A novel technology for margin extension and local control in breast conservation surgery: Saline-coupled intraoperative radiofrequency ablation (SIRA)

Abstract

Importance

Breast-conserving therapy (BCT) results in reoperation in ∼20 % of cases due to positive margins, and a 7–13 % recurrence risk at 5 years persists despite negative margins and radiation. Enhancing margin treatment is critical to reducing local recurrence and improving survival.

Objective

To optimize and evaluate the performance of a Saline-coupled Intraoperative Radiofrequency Ablation (SIRA) device in producing uniform 1 cm ablations in lumpectomy cavities and compare it to prior-generation RFA technology in previous clinical studies.

Design, setting, and participants

This case series (2018–2023) included 55 mock lumpectomies performed on prophylactic mastectomy or cadaver breasts under an IRB-approved protocol. Inclusion required disease-free, sufficient-volume breast tissue with patient consent.

Results

55 ablations were performed on breasts from 44 female patients. The SIRA produced an ablation depth of 1.0 ± 0.2 cm (mean, SD), no significant difference between margins (p = 0.056). No significant difference in ablation depth across the following: BI-RADS breast composition (p = 0.212), age (p = 0.188), height (p = 0.643), weight (p = 0.522), tissue volume removed (p = 1.000), breast surgery history (p = 0.246), chest chemotherapy/radiation history (p = 0.477), or surgeon (p = 0.579). Significant difference in depth and variance between the SIRA and previous-generation technology (p < 0.001 and p = 0.016), with SIRA significantly deeper and more uniform.

Conclusion

Lumpectomy followed by SIRA could reduce positive margin rates and treat additional tissue, resulting in reduction in re-excision rates and serve as a potential alternative to radiation therapy.