A Pericardium Bovine Matrix Pocket in DTI Prepectoral Breast Reconstruction.

Breast reconstructive surgery has evolved significantly over the years. One of the recent advancements is the use of prepectoral implants in combination with synthetic and biological material as a natural and effective coverage. To date, there is little published data on breast reconstruction using acellular bovine pericardium matrix and most concern submuscular breast reconstruction. This study aimed to describe the multicentric-multisurgeon experience in performing direct to implant (DTI) prepectoral breast reconstructions using acellular bovine pericardium matrix (ABPM) pocket. A retrospective multicentric data collection of the all the immediate prepectoral breast reconstructions using acellular bovine pericardium was carried out by the authors. Surgical data including type of mastectomy, axillary surgery, type and size of implant, size of ABPM, duration of surgery were collected for each patient. Postoperative data including adjuvant treatments, complications, necessity to perform other interventions, patient's satisfaction were collected. Cosmetic results were also evaluated by 7 different observers at minimum 1 year follow-up. A total of 65 breast reconstruction were included in the study. Mean follow up was 21.3 months. Average surgical time was 1,42 hours. Minor complications occurred in 4 breasts; major complications occurred in 2 breasts. After 6 months follow-up, 7 patients underwent fat grafting to correct any rippling and /or wrinkling. Breast aesthetic and patients reported outcomes were satisfactory. Not significant capsular contracture was noted at the follow up control. To date, this is the largest study about prepectoral breast reconstruction with ABPM. On the basis of our results, prepectoral breast reconstruction ABPM assisted is a reliable, safe and suitable option providing good patient satisfaction outcomes.

Tailor-Made Mastopexy Plus Implant, A Safe Journey Toward Breast Reshaping and Augmentation.

BACKGROUND: Augmentation/mastopexy represents one of the most complex procedures in the setting of cosmetic surgery, and there is still an ongoing debate about the most suitable approach to undertake to avoid major complications and deliver the desired result. The present study aims to offer a further contribute to the topic by presenting our personal experience with an implant-guided tailor-made mastopexy technique to manage moderate breast ptosis and hypotrophy. METHODS: A retrospective analysis of our database was carried out, and a total of 194 women who underwent a tailor-made resection pattern mastopexy plus implant from November 2016 to December 2021 were enrolled. All patients included in the study presented breast hypoplasia and ptosis classified as Regnault grade II. At the first-year follow-up visit, patients received an anonymous written questionnaire that addressed their self-perception of cosmetic results and overall satisfaction. RESULTS: The technique presented in the study showed a favorable safety profile with a total complication rate accounting for an 8.2% and an overall reoperation rate as low as 4.6%. Major concerns including wound dehiscence, implant exposure, and nipple necrosis are not reported. Patients' self-reported outcomes revealed high satisfaction rates and stable results in the long-term follow-up. CONCLUSIONS: The described approach ensures proper reshaping together with the desired increased breast volume minimizing the chance of implant exposure due to wound dehiscence or any sort of tissue necrosis from devascularized skin edges. The surgical procedure described herein is safe and reliable. 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 .

Regina Elena Institute (R.E.I.) Protocol for Breast Implant Salvage: Preliminary Results.

INTRODUCTION: implants are the most popular means of restoring the breast mound after mastectomy; the most feared complication is implant infection accounting for 4.8% to 35.4% of cases. Various antibiotic regimens or other surgical revisions to treat implant infections have been reported, but their failure rates are unacceptable. Implant removal is subsequently the most common recourse for managing prosthesis infections. we report preliminary results of infected breast implant salvage using our Regina Elena Institute (REI) protocol. METHODS: Since June 2021, a prospective single-centre study has been ongoing for patients burdened by implant infection or exposure. All qualifying participants underwent our REI protocol. They receive a temporary smooth implant and 1 week of implant's pocket irrigation with antibiotic solution along with systemic antibiotic and then a new permanent prosthesis positioning. RESULTS: Ten of whom completed at least 6 months of follow-up and were eligible for this preliminary analysis. Overall, the REI protocol was applied to 13 breasts. No infections relapsed during the 6-month minimum follow-up intervals; and no early capsular contraction was evident, resulting in good cosmetic outcomes for every treated breast. DISCUSSION: The smooth-surfaced implant's sizer helps maintain tissue expansion, preventing skin retraction; and the slightly smaller diameters used (compared with originals) facilitate antibiotic wash distribution. Combining a targeted systemic antibiotic and a topical agent is the best way to optimise infection resolution. This preliminary analysis has clear limitations. A larger population is warranted to increase the level of evidence. Longer follow-up is also advisable to monitor for delayed infection recurrence.

Managing the animation deformity in breast reconstruction transposing the implant to a partial prepectoral pocket: Early experience and preliminary results with a new technique.

BACKGROUND: Two-stage implant-based breast reconstruction remains the most commonly used technique for rebuilding a breast. Subpectoral implant placement minimizes complications, such as capsular contracture, implant visibility, malposition, and extrusion. Nevertheless, it is associated with high animation deformity (AD). Prepectoral reconstruction eliminates AD but is subject to a higher risk of implant extrusion and visibility. In this prospective, single-center study we present a new technique aimed to create a new hybrid pocket in which the upper portion of the implant is placed subcutaneously, whereas its inferior pole is still covered by a pectoralis muscle sling reducing implant lower pole visibility and palpability. MATERIAL AND METHODS: In each case, the prosthesis was removed and a new hybrid pocket was created by splitting the muscle into two portions, separating its cranial part from the overlying subcutaneous tissue and anchoring it back to the chest wall. The caudal muscle sling was left adherent to the subcutaneous tissue of the central part of the breast. Patient outcomes were evaluated with a BREAST-Q questionnaire preoperatively and 1 year after surgery. RESULTS: Forty-eight patients with severe postoperative breast animation were enrolled (8 bilateral and 40 unilateral). No major complications occurred. After a 1-year follow-up, the aesthetic and functional satisfaction rate was high and a good implant coverage was achieved. No residual AD of the breast was observed. CONCLUSIONS: Changing the implant placement from the subpectoral to a partially subcutaneous plane, both severe AD and implant extrusion can be avoided, expanding the indications for safe prosthetic breast reconstruction. LEVEL OF EVIDENCE: Level of evidence IV.

Synthetic Reabsorbable Mesh (GalaFLEX) as Soft Tissue Adjunct in Breast Augmentation Revision Surgery.

BACKGROUND: A significant number of patients with a previous submuscular breast augmentation require a revision surgical procedure during their long-term follow-up period that involves changing the implant pocket from submuscular to subglandular. Reduced soft tissue thickness represents a major concern, discouraging surgeons from undertaking this approach. OBJECTIVES: The aim of this study was to determine whether a synthetic resorbable mesh used as a supplemental covering device was safe and yielded improved soft tissue thickness and protection against capsular contracture in patients undergoing implant plane shift to subglandular. METHODS: A retrospective review of 34 patients who underwent revision of a previous breast augmentation involving implant change in a subglandular pocket and upper pole GalaFLEX (Galatea Surgical, BD; Franklin Lakes, NJ) mesh coverage was conducted. Onset of minor and major complications was recorded during short- and medium-term follow-up. Patient satisfaction was assessed via an anonymous questionnaire administered 6 months postoperatively. RESULTS: During the follow-up period, which ranged from a minimum of 6 months to a maximum of 28 months, no minor or major complications were reported. In particular, no wrinkling/rippling or significant capsular contracture onset was observed. High levels of patient satisfaction were determined, according to self-reporting questionnaires. CONCLUSIONS: The initial results of this preliminary report from this case series demonstrate the safety of GalaFLEX as a supplemental device in terms of improved soft tissue coverage of the implant for complex revisional cases in breast augmentation.

Clinical recommendations for diagnosis and treatment according to current updated knowledge on BIA-ALCL.

Shared strategies and correct information are essential to guide physicians in the management of such an uncommon disease as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). A systematic review of the literature was performed to collect the most relevant evidence on BIA-ALCL reported cases. A panel of multidisciplinary experts discussed the scientific evidence on BIA-ALCL, and updated consensus recommendations were developed through the Delphi process. The lastest reported Italian incidence of BIA-ALCL is 3.5 per 100.000 implanted patients (95% CI, 1.36 to 5.78), and the disease counts over 1216 cases worldwide as of June 2022. The most common presentation symptom is a late onset seroma followed by a palpable breast mass. In the event of a suspicious case, ultrasound-guided fine-needle aspiration should be the first step in evaluation, followed by cytologic and immunohistochemical examination. In patients with confirmed diagnosis of BIA-ALCL confined to the capsule, the en-bloc capsulectomy should be performed, followed by immediate autologous reconstruction, while delayed reconstruction applies for disseminate disease or radically unresectable tumor. Nevertheless, a multidisciplinary team approach is essential for the correct management of this pathology.

Extended Clinical Experience With Nipple-Sparing Mastectomy and Prepectoral Polyurethane Implant Positioning (BRAND4P method).

BACKGROUND: Direct-to-implant prepectoral breast reconstruction in the last years demonstrated to be a feasible and advantageous method in selected cases because it respects chest wall musculature integrity and avoids animation deformity. Current approaches involve implant wrapping with Acellular Dermal Matrix (ADM) or synthetic mesh to guarantee implant coverage and stability and reduce complications. Prepectoral polyurethane implant positioning without further coverage is an alternative breast reconstruction method poor described in literature. PATIENT AND METHODS: A single-institution retrospective analysis was performed on 453 patients, extending our previous preliminary experience, who underwent nipple-sparing mastectomy (NSM) and prepectoral polyurethane implant positioning between December 2017 and June 2021. Follow-up included postoperative complications record and self-reported patient's satisfaction. RESULTS: A total of 784 mastectomies were performed in 453 patients. 331 were bilateral procedures (73.1%) and 122 were unilateral (26.9%). Minimum follow-up time was 6 months and maximum was 42 months. No major complications were reported. Contour defects and excessive implant visibility occurred in 82 patients (18.1%) and was successfully managed with autologous fat grafting. CONCLUSION: Nipple-sparing mastectomy with immediate prepectoral polyurethane implant reconstruction without the need for ADM or mesh is a feasible and safe option. Accurate patient selection and respectful mastectomy technique is crucial to achieve optimal outcomes with this approach. Fat grafting is a useful refinement procedure to improve cosmetic results in this setting.

Revisional Breast Surgery: Are Surgical Plans Changed if the Patient Has a Textured Device?

SUMMARY: The authors reviewed the available evidence on revision surgery following implant-based breast surgery with the aim of investigating whether any difference in the surgical approach should be proposed if the patient has a textured device. They included in their review 31 studies presenting different approaches for revision surgery following implant-based breast surgery (both aesthetic and reconstructive), with a level of evidence ranging from 4 to 5. None of the included studies proposed different surgical approaches for revision surgery in patients carrying textured devices. The authors conclude that no different surgical attitudes in revision surgery following implant-based breast surgery should be adopted if the patient has a textured device according to the available evidence, when a correct approach is performed to face the complication or adverse event, following a thorough preoperative study of the patient with the proper diagnostic tools.

Chest wall infiltration is a critical prognostic factor in breast implant-associated anaplastic large-cell lymphoma affected patients.

BACKGROUND: Breast implant-associated anaplastic large-cell lymphoma is a rare disease with a favourable prognosis if adequately treated. Same staged patients have usually a similar prognosis and outcomes, but in our experience, IIA-staged patients have a wider prognosis with outcomes that vary from complete disease response to death. This study aimed to understand and identify all the factors that could influence the prognosis of this group of patients and verify if their prognosis matches the stage they belong to. MATERIAL AND METHODS: Patients in stage IIA have been divided into two subgroups: IIAb with lymphoma extension towards the glandular tissue and IIAcw with tumour extension towards the chest-wall. The overall survival (OS) and event-free survival (EFS) of 64 BIA-ALCL cases were evaluated for each staged group. RESULTS: Significant differences of OS and EFS between IIAb and IIAcw patients (log-rank p = 0.046 and log-rank p = 0.018, respectively) were observed and poor prognosis joined IIAcw- and IV-staged patients. CONCLUSION: Chest-wall infiltration is a critical prognostic factor in BIA-ALCL patients as it influences the possibility of performing a surgical radical tumour extirpation. Our results could represent valid assistance for the physicians in choosing the most appropriate BIA-ALCL prognostic category and treatment and could promote further wider studies to provide stronger evidence on a possible revision of the MDA TNM classification.

Dual-Plane Retro-pectoral Versus Pre-pectoral DTI Breast Reconstruction: An Italian Multicenter Experience.

BACKGROUND: The use of conservative mastectomies has risen significantly during the last few years. The reconstructive choice of direct-to-implant reconstruction has become more practicable with modern mastectomy techniques. The initial trend in Italian centers was to use dual-plane hybrid reconstruction. However, a high level of complications has been registered. From 2015 onward, in our centers, a pre-pectoral approach has been adopted. The authors sought to describe the Italian trend to gradually discard the sub-pectoral technique with lower lateral pole coverage of the prosthesis using ADMs comparing it with the pre-pectoral approach with ADMs, without any muscle dissection, in terms of complication rates. MATERIALS AND METHODS: A multicenter retrospective clinical study was performed from January 2010 to June 2018. The enrolled patients were divided into two groups: Cases with an ADM-only coverage pre-pectoral reconstruction made up the first group (Group 1). Those with the retro-pectoral muscular position + ADM implant coverage comprised the second one (Group 2). Complications such as seroma, hematoma, wound dehiscence, surgical site infection, reconstruction failure, animation deformity and capsular contracture were recorded. RESULTS: We performed 716 direct-to-implant reconstructions: 509 were partially sub-pectoral and 207 were pre-pectoral. Minimum follow-up was 1 year. Incidence of complications was higher in dual-plane reconstructions. There were statistical significant differences in the rates of seroma and hematoma. CONCLUSION: Using the pre-pectoral approach, the authors have experienced favorable aesthetics and superior clinical and functional outcomes. Retro-pectoral muscular ADM implant coverage has to be considered only in specific complicated second-stage surgeries. LEVEL OF EVIDENCE V: 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 cancer surgery during the Covid-19 pandemic: a monocentre experience from the Regina Elena National Cancer Institute of Rome.

The Covid-19 pandemic has challenged hard the national health systems worldwide. According to the national policy issued in March 2020 in response to the evolving Covid-19 pandemic, several hospitals were re-configured as Covid-19 centers and elective surgery procedures were rescheduled according to the most recent recommendations. In addition, Covid-19 protected cancer hubs were established, including the Regina Elena National Cancer Institute of Rome, Central Italy. At our Institute, the Breast Surgery Department continued working under the sign of a multidisciplinary approach. The number of professional figures involved in case evaluation was reduced to a minimum and interactions took place in the full respect of the required safety measures. Treatments for benign disease, pure prophylactic surgery and elective reconstructive procedures were all postponed and priority was assigned to the histologically-proven malignant breast tumors and highly suspicious lesions. From March 15th though April 30th 2020, we treated a total of 79 patients. This number is fully consistent with the average quantitative standards reached by our Department under ordinary circumstances. Patients were mostly discharged the day after surgery and none was readmitted due to surgery-related late complications. More generally, post-operative complications rates were unexpectedly low, particularly in light of the relatively high number of reconstructive procedures performed in this emergency situation. A strict follow up was performed based on the close contact with the surgical staff by telephone, messaging apps and telemedicine.Patients ascertainment for their Covid-19 status prior to hospital admission and hospital discharge allowed to maintain the "no-Covid-19" status at our Institution. In addition, during the aforementioned time window, none of the care providers developed SARS-CoV-2 infection or disease, as shown by the results of anti-SARS-CoV-2 immunoglobulin M and G profiling. In conclusions, elective breast cancer surgery procedures were successfully performed in a lockdown situation due to a novel viral pandemic. The well-coordinated regional and hospital efforts in terms of medical resource re-allocation and definition of clinical priorities allowed to maintain high quality standards of breast cancer care while ensuring safety to the cancer patients and care providers involved.

Why Do We Need Anatomical Implants? the Science and Rationale for Maintaining Their Availability and Use in Breast Surgery.

The choice between anatomical and round implants is an important decision in breast augmentation surgery; however, both have their place and the decision between them that should be made on a patient-by-patient basis, taking into account the patient's desires, anatomy, and surgical history. In some individuals, there are clear indications for using either anatomical or round devices, and there is good evidence that aesthetic outcomes are better with anatomical implants in some instances. When both types are an option, anatomical devices may offer increased flexibility and, despite a longer learning curve needed to properly manage them, they are associated with positive long-term outcomes and high levels of patient satisfaction. Concerns about implant rotation can be minimized with proper patient selection and surgical technique, and the overall complication rate may favor anatomical over round devices in appropriate patients. Breast implant-associated anaplastic large-cell lymphoma is an important issue, and while rare, it must be considered in the context of the entire patient risk profile. Both anatomical and round implants remain key elements of a complete surgical toolbox in breast augmentation. 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.

International Expert Panel Consensus on Fat Grafting of the Breast.

BACKGROUND: Autologous fat grafting has broad applications in reconstructive and aesthetic breast surgery as a natural filler and for its regenerative purposes. Despite the widespread use of fat grafting, there remains no shared consensus on what constitutes the optimal fat grafting technique and its oncological safety. For this reason, the authors of this study have organized a Survey and an International Consensus Conference that was held at the Aesthetic Breast Meeting in Milan (December 15, 2018). METHODS: All studies on fat grafting, both for breast aesthetic and reconstructive purposes, were electronically screened. The literature review led to 17 "key questions" that were used for the Survey. The authors prepared a set of 10 "key statements" that have been discussed in a dedicated face-to-face session during the meeting. RESULTS: The 10 key statements addressed all the most debated topics on fat grafting of the breast. Levels of evidence for the key statements ranged from III to IV with 2 statements (20%) supported by a level of evidence III and 6 statements (60%) by level of evidence IV. Overall consensus was reached for 2 statements (20%) with >75% agreement reached for 7 statements. CONCLUSIONS: The survey demonstrated a diversity of opinion and attitude among the panelists with regard to technique. Clear recommendations for evidence-based clinical practice for fat grafting use both in aesthetic and reconstructive breast surgery could not be defined due to the scarcity of level 1 or 2 studies.