Search Results (47)

Background: Cardiac surgery patients with pre- or post-operative atrial fibrillation are at an increased risk for thromboembolic stroke, often due left atrial appendage (LAA) thrombus. Surgical LAA exclusion (LAAE) can be performed and must be complete to avoid increased thrombus formation. Methods: This prospective, multi-center, post-market study (NCT05101993) evaluated the long-term safety and performance of the epicardial V-shape AtriClip device. Patients ≥18 years who had received V-shape AtriClip devices during non-emergent cardiac surgery consented to a prospective 12-month follow-up visit and LAA imaging. The primary performance was LAAE without residual left atrium-LAA communication, assessed by imaging at the last follow-up visit. The primary safety was device- or implant procedure-related serious adverse events (SAEs) (death, major bleeding, surgical site infection, pericardial effusion requiring intervention, myocardial infarction) within 30 days. Results: Of 155 patients from 11 U.S. centers, 151 patients had evaluable imaging. Complete LAAE was obtained in all patients. Primary performance in the intent-to-treat population was met, with 97% (95% CI 93.52%, 99.29%; p = 0.0001) complete LAAE. Primary safety was met, with 100% (95% CI 97.75%, 100%; p < 0.0001) of patients free from pre-defined SAEs within 30 days. One device-related SAE was reported, which resolved intraprocedurally. Conclusions: AtriClip V-Clip showed safe and successful LAAE through 12 months of follow-up. Full article

Background/Objectives: Extracellular volume (ECV) expansion reflects myocardial fibrosis and may play a role in subjects with severe aortic stenosis (AS) receiving transcatheter aortic valve implantation (TAVI). This study aimed to assess the relationship between cardiovascular risk factors (CVRF), AS severity and left ventricular myocardial ECV measured by cardiac computed tomography (CCT). Methods: 61 patients qualified for TAVI underwent pre-procedural CCT. CVRFs were recorded, including advanced age, male gender, obesity, hypertension, hypercholesterolemia, hypertriglyceridemia, type 2 diabetes, and smoking. The CCT protocol included non-contrast (for aortic valve calcium score, AVCS), angiographic (for vascular access planning), and delayed phases (for left atrial appendage thrombus assessment). ECV was calculated from attenuation values of the interventricular septum and left ventricular cavity assessed in native and delayed phases. Patients were stratified based on the presence/absence of individual CVRFs, median AVCS, and aortic valve area (AVA). Results: Mean ECV was higher in patients with hypertension (28.01% vs. 26.93%, p = 0.03), smokers (28.71% vs. 26.52%, p = 0.01), AVCS ≥ 2975 (28.08% vs. 26.95%, p = 0.02), and AVA < 0.95 cm² (28.63% vs. 26.53%, p = 0.01). Positive correlations were found between ECV and the number of CVRFs (r = 0.49, p = 0.01), BMI (r = 0.30, p = 0.01), systolic BP (r = 0.31, p = 0.02), and AVCS (r = 0.36, p = 0.01); AVA correlated negatively (r = −0.59, p = 0.01). Regression showed that hypertension, smoking, and smaller AVA were independent predictors of higher ECV. Conclusions: Among TAVI candidates, hypertension, smoking, and more advanced AS are independently associated with increased myocardial ECV on CCT. These findings may reflect subclinical myocardial remodeling and support the added diagnostic value of ECV in pre-TAVI assessment. Full article

Objective: This study aims to investigate the correlation between the morphological and functional characteristics of the left atrial appendage (LAA) and the incidence of thromboembolic events by transesophageal echocardiography (TEE) in patients with acute ischemic stroke. Methods: This cross-sectional study included 171 patients with acute ischemic stroke, running from November 2022 to September 2024. Transesophageal echocardiography was performed to evaluate the presence of LAA thrombus. Multivariable logistic regression analysis was performed to identify risk factors for LAA thrombus. Results: Of the 171 patients, 19 (11.1%) were found to have LAA thrombus. Multivariable logistic regression identified two independent predictors of LAA thrombus formation: (1) left atrial spontaneous echo contrast (OR = 8, 95% CI: 3–19, p < 0.001) and (2) atrial fibrillation (OR = 8, 95% CI: 1.057–76.095, p = 0.044). Conclusions: Left atrial spontaneous echo contrast and atrial fibrillation are independent predictors of LAA thrombus in patients with acute ischemic stroke. The use of transesophageal echocardiography for early detection of LAA thrombus may help improve treatment strategies and prevent recurrent strokes. Full article

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in adults and is associated with significant morbidity and mortality, including an increased risk of stroke, heart failure, dementia, and recurrent hospitalizations. As life expectancy rises, both the incidence and prevalence of AF continue to grow. Stroke prevention remains a cornerstone of AF management, with oral anticoagulation being the primary strategy to reduce thromboembolic risk. However, despite their advantages, direct oral anticoagulants do not completely eliminate the risk of bleeding complications. For patients in whom anticoagulation is contraindicated, poorly tolerated, or ineffective at preventing AF-related stroke, interventional alternatives have gained traction. The left atrial appendage (LAA), a primary site of thrombus formation in AF, can be occluded through a catheter-based procedure known as left atrial appendage closure (LAAC) or left atrial appendage occlusion (LAAO). This review aims to provide imaging specialists with a comprehensive understanding of their role in LAAC, underscoring the importance of a multidisciplinary approach to enhance patient selection, procedural success, and long-term efficacy. Full article

The CHA₂DS₂-VASc score is the most widely used and recognized method for stroke risk stratification in atrial fibrillation (AF) patients. However, some patients with low scores still experience strokes. Given that 90% of cardiogenic strokes are caused by thrombus in the left atrial appendage (LAA), it is essential to incorporate hemodynamic and geometric features of the LAA into existing risk stratification models. This review first evaluates current stroke and bleeding risk stratification strategies, then analyzes the geometric and hemodynamic parameters within the left atrium and LAA, and finally compares the methods and techniques available for acquiring these parameters. Through these retrospective analyses, insights and recommendations for the management of AF patients and stroke prevention are provided. Outlooks on future research directions, such as the exploration of the mechanism of thrombus detachment, are discussed. Full article

Background/Objectives: Atrial fibrillation is a frequent comorbidity amongst patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation. Left atrial appendage occlusion (LAAO) can be performed to reduce the risk of stroke in patients with atrial fibrillation. Both procedures require large-bore venous access, transseptal puncture, and real-time imaging of the left atrium. However, limited data exist evaluating the safety and feasibility of concomitant M-TEER and LAAO. Methods: We performed a retrospective review of all concomitant M-TEER and LAAO procedures at our institution between May 2019 and September 2024 to evaluate the safety and feasibility of this approach. Results: Concomitant left atrial appendage occlusion was successful in all 15 patients, requiring an additional 15 min (IQR 11–29) of procedural time. No patients died or had a major vascular complication. Routine transesophageal echocardiography performed within 90 days showed no device related thrombus, and no significant peri-device leak in any patients. Conclusions: Concomitant M-TEER and LAAO are feasible but additional prospective studies or randomized trials are needed to evaluate the potential clinical benefit. Full article

Introduction: Due to the aging population, the number of elderly patients with atrial fibrillation and contraindications for anticoagulation due to bleeding complications is growing. After the epicardial ligation of the left atrial appendage (LAA), anticoagulation can be omitted. We present the single-center procedure data and long-term data of octogenarians being treated with LARIAT^®. Method: Out of 145 patients eligible for the epicardial ligation of the LAA, 45 were older than 80 y and included in this analysis. After successful ligation, patients were screened at 6 weeks of follow-up (FUP), at 12 weeks and after 12 months for transesophageal echocardiography (TOE) and clinical events. During long-term FUP, TOE sessions and clinical events for embolic events and death were documented. Results: The procedure was successful in 93% of patients, with a mean CHA₂DS₂VASC score of 4.6 and HASBLED score of 3.7 and a mean age of 82 y. One major complication occurred, with the laceration of the LAA and surgical closure of the LAA with an Atriclip. The 6-week FUP data were available in 39 patients, with the detection of four leaks (1–3 mm, median 2 mm) and three thrombi; one thrombus occurred at the site of a leak. The 12-week FUP (in 26 patients) showed that three leaks were closed, one leak persisted and one new thrombus developed at the site of the leak. All thrombi were resolved. The 12-month FUP showed the persistent resolution of three thrombi; one thrombus recurred after the withdrawal of the anticoagulant, and no new gap or thrombus could be detected. The long-term FUP (mean 38 months) was documented in 30 patients, with no new gaps and no new thrombi; one patient suffered from a stroke, with a good long-term result of LAA closure in TOE (stroke rate 1%/y, absolute risk reduction of 4.4% to a stroke rate of 5.4% related to the score, relative CHA₂DS₂VASC risk reduction of 88%). Eleven patients died: four in the first year of ligation and seven during long-term FUP. Conclusions: The epicardial ligation of the LAA for stroke prevention in octogenarians is highly safe and effective. Early TOE FUP is crucial for the detection of thrombi and establishing an optimal anticoagulation regime. No late development of thrombi or gaps can be observed at up to 5 years. Full article

With FDA-approved devices, left atrial appendage (LAA) occlusion has emerged as a well-established and rapidly growing approach to stroke prevention in patients with non-valvular atrial fibrillation. These devices are indicated for use in patients who are at increased risk of stroke and systemic embolism, as determined by CHA₂DS₂-VASc scores, and are suitable for anticoagulation therapy, with an appropriate rationale for seeking a non-pharmacologic alternative. This includes patients who may be unsuitable for long-term anticoagulation due to contra-indications. These devices, generally consisting of a nitinol-framed structure with a circular cross-section, are positioned within the LAA to obstruct the ostium, effectively preventing the thrombus from embolizing the brain. The initial clinical data from pivotal trials and observational registries indicated no strong correlation between peri-device leaks (PDLs) and adverse events. However, recent studies have shown that PDLs are associated with a higher risk of thrombo-embolic events, leading to renewed interest in managing PDLs. This paper reviews the occurrence of PDLs after percutaneous LAA occlusion using current FDA-approved devices, highlighting the need for non-circular occluders to better-accommodate the inherent variability in LAA anatomy. It also compares the benefits and limitations of emerging approaches still under investigation, focusing on addressing PDLs. 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: The risks of blood clot formation, stroke, heart failure (HF), and cardiovascular death are enhanced in individuals with atrial flutter (AFL). However, it remains unclear whether left atrial appendage thrombus (LAAT) in individuals with AFL with anticoagulation enhances the risk of cardiovascular morbidity and mortality. Thus, in the current trial, we aimed to evaluate the predictive role of LAAT for cardiovascular outcomes in individuals with AFL who were receiving anticoagulation and admitted for electrical cardioversion. Methods: Ninety patients were included in this prospective observational cohort study. The primary endpoint was the identification of LAAT by transesophageal echocardiographic examination. All participants were observed for a median of 2114.5 (interquartile range, 1487.5–2591) days to identify the secondary endpoints: cardiovascular death, transient ischemic attack (TIA), stroke, systemic thromboembolic complications, hospitalization due to HF, or myocardial infarction. Results: LAAT was identified in nine (10%) patients. No differences in cardiovascular outcomes between patients with and without LAAT were documented. However, a higher CHA₂DS₂-VASc score, previous myocardial infarction, and previous stroke/TIA/systemic thromboembolism were associated with significantly higher rates of hospitalization due to HF. Decreased left ventricular ejection fraction (LVEF) was associated with significantly higher rates of cardiovascular death, underscoring the significance of this marker in disease prognosis. Conclusions: The impact of LAAT on cardiovascular outcomes was insignificant. Higher CHA₂DS₂-VASc scores, previous myocardial infarction, previous stroke/TIA/systemic thromboembolism, and lower LVEF significantly affected long-term prognosis and were associated with a poor prognosis. Full article

Background: In patients with atrial fibrillation and contraindications for oral anticoagulation, in which an increased risk of stroke remains, a left atrial appendage exclusion should be considered for elimination, because the left atrial appendage is the most common site of thrombus. The aim of this study is to present the first-in-human study results of the Sierra Aegis Left Atrial Appendage Ligation System, a new epicardial-only left atrial appendage closure system. Methods: This study was a prospective, first-in-human, single-center study evaluating the effectiveness and safety of the Sierra Aegis Left Atrial Appendage Ligation System device for epicardial left atrial appendage closure. Seven patients (mean age: 57.3 ± 10.6 years, 71.4% male) were qualified for a left atrial appendage closure because of an increased risk of bleeding with the need for lifelong anticoagulation pharmacology due to an increased risk of stroke. The patients’ preoperative and intraoperative characteristics were collected. Patients were observed during their 1-month, 3-month, 6-month, and 1-year follow-up. Results: The mean procedure time was 21.2 ± 8.2 min. All patients spent 3 days in the hospital including monitoring, the performance of preoperative CT scans, and anatomical evaluation. No tamponade, bleeding, thrombus, or left atrial appendage leakage were observed during the procedure or in-hospital stay. During the 1-month, 3-month, 6-month, and 1-year follow-up visits, none of the patients reported any complications. No tamponade, leakage, or left atrial appendage thrombus were observed. Conclusions: This first-in-human study regarding Sierra use for left atrial appendage closure shows promising results regarding the effectiveness and safety of the Sierra device for use in humans. Full article

Left atrial appendage occlusion (LAAO) has emerged as a highly effective alternative to oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation. Precise pre-procedural planning and meticulous post-procedural follow-up are essential for achieving successful LAAO outcomes. This review explores the latest advancements in three-dimensional (3D) transoesophageal echocardiography (TOE) and computed tomography (CT) imaging modalities, which have considerably improved the planning, intra-procedural guidance, and follow-up processes for LAAO interventions. Innovations in 3D TOE and CT imaging have transformed the approach to LAAO by providing a more detailed and accurate assessment of the left atrial appendage, enabling clinicians to acquire comprehensive anatomical and morphological information, crucial for optimising device selection and positioning, thus reducing the risk of complications and enhancing the overall safety and efficacy of the procedure. Post-procedurally, CT and TOE imaging are invaluable in the monitoring of patients, ensuring that the device is correctly positioned and functioning as intended. Early detection of any complications (e.g., device-related thrombus and peri-device leaks) can help to risk-stratify patient at increased risk of stroke and initiate timely interventions, thereby improving long-term outcomes for patients. Full article

Background/Objective: Whether left atrial appendage thrombus (LAAT) in patients with atrial fibrillation (AF) on chronic anticoagulation significantly increases cardiovascular risk is unknown. This study aimed to assess LAAT prevalence and its predictive role in cardiovascular events among consecutive anticoagulated patients with AF admitted for electrical cardioversion. Methods: This prospective study included 500 patients. The primary outcome was LAAT on transesophageal echocardiography. Patients were followed up for a median of 1927.5 (interquartile range 1004–2643) days to assess cardiovascular events. Results: LAAT was detected in 65 (13%) patients. No significant differences in stroke, transient ischemic attack, systemic thromboembolic events, or myocardial infarction prevalence were observed between patients with AF with and without LAAT. Hospitalization for heart failure (HF) was more frequent in patients with LAAT than in those without LAAT; however, the effect of LAAT on HF hospitalization was not statistically significant. Patients with LAAT had a significantly higher risk of cardiovascular death than those without LAAT. LAAT and greater left atrial (LA) diameter were associated with higher rates of cardiovascular death. The independent HF hospitalization predictors were greater LA diameter, lower left ventricular ejection fraction (LVEF), and estimated glomerular filtration rate (eGFR). Conclusions: Patients with AF who received anticoagulation therapy showed a high prevalence of LAAT. LAAT and greater LA diameter were associated with significantly higher rates of cardiovascular death. LAAT, greater LA diameter, lower LVEF, and lower eGFR were associated with poor prognosis in anticoagulated patients with AF and were predictors of disease severity. Full article

(1) Background: Meteorological factors seem to exert various effects on human health, influencing the occurrence of diseases such as thromboembolic events and strokes. Low atmospheric pressure in summer may be associated with an increased likelihood of ischemic stroke. The aim of this study was to investigate the potential impact of meteorological conditions on left atrial appendage (LAA) thrombus formation. (2) Methods: A total of 131 patients were included, diagnosed with a first instance of thrombus via 3D transesophageal echocardiography (TEE) between February 2009 and February 2019. Months with frequent thrombus diagnoses of at least 10 thrombi per month were categorized as frequent months (F-months), while months with fewer than 10 thrombus diagnoses per month were labelled as non-frequent months (N-months). The analysis focused on differences in meteorological parameters in two-week and four-week periods before the diagnosis. (3) Results: F-months were predominantly observed in spring and summer (April, May, June, and July), as well as in February and November. During F-months, a higher absolute temperature difference, lower relative humidity, longer daily sunshine duration, and greater wind speed maximum were observed in the two- and four-week periods rather than for N-months. In the two-week period, average temperatures, equivalent temperatures, and temperature maxima were also significantly higher during F-months than N-months. (4) Conclusion: Thrombi in the left atrial appendage are more prevalent during periods characterized by high absolute temperature differences, low relative humidity, and long daily sunshine duration. Full article

A 69-year-old female presented with symptomatic atrial fibrillation. Cardiac amyloidosis was suspected due to an artificial intelligence clinical tool applied to the presenting electrocardiogram predicting a high probability for amyloidosis, and the subsequent unexpected finding of left atrial appendage thrombus reinforced this clinical suspicion. This facilitated an early diagnosis by the biopsy of AL cardiac amyloidosis and the prompt initiation of targeted therapy. This case highlights the utilization of an AI clinical tool and its impact on clinical care, particularly for the early detection of a rare and difficult to diagnose condition where early therapy is critical. Full article