Vasculitic rash and cerebral emboli in an adolescent with left atrial myxoma.

A previously healthy woman in late adolescence presented to the emergency department with stroke-like symptoms following a two-month history of bilateral foot pain and oedema, accompanied by a macular rash and progressive lower extremity weakness. On further investigation, she was found to have multiple cerebral emboli and a left atrial myxoma fixed to the interatrial septum. The patient subsequently underwent urgent surgical excision of the myxoma. On follow-up, her cutaneous and neurological symptoms were significantly improved. This case suggests that, in the presence of a vasculitic rash without evident or obvious cause, cardiac myxoma should be included in the differential diagnosis.

Large Tissue Debris Causing Cerebral Embolism After Transcatheter Aortic Valve Replacement.

Cerebral vascular embolism is one of the complications of transcatheter aortic valve replacement (TAVR). Thrombolytic therapy is not expected to be effective when embolic material consists of a large tissue fragment. Instead, mechanical aspiration may be more effective therapy for acute cerebral infarction after TAVR. Here, we describe the case of an 87-year-old woman with aortic valve stenosis and heart failure who underwent TAVR using a self-expandable valve. Acute cerebral infarction with left middle cerebral artery occlusion caused by a large tissue fragment developed after the procedure.

Cerebral Embolism and MINOCA Secondary to Left Atrial Myxoma after Occlusion of Atrial Septal Defect by Amplatzer Occluder: A Case Report.

Primary heart tumors are rare, with atrial myxomas being the most common type. Atrial myxomas can lead to embolisms, heart obstruction, and systemic symptoms. Herein, we report a case of 72-year-old woman who presented with a left atrial myxoma at the atrial septal defect occluder, a new acute cerebral infarction, and MINOCA (myocardial infarction with no obstructive coronary atherosclerosis). Left atrial myxoma is a common primary cardiac tumor; however, left atrial myxomas arising after percutaneous atrial septal defect occlusion are rare. Additionally, the patient presented with a new case of multiple systemic emboli. The patient underwent surgical resection of a left atrial myxoma, occluder, and left atrium, and atrial septal repair, and was discharged with good recovery for outpatient follow-up. The possibility of a cardiac tumor, especially an atrial myxoma, which can lead to a series of complications, should be considered at the closure site after percutaneous atrial septal closure. Therefore, active surgical treatment and long-term follow-up are warranted in such cases.

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.

Thin aortic arch plaque is associated with the development of atrial fibrillation for embolic stroke of undetermined source in patients with an insertable cardiac monitor.

BACKGROUND AND OBJECTIVE: This study's objective is to investigate whether mild aortic arch plaque is associated with the development of atrial fibrillation (AF) in stroke patients with embolic stroke of undetermined source (ESUS) during the first year following the implantation of an insertable cardiac monitor (ICM). METHODS: The participants in this cross-sectional observational study were consecutive patients with ESUS, even after transesophageal echocardiography. We assessed the relationship between the thickness of the participants' aortic arch plaque and AF detected after ICM implantation. RESULTS: Of the 50 consecutive patients with ESUS enrolled in this study, 12 (24%) developed AF. We observed that thicker aortic arch plaque was associated with undetected AF (2.3 mm vs. 1.2 mm, p < 0.001). Aortic arch plaque thickness was independent associated with undetected AF (OR 54.00, 95% CI 2.706-1077.544, p = 0.009). When the cut-off value for aortic arch plaque thickness was 1.8 mm, the sensitivity and specificity were 71.1% and 91.7%, respectively (95% CI = 0.75-0.98, p < 0.001). Also, patients having both aortic arch plaque with a thickness < 1.8 mm and a CHADS2 score ≥ 4 were more likely to have detectable AF than no AF (88% vs. 12%, p < 0.001). CONCLUSION: A thinner aortic arch plaque was associated with the development of AF. Patients with mild aortic plaques below 4 mm but ≥1.8 mm in thickness and without other high-risk features are less likely to have paroxysmal AF on ICM, and these plaques may be a possible source of embolism for their strokes.

Midterm follow-up after computed tomography angiography planned left atrial appendage closure.

BACKGROUND: While studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™ legacy and FLX devices, there has been no reported long-term data for this approach. OBJECTIVES: We sought to evaluate long-term outcomes using CTA-based preprocedural planning for LAAC using the WATCHMAN™ device. METHODS: A prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5-year period. CTA-guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2-Vasc and HAS-BLED scores, respectively. RESULTS: From January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS-BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri-procedural complication rate was 2.2%. 6 patients were lost to follow-up. Mean follow-up was 608.94 days with a total of 377.04 patient years. Median follow-up period of 368 days (interquartile range: 209-1067 days). There were 51 deaths from all causes (13.52 per 100 patient-years), 10 cases of cerebral embolism (2.65 per 100 patient-years), 2 cases of systemic embolism (0.53 per 100 patient-years), 17 cases of major bleeding (4.50 per 100 patient-years), and 31 cases of minor bleeding (8.2 per 100 patient-years). All-cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively. CONCLUSIONS: CTA-based preprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

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.

[Cerebral arterial air embolism: the effect of hyperbaric oxygen therapy]. / Cerebrale arteriële luchtembolie.

BACKGROUND: Iatrogenic gas embolism is the presence of gas in vascular structures. Feared are those in coronary or cerebral arteries. These can result in cerebral or myocardial infarction. CASE DESCRIPTION: A 79-year-old female underwent CT-guided biopsy of the lung. Minutes later she developed neurological symptoms. After administration of oxygen her symptoms initially improved, but later worsened. Based on her symptoms air embolism was suspected. She recovered fully after treatment with hyperbaric oxygen. CONCLUSION: Air embolism is a potentially life-threatening complication of surgical, radiological or vascular interventions. Early recognition can lead to prompt treatment and better prognosis. If air embolism is suspected the patient should be treated according to ABCDE principles and oxygen should be administered. In case of neurological or circulatory symptoms a hospital that could provide hyperbaric oxygen therapy should be contacted as soon as possible.

Cerebral embolic protection during transcatheter heart interventions.

Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), with the incidence of clinically apparent stroke seemingly fixed at around 3% despite TAVR's significant evolution during the past decade. Embolic showers of debris (calcium, atheroma, valve material, foreign material) are captured in the majority of patients who have TAVR using a filter-based cerebral embolic protection device (CEPD). Additionally, in systematic brain imaging studies, the majority of patients receiving TAVR exhibit new cerebral lesions. Mechanistic studies have shown reductions in the volume of new cerebral lesions using CEPDs, yet the first randomised trial powered for periprocedural stroke within 72 hours of a transfemoral TAVR failed to meet its primary endpoint of showing superiority of the SENTINEL CEPD. The present review summarises the clinicopathological rationale for the development of CEPDs, the evidence behind these devices to date and the emerging recognition of cerebral embolisation in many non-TAVR transcatheter procedures. Given the uniqueness of each of the various CEPDs under development, specific trials tailored to their designs will need to be undertaken to broaden the CEPD field, in addition to evaluating the role of CEPD in non-TAVR transcatheter heart interventions. Importantly, the cost-effectiveness of these devices will require assessment to broaden the adoption of CEPDs globally.

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.

Cognitive changes associated with cerebral emboli during coronary intervention.

OBJECTIVE: To investigate factors influencing the frequency and type of microembolic signals (MES) detected using transcranial Doppler (TCD) in patients undergoing elective coronary intervention, and to correlate MES with silent stroke detected using magnetic resonance imaging (MRI) and cognitive dysfunction. METHODS: The subset study of a randomized clinical trial was conducted on 70 patients (58 males; mean age 59.9 ± 8.4 years) who underwent bilateral TCD monitoring of middle cerebral arteries (MCAs) during elective coronary interventions. Neurologic examination and brain MRI were performed prior to, and 24 h post­intervention. Cognitive function tests were performed prior to, and on day 30 post­intervention. RESULTS: The incidence of detected MES was 94.3 %. Eighteen (25.7 %) patients had new clinically asymptomatic ischemic lesions on MRI. The number of solid MES negatively correlated with changes in revised Addenbrooke's Cognitive Examination test (ACE-R) and, the number of solid MES and combinations of solid and gaseous MES negatively correlated with changes in Mini Mental­State Examination (MMSE) conducted on day 30 after the intervention (p < 0.05 in all cases). CONCLUSION: Cardiac catheterization was associated with a high risk of cerebral embolism in our patients. A higher number of solid MES and combinations of solid and gaseous MES was associated with the deterioration in cognitive tests (Tab. 5, Fig. 3, Ref. 30).

Atrial fibrillation catheter ablation associated silent cerebral emboli: A narrative review.

The incidence of silent cerebral emboli (SCE) associated with atrial fibrillation catheter ablation (AFCA) is much higher than that of stroke/transient ischemic attack (TIA). Interventional electrophysiologists have been increasingly alerted to asymptomatic cerebral infarction over the years. Plentiful studies revealed that diagnostic definitions, detection modalities, energy sources, ablation strategies, perioperative anticoagulation regimens, and patient-related factors were associated with the risk of AFCA-associated SCE. Studies related to non-interventional procedures found that SCE may prompt stroke, cognitive decline, and dementia later in life, suggesting a possible role of AFCA-associated SCE in the cognitive function of patients with AF. However, there is no consistent evidence for this view to date. Given that the majority of patients with AF being elderly and the increased risk of cognitive impairment in AF itself, efforts should be made to minimize the occurrence of AFCA-associated SCE.

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.

Spontaneous calcific cerebral embolization revealing a calcified rheumatic mitral stenosis: a case report.

BACKGROUND: Cerebral cardiac embolism accounts for an increasing proportion of ischemic strokes and transient ischemic attacks. Calcified cerebral emboli are rare and mostly iatrogenic secondary to heart or aorta catheterization. However, spontaneous cerebral calcified embolism in the case of calcified aortic valve is very rare and there are less than 10 case reports in the literature. And a more interesting fact is that such an event, in the context of calcified mitral valve disease, has never been reported, at least to our knowledge. We are reporting a case of spontaneous calcified cerebral embolism revealing a calcified rheumatic mitral valve stenosis. CASE PRESENTATION: We report a case of a 59 year-old Moroccan patient, with a history of rheumatic fever at the age of 14 and no history of recent cardiac intervention or aortic/carotid manipulation, who was admitted to the emergency department after a transient ischemic attack. Physical examination at admission found normal blood pressure of 124/79 mmHg and heart rate of 90 bpm. A 12-lead electrocardiogram showed an atrial fibrillation, no other anomalies. Unenhanced cerebral computed tomography imaging was performed, revealing calcified material inside both middle cerebral arteries. Transthoracic echocardiography was performed, showing severe mitral leaflets calcification with a severe mitral stenosis, probably due to rheumatic heart disease. Cervical arteries Duplex was normal. A vitamin K antagonist (acenocoumarol) was prescribed, targeting an international normalized ratio of 2-3 and mitral valve replacement surgery was performed using mechanical prosthesis. Short- and long-term health, with a 1-year follow-up, were good and the patient did not experience any stroke. CONCLUSION: Spontaneous calcified cerebral emboli secondary to mitral valve leaflet calcifications is an extremely rare condition. Replacement of the valve is the only option to prevent recurrent emboli and outcomes are still to be determined.

Outcomes of Cerebral Embolic Protection for Bicuspid Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Replacement.

Background There was limited high-quality evidence that illuminated the efficiency of cerebral embolic protection (CEP) use during transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) stenosis. Methods and Results In this retrospective cohort study, patients with BAV stenosis undergoing TAVR with or without CEP were identified by querying the National Inpatient Sample database. The primary end point was any stroke during the hospitalization. The composite safety end point included any in-hospital death and stroke. We applied propensity score-matched analysis to minimize standardized mean differences of baseline variables and compare in-hospital outcomes. From July 2017 to December 2020, 4610 weighted hospitalizations with BAV stenosis undergoing TAVR were identified, of which 795 were treated with CEP. There was a significant increase in the CEP use rate for BAV stenosis (P-trend <0.001). A total of 795 discharges with CEP use were propensity score matched to 1590 comparable discharges but without CEP. CEP use was associated with a lower incidence of in-hospital stroke (1.3% versus 3.8%; P<0.001), which in multivariable regression was also independently associated with the primary outcome (adjusted odds ratio=0.38 [95% CI, 0.18-0.71]; P=0.005) and the safety end point (adjusted odds ratio=0.41 [95% CI, 0.22-0.68] P=0.001). Meanwhile, no significant difference was found in the cost of hospitalization ($46 629 versus $45 147; P=0.18) or the risk of vascular complications (1.9% versus 2.5%; P=0.41). Conclusions This observational study supported CEP use for BAV stenosis, which was independently associated with less in-hospital stroke without burdening the patients with a high hospitalization cost.

Dual-layered stents reduce cerebral embolism compared with first-generation stents during carotid stenting of high lipid core plaque lesions.

BACKGROUND: Periprocedural lipid core plaque (LCP) has been detected in carotid arteries assessed by catheter-based near-infrared spectroscopy (NIRS). High LCP is associated with cerebral embolism after carotid artery stenting (CAS) using a first-generation stent. We aimed to evaluate whether dual-layered stents reduce embolic infarcts in patients with high LCP and change of lipid signal as assessed by NIRS during CAS. METHODS: Participants comprised 210 consecutive patients undergoing CAS. The study was divided into two distinct periods, with first-generation closed-cell stents used in the earlier period and dual-layered stents used in the later period. NIRS was performed at baseline, after stent implantation, and after balloon post-dilatation to analyze maximal lipid core burden index at minimal luminal area (max-LCBIMLA). RESULTS: The ipsilateral cerebral embolism rate was significantly lower with dual-layered stents (9%) than with first-generation stents (33%, p<0.001), particularly with highly lipidic lesions (12% vs 60%, p<0.001). On multivariate logistic regression analysis, high LCP and first-generation stent usage were factors related to ipsilateral cerebral embolism (both p<0.001; OR 8.28 (95% CI 3.49 to 19.64) and OR 8.07 (95% CI 2.33 to 27.93), respectively). Max-LCBIMLA decreased significantly after stenting in both groups (both p<0.01) and max-LCBIMLA after balloon post-dilatation was significantly lower with dual-layered stents (22.4±65.6) than with first-generation stents (124.2±208.2; p=0.006). CONCLUSIONS: Dual-layered stents reduce embolic infarcts in patients with highly lipidic plaque lesions as assessed by NIRS who undergo CAS. Dual-layered stents significantly reduced NIRS-derived lipid signals after stenting.

[Result of Surgical Treatment for Active Infective Endocarditis at the Aortic Position].

Herein, we retrospectively review our experience with surgical treatment of active aortic valve infective endocarditis, particularly aortic annular abscess, and central nervous system complications. From 2012 to 2021, 46 consecutive patients underwent surgery during the active phase of infective endocarditis, 25 of which were performed at the aortic position. One patient died early (<30 days) due to low output syndrome and another 2 patients who were never discharged died because of general prostration. The actuarial survival rate was 84% at 1 year, and 80% at 3 and 5 years. Eleven patients [6 native valve endocarditis (NVE), 5 prosthetic valve endocarditis (PVE)] had valve annular abscess requiring removal of the infected tissue and reconstruction of a definite anatomic continuity, and aortic valve replacement was subsequently performed in 7 patients and aortic root replacement in 4 patients. Direct closure was performed in 4 patients with partial annulus defects, and reconstruction with an autologous nor bovine pericardium patch was performed in 6 patients with large annulus defects. Preoperative imaging revealed acute cerebral embolism in 10 patients. In eight cases, surgery was performed within 7 days after diagnosis of cerebral embolism. No patient had abnormal postoperative neurological findings. There were no reoperations and no recurrence of infective endocarditis.

Surgical and percutaneous left atrial appendage intervention: silent cerebral embolism considerations.

OBJECTIVES: Left atrial appendage intervention is an alternative to oral anticoagulation for thromboprophylaxis in atrial fibrillation. The aim of our study was to compare the incidence of silent cerebral embolisms after surgical and percutaneous intervention and to identify the risk factors for procedure-related silent cerebral embolisms after intervention. METHODS: This prospective observational study included consecutive atrial fibrillation patients from 2 independent cohorts (left atrial appendage excision (LAAE) cohort and left atrial appendage occlusion cohort) between September 2018 and December 2020. All patients underwent cerebral magnetic resonance imaging before and after the procedure. Silent cerebral embolism was defined as new focal hyperintense lesions detected only on postprocedural sequence. RESULTS: Thirty-two patients from the LAAE cohort and 42 patients from the occlusion cohort were enrolled. A significantly lower incidence of silent cerebral embolism was observed in the LAAE cohort as compared with occlusion (6.3% vs 54.8%, P < 0.001). In the left atrial appendage occlusion cohort, patients who developed silent cerebral embolism after the procedure had significantly higher CHA2DS2-VASc scores [odds ratio (OR) 2.172; 95% confidence interval (CI) 1.149-4.104; P = 0.017], longer occlusion placement time (OR 1.067; 95% CI 1.018-1.118; P = 0.006) and lower peak activated clotting time level after transseptal puncture (OR 0.976; 95% CI 0.954-0.998; P = 0.035). CONCLUSIONS: The incidence of procedure-related silent cerebral embolism was strikingly lower in patients with LAAE than in patients with occlusion. More cardiovascular comorbidities, longer occlusion placement time and lower activated clotting time level were significantly associated with the development of procedure-related silent cerebral embolism.

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.