Contrast-enhanced Ultrasound Using Intradermal Microbubble Sulfur Hexafluoride for Identification of Sentinel Lymph Nodes During Breast Cancer Surgery: A Clinical Trial.

BACKGROUND/AIM: Sentinel lymph node (SLN) procedures have gained popularity in early breast cancer thanks to the reduction of surgical side-effects. The standard SLN mapping procedure uses 99mTc-nanocolloid human serum albumin with/without blue dye; limitations include logistical challenges and adverse reactions. Recently, contrast-enhanced ultrasound (CEUS) using sulfur hexafluoride has emerged as a promising technique for SLN mapping. Our study aimed to compare the CEUS technique with the standard isotope method. MATERIALS AND METHODS: AX-CES, a prospective, monocentric, single-arm phase-3 study was designed (EudraCT: 2020-000393-20). Inclusion criteria were histologically diagnosed early breast cancer eligible for upfront surgery and SLN resection, bodyweight 40-85 kg, and no prior history of ipsilateral surgery or radiotherapy. All patients underwent CEUS prior to surgery and blue dye injection was performed in areas with contrast accumulation. After the experimental procedure, all patients underwent the standard mapping procedure and SLN frozen section assessment was performed. Data on the success rate, systemic reactions, mean procedure time, CEUS appearance, SLN number, and concordance with standard mapping procedure were collected. RESULTS: Among 16 cases, a median of two SLNs were identified during CEUS. In all cases, at least one SLN was identified by CEUS (100%). In six cases, SLNs were classified during CEUS as abnormal, which was confirmed by definitive staining in four cases. After the standard mapping technique, in 15 out of the 16 cases (87.50%), at least one SLN from the standard mapping procedure was marked with blue dye in the CEUS procedure. In our series, sensitivity and specificity of SLN detection by CEUS were 75% and 100%, respectively. CONCLUSION: CEUS is a safe and manageable intraoperative procedure. When compared with standard techniques, US appearance during CEUS may provide additional information when associated with histological assessment.

Awake Breast Conservative Surgery: A Strategy to Shorten Surgical Waiting Lists During and Post COVID-19 Emergency.

BACKGROUND/AIM: SARS-CoV-2 with a dramatical worldwide spread, impacted greatly daily life and healthcare. In order to avoid delay in cancer treatment, many strategies and measures were implemented. The Awake breast surgery was a strategy implemented in our Unit during the pandemic, aimed to reduce operatory room occupancy and increase the number of procedures performed during the daily surgical session. The aim of the study was to evaluate how the use of this strategy has changed before and after the advent of the COVID-19 pandemic, and its relative benefits. PATIENTS AND METHODS: This was a retrospective study analysing all patients subjected to breast conservative surgery for oncological disease from July 2018 to December 2021. RESULTS: Out of 498 patients enrolled in the study, 253 (50.8%) cases were treated before the pandemic and were designated as "pre-COVID-19" group. The remaining 245 (49.1%) cases were considered the "COVID-19" group. Cases of awake surgery in COVID-19 group were 141 (54.7%) vs. 84 (33.2%), p<0.001. Length of hospitalization and surgical time were comparable between the groups: relative p=0.188 and 0.264, respectively. Differently, operation room occupation was significantly shorter in the COVID-19 group, p<0.001; and number of outpatient surgical procedures was higher, p=0.0304. Multivariate analysis identified the period of surgery (OR=1.47) as a statistically significant factor, p=0.011, predictive of prolonged operatory room occupancy. CONCLUSION: Awake surgery was one of the strategies which made more operating rooms available and allowed avoiding further delays.

Acute Appendicitis During Coronavirus Disease 2019 (COVID-19): Increasing Incidence of Complicate Appendicitis, Severity and Length of Hospitalization.

BACKGROUND/AIM: COVID-19 is rapidly spreading, and due to the high morbidity and mortality caused by the pandemic many Governments have introduced social restrictions. Those measures combined with infection-related patient anxiety, led to hiding other diseases. The aim of this study was to evaluate the impact of COVID-19 on numbers and severity of acute appendicitis cases referred during the pandemic. PATIENTS AND METHODS: Between March 2019 and March 2021, all patients who underwent appendectomy in Tor Vergata Hospital, Rome were included. Patients were divided in two groups (COVID-19/pre-COVID-19). Clinical features, intraoperative findings, hospital stay, and histologic examination data were included in the retrospective analysis. RESULTS: Out of 334 admitted patients, 36 (10.7%) had a diagnosis of acute appendicitis (COVID-19 group) vs. 59(11.2%) in the pre-COVID-19 group. The COVID-19 group presented significantly longer hospitalization, incidence of appendicular abscess, perforation, and severity of inflammation at univariate analysis p=0.002, p=0.021, p=0.001, p=0.006, p=0.001, respectively. At multivariate analysis, appendicular abscess (p=0.015) and higher serum levels of C reactive protein (p<0.008) were associated with prolonged hospital stay. CONCLUSION: This study highlights the correlation between COVID-19 pandemic and the severity of acute appendicitis presentations.

Role of Breast-Conserving Surgery on the National Health System Economy From and to SARS-COVID-19 Era.

Day surgery breast-conserving surgery (DS-BCS) is a surgical approach applied in many specialized breast surgery departments. This study demonstrates the benefits of this approach from the perspectives of patients and of the Hospital/National Health System compared to ordinary breast-conserving surgery (ORD-BCS) under general anesthetic. A comparison of costs and diagnosis-related group (DRG) reimbursement demonstrated improved cost-effectiveness in DS-BCS compared to ORD-BCS.

Metabolic characteristics in patients with COVID-19 and no-COVID-19 interstitial pneumonia with mild-to-moderate symptoms and similar radiological severity.

BACKGROUND AND AIMS: It is known that the highest COVID-19 mortality rates are among patients who develop severe COVID-19 pneumonia. However, despite the high sensitivity of chest CT scans for diagnosing COVID-19 in a screening population, the appearance of a chest CT is thought to have low diagnostic specificity. The aim of this retrospective case-control study is based on evaluation of clinical and radiological characteristics in patients with COVID-19 (n = 41) and no-COVID-19 interstitial pneumonia (n = 48) with mild-to-moderate symptoms. METHODS AND RESULTS: To this purpose we compared radiological, clinical, biochemical, inflammatory, and metabolic characteristics, as well as clinical outcomes, between the two groups. Notably, we found similar radiological severity of pneumonia, which we quantified using a disease score based on a high-resolution computed tomography scan (COVID-19 = 18.6 ± 14.5 vs n-COVID-19 = 23.2 ± 15.2, p = 0.289), and comparable biochemical and inflammatory characteristics. However, among patients without diabetes, we observed that COVID-19 patients had significantly higher levels of HbA1c than n-COVID-19 patients (COVID-19 = 41.5 ± 2.6 vs n-COVID-19 = 38.4 ± 5.1, p = 0.012). After adjusting for age, sex, and BMI, we found that HbA1c levels were significantly associated with the risk of COVID-19 pneumonia (odds ratio = 1.234 [95%CI = 1.051-1.449], p = 0.010). CONCLUSIONS: In this retrospective case-control study, we found similar radiological and clinical characteristics in patients with COVID-19 and n-COVID-19 pneumonia with mild-to-moderate symptoms. However, among patients without diabetes HbA1c levels were higher in COVID-19 patients than in no-COVID-19 individuals. Future studies should assess whether reducing transient hyperglycemia in individuals without overt diabetes may lower the risk of SARS-CoV-2 infection.

Impact of COVID-19 Pandemic on Surgical Breast Cancer Patients Undergoing Neoadjuvant Therapy: A Multicentric Study.

BACKGROUND/AIM: Due to the SARS-CoV-2 pandemic, many scientific committees proposed neoadjuvant therapy (NACT) bridging treatment as a novel strategy and indication. The aim of the study was to evaluate the impact of COVID-19 pandemic on breast cancer patients undergoing NACT. PATIENTS AND METHODS: All breast cancer patients referred to two Breast Units during COVID-19-pandemic were enrolled. RESULTS: Out of 814 patients, 43(5.3%) were enrolled in the COVID-19-group and compared with 94 (7.9%) similar Pre-COVID-19 patients. We observed a reduction in the number of patients undergoing NACT, p=0.0019. No difference was reported in terms of clinical presentation, indications, and tumor response. In contrast, a higher number of vascular adverse events was reported (6.9% vs. 0% p=0.029). Immediate breast cancer reconstructions following invasive surgery suffered a significant slowdown (5.9% vs. 47.7%, p=0.019). CONCLUSION: COVID-19 caused a reduction in the number of patients undergoing NACT, with no changes in terms of indications, clinical presentation, and tumor response. Furthermore, there was an increased incidence of vascular events.

Unusual Presentation of a Post-procedural Breast Hematoma: A Case Report.

BACKGROUND/AIM: Hematoma is the most frequent complication after Vacuum-Assisted Breast Biopsy (VABB) in 13% of cases. A direct communication channel with patients eases the diagnosis of VABB complications and ensures treatment at an early stage, as outpatients, in most cases. In 2020, due to the COVID-19 pandemic, we observed a reduction of self-reported postoperative complication leading to delay in the identification of harmful complications, therefore leading to need for more invasive treatment. CASE REPORT: A 50-year-old patient was admitted to the Emergency Department for dry cough, fever, chest discomfort, dyspnea, and slight confusion four days after VABB. Due to the reported symptoms, the patient was sent to our COVID-19 Emergency Department. The COVID-19 swab was negative. Ultrasound revealed a large hematoma at the biopsy site, with active bleeding. Open evacuation with accurate hemostasis was planned with rapid and complete resolution of the clinical symptoms. After surgery, the patient reported that she intentionally avoided admittance in the hospital due to the risk of COVID-19 infection. The patient was discharged in the first postoperative day and maintained in quarantine for 14 days. CONCLUSION: In the COVID-19 era due to the risk of hospital cross-infections, reduction of patient-doctor communication could lead to misdiagnosis, delay in recognition of procedural complications thus leading to requirement for invasive treatment, hospitalization, while also further multiplying the risk of COVID-19 infection.

Extremely Advanced Breast Cancer Presentation: Possible Effect of Coronavirus Pandemic Anxiety.

BACKGROUND/AIM: Corona virus infection dramatically spread worldwide during 2020 and extraordinary restrictions have been implemented in order to reduce viral transmission. These measures compelled a complete restructuring of the health system, including temporary cancer screening suspension and a significant slow-down in cancer diagnoses and treatments. CASE REPORT: We report five cases of extremely advanced breast cancer referred to our Department amid the COVID-19 pandemic. These patients exhibited a poor prognosis or worse quality of life due to their oncological disease. CONCLUSION: In our opinion, both the slow-down of diagnosis and treatment of oncological disease and anxiety over COVID-19 influenced this presentation. Moreover, other patients were unable to receive palliative care. Hopefully, these cases will not develop into extremely advanced-stage disease, and we will be able to provide at least the necessary palliative care.

Incidence of pneumomediastinum in COVID-19: A single-center comparison between 1st and 2nd wave.

In this study, we compared the incidence of pneumomediastinum in coronavirus disease (COVID-19) patients during the ascending phases of the 1st and 2nd epidemic waves. Crude incidence was higher during the 2nd wave at a quasi-significant level (0.68/1000 vs. 2.05/1000 patient-days, p = 0.05). When restricting the analysis to patients who developed pneumomediastinum during noninvasive ventilation, the difference became clearly significant (0.17/1000 vs 1.36/1000 patient-days, p = 0.039). At logistic regression, predisposing factors (p = 0.031), and COVID-19 radiological severity (p = 0.019) were independently associated with pneumomediastinum. Mortality in patients with pneumomediastinum was 87.5%. However, pneumomediastinum seemed to be related to a generally worse disease presentation in hospitalized patients during the 2nd wave, rather than to a separate pattern of disease.

Advanced Stages and Increased Need for Adjuvant Treatments in Breast Cancer Patients: The Effect of the One-year COVID-19 Pandemic.

BACKGROUND/AIM: The COVID-19 lockdown includes restrictive measures and temporary health system reorganization. Resources were shifted to COVID-19 patients, screening programs were temporary suspended, and oncological care suffered slow-down. The aim of the study was to evaluate the impact of these measures on breast cancer patients. PATIENTS AND METHODS: All breast cancer patients referred to our unit from February 21, 2019 to February 21, 2021 were enrolled. Type of treatments and surgery, TNM, tumor diameter, and predictive and prognostic factors were analyzed. RESULTS: Out of 445 patients with a breast cancer diagnosis, 182 (40.9%) were enrolled in the COVID-19 group (from February 21, 2010 to February 21, 2021). These patients were compared with 263 (59.1%) patients pre-COVID-19. Tumor diameters were bigger in the COVID-19 group. Type of surgery and N staging were statistically significantly different. Extreme advanced disease incidence was significantly different between the groups (2.7% COVID-19 group vs. 0 pre-COVID-19 group, p=0.011). Incidence of post-surgical radiation-therapy was higher in the COVID-19 group. Other variables analyzed were comparable without a statistically significant difference. CONCLUSION: COVID-19 led to increased tumor dimensions, advanced N-staging, and increased need for adjuvant treatments in breast cancer.

COVID-19 Unintended Effects on Breast Cancer in Italy After the Great Lockdown.

Italy introduced social distancing measures, which limited the spread of COVID-19; all the non-life-threatening treatments have been temporarily suspended, including screening programs. This decision leads to unintended effects on the ability to detected neoplasia in their first stages. Possible future outcomes of the ability to detect new breast cancer cases based on two alternative scenarios show that the reduction in organized screening activities will limit the ability to detect no <3.43% of the new cases; the economic crisis will reduce voluntary screening, increasing the undetected new cases up to 11.73%. Cases diagnosed with delay will show up in their advanced stage along with unknown effects on mortality and health care costs. Global health care policies should be implemented to counterbalance these adverse effects.

Lymphocytes, Interleukin 6 and D-dimer Cannot Predict Clinical Outcome in Coronavirus Cancer Patients: LyNC1.20 Study.

BACKGROUND/AIM: Knowledge of Coronavirus 19 (COVID19) pathogenetic mechanisms is necessary to provide new treatment strategies. This study aims to assess how oncological disease impacts on the clinical course of COVID-19 patients. PATIENTS AND METHODS: From 1st March to 30th April 2020, 96 COVID-19 patients were classified according to clinical outcome as severe (n=67) and moderate (n=29). Demographic data, medical history, admission lymphocytes, procalcitonin (PCT), c-reactive-protein (CRP), D-dimer, and Interleukin-6 (IL-6) were collected. RESULTS: A statistically significant association was found between hypertension (p=0.007) and three or more comorbidities with severe outcomes (p=0.034). No statistical differences were found between the severe and moderate groups with regards to the rate of patients with past oncological history. However, no patient allocated in the moderate group had received oncological treatment within 12 months. Higher values of CRP, IL-6, D-Dimer and lower values of lymphocytes were reported in the severe group (p=0.0007, p=0.00386, p=0.041, and p=0.007, respectively). Using binary logistic regression, higher values of CRP (OR=8.861; p=0.012) and PCT were associated with a higher risk of severe outcome (OR=21.075; p=0.008). Within the oncological population, D-Dimer and IL-6 did not confirm their prognostic significance as in the general population (p>0.05). CONCLUSION: Specific prognostic factors for oncological patients should be designed for COVID-19 clinical practice.

Delay in Breast Cancer Treatments During the First COVID-19 Lockdown. A Multicentric Analysis of 432 Patients.

BACKGROUND/AIM: Extraordinary restrictions aimed to limit Sars-CoV-2 spreading; they imposed a total reorganization of the health-system. Oncological treatments experienced a significant slowdown. The aim of our multicentric retrospective study was to evaluate screening suspension and surgical treatment delay during COVID-19 and the impact on breast cancer presentation. PATIENTS AND METHODS: All patients who underwent breast surgery from March 11, 2020 to May 30, 2020 were evaluated and considered as the Lockdown group. These patients were compared with similar patients of the previous year, the Pre-Lockdown group. RESULTS: A total of 432 patients were evaluated; n=223 and n=209 in the Lockdown and Pre-lockdown-groups, respectively. At univariate analysis, waiting times, lymph-nodes involvement and cancer grading, showed a statistically significant difference (p<0.05). Multivariate analysis identified waiting-time on list (OR=1.07) as a statistically significant predictive factor of lymph node involvement. CONCLUSION: Although we did not observe a clinically evident difference in breast cancer presentation, we reported an increase in lymph node involvement.

Chest Computed Tomography Scoring in Patients With Novel Coronavirus-infected Pneumonia: Correlation With Clinical and Laboratory Features and Disease Outcome.

BACKGROUND/AIM: This study investigated the correlation of chest computed tomography (CT), findings, graded using two different scoring methods, with clinical and laboratory features and disease outcome, including a novel clinical predictive score, in patients with novel coronavirus-infected pneumonia (NCIP). PATIENTS AND METHODS: In this retrospective, observational study, CT scan of 92 NCIP patients admitted to Policlinico Tor Vergata, were analyzed using a quantitative, computed-based and a semiquantitative, radiologist-assessed scoring system. Correlations of the two radiological scores with clinical and laboratory features, the CALL score, and their association with a composite adverse outcome were assessed. RESULTS: The two scores correlated significantly with each other (ρ=0.637, p<0.0001) and were independently associated with age, LDH, estimated glomerular filtration rate, diabetes, and with the composite outcome, which occurred in 24 patients. CONCLUSION: In NCIP patients, two different radiological scores correlated with each other and with several clinical, laboratory features, and the CALL score. The quantitative score was a better independent predictor of the composite adverse outcome than the semiquantitative score.

Breast cancer patients with hormone neoadjuvant bridging therapy due to asymptomatic Corona virus infection. Case report, clinical and histopathologic findings.

INTRODUCTION: Breast cancer management during COVID-19 pandemic has changed and in case of COVID-19 patients with simultaneous neoplasia, it has been strongly recommended to treat Sars-CoV-2 infection firstly. PRESENTATION OF CASE: We reported a case of a 53-years-old women with early breast cancer and simultaneous asymptomatic SARS-CoV-2 infection. According to COVID-19 breast cancer recommendations she underwent hormone neoadjuvant treatment as a bridging therapy for surgery. Six months from the diagnosis, after virus eradication, patient underwent breast surgery. No SARS-CoV-2 RNA was found both in the surgical specimen and sentinel lymph node but micrometastasis were reported. During the last follow-up, the patient was in good clinical condition and started the adjuvant chemotherapy. DISCUSSION: COVID-19 outbreak determined the publication of temporary recommendation leading to an extensive use of neoadjuvant chemotherapy in breast cancer patients. Although endocrine therapy is a mainstay in the adjuvant treatment, its role in the neoadjuvant schedule is unclear. CONCLUSION: Upfront awake surgery should be preferred especially in asymptomatic COVID-19 patient with early breast cancer when monitoring of tumor response is not feasible.

Lockdown of Breast Cancer Screening for COVID-19: Possible Scenario.

BACKGROUND/AIM: Coronavirus disease is spreading worldwide. Due to fast transmission and high fatality rate drastic emergency restrictions were issued. During the lockdown, only urgent medical services are guaranteed. All non-urgent services, as breast cancer (BC) screening, are temporarily suspended. The potential of breast cancer screening programs in increasing the survival rate and decreasing the mortality rate has been widely confirmed. Suspension could lead to worse outcomes for breast cancer patients. Our study aimed to analyse the data and provide estimates regarding the temporary BC screening suspension. PATIENTS AND METHODS: Data regarding breast cancer and respective screening programs were achieved through literature research and analysis. RESULTS: Considering three different scenarios with respect to the lockdown's impact on breast cancer screening, we estimate that approximately 10,000 patients could have a missed diagnosis during these 3 months. Considering a 6-month period, as suggested by the Imperial college model, the number of patients who will not receive a diagnosis will rise to 16,000. CONCLUSION: Breast cancer screening should be resumed as soon as possible in order to avoid further breast cancer missed diagnosis and reduce the impact of delayed diagnosis.

Effect of Lockdown in Surgical Emergency Accesses: Experience of a COVID-19 Hospital.

BACKGROUND/AIM: SARS-CoV-2 pandemic imposed extraordinary restriction measures and a complete reorganization of the Health System. The aim of the study was to evaluate the impact of COVID-19 on emergency surgical department accesses. PATIENTS AND METHODS: Patients admitted to surgical emergency departments was retrospectively recorded during the Lockdown (March 11, 2020-May 3, 2020) and compared with the same number of days in 2019 and immediately before Lockdown (January 16, 2020-March 10, 2020). Diagnoses, priority levels, modes of patient's transportation, waiting times and outcomes were analysed. RESULTS: During the lockdown phase, we ob-served a reduction in the access to emergency surgical departments of 84.45% and 79.78%, com-pared with the Pre-Lockdown2019 and Pre-Lockdown2020 groups, respectively. Patient's transportation, hospitalization and patients discharge with indications to an outpatient visit, waiting and total times exhibited a significant difference during the lockdown (p<0.005). CONCLUSION: We observed a reduction of surgical emergency accesses during the lockdown. Implementing the use of the regional systems and preventing overcrowding of emergency departments could be beneficial for reducing waiting times and improving the quality of treatments for patients.

Awake breast cancer surgery: strategy in the beginning of COVID-19 emergency.

INTRODUCTION: COVID-19 is a declared worldwide pandemic. In our country, due to shortage of hospitals and beds in intensive care unit, oncological and breast cancer (BC) resources are temporarily shifted to COVID-19 patients. In addition, risk of cross-infections should be considered in these frail patients. To accomplish more surgical procedures and to reduce the length of hospital stay (LOS), fast track awake BC surgery should be implemented. The aim of the study is to estimate the effects of surgical shift in our facility during the early COVID-19 outbreak. MATERIALS AND METHODS: From 30th January 2020 to 30th of March 2020, 86 consecutive patients were retrospectively enrolled and divided into pre-COVID-19-BC and COVID-19-BC. Clinical parameters and anamnestic data were collected and analyzed. Surgical procedures, relative complications and type of anaesthesia were reported. The effect on surgical time (ST), operative room time (ORT) and length of stay (LOS) were described and examined. RESULTS: No statistical difference was found in complications rate, clinical data and surgical procedures (p > 0.05). Awake breast conservative surgery (BCS) was the most frequent procedure in COVID-19-BC (p = 0.006). A statistically significant decrease in ORT and LOS was reported in COVID-19-BC (p = 0.040 and p = 0.0015 respectively), while comparable time resulted for ST (p = 0.976). Mean ORT and LOS reduction were 20.79 min and 0.57 hospital bed days. CONCLUSION: In the "COVID-19 era", fast track awake breast surgery provides a reduction of ORT, LOS and potentially surgical treatment for a wider number of oncological patients.

Breast Cancer and COVID-19: The Effect of Fear on Patients' Decision-making Process.

BACKGROUND/AIM: Coronavirus-19 (COVID-19) pandemic outbreak is currently having a huge impact on medical resource allocation. Breast Cancer (BC) patients are concerned both with BC treatment and COVID-19. This study aimed to estimate the impact of anxiety among patients, caused by the spreading of COVID-19. PATIENTS AND METHODS: Between the 16th of January and the 20th of March 2020, we retrospectively enrolled 160 patients. Eighty-two patients with a suspected breast lesion (SBL) were divided into two groups: PRE-COVID-19-SBL and POST-COVID-19-SBL. Seventy-eight BC patients were divided into PRE-COVID-19-BC and POST-COVID-19-BC. Patient characteristics including age, marital status, SBL/BC diameter, personal and family history of BC, clinical stage and molecular subtype were recorded. Procedure Refusal (PR) and Surgical Refusal (SR) were also recorded with their reason. RESULTS: BC and SBL analysis showed no difference in pre-treatment characteristics (p>0.05). Both POST-COVID-19-SBL and POST-COVID-19-BC groups showed higher rates of PR and SR (p=0.0208, p=0.0065 respectively). Infection risk represented primary reason for refusal among POST-COVID-19 patients. CONCLUSION: COVID-19-related anxiety could affect patients' decision-making process.