Embolic Protection Devices Research Articles

Embolic protection devices for carotid artery stenting: A network meta-analysis.

Carotid artery stenting (CAS) is an alternative treatment option for patients at high risk for carotid endarterectomy (CEA) but has been correlated with increased risk for distal embolization and periprocedural stroke despite the use of adjunctive embolic protection devices (EPD). This study compared four types of EPDs and their intra and periprocedural related complications. A systematic review of the literature was conducted in PubMed/Medline to identify studies that investigated the outcomes of CAS with adjuvant use of EPDs, including Proximal Balloon (PB), Distal Filter (DF), and Distal Balloon (DB) strategy. Continuous flow reversal performed via transcarotid approach by a commercially available device as an embolic protection strategy was intentionally excluded based on its distinct procedural characteristics and lack of availability outside of the United States. This network meta-analysis was performed according to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Overall, 45 studies, consisting of 7600 participants satisfied the predetermined search criteria and were included in this network meta-analysis. Overall, 13 studies provided data regarding the number of patients with new ischemic lesions detected in the DW-MRI. DF (OR: 3.15; 95% CI: 1.54-6.44; p = 0.002) and DB (OR: 2.28; 95% CI: 1.58-3.29; p < 0.001) were associated with higher odds of new ischemic lesions compared to PB on DW-MRI imaging. No statistical difference was identified between DB versus DF groups (OR: 1.48; 95% CI: 0.73-2.59; p = 0.317). 36 and 27 studies reported on periprocedural stroke and transient ischemic attack (TIA) rates, respectively, showing similar odds of neurologic adverse events between all three groups. PB deployment during CAS is superior to DF and DB in preventing distal embolization phenomena. However, no statistically significant difference in TIA and stroke rate was found among any of the analyzed EPD groups. Further research is warranted to investigate the association of embolic phenomena on imaging after CAS with clinically significant neurologic deficits.

Abstract 13412: Updated Meta-Analysis on Safety and Efficacy of Cerebral Embolic Protection Devices Among Patients Undergoing Transcatheter Aortic Valve Replacement

Introduction: Cerebral embolic protection devices (CEP) have been introduced to capture embolic debris and reduce the risk of stroke during Transcatheter Aortic Valve Replacement (TAVR). Available evidence regarding the safety and efficacy of CEP is inconclusive. Therefore, we aimed to determine the safety and efficacy of CEP use during TAVR. Methods: Major electronic databases were searched for the relevant articles with appropriate search terms. All relevant data from 17 studies were extracted into a standardized form. Statistical analyses were performed using Revman 5.4. Odds Ratio (OR) or mean differences (MD) were used to estimate the desired outcome with a 95% confidence interval (CI). Results: A total of 17 studies involving 204,875 patients (15,880 in the CEP arm and 188,995 in the non-CEP arm) were included. No significant difference in 30-day stroke was observed with the use of CEP between the two groups (OR 0.75, 95% CI 0.55 to 1.03). The use of CEP was associated with a lower odds of 30-day mortality by 39% (OR 0.61, 95% CI 0.53 to 0.70). Based on diffusion weighted-magnetic resonance imaging (DW-MRI), there were no differences in the occurrence of new lesions, the total volume of lesions, and the number of new lesions. In addition, the use of CEP in patients undergoing TAVR was associated with a reduction in major or life-threatening bleeding events (OR 0.89, 95% CI 0.81 to 0.98). No differences were observed in the outcomes of acute kidney injury and major vascular complications between both arms. Conclusion: No significant difference in 30-day stroke was observed with the use of CEP in TAVR patients. The use of CEP was associated with significantly lower odds of 30-day mortality and lower rates of major or life-threatening bleeding compared with no CEP in patients undergoing TAVR. Further studies are needed to confirm current findings

A balloon-supported embolism protection technique during vertebral/subclavian artery angioplasty stenting.

A balloon-supported embolism protection technique during vertebral/subclavian artery angioplasty stenting.

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

Feasibility of Sentinel Cerebral Embolic Protection Device Deployment During Transfemoral Transcatheter Aortic Valve Replacement

Cerebral embolic protection has emerged as a preventive measure for procedural stroke in transcatheter aortic valve replacement (TAVR).1 The Sentinel System (Boston Scientific Corp. Boston, Massachusetts), a 2-filter debris-capturing system, has been the only commercially available protection device in the United States since its approval by the Food and Drug Administration in 2017. In the Sentinel trial, the largest randomized trial (n = 363) so far, the device was successfully deployed in 94.7% of patients.

Drug-Coated Balloon Angioplasty for Carotid Artery In-Stent Restenosis: Case Series

Objectives: Few case reports have demonstrated promising results of drug-coated balloons (DCBs) as an emerging management for carotid artery in-stent restenosis (CAISR). Herein, we report 6 cases of CAISR which were treated with a DCB with or without new stent deployment. Background: Carotid artery in-stent restenosis is a high-risk condition with an estimated incidence rate that varies widely from 6% to 40%. Several strategies are available now for the management of the CAISR including conventional balloon angioplasty, plaque modification balloon angioplasty, and new stent placement. Methods: A retrospective review of consecutive patients with a diagnosis of severe CAISR at Baylor Scott & White The Heart Hospital Plano from 2011 to 2021 was performed. This study was approved by the Baylor Scott & White Research Institute institutional review board. Results: Six patients underwent DCB angioplasty with or without stent placement under an embolic protection device. Resolution of CAISR was achieved in all cases with 0% to 10% residual stenosis in all cases. Following the procedure, 1 patient had a brief episode of syncope with balloon inflation with immediate recovery on deflation of the balloon. There were otherwise no significant neurological or cardiac events prior to discharge. All patients were asymptomatic at their follow-up visit with no neurological or cardiac events reported at 12, 24, and 36 months following the procedure. Conclusion: While CAISR treatment remains a challenging condition, our study shows that the use of DCB with or without stent placement is a feasible and promising treatment option when compared with other conventional treatment options. Clinical Impact Carotid artery in-stent restenosis treatment remains a challenging condition. Our study shows that the use of drug coated balloon with or without stent placement is a feasible and promising treatment option when compared with current conventional treatment options.

New Distal Balloon Protection System for Transradial Carotid Artery Stenting After Percusurge Guardwire Withdrawal: Jailbreak Technique

Embolic protection devices are commonly used to prevent cerebral embolism during carotid artery stenting (CAS). However, the PercuSurge Guardwire device, a distal balloon protection device, was discontinued in April 2021. We present a case of successful CAS using a new distal balloon protection system. The procedure, referred to as the jailbreak technique, was performed via transradial access. A 67-year-old man underwent CAS, using the jailbreak technique, for right carotid stenosis with a vulnerable plaque. 6-French (Fr) and 4-Fr Simmons guiding sheaths were delivered into the right common carotid artery via the right and left transradial access, respectively. Distal balloon protection was provided using a 2.6-Fr dual-lumen balloon microcatheter (Pinnacle Blue 20, Tokai Medical Products, Aichi, Japan) via the 4-Fr Simmons guiding sheath. A 4.2-Fr catheter was coaxially delivered proximal to the balloon and distal to the lesion. After CAS was successfully performed via the 6-Fr Simmons guiding sheath, the Pinnacle Blue 20 was retrieved through the 4.2-Fr catheter without interfering with the distal stent flare and stent struts. Postprocedural neuroimaging revealed no evidence of ischemic stroke. The jailbreak technique allows distal balloon protection during transradial CAS. This is a useful treatment option for patients with carotid stenosis.

The safety and efficacy of the Mo.Ma system device for carotid artery stenting: A single-center experience from Taiwan.

BackgroundProximal protection devices, such as the Mo.Ma system provides better neurological outcomes than the distal filter system in the carotid artery stenting (CAS) procedure. This study first evaluated the safety and efficacy of the Mo.Ma system during CAS in a single tertiary referral hospital from Taiwan. The outcomes of distal vs. proximal embolic protection devices were also studied.MethodsA total of 294 patients with carotid artery stenosis who underwent the CAS procedure were retrospectively included and divided into two groups: 152 patients in the distal filter system group and 142 patients in the Mo.Ma system. The outcomes of interest were compared between the two groups. The factors contributing to occlusion intolerance (OI) in the Mo.Ma system were evaluated.ResultsThe procedure success rates were more than 98% in both groups. No major stroke occurred in this study. The minor stroke rates were 2.8% (4/142) and 4.6% (7/152) in the Mo.Ma system and filter system, respectively (p = 0.419). Patients with hypoalbuminemia significantly predicted the risk of stroke with an odds ratio of 0.08 [95% confidence interval (CI), 0.01–0.68, p = 0.020] per 1 g/day of serum albumin in the filter group. A total of 12 patients developed OI in the Mo.Ma system (12/142, 8%). Low occlusion pressure predicted the occurrence of OI in the Mo.Ma group with the hazard ratios of 0.88 (95% CI: 0.82–0.96) and 0.90 (95% CI: 0.84–0.98) per 1 mmHg of occlusion systolic pressure (OSP) and diastolic pressure (ODP), respectively. We further indicated that patients with an OSP of ≥60 mmHg or an ODP of ≥44 mmHg could tolerate the procedure of occlusion time up to 400 s, while patients with an OSP of <49 mmHg or an ODP of <34 mmHg should undergo the procedure of occlusion time less than 300 s to prevent the occurrence of OI.ConclusionWe have demonstrated the safety and effectiveness of the Mo.Ma system during CAS in an Asia population. By reducing the occlusion time, our study indicated a lower risk of OI in the Mo.Ma system and proposed the optimal occlusion time according to occlusion pressure to prevent OI during the CAS procedure. Further large-scale and prospective studies are needed to verify our results.

Hybrid surgery versus endovascular intervention for patients with chronic internal carotid artery occlusion: A single-center retrospective study.

ObjectiveChronic internal carotid artery occlusion (CICAO) can cause transient ischemic attack (TIA) and ischemic stroke. Carotid artery stenting (CAS) with embolic protection devices and hybrid surgery combining carotid endarterectomy and endovascular treatment are effective methods for carotid revascularization. The objective of this study was to evaluate and compare the effect and safety of the two surgical procedures.MethodsThis was a single-center retrospective study. In this study, 44 patients who underwent hybrid surgery and 35 who underwent endovascular intervention (EI) at our center were enrolled consecutively between May 2016 and March 2022. All patients were classified into four groups (A-D), as described by Hasan et al. We recorded and analyzed clinical data, angiographic characteristics, technical success rate, perioperative complications, and follow-up data.ResultsThere was no significant difference in baseline characteristics between hybrid surgery group and EI group, except for plasma high density lipoproteins (HDL) levels (median [interquartile range]: hybrid surgery, 0.99 [0.88–1.18] vs. EI, 0.85 [0.78–0.98] mmol/L, P = 0.001). The technical success rate of hybrid surgery was higher than that of EI (37/44 [84.1%] vs. 18/35 [51.4%], P = 0.002; type A: 15/16 [93.8%] vs. 10/11 [90.9%], P = 1.000; type B: 9/10 [90.0%] vs. 5/7 [71.4%], P = 0.537; type C: 12/15 [80.0%] vs. 3/12 [25.0%], P = 0.004; type D: 1/3 [33.3%] vs. 0/5 [0%], P = 0.375). No significant difference was observed in the incidence of perioperative complications between the two procedures (hybrid surgery: 7/44 [15.9%] vs. EI: 6/35 [17.1%], P = 0.883). In addition, there were no significant differences in the rates of stroke and restenosis during follow-up.ConclusionsFor patients with symptomatic CICAO, hybrid surgery may have an advantage over EI in successfully recanalizing occluded segments. There was no significant difference in safety and restenosis between hybrid surgery and EI.

TCT-329 Cerebral Embolic Protection Devices for Prevention of Post-Procedural Ischemic Stroke With Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

TCT-329 Cerebral Embolic Protection Devices for Prevention of Post-Procedural Ischemic Stroke With Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

TCT-324 Cerebral Embolic Protection Devices and Outcomes of Transcatheter Aortic Valve Replacement: Insight From National Readmission Database 2017-2019

TCT-324 Cerebral Embolic Protection Devices and Outcomes of Transcatheter Aortic Valve Replacement: Insight From National Readmission Database 2017-2019

TCT-327 Clinical and Radiographic Measures of Stroke-Related Outcomes With Cerebral Embolic Protection Devices During TAVR: A Meta-Analysis

TCT-327 Clinical and Radiographic Measures of Stroke-Related Outcomes With Cerebral Embolic Protection Devices During TAVR: A Meta-Analysis

Protected carotid artery stenting in patients with severe stenosis.

Intraplaque hemorrhage (IPH) and ulcers are the major findings of unstable plaques. In addition, initial symptoms are associated with postprocedural complications after carotid artery stenting (CAS). The aim of this study was to determine the safety of CAS using an embolic protection device in symptomatic patients with severe carotid artery stenosis and unstable plaques such as IPH and ulcers.This retrospective study included 140 consecutive patients with severe carotid stenosis. These patients underwent preprocedural carotid vessel wall imaging to evaluate the plaque status. We analyzed the incidence of initial clinical symptoms, such as headache, nausea, and vomiting, after CAS. The primary outcomes analyzed were the incidence of stroke, myocardial infarction, and death within 30 days of CAS.Sixty-seven patients (47.9%) had IPH, and 53 (38.9%) had ulcers on carotid wall imaging/angiography. Sixty-three patients (45.0%) had acute neurological symptoms with positive diffusion-weighted image findings. Intraluminal thrombi on initial angiography and flow arrest during CAS were significantly higher in patients with IPH and symptomatic patients. Symptoms were significantly higher in patients with IPH than in those without (63.5% vs 35.1%, P < .001). There were no significant differences in clinical symptoms after stenting or in primary outcomes, regardless of IPH, ulcer, or initial symptoms.IPH and plaque ulceration are risk factors in symptomatic carotid stenosis. However, IPH and plaque ulceration were not a significant risk factors for cerebral embolism during protected carotid artery stent placement in patients with carotid stenosis. Protected CAS might be feasible and safe despite the presence of unstable plaques.

Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use

In the setting of uncertain efficacy and additional, unreimbursed cost, use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) has had variable uptake. The Centers for Medicare & Medicaid Services (CMS) instituted a new technology add-on payment to cover EPD use in October 2018. To evaluate the association between CMS TAVR reimbursement rates and EPD use. This cohort study used the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry to identify patients who underwent TAVR between January 2018 and September 2019. Analysis took place between July 2020 and February 2022. The association between EPD use and CMS reimbursement was assessed using multivariable logistic regression models adjusted for patient characteristics (model 1) and patient/hospital (annualized TAVR volume and teaching status) characteristics (model 2). Among 511 institutions, CMS reimbursement for TAVR ranged from $28 062 to $111 280 with a median (IQR) of $45 884 ($40 331-$53 627). Among 84 353 patients (median [IQR] age, 81.0 [75.0-86.0] years; 46 247 male individuals [54.8%]; 3958 [4.7%] of Hispanic or Latino ethnicity; 78 170 White individuals [92.7%]) treated at the sites, 6012 (7.1%) underwent TAVR with EPD. Patient characteristics associated with EPD use included prior stroke (adjusted odds ratio [aOR], 1.13 [95% CI, 1.00-1.27]; P = .048), female sex (aOR, 0.85 [95% CI, 0.78-0.93]; P < .001), hemodialysis (aOR, 0.52 [95% CI, 0.40-0.68]; P < .001), and shock (aOR, 0.62 [95% CI, 0.41-0.94]; P = .03). Higher CMS reimbursement up to $50 000 per TAVR was associated with greater likelihood of EPD use in model 1 (per $1000; aOR, 1.08 [95% CI, 1.01-1.16]; P = .02). However, this association was no longer apparent after adjusting for site characteristics (model 2; aOR, 1.03 [95% CI, 0.96-1.11]; P = .38). Higher TAVR volume was associated with increased EPD use (per 25 TAVRs; aOR, 1.15 [95% CI, 1.09-1.21]; P < .001). There was no significant change in the odds of EPD uptake before vs after institution of the CMS new technology add-on payment across tertiles of CMS TAVR reimbursement (Wald χ2 = 3.59; P = .17). EPD use during TAVR remains infrequent and is associated with multiple patient and site characteristics. While CMS reimbursement varies significantly across institutions, TAVR case volume, rather than CMS TAVR reimbursement or the CMS new technology add-on payment, appears to be the predominant factor associated with EPD use. Ongoing work is needed to understand the economic drivers that contribute to the association between procedural volume and EPD use.

Innovation’s Disjointed Path From Approval to Payment—The Case of Embolic Protection Devices for Transcatheter Aortic Valve Replacement

Innovation’s Disjointed Path From Approval to Payment—The Case of Embolic Protection Devices for Transcatheter Aortic Valve Replacement

Cerebral embolic protection and severity of stroke following transcatheter aortic valve replacement.

The cerebral embolic protection (CEP) device captures embolic debris during transcatheter aortic valve replacement (TAVR). However, the impact of CEP on stroke severity following TAVR remains unclear. Therefore, we aimed to examine whether CEP was associated with reduced severity of stroke following TAVR. This was a retrospective cohort study of 2839 consecutive patients (mean age: 79.2 ± 9.5 years, females: 41.5%) who underwent transfemoral TAVR at our institution between 2013 and 2020. We categorized patients into Sentinel CEP users and nonusers. Neuroimaging data were reviewed and the final diagnosis of a cerebrovascular event was adjudicated by a neurologist blinded to the CEP use or nonuse. We compared the incidence and severity (assessed by the National Institutes of Health Stroke Scale [NIHSS]) of stroke through 72 h post-TAVR or discharge between the two groups using stabilized inverse probability of treatment weighting (IPTW) of propensity scores. Of the eligible patients, 1802 (63.5%) received CEP during TAVR and 1037 (36.5%) did not. After adjustment for patient characteristics by stabilized IPTW, the rate of overall stroke was numerically lower in CEP users than in CEP nonusers, but the difference did not reach statistical significance (0.49% vs. 1.18%, p = 0.064). However, CEP users had significantly lower rates of moderate-or-severe stroke (NIHSS ≥ 6: 0.11% vs. 0.69%, p = 0.013) and severe stroke (NIHSS ≥ 15: 0% vs. 0.29%, p = 0.046). Stroke following CEP use (n = 8), compared with stroke following CEP nonuse (n = 15), tended to carry a lower NIHSS (median [IQR], 4.0 [2.0-7.0] vs. 7.0 [4.5-19.0], p = 0.087). Four (26.7%) out of 15 patients with stroke following CEP nonuse died within 30 days, with no death after stroke following CEP use. CEP use may be associated with attenuated severity of stroke despite no significant difference in overall stroke incidence compared with CEP nonuse. This finding is considered hypothesis-generating and needs to be confirmed in large prospective studies.

Neurological outcomes of transcatheter aortic valve implantation with or without cerebral embolic protection devices: A meta-analysis

IntroductionCerebral embolic protection devices (CEPDs) are designed to prevent embolization of debris during transcatheter aortic valve implantation (TAVI). Current evidence from randomized clinical trials (RCTs) and observational studies is controversial. AimsThe purpose of this meta-analysis was to study the influence of CEPDs on stroke, silent ischemic lesions and neurocognitive function. MethodsA systematic search was conducted including RCTs or adjusted observational studies comparing TAVI with or without CEPDs. Pooled odds ratios, risk ratios or standardized mean differences with 95% confidence intervals were calculated using the inverse of variance method. Risk of bias sensitivity analyses and meta regression for CEPD type were also conducted. ResultsFive RCTs and five adjusted observational studies were included (n= 159,865). Mean age of the patients was 81.1 (SD 1.04) years in CEPDs and 81 (SD 1.86) in non-CEPD. The overall quality of evidence using the GRADE system for each endpoint was low to very low, mainly due to serious risk of bias, inconsistency and imprecision. Random effects meta-analysis detected no significant differences between CEPD and non-CEPD (OR= 0.74; 95% CI 0.51-1.07; P= 0.105; I2= 82.1%) for 30-day stroke. This finding was consistent in meta regression for CEPD type and subgroup analyses by study type and CEPD type. No significant differences between groups were observed in cerebral DW-MRI assessment and neurocognitive function evaluation. ConclusionIn the present meta- analysis of five RCTs and five adjusted observational studies, the use of a CEPD during TAVI was not associated with a significant benefit on 30- day stroke, total lesion volume per patient, number of ischemic lesions per patient and neurocognitive function assessments.

Use of Carotid Embolic Protection Devices for Left Atrial Myxoma Resection in a Pediatric Patient

Use of Carotid Embolic Protection Devices for Left Atrial Myxoma Resection in a Pediatric Patient

Cerebral embolic protection in patients undergoing transcatheter aortic valve implantation: Recent advances.

Despite major advances in transcatheter aortic valve implantation (TAVI) technology during the last years, stroke remains one of the most serious complications of TAVI, tremendously increasing mortality and the loss of neurocognitive function. Since TAVI is expected to further spread into lower-risk patient groups, there will be greater emphasis to obviate such serious complications. One possible technique for preventing stroke is using cerebral embolic protection devices (CEPDs). CEPDs are designed for capturing or deflecting emboli that are en route to the brain and hence to protect the brain from embolism. Although their clinical utilization is increasing, the evidence for using CEPDs is not yet clear. Since this is a rapidly growing field with recent advances, and the impact of CEPD on preventing neurological events is still limited, there is an urgent need for understanding the role of CEPD in preventing clinically significant strokes. In this review, we present an overview of the available literature on CEPDs in patients undergoing TAVI and outline recent advances within this field.

Clinical Predictors for Procedural Stroke and Implications for Embolic Protection Devices during TAVR: Results from the Multicenter Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) Study.

Background: Data to support the routine use of embolic protection devices for stroke prevention during transcatheter aortic valve replacement (TAVR) are controversial. Identifying patients at high risk for peri-procedural cerebrovascular events may facilitate effective patient selection for embolic protection devices during TAVR. Aim: To generate a risk score model for stratifying TAVR patients according to peri-procedural cerebrovascular events risk. Methods and results: A total of 8779 TAVR patients from 12 centers worldwide were included. Peri-procedural cerebrovascular events were defined as an ischemic stroke or a transient ischemic attack occurring ≤24 h from TAVR. The peri-procedural cerebrovascular events rate was 1.4% (n = 127), which was independently associated with 1-year mortality (hazards ratio (HR) 1.78, 95% confidence interval (CI) 1.06–2.98, p < 0.028). The TASK risk score parameters were history of stroke, use of a non-balloon expandable valve, chronic kidney disease, and peripheral vascular disease, and each parameter was assigned one point. Each one-point increment was associated with a significant increase in peri-procedural cerebrovascular events risk (OR 1.96, 95% CI 1.56–2.45, p < 0.001). The TASK score was dichotomized into very-low, low, intermediate, and high (0, 1, 2, 3–4 points, respectively). The high-risk TASK score group (OR 5.4, 95% CI 2.06–14.16, p = 0.001) was associated with a significantly higher risk of peri-procedural cerebrovascular events compared with the low TASK score group. Conclusions: The proposed novel TASK risk score may assist in the pre-procedural risk stratification of TAVR patients for peri-procedural cerebrovascular events.