Decennial Analysis of Interventional Left Atrial Appendage Closure.

INTRODUCTION: Data on long-term follow-up (LTFU) after interventional closure of the left atrial appendage (LAAC) in patients with nonvalvular atrial fibrillation (AF) are scarce. We sought to determine the outcome of patients after LAAC with the first generation device. METHODS AND RESULTS: The Cardioangiologisches Centrum Bethanien (CCB) LAAC registry database was analyzed. Between October 2001 and July 2007, 45 AF patients (23 male, mean age 71 ± 6 years; mean CHA2 DS2 -VaSc 4.3 ± 1.7 [range 1-7]; mean HASBLED score 3.3 ± 1.2 [1-5]) received LAAC. Postimplant dual-platelet inhibition with clopidogrel 75 mg/day and aspirine (ASA) 300 mg/day was prescribed for 6 months, followed by ASA 300 mg indefinitely. The primary endpoint was defined as any thrombembolic complication and/or any bleeding complication. The median FU was 7.4 years (1-12.4 years) resulting in 292 patient years. Fourteen patients died due to heart failure (n = 4), noncardiac reasons (n = 7), or due to unknown etiology (n = 3). No patient died from a bleeding or a stroke. Five ischemic strokes occurred at a median of 794 days (range 304-3,706 days) after LAAC. The observed annual stroke rate was 1.7% (RR 0.43; 95% CI 0.24-0.74; P = 0.0028). In 6 patients bleeding occurred (2 acute procedural, 4 during follow-up). The observed annual bleeding rate was 2.1% (RR 0.56; 95% CI 0.48-0.66; P < 0.0001). CONCLUSION: During LTFU after LAAC in patients with nonvalvular AF, lower event rates than expected are observed for both thrombembolic and bleeding complications.

Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience.

BACKGROUND: Thromboembolism due to atrial fibrillation (AF) is a frequent cause of stroke. More than 90% of thrombi in AF form in the left atrial appendage (LAA). Obliteration of the appendage may prevent embolic complications. METHODS AND RESULTS: We evaluated the feasibility and safety of implanting a novel device for percutaneous left atrial appendage transcatheter occlusion (PLAATO). LAA occlusion using the PLAATO system was attempted in 15 patients with chronic AF at high risk for stroke, who are poor candidates for long-term warfarin therapy. The implant consists of a self-expanding nitinol cage covered with a polymeric membrane (ePTFE). The LAA was successfully occluded in 15/15 patients (100%). Angiography and transesophageal echocardiography (TEE) during the procedure showed that the device was well-seated in all patients and that there was no evidence of perforation, device embolization, or interference with surrounding structures. In 1 patient, the first procedure was complicated by a hemopericardium, which occurred during LAA access. A second attempt 30 days later was successful with no untoward sequela. No other complications occurred. At 1-month follow-up, chest fluoroscopy and TEE revealed continued stable implant position with smooth atrial-facing surface and no evidence of thrombus. CONCLUSIONS: Thus, transcatheter closure of the LAA is feasible in humans. This novel implant technology may be appropriate for patients with AF who are not suitable candidates for anticoagulation therapy. Further trials are needed to show the long-term safety and its efficacy in reducing stroke.