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 .

Management decisions of an Academic Radiology Department during COVID-19 pandemic: the important support of a business analytics software.

OBJECTIVES: To analyze the response in the management of both radiological emergencies and continuity of care in oncologic/fragile patients of a radiology department of Sant'Andrea Academic Hospital in Rome supported by a dedicated business analytics software during the COVID-19 pandemic. METHODS: Imaging volumes and workflows for 2019 and 2020 were analyzed. Information was collected from the hospital data warehouse and evaluated using a business analytics software, aggregated both per week and per quarter, stratified by patient service location (emergency department, inpatients, outpatients) and imaging modality. For emergency radiology subunit, radiologist workload, machine workload, and turnaround times (TATs) were also analyzed. RESULTS: Total imaging volume in 2020 decreased by 21.5% compared to that in 2019 (p < .001); CT in outpatients increased by 11.7% (p < .005). Median global TAT and median code-blue global TAT were not statistically significantly different between 2019 and 2020 and between the first and the second pandemic waves in 2020 (all p > .09). Radiologist workload decreased by 24.7% (p < .001) during the first pandemic wave in 2020 compared with the same weeks of 2019 and showed no statistically significant difference during the second pandemic wave, compared with the same weeks of 2019 (p = 0.19). CONCLUSIONS: Despite the reduction of total imaging volume due to the COVID-19 pandemic in 2020 compared to 2019, management decisions supported by a dedicated business analytics software allowed to increase the number of CT in fragile/oncologic outpatients without significantly affecting emergency radiology TATs, and emergency radiologist workload. KEY POINTS: • During the COVID-19 pandemic, management decisions supported by business analytics software guaranteed efficiency of emergency and preservation of fragile/oncologic patient continuity of care. • Real-time data monitoring using business analytics software is essential for appropriate management decisions in a department of radiology. • Business analytics should be gradually introduced in all healthcare institutions to identify strong and weak points in workflow taking correct decisions.

Multi-omic approach identifies a transcriptional network coupling innate immune response to proliferation in the blood of COVID-19 cancer patients.

Clinical outcomes of COVID-19 patients are worsened by the presence of co-morbidities, especially cancer leading to elevated mortality rates. SARS-CoV-2 infection is known to alter immune system homeostasis. Whether cancer patients developing COVID-19 present alterations of immune functions which might contribute to worse outcomes have so far been poorly investigated. We conducted a multi-omic analysis of immunological parameters in peripheral blood mononuclear cells (PBMCs) of COVID-19 patients with and without cancer. Healthy donors and SARS-CoV-2-negative cancer patients were also included as controls. At the infection peak, cytokine multiplex analysis of blood samples, cytometry by time of flight (CyTOF) cell population analyses, and Nanostring gene expression using Pancancer array on PBMCs were performed. We found that eight pro-inflammatory factors (IL-6, IL-8, IL-13, IL-1ra, MIP-1a, IP-10) out of 27 analyzed serum cytokines were modulated in COVID-19 patients irrespective of cancer status. Diverse subpopulations of T lymphocytes such as CD8+T, CD4+T central memory, Mucosal-associated invariant T (MAIT), natural killer (NK), and γδ T cells were reduced, while B plasmablasts were expanded in COVID-19 cancer patients. Our findings illustrate a repertoire of aberrant alterations of gene expression in circulating immune cells of COVID-19 cancer patients. A 19-gene expression signature of PBMCs is able to discriminate COVID-19 patients with and without solid cancers. Gene set enrichment analysis highlights an increased gene expression linked to Interferon α, γ, α/ß response and signaling which paired with aberrant cell cycle regulation in cancer patients. Ten out of the 19 genes, validated in a real-world consecutive cohort, were specific of COVID-19 cancer patients independently from different cancer types and stages of the diseases, and useful to stratify patients in a COVID-19 disease severity-manner. We also unveil a transcriptional network involving gene regulators of both inflammation response and proliferation in PBMCs of COVID-19 cancer patients.

H-Ras gene takes part to the host immune response to COVID-19.

Ras gene family members play a relevant role in cancer, especially when they are mutated. However, they may play additional roles in other conditions beside cancer. We performed gene expression analysis using the NanoString PanCancer IO 360 panel in the peripheral blood mononuclear cell (PBMC) of six COVID-19 patients and we found that H-Ras gene was significantly upregulated, while both K-Ras and N-Ras genes were downregulated. In particular, H-Ras gene upregulation was more evident in COVID-19 patients with a more severe disease. We compared our results with those obtained by analyzing two different and independent datasets, including a total of 53 COVID-19 patients, in which the gene expression analysis was performed using the Immunology_V2 panel. Comparative analysis of the H-Ras gene expression in these patients confirmed our preliminary results. In both of them, in fact, we were able to confirm the upregulation of the expression of the H-Ras gene. The exact role of this specific upregulation of the H-Ras gene in response to SARS-CoV-2 infection and its possible role in cancer still remains to be elucidated. In conclusion, H-Ras gene participates to the host immune response to SARS-CoV-2 virus infection, especially in patients affected by the most severe form of the COVID-19.

Gene signature and immune cell profiling by high-dimensional, single-cell analysis in COVID-19 patients, presenting Low T3 syndrome and coexistent hematological malignancies.

BACKGROUND: Low T3 syndrome is frequent in patients admitted to intensive care units for critical illness and pneumonia. It has been reported also in patients with COVID-19, Hodgkin disease and chronic lymphocytic leukemia. We analyzed the clinical relevance of Low T3 syndrome in COVID-19 patients and, in particular, in those with associated hematological malignancies. METHODS: Sixty-two consecutive patients, hospitalized during the first wave of SARS-CoV-2 outbreak in Sant'Andrea University Hospital in Rome, were subdivided in 38 patients (Group A), showing low levels of FT3, and in 24 patients (Group B), with normal FT3 serum values. During the acute phase of the disease, we measured serum, radiologic and clinical disease severity markers and scores, in search of possible correlations with FT3 serum values. In addition, in 6 COVID-19 patients, 4 with Low T3 syndrome, including 2 with a hematological malignancy, and 2 with normal FT3 values, we performed, high-dimensional single-cell analysis by mass cytometry, multiplex cytokine assay and gene expression profiling in peripheral blood mononuclear cells (PBMC). RESULTS: Low FT3 serum values were correlated with increased Absolute Neutrophil Count, NLR and dNLR ratios and with reduced total count of CD3+, CD4+ and CD8+ T cells. Low FT3 values correlated also with increased levels of inflammation, tissue damage and coagulation serum markers as well as with SOFA, LIPI and TSS scores. The CyTOF analysis demonstrated reduction of the effector memory and terminal effector subtypes of the CD4+ T lymphocytes. Multiplex cytokine assay indicates that mainly IL-6, IP-10 and MCAF changes are associated with FT3 serum levels, particularly in patients with coexistent hematological malignancies. Gene expression analysis using Nanostring identified four genes differently expressed involved in host immune response, namely CD38, CD79B, IFIT3 and NLRP3. CONCLUSIONS: Our study demonstrates that low FT3 serum levels are associated with severe COVID-19. Our multi-omics approach suggests that T3 is involved in the immune response in COVID-19 and coexistent hematological malignancy and new possible T3 target genes in these patients have been identified.

Gastrointestinal endoscopy can be safely performed during pandemic SARS-CoV-2 infection in Central Italy.

OBJECTIVES: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is highly contagious; gastrointestinal endoscopies are considered risky procedures for the endoscopy staff. Data on the SARS-CoV-2-exposure/infection rate of gastrointestinal endoscopy staff is scarce. This study aimed to assess the SARS-CoV-2-exposure/infection rate among gastrointestinal endoscopists/nurses performing gastrointestinal endoscopies before and after the adoption of specific prevention measures. PATIENTS AND METHODS: Cross-sectional study in a teaching hospital (Rome, Central Italy) on retrospective data (9 March-15 April 2020) of consecutive gastrointestinal endoscopies, characteristics of procedures, patients and endoscopy staff, SARS-CoV-2-exposure/positivity of patients and staff before and after adoption of prevention measures. Exposed staff tested for SARS-CoV-2 by nasopharyngeal swabs(RNA-PCR) and serology. RESULTS: A total of 130 gastrointestinal endoscopies were performed in 130 patients (age 66 ± 14 years, 51% women, 51% inpatients, 56.9% lower). A total of 12 (9.2%) patients were SARS-CoV-2-positive and 14(10.8%) had a high risk of potential infection. Of the endoscopy staff (n = 16, 5 endoscopists, 8 nurses and 3 residents), 14 (87.5%) were exposed to SARS-CoV-2-infected and 16 (100%) to potentially infected patients. 3/5 and 5/5 endoscopists were exposed to actual and potential, 1/3 and 3/3 residents to actual and potential and 8/8 nurses to actual and potential infection, respectively. None of the staff was found to be infected with SARS-CoV-2. None experienced fever or any other suspicious symptoms of coronavirus disease 2019. Before the adoption of prevention measures, more endoscopists/nurses were in the endoscopy room than after (3.5 ± 0.6 vs. 2.1 ± 0.3, P < 0.0001). CONCLUSIONS: Despite supposed high infection risk, gastrointestinal endoscopies may be safe for the endoscopy staff during the SARS-CoV-2 pandemic.

Optimization of contrast medium volume for abdominal CT in oncologic patients: prospective comparison between fixed and lean body weight-adapted dosing protocols.

BACKGROUND: Patient body size represents the main determinant of parenchymal enhancement and by adjusting the contrast media (CM) dose to patient weight may be a more appropriate approach to avoid a patient over dosage of CM. To compare the performance of fixed-dose and lean body weight (LBW)-adapted contrast media dosing protocols, in terms of image quality and parenchymal enhancement. RESULTS: One-hundred cancer patients undergoing multiphasic abdominal CT were prospectively enrolled in this multicentric study and randomly divided in two groups: patients in fixed-dose group (n = 50) received 120 mL of CM while in LBW group (n = 50) the amount of CM was computed according to the patient's LBW. LBW protocol group received a significantly lower amount of CM (103.47 ± 17.65 mL vs. 120.00 ± 0.00 mL, p < 0.001). Arterial kidney signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) and pancreatic CNR were significantly higher in LBW group (all p ≤ 0.004). LBW group provided significantly higher arterial liver, kidney, and pancreatic contrast enhancement index (CEI) and portal venous phase kidney CEI (all p ≤ 0.002). Significantly lower portal vein SNR and CNR were observed in LBW-Group (all p ≤ 0.020). CONCLUSIONS: LBW-adapted CM administration for abdominal CT reduces the volume of injected CM and improves both image quality and parenchymal enhancement.

A modified sentinel node and occult lesion localization (SNOLL) technique in non-palpable breast cancer: a pilot study.

BACKGROUND: The spread of mammographic screening programs has allowed an increasing amount of early breast cancer diagnosis. A modern approach to non-palpable breast lesions requires an accurate intraoperative localization, in order to achieve a complete surgical resection. In addiction, the assessment of lymph node status is mandatory as it represents a major prognostic factor in these patients. The aim of this study is to evaluate the reliability of a modified technical approach using a single nanocolloidal radiotracer to localize both sentinel node and breast occult lesion. METHODS: Twenty-five patients with a single non-palpable breast lesions and clinically negative axilla were enrolled. In the same day of surgery, patients underwent intratumoral and peritumoral administration of (99m)Tc-labeled nanocolloid tracer under sonographic guidance. A lymphoscintigraphy was performed to localize the sentinel lymph node and its cutaneous projection was marked on the skin in order to guide the surgeon to an optimal incision. During surgery an hand-held gamma-detection probe was used to select the best surgical access route and to guide localization of both occult breast lesion and sentinel lymph node. After specimen excision, the surgical field was checked with the gamma-probe to verify the absence of residual sources of significant radioactivity, thereby ensuring a radical treatment in a single surgical session and minimizing normal tissue excision. RESULTS: Both targeted breast lesion and sentinel lymph node were localized and removed at the first attempt in every patients and histopathological diagnosis of malignancy was confirmed in 25/26 samples. Non-palpable lesions were included within the surgical margins in all patients and in all samples surgical margins were free from neoplastic infiltration thus avoiding any further reintervention. Only two patients showed metastatic involvement of sentinel lymph node. CONCLUSIONS: The modified sentinel node and occult lesion localization (SNOLL) technique performed with a single injection of nanocolloidal radiotracer has shown an excellent intraoperative identification rate of both non-palpable lesion and sentinel lymph node. This procedure offers, as opposed to standard techniques, an accurate, simple and reliable approach to the management of non-palpable breast cancer.