LARIAT or AtriClip: Complications Profile and Comparison in Patients with Atrial Fibrillations Based on Manufacturer and User Facility Device Experience Database
Radosław Litwinowicz,
Jakub Batko,
Jakub Rusinek,
Wojciech Olejek,
Daniel Rams,
Mariusz Kowalewski,
Krzysztof Bartuś,
Marian Burysz
Affiliations
Radosław Litwinowicz
CAROL—Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland
Jakub Batko
CAROL—Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland
Jakub Rusinek
CAROL—Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland
Wojciech Olejek
CAROL—Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland
Daniel Rams
CAROL—Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland
Mariusz Kowalewski
Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Krzysztof Bartuś
Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland
Marian Burysz
Department of Cardiac Surgery, Regional Specialist Hospital, 86-300 Grudziądz, Poland
Background and Objectives: Left atrial appendage closure is an alternative treatment to reduce thromboembolism in patients with atrial fibrillation in whom oral anticoagulation (OAC) is contraindicated. The aim of this study was to evaluate the complications profiles of the LARIAT and AtriClip devices and perform a comparison between them based on the MAUDE (Manufacturer and User Facility Device Experience) database. Materials and Methods: The Manufacturer and User Facility Device Experience database was searched on 15 January 2023. For AtriClip, only reports regarding isolated procedures or procedures associated with minimally invasive ablation were included. Adverse effects and causes of death were defined based on the literature on the topic and the causes described in the reports. In total, 63 patients were included in the LARIAT group and 53 patients were included in the AtriClip group. Results: With the LARIAT device, the most common complication without device problems was pericardial effusion (n = 18, 52.9%), whereas this complication was not observed with AtriClip (p p n = 0 vs. AtriClip n = 7, 18.9%, p = 0.012) and thrombus (LARIAT n = 2, 5.9% vs. n = 11, 29.7%, p = 0.013). Conclusions: Each type of left atrial appendage closure procedure is associated with device-specific requirements and complications that, if known, can be avoided.
