• Arrhythmias
• Cardiology Clinical Trials
• Thrombotic Disorders

• Cardiology & Cardiovascular Medicine
• Arrhythmias
• Cardiology Clinical Trials
• Thrombotic Disorders

Randy Lee, MD, PhD, University of California, San Francisco, San Francisco, California, USA, reported follow-up results of the Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation III [PLACE III; NCT01680757] in patients who underwent left atrial appendage (LAA) ligation with the LARIAT Suture Delivery Device (SentreHEART, Redwood City, California). Dr. Lee believes that the low incidence of access complications and embolic events in this high-risk atrial fibrillation population suggests that LAA ligation may be a treatment option for the prevention of thromboembolic complications in patients with contraindications to oral anticoagulation therapy.

The purpose of this multicenter observational study was to assess the procedural and 30-day periprocedural safety of LAA closure with the LARIAT device. Long-term clinical end points included first event of stroke (ischemic, hemorrhagic, or undefined) or systemic embolism and stroke, systemic embolism, or death of any cause.

The study cohort consisted of 143 consecutive patients with nonvalvular AF, ≥18 years of age, with CHADS₂ scores ≥1, and with life expectancies ≥1 year who were not candidates for oral anticoagulation therapy. Patients underwent LAA ligation with the LARIAT device between December 2009 and November 2012. LAA closure was verified by left atrial angiography and transesophageal echocardiography. Patients received aspirin, aspirin with clopidogrel, or no antiplatelet therapy after LAA ligation. No patients were treated with oral anticoagulation therapy following LAA ligation.

The average age of the cohort was 67 years, and the majority of patients were male. Clinical characteristics were as follows: 24% had heart failure, 95% hypertension, and 32% prior stroke or transient ischemic attack; the mean CHADS₂ score was 2.4±1.2; the mean CHADS₂-VASc score was 3.6±1.8; the mean HAS-BLED score was 2.8±1.2; and the mean follow-up duration was 2.2±1.1 years. Successful closure was obtained in 99.3% of patients (n=138).

Clinical outcomes at follow-up included 4 strokes (2 embolic/ischemic strokes) and 6 deaths (1 procedural). The incidence of stroke, embolism, or death was 3.3% per year. The mean CHADS₂ score of the cohort was 2.4; previous studies have suggested that a cohort with this CHADS₂ score would be expected to have an incidence of stroke or systemic embolism of approximately 6.2%; however, in the patients treated with LAA ligation in this study, the incidence of stroke or systemic embolism was 1.3% per year [Gage BF et al. Circulation 2004; JAMA 2001].

Procedure-related adverse events included pericardial effusion (n=1), pulmonary embolus (n=1), periprocedural death (n=1), and cardiac perforation (n=2). Inflammation-related adverse events included pericarditis (most initially; n=8), late hemopericardium (n=1), later pericardial effusion (n=1), and left atrial thrombus (n=2).

These findings suggest the need for prospective, appropriately powered, randomized stroke studies in patients with atrial fibrillation with contraindications or intolerance to oral anticoagulation therapy to assess the efficacy of LAA ligation.

• © 2014 MD Conference Express®