Diagnostic Agreement Between TEG5000 and TEG6S in the Assessment of Hemostasis in Pediatric Cardiac Surgery: A Prospective Non-inferiority Study.

Thromboelastography (TEG) is a point-of-care test (POCT) used to analyze the hemostatic properties of whole blood. TEG® 5000and TEG® 6s (Haemonetics Corp, USA) measure the same parameters describing clot viscoelasticity using different methodologies. The purpose of this study was to evaluate agreement between TEG5000 and TEG6s measurements. We analyzed prospectively collected tests resulting from paired blood samples in cardiac surgery pediatric patients at one hour (T0) and 24 h (T1) postoperatively. Each citrated sample was utilized for TEG® 5000 and TEG ®6s. Six specific TEG parameters were analyzed and compared: R kaolin time (RK), R kaolin heparinase (RKH) time, K kaolin time (KK), K kaolin heparinase time KH (KKH), Maximum Amplitude kaolin (MAK), Maximal Amplitude Kaolin Heparinase (MAKH). We enrolled 30 patients. Median (interquartile range) patients' age was 206 (20-597) days. All surgical patients underwent correction except 5 who were palliated. At T0, RK and RKH showed an average (standard deviation) % bias of 15.8 (31) and 16.1 (28), respectively, with similar results at T1. A % bias of -6 (23) and - 6 [15] in MAK was found at T0 and T1, respectively. Similarly, MAKH % bias was 1.5 (22) and 7.6 (29) at T0 and T1, respectively. At both timepoints, low % biases (< ± 6%) were demonstrated in KK and KKH. All parameters showed improved coagulation from T0 to T1, but without significant interaction between type of device and time. Analysis of the entire pool of 60 paired samples showed no agreement in diagnostic performance (within the range vs. outside the range) in 12 (20%), 5 (9.8%), 1 (1.7%), 4 (7.8%), 9 (15%), and 5 (9.8%) cases for RK, RKH, MAK, MAKH, KK and KKH, respectively. We observed substantial agreement in MAK and KK in a cohort of pediatric patients undergoing uncomplicated cardiac surgery. Our findings suggest that TEG®5000 and TEG®6s are interchangeable for assessing these parameters.

Awake Breast Surgery: A Systematic Review.

BACKGROUND/AIM: Awake surgery has become a valid alternative to general anesthesia in many surgery fields. This technique played a very important role during the COVID-19 period. The growing use of this technique has many advantages. We performed a systematic review to study the potentialities of awake breast surgery. MATERIALS AND METHODS: We searched Pubmed, Embase, and Cochrane library database and retrieved a total of 109 records. Forty-nine of them were excluded as unsuitable. Finally, we selected a total of 12 records concerning different types of studies for topic appropriateness. Three reviewers reviewed independently each record. RESULTS: Five articles analyzing the sustainability of awake surgery during the COVID-19 period were selected. In addition, one article analyzing the impact on the immune system and six articles and eight case reports analyzing anesthetic techniques were also selected. The studies analyzing awake breast surgery during the COVID-19 period showed advantages in terms of sustainability and length of hospitalization. The study analyzing the immune response after awake breast surgery showed lesser lymphocyte response than the general anesthesia group. The studies analyzing anesthetic techniques in awake breast surgery showed that the nerve blocks allow good level of safety and postoperative pain control. CONCLUSION: The awake breast surgery and fast track implementation shortened hospital stays and reduced costs, without influencing the surgical results. Furthermore, awake breast surgery reduced surgical stress compared to general anesthesia. Among the various anesthetic techniques, nerve blocks are the most advantageous in terms of safety and efficacy compared to epidural anesthesia.

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.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in a young transgender woman: A case report.

INTRODUCTION: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare T-cell lymphoma occurring after breast implant procedures. As gender confirmation therapy (GCT) in male-to-female transgender (FT), up to 60-70 % of patients require breast augmentation and are at risk for BIA-ALCL. Hence, we report the youngest BIA-ALCL case in the Italian population and the first early-stage BIA-ALCL occurred in FT patients. CASE PRESENTATION: A 27-years-old FT was admitted to outpatients' clinics due to swollen left breast. The patient underwent GCT with a macrotextured implant four years before. Clinical examination revealed swollen left breast. Ultrasound and magnetic resonance imaging confirmed left breast periprosthetic effusion. Positron emission tomography-computed tomography scan did not reveal any focal pathological uptake. Fine needle aspiration cytology confirmed BIA-ALCL suspect. The patient underwent bilateral en bloc breast implant removal and periprosthetic capsulectomy. Due to the early stage, adjuvant chemotherapy was omitted. Postoperative follow-up was unremarkable. CLINICAL DISCUSSION: BIA-ALCL is a rare, emergent clinical concern after breast implant surgery. GCT leads to improved body satisfaction and quality of life in FT individuals. As for non-trans patients undergoing breast reconstruction or breast augmentation, this clinical case once again demonstrates that FT patients undergoing breast implant surgery are at risk of BIA-ALCL. CONCLUSION: Physicians should promote awareness among patients' GCT and tailored postoperative follow-up.

Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Α Randomized Controlled Trial.

BACKGROUND/AIM: Erector spinae plane block (ESP Block) was introduced in 2016 as a surgical post-operative analgesia procedure. The present prospective, randomized trial aimed to compare ESP Block with serratus plane block (SPB) plus pectoral nerve blocks (PECS I) during breast conserving surgery (BCS). PATIENTS AND METHODS: Between February 2019 and March 2021, 104 patients undergoing BCS were randomized to receive either ESP block (ESP group n=54) or SPB+PECS I (SPB group=49). Assessment of postoperative pain was recorded by the dynamic and static visual analog scale (VAS) and was compared between groups. RESULTS: Between-group two-way ANOVA did not reach a statistically significant difference in static and dynamic VAS (p=0.879; p=0.917, respectively). Despite ESP group requiring for higher value of patient-controlled analgesia (PCA) bolus, no statistically significant difference was found in PCA activation pattern between groups (p=0.109). ESP block was a faster technique when compared to SPB+PECS I (p=0.007) and no complications or opioid side-effects were recorded in all groups examined. CONCLUSION: ESP Block could represent a safe, faster alternative with a single injection to SPB+PECS I in BCS.

Feasibility and Oncological Safety of Axillary Reverse Mapping in Patients With Locally Advanced Breast Cancer and Partial Response After Neoadjuvant Chemotherapy.

BACKGROUND/AIM: Axillary reverse mapping (ARM) aims to identify and preserve arm drainage in order to prevent lymphedema following axillary lymph node dissection. Oncological-safety and feasibility are still debated, especially in patients with locally-advanced breast cancer (LABC). We report the first case of the AXMAP 1.0 study performed in our Institution. PATIENTS AND METHODS: A 52-year-old patient with a triple-negative LABC and partial response to neoadjuvant chemotherapy underwent axillary lymph-node dissection using fluorescence ARM. RESULTS: Two lymph-nodes draining the ipsilateral upper arm were identified and were not preserved due to suspicion of malignancy. Pathological examination confirmed the presence of malignancy in both lymph nodes. CONCLUSION: Further studies should be designed in order to validate the oncological safety of this technique, especially in patients with LABC requiring neoadjuvant chemotherapy.

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.

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.

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.

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.

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.

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.

Impact of Awake Breast Cancer Surgery on Postoperative Lymphocyte Responses.

BACKGROUND: Surgical stress and anesthesia affect the patient's immune system. Analysis of the lymphocyte response after breast-conserving surgery was conducted to investigate the differences between effects after general and local anesthesia. MATERIALS AND METHODS: Fifty-six patients with breast cancer were enrolled for BCS through local or general anesthesia. Total leukocytes, total lymphocytes, lymphocyte-subsets including CD3+, CD19+, CD4+, CD8+, CD16+CD56+ and CD4+/CD8+ ratio was examined at baseline and on postoperative days 1, 2 and 3. RESULTS: Baseline data showed no statistical difference between the two groups. Within-group ANOVA test showed significant differences for total leukocyte count (p<0.001), total lymphocyte count (p=0.009) and proportion of natural-killer cells (p=0.01) in the control group. Between-group analysis showed lower median values of total lymphocytes in the awake surgery group on postoperative days 1, 2 and 3 (p=0.001, p=0.02 and p=0.01, respectively) when compared to the control group. Patients who underwent surgery under general anesthesia had higher total lymphocyte counts on postoperative day 2 (p=0.04). CONCLUSION: In this randomized study, breast-conserving surgery plus local anesthesia had a lower impact on postoperative lymphocyte response when compared to the same procedure performed under general anesthesia.

Safety and efficacy of citrate anti-coagulation continuous renal replacement therapies in post-cardiac surgery patients with liver dysfunction.

The study's aim was to examine safety and efficiency of citrate anticoagulated continuous renal replacement therapies (CRRT) in cardiac surgery patients with acute kidney injury and associated liver dysfunction. The study was conducted on critical ICU patients, hospitalized after cardiac surgery, who developed renal and liver acute failures due to low-flow syndrome. CRRT in continuous veno-venous hemodiafiltration with regional citrate anticoagulation (RCA) was prescribed to address renal failure and avoid bleeding-risk. Patient Ca(++) was measured to monitor RCA safety, while thromboelastography (TEG) and circuit Ca(++) were used to verify efficacy. CRRT effectiveness was evaluated through creatinine and urea levels, while liver function was monitored through bilirubin, aspartate aminotransferase, glutamic oxaloacetic transaminase (AST GOT) and gamma glutamyl transferase (GT) levels. The study did not require ethical approval. Hepatic and renal failures were confirmed by baseline levels (total bilirubin=3.1 ± 3.37 mg/dL, AST GOT=153 ± 147 U/L and gamma GT=93.3 ± 86 IU/L, creatinine=1.97 ± 0.88 and blood urea nitrogen [BUN] 98.13 ± 71.34) assessed in 15 patients. During treatment, Ca(++) (patient and circuit) remained stable and within range for the whole therapy thanks to low citrate dose (2.8 ± 0.3 mmol/L of blood), while hepatic markers did not show any significant changes the therapy, although treatment with citrate is contraindicated in patients with hepatic failure. RCA quality was confirmed by TEG values, which showed an anticoagulated circuit with no effects on patients. These results involved a high filter lifespan (49.76 ± 22.10 h) and with an effective creatinine and BUN clearance. No episodes of citrate intoxication were reported (total/ionized calcium ratio remained stable and physiologic). RCA during CRRT with dilute solutions proved both effective and safe, even in patients with acute liver failure.