Preoperative non-palpable breast lesion localization, innovative techniques and clinical outcomes in surgical practice: A systematic review and meta-analysis.

Pre-operative localization of non-palpable breast lesions with non-wired non-ionizing (NWNI) techniques may improve clinical outcomes as reoperation rate, cosmetic outcome and contribute to organizational aspects improvement in breast-conserving surgery (BCS). However only limited literature is available and clinical studies involving these forefront devices are often small and non-randomized. Furthermore, there is a lack of consensus on free margins and cosmetic outcomes definitions. The objective of the present meta-analysis was to determine the crude clinical outcomes reported for the NWNI techniques on BCS. A literature search was performed of PubMed, Embase and Scopus databases up to February 2021 in order to select all prospective or retrospective clinical trials on pre-operative breast lesion localization done with NWNI devices. All studies were assessed following the PRISMA recommendations. Continuous outcomes were described in averages corrected for sample size, while binomial outcomes were described using the weighted average proportion. Twenty-seven studies with a total of 2103 procedures were identified. The technique is consolidated, showing for both reflectors' positioning and localization nearly the 100% rate of success. The re-excision and clear margins rates were 14% (95% CI, 11-17%) and 87% (80-92%), respectively. Overall, positive margins rates were 12% (8-17%). In studies that compared NWNI and wire localization techniques, positive margin rate is lower for the first techniques (12%, 6-22% vs 17%, 12-23%) and re-excision rate is slightly higher using the latter (13%, 9-19% vs 16%, 13-18%). Pre-operative NWNI techniques are effective in the localization of non-palpable breast lesions and are promising in obtaining clear (or negative) margins minimizing the need for re-excision and improving the cosmetic outcomes. Randomized trials are needed to confirm these findings.

Preventing infectious diseases in Intensive Care Unit by medical devices remote control: Lessons from COVID-19.

The management of COVID-19 patients in the ICUs requires several and prolonged life-support systems (mechanical ventilation, continuous infusions of medications and nutrition, renal replacement therapy). Parameters have to be entered continuously into the device user interface by healthcare personnel according to the dynamic clinical condition. This leads to an increased risk of cross-contamination, use of personal protective equipment and the need for stringent and demanding protocols. Cables and tubing extensions have been utilized to make certain devices usable outside the patient's room but at the cost of introducing further hazards. Remote control of these devices decreases the frequency of unnecessary interventions and reduces the risk of exposure for both patients and healthcare personnel.

Pembrolizumab Activity in Recurrent High-Grade Gliomas with Partial or Complete Loss of Mismatch Repair Protein Expression: A Monocentric, Observational and Prospective Pilot Study.

INTRODUCTION: Pembrolizumab demonstrated promising results in hypermutated tumors of diverse origin. Immunohistochemical loss of mismatch repair (MMR) proteins has been suggested as a surrogate of hypermutation in high-grade gliomas (HGG). We evaluated the efficacy and safety of pembrolizumab in relapsing HGGs with immunohistochemical loss of at least 1 MMR protein. Molecular biomarkers of pembrolizumab activity were also analyzed. METHODS: Consecutive patients with recurrent HGG and partial or complete loss of MMR protein expression were prospectively enrolled; they received pembrolizumab 200 mg once every 3 weeks until disease progression. The primary endpoint was disease control rate (DCR). Post hoc exploratory analyses included next-generation sequencing to assess tumor mutational burden (TMB), and immunostaining for CD8+ T-cells and CD68+ macrophages. RESULTS: Among 310 HGG patients screened, 13 cases with MMR loss were enrolled: eight glioblastoma, four anaplastic astrocytoma, and one anaplastic oligodendroglioma. Median age was 43 years. DCR was 31%: four patients had stable disease and no patient had complete or partial response. TMB ranged between 6.8 and 23.4 mutations/megabase. Neither TMB nor gene mutations, nor CD8+ T-cell and CD68+ macrophage content, were associated with pembrolizumab activity. CONCLUSIONS: pembrolizumab showed no apparent benefit in these patients. No molecular biomarker was found to be associated with pembrolizumab activity.

COVID-19: ensuring our medical equipment can meet the challenge.

To predict the spread of coronavirus disease globally and consequently prepare the hospital facilities with the required technology is a challenge. The availability of essential medical equipment to support patients affected by Covid-19 is globally limited. Areas covered This perspective gives a technical view of the pandemic focusing on the main actions taken by regulatory agencies to cope with the shortage of devices. The risk/benefit assessment and the main infection control policies in the clinical practices are also looked at. Expert opinion Regulatory agencies have amended their medical devices directives to address the pandemic, but each in a different way. In this exceptional situation scientist and technology experts in collaboration with medical specialists should work together to re-assess the risk analysis on medical equipment management and their use and re-use in this context with the aim to improve global health care Every effort must be made to provide the necessary devices at least with the minimum acceptable performances for Covid-19 patients while maintaining a high standard of safety for users. The aim of the present manuscript is to highlight the technical challenges in order to prevent, through targeted actions, operating standards from falling below the standards of care due to a lack of medical devices. Abbreviations AKI: acute Kidney Injury; ARGMD: Australian Regulatory Guidelines for Medical Devices; Covid-19: Coronavirus disease; FDA: Food and Drug Administration; ECMO: Extracorporeal Membrane Oxygenation; EU: European Union; ICU: Intensive Care Unit; WHO: World Health Organization; MHRA: Medicines and Healthcare products Regulatory Agency; MDR: Medical Device Regulation; SARI: Severe Acute Respiratory Infection.

Cost-effectiveness of a melanoma screening programme using whole disease modelling.

OBJECTIVE: To assess the potential impact of a melanoma screening programme, compared with usual care, on direct costs and life expectancy in the era of targeted drugs and cancer immunotherapy. METHODS: Using a Whole Disease Model approach, a Markov simulation model with a time horizon of 25 years was devised to analyse the cost-effectiveness of a one-time, general practitioner-based melanoma screening strategy in the population aged over 20, compared with no screening. The study considered the most up-to-date drug therapy and was conducted from the perspective of the Veneto regional healthcare system within the Italian National Health Service. Only direct costs were considered. Sensitivity analyses, both one-way and probabilistic, were performed to identify the parameters with the greatest impact on cost-effectiveness, and to assess the robustness of our model. RESULTS: Over a 25-year time horizon, the screening intervention dominated usual care. The probabilistic sensitivity analyses confirmed the robustness of these findings. The key drivers of the model were the proportion of melanomas detected by the screening procedure and the adherence of the target population to the screening programme. CONCLUSIONS: The screening programme proved to be a dominant option compared with usual care. These findings should prompt serious consideration of the design and implementation of a regional or national melanoma screening strategy within a National Health Service.

Desmoid Fibromatosis of the Abdominal Wall: Surgical Resection and Reconstruction with Biological Matrix Egis®.

Desmoid tumor is a rare monoclonal fibroblast proliferation that is regarded as benign. The clinical management of desmoid tumors is very complex and requires a multidisciplinary approach because of the unpredictable disease course. For those cases localized in the anterior abdominal wall, symptomatic and unresponsive to medical treatment, radical resection and reconstruction with a prosthetic device are indicated. We present here a case of desmoid fibromatosis of the left anterolateral abdominal wall with a marked increase of the mass that required a large excision followed by reconstruction with biological matrix. The fact that it can be incorporated in patient tissue without a fibrotic response and that it can resist future infections, together with a very competetive price, made the new collagen matrix Egis® our first choice.

Clinical results and economic considerations of 68Ga-PSMA and radiolabeled choline in prostate cancer.

In recent years there was an impressive improvement in the options for the management of patients with prostate cancer. Nuclear Medicine has significantly enriched its diagnostic options, both in radiopharmacy and in instrumentation, in order to accurately target prostatic cancer cells, thus rendering the physicians able to adopt the best therapeutic strategy. In the present analysis, we have evaluated the available published data about 68Ga-PSMA and radio-labeled choline, two radiopharmaceutical agents for positron emission tomography/computed tomography (PET/CT) examination, by reporting clinical information and considering data about legal, economic and organization aspects.

A Case of "en bloc" Excision of a Chest Wall Leiomyosarcoma and Closure of the Defect with Non-Cross-Linked Collagen Matrix (Egis®).

Sarcomas arising from the chest wall account for less than 20% of all soft tissue sarcomas, and at this site, primitive tumors are the most frequent to occur. Leiomyosarcoma is a malignant smooth muscle tumor and the best outcomes are achieved with wide surgical excision. Although advancements have been made in treatment protocols, leiomyosarcoma remains one of the more difficult soft tissue sarcoma to treat. Currently, general local control is obtained with surgical treatment with wide negative margins. We describe the case of a 50-year-old man who underwent a chest wall resection involving a wide portion of the pectoralis major and minor muscle, the serratus and part of the second, third and fourth ribs of the left side. The full-thickness chest wall defect of 10 × 8 cm was closed using a non-cross-linked acellular dermal matrix (Egis®) placed in two layers, beneath the rib plane and over it. A successful repair was achieved with no incisional herniation and with complete tissue regeneration, allowing natural respiratory movements. No complications were observed in the postoperative course. Biological non-cross-linked matrix, derived from porcine dermis, behaves like a scaffold supporting tissue regeneration; it can be successfully used as an alternative to synthetic mesh for chest wall reconstruction.

Diffusion-weighted magnetic resonance imaging in the characterization of axillary lymph nodes in patients with breast cancer.

PURPOSE: To assess prospectively the accuracy of diffusion-weighted magnetic resonance imaging (DWI) in differentiating between metastatic and benign axillary lymph nodes in patients with breast cancer. MATERIALS AND METHODS: In all, 215 patients with histologically proven breast cancer, prior to axillary dissection, underwent breast and axillary 1.5 T MRI. In 102 patients in whom at least one axillary lymph node with a short axis of 6 mm or more was found the apparent diffusion coefficient (ADC) was measured in one lymph node per patient by means of an echo planar, parallel imaging DWI sequence. Forty-three lymph nodes were finally included which, on histological examination, either contained a metastasis larger than 5 mm or were metastasis-free; nodes with metastases smaller than 5 mm were excluded. RESULTS: From histological examination, 19/43 lymph nodes had a metastasis at least 5 mm, while in 24/43 no malignant cells were found. The ADC values of the lymph nodes with metastases (mean: 0.878 × 10(-3) mm(2) /s; range: 0.30 -1.20) were significantly lower (P < 0.001) than those of the benign lymph nodes (mean: 1.494; range: 0.60 -2.50). Adopting a threshold value of 1.09 × 10(-3) mm(2) /s DWI resulted in 94.7% sensitivity, 91.7% specificity, and 93.0% accuracy in the identification of metastasis in this series of lymph nodes. CONCLUSION: From these preliminary data DWI seems a promising method in the differential diagnosis between metastatic and benign axillary lymph nodes in patients with breast cancer.