Initial Experience Using the LARIAT Device

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Grant R. Simons, MD, FACC, FHRS Chief, Cardiac Electrophysiology Englewood Hospital and Medical Center Associate Clinical Professor of Medicine Mt. Sinai School of Medicine Englewood, New Jersey

Atrial fibrillation (AF) is the most commonly diagnosed adult arrhythmia in the U.S.1 and worldwide.2 Due to an aging population and rising incidence, the prevalence of AF in the U.S. is projected to reach 12–15 million patients by the year 2050.2-4 Because of decreased flow in the left atrial appendage (LAA) during AF and resultant thrombus formation,5,6 AF is a major risk factor for stroke, accounting for 15% of all strokes, and more than a third of strokes among patients above 80 years of age.2,7-10 AF-related strokes are more frequently fatal and disabling than non-AF-related strokes, and they carry a worse prognosis than embolic events from other causes.11-13

Current ACC/AHA/HRS guidelines stress the critical role of antithrombotic therapy for the prevention of stroke and systemic embolism, with aspirin therapy recommended only for low-risk patients.1 For many decades, the vitamin K epoxide reductase inhibitor warfarin had been the only approved antithrombotic therapy for prevention of ischemic stroke in patients with AF. However, its use can be challenging due to its variable pharmacokinetic and pharmacodynamic profile, numerous drug and dietary interactions, delayed onset of action, need for substantial laboratory monitoring and dosage titrations, and most importantly, bleeding complications. These disadvantages have engendered great interest in the development of alternative antithrombotic therapies that may overcome these limitations. Three new oral anticoagulants — dabigatran, rivaroxaban, and apixaban — have received FDA approval for the prevention of stroke and systemic embolism in patients with AF. 

However, a significant number of patients with AF have absolute or relative contraindications to anticoagulation. Among such patients faced with this difficult dilemma, therapies targeting the LAA through exclusion or ligation are of great potential benefit. The LARIAT device (SentreHEART, Inc.) is a suture delivery device that is FDA approved for suture placement and knot tying in surgical applications. Although it is not FDA approved specifically for treatment of AF or for stroke reduction in AF, it has recently gained interest because of its potential use in LAA ligation, and a recent study documented promising efficacy and safety in this application.14

We describe here our recent use of this device at Englewood Hospital and Medical Center for intra-pericardial ligation of the LAA in two patients with multiple risk factors for stroke and absolute contraindications to systemic anticoagulation. Our center was the first in the state of New Jersey to perform these procedures.



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