Left atrial appendage closure with the AMPLATZER cardiac plug was successfully achieved in 95% of patients, with no strokes or deaths occurring over a mean follow-up of 12.7 months.
Observational (n=20)
Yes
Does AMPLATZER cardiac plug implantation safely prevent stroke in NVAF patients with contraindications to warfarin?
LAA closure with the AMPLATZER cardiac plug appears safe and feasible for stroke prevention in an initial Asia-Pacific cohort of NVAF patients with contraindications to warfarin.
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.
Lam et al. (Tue,) conducted a observational in Non-valvular atrial fibrillation (NVAF) (n=20). AMPLATZER cardiac plug (ACP) implantation was evaluated on Successful LAA occlusion. Left atrial appendage closure with the AMPLATZER cardiac plug was successfully achieved in 95% of patients, with no strokes or deaths occurring over a mean follow-up of 12.7 months.