Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Lakkireddy Dhanunjaya, Saw Jacqueline, Makkar Akash, Shah Dipak, Satpathy Ruby, Saric Muhamed, Sharma Rahul, Cuoco Frank, Percell Robert, Manoukian George, Gage Ryan, Anderson Jordan A, Agarwal Himanshu
Аннотация
AIMS: The Watchman device is widely used for left atrial appendage occlusion 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.
METHODS AND RESULTS: 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, ischaemic 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 transoesophageal 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).
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: URL https://clinicaltrials.gov Unique Identifier NCT05997446.
METHODS AND RESULTS: 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, ischaemic 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 transoesophageal 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).
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: URL https://clinicaltrials.gov Unique Identifier NCT05997446.