IRIS UniSR (’Università Vita-Salute San Raffaele)
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Apical Access Management in Transapical Transcatheter Mitral Valve Replacement
Background: The role of the surgical technique and anatomy in transapical mitral valve replacement are scarcely investigated. Methods: Computed tomography scans, surgical reports and planning slides of 127 patients undergoing transapical mitral valve replacement with the Tendyne valve system (Abbott Vascular) at 15 centers, participating in a European observational study, were retrospectively analyzed and compared between patients with (cohort A) and without (cohort B) apical access complications (AACs). Results: A total of 8 (6.3%) AACs were recorded, of which 7 of 8 were observed in the first 10 patients of the respective center. Patients with AACs showed a trend to a thinner myocardium at the target access compared with those with regular access (median 4.4 vs 6.1 mm, P = .086). Technical difficulties along with AACs were reflected by a significant longer procedural time (median 180 vs 123 min, P = .011), higher rates of circulation support (50% vs 0%, P < .001), valve retrieval (38% vs 3%, P = .005), and bailout full sternotomy (13% vs 0%, P = .063). AACs were related with an intraprocedural mortality and in-hospital mortality rate of 25% (vs 0%, P = .010) and 50% (vs 7%, P = .003), respectively. In total, 8 of 12 in-hospital deaths were attributed to AACs and/or sepsis. AACs significantly increased the risk for 30-day (adjusted odds ratio, 19.5; 95% CI, 2.19–178.3; P = .008) and in-hospital mortality (adjusted hazard ratio, 9.00; 95% CI, 1.95–41.42; P = .005). Conclusions: Access complications in transapical mitral valve replacement are relatively rare but associated with poor short-term outcome. Focus on the apical myocardium within the screening process and specific surgical training might avoid AACs and improve outcome
Predictors of Nurses' Job Satisfaction in Home Care Settings: Findings From the AIDOMUS‐IT Study
ABSTRACTIntroduction: Nurses' job satisfaction in hospitals is fundamental for the quality of care and the safety of patients. However,sociodemographic trends require moving care to patients' homes, and the predictors of job satisfaction for nurses working in thehome care settings remain largely unknown. Therefore, the aim of this study was to investigate job satisfaction of nurses workingin Italian home care settings and its determinants.Design: Multicenter observational cross-sectional study.Methods: This study was conducted in the districts of 70 local health authorities in Italy. Data on the characteristics of the or-ganization and nurses were collected. Nursing job satisfaction was evaluated on a four-point scale ranging from “very satisfied”to “very dissatisfied.” Additionally, the following variables were assessed: workload, quality of leadership, work–private life con-flict, burnout symptoms, possibility for development, staffing and resource adequacy, nurse manager ability, safety climate, andteamwork climate. A logistic regression analysis was conducted to identify factors influencing job satisfaction.Results: Only organizational variables had a predictive value for nurses' job satisfaction. Workload (OR = 1.01; p = 0.033), work–private life conflict (OR = 1.02; p < 0.001), burnout (OR = 1.02; p < 0.001), and staffing inadequacy (OR = 1.44; p = 0.003) pre-dicted higher levels of nurse dissatisfaction. Instead, high-quality leadership (OR = 0.981; p < 0.001), possibility for development(OR = 0.973; p < 0.001), and good teamwork climate (OR = 0.994; p = 0.003) were predictors of better levels of satisfaction.Conclusions: This study suggested that home care nurses are generally satisfied with their jobs. To enhance job satisfaction, it is essential to improve nurses' work environment, the leadership quality and ensure professional development
Age Matters in Multiple Sclerosis: Novel Insights Into Disease Progression From Clinical Onset
Conformational Antibodies to Proteolipid Protein-1 and Its Peripheral Isoform DM20 in Patients With CNS Autoimmune Demyelinating Disorders
Background and ObjectivesAntibodies to proteolipid protein-1 (PLP1-IgG), a major central myelin protein also expressed in the peripheral nervous system (PNS) as the isoform DM20, have been previously identified mostly in patients with multiple sclerosis (MS), with unclear clinical implications. However, most studies relied on nonconformational immunoassays and included few patients with non-MS CNS autoimmune demyelinating disorders (ADDs). We aimed to investigate conformational PLP1-IgG in the whole ADD spectrum. METHODS We devised a new live cell-based assay (CBA) for PLP1-IgG and used it to test 2 cohorts (retrospective exploratory, n = 284; prospective validation, n = 824) of patients with ADDs and controls (n = 177). Patients were classified as MS, neuromyelitis optica spectrum disorders (NMOSDs), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), and other ADDs. PLP1-IgG-positive samples were tested for IgG subclasses, DM20-IgG, and on rat brain tissue-based ..
Obesity and blunted FGF23 response associate with kidney impairment in patients with hypoparathyroidism
Purpose: Chronic kidney disease (CKD) is a common complication of patients affected by chronic hypoparathyroidism managed with conventional therapies. However, no data are currently available regarding the endocrine and metabolic determinants of renal function in these patients. Methods: This was a multicenter observational study performed in three health-care centres. Patients with hypoparathyroidism were consecutively enrolled during follow-up visits in 2022–2023. These exclusion criteria were adopted: patients managed with dialysis, proteinuria (>200 mg/24 h), use of antihypertensive drugs including thiazides, ACE-inhibitors, angiotensin-II-receptor antagonists, alpha-beta blocking-agents, aldosterone-antagonists, and insulin-treated diabetes. Results: A total of 46 patients were enrolled. Median age was 53 years, 34 (74%) were female and the median disease duration was 11 years. In all patients, the calcium-phosphate product was within the normal range. The 23.7% of patients was obese (BMI ≥ 30) and CKD (defined with an eGFR < 60 mL/min1.73m2) was found in the 21.7% of patients. Patients with CKD were older, affected by a longer-disease, more frequently obese and with higher BMI. In multivariate analyses, obesity resulted as the only significant independent risk factor associated with CKD. In addition, a significant negative correlation was found between BMI and eGFR, and ROC analyses showed a significant global-performances of BMI to predict CKD. Patients with CKD were characterized also by higher FGF23 levels. A significant negative correlation was found between FGF23 and eGFR, however, evaluating separately those with and without CKD, this correlation remained significant only in the second group. Conclusions: For the first-time, obesity was demonstrated to be independently associated with CKD in patients with hypoparathyroidism, and a blunted eGFR-related response of FGF23 was shown in patients with CKD potentially worsening the renal function in the context of hypoparathyroidism
Failure to Rescue After Resection of Perhilar Cholangiocarcinoma in an International Multicenter Cohort
Background: Failure to rescue (FTR) is defined as the inability to prevent death after the development of a complication. FTR is a parameter in evaluating multidisciplinary postoperative complication management. The aim of this study was to evaluate FTR rates after major liver resection for perihilar cholangiocarcinoma (pCCA) and analyze factors associated with FTR. Patients and Method: Patients who underwent major liver resection for pCCA at 27 centers were included. FTR was defined as the presence of a Dindo grade III or higher complication followed by death within 90 days after surgery. Liver failure ISGLS grade B/C were scored. Multivariable logistic analysis was performed to identify predictors of FTR and reported using odds ratio and 95% confidence intervals. Results: In the 2186 included patients, major morbidity rate was 49%, 90-day mortality rate 13%, and FTR occurred in 24% of patients with a grade III or higher complication. Across centers, major complication rate varied from 19 to 87%, 90-day mortality rate from 5 to 33%, and FTR ranged from 11 to 50% across hospitals. Age [1.04 (1.02–1.05) years], ASA 3 or 4 [1.40 (1.01–1.95)], jaundice at presentation [1.79 (1.16–2.76)], right-sided resection [1.45 (1.06–1.98)], and annual hospital volume < 6 [1.44 (1.07–1.94)] were positively associated with FTR. When liver failure is included, the odds ratio for FTR is 9.58 (6.76–13.68). Conclusion: FTR occurred in 24% of patients after resection for pCCA. Liver failure was associated with a nine-fold increase of FTR and hospital volume below six was also associated with an increased risk of FTR
The risk for preeclampsia at 36 weeks and at 12 weeks predicts intrapartum fetal compromise and spontaneous onset of labor
Data-Driven Motion Correction of 11C-Methionine PET Images on a Cohort of Pediatric Patients With Brain Tumor in a PET/MRI Study
A data-driven head Motion Correction (MoCo) method was tested on 11C-Methionine brain PET images in a cohort of 44 pediatric patients with brain tumors referred to a PET/MR study. Its impact was investigated both qualitatively and quantitatively. For each patient, PET images were reconstructed offline both with (PETddMoCo) and without (PETnoMoCo) MoCo algorithm. An expert Nuclear Medicine physician qualitatively evaluated PET images, and segmented PET positive lesions in both datasets, extracting the following PET parameters: maximum and mean Standardized Uptake Value (SUVmax and SUVmean, respectively), and Metabolic Tumor Volume (MTV). PET parameters before and after MoCo were compared and their absolute percentage difference was calculated (Δ%). Contrast-to-Noise (CNR) and its difference (Δ) before and after MoCo were calculated. Thirty-one patients had a “low” level of motion, 8 patients “medium” and 5 patients “high”. Twenty-one patients out of forty-four had positive 11C-Methionine uptake (26 lesions). Qualitatively, no difference was evident in negative patients, while two PET positive lesions could be better defined after motion correction. Quantitatively, CNR increased significantly after motion correction for “medium+high” lesions, while none of the PET parameters showed significant difference. Increasing the sample of patients might confirm these results
Intraoperative fluorescence angiography with indocyanine green to prevent anastomotic leak in rectal cancer surgery (IntAct): an unblinded randomised controlled trial
Background Data are mixed on whether indocyanine green (ICG) fluorescence angiography can reduce the high rate of anastomotic leaks in patients undergoing surgery for rectal cancer. Therefore, we aimed to investigate the safety and efficacy of ICG fluorescence angiography in reducing the rate of clinical anastomotic leaks in these patients. Methods IntAct was an unblinded randomised controlled trial conducted at 28 specialist rectal cancer centres across eight European countries. Adults (>= 18 years) with rectal cancer (lower margin of cancer <= 15 cm from the anal verge) medically fit for elective, curative, laparoscopic or robotic high or low anterior resection were eligible. Patients not undergoing colorectal or anal anastomosis and those with synchronous colonic tumours or recurrent or locally advanced rectal cancer requiring extended or multi-visceral excision were excluded. Eligible participants were randomly assigned (1:1) by use of minimisation with a random element to undergo surgery with or without ICG (standard care). Resections and anastomoses were done per surgeon preference. In the ICG group, surgeons first marked proximal transection levels via standard white-light laparoscopy and then administered an intravenous bolus of 01 mg/kg of ICG for perfusion assessment. A second 01 mg/kg ICG assessment was done following anastomosis. In the standard care group, only a white-light assessment of bowel perfusion was performed. The primary endpoint was the rate of clinical anastomotic leak (grades B or C, per the International Study Group of Rectal Cancer) within 90 postoperative days. Analyses were done in the intention-to-treat population for complete cases. This trial is registered with the ISRCTN registry (ISRCTN13334746) and is now complete. Findings Between Oct 20, 2017, and Aug 15, 2023, 2534 patients were assessed for eligibility and 766 participants were randomly assigned (383 to the ICG group and 383 to the standard care group). 501 (65%) of 766 participants were male, 726 (95%) were of White ethnicity, and the median age was 640 years (IQR 560-720). 343 patients in the ICG group and 355 in the standard care group were included in the intention-to-treat analysis. The rates of anastomotic leak were 11 (3%) of 343 in the ICG group and 20 (6%) in the standard care group for grade A, 11 (3%) and 31 (9%) for grade B, and 25 (7%) and 23 (6%) for grade C. Within 90 days, a clinical anastomotic leak occurred in 90 (13%) of 698 participants: 36 (10%) of 343 in the ICG group and 54 (15%) of 355 in the standard care group (adjusted odds ratio 0667 [95% CI 0419-1060]; p=0087). There were no serious adverse events related to ICG. Interpretation Although IntAct did not show a significant benefit for ICG fluorescence angiography, a signal towards a reduction in clinical anastomotic leak rate was observed. The benefit of ICG could be in preventing grade A or B leaks, given similar rates of grade C leaks between groups. Future research is needed to standardise ICG fluorescence assessment and understand its relevance to anastomotic leak. Funding National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme. Copyright (c) 2025 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
Emerging therapeutic strategies in Lynch syndrome-associated colorectal cancer and the role of MMR testing
Lynch syndrome is the most common hereditary cancer predisposition, accounting for 1-5% of colorectal cancer cases, and is driven by germline mutations in DNA mismatch repair genes. Despite established diagnostic criteria, such as the Amsterdam guidelines, Lynch syndrome remains largely underdiagnosed. To address this gap, universal tumour screening has been introduced for all newly diagnosed cases of colorectal cancer and endometrial cancer, significantly improving early detection. The surgical management of colorectal cancer in patients with Lynch syndrome remains controversial. While extended colectomy reduces the risk of metachronous colorectal cancer, surgical strategies must be carefully individualised based on patient-specific factors. Chemoprevention with aspirin has shown promise in reducing the risk of colorectal cancer, with ongoing trials investigating optimal dosing. Immunotherapy, particularly immune checkpoint inhibitors, has revolutionised the treatment of Microsatellite Instability-High/deficient Mismatch Repair colorectal cancer, offering durable responses and significant survival benefits. In addition, the neoadjuvant use of immune checkpoint inhibitors is paving the way for non-surgical interventions, potentially transforming the management of colorectal cancer in patients with Lynch syndrome. A multidisciplinary approach and continued research are essential to optimise cancer prevention, treatment and quality of life for people with Lynch syndrome