Abstract
The Watchman device is widely used for left atrial appendage occlusion (LAAO) but may be unsuitable in patients with complex anatomies resulting in screening failures. The Amulet occluder, with its dual-seal design, may overcome these limitations. The aim of this analysis is to evaluate procedural success, closure, and clinical outcomes of Amulet occluder implantation in patients who failed Watchman screening.
This analysis from the ADVANCE LAA study included patients ineligible for Watchman (Screen Fail) compared to patients eligible for Amulet and Watchman (Device Eligible). Baseline characteristics, procedural details, cardiac imaging, and clinical events were assessed through 1 year. The safety endpoint composite was a composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or major endovascular intervention within hospital discharge or 7 days post-implant. Independent core laboratory and clinical events committee adjudicated imaging and adverse events, respectively.
A total of 609 patients underwent Amulet implantation (Screen Fail: n = 97; Device Eligible: n = 512). Screen Fail patients had more complex anatomy and higher CHA2DS2-VASc and HAS-BLED scores. Despite these differences, implant success was high (96.9% vs. 98.0%; p = 0.446). Clinically relevant closure on transesophageal echocardiography (≤3 mm peri-device leak) was achieved in ≥97% of patients in both groups at implant and 1-3 months. The peri-procedural safety endpoint composite rate was similar in both groups (3.1% vs. 2.7% (OR: 1.14 [0.32, 4.03]; p = 0.742). One-year rates of stroke (1.1% vs. 1.0%), major bleeding (9.6% vs. 6.2%), cardiovascular/unknown death (2.1% vs. 5.2%) and all-cause death (6.3% vs. 6.6%) were similar between groups (p > 0.05).
Amulet occluder implantation was feasible, safe and effective in patients with or without failed Watchman screening, providing a viable option for both anatomically simple and complex anatomies.