Cerebral Embolic Protection Research Articles

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 <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.

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.

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 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.

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.

TCT-845 Impact of Cerebral Embolic Protection on Perioperative Stroke in TAVR for Patients With Atrial Fibrillation

TCT-845 Impact of Cerebral Embolic Protection on Perioperative Stroke in TAVR for Patients With Atrial Fibrillation

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

Transcatheter aortic valve replacement (TAVR) is frequently associated with stroke due to debris embolization. Although the risk of stroke with newer-generation devices is lower, stroke still represents a significant cause of mortality and morbidity post-TAVR. The Sentinel cerebral embolic protection device (CEPD) is a dual-embolic filter device designed to capture debris dislodged during TAVR. A systematic literature search was performed on the major bibliographic databases to retrieve studies that compared TAVR with and without Sentinel CEPD. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using the DerSimonian-Laird random-effects model, with a P value of <0.05 considered statistically significant. This meta-analysis included 6 studies with 25,130 patients undergoing TAVR (12,608: Sentinel CEPD; 12,522: without Sentinel CEPD). The use of the Sentinel CEPD 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 CEPD in TAVR was associated with a statistically insignificant trend toward a 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). The use of Sentinel CEPD in patients undergoing TAVR does not lead to a statistically significant reduction in stroke, all-cause mortality, or major vascular complications; however, the risk of acute kidney injury is lower. Further randomized studies are warranted to confirm these findings.

Cerebral Embolic Protection Devices: Are There Any Indications in Transcatheter Aortic Valve Replacement?

Stroke following transcatheter aortic valve replacement (TAVR) is a significant and life-threatening adverse event. The vast majority of these incidents occur during the TAVR procedure or within the first 24 h following TAVR, with a notable prevalence of cerebral embolic events. In response to this concern, cerebral embolic protection devices (CEPDs) have been designed to mitigate the risk of peri-procedural ischemic stroke during TAVR. The primary objective of CEPDs is to diminish the intraprocedural burden associated with new silent ischemic brain injuries. Despite the development of several CEPDs, their clinical efficacy remains uncertain. In this review, we delve into a comprehensive analysis of the utilization of CEPDs in patients undergoing TAVR, exploring insights from the existing literature. Additionally, we aim to present future perspectives and discuss the clinical implications associated with the incorporation of CEPDs in TAVR procedures.

Impact of cerebral protection on observed versus predicted in-hospital stroke in a high stroke risk TAVR cohort

BackgroundDespite 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.MethodsThe 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.ResultsThe 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).ConclusionIn 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 numberN/A.

Cerebrovascular events after transcatheter aortic valve implantation.

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.

Clinical Outcomes of Percutaneous Transcatheter Release of Stuck Mechanical Mitral Valve With Cerebral Embolic Protection.

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. 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. 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. 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.

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

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. 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. 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 (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). 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.

Cerebral Embolic Protection Devices for Transcatheter Aortic Valve Replacement: Review of the Literature and Future Perspectives.

Transcatheter aortic valve replacement (TAVR) has been a revolutionary therapy in the treatment of aortic valve stenosis. The risk of stroke associated with TAVR has decreased significantly since its introduction; however, it remains a devastating complication when it does occur. Many of the strokes associated with TAVR occur peri-procedurally and are thought to be due to embolic debris entering the cerebrovascular circulation. A number of different cerebral embolic protection devices (CEPD) have been developed and are in various stages of testing and use. The results from clinical trials evaluating the role for CEPD to reduce the risk of stroke have been mixed. As a result, their uptake has been very heterogeneous. This review provides a summary of the diverse CEPD devices available for use and outlines the clinical evidence available to date.

Examining the Role of Cerebral Embolic Protection Devices in Preventing Postoperative Stroke in Patients with a History of Stroke or Transient Ischemic: Insights from the National Inpatient Sample.

Cerebral embolic protection devices (CEPD) during transcatheter aortic valve replacement (TAVR) have been shown to lower the risk of stroke during the procedure. However, their long-term and clinical effects on neuro-cognition are unknown. Therefore, we hypothesized the benefit of CEPD in TAVR patients with a prior history of stroke or transient ischemic attack (TIA). National Inpatient Sample (2019) and International Classification of Diseases, 10th Revision codes were used to identify patients undergoing TAVR with prior stroke or TIA. Propensity-matched analysis was performed to adjust for baseline characteristics and comorbidities. Primary outcome measures were postoperative stroke and all-cause mortality. Length of stay and hospital cost were secondary outcomes. Of 8450 unmatched TAVR patients with prior stroke or TIA in 2019, 1095 (13%) utilized CEPD. After propensity matching previous myocardial infarction (MI), coronary artery bypass grafting, and drug abuse were higher in the TAVR-only cohort. Postoperative stroke rate (1.4% vs 2.2%; P = 0.081) and odds [adjusted odds ratio (aOR), 0.48; 95% confidence interval (CI), 0.11-2.17; P = 0.341] were lower in the CEPD group. There was no difference in all-cause in-hospital mortality between the 2 groups (0.9% vs 1.0%). Length of stay (3 vs 2 days, P <0.001) and hospital expenditure ($172,711 vs $162,284; P = 0.002) were higher for the TAVR-only cohort. CEPD in TAVR patients with prior stroke or TIA did not show statistically significant postoperative stroke benefits. However, further larger-scale prospective studies are needed to evaluate the long-term neurocognitive benefits of CEPD in these patients. As the use of TAVR continues to expand, optimizing peri-procedural strategies such as the use of CEPD remains a critical area of research to improve patient outcomes.

Uncommon Carotid Artery Stenting Complications: A Series by Images.

To describe through emblematic images rare but clinically relevant carotid artery stenting complications that occurred at two high-volume centres for carotid artery stenting (CAS). CAS is an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis in patients judged to be at high risk for CEA. CAS complications range between 1 and 9% and are higher in older patients complaining of neurological symptoms at the time of presentation. Besides periprocedural or early-after-procedure stroke, which remains the true Achilles' heel of CAS, other dramatic complications might compromise the clinical outcomes of this procedure. Five infrequent complications, out of more than 1000 CAS performed in the years 2016-2021, have been described. Among CAS complications, acute carotid stent thrombosis, rescue retrieval of a disconnected distal cerebral embolic protection device, plaque prolapse after carotid stenting, cerebral hyperperfusion syndrome (CHS), and radial artery long sheath entrapment requiring surgical intervention were found to account for 0.3% of the total number of procedures performed by operators with high CAS volume. Unusual CAS complications may infrequently occur, even in hands of expert operators. To know how to deal with such complications might help interventionalists to improve CAS performance.

The efficacy of different types of cerebral embolic protection device during transcatheter aortic valve implantation: a meta-analysis.

Perioperative stroke remains a devastating complication after transcatheter aortic valve implantation (TAVI), and using a cerebral embolic protection device (CEPD) during TAVI may reduce the occurrence of stroke according to some studies. Therefore, we conducted this meta-analysis to determine whether CEPD should be routinely used during TAVI. The inclusion criteria for this study were randomized controlled trials (RCTs) that examined the outcome of stroke with or without CEPD during TAVI, with a minimum follow-up period of 30 days. The primary endpoint was the occurrence of stroke (including both cerebrovascular accidents and death due to cerebrovascular accidents). The risk of stroke was lower in the CEPD group: RR 0.68, 95% CI 0.49-0.96, p = 0.03, I2 = 0%. A subgroup analysis was conducted according to the type of CEPD. The risk of stroke was lower in the I&LCCA (filter cover the innominate and the left common carotid arteries) type CEPD group: RR 0.66, 95% CI 0.49-0.96, p = 0.03, I2 = 36%. However, there was no statistically significant difference in the risk of stroke in the TMCA [filter cover the three major cerebral arteries (innominate, left common carotid, and subclavian arteries)] type CEPD group: RR 0.81, 95% CI 0.36-1.80, p = 0.60, I2 = 0%. In this meta-analysis, the I&LCCA-type CEPD can reduce the risk of stroke within 30 days following TAVI, but the TMCA type cannot.

Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation Using the Sentinel Cerebral Protection System: A Systematic Review and Meta-Analysis.

Transcatheter aortic valve implantation (TAVI) plays a vital role in patients with symptomatic aortic stenosis. Despite the mortality benefit of TAVI, embolic stroke remains a feared complication. As a result, transcatheter cerebral embolic protection (TCEP) devices have been developed to reduce this risk. Given the ongoing debate of TCEP in TAVI, we performed a systematic review and meta-analysis of all randomized controlled trials to date to identify outcomes of periprocedural stroke using the Sentinel™ cerebral protection system (CPS). MEDLINE, Cochrane, and Scopus databases were utilized from inception until 12/2023. PRISMA criteria was utilized. Keywords included "cerebral embolic protection", "sentinel cerebral protection system", "transcatheter aortic valve implantation", and "transcatheter aortic valve replacement". Primary outcome was periprocedural stroke. Secondary outcomes included periprocedural disabling and non-disabling stroke, all-cause mortality, transient ischemic attack, delirium, acute kidney injury, vascular complications, bleeding, and pacemaker implantation. Risk ratios (RR) were measured via Mantel-Haenszel method with fixed analysis. Heterogeneity was assessed via chi-squared and Higgin's I2 test. Four trials with 3528 patients were assessed. SAPIEN 3 was the most common bioprosthetic valve used. The average age was 79.4years with 41.9% of the sample size being females. The most prevalent comorbidities were hypertension, diabetes mellitus, and coronary artery disease. There was no difference in periprocedural stroke in patients who underwent TAVI with the Sentinel™ CPS compared to no TCEP (RR 0.75, P = 0.12). Periprocedural disabling strokes were less likely in those who underwent TAVI with the Sentinel™ CPS compared to no TCEP (RR 0.41, P = 0.02) with a number needed to treat (NNT) of 123. All other outcomes did not reach statistical significance. In our analysis, there was no difference between TAVI with the Sentinel™ CPS compared to TAVI without TCEP in regard to risk of periprocedural stroke; however, it was associated with a decreased risk of periprocedural disabling stroke.

Safety and efficacy of cerebral embolic protection in transcatheter aortic valve implantation: an updated meta-analysis.

The use of cerebral embolic protection devices during transcatheter aortic valve implantation (TAVI) reveals conflicting data. This updated meta-analysis aims to evaluate the efficacy and safety of the SENTINEL Cerebral Protection System. A literature search for relevant studies up to September 2022 was performed. Study outcomes were divided based on time period - overall (up to 30 days) and short (≤7 days). The outcomes studied include stroke (disabling, non-disabling), mortality, neuroimaging findings, transient ischaemic attack, acute kidney injury and major vascular and bleeding complications. A total of 15 studies involving 294,134 patients were included. Regarding overall outcomes, significant reductions were noted for mortality (odds ratio [OR] 0.60, 95% confidence interval [CI]: 0.41-0.88; p=0.008), all stroke (OR 0.64, 95% CI: 0.46-0.88; p=0.006) and disabling stroke (OR 0.42, 95% CI: 0.23-0.74; p=0.003) using the SENTINEL device. No significant differences were noted for other outcomes. There was significant heterogeneity across the studies for mortality (p=0.013) and all stroke (p=0.003). Including only randomised data (n=4), there was only significant reduction in the incidence of disabling stroke (OR 0.39, 95% CI: 0.17-0.89; p=0.026) in the SENTINEL group. In studies reporting ≤7-day outcomes (n=8), use of the SENTINEL device demonstrated significantly lower rates of all stroke (p<0.001), disabling stroke (p<0.001) and major bleeding complications (p=0.02). No differences in neuroimaging outcomes were noted. In this updated meta-analysis, use of the SENTINEL Cerebral Protection System was associated with lower rates of mortality, all stroke and disabling stroke, although significant heterogeneity was noted for mortality and all stroke. Including exclusively randomised data, there was only significant reduction in the incidence of disabling stroke. No significant adverse outcomes with device use were noted.

Cerebral embolic protection with filters and an occlusion balloon catheter during transcatheter aortic valve replacement

Cerebral embolic protection with filters and an occlusion balloon catheter during transcatheter aortic valve replacement

Cerebral Protection in Trans-Catheter Aortic Valve Replacement: Review and Contemporary Assessment of Randomized Trial Data.

As the population has aged and as aortic valve therapies have evolved, the use of trans-catheter aortic valve replacement (TAVR) has grown dramatically over the past decade. A well-known complication of percutaneous cardiac intervention is embolic phenomena, and TAVR is among the highest risk procedures for clinical and subclinical stroke. As indications for TAVR expand to lower-risk and ultimately younger patients, the long-term consequences of stroke are amplified. Cerebral embolic protection (CEP) devices have taken a on unique preventative role following the Food and Drug Administration approval of the SentinelTM Cerebral Protection System (CPS). More recently, the PROTECTED TAVR study has spurred extensive debate in the neuro-cardiac community. In this review we describe the contemporary literature regarding stroke risk associated with TAVR, the history and role of CEP devices, a PROTECTED TAVR sub-group analysis, and implications for next steps in the field. Lastly, we explore the unique need for CEP in a younger TAVR population, as well as directions for future research.