A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Skin Sparing Mastectomy with Immediate Reconstruction

Background:  Nipple-areola and skin sparing mastectomy (NASSM) is an accepted and sought after option for eligible patients.  Studies suggest that perfusion is received primarily from superior, medial, and lateral contributions.  Therefore the inframammary (IMF) incision may lead to an improved result with fewer complications than the lateral radial (LR) incision.  We aim to assess perfusion to nipple-areola complex as well as outcomes and patient satisfaction.

Methods:  Patients with age >18 with BMI 18-35, estimated breast size 100-800g were included in this prospective study.  Patients were randomized to recieve either an IMF or LR incision unless one was given a strong preference by patient or surgeon.  Laser angiography (SPY system, Lifecell) was performed pre-operatively, post-NASSM, and post-reconstruction.  Patients were followed for at least 3 months.  Two-tailed Mann-Whitney U and Chi-squared tests were used to compare group medians and proportions with P<0.05 indicating significance.

Results:  Forty-seven patients received an IMF incision, and 21 a LR incision.  There was no difference in demographics, comorbidities, specimen weight, initial implant volume, or intraoperative blood pressure.  Similarly, there was no there a difference in distribution of perfusion pattern between groups.  The decrease in perfusion to the whole breast did not differ between groups between surgical stages.  From pre-operative measurements to post-reconstruction measurements, decrease in perfusion to the nipple was 67.68% (IMF) versus 82.76% (LR), p=0.01, and 66.98% (IMF) versus 77.1% (RL) to the inferolateral breast, p=0.01.  Rates of necrosis, infection, implant exposure or malposition, and explant did not differ  between incision location.  Furthermore, there was no difference in BreastQ scores or final aesthetic mammometric measurements.

Conclusions:  There is a significant decrease in blood flow to the nipple and inferolateral portion of the skin envelope using the RL incision.  Despite this, there is no difference in complications, outcomes, or patient satisfaction over a 3 month period.