Key result
Epicardial left atrial appendage clip occlusion during cardiac surgery was safe and durable, with 0 strokes occurring among the cohort over a mean follow-up of 3.5 years.
Why the study?
Is epicardial LAA clip occlusion safe and effective for stroke prevention in patients with AF undergoing cardiac surgery?
Cohort (n=34)
No
Is epicardial LAA clip occlusion safe and effective for stroke prevention in patients with AF undergoing cardiac surgery?
Epicardial LAA clip occlusion during cardiac surgery appears safe and durable at 3 years, with no strokes or device failures observed.
Supports safety of epicardial LAA clip in surgical AF patients; leaves open stroke prevention efficacy pending randomized trials.
Introduction: Atrial fibrillation (AF) is a risk factor for stroke originating mainly from the left atrial appendage (LAA). We have recently reported the effectiveness and safety of left atrial appendage (LAA) clip occlusion as a concomitant procedure in patients AF undergoing cardiac surgery. Herein we report the 3-year results on these patients. Methods: In this trial, a total of 34 patients with atrial fibrillation (AF) were enrolled at our institution between 09/2007 and 12/2008. Mean CHA 2 DS 2- Vasc score was 3.7 ± 1.7 points. Inclusion criterion was elective cardiac surgery in adult patients with AF for which an ablation procedure was planned. Exclusion criteria were: reoperation, thrombus in the LAA, patients from the ICU, recent myocardial infarction (< 90 days), and a known allergy to the devices component. Intra-operative TEE was used to rule out LAA thrombus at baseline (exclusion criteria) and to evaluate LAA perfusion at the end of the procedure. All patients underwent serial clinical and Imagery follow-up by CT (3 Months; 1, 2 and 3 years). Results: Operative mortality was 8.8% (n = 3) and late mortality was 14.7% (n = 5), none of these deaths were related to the device or study participation. One patient was lost to follow up.Overall follow up consisted of 1285 patient-days. A total of 25 patients underwent follow-up at our hospital. Mean duration of follow-up was 3.5 ± 0.5 years. Of the patients in AF at follow-up (n = 10), only 2 patients were still being anticoagulated. During follow-up no strokes occurred in any of the patients. On CT all clips were found to be stable showing no secondary dislocation. Intra-cardial thrombi were not seen, and none of the LAA were re-perfused. In regard to LAA stump, none of the patients demonstrated a residual neck of over 1 cm. The results of imaging follow-up were consistent after 3 years follow-up in all patients. Conclusion: Our results indicate that epicardial LAA clip occlusion is safe and durable. Closure of the LAA is an interesting therapeutic option for patients not amenable for anticoagulation with AF. Further data is necessary to establish LAA occlusion as a true and viable therapy for stroke prevention.
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Emmert et al. (2013) conducted a cohort in Atrial fibrillation (n=34). Epicardial left atrial appendage (LAA) clip occlusion was evaluated on Stroke. Epicardial left atrial appendage clip occlusion during cardiac surgery was safe and durable, with 0 strokes occurring among the cohort over a mean follow-up of 3.5 years.
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