Abstract P3-04-13: Patient experience with automated SoftVue 3D whole breast tomographic ultrasound
Authors: Yamashita Mary , Brem Rachel F. , Baker Lauren , Mahoney Taylor F. , Walker Patrick , Treat Rachel M. , Larsen Linda Hovanessian 
Published: March 2023

Authors: Mary Yamashita, MD; Rachel Brem, MD; Lauren Baker, Ph.D; MD; Taylor Mahoney, PhD; Patrick Walker, PharmD, MPH; Rachel Treat, MA; Linda Hovanessian Larsen, MD. Title: Patient experience with automated SoftVue 3D whole breast tomographic ultrasound. Purpose: SoftVue (SV) is an automated, 3D whole breast ultrasound tomographic imaging device which is FDA PMA approved as adjunct to mammography for women with dense breasts. Screening with handheld US is labor intensive and with ABUS is associated with significant patient discomfort. A benefit of SV is that image acquisition is not operator dependent and does not require compression. Because acceptance by patients is crucial to implementation of US screening, we evaluated patients’ experience with SV, specifically, asymptomatic women with BI-RADS c or d density undergoing FFDM. Materials and Methods: As part of a prospective, 10-site study, 7,439 asymptomatic women with BI-RADS density category c or d were screened on the same day with FFDM and SV. Each patient’s experience was assessed for perceived pain, discomfort and anxiety, discretion and modesty, overall satisfaction, and whether they would recommend it to others. The responses were measured on a Likert scale with 5 choices from strongly agree to strongly disagree, then studied by Chi-Squared analysis. Results: The mean age was 53.9 ± 9.7 yo, mostly white women (87.7%). The median BMI was 24.4. Majority had no personal history of breast cancer (97.2%), but 24.8% had a previous biopsy and almost half (46.3%) had a family history of breast cancer. Almost all patients (99.6%) completed the survey. SV was perceived as significantly more comfortable than FFDM (83.7% vs 52.2%, p&lt; 0.001), was painless (94.9% vs 53.1%, p&lt; 0.001), and was associated with less anxiety during the procedure (95.1% vs 79.9, p&lt; 0.001). Lastly, 99.3% felt the experience was private and discreet, and 95% would recommend the SV exam to other women. Conclusion: Pain, fear, anxiety, and modesty concerns are some of the barriers preventing widespread implementation of screening breast US. This data suggests that SV, an FDA PMA approved adjunctive screening exam for women with dense breast tissue, is painless, offers a private and discreet scan that limits anxiety, and is well accepted by patients. Clinical relevance statement: SV is a novel automated US tomographic screening technology that is comfortable, well-accepted, FDA PMA approved, and will likely result in improved implementation of screening breast ultrasound in women with dense breasts.

Citation Format: Mary Yamashita, Rachel F. Brem, Lauren Baker, Taylor F. Mahoney, Patrick Walker, Rachel M. Treat, Linda Hovanessian Larsen. Patient experience with automated SoftVue 3D whole breast tomographic ultrasound [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-04-13.