Tamas Fulop1, István Rákóczi, István Barna. 1. Department of Obstetrics and Gynecology, St. Imre Teaching Hospital, Budapest, Hungary. tamasfulopmd@gmail.com
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.
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.
Authors: Jeffrey D Miller; Gregory M Lenhart; Machaon M Bonafede; Cindy M Basinski; Andrea S Lukes; Kathleen A Troeger Journal: Int J Womens Health Date: 2015-01-06