RESUMO
PURPOSE: Successful adoption of a new surgical procedure varies among practicing surgeons, and skill acquisition depends on the surgeon's innate ability, the complexity of the technique, and training. We report intraoperative and near-term postoperative outcomes from the Acessa procedure conducted by minimally invasive gynecologic surgeons new to Acessa, and report the surgeons' experiences during the training period. PATIENTS AND METHODS: The study was designed as a postmarket, prospective, single-arm, multicenter analysis of operative and early postoperative outcomes after proctored surgical training with the Acessa device and procedure (laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic fibroids) in premenopausal, menstruating women as conducted in community and university hospitals in the USA and Canada. Surgeons completed evaluation forms once they felt they could safely and comfortably conduct the operations. RESULTS: Ten gynecologic surgeons without prior Acessa experience completed 40 Acessa procedures - all on an outpatient basis. Mean procedure time was 1.9±1.0 hours and was similar to that reported in the pivotal premarket study (2.1±1.0 hours). Two intraoperative complications occurred: a 1 cm uterine serosal laceration due to uterine manipulation and blood loss from both the probe insertion site and the lysis of uterine-omental adhesions. No postoperative complications or reinterventions for fibroid symptoms were reported. The surgeons completed the evaluation forms after two to five cases, and none found any factors affecting procedure efficiency to be inferior or needing improvement. CONCLUSION: Minimally invasive gynecologic surgeons new to Acessa can perform the procedure and provide acceptable outcomes after two to five proctored cases.
RESUMO
OBJECTIVE: To review the use of three-dimensional ultrasound follow-up of the Essure micro-insert placement at three months for the identification of misplaced coils and complications. METHODS: We conducted a retrospective cohort study of reproductive age women requesting permanent sterilization in a tertiary care ambulatory women's clinic. Women who underwent placement of the Essure micro-insert were assessed for appropriate positioning of the Essure micro-insert coil using three-dimensional ultrasound as well as hysterosalpingography when indicated. RESULTS: A total of 610 women who had undergone the Essure procedure with ultrasound follow-up at three months were retrospectively reviewed and in 524 (86%) the location and shape were both normal. The remaining 86 (15%) required hysterosalpingography to confirm proper placement, 34 because of a non-diagnostic ultrasound and the remaining 52 for a complication noted on ultrasound, including perforation, proximal or distal migration of the device, or device expulsion. CONCLUSION: Ultrasound can be used at three months after Essure placement to identify normal placement as well as misplaced and perforated devices.
