Clinical Research
Structural
Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices

https://doi.org/10.1016/j.jcin.2016.04.019Get rights and content
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Abstract

Objectives

The aim of this study was to assess predictors of adverse 1-week outcomes and determine the effect of left atrial appendage (LAA) morphology following LAA closure (LAAC) with Amplatzer devices.

Background

Percutaneous LAAC is a valuable treatment option for stroke prevention in patients with atrial fibrillation. Determinants of procedural safety events with Amplatzer occluders are not well established, and the possibly interrelating effect of LAA anatomy is unknown.

Methods

Between 2009 and 2014, 500 consecutive patients with atrial fibrillation ineligible or at high risk for oral anticoagulation underwent LAAC using Amplatzer devices. Procedure- and device-related major adverse events (MAEs) were defined as the composite of death, stroke, major or life-threatening bleeding, serious pericardial effusion, device embolization, major access-site vascular complication, or need for cardiovascular surgery within 7 days following the intervention.

Results

Patients (mean age 73.9 ± 10.1 years) were treated with Amplatzer Cardiac Plug (n = 408 [82%]) or Amulet (n = 92 [18%]) devices. Early procedural success was 97.8%, and MAEs occurred in 29 patients (5.8%). Independent predictors of MAEs included device repositioning (odds ratio: 9.13; 95% confidence interval: 2.85 to 33.54; p < 0.001) and left ventricular ejection fraction <30% (odds ratio: 4.08; 95% confidence interval: 1.49 to 11.20; p = 0.006), with no effect of device type or size. Angiographic LAA morphology, characterized as cauliflower (33%), cactus (32%), windsock (20%), or chicken wing (15%), was not associated with procedural success (p = 0.51) or the occurrence of MAEs (p = 0.78).

Conclusions

In this nonrandomized study, procedural success of LAAC using Amplatzer devices was high. MAEs within 7 days were predicted by patient- and procedure-related factors. Although LAA morphology displayed substantial heterogeneity, outcomes were comparable across the spectrum of LAA anatomies.

Key Words

atrial fibrillation
complications
left atrial appendage closure
safety

Abbreviations and Acronyms

ACP
Amplatzer Cardiac Plug
AF
atrial fibrillation
LAA
left atrial appendage
LAAC
left atrial appendage closure
LVEF
left ventricular ejection fraction
MAE
major adverse event(s)
OAC
oral anticoagulation
PCI
percutaneous coronary intervention
PFO
patent foramen ovale

Cited by (0)

Prof. Meier is a consultant to and has received grants to the institution from St. Jude Medical. Prof. Windecker has received grants to the institution from Abbott, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, and St Jude Medical. Dr. Nietlispach is a consultant to St. Jude Medical, Edwards Lifesciences, Direct Flow Medical, and Medtronic. Dr. Gloekler has received a grant from the Swiss Heart Foundation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Koskinas and Shakir contributed equally to this work.