CT-Based Preplanning Allows Abstaining from Intraprocedural TEE during Interventional Closure of the LAA in Patients with Atrial Fibrillation.

OBJECTIVES: The aim of this study was to determine whether the application of a CT-based preplanning algorithm might allow abstaining from TEE during LAAC. BACKGROUND: LAAC is an established treatment alternative for patients with atrial fibrillation. 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. CT-based preplanning of the LAAC procedure, in combination with technical improvements in device design and interventional experience, might allow abstaining 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. The study hypothesis is that under these circumstances, a sole fluoroscopy-guided LAAC is an alternative to a TEE-guided approach. All procedures are preplanned 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 the 31 consecutive patients did TEE lead to a change in the preplanned fluoroscopy-guided LAAC (success ratio: 1.00; CI: 0.94-1.00), thereby meeting the primary endpoint (performance goal: 0.90). There were no procedure-related adverse cardiac or 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 preplanning is performed using cardiac CT. This might be worth considering, especially in patients who are at high risk for TEE-related adverse events.

Transition from WATCHMAN V.2.5 to WATCHMAN FLX for closure of the left atrial appendage: echocardiographic and clinical findings.

INTRODUCTION: Interventional closure of the left atrial appendage (LAAC) has been established as an alternative treatment for patients with atrial fibrillation (AF) and an elevated risk of stroke. The WATCHMAN FLX (WM FLX) as the newest WATCHMAN LAAC device differs in several technical characteristics from its precursor, the WATCHMAN V.2.5 (WM V.2.5). METHODS: The data presented here are derived from a retrospective single-centre study. All patients in which an LAAC was performed between February 2017 and March 2021 with either a WM V.2.5 or WM FLX device were included. RESULTS: 169 patients were included in this study, of whom 95 had been treated with WM V.2.5 and 74 with WM FLX, respectively. Directly after implantation, only minor differences regarding membrane thickness and connector protrusion were noted, whereas no relevant differences were found regarding device sizing, device compression or peridevice leakage, respectively. However, at 3-month follow-up, device compression was significantly reduced in WM FLX indicating a continued device expansion which was paralleled by a reduced number of peridevice leakage in comparison to WM V.2.5. Additionally, the combined clinical endpoint of death, stroke/transistoric ischaemic attack, tamponade, device embolisation, device-related thrombosis or peridevice leakage was reduced in WM FLX. CONCLUSION: LAAC using the WM FLX device results in a continued device expansion over the first 3 months based on differences in radial force in comparison to WM V.2.5. This is accompanied by a reduction in adverse clinical endpoints.