Use of Hysterosalpingo-Foam Sonography for Assessment of the Efficacy of Essure Hysteroscopic Sterilization.

Abstract

Hysterosalpingo-foam sonography (HyFoSy) has been suggested to be a possible less invasive alternative to hysterosalpingography (HSG), which is the reference standard for confirmation of tubal occlusion after Essure (Bayer AG, Leverkusen, Germany) hysteroscopic sterilization. The purpose of our study was to evaluate the accuracy of HyFoSy compared to HSG for confirmation of tubal occlusion after Essure hysteroscopic sterilization. A prospective study included 90 patients who underwent Essure hysteroscopic sterilization. Twelve weeks after the sterilization, 2-dimensional transvaginal ultrasonography was performed to assess the microinsert position and was followed by HyFoSy and HSG for evaluation of tubal occlusion. Patients with patent fallopian tubes on HSG were scheduled for additional HSG procedures at 3-month intervals until tubal occlusion was documented. Of 90 enrolled patients, 86 patients with 170 fallopian tubes underwent the complete imaging protocol. Tubal occlusion was evaluated by HyFoSy as an index test and HSG as a reference standard. The accuracy of HyFoSy was 97.1% (95% confidence interval [CI], 93%-99%). The sensitivity and specificity were 100% (95% CI, 97%-100%) and 54.6% (95% CI, 23%-83%), whereas the positive and negative predictive values were 97.0% (95% CI, 93%-99%) and 100% (95% CI, 42%-100%), respectively. No long-term complications were reported for HyFoSy or HSG. Given that the concordance rate for tubal occlusion between HyFoSy and HSG was not 100%, an occluded fallopian tube on HyFoSy should be confirmed by HSG, which remains the reference standard for confirmation of tubal occlusion after Essure hysteroscopic sterilization.