Objective
We sought to assess the long-term success rate of the HydroThermAblator system (HTA).
Study Design
We conducted a retrospective cohort study of 376 patients who underwent HTA at our hospital during an 8-year period, following case note review and distribution of a validated menorrhagia questionnaire.
Results
The mean age of patients was 43 years. Operative complications included 3 women (0.8%) who experienced intraoperative burns. Of the 248 (66%) returned questionnaires, satisfaction rates were high at 77%. The amenorrhea rate was 38%, with a further 37% of women reporting a substantial decrease in their blood loss. In all, 29 (11%) women underwent subsequent hysterectomy for persistent menorrhagia or dysmenorrhea. Younger women had a significantly higher chance of proceeding to subsequent ( P < .05) hysterectomy.
Conclusion
This study confirms the long-term patient satisfaction with HTA and that the overall probability of proceeding to subsequent hysterectomy over 8 years was only 11%.
Heavy menstrual bleeding is a significant health problem that also has an adverse effect on the quality of life of women. According to the United Kingdom–published National Institute for Health and Clinical Excellence (NICE) Guideline number 44, “Heavy menstrual bleeding should be recognized as having a major impact on a woman’s quality of life, and any intervention should aim to improve this rather than focusing on menstrual blood loss.”
See Journal Club, page 275
World Health Organization studies undertaken in developing countries suggest heavy menstrual bleeding rates of between 8-27%. In the Western world, at least 22% of general gynecological referrals for secondary care are related to menstrual disorders.
Until the introduction of endometrial ablative techniques and the Mirena (Schering Healthcare Ltd, Burgess Hill, UK) intrauterine system at the end of the 20th century in the United Kingdom, hysterectomy remained the only treatment for persistent symptoms from menstrual dysfunction. In just 10 years, these minimally invasive techniques to permanently ablate the endometrium have more than halved the hysterectomy rate, from 24,355 cases in 1993 to 10,559 cases in 2002.
By comparison, different states in the United States have seen either minimal change, or a slower decline in hysterectomy rates, varying from 11-37%.
The first-generation technique, transcervical resection of the endometrium, did show promising results in terms of patient satisfaction, but it required significant operator skills, required endometrial preparation for improved success, and had a steep learning curve. The second generation of ablative techniques evolved in response to the demand for a more reproducible technique that could be used by the majority of clinicians, without the extensive training required previously. The HydroThermAblator (HTA; Boston Scientific Limited, Natick, MA) appeared on the international market in 1996, providing the only system for global endometrial ablation performed under direct hysteroscopic control, by using circulating free-flowing, heated saline to 90°C, such that it could be used for treating patients with irregular uterine cavities and those with benign intrauterine pathology. It is an easily learned technique and requires little supervision.
Early reports by Richart et al and Weisberg et al on the safety of the HTA device, in combination with randomized controlled comparative studies with rollerball ablation by Corson and Goldrath, showed amenorrhea rates between 40-50%. However, data on long-term follow-up are still limited and most report on a relatively small population of patients. The study by Hefni et al showed a 79% satisfaction rate and 7% hysterectomy rate in 67 patients but only had a 24-month follow-up.
The aim of this study was to review all cases of HTA performed from 1998 through 2006 at Benenden Hospital and assess the patient satisfaction rates via a validated menorrhagia questionnaire, as well as the amenorrhea rates and avoidance of further surgical intervention. The study proposal was reviewed and accepted by the local hospital research committee.
Materials and Methods
Hydrothermal ablation has been offered as a routine treatment for menorrhagia at Benenden Hospital since 1998. Inclusion criteria included women who had medical therapy–resistant menorrhagia. All women had a physical examination, transvaginal scan, and full blood cell count prior to surgery. Women who were uncertain about future fertility, those who had a submucosal fibroid or intramural myoma of ≥5 cm in the largest diameters as shown by ultrasound, or those with structural uterine anomalies or adnexal masses were not offered HTA.
Eligible women were given subcutaneous goserelin depot injection (3.6 mg Zoladex; AstraZeneca, London, UK) on 2-3 occasions 28 days apart. Hydrothermal ablation was carried out with the HTA. The operative technique has previously been described by the authors.
There were 2 stages to the study. The first included a retrospective analysis of all 376 case notes of patients who had undergone HTA at Benenden Hospital from 1998 through 2006, identified by the surgical operative record system (Surgica; Calcius Systems Ltd, Edenbridge, UK). The second stage involved a postal questionnaire including a validated postoperative menorrhagia questionnaire and quality of life scores.
This questionnaire is a scientific measure of the outcome from the woman’s perspective following surgical treatment for menorrhagia due to benign disease. The patients were asked about their perception of menstrual blood loss before and after surgery, and their view on the operative outcome in terms of changes in their health, quality of life, and ability to undertake daily activities. Quality of life/satisfaction was assessed through questions about fatigue, irritability, depression, general health, improvement in symptoms, limitation in daily activities, sexual functioning, body image, satisfaction with information about the operation and with the results, and a willingness to recommend the operation to a friend with a similar problem. This questionnaire has been shown to perform well from a scientific point of view, having met standard psychometric criteria for reliability and validity.
A second reminder letter with an enclosed copy of the questionnaire was sent to all patients who did not respond to the first request.
Retrospective data were collected using the Contensis software package (Telford, UK). Data were processed and analyzed using Excel (Microsoft Office Excel, 2007; Microsoft Corp., Redmond, WA) and SPSS 16.0 (SPSS, Inc, Chicago, IL) spreadsheets. Student t test and Fisher’s exact test were applied where appropriate. A P value of < .05 was considered statistically significant.
Results
The mean age of patients was 43 years ( Table 1 ), with a predominantly Caucasian population proceeding to HTA. As well as subjective menorrhagia in all women, a significant proportion (47%) also had dysmenorrhea. Endometrial biopsy is not routinely performed preoperatively as per NICE Guidelines, unless there is persistent intermenstrual bleeding or the woman is aged >45 years. In this study 74% of patients had a biopsy prior to HTA, with no cases of malignancy detected. Of cases, 97% were performed as a day case.
| Characteristics | Mean (SD) n = 248 |
|---|---|
| Age, y | 43 (5.7) |
| Duration since operation, mo | 45 (25) |
| Preoperative GnRH analog | 100% |
| Ethnicity | |
| Caucasian | 82% |
| Indian | 8% |
| Black Caribbean | 2.4% |
| Black African | 0.8% |
| Black other | 0.8% |
| Pakistani | 0.8% |
| Other | 5.2% |
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