The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.
The global burden of atrial fibrillation (AF) is high and thromboembolic stroke may be one of the fatal complications. Oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation non-pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option. LAA shape and size varies widely and incomplete LAA closure or new leaks, due to LAA remodeling after the procedure, are observed in up to 30% of patients. Those leaks may cause turbulent flow and increase the risk for thrombus formation and subsequent thromboembolic events. However, the clinical significance after percutaneous LAAO has yet to be determined. If significant leaks are present, patients usually remain on oral anticoagulation. In very few cases, an interventional approach is used to close peri-device leaks. This is the first systematic study, trying to include a respectable number of patients who underwent peri-device leakage closure after LAAO. In this multi-center, collaborative study the investigators aim to identify different peri-device leak closure strategies with associated clinical outcomes and evaluate safety and feasibility of the procedure.
Study Type
OBSERVATIONAL
Enrollment
85
Peri-device leakage closure after left atrial appendage occlusion
• Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Scripps Health
La Jolla, California, United States
Procedural mortality
Rate of all-cause mortality during the index procedure, number of participants experiencing a procedure-related death within 30days or during in-hospital stay for the index procedure (if\>30days)
Time frame: In-hospital stay, assessed up to 30days
Procedure-related clinically relevant pericardial effusion
Number of participants experiencing pericardial effusion with hemodynamic relevance, treated with therapeutic pericardiocentesis or surgical intervention, requiring blood transfusion or resulting in shock and/or death, which was procedure related
Time frame: In-hospital stay, assessed up to 30days
Procedure-related ischemic stroke
Number of participants experiencing an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, which was procedure related
Time frame: In-hospital stay, assessed up to 30days
Bleeding complications
Number of participants experiencing bleeding complications evaluated by using VARC-2 criteria with LAAO specific modifications (after the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies)
Time frame: through study completion, an average of 1 year
Vascular access site complications
Number of participants experiencing retroperitoneal haematoma, AV-fistula, arterial complications, venous complications, symptomatic peripheral ischemia, nerve injury with clinical symptoms \>24h, vascular surgical repair at access site, pulmonary embolism, ipsilateral deep vein thrombosis, access site-related infection requiring iv. antibiotics or extended hospitalization
Time frame: during procedure, assessed up to 7 days
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Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Mayo Clinic Hospital - Saint Mary's Campus
Rochester, Minnesota, United States
Vanderbilt Heart Institute
Nashville, Tennessee, United States
Austin Heart
Austin, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark
Cardio Vascular Center Frankfurt
Frankfurt am Main, Hesse, Germany
...and 6 more locations
Liver- and kidney failure associated with the procedure
Number of participants experiencing liver- and kidney failure potentially associated with the procedure evaluated by using the definitions of Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies
Time frame: In-hospital stay, assessed up to 30days
Device-associated complications
Number of participants experiencingdevice migration, perforation, laceration, erosion, device infection, pericarditis, device-related thrombus and persistent or occurrence of new peri-device leakage
Time frame: through study completion, an average of 1 year
Ischemic stroke or transitory ischemic attack
Number of participants experiencing an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue not directly related to the procedure
Time frame: through study completion, an average of 1 year