Watchman LAA

Background The interrelationships between left atrial appendage (LAA) dimensions and device following implantation are unknown. We aimed to analyze the impact of Watchman device implantation on LAA dimensions following its percutaneous closure and potential predictors of remodeling. Methods and Results All consecutive LAA closure procedures performed at 2 centers between November 2017 and December 2020 were included in the WATCH-DUAL (Watchman 2.5 Versus Watchman FLX in a Dual-Center Left Atrial Appendage Closure Cohort) registry...

BACKGROUND: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years. OBJECTIVES: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial. METHODS: The medication regimen and key clinical outcomes were reported through 3 years including: 1) the composite of ischemic stroke or systemic embolism (SE); 2) the composite of all strokes, SE, or cardiovascular (CV) death; 3) major bleeding; and 4) all-cause death and CV death...

AIMS: Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. METHODS AND RESULTS: An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm)...

This case report describes a successful procedure involving pulmonary vein isolation (PVI) and left atrial appendage (LAA) closure with a watchman device in a 78-year-old male with atrial fibrillation and an interrupted inferior vena cava. Due to the vascular anomaly, a transhepatic approach was used, which proved successful.

INTRODUCTION: Among patients with non-valvular atrial fibrillation (AF) and percutaneous left atrial appendage closure (LAAC) undergoing direct current cardioversion (DCCV), the need for and use of LAA imaging and oral anticoagulation (OAC) is unclear. OBJECTIVE: The purpose of this study is to evaluate the real-world use of transesophageal echocardiography (TEE) or cardiac computed tomography angiography (CCTA) before DCCV and use of OAC pre- and post-DCCV in patients with AF status post percutaneous LAAC...

INTRODUCTION: Nonvalvular atrial fibrillation (NVAF) is a highly prevalent arrhythmia where loss of synchronized atrial contraction increases the risk of intracardiac thrombus particularly within the left atrial appendage (LAA). Anticoagulation is the mainstay of stroke prevention based on the CHA2 DS2 -VASc score; however, it does not account for LAA structural characteristics. METHODS: The research comprises a retrospective matched case-control study of 196 subjects with NVAF who underwent transesophageal echo (TEE)...

BACKGROUND: The Amplatzer Amulet (AA) and Watchman devices (WD) are the 2 most frequently used devices for percutaneous LAA closure globally. OBJECTIVE: To evaluate the safety and clinical outcomes associated with these 2 devices in patients undergoing percutaneous LAA closure. METHOD: We systematically searched all electronic databases from inception until February 21, 2023. The primary endpoint was procedure related complications. Secondary endpoints were device related thrombus, stroke, cardiovascular mortality, peri device leak, systemic embolism, and all-cause mortality...

BACKGROUND: Percutaneous left atrial appendage (LAA) closure (LAAC) was developed as a nonpharmacologic alternative to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) who are at an increased risk for stroke or systemic embolism. The Watchman device permanently seals off the LAA to prevent thrombi from escaping into the circulation. Previous randomized trials have established the safety and efficacy of LAAC compared to warfarin. However, direct OACs (DOACs) have become the preferred pharmacologic strategy for stroke prevention in patients with AF, and there is limited data comparing Watchman FLX to DOACs in a broad AF patient population...

BACKGROUND: Transesophageal echocardiography (TEE) and cardiac computed tomography angiography (CCTA) are currently utilized for left atrial appendage closure (LAAC) planning. During the recent global iodine contrast media shortage in 2022, cardiac magnetic resonance imaging (CMR) was utilized for the first time for LAAC planning. This study sought to assess the utility of CMR versus TEE for LAAC planning. METHODS: This single center retrospective study consisted of all patients who underwent preoperative CMR for LAAC with Watchman FLX or Amplatzer Amulet...

BACKGROUND: In patients with non-valvular atrial fibrillation, the vast majority of thrombi originate in the left atrial appendage (LAA). Thus, occluding the LAA significantly reduces one's risk for developing an ischaemic stroke. To date, many different surgical methodologies in LAA occlusion (LAAO)/exclusion have been studied and utilized. Unfortunately, patients are often left with incomplete closure of their LAA, leaving behind residual lobes that continue to allow thrombus formations...

AIM: To explore the feasibility and accuracy of virtual reality (VR) derived from cardiac computed angiography (CCTA) data to predict left atrial appendage occlusion (LAAO) device size. METHOD: Retrospective data of patients who underwent LAAO according to clinical indication were reviewed; all patients underwent a pre-procedural CCTA. Measurements of the left atrial appendage (LAA) orifice diameters by CCTA, VR, and transesophageal echocardiography (TEE) (acquired during the procedure) were compared to the implanted device size...

INTRODUCTION: Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization (DME) requiring percutaneous or surgical retrieval. METHODS: We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information...

Background The PINNACLE FLX (Protection Against Embolism for Non-valvular AF [Atrial Fibrillation] Patients: Investigational Device Evaluation of the Watchman FLX LAA [Left Atrial Appendage] Closure Technology) trial evaluated the safety and efficacy of a next-generation left atrial appendage closure device (WATCHMAN FLX; Boston Scientific, Marlborough, MA). At 1 year, the study met the primary end points of safety and anatomical efficacy/appendage closure. This final report of the PINNACLE FLX trial includes the prespecified secondary end point of ischemic stroke or systemic embolism at 2 years, also making it the first report of 2-year outcomes with this next-generation left atrial appendage closure device...

Objective . To evaluate the value of individualized planning of left atrial appendage occlusion (LAAO) using cardiac computed tomography angiography (CCTA) reconstruction techniques. Methods . A total of 96 patients treated for LAAO with the Watchman occluder were included in this study. All patients were randomized by random number table in a 2:1 ratio into the CCTA (+) and CCTA (-) groups according to whether CCTA was performed preoperatively. 3D cardiac reconstruction was performed preoperatively in the CCTA (+) group to plan the location of the atrial septal puncture site, left atrial appendage(LAA) landing zone, predict the size of the occluder and simulate occluder release...

BACKGROUND: Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage closure (LAAC). OBJECTIVES: The aim of this study was to investigate the efficacy and safety of ICE-guided LAAC with the Watchman FLX device. METHODS: The ICE LAA (I Can See Left Atrial Appendage) study was a prospective, multicenter study with independent adjudication of echocardiographic data by a core laboratory and clinical events by a clinical events committee...

AIMS: The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting. METHODS AND RESULTS: Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory...

BACKGROUND: Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited. OBJECTIVES: This analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial. METHODS: Successful implants occurred in 903 patients with an Amulet occluder (dual occlusive mechanism device) and 885 patients with a Watchman device (single occlusive mechanism device)...

BACKGROUND: Although peri-device leakage is frequently observed after left atrial appendage occlusion (LAAO), there is no consensus on the optimal management strategy. It is unknown whether additional plugging should be preferred over surgical exclusion of the LAA, as experience with additional plugging is limited. CASE SUMMARY: In this case report, we demonstrate the clinical implications of additional plugging and surgical exclusion in a 65-year-old male patient with peri-device leakage and recurrent thromboembolic events...

BACKGROUND: Left atrial appendage (LAA) closure (LAAC) in atrial fibrillation (AF) patients with the reversed chicken-wing (RCW) LAA is challenging. AIMS: To elucidate the LAAC strategy of the RCW-LAA. METHODS: A total of 802 AF patients who were enrolled in the LAACablation registry for LAAC procedure were included, 55 of whom presented with the RCW-LAA. The WATCHMAN device was implanted using the standard protocol when the sheath depth was no less than the device depth (the simple group)...

BACKGROUND: Though uncommon, pericardial effusion and cardiac tamponade are serious complications of left atrial appendage closure (LAAC). There are few data related to delayed pericardial effusions from this procedure. METHODS: This is a single-center prospective analysis of 369 patients who underwent LAAC from December 2016 to March 2022 at a large teaching hospital. We compared patients who developed effusion (n = 5) to patients who did not (n = 364) to determine if there were any factors that predispose patients to developing acute (AEs) or delayed pericardial effusions (DEs)...