Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study.

Christian Fastner,Ibrahim Akin,Mustafa Yildiz,Ibrahim El-Battrawy,Benjamin Sartorius,Martin Borggrefe,Tobias Becher,Michael Behnes,Kambis Mashayekhi,Stefan Baumann,Ralf Lehmann

doi:10.1186/s12872-016-0200-z

Abstract

BackgroundImplantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation. However, only few data about in-hospital and peri-procedural data are currently available. This study aims to report about echocardiographic, procedural and in-hospital data of patients receiving LAA occlusion devices.MethodsThis single-center, prospective and observational study includes consecutively patients being eligible for percutaneous implantation of LAA occlusion devices (either Watchman™ or Amplatzer™ Cardiac Plug 2). Data on pre- and peri-procedural transesophageal echocardiography (TEE), implantation and procedure related in-hospital complications were collected. The primary efficacy outcome measure was a successful device implantation without relevant peri-device leaks (i.e., < 5 mm).ResultsIn total, 37 patients were included, 22 receiving the Watchman™ and 15 ACP 2 device. Baseline characteristics did not differ significantly in both patient groups. The primary efficacy outcome measure was reached in 91.9 % of patients (90.9 % for the Watchman™, 93.3 % for the ACP 2 group). One device embolization (Watchman™ group) with successful retrieval occurred (2.7 % of patients). No thromboembolism or device thrombosis were present. The majority of bleedings was caused by access site bleedings (88.3 % of all bleedings), consisting mostly of mild hematomas corresponding to a BARC type 1 bleeding (80.0 % of all access-site complications). One patient died due to septic shock (non-procedure related).ConclusionsIn daily real-life practice, percutaneous treatment with LAA occlusion devices appears to be an effective and safe.

Highlights

Implantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation
The study was carried out according to the principles of the declaration of Helsinki and was approved by the medical ethics committee II of the Faculty of Medicine Mannheim, University of Heidelberg, Germany
The most common indication was a prior history of bleedings (78.4 %) under treatment with Oral anticoagulation (OAC). 51.4 % of all patients were not treated with OAC, whereas patients with OAC were mostly treated with direct oral anticoagulants (DOACs) (66.7 %)

Summary

Introduction

Implantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation. This study aims to report about echocardiographic, procedural and in-hospital data of patients receiving LAA occlusion devices. Cerebral ischemic stroke represents the most important fatal complication of AF deteriorating the prognosis of each individual patient. The so called CHA2DS2-VASc score assesses the patient’s individual annual stroke risk and allows a specific risk-adapted anticoagulant treatment [5]. Major bleedings- cerebral bleedings-still represent a most crucial complication of OAC, despite the fact that DOACs were shown to reduce the occurrence of intracranial hemorrhage [7]. Half of patients with an increased risk for thromboembolic complications and without any contraindication against OAC does not receive this treatment [8]

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