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BACKGROUND: Surgery or fibrinolysis is the currently available evidence-based treatment for obstructive mechanical valve thrombus. We reported the feasibility and short-term outcomes of percutaneous transcatheter therapy with cerebral embolic protection. Mid- and long-term outcomes remain unknown. METHODS: From 2020 to 2023, 24 patients underwent percutaneous transcatheter release of stuck leaflets with cerebral embolic protection for obstructive mitral mechanical valve thrombus. The indications for the transcatheter therapy were failed fibrinolysis, contraindications for fibrinolysis, not willing for fibrinolysis, or high risk for surgery. The study participants were followed up for a median period of 344.50 (65.00-953.75) days. RESULTS: Technical success was achieved in 91.67% (n=22) of procedures. During the follow-up, 12.50% (n=3) all-cause death, 4.17% (n=1) stroke, and 16.67% (n=4) recurrence were seen. The mean survival time free from death was 1101.48 (95% CI, 929.49-1273.47) days, stroke was 1211.38 (95% CI, 1110.40-1312.35) days, and recurrence was 907.71 (95% CI, 760.20-1055.21) days. CONCLUSIONS: Transcatheter release of the stuck mitral mechanical valve with cerebral embolic protection is an alternative therapy with promising mid-term outcomes where surgery or fibrinolysis is not possible or in failed fibrinolysis subsets. [ABSTRACT FROM AUTHOR]

The use of embolic protection devices (EPD) in peripheral vascular procedures with higher risk of distal embolic shower has gained wider acceptance with evidence mounting in favor of its use. We report our unique experience on the circumstances leading to and management of entrapment of an EPD within peripheral stent during management of a patient with critical limb ischemia.

Objective: We aimed to investigate the incidence of flow arrest during carotid artery stenting (CAS) with filter-type embolic protection device (EPD), identify any predisposing factors for those situations, and contemplate intraprocedural precautionary steps. Methods: CAS was performed in 128 patients with 132 arteries using filter-type EPD. The characteristics of treated patients and arteries were compared between groups with and without flow arrest. Results: The incidence of flow arrest during CAS with filter-type EPD was 17.4%. In flow arrest group, cases of vulnerable plaques (p=0.02) and symptomatic lesions (p=0.01) were significantly more common, and there were more cases of debris captured by EPD in a planar pattern (p<0.01). Vulnerable plaques were significantly more common in the procedures showing a planar pattern than in the cases with other patterns (p<0.01). Flow arrest group showed a significantly higher rate of ischemic complications (p<0.05), although there were no significant periprocedural neurological changes. The planar pattern of captured debris in filter-type EPD was the only significant risk factor for flow arrest (adjusted odds ratio 88.44, 95% confidence interval 15.21-514.45, p<0.05). Conclusions: Flow arrest during CAS with filter-type EPD is not uncommon and associated with increased ischemic complications. Symptomatic stenoses and vulnerable plaque are related to this event. The planar pattern of captured debris on the EPD was the only significant risk factor for the flow arrest. Clinicians must pay attention to the occurrence of flow arrest and react quickly when performing CAS. [ABSTRACT FROM AUTHOR]

After more than 20 years of development, the complications of transcatheter aortic valve replacement (TAVR) have been significantly reduced, but the incidence of stroke has not been significantly reduced. In recent years, a variety of cerebral embolic protection device (CEPD) have been applied in clinical practice, but their effectiveness is still controversial due to the lack of high ⁃ quality clinical evidence. This article reviews progress on the risk factors for stroke and the characteristics of intraoperative CEPD in TAVR, so as to provide reference for the selection of TAVR cases and the formulation of cerebral embolic protection strategies.

[Display omitted] [ABSTRACT FROM AUTHOR]

The use of embolic protection devices (EPD) in peripheral vascular procedures with higher risk of distal embolic shower has gained wider acceptance with evidence mounting in favor of its use. We report our unique experience on the circumstances leading to and management of entrapment of an EPD within peripheral stent during management of a patient with critical limb ischemia. [ABSTRACT FROM AUTHOR]

In this technical report, we describe a challenging case concerning the retrieval of a distal embolic protection device (DEPD) post-carotid artery stenting. We propose a novel rescue retrieval technique for DEPD, employing a fabricated monorail-type HN5 diagnostic catheter. When integrated with existing strategies, this approach may optimize and streamline the process of DEPD removal. [ABSTRACT FROM AUTHOR]

BackgroundOutcomes data on the use of cerebral embolic protection devices (CPDs) with transcatheter aortic valve replacement (TAVR) remain limited. Previous randomized trials were underpowered for primary outcomes of stroke prevention and mortality.MethodsThe National Inpatient Sample and Nationwide Readmissions Database were queried from 2017 to 2018 to study utilization and inpatient mortality, neurological complications (ischemic stroke, hemorrhagic stroke, and transient ischemic attack), procedural complications, resource utilization, and 30-day readmissions with and without use of CPD. A 1:3 ratio propensity score matched model was created.ResultsAmong 108,315 weighted encounters, CPD was used in 4380 patients (4.0%). Adjusted mortality was lower in patients undergoing TAVR with CPD (1.3% vs. 0.5%, p

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Background and purpose: The carotid stent placement as a therapeutic option for carotid stenosis has been increasing among years; therefore, studies are required to evaluate the security and efficacy of its materials. The purpose of this study was to evaluate the distal filter and the proximal balloon-guided catheter with flow inversion as protection devices during carotid angioplasty and stenting. Methods: This is a retrospective, observational study of patients diagnosed with carotid stenosis treated with angioplasty between January 1, 2014, and June 30, 2020; we analyzed a radiology service database to compare the distal filter and the proximal balloon-guided catheter as protection devices during angioplasty. Results: One hundred seventy-five angioplasties were performed, the distal filter was the most prevalent embolic protection device used (66%), patients baseline characteristics did not differ between groups with different embolic protection devices, except for history of dyslipidemia (p < 0.000). As well, we did not find any significant differences between the groups in the device related complications, intervention time (p = 0.140), unrelated complications (p = 0.693) and functional independence at 90 days (p = 0.096). Conclusions: In our study the proximal balloon-guided catheter and the distal filter protection device as protection devices during the carotid stenting didn't show significant differences regarding complications related to the system. [ABSTRACT FROM AUTHOR]

Purpose: We aimed to correlate the presence or absence of embolic debris in filter-type embolic protection devices (EPD), which are frequently used during carotid artery stenting (CAS), with possible risk factors and ultrasonographic plaque features. Materials and Methods: Eighty patients, who underwent CAS using a filter-type EPD in the period between July 2016 and March 2019, were included in our study. The modified Gray-Weale classification (mGWC) subtypes obtained in the pre-procedural ultrasonographic examinations were recorded. In addition, other patient-related risk factors considered to be related to a distal embolism were recorded. After the procedure the filters were evaluated to detect and examine embolic debris in the pathology clinic. The presence and features of embolic debris in the filters were recorded. Results: In the examinations performed after CAS, embolic debris was macroscopically and microscopically detected in 22 (27%) and 34 (42.5%) of the filter-type EPDs, respectively. A significant correlation was found between the change in the mGWC category of stenotic plaques from type 5 to type 1 and the presence of embolic debris in the filter (p < 0.05). Furthermore, a significant relationship was found between stenotic segment length and the presence of embolic debris in the filter (p < 0.05). The presence of embolic debris was not statistically significantly related to predisposing risk factors for atherosclerosis (p > 0.05). Conclusions: During CAS, the likelihood of the presence of embolic debris in the EPDs increases as mGWC categories change from type 5 to type 1 and as the length of the stenotic segment increases. [ABSTRACT FROM AUTHOR]

BackgroundAcute in situ thrombosis is an ischaemic phenomenon during Pipeline embolisation device (PED) procedures with potentially high morbidity and mortality. There is controversy regarding the role of platelet function testing with P2Y12 assay as a predictor of intraprocedural thromboembolic events. There is limited knowledge on whether procedural complexity influences these events.MethodsData were collected retrospectively on 742 consecutive PED cases at a single institution. Patients with intraprocedural acute thrombosis were compared with patients without these events.ResultsA cohort of 37 PED cases with acute in situ thrombosis (mean age 53.8 years, mean aneurysm size 8.4 mm) was matched with a cohort of 705 PED cases without intraprocedural thromboembolic events (mean age 56.4 years, mean aneurysm size 6.9 mm). All patients with in situ thrombosis received intra-arterial and/or intravenous abciximab. The two groups were evenly matched in patient demographics, previous treatment/subarachnoid hemorrhage (SAH) and aneurysm location. There was no statistical difference in postprocedural P2Y12 reaction unit (PRU) values between the two groups, with a mean of 156 in the in situ thrombosis group vs 148 in the control group (p=0.5894). Presence of cervical carotid tortuosity, high cavernous internal carotid artery grade, need for multiple PED and vasospasm were not significantly different between the two groups. The in situ thrombosis group had statistically significant longer fluoroscopy time (60.4 vs 38.4 min, p

Objective: The frequency of atherectomy in lower extremity arterial disease has increased substantially over the past several years, specifically in the office-based laboratory (OBL) setting, yet the efficacy compared with other interventions and the consequences of distal embolization remain unknown. Embolic protection devices (EPDs) have been used at varying rates depending on physician and practice setting. Previous studies have described lesion characteristics to consider when weighing the benefits and drawbacks associated with device use. Our study focuses on the use of atherectomy and EPDs in femoropopliteal arterial disease to better characterize resource use trends and postoperative outcomes in the inpatient and OBL interventional settings., Methods: We conducted a retrospective analysis on endovascular interventions performed for femoral-popliteal occlusive disease that were entered into the Vascular Quality Initiative data registry between 2017 and 2021. A one:one greedy match, adjusted analysis based on inpatient or OBL location of procedure was used to compare the groups. Hierarchical logistical regression with selective use of principal component analysis was used to further explore the differences in EPD use and immediate postoperative outcomes. A proportional hazard model was used to demonstrate differences in reintervention rates up to 2 years postoperatively between patients who underwent atherectomy in the inpatient vs OBL treatment setting., Results: 2849 matched pairs were inlcuded in the final analysis. In our cohort, there was 22% EPD use overall, 40% in the hospital setting and 4.4% in the OBL setting (P < .001). Among the patients with available follow-up information, OBL intervention setting increased probability of reintervention by 18% at 2 years postoperatively compared with the inpatient setting; however, there was no difference associated with EPD placement and rate of reintervention., Conclusions: Use of EPDs in the OBL setting compared with the hospital setting is dramatically decreased; however, no increased incidence of postoperative complications was seen compared to procedures performed in the hospital setting when controlling for patient and lesion characteristics. Patients with available follow-up data were more likely to undergo ipsilateral reintervention between 6 months and 2 years postoperatively if atherectomy was done in the OBL setting. Dedicated studies are encouraged to ensure patient safety, effective resource allocation, and long-term efficacy of OBL atherectomy as an ever-growing number of peripheral arterial procedures are transitioned to the OBL setting., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Failure to retrieve a distal filter-based embolic protection device (EPD) is a potential complication of carotid artery stenting. This may be caused by trapping of the proximal marker of the EPD within the stent tip marker. Maintaining an adequate distance between the two can prevent this. We examined the behavior of several stent-filter-based EPD combinations, focusing on their propensity to become trapped or disengage in vitro. Four physicians subjectively rated the force required to result in trapping using a 5-point scale. Moreover, the force required to disengage trapped devices was evaluated. The Casper stent-Spider FX EPD combination was difficult to disengage when entrapment occurred, which suggested that this phenomenon tended to occur with this combination. The stent tip marker of the closed-cell stents advanced as they shortened, which may be a unique feature of closed-cell stents. Although trapping is uncommon, it can cause serious complications. To prevent these complications, device characteristics should be well understood before they are used in patients.

Background: Periprocedural ischemic stroke remains a serious complication in patients undergoing transcatheter aortic valve replacement (TAVR). We used a novel robotic transcranial Doppler (TCD) system equipped with artificial intelligence (AI) for real-time continuous intraoperative neuromonitoring during TAVR to establish the safety and potential validity of this tool in detecting cerebral emboli, report the quantity and distribution of high intensity transient signals (HITS) with and without cerebral protection, and correlate HITS occurrence with various procedural steps., Methods: Consecutive patients undergoing TAVR procedures during which the robotic system was used between October 2021 and May 2022 were prospectively enrolled in this pilot study. The robotic TCD system included autonomous adjustment of the TCD probes and AI-assisted post-processing of HITS and other cerebral flow parameters. Basic demographics and procedural details were recorded. Continuous variables were analyzed by a two-sample Mann-Whitney t-test and categorical variables by a χ 2 or Fisher test., Results: Thirty-one patients were prospectively enrolled (mean age 79.9±7.6 years; 16 men (51.6%)). Mean aortic valve stenotic area was 0.7 cm 2 and mean aortic-ventricular gradient was 43 mmHg (IQR 31.5-50 mmHg). Cerebral protection was used in 16 cases (51.6%). Significantly fewer emboli were observed in the protection group than in the non-protection group (mean 470.38 vs 693.33; p=0.01). Emboli counts during valve positioning and implantation were significantly different in the protection and non-protection groups (mean 249.92 and 387.5, respectively; p=0.01). One (4%) transient ischemic attack occurred post-procedurally in the non-protection group., Conclusion: We describe a novel real-time intraoperative neuromonitoring tool used in patients undergoing TAVR. Significantly fewer HITS were detected with protection. Valve positioning-implantation was the most significant stage for intraprocedural HITS., Competing Interests: Competing interests: LNH: Grant/research support: Canon Medical; major stock shareholder/equity: Boston Scientific, Imperative Care, Ostial, Synchron, Spinnaker, Serenity, Cerebrotech, Reist. JMD: Consulting fees, payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events: Medtronic, Rapid Medical; support for attending meetings and/or travel: Medtronic, Rapid Medical; patents planned, issued, or pending: QAS.ai; participation on a Data Safety Monitoring Board or Advisory Board: NIH NIHDS Strokenet; stock or stock options: Synchron, Cerebrotech, QAS.ai. EIL: Shareholder/ownership interest: NeXtGen Biologics, Rapid Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical; patent: Bone Scalpel; honorarium: Medtronic, Penumbra, MicroVention, Integra; consultant: Clarion, GLG Consulting, Guidepoint Global, Imperative Care, Medtronic, StimMed, Misionix, Mosiac; Chief Medical Officer: Haniva Technology; Advisory Board: Stryker, NeXtGen Biologics, MEDX, Cognition Medical, Endostream Medical, IRRAS AB. AHS: Grants or contracts: Co-investigator for NIH - 1R01EB030092-01, Project Title: High Speed Angiography at 1000 frames per second; Mentor for Brain Aneurysm Foundation Carol W Harvey Chair of Research, Sharon Epperson Chair of Research, Project Title: A Whole Blood RNA Diagnostic for Unruptured Brain Aneurysm: Risk Assessment Prototype Development and Testing; consulting fees: Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems USA, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Cordis, Corindus, Inc., Endostream Medical, Imperative Care, InspireMD, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Peijia Medical, Penumbra, Q’Apel Medical, Rapid Medical, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Three Rivers Medical, VasSol, Viz.ai; leadership or fiduciary role in other board, society, committee or advocacy group: Secretary – Board of the Society of NeuroInterventional Surgery 2020-2021, Chair – Cerebrovascular Section of the AANS/CNS 2020-2021; stock or stock options: Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Borvo Medical, Bridgewater Ventures, Cerebrotech Medical Systems, Cerevatech Medical, Code Zero Medical, Cognition Medical, Collavidence, CVAID, E8, Endostream Medical, Galaxy Therapeutics, Imperative Care, InspireMD, Instylla, International Medical Distribution Partners, Launch NY, Neurolutions, NeuroRadial Technologies, NeuroTechnology Investors, Neurovascular Diagnostics, Peijia Medical, PerFlow Medical, Piraeus Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences Corp), Rist Neurovascular, (purchased 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Sim & Cure, SongBird Therapy, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Tulavi Therapeutics, Vastrax, VICIS, Viseon, Whisper Medical, Willow Medtech; other financial or non-financial interests: National PI/Steering Committees: Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial and CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: In patients undergoing transcatheter aortic valve replacement (TAVR), cerebral embolic protection devices (CEPD) are used to possibly diminish the risk of periprocedural stroke. Trends and outcomes of CEPD usage in TAVR are not well characterized., Methods: National readmission databases (NRD) 2017-2019 was used to identify hospital admissions for TAVR using ICD-10 codes, with versus without Sentinel CEPD. Primary outcomes of the study were in-hospital and 30-day stroke. Secondary outcomes include in-hospital mortality, 30-day mortality, 30-day readmission rate, and other procedural complications. We matched both cohorts using propensity score matching (PSM) and performed logistic regression to compute the odds ratios (ORs) and corresponding 95 % confidence intervals (CI)., Results: Out of 190,837 TAVR admissions in the United States, 10,643 (5.6 %) patients had TAVR with Sentinel CEPD. After propensity score matching, our cohort included 10,503 patients with CEPD and 10,541 without CEPD. Trends in CEPD utilization are noted in Fig. 1. In the PSM cohort, Sentinel CEPD was not associated with decreased risk of in-hospital stroke (1.9 % vs. 1.8 %, OR: 0.98, 95 % CI: 0.76-1.26, p = 0.88), 30-day stroke (2.1 % vs. 2.1 %, OR: 1.01, 95 % CI: 0.78-1.30, p = 0.96), or 30-day mortality (1.3 % vs. 1.0 %, OR: 0.74, 95 % CI: 0.51-1.07, p = 0.11) when compared to TAVR without CEPD. Other in-hospital and short-term outcomes post-TAVR were not impacted by Sentinel CEPD usage, including acute kidney injury, vascular complications, paravalvular leak, cardiogenic shock, circulatory support, or permanent pacemaker (Table 1)., Conclusion: In this nationally representative cohort, Sentinel CEPD utilization during transfemoral TAVR for stroke prevention was not associated with reduced odds of in-hospital stroke, 30-day stroke, or 30-day mortality. Future studies should focus on optimizing patient selection for CEPD and establishing predictive models to identify the subset of TAVR patients with higher risk for periprocedural stroke who might benefit from CEPD., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To investigate the effect of embolic protection device (EPD) use on periprocedural complications in patients with carotid artery stenosis with anatomical variations., Method: The study retrospectively evaluated 185 patients who consecutively underwent carotid artery stenting between November 2020 and December 2023. Forty-four patients with difficult anatomical structures, anatomical variations in the common carotid artery (CCA) and internal carotid artery (ICA) (tortuosity, kinking, or coiling), and a CCA-ICA angle of >60 degrees were included in the sample. The patients were divided into two groups according to the use of EPD filters during the procedure and compared in terms of periprocedural events., Results: Of the 44 patients included in the study, 24 (54.5 %) were male, and the mean age of all patients was 68.7 ± 8.7 years. Comorbidities were present in 93.2 % (n = 41) of the patients. The most common comorbidity was hypertension (n = 32, 72.8 %). The CCA-ICA angle was ≥60 degrees in 45.4 % (n = 20) of all patients. ICA tortuosity was detected in 27.2 % (n = 12) of the patients, ICA kinking in 13.6 % (n = 6), ICA coiling in 6.8 % (n = 3), and CCA tortuosity in 6.8 % (n = 3). Procedure-related periprocedural events developed in 38.6 % (n = 17) of the patients. Postprocedural mortality occurred in two patients, secondary to myocardial infarction in one and COVID-19 pneumonia in the other. There was no significant difference between the filter and non-filter groups in relation to periprocedural events (p = 0.638). Major stroke did not occur in either group. Minor neurological events occurred in 15 % (n = 3/20) of the patients in the filter group and 16.7 % (n = 4/24) of those in the non-filter group. The incidence of vasospasm was statistically higher in patients using filters compared to those without filters (30 % vs. 0 %; P = 0.005, respectively)., Conclusion: Evaluation of vascular anatomy before carotid artery stenting is important to decide on the technical procedure to be applied in the procedure. The use of EPD in unfavorable anatomy does not reduce periprocedural neurological events. Instead, it results in technical difficulties, prolongs the duration of procedure, and leads to arterial vasospasm. Considering the high periprocedural events in this study, carotid endarterectomy may be a better alternative to endovascular treatment in patients with unfavorable carotid artery anatomy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: Stroke remains one of the most important complications of cardiac surgery and occurs in 2.2% after open-heart procedure. It is associated with significant morbidity and mortality. The use of a cerebral protection system during transcatheter aortic valve implantation may be associated with a lower risk of periprocedural strokes, and mortality at 30 days. The aim of the present study was to assess the safety and feasibility of this device in patients at high risk for stroke during open cardiac surgery.Methods: We present six patients with a high risk of perioperative stroke who underwent placement of Sentinel cerebral protection system during various open-heart operations between 2018 and 2021.Results: The system was successfully deployed, and debris was retrieved in all patients. There was no device-related complication or development of ischemic stroke postoperatively. One patient suffered from intracranial hemorrhage due to peri-operative coagulopathy.Conclusions: We demonstrated the feasibility and safety of this hybrid approach with a high debris capture rate. It encourages further study to evaluate the benefits of the Sentinel cerebral protection system in reducing stroke and mortality in selected patients undergoing open-heart surgery. [ABSTRACT FROM AUTHOR]

The authors report a successful thrombectomy using the AngioJet Rheolytic Thrombectomy System (AngioJet) and an embolic protection device in a patient with femorofemoral bypass graft occlusion. Lower extremity CT angiograms showed occlusion in the left-to-right femorofemoral bypass graft. A rheolytic thrombectomy using the AngioJet and balloon angioplasty restored blood flow to the right lower extremity, and distal embolization may be effectively prevented by placing an embolic protection device within the right superficial femoral artery during the procedure.

Embolic protection device (EPD) is a well-described adjunct in carotid artery stenting for its benefit of reducing perioperative stroke, but EPD retrieval is sometimes challenging, especially in elderly patients. We described a 73-year-old patient of EPD retrieval difficulty with falling of the guide catheter into hostile aortic arch during the right carotid open-cell stent placement under filter device. In this case, type III arch, tortuosity distal to stenosis and calcified plaque resulted in angulated path, made filter wire entrapped in stent struts, and pulled back guide catheter into aortic arch. A 6-French Sofia intermediate catheter was performed to bail the operator out and retrieve the EPD which was unsuccessfully resolved by all the other methods. The Sofia intermediate catheter is a valuable and final tool to resolve an EPD retrieval difficulty, especially when the filter wire is trapped in the stent and the guide catheter loses an access to carotid artery in elderly patients. [ABSTRACT FROM AUTHOR]

Inferior vena cava (IVC) thrombosis, a type of deep vein thrombosis (DVT), is a relatively rare and poorly known disease compared to lower extremity DVT. We present a case of a 68-year-old woman with abdominal pain and mild lower leg swelling due to IVC thrombosis extending from the common iliac vein to the infrahepatic IVC. The thrombus was removed using a 14-mm Niti-S stent (Taewoong Medical, Korea) inserted via the right internal jugular vein. The stent was partially deployed and gently advanced to cover the thrombus, and then retracted through a vascular sheath capturing the thrombus. This case presents a therapeutic approach for the treatment of IVC thrombosis using a half-deployed stent as a filter and a basket. Follow-up evaluation after 5 years revealed a patent IVC and common iliac vein.

ObjectiveThis study aimed to review studies comparing outcomes following percutaneous coronary intervention (PCI) in saphenous vein grafts (SVG) with and without embolic protection devices (EPD).MethodsDatabases including PubMed Central, Cochrane Library, EMBASE, CINAHL, MEDLINE, Google Scholar, ScienceDirect, and Scopus were searched from January 1964 to April 2021. We used the Cochrane risk of bias tool and the Newcastle Ottawa scale to assess the quality of published studies based on study design. From the results, we carried out a meta-analysis with a random-effects model and reported pooled odds ratio (OR) with 95% CI.ResultsIn total, 11 studies were analyzed that included 79,009 total participants. EPD use had significantly lower odds of mortality (pooled OR = 0.69; 95% CI: 0.5–0.94). There was no significant difference in terms of major adverse cardiovascular events (MACE) (pooled OR = 0.83; 95% CI: 0.67–1.03), target vessel revascularization (pooled OR = 1; 95% CI: 0.95–1.05), periprocedural (pooled OR = 1.12; 95% CI: 0.65–1.9) and late myocardial infarction (MI) (pooled OR = 0.79; 95% CI: 0.55–1.14) with or without EPD for PCI in SVG patients.ConclusionAlthough not statistically beneficial for MACE, target vessel revascularization, periprocedural, and late MI, EPD use does appear to significantly reduce mortality for the patients undergoing PCI in SVG. Clinicians might consider using EPD for such patients to reduce the burden of post-procedural morbidity and mortality.

Competing Interests: Disclosures None.

Background: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear., Methods: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis., Results: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke ( P interaction <0.05 for both instrumental variable and propensity-weighted analyses)., Conclusions: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR., Competing Interests: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs, the US Government, or the National Institutes of Health. Dr Butala is supported by grants from the Boettcher Foundation and the American Heart Association and reports consulting fees from Shockwave Medical and Boston Scientific and consulting fees and ownership interest in HiLabs and Catch Bio, outside the current work. Dr Yeh is a Special Government Employee of the US Food and Drug Administration. He has institutional research grants with the US FDA, Boston Scientific, Abbott Vascular and Medtronic. He is a consultant for Abbott Vascular, Boston Scientific, Elixir Medical, InfraRedx, Medtronic, Shockwave Medical, and Zoll. Dr Messenger reports institutional grant support from Philips Medical Systems and Medtronic. Dr Cohen reports institutional research grants from Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, Zoll, IRhythm, Corvia, Philips, CathWorks, and Ancora. He is a consultant to Abbott, Boston Scientific, Edwards Lifesciences, and Heartbeam. Dr Vemulapalli reports grants/contracts from: American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and UG3), Cytokinetics, Abbott Vascular, Boston Scientific. Consulting/Advisory Board: Astra Zeneca, Medtronic, Boehringer Ingelheim, Veralox Therapeutics, Icon, HeartFlow, TotalCME.

Background: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States., Methods: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year., Results: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients., Conclusions: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice., Competing Interests: Dr R.W. Yeh is a consultant and has research grants with Boston Scientific Corporation. Dr J.P. Piccini is a consultant and has research grants with Abbott, Boston Scientific Corporation and Bayer. Drs T. Christen and D.J. Allocco are full time employees and stockholders in Boston Scientific Corporation. The other authors report no conflicts.

Background: Despite impressive improvements in the safety profile of Transcatheter aortic valve replacement (TAVR), the risk for peri-procedural stroke after TAVR has not declined substantially. In an effort to reduce periprocedural stroke, cerebral embolic protection (CEP) devices have been utilized but have yet to demonstrate benefit in all-comers. There is a paucity of data supporting the utilization of CEP in TAVR patients with an anticipated high risk for peri-procedural stroke., Methods: The Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) score is a clinical risk tool for predicting the in-hospital stroke risk of patients undergoing transfemoral TAVR. This score was used to identify high-risk patients and calculate the expected in-hospital stroke risk. This was a single-centre cohort study in all consecutive TAVR patients who had placement of CEP. The observed versus expected ratio for peri-procedural stroke was calculated. To obtain 95% credible intervals, we used 1000 bootstrapped samples of the original cohort sample size without replacement and recalculated the TASK predicted scores., Results: The study included 103 patients. The median age was 83 (IQR 78,89). 63 were male (61.1%) and 45 (43.69%) had a history of previous Stroke or TIA. Two patients had an in-hospital stroke after TAVR (1.94%). The expected risk of in-hospital stroke based on the TASK score was 3.39% (95% CI 3.07-3.73). The observed versus expected ratio was 0.57 (95% CI 0.52-0.64)., Conclusion: In this single-center study, we found that in patients undergoing TAVR with high stroke risk, CEP reduced the in-hospital stroke risk by 43% when compared with the risk-score predicted rate., Clinical Trial Number: N/A., (© 2024. The Author(s).)

Background: Studies have shown inconclusive results on the effectiveness of cerebral protection devices (CPDs) with transcatheter aortic valve replacement. We aimed to analyze the national statistics on stroke and other outcomes with CPD use., Methods and Results: The Nationwide Readmissions Database (2017-2020) was queried to obtain data on patients undergoing transcatheter aortic valve replacement. Outcomes were compared between patients with a CPD and patients without a CPD. Of 271 804 patients undergoing transcatheter aortic valve replacement, CPD was used in 7.3% of patients. In a multivariable logistic regression analysis, CPD use was not associated with lower overall stroke rates (1.6% versus 1.9% without CPD; odds ratio, 0.95 [95% CI, 0.84-1.07]; P =0.364), but it was significantly associated with lower major stroke rates (1.2% versus 1.5% without CPD; odds ratio, 0.85 [95% CI, 0.74-0.98]; P =0.02). Patients with a CPD also had a shorter length of stay, higher routine discharges to home/self-care (74.9% versus 70.6%), and lower mortality rates (0.7% versus 1.3%). The 30-day (9.6% versus 11.7%) and 180-day (24.6% versus 28.2%) readmission rates were significantly lower in the CPD cohort. Among patients who developed stroke, patients with a CPD had more frequent routine discharges. Prior valve surgery was associated with the highest risk of overall and major stroke., Conclusions: CPD use during transcatheter aortic valve replacement was not independently associated with a lower risk of overall stroke but was associated with a lower risk of major stroke in a multivariable model. Data from future randomized trials that may offset any potential confounders in our study are required to help identify patients who would benefit from the use of these devices.

Distal embolus due to mechanical thrombectomy is a frequent complication and directly results in a poor prognosis. Therefore, it is important to decrease distal embolus as much as possible in mechanical thrombectomy. EmboTrap III may be useful as a filter to prevent distal embolus in patients with a large volume of thrombus. Here, we report the results of one suggestive case and we also provide experimental data from a vessel model. The patient was a 78-year-old female who was admitted to hospital as an emergency case with chief complaints including dysarthria and left hemiplegia, including facial paralysis. She was diagnosed as large vessel occlusion-acute ischemic stroke with right tandem lesions by workup and underwent mechanical thrombectomy. A large volume of secondary thrombus due to flow stasis was assumed based around the occlusion site, and worsening of neurological symptoms was a concern due to distal embolus caused by recanalization of the cervical internal carotid artery. The SEIMLESS technique was performed under distal protection using EmboTrap III. There was no distal embolus or deterioration of neurological symptoms, and a good prognosis was achieved. This outcome suggests that PTA under distal protection using EmboTrap III may be useful for prevention of distal embolus.

Introduction: Cerebral Embolic Protection Device (CEPD) captures emboli during Transcatheter Aortic Valve Replacement (TAVR). With recently published pivotal trials and multiple cohort studies reporting new data, there is a need to re-calibrate available statistical evidence., Methods: A systematic literature search was conducted across databases from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR), while continuous outcomes were pooled using Standardized Mean Difference (SMD) along with 95% corresponding intervals (95% CIs)., Results: Data was included from 17 studies (7 RCTs, 10 cohorts, n  = 155,829). Use of CEPD was associated with significantly reduced odds of stroke (OR = 0.60, 95% CI = 0.43-0.85, p  = 0.003). There was no significant difference in disabling stroke ( p  = 0.25), non-disabling stroke ( p  = 0.72), and 30-day mortality ( p  = 0.10) between the two groups. There were no significant differences between the two groups for Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) findings, acute kidney injury, risk of pacemaker implantation life-threatening bleed, major bleed, minor bleed, worsening National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and vascular complications ( p  > 0.05)., Conclusions: The use of CEPD during TAVR reduced the incidence of all-stroke ( p  = 0.003); however, there were no significant differences in any of the other pooled outcomes ( p  > 0.05)., Registration: The protocol of this meta-analysis was registered with the Open Science framework [https://doi.org/10.17605/OSF.IO/7W564] before data acquisition was started.

Purpose: The purpose of the study is to describe a bailout technical strategy to prevent below-the-knee (BTK) distal embolization during procedures with increased inherent risk using universally-available "off-the-shelf" devices., Technique: A conventional retrograde access is obtained of the BTK target vessel where embolization protection is sought. Before starting any potential proximal maneuver with an associated significant risk of distal embolization (eg, atherectomy and mechanical thrombectomy), a low-profile balloon is inserted and inflated through the distal retrograde access, so that any debris resulting from the recanalization procedure is blocked by the stagnant column of blood generated by the inflated balloon. Once the revascularization procedure has been completed, a 4F curved catheter is antegradely advanced down to the distally-inflated balloon, and in case of distal embolization the debris is aspirated in a standard fashion way., Conclusion: A retrograde balloon-assisted "off-the-shelf" embolic protection approach may be considered for BTK revascularization procedures where there is an inherent increased risk of distal trash, especially in the presence of distal single-vessel runoff., Clinical Impact: Distal embolization following endovascular procedures can have devastating consequences and there is a general recommendation for selective use of EPDs in high-risk-scenarios. The increased cost and low availability of the current EPD devices for BTK/BTA arteries have prohibited their widespread use. The retrograde balloon-assisted "off-the-shelf" EPD prevents distal embolization during procedures with increased risk of distal trash using inexpensive, nonspecific equipment available in any basic endovascular suite., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Periprocedural stroke after transcatheter aortic valve implantation (TAVI) remains a significant issue, which is associated with high morbidity, and is increasingly important as intervention shifts to younger and lower-risk populations. Over the last decade of clinical experience with TAVI, the incidence of periprocedural stroke has stayed largely unchanged, although it is prone to underreporting due to variation in ascertainment methods. The aetiology of stroke in TAVI patients is multifactorial, and changing risk profiles, differing study populations, and frequent device iterations have made it difficult to discern consistent risk factors. The objective of this review is to analyse and clarify the contemporary published literature on the epidemiology and mechanisms of neurological events in TAVI patients and evaluate potential preventive measures. This summary aims to improve patient risk assessment and refine case selection for cerebral embolic protection devices, while also providing a foundation for designing future trials focused on stroke prevention.

Objective: The aim of this trial was to compare the efficacy of closed-cell stents with Casper stents during carotid angioplasty stenting (CAS). Methods: This was a randomized superiority trial in which 88 patients were enrolled. The primary end points were the incidence, number, and size of new ischemic brain lesions after CAS under distal embolic protection devices (EPD). The secondary end points included stroke, transient ischemic attack (TIA) and myocardial infarction (MI). Ischemic brain lesions were assessed by a diffusion-weighted magnetic resonance image (DW-MRI). Neurological outcomes were evaluated by means of the National Institutes of Health scale score (NIHSS) and the modified Rankin scale (mRS). Results: Compared with closed-cell stents (n = 47), Casper stents (n = 41), resulted in no significant reduction in the incidence (44.7% versus 39%, P = 0.592), number (1.3 ± 1.8 versus 0.9 ± 1.5, p = 0.444), and size (3.9 ± 5.8 mm versus 2.8 ± 4.1 mm, p = 0.353) of new ischemic brain lesions. The global rate of stroke/TIA/MI was (2/88, 2.3%). Two TIA occurred during the hospitalization period, one in each group (1/41, 2.4% vs 1/47, 2.1%). One patient of the Casper group had an asymptomatic in-stent thrombosis. One patient of the control group had a MI (1/47, 2.1%) after discharge. Conclusion: The Casper stents did not show superiority in the rate of incidence, number and size of new silent ischemic brain lesions detect by DW-MRI when compared to close cell stents during CAS under distal EPD. [ABSTRACT FROM AUTHOR]

Saphenous vein grafts (SVGs) remain the most frequently used conduits in coronary artery bypass graft surgery (CABG). Despite advances in surgical techniques and pharmacotherapy, SVG failure rates remain high, often leading to repeat coronary revascularization. The no-touch SVG harvesting technique (minimal graft manipulation with preservation of vasa vasorum and nerves) reduces the risk of SVG failure, whereas the effect of the off-pump technique on SVG patency remains unclear. Use of buffered storage solutions, intraoperative graft flow measurement, careful selection of the target vessels, and physiological assessment of the native coronary circulation before CABG may also reduce the incidence of SVG failure. Perioperative aspirin and high-intensity statin administration are the cornerstones of secondary prevention after CABG. Dual antiplatelet therapy is recommended for off-pump CABG and in patients with a recent acute coronary syndrome. Intermediate (30%-60%) SVG stenoses often progress rapidly. Stenting of intermediate SVG stenoses failed to improve outcomes; hence, treatment focuses on strict control of coronary artery disease risk factors. Redo CABG is associated with higher perioperative mortality compared with percutaneous coronary intervention (PCI); hence, the latter is preferred for most patients requiring repeat revascularization after CABG. SVG PCI is limited by high rates of no-reflow and a high incidence of restenosis during follow-up. Drug-eluting and bare metal stents provide similar long-term outcomes in SVG PCI. Embolic protection devices reduce no-reflow and should be used when feasible. PCI of the corresponding native coronary artery is associated with better short- and long-term outcomes and is preferred over SVG PCI, if technically feasible. [ABSTRACT FROM AUTHOR]

Background: Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited.Methods: We performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights.Results: Our analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses.Conclusions: In this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR. [ABSTRACT FROM AUTHOR]

Ascending aortic pseudoaneurysms following open-heart surgery are treated by redo surgery or endovascular therapy when surgical risks are high. Extreme variations in their morphology, proximity to coronary and arch branches and vascular access may vary the timing, strategy, device choice, and technique in each patient. Three patients with varying etiology, presentations, and morphology of the pseudoaneurysms underwent successful endovascular exclusion by individually tailored strategies. The approach includes optimal treatment of the underlying infections before the endovascular intervention despite the emergency to treat the condition; choosing appropriate device depending on the proximity to aortic branches, choosing appropriate access depending on the angulation of the entry of pseudoaneurysm to the aortic lumen, and use of adequate imaging for achieving procedural success. < Learning objective: A tailored approach for transcatheter closure of postsurgical ascending aortic pseudoaneurysms should include: 1 Optimal infection control before the intervention. 2 Choosing nitinol occluders in high-flow aneurysms; vascular plugs and coils for residual leaks; and embolic protection for high clot burden. 3 Choice of femoral, brachial, or transapical access is decided based on angulation of the aneurysm with ascending aorta. 4 Meticulous planning of the interventions based on advanced three-dimensional imaging.> [ABSTRACT FROM AUTHOR]

The authors report a successful thrombectomy using the AngioJet Rheolytic Thrombectomy System (AngioJet) and an embolic protection device in a patient with femoro-femoral bypass graft occlusion. Lower extremity CT angiograms showed occlusion in the left-to-right femoro-femoral bypass graft. A rheolytic thrombectomy using the AngioJet and balloon angioplasty restored blood flow to the right lower extremity, and distal embolization may be effectively prevented by placing an embolic protection device within the right superficial femoral artery during the procedure. [ABSTRACT FROM AUTHOR]

The authors report a successful thrombectomy using the AngioJet Rheolytic Thrombectomy System (AngioJet) and an embolic protection device in a patient with femoro-femoral bypass graft occlusion. Lower extremity CT angiograms showed occlusion in the left-to-right femoro-femoral bypass graft. A rheolytic thrombectomy using the AngioJet and balloon angioplasty restored blood flow to the right lower extremity, and distal embolization may be effectively prevented by placing an embolic protection device within the right superficial femoral artery during the procedure. [ABSTRACT FROM AUTHOR]

Background: Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm 2 ) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated., Methods: We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm 2 ) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism., Results: One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler., Conclusions: Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).