The Lazarus Funnel: a blinded prospective randomized in vitro trial of a novel CE-marked thrombectomy assist device

2014 ◽  
Vol 8 (1) ◽  
pp. 66-68 ◽  
Author(s):  
Kyle M Fargen ◽  
J Mocco ◽  
Y Pierre Gobin

IntroductionThe use of retrievable stents for acute ischemic stroke (AIS) may result in the release of distal emboli in 12–22% of cases. The Lazarus Funnel is a novel CE-marked thrombectomy assist device designed to capture the stentriever and thrombus to minimize the likelihood of distal embolization. To study this technology, we performed a randomized blinded in vitro evaluation of this device.MethodsA cerebral flow model was used as an in vitro simulator for cerebral arterial thrombectomy procedures. Stratified block randomization was performed following embolus injection into one of three cohorts: Solitaire stentriever plus guide catheter (control); control plus proximal Funnel placement; or control plus distal Funnel placement. Time to embolectomy, recanalization, and incidence of distal emboli were determined by a blinded observer.ResultsForty-five thrombectomy trials were performed (15 in each group). The average time required for thrombectomy in each group was 8 min 26 s, 11 min 0 s and 9 min 24 s, respectively (p=NS). Use of the Funnel was associated with significantly improved recanalization compared with stentriever alone (p<0.01). Use of the proximal Funnel resulted in a 25% increase in successful recanalization and a 20% reduction in distal emboli. Use of the distal Funnel resulted in a 200% increase in successful recanalization and a 60% reduction in emboli.ConclusionsIn this AIS embolism flow model with Solitaire thrombectomy, the Lazarus Funnel resulted in a significant increase in recanalization and significant reduction in distal emboli without increase in time to recanalization.

2020 ◽  
Vol 12 (10) ◽  
pp. 1002-1007
Author(s):  
Sarah Johnson ◽  
Ray McCarthy ◽  
Brian Fahy ◽  
Oana Madalina Mereuta ◽  
Seán Fitzgerald ◽  
...  

​BackgroundCalcified cerebral emboli (CCEs) are a rare cause of acute ischemic stroke (AIS) and are frequently associated with poor outcomes. The presence of dense calcified material enables reliable identification of CCEs using non-contrast CT. However, recanalization rates with the available mechanical thrombectomy (MT) devices remain low.ObjectiveTo recreate a large vessel occlusion involving a CCE using an in vitro silicone model of the intracranial vessels and to demonstrate the feasability of this model to test different endovascular strategies to recanalize an occlusion of the M1 segment of the middle cerebral artery (MCA).​MethodsAn in vitro model was developed to evaluate different endovascular treatment approaches using contemporary devices in the M1 segment of the MCA. The in vitro model consisted of a CCE analog placed in a silicone neurovascular model. Development of an appropriate CCE analog was based on characterization of human calcified tissues that represent likely sources of CCEs. Feasibility of the model was demonstrated in a small number of MT devices using four common procedural techniques.​ResultsCCE analogs were developed with similar mechanical behavior to that of ex vivo calcified material. The in vitro model was evaluated with various MT techniques and devices to show feasibility of the model. In this limited evaluation, the most successful retrieval approach was performed with a stent retriever combined with local aspiration through a distal access catheter, and importantly, with flow arrest and dual aspiration using a balloon guide catheter.​ConclusionCharacterization of calcified tissues, which are likely sources of CCEs, has shown that CCEs are considerably stiffer than thrombus. This highlights the need for a different in vitro AIS model for CCEs than those used for thromboemboli. Consequentially, an in vitro AIS model representative of a CCE occlusion in the M1 segment of the MCA has been developed.


Biomolecules ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 347
Author(s):  
Zsuzsa Bagoly ◽  
Barbara Baráth ◽  
Rita Orbán-Kálmándi ◽  
István Szegedi ◽  
Réka Bogáti ◽  
...  

Cross-linking of α2-plasmin inhibitor (α2-PI) to fibrin by activated factor XIII (FXIIIa) is essential for the inhibition of fibrinolysis. Little is known about the factors modifying α2-PI incorporation into the fibrin clot and whether the extent of incorporation has clinical consequences. Herein we calculated the extent of α2-PI incorporation by measuring α2-PI antigen levels from plasma and serum obtained after clotting the plasma by thrombin and Ca2+. The modifying effect of FXIII was studied by spiking of FXIII-A-deficient plasma with purified plasma FXIII. Fibrinogen, FXIII, α2-PI incorporation, in vitro clot-lysis, soluble fibroblast activation protein and α2-PI p.Arg6Trp polymorphism were measured from samples of 57 acute ischemic stroke patients obtained before thrombolysis and of 26 healthy controls. Increasing FXIII levels even at levels above the upper limit of normal increased α2-PI incorporation into the fibrin clot. α2-PI incorporation of controls and patients with good outcomes did not differ significantly (49.4 ± 4.6% vs. 47.4 ± 6.7%, p = 1.000), however it was significantly lower in patients suffering post-lysis intracranial hemorrhage (37.3 ± 14.0%, p = 0.004). In conclusion, increased FXIII levels resulted in elevated incorporation of α2-PI into fibrin clots. In stroke patients undergoing intravenous thrombolysis treatment, α2-PI incorporation shows an association with the outcome of therapy, particularly with thrombolysis-associated intracranial hemorrhage.


2021 ◽  
pp. 110693
Author(s):  
Giulia Luraghi ◽  
Rachel M. E. Cahalane ◽  
Emma van de Ven ◽  
Serena Overschie ◽  
Frank J. H. Gijsen ◽  
...  

2016 ◽  
Vol 11 (3) ◽  
Author(s):  
Rafiq A Basharat ◽  
Kamran Rashid Mirza ◽  
Muhammad Yousuf Qamar

Objectives: To find out the time interval from onset of the symptoms to admission in the hospital of patients suffering from acute ischemic stroke, in order to assess the feasibility of thrombolytic therapy in Lahore General Hospital. Design: Hospital-based, prospective and observational study Setting: Lahore General Hospital Lahore. Duration: Six months from January - June 2004. Patients: Seventy two patients with acute ischemic stroke diagnosed on basis of clinical findings and CT scan. Methods: Patients o f a cute ischemic stroke including cerebral infarct, T IA, venous infarct and lacunar infarct were diagnosed on basis of clinical history, examination and CT scan and enrolled in the study. Data was collected on a Performa. Time taken by patients to reach hospital after onset of symptoms, distance of patients` residences from hospital, education level of patients and time required to do a CT scan after arrival of patient in hospital were studied. Results: 54.2% were male and mean age of patients was 60 years. 58 patients had cerebral infarction, TIA`s and venous infarction were 8 and 6 respectively. Delay in presentation was divided in three groups. Within three hours (hrs) 15 (21%) patients arrived. 54 and 18 patients arrived in 3-- 24 hrs group and >24 firs group. Mean distance was roughly 44 km. Mean distance for 0-3hrs, 3-24hrs and >24hrs group was 14, 35, and 85 Km respectively. Average time required to do CT scan was nine hours after arrival of patient in emergency department. Sixty-five percent of patients coming were illiterate. Conclusion: Majority of the patients with ischemic stroke present late to. emergency department. Many factors including distance from hospital, illiteracy, non-availability of ambulance services responsible for it. Evaluation-of patients and provision of urgent CT scan is required. in hospitals.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Alejandro Spiotta ◽  
Jan Vargas ◽  
Harris Hawk ◽  
Raymond Turner ◽  
Imran Chaudry ◽  
...  

Introduction: Intra-arterial therapy for acute ischemic stroke (AIS) now has an established role. We investigated if Hounsfield Units (HU) quantification on noncontrast CT is associated with ease and efficacy of mechanical thrombectomy and outcomes. Methods: We retrospectively studied a prospectively maintained database of cases of acute ischemic stroke that underwent intra-arterial therapy between May 2008 and August 2012. Functional outcome was assessed by ninety-day follow up modified Rankin Scale (mRS). Patients were dichotomized base on time to recanalization. Hounsfield units were calculated on head CT. Thrombus location and length were determined on CT angiography. Simple linear regression was used to analyze the association between clot length, average HU, and other clinical variables. Results: 141 patients were included. There was no difference in clot length or average HU among patients with good recanalization achieved within an hour compared to those in which procedures extended beyond an hour. There was no relationship between clot length or density and recanalization. The thrombus length and density were not significantly different between patients with procedural complications and those without. The presence of post procedure intracranial hemorrhage was not associated with thrombus length or density. Ninety day mRS was not associated with thrombus length or density. Conclusions: We have not found any significant associations between either thrombus length or density and likelihood of recanalization, time to achieve recanalization, intraprocedural complications, postprocedural hemorrhage or functional outcome at ninety days. These results do not support a predictive value for thrombus quantification in the evaluation of AIS.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Sunil A Sheth ◽  
Abhishek Verma ◽  
David S Liebeskind ◽  
Jeffrey L Saver ◽  
Gary Duckwiler ◽  
...  

Introduction: The cerebrovascular endothelium plays a critical role in the pathogenesis of and response to acute ischemic stroke (AIS). To date, techniques to study its function have relied on animal and in vitro models. A robust method of endothelial cell (EC) capture in patients with AIS at early time points, from within the ischemic region, could greatly advance our understanding of cerebrovascular injury. Method: Patients undergoing thrombectomy for middle cerebral artery occlusion (MCA) within 8 hours of onset were offered enrollment if the pass of their stent-retriever device occurred directly into a distal access catheter in the proximal M1 segment, limiting exposure of the device to only the MCA. After retrieval, ECs adherent to the devices were retrieved and stained for EC (CD31) and leukocyte (CD45) markers. EC identity and yield were confirmed by flow cytometry with simultaneous immuno-fluorescence microscopy. Cultured human ECs were used as positive controls. The EC fraction was defined as CD31 + CD45 - with size and morphological features consistent with the positive controls. Results: ECs from stent-retriever devices (n=3) were collected and pooled. Approximately 8% of the collected cells represented ECs. EC collected from the stent-retrievers demonstrated highly similar shape, morphology and antibody staining patterns compared to the positive controls (Figure). Conclusions: Here we provide the first demonstration of a rapid post-thrombectomy method for reliable harvesting of cerebral ECs in humans. The ability to capture these cells in patients with AIS within hours of symptom onset opens many avenues of exploration for determining the role of ECs in AIS.


2019 ◽  
Vol 30 (11) ◽  
pp. 1759-1764.e6 ◽  
Author(s):  
Robert-Jan B. Goldhoorn ◽  
Nele Duijsters ◽  
Charles B.L.M. Majoie ◽  
Yvo B.W.E.M. Roos ◽  
Diederik W.J. Dippel ◽  
...  

Author(s):  
Jawid Madjidyar ◽  
Lars Nerkada ◽  
Naomi Larsen ◽  
Fritz Wodarg ◽  
Johannes Hensler ◽  
...  

Purpose A direct aspiration first pass technique (ADAPT) is an effective thrombectomy option in patients with acute ischemic stroke. Balloon guide catheters (BGC) seem to improve the efficacy of stent retrievers and ADAPT. The last generation 6F aspiration catheters require 9F BGCs, which are rigid devices that are challenging to position in a tortuous anatomy. In this experimental study the efficacy of 6F ADAPT alone and 5F ADAPT combined with 8F BGC was evaluated. Materials and Methods Either a fibrin rich (white) clot or an RBC rich (red) clot was placed in the M1 segment of a transparent silicon phantom. Physiological hemodynamic conditions were maintained. The clots were retrieved by 6F aspiration catheter via 8F long sheath or 5F aspiration catheter via a flexible 8F BGC. Thrombectomy was performed under direct visual control. The primary endpoints were the number of passes and the number of distal emboli. Results Ten experiments were made with each clot model and thrombectomy technique (n = 40). Full recanalization could be achieved in every experiment. First pass mTICI 3 could be achieved by 6F ADAPT in 80 % of red clots and 90 % of white clots. Distal emboli were caused in 10 % and 20 %, respectively. When using 5F ADAPT combined with BGC, a first pass mTICI 3 rate of 90 % in red clots and 100 % in white clots could be achieved. A 10 % rate of distal emboli occurred in both groups. In almost all experiments (both techniques), the thrombi clogged the aspiration catheter. No statistically significant differences could be found between the techniques and clot models. Conclusion 6F ADAPT without BGC was as effective as 5F ADAPT combined with a flexible 8F BGC, with both techniques showing high first-pass recanalization rates and low distal emboli rates. Especially in the case of a tortuous anatomy, these setups should be considered as alternatives to a rigid 9F BGC. The thrombus compositions seemed to be irrelevant in this setting. Key Points:  Citation Format


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