MATERIALS AND METHODS: All patients who had 3D-ABUS between January 2014 and January 2022 for screening were included in this retrospective study. The images were reported by 1 of 6 breast radiologists based on the Breast Imaging Reporting and Data Systems (BI-RADS). The 3D-ABUS was reviewed together with the digital breast tomosynthesis (DBT). Recall rate, biopsy rate, positive predictive value (PPV) and cancer detection yield were calculated.

RESULTS: In total, 3616 studies were performed in 1555 women (breast density C/D 95.5% (n = 3455/3616), breast density A/B 4.0% (n = 144/3616), density unknown (0.5% (n = 17/3616)). A total of 259 lesions were detected on 3D-ABUS (87.6% (n = 227/259) masses and 12.4% (n = 32/259) architectural distortions). The recall rate was 5.2% (n = 188/3616) (CI 4.5-6.0%) with only 36.7% (n = 69/188) cases recalled to another date. Moreover, recall declined over time. There were 3.4% (n = 123/3616) biopsies performed, with 52.8% (n = 65/123) biopsies due to an abnormality detected in 3D-ABUS alone. Ten of 65 lesions were malignant, resulting in a positive predictive value (PPV) of 15.4% (n = 10/65) (CI 7.6-26.5%)). The cancer detection yield of 3D-ABUS is 2.77 per 1000 screening tests (CI 1.30-5.1).

CONCLUSION: The cancer detection yield of 3D-ABUS in a real clinical screening setting is comparable to the results reported in previous prospective studies, with lower recall and biopsy rates. 3D-ABUS also may be an alternative for screening when mammography is not possible or declined.

CLINICAL RELEVANCE STATEMENT: 3D automated breast ultrasound screening performance in a clinical setting is comparable to previous prospective studies, with better recall and biopsy rates.