A novel 3D-printed scaffold for patient-specific partial breast reconstruction: A prospective, single-arm clinical trial.

Abstract

e23227 Background: The current scarcity of appropriate breast fillers restricts the availability of breast-conserving surgery for breast cancer patients. The advent of 3D printing technology has introduced novel possibilities for breast reconstruction by fabricating the patient-specific and custom-designed medical products in three dimensions. Methods: We performed a prospective, single-arm clinical trial. The trial population included woman aged between 18 and 60 years with histologically confirmed breast cancer. (Primary) tumors with a size greater than 1.0 cm and less than 8.0 cm, or those presenting as multiple diffuse lesions limited to a single quadrant, preclude the feasibility of traditional breast-conserving surgery. Patients were assigned to receive the patient-specific 3D-printed scaffolds transplantation surgery. Degradation of 3D-printed scaffold, cosmetic outcomes, complications, satisfaction of patients was assessed. Results: Between August of 2016 and August of 2023, 26 patients received partial breast reconstruction using 3D-printed patient-specific scaffolds. The median follow-up was 58.9 months (range, 29 to 88 months). Patients who received partial breast reconstruction with 3D-printed scaffolds have natural-looking and symmetrical breasts after surgery. One year after operation, mild depression at the implantation site was observed in four patients (15.4%). This number increased to seven (26.9%) after two years of surgery. No flap necrosis or ischemia was observed in the nipple and areola area in all patients. Hematoxylin & Eosin showed that fibrous connective tissue, fibroblast cells and blood vessels were observed inside/around the scaffold after one year of surgery. The average degradation rate of 3D-printed scaffolds is 54.07% at 12 months, 74.48% at 24 months, 86.94% at 36 months,87.36% at 48 months, and 92.76% at 60 months. The breast satisfaction score rating by Breast-q scale is 68.5±15.7 at 6 months, 65.4±14.2 at 12 months, and 62.8±15.9 at 24 months. Conclusions: This is the first report of 3D-printed biodegradable scaffolds for breast reconstruction. Partial breast reconstruction using a 3D-printed scaffold presents a viable alternative for breast cancer patients who are not suitable candidates for conventional breast-conserving surgery, yielding promising outcomes. Clinical trial information: NCT03348293 .