Cerebral Embolic Protection Devices Research Articles

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.

Mid-Term Results of an Italian Multicentric Experience with the RoadsaverTM Dual-Layer Carotid Stent System.

Carotid artery stenting (CAS) using first-generation single-layer stents is widely accepted as a good alternative to standard carotid endarterectomy (CEA) but it is associated with worse outcomes in terms of both plaque prolapse and cerebral embolization. To evaluate the perioperative and midterm outcomes of CAS using the new-generation RoadsaverTM dual-layer micromesh-covered carotid stent. Herein, we present the results of an observational, retrospective, multicentric study on non-consecutive patients who underwent the CAS procedure between January 2017 and December 2022 at three Italian, high-volume vascular surgery centers. The inclusion criteria were the patients' eligibility for the CAS procedure in accordance with the current Italian guidelines, and the implantation of a Roadsaver stent. Both symptomatic and asymptomatic patients were included in the study. The patients requiring reintervention for carotid restenosis following CEA were also included. Perioperative data regarding procedural success was defined as the successful implantation of the device in the desired position, less than 30% residual stenosis, and the absence of intraoperative neurological complications. The primary outcome was any adverse cerebrovascular event such as stroke or transient ischemic attack (TIA) during the procedure and/or after discharge. The secondary outcomes were the need for further intervention, and all-cause death following procedure. Three-hundred-fifty-three (353) patients were included in our study; the mean age was 74.3 years. A total of 5.9% of the patients were symptomatic on their operated side, while 7.3% had contralateral carotid occlusion. A cerebral embolic protection device (CPD) was employed in all patients. A total of 13.3% of the patients were operated on for restenosis after CEA Technical success was achieved in 96.9% of the cases with an intraoperative report of six TIAs (1.7%) and six ipsilateral strokes (1.7%). The mean hospital stay was 1.8 days. The thirty-day follow up showed one TIA and one more stroke. At the mean 35-month follow-up time, the primary outcome was present in six patients (1.7%), where four TIAs (1.1%) and two strokes (0.5%) were reported. Restenosis occurred in five patients (1.4%). Death for any cause was reported in 11 patients (3.1%). As most recent, high-quality studies show, the CAS procedure with second-generation devices such as the Roadsaver stent is safe and effective in preventing carotid-related cerebrovascular events in both symptomatic and asymptomatic patients. The intraoperative and postoperative cerebrovascular complication rate in high volume centers is very low, ensuring confidence in its employment for the CAS procedure along with a CPD as a valid alternative to CEA.

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.

Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis

ObjectivesThe use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis...

Effectiveness of Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement with High Aortic Valve Calcium Burden

Abstract Background The use of a cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR) has not been shown to be effective in preventing stroke in the PROTECTED-TAVR randomized controlled trial. However, whether CEPD may specifically benefit patients with high aortic valve calcium burden has not been studied. Purpose This study aimed to determine the effectiveness of CEPD in preventing cerebrovascular events during TAVR in patients with high aortic valve calcium scores (AVCS) (&amp;gt;2000 AU in men and &amp;gt;1300 AU in women) detected on baseline computed tomography. Methods We retrospectively analyzed 3505 patients who underwent transfemoral TAVR at a single center between 2016-2020 (Figure 1a). Baseline demographic, clinical, and procedural characteristics were stratified by CEPD use and AVCS (high vs. low). We performed Cox Proportional Hazards regression analysis to examine whether the use of CEPD in patients with high AVCS was associated with a lower rate of cerebrovascular events (stroke or transient ischemic attack) within 30 days (primary outcome) after adjusting for baseline characteristics. Results We stratified our study cohort into four subgroups: low AVCS without CEPD (n=1163), low AVCS with CEPD (n=633), high AVCS without CEPD (n=1081), and high AVCS with CEPD (n=628). Patients for whom CEPD was used in high AVCS group had lower prevalence of peripheral arterial disease compared with no CEPD use. Otherwise, there were no significant differences in the baseline characteristics between patients with and without CEPD in either the low or high AVCS subgroups (Table). In adjusted analysis, CEPD use (HR 1.30 [95% CI, 0.64-2.65)] or high AVCS (HR 1.16 [95% CI, 0.64-2.02)] were not associated with a decreased rate of primary outcome (Figure 1b). Conclusion This study indicates that CEPD use is not associated with lower cerebrovascular events after TAVR, even in patients with a high aortic valve calcium burden. Further research is needed to identify effective stroke prevention strategies for this patient population.Study design and Cox regression analysesBaseline Characteristics and Outcomes

Cerebral embolic protection in transcatheter aortic valve replacement with bicuspid aortic stenosis

Abstract Background In the PROTECTED-TAVR randomized controlled trial, use of cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR) did not reduce procedural stroke. It is, however, not clear whether certain high-risk subgroups like young patients with bicuspid aortic stenosis may derive benefit from CEPD. Purpose This study aimed to determine the effectiveness of CEPD in preventing cerebrovascular events during TAVR in patients with severe bicuspid aortic stenosis. Methods We retrospectively analyzed 3505 patients who underwent transfemoral TAVR at a single center between 2016-2020 and identified 257 patients with bicuspid aortic valve stenosis. Baseline demographic, clinical, and procedural characteristics were stratified by CEPD use. We performed Cox Proportional Hazards regression analysis to examine whether the use of CEPD in patients was associated with a lower rate of cerebrovascular events (stroke or transient ischemic attack) after adjusting for baseline characteristics. Results Among 257 patients receiving TAVR for bicuspid aortic stenosis, median age was 74.7 years (IQR 66.9 – 83.2 years) and 62.6% were men. There were no significant differences in the baseline demographic and clinical characteristics between patients with (n=94) and without CEPD (n=163) (Figure 1a). In univariate analysis, there was no significant difference in rates of stroke or transient ischemic attack in-hospital or at 30-days (Figure 1b). In adjusted analysis, CEPD use (HR 1.55 [95% CI, 0.1-3.8)] was not associated with a decreased rate of stroke or transient ischemic attack. Conclusion These findings indicate that CEPD use is not associated with lower rates of cerebrovascular events in patients with bicuspid aortic stenosis and add to the growing body of evidence that questions the utility of CEPD during TAVR.Baseline Characteristics

Cerebral embolic protection devices during transcatheter aortic valve implantation: a meta-analysis of randomised controlled trials

Abstract Background Stroke is a feared complication of transcatheter aortic valve implantation (TAVI), which may be mitigated by embolic protection devices (EPDs). Purpose We performed a systematic review and meta-analysis of randomised controlled trials (RCTs) to test the effect of EPDs in TAVI. Methods All RCTs comparing EPDs with control during TAVI were systematically identified. Pre-specified primary endpoints were all stroke, disabling stroke, non-disabling stroke and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. This study was prospectively registered. Results Eight trials randomising 4043 patients were included. There was no significant difference between EPDs and control for all stroke [RR 0.88, 95%CI 0.65–1.18, p=0.386, I2=0%], disabling stroke [RR 0.59, 95%CI 0.31–1.14, p=0.117, I2=0%], non-disabling stroke [RR 0.99, 95%CI 0.71–1.40, p=0.967, I2=0%] or all-cause mortality [RR 0.88, 95%CI 0.44–1.78, p=0.727, I2=0%]. There were no differences in safety endpoints of bleeding, vascular complications, or acute kidney injury. EPDs resulted in reduced cerebral lesion volume [SMD -0.55, 95%CI -0.91– -0.18, p=0.003, I2=63.6%], but no difference in number of patients with new lesions. The Sentinel EPD significantly reduced risk of disabling stroke [RR 0.42, 95%CI 0.20–0.88, p=0.022, I2=0%] but did not impact all stroke, non-disabling stroke or all-cause mortality. Conclusion The totality of randomised data for EPDs during TAVI demonstrated no safety concerns or significant differences in clinical endpoints, although total cerebral lesion volume was reduced. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.Effects of cerebral embolic protectionEffects of the Sentinel device

Cerebral Embolic Protection Device protects against stroke during Transcatheter Aortic Valve Replacement (TAVR): An Updated Meta-Analysis

Abstract Background Cerebral Embolic Protection Device (CEPD) is used to capture emboli during Transcatheter Aortic Valve Replacement (TAVR). Previous meta-analyses have yielded conflicting results regarding efficacy and safety of CEPD in TAVR. With recently published pivotal trial and multiple Cohort studies reporting new data, there is a need of re-calibration of available statistical evidence. Aims The aim of our study was to explore the effects of using CEPD on TAVR outcomes. Methods A systematic literature search was conducted across Pubmed, Cochrane, Embase, and clinicaltrials.gov from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR) while continuous outcomes were pooled using Standardized Mean Difference (SMD). Revman 5.4 was used to pool the data using random effects model With Mantel-Haenszel method. Subgroup analysis for study type (RCT vs NRS) was conducted. Sensitivity analysis using leave one out method and multiple exit method was conducted to find out, if unadjusted cohort studies had an impact on the pooled outcomes. Results The initial search revealed 870 articles. After primary and secondary screening, data was included from 17 studies (6 RCTs, 11 cohorts, n= 180187). Use of CEPD was associated with 50% reduced odds of stroke (OR=0.50, 95% CI=0.03-0.75, p=&amp;lt;0.01, I2=32%). There was no significant difference in 30 days mortality between the two groups (OR=0.76, 95% CI=0.44-1.31, p=0.33, I2=18%). On Diffusion Weighted Magnetic Resonance Imaging (DW-MRI), the two groups did not have any significant differences in volume per lesion (SMD=-0.07,CI=-0.28-0.14, p=0.52,I2=71%), Total volume of lesions (SMD=-0.08, p=0.73, CI=-0.53,0.17, I2=84%) and Number of lesions per patient (SMD=-0.15, p=0.45, CI=-0.23,0.10, I2=84%). On subgroup analysis, RCTs were found to have high heterogeneity while NRS had zero heterogeneity. The pooled analysis revealed no significant association with either of the group regarding Acute Kidney Injury (OR=0.84, p=0.43,I2=0%), risk of pacemaker implantation (OR=1.17,p=0.35,I2=0%), major bleed (OR=0.97,p=0.94,I2=62%), Worsening National Institute of Health Stroke Scale (NIHSS) (OR=0.46,p=0.36,I2=76%), and Vascular complications VC (OR=0.85,p=0.35,I2=0%). The results remained insignificant for subgroup analysis for study type and sensitivity analysis using leave one out and exit multiple methods for unadjusted cohort studies. Conclusion The use of CEPD during TAVR was found to be associated with reduced risk of stroke, however, there was no significant association with mortality, DW-MRI findings, AKI, major bleed, minor bleed, risk of pacemaker implantation, worsening NIHSS score and vascular complications. Further, large scale prospective trials are needed to provide definitive evidenceFig 1:Plots for mortality and strokeFig 2:Plots for VC and AKI

Abstract 15586: Efficacy and Safety of Cerebral Embolic Protection Devices in Transcatheter Aortic-Valve Replacement: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

Introduction: Transcatheter aortic-valve replacement (TAVR) has emerged as a viable alternative to surgical aortic-valve replacement for high-risk patients. However, the procedure carries a significant risk of cerebral embolism. Cerebral embolic protection (CEP) devices have been proposed to mitigate this risk, yet current evidence of their efficacy remains inconsistent. Hypothesis: This study aims to comprehensively evaluate the effectiveness and safety of CEP devices during TAVR. Methods: A systematic literature search was conducted in MEDLINE, EMBASE, and Scopus up to April 2023. Randomized controlled trials (RCTs) comparing TAVR with and without CEP were included. The study assessed total lesion volume using mean difference (MD), while stroke, mortality, bleeding and vascular complications, and new magnetic resonance imaging (MRI) detected lesions were evaluated with relative risk (RR); both were analyzed via random-effects models using R software (version 4.0.3) with the metafor and meta packages. Results: The meta-analysis incorporated five RCTs involving 3,845 patients (2,070 received CEP devices, and 1,775 served as a control). The pooled analysis showed a non-significant mean difference in total lesion volume of -14.43 (95% CI: -104.97 to 76.09, P=0.75, I2=90%), indicating that CEP devices did not significantly alter the total lesion volume. In terms of other outcomes, the use of CEP devices did not significantly reduce the risk of stroke (RR 0.86, 95% CI: 0.62 to 1.22, P=0.41, I2=0%), disabling stroke (RR 0.50, 95% CI: 0.24 to 1.04, P=0.06, I2=0%), overall mortality (RR 1.35, 95% CI: 0.59 to 3.12, P=0.48, I2=0%), life-threatening or major bleeding (RR 1.09, 95% CI: 0.37 to 3.22, P=0.88, I2=19%), vascular complications (RR 1.83, 95% CI: 0.80 to 4.19, P=0.15, I2=29%), or the occurrence of new lesions seen on MRI (RR 0.99, 95% CI: 0.93 to 1.06, P=0.78, I2=17%). Conclusions: The results indicate that CEP devices during TAVR did not significantly alter important clinical outcomes, challenging the presumed benefits of these devices. Owing to the limited number of studies and short follow-up periods, further large-scale RCTs with more sophisticated designs and longer follow-ups are needed to validate these results and inform future guidelines.

Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Replacement: A Meta-analysis of Randomized Controlled Trials.

Stroke is a feared complication of transcatheter aortic valve replacement (TAVR), which embolic protection devices (EPDs) may mitigate. This systematic review and meta-analysis synthesized randomized controlled trials (RCTs) to evaluate the effect of EPDs in TAVR. All RCTs comparing EPDs with control during TAVR were systematically identified. Prespecified primary end points were all stroke, disabling stroke, nondisabling stroke, and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. Study registration was a priori (CRD42022377939). Eight trials randomizing 4043 patients were included. There was no significant difference between EPDs and control for all stroke (relative risk [RR], 0.88; 95% CI, 0.65-1.18; P = .39; I2 = 0%), disabling stroke (RR, 0.67; 95% CI, 0.31-1.46; P = .32; I2 = 8.6%), nondisabling stroke (RR, 0.99; 95% CI, 0.71-1.40; P = .97; I2 = 0%), or all-cause mortality (RR, 0.87; 95% CI, 0.43-1.78; P = .71; I2 = 2.3%). There were no differences in safety end points of bleeding, vascular complications, or acute kidney injury. EPDs did not result in differences in total lesion volume or the number of new lesions. The Sentinel EPD significantly reduced the risk of disabling stroke (RR, 0.42; 95% CI, 0.20-0.88; P = .022; I2 = 0%) but did not affect all stroke, nondisabling stroke, or all-cause mortality. The totality of randomized data for EPDs during TAVR demonstrated no safety concerns or significant differences in clinical or neuroimaging end points. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.

Safety and efficacy of cerebral embolic protection devices for patients undergoing transcatheter aortic valve replacement: An updated meta‐analysis

AbstractBackground and AimsCerebral embolic protection (CEP) devices are employed to capture embolic debris and reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). Evidence is mixed regarding the safety and efficacy of CEP. We aimed to summarize the safety and effectiveness of CEP use during TAVR.MethodsElectronic databases, including PubMed, PubMed Central, Scopus, Cochrane Library, and Embase, were searched using relevant search terms for articles relating to CEP. All relevant data from 20 studies were extracted into a standardized form. Statistical analyses were performed using Revman 5.4. Odds ratio (OR) or mean differences (MDs) were used to estimate the desired outcome with a 95% confidence interval (CI).ResultsTwenty studies (eight randomized controlled trials [RCTs]) involving 210,871 patients (19,261 in the CEP group and 191,610 in TAVR without the CEP group) were included. The use of CEP was associated with a lower odds of 30‐day mortality by 39% (OR: 0.61, 95% CI: 0.53–0.70) and stroke by 31% (OR: 0.69, 95% CI: 0.52–0.92). Comparing devices, benefit in terms of mortality and stroke was observed with the use of the Sentinel device (Boston Scientific), but not among other devices. No differences were observed in the outcomes of acute kidney injury, major or life‐threatening bleeding events, or major vascular complications between groups. When only RCTs were included, there were no observed differences in the primary or secondary outcomes for CEP versus no CEP use during TAVR.ConclusionsThe totality of evidence suggests a net benefit for the use of CEP, weighted by studies in which the Sentinal device was used. However, given the RCT subanalysis, additional evidence is needed to identify patients at the highest risk of stroke for optimal decision‐making.

A Narrative Review on Periprocedural Stroke and Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) has become the treatment option for symptomatic severe aortic stenosis patients across all risk profiles. Despite remarkable advancements in technology and operator experience, the occurrence of periprocedural stroke remains a significant concern, predominantly attributed to thromboembolic events in the immediate postprocedural period. To optimize patient outcomes, various strategies have been developed to minimize the risk of stroke, encompassing comprehensive preprocedural planning, effective management of comorbidities, utilization of cerebral embolic protection devices, and tailored medical therapy. This comprehensive review summarizes the currently available strategies for mitigating periprocedural stroke post-TAVR and provides insights into future directions.

Site Variability in Cerebral Embolic Protection for Transcatheter Aortic Valve Implantation and Association With Outcomes

BackgroundThe effectiveness of CEPD in mitigating post-TAVI stroke remains uncertain, and therefore CEPD may be utilized differently across US hospitals. This study aims to characterize the hospital-level pattern of cerebral embolic protection device (CEPD) use during transcatheter aortic valve implantation (TAVI) in the United States and its association with outcomes. MethodsPatients treated with nontransapical TAVI in the 2019 Nationwide Readmissions Database were included. Hospitals were categorized as CEPD non-users and CEPD users. The following outcomes were compared: the composite of in-hospital stroke or transient ischemic attack (TIA), in-hospital ischemic stroke, death, and cost of hospitalization. Logistic regression models were used for risk adjustment of clinical outcomes. ResultsOf 41,822 TAVI encounters, CEPD was used in 10.6% (n = 4422). Out of 392 hospitals, 65.8% were CEPD non-user hospitals and 34.2% were CEPD users. No difference was observed between CEPD non-users and CEPD users in the risk of in-hospital stroke or TIA (adjusted odds ratio (OR) = 0.99 [0.86-1.15]), ischemic stroke (adjusted OR = 1.00 [0.85-1.18]), or in-hospital death (adjusted OR = 0.86 [0.71-1.03]). The cost of hospitalization was lower in CEPD non-users. ConclusionsTwo-thirds of hospitals in the US do not use CEPD for TAVI, and no significant difference was observed in neurologic outcomes among patients treated at CEPD non-user and CEPD user hospitals.

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

BackgroundThe 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.MethodsEligible 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).ResultsA 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.ConclusionsThe use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.

An Updated Meta-Analysis on Cerebral Embolic Protection in Patients Undergoing Transcatheter Aortic Valve Intervention Stratified by Baseline Surgical Risk and Device Type

BackgroundTranscatheter aortic valve intervention (TAVI) can lead to the embolization of debris. Capturing the debris by cerebral embolic protection (CEP) devices may reduce the risk of stroke. New evidence has allowed us to examine the effects of CEP in patients undergoing TAVI. We aimed to assess the effects of CEP overall and stratified by the device used (SENTINEL or TriGuard) and the surgical risk of the patients. MethodsWe selected randomized controlled trials using electronic databases through September 17, 2022. We estimated random-effects risk ratios (RR) with (95% confidence interval) and calculated absolute risk differences at 30 days across baseline surgical risks derived from the TAVI trials for any stroke (disabling and nondisabling) and all-cause mortality. ResultsAmong 6 trials (n = 3921), CEP vs. control did not reduce any stroke [RR: 0.95 (0.50-1.81)], disabling [RR: 0.75 (0.18-3.16)] or nondisabling [RR: 0.99 (0.65-1.49)] strokes, or all-cause mortality [RR: 1.23 (0.55-2.77)]. However, when analyzed by device, SENTINEL reduced disabling stroke [RR: 0.46 (0.22-0.95)], translating into 6 fewer per 1000 in high-risk, 3 fewer per 1000 in intermediate-risk, and 1 fewer per 1000 in low surgical-risk patients. CEP vs. control did not reduce the risk of any bleeding [RR: 1.03 (0.44-2.40)], major vascular complications [RR: 1.41 (0.57-3.48)], or acute kidney injury [RR: 1.36 (0.57-3.28)]. ConclusionsThis updated meta-analysis showed that SENTINEL CEP might reduce disabling stroke in patients undergoing TAVI. Patients with high and intermediate surgical risks were most likely to derive benefits.