Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study

Abstract

Aims To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. Methods and results Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1–3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year—a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). Conclusion Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.

Registro Español de Hemodinámica y Cardiología Intervencionista. XXIX Informe Oficial de la Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2019)

“…En el intervencionismo estructural no valvular merece destacar el aumento de los procedimientos de cierre de la orejuela, en relación con la disminución de las complicaciones e incremento del éxito descrito en los últimos registros internacionales, así como la publicación de documentos de consenso apoyando la utilidad de esta técnica en pacientes seleccionados 44 , 45 .…”

Left Atrial Appendage Occlusion: Past, Present and Future

“…More recently, a prospective global study of 1,088 patients, where 83% had contraindications to anticoagulation, found that LAA occlusion with the Amulet device was associated with a 67% reduction in ischemic stroke rates compared with predicted risk by the CHA 2 DS 2 -VASc score. 37 Only a single study has specifically investigated the use of LAA occlusion in AF patients with resistant stroke despite OAC therapy. Data from the ACP multicentre registry showed that LAA occlusion was associated with a 65% risk reduction in annual rates of stroke or transient ischemic attack, and a 100% risk reduction in annual rates of major bleeding, compared with predicted rates based on the CHA 2 DS 2 -VASc and HAS-BLED scores, respectively.…”

Modification of the left atrial appendage and its role in stroke risk reduction with non-valvular atrial fibrillation

“…This has further reduced the risk of peri-device leak, as demonstrated in the Amulet Observational Study (1.8%) [52] . The longer-term outcomes from this large registry was recently published, demonstrating excellent implant success (99.1%) and acceptable periprocedural adverse events (4.0%) [53] . It was shown to reduce the risk of ischaemic stroke by 67% when compared to predicted risk.…”