The Women and Infants Center at UAB Endometrial Ablation (EA): p Indications and Complications Todd R. Jenkins, MD Professor and Director Division of Women’s Reproductive Healthcare 1 EA: History      1937 – Radiofrequency electrosurgical probe without endoscopic guidance 1967 – Cryoendometrial ablation probe without endoscopic guidance 1981 – Laser endometrial ablation with Nd:YAG laser via hysteroscope Late 80”s – Resectoscopic techniques 1997 – Nonresectoscopic techniques ACOG Practice Bulletin 81. May 2007 2 EA: Indications  3 Requires all of the following: – Premenopausal women – Patient-perceived heavy menstrual bleeding – Normal endometrial cavity – No desire for future fertility ACOG Practice Bulletin 81. May 2007 1 The Women and Infants Center at UAB EA: Indications  Additional factors – – “Willing to accept normalization of menstrual flow not necessarily amenorrhea flow, amenorrhea, as an outcome” outcome “Presence of anemia or failure or intolerance of medical therapy are important considerations but should not be construed as prerequisites for the procedure.” ACOG Practice Bulletin 81. May 2007 4 EA: Indications  ASRM Statement – – – Premenopausal women for the treatment of menorrhagia Significant uterine pathology and medical conditions should be excluded Medical treatments failed, are contraindicated, or are poorly tolerated 5 Fertility & Steriilty. 2008; 90(3) EA: Indications  ASRM Statement - Contraindications – – 6 Endometrial cancer or hyperplasia P Premenopausal l women who h wish i h to preserve their fertility Fertility & Steriilty. 2008; 90(3) 2 The Women and Infants Center at UAB EA: Unclear Situations  Uncertain Indications – – – – – – Abnormal uterine bleeding M bid obesity Morbid b i Leiomyoma, especially submucosal Previous cesarean section Previous endometrial ablation Women with bleeding disorders  Postmenopausal 7 EA: Preoperative Assessment  Evaluation of the endometrial cavity – Histology - Endometrial sampling  All women should be reviewed before ablation  Results – Structure – TV U/S, SIS, or HSC  Measure the length of the cavity the internal architecture for structural anomalies  Evaluate ACOG Practice Bulletin 81. May 2007 8 Endometrial Ablation COMPLICATIONS 9 3 The Women and Infants Center at UAB EA – Complications      Perioperative complications Failure to control menses (effectiveness) Post-ablation pregnancy Post-ablation pain Endometrial cancer 10 EA – Perioperative Complications Postoperative Adverse Events Occurring within 2 Weeks (%) Complication Thermal balloon Heated Free Fluid Cryotherapy RF Energy UTI 0.8 2 3 0.6 Vaginitis 0.8 0 1 0.6 0 Fever Endometritis Thermal injury 0 0 0 2.1 1 0 0 0 1 0 0 Abd Pain 0 2 4 0.6 Hematometra 0 0 0 0.6 Bacteremia 0 0 0 0 11 ACOG Practice Bulletin 81. 2007 EA – Complications  Failure to control menses (effectiveness) – – – – – – Satisfaction P d Di Pad Diary Continuation of use Amenorrhea Need for future surgery Hysterectomy 12 4 The Women and Infants Center at UAB EA: Effectiveness 5-Year Follow-up Oral Medical Therapy Endometrial ablation Continued therapy 10% 73% Surgery 77% 27% • Intrauterine medical therapy • Quality of life and satisfaction measures were similar • No difference in bleeding control in years 2 & 3 Cooper et al. BJOG 2001;108: 1222-8. 13 EA - Effectiveness Nonresectoscopic Ablation (%) at 12 Months Device Satisfaction Amenorrhea Diary Success Thermal balloon “Thermachoice” 96 13 80 Heated free fluid “HydroThermablator” ? 35 68 Cyrotherapy “Her Option” 86 22 67 Radiofrequency “Novasure” 92 36 78 Microwave energy “Microsulis” 92 55 14 87 U.S. FDA Pivotal Trials. 2006 EA - Effectiveness RCT of Ablation Techniques over Time Bipolar RF (Novasure) Heated Saline (Hydrotherm) RR (95% CI) Amenorrhea 1 year 47% 24% 2.0 (1.2-3.1) 5 years 55% 37% 1.5 (1.05-2.3) 10 years 50% 66% 1.1 (0.8-1.5) 0.92 (0.79-1.1) Dysmenorrhea 15 1 year 21% 14% 5 years 31% 48% 1.3 (0.96-1.7) 10 years 10% 13% 1.0 (0.88-1.2) Penninx et al. Obstet Gynecol. 2011;118: 1287-92. 5 The Women and Infants Center at UAB EA - Effectiveness Penninx et al. Obstet Gynecol. 2011;118: 1287-92. Satisfaction Rates 16 EA - Effectiveness  Hysterectomy rates at 2 years postop – – – English NHS Study S Scottish i hS Study d California 17 10.8% 16 0% 16.0% 14.4% Bansi-Matharu et al. BJOG. 2013 EA - Effectiveness English NHS Database Study Type of Initial EA All 2nd Generation 18 Total Number 58,071 No Subsequent Procedure Number % 50,285 86.6 Balloon 22,990 19,436 84.5 Microwave 17,486 14,752 84.4 Bipolar 15,064 13,968 92.7 Free Fluid 2,531 2,129 84.1 Unspecified 14,642 12,136 82.9 Bansi-Matharu et al. BJOG. 2013 6 The Women and Infants Center at UAB EA - Effectiveness English NHS Database Age at Initial EA, n (%) 18-35 yrs 36-40 yrs 41-45 yrs 6873 13,128 17,946 16,333 Well 4756 (69) 10,087 (77) 14,920 (83) 14,736 (90) Hyst 1668 (24) 2327 (18) 2208 (12) 1085 (7) 449 (7) 714 (5) 818 (5) 512 (3) Total EA Second EA 19 >45 years Bansi-Matharu et al. BJOG. 2013 EA - Effectiveness 20 Bansi-Matharu et al. BJOG. 2013 EA - Questions  Can a woman have a second endometrial ablation if her first ablation fails? – – No currently N tl marketed k t dd device i iis approved db by th the FDA for use in a previously ablated uterus. A second EA is an OFF-LABEL use and patients should be counseled regarding this fact. 21 7 The Women and Infants Center at UAB EA - Effectiveness English NHS Database Age at Second EA, n (%) 18-35 yrs 36-40 yrs 41-45 yrs 449 714 818 512 Well 315 (70) 537 (75) 664 (81) 440 (86) Hyst 115 (26) 145 (20) 125 (15) 50 (10) 19 (4) 32 (5) 29 (4) 22 (4.3) Second EA Third EA 22 >45 years Bansi-Matharu et al. BJOG. 2013 EA - Effectiveness  Second endometrial ablation – – – Prospective cohort study of 800 primary vs. 75 repeat ablation Complication rate of 9.3% in repeat ablation compared to 2% in primary cases Complications included uterine perforation, hemorrhage, excess fluid absorption, and genital tract burns. Wortman M et al. JAAGL 2001;8: 272-7. 23 EA - Effectiveness Second EA 24 Bansi-Matharu et al. BJOG. 2013 8 The Women and Infants Center at UAB EA - Questions  Does a previous cesarean section affect the outcomes of endometrial ablation? – – – N evidence No id th thatt previous i llow ttransverse C/S affects the outcome of EA. No evidence available for classical C/S and previous LSC or abdominal myomectomy. Some authors recommend transvaginal u/s in women with previous C/S to rule out a defect at the site of the previous cesarean incision. 25 EA - Effectiveness Previous Cesarean Section 26 Khan et al. AJOG 2011;205: 450.e1-4. EA - Questions  Does obesity affect the outcomes of endometrial ablation? – – No N Very limited data suggest that obesity does not effect the outcome of EA. 27 9 The Women and Infants Center at UAB EA - Effectiveness Madsen et al. Int J Obstet Gynecol. 2012 Obesity 28 EA - Effectiveness Madsen et al. Int J Obstet Gynecol. 2012 Obesity 29 EA - Effectiveness    Well-documented Age Uterine length Endometrial thickness    Controversial Tubal ligation Smoking Adenomyosis 30 10 The Women and Infants Center at UAB EA - Pregnancy     Reported to occur at a rate of 0.7% Can occur at any time after ablation Can occur in women with amenorrhea “The chance of pregnancy occurring after endometrial ablation and tubal sterilization is estimated to be 0.002%, or 1 in 50,000.” 31 Sharp. AJOG 2012. October EA - Pregnancy  Increased Risks in Pregnancy after EA – – – – – – – – Spontaneous abortion (28%) E Ectopic i pregnancy (6 (6.5%) %) Preterm birth (31%) PPROM (16%) Intrauterine scarring/chambering Abnormal placentation (25%) Cesarean section (44%) Postpartum hemorrhage 32 Sharp. AJOG 2012. October EA – Post-ablation pain  Post-ablation Pain – – – 33 Most believe that it is related to obstructed menses C Contracture and d scarring i iin the h presence off persistent endometrium can result in obstructed egress of menses. Present with severe cyclic cramping with a history of endometrial ablation Sharp. AJOG 2012. October 11 The Women and Infants Center at UAB EA – Post-ablation Pain  PATSS – – – Post-ablation tubal sterilization syndrome 6-8% incidence within 2-3 years after ablation Retrograde menstruation of cornual blood into tube 34 Sharp. AJOG. October 2012 EA – Post-ablation Pain Post-ablation Outcomes of 437 Women Post-ablation pain 20.8% Post-ablation bleeding 18.8% Hysterectomy 15.1% Hormonal treatment 9.4% Analgesia only 3.0% “75% of patients who developed pain reported it within approximately 2 years of their procedure.” Thomassee MS et al. JMIG. 2013;20: 642-47. 35 EA – Post-ablation Pain Predictors of Post-ablation Pain Pre-ablation dysmenorrhea 36 1.73 (1.05-2.85) Smoker 2.31 (1.36-3.93) Endometriosis 2.24 (0.98-5.14) Prior tubal ligation 1.68 (1.01-2.77) Age < 40 1.90 (1.14-3.15) Adenomyosis on ultrasound 0.65 (0.37-1.16) Chronic pain condition 1.81 (0.76-4.30) BMI < 30 1.47 (0.88-2.48) Thomassee MS et al. JMIG. 2013;20: 642-47. 12 The Women and Infants Center at UAB EA – Endometrial Cancer  Systematic review identified 22 cases in the literature – – – – – 37 No evidence of increased risk of endometrial cancer in women undergoing ablation Most patients with endometrial cancer after EA experience pelvic pain and bleeding Most patients had risk factors for endometrial cancer 76.5% of cases after EA were Stage I (73% general pop.) Endometrial biopsy, hysteroscopy, and SIS are more difficult but still feasible in the EA patient. AlHilli MM et al. JMIG. 2011;18: 393-400. 13