Embolic Protection Devices Research Articles

Cerebral Hyperperfusion Syndrome Risk Comparison between Transcarotid Artery Revascularization and Carotid Artery Stenting with Distal Embolic Protection.

Cerebral hyperperfusion syndrome (CHS) is a rare but serious complication after carotid artery revascularization. This study aims to determine the impact of carotid artery stenting (CAS) modality on the incidence, severity and overall outcomes of CHS after carotid revascularization. Data from patients who underwent CAS with either distal embolic protection (CAS+DEP) or transcarotid artery revascularization (TCAR) were obtained from the Vascular Quality Initiative (VQI) database 2016-2023. Cases without embolic protection device and patients suffering from carotid dissection, trauma, or fibromuscular dysplasia were excluded from the study. Patients were stratified into asymptomatic and symptomatic carotid stenosis groups and then further reviewed based on the urgency of their revascularization. The primary outcome was the occurrence of CHS after revascularization. A subgroup analysis was then performed, evaluating postprocedural outcomes and severity of CHS. Lastly, patients with CHS were further analyzed according to the severity of their stroke on admission using the Modified Rankin Scale (mRS). 69,480 (57.47% TCAR; 42.53% CAS+DEP) patients were included in this analysis. Postprocedural CHS was lower in the TCAR cohort compared to the CAS+DEP cohort (0.53% vs. 1.1%, p<0.001). On multivariate analysis, TCAR was associated with lower risk of CHS than CAS+DEP (p<0.001). When considering only asymptomatic patients, revascularization modality did not significantly affect CHS occurrence (p=0.610). However, in symptomatic patients, TCAR was associated with two-fold lower risk of CHS (adjusted odds ratio (aOR): 0.52, 95% confidence interval (CI): 0.40-0.68, p<0.001), in both elective (p=0.003), and urgent/emergency cases (p<0.001). Among patients who developed CHS, those undergoing TCAR had decreased in-hospital mortality (aOR: 0.51, 95% CI: 0.27 - 0.94, p=0.031) and at 30 days (aOR: 0.46, 95% CI: 0.26 - 0.80, p=0.006). TCAR patients with CHS also had a shorter length of hospitalization (aOR: 0.58, 95% CI: 0.36 - 0.92, p=0.022) and suffered less frequently from severe CHS with seizures and intracranial hemorrhage (aOR: 0.51, 95% CI: 0.29 - 0.89, p=0.019). Patients undergoing CAS+DEP who were admitted with severe stroke (mRS 3-5) developed severe CHS (p=0.014). In patients with symptomatic carotid artery stenosis, TCAR is associated with a lower risk of CHS compared to CAS+DEP. Among those who develop CHS, patients who undergo TCAR express a milder form of CHS and have lower in-hospital and 30-day mortality than those treated with CAS+DEP.

Three-Year Results of Combining Debulking Devices with Drug-coated Balloons for the Treatment of De Novo Femoropopliteal Arteriosclerosis Obliterans.

To compare the safety and efficacy of debulking devices, including directional atherectomy (DA) and excimer laser atherectomy (ELA), when combined with drug-coated balloons (DCB) for treating de novo femoropopliteal atherosclerotic obliterans (ASO). Additionally, to evaluate the long-term outcomes and application status of these different debulking devices. Clinical data were collected from patients with femoropopliteal ASO who underwent combined debulking and DCBs at the Vascular Surgery Department of Xuanwu Hospital, Capital Medical University, China, between January 2018 and January 2023. In accordance with the different atherectomy devices used during the surgery, patients were divided into the directional atherectomy group and the excimer laser group. Patient baseline characteristics, Rutherford classification, lesion length, stenosis degree, TASC II classification, calcification degree, and surgical-related data were recorded. Follow-up data over 36 months were collected to obtain efficacy indicators such as primary patency rate and freedom from clinically-driven target lesion revascularizition rate (fCD-TLR), etc. RESULTS: A total of 167 primary femoropopliteal lesions were treated with debulking combined with DCB intervention, with a technical success rate of 100%. The DA combined with DCB group included 90 cases, while the ELA combined with DCB group included 77 cases. Both groups showed significant improvement in postoperative Rutherford classification compared to preoperative. The primary patency rates at 12, 24, and 36 months for the DA and ELA groups were 88.89% vs. 81.74% (P=0.15), 74.66% vs. 74.01% (P=0.99), and 63.37% vs. 67.24% (P=0.84), respectively. The fCD-TLR rates were 94.44% vs. 92.15% (P=0.53); 83.82% vs. 80.87% (P=0.42); and 68.47% vs. 72.87% (P=0.22), with no significant statistical differences. Notably, there were certain intergroup differences. Patients in the DA group had more comorbidities but lighter Rutherford classification compared to the ELA group. In the ELA group, the average lesion length was significantly longer than that in the DA group (140 mm vs. 108 mm, P= 0.007), and 75.3% of the lesions were occlusive. In contrast, only 24.4% of the lesions in the DA group were occlusive (P<0.001). Additionally, the use of embolic protection devices was more common in the DA group (78.9% vs. 49.4%, P<0.001), while the ELA group had a higher incidence of dissection and a higher rate of bailout stent implantation. Subgroup analysis showed that for severe stenotic lesions, the primary patency rate in the DA group was higher than that in the ELA group (P=0.04), whereas for occlusive lesions, the ELA group had a better primary patency rate (P=0.002). Independent risk factors for restenosis included smoking history, hypertension, coronary artery disease, and severe calcified lesions. Both DA and ELA can treat femoropopliteal ASO effectively and improved clinical symptoms with few perioperative complications. However, the specific applications and long-term outcomes of the two debulking devices are influenced by the characteristics of the lesions. Additionally, there are certain differences in the use of bailout stenting and distal protection devices. Severe calcified lesions were an independent risk factor for reduced primary patency rate, warranting further in-depth research on the treatment of highly calcified lesions.

Optimizing Outcomes in Transcatheter Aortic Valve Replacement Addressing Cerebrovascular Complications and Enhancing Patient Safety.

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of severe aortic stenosis, becoming the gold standard for many patients. Despite its advantages over surgical aortic valve replacement, TAVR is associated with significant complications, including paravalvular leakage, conduction disorders, and cerebrovascular events. This review focuses on the pathophysiology, incidence, and management of cerebrovascular complications following TAVR. We explore the mechanisms leading to these events, including embolization of debris from the calcified valve and aortic arch, and the role of procedural factors. The review also discusses the timing of cerebrovascular events, diagnostic approaches, and potential preventive strategies, including embolic protection devices. Understanding these complications is crucial for improving patient outcomes and refining TAVR techniques.

Procedural and Short-Term Outcomes of Carotid Artery Stenting: A Single-Center Experience.

Background Carotid artery stenting is a well-established alternative treatment to carotid endarterectomy for carotid artery stenosis for preventing stroke. This study assessed the procedural and clinical outcomes in patients undergoing carotid artery stenting in a tertiary care center in India. Methods A total of 39 patients underwent carotid artery stenting from January 2022 to December 2023, with different embolic protection devices and carotid stents. All the patients had symptomatic carotid artery stenosis with at least 50% stenosis as per the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. Procedural and technical success was assessed, and patients were followed for 20 ± 7 months for survival, new-onset stroke, and quality of life. Results The mean age was 64.8 ± 9.1 years and 25 (64.1%) of the patients were males. A total of 26 (66.7%) patients were hypertensive and 21 (53.9%) patients had a history of diabetes mellitus. Out of 39 patients, 2 (5.1%) had recurrent transient ischemic attacks while the rest (37; 94.9%) had a subacute and chronic ischemic stroke. A total of 37 (94.9%) patients had carotid artery stenosis of more than 70%. In this study, 9 (23.1%) patients had a history of sub-acute ischemic stroke of a 1 to 3-week duration. Two patients underwent bilateral staged stenting over a gap of one month. The overall procedural success rate was 39 (100%) and none of the patients had access site-related major complications. Out of the total 41 implants, 21 (51.2%) were self-expanding carotid WALLSTENT (Boston Scientific, Marlborough, Massachusetts, US) and 20 (48.8%) implants were Protégé RX tapered self-expanding carotid stent (Medtronic, Dublin, Ireland). A FilterWire EZ (Boston Scientific) embolic protection device was used in 23 (56.1%) cases and Spider FX (Medtronic) in 18 (43.9%) cases. None of our patients had an intraprocedural death. One patient had postprocedural ipsilateral third nerve palsy, which was resolved partially on the next day of carotid angioplasty. We used dual-antiplatelet drug therapy post-procedure for a month followed by a single antiplatelet drug lifelong. All patients were followed for a minimum of six months and a maximum of 30 months. A total of three (7.7%) patients have died, and 2 (5.1%) patients had a new-onset ischemic stroke with one on the same side of the carotid stenting. A total of 31 (79.5%) patients were doing well and in the recovery phase while those two patients who had a recurrent stroke were bedridden. None of the patients had clinically significant restenosis that needed revascularization of the carotid artery over a mean follow-up period. Conclusion Carotid artery stenting is an effective method to reduce the recurrence of ischemic stroke in significant symptomatic carotid stenosis patients. Experience in neuro-interventional procedures at our center leads to an acceptable rate of peri-procedural stroke, recurrence, and mortality in carotid artery stenting procedures.

Management of Acute Ischemic Stroke Following Transcatheter Aortic Valve Implantation: A Systematic Review and Multidisciplinary Treatment Recommendations.

Background/Objectives: Acute ischemic stroke is an uncommon but potentially devastating complication of Transcatheter Aortic Valve Implantation (TAVI). Despite improvements in device technology and procedural techniques, stroke rates have remained stable, with cerebral embolic protection devices demonstrating only limited efficacy to date. Therefore, the management of acute ischemic stroke complicating TAVI (AISCT) remains a key priority. We conducted a systematic review of the management of AISCT and provided multidisciplinary consensus recommendations for optimal management. Methods: PubMed, Google Scholar, and Cochrane databases were searched from inception to October 2023. All the original studies focusing on the treatment of AISCT were included. Non-English language studies, review articles, and studies in pediatric populations were excluded. Consensus recommendations were made by a working group comprising experts in stroke medicine and structural interventional cardiology. Results: A total of 18 studies met the inclusion criteria, including 14 case reports/series and 4 observational studies. No clinical trials were identified. The included case reports and series suggest that tissue-type plasminogen activator (tPA) and mechanical thrombectomy (MT) might be effective strategies for managing AISCT. However, significant bleeding complications were reported in two out of the four patients receiving tPA. Four observational studies also suggest an association between tPA and/or MT and improved functional outcomes and survival compared to conservative management. Higher bleeding rates were reported following tPA. Observational data suggest that there is currently little real-world utilization of either reperfusion strategy. Conclusions: There is an absence of high-quality randomized data to guide clinical decision making in this important area. Observational data suggest reperfusion strategies are associated with improved clinical outcomes once important confounders such as stroke severity have been accounted for. While MT can be recommended as the standard of care in appropriately selected patients, significantly increased rates of bleeding with tPA following large-bore arterial access raise important safety concerns. We present simple clinical guidance for AISCT based on the limited available data. Close multidisciplinary work and patient-specific consideration of ischemic and bleeding risk is essential.

Technical Complications Associated with Embolic Protection Device During Carotid Artery Stenting: Incidence, Risk Factors, Clinical Implications, and Rescue Maneuvers.

Background/Objectives: This study aimed to evaluate the incidence, risk factors, clinical implications, and rescue maneuvers of technical complications related to embolic protection devices (EPDs) during carotid artery stenting (CAS). Materials and Methods: We retrospectively reviewed all patients who had undergone CAS with EPDs between April 2018 and March 2024. The incidence and types of technical complication associated with EPDs were assessed. Clinical, angiographical, and procedural factors were analyzed to identify risk factors for the occurrence of EPD-related adverse events. Various rescue techniques for managing adverse events were investigated based on the procedure record. Results: Of the 158 enrolled patients, the rate of EPD-related technical complications was 23.4% (n = 37). Among them, complicated filter retrieval was the most common adverse event (n = 23, 14.6%). Older age, a higher degree of residual stenosis, and the type of the EPD were significant risk factors for complicated filter retrieval (p < 0.05). Although distal thrombus migration requiring thrombectomy was more frequent in patients with complicated filter removal (2.2% vs. 13.0%, p = 0.041), there was no significant increase in postprocedural thromboembolic and hemorrhagic complications. When complicated filter retrieval occurred, careful to-and-fro movement of the patients' neck, such as rotation, or asking them to swallow was tried first in all 23 patients. When these attempts failed, manipulation of a curved-tip guiding catheter, the balloon bridge technique, and alternative use of a 5 Fr angiocatheter as a retrieval sheath were sequentially tried, and all filters were successfully retrieved. Conclusions: Complicated filter retrieval was the most common technical complication during CAS. Various rescue techniques for successful filter removal were effective for ensuring safety of CAS.

Abstract 4121516: Efficacy of Sentinel Cerebral Embolic Protection Device in Transcatheter Aortic Valve Replacement: A Meta-Analysis of Randomized Controlled Trials and Propensity Score Matched Studies

Background: Transcatheter aortic valve replacement (TAVR) is frequently associated with stroke due to debris embolization. Although the risk of stroke with the newer-generation devices is lower, stroke still represents a significant cause of mortality and morbidity after TAVR. The Sentinel cerebral embolic protection (CEP) device (Boston Scientific) is a dual embolic filter device designed to capture debris dislodged during TAVR. The current literature concerning the efficacy of Sentinel CEP in the reduction of stroke in patients undergoing TAVR is limited and inconsistent. Aim: This meta-analysis aimed to compare clinical outcomes with Sentinel CEP device in patients undergoing TAVR. Methods: A comprehensive systematic literature search was performed on PubMed, Embase, Cochrane Library and Clinicaltrial.gov from inception until 1st May 2024 to retrieve randomized controlled trials (RCTs) and propensity-matched studies comparing TAVR with and without the Sentinel CEP device. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated using the DerSimonian-Laird random-effects model, with a p-value of &lt;0.05 considered statistically significant. Results: 6 studies with a total of 25,130 patients undergoing TAVR (12608: Sentinel CEP device; 12522: Without Sentinel CEP device) were included in this meta-analysis. The use of the Sentinel CEP device in TAVR was associated with a statistically significant lower risk of acute kidney injury [OR: 0.89; 95% CI: 0.81, 0.97; p=0.01]. The use of Sentinel CEP device in TAVR was associated with a statistically insignificant trend towards reduction in stroke [OR: 0.80; 95% CI: 0.58, 1.10; p=0.18], all-cause mortality [OR: 0.74; 95% CI: 0.51, 1.07; p=0.11], and major vascular complications [OR: 0.74; 95% CI: 0.46, 1.19; p=0.21]. Conclusion: The use of the Sentinel CEP device in patients undergoing TAVR does not lead to a statistically significant reduction in stroke, all-cause mortality, and major vascular complications; however, the risk of acute kidney injury is lower. Large, multicentric RCTs are warranted to corroborate the findings of this meta-analysis.

Abstract 4118076: Right Innominate Artery Endovascular Intervention Via Single Radial Access and Use Of Embolic Protection

Introduction: The occurrence of innominate artery stenosis is less prevalent compared to subclavian artery disease. Small studies suggest up to 8% of individuals initially diagnosed with suspected subclavian steal syndrome may present with innominate artery lesions. Deployment of an embolic protection filter within the internal carotid artery during percutaneous intervention of the innominate artery presents a solution to mitigate embolism. Case: A 70-year-old female with a history of peripheral vascular disease presented with claudication in both arms, manifested as pain in both arms. Her left subclavian was stented months prior to presentation. An aortogram revealed severe stenosis of the innominate artery (Figure 1). Since multiple attempts to cross the lesion antegrade from the femoral access site were unsuccessful, we proceeded with the successful deployment of an embolic protection filter in the right internal carotid artery via our right radial artery access site (Figure 2). Using the right radial artery, we passed a long run-through guidewire into the distal abdominal aorta. Due to severe aortic tortuosity, we were unable to snare the wire from the aorta. Therefore, we upsized the radial sheath to 7 French over both wires (runthrough and bare). Using a support catheter, we exchanged the runthrough wire for a Glidewire Advantage. We advanced an 8 x 29mm balloon expandable stent to the area of innominate stenosis and deployed it (Figure 3). We postdilated the stent with a 14mm balloon. Angiography demonstrated adequate expansion. On follow up, the patient was without claudication and had triphasic flow in the innominate and left subclavian arteries. Discussion: Treating innominate artery stenosis via radial access employing a sole entry point for both embolic protection and treatment administration offers a substitute where additional access is infeasible. Modern embolic protection techniques are superior due to their flexibility and ease of use. In this case, placing the embolic protection device in the carotid artery was mandatory through the sole radial access to prevent trapping the filter behind the innominate artery stent. We were able to perform both the embolic device placement and the stenting with the same radial access. Conclusion: Endovascular intervention of innominate artery stenosis via radial access, utilizing a single radial access for both embolic protection and treatment delivery, presents an alternative when femoral access is not feasible.

Performance Assessment of an Electrostatic Filter-Diverter Stent Cerebrovascular Protection Device: Evaluation of a Range of Potential Electrostatic Fields Focusing on Small Particles.

Silent Brain Infarction (SBI) is increasingly recognized in patients with cardiac conditions, particularly Atrial Fibrillation (AF) in elderly patients and those undergoing Transcatheter Aortic Valve Implantation (TAVI). While these infarcts often go unnoticed due to a lack of acute symptoms, they are associated with a threefold increase in stroke risk and are considered a precursor to ischemic stroke. Moreover, accumulating evidence suggests that SBI may contribute to the development of dementia, depression, and cognitive decline, particularly in the elderly population. The burden of SBI is substantial, with studies showing that up to 11 million Americans may experience a silent stroke annually. In AF patients, silent brain infarcts are common and can lead to progressive brain damage, even in those receiving anticoagulation therapy. The use of cerebral embolic protection devices (CEPDs) during TAVI has been explored to mitigate the risk of stroke; however, their efficacy remains under debate. Despite advancements in TAVI technology, cerebrovascular events, including silent brain lesions, continue to pose significant challenges, underscoring the need for improved preventive strategies and therapeutic approaches. We propose a device consisting of a strut structure placed at the base of the treated artery to model the potential risk of cerebral embolisms caused by atrial fibrillation, thromboembolism, or dislodged debris of varying potential TAVI patients. The study has been carried out in two stages. Both are based on computational fluid dynamics (CFD) coupled with the Lagrangian particle tracking method. The first stage of the work evaluates a variety of strut thicknesses and inter-strut spacings, contrasting with the device-free baseline geometry. The analysis is carried out by imposing flow rate waveforms characteristic of healthy and AF patients. Boundary conditions are calibrated to reproduce physiological flow rates and pressures in a patient's aortic arch. In the second stage, the optimal geometric design from the first stage was employed, with the addition of lateral struts to prevent the filtration of particles and electronegatively charged strut surfaces, studying the effect of electrical forces on the clots if they are considered charged. Flowrate boundary conditions were used to emulate both healthy and AF conditions. Results from numerical simulations coming from the first stage indicate that the device blocks particles of sizes larger than the inter-strut spacing. It was found that lateral strut space had the highest impact on efficacy. Based on the results of the second stage, deploying the electronegatively charged device in all three aortic arch arteries, the number of particles entering these arteries was reduced on average by 62.6% and 51.2%, for the healthy and diseased models respectively, matching or surpassing current oral anticoagulant efficacy. In conclusion, the device demonstrated a two-fold mechanism for filtering emboli: (1) while the smallest particles are deflected by electrostatic repulsion, avoiding micro embolisms, which could lead to cognitive impairment, the largest ones are mechanically filtered since they cannot fit in between the struts, effectively blocking the full range of particle sizes analyzed in this study. The device presented in this manuscript offers an anticoagulant-free method to prevent stroke and SBIs, imperative given the growing population of AF and elderly patients.

Abstract 129: Periprocedural Events between Patients 70 Years and Older and less than 70 years who underwent Carotid Artery Stenting Comparted to the Historic Crest Trial; A Multicenter Cohort.

Background Equal benefits and comparable periprocedural events were observed between carotid endarterectomy (CEA) and carotid artery stenting (CAS) group in CREST trial. However, CAS group had more cerebral ischemic events (CIE) compared to CEA and patients ≥ 70 years have signaled better chance with CEA. In CAS arm more patients were smoker and 12% of the patient was not on dual antiplatelets for 4 weeks. Objective of this study is to evaluate the incidence of perioperative events including CEI in patients ≥ 70 years who underwent with CAS and compared to the younger and historic CREST trial. Methods From a prospectively maintained data base, consecutive patient who underwent CAS for ≥ 70% were collected and retrospectively analyzed from January 2012 to December 2020. Patients demographics, procedural techniques and perioperative events were captured. Outcome was measured using modified ranking scale (mRS). Patients stopped smoking for 2 weeks and received loading dose of dual antiplatelets on the day prior to the CAS and dual antiplatelets full dose was continued for 30 days followed by two 81 mg aspirin and plavix 75 for additional 9 months (antiplatelets strategies). Results off 177, 86 (48.6%) patients were ≥ 70 years with a median age of 69 (39‐91) female 39.55%, symptomatic 71% asymptomatic 29% underwent CAS in two community based tertiary care facilities. All patients, but one received conscious sedation who underwent general anesthesia. Embolic protection device (EPD) was used in 69% and 41% didn't receive EPD due to the tortuosity or critical stenosis prevented EPD to cross the lesion. Stent couldn't be deployed in one because of non‐tolerance and underwent CEA. The overall perioperative events without death, stroke and MI was observed in 7 cases (3.9%) and in ≥ 70 years patients it was 2.3% compared to CREST CEA 6.8% including death, stroke and MI. Total perioperative CIE were observed in 2 cases (1.2%) and in ≥ 70 years, it was 1.16% (1patient) compared to CREST CEA 2.3%; both events developed in symptomatic CAS cases. First event was in a 65 Y/O man with left MCA stroke due to the left ICA stenosis. Patient baseline aphasia and right‐hand fine motor activity worsen after the procedure and resolved in 2 weeks without any MRI evidence of stroke. The second event was observed on an 84‐year‐old man as a right fascial droop which resolved over 4 weeks. Groin complications in all patients was 2.42% (4patients) and in ≥ 70, it was 1.16% in 1patient; anterior small hematoma in 3, closure device related ischemic leg in a 65‐year‐old who required urgent repair and achieved mRS 0. Asymptomatic patients achieved their baseline mRS. Conclusions Our study demonstrated no differences in CAS related perioperative events in patients ≥ 70 years compared to the younger with overall low rate of events. When compared with historic CREST CEA arm, our events rate was lower and with no death or MI. These may be related to the cessation of smoking and adherence to dual antiplatelets strategies in our cohort. Further studies are required.

Abstract 098: Endovascular Treatment of Symptomatic Bilateral Carotid Artery Occlusions

Introduction The annual incidence of acute ischemic strokes or transient ischemic attacks due to chronic carotid occlusion (CCO) is estimated at 5‐10%. While initial trials did not show a clear benefit for surgical treatment of symptomatic CCO, emerging data suggests that endovascular treatment (EVT) may offer significant advantages over best medical management (BMM) in selected cases. However, the use of EVT for bilateral symptomatic CCO has not been previously investigated. Method We present the case of a 67‐year‐old male with a history of oropharyngeal carcinoma, treated with extensive neck radiation, leading to bilateral common carotid artery occlusions. The patient, initially presenting for elective gastric endoscopy, experienced hypotension during anesthesia induction and subsequently became comatose. Imaging revealed complete occlusion of the bilateral common carotid arteries and the right vertebral artery, with CT perfusion showing extensive global hypoperfusion correlating with severe EEG attenuation. Due to the failure of medical management, EVT was deemed necessary. Results A femoral approach was utilized for endovascular access to each common carotid artery. The procedure involved the use of a guide catheter, microwires for crossing occlusions, and multiple angioplasties with various balloon sizes to create a passage through the occlusions. An embolic protection device was employed to prevent iatrogenic distal embolization. Rheolytic thrombectomy aided in recanalization, followed by the placement of several stents in a telescopic fashion to achieve vessel patency. Intravascular ultrasound (IVUS) was performed pre‐ and post‐recanalization to evaluate vessel integrity. The procedure resulted in the complete recanalization of both carotid arteries, with subsequent resolution of perfusion abnormalities and normalization of electroencephalographic patterns. The patient returned to his neurological baseline within days post‐procedure. Conclusion This case demonstrates the safe and effective use of EVT for the treatment of bilateral chronic carotid artery occlusions. It highlights the potential of EVT as a promising therapeutic option in managing CCO, particularly in cases where medical management fails.

Abstract 080: Challenges Associated with The Embolic Protection Device (epd) And Perioperative Events Between Those Who Did and Did Not Receive Epd During Carotid Artery Stenting

Background In CREST trial 96.1% of the patient in carotid artery stenting (CAS) group had EPD and with a 4.1± 0.6 incidence of stroke. Despite the use of EPD, CAS has more cerebral ischemic events (CIE) compared to CEA. Additionally, the challenges associated with EPD device was not described and underreported. Objective of this study is to describe the challenges associated with EPD and compare the perioperative events between those with EP and without embolic protection. Additionally, to describe the unintentional strategies utilized for the EP. Methods From a prospectively maintained data base, Consecutive patient who underwent CAS for ≥ 70% stenosis based on NASCET criteria were collected and retrospectively analyzed from January 2012 to December 2020. Patients demographics, procedural techniques and perioperative events were captured. Outcome was measured using modified ranking scale (mRS). Our patients received acute loading doses of dual antiplatelets on the day prior to CAS. Results A total of 177 patients with baseline mRS 0.511±1.02 and 71% symptomatic, 29% asymptomatic underwent CAS in two community based tertiary care facilities. Patients received conscious sedation except one who underwent general anesthesia. Median age 69 (39‐91) female 39.55%. EPD was used in 69% and 41% didn't receive EPD due to the tortuosity or critical stenosis prevented DPD to cross the lesion. Stent couldn't be deployed in one because of non‐cooperation and underwent CEA. EPD associated challenges observed in 12 patients (9.8%). EPD couldn't be deployed in 3 required additional 3 devices and use of intraarterial eptifibatide (integrilin). EPD induced spasm developed in 5 required IA verapamil. Severe challenges were observed in 3 during retrieval of the capture device requiring multiple unintentional balloon angioplasties, patients head manipulations and IA intermittent delivery eptifibatide (5 mg at least 10 minutes interval maximum 2 doses). Unexpected EPD related events increased procedure time and have created significant stresses to the team and to the operators. Perioperative events without death, stroke and MI in 7 cases 3.9%. CEI in 2 cases (1.2%), one in an 88‐year‐old man without EPD and one in a 66‐year‐old man with EPD. Carotid artery asymptomatic dissection in one with EPD. Groin complications in 4 (2.3%). Anterior small hematoma in 3, had no impacts in hospital stay and outcomes. Closure device related femoral artery occlusion in 1, required emergent repair and achieved mRS 0. All asymptomatic patients achieved their baseline mRS and had no events. 30 days and 90 days mRS were 0.405 ±0.96 and 0.402 ± 0.95 respectively. Conclusions We observed significant challenges associated with EPD and unintentional interventions such as use of additional devices, vessels spasm, delivery of spasmolytic, balloon angioplasties and IA eptifibatide, especially during the retrieval of EPD. If the EPD couldn't be retrieved in our 3 cases, which might have potentially led to a life‐threatening stroke. We observed no added benefits in the prevention of embolic events between those who received or didn't receive EPD during CAS. A prospective randomized controlled trial is deemed necessary.

Abstract 140: Safety and Efficacy of Trans carotid Intervention in Multiple Scenarios: Medellin Experience using Direct Carotid access

Purpose Direct Carotid Puncture (DCP) has been validated such as an alternative route to reach the intracranial vasculature. However, this approach has not been considered routinely in INR.This study was conducted to investigate the feasibility and safety of trans carotid Neuro intervention for a variety of pathologies. Materials and methods Since 2018 we implemented a DCP under special considerations to perform a therapeutic approach. A total of 28 patients from our centers were analyzed. Patients were divided into a variety of neurovascular conditions: Carotid Stenting CAS (n = 4), Mechanical Thrombectomy MT (n=10), AVM´s treatment (n=4), intracranial Aneurysms treatment (n=10). Patient demographics, technical data, intervention time, type of intervention, closure device used, local or systemic complications and a patient perception assessment were registered. Results Mean age was 64.3 ± 10.3 years. in all cases but two were treated under GA. Major indication to this approach were: anatomical and access limitations in 24 cases and, two patients with Leriche Syndrome. All cases performed with ultrasound US assistance. A 4 Fr. Micro‐ puncture set were used in all procedures and posteriorly a 6Fr. Introducer was inserted. Technical success in all cases (100%) selected. Two patients presented mild vasospasm and resolved using IA vasodilators. All CAS were performed without any complications and none embolic protection device used. For MT(n=10): a SOFIA 6Fr for ADAPT was used in 6 cases with TICI 2b‐3 in all cases. Combined approach was used in four cases, one TICI 2a and one TICI 3. A total of 10 aneurysms were treated with this approach (4 ICA – ophthalmic; 4 MCA and two AcomA) Mean average time of the procedure was 34.5 min. (ranged 9‐59 min) Only one hemorrhagic complication observed at the closure device use. In all cases but one we use Angio‐Seal 6Fr as closure device, in a single case where we used a ProGlide suture device we had a serious complication at the puncture site. Conclusion Trans Carotid Intervention TCI. was feasible and safe in selected patients in this small series. A multiple variety of neurovascular conditions would be treated successfully by this way improving the learning curve. Complication rates and clinical outcomes were comparable with those in trans femoral or radial approach.

Abstract 344: Novel technique for endovascular biopsy of carotid endothelial cells in carotid artery stenosis: Proof of Concept &amp; Follow Up of SVIN 2023 Pilot Grant

Introduction Acute ischemic stroke remains to be one of the top causes for morbidity and mortality among the general population, with approximately 800,000 strokes occurring per year nationwide. While the potential etiologies of stroke are numerous, 15‐20% of all strokes are attributed to carotid artery stenosis. While isolated studies have been conducted sampling carotid plaques after CEA, there is a dearth of literature examining the characteristics of the endoluminal cells and their molecular characteristics (such as transcriptomes) in carotid artery disease. We therefore employed a novel method for endovascular biopsy of carotid endothelial cells in the setting of carotid artery stenosis. Methods A prospective registry of adult patients undergoing endovascular treatment for carotid artery stenosis was maintained from January 2024 to August 2024. Informed consent was obtained, and at the conclusion of the case, critical devices were collected and placed in dissociation buffer including the access wire/sheath tip, the distal embolic protection device, and any balloons utilized for balloon angioplasty. Cells were then washed from the samples using a series of centrifugation, wash, and pelleting steps. Once completed, the pellet was then resuspended in a solution containing Hibernate A, and a standard antibody staining and sorting protocol was performed utilizing fluorescence activated cell sorting (FACS) to identify endothelial cells (via CD31 antibodies) and to exclude white blood cells (negative sorting via CD45 antibodies). Results Six patients met inclusion criteria and gave consent for endothelial carotid biopsy. After sorting for endothelial cells via FACS, the mean number of endothelial cells collected from the access sheath/wire was 1506 cells per patient. Similarly, the mean number of endothelial cells collected from the balloons utilized for angioplasty was 1124 cells. Finally, the mean number of endothelial cells collected from the distal embolic protection device was 5021 cells per patient. Discussion The preliminary findings herein suggest that this method of endovascular biopsy may very well be a reliable method for collecting endothelial cells from the carotid artery in the setting of treatment for carotid artery stenosis. Sample collection is still ongoing to further support the viability of this technique. Collected endothelial cells will then undergo RNA sequencing in order to describe the transcriptomic profile present in endothelial cells of diseased carotid arteries.

Cerebral Embolic Protection by Geographic Region

Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated. To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR. This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024. TAVR with or without CEP. The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes. The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort. The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy. ClinicalTrials.gov Identifier: NCT04149535.

Cerebral emboli detection and autonomous neuromonitoring using robotic transcranial Doppler with artificial intelligence for transcatheter aortic valve replacement with and without embolic protection devices: a pilot study

BackgroundPeriprocedural 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...

Comparison of Thromboembolic Complications After Carotid Artery Stenting with and without Using Protection Devices: A Systematic Review and Meta-Analysis Study

Background: This study compared the rate of thromboembolic events during carotid angioplasty and stenting (CAS) with and without embolic protection devices (EPDs). We reviewed literature to find studies comparing embolic event rates during CAS with and without EPDs and conducted a meta-analysis to determine the safer approach.Methods: The Embase, PubMed, and Web of Science databases were thoroughly searched following PRISMA guidelines. Each estimation was executed using random-effects models. The I2 index was used to assess the heterogeneity among the studies. Egger and Begg’s tests were applied to evaluate publication bias. Stata version 14.2 was used for statistical analysis.Results: For 25% of patients, an EPD was used during CAS, and for 75% it was not. Of the patients undergoing CAS, the prevalences of hypertension, diabetes mellitus, coronary artery disease, and cigarette smoking were 81%, 37%, 39% and 43%, respectively. In total, of the patients included 52% were symptomatic and 48% were asymptomatic. The mortality rate reduced from 2% in the no-EPD subgroup to 1% in the EPD subgroup. The occurrence of all other complications was also reportedly higher in patients who did not receive an EPD, including major stroke and myocardial infarction, except for minor events, which were reported to be almost the same in both subgroups.Conclusions: We found that the use of an EPD can help reduce the occurrence of thromboembolic complications of CAS, including myocardial infarction, major stroke, and death. Altogether, our results suggest that the benefits of using an EPD during CAS outweigh its risks.

Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Replacement: A Review.

Cerebrovascular events (CVEs) are a dreaded complication of transcatheter aortic valve replacement (TAVR). They are associated with significant mortality, morbidity, and reduced quality of life and impose a significant burden to health care systems. Although the rates of clinical stroke have reduced since the advent of TAVR, it remains an important complication, particularly as TAVR is increasingly utilized. CVE may occur at the time of the TAVR, as a direct consequence of the procedure, or may occur later, related to thrombosis of the prosthetic valve, atrial fibrillation, and other comorbidities. Imaging of the brain has revealed a high prevalence of subclinical cerebral infarcts (68%-98%) associated with the TAVR procedure. Although their clinical significance has not been fully established, clinically evident CVE ranges between 3% and 5% in patients considered at high operative risk to between 1% and 3% in low operative risk patients. Periprocedural CVEs are largely the result of embolization of the thrombus and tissue derived from the valve, vasculature, or myocardium. Cerebral embolic protection devices have been studied in multiple trials, with some evidence supporting a reduction in new cerebral lesion volume, number, and potentially disabling strokes. However, thus far, there is no robust evidence that they reduce the overall stroke rate. The number and severity of comorbidities, in particular, new-onset atrial fibrillation, are associated with CVEs. Valve thrombosis diagnosed using computed tomography as areas of hypoattenuated leaflet thickening has been identified in 10% to 15% of patients. This is a dynamic process associated with an increase in CVEs, but that resolves with anticoagulation or sometimes without it. Routine use of anticoagulation compared with a single antiplatelet agent is associated with an increased risk of bleeding, without any additional alleviation in risk of thromboembolism. Future studies to improve risk stratification could facilitate the tailoring of preventive therapies to patients at high risk of CVE, who stand to gain the most benefit.

Cerebral Embolic Protection: Is There a Benefit for Left Atrial and Mitral Valve Procedures?

This review aims to highlight the current evidence on the use of cerebral embolic protection devices (CEPD) in left atrial and transcatheter mitral valve procedures. It also aims to summarize the antithrombotic management of patients undergoing such procedures. Ischemic stroke is one of the most devastating complications of structural heart procedures. The manifestation of periprocedural stroke can range from asymptomatic and detectable only through brain imaging to major stroke with neurological deficits. CEP devices were initially developed to mitigate the risk of stroke associated with transcatheter aortic valve replacement (TAVR). However, the efficacy of such devices during different cardiac interventions is yet to be fully demonstrated, especially in left atrial appendage closure (LAAO), and mitral valve interventions. Few studies demonstrated that the risk of periprocedural strokes after LAAO and mitral valve interventions is not negligible and is highest during the periprocedural period and then falls. The majority of patients undergoing those procedures have cerebral ischemic injuries detected on diffusion-weighted magnetic resonance imaging (DW-MRI). Moreover, a reasonable number of those patients had debris embolization on the filters of the CEPD. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is crucial and should be tailored to each patient's risk of bleeding and ischemia. Close monitoring that includes a full neurological assessment and frequent follow-up visits with cardiac echocardiography are important. The risk of periprocedural stroke in left atrial and transcatheter mitral valve procedures is not negligible. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is important to mitigate the risk of stroke, especially the long-term risk. More prospective studies are needed to assess the efficacy of CEPD in such procedures.

Successful Percutaneous Rescue Treatment of Acute Carotid Stent Thrombosis Utilizing a Modified Embolic Protection Device.

Acute Carotid Stent Thrombosis (ACST) is a rare complication of Carotid Artery Stenting (CAS) with a potentially fatal outcome. We report a case of ACST occurring five minutes after the end of a successful CAS procedure that was promptly treated by carotid stent-in-stent implantation using a new percutaneous strategy based on the creation of a modified embolic protection device. Following the procedure, we did not observe brain lesions suggestive of acute cerebral ischemic events at the CT scan performed at 48 hours, as well as no neurological deficits in the following days.