Periprocedural Stroke Research Articles

Cerebral Embolic Protection by Geographic Region

Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated. To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR. This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024. TAVR with or without CEP. The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes. The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort. The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy. ClinicalTrials.gov Identifier: NCT04149535.

Coronary artery bypass grafting vs. percutaneous coronary intervention in severe ischaemic cardiomyopathy: long-term survival.

The optimal revascularization strategy in patients with ischaemic cardiomyopathy remains unclear with no contemporary randomized trial data to guide clinical practice. This study aims to assess long-term survival in patients with severe ischaemic cardiomyopathy revascularized by either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). Using the Australian and New Zealand Society of Cardiac and Thoracic Surgeons and Melbourne Interventional Group registries (from January 2005 to 2018), patients with severe ischaemic cardiomyopathy [left ventricular ejection fraction (LVEF) <35%] undergoing PCI or isolated CABG were included in the analysis. Those with ST-elevation myocardial infarction and cardiogenic shock were excluded. The primary outcome was long-term National Death Index-linked mortality up to 10 years following revascularization. Risk adjustment was performed to estimate the average treatment effect using propensity score analysis with inverse probability of treatment weighting (IPTW). A total of 2042 patients were included, of whom 1451 patients were treated by CABG and 591 by PCI. Inverse probability of treatment weighting-adjusted demographics, procedural indication, coronary artery disease extent, and LVEF were well balanced between the two patient groups. After risk adjustment, patients treated by CABG compared with those treated by PCI experienced reduced long-term mortality [adjusted hazard ratio 0.59, 95% confidence interval (CI) 0.45-0.79, P = .001] over a median follow-up period of 4.0 (inter-quartile range 2.2-6.8) years. There was no difference between the groups in terms of in-hospital mortality [adjusted odds ratio (aOR) 1.42, 95% CI 0.41-4.96, P = .58], but there was an increased risk of peri-procedural stroke (aOR 19.6, 95% CI 4.21-91.6, P < .001) and increased length of hospital stay (exponentiated coefficient 3.58, 95% CI 3.00-4.28, P < .001) in patients treated with CABG. In this multi-centre IPTW analysis, patients with severe ischaemic cardiomyopathy undergoing revascularization by CABG rather than PCI showed improved long-term survival. However, future randomized controlled trials are needed to confirm the effect of any such benefits.

Impact of protruding and ulcerated aortic atheroma on periprocedural ischemic stroke in patients undergoing transcatheter aortic valve replacement: a comprehensive analysis

Abstract Backgrounds Aortic atherosclerosis has the potential to impact both the strategy and outcomes of transcatheter aortic valve replacement (TAVR). Past research has established a correlation between the thickness and volume of aortic atheroma with periprocedural ischemic stroke and long-term mortality. However, there is limited investigation into the relationship between the morphology of aortic atheroma and outcomes following TAVR. Purpose The study aimed to assess the influence of protruding and ulcerated aortic atheroma on the occurrence of periprocedural ischemic stroke following TAVR. Methods A total of 979 patients who underwent TAVR between February 2012 and May 2019, and had retrospectively available data from contrast-enhanced computed tomography, were included in this analysis. The presence of protruding or ulcerated atheroma was evaluated across four aortic segments: ascending aorta, aortic arch, descending aorta, and abdominal aorta. Protruding aortic atheroma was defined as atheroma with a thickness exceeding 3 mm and protruding components. Ulcerated aortic atheroma was defined as atheroma presenting with ulcer-like disruption of the intima. The primary endpoint assessed was periprocedural ischemic stroke occurring within 48 hours following TAVR. Results The frequencies of protruding and ulcerated aortic atheroma were as follows: 0.2% in the ascending aorta, 6.5% in the aortic arch, 11.1% in the descending aorta, 15.7% in the abdominal aorta, and 24.2% in the entire aorta (Figure 1). Among the 979 patients analyzed, 25 (2.6%) experienced periprocedural ischemic stroke. Patients with protruding or ulcerated aortic atheroma exhibited a significantly higher incidence of periprocedural ischemic stroke compared to those without (5.5% vs. 1.6%, p=0.0010). Multivariate logistic analysis revealed that protruding or ulcerated aortic atheroma, particularly in the aortic arch, independently increased the risk of periprocedural ischemic stroke. (Table 1). Among the subset of patients (309, 34%) undergoing transfemoral TAVR (TF-TAVR) with a self-expandable valve, those with protruding or ulcerated aortic atheroma had a notably higher incidence of periprocedural ischemic stroke compared to those without (9.6% vs. 1.6%, p=0.0083). Conversely, among patients (587, 66%) undergoing TF-TAVR with a balloon-expandable valve, there was no statistically significant difference in the incidence of periprocedural ischemic stroke between those with and without protruding or ulcerated aortic atheroma (4.2% vs. 1.8%, p=0.102). Conclusions Protruding and ulcerated aortic atheroma, particularly in the aortic arch, were linked to a higher risk of periprocedural ischemic stroke post-TAVR. Consequently, careful selection of TAVR strategy, including valve type and procedural approach, is essential for patients with such aortic lesions.Figure 1Table 1

In-hospital outcomes of ventricular tachycardia catheter ablation in the presence of intra-cardiac thrombus

Abstract Background Ventricular tachycardia (VT) catheter ablation in the presence of intracardiac thrombi was evaluated in very few studies. Objectives To investigate in-hospital outcomes of VT ablation in the presence of an intracardiac thrombus, in a large inpatient US registry. Methods Using the National Inpatient Sample (NIS) database, patients who underwent non-elective VT catheter ablations in the US between 2016 and 2019 were identified using ICD-10 codes. Sociodemographic, clinical data, in-hospital procedures and outcomes as well as in-hospital mortality were collected. In-hospital outcomes were compared using propensity score (PS) matching analysis with a 1:3 ratio between patients with and without intracardiac thrombus. Results A weighted total of 15,725 admissions for non-elective VT ablation were included in the study, of which 190 (1.2%) had a discharge diagnosis of intracardiac thrombus. Patients with intracardiac thrombus had a higher comorbidity burden and were more likely to have ischemic cardiomyopathy and a diagnosis of cardiac aneurysm. In PS analysis, the presence of intracardiac thrombus was significantly associated with higher rates of any in-hospital complications (42.1% vs 19.3%, P&amp;lt;0.009), driven by higher periprocedural cerebrovascular accident and vascular injury events. In-hospital mortality rates were not significantly different between the groups. Conclusions In patients undergoing non-elective VT ablation, intracardiac thrombus was associated with higher rates of in-hospital complications, but not higher in-hospital mortality. These findings suggest that intracardiac thrombus should not contraindicate VT ablation when deemed necessary, while efforts should be made to decrease potential complications.

Cerebral Embolic Protection: Is There a Benefit for Left Atrial and Mitral Valve Procedures?

This review aims to highlight the current evidence on the use of cerebral embolic protection devices (CEPD) in left atrial and transcatheter mitral valve procedures. It also aims to summarize the antithrombotic management of patients undergoing such procedures. Ischemic stroke is one of the most devastating complications of structural heart procedures. The manifestation of periprocedural stroke can range from asymptomatic and detectable only through brain imaging to major stroke with neurological deficits. CEP devices were initially developed to mitigate the risk of stroke associated with transcatheter aortic valve replacement (TAVR). However, the efficacy of such devices during different cardiac interventions is yet to be fully demonstrated, especially in left atrial appendage closure (LAAO), and mitral valve interventions. Few studies demonstrated that the risk of periprocedural strokes after LAAO and mitral valve interventions is not negligible and is highest during the periprocedural period and then falls. The majority of patients undergoing those procedures have cerebral ischemic injuries detected on diffusion-weighted magnetic resonance imaging (DW-MRI). Moreover, a reasonable number of those patients had debris embolization on the filters of the CEPD. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is crucial and should be tailored to each patient's risk of bleeding and ischemia. Close monitoring that includes a full neurological assessment and frequent follow-up visits with cardiac echocardiography are important. The risk of periprocedural stroke in left atrial and transcatheter mitral valve procedures is not negligible. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is important to mitigate the risk of stroke, especially the long-term risk. More prospective studies are needed to assess the efficacy of CEPD in such procedures.

Free-Cell Area Impact on Stroke Prevention in Asymptomatic Patients Undergoing Carotid Artery Stenting: The "Carotid Artery sTenting And CeLl-area Impact on Stroke and Major Adverse events" (CATACLISMA) Multicenter Registry.

The study investigated the association between cell-stent area and cerebrovascular events incidence in asymptomatic patients undergoing carotid artery stenting (CAS). This is an observational, retrospective, multicenter, cohort study. Between 2012 and 2022, all patients undergoing primary CAS for severe asymptomatic carotid artery stenosis were evaluated. Three groups were defined on the basis of the cell area (open cell, OC; closed cell, CC; double layer, DL). Periprocedural primary outcomes were 30-day stroke, mortality, myocardial infarction (MI), and major adverse event (MAE, stroke/mortality composite outcome) rates. Follow-up primary outcomes included overall survival, stroke-free survival (SFS), freedom from ipsilateral stroke (FFiS), and freedom from stroke-related mortality (FF-SRM). Data were analyzed at short-term (1 year) and mid-term (2.5 years) period. A total of 1096 CAS were considered (787 men, 71.8%, median age = 74 years). Technical success was achieved in 99.5% procedures. Periprocedural 30-day stroke rate was 1.5% (OC: 1.1%, CC: 2.3%, DL: 1%, p=0.27), mortality was 0.7% (OC: 1.1%, CC: 0.3%, DL: 0.5%, p=0.35), and no MI was recorded. The MAE rate was 2.1% (OC: 2%, CC: 2.6%, DL: 1.5%, p=0.66). Median follow-up was 46 months. At 1 and 2.5 years, estimated overall survival was 96.1% and 91% (p=0.41), SFS was 99.1% and 98.2% (p=0.007, CC stroke rates 2.9% and 4.2% at timepoints), FFiS was 99.4% and 99% (p=0.014, CC FFiS rates 1.7% and 2.6% at timepoints) and FF-SRM was 99.5% and 99% (p=0.28). During follow-up, no stroke events occurred in DL group. CC design showed higher rates of any (4.2%) and ipsilateral stroke (2.6%) within 2.5 years. In asymptomatic patients undergoing CAS, the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. The DL stents may offer the best available performances in terms of mid-term stroke prevention. The study analyzed the contemporary results of carotid artery stenting (CAS) focusing on the impact of cell-stent area on peri- and post-operative cerebrovascular events in a multicenter real-world experience. In asymptomatic patients undergoing CAS the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. DL stents may offer the best available performances in terms of mid-term stroke prevention.

Comparing percutaneous coronary intervention and coronary artery bypass grafting for left main stenosis on the basis of current regional registry evidence

ObjectivesThere is an ongoing debate whether percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) is the better choice for treatment of left main (LM) stenosis. We aimed to provide external validation for the recently reviewed guideline recommendations for invasive LM therapy by evaluating the impact of CABG or PCI on long-term survival from local reports of different regions in the world. We performed a systematic review and meta-analysis to address contemporary registry studies comparing PCI and CABG for patients with LM stenosis. MethodsThree databases were assessed. Our primary end point was long-term all-cause mortality. Secondary end points were major adverse cardiovascular events (MACE), myocardial infarction, repeat revascularization, stroke, and periprocedural mortality. Reconstruction of time-to-event data was performed. ResultsA total of 2477 studies were retrieved. Seven studies with risk-adjusted populations were selected for the analysis. Four studies favored CABG and 3 studies showed no difference for the primary end point. Compared with PCI, patients who underwent CABG had lower risk of death (hazard ratio, 1.15; 95% confidence interval, 1.05-1.26, P < .01) and MACE (hazard ratio, 1.54; 95% confidence interval, 1.40-1.69, P < .01) during follow-up. Moreover, PCI was associated with more myocardial infarction, repeat revascularization, but less strokes when compared with CABG. There was no significant difference regarding periprocedural mortality. The MACE rate was lower after CABG in both early and late phase, which outweighs the higher rate of periprocedural stroke after CABG. ConclusionsRegional registry evidence supports the current notion of superior long-term endpoints with CABG compared with PCI for the treatment of LM stenosis over time.

In-Hospital Outcomes of Ventricular Tachycardia Catheter Ablation in the Presence of Intra-Cardiac Thrombus.

Ventricular tachycardia (VT) catheter ablation in the presence of intracardiac thrombi was evaluated in very few studies. To investigate in-hospital outcomes of VT ablation in the presence of an intracardiac thrombus, in a large inpatient US registry. Using the National Inpatient Sample (NIS) database, patients who underwent non-elective VT catheter ablations in the United States between 2016 and 2019 were identified using ICD-10 codes. Sociodemographic, clinical data, in-hospital procedures, and outcomes as well as in-hospital mortality were collected. In-hospital outcomes were compared using propensity score (PS) matching analysis with a 1:3 ratio between patients with and without intracardiac thrombus. A weighted total of 15,725 admissions for non-elective VT ablation were included in the study, of which 190 (1.2%) had a discharge diagnosis of intracardiac thrombus. Patients with intracardiac thrombus had a higher comorbidity burden and were more likely to have ischemic cardiomyopathy and a diagnosis of cardiac aneurysm. In PS analysis, the presence of intracardiac thrombus was significantly associated with higher rates of any in-hospital complications (42.1%vs. 19.3%, p<0.009), driven by higher periprocedural cerebrovascular accident and vascular injury events. In-hospital mortality rates were not significantly different between the groups. In patients undergoing non-elective VT ablation, intracardiac thrombus was associated with higher rates of in-hospital complications, but not higher in-hospital mortality. These findings suggest that intracardiac thrombus should not contraindicate VT ablation when deemed necessary, while efforts should be made to decrease potential complications.

Cerebral Embolic Protection Devices: Are There Any Indications in Transcatheter Aortic Valve Replacement?

Stroke following transcatheter aortic valve replacement (TAVR) is a significant and life-threatening adverse event. The vast majority of these incidents occur during the TAVR procedure or within the first 24 h following TAVR, with a notable prevalence of cerebral embolic events. In response to this concern, cerebral embolic protection devices (CEPDs) have been designed to mitigate the risk of peri-procedural ischemic stroke during TAVR. The primary objective of CEPDs is to diminish the intraprocedural burden associated with new silent ischemic brain injuries. Despite the development of several CEPDs, their clinical efficacy remains uncertain. In this review, we delve into a comprehensive analysis of the utilization of CEPDs in patients undergoing TAVR, exploring insights from the existing literature. Additionally, we aim to present future perspectives and discuss the clinical implications associated with the incorporation of CEPDs in TAVR procedures.

RAPID software analysis and mechanical thrombectomy for periprocedural ischemic stroke after transcatheter aortic valve implantation.

RAPID software analysis and mechanical thrombectomy for periprocedural ischemic stroke after transcatheter aortic valve implantation.

Efficacy and safety of atrial fibrillation ablation in patients with aged 80 years or older.

Atrial fibrillation (AF) is the most common cardiac arrhythmia observed in the elderly. Its prevalence rises with age, particularly in individuals over 80 years old. While catheter ablation has emerged as a first line therapy for the patients with symptomatic AF, evidence on its application in elderly patients remains controversial. This study aimed to assess safety and efficacy outcomes of AF ablation in patients aged ≥ 80 years.Consecutive 1327 patients who underwent a first pulmonary vein isolation (PVI) for AF were retrospectively analyzed. Patients aged ≥ 80 years (elderly group, n = 107) were compared with patients aged < 80 years (younger group, n = 1220). At 1-year follow-up, there was no significant difference in AF free rate between the elderly and the younger group (72.0% vs. 73.9%, P = 0.786). Regarding major complications, the elderly patients had a greater incidence of periprocedural stroke (1.9% vs. 0.1%, P = 0.018). The rates of cardiac tamponade, phrenic palsy, and vascular complications were not significantly different between the 2 groups.PVI for AF is effective in patients aged ≥ 80 years with a similar success rate, but periprocedural stoke risk was higher compared to the younger population.

Peak Procedural ACT Is Associated With All-Cause Mortality After Femoral Access PCI

BackgroundA minimum threshold activated clotting time (ACT) to guide heparin dosing during percutaneous coronary intervention (PCI) is associated with lower ischemic complications. However, data are variable regarding the risk of high ACT levels. The aim of this study was to assess the impact of peak procedural ACT on complications and mortality for transfemoral and transradial access PCI. MethodsThe UC San Diego Health National Cardiovascular Data Registry CathPCI Registry was used to obtain data on patients who underwent native vessel PCI from January 2007 to September 2022. Coronary artery bypass graft patients and those who received bivalirudin were excluded. Complications and all-cause mortality at 30 days and 1-year post-PCI were assessed by ACT tertile. ResultsA total of 2473 patients (age 65 ± 12 years; 74% male) undergoing PCI with 53% femoral and 47% radial access were included. The majority (82%) had 1-vessel coronary artery disease with heterogeneous clinical presentations (21.8% ST-elevation myocardial infarction, 25.4% non–ST-elevation myocardial infarction, 4.9% unstable angina, 33.8% stable angina, 3.4% atypical chest pain, 10.7% other indication for PCI). With femoral access, patients in the third tertile (ACT ≥ 275) had significantly higher all-cause mortality at 30 days (5.3% vs 2.7% vs 0.9%; P < .001), 6 months (6.3% vs 4.0% vs 2.0%; P = .007), and 1 year (9.0% vs 6.0% vs 2.7%; P < .001) compared to the second (ACT 228-275) and first tertile (ACT ≤ 228), respectively. A 30-day landmark analysis revealed that there was no difference in all-cause mortality beyond 30 days (3.9% vs 3.4% vs 1.8%; P = .176). There were increased bleeding complications in the highest tertile (12.8% vs 9.8% vs 7.5%; P = .034) and a higher need for blood products (10.4% vs 6.7% vs 5.4%; P = .014). There was no difference in ischemic major adverse cardiovascular events specifically periprocedural myocardial infarction or stroke between tertiles. There was no difference in clinical outcomes by peak ACT for patients who had radial access. ConclusionsHigher ACT with transfemoral access PCI was associated with increased 30-day mortality, bleeding complications, and need for blood products post-PCI.

Management of Severe Bilateral Symptomatic Internal Carotid Artery Stenosis: Case Report and Literature Review.

Multiple strategies for tandem severe carotid artery stenosis are reported: bilateral carotid artery endarterectomy (CEA), bilateral carotid artery stenting (CAS), and hybrid procedures (CEA and CAS). The management is controversial, considering the reported high risk of periprocedural stroke, hemodynamic distress, and cerebral hyperperfusion syndrome. We present the case of a 64-year-old patient with severe symptomatic bilateral internal carotid artery stenosis (95% stenosis on the left internal carotid artery with recent ipsilateral watershed anterior cerebral artery-medial cerebral artery (ACA-MCA) and medial cerebral artery-posterior cerebral artery (MCA-PCA) ischemic strokes and 90% stenosis on the right internal carotid artery with chronic ipsilateral frontal ischemic stroke) managed successfully with staged CEA within a 3-day interval. The patient had a history of coronary angioplasty and stenting. Strategies for brain protection included shunt placement after the evaluation of carotid stump pressure, internal carotid backflow, and near-infrared spectroscopy. A collagen and silver-coated polyester patch was used to complete the endarterectomy using a 6.0 polypropylene continuous suture in both instances. Management also included neurological consults after extubation, dual antiplatelet therapy, head CT between the two surgeries, myocardial ischemia monitoring, and general anesthesia. Staged CEA with a small time interval between surgeries can be an option to treat tandem symptomatic carotid artery stenosis in highly selected patients. The decision should be tailored according to the patient's characteristics and should also be made by a cardiology specialist, a neurology specialist, and an anesthesia and intensive care physician.

Impact of cerebral protection on observed versus predicted in-hospital stroke in a high stroke risk TAVR cohort

BackgroundDespite impressive improvements in the safety profile of Transcatheter aortic valve replacement (TAVR), the risk for peri-procedural stroke after TAVR has not declined substantially. In an effort to reduce periprocedural stroke, cerebral embolic protection (CEP) devices have been utilized but have yet to demonstrate benefit in all-comers. There is a paucity of data supporting the utilization of CEP in TAVR patients with an anticipated high risk for peri-procedural stroke.MethodsThe Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) score is a clinical risk tool for predicting the in-hospital stroke risk of patients undergoing transfemoral TAVR. This score was used to identify high-risk patients and calculate the expected in-hospital stroke risk. This was a single-centre cohort study in all consecutive TAVR patients who had placement of CEP. The observed versus expected ratio for peri-procedural stroke was calculated. To obtain 95% credible intervals, we used 1000 bootstrapped samples of the original cohort sample size without replacement and recalculated the TASK predicted scores.ResultsThe study included 103 patients. The median age was 83 (IQR 78,89). 63 were male (61.1%) and 45 (43.69%) had a history of previous Stroke or TIA. Two patients had an in-hospital stroke after TAVR (1.94%). The expected risk of in-hospital stroke based on the TASK score was 3.39% (95% CI 3.07–3.73). The observed versus expected ratio was 0.57 (95% CI 0.52–0.64).ConclusionIn this single-center study, we found that in patients undergoing TAVR with high stroke risk, CEP reduced the in-hospital stroke risk by 43% when compared with the risk-score predicted rate.Clinical trial numberN/A.

Self-expanding intracranial drug-eluting stent system in patients with symptomatic intracranial atherosclerotic stenosis: initial experience and midterm angiographic follow-up.

Symptomatic intracranial atherosclerotic stenosis (ICAS) is a major cause of ischemic stroke worldwide. In patients undergoing endovascular treatment for ICAS, in-stent restenosis (ISR) is associated with ischemic stroke recurrence. Intracranial drug-eluting self-expanding stent systems (COMETIU; Sinomed Neurovita Technology Inc., CHN) are new devices for treating ICAS. This study evaluated the perioperative experience and medium-term outcomes of COMETIU in 16 patients. We prospectively analyzed 16 patients with ICAS (≥ 70% stenosis) who underwent intravascular therapy between September 4, 2022, and February 1, 2023. The primary outcome was the incidence of ISR at 6 months postoperatively. The secondary efficacy outcomes were device and technical success rates. The secondary safety outcomes included stroke or death within 30 days after the procedure and the cumulative annual rate of recurrent ischemic stroke in the target-vessel territory from 31 days to 6 months and 1 year. A total of 16 patients with 16 intracranial atherosclerotic lesions were treated with 16 COMETIUs. All procedures were performed under general anesthesia with 100% device and technical success rates, with no cases of periprocedural stroke or death. The mean radiographic follow-up duration was at least 6 months postoperatively, and all patients presented for radiographic and clinical follow-up. There were no reported ischemic or hemorrhagic strokes. Angiographic follow-up for all patients revealed no cases of ISR. COMETIU is safe and effective for treating ICAS, with minimal risk during the procedure and a low rate of ISR during medium-term follow-up.

Cerebrovascular events after transcatheter aortic valve implantation.

Periprocedural stroke after transcatheter aortic valve implantation (TAVI) remains a significant issue, which is associated with high morbidity, and is increasingly important as intervention shifts to younger and lower-risk populations. Over the last decade of clinical experience with TAVI, the incidence of periprocedural stroke has stayed largely unchanged, although it is prone to underreporting due to variation in ascertainment methods. The aetiology of stroke in TAVI patients is multifactorial, and changing risk profiles, differing study populations, and frequent device iterations have made it difficult to discern consistent risk factors. The objective of this review is to analyse and clarify the contemporary published literature on the epidemiology and mechanisms of neurological events in TAVI patients and evaluate potential preventive measures. This summary aims to improve patient risk assessment and refine case selection for cerebral embolic protection devices, while also providing a foundation for designing future trials focused on stroke prevention.

Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices - Insight From the OCEAN-LAAC Registry.

Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients. Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

A novel score to predict left atrial appendage thrombus and sludge in patients with persistent atrial fibrillation on chronic anticoagulants

Abstract Introduction Left atrium (LA) and left atrial appendage (LAA) thrombus may occur during atrial fibrillation (AF) and atrial flutter (AFl), and potentially cause main embolic events. Sludge is a pre-thrombotic condition, associated with long term adverse outcomes. Current guidelines do not recommend to perform transesophageal echocardiography (TEE) before cardioversion (CV) of patients with persistent AF/AFl when at least 3 weeks of anticoagulation are administered with appropriate compliance. Instead, they suggest TEE before atrial ablations (Abl), even in anticoagulated patients. Evidence to support these approaches are weak and conflicting, due to not infrequent occurrence of peri-procedural stroke and several reports of not negligible prevalence of LAA thrombus finding. Purpose Aim of the study was to evaluate the real prevalence of LAA thrombus and sludge in a retrospective cohort of consecutive anticoagulated patients with persistent AF and AFl, who underwent TEE before a scheduled cardioversion or catheter ablation. Moreover, clinical and echocardiographic characteristics were analyzed to develop a score that could predict the individual risk of combined thrombus/sludge. Methods We conducted a retrospective, monocentric, observational study, recruiting 1037 consecutive patients with persistent AF/AFl referred to our center for CV or Abl. TEE had been always performed to rule out thrombus and sludge before procedures. We collected data about patients characteristics, medication and compliance, electrographic and echocardiographic findings and type of scheduled procedure. Data was compared in univariate and multivariate analysis to identify possible predictors of LAA thrombus and sludge, and we used the last significant results to create a predictive score with logistic regression analysis. We identified best cutoff value with ROC curve. Results 767 patients were included in final dataset. Mean CHA2DS2-VASc was 3.2. LA/LAA thrombus and sludge were identified in 63 subjects (8.21%), 17 thrombi (2.21%) and 45 sludge (5.86%). Presence of valvular AF (+1), previous stroke or TIA (+1.5), heart failure history (+1), ventricular systolic (LVEF &amp;lt; 45%)(+0.5) and diastolic (Lateral E/e’ &amp;gt; 9) dysfunctions (+1) were significantly associated to higher risk of thrombus/sludge occurrence, meanwhile AFl (-1) was associated to lower risk. A novel score, called HEELP score, was developed based on these variables, and a threshold of 1 point showed high sensitivity (89%) and remarkable negative predictive value (98%). Conclusion Thrombus and sludge prevalence is not infrequent in anticoagulated patients with persistent AF/AFl. A strategy to perform TEE before procedures in patients with high risk features according to our score could be effective in preventing main embolic events, but it has to be validated in further studies.LAA empty (1), sludge (2), thrombus (3)HEELP score

Transcatheter or Surgical Replacement for Failed Bioprosthetic Aortic Valves

The use of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been rapidly expanding as an alternative treatment to redo surgical aortic valve replacement (SAVR) for failed bioprosthetic valves despite limited long-term data. To assess mortality and morbidity in patients undergoing intervention for failed bioprosthetic SAVR. This was a retrospective population-based cohort analysis conducted between January 1, 2015, and December 31, 2020, with a median (IQR) follow-up time of 2.3 (1.1-4.0) years. A total of 1771 patients with a history of bioprosthetic SAVR who underwent ViV-TAVR or redo SAVR in California, New York, and New Jersey were included. Data were obtained from the California Department of Health Care Access and Information, the New York Statewide Planning and Research Cooperative System, and the New Jersey Discharge Data Collection System. Exclusion criteria included undergoing TAVR or redo SAVR within 5 years from initial SAVR, as well as infective endocarditis, concomitant surgical procedures, and out-of-state residency. Propensity matching yielded 375 patient pairs. Data were analyzed from January to December 2023. ViV-TAVR vs redo SAVR. The primary outcome was all-cause mortality. Secondary outcomes were stroke, heart failure hospitalization, reoperation, major bleeding, acute kidney failure, new pacemaker insertion, and infective endocarditis. From 2015 through 2020, the proportion of patients undergoing ViV-TAVR vs redo SAVR increased from 159 of 451 (35.3%) to 498 or 797 (62.5%). Of 1771 participants, 653 (36.9%) were female, and the mean (SD) age was 74.4 (11.3) years. Periprocedural mortality and stroke rates were similar between propensity-matched groups. The ViV-TAVR group had lower periprocedural rates of major bleeding (2.4% vs 5.1%; P = .05), acute kidney failure (1.3% vs 7.2%; P < .001), and new pacemaker implantations (3.5% vs 10.9%; P < .001). The 5-year all-cause mortality rate was 23.4% (95% CI, 15.7-34.1) in the ViV-TAVR group and 13.3% (95% CI, 9.2-18.9) in the redo SAVR group. In a landmark analysis, no difference in mortality was observed up to 2 years (hazard ratio, 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV-TAVR was associated with higher mortality (hazard ratio, 2.97; 95% CI, 1.18-7.47) as well as with a higher incidence of heart failure hospitalization (hazard ratio, 3.81; 95% CI, 1.57-9.22). There were no differences in 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis. Compared with redo SAVR, ViV-TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years' follow-up. However, ViV-TAVR was associated with higher rates of late mortality and heart failure hospitalization. These findings may be influenced by residual confounding and require adjudication in a randomized clinical trial.