BACKGROUND: Left atrial appendage (LAA) is the main source of left atrial thrombus that causes stroke in patients with non-valvular atrial fibrillation (NVAF). This study reported the initial safety, feasibility, and 1-yr clinical outcomes following AMPLATZER cardiac plug (ACP) implantation in Asia-Pacific region. METHODS: Twenty NVAF patients (16 males, age 68 ± 9 yr) with high risk for developing cardioembolic stroke (CHADS(2) score: 2.3 ± 1.3) and contraindications to warfarin received ACP implants from June 2009 to May 2010. Patients received general anesthesia (n = 9) or controlled propofol sedation (n = 11) and the procedures were guided by fluoroscopy and transesophageal echocardiography (TEE). Clinical follow-up was arranged at 1 month and then every 3 months after implantation, whereas, a TEE was scheduled at 1 month upon completion of dual anti-platelet therapy. RESULTS: The LAA was successfully occluded in 19/20 patients (95%) at two Asian centers. One procedure was abandoned because of catheter-related thrombus formation. Other complications included coronary artery air embolism (n = 1) and TEE-attributed esophageal injury (n = 1). The median procedural and fluoroscopic times were 79 (IQR: 59-100) and 18 (IQR 12-27) minutes, respectively. The mean size of implant was 23.6 ± 3.1 mm. The average hospital stay was 1.8 ± 1.1 days. Follow-up TEE showed all the LAA orifices were sealed without device-related thrombus formation. No stroke or death occurred at a mean follow-up of 12.7 ± 3.1 months. CONCLUSIONS: Our preliminary data suggested LAA closure with ACP is safe, feasible with encouraging 1-yr clinical outcomes. Further large-scaled trials are needed to confirm the efficacy of this device.
BACKGROUND: Left atrial appendage (LAA) is the main source of left atrial thrombus that causes stroke in patients with non-valvular atrial fibrillation (NVAF). This study reported the initial safety, feasibility, and 1-yr clinical outcomes following AMPLATZER cardiac plug (ACP) implantation in Asia-Pacific region. METHODS: Twenty NVAF patients (16 males, age 68 ± 9 yr) with high risk for developing cardioembolic stroke (CHADS(2) score: 2.3 ± 1.3) and contraindications to warfarin received ACP implants from June 2009 to May 2010. Patients received general anesthesia (n = 9) or controlled propofol sedation (n = 11) and the procedures were guided by fluoroscopy and transesophageal echocardiography (TEE). Clinical follow-up was arranged at 1 month and then every 3 months after implantation, whereas, a TEE was scheduled at 1 month upon completion of dual anti-platelet therapy. RESULTS: The LAA was successfully occluded in 19/20 patients (95%) at two Asian centers. One procedure was abandoned because of catheter-related thrombus formation. Other complications included coronary artery air embolism (n = 1) and TEE-attributed esophageal injury (n = 1). The median procedural and fluoroscopic times were 79 (IQR: 59-100) and 18 (IQR 12-27) minutes, respectively. The mean size of implant was 23.6 ± 3.1 mm. The average hospital stay was 1.8 ± 1.1 days. Follow-up TEE showed all the LAA orifices were sealed without device-related thrombus formation. No stroke or death occurred at a mean follow-up of 12.7 ± 3.1 months. CONCLUSIONS: Our preliminary data suggested LAA closure with ACP is safe, feasible with encouraging 1-yr clinical outcomes. Further large-scaled trials are needed to confirm the efficacy of this device.