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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.

Study objective To assess the efficacy of performing myomectomies through 3- to 6-cm incisions for the removal of myomas up to 14 cm in diameter. Design A retrospective analysis of 139 myomectomies performed at our center from January 1995 through December 2003 (Canadian Task Force classification II-3). Setting A suburban medical center, part of a large prepaid health maintenance organization. Patients One hundred thirty-nine women. Interventions Myomectomies were performed through 3- to 6-cm suprapubic cruciate incisions using atraumatic elastic retractors with or without laparoscopic assist. Myomas were morcellated with a scalpel before being enucleated. The uterus was repaired in a classic three-layered closure in all cases. All procedures were performed in the ambulatory surgery unit of our hospital, which is part of the main operating room. Measurements and main results The median age of the patients in this series was 30.0 years (range 23–56 years). The median weight of the myomas removed was 275.0 g (range of 30–975 g). One hundred thirty-seven (98.5%) of 139 patients were discharged in 23 hours or less, with 24 patients leaving within 4 hours and 61 within 8 hours. The median length of stay was 6.0 hours, with two patients remaining hospitalized for 48 hours. The median operating time was 110 minutes (range 44–260 min). Estimated blood loss ranged from 50 to 2000 mL, with a median of 300 mL. Three hysterectomies were performed: one as an emergency for hemorrhage and two for recurrent myomas. Three patients developed wound seromas, and one developed a wound infection. Conclusions Minilaparotomy myomectomy is a safe, effective minimally invasive alternative to laparoscopic myomectomy. Early discharge and return to normal activities is comparable to laparoscopy and is far more cost effective. It affords the ability to palpate the uterus and close the myometrial defect easily with a standard three-layered closure making it particularly suitable for gynecologists with limited laparoscopic suturing skills.

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.Retrospective cohort analysis of 246 HTA procedures (Canadian Task Force classification II-2).Medical offices of a suburban community medical center that is part of a large health maintenance organization.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.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.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.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.

Hysteroscopy and endometrial ablation using the second-generation devices are safe, generally well tolerated, and effective when performed in the medical office as opposed to the ambulatory surgery center or hospital operating room. Not only does this benefit the patient and physician in terms of convenience and cost savings, and the overall economic benefit to the health care system is great. The availability of modern hysteroscopic and video equipment, the advent of second-generation "global"endometrial ablation devices, and use of minimal sedation combined with effective local anesthesia have made office procedures possible. Several states have enacted specific regulations and requirements for office based surgery. It is incumbent on the physician to be aware of which local regulations are applicable and the level of procedure he or she is willing to perform before embarking on an office-based surgery program. The AAGL ListServ discussion forum provides members with an invaluable source of clinical opinion about patient care issues in minimally invasive gynecology. These opinions come from experts around the world representing both academic centers and clinical practice who respond to questions or issues posed by colleagues. This review discusses each of the second-generation endometrial ablation devices in detail and some of the more pertinent issues related to office hysteroscopy and global endometrial ablation that were posted on the ListServ. Rollerball and transcervical resection of the endometrium are not discussed because the overwhelming majority of these procedures are performed in the operating room and there is little potential for their becoming office procedures. Practical clinical tips based on the evidence in the literature are discussed.