The HydroThermAblator system for management of menorrhagia in women with submucous myomas: 12- to 20-month follow-up.
STUDY OBJECTIVE: To assess the safety and efficacy of the HydroThermAblator (HTA) system to treat patients with menorrhagia and submucous myomas up to 4 cm in diameter.
DESIGN: Retrospective, multicenter, cohort study (Canadian Task Force classification II-2).
SETTING: Two medical centers from a large, prepaid, multispecialty health maintenance organization.
PATIENTS: Twenty-two women.
INTERVENTION: HTA endometrial ablation.
MEASUREMENTS AND MAIN RESULTS: The HTA circulates free-flowing, heated (90 degrees C) saline in the uterine cavity for 10 minutes under direct hysteroscopic control. All procedures were performed in the office under local anesthesia after premedication with oral anxiolytic and analgesic agents. At least 1 year after treatment (average follow-up 15.4 mo, range 12-20 mo), women were contacted regarding their menstrual history. Success was defined as no additional medical or surgical intervention. Amenorrhea was defined as no bleeding, eumenorrhea as normal periods, and oligomenorrhea as less than a normal period. Twelve patients (54%) reported complete amenorrhea; 7 were premenopausal (41% amenorrhea rate) and 5 were postmenopausal (100% amenorrhea rate). Five (23%) reported oligomenorrhea and three (14%) eumenorrhea, and were very satisfied with the result. The overall success rate was 91%. Of two failures (9%), one woman had a repeat HTA 13 months later for menorrhagia. The other had a repeat HTA for persistent spotting and sustained a false passage and small perforation before the procedure began. She elected to have a vaginal hysterectomy 1 month later. Although the results are not statistically significant, patients were extremely satisfied with the outcomes, and no serious complications were related to the device or its use for this indication.
CONCLUSION: HTA is probably safe and effective in treating women with menorrhagia and submucous myomas up to 4 cm in diameter. It offers advantages over hysterectomy and electrosurgical resection since it is an office-based procedure, and significant advantages over other global ablation technologies that, by their design, are unable to treat significantly distorted uterine cavities.
DESIGN: Retrospective, multicenter, cohort study (Canadian Task Force classification II-2).
SETTING: Two medical centers from a large, prepaid, multispecialty health maintenance organization.
PATIENTS: Twenty-two women.
INTERVENTION: HTA endometrial ablation.
MEASUREMENTS AND MAIN RESULTS: The HTA circulates free-flowing, heated (90 degrees C) saline in the uterine cavity for 10 minutes under direct hysteroscopic control. All procedures were performed in the office under local anesthesia after premedication with oral anxiolytic and analgesic agents. At least 1 year after treatment (average follow-up 15.4 mo, range 12-20 mo), women were contacted regarding their menstrual history. Success was defined as no additional medical or surgical intervention. Amenorrhea was defined as no bleeding, eumenorrhea as normal periods, and oligomenorrhea as less than a normal period. Twelve patients (54%) reported complete amenorrhea; 7 were premenopausal (41% amenorrhea rate) and 5 were postmenopausal (100% amenorrhea rate). Five (23%) reported oligomenorrhea and three (14%) eumenorrhea, and were very satisfied with the result. The overall success rate was 91%. Of two failures (9%), one woman had a repeat HTA 13 months later for menorrhagia. The other had a repeat HTA for persistent spotting and sustained a false passage and small perforation before the procedure began. She elected to have a vaginal hysterectomy 1 month later. Although the results are not statistically significant, patients were extremely satisfied with the outcomes, and no serious complications were related to the device or its use for this indication.
CONCLUSION: HTA is probably safe and effective in treating women with menorrhagia and submucous myomas up to 4 cm in diameter. It offers advantages over hysterectomy and electrosurgical resection since it is an office-based procedure, and significant advantages over other global ablation technologies that, by their design, are unable to treat significantly distorted uterine cavities.
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