Outcomes of DIEP flap and fluorescent angiography: a randomized controlled clinical trial.

BACKGROUND Breast reconstruction with DIEP flap can be associated with complications such as fat necrosis. Our objective was to assess the safety and efficacy of fluorescent angiography with indocyanine green (FA-ICG) to reduce fat necrosis. METHODS We designed a parallel, randomized, controlled clinical trial for unilateral breast reconstruction (NCT02759796). The poorly vascularized tissues of the DIEP flap were removed based on a clinical evaluation in group 1 and based on angiographic criteria in group 2. We recorded the flap dimensions, perfusion in terms of fluorescence intensity, complications, reoperations and BREAST-Q questionnaire scores for both groups. RESULTS The study included a total of 51 patients. The flaps showed no size differences after excising the tissue. The flaps of group 2 presented higher perfusion rates (p=.001). The incidence of fat necrosis was 59.3% in group 1 and 8.3% in group 2 (p=.001). Four cases of partial necrosis were recorded in group 1 (18.2%) and none in group 2 (0%) (p=.131). Four patients underwent reoperation in group 1 (14.8%) and none in group 2 (0%) (p=.113). The patients in group 2 reported higher scores in all domains of the BREAST-Q. CONCLUSIONS FA-ICG significantly reduced the incidence of fat necrosis without diminishing the flaps' dimensions. The perfusion rates were significantly higher in the flaps tailored according to FA-ICG. The patients in the FA group reported significantly greater satisfaction and quality of life. FA-ICG may be considered a safe and effective tool to enhance the outcomes of breast reconstruction with DIEP flap.