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.

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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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.

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.

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.

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.

BACKGROUND AND 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: We have launched a program for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with 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. RESULTS: We performed the combined procedure in 10 patients (50% male; median age 70 years) and excluded two patients (17%) because of complex LAA anatomy. No death, stroke or major bleeding, including pericardial effusion, occurred. For single procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. Total median procedure duration was 79 minutes (range 60; 125) for the combined procedure, 71 minutes (25; 241) for individual AF ablation (51 minutes without and 78 minutes with 3D electroanatomic mapping) and 47 minutes (15; 162) for individual LAAO. Respective fluoroscopy times were 21 (15; 26), 15 (5; 44) and 10 (3; 50) minutes. For the combined procedure, femoral vein access to last PFA application lasted 49 minutes (34; 93) and LAAO added 20 minutes (15; 37). CONCLUSION: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible, safe, and can be executed within a short overall procedure duration.

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.

Single-Operator Left atrial appendage Occlusion utilizing Conscious sedation TEE, Lack of Outpatient pre-imaging, and Same-day Expedited discharge (SOLO-CLOSE): A comparison with conventional approach.

BACKGROUND: Left atrial appendage occlusion (LAAO) with WATCHMAN currently requires preprocedural imaging, general anesthesia, and inpatient overnight admission. We sought to facilitate simplification of LAAO. AIMS: We describe and compare SOLO-CLOSE (single-operator LAA occlusion utilizing conscious sedation TEE, lack of outpatient pre-imaging, and same-day expedited discharge) with the conventional approach (CA). METHODS: A single-center retrospective analysis of 163 patients undergoing LAAO between January 2017 and April 2022 was conducted. The SOLO-CLOSE protocol was enacted on December 1, 2020. Before this date, we utilized the CA. The primary efficacy endpoint was defined as successful LAAO with ≤5 mm peri-device leak at time of closure. The primary safety endpoint was the composite incidence of all-cause deaths, any cerebrovascular accident (CVA), device embolization, pericardial effusion, or major postprocedure bleeding within 7 days of the index procedure. Procedure times, 7-day readmission rates, and cost analytics were collected as well. RESULTS: Baseline characteristics were similar in both cohorts. Congestive heart failure (37.5% vs. 11.1%) and malignancy (28.8% vs. 12.5%) were higher in SOLO-CLOSE. Median CHA2D2SVASc score was 5 in both cohorts. The primary efficacy endpoint was met 100% in both cohorts. Primary safety endpoint was similar between cohorts (p = 0.078). Mean procedure time was 30 min shorter in SOLO-CLOSE (p < 0.01). Seven-day readmissions for SOLO-CLOSE was zero. After SOLO-CLOSE implementation, there was a 188% increase in positive contribution margin per case. CONCLUSIONS: The SOLO-CLOSE methodology offers similar efficacy and safety when compared to the CA, while improving clinical efficiency, reducing procedural times, and increasing economic benefit.

Displacement of occluder after left atrial appendage closure: A case report.

Key Clinical Message: Atrial fibrillation is closely associated with thrombotic events. In non-valvular atrial fibrillation, 90% of thrombi are formed by the left atrial appendage. Left atrial appendage occlusion (LAAC) can effectively prevent the detachment of left atrial appendage thrombus during atrial fibrillation, thereby reducing the risk of long-term disability or death caused by thromboembolic events. However, the identification and management of complications in LAAC are also very important. Abstract: The efficacy and safety of left atrial appendage occlusion (LAAC) in preventing non-valvular atrial fibrillation stroke have been confirmed by multiple randomized controlled and registered studies, and have been recommended by several guidelines for stroke prevention in patients with atrial fibrillation at high-risk of stroke. We reported an 80-year-old male patient with persistent atrial fibrillation. The patient underwent left atrial appendage closure surgery due to high risk of embolism and bleeding. On the second day after surgery, echocardiography showed displacement of the left atrial appendage occluder. Immediately perform removal of left atrial appendage occlude and left atrial appendage occlusion on the same day, and the patient was discharged on the fifth day after surgery without any special circumstances. This case demonstrates the feasibility and important clinical significance of using interventional surgery to remove the left atrial appendage occluder after displacement in clinical practice.

Early LAAO device migration after combined atrial fibrillation ablation and left atrial appendage occlusion.

The combined procedure of catheter ablation and percutaneous left atrial appendage occlusion for patients with atrial fibrillation has been shown to be safe and feasible using radiofrequency energy or cryoballoon.

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 .

Combining echocardiography and fluoroscopy imaging in real time for left atrial appendage occlusion - single center experience from Poland.

Introduction: Atrial fibrillation (AF) presents a growing health concern, often requiring stroke prevention measures, primarily through oral anticoagulation (OAC). Surgical interventions such as left atrial appendage occlusion (LAAO) offer alternatives when OAC is contraindicated. In recent years, percutaneous procedures have gained traction as minimally invasive options, demanding precise anatomical insights. Fusion imaging (FI), which combines transesophageal echocardiography (TEE) and fluoroscopy, has emerged as a potential game-changer in transcatheter interventions. Aim: This study introduces FI to LAAO procedures in Poland, assessing its role in guiding interventions, highlighting advantages, and exploring its potential to reshape cardiovascular interventions. Material and methods: We conducted a retrospective study involving LAAO procedures from March 2015 to December 2018, all utilizing FI. Patient indications, procedural specifics, and safety metrics were collected and analyzed. Follow-ups were conducted at 3 and 6 months. Results: A cohort of 83 patients (mean age: 72.1 ±8.4 years) underwent successful LAAO procedures. FI provided precise device placement and anatomical assessment. Mean procedure time was 54.9 ±34.3 min, contrast medium usage averaged 33.7 ±22.7 ml, and creatinine levels remained stable. Patients were discharged in about 4.2 ±3.4 days. Adverse effects were rare, including minimal bleeding and cardiac tamponade. Follow-ups demonstrated favorable outcomes with low adverse event rates. Conclusions: This study marks the inaugural application of FI in Polish LAAO procedures. FI, offering enhanced visualization and reduced procedure times, holds promise in improving patient safety and treatment efficacy. We recommend its consideration as a standard visualization technique for LAAO procedures.

The left atrial appendage: An enigmatic friend or foe and implications of closure.

The left atrial appendage (LAA) is often thought of as a vestigial organ serving as a nidus for clot formation in those with atrial fibrillation (A-fib). The LAA, however, has unique anatomy which allows it to serve special functions in the human body. Closing the LAA has been shown to decrease the risk of thromboembolic events in patients who cannot tolerate anticoagulation. Several methods of closure exist including percutaneous endocardial closure, epicardial closure, and surgical clipping. In addition to decreasing stroke risk, there appears to be physiologic changes that occur after LAA closure. This comprehensive review aims to describe the functions of the LAA, compare the different methods of closure, and propose a new method for identifying which patients may benefit from LAA closure versus anticoagulation based on each patients' individual comorbidities rather than their contraindications.

Percutaneous left atrial appendage closure for stroke prevention in hypertrophic cardiomyopathy patients with atrial fibrillation.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is an effective alternative strategy for stroke prevention in patients with atrial fibrillation (AF) at high risk for bleeding with anticoagulation (AC). Efficacy of this strategy in hypertrophic cardiomyopathy (HCM) remains uncertain. OBJECTIVE: The study aimed to compare risk of stroke in HCM-AF patients treated with LAAC with those treated with AC. METHODS: By use of the TriNetX Global Research Network, HCM-AF patients from 2015 to 2024 were assigned to categories of treatment with LAAC and treatment solely with AC and observed for 3 years for ischemic stroke, systemic embolism, and all-cause mortality. Propensity score matching was used to limit confounders. RESULTS: Of 14,867 HCM-AF patients identified, 364 (2.5%) were treated with LAAC vs 14,503 (97.5%) treated with AC. HCM LAAC patients were older (72 vs 67 years; P < .001) and had more comorbidities and more prior bleeding events, including higher rate of prior gastrointestinal bleeding (68% vs 18%; P < .001), compared with HCM patients treated solely with AC. After propensity score matching, there was no baseline difference between groups including prior bleeding events (P > .05). During follow-up, HCM patients treated with LAAC had higher rates of ischemic stroke (13% vs 8%; hazard ratio, 1.9; P = .006) and systemic embolism (14% vs 9%; hazard ratio, 1.8; P = .006) but no difference in mortality compared with matched HCM patients receiving AC. CONCLUSION: These real-world data do not support percutaneous LAAC in HCM-AF patients as the primary treatment strategy during long-term AC to reduce stroke risk. However, LAAC may remain a reasonable option for HCM-AF patients who are unable to tolerate AC because of prohibitive bleeding risk.

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study.

BACKGROUND: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device. OBJECTIVE: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study. METHODS: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported. RESULTS: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group. CONCLUSION: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios.