IRIS UniSR (’Università Vita-Salute San Raffaele)
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Predictors of acute toxicity and flap failure after adjuvant treatment for locally advanced head and neck cancer.
Extracorporeal Blood Purification with CytoSorb in Patients with Shock: A Secondary Analysis of Standalone Circuit Configuration Versus Integrated Use within Extracorporeal Membrane Oxygenation in 359 Critically Ill Patients
Objectives: CytoSorb, an extracorporeal blood purification device composed of biocompatible, highly porous polymer beads, is being increasingly adopted in different critically ill settings to allow for both enhanced organ protection and control of inflammation derangement. This investigation aimed to evaluate the characteristics and performances of two different CytoSorb circuit configurations to inform clinical practice. Design: We performed a secondary analysis of the largest available cohort of critically ill patients undergoing hemoadsorption with CytoSorb. Setting: Cardiac intensive care unit of a tertiary referral center university-hospital. Participants: Critically ill patients receiving CytoSorb. Interventions: CytoSorb as a standalone circuit was compared to the CytoSorb cartridge integrated within the extracorporeal membrane oxygenation (ECMO) circuit. Measurement and Main Results: Among the 359 patients included in the study, 148 (41%) received CytoSorb treatment with a standalone circuit and 211 (59%) had the CytoSorb cartridge integrated into the ECMO circuit. The reasons for ICU admission differed between the two groups, with patients in the ECMO group exhibiting higher inotropic load at baseline. Renal replacement therapy was administered in up to 34% of the overall population, with significantly greater use among those receiving ECMO support (p < 0.001). Across both groups, patients received a median of two CytoSorb cartridges within a single cycle, and the duration of each cartridge and CytoSorb efficacy, assessed by reduction in inotropic load and improvement in laboratory exams, were comparable in both groups. Both ICU and hospital survival were higher in patients treated with CytoSorb as a standalone circuit (54.1% v 34.1%, p < 0.001, and 49.3% v 30.8%, p < 0.001, respectively). Conclusions: CytoSorb treatment proved safe and effective in both configurations. Despite substantial intergroup diversity at baseline and in their clinical outcomes, the choice of CytoSorb configuration had no impact on cartridge performance and duration.Objectives: CytoSorb, an extracorporeal blood purification device composed of biocompatible, highly porous polymer beads, is being increasingly adopted in different critically ill settings to allow for both enhanced organ protection and control of inflammation derangement. This investigation aimed to evaluate the characteristics and performances of two different CytoSorb circuit configurations to inform clinical practice. Design: We performed a secondary analysis of the largest available cohort of critically ill patients undergoing hemoadsorption with CytoSorb. Setting: Cardiac intensive care unit of a tertiary referral center university-hospital. Participants: Critically ill patients receiving CytoSorb. Interventions: CytoSorb as a standalone circuit was compared to the CytoSorb cartridge integrated within the extracorporeal membrane oxygenation (ECMO) circuit. Measurement and Main Results: Among the 359 patients included in the study, 148 (41%) received CytoSorb treatment with a standalone circuit and 211 (59%) had the CytoSorb cartridge integrated into the ECMO circuit. The reasons for ICU admission differed between the two groups, with patients in the ECMO group exhibiting higher inotropic load at baseline. Renal replacement therapy was administered in up to 34% of the overall population, with significantly greater use among those receiving ECMO support (p < 0.001). Across both groups, patients received a median of two CytoSorb cartridges within a single cycle, and the duration of each cartridge and CytoSorb efficacy, assessed by reduction in inotropic load and improvement in laboratory exams, were comparable in both groups. Both ICU and hospital survival were higher in patients treated with CytoSorb as a standalone circuit (54.1% v 34.1%, p < 0.001, and 49.3% v 30.8%, p < 0.001, respectively). Conclusions: CytoSorb treatment proved safe and effective in both configurations. Despite substantial intergroup diversity at baseline and in their clinical outcomes, the choice of CytoSorb configuration had no impact on cartridge performance and duration
Ectoparasite- and Vector-Borne-Related Dermatoses: A Single-Centre Study with Practical Diagnostic and Management Insights in a One Health Perspective
Background: Parasitic skin-related conditions represent a frequent and evolving challenge in human dermatology, as they often mimic other dermatoses, and are increasingly complicated by therapeutic resistance. With this study, we aimed to provide a practical, clinician-oriented overview of our experience, contextualising it within the current literature. Materials and Methods: We conducted a retrospective, single-centre observational study, reporting a case series of 88 patients diagnosed with parasitic or arthropod-related skin infestations at the San Raffaele Hospital Dermatology Unit (Milan) between 2019 and 2024, and integrated a concise narrative review of contemporary evidence on diagnosis, non-invasive imaging and management. For each case, we documented clinical presentation, dermoscopic or reflectance confocal microscopy (RCM) findings, and treatment response. Non-invasive tools (dermoscopy, videodermoscopy, RCM) were used when appropriate. Results: The spectrum of conditions included flea bites, bed bug bites, cutaneous larva migrans, subcutaneous dirofilariasis, Dermanyssus gallinae dermatitis, pediculosis, tick bites (including Lyme disease), myiasis, scabies, and cutaneous leishmaniasis. One case of eosinophilic dermatosis of haematologic malignancy was also considered due to its possible association with arthropod bites. Non-invasive imaging was critical in confirming suspected infestations, particularly in ambiguous cases or when invasive testing was not feasible. Several cases highlighted suspected therapeutic resistance: a paediatric pediculosis and three adult scabies cases required systemic therapy after standard regimens failed, raising concerns over putative resistance to permethrin and pyrethroids. In dirofilariasis, the persistence of filarial elements visualised by RCM justified the extension of antiparasitic therapy despite prior surgical removal. Conclusions: Our findings underline that accurate diagnosis, early intervention, and tailored treatment remain essential for the effective management of cutaneous infestations. The observed vast spectrum of isolated parasites reflects broader health and ecological dynamics, including zoonotic transmission, international mobility, and changing environmental conditions. At the same time, diagnostic delays, inappropriate treatments, and neglected parasitic diseases continue to pose significant risks. To address these challenges, clinicians should remain alert to atypical presentations, and consider a multidisciplinary approach including the consultation with parasitologists and veterinarians, as well as the incorporation of high-resolution imaging and alternative therapeutic strategies into their routine practice
Infondatezza normativa e ineluttabilità del giudizio: ritratti fenomenologici dei paradossi della giustizia
This paper discusses the aporias of judgment by analyzing Alessio Lo Giudice’s recent book “The Tragedy of Judgment”. These aporias consist in the fact that the judge is a human being judging another - which means he is never perfectly impartial -, in the lack of a universal notion of justice, and in the leap over the uncertainties of imputed events. Lo Giudice employs Hannah Arendt’s appropriation of the Kantian reflective judgment to grasp the features of juridical judgment. This contribution further delves into the aporia of the personality of judgment by analyzing its contraries: “nobody can judge” with Arendt and “nobody’s judgment” with Kafka. Thereby the enormous risks of impersonal judgment will be exposed
Glucagon-like peptide-1 receptor agonists for prevention of heart failure events in type 2 diabetes and/or obesity
INTRODUCTION: Heart failure (HF) is a common sequela of diabetes and obesity. Glucagon-like peptide-1 (GLP-1) receptor agonists may prevent HF events. This meta-analysis estimates absolute risk reduction (ARR) and number needed to treat (NNT) for GLP-1 receptor agonists to prevent one HF event in patients with type 2 diabetes and/or obesity, including those without baseline HF. METHODS: The Medline, Embase, and Cochrane Central databases were searched to 04 April 2025 for placebo-controlled randomized controlled trials (RCTs) of GLP-1 receptor agonists in a type 2 diabetes and/or obesity indication with a prespecified HF event endpoint. Random effects meta-analysis using the Mantel-Haenszel Method was performed to synthesize risk ratios (RR), ARRs, and NNTs with 95% confidence intervals (CI). RESULTS: Twelve placebo-controlled RCTs involving 95 023 patients were included. GLP-1 receptor agonists reduced HF events by 12% (RR 0.88, 95% CI 0.82-0.95; ARR 0.42%, 95% CI 0.17%-0.62%; NNT 238, 95% CI 161-588), and, in those without baseline HF, by 19% (RR 0.81, 95% CI 0.72-0.90; ARR 0.60%, 95% CI 0.32%-0.89%; NNT 167, 95% CI 113-313). Semaglutide reduced the risk of HF events by 16% (RR 0.84, 95% CI 0.74-0.95; ARR 0.62%, 95% CI 0.19%-1.00%; NNT 161, 95% CI 100-526), and by 31% in those without baseline HF (RR 0.69, 95% CI 0.55-0.88; ARR 1.25%, 95% CI 0.48%-1.82%; NNT 80, 95% CI 55-208). CONCLUSION: GLP-1 receptor agonists have limited absolute benefit for preventing HF events in patients with type 2 diabetes and/or obesity, including in those without baseline HF. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD420251074882
Defining a standards framework for ophthalmology real-world data methodologies through an expert-led Delphi consensus
Background/Objectives: Real-world data (RWD) is becoming increasingly important in ophthalmology, offering insights into clinical outcomes, therapeutic approaches, and healthcare practices. However, methodological variability limits comparability and generalisability across RWD studies. This Delphi consensus aimed to establish expert agreement on the need for standardised methodologies in ophthalmology RWD studies, identify the key clinical and patient-reported data elements that should be collected, and explore strategies for consistent implementation. Methods: A modified Delphi methodology was followed. A steering committee (SC) of three ophthalmologists developed 38 consensus statements across five key topics. These statements were developed into an online four-point Likert scale survey and distributed to healthcare professionals experienced in managing retinal diseases via members of The Ophthalmology Network. Consensus was defined a priori as ≥75% agreement. Results were shared with the SC and key recommendations were discussed. Results: A total of 244 responses were received, predominantly from retina specialists (n = 232, 95%), with broad representation across six regions, the largest being Europe (n = 116, 48%). Consensus was achieved for all 38 statements, with 36 (95%) reaching ≥90%. These statements covered key principles, including: variability of current standards, ideal clinical standards for RWD collection, RWD analysis methodology, ideal patient-reported standards, and implementing and reporting consistent standards/frameworks. As the stopping criteria were met, no further Delphi rounds were conducted. Eight key recommendations were developed. Conclusions: The outputs from this consensus aim to guide future ophthalmology RWD studies towards improved consistency, reliability, and generalisability, ultimately strengthening the evidence base for clinical decision-making to improve patient outcomes
A National Position Paper for the Strategic Development of HealthCare Simulation in Italy
Background: Simulation-based education is an essential tool in modern health care, enhancing technical, behavioral, and decision-making skills while improving patient safety and clinical outcomes. In Italy, health care simulation has developed over the past 2 decades, with multiple scientific societies and educational initiatives promoting its use. However, the absence of national data and standardized educational frameworks presents a barrier to its widespread adoption. Recognizing these challenges, the Italian Ministry of Health convened a panel of experts to establish a strategic framework for simulation in health care, aiming to standardize methodologies, promote quality assurance, and foster collaboration across institutions. Methods: The panel, composed of experts in health care simulation, clinical practice, and risk management, conducted a series of telematic meetings from April 2022 to July 2022. A consensus-driven approach was adopted to review existing literature, identify key areas for development, and formulate practical recommendations. Results: Key recommendations include: establishing a national registry of simulation programs, defining accreditation criteria for simulation-based education, standardizing professional competencies for simulation educators, integrating simulation into health care curricula and continuous professional development, developing national standards for simulation-based training in new technologies and clinical procedures, utilizing simulation in public health preparedness and emergency response planning, promoting research funding and inter-institutional collaborations. Conclusion: This position paper provides a strategic roadmap for standardizing simulation-based education across the Italian health care system. By establishing national standards and fostering collaboration, simulation can significantly improve patient safety, care quality, and health care system resilience
Response to ‘Towards an individualized strategy in perioperative chemotherapy for pancreatic cancer’
Quantitative assessment of gastric tube perfusion during Ivor Lewis esophagectomy using indocyanine-green: results from the prospective interventional trial SPY Q-ICG PAS study
Background: Indocyanine green (ICG) fluorescence angiography is increasingly used to assess the vascularization of abdominal organs. In recent years, there has been a growing need to move beyond the subjectivity associated with its qualitative assessment by introducing objective quantification parameters (Q-ICG). The aim of this study is to identify a potential correlation between Q-ICG parameters and the risk of anastomotic leakage (AL) following Ivor Lewis esophagectomy for cancer. Methods: The SPY Q-ICG PAS study (NCT05489757) is a single-center, prospective, interventional trial conducted at San Raffaele Hospital in Milan between 2022 and 2023. In all patients undergoing Ivor Lewis esophagectomy for cancer, the following Q-ICG parameters were evaluated at the end of gastric conduit creation: maximum intensity (Fmax), half of Fmax intensity (F1), plateau intensity, intensity at the future anastomosis site, the time to reach F1 intensity (T1), the time to reach Fmax (time-to-peak, TTP), the ratio of TTP and T1 (TR), and Slope (Fmax/TTP). Results: Overall, 7 out of 76 patients (9.2%) experienced AL. No statistically significant differences were found between the AL and no-AL groups in terms of perioperative variables. Considering the Q-ICG parameters, the AL group exhibited longer T1 (17 ± 10 vs. 7 ± 2 s; p < 0,001), higher TR (0.71 ± 0.09 vs. 0.40 ± 0.10; p < 0,001), and lower Slope (3.94 ± 1.98 vs. 6.26 ± 2.79; p = 0.04). After multivariate analysis, T1 remained the only independent predictive factor for AL (OR = 5.613; p = 0.044). Moreover, a T1 of 9.50 s was identified as the best cut-off able to correctly classify patients in terms of AL in 89% of cases, with a sensitivity of 100% and a specificity of 88% (p < 0.001). Conclusions: Among all Q-ICG parameters, T1 resulted the best indicator for identifying patients at higher risk of developing postoperative AL following Ivor Lewis esophagectomy