NovaSure impedance controlled endometrial ablation: Long-term follow-up results

Abstract

Study objective A 7-year follow-up evaluation of the safety, efficacy, and long-term outcome of endometrial ablation when using the NovaSure system in patients with menorrhagia secondary to abnormal uterine bleeding (AUB). Design Prospective, single-arm study (Canadian Task Force classification II-1). Setting St. Imre Teaching Hospital, Budapest, Hungary. Patients Seventy-five premenopausal women with menorrhagia secondary to AUB. Interventions Endometrial ablation using the NovaSure System without the use of endometrial pretreatment. Measurements and main results Loss of menstrual blood was measured using pictorial blood loss assessment chart diaries. Treatment times, complications, and rate of surgical re-interventions were recorded. No intra or postoperative complications were noted. Median follow-up period at the time was 7.8 years (range 6–8.6 years). The proportion of patients with fewer than 7 and 7 or more years of follow-up was 28.8% and 71.2%, respectively. The median treatment time was 92 seconds (range 40–120 seconds). At 7-year follow-up, 97.1% of evaluable patients reported amenorrhea. However, all patients (100%, actuarial rate: 97% with 95% CI [83%–100%]) experienced a successful reduction in bleeding to normal levels or less. Six of 75 patients underwent hysterectomy, and one of 75 had a repeat ablation representing a total of 92% (95% CI: 83%–96%) avoidance of additional surgery during the follow-up period. Conclusions Clinical results demonstrate that the use of NovaSure System is safe and effective, with a low rate of surgical re-intervention at 7-year follow-up.