November 9, 2017Heart

Outcome of left atrial appendage occlusion in high-risk patients

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Why the study?

Does percutaneous left atrial appendage occlusion prevent stroke in high-risk patients with atrial fibrillation ineligible for anticoagulation?

Structured PICO

Does percutaneous left atrial appendage occlusion prevent stroke in high-risk patients with atrial fibrillation ineligible for anticoagulation?

Population

High-risk patients with atrial fibrillation ineligible for anticoagulation, with high bleeding risk (95.3% had previous major bleeding, 59% intracranial).

Intervention

Percutaneous left atrial appendage (LAA) occlusion using the Amulet device.

Outcome

Efficacy and safety of the implant procedure, and 12-month outcomes (including stroke, bleeding, and mortality).hard clinical

LAA occlusion is a feasible stroke prevention strategy in high-risk AF patients ineligible for anticoagulation, though it carries a significant risk of procedural complications and ongoing adverse events.

Implication

Substantial residual risks caution adoption in ineligible AF; leaves open net benefit versus alternatives in RCTs.

Abstract

OBJECTIVE: Percutaneous left atrial appendage (LAA) occlusion can be an interventional alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation. METHODS: We delivered LAA occlusion therapy using a standardised approach to patient referral, multidisciplinary team assessment, implant criteria, imaging and follow-up. We analysed patient characteristics, efficacy and safety of the implant procedure, and 12-month outcomes. RESULTS: -VASc score 4 ±1) were offered LAA occlusion. Eighty (95.3%) had previous major bleeding (intracranial in 59%). LAA occluder implantation with an Amulet device was successful in 82 (98.8%), with periprocedural major adverse events occurring in 5 (6.0%) patients (2 device embolisations including 1 death, 2 major bleeds). Cardiac imaging in 75 (94%) patients 2months following implant showed device-related thrombus in 1 case (1.3%) and minor (<5mm) device leaks in 13 (17.1%). Over a median 12-month follow-up, 3 (3.8%) ischaemic strokes, 2 (2.5%) haemorrhagic strokes and 5 (6.3%) major extracranial bleeds occurred. All-cause mortality was 10%, with most deaths (7, 87.5%) due to non-cardiovascular causes. CONCLUSIONS: LAA occlusion may be a reasonable option for stroke prevention inhigh-risk patients with atrial fibrillation ineligible for anticoagulation. However, procedural complication rates are not insignificant, and patients remain at risk of serious adverse events and death even after successful implant.