Endometrial Ablation: Long-Term Outcome

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1 Endometrial Ablation: Long-Term Outcome Paul Martyn, MB BS (Honors), MRCOG, MRACOG, FRCSC Assistant Clinical Professor Department of Obstetrics and Gynaecology University of Calgary Calgary,AB Abstract: hysteroscopic endometrial ablation is an effective treatment for the management of chronic menorrhagia unresponsive to medical therapy, with acceptably low complication rates and high patient satisfaction rates when assessed at long term follow-up. Endometrial ablation compares favourably with hysterectomy in randomized trials comparing efficacy and cost. Global endometrial ablation devices are currently being evaluated and may prove useful alternatives to hysteroscopic endometrial ablation surgery in selected patients. Good patient selection may optimize outcome with hysteroscopic endometrial ablation surgery. Endometrial pretreatment does not improve long term outcome. Further studies of long term follow-up are necessary to assess the efficacy of this procedure. Resume :!'ablation de l'endometre par hysteroscopie offre un traitement efficace pour Ia prise en charge d'une menorragie chronique qui ne repond pas aux therapies medicales. Les taux de complications qui l'accompagnent sent assez bas et Ia satisfaction des patientes est elevee lorsqu'elles sent evaluees dans le cadre d'un suivi a long terme. L'ablation de l'endometre se compare favorablement a l'hysterectomie dans des essais randomises comparant leur efficacite et leur coot. On evalue en ce moment des instruments d'ablation globale de l'endometre et il se peut que ceux-ci offrent des solutions de rechange utiles a!'ablation de l'endometre par hysteroscopie pour certaines patientes. II est possible qu'un choix judicieux des patientes permette d'obtenir des resultats optimaux au moyen de!'ablation de l'endometre par hysteroscopie. Les pretraitements endometriaux n'ameliorent pas les resultats a long terme. II faudra mener d'autres etudes de suivi a long terme pour ihre en mesure d'evaluer l'efficacite de cette procedure. J Soc Obstet Gynaecol Can 2000;22(6): INTRODUCTION There are now a large number of techniques available for endometrial destruction, ranging from direct hysteroscopic endometrial resection and/or ablation to a variety of new blind global endometrial ablation devices. Several publications describe the long term follow-up of traditional hysteroscopic surgical techniques; however, longer follow-up is still required to establish the efficacy of this procedure. Most reports on the use of the global devices include only short term follow-up. Despite these limitations, endometrial ablation remains a useful alternative to hysterectomy in the management of chronic menorrhagia. KeyWords Endometrial ablation, long term followup, patient selection, endometrial preparation, hysterectomy Received on February 5th, Revised and accepted on May 5th, TRADITIONAL HYSTEROSCOPIC ABLATION SURGERY Following the initial report of endometrial ablation using the Nd:Yag laser by Goldrath in 1981, 1 several small studies reported short term follow-up after endometrial ablation surgery These authors reported on small numbers of patients with results at six to 12 months follow-up. Farrell and Baskett have described the poor predictive value of a menstrual pattern at six months follow-up for long-term success. 5 In their series, success rates declined from 93 percent at six months to 65 percent at 24 to 30 months. Several studies have now described the long term follow-up of traditional endometrial ablation techniques in patients with severe menorrhagia (Table I). Success in these studies is variously defined as amenorrhea, hypomenorrhea or eurnenorrhea, while failures are defined

2 TABLE I LONG-TERM OUTCOME OF ENDOMETRIAL ABLATION Author N Mean Success Follow- up (months) Garry eta/ % Baggish and Eddie % O'Connor and Mages % Martyn and Allan % at 2 yrs 76% at 5 yrs as recurrence of menorrhagia or significant dysmenorrhea, or need for further surgical treatment. Baggish and Eddie described a series of 568 patients treated over an 11 year period with a mean follow-up of four and a half years. 6 There were only 19 patients in this series who had resection of submucous fibroids in addition to ablation. These authors excluded patients with significant dysmenorrhea and their failure rate was only eight percent. Garry et al have described 600 laser ablations in 524 women with a mean follow-up period of 15 months? Patients were excluded if the uterus was larger than 12 week size or contained fibroids greater than two em in diameter. A successful outcome was reported by 83.4 percent. This series reported a 6.8 percent hysterectomy rate; however, follow-up length was inadequate to assess long term outcome. The chance of hysterectomy increased with length of follow-up. In a follow-up study, Phillips, Chien, and Garry reported on consecutive endometrial laser ablations in 7 46 patients. Life table analysis showed that the hysterectomy rate was 21 percent at 6.5 years. A repeat endometrial ablation procedure increased the risk of hysterectomy, whereas the presence of adequately treated intrauterine pathology such as polyps or intrauterine fibroids decreased the risk of subsequent hysterectomy. Patient age, uterine size, the presence or absence of dysmenorrhea, and method of endometrial preparation did not change the risk of subsequent hysterectomy. 8 In another large series, O'Connor and Magos followed 525 women for up to five years with mean follow-up period of 31 months. 9 Patients with fibroid tumors greater than 5 em diameter were excluded. Sixteen percent of patients required further surgery and three percent required medical therapy for menstrual symptoms. Decreasing success was associated with increased length of follow-up. Martyn and Allan have reported on 301 patients with follow-up of months with mean follow-up of 28 months. 10 Failure increased from 13 percent at two years to 27 percent at five years. The amenorrhea rates remained relatively constant with 44 percent at two years and 42 percent at five years. Mean time to failure, defined as need for repeat procedure, was 26.7 months. The hysterectomy rate at five years was 11.6 percent. Garry et al reported that 58.9 percent of patients reporting pre-existing dysmenorrhea showed improvement after endometrial ablation, while 8.2 percent reported increasingly severe dysmenorrhea? Martyn and Allan reported on 160 women with menorrhagia and dysmenorrhea and showed improved pain scores in 74 percent at two years follow-up, decreasing to 66 percent at 5 year follow-up. 10 These studies show long-term failure rates between eight and 27 percent. Satisfaction rates remain high in these studies and a large group of women have managed to avoid hysterectomy. Failure rates continue to increase with longer length of follow-up The procedure is also successful at reducing dysmenorrhea in patients presenting with both menorrhagia and dysmenorrhea. PATIENT SELECTION All patients should have pre-malignant or malignant disease excluded. Informed consent should emphasize loss of fertility and realistic expectations for outcome. 5 Proper patient selection is important to minimize the risk of concurrent or later development of endometrial malignancy. 11 Uterine size greater than 12 weeks size can make procedures technically difficult. AGE Most studies show an increased success rate in patients over O'Connor and Magos found that relative risk of further surgery was increased in women less than 45 years of age. 9 Martyn and Allan reported a 27 percent failure rate in patients less than 40 years compared to a 14 percent failure rate in women over 40 years. 10 DYSMENORRHEA The Scottish hysteroscopy audit group reported an increased rate of failure in 12 month follow-up in patients who complained of both dysmenorrhea and menorrhagia. 12 In the series reported by Baggish and Eddie, patients with significant dysmenorrhea were excluded. However, the series reported by Martyn and Allan did not show an increase in rate of failure in patients with significant dysmenorrhea. 10 These patients require careful clinical assessment to exclude extrauterine disease and/or adenomyoisis. Imaging studies such as transvaginal ultrasound or MRI may enhance the clinical diagnosis of adenomyosis. 13 UTERINE FIBROIDS Most hysteroscopic surgeons do not recommend operative hyteroscopic surgery in patients with submucous fibroids of greater than five em. O'Connor and Magos reported an increased failure rate in patients with uterine fibroids. 9 Garry et al excluded patients with uterine fibroids greater than two em in diameter? In the series by Baggish and Eddie, only 19 of 568 patients had submucous fibroids. Martyn and Allan treated 90 patients out of 317 with resection of submucous fibroids

3 in addition to endometrial resection and ablation. There was no increase in failure rate in this group. DOES ENDOMETRIAL PREPARATION AFFECT LONG-TERM OUTCOME? A large number of publications have addressed the issue of endometrial preparation prior to endometrial ablation surgery. The AZTEC trial (Adjunctive Zoladex for Thinning of the Endometrium Comparison) has shown a definite benefit of endometrial preparation with GnRH (Goserelin acetate) over placebo. This was seen mainly in terms of ease of surgical procedure, duration of surgery, and reduction in non-electrolye fluid absorption. Amenorrhea rates were increased at one year follow-up in the treatment group, compared with non-treated control groups. 14 In a prospective randomized trial, Romer and Schwesinger compared different pre-treatment regimens and showed a benefit when GnRH or Danazol pre-treatment was compared to progestin or no pre-treatment. 15 Surgical time was significantly shorter with GnRH or Danazol pre-treatment (16 ± 8 vs. 25 ± 9 minutes). Histological findings immediately pre-operatively showed a higher rate of endometrial atrophy (75 percent vs. 10 percent). Amenorrhea rate was significantly higher in the GnRH/Danazol group (60% vs. 20%) at two year follow-up; however, there was no difference in failure rate. In a study of 110 patients randomized to GnRH or Danazol pre-treatment prior to endometrial ablation, there was a significantly higher percentage of patients with atrophic endometrium in the GnRH group; however, there was no difference in subjective reduction of menstrual flow or patient satisfaction.16 Other studies have shown improvement in short term amenorrhea rates when GnRH is compared to Danazol, but no change in success rate Other authors have shown similar results to hormonal preparation with mechanical preparation using suction currettage prior to endometrial ablation In a further study, intracervical injection of vasopressin without hormonal pretreatment was shown to reduce the amount of intra-operative fluid absorption and decrease intra-operative bleeding when assessed subjectively. 21 Although studies have failed to show a definite benefit from TABLE Ill endometrial preparation in terms of long-term outcome, studies have so far not been designed to assess this Device with adequate length of follow-up. Thermal balloon ENDOMETRIAL RESECTION VS. ENDOMETRIAL ABLATION There has been little comparison between techniques of endometrial resection and endometrial ablation. To Vesta DUB system Hydrothermablator Microwave TABLE II FACTORS THAT MAY INFLUENCE SUCCESS RATES AT ENDOMETRIAL ABLATION Endometrial preparation Patient Age Uterine Size Fibroids Pelvic Pain date, no trial has established a long-term outcome benefit of resection over ablation. It was thought that the deeper destruction of endometrial resection techniques may result in improved success rates; however, this has not been supported by the literature. Vercellini et al compared vapourizing electrode endometrial ablation with a cutting loop in a randomized trial of 91 patients. 22 Although there was significantly less fluid absorption in the vapourization group, no difference in bleeding pattern at one year follow-up was found. Bhattacharya et al. randomized 372 patients to either transcervical resection or laser endometrial ablation. Both procedures were associated with low morbidity and satisfaction rates at 12 months were similar. Endometrial laser ablation was slightly more expensive. 23 GLOBAL ENDOMETRIAL ABLATION DEVICES There are now a multitude of blind global endometrial ablation devices available on the North American market. Reports on the efficacy of these devices are limited by small numbers and short term follow-up. The thermal balloon device (Thermachoice-Gynecare Inc., Menlow Park, Ca.) has been investigated more than any other blind endometrial ablation device. Vilos et al reported on a series of 121 patients treated by thermal balloon ablation. Follow-up was available in 68 patients at 12 months, with 17.6 percent of this group experiencing failure. 24 A further study of thermal balloon ablation reported on 296 patients with follow-up from three to 12 months with no intraoperative complications. The failure rates ranged from nine to 12 percent during the follow-up period. There was a significant decrease in menstrual blood loss and severity of menstrual pain. 25 Meyer et al compared thermal balloon ablation with traditional rollerball surgery in 255 patients. 26 At 12 month GLOBAL ENDOMETRIAL ABLATION DEVICES Energy source Heated latex balloon 85 C Radiofrequency Circulating heated saline 90 C Microwave Treatment time Follow up Failures (months) 8 min 12 12% 7 min % 10 min 12 12% 3 min 36 16%

4 follow-up, reduction in menstrual blood loss was similar in both groups, as was the percentage of patients that were highly satisfied with the results of their procedure. A 90 percent decrease in menstrual blood loss diary scores was reported by more than 60 percent of patients in both groups. There were no complications in the thermal balloon group; however, intraoperative complications were seen in 3.2 percent of the hysteroscopic rollerball group. Hormonal pre-treatment was not used in either group, which may account for the lower success rates at 12 months in the rollerball ablation surgery group when compared with other studies. Other studies have compared thermal balloon ablation with endometrial resection and microwave endometrial ablation with endometrial resection. Both studies show similar success and satisfaction rates. 2 7,Z8 Blind endometrial ablation techniques are usually easy to learn and are associated with low complication rates. Intrauterine fluid distension is not required. These devices usually require short treatment time (Table III) and may be performed in an office setting. Device costs are approximately $650 Cdn; however, hormonal pre-treatment is generally not required. ENDOMETRIAL ABLATION AND HYSTERECTOMY In a report on 204 patients randomized to either endometrial ablation or hysterectomy and followed for a minimum of four years, satisfaction rates with surgical results were high for both groups (80% vs. 89% respectively). Further surgical treatment was required by 38 percent of patients randomized to endometrial ablation and by 24 percent of women treated by hysterectomy. However, 76 percent of women randomized to endometrial ablation surgery had managed to avoid hysterectomy at four year follow-up. A cost analysis in this study suggested that savings associated with endometrial ablation, when compared with hysterectomy, are much less than initially seen at one year due to the high re-treatment rate in the endometrial ablation group. The re-treatrnent rate in endometrial ablation patients is patticularly high when compared to other studies, and the cost analysis did not include endometrial ablation performed as a day case procedure. 2 9 Pinion et al randomized 204 women to either hysterectomy or endometrial ablation using either endometrial resection or laser ablation. At one year follow-up, 17 of 105 women in the endometrial ablation group had undergone hysterectomy. Eighty-nine percent of the hysterectomy group and 78 percent of the endometrial ablation group were very satisfied with the results of their procedure. Endometrial ablation was superior to hysterectomy in terms of operative complications and length of hospital stay. 30 A Canadian study comparing costs of hysteroscopic endometrial ablation with vaginal hysterectomy showed that endometrial ablation is 58 percent less expensive based on costs in 1995 ($2,279 vs. $5,373 Cdn). Costs associated with subsequent surgical treatments were included. In the same study, there was a 41 percent complication rate in the vaginal hysterectomy group, and no complications in the endometrial ablation group. Eighty-two percent of patients were satisfied with the results of their endometrial ablation procedure. 31 In a study oflong term follow-up (mean 48.5 months), 64 women undergoing endometrial ablation were compared with 46 women undergoing hysterectomy. Operating time (38 vs. 107 minutes), hospital stay (0.7 vs. 2.7 days), frequency of post operative complications (6.3 percent vs percent), and recovery time (5 vs. 32 days) were less with endometrial ablation when compared to the hysterectomy group. The endometrial ablation group had a 12 percent failure rate. Total costs for endometrial ablation and hysterectomy respectively were $5,959 and $11,777 US.3 2 In a British study, Schulper et al. reported that the mean total cost of endometrial resection relative to hysterectomy was 53 percent at four months follow-up, rising to 71 percent at 2.2 year follow-up. 33 Other studies support a significant reduction in cost for hysteroscopic surgery vs. hysterectomy in the treatment of menorrhagia Cost analyses do not account for the economic benefit of the shorter return to normal function in endometrial ablation patients. In another study, 173 women were randomized to either medical treatment or endometrial resection for menorrhagia. At two year follow-up, women in the medical treatment arm were more likely to have undergone subsequent surgery, either endometrial resection or hysterectomy, than women in the endometrial resection arm (59% vs. 17%). Women receiving medical therapy were also significantly less satisfied with their treatment than those undergoing surgery (57% vs 79%).3 6 Patient attitudes about endometrial ablation were assessed in a study of 180 women randomly selected from a group of 658 patients who underwent the procedure for the treatment of menorrhagia. More than half the women indicated they would find endometrial ablation acceptable even if there were no chance of amenorrhea. Perceived advantages of endometrial ablation were the avoidance of major surgery, fast return to normal functioning, and shorter hospitalization. 37 SUMMARY Endometrial ablation has now been evaluated clinically for the past 20 years. Several studies with life table analysis up to 6.5 years have shown high satisfaction rates of approximately 85 percent. Surgical re-treatment rates are approximately ten percent for hysterectomy and ten percent for repeat endometrial ablation. Patients undergoing surgery after age 40 years appear to have a better outcome. There is no clear evidence that the presence of fibroids or dysmenorrhea prior to endometrial ablation surgery reduces the rates of success. Pre-operative medical treatment does not appear to improve long term outcome but

5 does improve ease of surgery and short term amenorrhea rates. Global endometrial ablation devices remain a promising alternative to traditional hysteroscopic surgery in patients with normal uterine cavities and are associated with low complication rates. Only short term follow-up data is available at this time. Endometrial ablation compares favourably with hysterectomy in randomized controlled trials and should be the surgical treatment of choice for chronic menorrhagia in appropriately selected patients. REFERENCES I. Goldrath MH, Fuller TA, Segel S. Laser photovaporization of endometrium for the treatment of menorrhagia.am J Obstet Gynecol 1981; 140: Townsend DE, Richard RM, Paskowitz RA,Wookfork RE."Rollerball" coagulation of the endometrium. Obstet Gynecol 1990;76: DeConey A, Polan ML. Hysteroscopic management of intrauterine lesions and intractable uterine bleeding. Obstet Gynecol 1983:61 : Fraser IS,Angsuwathana S, Mahmoud F,Yezerski S. 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