scholarly journals Endovascular Recanalization and Standard Medical Management for Symptomatic Non-acute Intracranial Artery Occlusion: Study Protocol for a Non-randomized, 24-Month, Multicenter Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Huijun Zhang ◽  
Jianjia Han ◽  
Xuan Sun ◽  
Zhongrong Miao ◽  
Xu Guo ◽  
...  

Background: The management of patients with symptomatic non-acute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. A number of small-sample clinical studies have also discussed endovascular recanalization (ER) for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The purpose of our present study was to evaluate the technical feasibility and safety of ER for sNA-ICAO.Methods: Our group is currently undertaking a multisite, non-randomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between January 1, 2020 and December 31, 2022. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is any stroke from enrollment to 2 years of follow-up. The secondary outcomes are all-cause mortality, mRS score, NIHSS score and cognitive function from enrollment to 30 days, 3 months, 8 months, 12 months, 18 months, and 2 years of follow-up. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat.Discussion: The management of patients with sNA-ICAO has been clinically challenging. The current protocol aims to evaluate the technical feasibility and safety of ER for sNA-ICAO.Trial Registration Number:www.ClinicalTrials.gov, identifier: NCT04864691.

2020 ◽  
pp. neurintsurg-2020-016754
Author(s):  
Feng Gao ◽  
Xu Guo ◽  
Xuan Sun ◽  
Yan Liu ◽  
Yingchun Wu ◽  
...  

BackgroundThe optimal treatment for medically refractory non-acute intracranial artery occlusion is uncertain, and endovascular recanalization remains a technical challenge. Here, a multicenter clinical experience of dual-roadmap guidance for endovascular recanalization of non-acute intracranial artery occlusion is reported, focusing on the technical feasibility and safety.MethodsFrom January 2014 to December 2019, 52 consecutive patients with medically refractory atherosclerotic non-acute intracranial artery occlusion who underwent endovascular recanalization under dual-roadmap guidance in three large regional referral stroke centers were analyzed retrospectively. Four types of dual-roadmap technical schemes were applied during endovascular recanalization. The rates of technical success, periprocedural complications, any stroke or death within 30 days, and follow-up results were evaluated.ResultsThe technical success rate was 92.3% (48/52). The perioperative complication rate was 7.7% (4/52), and the rate of any stroke or death within 30 days was 3.8% (2/52). Asymptomatic dissection occurred in two patients, acute in-stent thrombosis followed by postoperative mild stroke (National Institutes of Health Stroke Scale (NIHSS) 3) in one patient, and death due to reperfusion hemorrhage after successful recanalization in one patient. The rate of stroke or death beyond 30 days was 6.5% (3/46). The median clinical follow-up period was 19 months, and the median imaging follow-up period was 12 months. The restenosis rate was 13.2% (5/38).ConclusionsEndovascular recanalization of non-acute intracranial occlusions can be performed with a high rate of technical success and few complications with assistance of the dual-roadmap technique for navigation. Four types of dual-roadmap schemes provide technical references.


2021 ◽  
pp. 1-7
Author(s):  
Zhikai Hou ◽  
Long Yan ◽  
Zhe Zhang ◽  
Jing Jing ◽  
Jinhao Lyu ◽  
...  

OBJECTIVE On the basis of the characteristics of occluded segments on high-resolution magnetic resonance vessel wall imaging (MR-VWI), the authors evaluated the role of high-resolution MR-VWI–guided endovascular recanalization for patients with symptomatic nonacute intracranial artery occlusion (ICAO). METHODS Consecutive patients with symptomatic nonacute ICAO that was refractory to aggressive medical treatment were prospectively enrolled and underwent endovascular recanalization. High-resolution MR-VWI was performed before the recanalization intervention. The characteristics of the occluded segments on MR-VWI, including signal intensity, occlusion morphology, occlusion angle, and occlusion length, were evaluated. Technical success was defined as arterial recanalization with modified Thrombolysis in Cerebral Infarction grade 2b or 3 and residual stenosis < 50%. Perioperative complications were recorded. The characteristics of the occluded segments on MR-VWI were compared between the recanalized group and the failure group. RESULTS Twenty-five patients with symptomatic nonacute ICAO that was refractory to aggressive medical treatment were consecutively enrolled from April 2020 to February 2021. Technical success was achieved in 19 patients (76.0%). One patient (4.0%) had a nondisabling ischemic stroke during the perioperative period. Multivariable logistic analysis showed that successful recanalization of nonacute ICAO was associated with occlusion with residual lumen (OR 0.057, 95% CI 0.004–0.735, p = 0.028) and shorter occlusion length (OR 0.853, 95% CI 0.737–0.989, p = 0.035). CONCLUSIONS The high-resolution MR-VWI modality could be used to guide endovascular recanalization for nonacute ICAO. Occlusion with residual lumen and shorter occlusion length on high-resolution MR-VWI were identified as predictors of technical success of endovascular recanalization for nonacute ICAO.


Stroke ◽  
2020 ◽  
Vol 51 (11) ◽  
pp. 3340-3343 ◽  
Author(s):  
Feng Gao ◽  
Xuan Sun ◽  
Huijun Zhang ◽  
Ning Ma ◽  
Dapeng Mo ◽  
...  

Background and Purpose: Endovascular recanalization for patients with nonacute intracranial vertebral artery occlusion remains clinically challenging. We aim to evaluate the feasibility and safety of endovascular recanalization for nonacute intracranial vertebral artery occlusion and propose a new angiographic classification. Methods: Fifty patients with symptomatic atherosclerotic nonacute intracranial vertebral artery occlusion from January 2015 to December 2019 were analyzed, retrospectively. The rate of recanalization, peri-procedural complications, and follow-up results were evaluated. All patients were divided into 4 groups according to an angiographic classification. Results: Among the 50 patients, 38 (76%) achieved successful recanalization. Any stroke or death within 30 days was 4% (2/50). From type I to type IV, the recanalization rate gradually decreased (94.1%, 76.9%, 70%, and 50%, respectively, P =0.012), while the perioperative complication rate gradually increased (0.0%, 7.7%, 20%, and 50%, respectively, P =0.001). Conclusions: Endovascular recanalization may be feasible and safe for carefully selected patients with symptomatic atherosclerotic nonacute intracranial vertebral artery occlusion and, therefore, represents an alternative treatment, especially for type I and type II patients.


2021 ◽  
pp. neurintsurg-2020-017213
Author(s):  
Feng Gao ◽  
Ju Han ◽  
Xu Guo ◽  
Xuan Sun ◽  
Ning Ma ◽  
...  

BackgroundThere is no consensus on the optimal treatment of non-acute basilar artery occlusion (BAO), and endovascular recanalization still poses a therapeutic challenge for these patients. We report a multicenter clinical experience of endovascular recanalization for symptomatic non-acute BAO and propose an angiographic grouping to determine which patient subgroup most benefits from this treatment.MethodsForty-two patients with non-acute BAO with progressive or recurrent vertebrobasilar ischemic symptoms who underwent endovascular recanalization were retrospectively analyzed from January 2015 to December 2019. These patients were classified into three subtypes based on their occlusion length and distal collateral reconstruction on angiograms. The rates of technical success, periprocedural complications and outcome, any stroke or death within 1 month, and follow-up data were examined.ResultsThe success rate of endovascular recanalization was 76.2% (32/42). The rate of periprocedural complications was 14.3% (6/42). In the three subgroups (types I–III) the success rates of endovascular recanalization were reduced (90.0%, 71.4% and 50%, respectively, p=0.023), while the overall rates of periprocedural complications were increased (5.0%, 14.3% and 37.5%, respectively, p=0.034). Type I lesions, with short-segment occlusions and good distal BA collateral reconstruction, showed favorable responses to endovascular recanalization. The median follow-up time was 1 year (IQR 11.0–19.5 months), with any stroke or death during follow-up at a rate of 7.9%.ConclusionEndovascular recanalization can be safe and feasible for reasonably selected patients with non-acute BAO, especially type I lesions, and offers an alternative choice for those with progressive or recurrent vertebrobasilar ischemic symptoms despite aggressive medical therapy.


2018 ◽  
Vol 8 (1) ◽  
pp. 27-37 ◽  
Author(s):  
Luís Henrique de Castro-Afonso ◽  
Guilherme Seizem Nakiri ◽  
Lucas Moretti Monsignore ◽  
Francisco Antunes Dias ◽  
Frederico Fernandes Aléssio-Alves ◽  
...  

Background/Aims: Endovascular treatment improves the outcomes of patients presenting with acute large vessel occlusions. Isolated proximal carotid occlusions presenting with hemodynamic ischemic stroke may probably also benefit from endovascular treatment. We aimed to assess the clinical and radiological data findings on patients who underwent endovascular treatment for acute ischemic stroke related to an isolated cervical carotid artery occlusion. Methods: Of a consecutive series of 223 patients who were admitted with acute ische­mic stroke and were treated by thrombectomy, we included 9 patients with isolated cervical internal carotid occlusions. Results: The mean baseline National Institutes of Health Stroke Scale (NIHSS) score was 11.8. Complete carotid recanalization was achieved in 5 of the 9 patients (55.5%). In 2 patients, vertebral angioplasty was performed to improve the collateral flow. All patients had a modified Thrombolysis in Cerebral Infarction (mTICI) score of 3 at the end of the procedures. A good neurological outcome, defined as a modified Rankin Scale score ≤2 at the 3-month follow-up, was observed in 6 patients (66.7%). No symptomatic intracranial hemorrhages or deaths occurred during the 3 months of follow-up. Conclusions: The endovascular recanalization of isolated cervical carotid occlusions presenting with acute ischemic stroke symptoms is feasible. Because isolated cervical carotid occlusions are associated with hemodynamic ischemic symptoms, if carotid recanalization cannot be achieved, stenting other cervical arteries’ stenoses, with a focus on intracranial flow improvement, appears to be a reasonable strategy. Large controlled studies are necessary to assess the safety and efficacy of recanalization of acute isolated cervical carotid occlusions.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K Ray ◽  
I Bridges ◽  
E Bruckert ◽  
P Perrone-Filardi ◽  
L Annemans ◽  
...  

Abstract Background/Introduction FOURIER included 22,351 patients with a history of myocardial infarction (MI) and a median low-density lipoprotein cholesterol (LDL-C) of 2.4 mmol/L. Reducing LDL-C with evolocumab reduced the risk of major cardiovascular (CV) events by 1.3%, in absolute terms, over 2.2 years. Whether similar benefits might be observed in real-world evidence from evolocumab use is unknown. Purpose Simulate CV risk and assess the potential CV risk reduction among a large European cohort of evolocumab users with a history of MI. Methods We used interim data from HEYMANS, a register of patients initiating evolocumab in routine clinical practice across 12 European countries, from August 2015 with follow-up through July 2020. Demographic and clinical characteristics, lipid-lowering therapy (LLT), and lipid values were collected from routine medical records (6 months prior to evolocumab initiation through 30 months post initiation). Patients with a history of MI were considered and two sub-cohorts were created: recent MI (MI ≤1 year before evolocumab initiation) and remote MI (MI &gt;1 year before evolocumab initiation). For each patient, we 1) simulated their CV risk using three different sources, correcting for age and LDL-C: i) the REACH equation, ii) FOURIER, iii) an observational study including FOURIER-like patients; 2) calculated their absolute LDL-C reduction on evolocumab; 3) simulated their relative risk reduction (RRR) by randomly sampling from the inverse probability distribution of the rate ratio per 1 mmol/L from the key secondary endpoint in the FOURIER landmark analysis; 4) calculated their absolute risk reduction (ARR) and number needed to treat (NNT) over 2 years (recent MI) or 10 years (remote MI). Results Our analysis included 90 recent MI and 489 remote MI patients initiating evolocumab in clinical practice per local reimbursement criteria, with up to 24 months follow-up. Median (inter-quartile range) age was 59 (53–67) and 61 (53–68) years in recent MI and remote MI patients, respectively. LDL-C before evolocumab was 3.8 (3.2–4.6) and 3.6 (3.0–4.5) mmol/L. Absolute LDL-C reduction on evolocumab was 2.2 (1.4–2.8) and 2.2 (1.6–2.8) mmol/L, meaning relative LDL-C reduction of 60% (44%-73%) and 62% (47%-72%), respectively. Predicted ARR with evolocumab was substantial, whether over 2 years (recent MI) or over 10 years (remote MI). See Table 1. Conclusions This cohort of evolocumab users in clinical practice had a higher baseline LDL-C and CV risk than patients enrolled in FOURIER. LDL-C reduction and RRR were very similar in recent MI and remote MI patients. However, patients with a recent MI had a higher short-term CV risk and therefore showed a larger ARR on evolocumab. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Amgen


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Radenkovic ◽  
D Vakili ◽  
G Botta ◽  
A Boli ◽  
M Banach ◽  
...  

Abstract   Elevated plasma triglycerides (TG) are associated with insulin resistance, metabolic syndrome and major adverse cardiovascular events (MACE). Elevated plasma TG (&gt;150 and 200–499 mg/dL) were recently reported to be a predictor of heart failure in patients with coronary heart disease on statin therapy with a respective 19% and 24% risk increase compared to normal TG levels. REDUCE-IT was a major double-blind randomised controlled trial that tested a novel formulation of highly purified eicosapentaenoic acid ethyl ester (EPA) in 8179 patients with elevated TG on statin therapy. In the trial, daily 4g of EPA lowered MACE by an absolute rate of 4.8% compared to a placebo over a median 4.9-year follow-up. This reflected a 25% risk reduction in MACE and a number needed to treat of 21. EPA recently received significant public attention in late 2019 as the FDA has approved it for secondary prevention and high-risk primary prevention of cardiovascular disease (CVD) in patients with elevated TG that match the trial criteria in the USA. We aimed to investigate the risk reduction in MACE from using EPA in the UK population. We used the UK BioBank, a panomic resource following 500,000 participants over &gt;10 years, with similar age and sex adjusted rates of CVD as the UK population. We first calculated the hazard ratios and Kaplan-Meier survival curves by deciles of increasing TG for incidence of combined CV outcomes: stroke, coronary heart disease, and atherosclerosis. Non-linear CoxPH and DeepSurvival models were trained using different variables from &gt;200,000 UK BioBank participants' data. C-index with standard error and confidence interval estimated with bootstrap sampling ensured quality control. We then matched the UK Biobank population with the REDUCE-IT inclusion criteria and estimated the reduction of combined cardiovascular outcomes if EPA was approved in this population. Hazard ratios increased for TG levels to 5.44 between the 10th decile, and the 1st decile TG level, which was used as baseline. 3563 UK Biobank participants matched with the REDUCE-IT criteria. With the assumption that EPA would have the same effect on the UK Biobank population, we estimate that if the participants were taking EPA, only 29% of the risk group versus actual 37% would have suffered an outcome within the UK Biobank follow-up period. This means that 289 less individuals would have suffered an event instead of the recorded 1318, for a total of 1037. That means according to the number needed to treat analysis, 13 patients would need to be treated to prevent 1 patient from experiencing an event. Elevated TG increase risk for CV events in the UK Biobank population. Purified EPA might become an important tool in our arsenal for CVD secondary and primary prevention. Survival Curves & CI of TG for CVD Funding Acknowledgement Type of funding source: None


2019 ◽  
Vol 30 (1) ◽  
pp. 146-148
Author(s):  
Lara Girelli ◽  
Elena Prisciandaro ◽  
Niccolò Filippi ◽  
Lorenzo Spaggiari

Abstract Oesophago-pleural fistula is an uncommon complication after pneumonectomy, usually related to high morbidity and mortality. Due to its rarity and heterogeneous clinical presentation, its diagnosis and management are challenging issues. Here, we report the case of a patient with a history of pneumonectomy for a tracheal tumour, who developed an asymptomatic oesophago-pleural fistula 7 years after primary surgery. In consideration of the patient’s good clinical status and after verifying the preservation of respiratory and digestive functions, a bold conservative approach was adopted. Five-year follow-up computed tomography did not disclose any sign of recurrence of disease and showed a stable, chronic fistula.


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