A Pilot Study Comparing 2- and 3-Dimensional Ultrasound Imaging for Confirmation of ESSURE® Fallopian Tube Pregnancy Prevention Implants.

STUDY OBJECTIVE: To demonstrate the feasibility of 2-dimensional ultrasound (2DUS) imaging compared to 3-dimensionnal ultrasound (3DUS) to identify the location of implants and assess if the classification developed by Simorre et al described in 2016 was applicable to the 2 types of ultrasound imaging (2D and 3D).

DESIGN: A prospective study (Canadian Task Force classification II-2).

SETTING: Department of obstetrics and gynecology in a teaching hospital.

PATIENTS: One hundred and fifty patients who had undergone hysteroscopic sterilization with ESSURE® (Bayer Pharma AG Laboratory, Lyon, France) fallopian tube pregnancy prevention implants were invited by letter to participate in the study; 50 replied positively between January and August 2017.

INTERVENTION: An initial 2DUS was carried out followed by a 3DUS reconstruction. The primary endpoint was to compare identification of device placement with the 2DUS and 3DUS imaging procedures, according to this new classification. Secondary considerations were to evaluate the difficulty of attaining images, the quality of implant curvature, the duration of each imaging procedure, and the number of images carried out for each technique.

MEASUREMENTS AND MAIN RESULTS: 96% tubal implants were observed via 3DUS compared with 100% via 2DUS. The mean time of 2DUS was 14.64 seconds for the right fallopian tube and 15.25 seconds for the left fallopian tube compared with 25.11 seconds for the right and 31.57 seconds for the left fallopian tube in 3DUS (p < .01). The mean number of image acquisitions per patient was 1.02 (± 0.14 standard deviation [SD]) for 2DUS compared with 1.37 (± 0.64 SD) for 3DUS (p < .01). The sonographer had no difficulty performing 2DUS in 88% of cases compared with 58% of 3DUS cases.

CONCLUSION: Two-dimensional ultrasound appears to be an acceptable alternative to 3DUS. We propose a 2D classification for cross-section device localization to facilitate image interpretation.