Showing papers by "David Fiorella published in 2022"

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Abstract: Background The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. Methods PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. Results As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge–Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. Conclusions The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. Trial registration NCT02186561.

First-line thrombectomy strategy for distal and medium vessel occlusions: a systematic review

Abstract: Background The benefit of mechanical thrombectomy (MT) and efficacy of different first-line MT techniques remain unclear for distal and medium vessel occlusions (DMVOs). In this systematic review, we aimed to compare the performance of three first-line MT techniques in DMVOs. Methods The PubMed database was searched for studies examining the utility of MT in DMVOs (middle cerebral artery M2-3-4, anterior cerebral artery, and posterior cerebral artery). Studies providing data for aspiration thrombectomy (ASP), stent retriever thrombectomy (SR), and combined SR+ASP technique were included. Non-comparative studies were excluded. Safety and efficacy data were collected for each technique. The Nested Knowledge AutoLit platform was utilized for literature search, screening, and data extraction. Pooled data were presented as descriptive statistics. Results 13 studies comprising 2422 MT procedures were identified. The overall successful recanalization rate was 77.0% (1513/1964) for DMVOs. SR+ASP had a successful recanalization rate of 83.7% (297/355), SR had a 75.6% rate (638/844), while ASP alone had a 74.2% rate (386/520). The overall functional independence rate was 51.3% (851/1659) among DMVOs. The ASP alone group had a functional independence rate of 46.9% (219/467), while functional independence rates of the SR and SR+ASP groups were 51.5% (372/723) and 61.7% (174/282), respectively. Finally, the subarachnoid hemorrhage rates were 1.8% (4/217) for the ASP group, 9.3% (26/281) for the SR group, and 11.9% (41/344) for the SR+ASP group. Conclusions Our systematic review supports the proposition that MT is a safe and effective treatment option for DMVOs. Additionally, while the SR+ASP group had consistently high rates of clot clearance and good neurological outcomes, the SR and SR+ASP groups also had higher rates of subarachnoid hemorrhage, highlighting the need for improved DMVO treatment devices.

Immediate flow-diversion characteristics of a novel primarily bioresorbable flow-diverting stent.

Abstract: OBJECTIVE Flow-diverting stents with a resorbable component have significant theoretical benefits over full metal stents, although currently there are none in clinical use. In this study, the authors sought to determine the immediate flow-diversion characteristics of a novel primarily bioresorbable flow-diverting stent. METHODS Bioresorbable stents were deployed into glass tube models to determine porosity and pore density. In vitro flow diversion behavior was evaluated using high frame rate angiography under pulsatile flow conditions in a patient-specific silicone aneurysm model treated with the resorbable stent as well as the Surpass Evolve stent. In vivo flow diversion was characterized by deployment into 20 rabbit saccular aneurysm models, and grading was based on the O'Kelly-Marotta scale and the 4F-flow diversion predictive score. RESULTS Porosities and pore densities of the bioresorbable stent were in the flow-diverting range for all target vessel diameters. Quantified results of immediate angiography after placement of the bioresorbable stent into a silicone aneurysm model demonstrated greater flow diversion compared to the Evolve stent. Bioresorbable stent placement in saccular aneurysm models resulted in an immediate O'Kelly-Marotta grade of A3 or better and a 4F-flow diversion predictive score of 4 or better in all cases. CONCLUSIONS The bioresorbable stent has immediate flow-diversion characteristics that are comparable to commercially available metal stents. Longer-term studies are underway to determine the ability of the resorbable fibers to act as a neointimal scaffold and result in long-term aneurysm occlusion.

Aristotle 24 microwire early experience.

Abstract: Larger microcatheters are being used with increasing frequency in routine neurovascular procedures. Navigating catheters safely and effectively to the target intracranial vessels can be a challenge when using conventional 0.014″ microwires. A new family of 0.024″ Aristotle 24 microwires (Scientia Vascular, West Valley City, UT) specifically designed for intracranial navigation were recently introduced. These microwires offer significant technical advantages over the standard 0.014″ microwires, including a reduced ledge gap, improved torquability and support, and overall safety. This video case series contains several illustrative cases to demonstrate the features of the novel Aristotle 24 microwire for use in endovascular neurointervention.

O-054 Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a specific flow-diverter occlusion classification

Abstract:

Introduction

Flow diverters proved to be a safe and efficacious approach for the management of large intracranial lesions. The PREMIER trial was the first prospective study to examine the efficacy of the pipeline embolization device (PED, Medtornic) for the management of small and medium size wide-necked aneurysms. Herein, we present the 3-year follow-up results from the PREMIER cohort.

Methods

The PREMIER was a prospective, single-arm study, including patients with a target wide-necked aneurysm of ≤ 12 mm, located in the internal carotid artery or vertebral artery. The primary effectiveness endpoint (complete aneurysm occlusion) and primary safety endpoint (major stroke in the supplied territory or neurologic death) were independently monitored and adjudicated. Additional angiographic evaluation to highlight the natural history of aneurysms treated with flow diverters was performed using the modified Cekirge-Saatci Classification (mCSC).

Results

According to CRL review, of 141 patients treated with PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. Three (12%) of these patients progressed to complete occlusion, resulting in a complete aneurysm occlusion rate at 3-year of 83.3% (115/138). Further angiographic evaluation using mCSC demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in all cases with consecutive available follow-ups (97.1%). Overall safety endpoint occurred in 2.8% (4/140) of the patients over the 3-year follow-up, with only one event occurring after the first year – which was non-disabling at 2-year follow-up. Retreatment rate since initial device implantation was 5.0% (7/138): 4 within the first year and 3 within the second year, all carried on with PED in elective procedures. There was one case of aneurysm recurrence (0.7%) in a patient with an initially occluded aneurysm who afterward demonstrated residual neck at a 3-year follow-up. Not a single case of aneurysm rupture occurred in the series.

Conclusions

A high rate of aneurysm occlusion, low morbidity, and absence of aneurysm rupture emphasize the PED as a safe treatment strategy for small and medium-sized aneurysms located along the ICA and VA in the long term.

Disclosures

R. Hanel: 1; C; Unrestricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX. 2; C; Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. He is on advisory board for MiVI, eLum, Three Rivers, Shape Medical and Corindus. 4; C; InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. G. Cortez: None. D. Lopes: 2; C; Asahi, Medtronic, and Stryker; honoraria from Siemens, Medtronic, Stryker, and Phenox. P. Nelson: 2; C; Medtronic, Phenox, and GmbH. A. Siddiqui: 2; C; Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Rap. 4; C; in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical Ltd, Imperative Care, I. P. Jabbour: 2; C; Medtronic, Cerenovus, and Microvention. V. Pereira: 1; C; Philips. 2; C; Stryker, Penumbra, Balt, Medtronic, and Neurovasc. I. István: 2; C; Medtronic. O. Zaidat: 2; C; Medtronic, Stryker, Penumbra, and Cerenovus. C. Bettegowda: 2; C; Depuy-Synthes, Bionaut labs, and Galectin Therapeutics. G. Colby: 2; C; Medtronic, Microvention-Terumo, and Stryker. M. Mokin: 2; C; Cerebrotech, Imperative Care, and Penumbra; consulting fees form Medtronic, Cerenovus, and Canon Medical. C. Schirmer: 6; C; received honoraria from the American Association of Neurological Surgeons and Toshiba, and has ownership interest in NTI. F. Hellinger: None. C. Given II: 2; C; Medtronic and Stryker. 3; C; Medtronic and Stryker. T. Krings: 2; C; Stryker, Cerenovus, Penumbra, and Medtronic. P. Taussky: 2; C; Stryker Neurovascular, Cerenovus, and Medtronic. G. Toth: 2; C; Dynamed EBSCO and Microvention. J. Fraser: 2; C; Stream Biomedical, Penumbra, and Medtronic. 4; C; Fawkes Biotechnology, LLC, and Cerelux. M. Chen: 2; C; Medtronic, Stryker, Penumbra, Genentech, and GE. R. Priest: 2; C; Medtronic, Stryker, and Cerenovus. P. Kan: 2; C; Stryker Neurovascular, Medtronic, and Cerenovus. D. Fiorella: 1; C; Balt USA, Microvention, Penumbra, Siemens, and Stryker. 2; C; Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker, Siemens. 6; C; honorarium from Qapel Medicine. D. Frei: 2; C; Penumbra, Stryker Neurovascular, Genentech, MicroVention, and Codman. B. Aagaard-Kienitz: None. O. Diaz: 6; C; proctor for Microvention/Terumo. A. Malek: 6; C; Cofounder, investor, and shareholder of CereVasc. C. Cawley: None. A. Puri: 1; C; Medtronic Neurovascular, Stryker Neurovascular, and Cerenovus. 2; C; Microvention, Agile, Merit, Corindus, QApel, Arsenal, and Imperative Care. D. Kallmes: 1; C; Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera. 6; C; President of Marblehead Medical and has patent pending in balloon catheter technologies.

O-020 The tigertriever 13 distals study: distal ischemic stroke treatment with adjustable low-profile stentriever

Abstract:

Objectives

This is the first FDA approved IDE study for mechanical thrombectomy to treat distal occlusions. DISTALS is a randomized study planned to evaluate the safety and effectiveness of the TIGERTRIEVER 13 Revascularization Device in restoring blood flow in the neurovasculature by removing thrombus in subjects presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO), as compared to medical management.

Methods

118 patients of age 18–85 will be randomized in 1:1 ratio in USA and outside USA clinical centers. The primary endpoint will be successful reperfusion at 24 ± 6 hours post randomization, measured either by CTP or MR PWI. The secondary endpoints will include 90 days mRS shift, delta NIHSS at discharge compared to baseline, Quality of life measured by EQ-5D and cognitive assessment measured by MoCA at 90 days. Safety endpoints will include symptomatic and asymptomatic intracranial hemorrhages. Key inclusion criteria will be disabling presenting deficits that localize to the territory of the distal vessel occlusion; NIHSS 4–24, or NIHSS 2–24 for patients with aphasia and/or hemianopia, CTP or MR PWI confirmed lesions non-dominant or co-dominant M2, M3, PCA or ACA; 24 hours since last known well. Patients with excessive tortuosity, treated with IV thrombolysis therapy, intracranial hemorrhage, bilateral stroke or stroke in multiple territories will be excluded. CT, MRI and Radiographic Images will be analyzed by an independent core lab (UCLA).

Results

Technical aspects of the TIGERTIEVER 13 device, will be presented as well as summary of the European experience with the device. More study details and the study status will be discussed.

Conclusion

The TIGERTRIEVER 13 device with operator controllability and high fluoroscopy visibility and its small size can potentially provide a safe and effective clot removal in patients with distal vessels occlusion.

Disclosures

D. Fiorella: 1; C; Rapid Medical. R. Gupta: None. R. Chapot: None. J. Saver: None.

Abstract TMP73: Patterns Of Index And Recurrent Stroke In Patients With Intracranial Stenosis

Abstract: Background and Purpose: Pattern of infarct due to ICAS (e.g. borderzone) may predict recurrent stroke risk. We sought to describe the patterns of index and recurrent infarcts in patients enrolled in the medical arm of the SAMMPRIS Trial (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis). Methods: - Patients enrolled in the medical management arm of the SAMMPRIS trial with infarct as the qualifying event who had CT or MRI, or those with a recurrent infarct in the territory of the symptomatic artery during follow up were included. Infarct pattern for both the index infarct and any recurrent infarct in the territory was determined using criteria defined in prior SAMMPRIS publications as borderzone, MCA artery core, and perforator for anterior circulation and cerebellar, perforator and distal for posterior circulation (see figure for examples). Infarct pattern was adjudicated independently by 2 reviewers, with a 3 rd reviewer as tiebreaker. Results: - Among the 142 patients who had index infarcts in the anterior circulation (n=101) and posterior (n=41) circulation, the patterns were: 53 (37.3%) borderzone, 24 (16.9%) MCA core, 35 (24.6%) perforator, 13 (9.2%) distal, and 17 (12%) cerebellar. Among the 31 who had recurrent infarct in the territory, the patterns were: 10 (32.3%) borderzone, 6 (19.4%) MCA core, 6 (19.4%) perforator, 4 (12.9%) distal, 1 (3.2%) cerebellar, and 4 (12.9%) were missing imaging. Of the recurrent infarcts in territory, 21 had both index infarct and recurrent infarct in territory adjudications, with 11 demonstrating the same pattern of infarct for both events (7 borderzone, 2 core, 2 perforator). Conclusions: - The majority of patients with stroke due to severe symptomatic intracranial stenosis demonstrated borderzone pattern of infarct for index and recurrent infarcts. Ongoing analyses of this dataset will determine the association between pattern of index stroke and risk of recurrent stroke.

In vitro comparison of middle meningeal artery embolization with Squid liquid embolic agent and Contour polyvinyl alcohol particles

Abstract: Background Liquid embolic agents and polyvinyl alcohol (PVA) particles have been used for the embolization of the middle meningeal artery (MMA) for the treatment of chronic subdural hematomas. However, the vascular penetration and distribution of these embolic agents have not yet been compared. The current study compares distribution of a liquid embolic agent (Squid) to PVA particles (Contour) in an in vitro model of the MMA. Methods MMA models were embolized with Contour PVA particles 45–150 µm, Contour PVA particles 150–250 µm, and Squid-18 liquid embolic agent (n=5 each). The models were scanned and every vascular segment with embolic agent was manually marked on the images. Embolized vascular length as a percentage of control, average embolized vascular diameter, and embolization time were compared between the groups. Results The 150–250 µm Contour particles primarily accumulated close to the microcatheter tip, yielding proximal branch occlusions. The 45–150 µm Contour particles achieved a more distal distribution, but in a patchy segmental pattern. However, the models embolized with Squid-18 had a consistently distal, near-complete and homogenous distribution. Embolized vascular length was significantly higher (76±13% vs 5±3%, P=0.0007) and average embolized vessel diameter was significantly smaller (405±25 µm vs 775±225 µm, P=0.0006) with Squid than with Contour. Embolization time with Squid was also lower (2.8±2.4 min vs 6.4±2.7 min, P=0.09). Conclusions Squid-18 liquid results in a considerably more consistent, distal and homogeneous pattern of embolysate distribution than Contour PVA particles in an anatomical model of the MMA tree.

Machine Learning–Based Identification of Target Groups for Thrombectomy in Acute Stroke

Abstract: Whether endovascular thrombectomy (EVT) improves functional outcome in patients with large-vessel occlusion (LVO) stroke that do not comply with inclusion criteria of randomized controlled trials (RCTs) but that are considered for EVT in clinical practice is uncertain. We aimed to systematically identify patients with LVO stroke underrepresented in RCTs who might benefit from EVT. Following the premises that (i) patients without reperfusion after EVT represent a non-treated control group and (ii) the level of reperfusion affects outcome in patients with benefit from EVT but not in patients without treatment benefit, we systematically assessed the importance of reperfusion level on functional outcome prediction using machine learning in patients with LVO stroke treated with EVT in clinical practice (N = 5235, German-Stroke-Registry) and in patients treated with EVT or best medical management from RCTs (N = 1488, Virtual-International-Stroke-Trials-Archive). The importance of reperfusion level on outcome prediction in an RCT-like real-world cohort equaled the importance of EVT treatment allocation for outcome prediction in RCT data and was higher compared to an unselected real-world population. The importance of reperfusion level was magnified in patient groups underrepresented in RCTs, including patients with lower NIHSS scores (0-10), M2 occlusions, and lower ASPECTS (0-5 and 6-8). Reperfusion level was equally important in patients with vertebrobasilar as with anterior LVO stroke. The importance of reperfusion level for outcome prediction identifies patient target groups who likely benefit from EVT, including vertebrobasilar stroke patients and among patients underrepresented in RCT patients with low NIHSS scores, low ASPECTS, and M2 occlusions.

A novel angiographic method to estimate arterial blood flow rates using contrast reflux: Effect of injection parameters.

Abstract: BACKGROUND Contrast reflux, which is the retrograde movement of contrast against flow direction, is commonly observed during angiography. Despite a vast body of literature on angiography, the hemodynamic factors affecting contrast reflux have not been studied. Numerous methods have been developed to extract flow from angiography, but the reliability of these methods is not yet sufficient to be of routine clinical use. PURPOSE To evaluate the effect of baseline blood flow rates and injection conditions on the extent of contrast reflux. To estimate arterial flow rates based on measurement of contrast reflux length. MATERIALS AND METHODS Iodinated contrast was injected into an idealized tube as well as a physiologically accurate model of the cervico-cerebral vasculature. A total of 194 high-speed angiograms were acquired under varying 'blood' flow rates and injection conditions (catheter size, injection rate, injection time). The length of contrast reflux was compared to the input variables and to dimensionless fluid dynamics parameters at the catheter-tip. Arterial blood flow rates were estimated using contrast reflux length as well as a traditional transit-time method and compared to measured flow rates. RESULTS Contrast reflux lengths were significantly affected by contrast injection rate (p<0.0001), baseline blood flow rate (p = 0.0004), and catheter size (p = 0.04), but not by contrast injection time (p = 0.4). Reflux lengths were found to be correlated to dimensionless fluid dynamics parameters by an exponential function (R2 = 0.6 to 0.99). When considering the entire dataset in unison, flow estimation errors with the reflux-length method (39±33%) were significantly higher (p = 0.003) than the transit-time method (33±36%). However, when sub-grouped by catheter, the error with the reflux-length method was substantially reduced and was significantly lower (14±14%, p<0.0001) than the transit-time method. CONCLUSION Results show correlations between contrast reflux length and baseline hemodynamic parameters that have not been reported previously. Clinically relevant blood flow rate estimation is feasible by simple measurement of reflux length. In vivo and clinical studies are required to confirm these correlations and to refine the methodology of estimating blood flow by reflux. This article is protected by copyright. All rights reserved.

O-041 A unique embolic agent: solvent-free, shear-responsive biomaterial for microvascular penetration

Abstract:

Introduction

The Distally Penetrating Embolic (DPE) is a purpose-built, solvent-free, shear-responsive, silicone-based biomaterial designed for embolization applications where complete casting and occlusion of fine vessel branches is desired (e.g., embolization of the middle meningeal artery for meningiomas and chronic subdural hematoma). The DPE is supplied as a three-part system in small-volume syringes that are mixed prior to use, forming an injectable, shear-thinning paste that preferentially drives into distal vessels where shear is highest; ultimately, the DPE cures in situ into an elastomeric solid. Here, we report on DPE usability and embolization performance in vivo.

Methods

Usability: Six neurointerventional radiologists assessed device preparation and injection using a Likert scale (1-very difficult to 5-very easy). Embolization: A total of 57 injections in 20 swine at two sites were performed to acutely evaluate distal penetration and occlusion performance; injections were performed using a 0.017’ microcatheter (n=52) or with dual-lumen balloon occlusion (n=5). Seven and thirty-day studies were conducted against commercially-available controls to evaluate embolization and safety performance in kidney vasculature (n=8 per timepoint). Occlusion via angiography, distal penetration via micro-computed tomography (μCT), and biocompatibility via histopathology were assessed.

Results

Average device preparation time by clinicians was 2.3 ± 0.4 minutes. Usability was acceptable, and all clinicians were able to hand-inject the material through a 150 cm long, 0.017’ microcatheter. When injected into vessels with blood flow, the DPE shear-thinned and was carried distally into small branches; thereafter, it proceeded proximally to fill larger vessels. After injection was stopped, proximal blood pressure continued to ‘pack’ the material further into the distal vasculature and capillary bed until the material completely cured (~10 minutes from initial mixing). With balloon occlusion, the pressure from injection progressively advanced the DPE proximally to distally, whereupon it shear-thinned and evenly penetrated into small vessel branches. At follow-up, angiography showed effective occlusion of target vasculature without evidence of recanalization. μCT radiographs indicated complete casting of millimeter to micron-sized vessels. Histological sections confirmed full luminal occlusion in vessels down to 30-micron diameter (material was not detected in the venous vasculature). Vessel injury and necrosis were both absent while inflammation was only minimal. No hemorrhage occurred when DPE-embolized kidney tissue was surgically incised.

Conclusion

The solvent-free, shear-responsive DPE is an easily prepared, hand-injectable agent that penetrates deeply into distal vessels to provide complete casting and occlusion of target vasculature with favorable biocompatibility. These promising outcomes warrant further study in human subjects.

Disclosures

D. Fiorella: 1; C; National Cancer Institute – R44CA257802, Penumbra, Stryker, Balt USA, Siemens. 2; C; Arsenal Medical, Medtronic, Microventoin, Stryker, Balt USA, Mentice, Neurogami, Marblehead, Rapid.AI, Rapid Medical, Phenox, Scientia Vascular. 4; C; Mentice, Neurogami, Marblehead, Scientia Vascular, NVMed. C. Sadasivan: 1; C; National Cancer Institute – R44CA257802. R. Brownlee: 1; C; National Cancer Institute – R44CA257802. A. Arthur: 1; C; Balt USA, Medtronic, Microvention, Penumbra, Siemens. 2; C; Arsenal Medical, Balt USA, Johnson and Johnson, Medtronic, Microvention, Penumbra, Scientia Vascular, Stryker. 4; C; Azimuth, Bendit, Cerebrotech, Endostream, Magneto, Mentice, Neurogami, Neuros, Scientia Vascular, Serenity, Synchron, Tulavi, Vastrax, Viz.ai. J. Groom II: 1; C; National Cancer Institute – R44CA257802. 4; C; Arsenal Medical. C. Guertin: 1; C; National Cancer Institute – R44CA257802. 5; C; Arsenal Medical. Q. Pham: 1; C; National Cancer Institute – R44CA257802. 4; C; Arsenal Medical. M. Fornaciari: 1; C; National Cancer Institute – R44CA257802. 4; C; Arsenal Medical. C. Wiltsey: 1; C; National Cancer Institute – R44CA257802. 4; C; Arsenal Medical. L. Core: 4; C; Arsenal Medical. U. Sharma: 4; C; Arsenal Medical.

E-096 COVID status is related to clot burden during thrombectomy in acute stroke patients

Abstract:

Background

The INSIGHT Registry, a multicentered ‘multi-omic’ analysis of thrombi associated with acute hemorrhagic and ischemic stroke is currently enrolling, with over 300 subjects already enrolled. Through this effort, we can evaluate ischemic stroke thrombi in the setting of concurrent medical conditions. While it has been reported that COVID positivity can affect clotting mechanisms, there is a paucity of data on histopathology of stroke clot in this setting.

Aim

Our aim in this analysis was to study the relationship between COVID positivity and clot histopathology in large vessel occlusive stroke.

Methods

Patients, aged ≥18 years, treated frontline with the Penumbra System^® for thrombectomy are included in this analysis. Patient demographics, medical history, radiographic, and procedural information are collected in conjunction with extracted clot and concurrent extracranial arterial blood. While the protocol includes analysis for proteomics and transcriptomics, for this analysis we used histopathological evaluation of the thrombi.

Results/Conclusion

Of 230 patients included in this interim analysis across 24 centers in the United States, between 02/2021 and 01/2022, 16 patients had a history of COVID. Comparing COVID-positive to non-positive, patients with COVID were younger (median 66.5 years vs 71.5 years, p 0.042), and had more intracranial clot by weight (median 101.0 mg vs 42.0 mg, p 0.047). There was a trend toward COVID positive patients to have more clot volume (median 180 cc vs 77.5 cc p 0.08), suggesting the difference was a higher clot burden instead of more density to the thrombus. These results suggest different histopathological characteristics in clot formation in COVID patients with large vessel occlusive stroke.

Disclosures

J. Fraser: 1; C; University of Kentucky, American Heart Association. 2; C; Stream Biomedical, Penumbra, Medtronic. 4; C; Fawkes Biotechnology, Cerelux. A. Dabney: None. J. Vicari: None. D. Rivet: None. B. Woodward: None. A. Nanda: None. D. Fiorella: None. S. Baltan: None. F. Sohrabji: None. K. Pennypacker: None. C. Kellner: None.