One-step 3D-TV-hysterosalpingo-foam-sonography (3D-TV-HyFoSy) confirmation test for Essure® follow-up: a multicenter study.

OBJECTIVE To evaluate the feasibility and accuracy of a three-dimensional-transvaginal-hysterosalpingo-contrast-sonography using the new dedicated contrast-enhanced gel foam (3D-TV-HyFoSy) to assess the position of the tubal sterilization Essure® devices and consequent tubal occlusion in patients who underwent Essure® hysteroscopic tubal sterilization. METHODS This multicenter study was prospectively conducted from June 2012 to July 2014 in four italian centers and included 50 women who underwent hysteroscopic Essure® microinsert placement, for a total of 95 tubes. Insertion of the microinserts was performed in outpatient setting following standard procedure recommendations. All patients underwent 3D-TV-HyFoSy and hysterosalpingography (HSG) about 3 months to 3 months and 2 weeks after the procedure. The devices’ positions were first seen on 3D- transvaginal sonography (TVS) and classified according to specific criteria in 4 positions. Then a hysterosalpingo-contrast-sonography (HyCoSy) with 3D technique and ExEm® Foam gel as ultrasound contrast agent (HyFoSy) was performed to confirm tubal occlusion by the absence of contrast agent within the tubes and/or around the ovaries. To evaluate the feasibility of 3D-TV-HyFoSy, consecutive volume acquisitions were performed while injecting the gel foam. After sonographic evaluation all women underwent HSG to assess as standard methodology the success of sterilization. Side effects and pain evoked during and after 3D- TV-HyFoSy and HSG, using a 10-point numeric pain rating scale (NRS), were also evaluated. RESULTS At 3D-TVS, 10 devices (10.5%) were in position “A”, 2 (2.1%) in position“B”, 59 (62.1%) in position “C”, 24 (25.2%) in position“D”. During 3D-HyFoSy, we observed tubal occlusion in 89 out of 95 tubes (93.7%). In the 6 cases in which the passage of the contrast was observed, one device (16.7%) was in position “B”, one device (16.7%) in position “D”and four devices (66.7%) were found to lie in position “C”. Tubal patency was confirmed at HSG with a concordance rate of 100%. The mean pain score associated with 3D- TV-HyFoSy was significantly lower than HSG. CONCLUSIONS 3D-TV-HyFoSy allows the accurate simultaneous assessment of Essure microinserts’ position and tubal occlusion. It may be considered as a safe, reliable, non-invasive alternative to HSG.