Clinical Study For Evaluation Of An Inflatable Air Cushion To Reduce Patient Discomfort During Tomosynthesis Compression

In a clinical pilot study, we evaluated the impact of a radiolucent, inflatable air cushion during tomosynthesis breast imaging. 101 patients were included to quantify the degree of reduction in discomfort as well as the impact on image quality, patient positioning and applied compression force. All underwent tomosynthesis examination in two different settings, routine compression and compression including the cushion without exposing them to additional acquisitions. The cushion had the same size for all breasts and was placed directly on the patient support table of the mammography unit. In the study, the cushion was inflated with air after the standard compression to a breast-individual level. Due to inflation of the cushion, the contact area between breast and compression paddle increased and additional force was therefore added. We expected a decrease in the peak pressure and, due to increased contact area an increase in the desirable spreading of the breast tissue. After examination, patients were asked to complete a questionnaire to rate the tolerability of compression with and without the cushion. The deployment of the cushion decreased the negative perception significantly, lowering it by 18.4% and only 2.0% (p < 0.001, alpha = 0.05) of patients left to experience a discomfort during compression. When comparing the two compression settings, the increase in comfort did not have a negative impact on image quality, positioning, and the ability to detect all pertinent anatomy. Design and usability of the cushion as well as more sophisticated compression routines will be further investigated, analyzed, and discussed.