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Objectives: The aim of this study was to determine whether echocardiography is dispensible during interventional LAA closure when preplanning is done by cardiac CT.Background: Interventional closure of the LAA is an established treatment alternative for patients with atrial fibrillation who are at risk for bleeding events under oral anticoagulation. Today, most LAAC procedures are guided by TEE which, however, leads to the need for patient sedation and might even cause direct harm to the patient. Technical improvements in device design and interventional experience might allow to abstain from TEE.Methods: Fluoro-FLX is a prospective single center study to evaluate how often TEE leads to a procedural change during interventional LAAC if a dedicated CT planning algorithm is applied and the newest generation of the WATCHMAN device (WATCHMAN FLX) is used. The study hypothesis is that under these circumstances fluoroscopy-only guided LAAC is non-inferior to a TEE-guided approach, the primary endpoint is defined as the percentage of LAAC procedures without interruption by TEE. All procedures are pre-planned by cardiac CT and finally guided by fluoroscopy only while TEE is carried out in the background during the intervention for safety reasons. Results: In none of 31 consecutive patients, TEE led to a change of the fluoroscopy-guided LAAC (success ratio: 1.00; CI: 0.94 – 1.00) thereby meeting the primary endpoint of non-inferiority. There were no procedure-related adverse cerebrovascular events (no pericardial effusion, TIA, stroke, systemic embolism, device embolism, death).Conclusions: Our data suggest that it is feasible to perform LAAC under sole fluoroscopic guidance if pre-planning is performed by cardiac CT and WATCHMAN FLX is used. |
