Cerebral Embolic Protection Research Articles

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.

470 Robotic Transcranial Doppler With Artificial Intelligence for Real-Time Intraoperative Neuromonitoring During Endovascular Carotid Revascularization – A Novel and Autonomous Neuromonitoring Tool

INTRODUCTION: Real-time intraoperative neuromonitoring is crucial to account for cerebral blood flow and embolic protection offered by proximal and distal cerebral protection devices during carotid revascularization procedures. METHODS: All patients diagnosed with high-grade carotid stenosis were prospectively enrolled between October 2021 thru February 2022. The TCD Robot head-brace system was used to secure the patients head, and the robot calibrated to automatically identify ipsilateral MCA or the terminal ICA. Patient demographics and procedural characteristics relevant to the robotic system such as signal strength, time to find signal, intracranial depth of the relevant vessel, cerebral waveform, and emboli count were recorded for the 4 critical phases: i- Access to crossing the lesion, ii- Filter and balloon deployment, iii- Stent placement and implantation, and iv- Removal of delivery system. RESULTS: Eight patients were included in our study (6 males [75%]; mean age 71.5 ± 3.9). Six out of 8 patients were symptomatic with a mean diameter stenosis of 83.5 ± 4.1. Average time taken to find a stable signal was 62 seconds (Range: 10-122). Terminal ICA was the vessel identified in all cases with a mean depth of 64mm (Range: 59-71). Flow arrest was demonstrated in all cases with flow reversal demonstrated in 2. Mean duration for the TCD Robotic surveillance was 23.6 ± 0.9 minutes with an average of 117 distal emboli (Range: 45-143) recorded by the device. Linear regression model identified stent placement and implantation as statistically significant (P = 0.0419) contributor to the final emboli count. CONCLUSIONS: To our knowledge, this is the first case series of real-time comprehensive neuromonitoring using a Robotic Transcranial Doppler system with Artificial Intelligence demonstrating various cerebral blood flow parameters including flow arrest and distal embolic incidence intra-operatively.

Cerebral Embolic Protection Devices: Current State of the Art.

Transcatheter aortic valve replacement (TAVR) has become a first-line treatment for severe aortic stenosis with intermediate to high-risk population with its use increasingly expanding into younger and low-risk cohorts as well. Cerebrovascular events are one of the most serious consequential complications of TAVR, which increase morbidity and mortality. The most probable origin of such neurological events is embolic in nature and the majority occur in the acute phase after TAVR when embolic events are most frequent. Cerebral embolic protection devices have been designed to capture or deflect these emboli, reducing the risk of peri-procedural ischaemic events. They also carry the potential to diminish the burden of new silent ischemic lesions during TAVR. Our review explores different types of these device systems, their rationale, and the established clinical data.

Iatrogenic Strokes and Covert Brain Infarcts After Percutaneous Cardiac Procedures: An Update.

Millions of cardiac procedures are performed worldwide each year, making the potential complication of periprocedural iatrogenic stroke an important concern. These strokes can occur intraoperatively or within 30 days of a procedure and can be categorised as either overt or covert, occurring without obvious acute neurologic symptoms. Understanding the prevalence, risk factors, and strategies for preventing overt and covert strokes associated with cardiac procedures is imperative for reducing periprocedural morbidity and mortality. In this narrative review, we focus on the impacts of perioperative ischemic strokes for several of the most common interventional cardiac procedures, their relevance from a neurologic standpoint, and future directions for the care and research on perioperative strokes. Depending on the percutaneous procedure, the rates of periprocedural overt strokes can range from as little as 0.01% to as high as 2.9%. Meanwhile, covert brain infarctions (CBIs) occur much more frequently, with rates for different procedures ranging from 10%-84%. Risk factors include previous stroke, atherosclerotic disease, carotid stenosis, female sex, and African race, as well as other patient- and procedure-level factors. While the impact of covert brain infarctions is still a developing field, overt strokes for cardiac procedures lead to longer stays in hospital and increased costs. Potential preventative measures include screening and vascular risk factor control, premedicating, and procedural considerations such as the use of cerebral embolic protection devices. In addition, emerging treatments from the neurologic field, including neuroprotective drugs and remote ischemic conditioning, present promising avenues for preventing these strokes and merit investigation in cardiac procedures.

Safety and efficacy of cerebral embolic protection devices in transcatheter aortic valve implantation: a meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Background Stroke during Transcatheter Aortic Valve implantation (TAVI) is not an uncommon complication with potential devastating consequences. With the extension of TAVI to the low-risk patient, stroke prevention takes on increasing importance. The use of cerebral embolic protection device (EPD) reveals conflicting data. This meta-analysis aims to evaluate the clinical efficacy and safety of EPDs. Methods A comprehensive literature search for all studies till May 2022 reporting clinical safety and efficacy outcomes of the only EPD approved for use by the Food and Drug Administration (FDA) was performed. Study outcomes were divided based on time period - overall (up to 30 days and in-hospital) and short (≤7 days). Primary outcome was stroke - major and minor. Secondary outcomes included transient ischaemic attack (TIA), mortality, acute kidney injury (AKI), major vascular and bleeding complications. Results A total of 12 studies involving 288531 patients were analysed, which included 3 randomised controlled trials (RCTs), 7 propensity-matched and 2 cohort studies. Regarding overall outcomes, significant differences were noted for mortality (OR 0.59 [0.42-0.84], p=0.0036) and major stroke (OR 0.40 [0.18-0.91], p=0.028) (Fig 1). No significant differences were noted for all stroke (p=0.058), minor stroke (p=0.32), TIA (p=0.49), AKI (p=0.17), major vascular complications (p=0.40) and major bleeding complications (p=0.11). There was significant heterogeneity across the studies for mortality (p=0.032) and all stroke (p=0.009). In the subgroup analysis of studies reporting ≤7 days outcomes (n=5), EPDs showed significantly lower rates of all stroke (0.33 [95% CI 0.19-0.56], p=<0.0001), major stroke (0.19 [0.08-0.48], p=0.0004) and major bleeding complications (OR 0.29 [0.10-0.79], p=0.016), but no significant differences for mortality (p=0.67) and minor stroke (p=0.070). There was no significant heterogeneity across the studies (all p>0.05) Conclusions In this meta-analysis including non-randomised studies, the use of EPDs was associated with lower mortality and major stroke rates, although significant heterogeneity was noted for the studies reporting mortality. Further ongoing larger scale RCTs will further clarify these results.

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

ObjectivePeriprocedural 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. MethodsIn this prospective single-center study 117 patients (mean age 80.3 years, 53.8 % male) were included from July 2020 to December 2021. ResultsThe 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 %). ConclusionsThis 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.

Lithotripsy-Assisted Transcatheter Mitral Valve Replacement for Severe Mitral Annular and Valve Calcification.

Transcatheter mitral valve replacement (TMVR) is evolving; however, limitations include severe calcification of the mitral valve leaflets and mitral annular calcification (MAC), which may be associated with incomplete valve expansion. Shockwave intravascular lithotripsy (IVL)-assisted percutaneous mitral valvuloplasty to treat calcific mitral stenosis has been reported. We describe the first human use of IVL-assisted transseptal TMVR with the Intrepid valve to treat a severely calcified mitral valve in a patient with severe stenosis and regurgitation. An 83-year-old man with rheumatic heart disease and severe MAC (MAC score, 10; calcium volume score, 7756 cm3) presented with combined mitral stenosis and regurgitation (valve area, 1.5 cm2; 3+ mitral regurgitation [MR]) and medically refractory heart failure symptoms and was enrolled into the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial of Intrepid valve TMVR. Transseptal implantation of a 48-mm Intrepid valve was facilitated by Shockwave IVL delivered via two 8.0 × 60-mm M5+ balloons placed across the mitral annulus before implantation. Cerebral embolic protection during IVL and valve implant was provided by a Sentinel device and left subclavian balloon occlusion. Despite initial postimplant valve frame deformation and moderate central MR, postdilation achieved valve frame expansion and reduced MR. Echocardiography and computed tomography performed before hospital discharge and at 30 days show progressive valve frame expansion in the anteroposterior dimension, increased valve area, and resolution of MR. Intravascular lithotripsy of severe MAC before self-expanding TMVR may enhance annular compliance, mitigate fibroelastic recoil, and minimize TMVR valve frame deformation. Although promising, further study is required before IVL is considered a routine adjunct for TMVR in severe MAC.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

735 CLINICAL EFFICACY OF CEREBRAL EMBOLIC PROTECTION IN TRANSFEMORAL TAVI PROCEDURE

Abstract Background Although in the context of Transcatheter Aortic Valve Implantation (TAVI) technological improvements, refinements in technique and increased operator experience have led to progressive reduction in most complications, periprocedural neurological ischemic event (stroke and TIA) continues to occur in up to 2% of patients undergoing TAVI. Many of these are attributed to embolic events during the procedure and can lead to potentially devastating consequences. Cerebral Embolic Protection (CEP) devices have been developed to mitigate this risk. Data regarding the clinical efficacy of these devices in preventing neurological events in TAVI are conflicting. The aim of the present study is to investigate the impact of CEP on clinical neurological events in TAVI. Methods We performed a multicentric retrospective observational case-control study to evaluate the rate of periprocedural clinical neurological ischemic event in patients undergoing transfemoral TAVI with or without using CEP (Sentinel, Boston Scientific) during the procedure. Patients were consecutively enrolled between January 2018 and December 2021 by two tertiary centers (Verona and Ancona). A total population of 1042 patients were enrolled. The primary endpoint was the rate of a periprocedural clinical neurological ischemic event. The secondary was a composite endpoint: in-hospital death, periprocedural major vascular complication and periprocedural major bleeding. Clinical events at 30-day follow-up were evaluated (death, clinical neurological ischemic event, vascular complications, major bleeding). In consideration of the retrospective study design, we performed a propensity match analysis to account for differences in the baseline characteristics of patients in the two enrolling centers. Results The overall population comprised patients who underwent TAVI without using CEP (No-CEP group, n=581) and with CEP (CEP group, n=461). The propensity match analysis yielded a final population of 922 patients: 461 patients in the No-CEP group and 461 patients in the CEP group. There were no differences in baseline characteristics between the groups. Primary endpoint occurred in 8 (0,9%) patients overall, 3 (0,7%) patients in the No-CEP group and in 5 (1,1%) patients in CEP group (p=0,725). There were no differences in secondary endpoint: 25 (5,4) patients in No-CEP group and 20 (4,3%) in CEP group (p=0,541). In particular: in-hospital death (0,7% vs 1,3%, p=0,506), periprocedural major vascular complications (2,0% vs 0,7%, p=0,143), periprocedural major bleeding (5,0% vs 3,0%, p=0,179). No differences were observed in 30-days outcomes: death (0,0% vs 0,9%, p=0,131), clinical neurological ischemic events (0,8% vs 0,7%, p=1), vascular complications (0,3% vs 0,0%, p=0,450), major bleeding (0,8% vs 0,7%, p=1). The multiple logistic regression performed to estimate the effect of CEP on the primary endpoint showed Euroscore II (OR, 1.10; 95% CI, 1.00–1.19; P=0.028) and predilatation (OR, 4.84; 95% CI, 1.21–21.64; P=0.028) was associated with an increase in primary endpoint after TAVI, while CEP and valve type did not contribute significantly. Conclusions This study suggests that using CEP devices during transfemoral TAVI is safe and does not increase vascular complications, although it does not impact the rate of periprocedural clinical neurological ischemic events.

1066 THE USEFULNESS OF CEREBRAL PROTECTION DURING TAVR: A METANALYSIS

Abstract Introduction although transcatheter aortic valve replacement (TAVR) represents a milestone in the treatment of degenerative aortic stenosis, stroke remains an important complication compared to surgical aortic valve replacement (SAVR). Multiple magnetic resonance imaging (MRI) studies demonstrated a substantial rate of new cerebral ischemic lesions after TAVR. In order to avoid debris passage into the circulation and to prevent procedure-related embolic stroke, cerebral embolic protection (CEP) devices were developed. However, their safety and efficacy remain controversial. Very recently, new studies provided additional evidence on this topic. Aim to assess the entire body of evidence from randomized controlled studies about neurological outcomes after TAVR. Materials and Methods a systematic meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched MEDLINE, Scopus, and Google Scholar for randomized controlled studies. The following keywords were used for the search: “transcatheter aortic valve implantation” or “stroke prevention” or “embolic protection” and “cerebral protection”. Study groups were defined as a the “CEP group” and the “control group”. Non-randomized studies reporting outcomes with cerebral embolic protection (CEP) during TAVR were excluded to reduce the selection and confounding bias of observational pilot studies. The primary outcome was post-procedural stroke. Secondary outcomes included total lesion volume on MRI and new ischemic lesions on MRI. Results nine trials including 4077 patients were eligible for analysis and included to the meta-analysis. Of those, 2203 patients were randomized to cerebral embolic protection and 1874 patients to control group. Despite the rate of post-procedural stroke was higher in the CEP arm (2.27%) compared to the control arm (2.87%, p<0.001), the use of cerebral embolic protection was not associated with a significantly lower risk of stroke (OR=0.82, 95% CI 0.59-1.15; p=0.255). Cumulative meta-analysis revealed a trend towards a lower impact on stroke prevention with more recent trials. Conclusions use of cerebral embolic protection devices during TAVR is a safe procedure. However, the current outline of results from all randomized controlled trials available does not support its routine use, as no significant reduction of stroke risk was evident. The use of these devices might be considered in selected high-risk patients, such as in the setting of heavy calcified cusps or atherosclerotic aortic lesions.

623 PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE AND TRANSCATHETER CEREBRAL EMBOLIC PROTECTION: TWO CASES REPORT

Abstract Introduction Percutaneous left atrial appendage closure (LAAC) in AF patients is not inferior to oral anticoagulation (OAC) in terms of systemic embolism. LAA Closure is usually contraindicated in presence of intracardiac thrombus, a condition far from uncommon. The feasibility and safety of transcatheter cerebral embolic protection (TCEP) has been reported in literature as a successful off – label option in retrieving embolic debris during percutaneous LAAC. We present two cases of Watchman Flex insertion in the setting of LAA thrombus and prophylactic use of TCEP. Cases report The first patient was an 88-year-old male with history of symptomatic AF and post – traumatic cerebral bleeding, who was referred to LAAC because of high risk of bleeding in using OAC. Transthoracic echocardiography (TTE) documented a severely dilatated left atrial and preserved left ventricular systolic function. Transesophageal echocardiography (TEE) revealed a “chicken wing” shaped LAA with spontaneous echo-contrast and sludge effect confirmed with echo-contrast medium “SonoVue”. ECG – gated cardiac CT (CCT) showed a LAA filling defect and confirmed the diagnosis of LAA thrombus. The second patient was a 75-year-old man with valvular permanent AF and history of multiple ischemic strokes despite of OAC therapy with Warfarin. TTE documented a dilated left ventricle with severely depressed ejection fraction; TEE revealed a “windstock” shaped LAA with incompletely distal opacification with echo-contrast medium “SonoVue”. Both patients were candidate to LAAC with concomitant use of CEPDs in the event of neurological complication. TriGUARD 3 cerebral protection (TG3, Keystone Heart) was deployed in the aortic arch through right femoral artery access before LAAC procedure. Following transseptal puncture Watchman Flex device (Boston Scientific, Marlborough, MA) was deployed without complications or residual peri-device leaks. At the end the TriGurad 3 device was retracted and no debris were noted at the post operatory inspection. The first patient was discharged afterward with daily acetylsalicylic acid 100 mg and Clopidogrel 75 mg and the second patient with daily acetylsalicylic acid 100 mg and Warfarin. Both patients underwent follow-up TEE at four weeks. Neither device – related complications nor thrombotic/hemorrhagic adverse events have been not reported so far. Discussion Both patients were at very high risk for stroke and bleeding. They were not theoretically candidate to LAAC because of intracardiac thrombus. The prophylactic use of TCEP (including TG3) has been reported in a small retrospective study by Tarantini et al. and in some case series. Procedures were always successful and uneventful. Moreover, small captured debris on the device on visual examination proved its efficacy. The use of TCEP has been mentioned even by Beneduce et al. as a safer and more feasible strategy in AF patients. Conclusion Prophylactic use of TCEP during The Watchman Flex device implantation is safe and feasible.

692 THE USE OF ULTRASOUND ENHANCING AGENTS (UEA) IN THE EVALUATION OF LEFT ATRIAL APPENDAGE (LAA) THROMBUS IN PATIENT CANDIDATE TO PERCUTANEOUS LAA CLOSURE

Abstract Introduction Left atrial appendage closure (LAAC) is an emerging option in patients with atrial fibrillation (AF) and contraindication for oral anticoagulation (OAC) therapy. Patients with left atrial thrombus are usually excluded from this strategy. Therefore, pre-procedural transesophageal echocardiography (TEE) is usually performed for LAA thrombus exclusion. The application of second-generation lipid microspheres ultrasound enhancing agents (UEA) is of growing interest. The following clinical cases reports describe the benefit from UEA implication on subsequent decision-making regarding with LAAC procedure. Case report num.1 an 88-year-old male with history of symptomatic AF and post – traumatic cerebral bleeding was referred to LAAC because of high risk of bleeding in using OAC. Transthoracic echocardiography (TTE) documented a severely dilatated left atrium and preserved left ventricular systolic function. Pre – operative TEE revealed a “chicken wing” shaped LAA with severe spontaneous echo-contrast and sludge effect. Echo-contrast medium “SonoVue” showed an early filling defect with late but complete LAA opacification, excluding thrombus. Of note, ECG-gated cardiac CT (CCT) could not exclude filling defect with certainty. Consecutively, the patient was candidate to LAAC in a short time. Case report num.2 a 75-year-old man with valvular permanent AF and multi-territory ischemic ictus despite being on adequate prophylactic OAC (Warfarin). At TTE a dilated left ventricle with mildly reduced ejection fraction was documented. ECG – gated CCT with delayed phases imaging showed a possible filling defect in LAA, however imaging was suboptimal due to a reverb of voluminous hiatal hernia. TEE revealed a “windstock” shaped LAA with incomplete distal opacification when echo-contrast medium “SonoVue” was used, confirming thrombus. The patient was therefore referred for LAAC procedure with concomitant use of cerebral embolic protection devices (CEPDs). Discussion Transesophageal echocardiography is the test of choice for the exclusion of LAA thrombus. However technical difficulty, spontaneous echo contrast (SEC) and prominent pectinate musculature within the appendage may make the exclusion of LAA thrombus not easy. ECG – gated cardiac CT may be conclusive as well. UEA use is associated with higher diagnostic power for LAA thrombus exclusion and recent study have shown its utility also in terms of LAA sizing. Thus, the most recent guidelines of American Society of Echocardiography mention echo contrast use for the delineation of LAA thrombi and differentiate between them with SEC. Conclusion The use of ultrasound enhancing agents is useful and increases the interpretative confidence in exclusion of LAA thrombus.

Cerebral embolic protection during transcatheter aortic valve replacement: analysis of data from PROTECTED-TAVR and future perspectives

Cerebral embolic protection during transcatheter aortic valve replacement: analysis of data from PROTECTED-TAVR and future perspectives

Abstract 11421: Intervention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi): Does Carbon-Dioxide Flushing Reduce Vascular Brain Injury?

Background: Transcatheter Aortic Valve Implantation (TAVI) is associated with 2-3% clinical stroke rate and much higher incidence of silent cerebral infarction. This study investigated the neuroprotective benefits of minimising air emboli in TAVI. It aimed to demonstrate a reduction in vascular brain injury by flushing TAVI valves with CO 2 and saline compared to saline only as per standard practise. Methods: Patients undergoing transfemoral TAVI for aortic stenosis were enrolled. Patients were randomised to CO 2 and saline (TAVI-CO 2 ) versus saline only (TAVI-S) flushing of TAVI valves during preparation. Patients underwent MRI brain following TAVI to identify new cerebral infarcts and any reduction in vascular brain injury by reducing air emboli. Results: Twenty-Two patients were enrolled in the study with a mean age of 79±10 years. Fifteen (68%) were males. Nine patients (41%) had history of hypertension, 5 (23%) had previous cerebrovascular disease and 5 (23%) had diabetes. Two (9%) patients did not have their TAVI valve implanted and hence were excluded. No patients had any procedural related complications. Three (14%) patients required permanent pacemaker insertion post procedure and could not have their MRI. Fifteen patients (68%) had MRI brain post-TAVI, 7 patients in the TAVI-CO 2 group and 8 patients in the TAVI-S group. TAVI-CO 2 group had a total of 41 new cerebral lesions compared to 66 lesions in TAVI-S group. TAVI-CO 2 had on average 6.80 new lesions/patient compared to 8.25 lesions/patients in TAVI-S (p=0.34) Cerebral infarcts were also analysed according to valve type. In self-expanding valves (n=7), TAVI-CO 2 had 8 lesions/patient compared to 10 lesions/patient in TAVI-S (p=0.46). In balloon-expanding valves (n=8), TAVI-CO 2 had 4.25 lesions/patient compared to 6.25 lesions/patient in TAVI-S (p=0.25). Conclusion: There is a trend in the reduction in the number of new cerebral lesions in the TAVI-CO 2 arm compared to the TAVI-S patients. This is the first study that identifies the importance of air emboli in TAVI and the associated potential vascular brain injury. As brain injury remains a significant concern during TAVI, a larger randomised trial is required to further investigate the neuroprotective benefit of flushing TAVI valves with CO 2 .

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

What is the future role of cerebral embolic protection in transcatheter aortic valve implantation?

What is the future role of cerebral embolic protection in transcatheter aortic valve implantation?

Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement

BackgroundTranscatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke.MethodsWe randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR.ResultsA total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, −0.6 percentage points; 95% confidence interval, −1.7 to 0.5; P=0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site.ConclusionsAmong patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.)

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.

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