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

Isa-Aii, con Stroke Action Plan for Italy obiettivo 90% nel 2030

Circulation, Ahead of Print. Background: In patients with post-thrombotic syndrome (PTS), stent recanalization of iliofemoral veins or the inferior vena cava can restore venous patency and improve functional outcomes. The risk of stent thrombosis is particularly increased during the first 6 months after intervention. The ARIVA trial tested whether daily aspirin 100 mg plus rivaroxaban 20 mg is superior to rivaroxaban 20 mg alone to prevent stent thrombosis within 6 months after stent placement for PTS.Methods: In this multinational, academic, open-label, independently adjudicated trial, patients with a Villalta score >4 points, a stenosis or occlusion of the inferior vena cava, iliac veins, or common femoral vein, successfully treated with venous stent placement, were randomized in a 1:1 fashion to the study groups. Key exclusion criteria included age 75 years, contraindications to anticoagulant use or acute venous thrombosis

Background
Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk.

Objective
To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement.

Design
This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up.

Results
Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality.

Conclusion
This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement.

Trial registration number
NL5130.

Stroke, Ahead of Print. BACKGROUND:The double-stent retriever (SR) technique has been described as an effective rescue technique when single-SR fails to induce recanalization. We aimed to assess the safety and efficacy of first-line double-SR in patients with stroke undergoing thrombectomy.METHODS:This was a multicenter, randomized, controlled, blinded adjudicated primary outcome study. Patients with a large vessel occlusion stroke within 24 hours after onset and undergoing thrombectomy were included. Upon confirmation of large vessel occlusion on initial angiogram, patients were randomly allocated to receive a first-line strategy: single-SR versus double-SR technique. Investigators could use their technique of choice if further passes were needed. The primary objective was to evaluate the efficacy of double-SR defined as first-pass complete recanalization (expanded Treatment in Cerebral Infarction grade 2c-3) compared with single-SR. First-pass recanalization and final successful recanalization (expanded Treatment in Cerebral Infarction grade 2b50-3) were centrally assessed by a blinded investigator. The safety outcome was the occurrence of a symptomatic intracerebral hemorrhage. The data safety monitoring board stopped the recruitment after a preplanned interim analysis because a predefined efficacy boundary was reached.RESULTS:From April 2022 to October 2023, 108 patients were included: 50 (46%) in the single-SR group and 58 (54%) in the double-SR group. First-pass recanalization was achieved in 12 of 50 patients (24%) allocated to single-SR and 27 of 58 patients (46%) allocated to double-SR (adjusted odds ratio, 2.72 [95% CI, 1.19–6.46]). Substantial reperfusion within 3 attempts was obtained in 42 patients (84%) allocated to single-SR and in 52 patients (89%) allocated to double-SR (adjusted odds ratio, 1.74 [95% CI, 0.5–5.76]). The mean number of passes was 2±1.3 with single-SR and 1.7±1 with double-SR (mean difference, −0.37 [95% CI, −0.9 to 0.06]). A symptomatic intracerebral hemorrhage occurred in 3 patients (6%) allocated to single-SR and in 6 patients (10%) allocated to double-SR (adjusted odds ratio, 1.66 [95% CI, 0.40–8.35]).CONCLUSIONS:In patients with stroke undergoing thrombectomy, first-line double-SR is safe and superior to single-SR in achieving first-pass recanalization but not final recanalization. Implications on clinical outcomes should be studied in specifically designed trials.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT05632458.

Circulation, Ahead of Print. BACKGROUND:Covered stent correction for a sinus venosus atrial septal defect (SVASD) was first performed in 2009. This innovative approach was initially viewed as experimental and was reserved for highly selected patients with unusual anatomic variants. In 2016, increasing numbers of procedures began to be performed, and in several centers, it is now offered as a standard of care option alongside surgical repair. However, covered stent correction for SVASD is not recognized by regulatory authorities, and in the minds of many pediatric and adult congenital cardiologists and surgeons, the condition is viewed as treatable only by cardiac surgery with cardiopulmonary bypass.METHODS:In April 2023, all centers identified from international conferences, publications, and colleague networks to be undertaking covered stent correction for SVASD were invited to participate in a retrospective audit of their procedures.RESULTS:Data were received on 381 patients from 54 units over a 12-year period with 90% of procedures being performed over the past 5 years. Balloon-expandable stents (8 types) were used in the majority; self-expanding stents (4 types) were used in 4.5%. The commonest stent was the 10-zig covered Cheatham Platinum stent in 62% of cases. In 10 procedures, the stent embolized requiring surgical retrieval and repair of the defect, resulting in technically successful implantation in 371 of 381 (97.4%). Major complications (surgical drainage of tamponade, pacemaker implantation, surgery for pulmonary vein occlusion, and late stent removal) occurred in 5 patients (1.3%). Repeat catheterization to correct residual leaks was required in 7 patients (1.8%). Thus, 359 of 381 patients (94.2%) had successful correction without major complications or additional catheter interventions.CONCLUSIONS:This article details the exponential uptake of covered stent correction for SVASD during the past 5 years. Cardiopulmonary bypass was avoided in the majority of patients, and major complications were infrequent. Prospective registries with standardized definitions, inclusion criteria, and follow-up and comparative studies with surgery are now required to help support the extension of covered stent correction as an alternative standard-of-care option for patients with an SVASD.

Impegno per scambio di dati e studi per il recupero pazienti

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Stroke, Volume 55, Issue 12, Page 2776-2785, December 1, 2024. BACKGROUND:Restenosis after carotid artery stenting (CAS) is associated with the risk of developing ischemic stroke. We aimed to evaluate the inhibitory effect of cilostazol addition on in-stent restenosis (ISR) in patients treated with CAS.METHODS:In a randomized, open-label, blind-end point trial, patients with symptomatic and asymptomatic carotid artery stenosis and scheduled for CAS were randomly assigned to adding cilostazol (50 or 100 mg, twice per day) on other antiplatelets from 3 days before CAS or not adding cilostazol. Concomitant use of other antiplatelets was unrestricted. ISR was diagnosed by a peak systolic velocity of at least 1.75 m/s on duplex ultrasonography. The primary outcome was incidence of ISR within 2 years after CAS. Secondary outcomes included occurrences of cardiovascular events or any death and hemorrhagic events.RESULTS:Participants were recruited from December 2010 to September 2015. Although the sample size was initially set to be 900 (450 in each group), 631 patients (mean age 69.9 years, 558 men, 325 in the cilostazol, and 306 in the noncilostazol group) were included in the primary analysis. Within 2 years’ follow-up, ISR occurred in 31 of 325 patients (cumulative incidence 10.8%) in the cilostazol group and 46 of 306 patients (19.6%) in the noncilostazol group (hazard ratio, 0.64 [95% CI, 0.41–1.0];P=0.056). In the exploratory analysis, incidence of ISR beyond 30 days after CAS was lower in the cilostazol group than in the noncilostazol group (10.3% versus 19.3%;P=0.040). Incidences of cardiovascular events or any death and hemorrhagic events were similar between the groups (6.2% versus 6.7% and 2.3% versus 1.4%, respectively).CONCLUSIONS:The addition of cilostazol to other antiplatelet agents could contribute to the reduction of ISR in the chronic stage of patients who underwent CAS, the authenticity of which depends on further studies with sufficient statistical power.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT01261234.

Ipertensione, fibrillazione atriale e fumo

Circulation, Volume 150, Issue Suppl_1, Page A4141481-A4141481, November 12, 2024. Background:Upfront two-stent techniques are often used in bifurcation percutaneous coronary interventions (PCI), but there is controversy about optimal strategy selection.Methods:We examined the clinical, angiographic characteristics, and long-term outcomes of 206 bifurcation PCIs using the double kissing (DK) crush or the culotte techniques in 192 patients between 2014-2023 from the Prospective Global Registry for the Study of Bifurcation Lesion Interventions (NCT05100992). For the long-term outcomes adjusted hazard ratios (aHR) and 95% confidence intervals (CI) were calculated using the mixed effects Cox proportional hazards model.Results:DK crush was more commonly used (70.4%). Patients in the culotte group had similar baseline characteristics with the DK crush group. Lesions treated with culotte were more likely to be in the left anterior descending (54.1% vs. 35.9%, p

Circulation, Volume 150, Issue Suppl_1, Page A4145821-A4145821, November 12, 2024. Introduction and Background:Arterial dissection during endovascular therapy rarely occurs but can be lethal. A significant blood volume extravasation during coronary artery interventions is related to the very high mortality (20-30%). In this hyperacute emergent clinical situation, covered stents have been considered as a primary measure to prevent further serious arterial events. A fabric-based covered graft stents yield poor clinical outcomes. To overcome these challenges, the balloon-expandable stent with biodegradable film-type graft for treating arterial dissection was invented.Research Questions and Objectives:A novel balloon-expandable stent with biodegradable film graft for overcoming these issues would be valid for efficacy and safety in a rabbit iliac artery dissection model.Method and Approach:Eighteen iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0 x 24 mm). Subsequently, twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year.Results and Data:There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2weeks, 26.1 at 1month, 29.7 at 3months, 49.2 at 9months, and 51.0 at 1year), along with mild peri-strut inflammatory response (Grade: 1-2 at mid-term and 0-1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2weeks, 12.3 at 1month, 14.2 at 3months, 25.1 at 9months, and 26.6 at 1 year).Conclusion:The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model. Future human studies are warranted to validate these findings and elucidate the clinical outcomes of the study.