Influence of reimbursement policies on phlebological surgical practice in Belgium between 2007 and 2017

BACKGROUND: To date, it is unclear how treatment of patients with chronic venous disease (CVD) is influenced by national reimbursement systems. In Belgium, catheters or fibers used for endovenous thermal ablation (EVTA) are reimbursed only once in a lifetime. The potential impact of the Belgian public health insurance reimbursement policy on surgical practice in phlebology needs to be investigated. METHODS: Billing data available from the Belgian National Institute for Health and Disability Insurance (NIHDI) were used for analyzing the distribution of specific surgical procedures for treating varicose veins and their relative use from 2007 to 2017. The potential influence of age, sex, social status and geographical origin of insured patients on surgical practice in Belgium were studied. RESULTS: The annual intervention rate was 343 per 100,000 insured individuals for 2017 with a slight annual increase over the period 2007-2017 (+ 0.83% per year). Patients with limited resources, benefiting from a preferential reimbursement system, had a significantly lower intervention rate than those having the usual system (P<0.001). There was a large geographical variation in the use of care, ranging from 172 to 549 per 100.000 insured in 2017. The number of classic surgical procedures decreased (-6.17% per year) in the period 2015-2017) while EVTA, newly reimbursed in Belgium since 2012, increased during the same period (+ 3.6% per year). This evolution was more pronounced in the north (Flanders) than in the south (Wallonia) of the country. Bilateral treatment increased considerably from 2012 and stabilized at 33% of all surgical interventions in 2016 and 2017. CONCLUSIONS: Available data of the NIHDI in Belgium highlight remarkable differences in the use of care for CVD, depending on social status and geographical origin of insured patients. The introduction of EVTA techniques has been adopted more rapidly in the north of the country and has led to an increased percentage of bilateral procedures

Dynamic Performance of a Squeeze Film Damper with a Cylindrical Roller Bearing under a Large Static Radial Loading Range

Turbomachine rotors, supported by little damped rolling element bearings, are generally sensitive to unbalance excitation. Accordingly, most machines incorporate squeeze film damper technology to dissipate mechanical energy caused by rotor vibrations and to ensure stable operation. When developing a novel geared turbomachine able to cover a large power range, a uniform mechanical drivetrain needs to perform well over the large operational loading range. Especially, the rotor support, containing a squeeze film damper and cylindrical roller bearing in series, is of vital importance in this respect. Thus, the direct objective of this research project was to map the performance of the envisioned rotor support by estimating the damping ratio based on the simulated and measured vibration response during run-up. An academic test rig was developed to provide an in-depth analysis on the key components in a more controlled setting. Both the numerical simulation and measurement results exposed severe vibration problems for an insufficiently radial loaded bearing due to a pronounced anisotropic bearing stiffness. As a result, a split first whirl mode arose with its backward component heavily triggered by the synchronous unbalance excitation. Hence, the proposed SFD does not function properly in the lower radial loading range. Increasing the static load on the bearing or providing a modified rotor support for the lower power variants will help mitigating the vibration issues

Prevention of post-hepatectomy liver failure after major resection of colorectal liver metastases: is hepato-biliary scintigraphy the optimal tool?

International audienceBackground: Liver failure is the most threatening complication after hepatectomy for colorectal liver metastases. Recent studies indicate that liver functional evaluation by hepatobiliary scintigraphy (HBS) could be more sensitive than volumetry to predict the risk of post-hepatectomy liver failure (PHLF). The aim of this study was to evaluate the performance of 99mTc-mebrofenin HBS, when used as the main preoperative assessment before major hepatectomy in patients with liver metastases from colorectal cancer.Methods: This retrospective study reviewed data from all patients with colorectal liver metastases treated at Montpellier Cancer Institute between 2013 and 2020. Only patients who underwent HBS before surgery were included. The primary aim was to evaluate how the use of this functional imaging modifies the surgical management of patients with colorectal liver metastases.Results: Among the 80 patients included, 26 (32.5%) underwent two-stage hepatectomy and 13 (16.3%) repeated hepatectomies. Severe postoperative complications occurred in 16 patients (20%) and all-grade liver failure occurred in 13 patients (16.3%). Seventeen patients (21.3%) underwent major liver surgery based on sufficient mebrofenin uptake, although the retrospectively evaluated future liver remnant (FLR) volume was insufficient (<30% of total liver). None of these patients had PHLF.Conclusions: This study showed the reliability of HBS for the preoperative functional assessment of patients with colorectal liver metastases. Indeed, it allowed performing major hepatectomy safely in 20% more patients who would not have been considered for surgery on the basis of volumetric assessment

Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial

International audienceBackground: The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery has been associated with encouraging survival results in some patients with colorectal peritoneal metastases who were eligible for complete macroscopic resection. We aimed to assess the specific benefit of adding HIPEC to cytoreductive surgery compared with receiving cytoreductive surgery alone.Methods: We did a randomised, open-label, phase 3 trial at 17 cancer centres in France. Eligible patients were aged 18–70 years and had histologically proven colorectal cancer with peritoneal metastases, WHO performance status of 0 or 1, a Peritoneal Cancer Index of 25 or less, and were eligible to receive systemic chemotherapy for 6 months (ie, they had adequate organ function and life expectancy of at least 12 weeks). Patients in whom complete macroscopic resection or surgical resection with less than 1 mm residual tumour tissue was completed were randomly assigned (1:1) to cytoreductive surgery with or without oxaliplatin-based HIPEC. Randomisation was done centrally using minimisation, and stratified by centre, completeness of cytoreduction, number of previous systemic chemotherapy lines, and timing of protocol-mandated systemic chemotherapy. Oxaliplatin HIPEC was administered by the closed (360 mg/m2) or open (460 mg/m2) abdomen techniques, and systemic chemotherapy (400 mg/m2 fluorouracil and 20 mg/m2 folinic acid) was delivered intravenously 20 min before HIPEC. All individuals received systemic chemotherapy (of investigators' choosing) with or without targeted therapy before or after surgery, or both. The primary endpoint was overall survival, which was analysed in the intention-to-treat population. Safety was assessed in all patients who received surgery. This trial is registed with ClinicalTrials.gov, NCT00769405, and is now completed.Findings: Between Feb 11, 2008, and Jan 6, 2014, 265 patients were included and randomly assigned, 133 to the cytoreductive surgery plus HIPEC group and 132 to the cytoreductive surgery alone group. After median follow-up of 63·8 months (IQR 53·0–77·1), median overall survival was 41·7 months (95% CI 36·2–53·8) in the cytoreductive surgery plus HIPEC group and 41·2 months (35·1–49·7) in the cytoreductive surgery group (hazard ratio 1·00 [95·37% CI 0·63–1·58]; stratified log-rank p=0·99). At 30 days, two (2%) treatment-related deaths had occurred in each group.. Grade 3 or worse adverse events at 30 days were similar in frequency between groups (56 [42%] of 133 patients in the cytoreductive surgery plus HIPEC group vs 42 [32%] of 132 patients in the cytoreductive surgery group; p=0·083); however, at 60 days, grade 3 or worse adverse events were more common in the cytoreductive surgery plus HIPEC group (34 [26%] of 131 vs 20 [15%] of 130; p=0·035).Interpretation: Considering the absence of an overall survival benefit after adding HIPEC to cytoreductive surgery and more frequent postoperative late complications with this combination, our data suggest that cytoreductive surgery alone should be the cornerstone of therapeutic strategies with curative intent for colorectal peritoneal metastases

Tertiary lymphoid structures in epithelioid malignant peritoneal mesothelioma are associated with neoadjuvant chemotherapy, but not with prognosis

International audienc

Low incidence of SARS-CoV-2, risk factors of mortality and the course of illness in the French national cohort of dialysis patients

International audienceThe aim of this study was to estimate the incidence of COVID-19 disease in the French national population of dialysis patients, their course of illness and to identify the risk factors associated with mortality. Our study included all patients on dialysis recorded in the French REIN Registry in April 2020. Clinical characteristics at last follow-up and the evolution of COVID-19 illness severity over time were recorded for diagnosed cases (either suspicious clinical symptoms, characteristic signs on the chest scan or a positive reverse transcription polymerase chain reaction) for SARS-CoV-2. A total of 1,621 infected patients were reported on the REIN registry from March 16th, 2020 to May 4th, 2020. Of these, 344 died. The prevalence of COVID-19 patients varied from less than 1% to 10% between regions. The probability of being a case was higher in males, patients with diabetes, those in need of assistance for transfer or treated at a self-care unit. Dialysis at home was associated with a lower probability of being infected as was being a smoker, a former smoker, having an active malignancy, or peripheral vascular disease. Mortality in diagnosed cases (21%) was associated with the same causes as in the general population. Higher age, hypoalbuminemia and the presence of an ischemic heart disease were statistically independently associated with a higher risk of death. Being treated at a selfcare unit was associated with a lower risk. Thus, our study showed a relatively low frequency of COVID-19 among dialysis patients contrary to what might have been assumed

Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial

BackgroundSparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.MethodsPROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850.FindingsBetween Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals.InterpretationOver 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function