One-Year Results of the Vesta System for Endometrial Ablation

Abstract

Study Objective To compare a distensible multielectrode balloon for endometrial ablation with electrosurgical ablation performed by a combined resection-coagulation technique. Design Randomized, prospective trial (Canadian Task Force classification I). Setting Eight centers. Patients Women with menorrhagia validated with a standardized pictorial blood loss assessment chart (PBAC), without intracavitary organic uterine disease, who failed or poorly tolerated medical therapy. Intervention Results in 122 patients treated by Vesta and 112 treated surgically, evaluable at 1 year, were compared, with success defined as monthly blood loss of less than 80 ml and avoidance of additional therapy. Measurements and Main Results Pretreatment PBAC scores for patients treated by Vesta and resection or rollerball were 535 ± 612 and 445 ± 313, respectively; at 1 year they were 18 ± 37 and 28 ± 60, respectively. With PBAC below 75 as the definition of success, 86.9% of Vesta-treated patients were successful compared with 83.0% treated by rollerball or resection. Total amenorrhea, defined as no visible bleeding and no use of protective products, was 31.1% and 34.8%, respectively. None of the outcome comparisons between treatments showed statistical difference. Complications in both groups were few and minor. Most (86.6%) Vesta procedures were carried out with paracervical block with or without intravenous sedation in an office or outpatient setting, compared with 79.7% epidural or general anesthesia for rollerball or resection. Conclusion The Vesta system of endometrial ablation is equally effective and safe as classic resectoscopic methods. Potential advantages include avoidance of fluid and electrolyte disturbance associated with intravasation of distending media, and ability to perform the procedure under local anesthesia in an office setting with less total operating time.