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LAA closure device

Kazutaka Aonuma, Hiro Yamasaki, Masato Nakamura, Tatsushi Ootomo, Morimasa Takayama, Kenji Ando, Kenzo Hirao, Yoshihiro Morino, Kentaro Hayashida, Kengo Kusano, Michael L Main, Shigeru Saito
BACKGROUND: The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan. Methods and Results: A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA2 DS2 -VASc score ≥2 were enrolled...
October 11, 2018: Circulation Journal: Official Journal of the Japanese Circulation Society
Basel Ramlawi, Kareem Bedeir, James R Edgerton
The left atrial appendage (LAA) is a major site of clot formation in atrial fibrillation. Stand-alone thoracoscopic LAA complete closure can decrease stroke risk and may be an alternative to life-long oral anticoagulation.1 We describe our technique for totally thoracoscopic LAA exclusion with an epicardial clip device. This approach provides a safe and likely more effective alternative to LAA management than other endocardial devices.
September 18, 2018: Annals of Thoracic Surgery
Kaveh Oraii Yazdani, Satoru Mitomo, Neil Ruparelia, Luciano Candilio, Francesco Giannini, Richard J Jabbour, Damiano Regazzoli, Patrizio Mazzone, Stefano Stella, Nicoleta Sora, Matteo Montorfano, Antonio Colombo, Azeem Latib
OBJECTIVE: To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes. BACKGROUND: The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain. METHODS: Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n = 45) had complete LAA ostium coverage; group B (n = 42) had incomplete ostium coverage because of disc prolapse...
August 5, 2018: Catheterization and Cardiovascular Interventions
Paolo A Pagnotta, Mauro Chiarito, Elton Pllaha, Dennis Zavalloni Parenti, Marco L Rossi, Riccardo Mantovani, Francesco Pisano, Giulio G Stefanini, Bernhard Reimers
AIMS: Left atrial appendage (LAA) closure is considered an effective option in patients with non-valvular atrial fibrillation (NVAF) and contraindications to long-term oral anticoagulant (OAC) therapy. However, there are some concerns about safety of currently available devices. Our aim is to provide an initial assessment on feasibility and safety of the novel LAA closure Ultraseal device in patients with NVAF and contraindications to long-term OAC therapy. METHODS: Twenty-three consecutive patients with NVAF undergoing Ultraseal device implantation between July 2016 and February 2018 at two institutions were included...
July 27, 2018: Journal of Interventional Cardiology
Lucas V A Boersma, Benno J W M Rensing, Lisette I Wintgens, Martijn Klaver, Martin J Swaans
The left atrial appendage (LAA) is the main source of cardioembolic stroke in patients with atrial fibrillation without valvular disease. Oral anticoagulation (OAC) has proven effective for preventing strokes associated with atrial fibrillation but is complicated by inherent bleeding risk and therapeutic compliance. Mechanical closure of the left atrial appendage seems an attractive alternative, especially in patients for whom long-term oral anticoagulation is not a good option. In the past decade, several percutaneous techniques have become available for this, including the WATCHMAN device...
June 15, 2018: Nederlands Tijdschrift Voor Geneeskunde
Christopher R Ellis, Mohamed Metawee, Robert N Piana, Jeremy M Bennett, Mias Pretorius, Robert J Deegan
BACKGROUND: Incomplete surgical left atrial appendage occlusion (S-LAAO) with a narrow neck has been shown to predict an increased rate of embolic stroke. Patients with a previously attempted S-LAAO were systematically excluded from all clinical trials of LAA closure devices. OBJECTIVE: The purpose of this study was to evaluate the feasibility of Watchman LAA device closure for patients referred with chronically incomplete S-LAAO. METHODS: A prospective single-arm feasibility cohort evaluated only subjects undergoing Watchman LAA closure following incomplete S-LAAO...
August 15, 2018: Heart Rhythm: the Official Journal of the Heart Rhythm Society
John J Squiers, James R Edgerton
Occlusion of the left atrial appendage (LAA) may protect against stroke in patients with atrial fibrillation. While percutaneous LAA closure devices have demonstrated efficacy in stroke reduction, surgical LAA occlusion has been performed with mixed results to date. Although surgical exclusion via internal sutures or noncutting stapler is ineffective due to recanalization of the LAA, surgical excision and certain exclusion devices including the AtriClip device are effective methods to achieve complete closure of the LAA...
February 2018: Journal of Atrial Fibrillation
David Nehemiah Majule, Chang Jing, Willfredius Mugishagwe Rutahoile, Felix Samuel Shonyela
The standard treatment for stroke risk patients with non-valvular atrial fibrillation (NVAF) is the use of oral anticoagulants (OACs). However, a substantial number of patients have relative or absolute contraindications to OACs due to concerns of major bleeding risk and other adverse effects while using oral anticoagulation therapy. Recently, occurrences of exclusion of the left atrial appendage (LAA) in patients with contraindication to anticoagulation therapy are widely expanding worldwide, causing major contentious discussions...
June 29, 2018: Annals of Thoracic and Cardiovascular Surgery
Mohit K Turagam, Poonam Velagapudi, Saibal Kar, David Holmes, Vivek Y Reddy, Marwan M Refaat, Luigi Di Biase, Amin Al-Ahmed, Mina K Chung, Thorsten Lewalter, James Edgerton, James Cox, John Fisher, Andrea Natale, Dhanunjaya R Lakkireddy
Left atrial appendage (LAA) closure has evolved as an effective strategy for stroke prevention in patients with atrial fibrillation who are considered suitable for oral anticoagulation. There is strong evidence based on randomized clinical trials with 1 percutaneous device, as well as a large registry experience with several devices, regarding the safety and efficacy of this strategy. In addition, there is encouraging data regarding the effect of epicardial LAA closure on decreasing arrhythmia burden and improvements in systemic homeostasis by neurohormonal modulation...
July 24, 2018: Journal of the American College of Cardiology
Anne-Lise Hachulla, Stéphane Noble, Gabriel Guglielmi, Daniel Agulleiro, Hajo Müller, Jean-Paul Vallée
OBJECTIVES: Correct device sizing for left atrial appendage (LAA) closure remains challenging due to complex LAA shapes. The aim of our study was to investigative the utility of personalized 3D-printed models (P3DPM) of the LAA to guide device size selection. METHODS: Fifteen patients (75.4 ±8.5years) scheduled for LAA closure using an Amulet device underwent cardiac computed tomography (CT). The LAA was segmented by semiautomatic algorithms using Vitrea® software...
June 14, 2018: European Radiology
Nico Reinsch, Ute Ruprecht, Jochen Buchholz, Christoph Edel, Hagen Kälsch, Kars Neven
AIMS: Stroke due to atrial fibrillation has been associated with a high risk of disability and mortality. Percutaneous left atrial appendage (LAA) closure has been established as an alternative strategy for stroke prevention in patients not eligible for oral anticoagulation. The LAmbre is a novel occluder, specifically designed for LAA closure adaptive to various LAA anatomies. The aim of this study was to demonstrate feasibility and initial experience in a nonprescreened patient cohort for LAA occlusion using the novel LAmbre occluder...
September 2018: Journal of Cardiovascular Medicine
Thomas Fink, Michael Schlüter, Roland Richard Tilz, Christian-Hendrik Heeger, Christine Lemes, Tilmann Maurer, Bruno Reissmann, Laura Rottner, Francesco Santoro, Shibu Mathew, Andreas Rillig, Feifan Ouyang, Karl-Heinz Kuck, Andreas Metzner
BACKGROUND: Epicardial left atrial appendage (LAA) ligation may be an alternative to oral anticoagulation management and to endocardial LAA closure devices. We report long-term results after LAA ligation with the second-generation LARIAT device. METHODS: Retrospective study was performed on patients who underwent LAA ligation at our center. Follow-up included patient visits and transesophageal echocardiography (TEE) to assess LAA-to-LA leakages. RESULTS: 76 patients with an indication for LAA closure underwent cardiac CT-based screening with 16 patients (21%) excluded from LAA ligation due to anatomical reasons...
June 7, 2018: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
Mathieu Granier, Guillaume Laugaudin, Franc Massin, Stephane Cade, Pierre Francois Winum, Cornelia Freitag, Jean-Luc Pasquie
AIMS: Percutaneous left atrial appendage (LAA) occlusion is occasionally incomplete, with residual permeability of the LAA on cardiac computed tomography. The cause for this is unclear. Our objective was to determine if residual permeability was related to incomplete endothelialization. METHODS: A total of 35 consecutive patients contraindicated for anticoagulant therapy admitted for LAA occlusion were included; 12 patients received a Watchman device (Boston Scientific) and 23 patients received an Amplatzer Cardiac Plug (St...
July 2018: Journal of Invasive Cardiology
Christopher R Ellis, Sam G Aznaurov, Neel J Patel, Jennifer R Williams, Kim Lori Sandler, Steven J Hoff, Stephen K Ball, S Patrick Whalen, John Jeffrey Carr
OBJECTIVES: This study sought to assess long-term left atrial appendage (LAA) closure efficacy of the Atriclip applied via totally thoracoscopic (TT) approach with computed tomographic angiography. BACKGROUND: LAA closure is associated with a low risk for atrial fibrillation-related embolic stroke. The Atriclip exclusion device allows epicardial LAA closure, avoiding the need for post-operative oral anticoagulation. Previous data with Atriclip during open chest procedures show a high efficacy rate of closure >95%...
December 11, 2017: JACC. Clinical Electrophysiology
Lisheng Jiang, Erich Duenninger, Manuela Muenzel, Xin Xue, Adam Fazakas, Thorsten Keil, Jiangtao Yu
BACKGROUND: Left atrial appendage closure (LAAC) is an efficient alternative of oral anticoagulation to prevent stroke in patients with non-valvular atrial fibrillation (NVAF). Due to complexities of LAA anatomy, a complete closure may not always be obtained with a single device. The aim of this study was to evaluate the feasibility and safety of the staged 'kissing-Watchman' technology to occlude the LAA with complex anatomy. METHODS: In our center, among 300 cases underwent LAAC with Watchman device from February 2012 to December 2016, 7 complex LAAs were implanted double devices using the staged 'kissing-Watchman' technology...
August 15, 2018: International Journal of Cardiology
Srinivas R Dukkipati, Saibal Kar, David R Holmes, Shephal K Doshi, Vijendra Swarup, Douglas N Gibson, Brijeshwar Maini, Nicole T Gordon, Michael L Main, Vivek Y Reddy
Background -In patients with atrial fibrillation (AF), left atrial appendage closure (LAAC) with the Watchman device prevents thromboembolism from the LAA; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation. Methods -We studied the device arms of 4 prospective FDA trials: PROTECT-AF (n=463); PREVAIL (n=269); CAP (n=566); CAP2 (n=578)...
May 11, 2018: Circulation
David H Yoo, Brian Clark, Daniel Nguyen, Timm-Michael Dickfeld, Andrew S Zohlman, Libin Wang, Vincent Y See
A 72-year-old man who underwent a left atrial appendage (LAA) closure device 2 years ago presented with atrial flutter with rapid ventricular rate and was referred for cardioversion. Precardioversion transesophageal echocardiogram showed left atrial thrombus and therefore the procedure was aborted. Currently, there is no guideline on imaging surveillance or anticoagulation in patients with LAA closure device who develop intracardiac thrombus after the initial 6-month surveillance period.
May 10, 2018: Pacing and Clinical Electrophysiology: PACE
Amish S Dave, Miguel Valderrábano
Up to 6.1 million people in the United States have atrial fibrillation (AF), which is associated with an increased risk of stroke. Oral anticoagulants are the mainstay of stroke prevention in AF. For decades, warfarin was the only available drug, fraught with compliance limitations, a narrow therapeutic window, and a high risk of hemorrhage. Pharmacologic developments have produced new anticoagulants that have improved the rates of stroke related to AF; however, they still confer a high risk of bleeding, making them unsuitable for some patients...
July 2017: Methodist DeBakey Cardiovascular Journal
Boris Schmidt, Timothy R Betts, Horst Sievert, Martin W Bergmann, Stephan Kische, Evgeny Pokushalov, Thomas Schmitz, Felix Meincke, Patrizio Mazzone, Kenneth M Stein, Hüseyin Ince, Lucas V A Boersma
INTRODUCTION: Pericardial effusion/tamponade (PE/PT) is a rare but serious complication following left atrial appendage closure (LAAC). It may be speculated that LAA contraction during sinus rhythm (SR) exerts mechanical force on the device that eventually leads to PE. We sought to determine the incidence and predictors of PE following LAAC using Watchman with special emphasis on the underlying heart rhythm during implant. METHODS AND RESULTS: From 47 centers in 13 European countries 1,020 patients underwent LAAC and data on baseline rhythm were available from 1,010 patients (mean age 73 ± 9 years, 60% male, median CHA2DS2-VASc = 4)...
July 2018: Journal of Cardiovascular Electrophysiology
Kee Soo Ha, Jae Young Choi, Se Yong Jung, Jung-Sun Kim, Ki Hyun Byun, Teiji Akagi, Mirjamol M Zufarov
BACKGROUND: Device embolization is the most frequent procedural complication during transcatheter closure of congenital cardiac defects. Retrieval of an embolized device may often be complicated by failure to introduce the right atrial (RA) disk hub into the sheath or difficulty in securely grasping the hub pin of RA disk. We aimed to evaluate the efficiency and success rate of device retrieval using a novel double snare technique. METHODS: We reviewed retrieval procedures of embolized atrial septal defect (ASD) or left atrial appendage (LAA) occluder using double snare technique reported from five tertiary referral centers in Korea, Japan, and Uzbekistan...
April 25, 2018: Journal of Interventional Cardiology
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