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Evaluating SPY Elites’ Ability to Predict Nipple Necrosis in Nipple-Sparing Mastectomy and Immediate Expander-Based Breast Reconstruction
Libby R. Copeland-Halperin, MD, Louisa Yemc, PA-C, Victoria Y. Suh, MD FACS, Ali N. Mesbahi, MD FACS, Mark Venturi, MD FACS.
Inova Fairfax Hospital, Fairfax, VA, USA.

BACKGROUND: The popularization of the nipple-sparing mastectomy has dramatically improved the aesthetic results of breast reconstruction. Despite its advantages, however, post-mastectomy nipple necrosis still remains a challenging problem to predict. The authors sought to improve their ability to predict nipple necrosis by evaluating the SPY Elite® system's ability to successfully predict nipple necrosis in nipple-sparing mastectomy with immediate expander-based breast reconstruction.
METHODS: Twenty consecutive nipple-sparing mastectomy patients (mean age 48 years) were prospectively enrolled (twelve bilateral, seven unilateral) in an IRB-approved study. All patients underwent intraoperative indocyanine green fluorescence imaging (SPY Elite)® imaging immediately following their mastectomy and after completion of intraoperative expansion. No changes in intraoperative management were made based on the imaging results. A predicted necrotic event was defined as a quantified value of less than or equal to 5% on the nipple or within the areola.
RESULTS: A total of 20 patients and 31 breasts were evaluated (n = 31). The overall necrosis rate was 9.6% (3/31) and the complete necrosis rate was 3.2% (1/31), which also resulted in a failed expansion 3.2% (1/31). When partial and complete necrosis are grouped together as necrotic event then SPY Elite® (Novadaq Technologies, Ontario, Canada) was 100% sensitive and 100% specific for predicting necrosis (p = .0002). If partial necrosis is considered a false positive and only complete necrosis is considered a necrotic event, then Spy Elite® was still 100% sensitive, though only 93% specific at predicting complete necrosis (p = 0.097).
CONCLUSIONS: This study is unique in that imaging results were not considered in intraoperative management, thereby allowing assessment of their independent predictive value. The Spy Elite® system is a useful tool for predicting at least partial nipple necrosis in nipple-sparing mastectomy. Assurance of adequate nipple perfusion is very reliable when demonstrated by SPY Elite® imaging.

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