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Atrial fibrillation (AF) is the most common arrhythmia worldwide. Thromboembolism from the left atrial appendage (LAA) is the most feared complication in patients with AF. The cornerstone for the management of AF is oral anticoagulation to reduce the incidence of cardioembolic stroke. There is, however, a significant proportion of patients who cannot undergo long-term oral anticoagulation. Transcatheter LAA occlusion is an evolving technology with proven benefits in terms of AF-related stroke prevention, representing a valid alternative to anticoagulation for high-risk patients with contraindications for long-term oral anticoagulation. This has resulted in the development of a plethora of transcatheter devices to achieve endocardial occlusion or epicardial exclusion of the LAA.A panel of expert Italian cardiologists gathered under the aegis of the Italian Society of Interventional Cardiology (SICI-GISE) with the aim of reviewing the most relevant aspects of LAA occlusion, underlying anatomy and pathophysiology, summarizing current clinical knowledge, and discussing the practicalities of available devices and imaging techniques. Finally, the position paper highlights the importance of an adequate environment and of an appropriate organization in order to optimize all steps of the procedure.

Objectives: This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)-guided versus transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry., Background: TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO., Methods: Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed., Results: CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures., Conclusions: ICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding., Methods: From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset., Results: AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively., Conclusions: In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Data on device implantation safety and feasibility and long-term follow-up are limited., Methods and Results: LAAO was performed using the AMPLATZER Cardiac Plug (ACP) device in 134 NVAF patients with long-term OAC contraindication, with median (interquartile range) CHA2DS2-VASc and HAS-BLED scores of four (3-5) and three (2-3.75), respectively. Follow-up data were collected over a mean follow-up period of 680 days (range: 42 days to 4.3 years) comprising a total implant experience of 238 patient-years. Device implantation was successful in 95.5% of the procedures and associated with a rate of major procedural complications of 2.2%. At the most recent follow-up, almost all patients were receiving antiplatelet therapy. Ischaemic stroke was observed at an annual rate of 0.8% and the annual rate of any thromboembolic (TE) event was 2.5%. Major bleeding during follow-up occurred at an annual rate of 1.3%., Conclusions: LAAO is a safe and effective stroke prevention therapy in a high-risk NVAF cohort, both at implantation and over longer follow-up periods. The long-term assessed ischaemic stroke rate in patients treated with LAAO is markedly reduced compared to the expected rate based on the patients' risk scores.

Objectives: This dual-center study sought to demonstrate the utility and safety of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to transesophageal echocardiography (TEE) during Amplatzer Cardiac Plug device implantation., Background: Over 90% of intracardiac thrombi in atrial fibrillation originate from the left atrial appendage (LAA). Patients with contraindications to anticoagulation are potential candidates for LAA percutaneous occlusion. TEE is typically used to guide implantation., Methods: ICE-guided percutaneous LAA closure was performed in 121 patients to evaluate the following tasks typically achieved by TEE: assessment of the LAA dimension for device sizing; guidance of transseptal puncture; verification of the delivery sheath position; confirmation of location and stability of the device before and after release and continuous monitoring to detect procedural complications. In 51 consecutive patients, we compared the measurements obtained by ICE and fluoroscopy to choose the size of the device., Results: The device was successfully implanted in 117 patients, yielding a technical success rate of 96.7%. Procedural success was achieved in 113 cases (93.4%). Four major adverse events (3 cardiac tamponades and 1 in-hospital transient ischemic attack) occurred. There was significant correlation in the measurements for device sizing assessed by angiography and ICE (r = 0.94, p < 0.0001)., Conclusions: ICE imaging was able to perform the tasks typically provided by TEE during implantation of the Amplatzer Cardiac Plug device for LAA occlusion. Therefore, we provide evidence that the use of ICE offered accurate measurements of LAA dimension in order to select the correct device sizes., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)