We conducted a prospective study on a population of patients with a diagnosis of BC or BRCA carrier who underwent nipple sparing mastectomy (NSM) and subpectoral breast implant reconstruction with or without ADM. The enrolment started in January 2014 and ended in May 2017, at the Department of Surgical Sciences, Sapienza University of Rome. Before surgery, each patient was counseled and fully informed of all surgical treatment options.
The indication for surgical treatment was discussed during the periodical multidisciplinary breast board and the choice of the reconstructive technique was determined by preoperative and intraoperative anatomic evaluations. Inclusion criteria were: age 18 or older, pre-operative hystological diagnosis of BC and/or BRCA mutation carriers, no cutaneous and/or muscle infiltration, small–medium-sized breasts with first or second grade ptosis according to the three-tier Regnault ptosis scale [20] eligibility for mastectomy intervention and subsequent reconstruction. All patients were cN0 at the pre-operative imaging and in the case of clinic-radiological lymphoadenopathy, fine-needle agoaspiration for cytology was performed. All patients underwent sentinel lymph node biopsy (SLNB). Exclusion criteria were: previous radiation therapy, connective tissue disease, alterations of cutaneous trophism, patients eligible for autologous reconstruction, body mass index ≥ 30 kg/m2, active smoking patients (required not to smoke more than or equal to 3 months before surgery and for 4 months after surgery).
The study was performed according to the ethical standards of the Declaration of Helsinki and the protocol was approved by our Local Ethic Committee (Sapienza University of Rome). Written informed consent was obtained from all subjects and/or their legal guardian(s).
Surgical Technique
Patients enrolled were marked preoperatively, in the standing position, with different colors and the fundamental measures for breast reconstruction were detected (Fig. 1).
Breast volume was estimated preoperatively. Prophylactic antibiotic (cefazolin or clindamycin) was administered at appropriate dosage 30 minutes before the skin incision. All the patients continued antibiotic treatment therapy every 12/24 h until drain removal. Nipple-sparing mastectomy was performed with the patient in a supine position with the arm abducted at 90°. The preferred skin incisions used were in ‘’lazy S’’ (horizontal S-shaped, localized in the outer quadrants) (Fig. 1), allowing a single incision in BC patients undergoing SLNB. The single skin incision allows to perform mastectomy and remove the hypercaptant lymph node. In BRCA1/2 carrier we preferred submammary skin incision. The type of reconstruction (expander versus implant) was carefully chosen using sizers and avoiding exerting excessive tension on the muscle and skin flap to prevent blood supply reduction. We used the ADM when was necessary to offer support to the lower pole of the submuscular pocket, ensuring less tension and greater coverage of the prosthesis. Prior to ADM implant, it was removed from its sterile packaging, rehydrated in normal saline solution for 10 minutes and soaked in an antibiotic solution. To ensure better coverage and at the same time a better aesthetic result, the ADM was sutured at the inferior border of the muscle, from the four to eight o’clock position (Figs. 2;3) and fixed with detached resorbable stitches.
Before ending the surgery, 2 suction drains were positioned, the first one in subcutaneous space and the other one in the inframammary fold between the implant and the ADM (inframammary pocket). In order to reduce dead spaces, the breast was compressed using an elastic band.
Drains were removed when the drained volume was less than 20 mL/day for two consecutive days. All patients wore a postoperative bra for an average of 45 days after surgery.
Assessments
Post-operative complications
We recorded participants’ demographic and anthropometric characteristics (age, weight, height, body mass index), the presence/absence of comorbidities, histological diagnosis, tumor staging, and a detailed medical history. Particular attention was paid to registration of complications and relative frequencies. To facilitate the identification of complications, we defined before patients’ enrollment, the following classification: seroma, when a fluid collection that needs to be aspirated was clinically identified [21, 22]; hematoma, when a pool of mostly clotted blood that forms in an tissue or body space was documented; capsular contracture, when an alteration of the prosthetic profile was demonstrated by magnetic resonance imaging (MRI) scan [23, 24]; wound dehiscence was defined as a disruption of sutured tissue; infection, according to the definition of the Center for Disease Control and prevention criteria, was defined by: (i) presence of purulent drainage; (ii) positive aseptically obtained culture; (iii) peri-incisional erythema and incision opened by the surgeon; or (iiii) physician diagnosis of infection, such as cellulitis [25, 26]. Major infections required the removal of the prosthetic device, while minor infections were resolved only with antibiotic therapy [27–29].
Patients’ satisfaction
To investigate the satisfaction of aesthetic outcomes we used post-reconstruction BREAST-Q questionnaire, routinely used at our institution, and widely recognized and validated for research in breast reconstruction [30–33].
BREAST-Q questionnaire was submitted after 12 months from the placement of the definitive breast implant and all the patients answered the five domains of the questionnaire (Satisfaction with Breasts, Satisfaction with Outcome, Psychosocial Wellbeing, Sexual Wellbeing and Physical Wellbeing Chest).
All patients performed clinical, ultrasound and MRI exam at 18 months after implant placement to control the reconstruction outcomes and define presence/absence of capsule contracture and its severity according to Baker scores [34].
Statistical analysis
Statistical analysis was performed using the Vassarstats and MedCalc statistical software.
Pearson's X2 test, t-test, and Mann-Whitney test were used to assess statistical significance.
The BREAST-Q scores for each patient were converted from the survey scores (1 to 5) to a continuous range from 0 to 100 using QScore Scoring Software kindly provided to us by Memorial Sloan-Kettering Cancer Center. A higher score indicated grater satisfaction or a better HRQOL.