OP22.02: Accuracy of 2D/3D high‐definition flow imaging HyFoSy and 2D/3D HyFoSy in comparison to 2D air/saline HyCoSy and laparoscopy

Abstract

To estimate the diagnostic accuracy of two-/three-dimensional (2D/3D) hysterosalpingo-foam sonography (HyFoSy) and 2D/3D-high definition flow Doppler (HDF)-HyFoSy in comparison to laparoscopy with dye chromotubation as the reference method, and 2D air/saline-enhanced hysterosalpingosonography (HyCoSy) as initial index test. Design: Diagnostic accuracy study Setting: University hospital and private hospital and clinic. Patients: A prospective, observational study was performed on 132 infertile women (259 fallopian tubes) of reproductive age with unclear tubal patency consecutively enrolled between 2013 and 2015 Interventions: Index tests and the reference test were performed independently by experienced readers who were blinded to the results of other tests main outcome measures: Sensitivity, specificity, NPV and PPV, LR- and LR+, with 95% CI. Statistics: McNemar's test and relative predictive values was used to compare all the index tests. 2D-Air/saline-HyCoSy had a similarly high NPV to the foam methods (99%–99.6%) (P > 0.05), but had very low PPV (30.4%). Use of 2D/3D-HyFoSy, especially 2D/3D-HDFflow-HyFoSy with significantly higher PPV (48 and 71%, P < 0.05 and P < 0.01; respectively) resulted in lesser false positive and inconclusive findings than 2D-air/saline-HyCoSy. LR- and LR+ were 0.14 and 14.8 for 2D/3D-HyFoSy, 0.06 and 32.1 for 2D/3D-HDF-HyFoSy, and 0.08 and 6.9 for 2D-air/saline-HyCoSy, respectively. Inconclusive or positive results per patient were significantly rarer with 2D/3D-HyFoSy (OR = 0.5, CI = 0.3–0.95, P < 0.05) and 2D/3D-HDF-HyFoSy (OR = 0.4, 95% CI = 0.2–0.8, P < 0.01) than with 2D-air/saline-HyCoSy. Air/saline-HyCoSy, which has a high negative predictive value is suitable as an initial test and basic screening method, but 2D/3D-HDF-HyFoSy with significantly higher PPV can be used as a standard to verify any questionable or positive results obtained with 2D-HyCoSy. This high accurate algorithm may significantly reduce the need for laparoscopy as a reference standard.