Early Canadian Multicenter Experience With WATCHMAN for Percutaneous Left Atrial Appendage Closure

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Excerpt

Percutaneous left atrial appendage (LAA) closure is a feasible alternative to oral anticoagulation (OAC) for stroke prevention in patients with nonvalvular atrial fibrillation (AF). Two randomized controlled trials, the PROTECT (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation)1 and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation vs. Long‐Term Warfarin Therapy)2 studies, confirmed the safety and efficacy of WATCHMAN (Boston Scientific Corporation, Natick, MA, USA) device for LAA closure in patients eligible for OAC. These results led to the Food and Drug Administration (FDA) approval of WATCHMAN for patients suitable for OAC, but who have alternate reasons for nonpharmacologic therapy. Outside of the United States, and particularly in Canada, percutaneous LAA closure is primarily performed in patients with OAC contraindications due to funding restrictions. This practice is in keeping with the European Society of Cardiology class IIb (level of evidence B) recommendation for LAA closure for high stroke‐risk AF patients with contraindications to long‐term OAC, both in the original 2012 guidelines and the most recently updated 2016 guidelines.3
Even though LAA closure is increasingly being performed worldwide as an alternative to OAC predominantly in patients with contraindications to OAC, there has been no randomized trial evaluating LAA closure in this population. Only registry data are available for patients with OAC contraindication. This is a major contentious issue regarding the expansion of LAA closure for this population, especially since this procedure can impact a signification proportion of AF patients (∼30–40%) who are not on guideline‐indicated OAC due to contraindications, intolerance, high bleeding risk, or patient refusal.5
In Canada, LAA closure has been performed since 2009 primarily for OAC contraindicated AF patients, starting with the Amplatzer Cardiac Plug (ACP) device (St. Jude Medical, Maple Grove, MN, USA). The first published Canadian experience of LAA closure was a small study that included 52 patients deemed unsuitable for long‐term OAC who underwent ACP implantation.6 The WATCHMAN device first became available in Canada under the special access program in 2013. The clinical experience with WATCHMAN in Canada has not been previously described, and this is warranted since data on this device for OAC contraindicated population are limited.
We, therefore, sought to evaluate the safety and efficacy of WATCHMAN in the early experience of Canadian LAA centers in a pooled analysis for AF patients with contraindications to OAC.
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