scholarly journals A Novel Thrombectomy Device: An In Vitro Evaluation of a Prototype Catheter

Author(s):  
Yasemin Tanyildizi ◽  
Samantha Krost-Reuhl ◽  
Emily S. Payne ◽  
Axel Heimann ◽  
Oliver Kempski ◽  
...  

Abstract Purpose: This prototype catheter is a newly-developed distal access catheter featuring a self-expanding, flexible, funnel-shaped tip. The purpose of its design is to reduce the risk of thrombus fragmentation during mechanical thrombectomy and improve first-pass recanalization (TICI 3). In this experimental setup, we preclinically evaluated the effectiveness and navigability of the new catheter. Methods: A vessel model was filled with a blood-like-viscous medium, and the image was projected with the corresponding vessel area by camera transmission to correspond to the conditions in an angiography. Thrombi from porcine blood were placed into the Arteria Carotis interna of the vascular model and subsequently mechanically thrombectomized with a stent retriever. In the first part, the prototype was compared to a standard distal-access-catheter without using an external catheter. (N = 20 for each catheter). In the second part the prototype was inserted through a guiding catheter (n=11) to determine the navigability performance. Results: In the first experimental series, mechanical thrombectomy was successful 19 out of 20 times (95% success rate) for the prototype catheter versus 15 out of 20 times (75% success rate) for the standard distal-access-catheter. In the second experimental series, the prototype catheter achieved first-pass recanalization 10 out of 11 times (91 % success rate) and 1 out of 11 times at second pass (9%). Conclusion: This series of experiments demonstrated higher first-pass recanalization rates for the newly-developed funnel-shaped prototype featuring a self-expanding tip in comparison to a cylindrical standard distal-access-catheter.

2003 ◽  
Vol 26 (3) ◽  
pp. 265-268 ◽  
Author(s):  
Jan Grimm ◽  
Thomas Jahnke ◽  
Claus Muhle ◽  
Martin Heller ◽  
Stefan M�ller-H�lsbeck

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Eyad Almallouhi ◽  
Sami Al kasab ◽  
Ali Alawieh ◽  
Reda M Chalhoub ◽  
Marios Psychogios ◽  
...  

Introduction: Stroke thrombectomy devices and the experience of neurointerventionists have improved significantly over the last few years making targeting distal occlusions such as of the M2 segment of the middle cerebral artery more feasible. We aimed to study the trend in the successful first pass (SFP) of M2 occlusions over time using the data from a contemporary multicenter registry. Methods: We reviewed the data from the Stroke Thrombectomy and Aneurysm Registry (STAR), which included data from 11 thrombectomy-capable stroke centers to identify stroke patients who underwent mechanical thrombectomy of M2 segment occlusion. SFP was defined by achieving modified Thrombolysis in Cerebral Infarction (mTICI) score≥2b with a single thrombectomy device pass. We analyzed the linear trendline of the rate of SFP over time. Then, we used a logistic regression model to assess predictors of SFP of M2 segment occlusion. Results: We included 401 patients who underwent stroke thrombectomy of M2 occlusion; median age was 71 (IQR 60-80), 212 (52.9%) were females, 174 (43.4%) were white, National Institute of Health stroke scale (NIHSS) was 14 (IQR 8-19), Alberta Stroke Program Early CT (ASPECT) score on presentation was 9 (IQR 7-10) and onset wot groin time was 287 (IQR 181-454). SFP was achieved in 118 (29.4%) patients (linear trendline over time is in Figure 1). Presenting after 2014 was an independent predictor of SFP (OR 1.9, 95% CI 1.1-3.2, P=0.019) after controlling for age, sex, NIHSS on presentation, intravenous alteplase (IV-tPA), and onset to groin time. Conclusion: SFP rate of M2 segment occlusion has increased after 2014 likely secondary the improvement in stroke thrombectomy devices and neurointerventionists experience.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Mahmoud Mohammaden ◽  
Leonardo Pisani ◽  
Catarina Perry da Camara ◽  
Mehdi Bousalma ◽  
Alhamza Al bayati ◽  
...  

Introduction: The speed and completeness of endovascular reperfusion strongly correlate with functional outcomes. First-Pass Reperfusion (FPR) has been recently established as a critical procedural performance metric for mechanical thrombectomy (MT). We aimed to study the predictors of FPR and its effect on the outcome Methods: Review of a prospectively collected database of MT patients with large vessel occlusion strokes (LVOS) from 05/2012-11/2018. Patients were included in the analysis if they had an anterior circulation LVOS that was successfully reperfused (mTICI 2b-3). FPR was defined as the achievement of mTICI 2c-3 after a single pass with any thrombectomy device. Uni- and multivariate analyses were performed to identify the independent predictors of FPR. Results: A total of 563 patients qualified for the analysis (mean age, 64.4±12.3 years, baseline NIHSS 16.2). FPR was achieved in 202 (35.9%) patients. On univariate analysis, FPR was significantly associated with higher ASPECTS (8.1 vs. 7.8, p=0.008), higher usage of balloon guide catheters (BGC) (88.1% vs. 75.3%, p<0.001), lower use of general anesthesia (9.5% vs. 18.2%, p= 0.006), and shorter procedure duration (mean, 45.5 vs. 79.9 min, p <0.001 and 90.5%). Both BGC (OR, 2.26; 95%CI [1.32-3.87], p=0.003) and ASPECTS (OR, 1.15; 95% CI [1.03-1.28], p= 0.01) were independent predictors of FPE on multivariate regression analysis. Conclusion: Higher baseline ASPECTS score and the use of BGC are strong predictors of First-Pass Reperfusion in mechanical thrombectomy.


2019 ◽  
Vol 12 (1) ◽  
pp. 77-81 ◽  
Author(s):  
Sonia Sanchez ◽  
Ignacio Cortiñas ◽  
Helena Villanova ◽  
Anna Rios ◽  
Iñaki Galve ◽  
...  

IntroductionEndovascular treatment of stroke, although highly effective, may fail to reach complete recanalization in around 20% of cases. The Advanced Thrombectomy System (ANCD) is a novel stroke thrombectomy device designed to reduce clot fragmentation and facilitate retrieval by inducing local flow arrest and allowing distal aspiration in combination with a stent retriever. We aimed to assess the preclinical efficacy of ANCD.MethodsSoft red blood cell (RBC)-rich (n=20/group) and sticky fibrin-rich (n=30/group) clots were used to create middle cerebral artery (MCA) occlusions in two vascular phantoms. Three different treatment strategies were tested: (1) balloon guide catheter + Solitaire (BGC+SR); (2) distal access catheter + SR (DAC+SR); and (3) ANCD+SR, until complete recanalization was achieved or to a maximum of three passes. The recanalization rate was determined after each pass.ResultsAfter one pass, ANCD+SR resulted in an increased recanalization rate (94%) for all clots together compared with BGC+SR (66%; p<0.01) or DAC+SR (80%; p=0.04). After the final pass the recanalization rate increased in all three groups but remained higher with ANCD+SR (100%) than with BGC+SR (74%; p<0.01) or DAC+SR (90%; p=0.02). The mean number of passes was lower with ANCD+SR (1.06) than with BGC+SR (1.46) or DAC+SR (1.25) (p=0.01). A logistic regression model adjusted for treatment arm, clot type, and model used showed that both RBC-rich clots (OR 8.1, 95% CI 1.6 to 13.5) and ANCD+SR (OR 3.9, 95% CI 1.01 to 15.8) were independent predictors of first-pass recanalization.ConclusionIn in vitro three-dimensional models replicating MCA-M1 occlusion, ANCD+SR showed significantly better recanalization rates in fewer passes than other commonly used combinations of devices.


2020 ◽  
pp. 174749302092305 ◽  
Author(s):  
Federico Di Maria ◽  
Maéva Kyheng ◽  
Arturo Consoli ◽  
Jean-Philippe Desilles ◽  
Benjamin Gory ◽  
...  

Background The first-pass effect, defined as a complete or near-complete recanalization after one pass (first-pass effect) of a mechanical thrombectomy device, has been related to better clinical outcome than good recanalization after more than one pass in acute ischemic stroke. We searched for predictors of first-pass effect by analyzing the results within a large prospective multicentric registry. Methods We included patients treated by mechanical thrombectomy for isolated anterior intracranial occlusions. A multi-variate logistic regression analysis was carried out to search for predictors of first-pass effect. We also analyzed the percentage of patients with 90-day modified Rankin Scale score 0 to 2, excellent outcome (90-day modified Rankin Scale 0 to 1), 24-h NIHSS change, and 90-day all-cause mortality. Results Among the 1832 patients included, clinical outcome at 90 days was significantly better in first-pass effect patients (50.6% vs. 38.9% in patients without first-pass effect), with a center-adjusted OR associated with first-pass effect of 1.74 (95%CI, 1.24 to 1.77). Older age, a lower systolic blood pressure, an MCA-M1 occlusion, higher DWI-ASPECTS at admission, mechanical thrombectomy under local anesthesia, and combined first-line device strategy were independent predictors of first-pass effect. Conclusions In this study, a strategy combining thrombectomy and thrombo-aspiration was more effective than other strategies in achieving first-pass effect. In addition, we confirm that clinical outcome was better in patients with first-pass effect compared to non-first-pass effect patients.


2020 ◽  
Vol 12 (10) ◽  
pp. 1008-1013 ◽  
Author(s):  
Sonia Sanchez ◽  
Lynn Bailey ◽  
Rebecca Ducore ◽  
Tommy Andersson ◽  
Raul Nogueira ◽  
...  

BackgroundThe Advanced Thrombectomy System (ANCD) provides a new funnel component designed to reduce clot fragmentation and facilitate retrieval in patients with stroke by locally restricting flow, allowing distal aspiration in combination with a stent retriever (SR).ObjectiveTo evaluate the preclinical efficacy and safety of the ANCD in a swine clot model.MethodsSoft and firm clots were implanted in the lingual and cervical arteries of 11 swine to obtain Thrombolysis in Cerebral Infarction (TICI) 0 blood flow. Mechanical thrombectomy was performed with either a balloon guide catheter+Solitaire 2 stent retriever (BGC+SR, n=13) or ANCD+SR (n=13). TICI flow was evaluated and successful revascularization was defined as TICI 3 (normal perfusion). To characterize safety, a total of 3 passes were performed in each vessel independent of recanalization. Tissues were explanted for histopathological analysis after 3 and 30 days, respectively.ResultsFirst pass reperfusion rates were ANCD+SR: 69% and BGC+SR: 46%. Reperfusion increased after the third pass in both groups (ANCD+SR: 100%, vs BGC+SR: 77%). Recanalization was achieved after an average of 1.4 and 1.9 passes in ANCD+SR and BGC+SR (p=0.095), respectively. Vessel injury was comparable in both groups; endothelial loss at 3 days was the most common injury seen (ANCD+SR: 1.78±1.22; BGC+SR: 2.03±1.20; p=0.73), while other histopathological markers were absent or minimal. Tissues downstream from targeted vessels also showed absence or minimal lesions across both groups.ConclusionsResults in a swine clot model support the high efficacy of the ANCD+SR without causing clinically significant vessel injury potentially related to the new funnel component.


2021 ◽  
pp. 028418512110340
Author(s):  
Annette Thurner ◽  
Anne Marie Augustin ◽  
Oliver Götze ◽  
Thorsten A Bley ◽  
Ralph Kickuth

Background Despite improved shunt patency, transjugular intrahepatic portosystemic shunt (TIPS) occlusion remains a serious complication, and effective debulking of the existing tract is needed to restore sufficient blood flow. Purpose To evaluate the technical and clinical success of percutaneous mechanical thrombectomy in restoring patency of acutely and chronically thrombosed covered TIPS using the Aspirex®S and Rotarex®S system. Material and Methods We evaluated mechanical thrombectomy-assisted revisions in five patients between January 2012 and April 2021. Two patients had to be revised twice due to recurrent occlusion. We designated thrombosis within 10 days after shunt creation or revision as acute. Insidious deterioration of portal hypertension related symptoms for at least 6–8 weeks was recorded in chronic cases. We treated four acute and three chronic occlusions. After transjugular lesion crossing, we performed two mechanical thrombectomy device passages. If indicated, balloon dilatation, covered stent placement, or variceal embolization were added. Results The technical success rate was 100%. No procedure-related complications occurred. In one patient with acute decompensation of Budd–Chiari syndrome and acute-on-chronic liver failure, early re-thrombosis occurred twice with patency intervals of up to eight days. In contrast, stable patency was achieved in the other four patients with documented patency intervals of at least five months and improvement of portal hypertension-related symptoms, resulting in a patient based clinical success rate of 80%. Conclusion In five patients, percutaneous mechanical thrombectomy assisted TIPS recanalization of four acute and three chronic occlusions proved to be technically feasible and safe with a high clinical success rate.


2021 ◽  
Author(s):  
Emily S. Payne ◽  
Samantha Krost-Reuhl ◽  
Axel Heimann ◽  
Oliver Kempski ◽  
Naureen Keric ◽  
...  

Abstract Clot-retrieval failure and embolism in new territories (ENT) are complications reducing the efficacy of mechanical thrombectomy (MT). Reasons for these problems are clot abruption during stent retriever retraction into the cylindrical tip of a standard distal access catheter (DAC), and antegrade blood flow during retrieval. To overcome these complications, a funnel-shaped tip catheter model was developed and tested. Using an experimental in vitro setup, this study compared the efficacy of a funnel-shaped tip with a standard cylindrical tip in combination with different clot compositions. Mechanical thrombectomy was performed 80 times for each tip, using two stent retrievers (Trevo XP ProVue 3/20 mm and 4/20 mm) and four different clot types (mechanical vs. static preparation, 0-24h vs. 72h clot aging times). Significantly higher first-pass recanalization rates were observed for the funnel-shaped tip, which reached 70.0% vs. 30.0% for the standard tip (absolute difference, 32; relative difference 20.0%, P < 0.05), regardless of the clot type and stent retriever. Recanalization could be increased using fibrin-rich mechanical clots vs. clots prepared under static conditions, as well as 0-24h vs. 72h aged clots, respectively. The extended in vitro-experiments verified the usability of the recently patented funnel-shaped DAC, hereby implementing next-level in vivo-experiments.


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