patients All underwent Evaluation of the reproductive history 2D and 3D TVS scan (Voluson E6 ultrasound machine (GE Healthcare, Zipf, Austria) TVS HyFoSy with 3D and 2D and gel foam as ultrasound contrast agent Evaluation of feasybility of the method Evaluation of pain during and after the procedure 17

21 Methods To evaluate the feasibility of the method we considered: visualisation with 3D TVS of tubal patency or occlusion at two consecutive injections of gel foam; visualisation of the gel foam around the ovaries; final results of tubal patency after detection in 2D TVS realtime of the foam bubbles movement in the tube and around the ovaries; pain during and after the procedure (0-10 VAS scale); other side effects (vagal reactions, need of analgesic drugs). Methods 3D HyFoSy TVS volume acquisition was performed : during the first injection of 4-6ml gel foam during the following second injection of 4-6ml gel foam 2D realtime TVS was performed during further injection of gel foam to detect foam and bubbles movements - in the tubes -around the ovaries Sterile gel(hydroxyethylcellulose, glycerol and purified water) ( ExEm gel, Farco-Pharma GmbH, Köln, Germany) LABLE USA - ExEm gel is FDA approved for uterine intracavity ultrasound imaging and gel infusion sonography (GIS), ExEm Foam for HyCoSy is not yet FDA approved EUROPE -ExEm gel and ExEm Foam are both CE marked, on lable for GIS and HycoSy HyCoSy with Gel Foam =HyFoSy 2D 3D 5ml of sterile gel+10ml purified water or saline+3-5ml of air by mixing sterile gel and purified water or saline a gel foam is created. 5 fr HyCoSy balloon catheter 132 infertile patients 72 had primary infertility 60 had secondary infertility Mean age : 36.8 yrs (24-44) Gravidity : 0.71 (0-5) Parity: 0.24 (0-2) BMI: 21.9 ( ) 12 with hysteroscopic tubal sterilization Mean age : 41.6 yrs (34-49) Gravidity : 2.25 (0-4) Parity: 1.75 (0-3) BMI: 22.5 ( ) 3D HyFoSy first injection 3D HyFoSy second inject. 132 infertile patients 88 bilateral patency 8 bilateral occl. 36 unilateral occl bilateral patency 3 bilateral occl. 24 unilateral occl. 2D HyCoSy real time futher inject bilateral patency 2 bilateral occl. 22 unilateral occl. 18

22 HyFoSy in 132 INFERTILE patients (263 tubes*) first 3D volume acquisition second 3D volume acquisition Final results after 2D realtime Tubal patency status Bilaterally patent nr pts (%) Bilaterally occluded nr pts (%) Unilaterally occluded nr pts(%) Concordance rate to final 2D real-time results CONCORDANCE RATE 112 (84.8%) 129 (97.7%) 132 Patent tubes nr tubes (%) Occluded tubes nr tubes (%) Concordance rate to final 2D real-time results 236 (89.7%) 259 (98.4%) 263 3D HyFoSy first injection 3D HyFoSy second inject. 2D HyCoSy real time futher inject. 12 patients with hysteroscopic tubal sterilization 0 bilateral patency 11 bilateral occl. 1 unilateral occlusion 0 bilateral patency 10 bilateral occl. 2 unilateral occl. 0 bilateral patency 10 bilateral occl. 2 unilateral occl. 1 1 patients with unicorne uterus Salpingectomy for ectopic was considered as present-occluded tube HyFoSy in 12 patients hysteroscopic tubal sterilisation (24 tubes) first 3D volume acquisition second 3D volume acquisition Final results after 2D real-time Tubal patency status Bilaterally patent nr pts (%) Bilaterally occluded nr pts (%) Unilaterally occluded nr pts(%) Concordance rate to final 2D real-time results CONCORDANCE RATE 11 (91.6%) 12 (100%) 12 Patent tubes nr tubes (%) Occluded tubes nr tubes (%) Concordance rate to final 2D real-time results 23 (95.8%) 24 (100%) 24 EVALUATION OF PAIN PAIN (VAS 0-10) 132 infertile pts mean score nr pts (%) 12 pts tubal sterilization mean score nr pts (%) DURING HyFoSy 6.3 ± ± 2.8 AFTER HyFoSy 5.1 ± ± 1.9* DURING and AFTER HyFoSy 5.7 ± ± 3.1* Vagal reactions 1 (0.8%) 0 (0%) Analgesic drug administered 19 (14.4%) 0 (0%) s Many disadvantages associated to 2D HyCoSy are overcome by means of the 3D HyFoSy : After two 3D volume acquistion we obtained 97.8% of final results for tubal patency 3% of tubes which results occluded are patent after other injections Pain at HyFoSy is less when tubes were occluded s automated 3D volume acquisition show the tubal course in the space echogenicity of the gel foam is visualized clearer and more persistent compared to air bubbles the 3D volume acquisition during HyFoSy is static and avoids difficult probe movements and easier to perform also by less experienced of the operator Low costs compared to dedicated ultrasound contrast media volume can be stored and analyzed later reducing examination time images are similar to HSG and pictures and volumes can be evaluated by other clinicians 19

23 References 1. Boudghene FP, Bazot M, Robert Y, et al: Assessment of fallopian tube patency by HyCoSy: Comparison of a positive contrast agent with saline solution. Ultrasound Obstet Gynecol 18: , Exacoustos C, Zupi E, Carusotti C, Lanzi G, Marconi D, Arduini D Hysterosalpingo-Contrast Sonography Compared with Hysterosalpingography and Laparoscopic Dye Pertubation to Evaluate Tubal Patency J Am Assoc Gynecol Laparosc 10(3): 29-32, Volpi E, Zuccaio G, Patriarca A, et al: Transvaginal sonographic tubal patency testing using air and saline solution as contrast media in routine infertility clinic setting. Ultrasound Obstet Gynecol 7:43 48, Dijkman AB, Ben WJ, Van der Veen F, et al: Can hysterosalpingocontrast- sonography replace hysterosalpingography in the assessment of tubal subfertility? Eur J Radiol 35:44 48, Prefumo F, Serafini G, Martinoli C, Gandolfo N, Gandolfo NG, Derchi LE. The sonographic evaluation of tubal patency with stimulated acoustic emission imaging. Ultrasound Obstet Gynecol 20: , Dietrich M, Suren A, Hinney B, Osmers R, Kuhn W. Evaluation of tubal patency by HysterocontrastSonography (HyCoSy, Echovist) and its correlation with laparoscopic findings. J Clin Ultrasound 24: , Exacoustos C, Zupi E, Szabolcs B, Amoroso C, Di Giovanni A, Romanini ME, Arduini D. Contrast tuned imaging and second generation contrast agent SonoVue: a new ultrasound approach to evaluate tubal patency. J Minim Invasive Gynecol 16: , Lanzani C, Savasi V, Leone FPG, Ratti M, Ferrazzi E. Two dimensional HyCoSy with contrast tuned imaging technology and a second generation contrast media for the assessment of tubal patency in a infertility program. Fertil Steril 92: , Luciano DE, Exacoustos C, Johns DA, Luciano AA. Can hysterosalpingo-contrast sonography replace hysterosalpingography in confirming tubal blockage after hysteroscopic sterilization and in the evaluation of the uterus and tubes in infertile patients? Am J Obstet Gynecol 204: 79-84, Exalto N, Stappers C, van Raamsdonk LAM, Emanuel MH. Gel Instillation Sonohysterography: first experience with a new technique. Fertil Steril 87: , Emanuel MH, Exalto N. Hysterosalpingo-foam sonography (HyFoSy): a new technique to visualize tubal patency. Ultrasound Obstet Gynecol 37: 498-9, Emanuel MH, van Vliet M, Weber M, Exalto N. First experiences with hysterosalpingo-foam sonography (HyFoSy) for office tubal patency testing. Hum Reprod. 27: 114-7, Exacoustos C, Di Giovanni A, Szabolcs B, Binder-Reisinger H, Gabardi C, Arduini D. Automated sonographic tubal patency evaluation with three-dimensional coded contrast imaging (CCI) during hysterosalpingo-contrast sonography (HyCoSy).Ultrasound Obstet Gynecol 34: , Exacoustos C, Di Giovanni A, Szabolcs B. Romeo V, Romanini ME, Luciano D, Zupi E, Arduini D. Automated three-dimensional coded contrast hysterosalpingo-contrast-sonography: feasibility in office tubal patency testing. Ultrasound Obstet Gynecol 41:328-35,

24 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 (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 Language Spoken at Home California Language Spoken at Home English Spanish Spanish Indo-Euro Asian Other English Indo-Euro 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 (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 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 Executive Order 13166, Improving Access to Services for Persons with Limited English Proficiency, signed by the President on August 11, 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. 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. ~ 21