A descriptive comparison of satisfaction and well-being between expander-based and direct-to-implant breast reconstruction after Nipple-Sparing Mastectomy.

BACKGROUND: The literature that has explored differences between direct-to-implant (DTI) and expander-based (EB) breast reconstruction has mainly focused on complications, with results not always unambiguous. Moreover, there are limited data 1) comparing DTI and EB breast reconstruction after nipple-sparing mastectomy (NSM) and 2) from the patient's perspective. AIM: The aim of this study was to compare satisfaction and well-being in patients undergoing DTI and EB reconstruction after NSM in a Comprehensive Cancer Center, exploring what factors can be related to satisfaction and well-being. METHOD: The study design is monocentric, observational and retrospective. The participants completed an online questionnaire containing the Breast-Q and some socio-demographic variables (year of birth, level of education, civil status). Clinical information was obtained from the institutional database. Surgical techniques in the two branches of NSM were similar: all skin incisions, lateral to the areola; all implants, subpectoral (EB: conventionally submuscular; DTI: dual-plane pocket); all without synthetic mesh or acellular tissue matrix. RESULTS: A total of 120 patients (45% with EB and 55% with DTI) completed the questionnaire. We found that there are no differences between EB and DTI concerning the satisfaction and well-being of NSM patients, except for satisfaction with information, which is greater in the DTI group. In EB patients, no variables among those explored are related to satisfaction and well-being. In DTI patients, level of education is positive related to satisfaction with implants and physical well-being, Tumor-Node-Metastasis (TNM) and body mass index (BMI) are negative related to satisfaction with information and TNM also with satisfaction for plastic surgery. CONCLUSION: EB and DTI do not differ in terms of patient well-being, but EB requires a more careful counselling by the surgeon. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors   www.springer.com/00266 .

Oncologic surveillance of breast cancer patients after lipofilling.

BACKGROUND: The regenerative effects of fat injections are based on the same hormones, growth factors, and stem cells that stimulate neoplastic angiogenesis and cancer progression in basic research. Few studies have analyzed the oncologic risk. No report has covered 5 years of oncologic surveillance, and no long-term risk has been estimated. The in vivo relationship between lipofilling and breast cancer remains unclear and controversial. This observational study focused on locoregional recurrence (LR) risk after lipofilling. METHODS: The study enrolled 60 patients after breast cancer surgery (total mastectomy) from 2000 to 2007 treated by lipofilling (82 single-surgeon procedures with the same fat-decanting technique). The study ended when follow-up observation reached 10 years. RESULTS: The study included invasive carcinoma (55 cases), in situ carcinoma (five cases), T1 (71.6 %) and T2 (23.3 %) carcinoma, N+ carcinoma (45 %), and stages 1 (43.3 %) and 2 (45 %) carcinoma. The overall 12-year incidence of LR was 5 % (1.6 % before and 3.3 % after lipofilling). The incidence of local relapse per 100 person-years was 0.36 in the first observation period and 0.43 after lipofilling. All LRs were stage 2, and the same rate, limited to stage 2, was 1.04. The crude cumulative incidence after lipofilling was 7.25 % (95 % confidence interval [CI], 0-15.4 %) for LR and 7.6 % (95 % CI, 0.2-15 %) for distant metastases. DISCUSSION: Clinical data and recurrence incidences were compared with those of prior publications concerning lipofilling oncologic risk and discussed in relation to the inherent cancer literature. CONCLUSIONS: Lipofilling may be used safely to treat tumor node metastasis stage 1 subjects after mastectomy. The local risk is low. For stage 2 patients, local failure was not significantly higher. Compared with institutional data and prior publications, the risk still is reliable. Breast conservative treatment must be investigated further because of the high risk for local relapse. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Breast augmentation with extra-projected and high-cohesive Dual-Gel Prosthesis 510: a prospective study of 75 consecutive cases for a new method (the Zenith system).

BACKGROUND: Extra-projected Natrelle 510 belongs to a new generation of silicone breast implants. A single-surgeon prospective study set out to investigate the device's features, outcomes, and complications, and devise a proper measurement method based on the zenith system. METHODS: From December 2004 to June 2010, 75 subjects (150 implants) were enrolled in four cohorts: primary augmentation (66.7%), primary mastopexy augmentation (17.3%), secondary implant exchange (9.3%), and secondary implant exchange+pexy (6.7%). The system used to select the implant correlated the point of maximal projection (vertex-zenith) and nipple position. The surgical approach included (1) narrow pocket, preferably dual-plane; (2) device vertex 1-2.5 cm beneath nipple (zenith range=12°-23°) related to a nipple-inframammary fold distance of 7-7.5 cm at maximal stretch and a nipple-sternum/lower-pole line distance of 4-5 cm; (3) inframammary fold lowered minimally; (4) vertex at ±1 cm from the midbreast meridian crossing the nipple; and (5) maximizing the biomechanical effects between soft-tissue dynamics, firmer gel pressure, and pectoralis major counterpressure to expand the lower skin (dynamic tension). RESULTS: Mean follow-up was 26.5 months (range=6-72); in 20 subjects; follow-up was over 3 years (average=50 months) with a 90.8% patient satisfaction rate. This rate was lower in patients with preoperative ptosis. There was inframammary preservation with 60% of the implants and modification in 40% (0.80±0.45 cm). The overall complication rate per implant was 16.6% and included wound healing/scarring (7%), malrotation (2.6%, only 1% after primary augmentation), rippling (2%), capsular contracture (1.3%), and bottoming-out (0.6%). The revision rate was 6%, of which 3.3% were pocket revisions. Greater skills are required through the learning curve, patient education, case selection, planning using the nipple-vertex relationship (the zenith system), and improved surgical manipulation. Indications and contraindications were analyzed. Cosmetic results were compliant with different breast shapes, and excellent for the breast with poor projection, in thin subjects, and those with low BMI. Ptotic breast should require a larger amount of pexy, 510 did not lift the breast enough. CONCLUSION: Based on vertex-nipple distance, dynamic tension, and skin extensibility, this new approach gives guidelines and methods to perform breast augmentation with extra-projected implants. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

Local safety of immediate reconstruction during primary treatment of breast cancer. Direct-to-implant versus expander-based surgery.

INTRODUCTION: After mastectomy, immediate breast reconstruction is paramount. With the growing number of nipple-sparing mastectomies, the chances of successful one-stage reconstruction with implants are also increasing. Local safety is one of the main issues. This study investigated the factors that could lead to major or minor complications after expander-based versus direct-to-implant (DTI) reconstruction. METHODS: The studied factors were age, body mass index (BMI), hypertension, smoking, diabetes, type of mastectomy (nipple-sparing/total), implant size, neoadjuvant/adjuvant chemotherapy, and radiotherapy. The study sample included 294 immediate reconstructions over 3 years. The primary outcome was the incidence of complications, major or minor depending on the necessity of revision surgery. For the DTI pocket, we applied a variant of the conventional submuscular technique. RESULTS: In DTI reconstructions (median follow-up 26 months), the complication rate was 17.2% (4.3% major and 12.8% minor) with no significant association with clinical variables. In expander-based reconstructions (median follow-up 19 months), the complication rate was 18.3% (12.5% major and 5.8% minor). Univariate analysis showed a significant association between overall complications and radiotherapy (P = 0.01) as well as between major complications and expander size (P < 0.005), BMI (P < 0.005), and radiotherapy (P < 0.01); radiotherapy and BMI retained significance in multivariate analysis. Neoadjuvant/adjuvant chemotherapy did not affect the complication rate. CONCLUSIONS: There was evidence of an association between major complications and clinical variables in the expander-based cohort. Larger expander size was a predictor of failure, especially combined with radiation. Direct-to-implant reconstruction proved to be safe. We describe a reliable method of reconstruction and a safe range of implant sizes even beyond 500 g.

Autologous fat grafting after sarcoma surgery: Evaluation of oncological safety.

BACKGROUND: The regenerative effectiveness of lipoaspirate procedures relies on the presence of mesenchymal stem cells, but the stromal microenvironment and hormonal secretions of the adipose tissue may be involved in cancer growth. Only few oncological outcome studies of fat grafting at the surgical site of malignant neoplasms of mesenchymal origin are available; none of these studies examined a series of sarcoma cases. OBJECTIVES: We analyzed outcome in terms of local or distant spread and overall survival to investigate the oncological safety of fat grafting in patients with sarcoma. PATIENTS AND METHODS: Sixty consecutive patients who had undergone 143 fat grafting procedures after surgical resection of bone and soft tissue sarcomas of the head, trunk, and limbs with clear resection margins were enrolled from 2004 to 2015 in our tertiary care center. A multidisciplinary sarcoma team administered adjuvant therapies. Patients were recurrence free at fat grafting. RESULTS: The overall median follow-up was 7.5 years. At follow-up after fat grafting (2.4 years), one patient had distant metastasis and two had local relapse. Kaplan-Meier analysis showed disease-free survival rate of 95.4% (CI: 89.1-100.0) at 24 months. The risk of local recurrence (LR) within 24 months was 4.6% (CI: 0.0-20.9). The probability of not having LR after fat grafting was ≥ 89.1%. CONCLUSION: We found no evidence of an increased cancer risk after fat grafting procedures in patients with sarcoma, but a stimulatory role of fat cannot be excluded for bone sarcomas based on the cases reported here, and further studies are therefore needed.

Predictability of anthropomorphic measurements in implant selection for breast reconstruction: a retrospective cohort study.

BACKGROUND: Preoperative implant planning for breast reconstruction is often at risk of being changed perioperatively. This study examined which factors are associated with a change of implant selection. METHODS: Women who had unilateral two-stage breast reconstruction between 2002 and 2007 were studied. Inclusion criteria were photographic evidence of preoperative skin markings indicating breast dimensions and a selected implant model. Multivariable logistic regression was used to identify variables associated with a changed selection. RESULTS: Among the 496 women studied, 308 preoperative implant choices (62.1%) were changed during surgery. A change in plan was significantly associated with symmetrization surgery involving contralateral reduction mammaplasty (OR = 1.92; 95% CI, 1.12 to 3.29) and contralateral mastopexy (OR = 2.26; 95% CI, 1.29 to 3.96), but not with BMI. The required implant width changed more than 0.5 cm in 70 cases (14.1%) while height changed more than 0.5 cm in 215 cases (43.2%). The likelihood of a change was high for large preoperative widths (OR = 9.66 for 15.5 cm) and small preoperative heights (OR = 2.97 for 10.5 cm). At a mean follow-up of 16.6 months, patient satisfaction was good or average in 92.1% of cases and 5.9% of implants had been replaced with another model, indicating that the perioperative implant selection was usually appropriate. CONCLUSIONS: This study documents the frequency with which implant choices, despite accurate preoperative planning, are changed perioperatively as a result of relatively small differences in anthropomorphic measurements. Perioperative recalculation of breast dimensions may have an advantage in terms of patient reoperation rates. Changes in width were less frequent than changes in height and projection. Contralateral surgery, large width, and small height were the most influential factors. Level of Evidence: Level IV, risk / prognostic study.

Evaluation of Local Oncologic Safety in Nipple-Areola Complex-sparing Mastectomy After Primary Chemotherapy: A Propensity Score-matched Study.

BACKGROUND: Nipple-areola complex-sparing mastectomy (NSM), extending the concept of skin-sparing mastectomy, allows for the provision of a better cosmetic result. Large operable T2-T3 breast cancer might theoretically appear suitable for this surgical option as an alternative to conventional mastectomy or breast-conserving surgery, when a good response to primary chemotherapy has been achieved. PATIENTS AND METHODS: From January 2009 to May 2013, 422 patients with invasive breast cancer were progressively accrued to NSM. Of the 422 patients, 361 underwent NSM as first-line treatment (NSM group), and 61 underwent surgery after primary chemotherapy (NSM-PC group). A total of 151 breast cancer patients, who had undergone PC and conventional total mastectomy (TM-PC group) from 2004 to 2009 were evaluated as comparative group with respect to the NSM-PC group. Using propensity score matching, local disease-free survival (LDFS) was evaluated comparatively. RESULTS: The rate of nipple-areola involvement in the NSM and NSM-PC groups was 13.3% and 9.8%, respectively (P = .539). The nipple-areola involvement in the NSM and NSM-PC groups was significantly associated with the tumor size (odds ratio [OR], 1.48; 95% confidence interval [CI], 1.13-1.95; P = .004), plurifocal or pluricentric tumor (OR, 3.18; 95% CI, 1.72-5.89; P < .001), and the presence of an intraductal component (OR, 2.38; 95% CI, 1.22-4.64; P = .011). The LDFS in the NSM-PC and TM-PC matched cohorts did not show a significant difference, with a 4-year LDFS of 0.89 (95% CI, 0.77-0.95) and 0.93 (95% CI, 0.83-0.97), respectively (hazard ratio [HR], 1.31; 95% CI, 0.40-4.35; P = .655). The NSM-PC cohort was also compared with the NSM cohort in terms of LDFS using 2 different matching criteria, with the tumor size before and after neoadjuvant chemotherapy as the balancing covariate. In the first of the 2 comparisons, the hazards of local relapse were comparable between the 2 matched groups (HR, 1.23; 95% CI, 0.37-4.04; P = .739). In the second comparison, the NSM-PC patients showed a significant greater hazard of local relapse than did the NSM patients (HR, 3.60; 95% CI, 1.10-11.80; P = .035). CONCLUSION: NSM might be a valuable option for large breast cancer treated by primary chemotherapy. The rate of local relapse seemed to be related to the disease stage, and no significant association with the type of surgery was detected.

Can titanium mesh influence local recurrence management after implant-based breast reconstruction?

INTRODUCTION: TiLOOP(®) Bra is a permanent titanium-coated polypropylene mesh currently used in post-mastectomy breast reconstruction with implants. This mesh is generally presented as inducing low-grade inflammatory reactions, but only few reports focused on its possible side effects. In the case described here, the use of the mesh led to minor clinical problems that needed to be clinically and surgically managed at the same time as a local relapse. CASE DESCRIPTION: A patient with high-grade ductal carcinoma in situ underwent primary surgery (nipple-sparing mastectomy and one-stage reconstruction using the TiLOOP(®) Bra mesh) and was subsequently referred for radiological and clinical investigation when various nodules became apparent during a follow-up physical examination. Prior to the histopathological proof, the diagnosis of local recurrence was complicated by the occurrence of an extensive granulomatous reaction in the fixation areas along with mild inflammatory changes scattered on the surface of the mesh. DISCUSSION AND EVALUATION: This case illustrates a side effect of titanium-coated permanent mesh in immediate implant-based reconstruction, i.e. the formation of granulomas in the inframammary fold, probably in the area where the mesh had been folded or fixed. We propose a safer technical approach to avoid the problem and a clinical management strategy for patients at high risk of local recurrence who develop granuloma-like nodules. CONCLUSIONS: A surgical technique is suggested to prevent granuloma formation. If, however, subcutaneous nodules that may be local recurrences do appear, they should not be interpreted by default as a granulomatous reaction, but should be fully investigated and possibly excised.

Maximizing the use of abdominoplasty incision in oncoplastic and aesthetic breast surgery: four transabdominal (transumbilical-like) augmentations.

BACKGROUND: The transabdominal (transumbilical [TUBA]) procedure for breast implant insertion is known for aesthetic aims, but cosmetic and psychosocial improvements reported in aesthetic surgery should be transferred to breast reconstruction patients. METHODS: Surgical and psychological aspects were analyzed in four cases through clinical evaluation and psychosocial assessment. Three patients were candidates for postmastectomy reconstruction by transverse rectus abdominis myocutaneous (TRAM) flap, and one patient was a candidate for cosmetic abdominoplasty. The expectations of the patients were met, and body image improvement was provided through contralateral breast augmentation in all cases. Details of the surgical approach focused on the inframammary fascial system. The psychosocial implications of the TUBA-like breast augmentation combined with the abdominoplasty procedure were emphasized through the analysis of the technical details and the psychological behaviors affecting the surgery. RESULTS: The result, after long-term clinical follow-up (37 months) and administration of a satisfaction questionnaire (CSQ-8), established the importance of scarless surgery to healthy breast tissue and the positive reception by women with different life histories. CONCLUSION: This report concerns only a few potential patients, but supports a trend that surgeons should consider. An elective indication for transabdominal breast augmentation can be represented even by those few patients who are candidates for TRAM flap reconstruction, who are agreeable to a small augmentation in the absence of a scar on their healthy breast, and whose reconstructed breast is larger and more prominent at the central part of the mound than on the contralateral side.

Skin-reducing mastectomy.

BACKGROUND: The authors propose a combined flap technique to reconstruct large and medium-sized ptotic breasts in a single-stage operation by use of anatomical permanent implants. METHODS: The authors enrolled 28 patients fulfilling criteria for skin-sparing mastectomy and presenting with ptotic breasts whose areola-to-inframammary fold distance was more than 8 cm. All reconstructions were performed as a single-stage procedure. After preoperative planning, a large area in the lower half of the breast was deepithelialized according to the conventional Wise pattern. Mastectomy was then carried out. To perform reconstructions, the inferomedial fibers of the pectoralis major muscle were dissected and sutured to the superior border of the inferior dermal flap. An anatomical implant was then inserted into the pouch, which was closed laterally with the previously harvested serratus anterior fascia. Skin flaps were finally closed down to the inframammary fold. RESULTS: The authors performed 30 procedures on 28 patients. The medium size anatomical implants was 433 cc. Twelve women achieved symmetrization in a single stage ending in a symmetric inverted-T scar. The overall complication rate was 20 percent, with four cases (13 percent) complicated by severe, extensive necrosis of the skin flaps requiring implant removal. CONCLUSIONS: Breast cancer treatment must nowadays optimize cosmetic results. This can be accomplished in selected cases by means of a single-stage operation that the authors call "skin-reducing mastectomy." The final scars imitate those of cosmetic surgery. Careful patient selection and improvement in the learning curve may reduce the complication rate.