What question did this study set out to answer?

To evaluate the procedural safety and 1-year stroke prevention efficacy of left atrial appendage closure using the Amplatzer Cardiac Plug in nonvalvular atrial fibrillation patients.

December 17, 2012Pacing and Clinical Electrophysiology

Does Left Atrial Appendage Closure with a Cardiac Plug System Reduce the Stroke Risk in Nonvalvular Atrial Fibrillation Patients? A Single‐Center Case Series

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Nonvalvular Atrial Fibrillation (n=37). Intervention: Left atrial appendage closure using Amplatzer Cardiac Plug (ACP) vs. Expected stroke rate (CHADS2 and CHA2DS2-VASc). Primary outcome: ischemic stroke (50.2% and 26.5% reduction).

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Key result

Left atrial appendage closure using the Amplatzer Cardiac Plug resulted in a 1-year ischemic stroke rate of 2.94%, representing a 26.5% to 50.2% reduction compared to expected rates.

Why the study?

Does percutaneous left atrial appendage closure using the Amplatzer Cardiac Plug reduce stroke risk in patients with nonvalvular atrial fibrillation and contraindication to warfarin?

Key Points

To evaluate the procedural safety and 1-year stroke prevention efficacy of left atrial appendage closure using the Amplatzer Cardiac Plug in nonvalvular atrial fibrillation patients.
Enrolled 37 patients with permanent or paroxysmal atrial fibrillation, high stroke risk, and contraindications to warfarin therapy in a single-center Italian center.
Tracked acute procedural complications and assessed stroke and bleeding incidence during a 1-year follow-up period.
Device placement was attempted in 37 patients and achieved successfully in 34 (91.9%), with 4 patients experiencing serious adverse complications (one cardiac tamponade, two device embolizations, and one bradycardia requiring artificial pacing).
During 1-year follow-up, 1 of 34 patients experienced an ischemic stroke (stroke rate of 2.94%), representing a 50.2% and 26.5% reduction versus expected rates based on CHADS2 and CHA2DS2-VASc scores, respectively, with zero major bleeds.

Study Design

Type

Observational (n=37)

Multicenter

Structured PICO

Does percutaneous left atrial appendage closure using the Amplatzer Cardiac Plug reduce stroke risk in patients with nonvalvular atrial fibrillation and contraindication to warfarin?

Population

37 patients with permanent or paroxysmal AF, high stroke risk, and contraindication to warfarin therapy, followed for 1 year.

Exposure

Percutaneous left atrial appendage (LAA) closure using the Amplatzer Cardiac Plug (ACP) device

Outcome

Safety of LAA closure and efficacy in preventing strokes during a 1-year follow-uphard clinical

Main Result

Effect estimate: 50.2% and 26.5% reduction

LAA closure using the Amplatzer Cardiac Plug is feasible and may reduce stroke risk in AF patients with contraindications to oral anticoagulants, though procedural complications can occur.

Implication

May support LAA closure in select AF patients; leaves open efficacy confirmation in randomized trials.

Abstract

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and it is associated with an increased stroke risk, due mainly to cardiac embolism from the left atrial appendage (LAA). Percutaneous LAA closure is a method to reduce stroke risk in AF without using anticoagulant agents. In this study we report data from an Italian experience with the LAA occluder Amplatzer Cardiac Plug (ACP) device (Aga Medical Corporation, Plymouth, MN, USA). METHODS: The study was designed to evaluate the safety of LAA closure using ACP and the efficacy of the procedure in preventing strokes during a 1-year follow-up. Patients with permanent or paroxysmal AF, high stroke risk, and contraindication to warfarin therapy were selected for the procedure. RESULTS: The LAA closure was attempted in 37 patients and succeeded in 34 cases (91.9%). Four patients experienced serious complications (one cardiac tamponade requiring pericardiocentesis, two device embolizations, one low-rate response AF requiring artificial pacing). During a 1-year follow-up, ischemic stroke occurred in one of 34 patients, resulting in a stroke rate of 2.94%; thus there was a stroke rate reduction of 50.2% and 26.5% compared to the expected stroke rate, according to CHADS2 and CHA2 DS2 VASc score. None of the patients who received ACP experienced major bleeding during the follow-up. CONCLUSION: LAA closure using ACP is a relatively feasible procedure which can be performed by highly experienced operators to reduce stroke rate in patients with AF, high stroke risk, and contraindication to oral anticoagulants.

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Cite This Study

Danna et al. (2012) conducted an observational in Nonvalvular Atrial Fibrillation (n=37). Left atrial appendage closure using Amplatzer Cardiac Plug (ACP) vs. Expected stroke rate (CHADS2 and CHA2DS2-VASc) was evaluated on ischemic stroke (50.2% and 26.5% reduction). Left atrial appendage closure using the Amplatzer Cardiac Plug resulted in a 1-year ischemic stroke rate of 2.94%, representing a 26.5% to 50.2% reduction compared to expected rates.

synapsesocial.com/papers/6a773347df493903fd1ebdb0 https://doi.org/10.1111/pace.12058