Infective endocarditis associated with left atrial appendage occlusion device: a contemporary systematic review.

BACKGROUND: Data are limited regarding infective endocarditis (IE) complicating left atrial appendage occlusion (LAAO) device procedures. This systematic review examines the etiology, diagnosis, and management of infective endocarditis (IE) following LAAO. METHODS: A comprehensive search of six databases was performed between 2007 and 2022. In selecting studies, articles were included if they provided information about IE complicating LAAO, with relevant clinical and imaging details. Articles were excluded if they were editorials, study protocols, letters, or abstracts. RESULTS: We identified seven cases of IE complicating LAAO published between 2007 and 2022, from the United States and Europe, highlighting the exceedingly rare reported incidence of the condition. Staphylococcus aureus is the predominant organism implicated in LAAO infections. Echocardiography is a key imaging modality for diagnosing LAAO IE. Both antibiotic therapy and surgical intervention in appropriate patients are important for managing LAAO device-related IE. CONCLUSIONS: The limited data in the current literature regarding LAAO IE underscores the need for prospective clinical trials to establish evidence-based guidelines for infection prophylaxis, diagnosis, and management. Our findings emphasize the importance of vigilance for device-related infections, especially as the use of LAAO devices continues to grow worldwide.

Massive Hemoptysis: An Unusual Complication of Left Atrial Appendage Occlusion Device in Two Patients.

Left atrial appendage occlusion (LAAO) devices have emerged as a promising alternative for stroke prevention in non-valvular atrial fibrillation (NVAF) patients with contraindications to chronic anticoagulation therapy. The most common life-threatening procedural complications described in the literature include pericardial effusion, air embolism, and stroke. We here present a case report of two patients who experienced identical but rare post-procedural complications of pulmonary venous bleed, presenting as hemoptysis.

Structural Heart Imaging Using 3-Dimensional Intracardiac Echocardiography: JACC Cardiovascular Imaging Position Statement.

3-dimensional (3D) intracardiac echocardiography (ICE) is emerging as a promising complement and potential alternative to transesophageal echocardiography for imaging guidance in structural heart interventions. To establish standardized practices, our multidisciplinary expert position statement serves as a comprehensive guide for the appropriate indications and utilization of 3D-ICE in various structural heart procedures. The paper covers essential aspects such as the fundamentals of 3D-ICE imaging, basic views, and workflow recommendations specifically tailored for ICE-guided structural heart procedures, such as transeptal puncture, device closure of intracardiac structures, and transcatheter mitral and tricuspid valve interventions. Current challenges, future directions, and training requirements to ensure operator proficiency are also discussed, thereby promoting the safety and efficacy of this innovative imaging modality to support expanding its future clinical applications.

Left atrial appendage occlusion and patent foramen ovale closure using a steerable sheath and intracardiac echocardiography.

A patient presenting with acute ischemic stroke associated with patent foramen ovale (PFO) had concurrent deep vein thrombosis, pulmonary embolism, and new-onset atrial fibrillation. Upon initiation of anticoagulation therapy, the patient developed hemorrhagic transformation of the stroke. The patient's multiple potential sources of embolic stroke were treated with concomitant left atrial appendage occlusion and PFO closure through the PFO, made possible by using the Steerable Amulet Sheath under 3D-intracardiac echocardiography guidance.

Intracardiac Echocardiography-Applications in the Electrophysiology and the Cardiac Catheterization Labs.

Background. Intracardiac echocardiography (ICE) is routinely used in cardiac electrophysiology and catheterization labs. It plays a vital role in understanding cardiac anatomy, procedural planning, and early identification of complications. In this review, we describe the utility of ICE for procedures in the electrophysiology lab, including atrial fibrillation ablation, left atrial appendage occlusion device implantation, and cardiac implantable electronic device (CIED) extraction. Intracardiac echocardiography also helps in the identification of complications such as pericardial effusion, pulmonary vein stenosis, and left atrial appendage thrombus. Compared with traditional echocardiographic modalities such as transesophageal echocardiogram (TEE), ICE has equivalent image quality, requires less sedation, and possesses no risk of esophageal injury. The disadvantages of ICE include a learning curve and necessity for central vascular access.

Comparison of cardiac function and structure after left atrial appendage occlusion without versus with ablation in patients with non-valvular atrial fibrillation: a retrospective study.

The Aim of this study was to investigate the long-term impact of left atrial appendage occlusion (LAAO) on cardiac function and structure in patients with non-valvular atrial fibrillation (NVAF). 157 patients with NVAF who underwent LAAO or combined with ablation were included and divided into simple LAAO group or combined group. Long term impact of LAAO on cardiac function and structure were evaluated. Results showed that the procedures were performed successfully with 6.4% complications. During follow-up, there was a significant decrease of left atrial anteroposterior diameter (LAAD) at 6 months and a significant increase of left ventricular end-diastolic dimension (LVEDD) at 12 months after LAAO. A significant decrease in plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) was noted at 3 months, 6 months and 12 months after procedure. There was a significant decrease of LAAD, LVEDD, left ventricular end-systolic dimension (LVESD) and NT-proBNP levels in combined group at 3 months, 6 months and 12 months post- procedure, while an increase of left ventricular ejection fraction (LVEF). Meanwhile, no significant change of LAAD, LVEDD, LVESD, NT-proBNP and LVEF was seen in simple LAAO group at 3 months follow-up, but a decrease of NT-proBNP during 6 months and 12 months follow-up. Compared with simple LAAO group, combined group was associated with a significant increase of residual flow. In conclusion, LAAO has no significant effect on cardiac structure and function but can significantly reduce NT-proBNP. The improvement of cardiac structure and function in combined therapy comes from the result of ablation, not LAAO.

Understanding the role of the left atrial appendage on the flow in the atrium.

BACKGROUND: The exclusion/occlusion of the left atrial appendage (LAA) is a treatment option for atrial fibrillation (AF) patients who are at high risk of stroke and high risk of bleeding. As the role of the LAA is not well understood or explored, this study aims to assess its role on flow dynamics in the left atrium. METHODS: Computational fluid dynamics (CFD) simulations were carried out for nine AF patients before and after LAA exclusion. The flow parameters investigated included the LA velocities, Time Averaged Wall Shear Stress (TAWSS), Oscillatory Shear Index (OSI), Relative Residence Time (RRT), and Pressure in the LA. RESULTS: This study shows that, on average, a decrease in TAWSS (1.82 ± 1.85 Pa to 1.27 ± 0.96 Pa, p < 0.05) and a slight increase in OSI (0.16 ± 0.10 to 0.17 ± 0.10, p < 0.05), RRT (1.87 ± 1.84 Pa-1 to 2.11 ± 1.78 Pa-1, p < 0.05), and pressure (-19.2 ± 6.8 mmHg to -15.3 ± 8.3 mmHg, p < 0.05) were observed in the LA after the exclusion of the LAA, with a decrease in low-magnitude velocities. CONCLUSION: The exclusion of the LAA seems to be associated with changes in LA flow dynamics. Further studies are needed to elucidate the clinical implications of these changes.

Early Nonprocedural Bleeding After Left Atrial Appendage Occlusion.

BACKGROUND: Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. OBJECTIVES: This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. METHODS: This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. RESULTS: A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. CONCLUSIONS: Early nonprocedural bleeding after LAAO occurred in ∼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO.

Challenges and advances in device-related thrombus in left atrial appendage occlusion.

Oral anticoagulation therapy (OAC) is a mainstay for mitigating stroke and other embolic events in patients with atrial fibrillation (AF). Despite the demonstrated efficacy of OAC in reducing events, many patients are unable to tolerate OAC due to bleeding risks. Left atrial appendage occlusion (LAAO) devices were developed as implantable technologies to moderate stroke risk in patients with intolerance to OAC. Despite clinical data supporting near-comparable protection against thromboembolic events with OAC, device-related thrombus formation has emerged as a critical complication following LAAO that remains a potential limitation to the safety and efficacy of LAAO. Improved biocompatibility of LAAO devices with fluoropolymers, a well-established stent-coating technology used to reduce thrombus formation and promote endothelialization, may optimize outcomes after LAAO.

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Impact of Early Bleeding on Long-Term Mortality Following Left Atrial Appendage Occlusion.

BACKGROUND: Short-term antithrombotic therapy is recommended after left atrial appendage occlusion(LAAO) to reduce the risk of device-related thrombosis(DRT). However, patients referred for LAAO have excess bleeding risk. Yet, short-term bleeding events post-LAAO are not well characterized. OBJECTIVE: We aimed to evaluate the incidence of early bleeding post-LAAO and its association with long-term mortality risk. We also sought to identify predictors of early bleeding. METHODS: Patients who underwent LAAO at Mayo Clinic between 2018 and 2023 were included. Early bleeding was defined as bleeding that occurred within three months of discharge. A multivariable Cox proportional hazards model was used to assess the association between early bleeding and death and to estimate the hazard ratio(HR). Multivariable regression analysis was used to identify predictors of early bleeding. RESULTS: Among the 592 patients included, 389(66%) were male, and mean age was 75.6 years. Eighty-three patients(14.0%) experienced early bleeding, with the majority having minimal(63.4%) or minor(17.3%) bleeding. At a median follow-up of 14.4 months(IQR 4.2-27.9), early bleeding after LAAO was associated with an increased risk of all-cause mortality (adjustedHR, 2.07; 95%CI, 1.15-3.75; P=0.02). A history of intracranial bleeding, non-paroxysmal atrial fibrillation, CHA2DS2VASc score, and early DRT were independent predictors of early bleeding. Anti-thrombotic therapy on discharge was not associated with early non-procedural bleeding. CONCLUSIONS: One in seven patients experience a non-procedural bleeding event within 90 days after LAAO. Early bleeding after LAAO is associated with a higher all-cause mortality during mid-term follow-up. Further studies are needed to optimize the management of patients undergoing LAAO.

Step-by-step recommendations utilizing four-dimensional intracardiac echocardiography in left atrial appendage procedures.

INTRODUCTION: Four-dimensional (4D) intracardiac echocardiography (ICE) is a novel cardiac imaging modality that has been applied to various workflows, including catheter ablation, tricuspid valve repair, and left atrial appendage occlusion (LAAO). The use of this type of advanced ICE imaging may ultimately allow for the replacement of transesophageal echocardiography (TEE) for LAAO, providing comparable imaging quality while eliminating the need for general anesthesia. METHODS: Based on our initial clinical experience with 4D ICE in LAAO, we have developed an optimized workflow for the use of the NUVISION™ 4D ICE Catheter in conjunction with the GE E95 and S70N Ultrasound Systems in LAAO. In this manuscript, we provide a step-by-step guide to using 4D ICE in conjunction with compatible imaging consoles. We have also evaluated the performance of 4D ICE with the NUVISION Ultrasound Catheter versus TEE in one LAAO case and present those results here. RESULTS: In our comparison of 4D ICE using our optimized workflow with TEE in an LAAO case, ICE LAA measurements were similar to those from TEE. The best image resolution was seen via ICE in 2-dimensional and multislice modes (triplane and biplane). The FlexiSlice multiplanar reconstruction tool, which creates an en-face image derived from a 4D volume set, also provided valuable information but yielded slightly lower image quality, as expected for these volume-derived images. For this case, comparable images were obtained with TEE and ICE but with less need to reposition the ICE catheter. CONCLUSION: The use of optimized 4D ICE catheter workflow recommendations allows for efficient LAAO procedures, with higher resolution imaging, comparable to TEE.

Left Atrial Appendage Closure: Therapy Overview and Future Perspective.

The left atrial appendage (LAA) has gained increasing attention in the field of cardiology as a potential site for intervention in patients with atrial fibrillation (AF) and an elevated risk of thromboembolic events. Left atrial appendage occlusion (LAAO) has emerged as a promising therapeutic strategy to mitigate the risk of stroke and systemic embolism, especially in individuals who are unsuitable candidates for long-term anticoagulation therapy. This review aims to provide a comprehensive analysis of the current state of LAAO, encompassing its anatomic considerations, procedural techniques, clinical outcomes, and future directions.

Feasibility study on atrial fibrillation ablation with pulsed field ablation and concomitant occlusion of the left atrial appendage.

AIMS: Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach. METHODS AND RESULTS: We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60-125) for the combined procedure, 71 min (25-241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15-162) for individual LAAO. The respective fluoroscopy times were 21 (15-26), 15 (5-44), and 10 (3-50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34-93) and LAAO added 20 min (15-37). CONCLUSION: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration.

Outcomes of patients with cardiac amyloidosis undergoing percutaneous left atrial appendage occlusion.

BACKGROUND: There is limited data on the safety and efficacy of left atrial appendage occlusion (LAAO) devices in patients with cardiac amyloidosis. We examined the outcomes of patients with cardiac amyloidosis undergoing LAAO device implantation in a nationally representative cohort of patients. METHODS: The National Readmissions Database (NRD) was analyzed from 2016 to 2019 to identify patients ≥ 18 years old with atrial fibrillation (AF) undergoing LAAO. Patients were divided into those with cardiac amyloidosis and those without cardiac amyloidosis. A multivariable logistic regression model was utilized to assess the independent association of cardiac amyloidosis with in-hospital, 30-day/90-day/180-day outcomes after adjusting for confounders. RESULTS: Our cohort included 54,900 LAAO implantation procedures, of which 220 (0.4%) had cardiac amyloidosis. Patients with cardiac amyloidosis had a lower proportion of women and a lower prevalence of comorbidities including anemia, obesity, diabetes, and peripheral vascular disorders but a higher prevalence of stroke, as compared to those without cardiac amyloidosis. On multivariable analysis, cardiac amyloidosis was associated with significantly higher odds of peri-procedural major adverse events (adjusted odds ratio [aOR]: 2.69; 95% confidence interval [CI]: 1.41-5.14; p<0.01) and neurological complications (aOR: 5.48; 95% CI: 2.47-12.8; p<0.01). There was no difference in the odds of other peri-procedural complications, in-hospital mortality, hospital resource utilization, and 30/90/180-day all-cause/bleeding/stroke-related readmissions between both groups. CONCLUSION: Patients with cardiac amyloidosis undergoing LAAO device implantation have an increased risk of peri-procedural complications without any difference in bleeding/stroke-related readmissions. These hypothesis-generating findings need validation in future prospective studies.

The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients' stroke risk and preoperative atrial fibrillation status.

BACKGROUND: Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA2DS2-VASc score and preoperative atrial fibrillation or flutter (AF) status-the current trial attempts to provide such evidence. METHODS: The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA2DS2-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years. DISCUSSION: The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 . PROTOCOL VERSION: https://doi.org/10.1016/j.ahj.2023.06.003 .