DIEP flap perfusion assessment using microdialysis versus Doppler ultrasonography: A comparative study.

BACKGROUND: The increasing number of buried free-tissue transfer procedures and the need for an objective method to evaluate vascular complications of free flaps has led to the development of new technologies. Microdialysis has been used to monitor free flaps using interstitial biological markers. Previous uses mainly focused on muscular flaps. Our aim is to compare external Doppler ultrasonography (EDU) evaluation versus microdialysis in the early follow-up of adipocutaneous flaps, and propose an efficient postoperative monitoring protocol. METHODS: We retrospectively assessed 68 consecutive DIEP flaps (50 patients) performed between January 2019 and March 2021. All flaps received standardized post-operative monitoring using clinical signs, EDU and microdialysis. Glucose and lactate concentrations were assessed using glucose <1 mmol/L and lactate >6 mmol/L as ischemic trend thresholds. We calculated Glucose/Lactate ratio as a new parameter for the assessment of flap viability. RESULTS: Among all the 68 flaps, two flaps returned to the operative theater when a combination of unsatisfactory microdialysis values and clinical/EDU signs identified vascular impairment; only one developed total flap necrosis. Reoperation rate was 2.94% with an overall flap success rate of 98.53%. External Doppler ultrasonography had 100% sensitivity and 82% specificity, while microdialysis had 100% sensitivity and 100% specificity. CONCLUSIONS: Microdialysis values proved flap viability sooner than external Doppler ultrasonography, making it an excellent tool for post-operative monitoring. With the appropriate thresholds for glucose and lactate concentrations, and glucose/lactate ratio used as a new parameter, it can help potentially avoiding unnecessary re-explorations, and reducing flap ischemia times.

Breast Implants and the Risk of Squamous Cell Carcinoma of the Breast: A Systematic Literature Review and Epidemiologic Study.

Squamous cell carcinoma may arise primarily from the breast parenchyma (PSCCB) or from the periprosthetic capsule in patients with breast implants (breast implant-associated squamous cell carcinoma [BIA-SCC]). A systematic literature review was performed to identify all PSCCB and BIA-SCC cases, and to estimate prevalence, incidence rate (IR), and risk. Studies up to November 2023 were searched on PubMed, Web of Science, Google Scholar, and Cochrane Library for predefined keywords. The numerator for PSCCB and BIA-SCC was the number of cases obtained from the literature; the denominator for PSCCB was the female population aged from 18 to 99, and the denominator for BIA-SCC was the population with breast implants. Overall, 219 papers were included, featuring 2250 PSCCB and 30 BIA-SCC cases. PSCCB prevalence was 2.0 per 100,000 (95% CI, 0.2:100,000 to 7.2:100,000) individuals, with a lifetime risk of 1:49,509 (95% CI, 0.2:10,000 to 5.6:10,000); and BIA-SCC prevalence was 0.61 per 100,000 (95% CI, 0.2:100,000 to 1.3:100,000), with a lifetime risk of 1:164,884 (95% CI, 0.2:100,000 to 5.6:100,000). The prevalence of BIA-SCC is 3.33 times lower than that of PSCCB, while the prevalence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is 3.84 times higher than that of primary breast ALCL. When comparing the BIA-SCC prevalence of 1:164,910 individuals with breast implants regardless of texture to the BIA-ALCL prevalence of 1:914 patients with textured implants, the BIA-SCC risk is 180 times lower than the BIA-ALCL risk. BIA-SCC occurs less frequently than PSCCB and considerably less than BIA-ALCL. The association between textured implants and BIA-SCC cases is relevant for patient education regarding uncommon and rare risks associated with breast implants, and ongoing vigilance, research, and strengthened reporting systems remain imperative.

Free-style technique versus computed tomographic angiography-guided perforator selection in deep inferior epigastric perforator flap harvest: A prospective clinical study.

BACKGROUND: Computed tomographic angiography (CTA) is the preferred diagnostic tool in preoperative deep inferior epigastric perforator (DIEP) flap assessment, though some surgeons prefer approaching perforator selection with intraoperative findings alone. METHODS: This prospective observational study conducted between 2015 and 2020 assessed our intraoperative decision-making "free-style" technique for DIEP flap harvest. Any patient with indication for immediate or delayed breast reconstruction using abdominally based flaps and who received preoperative CTA was enrolled. Only unilateral cases performed by the same surgeon were considered. Allergy to iodine-based contrast media, renal impairment and claustrophobia were other exclusion criteria. Primary endpoint consisted in comparing operative times and complication rates between free-style technique and CTA-guided approach. Secondary endpoints included evaluation of agreement rate between intraoperative findings and CTA, and identification of variables affecting operative time and complication rate. Demographics, surgical information, agreement versus non-agreement and complications were collected. RESULTS: Starting from 206 patients, 100 were enrolled. Fifty were assigned to Group A, receiving DIEP flap with free-style technique. The other 50 were assigned to Group B, receiving DIEP flap with CTA-guided perforators selection. Study groups' demographics were homogenous. Operative time was statistically lower (p = .036) in free-style group (252.4 ± 44.77 min vs. 265.6 ± 31.67 min). Complication rates were higher in CTA-guided group (10% vs. 2%) though this was not significant (p = .092). Overall agreement rate in dominant perforator selection between intraoperatively and CTA-based assessment was 81%. Multiple regression analysis showed no variable increased complication rate, though CTA-guided approach, BMI > 30 and harvesting more than one perforator were respectively associated with B-coefficient of 17.391 (2.430-32.351, 95% CI) [p = .023], 3.50 (0.640-6.379, 95% CI) [p = .017] and 18.887 (6.232-31.542, 95% CI) [p = .004], predicting increased operative time. CONCLUSIONS: The free-style technique proved to be a useful tool for guiding DIEP flap harvest with good sensibility in detecting the dominant perforator suggested by CTA without statistically increasing surgery duration and complications.

Comment on the Invited Discussion on "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants".

We here present a few comments on the invited discussion of Dr. van Heijningen on the paper "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants". Dr. van Heijningen made some reservations regarding paper conclusions due to the high dropout rate, the adopted exclusion criteria and the location and mechanism of implant rupture. First of all, a high dropout rate is not unbeknown to researchers in surveys-based studies and may be expected when recalling in 6 months a population observed during last 20 years. In our study data are missing at random not affecting the risk of bias, while the population accurately depicts the people we care, mainly but not only reconstructive. Patients who did not respond to the questionnaire could not participate to the survey, while those who did not hold recent imaging were excluded because of the risk of false negative due to possible silent rupture, accounting to 10% in some reports. MRI imaging often shows that implants fold back on their selves when capsular contracture reduces implant pocket. As the use of the underwire bra prevents implant inferior displacement, repeated muscular contraction may worsen implant folds and the chronic wear-and-tear mechanism may be responsible for the rupture. Finally, folding is presumably easier to occur at the upper quadrants where anatomical implant shell is thinnest and gel concentration reduced than the opposite, therefore is not surprising that the higher percentage of ruptures is located in the upper implant quadrants.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 .

Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants.

BACKGROUND: Breast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reported to be around 10-15 years. No consensus exists regarding which factors are involved. OBJECTIVES: Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases. METHODS: In this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR. RESULTS: We report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347). CONCLUSION: Wearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged. 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 .

Determining Breast Implant Prevalence: A Population Study of Italian Chest Radiographs.

BACKGROUND: Current breast implant prevalence within the general population remains elusive. An accurate prevalence is critical to serve as the denominator for any assessment of breast implant-related complication. The purpose of this manuscript is to assess this prevalence in women aged 20-70 years in Italy. MATERIALS AND METHODS: Eight reviewers, demonstrating a mean sensitivity of 87.0% and specificity of 97.0%, were recruited for retrospective identification of implants on chest radiographs from a tertiary academic hospital in a major urban setting. Three final reviewers were selected, and they assessed all eligible chest radiographs collected between January and December 2019. The hospital-based population was compared to epidemiological data at a local, regional and national level to demonstrate homogeneity of age structures using the phi correlation coefficient. RESULTS: We identified 3,448 chest X-rays which yielded 140 implants, with an overall prevalence of 4.1% for women aged 20-70. Implants were bilateral in 76% of cases and unilateral in 24%. They were placed cosmetically in 47.1% cases and used for reconstruction in 52.9% cases. Phi correlation coefficient found no differences across hospital-based, local, regional and national populations. CONCLUSION: A validated method was performed to estimate implant prevalence from an academic hospital in a major urban setting at 4.1% and was used to estimate national prevalence in Italy. The implications of this epidemiologic study may reach across national borders for improved understanding of breast implant epidemiology and in predicting the total number of patients within a given population that may be affected by device complications. 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 .

Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

BACKGROUND: Because of poor knowledge of risks and benefits, prophylactic explantation of high BIA-ALCL risk breast implant (BI) is not indicated. Several surgical risks have been associated with BI surgery, with mortality being the most frightening. Primary aim of this study is to assess mortality rate in patients undergoing breast implant surgery for aesthetic or reconstructive indication. MATERIALS AND METHODS: In this retrospective observational cohort study, Breast Implant Surgery Mortality rate (BISM) was calculated as the perioperative mortality rate among 99,690 patients who underwent BI surgery for oncologic and non-oncologic indications. Mean age at first implant placement (A1P), implant lifespan (IL), and women's life expectancy (WLE) were obtained from a literature review and population database. RESULTS: BISM rate was 0, and mean A1P was 34 years for breast augmentation, and 50 years for breast reconstruction. Regardless of indication, overall mean A1P can be presumed to be 39 years, while mean BIL was estimated as 9 years and WLE as 85 years. CONCLUSION: This study first showed that the BISM risk is 0. This information, and the knowledge that BI patients will undergo one or more revisional procedures if not explantation during their lifetime, may help surgeons in the decision-making process of a pre-emptive substitution or explant in patients at high risk of BIA-ALCL. Our recommendation is that patients with existing macrotextured implants do have a relative indication for explantation and total capsulectomy. The final decision should be shared between patient and surgeon following an evaluation of benefits, surgical risks and comorbidities. 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 .

BIA-ALCL Epidemiological Findings From a Retrospective Study of 248 Cases Extracted From Relevant Case Reports and Series: A Systematic Review.

BACKGROUND: The epidemiologic picture of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is unclear, with no high-level evidence, because only case reports and series are available. OBJECTIVES: The aim of this study was to update knowledge on BIA-ALCL epidemiology by utilizing all available data through a systematic review of scientific literature. METHODS: A search on PubMed, Scopus, and Web of Science was conducted between October 2021 and April 2022. Out of the 2799 available records, 114 pertinent articles were selected, featuring 248 BIA-ALCL cases which were retrospectively analyzed by means of descriptive statistics, incidence rate (IR), Kaplan-Meier survival curves, and Pearson correlation coefficients. RESULTS: The United States, the Netherlands, Italy, and Australia were the countries reporting the most cases. The mean age at first implantation was 42 years, and the mean age at diagnosis was 53 years. Aesthetic indications were the reason for 52% of cases, and reconstruction for 48%; macrotextured surface was linked to 73.8% of cases, and seroma to 83%. Total follow-up was 492 months, and mean event-free time (EFT) to BIA-ALCL development was 129 months. The IR was 96 new cases/1,000 women per year after first implantation, and was directly correlated to the number of replacements. EFT was directly correlated to the number of replacements, implant rupture, and capsule contracture, and was inversely associated with patients' age at first implantation and to BRACA1/2 and TP53 mutations. CONCLUSIONS: Macrotextured implant use in older patients and in patients with BRCA1/2 and TP53 mutations should be reconsidered, because this is associated with earlier disease onset. Implant replacement of asymptomatic, risk-stratified patients can be indicated due to its protective role against BIA-ALCL, reducing IR and risk, while increasing the EFT.

Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in the United States: A Systematic Review.

BACKGROUND: Although textured implants represent fewer than 10% of implants used in the United States, the country reports the highest incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). OBJECTIVES: The aim of this study was to perform a systematic literature review on US-based epidemiology to update knowledge on BIA-ALCL in the United States. METHODS: Publications on US BIA-ALCL epidemiology were searched between September 2022 and March 2023 on MEDLINE (National Institutes of Health; Bethesda, MD), Embase (Elsevier, Amsterdam, the Netherlands), Web of Science (Clarivate, London, UK), and SCOPUS (Elsevier, Amsterdam, the Netherlands). The US numerator was obtained by averaging the FDA MAUDE database and the PSF PROFILE registry, while the denominator was estimated from chest X-rays, and included female transgender individuals. Prevalence and risk were assessed accordingly, but the incidence rate (IR) could not be updated due to the lack of available follow-up data. RESULTS: Out of 987 identified manuscripts, 10 were included. The US prevalence of BIA-ALCL in the literature ranged from 1:300 to 1:500,000 and the IR from 4.5 per 10,000 to 31.1 per 100 million persons per year. A mean value of 453.5 BIA-ALCL cases was calculated. From a denominator of 4,264,618 individuals, which includes all breast implant surfaces, we calculated 414,521 individuals with textured implants, indicating a textured prevalence of 109.4 cases per 100,000 individuals and a risk of 1:913. CONCLUSIONS: BIA-ALCL IR, prevalence, and risk has increased when calculated exclusively for patients with textured devices. Although US macrotextured implants were recalled by the FDA, these findings may influence the surveillance of existing patients and the use of macrotextured implants in other parts of the world where they remain widespread.

BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1501 Patients.

BACKGROUND: Epidemiologic studies on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) currently estimate the risk between 1:300 and 1:30,000, assessed mainly in large breast reconstruction populations. OBJECTIVES: The aim of the study was to assess BIA-ALCL epidemiology in a cohort of patients who have received textured implants for cosmetic indications. METHODS: In a prospective cohort observational study, 1501 patients who received a cosmetic breast augmentation between 2006 and 2016 were monitored, recording any implant-related complications, including BIA-ALCL. Cross-checking of clinical, pathology, and external records data identified cases. Prevalence, implant-specific prevalence (I-SP), incidence rate (IR), event-free time (EFT), and the Kaplan-Meier survival estimate were calculated. RESULTS: All but 2 patients received macrotextured or microtextured devices bilaterally. Mean follow-up was 3.2 years (1 months to 16.4 years). Five BIA-ALCL cases were investigated. Prevalence was 1:300 patients; I-SP was 6.9 cases/1000 individuals/Allergan BIOCELL devices and 1.3 cases/1000 individuals/Mentor Siltex devices; and IR was 1.07 cases/1000 females/year. Mean (SD) EFT was 9.2 years. CONCLUSIONS: When using a denominator based on a cohort of cosmetic patients, BIA-ALCL occurrence is higher than previously reported, particularly with macrotextured devices. Given the similar IRs in reconstructive and cosmetic cohorts, their even distribution could be consequent to underreporting due to poorer follow-up and lower awareness in the latter group. The genetic predisposition in the oncologic cohort reasonably affects the early onset more than the IR. The importance of accurate follow-up is confirmed. Stratification risks analysis can guide surgeons during patient counseling regarding the decision for prophylactic explantation.

Study of the Effect of Different Breast Implant Surfaces on Capsule Formation and Host Inflammatory Response in an Animal Model.

BACKGROUND: Breast implants are biomaterials eliciting a physiological and mandatory foreign body response. OBJECTIVES: The authors designed an animal study to investigate the impact of different implant surfaces on the formation of the periprosthetic capsule, the inflammatory response, and the cellular composition. METHODS: The authors implanted 1 scaled-down version of breast implants by different manufactures on 70 female Sprague Dawley rats. Animals were divided into 5 groups of 14 animals. Group A received a smooth implant (Ra ≈ 0.5 µm) according to the ISO 14607-2018 classification, Group B a smooth implant (Ra ≈ 3.2 µm), Group C a smooth implant (Ra ≈ 5 µm), Group D a macrotextured implant (Ra ≈ 62 µm), and Group E a macrotextured implant (Ra ≈ 75 µm). At 60 days, all animals received a magnetic resonance imaging (MRI), and 35 animals were killed and their capsules sent for histology (capsule thickness, inflammatory infiltrate) and immunohistochemistry analysis (cellular characterization). The remaining animals repeated the MRI at 120 days and were killed following the same protocol. RESULTS: MRI showed a thinner capsule in the smooth implants (Groups A-C) at 60 days (P < .001) but not at 120 days (P = .039), confirmed with histology both at 60 days (P = .005) and 120 days (P < .001). Smooth implants (Groups A-C) presented a mild inflammatory response at 60 days that was maintained at 120 days and a high M2-Macrophage concentration (anti-inflammatory). CONCLUSIONS: Our study confirms that smooth implants form a thinner capsule, inferior inflammatory infiltrate, and a cellular composition that indicates a mild host inflammatory response. A new host inflammatory response classification is elaborated classifying breast implants into mild, moderate, and high.

Successful Treatment of a Patient With Breast Implant-Associated Anaplastic Large Cell Lymphoma With Local Residual Disease: A Case Report.

BACKGROUND: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a hematological malignancy that may occur in patients undergoing breast implant placement. It more commonly behaves as a solid tumor, and the criterion standard treatment consists in an en bloc capsulectomy, which may not always be possible, according to the location of the implant. When local residual disease is present, BIA-ALCL must be treated with adjuvant therapies. CASE PRESENTATION: We describe the case of a 76-year-old woman who underwent unilateral placement of a breast implant after breast cancer surgery in 2004 and developed BIA-ALCL in 2019. A multidisciplinary team managed her case, and en bloc capsulectomy was indicated for the treatment of the malignancy. The histological report showed focal neoplastic infiltration of the posterolateral margin of resection, further supported by positron emission tomography/computed tomography scan, which showed a local uptake in the right anterolateral chest wall. Therefore, adjuvant radiotherapy treatment was indicated for the management of local residual disease, alongside a stringent follow-up protocol. More than 1 year later, imaging scans show no signs of BIA-ALCL recurrence. CONCLUSIONS: Local residual disease in BIA-ALCL is bound to be a progressively more common occurrence, as awareness of BIA-ALCL increases and more cases are diagnosed worldwide. Currently, there is no established consensus on a standard approach for the treatment for patients with a higher risk of local recurrence. Our experience describes the protocol we used to successfully manage a case of BIA-ALCL with incomplete surgical margins, which hopefully can serve colleagues treating patients with similar cases.

Low-vacuum negative pressure wound therapy protocol for complex wounds with exposed vessels.

OBJECTIVE: Treating high-risk surgical patients with complex wounds over exposed blood vessels is a challenge. Guided wound healing may be the only treatment possible. Negative pressure wound therapy (NPWT) is not recommended in these cases. The authors challenged these current recommendations and share their preliminary experience. METHOD: The authors adapted a NPWT protocol that uses low-vacuum continuous pressure (-80mmHg) with a silicone sheath and gauze/foam dressing between the wound bed and the device. They monitored the clinical features of patients' wounds to detect bleeding/ischaemia early on. Dressings were changed every 72-96 hours. RESULTS: This protocol was followed in five male patients (aged 23-68 years) with complex wounds over exposed vessels. Two cases were foot crush injuries, one midfoot amputation, one hand self-subamputation and one vascular bypass infection. Comorbidities included monoarterial limbs/stump, severe arteriopathy and psychiatric disorder. The exposed vessels were femoral, radial and ulnar, anterior and posterior tibial arteries and veins. Mean treatment lasted 37 days (range 20-61 days). No episodes of severe bleeding/ischaemia of the extremities were observed. Treatment was discontinued once debridement was complete and granulation tissue allowed spontaneous closure/grafting. All wounds appeared stable at 1-year follow-up. CONCLUSION: The low-vacuum NPWT protocol was successful in solving five difficult cases. This regimen reduces risks associated with NPWT use on wounds with exposed vessels. The authors believe further validation is required to strengthen the evidence. However, preliminary data are encouraging and might help to change future NPWT recommendations by extending the indications for its use to exposed vessels.

Impact on Patient's Appearance Perception of Autologous and Implant Based Breast Reconstruction Following Mastectomy Using BREAST-Q.

INTRODUCTION: The purpose of this study is to determine if there is a better quality of life with one of the two techniques and if the results are in line with those already present in the literature. The hypothesis from which we started is to demonstrate that cancer patients who undergo a deep inferior epigastric perforator flap (DIEP) breast reconstruction surgery are more satisfied and have a higher level of quality of life compared to those subjected to an intervention of reconstruction with prosthesis. MATERIALS AND METHODS: All patients undergoing reconstruction from January 2010 to July 2018 were eligible for inclusion. This is a retrospective cohort study carried out using the patients of two plastic surgery departments who have undergone monolateral or bilateral implant-based or DIEP flap breast reconstruction. We administered BREAST-Q questionnaire electronically almost 2 year after surgery. Patients were divided into two groups: implant-based and autologous breast reconstruction with DIEP flaps. Baseline demographics and patient characteristics were analyzed using a Students t-test (continuous variables) or Chi-square/Fisher's exact test (categorical variables). Mean standard deviation BREAST-Q scores were reported for the overall cohort and by modality for the postoperative period. The linear regression model was applied to all BREAST-Q score with all predictor factors. RESULTS: Of the 1125 patients involved, only 325 met the inclusion criteria and were enrolled in this study; specifically, 133 (41%) DIEP and 192 (59%) prosthetic reconstructions. We summarized the results of the principal scales of BREAST-Q module: satisfaction with breast, psychosocial well-being, satisfaction with outcome, and sexual well-being in which the autologous group was always more satisfied. We reported results of all linear regression models with higher values for the DIEP group independently from predictors. CONCLUSION: This is the first study performed on the Italian population that compares autologous surgical techniques with the implantation of breast implants. In this population, DIEP is considered the technique that leads to the highest satisfaction in all BREAST-Q scores. 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 .

Predictive Factors of Satisfaction Following Breast Reconstruction: Do they Influence Patients?

INTRODUCTION: This study aims to analyze whether there is any patient- or treatment-related factor that can influence patients' body perception after mastectomy and autologous or implant-based breast reconstruction. MATERIALS AND METHODS: This retrospective cohort study included patients who underwent immediate implant-based or DIEP flap breast reconstruction. Predictive factors analyzed included chemotherapy, radiotherapy, hormone therapy, body mass index, age, type of mastectomy, and follow-up length. The BREAST-Q was administered postoperatively almost 2 years from the last surgical procedure. Mean BREAST-Q scores were reported for the overall cohort and by modality for the postoperative period. A linear regression model was applied to all BREAST-Q scores with all predictor factors. RESULTS: In total, 325 patients were enrolled in this study (133 DIEP flap and 192 implant-based reconstructions). The DIEP flap reconstruction group with a previous nipple sparing mastectomy showed the highest scores. Patients with a longer follow-up were less satisfied than the ones with a shorter follow-up, which could be considered as an assessment of the outcome. No significant difference was reported between patients who underwent radiotherapy, chemotherapy or hormone therapy and those who did not. Furthermore, age and BMI had no influence on patient satisfaction. CONCLUSION: This study is the first that groups a large number of patients and analyzes predictive factors of long-term satisfaction of patients undergoing breast reconstruction. This can be regarded as a pilot study to raise the awareness of everyone's clinical practice to predict the attitude that patients have after surgery and to prepare them in the best possible way. 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 .

2022 Practice Recommendation Updates From the World Consensus Conference on BIA-ALCL.

BACKGROUND: Laboratory and clinical research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is rapidly evolving. Changes in standard of care and insights into best practice were recently presented at the 3rd World Consensus Conference on BIA-ALCL. OBJECTIVES: The authors sought to provide practice recommendations from a consensus of experts, supplemented with a literature review regarding epidemiology, etiology, pathogenesis, diagnosis, treatment, socio-psychological aspects, and international authority guidance. METHODS: A literature search of all manuscripts between 1997 and August 2021 for the above areas of BIA-ALCL was conducted with the PubMed database. Manuscripts in different languages, on non-human subjects, and/or discussing conditions separate from BIA-ALCL were excluded. The study was conducted employing the Delphi process, gathering 18 experts panelists and utilizing email-based questionnaires to record the level of agreement with each statement by applying a 5-point Likert Scale. Median response, interquartile range, and comments were employed to accept, reject, or revise each statement. RESULTS: The literature search initially yielded 764 manuscripts, of which 405 were discarded. From the remaining 359, only 218 were included in the review and utilized to prepare 36 statements subdivided into 5 sections. After 1 round, panelists agreed on all criteria. CONCLUSIONS: BIA-ALCL is uncommon and still largely underreported. Mandatory implant registries and actions by regulatory authorities are needed to better understand disease epidemiology and address initial lymphomagenesis and progression. Deviation from current diagnosis and treatment protocols can lead to disease recurrence, and research on breast implant risk factors provide insight to etiology.

IL-10, IL-13, Eotaxin and IL-10/IL-6 ratio distinguish breast implant-associated anaplastic large-cell lymphoma from all types of benign late seromas.

Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is an uncommon peripheral T cell lymphoma usually presenting as a delayed peri-implant effusion. Chronic inflammation elicited by the implant has been implicated in its pathogenesis. Infection or implant rupture may also be responsible for late seromas. Cytomorphological examination coupled with CD30 immunostaining and eventual T-cell clonality assessment are essential for BI-ALCL diagnosis. However, some benign effusions may also contain an oligo/monoclonal expansion of CD30 + cells that can make the diagnosis challenging. Since cytokines are key mediators of inflammation, we applied a multiplexed immuno-based assay to BI-ALCL seromas and to different types of reactive seromas to look for a potential diagnostic BI-ALCL-associated cytokine profile. We found that BI-ALCL is characterized by a Th2-type cytokine milieu associated with significant high levels of IL-10, IL-13 and Eotaxin which discriminate BI-ALCL from all types of reactive seroma. Moreover, we found a cutoff of IL10/IL-6 ratio of 0.104 is associated with specificity of 100% and sensitivity of 83% in recognizing BI-ALCL effusions. This study identifies promising biomarkers for initial screening of late seromas that can facilitate early diagnosis of BI-ALCL.

Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER).

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

Facial Transplantation: Nonimmune-Related Hyperacute Graft Failure-The Role of Perfusion Injury: A Case Report.

BACKGROUND: The aim of this study was to report the first case of acute facial allograft transplantation (facial allograft transplantation) failure with allograft removal and autologous free-flap reconstruction. METHODS: A 49-year-old female patient affected by neurofibromatosis type 1 with a massive neurofibroma infiltrating the whole left hemiface was planned for FAT for the left hemiface including the auricle, all skin and soft tissues from the temporal region, periorbital and nasal region, and up to the perioral area. The maxillary process of the zygomatic bone, left hemimaxilla, and hemimandible from contralateral parasyphysis to the incisura mandibulae were also included. RESULTS: Total surgical time was 26 hours. There were 2 intraoperative arterial thromboses that were solved with new anastomoses and sufficient flap perfusion. On postoperative day 2, the allograft became pale with suspected arterial occlusion and the patient returned to the operative room for exploration no flow into the FAT was found. The allograft was removed and the recipient site reconstructed with a skin-grafted composite left latissimus dorsi-serratus anterior flap. CONCLUSIONS: Hyperacute loss of FAT is a very dramatic event, and the activation of a backup surgical plan is crucial to save patient's life, give a reasonable temporary reconstruction, and return on the waiting-list for a second face transplantation.

Guiding Nipple-Areola Complex Reconstruction: Literature Review and Proposal of a New Decision-Making Algorithm.

BACKGROUND: Nipple-areola complex reconstruction (NAR) most commonly represents the finishing touch to breast reconstruction (BR). Nipple presence is particularly relevant to the patient's psyche, beyond any shadow of doubt. Many reconstructive options have been described in time. Surgery is easy, but final result is often disappointing on the long run. METHODS: The goal of this manuscript is to analyze and classify knowledge concerning NAR techniques and the factors that influence success, and then to elaborate a practical evidence-based algorithm. Out of the 3136 available articles as of August 8th, 2020, we selected 172 manuscripts that met inclusion criteria, which we subdivided into 5 main topics of discussion, being the various NAR techniques; patient factors (including patient selection, timing and ideal position); dressings; potential complications and finally, outcomes/patient satisfaction. RESULTS: We found 92 articles describing NAR techniques, 41 addressing patient factors (out of which 17 discussed patient selection, 14 described ideal NAC location, 10 described appropriate timing), 10 comparing dressings, 7 studying NAR complications, and 22 addressing outcomes and patient satisfaction. We elaborated a comprehensive decision-making algorithm to help narrow down the choice among NAR techniques, and choose the correct strategy according to the various scenarios, and particularly the BR technique and skin envelope. CONCLUSIONS: No single NAR technique provides definitive results, which is why we believe there is no "end-all be-all solution". NAR must be approached as a case-by-case situation. Furthermore, despite NAR being such a widely discussed topic in scientific literature, we still found a lack of clinical trials to allow for more thorough recommendations to be elaborated. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. 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.