A novel risk assessment tool for postoperative delirium in vascular surgery: The stress model (Siena posTopeRative dElirium in vaScular Surgery).

OBJECTIVE: Postoperative delirium (POD) is a common complication with a high health-related impact. The creation of a model (Siena posTopeRative dElirium in vaScular Surgery) to identify high-risk patients with consecutive prompt diagnosis and correct management. METHODS: This is an observational retrospective study to evaluate POD incidence in patients who underwent elective vascular surgery procedures between 2018 and 2020. POD was detected using CAM and defined as the onset of an acute confusional state, clinically manifesting as a disturbed state of consciousness, cognitive dysfunction, or alteration in perception and behavior. The total population was divided in the development and validation subsamples. Multivariable logistic regression analysis was performed, identifying variables related to the occurrence of POD. An additive score was created and the STRESS score was internally validated using the Validation subgroup. RESULTS: A total of 1067 patients were enrolled. POD occurred in 111 cases (10.4%). Multivariable logistic regression analysis for POD occurrence revealed as significant predictors: age>75 years, CKD, dyslipidaemia, psychiatric disease, CAD, hospitalization in the previous month, preoperative NLR >3.59, preoperative Hb < 12 g/dl, preoperative Barthel score <75, major amputation, CLTI revascularization, general anesthesia, and postoperative urinary catheter. These variables were used to create the STRESS score. The model was applied to both development and validation subgroups; AUC was respectively 0.7079 (p < .0001) and 0.7270 (p < .0001). CONCLUSION: The STRESS score has a good predictive potentiality for POD occurrence in elective vascular surgery procedures. However, implementation and external validation are needed to be correctly used in everyday clinical practice.

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

BACKGROUND: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. METHODS: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. RESULTS: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). CONCLUSIONS: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Optical coherence tomography assessment of newgeneration mesh-covered stents after carotid stenting.

AIMS: The aim of this study was to identify the findings (by optical coherence tomography [OCT]) after carotid artery stenting (CAS) with two different types of new-generation mesh-covered stent. METHODS AND RESULTS: Sixteen consecutive patients undergoing CAS with mesh-covered stents and highdefinition OCT image acquisition were enrolled in the study. Cross-sectional OCT images for the presence of strut malapposition (SM) and plaque prolapse (PP) were evaluated using a proximal or distal embolic protection device (EPD). CGuard stents were used in 11 patients (68.8%) and RoadSaver stents in five (31.2%). With OCT analysis, the incidence of SM was 20.5% for CGuard vs. 26.8% for RoadSaver, p=0.26, and the incidence of PP was 10.8% for CGuard vs. 20.7% for RoadSaver, p=0.05. No neurological complications (stroke/TIA) occurred during the procedural and post-procedural periods. CONCLUSIONS: The OCT findings of two different types of mesh-covered stent after CAS were obtained safely. Our work indicates that current mesh-covered carotid stents may show differences in SM and PP. The effect of stent design and implantation technique on OCT findings post CAS, and their relation to longterm clinical outcomes, require further evaluation.

Economic impact of endarterectomy vs carotid artery stenting: a one year, single centre study.

AIMS: Carotid artery stenting (CAS) has been suggested by some clinicians as an alternative to endarterectomy (CEA), especially in some specific subgroups of the population. The aim of this study is to evaluate the costs of these two procedures. METHODS AND RESULTS: A review of costs was performed on all patients who underwent elective treatment of carotid artery stenosis between January and December 2006 (184 CAS vs 97 CEA). Clinical data had been prospectively gathered from both the CAS and the CEA groups, while financial data was obtained retrospectively to match hospital admissions with the generated charge from the hospital business office. In this series there was one major event in CEA and one transient ischaemic attacks (TIA) in CAS. One death procedure-related event occurred in CEA. The mean total cost associated with a single CEA was slashed integral 3,897.86, whereas the cost associated with CAS was slashed integral 3,806.66. It was apparent that the increasing costs involved in purchasing material for CAS, were balanced by the lower spending for hospital stay. CONCLUSIONS: Costs for CAS and CEA are comparable. In our experience, the choice between CAS and CEA is based on the comorbidity of the patient, the type of the lesion and the preferences of the patient, without economic criteria being important.