Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry.

Background: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry.

Methods: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019.

Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry.

Background: Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach.

Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study.

Aims: Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up.

Methods And Results: We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA).

The Impact of CHADS-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study.

Objectives: The aim of this study was to evaluate the impact of CHADS-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study.

Background: Baseline CHADS-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO).

Methods: Subjects were stratified according to CHADS-VASc and HAS-BLED scores.

Incidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study.

Objectives: This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).

Background: DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.

Methods: A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year.

Left atrial appendage occlusion for stroke despite oral anticoagulation (resistant stroke). Results from the Amplatzer Cardiac Plug registry.

Introduction And Objectives: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment.

Methods: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO.

Contrast-free, echocardiography-guided left atrial appendage occlusion (LAAo): a propensity-matched comparison with conventional LAAo using the AMPLATZER™ Amulet™ device.

Aims: Percutaneous left atrial appendage occlusion (LAAo) is commonly performed under fluoroscopy including the use of contrast dye. In this study, we aimed to assess feasibility and safety of contrast-free, 3D-echo-based LAAo with the use of the AMPLATZER™ Amulet™ device.

Methods And Results: We analyzed 20 patients (74 ± 10 years, 65% males) at an increased thromboembolic and bleeding risk (CHADSVASC 4.

A History of Percutaneous Left Atrial Appendage Occlusion with the PLAATO Device.

Percutaneous left atrial appendage occlusion was introduced as an alternative method for prevention of thromboembolism in patients with nonvalvular atrial fibrillation after extensive animal work in 2001. The first device was named Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO) and patented by the company Appriva. The device was invented by Michael Lesh, MD.

Comparison of the Feasibility and Safety of First- versus Second-Generation AMPLATZER™ Occluders for Left Atrial Appendage Closure.

Introduction: Left atrial appendage closure (LAAC) is considered an alternative to oral anticoagulation therapy in patients with atrial fibrillation (AF). The aim of this study was to compare the safety and efficacy of the first- and second-generation AMPLATZER Devices for LAAC, AMPLATZER Cardiac Plug (ACP) versus AMPLATZER Amulet™.

Methods: Procedural data, such as fluoroscopy time, radiation dose, and contrast-dye, as well as VARC criteria and major adverse events (MAEs) were assessed for both devices.

Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study.

Aims: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study.

Methods And Results: This multicentre prospective real-world registry included 1,088 patients (75±8.

Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Previous Major Gastrointestinal Bleeding (from the Amplatzer Cardiac Plug Multicenter Registry).

History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed.

Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug.

Objectives: Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events.

Methods: Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication.

Patients with intracranial bleeding and atrial fibrillation treated with left atrial appendage occlusion: Results from the Amplatzer Cardiac Plug registry.

Background: In patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative.

Objectives: To investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB.

A comparison of two-dimensional and real-time 3D transoesophageal echocardiography and angiography for assessing the left atrial appendage anatomy for sizing a left atrial appendage occlusion system: impact of volume loading.

Aims: Correct sizing of a left atrial appendage (LAA) closure system is important to avoid redeployment of the device and peri-device leaks. The aims of this study were to assess the significance of two-dimensional transoesophageal echocardiography (2D-TEE), real-time 3D transoesophageal echocardiography (RT 3D-TEE) and angiography for measuring the size of the LAA landing zone and to determine the impact on sizing an LAA closure device. Furthermore, we investigated the relevance of volume loading on LAA size.

Characterization of Cerebrovascular Events After Left Atrial Appendage Occlusion.

Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available.

Left atrial appendage occlusion with the AMPLATZER Amulet device: an expert consensus step-by-step approach.

Aims: This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience.

Methods And Results: Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript.

Impact of chronic kidney disease on left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation.

Background: Left atrial appendage occlusion (LAAO) using the Amplatzer cardiac plug (ACP) is a preventive treatment of atrial fibrillation related thromboembolism.

Aim: To assess the safety and efficacy of LAAO in patients with chronic kidney disease (CKD).

Methods: Among the ACP multicentre registry, 1014 patients (75±8yrs) with available renal function were included.

Comparison of Efficacy and Safety of Left Atrial Appendage Occlusion in Patients Aged <75 to ≥ 75 Years.

Left atrial appendage occlusion (LAAO) is emerging as a promising alternative to oral anticoagulation. Because aged patients present a greater risk of not only cardioembolic events but also major bleeding, LAAO might represent a valid alternative as this would allow oral anticoagulation cessation while keeping cardioembolic protection. The objective of the study was to explore the safety and efficacy of LAAO in elderly patients.

SAfety of Fondaparinux in transoesophageal echocardiography-guided Electric cardioversion of Atrial Fibrillation (SAFE-AF) study: a pilot study.

Background: Current guidelines recommend unfractionated heparin (UFH) or low-molecular-weight heparin plus an oral anticoagulant for the prevention of thromboembolism in patients undergoing electric cardioversion of atrial fibrillation (AF). Selective factor Xa inhibitors, such as fondaparinux, which has a favourable benefit-risk profile in the prevention and treatment of venous thromboembolism and the management of acute coronary syndromes, have not been systematically evaluated in this setting.

Aim: To evaluate the efficacy and safety of fondaparinux versus standard treatment in patients undergoing echocardiographically-guided cardioversion of AF.

Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug.

Aims: To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF).

Methods And Results: Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study.

The HAS-BLED score predicts bleedings during bridging of chronic oral anticoagulation. Results from the national multicentre BNK Online bRiDging REgistRy (BORDER).

Patients who receive long-term oral anticoagulant (OAC) therapy often require interruption of OAC for an elective invasive procedure. Current guidelines allow bridging therapy with either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Apart from the risk of embolism, bleeding is an important complication in this setting and the optimal perioperative management of such patients is still under discussion.

Perioperative bridging of chronic oral anticoagulation in patients undergoing pacemaker implantation--a study in 200 patients.

Objective: To assess the risk of bleeding and thromboembolism (TE) of bridging therapy with low molecular weight heparin (LMWH) in patients undergoing pacemaker implantation.

Background: Current guidelines on peri-procedural management of patients with chronic oral anticoagulation (OAC) give no explicit recommendations on how to treat patients undergoing pacemaker implantations. METHODS AND RESULTS Since 2000 all patients with chronic OAC undergoing pacemaker implantation were prospectively enrolled and treated following a pre- specified bridging regimen with enoxaparin using reduced LMWH doses in patients at non high TE risk and renal impairment.

Prognosis of octogenarians with severe aortic valve stenosis at high risk for cardiovascular surgery.

Background: Calcified aortic valve stenosis (AVS) is a disease found in the elderly which is often complicated by severe co-morbidities.

Aims: To assess the survival of conservatively treated patients >75 years with severe AVS compared to patients with non-severe AVS but who have a similar clinical risk profile; and to identify risk factors affecting prognosis.

Methods And Results: From 2002 to 2006, 161 patients (mean age 86±7.