Clinical Research
Clinical Trial
Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO System) to Prevent Stroke in High-Risk Patients With Non-Rheumatic Atrial Fibrillation: Results From the International Multi-Center Feasibility Trials

https://doi.org/10.1016/j.jacc.2005.03.042Get rights and content
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Objectives

These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota).

Background

Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients.

Methods

Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 ± 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month.

Results

Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation.

Conclusions

Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.

Abbreviations and Acronyms

AF
atrial fibrillation
CI
confidence interval
LAA
left atrial appendage
LVEF
left ventricular ejection fraction
MAE
major adverse event
SAE
serious adverse event
TEE
transesophageal echocardiogram
TIA
transient ischemic attack

Cited by (0)

This research was supported by ev3 Inc., Plymouth, Minnesota. Dr Lesh is the inventor of the PLAATO device; he was founder, CEO, and a shareholder of APPRIVA Medical, the company that was taken over by ev3.