MENORRHAGIA TREATED BY THERMAL BALLOON ENDOMETRIAL ABLATION

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1 , ORIGINAL RESEARCH,,,, MENORRHAGIA TREATED BY THERMAL BALLOON ENDOMETRIAL ABLATION Douglass B. Yackel, MD, FRCSC, Consultant Gynaecologist, Delta Hospital, Delta, British Columbia ABSTRACT RESUME One hundred and twenty-five patients with menorrhagia were treated by thermal balloon endometrial ablation (Therma Choice TM System) in a community hospital. Median follow-up was 21 months, with 38 percent followed for more than two years. An overall satisfaction rate of 91 percent was achieved with this very simple and safe procedure. Dans un hopital communautaire, on a traire 125 patientes, souffrant de minorragie, au moyen d' une ablation de I' endometre par ballonnet thermique (Sysreme Therma Choice TM). La moyenne de suivi des patientes a ere de 21 mois, mais 38 pour cent d' entre elles ont fait I' objet d' un suivi de plus de deux ans. Ce procede, simple et securitaire, a permis d' atteindre un taux global de satisfaction de 91 pour cent. J soc OBSTET GYNAECOL CAN 1999;21(11): KEY WORDS Menorrhagia, themwl balloon endometrial ablation. Received on March 17th, Revised and accepted on April 26th, JOURNAL SOGC 1076 OCTOBER 1999

7 In 1995, a new technique for endometrial ablation using a thermal balloon was approved for use in Canada.

2 INTRODUCTION Menorrhagia is a common problem affecting as many as 20 percent of all women! and is the leading cause of iron deficiency anaemia. 2,3 Minor surgical treatments of abnormal uterine bleeding include the use of dilatation and curettage (D&C), laser photocoagulation,4loop resectoscope 5,6 and rollerball dessication. 7 In 1995, a new technique for endometrial ablation using a thermal balloon was approved for use in Canada. This is a report about 125 patients treated with the new thermal balloon system (ThermaChoice System). MATERIALS AND METHODS Between July 5,1995 and April 7, 1998, 125 patients were treated at Delta Hospital, Delta, BC, a small community hospital in suburban Vancouver. All patients were treated as surgical daycare outpatients with 103 (82%) having general anaesthesia and 22 (18%) having a paracervical block. The general anaesthesia selection is a reflection of the availability of this service in the community and is frequently requested by the patient. The procedure itself is simple enough to be performed in any well-equipped office or outpatient facility with less anaesthesia than we offer. One hour pre-operatively, each patient received a 100 mg indomethacin rectal suppository and very few patients needed any postoperative analgesics. All were discharged home within two hours of the procedure. The technique involved insertion of a 4,5 mm catheter with a latex balloon housing a shielded heating element. The balloon was filled with five percent dextrose in water, and connected to a control unit to monitor both temperature and pressure. After stabilizing the pressure at 180 to 185 mm Hg, the heating element was activated, quickly raising the temperature of the water to 87 C where it was maintained for eight minutes, coagulating the endometrium to a depth of approximately five mm. Prior to the procedure, each patient had a consultation which included a detailed history and physical examination, with Pap. smear and cultures added if indicated. The CBC, appropriate hormone assays and ultrasound examinations were carried out if clinical abnormalities were noted. Endometrial biopsy was employed in 20 patients (16%), with a D&C having been performed previously in 35 (28%). Forty-six patients (37%) had a hysteroscopy concurrent with the ablation procedure, five had a laparoscopy, one a cone biopsy and all had D&Cs immediately prior to the ablation. Concurrent medical problems were noted in five patients, of whom three had renal disease; two of them were receiving dialysis. One had a successful kidney transplant three and one-half months after ablation therapy. One patient had Von Wille brand's disease and another thrombocytopaenia. No endometrial hormonal pretreatment was used nor were the ablations timed to the menstrual cycles (Table O. The normal post-procedure course included vaginal discharge or spotting for the first few days followed by a profuse serosanguinous or watery discharge for the next seven to ten days. Reduction of menstrual flow was often present from the first period, although patients were told that several periods might need to be observed before gauging the effectiveness of the treatment. Follow-up was carried out either by repeat office visit or by telephone contact. RESULTS All patients had clinically convincing histories of menorrhagia. Ninety-five percent (119/125) of patients had a history of menorrhagia for six months or longer. Forty-eight (38%) had a documented history of anaemia (less than 115 grams per litre) while 51 (41 %) were TABLE! PRE-OPERATIVE ASSESSMENT AND CONCURRENT THERAPY Endometrial biopsy Previous D&C Concurrent hysteroscopy Concurrent laparoscopy 5 4 Concurrent cone biopsy 1 1 Co-existing medical problems Renal disease 3-2 on dialysis - Von Willebrand's 1 - Thrombocytopaenia 1 No hormonal pre-treatment or timed cycles. All had D&Cs immediately prior to the ablation. JOURNALSOGC 1077 OCTOBER 1999

TABLE 2 MENORRHAGIA HISTORY Duration>6 mos 119/125 95 Anaemia - haemoglobin < 115 grams per litre 481125 38 On iron therapy 51/125 41 TABLE 3 PATHOLOGICAL FINDINGS FOLLOWING DILATATION AND CURETTAGE

.c 10 z 0 11 TABLE 5 I 15 1 11-12 12-18 18-24 24-30 30-36 +36 Months SATISFACTION RATE 11 r taking iron when seen in consultation (Table 2).

Twenty-four (19%) had had at least one Caesarean section. Uterine soundings at the time of surgery ranged from seven cm in one patient up to 12 cm in four patients.

A dilatation and curretage was carried out at the time of each procedure and pathology examination showed 62 proliferative (50%), 51 secretory (40%), six menstrual endometrium (5%) and five simple or

One year post-therapy, a repeat biopsy showed the persistence of hyperplasia.

Fifty-five percent (69/125) were followed for one to two years, with 38 percent (47/125) followed for more than two years (Figure 4).

3 TABLE 2 MENORRHAGIA HISTORY Duration>6 mos 119/ Anaemia - haemoglobin < 115 grams per litre On iron therapy 51/ TABLE 3 PATHOLOGICAL FINDINGS FOLLOWING DILATATION AND CURETTAGE Proliferative Secretory Menstrual 6 5 Hyperplasia - Cystic, simple Focal, complex 1 1 TABLE 4... ~ c.. '"., III 39 FOLLOW-UP Median '020 ; c 10 z 0 11 TABLE 5 I Months SATISFACTION RATE 11 r taking iron when seen in consultation (Table 2). The ages and parities were as expected, with the mean age being 43.4 years (25 to 53). Ten were nulligravidas and 14 had four or more children with a mode (60 patients) of two. Twenty-four (19%) had had at least one Caesarean section. Uterine soundings at the time of surgery ranged from seven cm in one patient up to 12 cm in four patients. Balloon volume varied from six to 62 cc (mean = cc). A dilatation and curretage was carried out at the time of each procedure and pathology examination showed 62 proliferative (50%), 51 secretory (40%), six menstrual endometrium (5%) and five simple or cystic hyperplasia (4%) (Table 3). One patient had focal complex hyperplasia with minimal atypia, with an endometrial biopsy three months earlier showing mainly proliferative endometrium. One year post-therapy, a repeat biopsy showed the persistence of hyperplasia. While her menorrhagia was treated very successfully, a hysterectomy was carried out due to the persistence of endometrial atypia. Follow-up was carried out on all patients for a median of21 months. Fifty-five percent (69/125) were followed for one to two years, with 38 percent (47/125) followed for more than two years (Figure 4). While many series relate the outcome of therapy to the percentage reduction of menstrual flow or rate of amenorrhoea, these patients were simply asked how they would rate their own success. Eighty-six (69%) were very satisfied, 20 (16%) were satisfied and eight ( 6 %) felt the procedure was good, for an overall success rate of 91 percent. Only 11 (9%) were unsatisfied or felt that it had not worked (Figure 5). Eleven patients have been classed as treatment failures (Table 6). These include two who had total Very Satisfied Satisfied Good Not Satisfied TABLE 6 No. Condition UNSATISFACTORY OUTCOME Hysterectomy 3 Fibroids +I-Endometriosis 4,7,11 months 1 Fibroids + Endometriosis + Tamoxifen 10 months 4 Submucous fibroids 5 weeks, 11, 14,21 months 1 Adenomyosis - 3 CIS 12 months 1 Dysmenorrhoea 11 months 1 Pre-existing dysmenorrhoea 2112 years - no hysterectomy JOURNAL sogc 1078 OCTOBER 1999

4 abdominal hystectomies and bilateral salpingo-oophorectomies for fibroids and endometriosis four and seven months post-therapy. Both were forewarned that therapy was not likely to be helpful because of their symptoms and uterine size, but they pleaded for the opportunity to try the treatment before considering hysterectomy. A third patient with an initially good response lasting six months reverted to heavy, irregular bleeding and, at the time of hysterectomy 11 months posttherapy, was found to have small intramural fibroids. A fourth patient, who had been in a Tamoxifen protocol study, had marked cervical stenosis at the time of ablation. While her menorrhagia had been reduced by 75 percent, her dysmenorrhoea and cervical stenosis persisted and were untelieved with analgesics. At the time of her hysterectomy, she had small intramural fibroids and endometriosis. Four patients were subsequently found to have submucous fibroids. In one, a vaginal hysterectomy was performed five weeks after therapy because of persistent bleeding. She had a small cornual submucous fibroid. Three others initially had good responses to therapy but re-developed menorrhagia. All were found to have submucous fibroids 14 and 21 months post-treatment with none having a discernible lesion at the time of ablation. One patient, who had had three Caesarean sections and had a bulky uterus, initially experienced a good response. However, after six months the heavy bleeding and pain recurred and one year post-therapy, adenomyosis was found in her hysterectomy specimen. One patient with a clinically bulky uterus and dysmenorrhoea was thought to have adenomyosis. A laparoscopy concurrent with balloon therapy failed to reveal any endometriosis. While her periods were reduced in severity, she continued to have dysmenorrhoea. Eleven months post-treatment, no adenomyosis was found following removal of a normal 84 gram uterus. One additional patient with a symmetrically enlarged uterus and pre-existing dysmenorrhoea was clinically felt to have adenomyosis. Her periods have been reduced but she is continuing to have dysmenorrhoea two and one-half years after therapy. DISCUSSION Menorrhagia is a very common problem, and it is estimated that one-quarter of uteri removed for heavy bleeding are found to be structurally normal. s While hysterectomy is curative, there is an associated morbidity9 as well as high costs and extended recovery time. During the past two decades, ablation successes ranging from 75 to 96 percent (mean 85%) using laser, resection and rollerball desiccation have consistently been reported These procedures have not been free of complications including mechanical or thermal perforation, haemorrhage, visceral injury and fluid overload. While complications are infrequent, they can be serious, and deaths, while rare, have been reported with both laser and resection methods. 17 To produce good results, correct patient selection is essential, with the main indication being heavy menstrualloss in the absence of organic disease. The presence of fibroids, especially submucous, and the suspicion of adenomyosis are, as borne out in this series, both likely to reduce success. Absolute contra-indications include evidence of malignancy or pre-malignant changes, active pelvic infection, excessive uterine size (> 12 cms) and a desire to maintain fertility. During pretreatment counselling, it is extremely important to emphasize that amenorrhoea is not to be expected but, a decrease in flow to normal or subnormal amounts is anticipated. Caution needs to be exercised if adenomyosis is suspected. While the menorrhagia may be reduced, dysmenorrhoea may persist or become worse. No complications occurred. In an accumulated series of thermal balloon procedures, a low rate (2 to 4%) of minor problems involving postoperative infection or haematometra formation has been reported While our success rate has paralleled other ablative techniques, it is still too early to know the long-term results of this therapy.20 These results are encouraging and are equivalent to or better than other balloon therapy reports. 19 Thermal balloon ablation with the system we have used (ThermaChoice TM) is as simple as inserting an intra-uterine contraceptive device and does not involve any specialized training. The cost for the control unit and catheters is low when compared to that of other surgical equipment, and the short procedural time translates into operative cost savings. JOURNAL SOGC 1079 OCTOBER 1999

5 CONCLUSION Thermal balloon endometrial ablation is an exciting new, simple, safe and effective procedure. Widespread availability and acceptance of this simple therapy provide potential benefits for millions of women who now experience the vexation and misery of menorrhagia. REFERENCES 1. Snowden R, Christian B. Patterns and Perceptions of Menstruation - A World Health Organization International Study. London: Croom Helm ACOG Technical Bulletin. Dysfunctional uterine bleeding, Number 134, Oct Shaw RW. Proceedings of an official satellite symposium held at the eighth World Congress of Human Reproduction. BrJ ObstetGynaecol1994; 101 (SuppI11): Goldrath MH, Fuller T, Segal S. Laser photovaporization of endometrium for the treatment of menorrhagia. Am J Obstet Gynecol 1981; 140: Neuwirth RS. A new technique for and additional experience with hysteroscopic resection of submucous fibroids. Am J Obstet Gyneco11978;131 : DeCherney AH, Polan ML. Hysterscopic management of intrauterine lesion and intractable uterine bleeding. Obstet Gynecol 1983;61 : Vancaillie TG. Electrocoagulation ofthe endometrium with the ball-end resectoscope. Obstet Gynecol 1989; 74: Garry R. Endometrial laser ablation. Baillieres Clin Obstet Gynaecol 1995;9(2): Carlson KJ, Nichols DH, Schiff I. Indications for hysterectomy. N Engl J Med 1993;328: de Wit A. Hysteroscopy: an evolving case of minimally invasive therapy in gynecology. Health Policy 1993;23: Vilos GA, Vilos EC, King JH. Experience with 800 hysteroscopic endometrial ablations. J Am Assoc Gynecol Laparosc 1996;4(1 ): O'Connor H, Magos A. Endometrial resection for the treatment of menorrhagia. N Engl J Med 1996; 335(3): Erian S. Endometrial ablation in the treatment of menorrhagia. Br J Obstet Gynaecol1994;1 01 Suppl11 : Baggish MS, Sze EH. Endometrial ablation: a series of 568 patients treated over an 11-year period. Am J Obstet GynecoI1996:174(3): Garry R, Shelley-Jones D, Mooney P. Phillips G. Six hundred endometrial laser ablations. Obstet Gynecol 1995; 85(1): Phillips AG, Garry R, Whittaker M endometrial laser ablations. J Am Assoc Gynecol Laparosc 1995 (4, Supplement):S Baggish MS, Daniell JF. Death caused by air embolism associated with neodymium: yttrium-aluminum-garnet laser surgery and artificial sapphire tips. Am J Obstet GynecoI1989;161: Vilos GA, Fortin CA, Sanders B, Pendley L, Stabinsky SA. Clinical trial of the uterine balloon for treatment of menorrhagia. J Am Assoc Gynecol Laparosc 1997 (5): Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermal balloon and rollerball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol 1998;92: O'Connor H, Magos AL. Long-term results of endometrial resection. JAm Assoc Gynecol Laparosc 1996; (4, Supplement):535. JOURNAL SOGC 1080 OCTOBER 1999

INTERVENTIONAL PROCEDURES PROGRAMME

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of balloon thermal endometrial ablation (Cavaterm) Introduction This overview has been prepared