Clinical outcomes three years after PLAATO implantation.

Background: The percutaneous left atrial appendage transcatheter occlusion system (PLAATO) is an alternative to coumadin in patients with atrial fibrillation (AF) and contraindications to anticoagulation. It appears to be protective against stroke in intermediate follow-up studies.
Hypothesis: The PLAATO system is protective against stroke and is safe in long-term follow-up.
Methods: Eleven patients (age 72 +/- 9 years) enrolled in the PLAATO feasibility and safety trial at our institution were followed (36 +/- 1.4) months. All patients had contraindications to anticoagulation and had at least one risk factor for stroke. The predicted stroke risk for this cohort was 8.6% per year as calculated using the CHADS2 score (A validated scoring system assigning 1 point for CHF, hypertension, diabetes, and age >75 years, and 2 points for history of stroke). The primary end-point was the incidence of stroke, and secondary end points were complications related to PLAATO device and systemic embolic events.
Results: There was one stroke during follow-up; the stroke risk in our population was 3% per year. Interestingly, the observed stroke risk in these patients after occluding the left atrial appendage is comparable to what would have been observed with warfarin. No systemic embolic events were noted in our cohort and no long term complications related to PLAATO were seen.
Conclusion: The PLAATO device decreases the risk of stroke in a high-risk cohort of AF patients. Furthermore, the safety of this device is confirmed during this long-term follow-up study. A larger trial is needed to validate these findings.