https://doi.org/10.1007/s00392-025-02625-4
1Universitätsklinikum Schleswig-Holstein Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin Lübeck, Deutschland; 2Universitätsklinikum Schleswig-Holstein Klinik für Rhythmologie Lübeck, Deutschland; 3Asklepios Klinik Altona Kardiologie und Internistische Intensivmedizin Hamburg, Deutschland; 4Cardiance Clinic Pfäffikon SZ, Schweiz
Background: Electrical isolation of the left atrial appendage (LAA) is increasingly employed in patients with symptomatic atrial fibrillation (AF) refractory to pulmonary vein isolation (PVI). Due to an elevated thromboembolic risk in electrically isolated LAAs, endovascular LAA occlusion (LAAO) has become a common strategy.
Objective: We analyzed procedural and 12-month clinical outcomes in patients receiving two types of LAAO devices, comparing outcomes between those with and without LAA isolation (LAAi)
Methods: Between March 2019 and March 2024, 229 consecutive patients (median age 73 years; median CHA2DS2-VASc Score 3.0; 68.1% male) were enrolled, with a mean follow-up of 384 ± 339.2 days. Of these, 136 patients (59.4%) had LAA isolation (LAAi) and 93 (40.6%) did not (No-LAAi). Patients received either a Watchman FLX (n=78, 34.1%), Watchman 2.5 (n=10, 4.4%), or LAmbre device (n=141, 61.1%). All had prior AF catheter ablation, and LAAO was performed 6 weeks post-ablation. The main indication for LAAO was the implementation of electrical LAAi. In the no-LAAi group, all patients had lost persistent LAAi. Pertinent procedural data, periprocedural complications, as well as peri-device leaks (PDL) at 45 days were assessed according to device type. Composite endpoints (death, TIA/stroke, device thrombus, severe bleeding) were assessed during the follow-up.
Results: The distribution of LAAi/No LAAi were found in 57 [41.9%]/31 patients treated with the Watchman device (FLX and 2.5) and in 79 [58.1%]/62 patients treated with the LAmbre device. PDL on follow-up (f/u) TEE was observed in 13 LAAi patients (16,9 %) in the Watchman group and 23 (16,3%) in the LAmbre group. No-LAAi patients showing 6 (7,8%) PDL on f/u in the Watchman group vs. 39 (27,6%) in the Lambre group (p<0.001). Leak distribution (no leak/<3mm/3-5mm/>5mm) at f/u was different between LAAi vs. No-LAAi and both device groups (Watchman device LAAi: 45/8/4/1; No-LAAi: 24/6/0/0); LAmbre device LAAi: 56/20/0/3; No-LAAi 23/21/12/6). Procedural complications occurred in 7 (4,9 %) patients in the LAmbre group vs. 4 (5,2 %) patients in the watchman group and 9/128 (7 %) LAAI patients vs. 3/90 (3,3 %) No-LAAI patients (p=0.1). The composite endpoint of death, stroke, severe bleeding, device-related thrombus and thromboembolism was reached by a total of 8 (3,7 %) patients in the LAmbre group (LAAi/No-LAAi 4/4) vs. 5 (2,3 %) patients in the Watchman group (LAAi/No-LAAi 3/2).
Conclusions: At 45-day follow-up, Watchman patients without LAA isolation had the best sealing outcomes, while LAmbre patients without LAA isolation showed the highest rates of moderate and severe PDL (>5mm). Periprocedural complication and 12-month composite endpoint rates were similar across device types and isolation statuses. The elevated PDL in non-isolated LAmbre patients may result from persistent LAA contraction against the device. Larger studies are warranted to further evaluate these findings.