Nipple-Sparing Mastectomy Incisions for Cancer Extirpation Prospective Cohort Trial: Perfusion, Complications, and Patient Outcomes

Abstract

Background: Nipple-sparing mastectomy offers several advantages for women seeking postmastectomy breast reconstruction, but compromised skin and nipple perfusion may lead to skin and nipple necrosis. It is unclear whether the incisional approach contributes to these complications; therefore, the purpose of this study was to compare the impact of incision type on outcomes in patients undergoing nipple-sparing mastectomy.

Methods: This is a prospective cohort study of patients undergoing nipple-sparing mastectomy with prosthetic breast reconstruction through an inframammary fold versus a lateral radial incision. Skin and nipple perfusion as represented by fluorescence intensity, mammometric parameters, patient-reported outcomes, and clinical outcomes were analyzed and compared for the two cohorts, and multivariable logistic regression models were performed to evaluate the effects of covariates on outcomes.

Results: Seventy-nine patients were studied: 55 in the inframammary fold cohort and 24 in the lateral radial cohort. The inframammary fold group had significantly less fluorescence intensity to the inferior (21.9 percent versus 36.9 percent; p = 0.001) and lateral portions of breast skin (23.1 percent versus 40.7 percent; p = 0.003) after reconstruction. Decreased fluorescence intensity was associated with smoking, decreased mean arterial pressure, and greater specimen weight. Postreconstruction breast volumes were increased over preoperative volumes in the inframammary fold group (38.3 percent) versus the lateral radial (31.2 percent) group; however, patients with a lateral radial incision had a greater increase in satisfaction with their breasts and psychosocial well-being.

Conclusions: There are significant differences in patient-reported outcomes and final breast volumes based on the incisional approach to nipple-sparing mastectomy. These data can be used to guide providers and counsel patients considering nipple-sparing mastectomy with prosthetic reconstruction.

Clinical question/level of evidence: Therapeutic, II.

Trial registration: ClinicalTrials.gov NCT01969448.

Figures

Figure 1

Schematic of study design. Patients were excluded if they had no reconstruction, autologous flap reconstruction, prior radiation therapy, a body mass index less than 18 or greater than 35, breast size 800g by mammometric analysis (Vectra XT, Canfield Scientific Inc, Parsippany, NJ), or an allergy to indocyanine green (ICG). In bilateral cases, a “study breast” was randomly assigned for perfusion analysis. Patients who were lost to follow-up were excluded from analysis. Three patients were excluded due to poor quality perfusion imaging. Seven patients did not have both pre- and post-operative three-dimensional imaging and were excluded from mammometric analysis. Finally, seven patients did not have preoperative Q-score and 12 did not have post-operative Q-scores available.

Figure 2

Incision location on three dimensional breast images and Spy laser-assisted angiography. A. Inframammary incision (IMF) in blue. B. Lateral radial incision (LR) in red. C. Greyscale static image of perfusion following inframammary approach. “IMF” denotes inframammary fold incision. “N” denotes nipple. D. Color coded version of image demonstrates greater perfusion medially from internal mammary artery perforators labeled “IMA”. Limited blood supply in inferior breast approaching nipple in similar distribution to surgical retractor placement. “RI” denotes retractor injury.

Figure 3

Rate of nipple perfusion by breast region prior to surgery, after nipple-sparing mastectomy (NSM) and following mastectomy. A. Breast regions of interest. The inferior region of intrerest was bordered by the the central third of the caudal circumference of the areola and extended to the central third of the inframammary fold. The medial and lateral regions of interest were bordered by the inferior region of interest, the medial/lateral/inframammary fold, and a line that bisected the breast transversely with the patient lying supine. Overall breast perfusion represented the overall area captured by the camera. Mean breast perfusion, presented as 8-bit greyscale units/second, for the inframammary fold (IMF) and lateral radial (LR) groups pre-NSM, post-NSM, and post-reconstruction are presented. Rates of perfusion for the regions of interest include B. overall, C. nipple, D. medial, E. inferior, and F. lateral breast.