Study objective: To estimate the safety and efficacy of the HydroThermAblator (HTA) system for performance of endometrial ablation in the medical office setting using local anesthesia and minimal oral sedation and to compare results obtained in patients with submucous myomas with those in patients with normal endometrial cavities.
Design: Retrospective cohort analysis of 246 HTA procedures (Canadian Task Force classification II-2).
Setting: Medical offices of a suburban community medical center that is part of a large health maintenance organization.
Patients: Two hundred forty-six women aged 28 to 63 years (mean [SD], 45.1 [6.0] years) with abnormal uterine bleeding unresponsive to conservative management, including 104 patients (42.3%) with submucous myomas. Type 0 or type I myomas were present in at least 86 patients with submucous myomas (82.7%) and ranged from 1 to 4 cm in greatest diameter. In the other 18 patients, submucous myomas were not classified by type. Patients were evaluated at 2 to 70 months after the procedure (median follow-up, 31.0 months). Three patients were lost to follow-up, and 12 patients underwent hysterectomy for indications other than abnormal bleeding and were excluded from the analysis. Thus, 231 patients were included in the analysis.
Interventions: Endometrial ablation was performed using the HTA system with paracervical or intracervical block after oral premedication with ibuprophen, diazepam, and acetominophen or hydrocodone and intramuscular ketorolac. No intravenous or intramuscular narcotics were used. The anesthesia regimen was the same in patients with submucous myomas as in those with normal cavities, and the procedure was performed in exactly the same manner. All procedures were performed in the medical office procedure room by 7 board-certified gynecologists; most procedures were performed by the authors.
Measurements and main results: Of the 231 patients included in the analysis, 121 (53.4%) reported postablation amenorrhea, 62 (26.8%) reported light menses or spotting, 21 (9.1%) reported normal menses, 15 (6.5%) reported menorrhagia, and 12 (5.2%) underwent hysterectomy because of bleeding. In the 136 patients with normal cavities, amenorrhea was achieved in 84 patients (61.8%), oligomenorrhea in 35 (25.7%), and eumenorrhea in 12 (8.8%). Four patients (2.9%) continued to have menorrhagia requiring medical treatment. In the 95 patients with submucous myomas, amenorrhea was reported by 37 patients (38.9%), oligomenorrhea by 27 (28.4%), eumenorrhea by 9 (9.5%), and menorrhagia by 11 (11.6%). In 11 patients (11.6%), hysterectomy was performed because of menorrhagia. All patients who underwent hysterectomy had multiple myomas, and 9 (81.8%) also had adenomyosis. The failure rate, defined as patients with menorrhagia or undergoing hysterectomy because of bleeding, was 11.7% overall. The failure rate in patients with submucous myomas and normal cavities was 23.2% and 3.7%, respectively (relative risk, 6.3; 95% confidence interval, 2.5-16.0). While the failure rate in the group with myomas was statistically significantly higher than in the group without myomas, the failure rate in the myoma group was still comparable to that achieved using electrosurgical resection and ablation of similar types of myomas as reported in the literature. The amenorrhea rate achieved in the myoma group (38.9%) was also comparable to that achieved in US Food and Drug Administration pivotal trials in patients with normal cavities treated using all of the nonhysteroscopic global ablation devices as well those treated using rollerball endometrial ablation. The rate of hysterectomy because of bleeding was 5.2% overall. The hysterectomy rate in patients with submucous myomas and normal cavities was 11.6% and 0.7%, respectively. Only 1 procedure was discontinued (at 8 minutes) because of pain. Four patients had postoperative endometritis, with 2 requiring hospitalization for intravenous antibiotic therapy. Two false passages were created while dilating the cervix, with subsequent inability to perform the procedure.
Conclusions: Hydrothermablation performed in the medical office using local anesthesia seems to be a safe, effective, and cost-saving procedure for treatment of abnormal uterine bleeding in women with both normal and myomatous uteri. Although the success rate in patients with normal cavities was higher than that achieved in patients with submucous myomas, hysterectomy because of abnormal bleeding related to myomas was avoided in 88.4% of the group with myomas.