Search Results (27)

Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis (AS) across all surgical risk groups. However, periprocedural cerebrovascular events (CVEs), including overt stroke and silent cerebral embolism, remain significant complications. As a result, the use of embolic protection devices (EPDs) during TAVI has been proposed to mitigate this risk. Our aim was to provide a comprehensive review of the current evidence on the efficacy, safety, and clinical utility of embolic protection devices in TAVI procedures. According to the existing literature, EPDs are effective in capturing embolic debris during TAVI and are associated with a reduction in silent cerebral lesions as detected by diffusion-weighted MRI. While some RCTs and meta-analyses demonstrate a potential benefit in reducing disabling stroke, evidence for a consistent reduction in overall stroke or mortality remains inconclusive. Subgroup analyses suggest the greatest benefit in patients at elevated stroke risk, while current-generation EPDs demonstrate high technical success and an acceptable safety profile. Subsequently, EPDs represent a promising adjunct to TAVI, particularly in high-risk populations. However, routine use in all patients is not yet supported by consistent clinical evidence. Further large-scale trials and long-term outcome data are needed to clarify their role in improving neurological outcomes and to guide selective patient application. Full article

Neuroprotective strategies in coronary artery interventions are essential due to the rising number of high-risk patients undergoing procedures like coronary artery bypass grafting (CABG), totally endoscopic coronary artery bypass (TECAB), and hybrid revascularization. In this review article, we summarize the neurological complications associated with coronary artery disease intervention and the risk mitigation strategies. CABG carries significant risks, including ischemic stroke, encephalopathy, seizures, and peripheral nerve injuries. Risk factors include advanced age, hypertension, diabetes, and atherosclerosis. Off-pump CABG minimizes stroke risk by avoiding aortic manipulation and CPB. TECAB and hybrid revascularization have fewer reported neurological complications but still pose risks of stroke and cranial nerve injuries. Pharmacological neuroprotection includes agents such as barbiturates, volatile anesthetics, lidocaine, NMDA receptor antagonists, magnesium, nimodipine, corticosteroids, and aprotinin. Deep hypothermic circulatory arrest (DHCA) is reserved for complex aortic cases requiring a bloodless surgical field. Intraoperative strategies involve cerebral perfusion monitoring, embolic protection devices, and therapeutic hypothermia. Preoperative optimization targets risk factors, arrhythmia prevention, and antiplatelet therapy management. Postoperatively, timely antiplatelet administration, glucose control, hemodynamic stabilization, and cognitive monitoring are critical. Comprehensive neuroprotective approaches, spanning pre- to postoperative phases, aim to reduce neurological complications and enhance outcomes in coronary interventions. Full article

Stroke is a devastating complication of cardiovascular interventions. Intraprocedural stroke is a well-documented and feared risk of cardiac percutaneous transcatheter procedures. If clinically significant strokes are absent, silent strokes remain the next in line to pose large concerns related to future cognitive decline, stroke risk, and overall increased morbidity and mortality. Cerebral protection devices (CPD) developed overtime aim to neutralize this risk through either a capture-based filter or a deflector mechanism. Many CPDs exist currently, each one unique, with varying degrees of evidence. The adoption of CPDs has allowed cardiac percutaneous transcatheter procedures to be carried out in patients with high thromboembolic risks who may have historically been discommended. Though skewed towards certain devices and transcatheter procedures, a large body of evidence is still present across other devices and procedures. This review will discuss clinical importance and respective stroke rates, updated evidence surrounding CPDs, differing opinions across types of CPDs, cost benefits, and what lies ahead for CPDs within the realm of procedures undertaken in cardiac catheterization laboratories. Full article

(1) Background: Cerebral magnetic resonance imaging has reported new cerebral ischemic lesions after left atrial appendage (LAA) closure in about one- third of patients. Stroke occurs predominantly periprocedurally. This study evaluated the characteristics of embolized debris captured by the SENTINEL^TM cerebral embolic protection system in patients undergoing LAA closure; (2) Methods: Sixty filters of 30 consecutive patients undergoing LAA closure with the WATCHMAN FLX^TM device were collected and captured debris was analyzed by histopathology and histomorphometry. Clinical outcome measures were disabling and non-disabling stroke within 72 h; (3) Results: In most filters, no material was captured. The predominant captured debris was acute or organized thrombi. The most common pattern was acute fibrin-rich thrombus, which was detected in 11/30 (33.3%) patients. Particles of heart tissue were seen in 6/30 (20%) patients, and foreign material was seen in one (3.3%) patient. The number of particles ranged from 0 to 52 per patient with a maximum of 31 in the distal and 21 in the proximal filter. Particle diameter ranged from 131 to 2614 µm. By logistic regression analysis, only protected time remained a multivariable predictor for larger particles (p = 0.039). There was no disabling or non-disabling stroke. Compared to transfemoral aortic valve replacement, the number of particles is only about 1.5%. (4) Conclusion: LAA occlusion with the WATCHMAN FLX^TM was associated with a very low number of embolized particles captured with the double-filter SENTINEL^TM embolic protection system and no periprocedural stroke. Full article

Background/Objectives: Acute ischemic stroke is an uncommon but potentially devastating complication of Transcatheter Aortic Valve Implantation (TAVI). Despite improvements in device technology and procedural techniques, stroke rates have remained stable, with cerebral embolic protection devices demonstrating only limited efficacy to date. Therefore, the management of acute ischemic stroke complicating TAVI (AISCT) remains a key priority. We conducted a systematic review of the management of AISCT and provided multidisciplinary consensus recommendations for optimal management. Methods: PubMed, Google Scholar, and Cochrane databases were searched from inception to October 2023. All the original studies focusing on the treatment of AISCT were included. Non-English language studies, review articles, and studies in pediatric populations were excluded. Consensus recommendations were made by a working group comprising experts in stroke medicine and structural interventional cardiology. Results: A total of 18 studies met the inclusion criteria, including 14 case reports/series and 4 observational studies. No clinical trials were identified. The included case reports and series suggest that tissue-type plasminogen activator (tPA) and mechanical thrombectomy (MT) might be effective strategies for managing AISCT. However, significant bleeding complications were reported in two out of the four patients receiving tPA. Four observational studies also suggest an association between tPA and/or MT and improved functional outcomes and survival compared to conservative management. Higher bleeding rates were reported following tPA. Observational data suggest that there is currently little real-world utilization of either reperfusion strategy. Conclusions: There is an absence of high-quality randomized data to guide clinical decision making in this important area. Observational data suggest reperfusion strategies are associated with improved clinical outcomes once important confounders such as stroke severity have been accounted for. While MT can be recommended as the standard of care in appropriately selected patients, significantly increased rates of bleeding with tPA following large-bore arterial access raise important safety concerns. We present simple clinical guidance for AISCT based on the limited available data. Close multidisciplinary work and patient-specific consideration of ischemic and bleeding risk is essential. Full article

Cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR) has emerged as an important tool in reducing stroke risk associated with this intervention. With the recent expansion of TAVR into lower-risk populations, the role of preventive strategies gained greater significance. Despite advancements in TAVR technologies, peri-procedural stroke remains a significant complication, with rates ranging between 2 and 5%. CEP devices, introduced at the time of the procedure, have been developed to capture embolic debris and reduce the risk of neurological events. However, while MRI-detected embolic debris is commonly captured by these devices, the clinical benefit in reducing stroke remains debated. This review provides a comprehensive analysis of recent advances in relevant clinical research and CEP device development, offering recommendations for future studies to improve patient outcomes. Full article

Infective endocarditis (IE) is a life-threatening condition with increasing global incidence, primarily caused by Staphylococcus aureus, especially methicillin-resistant strains (MRSA). Biofilm formation by S. aureus is a critical factor in pathogenesis, contributing to antimicrobial resistance and complicating the treatment of infections involving prosthetic valves and cardiovascular devices. Biofilms provide a protective matrix for MRSA, shielding it from antibiotics and host immune defenses, leading to persistent infections and increased complications, particularly in cases involving prosthetic materials. Clinical manifestations range from acute to chronic presentations, with complications such as heart failure, embolic events, and neurological deficits. Diagnosis relies on the Modified Duke Criteria, which have been updated to incorporate modern cardiovascular interventions and advanced imaging techniques, such as PET/CT (positron emission tomography, computed tomography), to improve the detection of biofilm-associated infections. Management of MRSA-associated IE requires prolonged antimicrobial therapy, often with vancomycin or daptomycin, needing a combination of antimicrobials in the setting of prosthetic materials and frequently necessitates surgical intervention to remove infected prosthetic material or repair damaged heart valves. Anticoagulation remains controversial, with novel therapies like dabigatran showing potential benefits in reducing thrombus formation. Despite progress in treatment, biofilm-associated resistance poses ongoing challenges. Emerging therapeutic strategies, including combination antimicrobial regimens, bacteriophage therapy, antimicrobial peptides (AMPs), quorum sensing inhibitors (QSIs), hyperbaric oxygen therapy, and nanoparticle-based drug delivery systems, offer promising approaches to overcoming biofilm-related resistance and improving patient outcomes. This review provides an overview of the pathogenesis, current management guidelines, and future directions for treating biofilm-related MRSA IE. Full article

Background/Objectives: This study aimed to evaluate the incidence, risk factors, clinical implications, and rescue maneuvers of technical complications related to embolic protection devices (EPDs) during carotid artery stenting (CAS). Materials and Methods: We retrospectively reviewed all patients who had undergone CAS with EPDs between April 2018 and March 2024. The incidence and types of technical complication associated with EPDs were assessed. Clinical, angiographical, and procedural factors were analyzed to identify risk factors for the occurrence of EPD-related adverse events. Various rescue techniques for managing adverse events were investigated based on the procedure record. Results: Of the 158 enrolled patients, the rate of EPD-related technical complications was 23.4% (n = 37). Among them, complicated filter retrieval was the most common adverse event (n = 23, 14.6%). Older age, a higher degree of residual stenosis, and the type of the EPD were significant risk factors for complicated filter retrieval (p < 0.05). Although distal thrombus migration requiring thrombectomy was more frequent in patients with complicated filter removal (2.2% vs. 13.0%, p = 0.041), there was no significant increase in postprocedural thromboembolic and hemorrhagic complications. When complicated filter retrieval occurred, careful to-and-fro movement of the patients’ neck, such as rotation, or asking them to swallow was tried first in all 23 patients. When these attempts failed, manipulation of a curved-tip guiding catheter, the balloon bridge technique, and alternative use of a 5 Fr angiocatheter as a retrieval sheath were sequentially tried, and all filters were successfully retrieved. Conclusions: Complicated filter retrieval was the most common technical complication during CAS. Various rescue techniques for successful filter removal were effective for ensuring safety of CAS. Full article

Silent Brain Infarction (SBI) is increasingly recognized in patients with cardiac conditions, particularly Atrial Fibrillation (AF) in elderly patients and those undergoing Transcatheter Aortic Valve Implantation (TAVI). While these infarcts often go unnoticed due to a lack of acute symptoms, they are associated with a threefold increase in stroke risk and are considered a precursor to ischemic stroke. Moreover, accumulating evidence suggests that SBI may contribute to the development of dementia, depression, and cognitive decline, particularly in the elderly population. The burden of SBI is substantial, with studies showing that up to 11 million Americans may experience a silent stroke annually. In AF patients, silent brain infarcts are common and can lead to progressive brain damage, even in those receiving anticoagulation therapy. The use of cerebral embolic protection devices (CEPDs) during TAVI has been explored to mitigate the risk of stroke; however, their efficacy remains under debate. Despite advancements in TAVI technology, cerebrovascular events, including silent brain lesions, continue to pose significant challenges, underscoring the need for improved preventive strategies and therapeutic approaches. We propose a device consisting of a strut structure placed at the base of the treated artery to model the potential risk of cerebral embolisms caused by atrial fibrillation, thromboembolism, or dislodged debris of varying potential TAVI patients. The study has been carried out in two stages. Both are based on computational fluid dynamics (CFD) coupled with the Lagrangian particle tracking method. The first stage of the work evaluates a variety of strut thicknesses and inter-strut spacings, contrasting with the device-free baseline geometry. The analysis is carried out by imposing flow rate waveforms characteristic of healthy and AF patients. Boundary conditions are calibrated to reproduce physiological flow rates and pressures in a patient’s aortic arch. In the second stage, the optimal geometric design from the first stage was employed, with the addition of lateral struts to prevent the filtration of particles and electronegatively charged strut surfaces, studying the effect of electrical forces on the clots if they are considered charged. Flowrate boundary conditions were used to emulate both healthy and AF conditions. Results from numerical simulations coming from the first stage indicate that the device blocks particles of sizes larger than the inter-strut spacing. It was found that lateral strut space had the highest impact on efficacy. Based on the results of the second stage, deploying the electronegatively charged device in all three aortic arch arteries, the number of particles entering these arteries was reduced on average by $62.6$% and $51.2$%, for the healthy and diseased models respectively, matching or surpassing current oral anticoagulant efficacy. In conclusion, the device demonstrated a two-fold mechanism for filtering emboli: (1) while the smallest particles are deflected by electrostatic repulsion, avoiding micro embolisms, which could lead to cognitive impairment, the largest ones are mechanically filtered since they cannot fit in between the struts, effectively blocking the full range of particle sizes analyzed in this study. The device presented in this manuscript offers an anticoagulant-free method to prevent stroke and SBIs, imperative given the growing population of AF and elderly patients. Full article

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. Full article

Aims: To describe through emblematic images rare but clinically relevant carotid artery stenting complications that occurred at two high-volume centres for carotid artery stenting (CAS). Background: CAS is an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis in patients judged to be at high risk for CEA. CAS complications range between 1 and 9% and are higher in older patients complaining of neurological symptoms at the time of presentation. Besides periprocedural or early-after-procedure stroke, which remains the true Achilles’ heel of CAS, other dramatic complications might compromise the clinical outcomes of this procedure. Methods: Five infrequent complications, out of more than 1000 CAS performed in the years 2016–2021, have been described. Results: Among CAS complications, acute carotid stent thrombosis, rescue retrieval of a disconnected distal cerebral embolic protection device, plaque prolapse after carotid stenting, cerebral hyperperfusion syndrome (CHS), and radial artery long sheath entrapment requiring surgical intervention were found to account for 0.3% of the total number of procedures performed by operators with high CAS volume. Conclusions: Unusual CAS complications may infrequently occur, even in hands of expert operators. To know how to deal with such complications might help interventionalists to improve CAS performance. Full article

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

Intraprocedural stroke is a well-documented and feared potential risk of cardiovascular transcatheter procedures (TPs). Moreover, subclinical neurological events or covert central nervous system infarctions are concerns related to the development of dementia, future stroke, cognitive decline, and increased risk of mortality. Cerebral protection devices (CPDs) were developed to mitigate the risk of cardioembolic embolism during TPs. They are mechanical barriers designed to cover the ostium of the supra-aortic branches in the aortic arch, but newer devices are able to protect the descending aorta. CPDs have been mainly designed and tested to provide cerebral protection during transcatheter aortic valve replacement (TAVR), but their use in both Catheterization and Electrophysiology laboratories is rapidly increasing. CPDs have allowed us to perform procedures that were previously contraindicated due to high thromboembolic risk, such as in cases of intracardiac thrombosis identified at preprocedural assessment. However, several concerns related to their employment have to be defined. The selection of patients at high risk of thromboembolism is still a subjective choice of each center. The aim of this review is to update the evidence on the use of CPDs in either Cath labs or EP labs, providing an overview of their structural characteristics. Future perspectives focusing on their possible future employment are also discussed. Full article

(1) Background: This study aimed to investigate the effect of an additional catheter ablation (CA) procedure on the risk of post-procedure adverse events during CA combined with left atrial appendage closure (LAAC). (2) Methods: From July 2017 to February 2022, data from 361 patients with atrial fibrillation who underwent LAAC at our center were analyzed retrospectively. The adverse events were compared between CA + LAAC and LAAC-only groups. (3) Results: The incidence of device-related thrombus (DRT) and embolic events was significantly lower in the CA + LAAC group than in the LAAC-only group (p = 0.01 and 0.04, respectively). A logistic regression analysis revealed that the combined procedure served as a protective factor for DRT (OR = 0.09; 95% confidence interval: 0.01–0.89; p = 0.04). Based on a Cox regression analysis, the risk of embolism marginally increased in patients aged ≥65 years (HR = 7.49, 95% CI: 0.85–66.22 p = 0.07), whereas the combined procedure was found to be a protective factor (HR = 0.25, 95% CI: 0.07–0.87 p = 0.03). Further subgroup and interaction analyses revealed similar results. (4) Conclusions: The combined procedure may be associated with a lower rate of post-procedure DRT and embolization without a higher occurrence of other adverse events after LAAC. A risk-score-based prediction model was conducted, showing a good prediction performance. Full article

Background: Data to support the routine use of embolic protection devices for stroke prevention during transcatheter aortic valve replacement (TAVR) are controversial. Identifying patients at high risk for peri-procedural cerebrovascular events may facilitate effective patient selection for embolic protection devices during TAVR. Aim: To generate a risk score model for stratifying TAVR patients according to peri-procedural cerebrovascular events risk. Methods and results: A total of 8779 TAVR patients from 12 centers worldwide were included. Peri-procedural cerebrovascular events were defined as an ischemic stroke or a transient ischemic attack occurring ≤24 h from TAVR. The peri-procedural cerebrovascular events rate was 1.4% (n = 127), which was independently associated with 1-year mortality (hazards ratio (HR) 1.78, 95% confidence interval (CI) 1.06–2.98, p < 0.028). The TASK risk score parameters were history of stroke, use of a non-balloon expandable valve, chronic kidney disease, and peripheral vascular disease, and each parameter was assigned one point. Each one-point increment was associated with a significant increase in peri-procedural cerebrovascular events risk (OR 1.96, 95% CI 1.56–2.45, p < 0.001). The TASK score was dichotomized into very-low, low, intermediate, and high (0, 1, 2, 3–4 points, respectively). The high-risk TASK score group (OR 5.4, 95% CI 2.06–14.16, p = 0.001) was associated with a significantly higher risk of peri-procedural cerebrovascular events compared with the low TASK score group. Conclusions: The proposed novel TASK risk score may assist in the pre-procedural risk stratification of TAVR patients for peri-procedural cerebrovascular events. Full article