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Published on: July 16, 2020
NovaSure impedance controlled endometrial ablation: long-term follow-up results
Tamas Fulop1, István Rákóczi, István Barna
1Department of Obstetrics and Gynecology, St. Imre Teaching Hospital, Budapest, Hungary. tamasfulopmd@gmail.com
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.
