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PLAATO - PLAATO
Description:
The goal of the study was to evaluate the stroke rate in patients treated with the PLAATO device for percutaneous left atrial appendage occlusion among patients with atrial fibrillation at high-risk for embolization and stroke.
Study Design
Study Design:
Patients Enrolled: 111
Mean Follow Up: Average 9.8 months
Mean Patient Age: Mean age 71 years
Female: 41
Patient Populations:
Chronic paroxysmal or persistent atrial fibrillation >3 months; high risk of stroke; suboptimal warfarin candidates (e.g., contraindications to warfarin, increased bleeding risk, or INR unable to manage)
Primary Endpoints:
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.
Drug/Procedures Used:
The PLAATO device for percutaneous left atrial appendage occlusion was implanted in patients with atrial fibrillation at high-risk for embolization and stroke. Patients were followed for an average of 9.8 months. The study was designed as a registry.
Concomitant Medications:
Aspirin (300 to 325 mg) twice a day and clopidogrel (75 mg) twice a day 48 h before the procedure as well as antibiotic therapy 1 h before the intervention.
Principal Findings:
There were 111 patients enrolled in the study, with 108 receiving device implantation. History of TIA or stroke was present in 38% of patients. The CHADS risk score, a clinical classification scheme for predicting stroke, averaged 2.5, which corresponds to an expected annual risk of stroke of 6.3%. By 2 years, there were 6 deaths in the 111 patients (5.4%). Total cardiac tamponade occurred in 2 patients and pericardial effusion in 2 patients. Stroke occurred in 2 patients. An additional 2 patients had a total of 3 TIAs (2.7%). The observed annual stroke rate of 2.2% was lower than the expected 6.3% based on the CHADS risk score.
Interpretation:
Among patients with atrial fibrillation at high-risk for embolization and stroke, use of the PLAATO device for percutaneous left atrial appendage occlusion was feasible and was associated with a lower than expected stroke rate based on the baseline stroke risk estimate in the present registry. A larger randomized trial is in the planning stage which will allow for assessment of efficacy of the PLAATO device.
References:
Ostermayer SH, et al. Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO System) to Prevent Stroke in High-Risk Patients With Non-Rheumatic Atrial Fibrillation. J Am Coll Cardiol 2005; 46:9-14.
Presented by Dr. Feldman at the 2005 Cardiovascular Research Therapeutics Sessions, Washington, DC.
Keywords: International Normalized Ratio, Stroke, Embolization, Therapeutic, Ischemic Attack, Transient, Warfarin, Atrial Fibrillation, Pericardial Effusion, Cardiac Tamponade
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