Transcatheter left atrial appendage occlusion: patient selection and perspectives
Wojciech C Wąsek
Cardiology Department, Military Institute of Medicine, The Central Teaching Hospital of the Ministry of Defense, Szaserów, Warsaw, Poland
Abstract: The issues of stroke prevention in patients with nonvalvular atrial fibrillation are extremely important. Despite the availability of warfarin and novel non-vitamin K oral anticoagulants, many problems remain. The necessity of long-term therapy with the incremental lifetime risk of bleeding, underuse of anticoagulation treatment in population at high embolic risk due to contraindications or drug interactions, along with the lack of treatment efficacy, represent the vast spectrum of unachieved clinical needs. The local, device-based, preventive treatment targeting left atrial appendage occlusion was designed to fulfill the unmet clinical expectations and possibly constitutes an alternative to anticoagulation therapy. The short- and long-term results of the WATCHMAN Left Atrial Appendage Closure Device for Embolic PROTECTion in Patients with Atrial Fibrillation (PROTECT AF) randomized trial were promising; however, data derived from the second randomized Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL) trial were diverging, leaving uncertainty in appendage closure efficacy evaluation in comparison to anticoagulation. The totality of data, however, allowed the US Food and Drug Administration to register the WATCHMAN device for embolic prevention in patients deemed by their physicians to be suitable for warfarin and have appropriate rationale to seek a nonpharmacologic alternative to anticoagulation. In contrary to the Food and Drug Administration limited device registration, European implementation of this technology based on CE marking and the European Heart Rhythm Association and the European Association of Percutaneous Cardiovascular Interventions expert consensus allows for much wider clinical application. The aim of this paper is to present the pros and cons of this novel therapy, shed light on the complexity of data derived from clinical trials leading to final decisions on device registrations, and deliver evidence-based and expert opinion-based principles for proper selection of patients benefiting from left atrial appendage occlusion.
Keywords: atrial fibrillation, appendage occlusion, patient selection
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