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.

Driving electrochemical reactions at the microscale using CMOS microelectrode arrays.

Precise control of pH values at electrode interfaces enables the systematic investigation of pH-dependent processes by electrochemical means. In this work, we employed high-density complementary metal-oxide-semiconductor (CMOS) microelectrode arrays (MEAs) as miniaturized systems to induce and confine electrochemical reactions in areas corresponding to the pitch of single electrodes (17.5 µm). First, we present a strategy for generating localized pH patterns on the surface of the CMOS MEA with unprecedented spatial resolution. Leveraging the versatile routing capabilities of the switch matrix beneath the CMOS MEA, we created arbitrary combinations of anodic and cathodic electrodes and hence pH patterns. Moreover, we utilized the system to produce polymeric surface patterns by additive and subtractive methods. For additive patterning, we controlled the in situ formation of polydopamine at the microelectrode surface through oxidation of free dopamine above a threshold pH > 8.5. For subtractive patterning, we removed cell-adhesive poly-L-lysine from the electrode surface and backfilled the voids with antifouling polymers. Such polymers were chosen to provide a proof-of-concept application of controlling neuronal growth via electrochemically-induced patterns on the CMOS MEA surface. Importantly, our platform is compatible with commercially available high-density MEAs and requires no custom equipment, rendering the findings generalizable and accessible.

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.

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.

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.

Breast Reconstruction Actualized in Nipple-sparing Mastectomy and Direct-to-implant, Prepectoral Polyurethane Positioning: Early Experience and Preliminary Results.

BACKGROUND: Implant-based breast reconstruction after nipple-sparing mastectomy has been the most common breast reconstruction procedure performed, for both breast cancer treatment and prophylactically. Subpectoral implant placement with partial detachment of the pectoralis major muscle has been the procedure of choice for staged reconstruction and direct-to-implantation. Prepectoral implant placement has recently increased in popularity among plastic surgeons owing to the high rates of animation deformity, loss of muscle function, and chronic pain observed with submuscular implant placement. Acellular dermal matrices or synthetic meshes have been used for implant coverage and support to avoid capsular contracture and implant visibility. In the present study, we have introduced breast reconstruction actualized in nipple-sparing mastectomy and direct-to-implant with prepectoral polyurethane positioning (BRAND4P). PATIENTS AND METHODS: A total of 34 nipple-sparing mastectomies and immediate direct-to-implant breast reconstructions with prepectoral polyurethane-coated implant placement were performed in 21 patients (13 bilateral and 8 unilateral). The implant was placed subcutaneously in the exact place of the excised breast parenchyma with no further coverage. RESULTS: After a mean follow-up of 4 months, no major complications had been observed. No patient presented with animation deformity or grade III-IV capsular contracture. Patient satisfaction, assessed using the BREAST-Q, was excellent. CONCLUSIONS: The BRAND4P method represents a novel prepectoral approach and a feasible alternative to subpectoral implant placement among the available implant-based breast reconstruction techniques.

Outcome Evaluation after 2023 Nipple-Sparing Mastectomies: Our Experience.

BACKGROUND: Although quadrantectomy and lumpectomy help diminish the psychological and physical devastation inflicted, mastectomy is still elected in 20 to 30 percent of breast cancers. Although initially inciting controversy over heightened risk of local recurrences, recent studies maintain that nipple-sparing mastectomy can be used in any patient qualifying for total mastectomy and also improves aesthetic and psychologic outcomes. The manner in which mastectomy influences reconstructive implant outcomes has been documented by several groups. This report details the authors' experience performing nipple-sparing mastectomy with immediate implant-based breast reconstruction, focusing attention on patient characteristics and aspects of surgical mastectomy that influence reconstruction outcomes. The aim of the study was to examine various issues, such as surgical access, mode of tissue dissection, and flap thickness, clearly linked to development of complications and poor results. METHODS: A retrospective study was conducted, analyzing patients with breast cancer. An external three-surgeon panel served to generate average scores for predefined parameters. Based on total scores, outcomes were designated excellent, good, moderate, or poor. RESULTS: The authors' cohort included 1647 patients. Overall, 2023 nipple-sparing mastectomies were performed, including bilateral procedures in 376 patients. After a minimum follow-up period of 12 months, the authors' cohort was stratified by scored outcomes. Significant impact of body mass index, skin incision, flap thickness, and grade of ptosis has been demonstrated. CONCLUSIONS: The authors' data suggest that proper patient selection and well-executed operations are mandatory to limit complications. They also indicate that aesthetic outcome is clearly dependent on surgical proficiency and some patient characteristics. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Radiotherapy following surgery in keloid treatment: our protocol.

BACKGROUND: Despite the wide availability of literature on keloids, their onset is not completely understood. Several protocols have been described to treat keloids, but none are considered to be a gold standard. In this paper, we will report our experience treating recurrent keloids with surgical excision, followed by immediate postoperative radiotherapy, focusing on the irradiation protocol, to better define the treatment schedule, dose, and results. METHODS: From September 2009 to July 2012, 10 patients were referred to our department because of unresponsive keloids. All patients underwent 6-MeV electron beam radiotherapy, up to a total dose of 20 Gy, 24-48 hours after radical surgical keloid excision. RESULTS: Three patients had excellent results, while 5 patients had good results and 2 had moderate results; none of the cases had poor results. No major adverse events were observed. Small keloids can be treated with non-surgical therapy or radical excision, although followed by an adjuvant therapy. Radiotherapy seems to be a better adjuvant approach. The mechanism for the radiotherapeutic prevention of keloids is still poorly understood. It may act by controlling collagen synthesis through the elimination of abnormally-activated fibroblasts. CONCLUSIONS: From our results, postoperative electron radiotherapy is an effective and well-tolerated treatment to prevent keloid recurrence, especially in patients with bulky keloids or recurrent disease.

Skin-reducing mastectomy and immediate breast reconstruction in patients with macromastia.

INTRODUCTION: In women with macromastia, a type IV skin sparing mastectomy is often required to achieve an aesthetically pleasing reconstruction. The introduction of "skin-reducing mastectomy", which inserts a permanent prosthetic device into a large pouch made by the pectoralis major muscle and an inferior pedicle dermal flap, allows the surgeon to achieve a safe oncologic result plus a cosmetically satisfying reconstruction. OBJECTIVE: We report here our experience with the skin-reducing mastectomy with the aim of emphasizing the problems associated with the technique. MATERIALS AND METHOD: A study was conduced from April 2009 to November 2012, 74 patients with breast cancer were selected then received a skin-reducing mastectomy. The enrolled women satisfied the criteria of Nava. Statistical analysis was conduced to estimate the significance of the outcome results and complication rate. RESULT: A total of 88 SRMs were performed and the outcomes were as follows: excellent in 34 patients, good in 21, and poor in 8. We recorded 25 % of adverse events and statistic helped us to identify patient related factors whose can increase the complications onset. CONCLUSION: Skin-reducing mastectomy is an indispensable procedure to treat cancer in large and pendulous breasts. The correct patient selection is mandatory to reduce the not negligible complication risk. Skin reducing mastectomy when is well conduced allow to obtain good results with patient satisfaction but, like other breast-conserving surgeries, in some case is not the ultimate solution, because it may require some revisions to maintain the optimum results. To day it be consider relatively safe in selected patient and the gold standard in macormastia immediate reconstruction.

Direct to implant breast reconstruction by using SERI, preliminary report.

BACKGROUND: There has been a "rising tide" in mastectomy utilization that can be attributed to more skin-sparing mastectomies (SSMs) performed concurrently with immediate breast reconstruction. We report our experience of the first use of SERI Surgical Scaffold (SERI; Allergan, Inc.) in 21 cases of direct to implant (DTI) breast reconstruction after SSM. METHODS: Our retrospective experience, from April 2013 to May 2014, is based on 21 cases of direct to implant (DTI) breast reconstruction after SSM (9 monolateral 6 bilateral). All the patients were oncological with a preoperative cancer stage was into 0-2 stage. In order to assess the level of satisfaction with the aesthetical result, on 4-13 months post-operative patients were asked to complete a questionnaire that evaluated various parameters by means of a Visual Analogue Scale (V.A.S.). RESULTS: Over a 13-months period, a total of 15 patients underwent 21 immediate breast reconstructive procedures with Allergan Natrelle 410 style implants plus SERI after SSMs. Definitive histological examination give evidence of 5 patients intraductal carcinoma, 6 patients multifocal carcinoma and 4 patients carcinoma in situ. 6 bilateral cases of direct to implant (DTI) breast reconstruction after SSM had a monolateral oncological treatment and on the other side a prophylactic treatment. At the end of the short follow up (minimum 6 months) all the patient were cancer free with an excellent outcome. Complication rate presents just one implant exposure followed by a revised surgery. At V.A.S. the mean patient satisfaction was 5,77 (good), 4,09 (fair) for sensitivity of the nipple areola complex, 6,33 (good) assessment of implant position, 6,28 (good) self esteem, 5,2 (good) attraction ability, 4,99 (fair) intimate life, 6,81 (good) overall feelings about breast reconstruction, 6,71 (good) simmetry. CONCLUSIONS: The really encouraging results of our early experience will help surgeons introducing SERI into their practice to select appropriate patients for direct-to-implant single-stage immediate breast reconstruction. A larger study cohort and longer follow-up times are required to identify additional predictors and indications.

Technique to achieve the symmetry of the new inframammary fold.

The literature outlines several surgical techniques to restore inframmammary fold definition, but symmetry of the fold is often left to irreproducible procedures. We report our personal technique to restore the symmetry of the inframmammary fold during multistep breast reconstruction.

Non-pegylated liposomal Doxorubicin-cyclophosphamide in sequential regimens with taxanes as neoadjuvant chemotherapy in breast cancer patients.

PURPOSE: Chemotherapy regimens containing anthracyclines and taxanes represent the landmark of neoadjuvant systemic therapy of breast cancer. In advanced breast cancer patients liposomal anthracyclines (LA) have shown similar efficacy and less cardiac toxicity when compared to conventional anthracyclines. We performed this retrospective analysis in order to evaluate the efficacy and tolerability of neoadjuvant regimens including LA outside of clinical trials in routine clinical practice. METHODS: Fifty operable or locally advanced, HER2 negative, breast cancer patients were retrospectively identified in 5 Italian cancer centres. Nineteen patients had received 4 cycles of non-pegylated liposomal doxorubicin (NPLD) and cyclophosphamide, followed by 4 cycles of docetaxel, every 3 weeks. In 25 patients the reverse sequence was employed, and a third subgroup of 6 patients received 4 cycles of NPLD/cyclophosphamide every 3 weeks followed by 4 cycles of weekly carboplatin and paclitaxel. RESULTS: We observed 10 pathological complete responses (pCR) (20.0%, 95%CI, 9% to 31%), and 35 (70%, 95%CI, 57.3% to 82.7%) partial responses (pPR), whereas no patients progressed onto therapy. In the small subset of triple negative tumors the pCR rate was 37.5%, and in tumors expressing ER and/or PgR it was 16.7%. A pCR rate of 26.5% was observed in tumors with high Ki-67, whereas in tumors with low Ki-67 only one (6.2%) pCR was observed (p=0.14). Treatments were well tolerated. The most common toxicities were myelosuppression and palmar-plantar erytrodysesthesia; 4 asymptomatic and transient LVEF decrease have been recorded, without any case of clinical cardiotoxicity. CONCLUSIONS: NPLD-cyclophosphamide and taxanes sequential regimens were proven effective and well tolerated in breast cancer patients with contra-indication to conventional anthracyclines undergoing neoadjuvant chemotherapy, even outside of clinical trials in everyday clinical practice.

Nipple reconstruction using a star flap enhanced by scar tissue: the Regina Elena Cancer Institute experience.

BACKGROUND: We propose a new, simple, and reliable method of nipple reconstruction using a star flap and a free graft of a linear fragment of scar tissue. The harvested fragment is deepithelialized and fixed under the flap to give the reconstruction consistency and make it steady. METHODS: The study included 218 nipple reconstructions performed between 2002 and 2008. In an attempt to estimate their satisfaction, patients were then asked to complete a 1-year postoperative questionnaire. Patients were directed to use a numerical scale of 1-10, with 1 as the worst outcome and 10 as the best possible outcome. RESULTS: The average projection of the nipple in the immediate postoperative period was 7.08 ± 0.5 mm (mean ± standard deviation). After 1 year, the average projection of the reconstructed nipple was 6.08 ± 0.5 mm. The average diameter of the reconstructed nipple in the immediate postoperative period was 14.9 ± 3 mm. After 1 year, the average diameter of the reconstructed nipple was 14.2 ± 4 mm. The average patient satisfaction with nipple projection was 7.28, sensation of the nipple, 4.11; color of the nipple, 6.36; position of the reconstructed nipple, 7.34; and symmetry compared with the opposite nipple-areola complex, 7.97. Overall patient satisfaction was 6.61. CONCLUSION: We maintain that the technique presented here is safe, easy to perform, and reproducible and improves the long-term projection of the reconstructed nipple.