One-Stage Implant-Based Breast Reconstruction With Polyurethane-Coated Device: Standardized Assessment of Outcomes.

BACKGROUND: Nipple-sparing mastectomies (NSMs) and implant-based breast reconstructions have evolved from 2-stage reconstructions with tissue expansion and implant exchange to direct-to-implant procedures. In this study, we tested safety and efficacy of polyurethane-based implants according to standard assessment tools. OBJECTIVES: This study aimed to test safety and feasibility of polyurethane-coated implants with standardized assessment employing internationally acknowledged evaluation criteria. METHODS: Cases of NSMs followed by breast reconstruction in 1 stage with immediate prepectoral polyurethane-coated implant placement were retrospectively reviewed. Preoperative characteristics of the population have been collected. Adherence to quality assurance criteria of the Association of Breast Surgery-British Association of Plastic Reconstructive and Aesthetic Surgeons was verified. Complications were assessed with the Clavien Dindo classification, modified for the breast. Rippling, implant rotation, and malposition were also evaluated. RESULTS: Sixty-three consecutive patients underwent 74 NSMs and immediate breast reconstruction with micro polyurethane foam-coated anatomic implants. In 5 cases we had unplanned readmissions with return to the operating room under general anesthesia (6.7%) and implant loss within 3 months from breast reconstruction (5 implants, 6.7%). Postoperative complications according to Clavien Dindo were grade 1 in 6 cases (8.1%), grade 2 in 3 cases (4%), and 3b in 5 cases (6.7%). CONCLUSIONS: Polyurethane-coated implants may prevent rotation and malposition and capsular contracture in the short term. Unplanned readmission rates and implant loss rates in the short term may be slightly higher.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, Chinese, and Taiwanese online here: https://doi.org/10.1093/asj/sjad301.

Evaluation of word embedding models to extract and predict surgical data in breast cancer.

BACKGROUND: Decisions in healthcare usually rely on the goodness and completeness of data that could be coupled with heuristics to improve the decision process itself. However, this is often an incomplete process. Structured interviews denominated Delphi surveys investigate experts' opinions and solve by consensus complex matters like those underlying surgical decision-making. Natural Language Processing (NLP) is a field of study that combines computer science, artificial intelligence, and linguistics. NLP can then be used as a valuable help in building a correct context in surgical data, contributing to the amelioration of surgical decision-making. RESULTS: We applied NLP coupled with machine learning approaches to predict the context (words) owning high accuracy from the words nearest to Delphi surveys, used as input. CONCLUSIONS: The proposed methodology has increased the usefulness of Delphi surveys favoring the extraction of keywords that can represent a specific clinical context. It permits the characterization of the clinical context suggesting words for the evaluation process of the data.

The Impact of the COVID-19 Pandemic on Surgical Management of Breast Cancer: Global Trends and Future Perspectives.

INTRODUCTION: The rapid spread of COVID-19 across the globe is forcing surgical oncologists to change their daily practice. We sought to evaluate how breast surgeons are adapting their surgical activity to limit viral spread and spare hospital resources. METHODS: A panel of 12 breast surgeons from the most affected regions of the world convened a virtual meeting on April 7, 2020, to discuss the changes in their local surgical practice during the COVID-19 pandemic. Similarly, a Web-based poll based was created to evaluate changes in surgical practice among breast surgeons from several countries. RESULTS: The virtual meeting showed that distinct countries and regions were experiencing different phases of the pandemic. Surgical priority was given to patients with aggressive disease not candidate for primary systemic therapy, those with progressive disease under neoadjuvant systemic therapy, and patients who have finished neoadjuvant therapy. One hundred breast surgeons filled out the poll. The trend showed reductions in operating room schedules, indications for surgery, and consultations, with an increasingly restrictive approach to elective surgery with worsening of the pandemic. CONCLUSION: The COVID-19 emergency should not compromise treatment of a potentially lethal disease such as breast cancer. Our results reveal that physicians are instinctively reluctant to abandon conventional standards of care when possible. However, as the situation deteriorates, alternative strategies of de-escalation are being adopted. IMPLICATIONS FOR PRACTICE: This study aimed to characterize how the COVID-19 pandemic is affecting breast cancer surgery and which strategies are being adopted to cope with the situation.

Is Breast Implant Associated-Anaplastic Large Cell Lymphoma linked to textured implants?

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a distinctive type of T-cell lymphoma arising around breast implants. We performed a review of the existing literature with the aim of providing an evidence-based overview of the available data on BIA-ALCL with a standardized evaluation of the quality of the studies and investigating the potential association between textured breast implants and BIA-ALCL.We analyzed the literature reporting estimates of relative or absolute risks of BIA-ALCL in case-control, cohort studies and case series studies. The total number of BIA-ALCL cases reported in literature is very low. Furthermore, most of the reported cases have been reported in case-control studies or case series. This means that our knowledge is based on a low level of evidence. Moreover, low-medium quality scores were observed in the included case series studies. In relation to the rarity of the event, better information could only derived by international cooperation to pool together data deriving from all over the world, with the clear need of better reporting patients and implant characteristics in case series and when adding data to public registries. LEVEL OF EVIDENCE IV: 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 Shape Analysis With Curvature Estimates and Principal Component Analysis for Cosmetic and Reconstructive Breast Surgery.

Background: Breast shape is defined utilizing mainly qualitative assessment (full, flat, ptotic) or estimates, such as volume or distances between reference points, that cannot describe it reliably. Objectives: The authors quantitatively described breast shape with two parameters derived from a statistical methodology denominated by principal component analysis (PCA). Methods: The authors created a heterogeneous dataset of breast shapes acquired with a commercial infrared 3-dimensional scanner on which PCA was performed. The authors plotted on a Cartesian plane the two highest values of PCA for each breast (principal components 1 and 2). Testing of the methodology on a preoperative and posttreatment surgical case and test-retest was performed by two operators. Results: The first two principal components derived from PCA characterize the shape of the breast included in the dataset. The test-retest demonstrated that different operators obtain very similar values of PCA. The system is also able to identify major changes in the preoperative and posttreatment stages of a two-stage reconstruction. Even minor changes were correctly detected by the system. Conclusions: This methodology can reliably describe the shape of a breast. An expert operator and a newly trained operator can reach similar results in a test/re-testing validation. Once developed and after further validation, this methodology could be employed as a good tool for outcome evaluation, auditing, and benchmarking.

Oncoplastic Breast Consortium consensus conference on nipple-sparing mastectomy.

PURPOSE: Indications for nipple-sparing mastectomy (NSM) have broadened to include the risk reducing setting and locally advanced tumors, which resulted in a dramatic increase in the use of NSM. The Oncoplastic Breast Consortium consensus conference on NSM and immediate reconstruction was held to address a variety of questions in clinical practice and research based on published evidence and expert panel opinion. METHODS: The panel consisted of 44 breast surgeons from 14 countries across four continents with a background in gynecology, general or reconstructive surgery and a practice dedicated to breast cancer, as well as a patient advocate. Panelists presented evidence summaries relating to each topic for debate during the in-person consensus conference. The iterative process in question development, voting, and wording of the recommendations followed the modified Delphi methodology. RESULTS: Consensus recommendations were reached in 35, majority recommendations in 24, and no recommendations in the remaining 12 questions. The panel acknowledged the need for standardization of various aspects of NSM and immediate reconstruction. It endorsed several oncological contraindications to the preservation of the skin and nipple. Furthermore, it recommended inclusion of patients in prospective registries and routine assessment of patient-reported outcomes. Considerable heterogeneity in breast reconstruction practice became obvious during the conference. CONCLUSIONS: In case of conflicting or missing evidence to guide treatment, the consensus conference revealed substantial disagreement in expert panel opinion, which, among others, supports the need for a randomized trial to evaluate the safest and most efficacious reconstruction techniques.

A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market: Preliminary Results.

INTRODUCTION: The introduction of acellular dermal matrices (ADMs) contributed to the growing diffusion of direct-to-implant breast reconstruction (DTI-BR) following mastectomy for breast cancer. According to specific legislations, European specialists could not benefit from the use of human-derived ADMs, even though most evidence in the literature are available for this kind of device, showed optimal outcomes in breast reconstruction. The Skin Bank of the Bufalini Hospital (Cesena, Italy) obtained in 2009 the approval for the production and distribution of a new human cadaver-donor-derived ADM (named with the Italian acronym, MODA, for matrice omologa dermica acellulata) from the Italian National Transplant Center and National Health Institute. We report preliminary results of MODA application in direct-to-implant breast reconstruction following nipple-areola complex (NAC)-sparing mastectomy for breast cancer treatment. MATERIALS AND METHODS: We prospectively enrolled all women undergoing NAC-sparing mastectomy for breast cancer and DTI-BR in our breast surgical unit from June 2015 to January 2017. We enrolled a selected population without previous chest wall irradiation, not being heavy tobacco smokers or diabetic, with a BMI < 30 kg/m2 and requiring less than 550 cc silicone implants. We assessed short-term outcomes, defined as postoperative complications presenting in the first 30 postoperative days and long-term outcomes at 6 and 12 months. RESULTS: From June 2015 to January 2017, we treated 56 breasts. At a mean follow-up of 14 months, we observed only two minor complications described as limited wound dehiscences, conservatively managed with complete resolution without implant exposure or re-intervention. CONCLUSIONS: Our preliminary results show very good performance of MODA in direct-to-implant breast reconstruction following NAC-sparing mastectomy for breast cancer treatment. This is particularly relevant for the European market, where no other human-derived devices are available for breast reconstruction due to regulatory restrictions. LEVEL OF EVIDENCE IV: 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 .

Different types of implants for reconstructive breast surgery.

BACKGROUND: Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast. OBJECTIVES: To assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. MAIN RESULTS: Five RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies. AUTHORS' CONCLUSIONS: Despite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.

European guidelines for the diagnosis, treatment and follow-up of breast lesions with uncertain malignant potential (B3 lesions) developed jointly by EUSOMA, EUSOBI, ESP (BWG) and ESSO.

INTRODUCTION: Breast lesions of uncertain malignant potential (B3) include atypical ductal and lobular hyperplasias, lobular carcinoma in situ, flat epithelial atypia, papillary lesions, radial scars and fibroepithelial lesions as well as other rare miscellaneous lesions. They are challenging to categorise histologically, requiring specialist training and multidisciplinary input. They may coexist with in situ or invasive breast cancer (BC) and increase the risk of subsequent BC development. Management should focus on adequate classification and management whilst avoiding overtreatment. The aim of these guidelines is to provide updated information regarding the diagnosis and management of B3 lesions, according to updated literature review evidence. METHODS: These guidelines provide practical recommendations which can be applied in clinical practice which include recommendation grade and level of evidence. All sections were written according to an updated literature review and discussed at a consensus meeting. Critical appraisal by the expert writing committee adhered to the 23 items in the international Appraisal of Guidelines, Research and Evaluation (AGREE) tool. RESULTS: Recommendations for further management after core-needle biopsy (CNB) or vacuum-assisted biopsy (VAB) diagnosis of a B3 lesion reported in this guideline, vary depending on the presence of atypia, size of lesion, sampling size, and patient preferences. After CNB or VAB, the option of vacuum-assisted excision or surgical excision should be evaluated by a multidisciplinary team and shared decision-making with the patient is crucial for personalizing further treatment. De-escalation of surgical intervention for B3 breast lesions is ongoing, and the inclusion of vacuum-assisted excision (VAE) will decrease the need for surgical intervention in further approaches. Communication with patients may be different according to histological diagnosis, presence or absence of atypia, or risk of upgrade due to discordant imaging. Written information resources to help patients understand these issues alongside with verbal communication is recommended. Lifestyle interventions have a significant impact on BC incidence so lifestyle interventions need to be suggested to women at increased BC risk as a result of a diagnosis of a B3 lesion. CONCLUSIONS: These guidelines provide a state-of-the-art overview of the diagnosis, management and prognosis of B3 lesions in modern multidisciplinary breast practice.

Easy Anthropometric Measurements Are Representative of Baseline Values of Breast Q Values in Asymptomatic Women.

BACKGROUND: Measurements of breast morphology are a determinant of the assessment of any surgical procedure, either reconstructive or cosmetic. This study aims to investigate the association between easy anthropometric measurements and values of quality of life assessed in a sample of asymptomatic women. METHODOLOGY: Healthy asymptomatic women were admitted for this study. The following measurements were assessed: height, weight, nipple to sternal notch distance, areola to infra-mammary fold distance (right vs. left), right-left nipple distance. The Breast Q questionnaire (Italian translation V.1, pre-op breast conservation surgery) in the following domains: satisfaction with breasts; psycho-social satisfaction; physical satisfaction; sexual satisfaction, which was used to assess breast-related quality of life. RESULTS: One hundred and forty-five women responded to the breast Q questionnaire. The mean age of the sample was 44.3 years; the medium BMI was 24.1; Spearman correlation coefficients revealed that all the investigated values were negatively correlated to the "satisfaction with breasts" domain. Psychosexual satisfaction was associated with age; BMI; nipple to sternal notch distance. After normalization for age values, we observed that "satisfaction with breast" was, once again, highly correlated to BMI; nipple to sternal notch distance; areola to IMF distance. In all cases, the higher the values, the lower the scores. CONCLUSIONS: Distances between easy relevant anatomical landmarks are representative of patients' breast-related quality of life in a population of asymptomatic women. These findings allow us to identify an ideal anthropometric framework that can be used as a validated surgical endpoint for cosmetic and oncological procedures.

The Evolution of Educational Events during the COVID-19 Pandemic: The Experience of G.Re.T.A. Foundation.

Introduction: The educational and professional lives of everyone have significantly been affected by the COVID-19 pandemic. Many courses and meetings traditionally structured and organized as face-to-face events have been transformed into virtual events. Methods: We report on the experience of G.Re.T.A. Fondazione in organizing international conferences, webinars, and masterclasses on oncoplastic and aesthetic breast surgery before, during, and after the pandemic. Results: The organization of the meetings as online or hybrid events allowed to maintain a high number of participants with numbers being in line with those achieved in the traditional face-to-face events or even showing an increased number of participants, in particular from countries not traditionally involved such as Saudi Arabia, the United Arab Emirates, India, and Russian Federation. Discussion: We think that the hybrid modality is likely to become a gold standard, even though purely online meetings will still survive in the post-pandemic era. Webinars are frugal and highly efficient events that can easily reach a worldwide audience with acceptable interaction.

Thoraco-dorsal artery perforator flap for totally autologous primary breast reconstruction. Assessment of feasibility with standard reporting scales.

This study reports on feasibility and applicability of totally autologous primary breast reconstructions based on TDAP flaps using a standard set of internationally approved reporting scales. We reviewed 15 cases in patients with a good donor area in the back not suitable for implant or free flaps reconstructions. Complications according to Clavien Dindo were: 1 Grade 1 (seroma in the back). The ABS-BAPRAS quality assurance indicators 10, 11, and 12 were entirely fulfilled. No pedicled flap loss occurred; no unplanned return to theatre and no unplanned readmission within 3 months. Breast-related quality of life values are reported at 3 months and one year in four domains of the BREAST Q v. 2.0 (breast reconstruction post-op questionnaire). At 1 year the mean Q-score for satisfaction with breast was 70.5, for psychosocial well-being was 72.3; for sexual well-being was 58.8; for physical well-being (chest wall) was 70.60. The TDAP based totally autologous breast reconstruction reported to be a feasible and safe alternative to implant based or free flaps reconstructions according to consolidate international outcome reporting measures.

Natural Language Processing to Extract Meaningful Information from a Corpus of Written Knowledge in Breast Cancer: Transforming Books into Data.

Introduction: Books and papers are the most relevant source of theoretical knowledge for medical education. New technologies of artificial intelligence can be designed to assist in selected educational tasks, such as reading a corpus made up of multiple documents and extracting relevant information in a quantitative way. Methods: Thirty experts were selected transparently using an online public call on the website of the sponsor organization and on its social media. Six books edited or co-edited by members of this panel containing a general knowledge of breast cancer or specific surgical knowledge have been acquired. This collection was used by a team of computer scientists to train an artificial neural network based on a technique called Word2Vec. Results: The corpus of six books contained about 2.2 billion words for 300d vectors. A few tests were performed. We evaluated cosine similarity between different words. Discussion: This work represents an initial attempt to derive formal information from textual corpus. It can be used to perform an augmented reading of the corpus of knowledge available in books and papers as part of a discipline. This can generate new hypothesis and provide an actual estimate of their association within the expert opinions. Word embedding can also be a good tool when used in accruing narrative information from clinical notes, reports, etc., and produce prediction about outcomes. More work is expected in this promising field to generate "real-world evidence."