Risultati per: Utilizzo degli stent-retriever nell’ictus ischemico acuto

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Introduction
The surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct.

Methods and analysis
This is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the X2 test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests.

Ethics and dissemination
The study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal.

Trial registration number
NCT05523778.

This clinical trial compares a paclitaxel-coated balloon vs an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention.

Over the past 2 decades, percutaneous coronary intervention (PCI) with placement of metallic drug-eluting stents (DES) has revolutionized the management of coronary artery disease and stands as one of the most performed therapeutic procedures in modern medicine. The use of metallic stents, however, comes with inherent limitations from permanently placing foreign material within the coronary artery, most notably thrombus formation and vascular inflammation, both of which lead to new tissue growth (neointimal hyperplasia) resulting in some degree of vessel renarrowing. Despite thinner stent struts and antiproliferative drugs, this process occasionally becomes pathologic from extensive neointimal tissue formation early (restenosis) or atherosclerosis late (neoatherosclerosis). Although the latest generation of drug-eluting stents has low rates of in-stent restenosis (6%-8%) that occurs primarily in the first year, it is estimated that after the first year, drug-eluting stents have an adverse ischemic event rate of 2% per year with no discernible plateau. As a result, interventions to treat in-stent restenosis account for nearly 10% of all PCIs performed in the US and can present a therapeutic challenge with suboptimal long-term outcomes. Although the best management strategy is still a matter of debate, in-stent restenosis in the US is most commonly treated with repeat drug-eluting stent placement (ie, stent within a stent).

Studio Univaq su Journal of Neurology, Neurosurgery, Psychiatry

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Esperto Imperial College: ‘Piani qualità dell’aria più radicali’

Stroke, Volume 55, Issue Suppl_1, Page A48-A48, February 1, 2024. Background:The American Heart Association/American Stroke Association (AHA/ASA) 2021 guidelines state that in patients in whom revascularization is planned within 1 week of the index stroke, it is reasonable to choose carotid endarterectomy (CEA) over carotid artery stent placement (CAS) to reduce the periprocedural stroke rate (level of evidence 2A, weak evidence, [B-R] moderate quality data).Objective:To compare the 1-month stroke, myocardial infarction (MI), and/or death rates among symptomatic patients undergoing either CAS or CEA according to the timing of the procedure in Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).Methods:We analyzed the effect of CAS and CEA on the rates of 1-month stroke, MI, and/or death after adjusting age, gender, presenting symptom (transient ischemic attack [TIA], retinal ischemia, or minor ischemic stroke), severity of stenosis (50-69% and 70-99%), and timing of procedure (≤7 days and >7 days post qualifying event) using multivariate analysis.Results:The rate of 1-month stroke, MI, and/or death was higher (non-significant) in patients who underwent CAS compared with those who underwent CEA within ≤7 days post-qualifying event (8 of 157 [5.1%] versus 3 of 124 [2.4%], p=0.251). In the multivariate analysis, there was no difference in the odds of 1-month stroke, MI, and/or death in patients who underwent CEA compared with those who underwent CAS (odds ratio [OR] 0.57, 95% CI 0.26-1.20, p=0.15). There was no effect of the timing of the procedure (OR 1.19,95% CI 0.48-3.47, p=0.72). The interaction term between CEA versus CAS and the timing of the procedure was not significant (OR 1.69, 95% 0.21-36.31 CI p=0.66). The only significant factors associated with decreased odds of 1-month stroke, MI, and/or death were the qualifying event of TIA (OR 0.13, 95% CI 0.02-0.57, p=0.02) and retinal ischemic event (OR 0.13, 95% CI 0.01-0.63, p=0.02).Conclusions:In our analysis, we did not identify any increase in odds of a 1-month stroke, MI, and/or death rate with CAS compared with CEA according to the timing of the procedure. Qualifying event characteristics rather than the timing of procedure appeared to be the most determinant, highlighting the need to revisit the recommendations in the AHA/ASA guidelines.

Stroke, Volume 55, Issue Suppl_1, Page AWMP88-AWMP88, February 1, 2024. Background:In stroke patients undergoing EVT, angioplasty and stenting (A&S) has been described as a bailout technique when thrombectomy fails or intracranial stenosis is suspected. We aim to investigate effects of the administration of intraarterial (IA) tirofiban through a deployed stent-retriever over the occluding lesion prior to A&S.Methods:Patients with LVO in the anterior circulation undergoing EVT were reviewed. We include patients in which stent-retriever/direct aspiration failed (TICI 0-2a) or underlying intracranial stenosis was suspected and received the loading dose of tirofiban prior to intended A&S bailout. A stent-retriever was deployed over the lesion to create a by-pass channel and 8 to 12 ml of tirofiban were locally infused during 10 minutes through a distal access catheter proximally positioned. The stent-retriever was re-sheathed into the microcatheter before retrieval. Additionally, 10-15 ml of tirofiban were administered intravenously. An angiogram was performed to determine recanalization grade and indicate potential A&S.Results:From 546 consecutive EVT patients, 14 (2.6%) were considered potential candidates for A&S bailout and received the study protocol: mean age 76 years, median admission NIHSS 17 (IQR 11-21). The occlusion locations were: ICA (3, 21,4%), M1-MCA (9, 64.3%), M2-MCA (2, 14.3%), Mean IA tirofiban dose was 10mg. Post-infusion angiogram showed succesful reperfusion (TICI2b-3) in 11 patients (78.6%). In 4 cases (28.6%) A&S was finally performed. At 24 hours median NIHSS was 14 (IQR 9-20) and the rates of reocclusion (follow-up imaging in 8/12) and SICH were 0%.Conclusion:In stroke patients undergoing EVT in which A&S is considered as bailout, IA administration of tirofiban through a deployed stentretriever may safely achieve sustained recanalization in a substantial number of patients, ultimately avoiding definitive stenting. Further prospective data is warranted.

Stroke, Volume 55, Issue Suppl_1, Page ATP214-ATP214, February 1, 2024. Introduction:In-vitro evaluation (analysis in a bench top flow model) is the gold standard for pre-clinical investigation of devices being developed for endovascular thrombectomy (EVT). In-silico evaluation (computer simulated analysis in a virtual stroke model) has the potential to test and optimize large number of stent-retriever design variations in a relatively time and cost-effective manner. We aim to validate the utility of in-silico evaluation when compared with in-vitro evaluation for the SuperNova Stent-retriever.Methods:In-silico analysis was performed using a virtual thrombectomy model, built using data from a fine-grained finite-element model, to estimate the probability of successful recanalization. Neurovascular anatomy of the virtual model was built based on digital subtraction angiography of an in-vitro model (Sim Agility, Mentice, Inc). Gravity Medical Technology’s SuperNova Stent-retriever was the device under investigation. Multiple thrombectomy scenarios were defined and validation analysis was performed.Results:We defined multiple thrombectomy scenarios including 1 cm red blood clot in M1 artery, 2 cm bifurcation M1-M2 red blood clot (Y-shaped clot), 1 cm white blood clot in M1 artery, and 1 cm white blood clot in superior M2 artery. The figure below demonstrates a pictorial representation of the first scenario- 1 cm red blood clot in M1 artery followed by mechanical thrombectomy simulation using the SuperNova stent-retriever. Per our in-vitro analysis (10 thrombectomy experiments), the rate of first pass effect and the rate of complete recanalization after a maximum of 3 passes using SuperNova stent-retriever was 50% and 90%, respectively. Preliminary data suggests 97% concordance.Conclusion:In-silico analysis has the potential to improve and expedite pre-clinical thrombectomy device development. Further studies are required to better understand the scope and potential of this technology.