The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR.

BACKGROUND: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention. OBJECTIVES: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+). METHODS: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups. RESULTS: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively. CONCLUSIONS: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.

Fabrication of a monorail-type diagnostic catheter for rescue retrieval technique of a distal embolic protection device.

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

Role of Cerebral Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement: An Updated Meta-Analysis.

BACKGROUND: Cerebral embolic protection devices (CEPD) capture embolic material in an attempt to reduce ischemic brain injury during transcatheter aortic valve replacement. Prior reports have indicated mixed results regarding the benefits of these devices. With new data emerging, we performed an updated meta-analysis examining the effect of CEPD during transcatheter aortic valve replacement on various clinical, neurological, and safety parameters. METHODS AND RESULTS: A comprehensive review of electronic databases was performed comparing CEPD and no-CEPD in transcatheter aortic valve replacement. Primary clinical outcome was all-cause stroke. Secondary clinical outcomes were disabling stroke and all-cause mortality. Neurological outcomes included worsening of the National Institutes of Health Stroke Scale score, Montreal Cognitive Assessment score from baseline at discharge, presence of new ischemic lesions, and total lesion volume on neuroimaging. Safety outcomes included major or minor vascular complications and stage 2 or 3 acute kidney injury. Seven randomized controlled trials with 4016 patients met the inclusion criteria. There was no statistically significant difference in the primary clinical outcome of all-cause stroke; secondary clinical outcomes of disabling stroke, all-cause mortality, neurological outcomes of National Institutes of Health Stroke Scale score worsening, Montreal Cognitive Assessment worsening, presence of new ischemic lesions, or total lesion volume on diffusion-weighted magnetic resonance imaging between CEPD versus control groups. There was no statistically significant difference in major or minor vascular complications or stage 2 or 3 acute kidney injury between the groups. CONCLUSIONS: The use of CEPD in transcatheter aortic valve replacement was not associated with a statistically significant reduction in the risk of clinical, neurological, and safety outcomes.

TriGuard Embolic Protection Device in percutaneous cardiac interventions with intracavitary cardiac thrombosis: A case series.

Embolic cerebral protection devices are not routinely used in clinical practice during electrophysiological interventions. We report a case series of patients with intracardiac thrombosis undergoing a percutaneous left atrial appendage (LAA) closure and a ventricular tachycardia (VT) catheter ablation supported by TriGuard 3 Cerebral Embolic Protection Device.

Cerebral embolic protection during transcatheter stent expansion of restrictive extra-cardiac Fontan conduit.

We report a 20-year-old female patient (76 Kg/164 cm) with an extra-cardiac Fontan circulation who was referred to our institution for exertional dyspnoea and desaturation. The patient was diagnosed with a large calcified thrombus at the level of the Fontan fenestration, protruding inside the lumen of the conduit and reducing the diameter by half with a 3 mmHg pressure gradient. Transcatheter stent expansion of the obstructed extra-cardiac conduit was done with a 48 mm long XXL PTFE-covered Optimus-CVS® under temporary cerebral embolic protection with a TriGUARD-3™ deflection filter device (Keystone Heart). There was no procedural complication and the 3 months clinical outcomes are good.

First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement.

BACKGROUND: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation. AIMS: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR. METHODS: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours. RESULTS: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients. CONCLUSIONS: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.

Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study.

Transcatheter aortic valve replacement (TAVR) generates significant debris, and strategies to mitigate cerebral embolization are needed. The novel Emboliner embolic protection catheter (Emboline, Inc., Santa Cruz, California) is designed to capture all particles generated during TAVR. This first-in-human study sought to assess the safety and feasibility of the device and to characterize the distribution and histopathology of the debris generated during TAVR. The SafePass 2 study was a prospective, nonrandomized, multicenter, single-arm investigation of the Emboliner device. Primary end points included 30-day major adverse cardiac and cerebrovascular events (MACCE) and technical performance. Computed tomography angiography was analyzed by an independent core laboratory, and filters were sent for histopathology of captured debris. Predictors of particle number were identified using >150 µm and >500 µm size thresholds. Of 31 subjects enrolled, technical success was 100%, and 30-day MACCE was 6.5% (2 cerebrovascular accidents, with 1 attributed to subtherapeutic dosing of rivaroxaban along with atrial fibrillation and the other to possible previous small ischemic strokes on magnetic resonance imaging; neither MACCE event had a causal relation to the Emboliner). All filters contained debris, with a median of 191.0 particles >150 µm and 14.0 particles >500 µm. Histopathology revealed mostly acute thrombus and valve or arterial tissue with lesser amounts of calcified tissue. A history of atrial fibrillation predicted a greater number of particles >500 µm (p = 0.0259) and its presence on admission was associated with 4.1 times more particles >150 µm (p = 0.0130) and 8.1 times more particles >500 µm (p = 0.0086). Self-expanding valves were associated with twice the number of particles >150 µm (p = 0.0281). TASK score was positively correlated with number of particles >500 µm (p = 0.0337). The Emboliner device was safe and feasible. Emboli after TAVR appear more numerous than previously documented. Atrial fibrillation, higher TASK score, and self-expanding valve use conferred higher embolic burden. Notably, none of the tested computed tomography angiography features were able to identify with higher embolic risk. Larger-scale studies are needed to identify high-risk patients for selective embolic protection device use.

Impact of Carotid Stent Design on Embolic Filter Debris Load During Carotid Artery Stenting.

BACKGROUND: The carotid stent design may influence the risk of embolization during carotid artery stenting. The aim of the study was to assess this risk by comparing the quantity of embolized material captured by filters during carotid artery stenting, using different stent designs. METHODS: We conducted a single-center retrospective study of patients undergoing carotid artery stenting for asymptomatic carotid stenosis >70% (2010-2022) in a tertiary academic hospital (Padua University Hospital, Italy). Carotid stents were classified according to their design as open-cell (OCS), closed-cell (CCS), or micromesh stents (MMS). A distal filter protection was used in all patients, and the amount of captured embolized particles was semiautomatically analyzed using a dedicated software (Image-Pro Plus, Media Cybernetics). Primary end point was embolic filter debris (EFD) load, defined as the ratio of the filter area covered by particulate material to the total filter area. Secondary end points were 30 days major stroke and death. RESULTS: Four-hundred-eighty-one carotid artery stentings were included; 171 (35%) using an OCS, 68 (14%) a CCS, and 242 (50%) a MMS. Thirty-days mortality was 0.2% (n=1) and major stroke rate was 0.2% (P=0.987). Filters of patients receiving MMS were more likely to be free from embolized material (OCS, 30%; CCS, 13%; MMS, 41%; P<0.001) and had a lower EFD load (OCS, 9.1±14.5%; CCS, 7.9±14.0%; MMS, 5.0±9.1%; P<0.001) compared with other stent designs. After stratification by plaque characteristics, MMS had a lower EFD load in cases of hypoechogenic plaque (OCS, 13.4±9.9%; CCS, 10.9±8.7%; MMS, 6.5±13.1%; P<0.001), plaque length>15 mm (OC, 10.2±15.3; CC, 8.6±12.4; MM, 8.2±13.6; P<0.001), and preoperative ipsilateral asymptomatic ischemic cerebral lesion (OCS, 12.9±16.8%; CCS, 8.7±19.5%; MMS, 5.4±9.7%; P<0.001). After multivariate linear regression, use of MMS was associated with lower EFD load (P=0.038). CONCLUSIONS: The use of MMS seems to be associated with a lower embolization rate and EFD load, especially in hypoechogenic and long plaques and in patients with a preoperative evidence of asymptomatic ischemic cerebral lesion.

Cerebral embolic protection during transcatheter aortic valve replacement: a systematic review and meta-analysis of propensity score matched and randomized controlled trials using the Sentinel cerebral embolic protection device.

BACKGROUND: The Sentinel cerebral embolic protection device (CEP) aims to reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis of propensity score matched (PSM) and randomized controlled trials (RCT) investigating the effect of the Sentinel CEP to prevent strokes during TAVR. METHODS: Eligible trials were searched through PubMed, ISI Web of science databases, Cochrane database, and proceedings of major congresses. Primary outcome was stroke. Secondary outcomes included all-cause mortality, major or life-threatening bleeding, major vascular complications and acute kidney injury at discharge. Fixed and random effect models were used to calculate the pooled risk ratio (RR) with 95% confidence intervals (CI) and absolute risk difference (ARD). RESULTS: A total of 4066 patients from 4 RCTs (3'506 patients) and 1 PSM study (560 patients) were included. Use of Sentinel CEP was successful in 92% of patients and was associated with a significantly lower risk of stroke (RR: 0.67, 95% CI: 0.48-0.95, p = 0.02. ARD: -1.3%, 95% CI: -2.3 - -0.2, p = 0.02, number needed to treat (NNT) = 77), and a reduced risk of disabling stroke (RR: 0.33, 95% CI: 0.17-0.65. ARD: -0.9%, 95% CI: -1.5 - -0.3, p = 0.004, NNT = 111). Use of Sentinel CEP was associated with a lower risk of major or life-threatening bleeding (RR: 0.37, 95% CI: 0.16-0.87, p = 0.02). Risk for nondisabling stroke (RR: 0.93, 95% CI: 0.62-1.40, p = 0.73), all-cause mortality (RR: 0.70, 95% CI: 0.35-1.40, p = 0.31), major vascular complications (RR: 0.74, 95% CI: 0.33-1.67, p = 0.47) and acute kidney injury (RR: 0.74, 95% CI: 0.37-1.50, p = 0.40) were similar. CONCLUSIONS: The use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.

Cerebral embolic protection during transcatheter aortic valve replacement: Insights from a consecutive series with the Sentinel cerebral protection device.

BACKGROUND: Growing interest in neuroprotection in transcatheter aortic valve replacement (TAVR) has catalyzed the development of cerebral protection systems (CPS). OBJECTIVES: Report insights from consecutive real-world patients undergoing TAVR with the Sentinel-CPS. METHODS: Patients with severe aortic stenosis undergoing TAVR from April 2019 to May 2022 were enrolled in a prospective registry. The reason for unsuccessful Sentinel-CPS deployment and the amount of debris captured by the filters were prospectively recorded. RESULTS: The Sentinal CPS was successfully deployed in 330 patients (85%, Group 1). Deployment was not attempted, unsuccessful or only partially successful in 59 patients (15%, Group 2), caused by anatomical factors such as tortuosity, heavy calcification or small dimensions of radial or brachial artery in 46, technical aspects such as puncture failure or dissection in 5 or use of right radial access for the pigtail in 6. Debris was captured in 98% of patients in Group 1. In 40%, the amount of debris was graded moderate or extensive. Predictors for moderate/extensive debris were moderate/severe aortic calcification (OR 1.50, CI 1.05-2.15, p = 0.03), pre- and postdilatation (OR 1.97, CI 1.02-3.79, p = 0.04 and OR 1.71, CI 1.01-2.89, p = 0.048). The risk of stroke was numerically lower in patients who underwent TAVR with the Sentinel CPS (2.1 vs. 5.1%, respectively, p = 0.15). There was no stroke during CPS deployment, but one patient had a stroke immediately after device retrieval. CONCLUSIONS: The Sentinel-CPS was successfully deployed in 85% of patients. Predictors for moderate/extensive debris captured were moderate/severe aortic calcification, pre- and postdilatation.

[Carotid Artery Stenosis:Endovascular Techniques and Devices].

The increase in the number of carotid artery stenting cases can be attributed to a decrease in complications owing to the evolution of devices. In this procedure, the choice of the protection device and stent for each case is the main concern. Embolic protection devices(EPD)that prevent distal embolization can be divided into proximal and distal types. Previously, balloon-type devices were used as distal EPDs; however, since they are no longer available, filter-type devices are now mainstream. Carotid stents are also divided into open- and closed-cell types. Therefore, this review describes the characteristics of each device in the actual cases at our hospital.

Utility of Cerebral Embolic Protection Devices in Transcatheter Procedures: A Systematic Review and Meta-Analysis.

With the emergence of the largest randomized control trial to date-the Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) study-we sought to conduct an updated meta-analyses to evaluate the utility of CEP devices on both clinical outcomes and neuroimaging parameters. Electronic databases were queried through November 2022 for clinical trials comparing the utility of Cerebral Embolic Protection (CEP) devices in Transcatheter Aortic Valve Replacement (TAVR) with non-CEP TAVR procedures. Meta-analyses were performed using the generic inverse variance technique, and a random-effects model, and results are presented as weighted mean differences (WMD) for continuous outcomes, and hazard ratios (HR) for dichotomous outcomes. Outcomes of interest included stroke, disabling stroke, nondisabling stroke, bleeding, mortality, vascular complications, new ischemic lesions, acute kidney injury (AKI), and total lesion volume. Thirteen studies (8 RCTs, 5 observational studies) consisting of 128,471 patients were included in the analysis. Results from our meta-analyses showed a significant reduction in stroke (OR: 0.84 [0.74-0.95]; P < 0.01; I2 = 0%), disabling stroke (OR: 0.37 [0.21-0.67]; P < 0.01; I2 = 0%) and bleeding events (OR: 0.91 [0.83-0.99]; P = 0.04; I2 = 0%) through CEP device use in TAVR. The use of CEP devices had no significant impact on nondisabling stroke (OR: 0.94 [0.65-1.37]; P < 0.01; I2 = 0%), mortality (OR: 0.78 [0.53-1.14]; P < 0.01; I2 = 17%), vascular complications (OR: 0.99 [0.63-1.57]; P < 0.01; I2 = 28%), AKI (OR: 0.78 [0.46-1.32]; P < 0.01; I2 = 0%), new ischemic lesions (MD: -1.72 [-4.01, 0.57]; P < 0.001; I2 = 95%) and total lesion volume (MD: -46.11 [-97.38, 5.16]; P < 0.001; I2 = 81%). The results suggest that CEP device use was associated with a lower risk of disabling stroke and bleeding events in patients undergoing TAVR.

Procedural embolic protection strategies for carotid artery stenting: current status and future prospects.

INTRODUCTION: Carotid artery angioplasty and stenting (CAS) is an established procedure to treat carotid artery stenosis for either primary or secondary prevention of stroke. Randomized clinical trials have shown an increased risk of periprocedural cerebrovascular events with CAS compared with carotid endarterectomy (CEA). Several strategies have been proposed to mitigate this risk, including alternative vascular access site, proximal/distal embolic protection devices, and dual-layer stents, among others. AREAS COVERED: This review provides a general overview of current embolic protection strategies for CAS. The phases of the procedure which can affect the early risk of stroke and how to reduce it with novel techniques and devices have been discussed. EXPERT OPINION: Innovations in device technologies have dramatically improved the safety and efficacy of CAS. To minimize the gap with surgery, a thorough, patient-oriented approach should be pursued. Endovascular technologies and techniques should be selected on an individual basis to address unique lesion characteristics and vascular anatomies. Meticulous pre-procedural planning, both clinical and anatomical, is needed to assess the embolic risk of each procedure. Only by having an in-depth understanding of the wide range of available endovascular devices and techniques, the operator will choose the most appropriate strategy to optimize CAS results.

Clinical Outcome of Transcatheter Aortic Valve Replacement With TriGUARD 3™ Cerebral Embolic Protection Device.

OBJECTIVE: Periprocedural stroke during transcatheter aortic valve replacement (TAVR) is a highly feared adverse event. The TriGUARD 3 cerebral embolic protection device (CEPD) may have the potential benefit of reduction of embolic events, but it still remains unclear whether it reduces the incidence of periprocedural stroke or transient ischemic attack (TIA). We aimed to investigate whether the latest TriGUARD 3 CEPD reduces the incidence of clinically overt stroke within 72 h or at discharge after TAVR. METHODS: In this prospective single-center study 117 patients (mean age 80.3 years, 53.8 % male) were included from July 2020 to December 2021. RESULTS: The primary efficacy endpoint of this study, periprocedural clinically overt stroke or TIA, within 72 h or at discharge after TAVR with the TriGUARD 3 CEPD occurred in 1/117 pts (0.8 %). Secondary endpoints (device related issues such as life-threatening or disabling bleeding, acute kidney injury, major vascular complications) were reported in 4/117 pts (3.4 %). CONCLUSIONS: This study suggests that the use of the latest TriGUARD 3™ CEPD in transfemoral TAVR seems to be associated with a low rate of clinically overt stroke and a low rate of device related adverse events, reflecting "real world" TAVR practice. However these results should be hypothesis generating and confirmed in a large RCT.