Outpatient Thermachoice Endometrial Balloon Ablation: Long-term, Prognostic and Quality-of-life Measures

Abstract

Among the several endometrial ablation devices available for treatment of menorrhagia, there is wide variation in the preferred device. It is unclear whether patients should be treated in the outpatient or day-case general anesthesia setting. One device, thermal balloon endometrial ablation (TBEA), has become popular in the last decade. Several prognostic factors are associated with favorable outcome after TBEA: older age, higher intrauterine pressure, anteverted compared with retroverted uterus, shorter uterine length, and lower (<10 mL) intrauterine balloon volumes. This prospective observational study evaluated long-term treatment outcomes of local anesthetic-TBEA among women with menorrhagia and also investigated prognostic factors. The study was conducted at a teaching hospital in the United Kingdom between 2001 and 2005. A total of 102 premenopausal menorrhagic women underwent local anesthetic-TBEA using either Gynecare Thermachoice I (n = 51) or Thermachoice III (n = 51) TBEA in an outpatient setting under local anesthesia with no conscious sedation. The long-term effectiveness of therapy was assessed with a postal questionnaire sent to all participants in the summer of 2006. The primary study outcome measures included completion of treatment, pain and analgesia, duration of stay and follow-up, primary treatment success, use of secondary treatment, improvements in amenorrhea and other menstrual symptoms, level of patient satisfaction, and quality of life. The questionnaire response rate was 86% (88/102). The TBEA procedure was completed in 97% of patients. Mean duration of hospital stay was 8.0 hours, with a 95% confidence interval of 6.6 to 9.3. Mean treatment follow-up was 30 months (95% confidence interval: 26–32). Secondary treatment occurred in 19% (19/102) of patients and included levonorgestrel intrauterine system, repeat TBEA, or hysterectomy. Surgical re-intervention occurred in 50% of patients by 19 months. The rate of amenorrhea was 29%, and the level of treatment satisfaction was 76%. Higher mean intrauterine ablation pressure was associated with better long-term patient satisfaction. These findings show that TBEA is an effective day-case procedure that can be successfully performed in the outpatient setting. The data suggest that higher intrauterine ablation pressure is associated with improved long-term treatment outcome.