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JOURNAL ARTICLE
Fadi Sawaya, Bernard Abi-Saleh, Abbas Hoteit, Jennifer Jdaidany, Mohamad B Moumneh, Bernard Harbieh, Maurice Khoury, Salim Aramouni, Farah Abdulhai, Marwan Refaat
BACKGROUND: Left atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure, with the Amplatzer Amulet LAA Occluder (Abbott, Chicago, IL, USA) and Watchman device (Boston Scientific, Marlborough, MA, USA) being the most commonly used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in the safety profile of the Amplatzer Amulet LAA Occluder device in comparison to the Watchman device...
March 2024: Curēus
#2
JOURNAL ARTICLE
Xing-Wang Wang, Yi-Jing Yin, Jing Wang, Hong-Mei Yu, Qian Tang, Zhao-Yang Chen, Guo-Sheng Fu, Ke-Feng Ren, Jian Ji, Lu Yu
The left atrial appendage (LAA) occluder is an important medical device for closing the LAA and preventing stroke. The device-related thrombus (DRT) prevents the implantation of the occluder in exerting the desired therapeutic effect, which is primarily caused by the delayed endothelialization of the occluder. Functional coatings are an effective strategy for accelerating the endothelialization of occluders. However, the occluder surface area is particularly large and structurally complex, and the device is subjected to a large shear friction in the sheath during implantation, which poses a significant challenge to the coating...
March 28, 2024: Advanced Science (Weinheim, Baden-Wurttemberg, Germany)
#3
Xiaohua Liu, Yizhou Xu
INTRODUCTION: Left atrial appendage (LAA) closure (LAAC) is considered a viable alternative to anticoagulation therapy for stroke prevention in nonvalvular atrial fibrillation, we report a case with a less common shunt resulting from a device-related coronary artery-appendage fistula (CAAF) following LAAC. METHODS AND RESULTS: A 67-year-old male with a history of LAAC was referred to our emergency room with recurrent chest pain and palpitations and was diagnosed with ischemic angina pectoris...
March 11, 2024: Journal of Cardiovascular Electrophysiology
#4
JOURNAL ARTICLE
Sophie Eppinger, Kerstin Piayda, Roberto Galea, Marcus Sandri, Moniek Maarse, Ahmet Güner, Can Y Karabay, Ashish Pershad, Wern Y Ding, Adel Aminian, Ibrahim Akin, Karapet V Davtyan, Ivan A Chugunov, Eloi Marijon, Liesbeth Rosseel, Thomas Robert Schmidt, Nicolas Amabile, Kasper Korsholm, Juha Lund, Enio Guerios, Ignacio J Amat-Santos, Giacomo Boccuzzi, Christopher R Ellis, Avi Sabbag, Henning Ebelt, Brian Clapp, Hana Vaknin Assa, Amos Levi, Jakob Ledwoch, Sonja Lehmann, Oh-Hyun Lee, George Mark, Wendy Schell, Domenico G Della Rocca, Andrea Natale, Ole de Backer, Joelle Kefer, Pablo P Esteban, Mark Abelson, Pradhum Ram, Pamela Moceri, Jose G Galache Osuna, Xavier Millán Alvarez, Ignacio Cruz-Gonzalez, Tom de Potter, Moubarak Ghassan, Andrey Osadchiy, Weita Chen, Sandeep K Goyal, Francesco Giannini, Máximo Rivero-Ayerza, Shazia Afzal, Christian Jung, Carsten Skurk, Martin Langel, Mark Spence, Evgeny Merkulov, Mathieu Lempereur, Seung Y Shin, Jules Mesnier, Heather L McKinney, Brian T Schuler, Sebastien Armero, Livia Gheorghe, Marco B M Ancona, Lino Santos, Jacques Mansourati, Luis Nombela-Franco, Francesco Nappi, Michael Kühne, Achille Gaspardone, Jesper van der Pals, Matteo Montorfano, Juan Fernández-Armenta, James E Harvey, Josep Rodés-Cabau, Norbert Klein, Sajjad A Sabir, Jung-Sun Kim, Stephane Cook, Ran Kornowski, Antti Saraste, Jens E Nielsen-Kudsk, Dhiraj Gupta, Lucas Boersma, Lorenz Räber, Kolja Sievert, Horst Sievert, Stefan Bertog
BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes...
February 28, 2024: Cardiovascular Revascularization Medicine: Including Molecular Interventions
#5
Ahmad O Armouti, Sheyar Amin, David Z Rose
INTRODUCTION: The use of Left Atrial Appendage (LAA) occluder devices has been on the rise in patients with atrial fibrillation. Studies regarding the long-term risks of occluder devices remain sparse. MATERIALS & METHODS: In this brief report, we discuss the unusual case of an 85-year-old female with long-term complication from Left Atrial Appendage (LAA) closure: Device-Related Thrombus (DRT) about two years after insertion. RESULTS: Compared to the expected stroke rate without anticoagulation, patients with DRT on their LAAO device still had a 28 % relative reduction in ischemic stroke...
February 2, 2024: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
#6
JOURNAL ARTICLE
Alireza Mahjoubnia, Dunpeng Cai, Yuchao Wu, Skylar D King, Pooya Torkian, Andy C Chen, Reza Talaie, Shi-You Chen, Jian Lin
Four-dimensional (4D) printing unlocks new potentials for personalized biomedical implantation, but still with hurdles of lacking suitable materials. Herein, we demonstrate a bioresorbable shape memory elastomer (SME) with high elasticity at both below and above its phase transition temperature (Ttrans ). This SME can be digital light 3D printed by co-polymerizing glycerol dodecanoate acrylate prepolymer (pre-PGDA) with acrylic acid monomer to form crosslinked Poly(glycerol dodecanoate acrylate) (PGDA)-Polyacrylic acid (PAA), or PGDA-PAA network...
February 12, 2024: Acta Biomaterialia
#7
Raef Fadel, Essaq Khan, Waddah Maskoun
BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and the most common cause of cardioembolic stroke. The left atrial appendage (LAA) is the main source of thrombus formation in patients with AF. Therapies include use of percutaneous LAA closure devices, or surgical LAA occlusion (LAAO). Despite these options, complete closure of the LAA is not always achieved, and residual communication between the LAA and atrium may result in increased thrombus formation...
February 2024: European Heart Journal. Case Reports
#8
JOURNAL ARTICLE
Mohamad Alkhouli, James V Freeman, Christopher R Ellis, Atman P Shah, Hemal Gada, Megan Coylewright, Monica Lo, Akash Makkar, Himanshu Agarwal, Dhanunjaya Lakkireddy
BACKGROUND: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. OBJECTIVES: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. METHODS: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included...
January 19, 2024: JACC. Cardiovascular Interventions
#9
JOURNAL ARTICLE
Weidong Zhuo, Binhao Wang, Guohua Fu, Yibo Yu, Mingjun Feng, Jing Liu, Xianfeng Du, Huimin Chu
BACKGROUND: The diameter and shape of the left atrial appendage (LAA) orifices may influence occluder selection and the outcomes of left atrial appendage closure (LAAC) procedure. This study aimed to evaluate the impact of LAA orifice diameter on the safety and efficacy of LAAC using the LAmbre device. METHODS: A total of 133 patients with nonvalvular atrial fibrillation (AF) who underwent LAAC with the LAmbre device between June 2018 and June 2020 were included in this study...
January 17, 2024: Journal of the Formosan Medical Association
#10
JOURNAL ARTICLE
Zhiyong Duan, Genling Shi, Bin Wang, Yongjian Shen, Mengshi Xie, Zhenzhou Zhang, Xixi Dai, Weifeng Yao, Yunfei Liu, Hongyu Shi
INTRODUCTION: This study was performed to explore the diagnostic value of cardiac computed tomography angiography (CCTA) for endothelial insufficiency (EIS) of a left atrial appendage (LAA) disc-like occluder. METHODS: Fifty-nine patients with nonvalvular atrial fibrillation who underwent placement of an LAA disc-like occluder (LAmbre; Lifetech Scientific) in our hospital were retrospectively analyzed. Patients who were found to have contrast agent entering the LAA at the 3-month postoperative CCTA examination underwent Hounsfield unit (HU) measurement of the LAA and construction of a three-dimensional (3D) model of the device for preliminary discernment between peri-device leakage (PDL) and EIS...
January 8, 2024: Journal of Cardiovascular Electrophysiology
#11
REVIEW
Baraa Helal, Jibran Khan, Dalia AlJayar, Mohammad Salman Khan, Mohamad S Alabdaljabar, Zain Ul Abideen Asad, Christopher V DeSimone, Abhishek Deshmukh
BACKGROUND: Left atrial appendage closure (LAAC) is a treatment modality for stroke prevention in patients with atrial fibrillation (AF). One of the potential complications of LAAC is a peri-device leak (PDL), which could potentially increase the risk of thromboembolism formation. METHODS: This systematic review was done according to PRISMA guidelines. Using four databases, all primary studies through April 2022 that met selection criteria were included. Outcomes of interest were studies reporting on PDL characteristics, risk factors and management...
January 6, 2024: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
#12
JOURNAL ARTICLE
Franz Haertel, Paul Lustermann, Ali Hamadanchi, Katja Gruen, Jurgen Bogoviku, Pawel Aftanski, Julian Westphal, Laura Baez, Marcus Franz, P Christian Schulze, Sven Moebius-Winkler
Echocardiographic detection of residual peri-device leakage (PDL) after percutaneous left atrial appendage occlusion (LAAO) is crucial for managing anticoagulation. Galectin-3, a protein involved in tissue-foreign body interactions, may hold significance in understanding PDL and cardiac tissue remodeling after LAAO. This study aimed to analyze galectin-3 serum levels in relation to PDL using a novel echo-morphological classification. LAAO eligible patients were included in the study. Galectin-3 serum levels were measured before LAAO, at 45 days (45D), and at 6 months (6M) after the procedure...
November 27, 2023: International Journal of Molecular Sciences
#13
Sung-Han Yoon, Akram Y Elgendy, Luis Augusto Palma Dallan, Steven J Filby
Peri-device leak after left atrial appendage closure (LAAC) is often treated with endovascular coils, plugs, or second occluders. This is the first study reporting the Amulet device used for peri-device leak. An 80-year-old male with paroxysmal atrial fibrillation and recurrent falls with head trauma who underwent LAAC with a 24 mm Watchman 2.5 device 3 years ago at another institution was referred to our clinic for management of the peri-device leak. Transesophageal echocardiogram showed persistent residual peri-device leak with 5 mm width along the Coumadin ridge aspect of the device...
October 23, 2023: Catheterization and Cardiovascular Interventions
#14
JOURNAL ARTICLE
Mengxuan Zou, Donglin Zhuang, Horst Sievert, Yat-Yin Lam, Guangzhi Zhao, Wenbin Ouyang, Fengwen Zhang, Fang Fang, Deyuan Zhang, Anning Li, Xiangbin Pan
BACKGROUND: Most patients undergoing left atrial appendage closure (LAAC) are older adult individuals with atrial fibrillation (AF) and many comorbidities, which may elevate the risk for complications associated with contrast agents with the fluoroscopic image-guided procedure. This retrospective cohort study of patients with AF at high risk for use of contrast agents compared the feasibility and safety of LAAC using percutaneous and non-fluoroscopic procedure with transesophageal echocardiography (TEE) as the only image guidance relative to those under fluoroscopic image guidance...
September 1, 2023: Quantitative Imaging in Medicine and Surgery
#15
JOURNAL ARTICLE
Wei Li, Juan Zhao, Zhongbao Ruan, Li Zhu, Yin Ren, Bo Zhang
OBJECTIVE: The Watchman 2.5 occluder device is a useful device to treat atrial fibrillation (AF), and predicting the size of the Watchman 2.5 occluder device is important to the therapeutic efficacy. To use cardiac computed tomography angiography (CCTA) to predict the size of a Watchman 2.5 occluder device is a potential approach. METHODS: The CCTA was used to individually plan the left atrial appendage (LAA) landing zone and measure the longest and shortest diameters, in addition to the perimeter...
September 15, 2023: Alternative Therapies in Health and Medicine
#16
RANDOMIZED CONTROLLED TRIAL
Dhanunjaya Lakkireddy, David Thaler, Christopher R Ellis, Vijendra Swarup, Alok Gambhir, James Hermiller, Jens Erik Nielsen-Kudsk, Stephen Worthley, Devi Nair, Boris Schmidt, Rodney Horton, Nigel Gupta, Jordan A Anderson, Ryan Gage, Mohamad Alkhouli, Stephan Windecker
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...
August 14, 2023: JACC. Cardiovascular Interventions
#17
RANDOMIZED CONTROLLED TRIAL
Dhanunjaya Lakkireddy, Jens Erik Nielsen-Kudsk, Stephan Windecker, David Thaler, Matthew J Price, Alok Gambhir, Nigel Gupta, Konstantinos Koulogiannis, Leo Marcoff, Anuj Mediratta, Jordan A Anderson, Ryan Gage, Christopher R Ellis
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)...
August 2, 2023: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
#18
JOURNAL ARTICLE
Kyungsub Song, Woo Sung Jang, Namhee Park, Yun Seok Kim, Jae Bum Kim
BACKGROUND AND OBJECTIVES: The left atrial appendage (LAA) can contribute significantly to LA mechanical contraction. Nevertheless, the preventive effect of LAA occlusion during the maze procedure against cerebral infarction remains controversial. In this study, we compared the surgical, cardiac hemodynamic, and neurologic outcomes between LAA preservation and occlusion performed during the maze procedure. METHODS: Between January 2015 and August 2021, 252 patients underwent the maze procedure using cryoablation at our medical center...
June 9, 2023: Korean Circulation Journal
#19
JOURNAL ARTICLE
Min Jae Cha, Don-Gwan An, Minsoo Kang, Hyue Mee Kim, Sang-Wook Kim, Iksung Cho, Joonhwa Hong, Hyewon Choi, Jee-Hyun Cho, Seung Yong Shin, Simon Song
OBJECTIVE: The study was conducted to investigate the effect of correct occlusion of the left atrial appendage (LAA) on intracardiac blood flow and thrombus formation in patients with atrial fibrillation (AF) using four-dimensional (4D) flow magnetic resonance imaging (MRI) and three-dimensional (3D)-printed phantoms. MATERIALS AND METHODS: Three life-sized 3D-printed left atrium (LA) phantoms, including a pre-occlusion (i.e., before the occlusion procedure) model and correctly and incorrectly occluded post-procedural models, were constructed based on cardiac computed tomography images from an 86-year-old male with long-standing persistent AF...
July 2023: Korean Journal of Radiology: Official Journal of the Korean Radiological Society
#20
JOURNAL ARTICLE
Vikash Jaiswal, Song Peng Ang, Abhigan Babu Shrestha, Zarghoona Wajid, Evbayekha Osas Endurance, Fathima Shehnaz Ayoobkhan, Shazia Khan, Vamsi Garimellla, Helen Huang, Mohammed Ghanim, David Song, Prachi Sharma, M Chadi Alraies, Monodeep Biswas
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...
June 30, 2023: Medicine (Baltimore)
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