Outpatient thermal balloon ablation of the endometrium

Transcription

1 FERTILITY AND STERILITY VOL. 82, NO. 5, NOVEMBER 2004 Copyright 2004 American Society for Reproductive Medicine Published by Elsevier Inc. Printed on acid-free paper in U.S.A. Outpatient thermal balloon ablation of the endometrium Thomas Justin Clark, M.D., and Janesh Kumar Gupta, M.Sc., M.D. Academic Department of Obstetrics and Gynaecology, Birmingham Women s Hospital, Birmingham, United Kingdom Objective: To determine the feasibility and potential efficacy of thermal balloon ablation of the endometrium in the outpatient setting without the need for general anesthesia or conscious sedation. Design: Prospective observational study. Setting: Outpatient hysteroscopy clinic in a university-affiliated teaching hospital. Patient(s): Fifty-three consecutively recruited women with menorrhagia that was unresponsive to medical treatment. Intervention(s): Thermal balloon endometrial ablation using local anesthetic without conscious sedation. Main Outcome Measure(s): Procedure feasibility, change in menstrual symptoms, and patient satisfaction and quality of life (Menorrhagia Utility Scale and EuroQol) at 6-month follow-up. Result(s): Thermal balloon ablation was successfully completed in 50 (94%) of 53 women. The three failed procedures consisted of one case in which the woman could not tolerate the procedure because of severe discomfort, one case of equipment failure, and one case in which the balloon catheter could not be inserted into the uterine cavity. Completed outcome questionnaires were returned by 49 (98%) of 50 treated women. Improvement in menstrual loss was experienced by 39 (80%) of 49 women, and satisfaction with the outcome of treatment on menstrual symptoms was reported by 33 (67%) of 49 women. Significantly higher conditionspecific quality-of-life scores were associated with treatment satisfaction. Conclusion(s): Thermal balloon ablation of the endometrium is feasible in the outpatient setting. Improvement in menstrual symptoms and satisfaction with the outcome of treatment appear to be comparable to published inpatient data. Further studies are required to determine the cost-effectiveness of outpatient compared with inpatient thermal balloon therapy. (Fertil Steril 2004;82: by American Society for Reproductive Medicine.) Key Words: Ambulatory, local anesthesia, menorrhagia, outpatient, thermal balloon ablation Received January 22, 2004; revised and accepted April 30, T.J.C. and J.K.G. received travel costs, conference fees, and honorarium payments from Gynecare, Menlo Park, California for participating in training workshops. Reprint requests: Thomas Justin Clark, M.D., Academic Department of Obstetrics and Gynaecology, Birmingham Women s Hospital, Birmingham, United Kingdom B15 2TG (FAX: ; t.j.clark@bham.ac.uk) /04/$30.00 doi: /j.fertnstert Menorrhagia is a common problem with adverse affects on women s quality of life. Management of excess menstrual bleeding is associated with significant utilization of health care resources (1). Hysterectomy is frequently performed when medical treatments fail (2). However, less invasive surgical interventions have been developed to reduce patient morbidity and costs (3 6). Thermal balloon ablation of the endometrium (Thermachoice; Gynecare Inc., Menlo Park, CA) is one such treatment that has been recently introduced. This minimally invasive technique is simple, and its effectiveness for treating menorrhagia has been shown in large observational series (3, 7) and in comparative randomized trials (8 12). As with traditional transcervical endometrial resection or rollerball ablation (firstgeneration techniques), endometrial ablation with thermal balloons or microwave energy (second-generation techniques) is invariably performed on an inpatient basis, under general anesthesia. However, it may be possible to perform the procedure on an outpatient basis in the conscious patient (13, 14). This is because the technique is simple, minimally invasive, and has a shorter postoperative recovery time. Transfer of traditionally inpatient procedures to the outpatient setting is convenient, potentially more cost effective, and increases health service capacity (15). However, these potential advantages may be offset by a lack of patient tolerance to invasive procedures and technical limitations resulting in reduced effectiveness. We therefore wanted to determine the feasibility 1395

2 (safety, practicality, and potential efficacy) of thermal balloon ablation in the outpatient setting. MATERIALS AND METHODS Study Design and Patient Population This prospective, observational study was designed to determine the feasibility of an outpatient thermal balloon ablation system (Thermachoice; Gynecare Inc.) in the treatment of menorrhagia in terms of safety, practicality, and clinical efficacy. All women referred to our general gynecological outpatient clinic over a 2-year period (March 2001 to March 2003), with menorrhagia unresponsive to medical management and no desire to retain their fertility, were offered thermal balloon ablation. All women opting for this form of treatment underwent an outpatient endometrial biopsy. Women were excluded from the study if there were significant uterine fibroids (clinically enlarged uterus greater than 12-week size or substantial distortion of the uterine cavity on ultrasound or hysteroscopy), serious endometrial disease (cancer or hyperplasia), or suspected infection. The 68 women agreeing to thermal balloon ablation were given the option of having the procedure performed on an inpatient basis under general anesthesia or on an outpatient basis under local anesthesia. Fifty-three (78%) of 68 women opted for the outpatient procedure and only these women are considered further. Procedure Outpatient endometrial thermal balloon ablation was performed using a standard prospective protocol. All women were informed not to fast for the procedure and were premedicated 1 hour before it with simple analgesics (diclofenac, 100-mg rectal suppository; plus two co-dydramol tablets orally) and an antiemetic (ondansetron, 4 mg orally). The oral opiate tramadol hydrochloride (100 mg) was administered to women in whom nonsteroidal analgesics were contraindicated. The first seven women recruited also received a single dose of the antibiotic augmentin (amoxycillin clavulonic acid; 375 mg). However, after revision of our protocol, the use of preoperative antibiotics was discontinued because the risk of pelvic infection was considered negligible (3). The procedure was carried out in our outpatient hysteroscopy clinic. Women were placed in the dorsal lithotomy position, and the cervix was directly infiltrated with three 2.2-mL vials of the local anesthetic Citanest (Dentsply, Weybridge, Surrey, United Kingdom; prilocaine 3% felypressin 0.03 U/mL) injected at the 3, 6, 9 and 12 o clock positions. The majority of local anesthetic (1.5 ml) was injected at the deepest possible point in each quadrant, with a 35-mm, 27-G dental syringe, approximating the level of the internal cervical os, and the remainder was distributed evenly throughout the length of the cervix on withdrawal. Some women received an additional single 2.2-mL dose of Citanest ampule, injected posterior to the cervix at the 5-o clock and 7-o clock positions (representing the insertions of the uterosacral ligaments into the cervix) at the discretion of one of the operators (J.K.G.). No IV sedation or narcotic analgesia was given, and no anesthetist was present. A standard hysteroscopy was then performed with a 0, semirigid, using a 1.2-mm microhysteroscope with 2.5-mm rigid sheath (Karl Storz, Tuttlingen, Germany) to exclude intrauterine pathology distorting the uterine cavity. Significant intrauterine polyps or fibroids were blindly avulsed (one case) or were excised under direct endoscopic vision (in one case by using Versapoint [Gynecare; a division of Ethicon, Somerville, NJ]) before undertaking endometrial ablation (16, 17). The uterine balloon system comprises a 4-mm diameter, graded dual-lumen catheter with a latex balloon at its distal end containing the heating element. The plastic catheter connects to a unit that monitors, displays, and controls intrauterine balloon pressure, temperature, and duration of treatment (8 minutes). Grasping forceps were not routinely applied to the cervix, nor were dilators inserted unless required to correctly place the uterine catheter. The technique for thermal balloon ablation was identical to that described elsewhere (18), using a stabilized minimum starting pressure of 160 mm Hg. The addition of additional dextrose water to the intrauterine balloon to maintain the intrauterine pressure between 160 and 180 mm Hg was at the discretion of the operator. One of two experienced surgeons performed or supervised all procedures (T.J.C. or J.K.G.). A designated nurse stayed with the patient throughout the procedure to offer support and distraction, providing a vocal-local to supplement our local anesthetic protocol. On completion of the procedure, women returned to the day-case ward, where they were encouraged to eat and drink and were given analgesia as required. Women were allowed home after a minimum stay of 2 hours once they had tolerated oral diet, passed urine, and had adequate pain control. All women were discharged with an information leaflet describing expected postoperative symptoms and were given instructions to take simple analgesics regularly for the first 24 hours (diclofenac, 50 mg, three times daily and/or codydramol 10/500, two tablets, four times daily). In addition, all women were contacted by telephone at home the following day to check on their progress. Outcome Measures Baseline characteristics of the women enrolled included women s age and clinical, ultrasound, and hysteroscopic findings. Procedure-related data were collected that included use of pretreatment endometrial thinning agents, terminal balloon pressures, and maximum subjective pain experienced by the patient, which was recorded on an ungraduated 10-cm visual analogue scale immediately after completion of the procedure (0 representing no pain and 10 representing 1396 Clark and Gupta Outpatient endometrial ablation Vol. 82, No. 5, November 2004

3 the worst pain imaginable). Failed procedures, complications, and information on postoperative course were also recorded. A questionnaire was administered by mail 6 months later to determine the efficacy of the outpatient ablative therapy. Satisfaction with treatment and improvement of menstrual loss (normalization) were the primary outcomes measured. Patients were asked to respond on a four-point ordinal scale to assess satisfaction with treatment (very satisfied, satisfied, dissatisfied, or very dissatisfied). Symptomatic improvement was assessed by asking women to grade the heaviness of their menstrual blood loss as none (amenorrhea), lighter than before (included spotting and vaginal discharge only), same as before, or heavier than before treatment. Improvement was defined as amenorrhea or lighter bleeding than before. Objective measurement of blood loss was not undertaken because of its limited utility, in that such an approach does not relate to women s individual subjective perception of their blood loss. Furthermore, the threshold for treating benign causes of abnormal uterine bleeding is determined by the expectation of patients (19). Secondary outcomes included duration of bleeding, presence of period pain, visits to a doctor with menstrual complaints, and the need for further medical or surgical treatments. Health-related quality of life was also measured with a validated menorrhagia utility scale (20) and with the generic EuroQol 5D instrument (21). The impact of predefined clinical factors (age, substantial dysmenorrhea [yes vs. no], presence of uterine fibroids [yes vs. no], phase of menstrual cycle [menstrual or endometrial preparation vs. proliferative or secretory phase], uterine size and axis [anteverted vs. retroverted], and procedure-related pain [pain score 5 vs. 5 on visual analogue scale] and maintenance of uterine pressures [ 160 mm Hg vs. 160 mm Hg]) on prognosis (satisfaction with treatment at 6 months) was also explored in the context of hypothesis generation. Statistical Analysis Dichotomous data were presented as simple proportions. Relative risks and their 95% confidence intervals were calculated for comparison of proportions. Continuous variables were summarized by the median and interquartile range, and comparisons between groups were performed by using the Mann Whitney U test. All statistical tests were two sided. P.05 was considered statistically significant. RESULTS Fifty-three women underwent thermal balloon ablation as outpatients. Baseline clinical characteristics of the cohort studied are shown in Table 1. Thermal balloon ablation was successfully completed in 50 (94%) of 53 women. One failure was the result of equipment breakdown (malfunction of the heating cable). The other technical failure arose from severe cervical stenosis preventing insertion of the balloon TABLE 1 Demographic data. Variable No. (%) Mean age in y (range) 43 (33 53) Dysmenorrhea, n (%) Substantial 6 (12) Minimal or none 43 (88) Cycle phase, n (%) Menstrual or endometrial preparation a 8 (16) Proliferative 22 (45) Secretory 19 (39) Clinical (ultrasound and hysteroscopic) findings, n (%) Normal 32 (66) Submucous fibroids 5 (10) Intramural fibroids 11 (22) Polyps 1 (2) Uterine axis, n (%) Axial 1 (5) Anteverted 14 (74) Retroverted 4 (21) Not recorded 26 Uterine size, n (%) 10 cm 13 (72) 10 cm 5 (28) Not recorded 31 Mean uterine size in cm (range) 8 (7 10) a Preprocedural endometrial thinning using gonadotropin-releasing analogues (n 2). We regarded menstrual endometrium as similar to the thin endometrium obtained after endometrial preparation. catheter into the uterine cavity. This woman eventually had a hysterectomy after a further attempt under general anesthetic failed to overcome the cervical stenosis. In only one case was the procedure abandoned (3 minutes into the treatment cycle) because of severe discomfort. The procedure was well tolerated by most women, although a significant minority (14%) experienced severe discomfort (Table 2). However, only 2 of these 7 women would have preferred a general anesthetic in hindsight. Pain during the procedure was not significantly associated with maintenance of intrauterine pressures above 160 mm Hg (P.21). There was no serious morbidity. Relevant procedural data are shown in Table 2. Completed outcome questionnaires were returned by 49 (98%) of 50 successfully treated women. Improvement in menstrual loss was experienced by 39 (80%) of 49 women. However, this translated into satisfaction with the outcome of treatment on menstrual symptoms in slightly fewer women (33/49, 67%; Table 3). A statistically significant association between satisfaction with treatment outcome and reduction in subjective menstrual loss was not demonstrated (P.17). Subsequent hysteroscopic investigation in 2 of the dissatisfied women revealed significant uterine anomalies that had been missed (a bicornuate uterus and a large intra- FERTILITY & STERILITY 1397

4 TABLE 2 Outpatient thermal balloon ablation: procedural data. Procedural data No. (%) Pain during procedure a Severe 7 (14) Not severe 33 (86) Mean pain scores on VAS (range) 6 (1 10) General anaesthetic preferred next time Yes 2 (4) No 47 (96) Uterine pressures b Maintained 160 mm Hg 14 (26) Not maintained 160 mm Hg 35 (74) Postoperative analgesia Morphine 13 (27) Tramadol 14 (29) Codeine and diclofenac 22 (46) Complications None 44 (90) Vasovagal episode 1 (2) Endometritis 1 (2) Admission overnight (vomiting) 1 (2) Admission overnight (pain) 1 (2) Abdominal cramps (lasting 1 wk) 1 (2) Note: All data in parentheses are percentages unless otherwise noted. VAS visual analogue score. a Pain was considered to be severe if visual analogue score was 8 (where recorded), when the patient reported severe discomfort, or when the operator s impression was of severe discomfort (before VAS was introduced). Data include the one case in which the procedure was abandoned because of pain. b Uterine pressure maintained either spontaneously or with the aid of top-up instillation of dextrose water. cavity fibroid, respectively). Dysmenorrhea improved in 40% of women and worsened in 13%. Six (38%) of 16 dissatisfied women consulted their general practitioner or gynecologist within the 6-month follow-up period because of continuing excess bleeding (2/6), bleeding and pain (3/6), or pain alone (1/6). Further management of these women is listed in Table 3. Satisfaction with the treatment outcome was associated with significantly higher disease (menorrhagia)-specific quality-of-life scores (P.0001). A statistically significant increase in generic quality of life was not demonstrated (Table 4). Satisfaction with treatment was more likely with an anteverted uterus compared with a retroverted uterus (relative rate, 2.6 [95% confidence interval, CI, ]) and in association with lower procedure-related pain (pain scores 5 vs. pain scores 5), where the relative rate was 1.7 (95% CI, ). The other predefined clinical factors (i.e., dysmenorrhea, presence of intramural fibroids, phase of menstrual cycle, uterine size, and maintenance of operative pressures) were not associated with treatment satisfaction. Increased age was, however, associated with improvement in TABLE 3 Treatment outcomes at 6 months after outpatient thermal balloon ablation. Symptomatic outcome No. (%) Satisfaction 33 (67, 53 80) a Very satisfied 19 (39) Satisfied 14 (28) Dissatisfied 14 (28) Very dissatisfied 2 (5) Menstrual blood loss Improved b 39 (80, 66 90) a Not improved 10 (20, 10 34) a Median duration of bleeding (d) 3 5 Pain (dysmenorrhea) None 15 (32) Less 19 (40) Same 7 (15) Worse 6 (13) Not recorded 2 Consulted doctor for menstrual problem Yes 5 (10) No 44 (90) Further treatment c None 43 (88) Hysterectomy 3 (6) Mirena coil 2 (4) Repeat thermal ablation 1 (2) Note: All data are n (%) unless otherwise noted. a Parenthetical data include 95% confidence interval. b Four women (8%) reported being amenorrheic, 6 women (12%) reported light spotting or discharge only, and 29 women (60%) reported lighter menstrual blood loss. c All further treatments in women dissatisfied with results of thermal ablation. menstrual symptoms (P.05) although not with overall satisfaction (P.12). However, because of the small, and in some cases, incomplete data set, these findings should only be considered in the context of hypothesis generation. DISCUSSION This observational study shows that thermal balloon ablation of the endometrium is feasible in the outpatient setting and appears to have potential efficacy in treating excessive menstrual bleeding. Moreover, symptomatic improvement and satisfaction with the outcome of treatment appear to be comparable to those in published inpatient data. The procedure was successfully completed in 90%, with only one failure (lack of patient tolerance) directly attributable to the outpatient, conscious setting. No serious complications arising from surgery were recorded. Symptomatic improvement has been defined in many inpatient studies in terms of normalization or less menstrual bleeding (3, 7, 9, 10). However, the validity of approaches for measuring so-called normal blood loss is 1398 Clark and Gupta Outpatient endometrial ablation Vol. 82, No. 5, November 2004

5 TABLE 4 Comparison of quality of life (QoL) between those women satisfied with the results of outpatient thermal balloon ablation therapy and those dissatisfied with treatment outcome. Quality of life Satisfied Dissatisfied P value a Median disease-specific QoL (MUS b ) Median generic QoL (Euroqol) Median generic QoL (Euroqol visual analogue scale) a Mann-Whitney U test. b MUS Menorrhagia Utility Scale. questionable. Despite this, it seems reasonable to assume that normal blood loss (eumenorrhea) or less is equivalent to periods being considered subjectively lighter than before the treatment for menorrhagia, as was used in this study. Eighty percent (95% CI, 66% to 90%) of women in the present study reported lighter menstrual blood loss (symptomatic improvement), and this proportion is comparable to the 80% 91% reported in several preceding inpatient series (3, 7, 9, 10). Patient satisfaction with the outpatient procedure for treating menorrhagia was also high, at 67% (95% CI, 53% 80%) and was comparable with that in previously reported inpatient series that report rates of satisfaction at 6 12 months of between 57% and 95% (3, 8 10, 12, 14, 22). Differences in treatment outcomes between studies are probably explained by various population factors, including inappropriate patient selection (one uterine anomaly and large intracavity fibroid overlooked in this series). Uterine retroversion (23), decreasing age (7, 23), and increasing endometrial thickness and duration of menstruation (23) have previously been reported as predictive of an adverse outcome. In addition, we also believed that lower perioperative uterine pressures may result in poorer outcomes (24). Initially, in line with the manufacturer instructions for Thermachoice (Gynecare Inc.), if the intrauterine pressure dropped below 160 mm Hg, we did not top up the pressure to maintain it in the 160- to 180-mm Hg range, although now this is our standard practice. Our exploratory analyses did not however, show any of these factors to affect prognosis, apart from a retroverted uterine position or high perioperative pain. However, these analyses should be regarded as hypothesis generating, given the small data set available. The potential advantages of the outpatient setting in terms of convenience, safety, and cost effectiveness are supported by the results of this study. Because thermal balloon ablation is a simple, standardized technique, one may expect effectiveness to be comparable for successfully completed procedures, regardless of the setting employed. However, the potential advantages of the outpatient, conscious patient setting will be offset by high rates of failure secondary to patient intolerance or reduced efficacy arising from technical limitations associated with the outpatient setting (e.g., lower tolerated operating pressures). It was reassuring to note that the results for outpatient thermal balloon ablation were comparable, in terms of safety and efficacy, to the inpatient setting under general anesthesia (3, 8 10, 12) and that failure rates were low. Indeed, only one failure resulted from patient intolerance because of pain (2%). The remaining two failures were not related to the outpatient setting; one resulted from equipment failure and the other from cervical stenosis preventing insertion of the balloon catheter, which was not overcome when the procedure was attempted subsequently under general anesthetic. No other second-generation ablative device has been reported to be feasible under local anesthetic alone and, hence, to be a true outpatient or ambulatory procedure. For example, an alternative thermal balloon system (Cavaterm ablation system; Wallsten Medical SA, Moryes, Switzerland) reported use in the outpatient setting, but in fact the procedures were carried out under general anesthesia (25). Microwave ablative treatment (Microsulis plc, Waterlooville, Hampshire, United Kingdom) requires IV sedation (and consequent anesthetic monitoring) in the majority of cases attempted without general anesthesia (26). Outpatient fitting of the levonorgestrel-releasing intrauterine device (Mirena; Schering Healthcare, Burgess Hill, West Sussex, United Kingdom) is a popular alternative to endometrial ablation. Treatment success appears to be comparable between this approach and Thermachoice (Gynecare Inc.) (5, 11, 27), and thus women wanting outpatient intervention should be counseled about both treatment modalities. Patient selection is potentially more important for outpatient interventions under local anesthetic because conscious compliance is necessary. Although selection bias cannot be excluded in a nonrandomized study such as this one, it may not be operating to a significant degree. This is because all women suitable for endometrial ablation were offered treatment in the outpatient setting without exclusion, and only 22% opted for a general anesthetic. Good clinical practice would dictate that women unable to comfortably tolerate a clinical or hysteroscopic examination should not undergo a more invasive outpatient gynecological procedure. However, in our series, no planned thermal ablations were canceled as a result of intolerance of preprocedure examinations. In addition to possible selection bias, our study may be criticized because of the small numbers, short length of follow-up and the lack of baseline data regarding severity of menstrual symptoms and associated health-related quality of life. However, this pilot study should be viewed in the context of a feasibility assessment. Small numbers FERTILITY & STERILITY 1399

6 of women undergoing outpatient treatment, invariably under conscious sedation, have been previously reported (28), mainly as subgroups within larger inpatient series (3, 7, 9, 10). However, apart from two studies, the results have not been presented in terms of feasibility and efficacy. One study that did report this data included only 11 women in whom the procedure was performed under local anesthetic alone, without the need for sedation (13). The other study reported 45 women undergoing the procedure under local anesthetic in combination with a powerful IV opiate analgesic and anxiolytic (fentanyl) (14). Although not explicitly reported, all 8-minute procedures appeared to be successfully completed. Our study is thus the largest outpatient series reported to date and is the only one to avoid the use of perioperative sedation or narcotic analgesia, requiring more intensive monitoring. During longterm follow-up (2 to 6 years) in larger inpatient series, the effectiveness of thermal balloon ablation is only marginally reduced (29, 30). There is no plausible reason to suspect the effectiveness of outpatient procedures to decline any more rapidly. Our longer-term follow-up will be the subject of a future report. A further criticism may be directed toward the assessment of patient satisfaction with medical treatments, which is known to be problematic (31). However, satisfaction with treatment outcome was shown in this study to be correlated with significant improvement in quality of life, and thus measurement of the primary end point appears to be valid. Satisfaction with treatment outcome was not, however, shown to be correlated with reduction in menstrual loss. Thus, doubt is cast upon the validity of using subjective reduction in menstrual blood loss as a primary end point, as has been the case in several earlier inpatient series (3, 7, 9, 10). The threshold for managing menorrhagia is determined by patients expectation, not by measurement of blood loss during a period. Furthermore, the overall aim of management of chronic, benign conditions such as menorrhagia is to reduce the adverse impact of the condition thereby improving the sufferer s quality of life. Measurement of satisfaction and quality of life is therefore a more valid outcome on which to judge treatment success (19). Thermal balloon ablation is a quick and simple procedure, and special expertise is not required for setting up this service in established outpatient hysteroscopy clinics. The convenience of immediate ambulatory therapy will benefit patients by expediting effective treatment and increasing the operating capacity of health services (15). Furthermore, the avoidance of general anesthesia in women with coexistent medical morbidity means that outpatient treatment should be safer in this higher risk group. 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