VERITAS Amulet 360 Study

doi:10.1016/j.jcin.2026.10.023

VERITAS

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In patients with non-valvular atrial fibrillation at increased thromboembolic risk, a next-generation dual-seal left atrial appendage occluder achieved complete appendage closure in most patients with low rates of stroke, systemic embolism and device embolisation at one year.

N

458pazienti

Disegno

Prospective, single-arm, multicentre study (Abbott; 35 sites in the US, Canada and Europe) of the next-generation Amulet left atrial appendage occluder (registered as Amulet 2) in non-valvular AF with CHA2DS2-VASc of 2 or more (men) or 3 or more (women)

Esito

Safety events to 7 days or discharge; appendage closure (peri-device flow of 5 mm or less on TEE) at 45 days. TCT presents one-year outcomes

RisultatoComplete left atrial appendage closure (0 mm leak) at one year in 91.1% (95% CI 87.9%-93.7%) by TEE or cardiac CT and 96.3% (95% CI 93.2%-98.2%) by TEE alone. Cumulative device-related thrombus 3.3% (95% CI 2.0%-5.3%), clinically relevant in 0.4% (95% CI 0.1%-1.5%). One-year all-cause mortality 3.9% (95% CI 2.4%-6.3%), cardiovascular mortality 1.9% (95% CI 0.9%-3.8%), major bleeding 6.6% (95% CI 4.5%-9.2%), ischaemic stroke or systemic embolism 1.8% (95% CI 0.8%-3.3%) and pericardial effusion requiring intervention 0.9% (95% CI 0.3%-2.1%). No (0%) device embolisation. Median follow-up 365 days (IQR 349-380).

Lakkireddy D, Makkar A, et al. JACC Cardiovasc Interv. 2026; published online 1 November. 10.1016/j.jcin.2026.10.023

Discussione e critica

This single-arm study shows high rates of complete appendage sealing and low event rates one year after implantation of the next-generation dual-seal occluder. With no control arm, the one-year clinical outcomes are descriptive and cannot show that the device prevents stroke as well as oral anticoagulation or an earlier device. Closure is an imaging surrogate, and the rate depends on the modality: it is lower when CT is counted alongside TEE. Follow-up stops at a median of one year, and the abstract does not say how many patients had imaging or how many events lie behind each rate.