Peri-device Leak Research Articles

Safety of Amulet Left Atrial Appendage Occluder and Watchman Device for Left Atrial Appendage Closure in Patients With Atrial Fibrillation.

Left atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure, with the Amplatzer Amulet LAA Occluder (Abbott,Chicago, IL, USA) and Watchman device (Boston Scientific,Marlborough, MA, USA) being the most commonly used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in the safety profile of the Amplatzer Amulet LAA Occluder device in comparison to the Watchman device. The aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA Occluder and Watchman devices. Patients who underwent LAA closure using Watchman or Amulet devices from July 2015 to August 2020 at the American University of Beirut Medical Center were included in the analysis. Primary endpoints included peri-operative and post-procedural complications (thromboembolic events, bleeding complications, vascular access complications, pericardial effusion/tamponade, device positional complications and in-hospital death). The study included 37 patients (21 had Watchman devices, 16 had Amplatzer Amulet LAA Occluder devices, and 28 were men, mean age 76.57 ± 9.3 years). Seven patients developed post-procedural iatrogenic atrial septal defects (four in the Watchman group vs three in the Amulet group, p-value=0.982). Three patients developed pericardial effusion (one in the Watchman vs two in the Amulet group, p-value=0.394). Only one patient developed peri-device leak (one in the Watchman group vs none in the Amulet group, p-value=0.283). One device could not be deployed (one in the Amulet group vs none in the Watchman group, p-value=0.191). None of the patients developed in-hospital death, cardiac tamponade, device embolism, device thrombosis, stroke/transient ischemic attack (TIA), cranial bleeding, or arrhythmias after the procedure. The rate of peri-operative complications was similar between both groups. Both groups displayed low rates of adverse events in the peri-operative and post-operative periods. There was no significant difference in the safety profile of Amplatzer Amulet LAA Occluders and Watchman devices. There was a low incidence of peri-operative and post-operative adverse events with the implanted devices.

Combining catheter ablation and left atrial appendage occlusion in high-risk patients with atrial fibrillation: a propensity score-matched analysis

BackgroundThe safety and efficacy of a combined approach of catheter ablation (CA) and left atrial appendage occlusion (LAAO) compared to LAAO alone remain unknown. MethodsPatients with atrial fibrillation (AF) at increased stroke risk who underwent LAAO were divided into either combined (CA and LAAO) procedures or LAAO alone group. Propensity score matching was utilized to balance baseline characteristics. The primary endpoint of the study was a composite of death, thromboembolic events, major bleeding, heart failure (HF) rehospitalization, and major periprocedural complications. ResultsA total of 707 AF patients who underwent LAAO were included. After 1:1 propensity score matching, 166 patients who underwent LAAO alone (n = 83) or the combined procedure (n = 83) were analyzed. Successful LAAO was achieved in all (100%) patients, with a low incidence of periprocedural complications in both groups (2.4% vs. 4.8%, LAAO vs. combined, p = 0.68). The incidence of peri-device leak post-LAAO was significantly higher in the combined group (25.3% vs. 43.4%, p = 0.01). After a median follow-up of 2 years, there were no significant differences in the rates of the primary composite endpoint between the two strategies (22.2% vs. 14.3%, HR: 1.24 [95% CI: 0.51–2.97], p = 0.63). However, the rate of HF rehospitalization was significantly lower in the combined group (19.6% vs. 3.6%, HR: 4.89 [95% CI: 1.50–15.97], p = 0.024). ConclusionsCombining CA and LAAO in a “one-stop” approach is safe and brings additional benefits in relieving symptoms of heart failure, although peri-device leak was more common compared to LAAO alone.

Minimally invasive left atrial appendage occlusion plus reduced dose direct oral anticoagulant to prevent stroke in patients with atrial fibrillation-the LAAO-PlusRE.

The onset of atrial fibrillation (AF) has a direct association with left atrial appendage (LAA) function, as demonstrated by recent studies demonstrating the link between left atrial (LA) wall fibrosis, impaired contractility, and the development of AF. Non-valvular AF (NVAF) affects almost 30 million people worldwide, with this number expected to increase in the next 20 years. It is the main cause of ischemic stroke, with significant subsequent economic and social impact. Currently, the mainstay of stroke prevention in patients with NVAF is oral anticoagulation (OAC), which reduces the incidence of ischemic events at the stake of increased hemorrhagic events. Despite the introduction and widespread use of direct oral anticoagulants (DOACs), which almost completely replaced vitamin K antagonists (VKAs), the adherence to OAC is still low, hindering the efficacy of stroke prevention. Percutaneous LAA occlusion (LAAO) is now indicated (class IIB) in patients with NVAF at increased ischemic risk who cannot undergo OAC. Recently published data demonstrated that a reduced dose of DOAC after percutaneous LAAO is superior to long-term dual antiplatelet therapy (DAPT) for stroke prevention in the mid-term. One of the possible pitfalls of percutaneous LAAO is postprocedural peri-device leaks (PDLs) that have been associated with increased thromboembolic events. According to LAAOS III results, surgical LAAO during cardiac surgery brings a 33% reduction in risk of stroke at five years, independently from the OAC regimen with a high rate of complete appendage occlusion. The combination of surgical LAAO and reduced dose DOAC might ensure adequate embolic prevention, lowering the hemorrhagic risk. The present manuscript aims to describe the rationale and design of the Minimally Invasive Left Atrial Appendage Occlusion Plus REduced Dose DOAC To Prevent Stroke In Patients With Atrial Fibrillation Randomized Clinical Trial (LAAO-PlusRE).

Association of transcatheter left atrial appendage occlusion with acute changes in left atrial pressure: An invasive hemodynamic study

BackgroundThe hemodynamic effects of transcatheter left atrial appendage occlusion (LAAO) remain unclear. ObjectiveWe sought to assess the effect of LAAO on invasive hemodynamics and their correlation with clinical outcomes. MethodsWe recorded mean left atrial pressure (mLAP) before and after device deployment. We assessed the prevalence and predictors of mLAP increase after deployment, the association between significant mLAP increase after deployment and 45-day peridevice leak (PDL), and the association between mLAP increase and heart failure (HF) hospitalization. A significant mLAP increase was defined as one equal to or greater than the mean percentage increase in mLAP after deployment (≥28%). ResultsWe included 302 patients (36.4% female; mean age, 75.8 ± 9.5 years). After deployment, mLAP increased in 48% of patients, 38% of whom experienced significant mLAP increase. Independent predictors of mLAP increase were baseline mLAP ≤14 mm Hg, nonparoxysmal atrial fibrillation, and age per 5 years (odds ratios: 3.66 [95% CI, 2.21–6.05], 1.81 [95% CI, 1.08–3.02], and 0.85 [95% CI, 0.73–0.99], respectively). Significant mLAP increase was an independent predictor of 45-day PDL (odds ratio, 2.55; 95% CI, 1.04–6.26). There was no association between mLAP increase and HF hospitalization. ConclusionAfter deployment, mLAP acutely rises in 48% of patients, although this is not associated with increased HF hospitalizations. PDL is more likely to develop at 45 days in patients with significant increase in mLAP after deployment, although most leaks were small (<5 mm). These findings suggest that mLAP increase after deployment is not associated with major safety concerns. Additional studies are warranted to explore the long-term hemodynamic effects of LAAO.

Characteristics and outcome of patients with left atrial appendage closure in China: a single-center experience

BackgroundClinical characteristics and long-term data on the safety and efficacy of LAAC in preventing cerebrovascular accident and thromboembolism among Chinese patients with non-valvular AF (NVAF) remain limited.MethodsData of consecutive NVAF patients who underwent LAAC at Beijing Anzhen Hospital, Capital Medical University, from June 1, 2014, to December 31, 2021, were collected and analyzed retrospectively. The primary effectiveness endpoint was the composite endpoint of stroke/transient ischemic attack, systemic embolism, and death from cardiovascular causes. The primary safety endpoint is the severe bleeding defined by the LAAC Munich consensus.ResultsOf the 222 patients enrolled, the mean age was 66.90 ± 9.62 years, with a majority being male (77.03%). Many patients are non-paroxysmal AF (71.19%) with a median duration of AF of 4.00 years. The mean CHA2DS2-VASc score was 3.78 ± 1.49, and the mean HAS-BLED score was 1.68 ± 0.86. Thromboembolic events (76.58%) were the most common indication for LAAC. The device, technical, and procedural success rates were 98.65%, 98.65%, and 93.69%, respectively. The anticoagulation continuation rate was 56.36%, 31.25%, and 22.60% at 3-, 6- and 12 months post-procedure, respectively. Throughout a mean 2.81 years of follow-up, the incidence of the primary efficacy endpoint was 4.27 per 100 patient-years, predominantly attributable to stroke/TIA (3.12 per 100 PYs). Five patients experienced major bleeding during the follow-up period. Post-procedure imaging revealed minimal complications, with only one substantial peri-device leak. Device-related thrombus occurred in 2.33% of patients, resolving with anticoagulation.ConclusionThe study demonstrates that LAAC is a safe and effective alternative option for Chinese patients with AF, with a high success rate, few complications as well as fewer long-term adverse outcome events.

The use of percutaneous left atrial appendage occluder device in a patient with prior surgical ligation with incomplete exclusion: a case report

Abstract Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and the most common cause of cardioembolic stroke. The left atrial appendage (LAA) is the main source of thrombus formation in patients with AF. Therapies include use of percutaneous LAA closure devices, or surgical LAA occlusion (LAAO). Despite these options, complete closure of the LAA is not always achieved, and residual communication between the LAA and atrium may result in increased thrombus formation. Although studies have analysed the use of percutaneous measures such as coils, plugs, or second occluder device deployment in LAA with peri-device leak (PDL), use of percutaneous occlude devices in surgically occluded LAA is far less studied. Case summary We present a case of a 79-year-old female patient who underwent LAAO device deployment within a surgically occluded LAA with PDL. She underwent 27 mm LAAO device (WATCHMANTM) deployment and all the P.A.S.S. (Position, Anchor, Size, and Seal) criteria were satisfied. Only 1.4 mm PDL was present. She was continued on apixaban and aspirin post-operatively. Post-operative transoesophageal echocardiogram at 6 weeks demonstrated trivial PDL measuring 1.49 mm. Patient was continued on aspirin and clopidogrel, with discontinuation of apixaban. Discussion Percutaneous LAAO device deployment in previously surgically ligated LAA with incomplete exclusion is a potential therapeutic option for patients with AF and a high bleeding risk seeking a minimally invasive strategy, in an attempt to de-escalate anticoagulation therapy.

Left atrial appendage closure in patients with left atrial appendage thrombus guided by intracardiac echocardiography

BackgroundData regarding left atrial appendage closure (LAAC) in patients with left atrial appendage (LAA) thrombus are limited. Recently published cases have mostly been guided by transesophageal echocardiography. Intracardiac echocardiography (ICE) is now widely used during LAAC procedures. ObjectiveThis is the first study to report the feasibility of LAAC in patients with LAA thrombus guided by ICE. MethodsPatients with persistent LAA thrombus despite anticoagulation or contraindications to anticoagulation who underwent a modified ICE-guided LAAC procedure between June 2021 and April 2023 were included. Periprocedural events and clinical outcomes during follow-up were recorded. ResultsA total of 12 patients (mean age 65 ± 7 years; 92% male) were included: 10 with persistent LAA thrombus and 2 with contraindications to anticoagulation. Most of the thrombus was at the apex (n = 6), followed by the body (n = 3) and the ostium (n = 3). A LAmbre device was used and successfully implanted in all patients with the guidance of ICE. No thrombotic material was retrieved from patients with the protection of cerebral protection device (n = 11). No patient experienced severe periprocedural complications. All patients completed transesophageal echocardiography follow-up, and no device-related thrombus or peridevice leak > 3 mm was detected. None of the patients experienced stroke/transient ischemic attack, systemic embolism, or major bleeding events during a median follow-up of 147 days (interquartile range 80–306 days). ConclusionLAAC using the LAmbre device guided by ICE may be feasible in patients with LAA thrombus when performed by experienced operators.

Cardiac computed tomography angiography for assessment of endothelial insufficiency of left atrial appendage disc-like occluder.

This study was performed to explore the diagnostic value of cardiac computed tomography angiography (CCTA) for endothelial insufficiency (EIS) of a left atrial appendage (LAA) disc-like occluder. Fifty-nine patients with nonvalvular atrial fibrillation who underwent placement of an LAA disc-like occluder (LAmbre; Lifetech Scientific) in our hospital were retrospectively analyzed. Patients who were found to have contrast agent entering the LAA at the 3-month postoperative CCTA examination underwent Hounsfield unit (HU) measurement of the LAA and construction of a three-dimensional(3D) model of the device for preliminary discernment between peri-device leakage (PDL) and EIS. These patients were then further examined by transesophageal echocardiography (TEE) to check for concordance with the computed tomography (CT) findings. According to the CT and TEE results, all patients were divided into the PDL group, total endothelialization group, and EIS group. The endothelial conditions and other implantation-related results were also tracked at the 6-month follow-up. All 59 patients underwent successful implantation of the LAmbre LAA closure device with no severe adverse events during the procedure. Thirty-five patients were found to have contrast agent entering the LAA at the 3-month postoperative CCTA follow-up. Based on the CT HU measurement and the 3D construction analysis results, these 35 patients were divided into the PDL group (19 patients) and the EIS group (16 patients). In the PDL group, the contrast agent infiltrated from the shoulder along the periphery of the occluder on two-dimensional (2D)CT images, and the 3D model showed a gap between the LAA and the device cover. However, the CCTA images of the other 16 patients in the EIS group showed that the contrast agent in the occluder on the 2D CTA images and 3D construction model confirmed the absence of a gap between the LAA and the device cover. TEE confirmed all of the CT results. The 6-month follow-up results showed that 14 of 19 patients in the EIS group achieved total endothelialization, whereas this number in the PDL group was only five of 19 patients. CCTA can replace TEE for examination of the endothelialization status, and patients with EIS have a higher chance of endothelialization than patients with PDL.

Percutaneous left atrial appendage closure with the Watchman device: a systematic review.

Atrial fibrillation (AF) is the most commonly observed arrhythmia in the world and its prevalence increases with age. The main and most severe complication of AF is ischemic stroke. Oral anticoagulation (OAC) therapy is the standard of care for stroke prevention in the high risk population. Initiation of this treatment is associated with a substantial risk of bleeding complications. Moreover, there is a group of patients who cannot tolerate OAC. In patients with AF the left atrial appendage (LAA) is the main source of thrombus formation. Percutaneous left atrial appendage closure (LAAC) has become an important non-pharmacological intervention for stroke prevention in patients with non-valvular AF. The procedure aims to reduce the risk of thromboembolism without increasing the risk of bleeding. Over the last few years, the safety and long-term efficacy of the procedure in specific populations have increased and more patients are being treated. The Watchman device is the most studied device in this field. Randomized controlled trials demonstrated non-inferiority of percutaneous left atrial appendage closure using the WATCHMAN 2.5 device to OAC (Boston Scientific, Marlborough, MA, USA). The new generation device, WATCHMAN FLX, was introduced and its use was associated with fewer safety events and a higher success rate of effective appendage closure. Nevertheless, several unsolved problems remain, including device-related thrombosis, the post-LAAC antithrombotic regimen, and peri-device leakage. This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized.

Residual leaks following percutaneous left atrial appendage occlusion and outcomes: a meta-analysis.

Residual leaks are not infrequent after left atrial appendage occlusion. However, there is still uncertainty regarding their prognostic implications. The aim of this study is to evaluate the impact of residual leaks after left atrial appendage occlusion. A literature search was conducted until 19 February 2023. Residual leaks comprised peri-device leaks (PDLs) on transoesophageal echocardiography (TEE) or computed tomography (CT), as well as left atrial appendage patency on CT. Random-effects meta-analyses were performed to assess the clinical impact of residual leaks. Overall 48 eligible studies (44 non-randomized/observational and 4 randomized studies) including 61 666 patients with atrial fibrillation who underwent left atrial appendage occlusion were analysed. Peri-device leak by TEE was present in 26.1% of patients. Computed tomography-based left atrial appendage patency and PDL were present in 54.9% and 57.3% of patients, respectively. Transoesophageal echocardiography-based PDL (i.e. any reported PDL regardless of its size) was significantly associated with a higher risk of thromboembolism [pooled odds ratio (pOR) 2.04, 95% confidence interval (CI): 1.52-2.74], all-cause mortality (pOR 1.16, 95% CI: 1.08-1.24), and major bleeding (pOR 1.12, 95% CI: 1.03-1.22), compared with no reported PDL. A positive graded association between PDL size and risk of thromboembolism was noted across TEE cut-offs. For any PDL of >0, >1, >3, and >5 mm, the pORs for thromboembolism were 1.82 (95% CI: 1.35-2.47), 2.13 (95% CI: 1.04-4.35), 4.14 (95% CI: 2.07-8.27), and 4.44 (95% CI: 2.09-9.43), respectively, compared with either no PDL or PDL smaller than each cut-off. Neither left atrial appendage patency, nor PDL by CT was associated with thromboembolism (pOR 1.45 and 1.04, 95% CI: 0.84-2.50 and 0.52-2.07, respectively). Peri-device leak detected by TEE was associated with adverse events, primarily thromboembolism. Residual leaks detected by CT were more frequent but lacked prognostic significance.

Feasibility of contrast-free left atrial appendage closure with WATCHMAN FLX device for patients with chronic kidney disease.

Contrast media are generally necessary for transcatheter left atrial appendage closure (LAAC), however, it should be avoided in patients with chronic kidney disease (CKD). The objective of this study was to evaluate the safety and feasibility of contrast-free LAAC with WATCHMAN FLX device for patients with CKD. Among 141 patients undergoing LAAC using the WATCHMAN FLX between May 2021 and March 2023, we performed LAAC without contrast media in 10 patients. Procedural and follow-up results were evaluated. The device size was selected based on the transesophageal echocardiographic (TEE) measurements. The device shape was assessed by fluoroscopy, and the device position was adjusted by TEE images. The mean age was 78 ± 4.9years, CHADS2 score was 3.2 ± 1.1, and the estimated glomerular filtration rate (eGFR) was 28 ± 12mL/min/1.73m2. The procedure was completed without contrast media in ten patients. Partial recapture of the device was required in four patients, but the initially selected device was finally implanted in all patients. Mean procedure time was significantly shorter in the contrast-free LAAC than in the contrast-use LAAC (41.6 ± 14.1min vs 30.3 ± 7.6min, p = 0.01). Postprocedural eGFR did not change from baseline, and there were no adverse events during the hospital stay. Follow-up TEE or cardiac computed tomography performed within 3months after the procedure revealed no device-related thrombus or peri-device leak > 3mm, and oral antithrombotic therapy was discontinued in all patients. Our experience shows that contrast-free LAAC using the WATCHMAN FLX device was safe and feasible. Non-contrast LAAC is one of the therapeutic options for patients with severe CKD.

Incidence, impact and predictors of residual device patency after left atrial appendage closure with the LACbes device

BackgroundThe residual device patency (RDP) after left atrial appendage closure (LAAC) with the LACbes device has not been specifically explored in atrial fibrillation (AF) patients. This study aims to explore the incidence, impact and predictors of RDP detected by cardiac computed tomography angiography (CCTA) post LAAC. MethodsAF patients implanted with the LACbes device were prospectively enrolled. CCTA device surveillance was performed at 3 months post-procedure. Major adverse events (MAEs), including stroke/transient ischemic attack, major bleeding and all-cause death, were evaluated. ResultsAmong 141 patients with CCTA surveillance, 56 (39.7%) showed no visible leak and 85 (60.3%) showed RDP. During the median follow-up of 443 [232, 706] days, the presence of RDP was not associated with an increased risk of MAEs (adjusted hazard ratio [HR]: 4.07, 95% confidence interval [CI]: 0.49–34.24, p = 0.196), while peri-device leak (PDL) at the lobe was associated with heightened risks of MAEs (adjusted HR: 6.85, 95% CI: 1.62–28.89, p = 0.009). In patients with PDL at the lobe, antiplatelet after 6 months (HR: 0.20, 95% CI: 0.05–0.91, p = 0.038) was independent protective predictor of MAEs. Besides, current smoking (odds ratio [OR]: 7.52, 95% CI: 2.68–21.08, p < 0.001) and maximum diameter of LAA orifice (OR: 1.16, 95% CI: 1.00–1.34, p = 0.048) were independent predictors of PDL at the lobe. ConclusionsPresence of PDL at the device lobe detected by CCTA at 3-month post LAAC with LACbes is associated with unfavorable prognosis in AF patients.Clinical trial registration: ClinicalTrials.gov Identifier: NCT03788941.

Prognostic Value of Galectin-3 after Left Atrial Appendage Occlusion for Predicting Peri-Device Leakage

Echocardiographic detection of residual peri-device leakage (PDL) after percutaneous left atrial appendage occlusion (LAAO) is crucial for managing anticoagulation. Galectin-3, a protein involved in tissue–foreign body interactions, may hold significance in understanding PDL and cardiac tissue remodeling after LAAO. This study aimed to analyze galectin-3 serum levels in relation to PDL using a novel echo-morphological classification. LAAO eligible patients were included in the study. Galectin-3 serum levels were measured before LAAO, at 45 days (45D), and at 6 months (6M) after the procedure. Transesophageal echocardiography was used to assess LAAO success. A new echo-morphological classification categorized the degree of LAAO into three different types (A: homogenous echodensity, indicating completely thrombosed device; B: inhomogeneous echolucencies (&lt;50% of device); and C: partially thrombosed device with echolucencies &gt; 50%). Among 47 patients, complete LAAO was achieved in 60% after 45D and in 74% after 6M. We observed a significant increase and distribution of serum levels of galectin-3 [ng/mL] after 45D among the three types (baseline: 13.1 ± 5.8 ng/mL; 45D: 16.3 ± 7.2 ng/mL (Type A) vs. 19.2 ± 8.6 ng/mL (Type B) vs. 25.8 ± 9.4 ng/mL (Type C); p = 0.031), followed by a drop in galectin-3 for Types A and B after 6M toward and below the baseline levels (6M: 8.9 ± 3.1 ng/mL (Type A) vs. 12.4 ± 5.5 ng/mL (Type B)), whereas Type C persisted in showing elevated galectin-3 levels compared to all other types (6M: 17.5 ± 4.5 ng/mL (Type C); p &lt; 0.01). Increased galectin-3 serum levels after LAAO likely reflect the transition from thrombus formation to fibrotic scar development in the LAA lumen. Successful occlusion is associated with a time-restricted decrease in galectin-3 levels after 6 months, while relevant PDL leads to persistently elevated levels, making galectin-3 a potential predictor of occlusion success.

Peri-device leak after left atrial appendage closure: echocardiographic characteristics and thromboembolism risk

Abstract Background Structural variations in left atrial appendage (LAA) ostial morphology can contribute to incomplete closure of the LAA and peri-device leak (PDL) after LAA closure (LAAC). Prior data suggests that there is an increased residual risk of thromboembolism in patients with PDL after LAAC. However, there is a paucity of information on the interpretation of imaging data to risk stratify patients with PDL. Purpose We evaluated echocardiographic characteristics on post-LAAC imaging, and their association with residual risk of thromboembolism. Methods We analyzed data from follow up imaging with transesophageal echocardiograms (TEEs) which were performed at ∼1-year follow up after the LAAC with either the Watchman or Watchman-FLX device (Boston Scientific Inc). The images were reviewed in a blinded manner with regard to thromboembolic events after LAAC. In our analyses, we further classified the TEE images into 3 categories: 1) no leak, and completely thrombosed distal LAA, 2) no leak, but echolucent distal LAA (indicative of some residual, but undetectable, connection), or 3) presence of leak and echolucent distal LAA (Figure 1). Results A total of 650 patients underwent LAAC at our center between 3/2015 and 12/2021: age 75.8±8.9 years, 64% male, and CHA2DS2-Vasc 4.2±1.4. TEE imaging data (performed at 1-year or later after LAAC) was available for review in 460 patients. In 238 of 460 patients (51.7%) there was no leak and the LAA was completely thrombosed (Cohort 1). In 83 of 460 (18%) patients there no detectable leak but the LAA was echolucent (Cohort 2), and in 139 of 460 (30.2%) patients there was a discernible leak and the LAA was echolucent (Cohort 3). In this subset of 460 patients, there were 29 (3.2% per year) thromboembolic events (stroke or transient ischemic attack) over 2.0±0.2 years of follow-up; of these, only 3 (0.6% per year) strokes were disabling, and none were fatal. The median NIH stroke scale in patients with stroke/TIA was 2 (range 0-14; NIHSS &amp;lt; 5 is considered mild to moderate severity). During follow-up (2.0±0.2 years), the incidence of thromboembolism was highest in Cohort 3 (7.5% per year) in comparison to Cohort 2 (3.1% per year) and Cohort 1 (0.84% per year) (Figure 2). Upon analysis with 2 separate multivariable models, the risk of thromboembolism was highest in Cohort 3 vs Cohort 1 (adjusted OR 10.0, 95% CI: 3.3-30.0; p &amp;lt; 0.001) after adjusting for age, gender, CHA2DS2-VASc and LVEF. In contrast, when comparing Cohort 2 vs Cohort 1 in a multivariable model, the difference in thromboembolic risk was an adjusted OR 3.4 (95% CI: 0. 9-13.1; p = 0.07). Conclusions The presence of PDL after LAAC is not uncommon and confers a significant residual thromboembolic risk in patients with AF. TEE imaging characteristics aid in risk stratification of patients with PDL, and may help guide management decisions such as leak closure or resumption/continuation of anticoagulation to mitigate stroke risk.Figure 1:Classification based on reviewFigure 2:Comparison of incidence of th

Abstract 14182: Outcomes From Left Atrial Appendage Occlusion Utilizing the Watchman FLX versus Watchman 2.5: A Systematic Review and Meta-Analysis

Introduction: Left atrial appendage occlusion with the Watchman device has been shown to be noninferior to oral anticoagulation in preventing strokes in patients with atrial fibrillation. The Watchman FLX device was designed to overcome many of the limitations of the Watchman 2.5. Hypothesis: The Watchman FLX will have better short- and long-term safety and efficacy relative to the Watchman 2.5. Methods: We performed an extensive literature search and systematic review of studies that compared the short- and/or long-term safety and efficacy of the Watchman FLX versus Watchman 2.5. Risk ratio 95% confidence intervals (CI) were measured using the Mantel-Haenszel method for dichotomous variables, where a RR&lt;1.0 favors the FLX group. Results: Seven studies with a total of 2315 patients were included, of which 24.0% (n=555) had the FLX and 76.0% (n=1760) had the 2.5 implanted. There were no statistically significant differences in procedural complications or device-related thrombosis, but significantly less peri-device leak at follow-up, as shown in Figure 1. There were no statistically significant differences in pericardial effusion/tamponade (MD 0.54; 95% CI 0.09-3.25) or device embolization (MD 0.44; 95% CI 0.05-4.14). No statistically significant differences were seen in major bleeding (MD 1.06; 95% CI 0.55-2.05), transient ischemic attack, stroke or systemic embolism (MD 0.31; 95% CI 0.08-1.20) or all-cause mortality (MD 1.65; 95% CI 0.76-3.57) at follow-up. Conclusion: Based on the results of this meta-analysis, the Watchman FLX appears to be as safe as the Watchman 2.5, but with lower rates of peri-device leak.

Computed tomography-based device-sizing in Amplatzer Amulet left atrial appendage occlusion.

Amplatzer Amulet is a frequently used device for left atrial appendage occlusion (LAAO). The current sizing protocol is based on the maximum diameter of the left atrial appendage (LAA) landing zone. However, mean, perimeter-, or area-derived diameter might be more accurate measures for device sizing. Retrospective analysis of 150 consecutive patients undergoing LAAO is guided by pre-procedural cardiac CT. A total of 117 patients were included; 7 were excluded due to renal failure and 26 due to closure with the sandwich technique. The maximum, mean, area-, and perimeter-derived diameters of the landing zone were derived from pre-procedural cardiac CT scans, and their accuracy to predict the implanted device size was investigated. The predicted device size was determined based on the currently recommended sizing algorithm. Peri-device leak (PDL) was assessed (grade 1-3) along with the underlying mechanism. Device-sizing accuracy was superior for mean, area-, and perimeter derived diameters compared with the maximal diameter, especially for eccentric landing zones. Mean difference between predicted and actually implanted device size was 0.08mm (± 2.77), 0.30mm (± 2.40), - 0.39mm (± 2.43), and - 2.55mm (± 2.57) across mean, area-derived, perimeter-derived, and maximal diameter, respectively. Grade 3 peri-device leak was seen in 8.5% of implants without a significant association to the eccentricity of the landing zone. The leading mechanism for PDL was device malalignment. Our results indicate mean, area-, and perimeter-derived diameters of the device landing zone to perform similar and superior in device-sizing accuracy compared with the maximum diameter.

The CT derived angle between the transseptal puncture site and the left atrial appendage as a predictor for complex interventional occlusion procedures.

To evaluate the role of the CT-derived angle between the intra-atrial septum (IAS) and the left atrial appendage (LAA) on procedural complexity and clinical outcomes in left atrial appendage occlusion (LAAO) procedures. Given the broad variations in anatomy, LAAO remains one of the most challenging interventional procedures in structural heart disease. In recent years, preprocedural cardiac tomography (CT) has evolved as a valuable tool; however, prediction of procedural complexity remains cumbersome. We retrospectively analyzed 47 patients that underwent LAAO at our center in whom pre-procedural cardiac CT-scans were available. Among other baseline parameters, we measured the angle between the LAA ostium and the preferred transseptal puncture site at the IAS. We compared patients with an angle above and below the median regarding procedural characteristics and procedural outcome. The median angle between the LAA and the IAS was 127.3° (IQR: 120.9-141.3). LAAO took longer in patients with a measured angle below the median (55.0±22.7min vs. 41.3±17.5min; p=.04), resulting in longer radiation times (13.0±5.3min vs. 9.8±5.7min; p=.04) and more contrast use (61.1±47.5mL vs. 33.6±24.7mL; p=.05). Moreover, the necessity for a sheath exchange was significantly higher (30.4%vs. 4.2%, p=.02) and device repositioning or device resizing trended to be more frequent (26.1%vs. 8.3%; p=.1 and 21.7%vs. 8.3%; p=.2). There were no differences in procedural outcome, device-position and peri-device leak (PDL). The angle between the transseptal puncture site and the LAA ostium may serve as a predictor for more demanding LAAO interventions. In our study a steeper angle led to a prolonged procedure resulting in higher doses of contrast and radiation, but was not associated with a worse procedural outcome.

Mid-Term Feasibility of Percutaneous Left Atrial Appendage Occlusion in Elderly Patients with Non-Valvular Atrial Fibrillation.

Percutaneous left atrial appendage occlusion (LAAO) therapy using the WATCHMAN system has been introduced to prevent thrombosis and minimize the use of anticoagulants in patients with non-valvular atrial fibrillation. Given the high risk of bleeding and stroke in elderly patients, these patients would be good candidates for this therapy. However, the efficacy and feasibility of LAAO therapy in elderly patients remains uncertain. Consecutive patients who underwent LAAO therapy using the WATCHMAN system in a large academic center between June 2020 and March 2023 were included. The safety and efficacy of LAAO therapy during the 1-year observation period in patients aged ≥85 years old were compared with those in the younger cohort. A total of 188 patients (78.4 ± 6.9 years old, 133 male patients) were included. 34 patients were ≥85 years old, 96 were between 75 and 84 years old, and 58 were <75 years old. The elderly group had a higher CHA2DS2-VASc score and were at greater risk of falling-related bleeding compared with the younger cohort. The device implantations were successful in all patients except for one. During the 1-year observation period, one patient had a peri-device leak >5 mm and there were 6 device-related cases of thrombosis, whose incidence was not significantly different between the groups (p = 0.98). The cumulative incidences of bleeding and thrombotic events in the elderly group were as low as in the younger cohort (p > 0.05 for both). Most anticoagulants were terminated regardless of age. The mid-term feasibility and efficacy of percutaneous LAAO therapy using the WATCHMAN system in elderly patients aged ≥85 years were as acceptable as in the younger cohort.

Efficiency of optimal fluoroscopic projection angle defined by computed tomography angiography for left atrial appendage closure

BackgroundLeft atrial appendage (LAA) closure (LAAC) procedures are conventionally performed using empirical fluoroscopic viewing angles. However, because the LAA is a highly variable anatomical structure, these angles cannot depict the LAA in the optimal position. The present study aimed to assess the efficiency of using a novel optimal fluoroscopic projection angle (OPA) for LAAC and to validate its feasibility. MethodsThe OPAs of the derivation cohort were acquired using cardiac computed tomography angiography (CCTA) to assess its superiority for depicting LAA depth versus traditional working angles (TAs) of RAO 30°, CAU 20°. The practicability of OPA-guided LAAC was demonstrated by comparison between clinical data from the validation cohort and those from a propensity-score matched (PSM) control group, as well as randomized controlled studies investigating LAAC. ResultsOf 705 patients in the derivation cohort, the median OPA was RAO 46°, CAU 31°. Compared with TA, the OPA depicted a longer mean (±SD) LAA depth (5.1 ± 4.4) mm and a larger orifice diameter (1.1 ± 1.1 mm), (P < 0.0001 for both). All 38 OPA-guided LAACs were successful, with a shorter mean procedure duration (42.9 ± 12.3 min versus [vs.] 107.2 ± 41.5 min; P < 0.0001) and reduced device consumption (1.08 vs. 1.5 per case), compared with the PSM control group. At the 3-month follow-up, the incidence of peri-device leak was 52.6% (20/38) detected by CCTA, with a mean leakage of 1.6 ± 0.8 mm. ConclusionBy unfolding the LAA depth and orifice diameter for a better view, OPA demonstrated the potential to optimize LAAC procedural efficiency, although further larger-scale studies are required to confirm this.

Feasibility and safety of the direct current cardioversion at the time of left atrial appendage occlusion for patients with atrial fibrillation.

With an increasing number of patients undergoing left atrial appendage occlusion (LAAO), more attention is being paid to relieving clinical symptoms and improving the quality of life of these patients. For patients with atrial fibrillation (AF), direct current cardioversion (DCCV) is an alternate, nonpharmacological choice to restore sinus rhythm and relieve clinical symptoms. The purpose of this study was to assess the feasibility and safety of the DCCV at the time of LAAO for patients with AF. Forty patients were enrolled in the DCCV group undergoing the DCCV at the time of LAAO. The control group undergoing LAAO alone was formed by 1:1 matching. In the DCCV group, cardioversion was immediately successful in 30 (75%) patients, of which 12 (40%) had AF recurrence at the three-month follow-up. The failed-DCCV group was older (73.70 ± 4.74 vs. 62.20 ± 9.01 years old, P = 0.000), had a faster postcardioversion heart rate (88.80 ± 16.58 vs. 70.97 ± 14.73 times, P = 0.03), and had a higher mean HAS-BLED score (4.00 vs. 3.00, P = 0.01) than the successful-DCCV group. No patients experienced periprocedural pericardial effusion, occluder displacement, device embolism, or >5 mm peridevice leakage. One patient experienced a transient ischemic attack (TIA) in the DCCV group during the follow-up. The DCCV at the time of LAAO is feasible and safe for AF patients with contraindications for catheter ablation or AF recurrence after previous catheter ablation to restore the sinus rhythm and relieve clinical symptoms. The DCCV at the time of LAAO is more likely to succeed for younger patients and patients with lower HAS-BLED scores.